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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

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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


*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 1000502. 国家食品安全风险评估中心,北京 1000223. 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,限量制定的般步骤以及植物类中药材中重金属及有害元素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:0254-1793202004-0688-06doi10.16155/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-tian1ZHANG Lei2WANG Ying1SHI Shang-mei3SHEN Ming-rui3JIN Hong-yu1**MA Shuang-cheng1**


1National Institutes for Food and Drug ControlBeijing 100050China2China National Center for Food Safety Risk AssessmentBeijing 100022China3Chinese Pharmacopoeia CommissionBeijing 100061China


AbstractThe 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 standardsThis 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 MedicineTCM in Pharmacopoeia of the Peoples Republic of ChinaChinese Pharmacopoeia),2015 editionVolume Ⅳ.And the similarities and differences between standards in Chinese Pharmacopoeia and ISO limit were comparedIt 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 standardsconsidering the drug safety insurance and the sustainable and healthy development of the TCM industry.


KeywordsChinese medicinal materialsdecoction piecesheavy metals and harmful elementstheoretical value of the maximum limitlimit standardrisk assessment


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