HPLC多指标成分测定结合多元统计分析的益宫颗粒质量控制研究  

Quality control of Yigong Granules by HPLC multi-index component determination combined with multivariate statistical analysis

作　　者：田丹 王东孝 景贤 李俊涛 陈淑敏 TIAN Dan;WANG Dong-xiao;JING Xian;LI Jun-tao;CHEN Shu-min(Department of Pharmacy,Zhengzhou Yihe Hospital,Zhengzhou 450047,China;Institute of Pharmacology,Henan Institute of Medical and Pharmaceutical Sciences,Zhengzhou 450052,China)

机构地区：[1]郑州颐和医院药学部,河南郑州450047 [2]河南省医药科学研究院药物研究所,河南郑州450052

出　　处：《现代药物与临床》2023年第3期559-565,共7页Drugs & Clinic

基　　金：河南省医学科技攻关计划省部共建指导性计划重点项目(SBGJ202002105)。

摘　　要：目的建立HPLC法同时测定益宫颗粒中多种活性成分,结合多元统计分析对益宫颗粒产品质量进行全面评价。方法采用HPLC法同时测定毛蕊异黄酮葡萄糖苷、芒柄花苷、黄芪紫檀烷苷、黄芪异黄烷苷、川续断皂苷Ⅵ、续断苷A、续断苷B和常春藤皂苷元。结合聚类分析、主成分分析和因子分析对不同批次益宫颗粒产品质量进行综合评价。结果毛蕊异黄酮葡萄糖苷、芒柄花苷、黄芪紫檀烷苷、黄芪异黄烷苷、川续断皂苷Ⅵ、续断苷A、续断苷B和常春藤皂苷元平均加样回收率分别为99.75%、98.41%、98.22%、96.90%、100.08%、97.81%、97.20%、96.97%,RSD值分别为0.87%、1.09%、1.36%、1.45%、0.77%、1.20%、1.33%、1.15%(n=9);通过聚类分析10批益宫颗粒样品分为3类,样品S5、S6、S7聚为第1类,样品S1、S2、S3、S4聚为第2类,样品S8、S9、S10聚为第3类。经主成分分析,前3个主成分特征值依次为4.265、1.611、1.052,累积方差贡献率达到86.602%,主成分因子综合得分与聚类分析分类结果一致。结论建立的HPLC法测定益宫颗粒中活性成分结合多元统计分析的操作便捷,重复性好,结果准确可靠,可用于益宫颗粒的综合质量评价。ObjectiveTo establish a HPLC method for simultaneous determination of various active components in Yigong Granules.Multivariate statistical analysis was used to evaluate the quality of Yigong Granules.MethodsHPLC method wasused to determine contents of calycosin 7-O-β-D-glucopyranoside,ononin,9,10-dimethoxy-pterocarpan-glucoside,2'-dihydroxy-3',4'-dimethoxyisoflavan-7-O-β-D-glucopyranoside,asperosaponin VI,dipsanoside A,dipsanoside B,and hederagenin in Yigong Granules.The quality of differentbatches of Yigong Granules was comprehensively evaluated by cluster analysis,principal component analysis,and factor analysis.ResultsThe average recoveries ofcalycosin 7-O-β-D-glucopyranoside,ononin,9,10-dimethoxy-pterocarpan-glucoside,2'-dihydroxy-3',4'-dimethoxyisoflavan-7-O-β-D-glucopyranoside,asperosaponin VI,dipsanoside A,dipsanoside B,and hederagenin were 99.75%,98.41%,98.22%,96.90%,100.08%,97.81%,97.20%,and 96.97%with the RSD values of 0.87%,1.09%,1.36%,1.45%,0.77%,1.20%,1.33%,and 1.15%(n=9).Ten batches of Yigong Granules were clustered into three categories through cluster analysis,and samples S5,S6,and S7 were clustered into one category,samples S1,S2,S3,and S4 were clustered into one category,and samples S8,S9,and S10 were clustered into one category.The first three principal component eigenvalues were 4.265,1.611,and 1.052 through principal component analysis,and the cumulative variance contribution rate was 86.602%.The comprehensive score of principalcomponent factor was consistent with the classification result of cluster analysis.ConclusionThe established quality controlmethod for determination of active ingredients in Yigong Granules by HPLC combined with multivariate statistical analysis is convenient,reproducible,accurate,and reliable,and can be used for comprehensivequality evaluation of Yigong Granules.

关 键 词：益宫颗粒 毛蕊异黄酮葡萄糖苷 芒柄花苷 黄芪紫檀烷苷 高效液相色谱 聚类分析 主成分分析 因子分析 

分 类 号：R286.02[医药卫生—中药学]