基于HPLC多指标成分定量测定联合化学计量学、熵权优劣解距离法的降糖通脉片质量评价研究  

Study on quality evaluation of Jiangtang Tongmai Tablets based on HPLC multi-index component quantification combined with chemometrics and EW-TOPSIS method

作　　者：李平 李新锋 蔡晓旭 杨红 韩晓静 冀小君 孙立艳[5] LI Ping;LI Xin-feng;CAI Xiao-xu;YANG Hong;HAN Xiao-jing;JI Xiao-jun;SUN Li-yan(Department of Pharmaceutical Engineering,Shanxi Pharmaceutical Vocational College,Taiyuan 030031,China;Scientific Instrument Center,Shanxi University,Taiyuan 030006,China;College of Chinese Medicine and Food Engineering,Shanxi University of Chinese Medicine,Jinzhong 030619,China;Shanxi Modern Chinese Medicine Engineering Laboratory,Jinzhong 030619,China;Department of Chinese Medicine,Tianjin Vocational College of Bioengineering,Tianjin 300000,China)

机构地区：[1]山西药科职业学院制药工程系,山西太原030031 [2]山西大学大型科学仪器中心,山西太原030006 [3]山西中医药大学中药与食品工程学院,山西晋中030619 [4]山西省现代中药工程实验室,山西晋中030619 [5]天津生物工程职业技术学院中药系,天津300000

出　　处：《中草药》2023年第8期2417-2426,共10页Chinese Traditional and Herbal Drugs

基　　金：山西省教育科学“十四五”规划2021年度课题项目(GH-21421)。

摘　　要：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,EWTOPSIS)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SPSS26.0和SIMCA14.1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7.97~398.50μg/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、OPObjective 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 squaresdiscriminant 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 IIA 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—398.50µg/mL(r≥0.9991),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

关 键 词：降糖通脉片 HPLC 化学计量学 正交偏最小二乘-判别分析 熵权优劣解距离法 质量评价 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 丹参酮Ⅱ_(A) 主成分分析 

分 类 号：R283.6[医药卫生—中药学]