| 平行人工膜体外渗透技术在药物一致性评价中的应用 |
| |
| 引用本文： | 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. |
| |
| 作者姓名： | 关皓月 张广超 牛剑钊 许鸣镝 |
| |
| 作者单位： | 中国食品药品检定研究院,北京 100050 |
| |
| 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) |
| |
| 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。
|
| 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 |
Application of PAMPA in Drug Evaluation of Drug Consistency |
| |
| Guan Haoyue,Zhang Guangchao,Niu Jianzhao,Xu Mingdi.Application of PAMPA in Drug Evaluation of Drug Consistency[J].Chinese Pharmaceutical Affairs,2020,34(8):891-896. |
| |
| Authors: | Guan Haoyue Zhang Guangchao Niu Jianzhao Xu Mingdi |
| |
| Institution: | National Institutes for Food and Drug Control,Beijing 100050 , China |
| |
| Abstract: | 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. |
| |
| Keywords: | |
|
| 点击此处可从《中国药事》浏览原始摘要信息 |
| 点击此处可从《中国药事》下载免费的PDF全文 |
|
