通淋颗粒的质量标准研究

Quality Standard of Tonglin Granules

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KromasilC18（250mm×4．6mm，5μm），流动相为乙腈-0．2％磷酸溶液（11：89．V／V）．检测波长为323nm。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1．68～107．60gg／ml范围内与其峰面积积分值呈良好的线性关系（r=0．9995）；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。

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 deter- mination was performed on Kromasil C188 （250 mm × 4.6 mm, 5μm）column with mobile phase consisted of acetonitrile-0.2 % phos- phoric 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 ~tg/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.