中药外源性有害物质和内源性有毒成分风险评估技术体系研究进展及展望  

Research Progress and Prospect of Risk Assessment System for Exogenous Harmful Substances and Endogenous Toxic Components in Chinese Medicinal Materials

作　　者：左甜甜 刘静[1] 王莹[1] 聂黎行[1] 昝珂[1] 刘丽娜[1] 刘芫汐 魏锋[1] 金红宇[1] 马双成[1] ZUO Tian-tian;LIU Jing;WANG Ying;NIE Li-xing;ZAN Ke;LIU Li-na;LIU Yuan-xi;WEI Feng;JIN Hong-yu;MA Shuang-cheng(NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine,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国家药品监督管理局中药质量研究与评价重点实验室,北京102629

出　　处：《中国现代中药》2023年第6期1179-1186,共8页Modern Chinese Medicine

基　　金：国家“重大新药创制”科技重大专项(2018ZX09303-024);国家重点研发计划项目(2022YFC3501500)。

摘　　要：中药是中华民族的瑰宝,其质量安全备受关注。中药安全性控制涉及外源性有害物质和内源性有毒成分两部分内容,其中外源性有害物质主要包括重金属及有害元素、农药残留、真菌毒素等,内源性有毒成分以马兜铃酸、吡咯里西啶生物碱为代表。外源性有害物质和内源性有毒成分虽然具有不同的毒性特点,但都需要在科学的风险评估基础上,通过建立检验检测方法、提高标准、加强监管来引导产业发展。综述了中药中典型外源性有害物质和内源性有毒成分的健康风险评估研究进展,对比不同外源性有害物质和内源性有毒成分健康风险评估方法的异同。初步认为,通过近年来国家监管部门在中药安全性监管方面的积极引导,中药外源性有害物质和内源性有毒成分的风险评估和风险管理取得了阶段性成效。对中药外源性有害物质和内源性有毒成分风险评估的发展方向进行展望,旨在为中药安全性相关标准和监管政策的制订、保障中药用药安全、引导行业健康发展提供参考。Chinese medicinal materials are the treasure of the Chinese nation,and their quality and safety are of great concern.The safety control of Chinese medicinal materials involves exogenous harmful substances and endogenous toxic components.The exogenous harmful substances mainly include heavy metals,harmful elements,pesticide residues,and mycotoxins.The endogenous toxic components are represented by aristolochic acid and pyrrolizidine alkaloids.Although exogenous hazardous substances and endogenous toxic components have different toxic characteristics,risk assessment can be taken as the basis to develop the detection methods,improve the standards,and strengthen the supervision,so as to guide the industrial development.The research progress in the health risk assessment of typical exogenous harmful substances and endogenous toxic components in Chinese medicinal materials was reviewed.The risk assessment methods of different exogenous harmful substances and endogenous toxic components were compared.The review showed that with the active guidance of the national regulatory authorities in the safety supervision of Chinese medicinal materials in recent years,staged progress has been achieved in the risk assessment and management of exogenous harmful substances and endogenous toxic components.Finally,this paper prospected the development direction of risk assessment of exogenous harmful substances and endogenous toxic components,aiming to provide references for the formulation of relevant safety standards and regulatory policies,guarantee the safety of Chinese medicinal materials and guide the healthy development of this industry.

关 键 词：中药 外源性有害物质 内源性有毒成分 健康风险评估 限量标准 

分 类 号：R284[医药卫生—中药学]