| 关皓月,张广超,牛剑钊,许鸣镝.平行人工膜体外渗透技术在药物一致性评价中的应用[J].中国药事,2020,34(8):891-896 |
| 平行人工膜体外渗透技术在药物一致性评价中的应用 |
| Application of PAMPA in Drug Evaluation of Drug Consistency |
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| DOI：10.16153/j.1002-7777.2020.08.006 |
| 中文关键词: 平行人工膜技术 体外渗透 一致性评价 仿制药 处方筛选 |
| 英文关键词: parallel artificial membrane permeability assay in vitro permeability evaluation of drug consistency generic drug prescription screening |
| 基金项目:国家“重大新药创新”科技重大专项资助项目(编号 2017ZX09101001) |
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| 中文摘要: |
| 目的：平行人工膜体外渗透技术(PAMPA)是一种较为快速可靠的可预测药物渗透性的方法， 本文梳理了平行人工膜体外渗透技术在药物一致性评价中的应用。方法：通过查阅国内外文献中关于平行人工膜体外渗透试验及评价方法，介绍平行人工膜体外渗透概念及分类，总结并梳理了该方法在原辅料及制剂方面的应用。结果与结论：PAMPA在化合物筛选、制剂开发及验证等方面具有快速高通量筛选的优势，同时也为药物吸收预测方面增加了多角度全方位考察，有效的提高研发质量和研发效率。 |
| 英文摘要: |
| Objective: Parallel artificial membrane permeability assay(PAMPA) is one of the main method for the permeability prediction. This paper summarized the application of PAMPA in drug research and development (R&D). Methods: Through introducing the conception and classification of PAMPA, consulting literature at home and abroad, the application of PAMPA was summarized. Results and Conclusion: PAMPA shows the advantatges in rapid high throughput screening for compound screening, preparation development and validation. Meanwhile, it also adds a multi-angle inspection to the drug absorption prediction which can effectively improve the quality and efficiency of R&D. |
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