腰痹通胶囊的高效液相指纹图谱研究

Study on HPLC fingerprint of Yaobitong Capsules

目的建立复方制剂腰痹通胶囊的高效液相指纹图谱,完善其质量控制方法。方法采用RP-HPLC-DAD法,选用色谱柱Hypersil ODS2(250 mm×4.6 mm,5μm),在柱温为30℃、检测波长为203 nm下,以乙腈-体积分数为0.1%磷酸水溶液为流动相进行梯度洗脱,流速为1.0 mL·min-1,每次进样量为10μL。以人参皂苷Rg1为参照,建立了10批腰痹通胶囊的高效液相中药指纹图谱。采用《中药色谱指纹图谱相似度评价系统》(2012版)对10批样品进行相似度评价,确定共有峰,并对共有峰进行指认。结果 10批腰痹通胶囊的HPLC图谱共有27个共有峰,10批腰痹通胶囊相似度良好(均大于0.9),通过与标准品的保留时间和高效液相色谱图对比,确定了8种主要成分,分别为儿茶素、芍药内酯苷、芍药苷、人参皂苷Rg1、延胡索乙素、丹皮酚、人参皂苷Rb1和蛇床子素。结论所建立的腰痹通胶囊的指纹图谱方法特征性强、专属性高,可用于腰痹通胶囊的质量控制研究。

Objective The HPLC fingerprint of Yaobitong capsule was developed to improve its quality control method.Methods The RP-HPLC-DAD method was used with the column Hypersil ODS2(250 mm × 4.6 mm,5 μm),and the gradient was eluted with acetonitrile-0.1% phosphoric acid aqueous solution at a column temperature of 30 ℃ and a detection wavelength of 203 nm.The flow rate was set at 1.0 mL·min-1,and the injection volume was 10 μL.Based on ginsenoside Rg1,the HPLC fingerprints of 10 batches of Yaobitong capsules were determined.According to the Chinese traditional medicine chromatographic fingerprint similarity evaluation system(2012 edition),the common peaks were determined and the similarity of 10 batches of samples was further evaluated.Results The HPLC spectra of 10 batches of samples had 27 common peaks,and the 10 batches of Yaobitong capsules had a good similarity(all more than 0.9).Compared to the retention time and UV spectrum of the standard,8 components were identified as catechin,albiflorin,paeoniflorin,ginsenoside Rg1,tetrahydropalmatine,paeonol,ginsenoside Rb1 and osthole.Conclusion The established fingerprint method of Yaobitong capsule was of the highly characteristics and specificity,and could be further applied for the research of the material basis and the quality control of Yaobitong capsule.