中药真菌毒素质量控制概况、限量标准制定及有关问题的思考  

Overview on quality control of mycotoxins in traditional Chinese medicine,limit requirements and discussion on related issues

作　　者：刘丽娜[1] 李海亮 李耀磊[1] 金红宇[1] 马双成[1] LIU Li-na;LI Hai-liang;LI Yao-lei;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中草药》2023年第19期6197-6207,共11页Chinese Traditional and Herbal Drugs

基　　金：中医药现代化国家重点研发计划:生态种植药材品质多维评价及价值评估(2022YFC3501505)。

摘　　要：外源性有害残留物污染引起的中药安全性问题日益受到关注。中药在种植、采集、贮藏、制备、运输过程中可导致真菌毒素污染,给中药带来安全风险。通过对中药中真菌毒素质量控制、限量标准制订情况进行概述,分析梳理中药中真菌毒素质量控制及限量标准的现状,并对存在的问题进行归纳总结,针对中药真菌毒素的监管提出建议,以保证中药质量,促进行业发展。The safety of traditional Chinese medicine(TCM)caused by pollution of exogenous harmful residues has attracted increasing attention.TCM can cause mycotoxin pollution in the process of planting,collection,storage,preparation and transportation,which brings safety risk to traditional Chinese medicine.This paper summarized current situation of mycotoxin prevention and control in TCM,analyzed the current situation of quality control and limit standards of mycotoxins in TCM,and summarized the existing problems.Countermeasures and suggestions were put forward for the effective prevention,control and supervision of mycotoxins in TCM,to ensure the quality and safety of TCM and promote the development of the industry.

关 键 词：中药 外源性有害残留 风险控制 真菌毒素 限量标准 黄曲霉毒素 

分 类 号：R286[医药卫生—中药学]