《中药生物效应检测研究技术指导原则(试行)》解读  

Interpretation of Guidance on Biological Assay of Traditional Chinese Medicine

作　　者：李慧 朱家谷[1] 杨平 陈浩 吴静义 刘思燚 王伽伯 肖小河 马秀璟[1] LI Hui;ZHU Jia-gu;YANG Ping;CHEN Hao;WU Jing-yi;LIU Si-yi;WANG Jia-bo;XIAO Xiao-he;MA Xiu-jing(Center for Drug Evaluation,National Medical Products Administration;School of Traditional Chinese Medicine,Capital Medical University;China Military Institute of Chinese Medicine,Fifth Medical Center of Chinese PLA General Hospital)

机构地区：[1]国家药品监督管理局药品审评中心 [2]首都医科大学中医药学院 [3]解放军总医院第五医学中心全军中医药研究所

出　　处：《中国食品药品监管》2021年第9期88-93,共6页China Food & Drug Administration Magazine

摘　　要：为制定并完善符合中药特点的中药质量控制体系,国家药品监督管理局药品审评中心于2020年12月17日发布了《中药生物效应检测研究技术指导原则(试行)》,本文结合起草背景,对指导原则进行解读,阐述本指导原则制定的目的、意义和内容。In order to establish a quality control system for traditional Chinese medicine(TCM)in line with its characteristics,the Center for Drug Evaluation of NMPA issued the Guidance on Biological Assay for Traditional Chinese Medicine(Interim)on Dec.17,2020.This article interprets the guidance by introducing its background,purpose,significance and contents.

关 键 词：中药 生物效应 生物检测 指导原则 质量控制 

分 类 号：R95[医药卫生—药学]