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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 establish a quality control method of Shenqi Yiqi capsule. Methods: Astragalus and Atractylodes macrocephalae were identified by TLC in Shenqi Yiqi Capsules. The content of psoralen was determined by high performance liquid chromatography. Results: The TLC spots were clear and no interference was found in the negative control. The injection volume of psoralen was good in the range of 7.02 ~ 63.18μg · ml ~ (-1) (r = 0.999 9), the average recovery was 98.91% , RSD was 0.63% (n = 9). Conclusion: The TLC and HPLC established in this study are highly specific, accurate and repeatable and can be used for quality control of Shenqi Yiqi Capsules.