目的 采用HPLC法多指标成分定量测定联合正交偏最小二乘-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA）及熵权优劣解距离法（entropy weight technique for order preference by similarity to ideal solution，EW- TOPSIS）对不同厂家降糖通脉片（Jiangtang Tongmai Tablets，JTT）质量进行综合评价，为科学评价JTT质量提供参考。方法 收集3个厂家15批JTT样品，采用HPLC法同时测定JTT中3′-羟基葛根素、葛根素、3′-甲氧基葛根素、太子参环肽B、哈巴苷、哈巴俄苷、二氢丹参酮I、隐丹参酮、丹参酮I和丹参酮II_A的含量，运用SPSS 26.0和SIMCA 14.1统计软件进行层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）和OPLS-DA，建立JTT HCA、PCA和OPLS-DA模型，获取得分图和载荷图及变量重要性投影（variable importance in projection，VIP）值，筛选并分析影响JTT质量差异的主要物质基础，并运用EW-TOPSIS法对不同厂家JTT进行质量优劣性评价。结果 3′-羟基葛根素、葛根素、3′-甲氧基葛根素、太子参环肽B、哈巴苷、哈巴俄苷、二氢丹参酮I、隐丹参酮、丹参酮I和丹参酮II_A分别在5.97～298.50、14.45～722.50、4.89～244.50、0.58～29.00、6.55～327.50、2.46～123.00、1.39～69.50、3.56～178.00、4.25～212.50和7.97～398.50 µg/mL（r≥0.999 1）线性关系良好，平均加样回收率（n＝9）分别为99.53%、100.10%、98.95%、96.97%、100.03%、98.84%、97.06%、98.37%、99.31%、99.18%，RSD分别为0.71%、0.63%、0.98%、1.47%、0.79%、1.30%、1.26%、1.18%、1.39%、1.55%。化学计量学分析结果显示15批JTT样品聚为3类，同一厂家JTT样品聚为一类，不同生产厂家样品质量存在一定差异；葛根素、丹参酮I、哈巴苷和丹参酮II_A是影响JTT样品质量的主要潜在标志物；EW-TOPSIS法可用于不同厂家JTT质量优劣的评价。结论 建立的HPLC多指标成分定量测定方法操作便捷、结果准确，结合HCA、PCA、OPLS-DA及EW-TOPSIS法可用于JTT质量的综合评价。

Objective To comprehensively evaluate the quality of Jiangtang Tongmai Tablets (降糖通脉片, JTT) from different manufacturers by HPLC multi-index component quantitative determination combined with orthogonal partial least squares- discriminant analysis (OPLS-DA) and entropy weight-technique for order preference by similarity to ideal solution (EW-TOPSIS) method, which provided reference for scientific evaluation of the quality of JTT. Methods A total of 15 samples from three manufacturers were collected to measure the content of 3′-hydroxy puerarin, puerarin, 3′-methoxy puerarin, heterophyllin B, harpagide, harpagoside, 15,16-dihydrotanshinone I, cryptotanshinone, tanshinone I and tanshinone II_A in JTT by HPLC. To establish the hierarchical cluster analysis (HCA), principal component analysis (PCA) and OPLS-DA model of JTT by using SPSS 26.0 and SIMCA 14.1 statistical software for HCA, PCA and OPLS-DA, and to get the score chart, load chart and importance variable (VIP) value, thus to screen and analyze the material basis affecting the main differences of JTT, and EW-TOPSIS method was used to evaluate the quality of JTT from different manufacturers. Results 3′-hydroxy puerarin, puerarin, 3′-methoxy puerarin, heterophyllin B, harpagide, harpagoside, 15,16-dihydrotanshinone I, cryptotanshinone, tanshinone I and tanshinone II_A showed good linear relationships within the ranges of 5.97—298.50, 14.45—722.50, 4.89—244.50, 0.58—29.00, 6.55—327.50, 2.46—123.00, 1.39—69.50, 3.56—178.00, 4.25—212.50, and 7.97—398.50 µg/mL (r ≥ 0.999 1), whose average recoveries and RSD were 99.53% (0.71%), 100.10% (0.63%), 98.95% (0.98%), 96.97% (1.47%), 100.03% (0.79%), 98.84% (1.30%), 97.06% (1.26%), 98.37% (1.18%), 99.31% (1.39%), and 99.18% (1.55%) (n = 9), respectively. The chemometrics method showed that 15 batches of JTT could be clustered into three categories, and JTT from the same manufacturer were clustered into one category. There were some differences in product quality among different manufacturers. Puerarin, tanshinone I, harpagide and tanshinone II_A were the main potential markers affecting the quality of JTT. The EW-TOPSIS method cound be used to evaluate the quality of JTT from different manufacturers. Conclusion The established HPLC method for quantitative determination of multi-components is convenient and accurate, and combined with HCA, PCA, OPLS-DA and EW-TOPSIS methods can be used for the comprehensive evaluation of the quality of JTT.

R283.6

山西省教育科学“十四五”规划2021年度课题项目（GH-21421）