提高咽炎颗粒的质量标准研究

Study on the quality standard promotion of Pharyngitis Granules

目的提高咽炎颗粒的质量标准。方法采用TLC法对主要成分菊花进行定性鉴别;采用HPLC法测定菊花、金银花中绿原酸的总含量。色谱柱:ECOSIL C18色谱柱(250mm×4.6mm,5μm);流动相:乙腈-4mL·L-1磷酸溶液(13∶87);流速:1.0mL·min-1;进样量:10μL;检测波长:328nm;柱温:30℃。理论塔板数按照绿原酸峰计算应不低于2 000。结果 TLC法鉴别斑点清晰,阴性样品无干扰,与对照药材相同的位置上,显相同颜色的荧光斑点;金银花、菊花中绿原酸总含量在214.526~1 072.63ng之间线性关系良好,平均回收率为98.1%,RSD值为1.9%。结论该方法专属性高、重复性良好,可作为提升咽炎颗粒质量控制的方法。

Objective To improve the quality standard for Pharyngitis Granules.Methods The qualitative identification of the main components of Chrysanthemum was performed by TLC method.The content of chlorogenic acid was determined by HPLC method.Chromatographic separation was carried out by using an ECOSIL C18 column（250 mm×4.6 mm,5μm）and the mobile phase consisted of acetonitrile-4 mL·L^-1 phosphoric acid（13∶87）with gradient elution at a flow rate of 1.0 mL·min^-1,and the injection volume was 10μL.The detection wavelength and column temperature was 328 nm and 30 ℃,respectively.According to the chlorogenic acid peak,the theoretical plate number should not be less than 2 000.Results TLC spots were clear without interference;chlorogenic acid showed good linear relationship in the range of 214.526-1 072.63 ng,the average recovery rate was 98.1%,and RSD was 1.9%.Conclusion The method has high specificity and good repeatability.It can be used as a method to improve the quality control of Pharyngitis Granules.