抗栓胶囊中黄曲霉毒素的含量测定及安全性评价  

Content determination and safety evaluation of aflatoxin in Kangshuan capsules

作　　者：薛平 顾峥嵘 刘旻虹 李莉 XUE Ping;GU Zheng-rong;LIU Min-hong;LI Li(Changzhou Institute for Food,Drug and Fiber Control,Changzhou Jiangsu 213000)

机构地区：[1]常州市食品药品纤维质量监督检验中心,江苏常州213000

出　　处：《中南药学》2022年第10期2394-2399,共6页Central South Pharmacy

基　　金：国家药品监督管理局2021年国家药品抽验计划(序号7)。

摘　　要：目的 测定抗栓胶囊中黄曲霉毒素B、B、G和G的含量,评价抗栓胶囊中黄曲霉毒素的安全性。方法 70%乙腈提取样品,免疫亲和柱净化提取液,采用高效液相色谱柱后衍生荧光法和液相色谱-串联质谱法两种方法测定。结果 两种测定方法线性关系均良好,进样精密度、重复性、稳定性和加样回收率均符合要求。29 批次样品中10个批次样品黄曲霉毒素B超过5 μg,黄曲霉毒素G_(2)、G_(1)、B_(2)和B_(1)的总量超过10 μg;1个批次样品黄曲霉毒素G_(2)、G_(1)、B_(2)和B_(1)的总量超过10 μg。结论 抗栓胶囊中黄曲霉毒素污染的原因可能是处方中多种高危原料药材共同导致的。本方法可以用于抗栓胶囊中的黄曲霉毒素含量测定及质量控制。Objective To determine the content of aflatoxin B_(1),B_(2),G_(1)and G_(2) in Kangshuan capsules and to evaluate its safty.Methods The samples were extracted with 70% acetonitrile,purified by immunoaffinity column,and determined by both HPLC with fluorescence detection after photochemical derivation and liquid chromatography-tandem mass spectrometry.Results Both detection methods showed good linearity,and the repeatability,stability and sample recovery all met the requirements.The content of aflatoxin B_(1)in 10 out of the 29 batches samples was more than 5 μg.The total amount of aflatoxin G_(2),G_(1),B_(2) and B_(1) in these samples exceeded 10 μg.The total amount of aflatoxin G,G,Band Bin 1 batch exceeded 10 μg.Conclusion The pollution of aflatoxin in Kangshuan capsules may be caused by various high-risk raw materials in the prescription.The method can be used to determine the content of aflatoxin in Kangshuan capsules,a suitable reference for the quality control of this drug.

关 键 词：抗栓胶囊 黄曲霉毒素 含量测定 

分 类 号：R927[医药卫生—药学]