高原康胶囊质量标准研究  

Quality standard of Gaoyuankang capsules

作　　者：伍丽萍 王建军[2] 陈聪[3] 陈重华[3] 叶利明[3] 

机构地区：[1]成都市妇女儿童中心医院,成都610091 [2]西藏军区总医院,拉萨850000 [3]四川大学华西药学院,成都610041

出　　处：《药物分析杂志》2013年第3期503-507,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高原康胶囊的质量标准。方法:采用高效液相色谱法测定高原康胶囊中地西泮、地塞米松磷酸钠、氨茶碱3组分含量,并对高原康胶囊的有关物质、溶出度进行检测。结果:该方法下胶囊中3组分具有很好的分离效果,线性关系良好(r均大于0.99),回收率测定结果均在99.6%～101.0%之间,精密度试验(地塞米松磷酸钠、地西泮、氨茶碱峰面积的RSD分别为0.35%、1.27%、0.15%)和重复性试验(地塞米松磷酸钠、地西泮、氨茶碱含量的RSD分别为0.54%、0.57%、0.23%)结果较佳。结论:本方法操作简便,准确,重复性好,可用于高原康胶囊的质量控制。Objective ：To establish the quality standard of Gaoyuankang capsules. Method：HPLC was adopted to determine diazepam, dexamethasone sodium phosphate and aminophylline in Gaoyuankang capsules. Then, related substances and dissolution were studied. Results：The three constituents were well separated, all the recoveries were between 99.6% and 101.0% , the results of precision（peak area RSDs of dexamethasone sodium phosphate, diaze- pam,aminophylline were 0.35%, 1.27% and 0. 15% ,respectively）and repeatability（ content RSDs of dexametha- sone sodium phosphate, diazepam, aminophylline were 0. 54%, 0. 57% and 0. 23%, respectively）were good. Con- clusion：The method is simple, accurate with good reproducibility and can be used for quality control of Gaoyuan- kang capsules.

关 键 词：地西泮 地塞米松磷酸钠 氨茶碱 含量测定 有关物质 质量控制 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]