基于多成分定量联合多元统计分析及熵权优劣解距离法评价寒喘祖帕颗粒的质量  

Quality evaluation of Hanchuan Zupa Granules by multi-component quantitative and multivariate statistical analysis and the entropy weight-technique for order preference by similarity to ideal solution method

作　　者：徐建华 徐月华 周虹 李志明 XU Jianhua;XU Yuehua;ZHOU Hong;LI Zhiming(Department of Pharmacy,The People’s Hospital of Haian,Haian 226600,China;School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]海安市人民医院药剂科,海安226600 [2]南京中医药大学药学院,南京210023

出　　处：《西北药学杂志》2025年第2期35-46,共12页Northwest Pharmaceutical Journal

基　　金：江苏省中医药科技发展计划面上项目(编号:MS2021008)。

摘　　要：目的采用一测多评法(quantitative analysis of multi-components by single marker,QAMS)测定寒喘祖帕颗粒中12种成分的含量,并联合多元统计分析及熵权优劣解距离法(entropy weight-technique for order preference by similarity to ideal solution,EW-TOPSIS)对寒喘祖帕颗粒的质量进行综合评价。方法色谱柱为Waters Atlantis T3-C_(18)柱(250 mm×4.6 mm,5μm),流动相为体积分数0.2%冰醋酸-乙腈,同时测定18批寒喘祖帕颗粒中槲皮素、木犀草素、柚皮素、山柰酚、没食子酸、绿原酸、咖啡酸、迷迭香酸、甘草苷、甘草酸、茴香醛和胡芦巴碱的含量,采用SPSS 26.0和SIMCA 14.1统计学软件对18批样品进行差异分析。结果12种成分在各自线性范围内线性关系良好(r>0.999),平均加样回收率范围为96.92%~100.14%(n=9),相对标准偏差(relative standard deviation,RSD)≤1.44%。统计学分析结果显示,18批样品聚为3类,批次间呈现一定差异;甘草苷、木犀草素、甘草酸、没食子酸、绿原酸和槲皮素是影响寒喘祖帕颗粒产品质量的主要潜在标志物。18批寒喘祖帕颗粒的Ci值在0.1354~0.7193之间,质量差异较大。结论所建立的方法简便科学,结果准确可靠,可用于寒喘祖帕颗粒质量的综合评价。Objective To establish a method for the simultaneous determination of the contents of 12 components in Hanchuan Zupa Granules using quantitative analysis of multi-components by single marker(QAMS),and to comprehensively evaluate the quality of Hanchuan Zupa Granules by multivariate statistical analysis and entropy weight-Technique for Order Preference by Similarity to Ideal Solution(EW-TOPSIS).Methods High-performance liquid chromatography(HPLC)was used with Waters Atlantis T3-C_(18) as the chromatographic column and a mobile phase consisting of acetonitrile-0.2%glacial acetic acid.The contents of quercetin,luteolin,naringenin,kaempferol,gallic acid,chlorogenic acid,caffeic acid,rosmarinic acid,liquiritin,ammonium glycyrrhizinate,4-methoxybenzaldehyde and trigonelline in 18 batches of Hanchuan Zupa Granules were quantified.The variations among the 18 batches of samples were analyzed by statistical software.Results The linear relationship between the 12 components and peak areas were good in their respective ranges(r>0.999),and the average recovery rate(n=9)was 96.92%—100.14%(RSD≤1.44%).Statistical analysis showed that the 18 batches of samples clustered into 3 groups,showing some differences among the batches.Liquiritin,luteolin,ammonium glycyrrhizinate,gallic acid,chlorogenic acid and quercetin were the main potential markers influencing the quality of Hanchuan Zupa Granules.The Ci value of 18 Hanchuan Zupa Granules ranged from 0.1354 to 0.7193,indicating significant quality variation.Conclusion The established method is simple and scientific,and the results are accurate and intuitive,and can be used for the comprehensive evaluation of the quality of Hanchuan Zupa Granules.

关 键 词：寒喘祖帕颗粒 一测多评法 多元统计分析 熵权优劣解距离法 

分 类 号：R927.2[医药卫生—药学]