Objective To establish the quality standard of Jiangzhi Fugan Capules. Methods TLC was used to the qualitative identification of Paeoniae Radix Rubra and Salviae Miltiorrhizae Radix et Rhizoma. The contents of Paeoniflorin and Tanshinone ⅡA were determined by HPLC. The HPLC separation was performed on Phenomenex C18 column (4.6 mm×250 mm, 5 μm), with methanol-0.1% phsophonic acid (31∶69, 75∶25) as mobile phase, and the flow rate was 1.0 mL/min. Results The results of TLC showed that relevant spots were clear without interference against the negative sample. The calibration curves for Paeoniflorin and Tanshinone ⅡA were found to be liner within the range of 0.448-4.48μg, 0.057 6-0.576μg, respectively. The correlation coefficients were 0.999 4 and 0.999 5, respectively. The average recoveries were 99.93%and 99.75%, with RSD of 1.98%(n=9) and 1.70%(n=9), respectively. Conclusion The method is accurate, reliable, stable, rapid, and reproducible, and can be used for the quality control and evaluation of Jiangzhi Fugan Capules.%目的：建立降脂复肝胶囊的质量标准。方法采用薄层色谱法对制剂中赤芍、丹参进行薄层定性鉴别。采用高效液相色谱法,Phenomenex C18色谱柱,以甲醇-0.1%磷酸水溶液(31∶69、75∶25)为流动相,流速1.0 mL/min,分别对制剂中芍药苷和丹参酮ⅡA的含量进行分析测定。结果薄层鉴别图谱斑点清晰,阴性对照无干扰。芍药苷和丹参酮ⅡA进样量分别在0.448～4.48μg和0.0576～0.576μg范围内线性关系良好,相关系数分别为0.9994、0.9995,平均加样回收率分别为99.93%(RSD＝1.98%,n＝9)、99.75%(RSD＝1.70%,n＝9)。结论本试验定性定量检测方法准确、可靠、稳定、快速,重复性好,可用于降脂复肝胶囊的质量控制及评价。
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