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高原康胶囊质量标准研究

Quality standard of Gaoyuankang capsules

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【作者】 伍丽萍王建军陈聪陈重华叶利明

【Author】 WU Li-ping1,WANG Jian-jun2,CHEN Cong3,CHEN Chong-hua3,YE Li-ming3*(1.Chengdu Women and Children Central Hospital,Chengdu 610091,China; 2.General Hospital of Tibet Military Region,Lhasa 850000,China; 3.West China School of Pharmacy,Sichuan University,Chengdu 610041,China)

【机构】 成都市妇女儿童中心医院西藏军区总医院四川大学华西药学院

【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。

【Abstract】 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,diazepam,aminophylline were 0.35%,1.27% and 0.15%,respectively)and repeatability(content RSDs of dexamethasone sodium phosphate,diazepam,aminophylline were 0.54%,0.57% and 0.23%,respectively)were good.Conclusion:The method is simple,accurate with good reproducibility and can be used for quality control of Gaoyuankang capsules.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2013年03期
  • 【分类号】R82
  • 【被引频次】2
  • 【下载频次】170
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