复方红芪颗粒剂的质量标准研究

A Study on Quality Standard of Compound Hongqi Granules

目的：建立复方红芪颗粒剂的质量标准.方法：采用薄层色谱法对复方红芪颗粒剂中红芪、白术和防风药材进行定性鉴别及对方中红芪进行定量分析（以γ-氨基丁酸为测定指标）.结果：方中红芪、白术和防风的薄层图谱斑点清晰,阴性对照无干扰.γ-氨基丁酸含量在5～50μg间线性关系良好（r=0.9968）,其平均回收率为98.8%,RSD为2.2%.结论：本方法简便、准确、具专属性,可用于该制剂的质量控制.

Objective： To establish the quality control standard of compound Hongqi granules. Methods： Radix Hedysari, Rhizoma Atractylodis Macrocephalae and Radix Saposhnikoviae in compound Hongqi granules were identified and Radix Hedysari was analysed quantitatively, using the content of γ-aminobutyric acid as a determining target by TLC. Results： Radix Hedysari, Rhizoma Atractylodis Macrocephalae and Radix Saposhnikoviae in the granules were well-separated by TLC, without interference. The calibration curve of γ- aminobutyric acid was linear in the range of 5-50 μg（ r = 0.9968）. The average recovery was 98.8 % and RSD was 2.2% （ n = 6） .Conclusion： The method is simple, specific and accurate. It can be used for the quality control of compound Hongqi granules.