中药材和饮片质量控制与质量标准体系的构建  

Quality Control and Standard System Construction of Chinese Crude Drugs and its Decoction Pieces

作　　者：屠鹏飞[1] 姜勇 何轶 石上梅[2] 钱忠直[2] TU Peng-fei;JIANG Yong;HE Yi;SHI Shang-mei;QIAN Zhong-zhi(State Key Laboratory of Natural and Biomimetic Drugs,School of Pharmaceutical Sciences,Peking University;Chinese Pharmacopoeia Commission)

机构地区：[1]北京大学药学院,天然药物及仿生药物国家重点实验室 [2]国家药典委员会

出　　处：《中国食品药品监管》2022年第10期34-45,共12页China Food & Drug Administration Magazine

基　　金：国家重点研发计划项目(2018YFC1707300,2018YFC1707904)。

摘　　要：中药材是中药饮片和中成药生产的起始原料,是中医药事业和中药产业发展的物质基础。中药饮片是临床用药和中成药生产的直接原料,直接影响中药的临床疗效和中成药的质量。本文基于中药质量控制与质量标准是保障中药“质量一致性,生物等效性,用药安全性”的理念,提出中药材和饮片生产过程质量控制要点以及质量标准体系构建思路,以期为中药产业高质量发展提供参考。Chinese crude drug is the starting material of decoction pieces of traditional Chinese medicine(TCM)and Chinese patent medicine,and also the material basis for developing TCM and TCM industry.Decoction pieces of TCM are the raw materials for clinical medication and production of Chinese patent medicine,which directly affect the clinical efficacy and quality of Chinese patent medicines.Herein,based on the concept that quality control and quality standard are the guarantee for the“quality consistency,bioequivalence,and safety”of TCM,this paper puts forward the key points of quality control for the production of Chinese crude drug and its decoction pieces,as well as the idea of constructing quality standard system,so as to provide reference for the high-quality development of TCM industry.

关 键 词：中药材 中药材生产 中药饮片 质量控制 质量标准 

分 类 号：R288[医药卫生—中药学]