银翘口服液质量标准研究

Study on Quality Standard of Yinqiao Oral Liquid

为了建立银翘口服液的质量标准,采用薄层色谱法（TLC）对处方中的金银花、连翘、牛蒡子、薄荷、荆芥进行了定性鉴别,并采用高效液相色谱法（HPLC）对牛蒡苷含量进行测定。结果显示,TLC色谱斑点清晰、专属性强、阴性对照无干扰;在0.0622~0.6220 mg/m L范围内,牛蒡苷浓度与峰面积呈良好的线性关系,平均加样回收率为102.4%,RSD为2.2%,样品中牛蒡苷的平均含量为6.7246 mg/m L。本研究所建立的检测方法简便、准确、专属性强、重复性好,可对银翘口服液的质量进行有效控制。

In order to establish the quality standard of Yinqiao oral liquid,the Flos Lonicerae,Fructus Forsythiae,Fructus Arctii,Herba Menthae and Herba Schizonepetae in prescription were made qualitative identification by TLC,and the arctiin content was determined by HPLC. The results showed that the TLC spots were clear with strong specificity,and the negative control had no interference. In the range of 0. 0622 ~0. 6220 mg / m L,the arctiin concentration showed good linear relationship with peak area. The average recovery rate of arctiin was 102. 4% with the RSD of 2. 2%. The average content of arctiin in samples was 6. 7246 mg / m L. The method established in this study was simple and accurate with strong specificity and high repeatability,so it could be used to effectively control the quality of the Yinqiao oral liquid.