药物制剂产业化发展的前沿科学技术问题探讨  

Discussion of Frontier Science and Technology for Pharmaceutical Preparation Industrialization

作　　者：刘昌孝[1] 王玉丽[1,2] LIU Chang-xiao;WANG Yu-li(State Key Laboratory of Drug Delivery Technology and Pharmacokinetics,Tianjin Institute of Pharmaceutical Research;Institute of Chemical Engineering,Tianjin University)

机构地区：[1]天津药物研究院释药技术与药代动力学国家重点实验室 [2]天津大学化工学院

出　　处：《中国食品药品监管》2021年第1期6-15,共10页China Food & Drug Administration Magazine

摘　　要：随着国际医药产业格局的变化,新药投入风险越来越大。与开发一个新分子实体相比,新剂型的创新路径具有周期短、投资少、风险小、回报高等特点。企业逐步从原料药研发向下游制剂和具有自主品牌的高端制剂创新发展。国家政策鼓励药企创新发展制剂技术和药物释放系统(DDS)等,开发新型制剂、改良型制剂(如创新的给药释药系统),以及鼓励中药“经典名方”向高端中药制剂研发,提高已上市药物的安全性、有效性和临床依从性。高端制剂是新药研发的重要方向,也是应对国际、国内药企竞争的发展战略和策略。本文针对中国药物制剂高质量发展所关注的问题,对比分析国内外药物制剂情况,围绕药物制剂发展的挑战、高端制剂、释药技术与药动学、科学技术问题等方面予以评述。With the development of international pharmaceutical industry,the risk of new drug investment is increasing.Compared with developing a new molecular entity,the innovation path of developing new dosage forms has the characteristics of short development cycle,less investment,low risk and high return.Therefore,pharmaceutical companies will inevitably transition from the development of API to the innovation and development of downstream preparations and complex preparations with independent brands.National policies encourage pharmaceutical enterprises to develop innovative preparation technology and drug delivery system(DDS),to develop new preparations and improved new drug preparations(such as innovative drug delivery and release system),and encourage the development of complex preparations for traditional Chinese medicine“classic prescription”,so as to improve the safety,effectiveness and clinical compliance of marketed drugs.Complex preparation is an important trend for new drug development,and an industry development strategy in coping with international and domestic competition.This paper discusses issues central to the highquality development of pharmaceutical preparations in China,including the challenges of pharmaceutical preparations development,complex preparations,drug release technology and pharmacokinetics,and other new technologies.

关 键 词：高端制剂 技术 释药技术与药动学 工艺 辅料 产业化 

分 类 号：R95[医药卫生—药学]