【摘要】 目的:建立通淋颗粒的质量标准。方法:采用薄层色谱(TLC)法对处方中的蒲公英、鱼腥草、桂枝、蒲黄进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中咖啡酸的含量:色谱柱为Kromasil C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸溶液(11∶89,V/V),检测波长为323 nm。结果:在TLC图中能清晰地检出蒲公英、鱼腥草、桂枝、蒲黄的特征斑点,且阴性对照无干扰、专属性强。咖啡酸的质量浓度在1.68~107.60μg/ml范围内与其峰面积积分值呈良好的线性关系(r=0.999 5);精密度、稳定性、重复性试验的RSD<2%;低、中、高质量浓度对照品对应的平均加样回收率分别为99.07%、99.10%、100.17%,RSD分别为1.21%、0.41%、0.61%(n均为3)。结论:所建标准可用于通淋颗粒的质量控制。更多还原

【Abstract】 OBJECTIVE:To establish the quality standard for Tonglin granule.METHODS:Taraxaci Herba,Houttuynia cordata,Cinnamomum cassia and Typhae Pollen were identified by TLC.The content of caffeic acid was detected by HPLC.The determination was performed on Kromasil C18(250 mm×4.6 mm,5 μm)column with mobile phase consisted of acetonitrile-0.2% phosphoric acid(11 ∶ 89,V/V);the detection wavelength was set at 323 nm.RESULTS:TLC spots of them could be detected clearly and were specific without interference from negative control.The linear range of caffeic acid were 1.68-107.60 μg/ml(r=0.999 5);RSD of precision,stability and reproducibility tests were all lower than 2%;the average recoveries were 99.07%(RSD=1.21%,n=3),99.10%(RSD=0.41%,n=3) and 100.17%(RSD=0.61%,n=3) at low,medium and high concentrations.CONCLUSIONS:The standard can be used for quality control of Tonglin granule.更多还原