Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (11): 1186-1190.
DOI: 10.19803/j.1672-8629.20220317

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Content determination and health risk assessment of pyrrolizidine alkaloid N-oxides in Vignae Semen

ZAN Ke1, ZHOU Ying, LI Yaolei1, WANG Ying1, JIN Hongyu1, ZUO Tiantian1#, MA Shuangcheng1,*   

  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
  • Received:2022-06-10 Published:2022-11-17

Abstract: Objective To determine the contents of pyrrolizidine alkaloid N-oxides in Vignae Semen, and to assess the risks. Methods A UPLC-MS/MS method was established to determine the contents of monocrotaline N-oxide, echinatine N-oxide,intermedine N-oxide and lycosamine N-oxide. An Acquity UPLC BEH C18 (50 mm× 2.1 mm, 1.7 μm) was used as the chromatographic column. The mobile phase was eluted with acetonitrile-0.1% formic acid solution (10:90) at a constant flow rate of 0.35 mL·min-1, and the injection volume was 2 μL. The electrospray spray ion source and positive ion multi-reaction monitoring mode were used. The contents were calculated using the standard curve method. Results The contents of monocrotaline N-oxide, echinatine N-oxide, intermedine N-oxide and lycosamine N-oxide in eight batches of Vignae Semen were 17.54-31.67 μg·kg-1. The risk assessment showed that the health risk of Vignae Semen was low. Conclusion This study provides data for quality control and safety evaluation of pyrrolizidine alkaloids in Vignae Semen.

Key words: Vignae Semen, monocrotaline N-oxide, echinatine N-oxide, intermedine N-oxide, lycosamine N-oxide, UPLC-MS/MS, risk assessment

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