《中国药典》2020年版外源性有害物质标准现状及制定思路  

Standards of Exogenous Harmful Residues for Traditional Chinese Medicines in the Chinese Pharmacopoeia 2020 Edition: Current Status and Development Process

作　　者：申明睿 翟为民[1] 何轶 石上梅[1] 杨昭鹏 兰奋[1] SHEN Ming-rui;ZHAI Wei-min;HE Yi;SHI Shang-mei;YANG Zhao-peng;LAN Fen(Chinese Pharmacopoeia Commission)

机构地区：[1]国家药典委员会

出　　处：《中国食品药品监管》2022年第3期16-24,共9页China Food & Drug Administration Magazine

摘　　要：《中国药典》一直以来十分关注中药外源性有害物质的污染情况,并且不断加深相关品种的质量标准研究。《中国药典》自2000年版起制定了部分品种的重金属及有害元素、农药残留的限量标准,并逐步增加品种数目及控制指标,至《中国药典》2020年版提出针对所有植物类药材及饮片的33种禁用农药残留限量要求,进一步全方位加强中药安全性质量控制。本文从重金属及有害元素、农药残留、真菌毒素、二氧化硫残留量4个质量控制方向,介绍《中国药典》2020年版相关标准现状、标准制定思路、未来标准制定方向等,以促进相关标准宣贯、执行。The Chinese Pharmacopoeia has been paying close attention to exogenous Harmful Residues in traditional Chinese medicines (TCM) and continuously deepens research on quality standards of relevant varieties.Starting from the 2000 Edition,the Chinese Pharmacopoeia has established limits of heavy metals and harmful elements as well as pesticide residues for some varieties,and there is the gradual increase in the number of varieties and control targets;by the 2020 Edition,residue limits of 33 forbidden pesticides have been established for all herbal medicinal materials and decoction pieces in the Chinese Pharmacopoeia,further strengthening quality control of TCM.This paper introduces current standards in the Chinese Pharmacopoeia (2020 Edition),and the strategies and future plans for standards development with regard to heavy metals and harmful elements,pesticide residues,mycotoxins and sulfur dioxide residues.We hope this paper could facilitate better implementation of relevant standards.

关 键 词：《中国药典》2020年版 标准制定 重金属及有害元素 农药残留 真菌毒素 二氧化硫残留量 

分 类 号：R288[医药卫生—中药学]