飞扬草中肝毒性吡咯里西啶生物碱的含量分析及风险评估  

Risk Assessment and Determination of Hepatotoxic Pyrrolizidine Alkaloids in Euphorbiae Hirtae Herba

作　　者：昝珂[1] 周颖 李耀磊 王莹[1] 金红宇[1] 左甜甜 马双成[1] ZAN Ke;ZHOU Ying;LI Yao-lei;WANG Ying;JIN Hong-yu;ZUO Tian-tian;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 102629,China;Zhejiang Institute for Food and Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),Hangzhou 310052,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[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,杭州310052 [3]北京中医药大学中药学院,北京102488

出　　处：《中国药学杂志》2021年第22期1829-1833,共5页Chinese Pharmaceutical Journal

摘　　要：目的对飞扬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。方法建立液质联用法测定印美定、石松胺、N-氧化印美定、N-氧化石松胺和克氏千里光碱的含量。根据含量测定结果,采用暴露限制(MOE)法进行风险评估。结果6批飞扬草样品中印美定、石松胺、N-氧化印美定、N-氧化石松胺和克氏千里光碱的含量范围分别为45.62~91.04、10.12~58.26、28.34~85.23、25.34~88.43、19.85~54.43μg·kg^(-1)。MOE值为5228~9775。结论本研究所建立的方法为飞扬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。OBJECTIVE To analyze the contents of hepatotoxic pyrrolizidine alkaloids in Euphorbiae Hirtae Herba,and carry out preliminary risk assessment according to the research results.METHODS A UPLC-MS/MS method was established to determine the contents of intermedine,lycopsamine,intermedineN-oxide,lycopsamine N-oxide and senkirkine.According to the content determination results,risk assessment was carried out by margin of exposure(MOE)method.RESULTS The content ranges of intermedine,lycopsamine,intermedine N-oxide,lycopsamine N-oxide and senkirkinein six batches of Euphorbiae Hirtae Herba were 45.62-91.04,10.12-58.26,28.34-85.23,25.34-88.43,and 19.85-54.43μg·kg^(-1),respectively.The MOE values ranged from 5228 to 9775.CONCLUSION The method established in this study provides a scientific basis for the quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloids in Euphorbiae Hirtae Herba.

关 键 词：飞扬草 肝毒性成分 吡咯里西啶生物碱 超高效液相色谱-串联质谱 含量测定 风险评估 

分 类 号：R284[医药卫生—中药学]