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中药材及饮片中重金属及有害元素限量制定的探讨5300
发表时间:2020-05-21 16:32作者:左甜甜…马双成等网址:https://kns.cnki.net/KCMS/detail/detail.aspx?dbcode=CJFQ&dbname=CJFDAUTO&filename=YWFX202004015&uid=WEEvREcwSlJHSldRa1FhcEFLUmViU2FuOS9kV0c5WXFRWThKT3dXYkV6Zz0=$9A4hF_YAuvQ5obgVAqNKPCYcEjKensW4IQMovwHtwkF4VYPoHbKxJw!!&v=MjkzMTMzcVRyV00xRnJDVVI3cWZZdVJ2RnlybFU3ek1QRHJOZHJHNEhOSE1xNDlFWVlSOGVYMUx1eFlTN0RoMVQ= 中药材及饮片中重金属及有害元素限量制定的探讨 *左甜甜 1,张磊 2,王莹 1,石上梅 3,申明睿 3,金红宇 1**,马双成 1** (1. 中国食品药品检定研究院,北京 100050;2. 国家食品安全风险评估中心,北京 100022;3. 国家药典委员会,北京 100061) 摘要:中药材及饮片中重金属及有害元素最大限量理论值是制定科学、合理的限量标准的重要基础。本文重点针对《中华人民共和国药典》(简称《中国药典》)2015 年版四部“中药有害残留物限量制定指导原则”中重金属及有害元素最大限量理论值计算公式的修订背景和修订内容,限量制定的一般步骤以及植物类中药材中重金属及有害元素一致性限量标准的制定过程进行探讨。同时,将《中国药典》标准与 ISO 限量制定的异同进行比较论述。制定适用于中国国情的、符合中药使用特点的中药材及饮片中重金属及有害元素最大限量理论值的计算公式,并推行科学、合理的残留限量标准,为保障人民用药安全,并促进中药产业的可持续、健康发展具有重要的实际意义。关键词:中药材;饮片;重金属及有害元素;最大限量理论值;限量标准;风险评估中图分类号:R 917文献标识码:A文章编号:0254-1793(2020)04-0688-06doi:10.16155/j.0254-1793.2020.04.14 Exploration of the limit of heavy metals and harmful elements in Chinese medicinal materials and decoction pieces *ZUO Tian-tian1,ZHANG Lei2,WANG Ying1,SHI Shang-mei3,SHEN Ming-rui3,JIN Hong-yu1**,MA Shuang-cheng1** (1.National Institutes for Food and Drug Control,Beijing 100050,China;2.China National Center for Food Safety Risk Assessment,Beijing 100022,China;3.Chinese Pharmacopoeia Commission,Beijing 100061,China) Abstract:The theoretical value of the maximum limit of heavy metals and harmful elements in Chinese medicinal materials and decoction pieces is an important basis for the establishment of scientific and reasonable limit standards.This paper focused on the background and the revision of the theoretical value of the maximum limit of heavy metals and harmful elements in “Guideline for the Formulation of the Limit of Harmful Residue of Traditional Chinese Medicine(TCM)” in Pharmacopoeia of the People’s Republic of China(Chinese Pharmacopoeia),2015 edition,Volume Ⅳ.And the similarities and differences between standards in Chinese Pharmacopoeia and ISO limit were compared.It is of crucial practical significance to formulate the theoretical maximum limit formula of heavy metals and harmful elements in Chinese medicinal materials and decoction pieces that are suitable for the national conditions and applicable to traditional Chinese medicines in order to formulate the scientific and reasonable residue limit standards,considering the drug safety insurance and the sustainable and healthy development of the TCM industry. Keywords:Chinese medicinal materials;decoction pieces;heavy metals and harmful elements;theoretical value of the maximum limit;limit standard;risk assessment |