中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 553-559.
DOI: 10.19803/j.1672-8629.20220175

• 安全与合理用药 • 上一篇    下一篇

中药材（饮片）中马兜铃酸的含量分析及初步风险评估

聂黎行1, 王馨平1,2△, 李静1, 戴忠1, 康帅1#, 马双成1,2,*   

  1. 1中国食品药品检定研究院,北京 100050;
    2河北中医学院,河北 石家庄 050000
  • 收稿日期:2022-04-19 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *马双成,男,博士,研究员·博导,中药民族药物质基础与质量安全评价。E-mail：masc@nifdc.org.cn;#为共同通信作者。
  • 作者简介:聂黎行,女,博士,研究员,中药分析。Δ为并列第一作者。
  • 基金资助:
    国家科技重大专项重大新药创新（2018ZX09735006）

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

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摘要： 目的 分析中药材（饮片）中马兜铃酸类成分的含量特征,并开展初步风险评估。方法 基于近10年的文献数据,从分布情况、相关性、样品差异等角度,分析了12个品种478批中药材（饮片）中马兜铃酸类成分的含量特征。按照危害识别、危害特征描述、暴露评估和风险描述的步骤,明确了计算公式和具体参数,采用靶标危害系数法对细辛中马兜铃酸I的安全风险进行评估。结果 12个品种478批中药材（饮片）中共检出25种马兜铃酸类成分,整体含量马兜铃酸I最高,马兜铃内酰胺F1最低,部分成分含量之间存在相关性。含马兜铃酸的药用植物的果实中马兜铃酸类成分远高于其他部位,各药材经炮制后马兜铃酸含量显著降低。按法定用药部位统计,各品种中马兜铃酸I和马兜铃酸П含量存在显著性差异,朱砂莲最高,鱼腥草最低。风险评估结果显示,11批细辛药材中有1批样品中马兜铃酸I的靶标危害系数（THQ）大于1,提示其用药存在安全风险。结论 获得的中药材（饮片）中马兜铃酸类成分的含量现状和建立的风险评估方法,可为含马兜铃酸中药材（饮片）的质量控制和安全用药提供参考。

关键词: 中药材, 饮片, 马兜铃酸I, 马兜铃酸П, 马兜铃内酰胺F1, 细辛, 风险评估

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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