中药材及饮片中重金属及有害元素限量制定的探讨

Exploration of the limit of heavy metals and harmful elements in Chinese medicinal materials and decoction pieces

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。

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.