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目的:建立清肝利黄口服液的质量标准。方法:采用薄层色谱法对制剂中虎杖、茵陈进行鉴别,用高效液相色谱法对口服液中的丹参素进行含量测定。结果:茵陈虎杖可用薄层色谱法进行定性鉴别。丹参素在0.04~0.20μg之间与峰面积呈良好的线性关系(r=0.999 7),平均加样回收率为98.8%,RSD为1.5%(n=5)。结论:方法灵敏、简便、准确、重复性好,可作为该制剂的质量控制方法。
Objective: To establish the quality standard of Qinggan Lihuang Oral Liquid. Methods: T. lucidum and capillaris were identified by TLC, and the contents of danshensu in oral liquid were determined by high performance liquid chromatography. RESULTS: Yinchenhu can be qualitatively identified by thin layer chromatography. Danshensu showed a good linear relationship with the peak area between 0.04 and 0.20 μg (r=0.999 7). The average recovery was 98.8% and the RSD was 1.5% (n=5). Conclusion: The method is sensitive, simple, accurate and reproducible. It can be used as a quality control method for the preparation.