医院制剂肺炎合剂质量控制的方法研究  

Study on quality control of pneumonia mixture

作　　者：张海波[1] 谢伟娜 唐国华 陈迹[1] 胡君萍[2] 杨建华[1,2] ZHANG Haibo;XIE Weina;TANG Guohua;CHEN Ji;HU Junping;YANG Jianhua(Department of Pharmacy,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;College of Pharmacy,Xinjiang Medical University,Urumqi 830011,China)

机构地区：[1]新疆医科大学第一附属医院药学部,乌鲁木齐830054 [2]新疆医科大学药学院,乌鲁木齐830011

出　　处：《新疆医科大学学报》2019年第6期801-804,共4页Journal of Xinjiang Medical University

基　　金：新疆维吾尔自治区区域协同创新专项(科技援疆计划;2018E02070);新疆维吾尔自治区药学会科研基金资助项目(YXH201701)

摘　　要：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.

关 键 词：肺炎合剂 质量控制 麻黄 盐酸麻黄碱 盐酸伪麻黄碱 

分 类 号：R914[医药卫生—药物化学]