愈骨疗伤胶囊的质量标准研究

Quality Standard Study on Yuguliaoshang Capsule

目的建立愈骨疗伤胶囊的质量标准。方法采用TLC法对续断、白芍、地黄进行定性鉴别;采用HPLC法测定川续断皂苷Ⅵ与柚皮苷的含量。色谱条件为SunfireTMC18柱(250 mm×4.6 mm,5μm);流动相为水-乙腈梯度洗脱,流速为1.0 ml/min,进样量20μl。采用双波长检测212、283 nm分别处对川续断皂苷Ⅵ、柚皮苷进行检测。结果薄层色谱斑点清晰,分离效果好。续断皂苷Ⅵ的回归方程为Y=228217X-4176,r=0.9998,在0.04～8.0μg/ml范围内峰面积与进样量呈良好的线性关系;柚皮苷的回归方程为Y=2E+06X-885.61,r=0.9999,在0.021～4.1μg/ml范围内峰面积与进样量呈良好的线性关系。川续断皂苷Ⅵ和柚皮苷的平均回收率为101.36%、100.45%。结论所建立的方法简便、准确、专属性强,可用于愈骨疗伤胶囊含量测定。

Objective To establish quality standards Yuguliaoshang capsulse.Methods Dipsacus root,catalpol and paeoniae in the medicine were identified by TLC.Asperosaponin Ⅵ and naringin in this medicine were determined by HPLC.SunfireTM C18（250 mm×4.6 mm,5 μm） was used.The mobile phase consisted of acetonitrile-water（gradient elution）,at a flow rate of 1.0 ml/min.The detection wavelength was set at 212 nm for asperosaponin Ⅵ and 283 nm for naringin.The injection volume was 20 μl.Results Thin layer chromatography spots were clear,with good separation effect.Asperosaponin Ⅵ showed good linear relationship within the range of 0.04-8.0 μg/ml（r=0.9998）,naringin within the range of 0.021-4.1 μg/ml（r=0.9999）.The average recovery of asperosaponin Ⅵ was 101.36%and naringin was 100.45%.Conclusion The method is simple,accurate,specific,and can be used for quality control of Yuguliaoshang capsules.