地塞米松片溶出曲线研究

Research of Dexamethasone Tablets by Dissolution Curve

目的通过研究地塞米松片在4种介质中溶出曲线间的差异,为评价药品质量提供参考。方法照溶出度与释放度测定法(通则0931第一法),分别以4种介质(pH1.0、pH4.5、pH6.8、水)1 000 ml为溶出介质,转速为每分钟50转,照高效液相色谱法(通则0512)测定溶出曲线中地塞米松的浓度,绘制溶出曲线。结果国产地塞米松片的溶出曲线与日本橙皮书中的标准曲线不相似,国内不同企业间和企业内不同批次的溶出行为也存在较大差异。结论加强对药品溶出曲线的监控是确保药品质量的有效性、均一性和稳定性的重要保证。

Objective To compare the dissolution profiles of domestic dexamethasone tablets in four dissolution mediums,and to provide the reference for a comprehensive evaluation of the quality of dexamethasone tablets.Methods The dissolution tests were performed by the first dissolution in ChP,with pH1.0 hydrochloric acid,water,pH4.5 phosphate buffer and pH6.8 phosphate buffer as dissolution solvents respectively.the rotate speed was 50 r/min with dissolution medium volume 1 000 ml,The concentration of dexamethasone in dissolution solvents was determined by high performance liquid chromatography（HPLC）method.Results dissloution curve of domestic samples were not similar with standard dissloution curves of the Orange Book,and there was great difference in different domestic pharmaceutical enterprises and different lots among products.Conclusions It is necessary to strengthen monitoring of dissolution profiles,to ensure effectiveness,homogeneous and stability of drug quality.