骨康胶囊的质量控制研究

目的建立骨康胶囊(淫羊藿、骨碎补等)的质量控制方法。方法采用TLC法对淫羊藿和骨碎补进行定性鉴别;采用HPLC法对淫羊藿苷和柚皮苷进行定量分析。色谱柱为SinoChrom ODS-BP(5μm,4.6 mm×250 mm);流动相为乙腈-4%的乙酸(梯度洗脱);体积流量为1.0 mL/min;检测波长为270 nm和283 nm。结果薄层色谱斑点清晰,阴性对照无干扰;淫羊藿苷进样量在0.266～2.66μg范围内线性关系良好(r=0.999 98),平均加样回收率为99.10%,RSD为1.27%;柚皮苷进样量在0.099～0.99μg范围内线性关系良好(r=0.999 96),平均加样回收率为99.50%,RSD为1.45%。结论所建立的方法能准确可靠地进行定性、定量检测,重复性好,可作为本产品的质量控制方法。

Quality control of Gukang Capsules

AIM To establish qualitative and quantitative methods for Gukang Capsules(Epimedii Folium,Drynariae Rhizoma).METHODS TLC was performed to identify Epimedii Folium,Drynarial Rhizoma in Gukang Capsules.HPLC was used to determine the contents of icariin and naringin.The gradient elution was performed on a SinoChrom ODS-BP column(5 μm,4.6 mm×250 mm) with acetonitrile-4% acetic acid solution as the mobile phase.The flow rate was 1.0 mL/min.The detection wavelength was set at 270 nm and 283 nm.RESULTS The spots on TLC plates were clear without interference.The calibration curve was linear within the range of 0.266~2.66 μg for icariin,and the average recovery was 99.10%(RSD was 1.27%).The calibration curve was linear within the range of 0.099-0.99 μg for naringin,and the average recovery was 99.50%(RSD was 1.45%).CONCLUSION The methods are simple,reliable,accurate,reproducible,and suitable for the quality control of Gukang Capsules.