中国药物警戒 ›› 2021, Vol. 18 ›› Issue (11): 1039-1042.
DOI: 10.19803/j.1672-8629.2021.11.09

• 基础与临床研究 • 上一篇    下一篇

返魂草中肝毒性吡咯里西啶生物碱的含量分析及风险评估

昝珂1, 周颖2, 逄瑜3, 李耀磊1, 王莹1, 金红宇1, 左甜甜1#, 马双成1,*   

  1. 1中国食品药品检定研究院,北京 102629;
    2浙江省食品药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,浙江 杭州310052;
    3国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022
  • 收稿日期:2021-05-27 发布日期:2021-11-18
  • 通讯作者: *马双成,男,博士,研究员,中药质量控制。E-mail：masc@nifdc.org.cn #为共同通信作者。
  • 作者简介:昝珂,男,博士,副研究员,中药质量研究。
  • 基金资助:
    重大新药创制国家科技重大专项2018年度（2018ZX09735-006）

Risk Assessment and Determination of Hepatotoxic Pyrrolizidine Alkaloids in Senecionis Cannabifolii Herba

ZAN Ke1, ZHOU Ying2, PANG Yu3, LI Yaolei1, WANG Ying1, JIN Hongyu1, ZUO Tiantian1#, MA Shuang-cheng1,*   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2Zhejiang Institute for Food and Drug Control/NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine, Hangzhou Zhejiang 310052, China;
    3Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2021-05-27 Published:2021-11-18

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摘要： 目的 对返魂草中肝毒性吡咯里西啶生物碱的含量进行测定,并根据测定结果进行初步的风险评估。方法 建立超高效液相色谱-串联质谱测定夹可灵、夹可灵氮氧化物、夹可碱、夹克宁和夹可碱氮氧化物的含量。根据含量测定结果,采用暴露限值（margin of exposure, MOE）法进行风险评估。结果 6批返魂草样品中夹可灵、夹可灵氮氧化物、夹可碱、夹克宁和夹可碱氮氧化物的含量范围分别为0.23~0.85、0.25~0.98、0.85~2.65、0.37~1.85和2.32~7.58 μg/g。MOE值为2 131~4 845。结论 本研究所建立的方法为返魂草中肝毒性吡咯里西啶生物碱的质量控制和安全性评价提供了科学依据。

关键词: 返魂草, 肝毒性成分, 吡咯里西啶生物碱, 超高效液相色谱-串联质谱, 风险评估

Abstract: Objectiv eTo analyze the contents of hepatotoxic pyrrolizidine alkaloids in Senecionis cannabifolii Herba, and to carry out preliminary risk assessment based on the research results. Methods A UPLC-MS/MS method was established to determine the contents of jacoline, jacoline N-oxide, jacobine, jaconine and jacobine N-oxide. According to the content determination results, the risk was assessed using the margin of exposure (MOE) method. Results The contents of jacoline, jacoline N-oxide, jacobine, jaconine, and jacobine N-oxide in six batches of Senecionis cannabifolii Herba were 0.23-0.85, 0.25-0.98, 0.85-2.65, 0.37-1.85 and 2.32-7.58 μg/g, respectively. The MOE values ranged from 2 131 to 4 845. Conclusion The method established in this study provides data for quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloids in Senecionis cannabifolii Herba.

Key words: Senecionis cannabifolii Herba, hepatotoxic component, pyrrolizidine alkaloids, UPLC-MS/MS, risk assessment

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