目的 對(duì)天丹通絡(luò)膠囊進(jìn)行質(zhì)量評(píng)價(jià)研究。方法 采用HPLC法測(cè)定天丹通絡(luò)膠囊中天麻素、巴利森苷E、巴利森苷、奇壬醇、豨薟苷、豨薟精醇、洋川芎內(nèi)酯H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A、丹參素、丹酚酸B、隱丹參酮和丹參酮Ⅱ_A，結(jié)合正交偏最小二乘法判別分析（OPLS-DA）法和熵權(quán)優(yōu)劣解距離（EW-TOPSIS）法對(duì)天丹通絡(luò)膠囊產(chǎn)品質(zhì)量?jī)?yōu)劣進(jìn)行評(píng)價(jià)。結(jié)果 天麻素、巴利森苷E、巴利森苷、奇壬醇、豨薟苷、豨薟精醇、洋川芎內(nèi)酯H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A、丹參素鈉、丹酚酸B、隱丹參酮和丹參酮Ⅱ_A的平均回收率分別為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值分別為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批天丹通絡(luò)膠囊樣品明顯分成3類。丹酚酸B、巴利森苷、豨薟苷、巴利森苷E、天麻素和洋川芎內(nèi)酯A可以作為影響天丹通絡(luò)膠囊產(chǎn)品質(zhì)量的關(guān)鍵成分。EW-TOPSIS分析法可確定15批天丹通絡(luò)膠囊樣品質(zhì)量?jī)?yōu)劣綜合排序。結(jié)論 所建立方法操作便捷，結(jié)果準(zhǔn)確可靠，為提升天丹通絡(luò)膠囊的整體質(zhì)量控制方法提供了參考和借鑒。

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.

R286.02

山東省中醫(yī)藥科技發(fā)展計(jì)劃項(xiàng)目（2019-0033）