金乌健骨胶囊的质量标准研究

Study on the Quality Standard of Jinwu Jiangu Capsule

目的：建立金乌健骨胶囊的质量标准。方法：采用显微鉴别法对制剂中的三七进行显微鉴别;采用薄层色谱（TLC）法对制剂中的白芍、青风藤进行定性鉴别;采用高效液相色谱法测定制剂中芍药苷的含量。色谱柱为ZORBAX SB-C18,流动相为乙腈-0.1%磷酸（13∶87,V/V）,流速为1.0 ml/min,检测波长为230 nm,柱温为30℃,进样量为10μl。结果：三七显微鉴别特征明显;白芍、青风藤TLC分离度好、斑点清晰;芍药苷检测质量浓度线性范围为0.014～1.412μg/ml（r=0.999 2）;精密度、稳定性、重复性试验的RSD〈2%;加样回收率为95.73%～99.48%,RSD为1.54%（n=6）。结论：该方法简便、准确、重复性好,可用于金乌健骨胶囊的质量控制。

OBJECTIVE ： To establish the quality standard of Jinwu jiangu capsule. METHODS ： Microscopy was used to identi- fy Panax notoginseng; TLC was used to identify Paeonia lactiflora and Sinomenii Caulis; HPLC was used to determine the content of paeoniflorin. The column was ZORBAX SB-C18 with mobile phase of acetonitrile -0.1% phosphoric acid （13：87, V/V） at a flow rate of 1.0 ml/min, detection wavelength was 230 nm, column temperature was 30℃ and injection volume was 10μl. RESULTS： Microscopy showed P notoginseng had obvious features; P lactiflora and Sinomenii Caulis in preparation were well-separated with clear spots. The linear range of paeoniflorin was 0.014-1.412 μg/μl（r=0.999 2）; RSDs of precision, stability and reproducibility tests were lower than 2% ; recovery was 95.73%-99.48% （RSD=1.54% ,n=6）. CONCLUSIONS： The method is simple, accurate and reproducible, and can be used for the quality control of Jinwu jiangu capsule.