橘半枳术丸的质量标准

Study on Quality Standard of Juban Zhishu Pills

目的:对橘半枳术丸的质量控制方法进行研究,建立橘半枳术丸定性和定量检测方法。方法:采用薄层色谱法对制剂中的枳实、陈皮、白术进行定性鉴别;采用HPLC法测定黄芩中黄芩苷的含量,甲醇-水-磷酸(47∶53∶0.2)为流动相,流速为1.0 ml.min-1,柱温:40℃,检测波长为280 nm。结果:TLC鉴别法能特征鉴别枳实、陈皮和白术,斑点显色清晰,阴性样品无干扰。黄芩苷在0.078～1.561μg范围内线性关系良好,平均加样回收率99.9%,RSD为1.49%(n=6)。结论:本法操作简便、准确、重复性好,可用于该制剂的质量控制。

Objective： To study the quality control methods of Juban Zhishu pills and establish the quality standard.Method： Feuctus aurantii immaturus,Pericarpium citri reticulatae and Rhizoma atractylodis macrocephalae in the herb medicines were identified by TLC.The content of baicalin in Scutellaria baicalensis was determined by HPLC.The chromatographic conditions were as fallows： the mobile phase consisted of methanol-water-phosphoric acid（47∶ 53∶ 0.2） at a flow rate of 1.0 ml·min-1.The column temperature was 40℃ and the detection wavelength was 280 nm.Result： Feuctus aurantii immaturus,Pericarpium citri reticulatae and Rhizoma atractylodis macrocephalae could be identified by TLC distinctively with clear and respective spots.The calibration curve of baicalin was linear within the range of 0.078-1.561 μg.The average recovery was 99.9% with RSD of 1.49%（n=6）.Conclusion： This method is simple,accurate and reproducible.It can be applied in the quality control of Juban Zhishu pills.