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目的建立双丹片的质量控制方法。方法采用薄层色谱法(TLC)对双丹片中丹参和牡丹皮2味药材进行定性鉴别;采用高效液相色谱(HPLC)法同时测定丹参素、丹酚酸B和丹皮酚3种成分含量。结果在TLC色谱中可检出丹参、牡丹皮的特征斑点,斑点清晰可见,易于观察;丹参素在0.73~10.95μg范围内进样量与其峰面积线性关系良好(r=1.000 0),平均加样回收率为96.5%,RSD=1.0%(n=6);丹酚酸B在0.37~5.55μg范围内进样量与其峰面积线性关系良好(r=1.000 0),平均加样回收率为98.6%,RSD为1.3%(n=6);丹皮酚在0.30~4.44μg范围内进样量与其峰面积线性关系良好(r=0.999 9),平均加样回收率为100.1%,RSD为1.6%(n=6)。结论该方法可以同时测定双丹片中3种特征性成分,方法简便、准确、稳定且无干扰,可作为双丹片的质量控制方法。
Objective To establish the quality control method of Shuang Dan tablets. Methods TLC (TLC) was used to qualitatively identify the two medicinal materials of Danshen and Cortex Moutan in Shuangdan Tablets. The three components of Danshensu, Salvianolic acid B and Paeonol were determined simultaneously by high performance liquid chromatography (HPLC) content. Results The spots of Salvia miltiorrhiza and Paeonia suffruticosa were detected by TLC. The spots were clearly visible and easy to observe. The injection volume of Danshensu in the range of 0.73 ~ 10.95 μg had a good linear relationship with the peak area (r = 1.000 0) The average recoveries were 96.5%, RSD = 1.0% (n = 6). The linear range was 0.37 ~ 5.55μg for salvianolic acid B (r = 1.000 0) (R = 0.999 9). The mean recovery was 100.1% with a RSD of (0.989), and the RSD was 1.6% (n = 6). Conclusion This method can be used to determine the three characteristic components in Shuang Dan tablets at the same time. The method is simple, accurate, stable and free from interference and can be used as a quality control method for Shuang Dan tablets.