经皮给药系统产业化开发的关键问题探讨-药学进展.pdfVIP

PROGRESS IN PHARMACEUTICAL SCIENCES 2016,40 7 :490-497 490 ( ) 经皮给药系统产业化开发的关键问题探讨 罗华菲 *，林国钡，朱壮志，张成豪 （中国医药工业研究总院药物制剂国家工程研究中心，上海 20203） [ 摘要 ] 以经皮给药系统的开发及产业化为主体思路，在对经皮给药系统发展现状认识的基础上，重点对经皮给药产品研发中的吸收模型 及体内外相关性评价研究、产业化设备、国内外研发模式等进行初步探讨，分析经皮给药系统开发中存在的问题和挑战并提出相应的解 决方案，以期为今后国内经皮给药制剂的发展提供思路。 [ 关键词 ] 经皮给药系统；产业化；体内外相关性研究；研发模式 [ 中图分类号 ] R944 [ 文献标志码 ] A [ 文章编号 ] 1001-5094（2016）07-0490-08 Discussions on Key Problems in Industrial Development of Transdermal Drug Delivery Systems LUO Huafei, LIN Guobei, ZHU Zhuangzhi, ZHANG Chenghao (National Pharmaceutical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai 201203, China) [Abstract] Based on the current development of transdermal drug delivery systems in China and with the purpose of promoting its development and industrialization, this article discussed absorption models in RD of transdermal drug delivery systems, the correlation between in vitro and in vivo studies, equipment for industrial scale production as well as the RD modes at home and abroad. Meanwhile, the current problems and challenges in the development of transdermal drug delivery systems were analyzed, so as to provide ideas for future development of transdermal drug delivery systems in China. – [Key words] transdermal drug delivery system; industrialization; in vitro in vivo correlation study; RD strategy 1979年，美国食品药品管理局（FDA）批准了首 距主要体现在：缺乏规范、标准的评价体系，产品研 个经皮给药系统（TDDS）产品——东莨菪碱透皮贴剂 发缺少科学、合理的指导和控制，导致研发效率低、 （TransdermScop）上市。经过几十年的发展，经皮给 产品内在质量差；TDDS的新剂型、新技术开发力度 药领域取得了重大进展，已有许多新技术、新剂型应 不够，除了被动释药的透皮贴剂，国外已有多种相关 用于该领域，剂型从初期的透皮贴剂发展到涵盖凝胶 新剂型、新技