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目的:建立中药复方愈溃胶囊的质量标准,控制制剂的质量。方法:用薄层色谱法对制剂中的当归、桂枝、浙贝母和黄连进行定性鉴别,用高效液相色谱法对制剂中的黄芪甲苷进行定量分析。结果:薄层色谱斑点清晰,阴性对照无干扰;高效液相色谱方法精密度、稳定性、重现性、准确性良好,黄芪甲苷在0.138-6.880μg与峰面积呈良好的线性关系,平均加样回收率为96.5%,RSD 0.87%。结论:本研究建立的方法准确、稳定、可靠,可用于中药复方愈溃胶囊的质量控制。
Objective: To establish the quality standard of Chinese medicine compound Yufu capsule and control the quality of preparation. Methods: The Angelica sinensis, Guizhi, Fritillaria cirrhosae and Coptis chinensis Franch. Were identified by TLC, and the content of Astragaloside A in the preparation was quantitatively analyzed by HPLC. Results: The TLC spots were clear and no interference was observed in the negative control. The precision, stability, reproducibility and accuracy of the HPLC method were good. Astragaloside showed a good linear relationship at the peak area of 0.138-6.880μg with an average of The recovery rate was 96.5% with RSD 0.87%. Conclusion: The method established in this study is accurate, stable and reliable and can be used for quality control of compound Yuyao capsule.