更年安片质量标准提高的研究

Improving Quality Standard of Gengnianan Tablet

目的 ：进一步提高更年安片质量标准。方法 ：采用薄层色谱法（TLC法）鉴别制剂中的茯苓、泽泻、牡丹皮、钩藤;采用高效液相色谱法（HPLC法）测定五味子中五味子醇甲的含量。色谱柱：Kromasil-C18（4.6 mm×200 mm,5μm）;流动相：甲醇（A）-水（B）=64∶36;流速：1 m L/min;检测波长：250 nm;柱温：30℃。结果：TLC法能对茯苓、泽泻、牡丹皮、钩藤进行鉴别;五味子醇甲的含量在3.0~24.0μg/m L（r=0.999 9）范围内与峰面积呈良好的线性关系,五味子醇甲的加样回收率平均值为98.28%,RSD=1.03%。结论：该方法能有效检测更年安片的质量标准,可更好地控制其质量。

Objective：To improve the quality standard of Gengnianan tablet. Methods：Thin layer chromatography（TLC） was used to identify Poria,Alismatis Rrizoma,Moutan Cortex and Uncariae,The concentration of Schizandrin in the preparation was determined by high performance liquid chromatography （HPLC） method. The samples were separated by Kromasil-C18（4.6 mm×200 mm,5 μm）,and the mobile phase was methanol-water（64：36） with the flow rate of 1 mL/min and the detection wavelength was set at 250 nm. The column temperature was maintained at 30℃. Resuhs：Poria,Alismatis Rrizoma,Moutan Cortex and Uncariae could be identified by TLC method. The linear relation between peak area and concentration of Schizandrin was good in the range of 3.0--24.0 μg/mL（r=0.999 9）,the average recovery was 98.28% with RSD 1.03%. Conclusion：This method could determine the quality standard of Gengnianan tablet and be used to control the quality effectively.