医院制剂肺炎合剂质量控制的方法研究

Study on quality control of pneumonia mixture

目的优化院内制剂肺炎合剂质量控制方法。方法采用薄层色谱(TLC)法对肺炎合剂处方中君药麻黄的主要活性成分盐酸麻黄碱进行定性鉴别;采用高效液相色谱(HPLC)法对肺炎合剂中的盐酸麻黄碱和盐酸伪麻黄碱进行含量测定。结果 TLC图谱中盐酸麻黄碱特征斑点清晰,阴性对照无干扰,专属性强;3批样品中盐酸麻黄碱含量分别为17.25、17.38、17.13μg/mL,盐酸伪麻黄碱含量分别为27.50、27.42、27.26μg/mL。结论该方法简便可行、重复性好,结果稳定、准确,适用于肺炎合剂质量控制。

Objective To optimize quality control methods of pneumonia mixture. Methods Ephedrine hydrochloride was identified by Thin Layer Chromatography(TLC). The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were determined by HPLC. Results The spots of ephedrine hydrochloride in TLC were clear without interference. The contents of the ephedrine hydrochloride in three batches of samples were 17.25, 17.38 and 17.13 μg/mL, and those of pseudoephedrine hydrochloride were 27.50, 27.42 and 27.26 μg/mL, respectively. Conclusion This method we described here was simple, reproducible, stable and accurate, and it can be used for quality control of pneumonia mixture.