克淋通胶囊质量标准提升研究

Promotion on Quality Standard of Kelintong Capsules

目的:提高克淋通胶囊的质量标准,便于控制其质量。方法:采用薄层色谱法(TLC)法鉴别黄柏,并检查关黄柏;采用高相液相色谱法(HPLC)法测定克淋通胶囊中没食子酸的含量。结果:TLC方法斑点清晰,专属性强;HPLC法测定没食子酸在0.04242~0.6363μg范围内线性关系良好,平均加样回收率为99.76%,RSD值0.25%。结论:该方法操作简便、结果准确可靠、专属性及重现性好,可用于有效地控制克淋通胶囊的质量。

Objective To improve the quality standards of Kelintong Capsules in order to conveniently and effectively control its internal quality.Methods The TLC method was used to identify Phellodendron amurense and check Guan Phellodendron,and the content of gallic acid in Kelintong capsules was determined by HPLC.Results The TLC method has clear spots and strong specificity.The linear relationship of gallic acid measured by HPLC in the range of 0.04242~0.6363μg is good.The average recovery rate is 99.76%and RSD=0.25%.Conclusion This method is easy to operate,accurate and reliable,specific and reproducible,and can be used to effectively control the quality of Kelintong capsules.