蛇胆川贝液中蛇胆汁的掺伪筛查与现行标准商榷  

Screening for Adulteration of Snake Bile in Shedan Chuanbei Liquid and Discussion on Current Standard

作　　者：刘德丽 马斐 张艳红 张静 任菲菲 Liu Deli;Ma Fei;Zhang Yanhong;Zhang Jing;Ren feifei(Dezhou Center for Food and Drug Control,Dezhou,250315,China)

机构地区：[1]德州市食品药品检验检测中心,山东德州253015

出　　处：《成都中医药大学学报》2021年第4期23-27,共5页Journal of Chengdu University of Traditional Chinese Medicine

基　　金：山东省2020年药品风险监测项目。

摘　　要：目的:通过考察蛇胆汁掺伪情况对不同厂家蛇胆川贝液的质量及现行标准进行评价。方法:采用高效液相色谱串联质谱法(LC-MS),电喷雾离子源,负离子多反应监测模式,以甘氨猪去氧胆酸(GHDCA)和甘氨去氧胆酸(GDCA)为检测指标,对蛇胆川贝液中的蛇胆汁进行掺伪筛查,并将试验结果与实验室前期按照法定标准检验得到的结果进行比较。结果:35批蛇胆川贝液样品中13批检出猪胆汁掺伪,1批检出牛、羊胆汁掺伪。不同厂家产品质量差异明显。结论:市售蛇胆川贝液质量参差不齐,存在其他动物胆汁掺伪入药的情况。现行标准不能充分反映药品的真实质量,应建立多元化质控标准。Objective:The current quality standard and quality of Shedan Chuanbei Liquid from different manufacturers were evaluated by investigating the adulteration of snake bile.Methods:Adulteration screening of snake bile in Shedan Chuanbei Liquid was carried out by HPLC-MS with GHDCA and GDCA as detection indexes,and the test results were compared with those obtained in the laboratory according to the legal standards.Results:Of the 35 batches of Shedan Chuanbei Liquid samples,13 batches were detected to be adulterated with pig bile,and 1 batch was detected to be adulterated with cow and sheep bile.The quality of products from different manufacturers is significantly different.Conclusion:The overall quality of the commercially available Shedan Chuanbei Liquid is poor.Adulteration of bile from other animals is common.The current standard can not fully reflect the real quality of drugs,so diversified quality standards should be established.

关 键 词：蛇胆川贝液 蛇胆汁 掺伪筛查 液质联用 质量控制 质量标准 

分 类 号：O213.1[理学—概率论与数理统计] R931.74[理学—数学]