目的 建立HPLC法同時測定益宮顆粒中多種活性成分，結合多元統(tǒng)計分析對益宮顆粒產品質量進行全面評價。方法 采用HPLC法同時測定毛蕊異黃酮葡萄糖苷、芒柄花苷、黃芪紫檀烷苷、黃芪異黃烷苷、川續(xù)斷皂苷Ⅵ、續(xù)斷苷A、續(xù)斷苷B和常春藤皂苷元。結合聚類分析、主成分分析和因子分析對不同批次益宮顆粒產品質量進行綜合評價。結果 毛蕊異黃酮葡萄糖苷、芒柄花苷、黃芪紫檀烷苷、黃芪異黃烷苷、川續(xù)斷皂苷Ⅵ、續(xù)斷苷A、續(xù)斷苷B和常春藤皂苷元平均加樣回收率分別為99.75%、98.41%、98.22%、96.90%、100.08%、97.81%、97.20%、96.97%，RSD值分別為0.87%、1.09%、1.36%、1.45%、0.77%、1.20%、1.33%、1.15%（n＝9）；通過聚類分析10批益宮顆粒樣品分為3類，樣品S5、S6、S7聚為第1類，樣品S1、S2、S3、S4聚為第2類，樣品S8、S9、S10聚為第3類。經主成分分析，前3個主成分特征值依次為4.265、1.611、1.052，累積方差貢獻率達到86.602%，主成分因子綜合得分與聚類分析分類結果一致。結論 建立的HPLC法測定益宮顆粒中活性成分結合多元統(tǒng)計分析的操作便捷，重復性好，結果準確可靠，可用于益宮顆粒的綜合質量評價。

Objective To 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. Methods HPLC method was used 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 different batches of Yigong Granules was comprehensively evaluated by cluster analysis, principal component analysis, and factor analysis. Results The average recoveries 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 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 principal component factor was consistent with the classification result of cluster analysis. Conclusion The established quality control method 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 comprehensive quality evaluation of Yigong Granules.

R286.02

河南省醫(yī)學科技攻關計劃省部共建指導性計劃重點項目（SBGJ202002105）