基于胆酸类成分的牛胆粉质量控制与掺伪检测研究  

Quality Control and Adulteration Detection of Cattle Bile Powder Based on Bile Acids

作　　者：曹帅[1] 夏晶[1] 付泽晓 李家豪 李丽敏[1] 胡文言 胡青[1] 毛秀红[1] 季申[1] CAO Shuai;XIA Jing;FU Ze-xiao;LI Jia-hao;LI Li-min;HU Wen-yan;HU Qing;MAO Xiu-hong;JI Shen(Shanghai Institute for Food and Drug Control,Shanghai 201203,China;China Biochemical Pharmaceutical Industry Association,Beijing 100054,China)

机构地区：[1]上海市食品药品检验所,国家药品监督管理局中药质量控制重点实验室,上海201203 [2]中国生化制药工业协会,北京100054

出　　处：《中国药学杂志》2020年第5期383-388,共6页Chinese Pharmaceutical Journal

基　　金：上海市科学技术委员会项目资助(18DZ2292200,19DZ2202800);国家药典委员会人工牛黄及制剂质量标准研究专项资助。

摘　　要：目的建立基于胆酸类成分的牛胆粉质量控制方法,对市售牛胆粉的质量进行评价,分析可能存在的摻伪情况。方法建立同时测定牛、羊、猪、鸡、鸭等动物胆粉中胆酸类成分含量的方法,对自制样品与企业收集样品分别进行研究,以自制样品为主要依据,考察牛胆粉与猪、羊等动物胆粉的差异及含量规律,评价企业收集样品的质量及可能存在的掺伪情况。结果建立了HPLC-ELSD法同时测定牛、羊、猪、鸡、鸭等动物胆粉中12种胆酸类成分含量的方法。分析23批自制动物胆粉的测定结果,明确了牛胆粉与其他动物胆粉中胆酸类成分的含量差异;分析23批企业收集牛胆粉样品的测定结果,发现了牛胆粉中可能掺杂羊胆粉、胆酸下脚料两种主要掺伪情况。23批企业收集样品中仅8批符合规定,合格率仅34.8%,品种质量亟须加强提升和监管。结论研究建立的方法可有效控制牛胆粉的质量,识别牛胆粉中可能存在的掺伪情况,为提高牛胆粉的质量标准及加强市场监管提供了参考和依据。OBJECTIVE To establish a method for the quality control of cattle bile powder based on cholic acid components,e-valuate the quality of commercially sold cattle bile powder,and analyze the possible adulteration.METHODS A method was established for simultaneous determination of cholic acid content in bile powder of cattle,sheep,pig,chicken,duck and other animals.Self-made samples and samples collected by enterprises were studied respectively.Based on self-made samples,the differences and content rules of bile powder of cattle,pig,sheep and other animals were investigated,and the quality and possible adulteration of samples collected by enterprises were evaluated.RESULTS An HPLC-ELSD method was established for simultaneous determination of 12 cholic acids in bile powder of cattle,sheep,pigs,chickens and ducks.By analyzing the determination results of 23 batches of self-made animal bile powder,the contents of cholic acid in cattle bile powder and other animal bile powder were determined.By analyzing the determination results of cattle bile powder samples collected from 23 enterprises,it was found that there were mainly two kinds of a-dulteration of cattle bile powder likely:sheep bile powder and cholic acid waste.Only 8 of the 23 batches of samples collected by enterprises met the requirements,and the qualified rate was only 34.8%.The quality of varieties needs to be improved and supervised urgently.CONCLUSION The method established in this study can effectively control the quality of cattle bile powder,identify possible adulteration of cattle bile powder,and provide reference and basis for improving the quality standard of cattle bile powder and strengthening market supervision.

关 键 词：牛胆粉 质量控制 胆酸类成分 掺伪检测 

分 类 号：R917[医药卫生—药物分析学] R284[医药卫生—药学]