五羚丹胶囊质量标准研究

目的建立五羚丹胶囊的质量标准。方法采用薄层色谱法鉴别南五味子和丹参。采用高效液相色谱法测定南五味子中五味子酯甲的含量:C18色谱柱(250mm×4.6mm,5μm),流动相:四氢呋喃-水(40∶60);流速:1.0mL/min,检测波长250nm。结果在薄层色谱中可检出南五味子和丹参的特征斑点;五味子酯甲在0.08192～0.8192μg范围内线性关系良好,r=0.9999,精密度RSD=0.46%(n=6),重复性试验RSD=0.40%(n=6),平均加样回收率为101.1%(RSD=0.40%,n=6)。结论本法简便、灵敏、专属性强、重复性好,可作为五羚丹胶囊的质量控制方法。

Study on Quality Standard of Wulingdan Capsule

Objective To study the quality standard of Wulingdan Capsule. Methods TLC was used to identify Fructus Sishisandrae Sphenantherae and Radix et Rhizoma Salviae Miltiorrhizae. HPLC was used to determine the content of Ester A. Schisandra with C18 ODS column （250 mm×4.6 mm, 5 μm）. The mobile phase was consisted of tetrahydrofuran-water （40 ： 60）. The flow rate was 1.0 mL/min. The detection wavelength was at 250 nm. Results The characteristic spot of Fructus Sishisandrae Sphenantherae and Radix et Rhizoma Salviae Miltiorrhizae could be easily detected by TLC. The calibration curve of Ester A. Schisandra was linear in the range of 0.08192-0.819 2 μg, r =0.9999. The precision （RSD） was 0.46% （n =6）. The reproducibility （RSD） of the method was 0.40% （n =6）. The average recovery of Ester A. Schisandra was 101.1% （RSD=0.40%, n =6）. Conclusions The method is easy, sensitive and specific, with good reproducibility. It can be used to control the quality of Wulingdan Capsule.