Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (5): 475-480.
DOI: 10.19803/j.1672-8629.2022.05.02

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Research on the application of clinical drug-oriented risk assessment method for harmful components of traditional Chinese medicine

LI Yaolei1,2, ZHANG Xiaomeng1,2, ZHANG Bing1,2,*, LIN Zhijian1,2, ZAN Ke3, JIN Hongyu3, MA Shuangcheng3   

  1. 1School of Traditional Chinese Medicine, Beijing University of Tradional Chinese Medicine, Beijing 102488, China;
    2Center for Traditional Chinese Medicine Pharmacovigilance and Rational Drug Use, Beijing University of Traditional Chinese Medicine, Beijing 102488, China;
    3National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2021-12-03 Online:2022-05-15 Published:2022-05-18

Abstract: Objective To explore the practicability of risk assessment methods for harmful components of traditional Chinese medicine (TCM) based on clinical medication. Methods The samples were processed by microwave digestion, and lead (Pb), cadmium (Cd), arsenic (As), mercury (Hg), copper (Cu) in Farfarae Flos, Patchouli, Sennae Folium and Arnebiae Radix by inductively coupled plasma mass spectrometry (ICP-MS) were determined. Based on clinical drug use factors such as drug frequency, use time limit, and decoction transfer rate, the health risk assessment of the carcinogenicity of harmful components in TCM was carried out. Furthermore, it also given weight to the security factor. Results The content levels of five heavy metals and harmful elements in Farfarae Flos, Patchouli, Sennae Folium and Arnebiae Radix were different. According to the risk assessment method with the characteristics of clinical use of TCM, the overall non-carcinogenic risk of Pb, Cd, As, Hg, and Cu was low, and the hazard coefficient (THQ) was less than 1. In addition, the carcinogenic risk (CR) of the three elements Pb, As, and Cd were all less than 1×10-6, and the overall carcinogenic risk was low. Conclusion The clinical drug-oriented risk assessment method for harmful components of TCM has strong overall practicability. It can reflect the risk of drug use of TCM and guide clinical rational drug use.

Key words: heavy metals, harmful elements, clinical medication, health risk assessment, Farfarae Flos、Patchouli、Sennae Folium、Arnebiae Radix

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