王智民,刘菊妍,刘晓谦,王德勤,闫利华,朱晶晶,高慧敏,李春,王锦玉,李楚源,倪庆纯,黄暨生,林娟
WANG Zhi-min,LIU Ju-yan,LIU Xiao-qian,WANG De-qin,YAN Li-hua,ZHU Jin-jin,GAO Hui-min,LI Chun,WANG Jin-yu,LI Chu-yuan,NI Qing-chun,HUANG Ji-sheng,LIN Juan

• 1:中国中医科学院中药研究所中药质量控制技术国家工程实验室
• 2:广州医药集团有限公司
• 3:广州白云山和记黄埔中药有限公司
• 4:广州医药研究总院有限公司

摘要(Abstract)：

经典名方是中药方剂的杰出代表,是历代医家临床经验的总结,是中医药宝库中最精华部分。为支持经典名方开发,国家及相关管理部门先后发布了相关鼓励性政策,但是研究中的一些关键问题目前还未能形成共识,因此经方的开发仍然任重道远。该文在分析主要发达国家对植物药研发、注册和管理规定的基础上,结合经典名方的实际,对其未来研发可能遇到的难关和关键问题进行了分析和建议,首次提出了"基于传统制法的对照汤剂"用于经典名方"原汁原味"研发的一致性评价,强调在质量一致性策略中的全成分质量平衡一致性和生物效价一致性用于生产工艺、过程控制和成品质控,同时提出应充分关注和考证处方的组成、剂量、药材基原等问题。此外,还就经典名方产品上市后可能出现的问题及相应解决办法提出了建议,以期达到能抛砖引玉,推动经典名方简化注册的进程。
As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties,classical TCM excellent prescriptions(c TCMe P) are the most valuable part of TCM system. To support the research and development of c TCMe P,a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology,registration and administration in c TCMe P R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan,and EMA of Europe,the possible key problems and countermeasures in chemistry,manufacture and control(CMC) of simplified registration of c TCMe P were analyzed on the consideration of its actual situation. The method of " reference decoction extract by traditional prescription"(RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of c TCMe P,instead of Standard Decoction method in Japan. " Totality of the evidence" approach,mass balance and bioassay/biological assay of c TCMe P were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material,drug substance and final product between the modern product and traditional decoction.

关键词(KeyWords)： 中药;经典名方;化学、生产和质量控制;研发策略;监督管理
traditional Chinese medicine;classical TCM excellent prescriptions(cTCMeP);chemistry;manufacture and control(CMC);research and development strategies;supervision and administration

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2017ZX09201010-001);; 2015年中医药行业科技专项(201507002-2,201507002-3)

作者(Author): 王智民,刘菊妍,刘晓谦,王德勤,闫利华,朱晶晶,高慧敏,李春,王锦玉,李楚源,倪庆纯,黄暨生,林娟
WANG Zhi-min,LIU Ju-yan,LIU Xiao-qian,WANG De-qin,YAN Li-hua,ZHU Jin-jin,GAO Hui-min,LI Chun,WANG Jin-yu,LI Chu-yuan,NI Qing-chun,HUANG Ji-sheng,LIN Juan

DOI: 10.19540/j.cnki.cjcmm.2017.0073

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