基于HPLC多指标成分定量联合OPLS-DA、EW-TOPSIS法的天丹通络胶囊质量评价研究  

Quality evaluation of Tiandan Tongluo Capsules based on HPLC multi-index component quantification combined with OPLS-DA and EW-TOPSIS

作　　者：巴小翠 孙俊英 陈玉洁 李占芳 BA Xiao-cui;SUN Jun-ying;CHEN Yu-jie;LI Zhan-fang(Department of Drug,Dongying Institute for Food and Drug Control,Dongying 257091,China;School of Pharmacy,Shandong University of Traditional Chinese Medicine,Jinan 250355,China)

机构地区：[1]东营市食品药品检验研究院药品科,山东东营257091 [2]山东中医药大学药学院,山东济南250355

出　　处：《现代药物与临床》2023年第5期1094-1101,共8页Drugs & Clinic

基　　金：山东省中医药科技发展计划项目(2019-0033)。

摘　　要：目的对天丹通络胶囊进行质量评价研究。方法采用HPLC法测定天丹通络胶囊中天麻素、巴利森苷E、巴利森苷、奇壬醇、豨莶苷、豨莶精醇、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、丹参素、丹酚酸B、隐丹参酮和丹参酮ⅡA,结合正交偏最小二乘法判别分析(OPLS-DA)法和熵权优劣解距离(EW-TOPSIS)法对天丹通络胶囊产品质量优劣进行评价。结果天麻素、巴利森苷E、巴利森苷、奇壬醇、豨莶苷、豨莶精醇、洋川芎内酯H、洋川芎内酯I、洋川芎内酯A、丹参素钠、丹酚酸B、隐丹参酮和丹参酮ⅡA的平均回收率分别为98.77%、99.45%、100.05%、96.94%、97.99%、98.43%、98.08%、97.90%、98.90%、97.86%、100.14%、96.97%、99.32%,RSD值分别为1.09%、1.32%、0.63%、1.43%、1.51%、1.30%、1.57%、0.83%、1.64%、0.94%、0.70%、1.41%、1.37%。15批天丹通络胶囊样品明显分成3类。丹酚酸B、巴利森苷、豨莶苷、巴利森苷E、天麻素和洋川芎内酯A可以作为影响天丹通络胶囊产品质量的关键成分。EW-TOPSIS分析法可确定15批天丹通络胶囊样品质量优劣综合排序。结论所建立方法操作便捷,结果准确可靠,为提升天丹通络胶囊的整体质量控制方法提供了参考和借鉴。Objective To evaluate quality of Tiandan Tongluo Capsules.Methods The contents of gastrodin,parishin E,parishin A,kirenol,darutoside,darutigenol,senkyunolide H,senkyunolide I,senkyunolide A,danshensu,salvianolic acid B,cryptotanshinone,and tanshinone IIA in Tiandan Tongluo Capsules were determined by HPLC.OPLS-DA and EW-TOPSIS methods were used to evaluate quality of Tiandan Tongluo Capsules.Results The average recoveries of gastrodin,parishin E,parishin A,kirenol,darutoside,darutigenol,senkyunolide H,senkyunolide I,senkyunolide A,danshensu,salvianolic acid B,cryptotanshinone,and tanshinone IIA were 98.77%,99.45%,100.05%,96.94%,97.99%,98.43%,98.08%,97.90%,98.90%,97.86%,100.14%,96.97%,and 99.32%with the RSD values of 1.09%,1.32%,0.63%,1.43%,1.51%,1.30%,1.57%,0.83%,1.64%,0.94%,0.70%,1.41%,and 1.37%.The 15 batches of Tiandan Tongluo Capsules samples were clustered into three categories.Salvianolic acid B,parishin A,darutoside,parishin E,gastrodin,and senkyunolide A were the key components affecting the quality of Tiandan Tongluo Capsules.The EW-TOPSIS method can be used for comprehensive evaluation of quality of Tiandan Tongluo Capsules.Conclusion The established method is rapid,sensitive,accurate,and reliable,and provides a reference for improving the overall quality control method of Tiandan Tongluo Capsules.

关 键 词：天丹通络胶囊 天麻素 巴利森苷E 丹参酮ⅡA 高效液相色谱 正交偏最小二乘判别分析 熵权优劣解距离 

分 类 号：R286.02[医药卫生—中药学]