Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (11): 1039-1042.
DOI: 10.19803/j.1672-8629.2021.11.09

Previous Articles     Next Articles

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

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

CLC Number: