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

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Ⅱ_A，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Ⅱ_A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。

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

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 II_A 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 II_A 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.