补肾强身胶囊质量标准研究

目的:建立补肾强身胶囊的质量标准。方法:采用薄层色谱(TLC)法对处方中淫羊藿、女贞子进行定性鉴别;用高效液相色谱(HPLC)法测定淫羊藿苷的含量:色谱柱为汉邦十八烷基硅烷键合硅胶填充柱(250mm×4.6mm,5μm),流动相为乙腈-甲醇(30∶70),流速为1.0mL.min-1,检测波长为270nm,柱温为30℃。结果:女贞子、淫羊藿的TLC斑点清晰,分离度好。淫羊藿苷进样量在0.266 4~0.932 4μg范围内与峰面积积分值呈良好线性关系(r=0.999 9);平均回收率为99.77%,RSD=1.89%(n=6)。结论:所建标准可用于补肾强身胶囊的质量控制。

On Quality Criteria of Bushenqiangshen Capsule

OBJECTIVE:To establish quality criteria for Bushenqiangshen capsule. METHODS:TLC was employed to identify Herba Epimedii and Fructus Ligustri Lucidi. HPLC was applied for the determination of content of Icariin. The chromatographic separation was performed on octadecylsilane chemically bonded silica packed column (250mm×4.6mm,5μm). The mobile phase was composed of acetonitrile and methyl alcohol (30∶70) at a flow rate of 1.0mL·min-1. The detection wavelength was 270nm and the column temperature was 30℃. RESULTS:Herba Epimedii and Fructus Ligustri Lucidi were well-separated and clear spots were noted in their TLC. The linear range of icariin was 0.266 4～0.932 4μg (r=0.999 9,n=6), and the average recoveries was 99.77%(RSD=1.89%). CONCLUSION:The established criteria can be used for the quality control of Bushenqiangshen capsules.