益心酮片中农药残留风险评估  

Risk assessment of pesticide residues in Yixintong tablets

作　　者：左甜甜 刘芫汐 王莹[1] 王丹丹 昝珂[1] 李静[1] 魏锋[1] 金红宇[1] 马双成 ZUO Tian-tian;LIU Yuan-xi;WANG Ying;WANG Dan-dan;ZAN Ke;LI Jing;WEI Feng;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,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

出　　处：《药物分析杂志》2024年第12期2072-2077,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家十三五“重大新药创制”课题(2018ZX09735006)。

摘　　要：目的:通过对益心酮片及其原料山楂叶提取物的农药残留情况进行测定及风险评估,明确相关品种的风险,并为相关限量标准的制定提供科学依据。方法:以乙睛为溶剂,高速匀浆提取,经氨基石墨化碳小柱净化。GC-MS/MS和LC-MS/MS方法对山楂叶和山楂叶提取物中262种农药进行检测。并采用确定性评估模式,分别计算其短期和长期摄入风险。结果:山楂叶提取物和益心酮片中分别检出农药25种和31种,检出共有农药18种,残留量范围分别为0.004~1.457 mg·kg^(-1)和0.007~2.1 mg·kg^(-1)。风险评估结果表明,除了己唑醇的短期危害指数(HIa)为1,风险需要进一步被关注外,益心酮片及其原料山楂叶提取物中其他检出农药的HIa和长期危害指数(HIc)均低于1,风险可接受。结论:本研究探索中药制剂益心酮片及其原料中农药残留情况,并评估其风险,为完善符合中药使用特点的风险评估技术体系及相关农药残留限量标准的制订提供技术支持。Objective:To identify the risks and provide a scientific basis for the formulation of the limit standards by the determination and risk assessment of pesticide residues in Yixintong tablets and hawthorn leaf extracts.Methods:The samples were extracted with acetonitrile by high speed homogenater,and purified by solid-phase extraction(SPE)column of envi-carb/NH_(2).262 pesticides in hawthorn leaf extracts and Yixintong tablets were detected by GC-MS/MS and LC-MS/MS.Moreover,the acute and chronic intake risks were calculated using the deterministic risk assessment model.Results:25 and 31 types of pesticides were detected in hawthorn leaf extracts and Yixintong tablets,respectively.18 types of pesticides were detected in all of them.The contents were 0.004-1.457 mg·kg^(-1),0.007-2.1 mg·kg^(-1),respectively.The results of risk assessment revealed that the short-term hazard index(HIa)of hexaconazole was 1 and the risk was needed to be paid more attention.HIa and long-term hazard index(HIc)of other pesticides detected in Yixintong tablets and hawthorn leaf extracts were much lower than 1,indicating an acceptable risk.Conclusion:In the present study,the pesticide residues were explored,and their health risks were assessed;therefore our study provided technical support for the improvement of risk assessment applicable to traditional Chinese medicines(TCMs)and the formulation of relevant pesticide residue limit standards.

关 键 词：农药残留 益心酮片 山楂叶提取物 风险评估 短期危害指数 长期危害指数 

分 类 号：R917[医药卫生—药物分析学]