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目的:建立蛭芪康胶囊的质量控制方法。方法:采用薄层色谱法对制剂中的天麻蜜环菌粉、大黄、黄芪进行定性鉴别。采用3,5-二硝基水杨酸光度法(DNS)测定制剂多糖含量,采用Folin-酚法(Lowry法)测定制剂肽含量。结果:定性鉴别检出制剂中的天麻蜜环菌粉、大黄、黄芪;DNS法测定结果,多糖在6.412~32.060μg·ml-1的范围内呈良好的线性关系(r=0.999 5),平均回收率为95.86%,RSD为0.86%(n=6);Folin-酚法测定结果,肽在0.059 7~0.298 4 mg·ml-1范围内呈良好的线性关系(r=0.999 0),平均回收率为100.3%,RSD为1.88%(n=6)。结论:本方法简便、准确,可作为该制剂的质控方法。
Objective: To establish the quality control method of Methods: Thin-layer chromatography (TLC) was used to qualitatively identify Radix Astragali, Rhubarb and Rhizoma. The polysaccharide content of the preparation was determined by 3,5-dinitrosalicylic acid spectrophotometry (DNS), and the content of the peptide was determined by Folin-phenol method (Lowry method). Results: The results showed that there was a good linearity (r = 0.999 5) between polysaccharides and polysaccharide in the range of 6.412 ~ 32.060μg · ml-1 The recovery was 95.86% with a RSD of 0.86% (n = 6). The results of folin-phenol showed that the peptide showed a good linear relationship (r = 0.999 0) in the range of 0.059 7-0.298 mg · ml-1 The recovery was 100.3% with a RSD of 1.88% (n = 6). Conclusion: The method is simple and accurate and can be used as quality control method of the preparation.