透皮贴剂质量控制与评价研究进展  

Research progress in quality control and evaluation of transdermal patches

作　　者：马迅[1,2] 左宁 陈华[1] 李又欣[2] MA Xun;ZUO Ning;CHEN Hua;LI You-xin(National Institute for Food and Drug Control, Beijing 102629 , China;School of Pharmacy, Yantai University, Yantai 264005 , China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]烟台大学药学院,烟台264005

出　　处：《中国新药杂志》2019年第5期551-557,共7页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2015ZX09303001);北京市科技计划课题资助项目(Z151100000115013)

摘　　要：透皮贴剂可将药物透过皮肤表面非侵入性递送到皮肤深部或循环系统,具有许多优于常规注射剂和口服制剂的优点,国内外已有多种透皮贴剂的上市产品。本文结合国内外透皮贴剂产品上市情况、质量控制现状、体外生物评价方法及皮肤吸收评价的数学模型等对透皮贴剂的质量控制与评价的研究进展进行综述。Transdermal patches,which can deliver drugs from skin surface to the deep skin or circulatory system in a non-invasive way,have many advantages over conventional injection and oral methods. There are a variety of transdermal patches available in both domestic and overseas. In this review,the research progress of quality control and evaluation of transdermal patch products was expounded in following aspects,such as onsale-products situation,current situation of quality control,in vitro biological evaluation method research,skin absorption mathematical model evaluation and others.

关 键 词：透皮贴剂 质量控制 体外生物评价 数学建模 

分 类 号：R972.6[医药卫生—药品]