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目的:建立复方蒲柴颗粒质量控制标准;方法:对制剂中柴胡、佛手采用薄层色谱法进行了定性鉴别;应用高效液相色谱法对制剂中有效成分咖啡酸进行了含量测定。结果:薄层色谱特征明显,专属性强;咖啡酸含量测定线性范围为20.2～404.0ng,平均回收率为98.94%,RSD为0.6%。结论:鉴别和含量测定方法简便、准确、重复性好,可作为该制剂的质量控制标准。
Objective: To establish the quality control standards for compound Fuchai granules; Method: To qualitatively identify the Bupleurum chinense and bergamot by thin layer chromatography in the preparation; and to determine the content of caffeic acid in the preparation by high performance liquid chromatography. RESULTS: The characteristics of TLC were obvious and the specificity was strong. The linear range of the determination of caffeic acid content was 20.2-404.0ng, the average recovery was 98.94%, and the RSD was 0.6%. Conclusion: The method of identification and content determination is simple, accurate and reproducible, and it can be used as the quality control standard of the preparation.