2025年版《中国药典》中药中外源性有害残留物检测标准制修订解读与思考  

Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition

作　　者：王莹[1,4] 申明睿 刘芫汐 左甜甜 王丹丹 何轶 程显隆 金红宇[1,4] 刘永利 魏锋[1,4] 马双成 WANG Ying;SHEN Mingrui;LIU Yuanxi;ZUO Tiantian;WANG Dandan;HE Yi;CHENG Xianlong;JIN Hongyu;LIU Yongli;WEI Feng;MA Shuangcheng(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;The Pharmacovigilance Center of Hebei,Shijiazhuang 050090,China;State Key Laboratory of Drug Regulatory Science,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,药品监管科学全国重点实验室,北京100061 [3]河北省药物警戒中心,石家庄050090 [4]药品监管科学全国重点实验室,北京100061

出　　处：《中国药品标准》2025年第1期83-92,共10页Drug Standards of China

基　　金：国家重点研发计划(2023YFC3504103);国家药监局药品监管科学全国重点实验室第一批开放课题(2023SKLDRS0103);2024年度国家药品标准制修订研究课题(2024Z01、2024Z02)。

摘　　要：随着人们对健康的关注度不断提高,中药的市场需求也日益增长,中药材的质量与安全受到社会前所未有的关注,尤其是中药中外源性有害残留污染是监管部门和社会关注的热点。2025年版《中国药典》对中药中外源性有害残留物的检测方法和限量标准进一步完善,反映了我国对中药质量安全的高度重视,也体现了我国在中药安全性监管领域的不断进步。在此基础上,本研究通过梳理中药中外源性有害残留物检测标准发展历程、2025年版《中国药典》中外源性有害残留检测标准的修订和更新,深入剖析了2025年版《中国药典》中药中外源性有害残留标准变化的关键要点,同时对中药中外源性残留物检测的未来发展方向及存在的挑战进行思考,为中药安全性监管政策的制定提供参考。As people′s attention to health continues to increase,the market demand for traditional Chinese medicine(TCM)is growing steadily.The quality and safety of Chinese medicinal materials have attracted unprecedented social attention.In particular,the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society.The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM.This not only reflects China′s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision.Basis on this study,by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition,deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition.Moreover,it interprets the future development directions of the detection of exogenous residues in TCM,aiming to provide a reference for the formulation of TCM safety supervision policies.

关 键 词：中药 外源性有害残留物 2025年版《中国药典》 发展方向 

分 类 号：R921.2[医药卫生—药学]