赤黄止痢颗粒中赤芍的薄层色谱鉴别与含量测定方法的建立

建立控制赤黄止痢颗粒中赤芍的分析方法。采用薄层色谱法(TLC)对赤黄止痢颗粒中赤芍进行定性分析,采用高效液相色谱法(HPLC)对制剂中芍药苷进行含量测定。薄层色谱结果表明,赤黄止痢颗粒中的赤芍在与对照品色谱相应的位置上,显相同的蓝紫色斑点,而阴性样品无相同特征斑点。HPLC结果表明,芍药苷在0.25~2.0 mg范围峰面积线性关系良好(R²=0.9996);芍药苷的平均回收率为99.74%,RSD为1.95%(n=9)。结果表明,研究建立的赤黄止痢颗粒中赤芍的薄层色谱鉴别方法和含量测定分析方法可操作性强,结果准确可靠,重复性好,为赤黄止痢颗粒质量标准的制定提供了方法学依据。

Establishment of TLC Identification and Content Determination Method of Paeoniae Rubra in Chihuang Zhili Granules

Establish an analytical method for controlling red peony in Chihuang Zhili Granules.The qualitative analysis of red peony in Chihuang Zhili Granules was carried out by thin-layer chromatography(TLC),and the content of paeoniflorin in the preparation was determined by high performance liquid chromatography(HPLC).The results of thin-layer chromatography showed that the red peony in Chihuang Zhili Granules showed the same blue-purple spots on the corresponding position of the chromatogram of the reference substance,while the negative samples did not have the same characteristic spots.HPLC results showed that the peak area of paeoniflorin had a good linear relationship in the range of 0.25~2.0 mg(R²=0.9996);the average recovery rate of paeoniflorin was 99.74%,and the RSD was 1.95%(n=9).The results show that the established TLC identification method and content determination method of red peony in Chihuang Zhili Granules are highly operable,the results are accurate and reliable,and the repeatability is good,which provides a basis for the formulation of quality standards for Chihuang Zhili Granules.Methodological basis.