中药中外源性有害残留物标准现状与监管建议  

Standards for Exogenous Harmful Residues in Chinese Medicinal Materials and Suggestions

作　　者：王莹[1] 刘芫汐 刘丽娜[1] 李耀磊[1] 左甜甜 于健东[1] 金红宇[1] 魏锋[1] 马双成[1] WANG Ying;LIU Yuan-xi;LIU Li-na;LI Yao-lei;ZUO Tian-tian;YU Jian-dong;JIN Hong-yu;WEI Feng;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：《中国现代中药》2023年第5期943-950,共8页Modern Chinese Medicine

基　　金：国家重点研发计划项目(2022YFC3501505)。

摘　　要：中药材作为中医药的重要组成部分,其质量安全备受关注。通过回顾中药中外源性有害残留物检测标准发展进程、比较国内外有害残留物标准,呈现中药中外源性有害残留检测标准发展脉络。近年来,中药中外源性有害残留物标准不断完善,检测技术与国际标准主流检测技术接轨,污染物的限量标准稳步增加完善。对中药中外源性有害残留物污染报道和本课题组近年来研究数据进行分析发现,中药中外源性有害残留物呈现总体检出率不高且大部分残留物检出量较低的特点。国家监管部门在中药安全性监控方面的政策引导使中药中外源性有害残留物防控取得了阶段性成效。然而,部分中药品种外源性有害残留污染情况仍较为严峻,如部分药用部位为花、果实及全草类的药材禁用农药检出率较高,甚至存在超标现象;部分种子、动物类药材中黄曲霉毒素污染状况不容乐观。通过分析目前标准及污染现状,提出中药中外源性有害残留监控的重点关注对象及发展方向,旨在为中药安全性监管政策的制定提供思路和参考。Chinese medicinal materials are an important part of traditional Chinese medicine,whose quality and safety,thus,have attracted wide attention.This study reviewed the detection standards for exogenous harmful residues in Chinese medicinal materials and compared the standards in China and other countries,thereby presenting the development process of the standards.In recent years,the relevant standards have been constantly improved and global leading detection techniques have been included.In addition,the limit standards for the pollutants have been mature.According to the reports on exogenous harmful residues in Chinese medicinal materials and research data in recent years,the overall detection rate and the detected levels of the exogenous harmful residues are relatively low.Owing to the policies for supervising the safety of Chinese medicinal materials released by the competent departments,major headway has been made in the prevention and control of the exogenous harmful residues.However,the control for some medicinal materials seems grim.For example,the detection rate of banned pesticides is high in medicinal materials derived from flowers,fruits,and whole plants of herbs and it happens that the detected amount is higher than the specified upper limit.Some medicinal materials derived from seeds and animals are seriously polluted by aflatoxin.On the basis of current standards and the pollution,this study summarized the key to the supervision of exogenous harmful residues in Chinese medicinal materials.Thereby,this study is expected to serve as a reference for the formulation of policies on the safety of Chinese medicinal materials.

关 键 词：中药 外源性有害残留物 限量标准 监管建议 

分 类 号：R284[医药卫生—中药学]