Standard Deliberation

Formulation of limit standards for heavy metals and harmful elements in TCMs and related reflections*

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  • 1. National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine, Beijing 102629, China;
    2. Chinese Pharmacopoeia Commission, Beijing 100061, China;
    3. China National Center for Food Safety Risk Assessment, Beijing 100022, China

Received date: 2022-06-19

  Online published: 2024-06-25

Abstract

This paper analyzes the pollution of heavy metals and harmful elements in traditional Chinese medicine(TCM), summarizes the detection methods, limit standards and guiding principles of heavy metals and harmful elements in TCM gradually improved in various editions of Chinese Pharmacopoeia, and compares with the limit standards of the heavy metals and harmful elements in botanical drugs at home and abroad. Additionally, based on the research practice of the author’s team for many years, the development process of the limit standard of heavy metals and harmful elements in TCM and the formulation process of the consistent limit guidance values of heavy metals and harmful elements in botanical drugs in Chinese Pharmacopoeia(2020 edition) arepresented. Up until now, the detection technology in TCM in Chinese Pharmacopoeia covers a relatively perfect technical system from total contents to speciation analysis of elements, reaching the international advanced level. The standard covers the limits of 41 varieties (Chinese medicinal materials, extracts and Chinese patent medicines included). The limits of lead, cadmium, arsenic, mercury and copper in TCM injections as well as consistent limit guidance values of heavy metals and harmful elements in botanical drugs are included. All of the above provides technical support for scientific supervision. It is suggested to strictly control the pollution of heavy metals and harmful elements in TCM, improve the study of speciation analysis of arsenic and mercury in animal drugs, marine drugs and Chinese patent medicine containing realgar and cinnabar, as well as strengthen the research on bioavailability and rapid detection methods of heavy metals and harmful elements. It is also suggested to formulate standards under the guidance of risk assessment, improve the pollution monitoring database of heavy metal and harmful element and establish a “trinity” quality and safety supervision system in order to achieve the balance between public health benefits and industrial development and promote the sustainable and healthy development of TCM industry.

Cite this article

ZUO Tian-tian, SHEN Ming-rui, ZHANG Lei, JIN Hong-yu, MA Shuang-cheng . Formulation of limit standards for heavy metals and harmful elements in TCMs and related reflections*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(4) : 701 -711 . DOI: 10.16155/j.0254-1793.2023.04.20

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