贝母类药材中农药残留检测方法及限量标准研究  

Research on Pesticide Residue Detection Methods and Limit Standards in Fritillaria Medicinal Herbs

作　　者：何成军 耿昭 钟恋 辜冬琳 金红宇[2] 王莹[2] 魏锋[2] 马双成 杨蕾 苟琰 HE Chengjun;GENG Zhao;ZHONG Lian;GU Donglin;JIN Hongyu;WANG Ying;WEI Feng;MA Shuangcheng;YANG Lei;GOU Yan(NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine),MIIT Public Service Platforms for Industrial Technological Base,Sichuan Institute for Drug Control,Chengdu 611731,China;National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]四川省药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,工业和信息化部产业技术基础公共服务平台,成都611731 [2]中国食品药品检定研究院,北京102629 [3]国家药典委员会,北京100061

出　　处：《中国药学杂志》2024年第16期1470-1477,共8页Chinese Pharmaceutical Journal

基　　金：国家药品监督管理局药品监管科学体系建设重点项目资助(RS2024Z006-110);四川省中医药管理局科学技术研究专项课题资助(2023MS415);四川省药品监督管理局科技计划项目资助(2022008);2024年度国家药品标准制定研究课题资助(2024Z01,2024Z02);药品监管科学全国重点实验室课题资助(2023SKLDRS0103)。

摘　　要：目的 建立同时测定贝母类药材中登记农药、禁用农药和拟新增禁用农药残留检测方法并提出参考限量值。方法 采用乙腈提取、分散固相萃取净化,结合气相色谱串联质谱联用(GC-MS/MS)和液相色谱串联质谱联用(LC-MS/MS)技术建立了贝母中95种农药残留检测方法,并对70批样品进行测定。结果 按照GB 2763转化指导原则将贝母中吡虫啉和阿维菌素进行最大残留限量药品标准转化,同时提出18种拟新增禁用农药的参考限量值。结论 通过对贝母的研究,以期为中药标准的转化和禁用农药的增加提供方向和思路,同时为贝母类药材乃至其他中药的农药残留监管政策和技术发展提供参考。OBJECTIVE To establish a method for simultaneous determination of registered pesticides,prohibited pesticides,and proposed new prohibited pesticide residues in Fritillaria Medicinal Herbs,and propose reference limits.METHODS The detection method for 95 pesticide residues in Fritillaria Medicinal Herbs was established using GC-MS/MS and LC-MS/MS.The prepared samples were extracted with acetonitrile and then purified with the QuEChERs method.A total of 70 batches of samples were detected by the established method.RESULTS According to the GB 2763 conversion guidelines,imidacloprid and avermectin in Fritillaria Medicinal Herbs should be converted to the maximum residue limit(MRL) standards.Additionally,reference limit values are proposed for the 18 prohibited pesticides that were previously suggested for addition.CONCLUSION The study of Fritillaria Medicinal Herbs aims to offer guidance and inspiration for the transformation of traditional Chinese medicine standards and the expansion of the list of banned pesticides.It also provides a reference for the regulatory policies and technological advancements related to pesticide residue management in Fritillaria Medicinal Herbs and other traditional Chinese medicines.

关 键 词：贝母 中药 串联质谱法 登记农药 禁用农药 限值 

分 类 号：R917[医药卫生—药物分析学]