地补更年安颗粒质量标准研究

Study on Quality Standard of DiBu GengNianAn Granules

目的：建立地补更年安颗粒的质量控制标准。方法：采用薄层色谱法对地补更年安颗粒中五味子、葛根、当归进行定性鉴别,测定制剂中五味子醇甲的含量,色谱柱为Dikma Diamonsil-C18（200mm×4.6mm,5μm）;流动相为乙腈-水（45：55）;流速1.0mL/min,检测波长250nm,进样量20μL。结果：薄层鉴别的色谱斑点清晰,阴性对照无干扰;五味子醇甲含量在1.26~20.16μg范围内线性关系良好,平均回收率为99.4%,RSD=0.5%。结论：该方法操作简便、重复性好、专属性强、可用于地补更年安颗粒的质量控制。

Objective： To establish the standard of quality control for DiBu GengNianAn granules. Methods： WuWeiZi （Schisandra chinensis）, GeGen （Lobed Kudzuvine Root） and DangGui （Angelica sinensis） of DiBu GengNiartA n granules were identified qualitatively by thin-layer chromatography （TLC）, the contents of schisandrin were measured in the preparation, chromatographic column： Dikma Diamonsil-Cas （200 min×4.6 μm, 51μm）; mobile phase： acetonitrile-water （45：55）; mobile phase： 1.0 mL/min, detection wavelength： 250nm, sample size： 20 μL. Resuits： TCL spotting was clear, and the blank tests showed no interference; schisandrin represented good linear relationship in the range between 1.26 and 20.16μg, average recovery rate was 99.4%, RSD=0.5%. Conclusion： The method, simple, accurate and specific, could be used for quality control ofDiBu GengNianAn granules.