复方蒲柴颗粒质量标准考察

Study on Quality Standard for Puchai Compound Granules

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 standard for Puchai compound granules. Method： The thin-layer chromatograthy was used to identify bupleurum chinense and finger citron, the content of caffeic acid was determined by HPLC. Result： The spots in the TLC were clear and distinguished well, the linear rang of caffeic acid was 20.2 -404.0ng, the average recovery was 98.94% ,with RSD of 0.6%. Conclusion： This method is simple, accurate, and repeatable, it can be used for quality control of Puchai compound granules.