高效液相色谱-柱后光化学衍生法测定活血止痛胶囊中黄曲霉毒素的含量  

Determination of Aflatoxins in Huoxuezhitong Capsules by High Performance Liquid Chromatography Coupled with Post-column Photochemical Derivatization

作　　者：李悦忱 崔韶婧 赵月然 LI Yue-chen;CUI Shao-jing;ZHAO Yue-ran(Dalian Center for Certification and Food and Drug Control,Liaoning Dalian 116021,China)

机构地区：[1]大连市检验检测认证技术服务中心,辽宁大连116021

出　　处：《中国药物评价》2023年第5期390-395,共6页Chinese Journal of Drug Evaluation

基　　金：2021国家评价性抽验项目:活血止痛胶囊。

摘　　要：目的:考察高效液相色谱(HPLC)-柱后光化学衍生法对活血止痛胶囊中黄曲霉毒素(AFs)测定的可行性,建立活血止痛胶囊中黄曲霉毒素B_(1)、B_(2)、G_(1)、G_(2)的测定方法,并对其污染情况进行检查,为开展中成药黄曲霉毒素污染监管提供依据。方法:采用高效液相色谱-柱后光化学衍生法对3个厂家共113批活血止痛胶囊中黄曲霉毒素的含量进行测定,并对测定结果进行分析。结果:活血止痛胶囊中黄曲霉毒素B_(1)、B_(2)、G_(1)、G_(2)的回收率均在75%~105%。113批样品中,90批检出黄曲霉毒素,检出率为79.6%,其中4批次出现不同程度的超标(AFB 1>5μg·kg^(-1),AFs>10μg·kg^(-1))。结论:HPLC-柱后光化学衍生法结果准确,重现性好,可用于活血止痛胶囊中黄曲霉毒素的测定。活血止痛胶囊中个别批次出现黄曲霉毒素污染,存在安全隐患,应引起生产企业的重视,确保用药安全。Objective:To investigate the feasibility of determination of aflatoxins in Huoxuezhitong capsules by high performance liquid chromatography(HPLC)coupled with post-column photochemical derivatization,and to establish a method for determination of aflatoxin B_(1),B_(2),G_(1) and G_(2) in Huoxuezhitong capsules.The contamination status was checked to provide a basis for the supervision of aflatoxin pollution of Chinese patent medicine.Methods:The content of aflatoxins in 113 batches of Huoxuezhitong capsules from three manufacturers was determined by HPLC coupled with post-column photochemical derivatization,and the results were analyzed.Results:The recoveries of aflatoxin B_(1),B_(2),G_(1) and G_(2) in Huoxuezhitong capsules were within 75%-105%.Among 113 batches of samples,aflatoxins were detected in 90 batches,with a detection rate of 79.6%,of which 4 batches exceeded the standard in varying degrees(AFB 1>5μg·kg^(-1),AFs>10μg·kg^(-1)).Conclusion:The HPLC method coupled with post-column photochemical derivatization is accurate and reproducible,which can be used for the determination of aflatoxins in Huoxuezhitong capsules.Aflatoxin pollution in some batches of Huoxuezhitong capsules is serious and there are potential safety hazards,which should be paid attention to by manufacturers to ensure the safety of medication.

关 键 词：活血止痛胶囊 黄曲霉毒素 高效液相色谱 光化学衍生 风险评估 

分 类 号：R284.1[医药卫生—中药学]