胃灵颗粒质量标准的提高

Improvement of Quality Standard for Weiling Granules

目的：建立胃灵颗粒的质量标准。方法：采用TLC法对胃灵颗粒中的主要药味白芍、甘草、延胡索及山楂进行定性鉴别;采用HPLC法测定白芍中芍药苷的含量,色谱柱：Agilent XDB-C18（250 mm×4.6 mm,5μm）,流动相：乙腈-0.1%磷酸溶液（10∶90）,检测波长：230 nm,流速：1.0 ml·min-1。结果：薄层色谱斑点清晰,在与对照药材或对照品相应的位置上显相同颜色的斑点,阴性对照无干扰;白芍中芍药苷的线性范围0.151-1.212μg,r=0.999 9,平均回收率为99.63%,RSD为2.01%（n=9）。结论：本方法操作简单,结果准确可靠,重复性好,可作为胃灵颗粒的质量控制方法。

Objective：To re-establish the quality control standard for Weiling granules. Methods：The 4 chief herbs in the prepa-ration, radices paeoniae alba, licorice, rhizoma corydalis and hawthorn were identified by TLC qualitatively. The content of paeoniflor-in in radices paeoniae alba was determined by HPLC. The separation was performed on an Agilent XDB-C18 （250 mm × 4. 6 mm, 5μm）coulme with mobile phase consisting of acetonitrile-0. 1% phosphoric acid solution （10：90）. The detection wavelength was 230 nm and the flow rate was 1. 0 ml·min-1 . Results：The spots in TLC were clear without any interference. The linear range for paeoni-florin was 0. 151-1. 212 μg（r=0. 999 9,n=5）. The average recovery was 99. 63% and RSD was 2. 01%（n=9）. Conclusion：The method is simple and accurate with high reproducibility, which can be used for the quality control of Weiling granules.