摘要
在皮肤用制剂的开发过程中,药物渗透性评估有助于理解产品的质量和性能。近年来,体外透皮试验(in vitro permeation test,IVPT)被广泛用于皮肤用制剂的研发及其生物等效性评价。但IVPT过程复杂,对研究人员的操作要求较高,且数据准确性和重现性易受皮肤、试验参数设置等多种因素的影响。国内外的药品监管机构制定了IVPT相关的指导原则,从试验设计、仪器选择、试验操作及数据分析等方面提供了规范的指导,促进了IVPT更好的应用与发展。本文汇总了美国FDA、EMA和NMPA发布的IVPT法规要求,结合本实验室的实践经验,综述了IVPT研究的关键要素,期望为业内人士提供参考。
Permeation study is very helpful to understand the quality and property of topical and transdermal products during the product development process.In recent years,in vitro permeation test(IVPT)has been widely used in the development and bioequivalence evaluation of dermatological products.However,the IVPT process is complicated,which requires well trained and skillful researchers.Data accuracy and reproducibility are easily affected by various factors such as skin and test parameter settings.Domestic and foreign regulatory agencies have provided standardized guidances in terms of experiment design,instrument selection,test operation and data analysis,which promote better development and application of IVPT.This paper summarizes the regulatory requirements of IVPT issued by the FDA,EMA and NMPA,and reviews the key factors of IVPT research combined with our laboratory’s practical experience,so as to provide some references for peers.
作者
马欢
赵静
葛庆华
郭晓迪
闻萍
MA Huan;ZHAO Jing;GE Qinghua;GUO Xiaodi;WEN Ping(National Pharmaceutical Engineering and Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;Prinbury Biopharm Co.,Ltd.,Shanghai 201203;Zhejiang Huahai Pharmceutical Co.,Ltd.,Linhai 317024)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2021年第8期1010-1018,1036,共10页
Chinese Journal of Pharmaceuticals
关键词
皮肤用制剂
体外透皮试验(IVPT)
法规要求
应用实例
dermatological product
in vitro permeation test(IVPT)
regulatory requirement
application example
