目的 建立清喉咽颗粒（Qinghouyan Granules，QHY）多指标成分定量分析方法，结合化学计量学及熵权-优劣解距离法（technique for order preference by similarity to an ideal solution，TOPSIS）分析，对9个厂家的QHY质量进行综合评价，为其质量控制与评价提供方法及参考依据。方法 HPLC法分析QHY中黄芩苷、连翘酯苷A、熊果苷、五福花苷酸、连翘酯苷I、连翘苷、汉黄芩苷、黄芩素、汉黄芩素、水苏糖、棉子糖11种成分含量，对9个厂家的177批次QHY样品进行定量测定；利用SIMCA 14.1和SPSS 25.0软件，对上述11种成分含量检测结果进行层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）和正交偏最小二乘法-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA），筛选造成QHY质量差异的特征标志物；在PCA基础上设定Hotlling’s T2和DModX控制限，对177批间样品进行质量差异的监控；运用熵权-TOPSIS模型对9个厂家QHY质量的优劣排序，多角度建立QHY质量综合评价方法。结果 11种成分含量测定方法学考察结果精密度、重复性、稳定性及准确度的RSD值均小于3.0%。HCA和PCA结果均显示，不同厂家间及厂家内部不同批次间样品质量均有差异。OPLS-DA模型以VIP值＞1为标准，筛选出水苏糖、棉子糖、汉黄芩素、黄芩苷、连翘酯苷I、连翘酯苷A 6个特征标志物，可能是影响QHY质量的主要成分。熵权-TOPSIS法结果显示，相对接近度C在0.084～0.850，表明不同厂家间QHY质量差异较大，厂家TCQ排序最优，厂家JM排序最后。结论 建立的QHY中11种化学成分含量测定方法准确可靠，HCA、PCA和OPLS-DA可有效筛选影响QHY质量的特征标志物，熵权-TOPSIS法可综合评价QHY质量。

Objective To establish a multi-index component quantitative method for analyzing Qinghouyan Granules (清喉咽颗粒, QHY), combined with chemometrics and technique for order preference by similarity to an ideal solution (TOPSIS) analysis to comprehensively evaluate the quality of QHY products from nine different manufacturers, thereby providing methods and reference basis for its quality control and evaluation. Methods An HPLC method was developed for simultaneous quantification of 11 components—baicalin, forsythiaside A, arbutin, pentaflorin acid, forsythiaside I, forsythin, wogonoside, baicalein, wogonin, stachyose, and raffinose in 177 batches of QHY sourced from nine manufacturers. Hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA) with SIMCA 14.1 and SPSS 25.0 software were conducted on the detection results of the 11 component contents to screen out the characteristic markers that cause the quality differences of QHY. Quality variations among batches were monitored by establishing Hotelling’s T2 and DModX control limits based on PCA. Entropy weight TOPSIS was applied to rank the quality of QHY from nine manufacturers, and a comprehensive evaluation method for QHY quality was established from multiple perspectives. Results The RSD values of the precision, repeatability, stability and accuracy of the methodological investigation results for the determination of the content of 11 components were less than 3.0%. HCA and PCA revealed show that there are differences in sample quality among different manufacturers and among different batches within a manufacturer. OPLS-DA identified six critical markers (VIP > 1.0): stachyose, raffinose, baicalin, wogonin, forsythiaside I, and forsythiaside A, which were confirmed as primary contributors to quality variation. The results of entropy weight TOPSIS show that the relative proximity degree C ranges from 0.084 to 0.850, indicating significant quality disparities of QHY among manufacturers, with manufacturer E ranking highest and C lowest. Conclusion The established method for determining the contents of 11 chemical components in QHY is accurate and reliable. HCA, PCA and OPLS-DA can effectively screen out the characteristic markers that affect the quality of QHY, and the entropy-weighted-TOPSIS method can comprehensively evaluate the quality of QHY.

R283.6

国家药品抽检计划（2024）