以风险控制为核心的中药外源性有害残留物标准建设初步成效及展望  

Preliminary Results and Prospects of the Standard Construction of Exogenous Harmful Residues in Traditional Chinese Medicine Based on Risk Control

作　　者：左甜甜 金红宇[1,2] 王莹 刘丽娜[1,2] 魏锋 于健东[1,2] 马双成 ZUO Tian-tian;JIN Hong-yu;WANG Ying;LIU Li-na;WEI Feng;YU Jian-dong;MA Shuang-cheng(National Institutes for Food and Drug Control;NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine)

机构地区：[1]中国食品药品检定研究院 [2]国家药品监督管理局中药质量研究与评价重点实验室

出　　处：《中国食品药品监管》2023年第1期26-35,共10页China Food & Drug Administration Magazine

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09303-024);中医药现代化项目(2022YFC3501505)。

摘　　要：中药是中华民族的瑰宝,中药作为中医药的重要组成部分,其质量安全备受关注。本文梳理了中药外源性有害残留物检测技术和限量标准的发展过程,国家药典委员会中药安全性质量控制专业委员会(原第十一届国家药典委员会中药风险评估专业委员会)成立后所建立的符合中药使用特点的外源性有害残留物安全性评价体系(包括收录于《中国药典》2020年版中的一系列检测方法、限量标准、指导原则等),以及在应对突发药品安全事件发现风险、评估风险、控制风险所取得的一系列成效。初步认为通过近几年国家药品监管部门在中药安全性监管方面的积极引导,中药外源性有害残留物防控取得了阶段性成效。最后展望了中药外源性有害残留物监管的发展方向,旨在为中药安全性相关标准和相关监管政策的制修订提供参考。Traditional Chinese medicine(TCM)is the treasure of our country.As an important part of traditional medicine,its quality and safety have attracted more and more attention.This study reviewed the development process of detection technology and limit standard of exogenous harmful residues in TCM.Especially this study reviewed the safety evaluation system of exogenous harmful residues(including a series of testing methods,limit standards,guidelines listed in the 2020 edition of the Chinese Pharmacopoeia)established by the TCM risk assessment Professional Committee of Chinese Pharmacopoeia Commission,which was in line with the characteristics of TCM,as well as a series of measures taken in response to drug safety emergencies to identify risks,assess risks,and control risks.It is believed that through the active guidance of the national regulatory authorities in the safety supervision of TCM recent years,the prevention and control of exogenous harmful residues in TCM are definitely effective.Finally,the development direction of the regulation of exogenous harmful residues in TCM was prospected,aiming to provide reference for the formulation and revision of relevant safe standards and regulatory policies.

关 键 词：中药 外源性有害残留物 检测技术 风险评估 限量标准 监管建议 

分 类 号：R921[医药卫生—药学]