消咳宁片质量标准研究

Study of Quality Standard of Xiaokening Tablets

目的采用薄层色谱法鉴别消咳宁片中苦杏仁和甘草浸膏,建立测定盐酸麻黄碱含量的高效液相色谱法。方法色谱柱为Diamonsil C18柱(150mm×4.6mm,5μm),柱温为30℃,流动相为乙腈-0.1%磷酸溶液(9∶88),检测波长为207nm。结果盐酸麻黄碱质量浓度在3.624～18.120μg/mL范围内与峰面积呈良好的线性关系,r=0.9998(n=5),平均回收率为99.24%,RSD=1.13%(n=9)。结论所建立的方法简单、快速、准确、重现性好,专属性更强。

Objective To identify bitter almond and glycyrrhiza extract by TLC and to establish a HPLC method to determine ephedrin hydrochloride in Xiaokening Tablets. Methods The chromatographic column used in this HPLC method was Diamonsil C18 column（150mm×4.6mm,5μm）.The column temperature was 30℃ and the detective wavelength was 207 nm. The mobile phase was acetonitrile-0. 1% phosphoric acid （9：88）. Results The good linear relationship for ephedrine hydrochloride was found within the range of 3.624-18.120μg/mL, r = 0. 999 8 （n = 5）. The average recovery rate was 99.24%, RSD = 1.13% （n = 9）. Conclusion This method is simple, rapid and accurate with good reproducibility and strong specificity.