Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (5): 553-559.
DOI: 10.19803/j.1672-8629.20220175

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Content analysis and risk assessment of aristolochic acids in Chinese medicinal materials (decoction pieces)

NIE Lixing1, WANG Xinping1,2△, LI Jing1, DAI Zhong1, KANG Shuai1#, MA Shuangcheng1,2,*   

  1. 1National Institutes for Food and Drug Control, Beijing 100050, China;
    2Hebei University of Chinese Medicine, Shijiazhuang Hebei 050000, China
  • Received:2022-04-19 Online:2023-05-15 Published:2023-05-16

Abstract: Objective To analyze the content of aristolochic acid analogues in Chinese medicinal materials (decoction pieces) and carry out preliminary risk assessment. Methods Based on related literature published over the past 10 years, the contents of aristolochic acid analogues in 478 samples of 12 types of Chinese medicinal materials (decoction pieces) were analyzed in terms of distribution, correlations and sample difference. Starting from hazard identification to hazard characterization, exposure assessment and risk characterization, the calculation formulas and specific parameters were defined, and the target hazard quotient (THQ) was used to evaluate the safety risk of aristolochic acid I in Asari Radix et Rhizoma. Results Twenty-five types of aristolochic acid analogues were detected in 478 samples of 12 types of Chinese medicinal materials (decoction pieces). In general, the content of aristolochic acid I was the highest and that of aristolochic acid F1 was the lowest. There were correlations between contents of some components. The contents of aristolochic acids in the fruits of medicinal plants were much higher than those in other parts, and the contents of aristolochic acids decreased significantly after processing. Based on the statistics of legal medicinal parts, there were significant differences in the contents of aristolochic acid I and aristolochic acid П between different varieties, with contents in Aristolochiae Cinnabaria Radix being the highest and contents in Houttuyniae Herba being the lowest. The results of risk assessment showed that the target hazard quotient (THQ) of aristolochic acid I in one of the 11 samples of Asari Radix et Rhizoma was above 1, indicating that there was a safety risk. Conclusion The current contents and risk assessment method of aristolochic acids in Chinese medicinal materials (decoction pieces) obtained in this study can provide reference for quality control and safe use of Chinese medicinal materials (decoction pieces) containing aristolochic acids.

Key words: Chinese medicinal materials, decoction pieces, aristolochic acid I, aristolochic acid П, aristolochic acid F1, Asari Radix et Rhizoma, risk assessment

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