灯盏细辛中吡咯里西啶生物碱的含量分析及其肝毒性风险评估
投稿时间:2021-06-01     点此下载全文
引用本文:昝珂,周颖,李耀磊,左甜甜,金红宇,王莹,马双成.灯盏细辛中吡咯里西啶生物碱的含量分析及其肝毒性风险评估[J].中国现代中药,2021,23(11):1897-1901
DOI:10.13313/j.issn.1673-4890.20210601004
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作者中文名作者英文名单位中文名单位英文名E-Mail
昝珂 ZAN Ke 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
周颖 ZHOU Ying 浙江省食品药品检验研究院,浙江 杭州 310052 Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China  
李耀磊 LI Yao-lei 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
左甜甜 ZUO Tian-tian 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
金红宇 JIN Hong-yu 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
王莹* WANG Ying 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
马双成 MA Shuang-cheng 中国食品药品检定研究院,北京 102629 National Institutes for Food and Drug Control, Beijing 102629, China  
基金项目:国家“重大新药创制”科技重大专项(2018ZX09735-006)
中文摘要:目的 测定灯盏细辛中吡咯里西啶生物碱的含量,根据测定结果对其肝毒性进行初步的风险评估。方法 灯盏细辛样品经过固相萃取法提取后,采用超高效液相色谱-串联质谱法(UPLC-MS/MS)测定印美定、石松胺、印美定-N-氧化物和石松胺-N-氧化物的含量。根据含量测定结果,采用暴露限制(MOE)法对其肝毒性风险进行评估。结果 8批灯盏细辛样品中印美定、石松胺、印美定-N-氧化物和石松胺-N-氧化物质量分数分别为15.14~66.72、11.32~42.55、26.32~98.34、19.82~55.23 μg·kg–1。MOE值为4787~12 130。结论 灯盏细辛中吡咯里西啶生物碱的含量超过欧洲药品管理局的规定,经初步风险评估显示部分批次存在一定的安全风险。
中文关键词:灯盏细辛  肝毒性成分  吡咯里西啶生物碱  超高效液相色谱-串联质谱法  含量测定  风险评估
 
Hepatotoxic Risk Assessment and Determination of Pyrrolizidine Alkaloids in Erigerontis Herba
Abstract:Objective To analyze the content of hepatotoxic pyrrolizidine alkaloids in Erigerontis Herba, and to carry out preliminary risk assessment based on the content.Methods Erigerontis Herba was extracted by solid phase extraction and then the content of intermedine, lycopsamine, intermedine-N-oxide, and lycopsamine-N-oxide was determined by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). According to the content, the hepatotoxicity was evaluated with the margin of exposure (MOE) approach.Results The content of intermedine, lycopsamine, intermedine-N-oxide, lycopsamine-N-oxide in the 8 batches of Erigerontis Herba was 15.14-66.72, 11.32-42.55, 26.32-98.34, and 19.82-55.23 μg·kg–1, respectively. The MOE values ranged from 4787 to 12 130.Conclusion The content of pyrrolizidine alkaloids in Erigerontis Herba exceeds the limit stipulated by the European Medicines Agency. The preliminary risk assessment shows that some batches have certain safety risks.
keywords:Erigerontis Herba  hepatotoxic component  pyrrolizidine alkaloid  UPLC-MS/MS  content determination  risk assessment
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