骨疏灵胶囊的质量标准研究

Studies on Quality Control of Gushuling Capsule

目的 研究骨疏灵胶囊的质量控制标准。方法 采用薄层色谱法对制剂中的补骨脂、女贞子进行定性鉴别;并利用高效液相色谱法对制剂中的淫羊藿苷进行定量分析,以CH_3CN-H_2O(30:70)为流动相,流速1.0 mL/min,色谱柱为C_(18)柱,检测波长为270 nm。结果 补骨脂与女贞子的薄层色谱鉴别专属性强,阴性对照无干扰;淫羊藿苷在0.0968～0.4840 μg范围内线性关系良好(r=0.9999),平均回收率为97.27％(RSD=1.88％,n=5)。结论 该方法可为骨疏灵胶囊的质量评价提供科学依据。

Objective To study the quality control standard of Gushuling capsule. Methods Fructus Psoraleae and Fructus Ligustri Lucidi in Gushuling capsule were identified by TLC; The content of ieariin was determined by HPLC with acetonitrile-water (30: 70) as mobile phase and the wavelength at 270 nm. Results TLC identification was positive; the linear range of icariin was 0.0968～0.4840 μg(r=0.9999), the average recovery was 97.27%(RSD=1.88%, n=5). Conclusion This method can be used as a standard of the quality control for Gushuling capsule.