檀桂胃宁颗粒的质量标准研究

Study on Quality Standard for Tangui Weining Granules

目的建立檀桂胃宁颗粒的质量控制方法。方法采用TLC法对方中檀香和肉桂进行定性鉴别;采用HPLC法对处方中甘草酸的含量进行定量检测,色谱条件:色谱柱:Diamonsil C18(4.6mm×250mm,5μm);流动相:甲醇-0.2mol/L醋酸铵溶液-冰醋酸(60∶40∶1);流速:1.0mL·min-1;检测波长:250nm。结果薄层色谱鉴别方法专属性强,重现性好,阴性对照无干扰;含量测定检查中甘草酸铵与其他组分分离良好,线性范围为0.1568～1.568μg,r=0.9998,平均回收率99.69%,RSD为0.58%。结论薄层色谱方法简便快捷,结果可靠;含量测定方法操作简便、灵敏度高、准确,可用于檀桂胃宁颗粒中甘草酸铵的测定。

Objective To establish a method for quality control of Tangui Weining granules. Methods TLC was used for the identification of Lignum Santali Albi and Cortex Cinnamomi. HPLC was used for the determination of Glycyrrhizin. The chromatographic conditions were as follows： Diamonsil C18（4.6 mm× 250 mm, 5 μm）was used as a stationary phase, the mobile phase consisted of methanol - 0.2 mol/L ammonium acetate solution - acetic acid （60 ： 40 ： 1）, the flow rate was at 1.0 mL · min^-1, and the detection wavelength was set at 250 nm. Results TLC was specific and reproducible, and the negative controll did not show interference. Glycyrrhizin was separated completely by HPLC and showed a good linearity in the range of 0. 1568 to 1. 568 Ixg, r = 0. 999 8, the average recovery was 99.69 % , and RSD was 0.58 %. Conclusion TLC is simple, convenient and accurate. The method of HPLC is proved to be simple and accurate with a good reproducibility and can be used for the inspection of Glycyrrhizin in Tangui Weining Granules. This study provides a foundation for quality control of Tangui Weining granules.