定心胶囊质量标准研究

Study on Quality Standard of Dingxin Capsule

目的建立定心胶囊的质量控制方法。方法采用薄层色谱法对处方中酸枣仁、丹参和黄芪进行定性鉴别,采用高效液相色谱法测定定心胶囊中人参皂苷Rg1的含量。结果在薄层色谱中可检出酸枣仁、丹参和黄芪的特征斑点。人参皂苷Rg1在2.156～10.78μg范围内线性关系良好,r=0.999 7,精密度RSD=1.90%(n=5),重复性试验RSD=1.29%(n=5),平均加样回收率为97.37%(RSD=1.90%,n=5)。结论该方法操作简单、准确、重复性好、专属性强,可用于控制定心胶囊的质量。

Objective To establish the quality control method of Dingxin capsule. Methods TLC was used to distinguish spina date seed, Tanshinone and Radix Astragali in prescription. HPLC was used to determine the content of panaxoside Rgl in Dingxin capsule. Result In TLC, the characteristic spots of spina date seed, Tanshinone and Radix Astragali can be detected. The panaxoside Rgl has good relationship in the range of 2.156~10.78 μg, r=0.999 7, precision RSD= 1.90% （n =5）, repeated experiment RSD----1.29% （n=5）. The average recovery was 97.37% （RSD=1.90%, n=5）. Conclusion The method is simple, accurate, reproducible and highly specific. It can control the quality of Dingxin capsule.