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		<title>[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)</title>
		<link>https://nikyang.com/news/yolanda-gliclazide-solid-dispersions/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Mon, 17 May 2021 04:30:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[药物研发及检测]]></category>
		<category><![CDATA[Sotax]]></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=11554</guid>

					<description><![CDATA[<p>随着药物研发和生产的深入，药物辅料和药物剂型一样，对药品质量和疗效起着越来越重要的作用。采用新辅料不仅可以改变 [&#8230;]</p>
<p><a rel="nofollow" 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>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>
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<p>随着药物研发和生产的深入，药物辅料和药物剂型一样，对药品质量和疗效起着越来越重要的作用。<strong>采用新辅料不仅可以改变药物制剂外观形态，还可以提高溶出度和生物利用度，并用于速释 / 缓释产品的制备</strong>，其技术愈来愈受重视。对药物制剂中辅料性质的研究和检测由此也变得越来越重要。</p>
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												<img width="900" height="625" src="/wp-content/uploads/2021/05/WechatIMG129-1024x711.jpeg" class="attachment-large size-large" alt="药品药物溶出-药物剂型" srcset="/wp-content/uploads/2021/05/WechatIMG129-1024x711.jpeg 1024w, /wp-content/uploads/2021/05/WechatIMG129-300x208.jpeg 300w, /wp-content/uploads/2021/05/WechatIMG129-768x533.jpeg 768w, /wp-content/uploads/2021/05/WechatIMG129.jpeg 1080w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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<p>本次分享的文献采用<strong>格列齐特固体分散体</strong>作为研究对象，对 MCC、HPMC、PEG8000 / 4000 等辅料及它们与 API 不同混合方式对 API 溶出的影响进行了考察。</p>
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<section>
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<p><span style="color: #000080;"><strong>实验混合方式</strong></span></p>
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<ul class="list-paddingleft-2">
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<p>物理混合：直接将辅料和 API 简单混匀</p>
</li>
<li>
<p>共研磨：将辅料和 API 研磨混匀</p>
</li>
</ul>
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<section></section>
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<p><span style="color: #000080;"><strong>实验测试辅料</strong></span></p>
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<section></section>
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<ul class="list-paddingleft-2">
<li>
<p>MCC</p>
</li>
<li>
<p>HPMC</p>
</li>
<li>
<p>PEG8000 / 4000</p>
</li>
</ul>
</section>
<section></section>
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<section>
<section>
<section></section>
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<p><span style="color: #000080;"><strong>实验测试方法</strong></span></p>
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<section></section>
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<section></section>
<section>
<p>采用<a href="https://www.nikyang.com/services/cro/dissolution/"><strong>流池法</strong></a>，把混合后的粉体分别填充到流池里，与 1mm 的玻璃珠进行混匀后，考察这些辅料对于溶出的影响。</p>
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<p><span style="color: #000080;"><strong>溶出度测试结果</strong></span></p>
<p><b>&#8211; MCC</b></p>
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</section>
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										<img width="900" height="596" src="/wp-content/uploads/2021/05/Yolanda-case-study-stat-1-1024x678.png" class="attachment-large size-large" alt="药物溶出：药物制剂中辅料及混合工艺的筛选 - 格列齐特固体分散体溶出度测试结果1" srcset="/wp-content/uploads/2021/05/Yolanda-case-study-stat-1-1024x678.png 1024w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-1-300x199.png 300w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-1-768x508.png 768w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-1.png 1310w" sizes="(max-width: 900px) 100vw, 900px" />											<figcaption class="widget-image-caption wp-caption-text">MCC 两种混合方式的溶出结果</figcaption>
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				<p> </p>
<p><strong>对比 MCC 共研磨和物理混合方式的溶出结果，共研磨方式的释放度低于物理混合方式</strong>。这是由于在共研磨的过程中，MCC 跟 API 进行了致密的结合，形成了一种塑性结构，对API释放形成了阻碍；而在物理混合时 MCC 作为一种稀释剂，它分散了 API ，同时 MCC 具有亲水性，这有利于 API 的溶出。</p>
<p><strong>&#8211; HPMC</strong></p>					</div>
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										<img width="900" height="592" src="/wp-content/uploads/2021/05/Yolanda-case-study-stat-2-1024x674.png" class="attachment-large size-large" alt="药物溶出：药物制剂中辅料及混合工艺的筛选 - 格列齐特固体分散体溶出度测试结果2" srcset="/wp-content/uploads/2021/05/Yolanda-case-study-stat-2-1024x674.png 1024w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-2-300x197.png 300w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-2-768x505.png 768w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-2.png 1082w" sizes="(max-width: 900px) 100vw, 900px" />											<figcaption class="widget-image-caption wp-caption-text">不同比例的HPMC辅料的溶出结果</figcaption>
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				<p> </p>
<p>实验结果显示，<strong>对于 HPMC 不同比例的共研磨状态，API 溶出会随着 HPMC 用量的增加而变慢</strong>。这是因为 HPMC 本身遇水会形成凝胶层，阻碍了 API 的溶出。</p>
<p><strong>&#8211; PEG8000/4000</strong></p>					</div>
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										<img width="900" height="591" src="/wp-content/uploads/2021/05/Yolanda-case-study-stat-3-1024x672.png" class="attachment-large size-large" alt="药物溶出：药物制剂中辅料及混合工艺的筛选 - 格列齐特固体分散体溶出度测试结果3" srcset="/wp-content/uploads/2021/05/Yolanda-case-study-stat-3-1024x672.png 1024w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-3-300x197.png 300w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-3-768x504.png 768w, /wp-content/uploads/2021/05/Yolanda-case-study-stat-3.png 1067w" sizes="(max-width: 900px) 100vw, 900px" />											<figcaption class="widget-image-caption wp-caption-text">PEG8000和PEG4000的溶出结果</figcaption>
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<p> </p>
<p>实验结果表明，<strong>对比 PEG8000 共研磨和物理混合方式的溶出结果，API 的溶出无显著差异</strong>。对比 PEG8000 和 PEG4000 两种不同辅料的溶出结果，<strong>使用 PEG4000 与 API 混合，溶出会增加</strong>。</p>
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<p><span style="color: #333399;"><strong>实验总结</strong></span></p>
</section>
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<section></section>
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</section>
<section></section>
<section>
<p>使用<strong>流池法</strong>可以对<strong>粉末混合的中间状态</strong>进行考察，这种考察<strong>有利于实验人员分析处方的关键影响因素，对处方的溶出进行更深入的研究</strong>。</p>
<p>可以说流池法的<strong>灵活性</strong>，使得制剂开发过程中研发人员可以从原料 API、制剂中间体和最终制剂层层剖析，获取最有利的信息，从而<strong>加快和辅助药物研发的进程</strong>。</p>
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<p><span style="font-weight: 400;">参考资料：</span></p>
<p>Emara LH, Elsayed EW, El-Ashmawy AA, Abdou AR, Morsi NM. The Flow-Through Cell as an in Vitro Dissolution Discriminative Tool for Evaluation of Gliclazide Solid Dispersions. J App Pharm Sci, 2017; 7 (05): 070-077.</p>
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												<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>
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				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>
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		<p><a rel="nofollow" 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>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>
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		<title>[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (六)</title>
		<link>https://nikyang.com/expert-column/simon-isynth-reaction-process/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Fri, 07 May 2021 06:03:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[高通量筛选]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=11108</guid>

					<description><![CDATA[<p>“在 ISYNTH 模块上完成高通量筛选后，可以进</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-isynth-reaction-process/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (六)</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="11108" class="elementor elementor-11108" data-elementor-settings="[]">
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<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><em>“在 ISYNTH 模块上完成高通量筛选后，可以进一步在工艺开发反应釜 (PD-Reactor) 模块进行的实验优化和放大过程，改模块中，每个反应釜有独立的控温、控压、搅拌等过程。”</em></p>
<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振博士丨力扬自动化合成及优化专家</strong></span></p>
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<div>
<p><span style="font-weight: 600; font-synthesis: style;"><span style="color: #000080;"><strong><b>【工艺反应釜的反应优化和放大过程】</b></strong></span></span></p>
<p>随着高通量筛选的普及，实验室自动化技术在药物研发中越来越重要。在之前的案例中介绍了用 ISYNTH 模块完成高通量的筛选过程，ISYNTH 高通量筛选过程中，所有的反应瓶都是在同一个反应条件下进行反应的。针对高通量筛选的某些感兴趣的结果，通常有必要进行针对性的反应条件优化过程，比如对 ISYNTH 的筛选结果进行初步的 HPLC 检测之后，能够找到某些配方进行后续的优化和放大实验。这种优化或放大实验需要在工艺开发反应釜模块进行，每个反应釜有独立温控以及搅拌速度等单独条件的控制，反应釜的规格可选择 100mL、 250mL或者是1000mL。</p>
<p>下图是一个反应釜的构造图，它的基本配置中包含了有不同的加样方式，如独立控温、控压、搅拌，还可以根据需要配置其他控制探头。</p>
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												<img width="709" height="524" src="/wp-content/uploads/2021/04/Chemspeed-case-study6-Reactor.jpg" class="attachment-large size-large" alt="Chemspeed高通量筛选-工艺开发反应器" srcset="/wp-content/uploads/2021/04/Chemspeed-case-study6-Reactor.jpg 709w, /wp-content/uploads/2021/04/Chemspeed-case-study6-Reactor-300x222.jpg 300w" sizes="(max-width: 709px) 100vw, 709px" />														</div>
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				<p>这里有一个视频介绍，可以完整展示整个反应斧的工作过程。</p>					</div>
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				<div class="elementor-element elementor-element-888dd00 elementor-aspect-ratio-169 elementor-widget elementor-widget-video" data-id="888dd00" data-element_type="widget" data-settings="{&quot;video_type&quot;:&quot;hosted&quot;,&quot;controls&quot;:&quot;yes&quot;,&quot;aspect_ratio&quot;:&quot;169&quot;}" data-widget_type="video.default">
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					<video class="elementor-video" src="http://www.nikyang.com/wp-content/uploads/video/Chemspeed/Perparative-synthesis_C.mp4" controls="" controlsList="nodownload" poster="/wp-content/uploads/2021/04/Automated-Process-RnD-and-preparative-Synthesis.png"></video>
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				<p> </p>
<p>视频中可以看到反应釜里有不同的<a href="https://www.nikyang.com/benchtop-solution/chemspeed/gdu-series/">加样工具</a>，上面是固体试剂加样口，下面是液体或气体的进样口，视频中也展示了回流工作的过程。另外，这种反应釜的特点是拆卸和组装非常方便，在整个拆卸和组装的过程中，无需用到任何螺丝的固定装置，这也是它便捷性的体现。反应釜可以耐 100bar的压力，最高使用温度为 250℃。</p>					</div>
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				<p><strong>了解更多关于 Chemspeed 药物研发的先进经验分享，例如 IBM 采用人工智能驱动的自动化实验室开发工作、像多伦多大学利用合成系统加快物料开发的过程、像默克建立的以数据科学驱动为主，自主的化学反应和优化技术等等，可以关注力扬企业官方微信账号 (NIKYANG_HK)，加入专家微信社群，或浏览<a href="https://v.qq.com/s/videoplus/889877194">力扬官方视频</a>频道，获取更多精彩内容。</strong></p>					</div>
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												<img width="781" height="424" src="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg" class="attachment-large size-large" alt="实验室自动化专家-杜世振博士Dr. Simon Du专家简历" srcset="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg 781w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-300x163.jpg 300w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
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				[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (六)			</a>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-isynth-reaction-process/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (六)</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>
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		<title>[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (五)</title>
		<link>https://nikyang.com/expert-column/simon-isynth-workflow/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Fri, 30 Apr 2021 02:03:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
		<category><![CDATA[高通量筛选]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=11034</guid>

					<description><![CDATA[<p>“FLEX ISYNTH 平台可以完成几乎所有的有</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-isynth-workflow/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (五)</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="11034" class="elementor elementor-11034" data-elementor-settings="[]">
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<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><em>“<a href="https://www.nikyang.com/benchtop-solutions/chemspeed/flex/">FLEX</a> ISYNTH 平台可以完成几乎所有的有机化合反应的高通量合成工作，如：碳氢活化、酰胺化、脂化、氧化、加氢等等。”</em></p>
<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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				<p><!-- wp:paragraph --></p><div><p><span style="font-weight: 600; font-synthesis: style;"><span style="color: #000080;"><strong><b>【高通量合成和筛选过程】</b></strong></span></span></p><p>高通量合成和筛选过程中用到最主要的工具是 ISYNTH 平行反应器，下图展示了平行反应器的拆解图，从最下面往上依次是涡旋振摇架;加热 / 冷却板 (控温范围：- 20 ℃ 至 150 ℃);反应瓶架 (2mL x 48、8mL x 48、24mL x 20、100mL x 12);反应器盖 (实验密封、回流、惰性气氛置换等)。平行反应器一般配合顶置式工具使用，比如固体加样工具 (GDU-P) 或者液体加样工具 (GDU-V) 或 4-通移移液工具 (4-NeedleHead) 来使用的。</p></div><p><!-- /wp:paragraph --></p>					</div>
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												<img width="900" height="574" src="/wp-content/uploads/2021/04/Simon-case-study-5-ISYNTH.jpg" class="attachment-large size-large" alt="ISYNTH平行反应器-高通量合成及筛选" srcset="/wp-content/uploads/2021/04/Simon-case-study-5-ISYNTH.jpg 963w, /wp-content/uploads/2021/04/Simon-case-study-5-ISYNTH-300x191.jpg 300w, /wp-content/uploads/2021/04/Simon-case-study-5-ISYNTH-768x490.jpg 768w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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				<p>与此同时，ISYNTH 平行反应器可以实现反应过程中惰性气体的保护，前面提到的反应器盖就可以实现惰性气氛的交换。对于工艺开发反应釜，它也配有惰性气体的进出阀门，可以实现惰性气氛的置换功能，或实现在反应过程中氮气或者是氩气的保护工作。针对整个实验环境的气氛要求更高的实验，<a href="https://www.nikyang.com/benchtop-solutions/chemspeed/">Chemspeed</a> 可以对整个反应平台进行配氮气吹扫，或配置专业的手套箱，以实现整个平台的惰性气氛环境。</p>
<p>ISYNTH 平行反应器的具体的操作流程如下：首先，多功能抓手把反应器最上层的盖子打开，这样位于下层的反应小瓶就处于开口的状态，再使用不同的<a href="https://www.nikyang.com/benchtop-solutions/chemspeed/gdu-series/">加样工具</a>进行试剂或溶剂加样，加到不同的反应瓶里，最后关闭反应器、对反应瓶进行控温和混合过程，反应过程中或结束之后，也可以通过4-通道移液工具实现在线检测过程，如HPCL、GC、MS 等。</p>
<p>这样一个 FLEX ISYNTH 平台可以完成几乎所有的有机化合反应的高通量合成工作，比如说碳氢活化、酰胺化、脂化、氧化、加氢等等。下面的视频简单介绍了 ISYNTH 工作的过程。</p>					</div>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-isynth-workflow/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (五)</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>
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		<title>[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (四)</title>
		<link>https://nikyang.com/expert-column/simon-reaction-execution/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Tue, 20 Apr 2021 08:19:50 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
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		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
		<category><![CDATA[高通量筛选]]></category>
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					<description><![CDATA[<p>  “Chemspeed 设计的突破性化合物存储技</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-reaction-execution/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (四)</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>
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				<p><!-- wp:paragraph --></p><p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"> </p><p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><em>“<a href="https://www.nikyang.com/benchtop-solutions/chemspeed/">Chemspeed</a> 设计的突破性化合物存储技术 &#8211; 玻璃胶囊化合物分装系统 (Smolefin) ，彻底颠覆了空气敏感、剧毒化合物传统存储方式，将化合物定质量 (或摩尔量) 储备于玻璃胶囊中，并实现在不同的压力下破碎玻璃胶囊，精准控制化合物的释放过程，轻松实现对空气敏感、剧毒化合物的管理，帮助实验科研人员避免遭受毒性化合物的侵害，让整个实验环境变得更安全、健康。”</em></p><p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p><p><!-- /wp:paragraph --></p>					</div>
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				<p><!-- wp:paragraph --></p><div><p><span style="font-weight: 600; font-synthesis: style;"><span style="color: #000080;"><strong><b>【化学试剂处废方案】</b></strong></span></span></p><p>化学试剂处废方案主要针对做实验时遇到对空气敏感性的化学物质和剧毒化合物的管理工作。Chemspeed 针对这种难点，设计出一种玻璃胶囊的化合物分装系统 (Smolefin)。这种分装系统可以把所需要的化学物按照特定的量，如按照反应常规所需的量 (如 1g, 1mmol 等) 分配到特制的毛细玻璃管中，然后将玻璃管放置在氩气条件下进行分装，之后再用激光烧结密封，把化学试剂安全地放在毛细玻璃管中进行储存。这种储存化学物质的玻璃管就像一个个盛放化学试剂的胶囊一样，实现了特殊化学品化繁为简的存储过程。这种玻璃胶囊的特点是它可以在特定的压力下完成玻璃管的破碎，通过改变压力的大小来控制化学品的释放过程。下面视频介绍了整个样品的封装过程，可参考。</p></div><p><!-- /wp:paragraph --></p>					</div>
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				<p> </p><p>首先会用到<a href="https://www.nikyang.com/benchtop-solution/chemspeed/gdu-series/">顶置式加样工具</a> (GDU-P、GDU-V、GDU-SWILE)，把不同类型的化学试剂按照设定质量分配到不同的毛细玻璃管中，然后在氮气或者是氩气保护下进行激光封装。封装完之后可以看到一个玻璃胶囊，这种玻璃胶囊完全隔离了空气中的水、氧气对化合物的影响，这种方式也彻底杜绝了剧毒化学物对科研人员的人体造成潜在危害的可能。</p><p>使用时，可以很简单地把这种玻璃胶囊放到实验室里的烧瓶中，通过搅拌等方式破碎胶囊释放化合物，也可以配合 Chemspeed 不同的反应器技术使用，比如高压的筛选模块、反应釜模块等。玻璃胶囊放进去之后，通过控制压力变化让玻璃胶囊破碎，释放化合物。下面视频展示了这种玻璃胶是如何在压力下进行破碎并释放化合物的。</p>					</div>
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				<p> </p><p>视频中展示了在反应瓶里放进不同的玻璃胶囊，密封处理后，用四通道液体处理工具 (4 NeedleHead) 往反应瓶里充氮气进行加压。视频中标注的部分可以看到，四通道液体处理工具给体系加压到 6 bar 时玻璃胶囊瞬间爆破，并释放化学药品。这种玻璃胶囊有不同压力规格的设计，如6 bar、10 bar、20 bar、30 bar、60 bar 等，可以根据具体的实验应用过程进行自由选择。</p>					</div>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-reaction-execution/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (四)</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>
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		<title>[专家专栏 – 实验室自动化]  Chemspeed 在药物研发领域的应用案例 (三)</title>
		<link>https://nikyang.com/expert-column/simon-automated-eluent-preparation/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Mon, 29 Mar 2021 09:00:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
		<category><![CDATA[高通量筛选]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=10864</guid>

					<description><![CDATA[<p>【流动相自动化配制方案】 “流动相的配置涉及大量的</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-automated-eluent-preparation/">[专家专栏 – 实验室自动化]  Chemspeed 在药物研发领域的应用案例 (三)</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>
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										<content:encoded><![CDATA[		<div data-elementor-type="wp-post" data-elementor-id="10864" class="elementor elementor-10864" data-elementor-settings="[]">
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<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><span style="font-weight: 600; font-synthesis: style;"><span style="color: #000080;"><strong><b>【流动相自动化配制方案】</b></strong></span></span></p>
<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><em>“流动相的配置涉及大量的重复且单一的操作过程，而且需要符合 GMP或者是 FDA 第 21 条对质量体系的认证要求。<a href="https://www.nikyang.com/benchtop-solutions/chemspeed/">Chemspeed</a> 的自动化方案，借助四针头工具进行液体加样，可完成不同液体组分的自动分配过程，还可以实现 pH 值的实时测定和在线控制，快速高效的完成流动相的配制工作。”</em></p>
<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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<p>流动相配制及操作是实验室日常工作中面临的一个非常繁琐且重复性的工作，针对这种繁琐的重复性劳动，Chemspeed 制定了一个自动化的解决方案。在这个解决方案里，用到的有固体加样工具 (<a href="https://www.nikyang.com/expert-column/simon-powder-dispensing/">详情可点击链接了解更多</a>），还有四通道液体处理工具，这个工具主要用于高效的对溶剂进行按体积分配操作。</p>
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<p>另外一个比较重要的特点是 Chemspeed 对这种四通道液体处理工具进行了升级，升级之后它可以进行对流动相在线 pH 值的控制和测定工作。除此之外，四通道液体处理工具还可以完成过滤和在线进样等实验过程，比如对 HPLC 的线进样过程。</p>
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												<img width="900" height="569" src="/wp-content/uploads/2021/03/2021_MAR_Simon_webinar_page12-1024x647.jpg" class="attachment-large size-large" alt="流动相自动化配制方案" srcset="/wp-content/uploads/2021/03/2021_MAR_Simon_webinar_page12-1024x647.jpg 1024w, /wp-content/uploads/2021/03/2021_MAR_Simon_webinar_page12-300x189.jpg 300w, /wp-content/uploads/2021/03/2021_MAR_Simon_webinar_page12-768x485.jpg 768w, /wp-content/uploads/2021/03/2021_MAR_Simon_webinar_page12.jpg 1080w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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				<p>上图是典型的流动相自动化平台案例，在平台上可以完成了 12 x 1 L 的流动相配制工作。在手动进行配置流动相过程中，会涉及到大量的重复且单一的操作步骤，这些重复性的工作又有非常高的质量的要求，比如说酸碱度精准控制的问题、对固体或者液体精确分配问题。最重要的一点是需要符合 GMP 或者是 FDA 第 21 条对质量体系的认证要求。只有完全遵照此标准保留的数据才可以作为通过检验或者今后追溯的有效数据来源，其厂商生产的产品才可以正常销往国外市场。 针对这种需求，Chemspeed 开发了一个自动化的加样程序，除了能够满足自动化的流程之外，它每一步操作过程都满足 GMP 环境实验室的认证过程，确保所有电子记录有因可循、清晰易懂、同步记录、原始、准确并且保存完整。</p>
<p>在 Chemspeed 流动相配制平台上,自动配制流动相的典型做法是：自动化抓手打开溶剂瓶，然后使用 GDU-Pfd (<a href="https://www.nikyang.com/benchtop-solution/chemspeed/gdu-series/">顶置式固体称重加样工具</a>) 加入设定质量的固体磷酸盐，再使用四通道液体处理工具加入水，然后进行 pH 的测定和在线控制，最后定容，并自动加盖涡旋混合，可观看以下视频详细了解：</p>					</div>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-automated-eluent-preparation/">[专家专栏 – 实验室自动化]  Chemspeed 在药物研发领域的应用案例 (三)</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>
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		<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</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="[]">
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<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>
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										<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>
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<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>
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<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>
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												<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>
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		<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>
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		<title>[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (二)</title>
		<link>https://nikyang.com/expert-column/simon-compound-management/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Mon, 15 Mar 2021 09:44:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[AI药物研发]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[微量粉末分配]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=10604</guid>

					<description><![CDATA[<p>前沿：化合物库管理与药物研发的关系 化合物库是按照</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-compound-management/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (二)</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>
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				<p><!-- wp:paragraph --></p><p><span style="color: #000080;"><strong><b>前沿：化合物库管理与药物研发的关系</b></strong></span></p><p>化合物库是按照特殊的研究目的研制的大量化合物集合，应用于高通量药物筛选，可帮助找到新药研发的先导化合物。随着人工智能大数据和实验筛选模型的迅速发展，化合物筛选已成为发现先导化合物的主要途径，因此化合物库的建设已经是我国发展创新药物研究的工作重点。</p><p><!-- /wp:paragraph --></p>					</div>
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<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><span style="font-weight: 600; font-synthesis: style;"><strong style="color: #000080;"><b>【化合物库管理】</b></strong><i><br /></i></span></p>
<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><span style="font-weight: 600; font-synthesis: style;"><i>“使用 Chemspeed <a href="https://www.nikyang.com/benchtop-solutions/chemspeed/gdu-series/swile/">SWILE</a> 工具可以更精确、更快速的进行亚毫克级别的化合物分配任务。它采用决策式分配过程，无死体积，无交叉污染，可实现一对一或一对多的加样方式。即使是 100µg 这样人手操作时束手无策的量也可以进行准确添加，无论是准确度还是精确度都可以满足严苛的标准。”</i></span></p>
<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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<p>化合物库中的化合物重新分配的过程，它通常面临三大难点：第一，化合物的种类繁多；第二，毫克或者是毫克级别以下的化合物分配时的高误差；第三， 96 / 384 孔板操作时位置上出错。而 Chemspeed 的解决方案中，完美的解决了以上三个难点。</p>
<p><a href="https://www.nikyang.com/benchtop-solutions/chemspeed/">Chemspeed</a> 的化合物库管理要用到的一个非常关键的工具叫 SWILE (取样分配工具)。它适合于毫克级别的化合物或是毫克以下的几百微克化合物的精确且快速的分配过程，SWILE 通过顶置式天平抓取的毛细管活塞来进行物料分配。根据不同的加料需求、不同量的范围，Chemspeed 有不同规格的毛细管可供选择。</p>
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												<img width="720" height="357" src="/wp-content/uploads/2021/03/Chemspeed-SWILE-Detail.jpg" class="attachment-large size-large" alt="化合物库管理 - Chemspeed SWILE 自动加样工具" srcset="/wp-content/uploads/2021/03/Chemspeed-SWILE-Detail.jpg 720w, /wp-content/uploads/2021/03/Chemspeed-SWILE-Detail-300x149.jpg 300w" sizes="(max-width: 720px) 100vw, 720px" />														</div>
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				<p><!-- wp:paragraph --></p><div style="caret-color: #000000; color: #000000;"><div><p>SWILE 一个非常关键的特点是其取样决策分配过程。具体指在原料瓶中取样结束之后，天平会对取样的量首先做一个判定，例如设定目标分配的量为 5 毫克，取样完成后天平随后进行判定，如果取样的量大于或等于 5 毫克，天平才会执行下一个分配任务，如果没有达到 5 毫克，天平会再次进行提取直到 5 毫克。这个特点可以最大限度地保证在加样过程的效率和准确性。</p><p>SWILE 对不同性质、不同类型的化合物进行了分配测试，测试样品包括了密度小且非常松散的气相的硅胶、实验室常用到的金属配合物、或者是香草醛为代表的以纯的有机物。从结果中可以看到， 1 毫克级别以下的准确度达到了 10% 左右。随着分配质量的逐渐增大，准确度会有一个非常大的提升，到 5 毫克的时候，准确度可达到 2% 以内。过往经验证明，人手准确分配一毫克以下的物料，几乎是不可能的，如果在分配过程中稍微地不小心，带来误差几乎都是 100% 以上的，所以说一毫克级别的加料对人手操作来说是极大的挑战。对于这种人手操作束手无策的微量物质加样过程，SWILE 可以进行自动化的准确添加，无论是准确度还是精确度都可以满足严苛的标准。</p></div></div><p><!-- /wp:paragraph --></p>					</div>
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				<p><!-- wp:paragraph --></p><div style="caret-color: #000000; color: #000000;"><p>视频案例中是SWILE 在 384 孔板上进行一个矩阵式的加样过程，384 孔板相较于常用的 96 孔板，其孔数更多，间隔更小，在视觉上极易造成混乱，尤其是在大批量按照 384 个孔的顺序进行加样操作的过程中，很容易因为无法准确识别每个孔的位置，而造成错加或漏加。借助自动化技术可以轻松解决这一难题，我们可将实验设计软件如 JMP、或编辑好的 excel 文件直接导入控制软件，无需手动逐一输入加样参数。仪器操作过程中自动记录所有数据，并可再以 excel 文件格式导出，方便查找和溯源，不会再因数据混乱而导致实验失败。 </p></div><p><!-- /wp:paragraph --></p>					</div>
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										<img width="720" height="354" src="/wp-content/uploads/2021/03/Chemspeed-SWILE-Automated-Platform.jpg" class="attachment-large size-large" alt="Chemspeed SWILE 全自动药物研发平台" srcset="/wp-content/uploads/2021/03/Chemspeed-SWILE-Automated-Platform.jpg 720w, /wp-content/uploads/2021/03/Chemspeed-SWILE-Automated-Platform-300x148.jpg 300w" sizes="(max-width: 720px) 100vw, 720px" />											<figcaption class="widget-image-caption wp-caption-text">Chemspeed SWILE 自动化操作平台</figcaption>
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												<img width="781" height="424" src="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg" class="attachment-large size-large" alt="实验室自动化专家-杜世振博士Dr. Simon Du专家简历" srcset="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg 781w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-300x163.jpg 300w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-compound-management/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (二)</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>
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		<title>[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (一)</title>
		<link>https://nikyang.com/expert-column/simon-powder-dispensing/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Wed, 24 Feb 2021 01:00:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[微量粉末分配]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
		<guid isPermaLink="false">http://www.nikyang.com/?p=10454</guid>

					<description><![CDATA[<p>前沿：固体粉末的分配在药物研发过程中的重要性 在医</p>
<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-powder-dispensing/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (一)</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>
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<p><span style="color: #000080;"><strong><b>前沿：固体粉末的分配在药物研发过程中的重要性</b></strong></span></p>
<p>在医药开发中，实验室自动化技术扮演着越来越重要的作用，特别是随着高通量筛选的普遍运用，自动化技术已成为全球知名药企的必备武器之一。在实际研发过程中，几乎所有反应都会涉及固体试剂，而高通量筛选过程更是对固体试剂的分配提出了高数量、高重复性、高准确性的要求。自动化的固体分配技术不仅可以将技术人员从重复性操作中解放出来，更重要的是从根本上避免了人为误差的发生，最大程度上提高了重复性，完美解决现有的瓶颈问题，最终为新药开发节约了宝贵的时间和人力成本，让药物研发速度和质量迈上更高的台阶。 </p>
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<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><span style="font-weight: 600; font-synthesis: style;"><strong style="color: #000080;"><b>【固体全自动分配方案】</b></strong><i><br /></i></span></p>
<p style="margin-top: 1.4em; margin-bottom: 1.4em; caret-color: #121212; color: #121212; font-family: -apple-system, BlinkMacSystemFont, 'Helvetica Neue', 'PingFang SC', 'Microsoft YaHei', 'Source Han Sans SC', 'Noto Sans CJK SC', 'WenQuanYi Micro Hei', sans-serif;"><span style="font-weight: 600; font-synthesis: style;"><i>“使用 <a href="https://www.nikyang.com/benchtop-solutions/chemspeed/">Chemspeed</a> GDU-P / GDU-P (fd) 可以轻松地完成毫克级别的固体粉末称重分配任务，适用于高重复性和高通量的固体分配任务，可达到人手操作所不能及的高效，且误差基本上都控制在 5% 以内。”</i></span></p>
<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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<p>在固体全自动分配方案中我们所用到的重点工具是适用于固体/粉末的顶置式 称重加样工具， GDU-P 或者是 GDU-P (fd) 。两者在粉末分配量稍有区别，GDU-P (fd)适用于单次分配 30 克以下固体样品的精细分配过程，天平分辨率可以达到 0.1 毫克; GDU-P 适用于固体 / 粉末的普通分配，它可以单次分配 0 – 100 克的固体样品，天平分辨率为 1 毫克。在分配过程中，固体 / 粉末样品会提前储存到GDU-P / GDU-P (fd) 物料罐里，分配任务执行时，机械手会带着天平把物料罐抓取到容器上方进行分配。</p>
<p>如下图展示了 GDU-P 内部的结构，里边有螺旋推出杆，可以保证样品顺利地从样品罐中分配出来。</p>
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												<img width="900" height="503" src="/wp-content/uploads/2021/02/Chemspeed-GDU-solid-dispensing-1024x572.jpg" class="attachment-large size-large" alt="固体试剂自动加样" srcset="/wp-content/uploads/2021/02/Chemspeed-GDU-solid-dispensing-1024x572.jpg 1024w, /wp-content/uploads/2021/02/Chemspeed-GDU-solid-dispensing-300x168.jpg 300w, /wp-content/uploads/2021/02/Chemspeed-GDU-solid-dispensing-768x429.jpg 768w, /wp-content/uploads/2021/02/Chemspeed-GDU-solid-dispensing.jpg 1280w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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<p>在分配过程中，控制软件会根据分配量的大小和精度来控制物料罐出口物的开关大小和速度。图中右侧是对不同类型的固体物质做的分配性测试，分别按 1 毫克、10 毫克、20 毫克、100 毫克来进行分配，每次分配 10 次，可以看到，无论是对气溶胶还是金属有机物或是纯的有机物，分配的结果的误差都控制在 5% 以内。 </p>
<p>另一个难点是在固体分配过程中，需要重复精准结果的质量要求十分高。采用 GDU-P 或者是 GDU-P (fd) 可以很轻松地完成这种重复性的工作，且可以很高效和精密地来完成不同量级的分配任务。具体做法是使用 Chemspeed 的控制软件 (AutoSuite) 导入设计好的程序，接着机械手会自动地把原料瓶和目标分配瓶的瓶头打开，然后通过 GDU-P (fd) 或者 GDU-P 按照设定的量进行分配固体，或者是用 <a href="https://www.nikyang.com/benchtop-solution/chemspeed/gdu-series/swile/">SWILE</a> 工具分配这种亚毫克级别的固体粉末。在分配的过程中，如果有必要的话，可以同步进行混合、加热、冷却等过程，分配完成后，机械手将关闭试剂瓶或物料瓶。以此类推重复操作完成这种大量的、多批次的化合物分配过程。</p>
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												<img width="781" height="424" src="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg" class="attachment-large size-large" alt="实验室自动化专家-杜世振博士Dr. Simon Du专家简历" srcset="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg 781w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-300x163.jpg 300w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
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		<p><a rel="nofollow" href="https://nikyang.com/expert-column/simon-powder-dispensing/">[专家专栏 – 实验室自动化] Chemspeed 在药物研发领域的应用案例 (一)</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>
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		<title>[专家专栏 – 实验室自动化] 中国医药市场展望，浅谈制药行业未来新趋势</title>
		<link>https://nikyang.com/news/simon-future-prospect/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Tue, 16 Feb 2021 01:33:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[AI药物研发]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[药物研发]]></category>
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					<description><![CDATA[<p>—— 杜世振丨力扬自动化合成及优化专家 去年 10</p>
<p><a rel="nofollow" href="https://nikyang.com/news/simon-future-prospect/">[专家专栏 – 实验室自动化] 中国医药市场展望，浅谈制药行业未来新趋势</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>
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<p style="text-align: right;"><span style="color: #3366ff;"><strong>—— 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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<p>去年 10 月第十九届中央委员会第五次全体会议通过了 《第十四个五年规划和二〇三五年远景目标的建议》，11 月 3 日，国家正式发布 “十四五” 规划，作为今后五年乃至更长时间中国经济社会发展的行动指南。《建议》中强调 “坚持创新驱动发展，全面塑造发展新优势”，当中整合了资源创新、技术创新和人才创新等等的创新战略，继 “十三五” 规划之后，“十四五” 必然更进一步推动及巩固创新的力量，医药行业定然也能乘风波浪，同步蜕变。《建议》 中也提及一些传统的行业需要进一步走向高端化和智能化，在 “十四五” 的规划下，未来制药工业领域又会有哪些新趋势？以下提出几点与大家分享。</p>
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<p><span style="color: #000080;"><strong>1.</strong> <strong>探索智能研发，自动化系统需求持续增加</strong></span></p>
<p>伴随着医药工业发展迅速、药品生产和质量管理规范日趋严格，我国医药行业一直都在逐步提升，尤其是在疫情下，更多药企开始思考如何加快研发新药，积极探索 AI 新药研发，例如: IBM 的 RoboRXN 云端制药实验室、腾讯的云深智药人工智能药物发现平台，诺华、阿斯利康和辉瑞等等多家药企也在积极探索 AI 在新药研发的应用，可见 AI 药物研发已经成为必然的趋势，而自动化系统及设备是构建智能研发平台中不可或缺的重要部分，像 IBM 的 RoboRXN 云端制药实验室就利用了 Chemspeed 的全自动研发平台，自动处理化合物合成，以加快推断药物的物质成分构成。自动化系统在精确性、可靠性和效率方面都有明显的优势，能帮助药企提高研发效能，因此未来对自动化系统及设备的需求相信也会有上升的趋势。</p>
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										<img width="900" height="524" src="/wp-content/uploads/2021/02/IBM_RoboRXN-1024x596.jpg" class="attachment-large size-large" alt="IBM RoboRXN Chemspeed 全自动智能药物研发平台" srcset="/wp-content/uploads/2021/02/IBM_RoboRXN-1024x596.jpg 1024w, /wp-content/uploads/2021/02/IBM_RoboRXN-300x175.jpg 300w, /wp-content/uploads/2021/02/IBM_RoboRXN-768x447.jpg 768w, /wp-content/uploads/2021/02/IBM_RoboRXN-1536x895.jpg 1536w, /wp-content/uploads/2021/02/IBM_RoboRXN-2048x1193.jpg 2048w" sizes="(max-width: 900px) 100vw, 900px" />											<figcaption class="widget-image-caption wp-caption-text">(IBM RoboRXN 应用的 Chemspeed 的全自动研发平台，图片来源：IBM)</figcaption>
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<p><span style="color: #000080;"><strong>2.</strong> <strong>信息集成，追求数据完整性</strong></span></p>
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<p>智能化建基于对数据的分析，并利用数据进行决策。一些药企以纸质流程的方式管理数据，不仅耗时长，而且容易出错。过去一年在疫情下，更多人员需要远程工作，也突显了数字化相比纸质流程更能有效进行远程传递、纪录及翻查。从 “十三五” 规划以来，我国就强调走向数字化，不少企业都奠定了数字化的基础，然而部分医药企业，由于缺乏有效的自动化和信息化管理系统，以致一些关键的工艺参数、药物信息等有所缺失，而未能完成监控及通过相关法规部门的审批，日后也难以溯源，寻找问题根源。但是如何进行完整及顺畅的数字化，正是目前制药行业面对的一大难题。在制药研发和生产的过程当中，多种设备及仪器之间独立运作，形成了信息断层，仪器之间未能相互沟通，数据未能充分利用。要解决这个难题，就需要自动化的系统集成现有设备的数据，自动进行加载及处理，研究人员及管理者才能掌握更完整的数据，加以监控，并作出最妥善的安排及决策，减少每个阶段的错误。如此一来，数字化才可以真正使药物的研发和生产过程更完善。</p>
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<p><span style="color: #000080;"><strong>3.</strong> <strong>模块化研发及生产，配合精准医疗</strong></span></p>
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<p>纵观全球，精准医疗以至精准用药近年来一直保持增长势头，个性化药物可以针对患者的身体状况或基因差异，使用药更精准同时降低病人所面对的风险及副作用。然而，个性化药物不同于批量制造的产品，唯有通过模块化的方式，才可在同一个工作站上研发或制造多种产品，而无需进行大量的仪器转换，大大降低成本。而且，由多个不同功能的模块组成的工作站，可以按需要延伸，实现即插即用的灵活性。随着精准药物的市场日渐发展，相信模块化的设备将会是未来制药的新趋势。</p>
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												<img width="900" height="600" src="/wp-content/uploads/2021/02/Depositphotos_33602013_1080_72dpi-1024x683.jpg" class="attachment-large size-large" alt="精准医疗，个性化药物针对患者的身体状况或基因差异，更精准投药" srcset="/wp-content/uploads/2021/02/Depositphotos_33602013_1080_72dpi-1024x683.jpg 1024w, /wp-content/uploads/2021/02/Depositphotos_33602013_1080_72dpi-300x200.jpg 300w, /wp-content/uploads/2021/02/Depositphotos_33602013_1080_72dpi-768x512.jpg 768w, /wp-content/uploads/2021/02/Depositphotos_33602013_1080_72dpi.jpg 1080w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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<p>当下，在药物研发中运用数字化、自动化逐渐成为趋势。加上在 “十四五” 的推动下，相信我国的药物研发效能会再进一步提升，企业必须把握机会，建立高端的自动化研发系统及分析设备，结合更多前沿的技术，才能紧贴市场的发展趋势。</p>
<p> </p>
<p><b>参考资料：</b></p>
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<p>1. 王振，冯变玲. 制药行业智能化发展现状趋势及建议. Hearald of Medicine Vol. 36 No. 9. Sep 2017.</p>
<p>2. Pharmaceutical automation trends for 2021. <a href="https://link.zhihu.com/?target=https%3A//www.manufacturingchemist.com/news/article_page/Pharmaceutical_automation_trends_for_2021/173208" target="_blank" rel="noreferrer noopener">https://www.manufacturingchemist.com/news/article_page/Pharmaceutical_automation_trends_for_2021/173208</a></p>
<p>3. How paperless manufacturing can support a virtual workforce environment. <a href="https://link.zhihu.com/?target=https%3A//www.manufacturingchemist.com/news/article_page/Promoting_virtual_form_flow_in_the_pharmaceutical_industry/170499" target="_blank" rel="noreferrer noopener">https://www.manufacturingchemist.com/news/article_page/Promoting_virtual_form_flow_in_the_pharmaceutical_industry/170499</a></p>
<p>4. 案例介绍视频: IBM 与 Chemspeed 采用人工智能驱动的自主化实验室. <a href="https://link.zhihu.com/?target=https%3A//v.youku.com/v_show/id_XNDk1OTU4MzcyMA%3D%3D.html" target="_blank" rel="noreferrer noopener">https://v.youku.com/v_show/id_XNDk1OTU4MzcyMA==.html</a></p>
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												<img width="781" height="424" src="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg" class="attachment-large size-large" alt="实验室自动化专家-杜世振博士Dr. Simon Du专家简历" srcset="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg 781w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-300x163.jpg 300w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
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		<title>[专家专栏 &#8211; 实验室自动化] 一文读懂关于实验室自动化的知识点，以 Chemspeed 为例</title>
		<link>https://nikyang.com/expert-column/simon-chemspeed-introduction/</link>
		
		<dc:creator><![CDATA[Ng, Queenie]]></dc:creator>
		<pubDate>Thu, 11 Feb 2021 03:00:00 +0000</pubDate>
				<category><![CDATA[专家专栏]]></category>
		<category><![CDATA[全自动研发方案]]></category>
		<category><![CDATA[最新动态]]></category>
		<category><![CDATA[Chemspeed]]></category>
		<category><![CDATA[微量粉末分配]]></category>
		<category><![CDATA[药物研发]]></category>
		<category><![CDATA[顶置式称重加样技术]]></category>
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					<description><![CDATA[<p>&#8212;&#8212; 杜世振丨力扬自动化合</p>
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				<p style="text-align: right;"><span style="color: #3366ff;"><strong>&#8212;&#8212; 杜世振丨力扬自动化合成及优化专家</strong></span></p>
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<p>对于从事生物学、基础医学、临床医学等领域的科研工作者来说，自动化工作台在实验室中必不可少，也正因此，科研人员才得以解放双手并将更多的时间和精力投入到更具价值的学术研究当中。 近年来，实验室自动化布局已是常态，越来越多的企业在升级自动化的同时也集成了许多智能化元素，如借助人工智能、大数据、物联网、5G 等新兴技术缔造新一代未来实验室。如果说工业 4.0 的时代已经到来，那么 “实验室 4.0” 更是紧追其后，为生化科研机构、生物医药企业、大学科研所等提供更智能化、数字化、模块化的服务。</p>
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<p>自 2016 年加入力扬企业以来，我参与了材料化学领域的自动化实验室解决方案和技术支持工作，负责欧洲知名的实验室自动化仪器设备提供商 Chemspeed 的高通量 / 自动化研发设备在中国北方的市场开发、客户应用、技术支持工作。</p>
<p><!-- /wp:paragraph --><!-- wp:paragraph --></p>
<p>下面我将以 Chemspeed 为例，为大家详细介绍实验室自动化平台的价值体现。</p>
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<p><span style="color: #000080;"><strong>【关于</strong> <strong>Chemspeed】</strong></span></p>
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<p>Chemspeed 是一家瑞士公司，在化学自动化研发领域有着超过 20 年的专业经验，总部位于巴塞尔，这里是欧洲传统的化学工业和精密加工制造行业的发达地区。一方面，这里众多的化学企业，如罗氏、诺华、巴斯夫、克莱恩化学等给 Chemspeed 相应的化学应用带来了很多先进的经验；另一方面，它先进的精密加工制造行业给 Chemspeed 发展化学自动化带来了硬件上的巨大优势。</p>
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<p>目前 Chemspeed 在全球范围内有着 500 多套不同类型的化学研发自动化设备，超过 70% 的员工都具有化学或者是工程学科的专业背景。对 Chemspeed 来说，它在化学自动化研发领域有着一系列配套的解决方案，比如从样品的制备到样品合成、工艺研究、配方的开发和探索以及后续的应用测试等等，Chemspeed都有相应配套的高通量解决方案。下图展示的螺旋形上升的过程代表了 Chemspeed 独特的研发哲学，这种螺旋形上升的研发哲学不同于我们日常所看到的闭环式研发模式，<strong>它是一个发展的、进化的、不断趋于完善的一个过程。</strong> <strong>Chemspeed</strong> <strong>的愿景是为科学家从新想法的出现，到创造价值的每一步提供创新科技支持，最终的目的是加速客户从构思探索到价值创造的整个过程。</strong></p>
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												<img width="892" height="673" src="/wp-content/uploads/2021/02/Chemspeed-Spiral.jpg" class="attachment-large size-large" alt="Chemspeed研发哲学" srcset="/wp-content/uploads/2021/02/Chemspeed-Spiral.jpg 892w, /wp-content/uploads/2021/02/Chemspeed-Spiral-300x226.jpg 300w, /wp-content/uploads/2021/02/Chemspeed-Spiral-768x579.jpg 768w" sizes="(max-width: 892px) 100vw, 892px" />														</div>
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<p><span style="color: #000080;"><strong>【Chemspeed</strong> <strong>的核心技术】-</strong> <strong>顶置式分配称重单元</strong></span></p>
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<p><strong>Chemspeed</strong> <strong>的关键核心技术之一，是顶置式分配称重单元</strong>。提到加样，我们脑海中首先想到的是把样品放在天平上进行分配、称量，而 Chemspeed 采取顶置式的称重分配过程，彻底地改变了传统的加样方式: 在操作过程中反应容器是固定不动的，而动起来的是天平。具体运行过程是: 机械手把天平抓起来，然后带着样品移动到反应容器上方，按照设定的质量把样品精确的分配到反应容器中，这样的做法一方面显著提高了加样的效率，另一方面加样过程不影响化学反应的进行，比如加热、混合、回流等等，这种加样方式是传统方式所不能达到的。</p>
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<p>可以说顶置式称重分配技术代表了 Chemspeed 最有创新性和颠覆性的自动化理念，彻底改变了传统的加样方式。它可以完成化学研发过程中所有物料的加样过程，比如对不同量级固体物料，从几克甚至上百克，下到毫克甚至是微克级别，Chemspeed 都有成熟和高效的自动加样方案。对于液体，无论是高粘度液体还是普通的常规化学试剂，Chempseed 都可以实现自动化的按体积或按重量的加样过程。</p>
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												<img width="900" height="484" src="/wp-content/uploads/2021/02/Chemspeed-GDU-Series-1024x551.png" class="attachment-large size-large" alt="GDU 全自动加样技术" srcset="/wp-content/uploads/2021/02/Chemspeed-GDU-Series-1024x551.png 1024w, /wp-content/uploads/2021/02/Chemspeed-GDU-Series-300x161.png 300w, /wp-content/uploads/2021/02/Chemspeed-GDU-Series-768x413.png 768w, /wp-content/uploads/2021/02/Chemspeed-GDU-Series.png 1263w" sizes="(max-width: 900px) 100vw, 900px" />														</div>
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<p><span style="color: #000080;"><strong>【Chemspeed</strong> <strong>的核心技术】-</strong> <strong>反应器技术</strong></span></p>
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<p>另外一个非常关键的技术是 <strong>Chemspeed</strong> <strong>的反应器技术，反应器技术是 Chemspeed</strong> <strong>长期和不同的大型化学化工企业共同合作开发的反应器解决方案，</strong>包括常压合成模块、高压合成模块、小体积合成模块、工艺开发反应器、配方开发反应器等等，这些反应器技术都是与巴塞尔地区的世界著名化学化工企业，像诺华、巴斯夫、欧莱雅等共同开发而来，最终成为了 Chemspeed 的专利产品，并逐步推向世界，服务于全世界的客户。</p>
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<p><span style="color: #000080;"><strong>【划重点】</strong></span></p>
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<p><strong>Chemspeed</strong> <strong>的自动化平台的构建过程</strong>主要包含两个步骤，1) 根据需求选择不同的试剂加样工具；2) 搭配不同的反应器技术，并结合 Chemspeed 专有的控制软件 (AutoSuite)，即完成模块化的平台构建过程。根据需求，平台上的工具或反应器可以随时替换或升级，以应对不同的新实验流程。</p>
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												<img width="781" height="424" src="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg" class="attachment-large size-large" alt="实验室自动化专家-杜世振博士Dr. Simon Du专家简历" srcset="/wp-content/uploads/2021/02/Simon_Profile_with_QRcode.jpg 781w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-300x163.jpg 300w, /wp-content/uploads/2021/02/Simon_Profile_with_QRcode-768x417.jpg 768w" sizes="(max-width: 781px) 100vw, 781px" />														</div>
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