五倍子凝胶剂制备及质量标准研究

Preparation and Quality Standard Establishment of Galla Chinensis Gel

目的:制备五倍子凝胶剂,并建立其质量分析标准。方法:用薄层色谱法对五倍子凝胶剂进行定性鉴别,并采用HPLC法,以没食子酸为指标,测定凝胶剂样品中没食子酸的含量。结果:薄层色谱鉴别的斑点清晰,阴性对照无干扰;没食子酸在质量浓度19.2~240.0μg/mL范围内线性关系良好,平均回收率为99.53%,RSD为0.33%(n=5)。结论:该研究的制备工艺简单,制得的五倍子凝胶剂成品质量稳定,且质量控制方法可行。

Objective:To prepare gall gel of Galla Chinensis Gel,and establish quality analysis standards.Methods:Galla Chinensis gel was identified by TLC,and the content of gallic acid in gallic acid was determined by HPLC with gallic acid as index.Results:The spots identified by TLC were clear,and there was no interference in the negative control;gallic acid had a good linear relationship in the mass concentration range of 19.2~240.0μg/mL,with an average recovery of 99.53%and an RSDof 0.33%(n=5).Conclusion:The preparation process of gall gel is simple,the quality of the prepared gallnut gel is stable,and the quality control method is feasible.