灵五颗粒质量标准的研究

Study On Quality Standard of Lingwu Granules

目的建立灵五颗粒的质量标准。方法采用TLC法对灵五颗粒中的灵芝、五味子、柴胡进行定性鉴别;采用HPLC法测定该制剂中五味子醇甲的含量,色谱柱为Agilent HC-C18(150 mm×4.6 mm,5μm);流动相:甲醇-水(52∶48);检测波长:250 nm;柱温:40℃;结果 TLC法可鉴别出该制剂中的灵芝、五味子、柴胡,薄层色谱斑点清晰,无干扰。五味子醇甲在0.049 36～1.234 mg范围内与峰面积线性关系良好(r=1);样品的平均加样回收率为99.41%,RSD为1.40%(n=6)。结论此方法简便、准确、重复性好,能有效的控制灵五颗粒的质量。

Objective To establish a quality standard for Lingwu granules. Methods Ganoderma, Schisandrae Chinensis Fructus and Bupleuri Radix were identified by TLC. Agilent HC-Cls （ 150 mm x4.6 mm,5 μm） was used as the stationary phase,with methanol-water（52： 48） as mobile phase. The photodiode array detector was set at 250 nm. Column temperature was set at 40℃. Results Spots on TLC were clear without interference. The calibration curve was linear over the range of 0. 049 36-1. 234 mg （ r = 1 ）. The average recovery of the method was 99.41%. RSD was 1.40% （ n =6）. Conclusion This method is reliable and accurate,able to separate and determine paeoniflorin in Lingwu granules.