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目的建立小儿止咳平喘合剂的质量标准。方法采用薄层色谱法对制剂中苦杏仁、黄芩、甘草进行定性鉴别;采用高效液相色谱法对制剂中麻黄碱、伪麻黄碱含量进行测定。结果薄层色谱中阴性无干扰,专属性强;麻黄碱、伪麻黄碱在1.728μg～8.640μg和1.36μg～6.80μg范围内成良好线性关系,平均回收率分别为:100.43%、100.55%。结论本试验建立的质量控制方法简便、快捷,重复性好,可用于小儿止咳平喘合剂的质量控制。
Objective To establish the quality standard of Xiaoerzhike Pingchuan Mixture. Methods The qualitative identification of bitter almond, Astragalus membranaceus and Glycyrrhiza uralensis Fisch in the preparations was carried out by TLC. The contents of ephedrine and pseudoephedrine in the preparations were determined by high performance liquid chromatography. RESULTS: TLC did not interfere with interference and was highly specific; ephedrine and pseudoephedrine were linear in the range of 1.728 μg to 8.640 μg and 1.36 μg to 6.80 μg, and the average recoveries were 100.43% and 100.55%, respectively. Conclusion The quality control method established in this experiment is simple, rapid, and reproducible, and can be used for the quality control of Xiaoer Zhike Pingchuan Mixture.