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目的:建立双丹胶囊的质量标准。方法:采用TLC法对双丹胶囊中丹酚酸B成分进行鉴别,采用HPLC法测定胶囊中丹皮酚的含量。色谱条件为Kromasil-C18柱;流动相:甲醇-0.1%磷酸(64∶36);检测波长274 nm。结果:TLC分离度好,阴性对照无干扰;丹皮酚在26.2~131.0μg·ml-1范围内线性良好(r=0.999 8),平均回收率为99.59%,RSD为0.85%(n=6)。结论:该方法简便、准确,可以控制该制剂的质量。
Objective: To establish the quality standard of Shuanghuan capsule. Methods: The content of salvianolic acid B in Shidan Capsules was identified by TLC, and the content of paeonol in capsules was determined by HPLC. Chromatographic conditions Kromasil-C18 column; mobile phase: methanol -0.1% phosphoric acid (64:36); detection wavelength 274 nm. Results: The separation of TLC was good and no interference was found in the negative control. Paeonol showed good linearity (r = 0.999 8) in the range of 26.2-131.0 μg · ml-1 with an average recovery of 99.59% and a RSD of 0.85% (n = 6 ). Conclusion: The method is simple and accurate, and can control the quality of the preparation.