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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 highland capsule. Methods: The contents of diazepam, dexamethasone sodium phosphate and aminophylline in Gao Yuan Kang Capsule were determined by HPLC, and the related substances and dissolution rate of Gao Yuan Kang Capsule were tested. Results: The results showed that the three components in the capsule had a good separation effect and good linearity (r> 0.99), and the recoveries were within 99.6% -101.0%. The precision test (dexamethasone sodium phosphate , RSD of peak area of diazepam and aminophylline were 0.35%, 1.27% and 0.15%, respectively) and repeatability test (RSD of dexamethasone sodium phosphate, diazepam and aminophylline were 0.54% and 0.57 %, 0.23%) The results are better. Conclusion: The method is simple, accurate, reproducible and can be used for the quality control of Gaoyuan Kang capsule.