小儿肺热平胶囊中牛胆粉的质量评价及投料混伪判别  

Quality Evaluation and Adulteration Detection of Cattle Bile Powder in Xiaoer Feireping Capsule

作　　者：谭春梅 方翠芬 董婷 王娟娟 郑成 张文婷 TAN Chun-mei;FANG Cui-feng;DONG Ting;WANG Juan-juan;ZHENG Cheng;ZHANG Wen-ting(Institute for Traditional Chinese Medicine Control,Zhejiang Institute for Food and Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine/Traditional Chinese Patent Medicine,Zhejiang Hangzhou 310052,China)

机构地区：[1]浙江省食品药品检验研究院中药天然药物检验所,国家药品监督管理局中成药质量评价重点实验室,浙江杭州310052

出　　处：《中国药物评价》2023年第4期316-321,共6页Chinese Journal of Drug Evaluation

基　　金：浙江省药品监督管理局科技计划项目(毒性中药材特征性成分群高辨识度多维数据库的构建,2022018)。

摘　　要：目的:建立小儿肺热平胶囊中牛胆粉质量评价方法。方法:采用HPLC-ELSD测定小儿肺平胶囊中结合胆酸的含量,采用Besil 5 C_(18)-H色谱柱(4.6 mm×250 mm,5μm),以乙腈为流动相A,以0.2%三氟乙酸溶液为流动相B,梯度洗脱;柱温为35℃;流速为1.0 mL·min^(-1),漂移管温度110℃,气体流速3 L·min^(-1);对牛磺胆酸/甘氨胆酸的比值进行测定,并通过主成分分析(PCA)和正交偏最小二乘-判别分析(OPLS-DA),筛选影响批次间一致性的成分。结果:2家生产企业的结合胆酸的含量差别较大;PCA结合OPLS-DA筛选出了引起不同生产企业差别较大的最大影响因素为牛磺胆酸/甘氨胆酸的比值,A企业的比值大于2.0,B企业的比值小于2.0。结论:本研究建立的方法能快速有效地评价小儿肺热平胶囊中牛胆粉的质量及是否存在羊胆粉混伪投料。Objective:To establish a quality evaluation method of cattle bile powder in Xiaoer feireping capsules.Methods:The content of conjugated cholic acid in Xiaoer feiping Capsules was determined by HPLC-ELSD.The chromatographic analysis was carried out on a Besil 5 C_(18)-H column(4.6 mm×250 mm,5μm)with a column temperature of 35℃and a liquid flow-rate of 1.0 mL·min^(-1)using 0.2%trifluoroacetic acid solution and acetonitrile as the mobile phase with a linear gradient.An ELSD was used with a nitrogen flow-rate of 3.0 L·min^(-1),at a drift tube temperature of 110℃.The ratio of taurocholic acid to glycolic acid was determined in addition,the principal component analysis(PCA)and orthogonal partial least squares-discriminant analysis(OPLS-DA)of each batch were carried out to obtain the components that affected the consistency between batches.Results:The content of conjugated cholic acid varied considerably between the two manufacturers.PCA combined with OPLS-DA screened out the ratio of taurocholic acid to glycolic acid that had the greatest impact on batch consistency,the ratio in company A was greater than 2.0,and the ratio in company B was less than 2.0.Conclusion:The established method can quickly and effectively evaluate the quality of cattle bile powder in Xiaoer feireping capsules and identify whether there is any false feeding of sheep bile powder.

关 键 词：小儿肺热平胶囊 质量评价 牛胆粉 羊胆粉 主成分分析 混伪判别 

分 类 号：R284[医药卫生—中药学]