中药中重金属及有害元素限量标准的制定及有关问题的思考  

Formulation of limit standards for heavy metals and harmful elements in TCMs and related reflections

作　　者：左甜甜 申明睿 张磊 金红宇[1] 马双成[1] ZUO Tian-tian;SHEN Ming-rui;ZHANG Lei;JIN Hong-yuu;MA Shuang-cheng(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;China National Center for Food Safety Risk Assessment,Beijing 100022,China)

机构地区：[1]中国食品药品检定研究院、国家药品监督管理局中药质量控制重点实验室,北京102629 [2]国家药典委员会,北京100061 [3]国家食品安全风险评估中心,北京100022

出　　处：《药物分析杂志》2023年第4期701-711,共11页Chinese Journal of Pharmaceutical Analysis

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09303-024);中国食品药品检定研究院中青年基金资助项目(2020A3)。

摘　　要：对中药中重金属及有害元素污染情况进行分析,对历版《中华人民共和国药典》逐步完善的中药中重金属及有害元素检测方法、限量标准和指导原则进行总结,并与国内外植物药中重金属及有害元素限量标准进行对比。同时,根据笔者团队多年的研究实践,对中药中重金属及有害元素限量标准的研制过程以及2020年版《中华人民共和国药典》植物类重金属及有害元素一致性限量指导值的制定思路进行梳理。目前,《中华人民共和国药典》中药重金属及有害元素检测技术涵盖从元素总量到形态分析较完善的技术体系,达到了国际先进水平;标准涵盖包括中药材、提取物和中成药的总计41个品种的限量,并规定了中药注射液中铅、镉、砷、汞、铜的限量以及植物药中重金属及有害元素一致性限量指导值,为科学监管提供了技术支撑。建议严控中药中重金属及有害元素污染;针对重金属及有害元素残留量较高的动物药、海洋药以及含雄黄、朱砂等矿物药的中成药,加强砷、汞元素形态、价态分析方法的研究;加强重金属及有害元素生物利用度及快检方法的研究;进一步通过风险评估指导限量标准建设;完善重金属及有害元素污染监测数据库;建立“生产规范-分析平台-风险评估”三位一体的中药质量安全监管体系,旨在实现公共卫生效益与产业发展的平衡,促进中药产业的可持续健康发展。This paper analyzes the pollution of heavy metals and harmful elements in traditional Chinese medicine(TCM),summarizes the detection methods,limit standards and guiding principles of heavy metals and harmful elements in TCM gradually improved in various editions of Chinese Pharmacopoeia,and compares with the limit standards of the heavy metals and harmful elements in botanical drugs at home and abroad.Additionally,based on the research practice of the author's team for many years,the development process of the limit standard of heavy metals and harmful elements in TCM and the formulation process of the consistent limit guidance values of heavy metals and harmful elements in botanical drugs in Chinese Pharmacopoeia(2020 edition)arepresented.Up until now,the detection technology in TCM in Chinese Pharmacopoeia covers a relatively perfect technical system from total contents to speciation analysis of elements,reaching the international advanced level.The standard covers the limits of 41 varieties(Chinese medicinal materials,extracts and Chinese patent medicines included).The limits of lead,cadmium,arsenic,mercury and copper in TCM injections as well as consistent limit guidance values of heavy metals and harmful elements in botanical drugs are included.All of the above provides technical support for scientific supervision.It is suggested to strictly control the pollution of heavy metals and harmful elements in TCM,improve the study of speciation analysis of arsenic and mercury in animal drugs,marine drugs and Chinese patent medicine containing realgar and cinnabar,as well as strengthen the research on bioavailability and rapid detection methods of heavy metals and harmful elements.It is also suggested to formulate standards under the guidance of risk assessment,improve the pollution monitoring database of heavy metal and harmful element and establish a“trinity”quality and safety supervision system in order to achieve the balance between public health benefits and industrial development and promote the sustainabl

关 键 词：中药 重金属及有害元素 限量标准 风险评估 生物利用度 形态价态 对策 

分 类 号：R917[医药卫生—药物分析学]