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目的:建立消渴生津汤的质量标准。方法:采用薄层色谱(TLC)法对葛根、黄芪进行定性鉴别,采用高效液相色谱(HPLC)法测定制剂中葛根素含量。结果:葛根、黄芪的薄层色谱中,特征斑点清晰,且斑点分离度好,阴性对照无干扰;含量测定时,葛根素进样量在0.1563~1.8721μg范围内与峰面积线性关系良好(r2=0.9999,n=6),平均回收率为99.4%,相对标准偏差(RSD)=1.57%(n=6)。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制和评价。
Objective: To establish the quality standard of Xiaoke Sheng Jin Tang. Methods: TLC and HPLC were used to identify Radix Puerariae and Radix Astragali. The content of puerarin in Radix Astragali was determined by high performance liquid chromatography (HPLC). Results: In the thin layer chromatogram of Radix Puerariae and Radix Astragali, characteristic spots were clear and the spot separation was good. There was no interference with the negative control. The content of puerarin was linear with the peak area in the range of 0.1563 ~ 1.8721μg (r2 = 0.9999, n = 6) with an average recovery of 99.4% and a relative standard deviation (RSD) of 1.57% (n = 6). Conclusion: The method is simple, accurate and specific and can be used for the quality control and evaluation of the preparation.