延肾胶囊的制备及质量标准研究

目的:制备延肾胶囊并建立其质量标准。方法:以薄层色谱法鉴别延肾胶囊中的三七、大黄、黄芪;以薄层双波长反射式锯齿扫描法测定大黄有效成分大黄素的含量:展开剂为正己烷-乙酸乙酯-甲酸(20∶10∶0.5);检测波长为437nm,参比波长为700nm,散射参数为3.0;狭缝为0.4mm×0.4mm。结果:三七、大黄、黄芪的薄层斑点清晰,分离良好。大黄素点样浓度在0.5~2.5μg·mL-1范围内与斑点峰面积积分值呈良好的线性关系(r=0.9971);平均加样回收率为95.06%,RSD=1.44%(n=5)。结论:制备方法简便、可行;所建标准可用于该制剂的质量控制。

Preparation and Quality Control of Yanshen Capsule

OBJECTIVE： To prepare Yanshen capsule and to establish its quality control method. METHODS： The contents of Panax Pseudo-ginseng,Radix Et Rhizoma Rhei and Radix Astragali in Yanshen capsules were identified by TLC; the content of Emodin in Yanshen capsule was determined by dual wavelength zigzag TLC scanning method with N - hexane - acetic ether - formic acid （20 ： 10 ： 0.5） as developer. The wavelength was 437nm and the reference wavelength was 700nm, and the scatter parameter was 3.0. The slit was 0.4mm × 0.4mm in size. RESULTS： The Panax Pseudo-ginseng, Radix Et Rhizoma Rhei and Radix Astragali showed clear spots and well - separated in TLC. The linear range of Emodin was 0.5- 2.5μg . mL^-1（r = 0.997 1）, with an average recovery of 95.06% （RSD = 1.44%, n = 5） .CONCLUSION： The method is simple and feasible, and the established criteria is suitable for the quality control of Yanshen capsules.