蒙药古日古木-13丸质量标准研究

Study on the quality standard of Mongolian medicine Gurigumu-13 pills

目的:建立蒙药古日古木-13丸的质量标准。方法:采用薄层色谱法(TLC)对古日古木-13丸中红花、诃子和丁香进行薄层色谱定性鉴别;采用高效液相色谱法(HPLC)测定古日古木-13丸中羟基红花黄色素A的含量。结果:TLC法中样品与对照药材或对照品色谱相对应位置上显相同颜色的斑点,阴性中无干扰。羟基红花黄色素A在65.64μg/mL~153.16μg/mL范围内呈良好的线性关系,回归方程为y=0.4965x-0.015,r^(2)=0.9999;平均回收率为100.4%。结论:红花、诃子和丁香薄层色谱定性鉴别专属性强;羟基红花黄色素A的含量测定方法专属性强,重现性好,灵敏度高,简便快捷,方中其他组分对其测定无干扰,故成功地建立了蒙药古日古木-13丸的质量标准。

Objective:To establish the quality standard of Gurigumu-13 pills of Mongolian medicine.Methods:Thin layer chromatography(TLC)was used to qualitatively identify saffron,chebulae and clove in Gurigumu-13 Pill.The content of hydroxy saffron yellow pigment A in Gurigumu-13 pills was determined by high performance liquid chromatography(HPLC).Results:The sample showed spots of the same color on the corresponding position of the chromatogram of the sample and the control herb in the TLC method,and there was no interference in the negative.Hydroxy saffron yellow pigment A showed good linearity in the range of 65.64μg/mL~153.16μg/mL,the regression equation was y=0.4965x-0.015,r^(2)=0.9999,and the mean recovery was 100.4%.Conclusion:The thin-layer chromatographic identification of saffron,chebulae and clove is highly specific;the content determination method of hydroxy saffron yellow pigment A is highly specific,reproducible,sensitive,simple,and fast,and the other components in the formula do not interfere with its determination,so the quality standard of the Mongolian medicine Gurigumu-13 pills is successfully established.