经典名方复方制剂研发策略  

Research and Development Strategy of Classical Formula Compound Preparation

作　　者：刘艳[1] 章军[1] 陈士林[1] 程锦堂[1] 李冬雪[2] 刘安[1] LIU Yan;ZHANG Jun;CHEN Shi-lin;CHEN Jing-tang;LI Dong-xue;LIU An(Institute of Chinese Materia Medica,China Academy of Chinese Medical Science,Beijing 100700,China;China National Center for Biotechnology Development,Beijing 100039,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中国生物技术发展中心,北京100039

出　　处：《中国实验方剂学杂志》2019年第24期166-172,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(81703948);国家“重大新药创制”科技重大专项(2018ZX09201010-001-003)

摘　　要：尽管国家颁布了100首经典名方目录,但是从经典名方开发成复方制剂依然面临着很多困惑和抉择。本文从成药性评价、工业化考量和临床定位三个角度阐述了经典名方复方制剂的研制策略。成药性评价主要考虑药学和临床前安全性两部分内容,应着重把握物质基准、用药剂量、"有毒"药味、临床使用等因素影响。工业化考量需重点关注如何采用现代工业化方法,制备出与物质基准等质的现代制剂。采用提取物投料也许是解决饮片利用率不高、工业化优势不能充分发挥等问题的有效方法。临床定位应明确主效应,兼顾次效应,重视负效应,考虑临床价值的高低。文中提出的研究思路和若干策略,旨在为企业及研究者挑选适宜品种进行研发布局提供参考,以期抛砖引玉,更好的推进经典名方复方制剂开发。Although the country has promulgated a list of 100 classical famous formula,there are still many confusions and choices in the development of compound preparations from classical prescriptions.In this paper,the development strategy of classical formula compound preparation was elaborated from three aspects:the evaluation of draggability,the consideration of industrialization and the clinical orientation.The draggability evaluation includes pharmacy and preclinical safety.It should focus on the factors such as substance benchmark,dosage,toxic herbal medicines,clinical use and so on.Industrialization considerations need to focus on how to use modern industrialization methods to prepare modern compound preparations with the same quality as material benchmarks.The use of extracts may be an effective way to solve the problems of low utilization rate of decoction pieces and inadequate industrial advantages.Clinical orientation should be clear about the main effect,take into account the secondary effect,pay attention to the negative effect,and consider the level of clinical value.A series of corresponding development strategies and ideas are proposed in order to provide references for enterprises and researchers who select and layout classical famous formula,to promote the development of classical prescription compound preparation.

关 键 词：经典名方 复方制剂 研发策略 成药性 工业化 临床定位 

分 类 号：R2[医药卫生—中医学] R1