参芪益气胶囊质量标准研究

Quality Standard of Shenqi Yiqi Capsules

目的:建立参芪益气胶囊的质量控制方法。方法:对参芪益气胶囊中黄芪、白术进行薄层色谱鉴别;采用高效液相色谱法对补骨脂素进行含量测定。结果:薄层色谱斑点清晰,阴性对照无干扰;补骨脂素进样量在7.02～63.18μg·ml^(-1)范围内线性关系良好(r=0.999 9),平均回收率为98.91%,RSD为0.63%(n=9)。结论:本研究建立的薄层色谱法和高效液相色谱法专属性强、准确度高、重复性好,可用于参芪益气胶囊的质量控制。

Objective： To established the method for quality control of shenqi yiqi capsules. Method： Radix Astragali,Rhizoma Atractylodis in shenqi yiqi capsules were identified by TLC. The content of psoralen in shenqi yiqi capsules was determined by HPLC. Re- sult： The spots on the TLC plate were clear, and the negative sample didn＇ t disturb. A good linearity was obtained for psoralen in the range of 7. 02-63.18 μg.ml^-1, r = 0. 999 9. The average recovery was 98. 91%, RSD = 0. 63 % （ n = 9 ）. Conclusion： The method is specific, accurate and reproducible, it can be used for quality control of shenqi yiqi capsules.