尿感宁颗粒的质量标准研究

Studies on Quality Standard of Niaoganning Granule

目的:建立尿感宁颗粒(无糖型)简单、快捷的质量控制方法。方法:采用薄层色谱法对尿感宁颗粒中的连钱草、凤尾草进行定性鉴别,用高效液相色谱法对尿感宁颗粒中秦皮乙素的含量进行测定,色谱柱为C18柱(4.6 mm×250 mm,5μm),流速为1.0 mL.min-1,流动相为甲醇-0.5%磷酸(28∶72),检测波长为345 nm。结果:连钱草、凤尾草和紫花地丁薄层色谱分离良好,斑点清晰可见;含量测定中秦皮乙素的含量在20.08～2 080 ng内线性关系良好,平均加样回收率为96.3%,RSD1.9%,n=6。结论:方法结果准确、重复性好,可作为该制剂的质量控制方法。

Objective：To establish the quality standard for Niaoganning Granule.Method：The TLC was applied to identify Herba Glechomae Longitubae and Herba Pteridis Nervosae in this prescription,and aesculetin content in Herba Violae was determined by HPLC.A column（4.6 mm × 250 mm,5 μm） was used with the mobile phase of methanol and 0.5% phosphoric acid（22∶ 78） at the detection wavelength of 345 nm.Result：Glechomae Longitubae and Pteridis Nervosae could be identified by TLC.The aesculetin linear rang of 20.08-2 080 ng,and the average recoverywas 96.3%,RSD 1.9%,Conclusion：The above methods are simple,sensitive,accurate and re-producible,and can be used for the quality control of this granule.