元和正胃片质量标准提升研究

Improvement of the Quality Standard for Yuanhe Zhengwei Tablets

本研究旨在提升元和正胃片的质量标准。采用TLC法对甘草进行鉴别;采用HPLC法测定甘草苷、甘草酸的含量,色谱条件如下,色谱柱:InertSustainSwift-C+(18);流动相:乙腈-0.05%磷酸,梯度洗脱;流速:1.0 mL/min;检测波长:237 nm;柱温:25℃。在TLC鉴别时,对照药材、对照品和样品图谱在对应位置显示相同的斑点,分离效果良好,对阴性样品无影响。甘草苷、甘草酸分别在0.003~0.024mg/mL(R^(2)=0.9996)、0.01249~0.09993mg/mL(R^(2)=0.9997)范围内与峰面积呈良好的线性关系,平均加样回收率分别为99.01%(RSD=1.53%)、99.16%(RSD=0.93%)。薄层鉴别和含量测定方法简单、精确、专属性强、重现性好,可为元和正胃片质量标准的完善提供参考。

This study aims to improve the quality standard of Yuanhe Zhengwei Tablets.Qualitative identification of licorice by thin-layer chromatography.The contents of Liquiritin and Glycyrrhizic acid were simultaneously determined by the high performance liquid chromatography(HPLC).The chromatography conditions as the flows,column:InertSustainSwift-C_(18);mobile phase:CH_(3)CN-0.05%H_(3)PO_(4),gradient elution;flowrate:1.0 mL/min;detection wavelength:237 nm;column temperature:25℃.In the identification of TLC,the reference medicinal material,the reference substance and the sample map all showed the same spots in the corresponding positions,the separation is good,and there is no interference with the negative sample.Within the range of 0.003~0.024 mg/mL(R^(2)=0.9996)and 0.01249~0.09993mg/mL(R^(2)=0.9997),Liquiritin and Glycyrrhizic acid showed a good linear relationship with the peak area,respectively.The average recovery rates of the two samples were 99.01%(RSD=1.53%)and 99.16%(RSD=0.93%),respectively.The method of TLC identification and content measurement is simple,accurate,specific and reproducible,providing a reference for improvement quality standard for Yuanhe Zhengwei Tablets.