透皮制剂质量评价要点分析及开发策略  

Analysis of quality evaluation key points of transdermal preparations and its development strategy

作　　者：宋波 张文晋 康传志 SONG Bo;ZHANG Wen-jin;KANG Chuan-zhi(Center For Food and Drug Inspection,National Medical Products Administration,Beijing 100037,China;Resource Center of Chinese Materia Medica,National Key Laboratory of Daodi Medicinal Materials Cultivation Base,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100037 [2]中国中医科学院中药资源中心道地药材国家重点实验室培育基地,北京100700

出　　处：《中国新药杂志》2022年第19期1865-1871,共7页Chinese Journal of New Drugs

基　　金：中国中医科学院科技创新工程资助项目(CI2021A 03905);国家重点研发计划项目(2020YFC1712702);现代农业产业技术体系建设专项资助项目(CARS-21)。

摘　　要：透皮制剂具有诸多优于口服制剂和常规注射剂的优点,国内外已上市多种透皮制剂。本文简要概述了各类透皮制剂的作用机制、结构、处方组成、制备工艺。在此基础上分析了透皮制剂需要重点关注的质量评价要点,包括产品的透过性、释放度、黏附性、皮肤滞留量、含量等。提出透皮制剂产品开发过程中只有基于风险合理选用原料、辅料及溶剂,选择适宜的制备工艺,才能制备出符合质量要求的透皮制剂。Transdermal preparations have many advantages over oral preparations and conventional injections,and many transdermal preparations have been marketed in China and abroad.This article briefly summarizes the mechanism of action,structure,formulation and preparation process of various transdermal preparations.On this basis,the quality evaluation points of the preparations that need to be paid attention to are analyzed,including product permeability,release,adhesion,skin retention,content,etc.We proposed that in the development process of transdermal preparations,it is rational to select raw materials,auxiliary materials and solvents,and choose appropriate preparation processes based on risks that can prepare transdermal preparations meeting the quality requirements.

关 键 词：透皮制剂 质量评价 开发策略 

分 类 号：R94[医药卫生—药剂学]