目的 建立双丹胶囊的质量标准。方法 用薄层色谱(TLC)法对双丹胶囊中的牡丹皮、丹参进行鉴别，用高效液相色谱法(HPLC)测定双丹胶囊中丹皮酚、丹参素和丹酚酸B的含量。结果 TLC法可对牡丹皮、丹参进行鉴别，且斑点清晰，分离度好，易于识别；HPLC测定结果显示，丹皮酚、丹参素和丹酚酸B浓度分别在3.63～36.30 μg·mL-1(r＝0.9998)、29.45～294.5 μg·mL-1(r＝0.9999)和24.32～243.2 μg·mL-1(r＝0.9998)范围内与其峰面积线性关系良好，平均回收率分别为100.2 %、100.5 %、100.45 %，RSD分别为2.2 %(n=6)、0.9 %(n=6)、2.88 %(n=6)。结论 本实验的定性、定量方法准确、简便，可为双丹胶囊质量标准的提高提供科学依据。

Objective To establish the quality standard of Shuangdan capsule. Methods Thin layer chromatography(TLC) was used for the identification of Cortex Moutan and Radix Salviae miltiorrhizae，and high performance liquid chromatography(HPLC) was used for content determination of paeonol，tanshinol and salvianolic acid B in Shuangdan capsule. Results Cortex Moutan and Radix Salviae miltiorrhizae could be detectable by TLC，the spots were clear and the dissociation was good. The established HPLC method was simple and accurate. And the linear ranges of paeonol，tanshinol and salvianolic acid B in Shuangdan capsule were 3.63～36.30 μg·mL-1(r＝0.9998)，29.45～294.5 μg·mL-1(r＝0.9999)，24.32～243.2 μg·mL-1(r＝0.9998)，respectively，and their recovery rates were 100.2 %(RSD=2.2 %，n=6)，100.5 %(RSD=0.9 %，n=6)，100.45 %(RSD=2.88 %，n=6)，respectively. Conclusion The established method are easy and accurate，and can be used for the quality control of Shuangdan capsule.

R284.1

国家药品标准提高研究课题(519,520,521)。