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目的:研究活血通淤片的质量控制标准。方法:采用高效液相色谱法分别测定活血通淤片中丹参素和丹酚酸B含量,色谱柱为KromasilC18柱(250mm×4.6mm,5μm);分别以水-乙腈-冰醋酸(93∶5∶2)和甲醇-0.2%磷酸水溶液(40∶60)为流动相;检测波长为280nm;流速1.0mL.min-1。结果:丹参素在0.1～2.0μg范围内具有良好线性关系(r=0.9998),平均回收率为97.55%,RSD为1.18%;丹酚酸B在0.1～2.0μg之间有良好的线性关系(r=0.9995),平均回收率为100.20%,RSD为1.33%。结论:该法灵敏、简便、准确和重复性好,可作为该制剂的质量控制标准。
Objective: To study the quality control standard of Huoxuetongxue Tablet. Methods: The content of Danshensu and Salvianolic acid B in Huoxue Tengxue tablets was determined by HPLC. The column was Kromasil C18 column (250mm × 4.6mm, 5μm). The column was separated by water-acetonitrile-glacial acetic acid (93: 5 : 2) and methanol-0.2% phosphoric acid solution (40:60) as the mobile phase. The detection wavelength was 280 nm. The flow rate was 1.0 mL.min-1. Results: Danshensu showed a good linearity (r = 0.9998) in the range of 0.1 ~ 2.0μg with an average recovery of 97.55% and a RSD of 1.18%. There was a good linear relationship between salvianolic acid B and 0.1 ~ 2.0μg r = 0.9995). The average recovery was 100.20% and the RSD was 1.33%. Conclusion: The method is sensitive, simple, accurate and reproducible, which can be used as the quality control standard of the preparation.