高原康胶囊质量标准研究

Quality standard of Gaoyuankang capsules

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.