关于中药新药用饮片质量标准研究的思考  

Thoughts on Specifications for Chinese Herbal Pieces Used in New TCM Drugs

作　　者：王玲玲 吴静义 林丹 唐溱 顾杰 李计萍[1] WANG Ling-ling;WU Jing-yi;LIN Dan;TANG Zhen;GU Jie;LI Ji-ping(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2021年第9期94-99,共6页China Food & Drug Administration Magazine

摘　　要：近年来,中药饮片质量问题频发,对饮片质量控制和监管带来了较大的考验。中药饮片作为衔接药材与中药制剂的桥梁,其质量直接影响中药制剂的质量。中药新药用饮片规格可与临床调剂用饮片不同,其质量控制方法的制定应结合中药新药研究设计的需要。2020年10月12日,国家药品监督管理局药品审评中心发布了《中药新药用饮片炮制研究技术指导原则》。本文以该指导原则的发布实施为契机,分析了中药新药用饮片质量标准现状,并讨论了中药新药用饮片质量标准研究的思路。本文认为中药新药用饮片质量标准研究过程中应关注:①注重饮片整体质量控制,充分考虑药材、饮片、中药制剂的关联性;②提高质控项目及指标成份设定的专属性;③动物来源饮片应对人畜共患病原微生物进行研究;④加强炮制用辅料的原材料源头控制、制备过程控制和辅料成品质量控制研究;⑤根据饮片稳定性研究情况,确定合适的饮片贮藏条件与养护技术。In recent years,quality problems with Chinese herbal pieces have been exposed frequently,presenting a serious challenge to the quality control and supervision of Chinese herbal pieces.As a bridge between Chinese medicinal materials and traditional Chinese medicine(TCM)preparations,the quality of Chinese herbal pieces directly affects the quality of the TCM preparations.The specifications for Chinese herbal pieces used in new TCM drugs can be different from those in clinical preparations.The quality control methods of Chinese herbal pieces should meet the needs of research and design of new TCM drugs.On October 12,2020,the Center for Drug Evaluation of National Medical Products Administration issued the Guidance on the Processing of Chinese Herbal Pieces for New TCM Drugs.This article analyzes the current status and research methods of specifications for Chinese herbal pieces used in new TCM drugs.Some suggestions are put forward.Firstly,attentions should be paid to the overall quality control of Chinese herbal pieces by fully considering the correlation among Chinese medicinal materials,Chinese herbal pieces,and TCM preparations.Secondly,specificity should be stressed when setting quality control items and markers.Thirdly,studies should be done on zoonotic pathogens with Chinese herbal pieces of animal origin.Fourthly,more efforts are needed to strengthen source control of raw materials,processing control,and quality control of excipients.Lastly,according to stability studies,appropriate storage conditions and maintenance technology should be selected for storing Chinese herbal pieces.

关 键 词：中药新药 饮片质量标准 炮制用辅料 饮片贮藏与养护 

分 类 号：R95[医药卫生—药学]