铁皮石斛中农药最大残留限量标准方法研究及40种常用农药筛查分析  

Establishment of Maximum Residue Limits for Pesticides in Dendrobium officinale and Screening Analysis of 40 Commonly Used Pesticides

作　　者：刘芫汐 王莹[1] 申明睿 王皓南 周婷婷[3] 金红宇[1] 马双成 魏锋[1] LIU Yuanxi;WANG Ying;SHEN Mingrui;WANG Haonan;ZHOU Tingting;JIN Hongyu;MA Shuangcheng;WEI Feng(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061 [3]中国药科大学,南京210009

出　　处：《中国药学杂志》2024年第16期1460-1465,共6页Chinese Pharmaceutical Journal

基　　金：药品监管科学全国重点实验室课题资助(2023SKLDRS0103);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);2024年度国家药品标准制修订研究课题资助(2024Z01);中国食品药品检定研究院中青年发展研究基金资助(2024A6)。

摘　　要：目的 对铁皮石斛中常用农药进行筛查以了解其农药残留情况,并结合《GB 2763-2021食品安全国家标准食品中农药最大残留限量》(GB 2763)和《中国药典》2020年版四部农药限度及检测方法探索制定铁皮石斛中常用农药的测定方法和限量标准。方法 采用液相色谱-串联质谱联用(LC-MS/MS)法对铁皮石斛中拟转化的6种农药进行测定,其灵敏度、回收率、重现性及精密度等均符合痕量分析方法学要求。采用符合中药特点的风险评估模式对GB 2763中石斛(干)拟转化农药的最大残留限量值进行评估。结果 结合GB 2763及《中国药典》2020年版相关要求初步拟定了转化农药指标及限度,分别为:吡虫啉3 mg·kg^(-1)、苯醚甲环唑2 mg·kg^(-1)、噻呋酰胺10 mg·kg^(-1)、烯酰吗啉20 mg·kg^(-1)、精甲霜灵2 mg·kg^(-1)。同时采用建立的方法对53批铁皮石斛中的40种常用和6种拟转化农药进行筛查分析,共检出农药37种,采用已建立的风险评估模型对检出农药进行慢性暴露评估,结果发现检出农药的慢性摄入风险均小于1,认为其慢性摄入风险可接受。结论 本研究对53批铁皮石斛中40种常用农药进行了筛查,结合GB 2763建立了转化农药残留测定方法及限量标准,有助于了解铁皮石斛农药残留风险,规范其种植过程中的农药使用并完善其质量标准。OBJECTIVE To screen the commonly used pesticides in Dendrobium officinale to understand their pesticide residues,and explore the establishment of a method for determining the transformation of pesticide residues in Dendrobium officinale and the development of limit standards in accordance with the requirements of GB 2763 Food Safety Standards for Maximum Residue Limits of Pesticides in Food and the Chinese Pharmacopoeia.METHODS LC-MS/MS methods were used to screen and risk assess 6 transformation pesticides in 53 batches of Dendrobium officinale,and the pesticide registration status and the maximum residue limit standards for Dendrobium officinale(dry) in GB 2763 were used to determine the indicators for the transformation of pesticides.RESULTS The pesticides in 53 batches of Dendrobium officinale were analyzed.The transformation pesticide were confirmed in accordance with GB 2763 and the requirements of the Chinese Pharmacopoeia 2020 Edition,and a method for determining the transformation of pesticide residues in Dendrobium officinale was established,along with the development of limit standards.CONCLUSION This study screened 40 commonly used pesticides and 6 transformation in 53 batches of Dendrobium officinale,established a method for determining the transformation of pesticide residues in accordance with GB 2763,and developed limit standards.This study is helpful for understanding the risk of pesticide residues in Dendrobium officinale,regulating the use of pesticides during its cultivation process,and improving its quality standards.

关 键 词：铁皮石斛 GB 2763 限量标准 转化原则 农药残留 

分 类 号：R917[医药卫生—药物分析学]