HPLC指纹图谱结合化学计量学方法用于乙肝解毒胶囊的质量评价  

Quality evaluation of Yigan Jiedu capsules using HPLC fingerprint coupled with chemometrics

作　　者：谭会洁 秦猛 林永强 林林 李军 TAN Hui-jie;QIN Meng;LIN Yong-qiang;LIN Lin;LI Jun(Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China;Shandong Taikang Pharmaceutical Co.Ltd.,Dezhou 253000,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]山东泰康药业有限公司,德州253000

出　　处：《药物分析杂志》2020年第3期529-535,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省自然科学基金项目(ZR2013HM074)。

摘　　要：目的:建立HPLC指纹图谱,结合化学计量学分析方法,对乙肝解毒胶囊进行质量评价。方法:采用Waters Atlantic T3 C18色谱柱(250 mm×4.6 mm,5μm),乙腈-0.1%甲酸溶液为流动相,梯度洗脱,柱温40℃,流速1 mL·min-1,检测波长290 nm,建立乙肝解毒胶囊的HPLC指纹图谱。结果:测定8家生产企业的128批样品,采用Chem Pattern软件进行分析,以80%以上样品中存在的色谱峰作为共有峰筛选条件,确定了20个共有峰,采用高分辨质谱指认了其中19个成分,并对其中12个成分采用对照品比对的方式进行确证。待测样品与共有模式的相似度为0.43~0.96,表明不同企业的乙肝解毒胶囊质量差异较大;对色谱数据进行主成分及聚类分析,对不同企业产品的质量一致性进行评价,阐明主要差异成分,结合相关成分的药材来源,推测部分企业在贯众、土茯苓等药材投料方面可能存在问题。结论:所建立的乙肝解毒胶囊HPLC指纹图谱结合化学计量学分析方法,信息全面,可用于乙肝解毒胶囊质量控制及评价。Objective:To establish a HPLC fingerprint analysis coupled with chemometrice for quality evaluation of Yigan Jiedu capsules.Methods:The fingerprint analysis was carried out on a Waters Atlantic T3 C18 column(250 mm×4.6 mm,5 μm),using mobile phase consisting of acetonitrile-0.1% formic acid solution with gradient elution at a flow rate of 1 mL·min-1.The column temperature was set at 40 ℃ and the detection wavelength was 290 nm.Results:A total of 128 batches of samples from eight manufacturers were measured by using the above method and the data were analyzed by ChemPattern software.The peak presented in more than 80% of the samples was defined as a common peaks and 20 common peaks were determined.Among them,19 peaks were identified by high resolution MS method,12 of which were confirmed by reference substances.The similarities of the tested samples were 0.43-0.96,suggesting the quality of the samples from different manufacturers varied greatly.Furthermore,principal component analysis(PCA)and hierarchical analysis(HCA)were performed to evaluate the quality consistency,and clarify the main different components in samples.The results indicated that a few manufacturers might have feeding problems concerning Cyrtomium Rhizome and Smilacis Glabrae Rhizoma.Conclusion:This method combined with HPLC fingerprint analysis and chemometrice is comprehensive and convenient for the quality control and evaluation of Yigan Jiedu capsules.

关 键 词：乙肝解毒胶囊 高效液相色谱 指纹图谱 化学计量学 质量评价 

分 类 号：R917[医药卫生—药物分析学]