文章摘要
昝珂,周颖,李耀磊,左甜甜,金红宇,王莹,马双成.罗布麻叶中肝毒性成分吡咯里西啶生物碱的含量分析及其初步风险评估[J].中国药事,2021,35(7):757-762
罗布麻叶中肝毒性成分吡咯里西啶生物碱的含量分析及其初步风险评估
Content Analysis and Preliminary Risk Assessment of Hepatotoxic Components of Pyrrolizidine Alkaloids in Apocyni veneti Folium
  
DOI:10.16153/j.1002-7777.2021.07.005
中文关键词: 罗布麻叶  肝毒性成分  吡咯里西啶生物碱  超高效液相色谱-串联质谱  含量测定  风险评估
英文关键词: Apocyni veneti Folium  hepatotoxic components  pyrrolizidine alkaloids  ultra-high performance liquid chromatography-tandem mass spectrometry  content determination  risk assessment
基金项目:科技部重大新药创制(编号 2018ZX09735-006)
作者单位
昝珂 中国食品药品检定研究院,北京 102629 
周颖 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,杭州 310052 
李耀磊 北京中医药大学中药学院,北京 102488 
左甜甜 中国食品药品检定研究院,北京 102629 
金红宇 中国食品药品检定研究院,北京 102629 
王莹 中国食品药品检定研究院,北京 102629 
马双成 中国食品药品检定研究院,北京 102629 
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中文摘要:
      目的:对罗布麻叶中吡咯里西啶生物碱的含量进行测定,并根据测定结果进行肝毒性初步风险评估。方法:样品经过QuEChERS法提取后,采用超高效液相色谱-串联质谱(UPLC-MS/MS)法测定印美定、石松胺、印美定氮氧化物和石松胺氮氧化物的含量。结果:6批罗布麻叶样品中印美定、石松胺、 印美定氮氧化物和石松胺氮氧化物的含量范围分别为10.51~27.56、20.66~42.54、40.54~76.89和61.45~ 164.23 μg·kg-1。含量超过一些国家或组织的规定,长期使用存在一定的安全风险。结论:本研究所建立的方法为罗布麻叶中肝毒性成分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。
英文摘要:
      Objective: To determine the content of hepatotoxic pyrrolizidine alkaloids in Apocyni veneti Folium, and to carry out the preliminary risk assessment of hepatotoxicity based on the determination results. Methods: After QuEChERS extraction, the content of intermedine, lycopsamine, intermedine N-oxide and lycopsamine N-oxide were determined by the method of ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Results: The content ranges of intermedine, lycopsamine, intermedine N-oxide and lycopsamine N-oxide in 6 batches of Apocyni veneti Folium were 10.51-27.56, 20.66-42.54, 40.54-76.89 and 61.45-164.23 μg·kg-1, respectively. These content have exceeded the regulations stipulated by some nations or organizations, and there exist certain safety risks in long-term use. Conclusion: The method established in this study will lay a scientific basis for the quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloidsin Apocyni veneti Folium.
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