﻿<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
	>

<channel>
	<title>一致性评价 归档 - 实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</title>
	<atom:link href="https://nikyang.com/tag/consistency-evaluation/feed/" rel="self" type="application/rss+xml" />
	<link>https://nikyang.com</link>
	<description>药物溶出仪厂家</description>
	<lastBuildDate>Wed, 19 Jan 2022 03:08:19 +0000</lastBuildDate>
	<language>zh-CN</language>
	<sy:updatePeriod>
	hourly	</sy:updatePeriod>
	<sy:updateFrequency>
	1	</sy:updateFrequency>
	<generator>https://wordpress.org/?v=5.8</generator>

<image>
	<url>/wp-content/uploads/2018/09/cropped-nikyang-32x32.png</url>
	<title>一致性评价 归档 - 实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</title>
	<link>https://nikyang.com</link>
	<width>32</width>
	<height>32</height>
</image> 
	<item>
		<title>[专家专栏 – 药物溶出研究] 缓释制剂释放机理研究 (双氯芬酸钠缓释片)</title>
		<link>https://nikyang.com/drug-discovery/yolanda-diclofenac-sodium-sr-tablet/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Tue, 23 Mar 2021 09:26:08 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[口服固体制剂]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<category><![CDATA[药物研发]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=10684</guid>

					<description><![CDATA[<p>口服药物进入体内后进行崩解、溶出和吸收是一个动态和连续的过程。在药物研发的过程当中，需要通过体外溶出实验模拟这 [&#8230;]</p>
<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/yolanda-diclofenac-sodium-sr-tablet/">[专家专栏 – 药物溶出研究] 缓释制剂释放机理研究 (双氯芬酸钠缓释片)</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="10684" class="elementor elementor-10684" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-3d6fdad elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3d6fdad" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3132f5b" data-id="3132f5b" data-element_type="column">
			<div class="elementor-column-wrap">
							<div class="elementor-widget-wrap">
								</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-7170161 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7170161" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-90a3eb5" data-id="90a3eb5" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-11832e5 elementor-widget elementor-widget-text-editor" data-id="11832e5" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><!-- wp:paragraph --></p>
<p><span style="font-weight: 400;">口服药物进入体内后进行崩解、溶出和吸收是一个动态和连续的过程。在药物研发的过程当中，需要通过体外溶出实验模拟这些体内的生理过程，以反映药物在体内行为的变化。而<a href="https://www.nikyang.com/new-280620/">缓释制剂</a>在口服后，需按要求缓慢地释放药物，进行体内外相关性（IVIVC）研究，才能保证药物在体内的溶出释放可控，但因为缓释制剂的特性，要进行准确的溶出度测定，先进的仪器和方法就至关重要。</span></p>
<p><span style="font-weight: 400;">目前，常规的溶出度测定方法（例如：桨法和篮法等等）在药物溶出研究方面尚有很多不足，而流池法具有特殊的流体动力学及其灵活性，多种制剂都能广泛应用，尤其在缓释制剂的研发上显示出了极大的优势，美国药典收录了流池法作为四法，而中国药典2020版也已经新增了<a href="https://www.nikyang.com/news-140820-1/">流池法</a>溶出度测试法，成为了篮法、桨法等方法以外的最新溶出度测试策略。</span></p>
<p><span style="color: #333399;"><strong>溶出度测定 &#8211; 缓释制剂释放机理研究 (双氯芬酸钠缓释片) </strong></span></p>
<p>Dissolution Technology曾发表一篇文献，研究了使用流池法进行双氯芬酸钠缓释片剂的溶出度筛选方法。文献当中使用了流池法进行实验，比较了流速和不同尺寸的流池以及载样方式对缓释片剂释放度的影响，找出了双氯芬酸钠缓释片最佳的释放条件后，建立了体外释放度测试，平行考察了诺华两个不同产地生产的参比制剂，以及埃及本地生产的仿制药，得到的溶出曲线显示了不同产品的释放结果。</p>
<p><!-- /wp:paragraph --></p>					</div>
						</div>
				</div>
				<div class="elementor-element elementor-element-8d15db1 elementor-widget elementor-widget-image" data-id="8d15db1" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
									<figure class="wp-caption">
										<img width="772" height="453" src="/wp-content/uploads/2021/03/20210322-Case-Study-Ref.png" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2021/03/20210322-Case-Study-Ref.png 772w, /wp-content/uploads/2021/03/20210322-Case-Study-Ref-300x176.png 300w, /wp-content/uploads/2021/03/20210322-Case-Study-Ref-768x451.png 768w" sizes="(max-width: 772px) 100vw, 772px" />											<figcaption class="widget-image-caption wp-caption-text">诺华不同产地生产的参比制剂以及埃及生产的仿制药的溶出度测定结果（Dissolution Technology, 2009）</figcaption>
										</figure>
								</div>
						</div>
				</div>
				<div class="elementor-element elementor-element-e6f708b elementor-widget elementor-widget-text-editor" data-id="e6f708b" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><!-- wp:paragraph --></p>
<div>
<p><span style="font-weight: 400;">从流池法溶出度测试的结果可以看到，参比制剂和仿制药有明显的差异。最下面的两条溶出曲线，是两个参比制剂的体外释放结果，一个是欧洲上市的，一个是埃及本地上市的。虽然它们有一定的区别，但是它们的释放曲线，可以看作是一个零级释放的曲线，证明它们是缓释效果非常好的处方。但是，埃及本地生产的处方的释放行为并没有显示出缓释的释放机理，跟参比有很大的差异，这个释放行为的巨大差异，肯定也会带来体内吸收行为很大的改变。研究也证明了以流池法进行溶出度测定，能很好的判别缓释制剂之间的释放度差异。</span></p>
<p><span style="font-weight: 400;">流池法克服了一些篮法、桨法等传统溶出度测试法的局限性，例如介质饱和、桨旋转时造成的物理影响、容易堵塞等等问题，尤其是对于一些缓释剂和难溶制剂，更灵活的溶出度测试法是必然的手段。同时，流池法溶出度测试的可重复性和可重现性已经在多项文献研究中等到证实，目前除了对于一些传统制剂的应用，很多新型制剂的研究文献当中也都应用了流池法，尤其是<a href="https://www.nikyang.com/benchtop-solutions/sotax/ce-7smart/">SOTAX CE7smart流池法溶出度测定系统</a>，为流池法的实际应用提供了强大的支持，对于药物研发必然有很大的优势。</span></p>
</div>
<p><!-- /wp:paragraph --></p>					</div>
						</div>
				</div>
				<div class="elementor-element elementor-element-2e35cb8 elementor-widget elementor-widget-text-editor" data-id="2e35cb8" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><!-- wp:paragraph --></p>
<div style="caret-color: #000000; color: #000000;">
<p><span style="font-weight: 400;">参考资料：</span></p>
<p><span style="font-weight: 400;">Laila H. Emara et al. (2009). Investigation of the Effect of Different Flow-Through Cell Designs on the Release of Diclofenac Sodium SR Tablets. Dissolution Technology. May 2009.</span></p>
</div>
<p><!-- /wp:paragraph --></p>					</div>
						</div>
				</div>
				<div class="elementor-element elementor-element-1abb221 elementor-widget elementor-widget-image" data-id="1abb221" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="781" height="424" src="/wp-content/uploads/2021/03/Yolanda-Professional-Profile-withQR.jpg" class="attachment-large size-large" alt="药物溶出流池法专家-赵宇Yolanda专家简历" srcset="/wp-content/uploads/2021/03/Yolanda-Professional-Profile-withQR.jpg 781w, /wp-content/uploads/2021/03/Yolanda-Professional-Profile-withQR-300x163.jpg 300w, /wp-content/uploads/2021/03/Yolanda-Professional-Profile-withQR-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
						</div>
				</div>
				<div class="elementor-element elementor-element-e056c33 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="e056c33" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
				<div class="elementor-element elementor-element-fcc952c elementor-widget elementor-widget-heading" data-id="fcc952c" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">相关文章</h2>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-ce4e136 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="ce4e136" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5bf7fa5" data-id="5bf7fa5" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-a1542c0 elementor-grid-2 elementor-posts--thumbnail-none elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-posts" data-id="a1542c0" data-element_type="widget" data-settings="{&quot;classic_columns&quot;:&quot;2&quot;,&quot;classic_columns_tablet&quot;:&quot;2&quot;,&quot;classic_columns_mobile&quot;:&quot;1&quot;,&quot;classic_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;classic_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;classic_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}" data-widget_type="posts.classic">
				<div class="elementor-widget-container">
					<div class="elementor-posts-container elementor-posts elementor-posts--skin-classic elementor-grid">
				<article class="elementor-post elementor-grid-item post-17928 post type-post status-publish format-standard has-post-thumbnail hentry category-automated-solution category-news category-sample-prep tag-camag tag-chemspeed tag-technobis tag-sample-prep tag-hptlc">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/automated-solution/event-invitation-bceia-2023/" >
				力扬企业带来 BCEIA 超前 “云” 剧透！			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-08-31		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/automated-solution/event-invitation-bceia-2023/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-17898 post type-post status-publish format-standard has-post-thumbnail hentry category-automated-solution category-news tag-chemspeed">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/automated-solution/ai-vs-manual/" >
				AI VS 人工，是一场关于 “进化速度” 的比拼			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-08-24		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/automated-solution/ai-vs-manual/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-17884 post type-post status-publish format-standard has-post-thumbnail hentry category-news category-bio-sample-prep tag-camag tag-dms">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/bio-sample-prep/dbs-animal_antibodies-detection-case/" >
				DBS 干血斑应用特集 4: 牛孢疹病毒抗体的检测			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-08-17		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/bio-sample-prep/dbs-animal_antibodies-detection-case/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-17844 post type-post status-publish format-standard has-post-thumbnail hentry category-news">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/news/2023-q2-newsletter/" >
				2023 第 2 季 – 季度通讯 | 实验室新模式  数字孪生技术引领智慧科研			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-07-20		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/news/2023-q2-newsletter/" >
				点击阅读 »			</a>
				</div>
				</article>
				</div>


		
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/yolanda-diclofenac-sodium-sr-tablet/">[专家专栏 – 药物溶出研究] 缓释制剂释放机理研究 (双氯芬酸钠缓释片)</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>有 TA 加持的仿制药一致性评价常态化是何种体</title>
		<link>https://nikyang.com/news/flow-cell-method-generic-drugs/</link>
		
		<dc:creator><![CDATA[Miro]]></dc:creator>
		<pubDate>Fri, 14 Aug 2020 10:30:00 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=8029</guid>

					<description><![CDATA[<p>​TA 是药品溶出界的强者   TA 是难溶 / </p>
<p><a rel="nofollow" href="https://nikyang.com/news/flow-cell-method-generic-drugs/">有 TA 加持的仿制药一致性评价常态化是何种体</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="8029" class="elementor elementor-8029" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-d5dafe6 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d5dafe6" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0a499c9" data-id="0a499c9" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-6699c97 elementor-widget elementor-widget-text-editor" data-id="6699c97" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h5 style="text-align: center;">​TA 是药品溶出界的强者</h5><p> </p><h5 style="text-align: center;">TA 是难溶 / 复杂制剂的克星</h5><p> </p><h5 style="text-align: center;">TA 是一致性评价的加速器</h5><p> </p><h5 style="text-align: center;">TA 是最能反映体内溶出过程的体外测试方法</h5><p> </p><h5 style="text-align: center;">TA 是……？</h5>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-12bb92a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="12bb92a" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7e5d937" data-id="7e5d937" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-29510c8 elementor-widget elementor-widget-spacer" data-id="29510c8" data-element_type="widget" data-widget_type="spacer.default">
				<div class="elementor-widget-container">
					<div class="elementor-spacer">
			<div class="elementor-spacer-inner"></div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-cdd301f elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="cdd301f" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-68ddecf" data-id="68ddecf" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-fcc54ab elementor-widget elementor-widget-heading" data-id="fcc54ab" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">中国药典 2020 版新增流池法</h2>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-1457e72 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1457e72" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-db55b49" data-id="db55b49" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-8e27828 elementor-view-default elementor-widget elementor-widget-icon" data-id="8e27828" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-stream"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-85b31bc elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="85b31bc" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-15f156a" data-id="15f156a" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-afef3ef elementor-widget elementor-widget-text-editor" data-id="afef3ef" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h5><strong>在风口浪尖旋转跳跃</strong></h5><p>把一致性评价比作一阵龙卷风，那仿制药企业就像是在旋涡中旋转跳跃的当事人，对于求生欲极强的药企，当即便会抓住救命稻草 (核心技术优势)，乘风破浪……</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3982559 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3982559" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-12c4ba9" data-id="12c4ba9" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-375c183 elementor-widget elementor-widget-image" data-id="375c183" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="500" height="500" src="/wp-content/uploads/2020/08/Aug-20_WeChat1_2.png" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/08/Aug-20_WeChat1_2.png 500w, /wp-content/uploads/2020/08/Aug-20_WeChat1_2-300x300.png 300w, /wp-content/uploads/2020/08/Aug-20_WeChat1_2-150x150.png 150w" sizes="(max-width: 500px) 100vw, 500px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-cfd40f6 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="cfd40f6" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3a11eb6" data-id="3a11eb6" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-afe832b elementor-widget elementor-widget-text-editor" data-id="afe832b" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>一年多以前，医药界曾掀起一波 “腥风血雨”，因集采政策落地及中标信息公布，制药企业无不绞尽脑汁，寻求生存的突破口。一时间，“抢首仿、难仿药”、“布局高端制剂”、“原料 API +制剂产业链一体化布局”、“争做全球创新药”，抑或是企业并购等策略呼之欲出。回首望，一些实力雄厚的企业也已然提前布局。</p><p>如今，在经历了一波强劲的“厮杀”后，仿制药一致性评价或趋于常态化，但竞争仍在继续，仿制药一致性及其相关延伸政策，无一不表达出只有掌握核心技术，全面控制药品生命周期成本的企业，才能在这场角逐中脱颖而出。</p><p>仿制药一致性评价成功与否最重要的一环就是<strong>生物等效性实验 (BE) </strong>的结果，可以说是仿制药成功与否的金标杆，同时也是仿制药研发环节费时耗力，成本付出极高的一环。而<strong>决定 BE 成功与否的关键核心技术就在于如何精确的找到仿制药与原研药溶出曲线的异同。</strong></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-11e4250 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="11e4250" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5b8c39c" data-id="5b8c39c" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-a7b1c1d elementor-view-default elementor-widget elementor-widget-icon" data-id="a7b1c1d" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-stream"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-6accb8a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="6accb8a" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8eb5b4f" data-id="8eb5b4f" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-b06056e elementor-widget elementor-widget-text-editor" data-id="b06056e" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<section><section><h5><strong>逆风翻盘也要高性价比</strong></h5></section></section><section></section><section><p>过去几年，一次 BE 实验的费用动辄以百万计数，甚至上千万不等，更不用提一次BE实验就能成功过关的药物更是屈指可数，成本费用居高不下。同时  BE 实验的排期也是个漫长的过程，因此在研发阶段，完全依靠BE来判断仿制成功与否并不是一个最有效的方法。<strong>需要寻求体外有效的模式来模拟人体内的情况，减少BE实验的投入，提高效率</strong><strong>。</strong></p></section>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-2ea187a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="2ea187a" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-984d880" data-id="984d880" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-4b6195f elementor-widget elementor-widget-image" data-id="4b6195f" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="1" height="1" src="/wp-content/uploads/2020/08/Aug-20_WeChat1_3-1.jpg" class="attachment-large size-large" alt="" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3a417a7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3a417a7" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-73f08f5" data-id="73f08f5" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-6aa4a84 elementor-widget elementor-widget-text-editor" data-id="6aa4a84" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>与常用的溶出度测试方法相比，中国药典 2020 版新增的流池法，更能有效模拟药物在人体不同消化部位 pH 的变化过程中的溶解吸收行为，有利于反馈药物处方和工艺的不同所产生的体内差异。这一点也在国内外大量的文献研究报道以及力扬实验室超过 50 个实例的验证得以证明 —— <strong>流池法能更快更有效地筛选药物处方和工艺，有利于加速仿制药的研发进程，进而提高 BE 的成功率。</strong></p><p>在药物的处方和工艺有误的情况下 BE 试验的结果往往是失败的，反复的 BE 试验需要投入大量的时间和金钱成本，而<strong>使用流池法设备一次性的投入，可以辐射多个品种的研发，无论从效率成本还是研发成本来说，都是高性价比的一种选择</strong>。来自瑞士 SOTAX 的流池法设备 &#8212; CE 7smart，设计精巧，灵活性强，一台设备适应多种剂型的体外溶出测试，无论是口服固体制剂、复杂注射剂，还是新型的特殊制剂都能游刃有余的应对，极大拓展企业的研发空间，灵活应对未来的发展。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d58fdd9 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d58fdd9" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7f5fc18" data-id="7f5fc18" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-33e8b73 elementor-widget elementor-widget-image" data-id="33e8b73" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="842" height="383" src="/wp-content/uploads/2020/08/Aug-20_WeChat1_4-1.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/08/Aug-20_WeChat1_4-1.jpg 842w, /wp-content/uploads/2020/08/Aug-20_WeChat1_4-1-300x136.jpg 300w, /wp-content/uploads/2020/08/Aug-20_WeChat1_4-1-768x349.jpg 768w" sizes="(max-width: 842px) 100vw, 842px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-5f4bbeb elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5f4bbeb" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4ac2c68" data-id="4ac2c68" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-8317932 elementor-widget elementor-widget-text-editor" data-id="8317932" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6 style="text-align: center;"><strong>想进一步与我们的专家讨论及交流, 扫描以下二维码, 立即加入</strong></h6><h6 style="text-align: center;"><span style="color: #ffffff; font-family: SimSun; font-size: 20px; background-color: #021eaa;">力扬药研新资讯交流群</span><strong><br /></strong></h6>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d87cde2 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d87cde2" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-035f56b" data-id="035f56b" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-c9f5562 elementor-widget elementor-widget-image" data-id="c9f5562" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="300" height="300" src="/wp-content/uploads/2020/08/Aug-20_WeChat1_5.png" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/08/Aug-20_WeChat1_5.png 300w, /wp-content/uploads/2020/08/Aug-20_WeChat1_5-150x150.png 150w" sizes="(max-width: 300px) 100vw, 300px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/news/flow-cell-method-generic-drugs/">有 TA 加持的仿制药一致性评价常态化是何种体</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>如何增加口服固体制剂的 BE 成功率？</title>
		<link>https://nikyang.com/news/increase-be-success-rate/</link>
		
		<dc:creator><![CDATA[Miro]]></dc:creator>
		<pubDate>Sun, 28 Jun 2020 04:30:00 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[口服固体制剂]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=7618</guid>

					<description><![CDATA[<p>近年来，不少制药机构对于固体制剂的溶出度测试投入了</p>
<p><a rel="nofollow" href="https://nikyang.com/news/increase-be-success-rate/">如何增加口服固体制剂的 BE 成功率？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="7618" class="elementor elementor-7618" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-a582a61 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="a582a61" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-34539f9" data-id="34539f9" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-d00f208 elementor-widget elementor-widget-text-editor" data-id="d00f208" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>近年来，不少制药机构对于<span style="color: #0000ff;"><strong>固体制剂的溶出度测试</strong></span>投入了相当大的精力，却碍于其复杂性，以致一直未能通过<span style="color: #0000ff;"><strong>一致性评价</strong></span>并把药物推出市场。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-254d18b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="254d18b" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c0e650b" data-id="c0e650b" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-475c4ff elementor-widget elementor-widget-image" data-id="475c4ff" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
									<figure class="wp-caption">
										<img width="499" height="333" src="/wp-content/uploads/2020/06/Jun-20_WeChat3_2.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/06/Jun-20_WeChat3_2.jpg 499w, /wp-content/uploads/2020/06/Jun-20_WeChat3_2-300x200.jpg 300w" sizes="(max-width: 499px) 100vw, 499px" />											<figcaption class="widget-image-caption wp-caption-text">（图片源于网络）</figcaption>
										</figure>
								</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-b075350 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b075350" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0bcabc6" data-id="0bcabc6" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-64c02bb elementor-widget elementor-widget-text-editor" data-id="64c02bb" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>虽然，目前部分产品的溶出测试顺利 “过关”，但仍有不少产品在生物等效性 (BE) 的实验中 “徘徊不前”，意味着药企相关领域存在着难以逾越的困境，特别是定量采购政策的落地，使得不少药企转而投入到附加值更高的 “高端制剂” 上，无疑又增加了药物研发的困难性和复杂性。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-8fe29bc elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="8fe29bc" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-475d615" data-id="475d615" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-deb6182 elementor-view-default elementor-widget elementor-widget-icon" data-id="deb6182" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-tablets"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-bf56f45 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="bf56f45" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c8b3659" data-id="c8b3659" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-fc86ddf elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="fc86ddf" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-e44236c elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="e44236c" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ecddd7e" data-id="ecddd7e" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-bbab216 elementor-widget elementor-widget-heading" data-id="bbab216" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">01. 投入资金高</h2>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3ea809c elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3ea809c" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ebed954" data-id="ebed954" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-0161d7a elementor-widget elementor-widget-image" data-id="0161d7a" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
									<figure class="wp-caption">
										<img width="450" height="293" src="/wp-content/uploads/2020/06/Jun-20_WeChat3_3.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/06/Jun-20_WeChat3_3.jpg 450w, /wp-content/uploads/2020/06/Jun-20_WeChat3_3-300x195.jpg 300w" sizes="(max-width: 450px) 100vw, 450px" />											<figcaption class="widget-image-caption wp-caption-text">（图片源于网络）</figcaption>
										</figure>
								</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-82a3efc elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="82a3efc" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3027734" data-id="3027734" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-eb5a26b elementor-widget elementor-widget-text-editor" data-id="eb5a26b" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>BE (生物等效性) 试验需投入大量资金，不同品种的测试所花费高达几十万到几千万不等，近年来更是成倍翻涨，加上固体制剂的一致性评价难度极高，一旦出现试验失败，便需要另外<span style="color: #0000ff;"><strong>投入更多资金</strong></span>继续测试。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3feb086 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3feb086" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-17ffe32" data-id="17ffe32" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-e751ed7 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="e751ed7" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-fe8698e elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="fe8698e" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bb33334" data-id="bb33334" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-cdf3db1 elementor-widget elementor-widget-heading" data-id="cdf3db1" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">02. 花费大量精力、时间</h2>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-ad57b1b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="ad57b1b" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b5126ba" data-id="b5126ba" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-34c78c5 elementor-widget elementor-widget-text-editor" data-id="34c78c5" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>是什么原因导致 BE (生物等效性) 测试进展停滞不前呢？终其原因，在于<strong><span style="color: #0000ff;">没有找到关键的溶出曲线</span>。</strong></p><p>在仿制药研发的过程中，选取合适的测试手段去对比自研处方和参比制剂的异同是仿制药开发中常用的测试手段。由于固体制剂的体外溶出度测试能部分有效地反映药物体内的行为，因此是仿制药在筛选处方和工艺中的有效方法。而能够有效反馈自制处方与参比制剂在溶出中的细微差别，结合体内药动学知识进行分析，才能有效地找到体外那条关键的曲线<strong>。</strong></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-2579ca1 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="2579ca1" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-63bc0b4" data-id="63bc0b4" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-3db4e4f elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="3db4e4f" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-5198bb0 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5198bb0" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-289a7d3" data-id="289a7d3" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-7bd0da0 elementor-view-default elementor-widget elementor-widget-icon" data-id="7bd0da0" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-tablets"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-885f69b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="885f69b" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-846e8b5" data-id="846e8b5" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-c7b4a7a elementor-widget elementor-widget-heading" data-id="c7b4a7a" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">流池法</h2>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-61307e6 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="61307e6" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7b51b5b" data-id="7b51b5b" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-36359e5 elementor-widget elementor-widget-text-editor" data-id="36359e5" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h5 style="text-align: center;"><strong>帮助提升口服制剂的 BE 成功率</strong></h5>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-533d8e3 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="533d8e3" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-853135c" data-id="853135c" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-b11e94c elementor-widget elementor-widget-image" data-id="b11e94c" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="687" height="535" src="/wp-content/uploads/2020/06/Jun-20_WeChat3_4.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2020/06/Jun-20_WeChat3_4.jpg 687w, /wp-content/uploads/2020/06/Jun-20_WeChat3_4-300x234.jpg 300w" sizes="(max-width: 687px) 100vw, 687px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-20eadc7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="20eadc7" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6339410" data-id="6339410" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-4139607 elementor-widget elementor-widget-text-editor" data-id="4139607" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6 style="text-align: right;"><span style="color: #0000ff;">RLD – 参比制剂</span></h6><h6 style="text-align: right;"><span style="color: #0000ff;">S – 自研药样品</span></h6>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3598553 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3598553" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-40ed963" data-id="40ed963" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-1d4e44d elementor-widget elementor-widget-text-editor" data-id="1d4e44d" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>美国药典第 4 法 (USP 4) —— 流池法的应用，为科研人员在仿制药开发的过程提供了更为有利的条件。如上图所述，某 pH 依赖型的 BCSII 类自研产品，在尝试了桨法多个介质条件后，预 BE 仍然失败了。</p><p>在运用流池法后，一次实验过程采用 3 种溶出介质进行测试，发现体外自研样品比参比释放更慢的情况，这与体内药物的释放趋势正好一致。而国外上市的相同仿制样品，显示其参比制剂相似性良好，从而更加说明流池法具有更优的判别结果。</p><p>流池法，以恒定的速率去溶解药品，有效模拟了人体体内药物溶解后被有效吸收的情况，并能表征体内不同消化部位 pH 的变化情况，因而能更真实、准确地反映药物在人体体内的溶出情况。而设备精密的构造让科研人员得到更精准的测试结果，因此可降低体外的溶出度试验与 BE 测试结果不一致的情况。因此，如果以流池法作为筛选处方或工艺的主要手段，可以大幅度减少资金预算、时间及精力。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-38011ec elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="38011ec" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-01f5984" data-id="01f5984" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-86e5857 elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="86e5857" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-b944067 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b944067" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-56fa64d" data-id="56fa64d" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-e3c8201 elementor-widget elementor-widget-text-editor" data-id="e3c8201" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6 style="text-align: center;"><strong>力扬提供 Sotax CE 7smart (USP 4) 流池法溶出仪</strong></h6><h6 style="text-align: center;"><strong>为口服制剂的 BE 成功率再增“砖瓦”！</strong></h6>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-5cc9cdd elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5cc9cdd" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b05fba1" data-id="b05fba1" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-2eccc78 elementor-widget elementor-widget-image" data-id="2eccc78" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="900" height="856" src="/wp-content/uploads/2018/11/Oct_WeChat3_4.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2018/11/Oct_WeChat3_4.jpg 965w, /wp-content/uploads/2018/11/Oct_WeChat3_4-300x285.jpg 300w, /wp-content/uploads/2018/11/Oct_WeChat3_4-768x731.jpg 768w, /wp-content/uploads/2018/11/Oct_WeChat3_4-600x571.jpg 600w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-1072cd1 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="1072cd1" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b8e80f7" data-id="b8e80f7" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-705b83b elementor-widget elementor-widget-text-editor" data-id="705b83b" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>Sotax CE 7smart 溶出仪是专为难溶和缓释药物制剂型设计，也支持对固体制剂及多种制剂如微球、脂质体、纳米、软胶囊、栓剂、微丸、缓控释胶囊 / 片剂等的溶出度测试。其满足流池法规定的介质流速、流动、温度等要求，助力科研人员更快捷、精准获取符合人体体内流体动力学模式的溶出曲线；同时，CE 7smart 溶出仪能实现整个溶出过程自动化，避免了传统测试模式所耗费的精力、时间等缺陷，提高固体制剂通过一致性评价检测的成功率。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d6bdf0c elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d6bdf0c" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e872541" data-id="e872541" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-a6ca373 elementor-view-default elementor-widget elementor-widget-icon" data-id="a6ca373" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-grip-lines"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-5a56a72 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5a56a72" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1c1d5e6" data-id="1c1d5e6" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-70ec2bc elementor-widget elementor-widget-text-editor" data-id="70ec2bc" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>在过去 2 年里, 力扬成功利用 CE 7smart 流池法溶出仪比对 40 多个 BE 失败的产品, 显示了 85% 以上的有效性，即找到了处方与参比的差异。最理想的一个案例是调整了 2 个实验条件，就找到了 BE 失败批次与参比之间的显着性差异，而原有方法做了几十上百条曲线仍然没有区分。最后客户结合实验现象分析，很快调整了处方后，重试预 BE 成功。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-883de8c elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="883de8c" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0e99076" data-id="0e99076" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-ef79a1c elementor-view-default elementor-widget elementor-widget-icon" data-id="ef79a1c" data-element_type="widget" data-widget_type="icon.default">
				<div class="elementor-widget-container">
					<div class="elementor-icon-wrapper">
			<div class="elementor-icon">
			<i aria-hidden="true" class="fas fa-grip-lines"></i>			</div>
		</div>
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-f5c86a7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f5c86a7" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-800c1a0" data-id="800c1a0" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-33b1ac8 elementor-widget elementor-widget-text-editor" data-id="33b1ac8" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>不要让一致性评价检测成为固体制剂溶出度测试的绊脚石。力扬推荐 Sotax CE 7smart (USP 4) 溶出仪，助力提高 BE 成功率！</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/news/increase-be-success-rate/">如何增加口服固体制剂的 BE 成功率？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>仿制药 BE 不易过关?</title>
		<link>https://nikyang.com/news/generic-drug-be/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Tue, 21 Apr 2020 02:48:45 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<category><![CDATA[药物研发]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=7773</guid>

					<description><![CDATA[<p>快速优化测试条件，寻找体外溶出特征曲线 BCSII</p>
<p><a rel="nofollow" href="https://nikyang.com/news/generic-drug-be/">仿制药 BE 不易过关?</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[
<h2><span style="color:#054ea1" class="has-inline-color">快速优化测试条件，寻找体外溶出特征曲线</span></h2>



<p>BCSII 类药，原有体外几十条溶出曲线均未判别 BE 失败处方，优化方法后，差别显而易见。</p>



<figure class="wp-block-gallery columns-2 is-cropped"><ul class="blocks-gallery-grid"><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-01-1024x850.png" alt="" data-id="7741" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-01.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-01/" class="wp-image-7741" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-01-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-01-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-01-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-01.png 1231w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-06-1024x850.png" alt="" data-id="7746" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-06.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-06/" class="wp-image-7746" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-06-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-06-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-06-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-06.png 1231w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li></ul></figure>



<p>BCSIII 类药，所有介质 5min 快速溶出，无法筛选方；优化方法后，体外差异一目了然。</p>



<figure class="wp-block-gallery columns-2 is-cropped"><ul class="blocks-gallery-grid"><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-02-1024x850.png" alt="" data-id="7742" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-02.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-02/" class="wp-image-7742" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-02-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-02-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-02-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-02.png 1231w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-05-1024x850.png" alt="" data-id="7745" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-05.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-05/" class="wp-image-7745" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-05-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-05-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-05-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-05.png 1231w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li></ul></figure>



<p>BCSIV 类药，原有体外判别方法体内与体外趋势相反；优化方法后，体外体内方法正相关。</p>



<figure class="wp-block-gallery columns-2 is-cropped"><ul class="blocks-gallery-grid"><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-03-1024x850.png" alt="" data-id="7743" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-03.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-03/" class="wp-image-7743" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-03-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-03-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-03-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-03.png 1231w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li><li class="blocks-gallery-item"><figure><img width="1024" height="850" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-04-1024x850.png" alt="" data-id="7744" data-full-url="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-04.png" data-link="http://www.nikyang.com/casestudies-20200417/usp4-case-study-data_cro-04/" class="wp-image-7744" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-04-1024x850.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-04-300x249.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-04-768x638.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-04.png 1230w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure></li></ul></figure>



<p>BCSIV 类药，原有体外判别方法体内与体外趋势相反；优化方法后，体外体内方法正相关。</p>
<p><a rel="nofollow" href="https://nikyang.com/news/generic-drug-be/">仿制药 BE 不易过关?</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>如何找出胶囊仿制产品的差异来源？</title>
		<link>https://nikyang.com/news/capsule-source-of-difference/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Mon, 02 Mar 2020 03:44:00 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<category><![CDATA[药物研发]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=7795</guid>

					<description><![CDATA[<p>以流池法配合各种流通池，分阶段对胶囊、内容物及 A</p>
<p><a rel="nofollow" href="https://nikyang.com/news/capsule-source-of-difference/">如何找出胶囊仿制产品的差异来源？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[
<h2><span style="color:#054ea1" class="has-inline-color">以流池法配合各种流通池，分阶段对胶囊、内容物及 API 进行检测</span></h2>



<p>以流池法配合各种流通池，分阶段对胶囊、内容物及 API 进行检测，找出差异来源。流池法配备的流通池可应用于速释胶囊/ 片剂，缓控释胶囊/ 片剂，复杂注射剂—混悬剂、微球、脂质体、纳米晶、微丸片/ 胶囊、软胶囊、栓剂、颗粒剂、粉末API，应用领域广阔。</p>



<h4 class="has-text-align-center">胶囊</h4>



<div class="wp-block-image"><figure class="aligncenter size-large is-resized"><img src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-24.png" alt="" class="wp-image-7796" width="407" height="272" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-24.png 616w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-24-300x201.png 300w" sizes="(max-width: 407px) 100vw, 407px" /></figure></div>



<h4 class="has-text-align-center">粉末内容物</h4>



<div class="wp-block-image"><figure class="aligncenter size-large is-resized"><img src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-26.png" alt="" class="wp-image-7797" width="397" height="273" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-26.png 597w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-26-300x207.png 300w" sizes="(max-width: 397px) 100vw, 397px" /></figure></div>



<h4 class="has-text-align-center">API</h4>



<div class="wp-block-image"><figure class="aligncenter size-large is-resized"><img src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-27.png" alt="" class="wp-image-7798" width="409" height="269" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-27.png 625w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-27-300x198.png 300w" sizes="(max-width: 409px) 100vw, 409px" /></figure></div>



<p></p>
<p><a rel="nofollow" href="https://nikyang.com/news/capsule-source-of-difference/">如何找出胶囊仿制产品的差异来源？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>如何节省成本，避免不必要的 BE？</title>
		<link>https://nikyang.com/news/save-cost-of-be/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Mon, 17 Feb 2020 03:30:55 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<category><![CDATA[药物研发]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=7791</guid>

					<description><![CDATA[<p>应用流池法放大自研处方和参比制剂的差异，预先发现问</p>
<p><a rel="nofollow" href="https://nikyang.com/news/save-cost-of-be/">如何节省成本，避免不必要的 BE？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[
<h2><span style="color:#054ea1" class="has-inline-color">应用流池法放大自研处方和参比制剂的差异，预先发现问题</span></h2>



<p>桨法多条溶出曲线对比自研产品与参比制剂显示无差异，然而 BE 失败。</p>



<figure class="wp-block-image size-large"><img width="1024" height="866" src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-1024x866.png" alt="" class="wp-image-7792" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-1024x866.png 1024w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-300x254.png 300w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-768x650.png 768w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-1536x1300.png 1536w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-22-2048x1733.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>使用流池法放大自研处方和参比制剂的差异，成功找出 BE 失败的原因。应用在 BE 前，可预先发现问题，避免不必要的 BE。</p>



<div class="wp-block-image"><figure class="aligncenter size-large is-resized"><img src="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-23.png" alt="" class="wp-image-7793" width="344" height="254" srcset="/wp-content/uploads/2020/07/USP4-case-study-data_CRO-23.png 591w, /wp-content/uploads/2020/07/USP4-case-study-data_CRO-23-300x222.png 300w" sizes="(max-width: 344px) 100vw, 344px" /></figure></div>
<p><a rel="nofollow" href="https://nikyang.com/news/save-cost-of-be/">如何节省成本，避免不必要的 BE？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>降低仿制药成本其实没这么难！</title>
		<link>https://nikyang.com/news/reduce-cost-of-generic-drugs/</link>
		
		<dc:creator><![CDATA[Miro]]></dc:creator>
		<pubDate>Sat, 05 Jan 2019 10:00:28 +0000</pubDate>
				<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=4387</guid>

					<description><![CDATA[<p>一款成功的仿制药的研发耗费高昂的投资成本，但是同品</p>
<p><a rel="nofollow" href="https://nikyang.com/news/reduce-cost-of-generic-drugs/">降低仿制药成本其实没这么难！</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="4387" class="elementor elementor-4387 elementor-bc-flex-widget" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-2d3ecfa elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="2d3ecfa" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9341da2" data-id="9341da2" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-0bbcb96 elementor-widget elementor-widget-text-editor" data-id="0bbcb96" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>一款成功的仿制药的研发耗费高昂的投资成本，但是<b>同品种的仿制药，不同药企所花费的成本却可以相差巨大</b>。从购买参比制剂，到开展药学研究，再从小中试规模生产，到生物等效性试验、复核检验，完成一个仿制药的一致性评价，有些药企花费 500 万元，而有些药企却要花费 1000 万元，到底是什么造成中间的差价</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-bf66f28 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="bf66f28" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d57ccd1" data-id="d57ccd1" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-5309147 elementor-widget elementor-widget-text-editor" data-id="5309147" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h5><b>研</b><b>制仿制药成本的组</b><b>成</b></h5><h6><b> </b></h6><h6><b>参比试剂（原研药） 成本</b></h6><p>仿制药的研发离不开与原研药进行对照实验，需要购买大量的原研药品，而原研药因其研发时间与资金投入巨大，价格持续走高。以格列卫为例，从发现靶点到获批上市，这款药耗费了约50年，制药企业诺华投资超过 50 亿美元，这也导致上市后多年，诺华格列卫的价格几乎雷打不动，120 粒一盒的价格在 23,500 元左右。   </p><p>资料参考：h t t p : / / w w w . c b . c o m . c n / i n d e x / s h o w / d s x / c v / c v 1 3 3 1 1 2 1 2 7 2</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-5ef1a59 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="5ef1a59" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-353725d" data-id="353725d" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-ff60f52 elementor-widget elementor-widget-image" data-id="ff60f52" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="600" height="400" src="/wp-content/uploads/2019/01/Dec_WeChat2_2.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2019/01/Dec_WeChat2_2.jpg 600w, /wp-content/uploads/2019/01/Dec_WeChat2_2-300x200.jpg 300w" sizes="(max-width: 600px) 100vw, 600px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-25ddb44 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="25ddb44" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5957f72" data-id="5957f72" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-f777811 elementor-widget elementor-widget-text-editor" data-id="f777811" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><b>辅</b><b>料成本</b></h6><p>我国药用辅料的研发与技术水平偏低,尤其在仿制药一致性评价与新药研发阶段,进口辅料的优势日趋渐现,例如微晶纤维素。进口品种会明确功能性指标,但国产辅料品种往往缺乏此类指标,这导致制药企业更偏向于采购进口辅料，但是进口辅料的大多价格昂贵。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-db4bcc0 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="db4bcc0" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2b299bf" data-id="2b299bf" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-12e457c elementor-widget elementor-widget-image" data-id="12e457c" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="363" height="225" src="/wp-content/uploads/2019/01/Dec_WeChat2_3.jpg" class="attachment-large size-large" alt="药用辅料" srcset="/wp-content/uploads/2019/01/Dec_WeChat2_3.jpg 363w, /wp-content/uploads/2019/01/Dec_WeChat2_3-300x186.jpg 300w" sizes="(max-width: 363px) 100vw, 363px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-7a6b4b3 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7a6b4b3" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c271a78" data-id="c271a78" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-696579a elementor-widget elementor-widget-text-editor" data-id="696579a" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><b>通过一致性评价成本</b></h6><p>仿制药一致性评价的高水平要求加大了仿制药研发成本。此前一款药品做临床数据的叫价可能只有 50 万元到 60 万元，但现在由于临床基地数量受限且时间较紧，临床试验出现塞车现象，目前一款药做一致性评价的价格涨至 300 万元，有的甚至高达 800 万元。更让人担忧的是，一旦失败，意味着血本无归，要么重新再来，要么彻底放弃。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-adb80aa elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="adb80aa" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-934ac30" data-id="934ac30" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-c3bbddf elementor-widget elementor-widget-image" data-id="c3bbddf" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="600" height="400" src="/wp-content/uploads/2019/01/Dec_WeChat2_4.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2019/01/Dec_WeChat2_4.jpg 600w, /wp-content/uploads/2019/01/Dec_WeChat2_4-300x200.jpg 300w" sizes="(max-width: 600px) 100vw, 600px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-3979de8 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="3979de8" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c34e5d3" data-id="c34e5d3" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-b9e4aa8 elementor-widget elementor-widget-text-editor" data-id="b9e4aa8" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>当然，还要考虑人工成本、实验室的场地成本等等，这都加剧仿制药研发成本之间的差异。</p><p> </p><p><b>想要降低仿制药研发成本，最好从降低通过一致性评价的成本出</b><b>发</b>，因为相较于降低参比试剂成本、辅料成本，降低一致性评价成本是企业更容易达到的结果。药企可以通过更换药品<a href="https://www.nikyang.com/benchtop-solutions/sotax/ce-7smart/" target="_blank" rel="noopener"><b>溶出仪</b></a>，使得溶出度检测实验结果更精准，从而快速通过一致性评价与生物等效性实验，达到降低成本的目的。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d33d54d elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d33d54d" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-023ec10" data-id="023ec10" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-f78e184 elementor-widget elementor-widget-image" data-id="f78e184" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
									<figure class="wp-caption">
										<img width="900" height="856" src="/wp-content/uploads/2018/11/Oct_WeChat3_4.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2018/11/Oct_WeChat3_4.jpg 965w, /wp-content/uploads/2018/11/Oct_WeChat3_4-300x285.jpg 300w, /wp-content/uploads/2018/11/Oct_WeChat3_4-768x731.jpg 768w, /wp-content/uploads/2018/11/Oct_WeChat3_4-600x571.jpg 600w" sizes="(max-width: 900px) 100vw, 900px" />											<figcaption class="widget-image-caption wp-caption-text">SOTAX CE 7smart 溶出仪</figcaption>
										</figure>
								</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-edb8dc8 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="edb8dc8" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c1b7a9a" data-id="c1b7a9a" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-fc26bba elementor-widget elementor-widget-text-editor" data-id="fc26bba" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><b>SOTAX </b><b>CE 7smart </b><a href="https://www.nikyang.com/benchtop-solutions/sotax/ce-7smart/" target="_blank" rel="noopener"><b>溶出仪</b></a>，满足流通池法规定的流速和温度要求，其更贴近人体内流体动力学模式，能得到更真实的溶出曲线，有助于药企通过一致性评价。</p><p><b>更多溶出度检测的关键技巧，欢迎联系力扬企业获取。</b></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/news/reduce-cost-of-generic-drugs/">降低仿制药成本其实没这么难！</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>仿制药大变局：带量集采，药企担心的打压药价利器来了！</title>
		<link>https://nikyang.com/drug-discovery/news_311018/</link>
		
		<dc:creator><![CDATA[Miro]]></dc:creator>
		<pubDate>Wed, 31 Oct 2018 01:00:43 +0000</pubDate>
				<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=3307</guid>

					<description><![CDATA[<p>发布日期: 2018 年 10 月31 日 所谓「</p>
<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/news_311018/">仿制药大变局：带量集采，药企担心的打压药价利器来了！</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="3307" class="elementor elementor-3307" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-f6a13ff elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f6a13ff" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0449af0" data-id="0449af0" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-3ba78b9 elementor-widget elementor-widget-text-editor" data-id="3ba78b9" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>发布日期: 2018 年 10 月31 日</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-c3722e3 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="c3722e3" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-94ac28f" data-id="94ac28f" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-5e1f2f4 elementor-widget elementor-widget-text-editor" data-id="5e1f2f4" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>所谓「带量集采」，即国家对已经通过一致性评价的 33 个品种药品进行集中招标，用 11 个试点城市 60～70% 的市场份额诱导药企把药价降下来，以量换价。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-4537af9 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="4537af9" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-046b51c" data-id="046b51c" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-76674da elementor-widget elementor-widget-text-editor" data-id="76674da" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><span style="font-family: 'Microsoft YaHei', sans-serif;">药企若想在这场新的药品战役中脱颖而出，必须</span><strong style="font-family: 'Microsoft YaHei', sans-serif;">快马加鞭尽快通过一致性评价</strong><span style="font-family: 'Microsoft YaHei', sans-serif;">，尤其是新剂型仿制药。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-0d04f67 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="0d04f67" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b313945" data-id="b313945" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-5640933 elementor-widget elementor-widget-text-editor" data-id="5640933" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">从目前<strong>新剂型仿制药</strong>一致性评价进展看</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">,</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">申请一致性评价企业很多</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">,</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">但真正通过的企业很少</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">,</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">这跟新剂型通过一致性评价的难度较大有关，可能未来数年内继续通过一致性评价的新剂型品种不会太多，所以此次带量集采中拥有独家新剂型品种的药企有望享受长时间的「<strong>带量集采红利</strong>」！</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-f26fff3 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f26fff3" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2a0c851" data-id="2a0c851" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-b53cbc5 elementor-position-top elementor-vertical-align-top elementor-widget elementor-widget-image-box" data-id="b53cbc5" data-element_type="widget" data-widget_type="image-box.default">
				<div class="elementor-widget-container">
			<div class="elementor-image-box-wrapper"><figure class="elementor-image-box-img"><img width="630" height="470" src="/wp-content/uploads/2018/11/Oct_WeChat3_2.jpg" class="attachment-large size-large" alt="" /></figure></div>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-860eaf6 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="860eaf6" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b8be798" data-id="b8be798" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-1c2f8f3 elementor-widget elementor-widget-text-editor" data-id="1c2f8f3" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">传统的溶出度测定方法</span> <span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">(</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">桨法、篮法等</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">)</span> <span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">在进行新剂型质量控制时遇到了许多困难，而<strong>流通池法</strong>作为一种新型的溶出度检查方法，不仅在传统剂型（片剂、胶囊剂）中有着广阔的应用前景，而且在贴剂、药物释放支架、混悬剂、植入剂及微球、脂质体等新剂型中的应用更具实用价值，可以很好地<strong>弥补桨法与篮法的不足</strong>。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-075d01b elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="075d01b" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fb73385" data-id="fb73385" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-0d5bb20 elementor-widget elementor-widget-text-editor" data-id="0d5bb20" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><strong><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">桨法</span></strong></h6><p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span style="font-family: 'Microsoft YaHei', sans-serif;">使用桨法时，制剂在杯中的位置（下沉或漂浮）会影响药物溶出，并且桨底易形成“锥形堆积”，影响实验精准性</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-8bd3d42 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="8bd3d42" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a2e58d4" data-id="a2e58d4" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-2b9c0b7 elementor-widget elementor-widget-text-editor" data-id="2b9c0b7" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6 style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><strong><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">篮法</span></strong></h6><p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">确保转篮网孔的通透性尤为重要，但处方中辅料或主药中常常存在影响转篮通透性的粘性物质，从而导致溶出仪搅拌速度过低，影响实验准确性。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-7751819 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="7751819" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b5ca714" data-id="b5ca714" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-ed58d15 elementor-widget elementor-widget-text-editor" data-id="ed58d15" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6 style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><strong><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">流通池法</span></strong></h6><p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">是一种有别于传统溶出度测定的新的溶出方法，克服了因缺乏漏槽条件而导致的饱和或吸附问题；或者对于低剂量制剂</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-fareast-font-family: 新細明體; mso-bidi-font-family: 'Microsoft YaHei'; mso-fareast-language: ZH-TW;"> (</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">例如</span> <span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">2.5</span> <span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">微克的制剂</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-fareast-font-family: 新細明體; mso-bidi-font-family: 'Microsoft YaHei'; mso-fareast-language: ZH-TW;">)</span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">，由于定量限的影响，需要提高检测浓度的情况，流通池法都能得以完善解决，因此在新剂型的溶出与释放度研究方面有着不能比拟的优势。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-b9ec961 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b9ec961" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0f68c49" data-id="0f68c49" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-5fd3f16 elementor-widget elementor-widget-text-editor" data-id="5fd3f16" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p style="line-height: 26.0pt; mso-line-height-rule: exactly; mso-pagination: widow-orphan;"><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">瑞士</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';"> SOTAX  CE 7smart </span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">溶出仪，符合流通池法并专为难溶和缓释类新剂型药物设计，满足</span> <span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">USP 4 </span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">规定的流速和温度要求。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-afd8d95 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="afd8d95" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fd7a04b" data-id="fd7a04b" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-34683c2 elementor-widget elementor-widget-image" data-id="34683c2" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="500" height="500" src="/wp-content/uploads/2019/04/CE7smart.png" class="attachment-large size-large" alt="流池法 USP4法 SOTAX CE7smart" srcset="/wp-content/uploads/2019/04/CE7smart.png 500w, /wp-content/uploads/2019/04/CE7smart-150x150.png 150w, /wp-content/uploads/2019/04/CE7smart-300x300.png 300w" sizes="(max-width: 500px) 100vw, 500px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-0b3056e elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="0b3056e" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4b50e2e" data-id="4b50e2e" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-1978774 elementor-widget elementor-widget-text-editor" data-id="1978774" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">拥有三大优势：</span></h6><ul><li><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';"> </span>良好的漏槽条件，溶出介质的体积不再受到限制。</li><li>液体流动的流体动力学模式，更贴近于人体内部药物的溶解吸收</li><li>贯穿 QbD 理念，可以把控从 API 和造粒过程到最终制剂的总体质量。</li></ul>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-72854da elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="72854da" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-38ef413" data-id="38ef413" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-5fce87a elementor-position-top elementor-vertical-align-top elementor-widget elementor-widget-image-box" data-id="5fce87a" data-element_type="widget" data-widget_type="image-box.default">
				<div class="elementor-widget-container">
			<div class="elementor-image-box-wrapper"><figure class="elementor-image-box-img"><img width="329" height="571" src="/wp-content/uploads/2018/11/Oct_WeChat3_3.jpg" class="attachment-full size-full" alt="CE7smart 流通池 流池法 媒介 选择 溶出 仿制药 一致性评价 药物" /></figure></div>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-c86b797 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="c86b797" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-079a588" data-id="079a588" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-90802b6 elementor-widget elementor-widget-text-editor" data-id="90802b6" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">众所周知，仿制药市场竞争十分激烈，对药企来说，带量集采中试点城市公立医院</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';"> 60%~70% </span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">的市场份额诱惑巨大，所以尽快通过一次向性评价是新剂型仿制药企业的<strong>当务之急</strong>。由力扬代理的</span><span lang="EN-US" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';"> SOTAX CE 7smart </span><span lang="ZH-CN" style="font-family: 'Microsoft YaHei','sans-serif'; mso-bidi-font-family: 'Microsoft YaHei';">溶出仪能帮助企业尽早通过一次性评价，参与竞争，抢夺市场，请与我们联系及查询更多。</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-f54a318 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="f54a318" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-42f7ac6" data-id="42f7ac6" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-04952fa elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="04952fa" data-element_type="widget" data-widget_type="divider.default">
				<div class="elementor-widget-container">
					<div class="elementor-divider">
			<span class="elementor-divider-separator">
						</span>
		</div>
				</div>
				</div>
				<div class="elementor-element elementor-element-dc70cb7 elementor-widget elementor-widget-heading" data-id="dc70cb7" data-element_type="widget" data-widget_type="heading.default">
				<div class="elementor-widget-container">
			<h2 class="elementor-heading-title elementor-size-default">相关文章</h2>		</div>
				</div>
				<div class="elementor-element elementor-element-41e7d2d elementor-grid-2 elementor-posts--thumbnail-none elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-posts" data-id="41e7d2d" data-element_type="widget" data-settings="{&quot;classic_columns&quot;:&quot;2&quot;,&quot;classic_columns_tablet&quot;:&quot;2&quot;,&quot;classic_columns_mobile&quot;:&quot;1&quot;,&quot;classic_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;classic_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;classic_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}" data-widget_type="posts.classic">
				<div class="elementor-widget-container">
					<div class="elementor-posts-container elementor-posts elementor-posts--skin-classic elementor-grid">
				<article class="elementor-post elementor-grid-item post-17747 post type-post status-publish format-standard has-post-thumbnail hentry category-automated-solution category-news category-sample-prep category-crystallization category-drug-discovery tag-chemspeed tag-sotax tag-sample-prep tag-flow-cell-method tag-dissolution-testing tag-drugs-discovery">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/news/event-cphi-2023/" >
				集结行业力量，共赴中国制药国际化新征程			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-06-21		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/news/event-cphi-2023/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-17502 post type-post status-publish format-standard has-post-thumbnail hentry category-news category-drug-discovery tag-sotax tag-flow-cell-method tag-dissolution-testing">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/news/usp4-training2023/" >
				流池法应用培训班     促进技术交流与提升			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2023-05-16		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/news/usp4-training2023/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-13061 post type-post status-publish format-standard has-post-thumbnail hentry category-automated-solution category-news category-crystallization category-drug-discovery category-tlc tag-camag tag-chemspeed tag-sotax tag-technobis tag-flow-cell-method tag-dissolution-testing tag-drugs-discovery tag-gdu tag-hptlc">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/news/2021-q2-newsletter/" >
				2021 第 2 季 – 季度通讯｜关于药物研发、实验室自动化，这几件事你要知道			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2021-07-08		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/news/2021-q2-newsletter/" >
				点击阅读 »			</a>
				</div>
				</article>
				<article class="elementor-post elementor-grid-item post-11554 post type-post status-publish format-standard has-post-thumbnail hentry category-expert-column category-news category-drug-discovery tag-sotax tag-flow-cell-method tag-dissolution-testing tag-drugs-discovery">
				<div class="elementor-post__text">
				<h3 class="elementor-post__title">
			<a href="https://nikyang.com/news/yolanda-gliclazide-solid-dispersions/" >
				[专家专栏 – 药物溶出研究] 药物制剂中辅料及混合工艺的筛选 (格列齐特固体分散体)			</a>
		</h3>
				<div class="elementor-post__meta-data">
					<span class="elementor-post-date">
			2021-05-17		</span>
				</div>
					<a class="elementor-post__read-more" href="https://nikyang.com/news/yolanda-gliclazide-solid-dispersions/" >
				点击阅读 »			</a>
				</div>
				</article>
				</div>


		
				</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/news_311018/">仿制药大变局：带量集采，药企担心的打压药价利器来了！</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>厂商如何应对一致性评价造成的仿制药成本上涨？</title>
		<link>https://nikyang.com/drug-discovery/deal-with-rising-cost-of-generic-drugs/</link>
		
		<dc:creator><![CDATA[Miro]]></dc:creator>
		<pubDate>Wed, 10 Oct 2018 04:00:09 +0000</pubDate>
				<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[BE 生物等效性实验]]></category>
		<category><![CDATA[Sotax]]></category>
		<category><![CDATA[一致性评价]]></category>
		<category><![CDATA[流池法]]></category>
		<category><![CDATA[溶出度测试]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=3430</guid>

					<description><![CDATA[<p>发布日期: 2018 年 10 月10 日 《我不</p>
<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/deal-with-rising-cost-of-generic-drugs/">厂商如何应对一致性评价造成的仿制药成本上涨？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></description>
										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="3430" class="elementor elementor-3430 elementor-bc-flex-widget" data-elementor-settings="[]">
						<div class="elementor-inner">
							<div class="elementor-section-wrap">
							<section class="elementor-section elementor-top-section elementor-element elementor-element-8b1d5a7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="8b1d5a7" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f1f03dc" data-id="f1f03dc" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-a48613d elementor-widget elementor-widget-text-editor" data-id="a48613d" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p class="MsoNormal"><span lang="ZH-CN" style="font-family: SimSun; mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-fareast-language: ZH-CN;">发布日期</span><span lang="EN-US">: 2018 </span><span lang="ZH-CN" style="font-family: SimSun; mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-fareast-language: ZH-CN;">年</span><span lang="EN-US"> 10 </span><span lang="ZH-CN" style="font-family: SimSun; mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-fareast-language: ZH-CN;">月</span><span lang="EN-US">10 </span><span lang="ZH-CN" style="font-family: SimSun; mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-fareast-language: ZH-CN;">日</span></p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-54d2626 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="54d2626" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b28a1df" data-id="b28a1df" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-6b01fce elementor-widget elementor-widget-text-editor" data-id="6b01fce" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>《我不是药神》这部热门电影成功地将「仿制药」推到大众的视线里。仿制药可以说是原研药的“副本”，与原研药相比，表面看似时间与资金投入更少，更容易生产。</p><p>可是，「仿制药一致性评价」的出现，却掀起了成本和时间的争议。所有仿制药必须通过「仿制药一致性评价」，即仿制药必须和原研药管理一致性、中间过程一致性、质量标准一致性等全过程一致的高标准要求。国家药监总局要求 2018 年底前要完成 289 个仿制药品种的一致性评价，没有通过的药品将注销药品批准文号，产品将面临下架风险！时间刻不容缓！</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-743a683 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="743a683" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-39f4843" data-id="39f4843" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-466aabd elementor-widget elementor-widget-image" data-id="466aabd" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="424" height="248" src="/wp-content/uploads/2018/11/Sep_WeChat4_2.jpg" class="attachment-large size-large" alt="仿制药" srcset="/wp-content/uploads/2018/11/Sep_WeChat4_2.jpg 424w, /wp-content/uploads/2018/11/Sep_WeChat4_2-300x175.jpg 300w" sizes="(max-width: 424px) 100vw, 424px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-95002a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="95002a8" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-52db0e3" data-id="52db0e3" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-8f2cfae elementor-widget elementor-widget-text-editor" data-id="8f2cfae" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><b>仿</b><b>制药价格持续走高</b><b>原因</b></h6><ol><li>生产成本变高，一致性评价检测增加仿制药的生产成本。进行一次一致性评价检测大概需要 300 &#8211; 500 万元 (其中 100 &#8211; 200 万是体外研究试验费用，另外 200 &#8211; 300 万是生物等效研究试验费用)，并且如果检测失败，就需另外投入更多的人力与资金进行重新检测，但大部分药物的年销量不超过 500 万元，这给药品厂商带来了不小的压力。</li><li>仿制药临床科研机构供不应求。制药需求量不断上升，而普遍临床研究机构规模较小且为数不多，难以应付庞大的生产量需求，导致价格持续走高。</li><li>流通体系复杂，销售中间环节太多。每个仿制药都要经过从药厂—&gt;经销商—&gt;批发商—&gt;药店和医院的过程，最终才能到达患者手中，经过层层加价，价格自然增高。</li></ol>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d276047 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d276047" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2195ce6" data-id="2195ce6" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-f4b2d66 elementor-widget elementor-widget-text-editor" data-id="f4b2d66" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>除了面对以上问题,在一致性评价的影响下,由于其要求仿制药必须和原研药保持管理一致性、中间过程一致性与质量标准一致性，这就无形中提高了生物等效性的过检标准。倘若生物等效试验结果和原研药对比不一致，厂商只能找出失败原因，并重新进行生物等效试验，这将大量增加制药成本，无论是资金成本还是时间成本。</p><p> </p><p>综观以上种种原因, 可见进行生物等效性实验所花费的高昂成本才是导致仿制药成本增加、市场价持续走高的最大原因。传统的生物等效性检测技术精准度不稳定，实验效果差，往往需要来回多次反复试验，耗费大量的时间、金钱成本。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-e9dd98d elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="e9dd98d" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-879776c" data-id="879776c" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-78f7e42 elementor-position-top elementor-vertical-align-top elementor-widget elementor-widget-image-box" data-id="78f7e42" data-element_type="widget" data-widget_type="image-box.default">
				<div class="elementor-widget-container">
			<div class="elementor-image-box-wrapper"><figure class="elementor-image-box-img"><img width="965" height="918" src="/wp-content/uploads/2018/11/Oct_WeChat3_4.jpg" class="attachment-full size-full" alt="" /></figure><div class="elementor-image-box-content"><p class="elementor-image-box-description">瑞士 SOTAX CE 7smart 为仿制药提供精准的生物等效性实验成效
</p></div></div>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-e2bf8a7 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="e2bf8a7" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c16cc6c" data-id="c16cc6c" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-d728e08 elementor-widget elementor-widget-text-editor" data-id="d728e08" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><b>流通池法是降低生产成本的关键</b></h6><p>流通池法溶出测试 ( USP4 &#8211; 美国药典第四法) 可以解决这个问题。相比于桨法与篮法，流通池法更能真实的模拟人体内的循环体系去溶解药品，真实的反映出人体内的溶出情况，能得出更准确的实验结果，降低体外的溶出度试验与生物等效性实验 ( BE ) 实验结果不一致的情况。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-b6d2d44 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="b6d2d44" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ae7a62a" data-id="ae7a62a" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-34aea46 elementor-widget elementor-widget-image" data-id="34aea46" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="832" height="427" src="/wp-content/uploads/2018/11/Sep_WeChat4_4.jpg" class="attachment-large size-large" alt="CE7smart 流通池 流池法 媒介 选择 溶出 仿制药 一致性评价" srcset="/wp-content/uploads/2018/11/Sep_WeChat4_4.jpg 832w, /wp-content/uploads/2018/11/Sep_WeChat4_4-300x154.jpg 300w, /wp-content/uploads/2018/11/Sep_WeChat4_4-768x394.jpg 768w, /wp-content/uploads/2018/11/Sep_WeChat4_4-600x308.jpg 600w" sizes="(max-width: 832px) 100vw, 832px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-d28b94a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="d28b94a" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1808f44" data-id="1808f44" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-a5d945d elementor-widget elementor-widget-text-editor" data-id="a5d945d" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><b>案例</b><b>分析</b></h6><p>样品 BCS 分类：II类，低溶解度，高渗透性</p><p>测试方法1</p><p>实验步骤：利用 USP 1 (篮法)、2 (桨法)，在不同 pH介质下测试溶出曲线</p><p>实验结果：参比制剂跟自研药样品表面看来极为相似，然而生物等效性实验实际显示自研产品比参比制剂释放慢，可是在以下图表未能呈现出来。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-054cfc3 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="054cfc3" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-664b8dc" data-id="664b8dc" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-052da14 elementor-position-top elementor-vertical-align-top elementor-widget elementor-widget-image-box" data-id="052da14" data-element_type="widget" data-widget_type="image-box.default">
				<div class="elementor-widget-container">
			<div class="elementor-image-box-wrapper"><figure class="elementor-image-box-img"><img width="780" height="353" src="/wp-content/uploads/2018/11/Sep_WeChat4_5.jpg" class="attachment-full size-full" alt="" /></figure><div class="elementor-image-box-content"><p class="elementor-image-box-description">RLD – 参比制     S – 自研药样品
</p></div></div>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-625f0b1 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="625f0b1" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-63ba958" data-id="63ba958" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-1c016f5 elementor-widget elementor-widget-text-editor" data-id="1c016f5" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>测试方法2</p><p>实验步骤：利用 USP 4 (流通池法)，一次实验采用 3 种溶出介质进行测试</p><p>实验结果：结果表明自研处方显示了更慢的释放行为，与体内获得的情况更为接近；而同时判别的国外上市某仿制样品，与参比制剂相似性良好，进一步说明流通池法具有更优的判别结果。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-80b4097 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="80b4097" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a22f94f" data-id="a22f94f" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-0f6bdda elementor-position-top elementor-vertical-align-top elementor-widget elementor-widget-image-box" data-id="0f6bdda" data-element_type="widget" data-widget_type="image-box.default">
				<div class="elementor-widget-container">
			<div class="elementor-image-box-wrapper"><figure class="elementor-image-box-img"><img width="381" height="297" src="/wp-content/uploads/2018/11/Sep_WeChat4_6.jpg" class="attachment-full size-full" alt="" /></figure><div class="elementor-image-box-content"><p class="elementor-image-box-description">RLD – 参比制剂     S – 自研药样品</p></div></div>		</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-91daa6c elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="91daa6c" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-972768d" data-id="972768d" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-f5eb9c0 elementor-widget elementor-widget-text-editor" data-id="f5eb9c0" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<h6><strong>结论</strong></h6><p>从以上案例，采用了 USP 4 仪器后,一般以 USP 1、2 法未能显示的生物等效性结果则能全面展示出来，更能了解与参比制剂的释放行为及差异，在重试生物等效性测试之前，更好地筛选处方或工艺；减少实验投入，不用动辄花费大量金钱和时间投入来重做生物等效性实验。</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-430ce2a elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="430ce2a" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-81999fc" data-id="81999fc" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-e992aad elementor-widget elementor-widget-image" data-id="e992aad" data-element_type="widget" data-widget_type="image.default">
				<div class="elementor-widget-container">
								<div class="elementor-image">
												<img width="900" height="374" src="/wp-content/uploads/2018/11/Sep_WeChat4_7-1024x425.jpg" class="attachment-large size-large" alt="" srcset="/wp-content/uploads/2018/11/Sep_WeChat4_7-1024x425.jpg 1024w, /wp-content/uploads/2018/11/Sep_WeChat4_7-300x125.jpg 300w, /wp-content/uploads/2018/11/Sep_WeChat4_7-768x319.jpg 768w, /wp-content/uploads/2018/11/Sep_WeChat4_7-600x249.jpg 600w, /wp-content/uploads/2018/11/Sep_WeChat4_7.jpg 1213w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-a71f099 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="a71f099" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-962ac46" data-id="962ac46" data-element_type="column">
			<div class="elementor-column-wrap">
							<div class="elementor-widget-wrap">
								</div>
					</div>
		</div>
								</div>
					</div>
		</section>
				<section class="elementor-section elementor-top-section elementor-element elementor-element-325d5d0 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="325d5d0" data-element_type="section">
						<div class="elementor-container elementor-column-gap-default">
							<div class="elementor-row">
					<div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a9655da" data-id="a9655da" data-element_type="column">
			<div class="elementor-column-wrap elementor-element-populated">
							<div class="elementor-widget-wrap">
						<div class="elementor-element elementor-element-fbb7152 elementor-widget elementor-widget-text-editor" data-id="fbb7152" data-element_type="widget" data-widget_type="text-editor.default">
				<div class="elementor-widget-container">
								<div class="elementor-text-editor elementor-clearfix">
				<p>Sotax CE 7smart（USP4）溶出仪不仅能降低药物在体内不等效的风险，同时能缩短检测时间。传统系统消耗 13 天的流程，而自动溶出度测试系统仅需 4 天，因为整个溶出过程都可实现在线自动化控制，减少了传统耗时的手动流程，在提高实验精准度的同时，缩短了实验时间。</p><p> </p><p>更多简单可靠的通过一致性评价检测与生物等效性实验的办法？欢迎联系力扬，获得更多自动化解决方案专家的独门秘笈！</p>					</div>
						</div>
				</div>
						</div>
					</div>
		</div>
								</div>
					</div>
		</section>
						</div>
						</div>
					</div>
		<p><a rel="nofollow" href="https://nikyang.com/drug-discovery/deal-with-rising-cost-of-generic-drugs/">厂商如何应对一致性评价造成的仿制药成本上涨？</a>最先出现在<a rel="nofollow" href="https://nikyang.com">实验室自动化应用一致性评价丨香港力扬企业-溶出仪-药物溶出度仪厂家</a>。</p>
]]></content:encoded>
					
		
		
			</item>
	</channel>
</rss>
