改良型透皮给药系统的开发要点阐述  

Key Points in Research and Development of Improved Transdermal Drug Delivery System

作　　者：卢望丁 朱慧勇[1] 黄英 杨晓钰 胡阳阳 罗华菲[1] LU Wangding;ZHU Huiyong;HUANG Ying;YANG Xiaoyu;HU Yangyang;LUO Huafei(National Pharmaceutical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;Guangdong Province Hydropower Hospital,Guangzhou 511300)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203 [2]广东省水电医院,广东广州511300

出　　处：《中国医药工业杂志》2022年第5期621-628,共8页Chinese Journal of Pharmaceuticals

摘　　要：透皮给药系统在改良型新药的开发中有其特有的临床优势,且显示了较好的市场价值。本研究分析了近年来FDA 批准的透皮贴剂产品的特点,从透皮给药系统在提高患者依从性以及药物使用安全性的角度进行分析,并介绍了改良型透皮贴剂的非临床研究及临床试验要求,期望为改良型透皮制剂的开发提供借鉴思路。同时,介绍了透皮贴剂产品研发过程中的技术要点。Transdermal drug delivery system shows unique clinical advantages as well as commercial value in the development of improved new drugs.This review analyzes the characteristics of transdermal patches approved by FDA in recent years from the perspectives of improving patient compliance and drug safety,and introduces the non-clinical and clinical assessment requirements of improved transdermal patches.It is expected to provide some references for the development of improved transdermal products.Meanwhile,the critical aspects in the development process of transdermal patches are also introduced.

关 键 词：透皮给药系统 改良型新药 透皮贴剂 

分 类 号：R944.9[医药卫生—药剂学]