HPLC指纹图谱结合化学计量学分析不同企业心脑健胶囊(片)的差异

Study on HPLC Fingerprint Combined with Chemometric to Analyze the Quality Differences of Xinnaojian Capsule(Tablet)in Different Enterprises

目的建立心脑健胶囊(片)质量评价方法,比较不同企业心脑健胶囊(片)的质量差异。方法将中国药典2020年版一部心脑健胶囊项下特征图谱转化为指纹图谱,并进行方法学考察。与对照品进行比较,确定特征峰成分。测定3个厂家的21批产品,通过相似度分析其指纹图谱的异同,进一步使用聚类分析和主成分分析进行模式识别。结果3家企业之间心脑健胶囊(片)指纹图谱存在差异,聚类分析和主成分分析结果基本一致,样品按厂家各自聚为一类,其中峰10(表没食子儿茶素没食子酸酯),13(没食子酸儿茶素没食子酸酯)、16(表儿茶素没食子酸酯)等特征峰对指纹图谱影响较大。在企业H样品中表没食子儿茶素没食子酸酯含量较低,仅为企业N样品中相应成分含量的60.08%,而没食子酸儿茶素没食子酸酯含量较高。在企业S样品中没食子酸儿茶素没食子酸酯含量较低,为企业N样品中相应成分含量的42.47%,而表儿茶素没食子酸酯含量相对较高。另外,各企业样品所含主要成分的比例均不相同。结论化学计量学辅助的HPLC指纹图谱具有简便、客观、可数字化的优点,可直观地区别不同企业心脑健胶囊(片)成分及其比例的差异。

OBJECTIVE To establish an approach for quality evaluation of Xinnaojian capsule(tablet)and to compare the quality differences of Xinnaojian capsules(tablets)in different enterprises.METHODS Transformed the characteristic chromatogram of Xinnaojian capsule(2020 edition of Chinese Pharmacopoeia)into fingerprint method,and method evaluation was performed.By comparing with control drugs,the characteristic peaks were investigated.Then twenty-one batches of samples from 3enterprises were determined and their fingerprints were compared by analysis of similarities.Then hierarchical cluster analysis and principal component analysis were applied in pattern recognition.RESULTS The fingerprints of Xinnaojian capsule(tablet)from three enterprises differed.The results of hierarchical cluster analysis and principal component analysis were consistent,which indicated that the fingerprints of the samples from the same manufacturer could cluster to their own group.The characteristic peaks of 10(epigallocatechin-3-gallate),13(gallocatechin gallate),16(epicatechin-3-gallate)showed the greatest impact on the fingerprints.The content of epigallocatechin-3-gallate in samples of enterprise H was low,which was only 60.08% of that in samples of enterprise N,while the content of gallocatechin gallate was higher in samples of enterprise H.The content of gallocatechin gallate in samples of enterprise S was lower,which was 42.47% of that in samples of enterprise N,while the content of epicatechin-3-gallate was higher in samples of enterprise S.In addition,the proportion of the main components in the samples of different enterprises were not the same.CONCLUSION HPLC fingerprinting with aid of chemometric analysis is simple,objective and easy to realize digitalization and can reflect the differences of chemical component and proportion between samples more intuitively.