头孢克肟干混悬剂制备工艺及沉降体积比影响因素研究

目的:确定头孢克肟干混悬剂的最佳制备工艺并考察其稳定性。方法:通过正交试验考察羟丙基甲基纤维素、黄原胶、十二烷基硫酸钠不同处方量对干混悬剂沉降体积比的影响,筛选出适当的制备工艺;通过加速试验对所制制剂进行稳定性研究。结果:最佳工艺为十二烷基硫酸钠、黄原胶、羟丙基甲基纤维素分别占处方量的10%、20%、15%;所设计的头孢克肟干混悬剂工艺简单、稳定性良好,各项质量指标合格。结论:本工艺所制备的干混悬剂可达到《中国药典》相关要求。

Preparation Technology of Cefixime Suspension and the Influencing Factors of Its Sedimentation Volume Ratio

OBJECTIVE： To optimize the preparation technology of cefixime suspension and study its stability. METHODS： The effects of hydroxypropyl cellulose, xanthan gum and sodium lauryl sulfate in different proportions on the sedimentation volume ratios of the suspensions were investigated by orthogonal experiments to optimize the preparation technology. The stability of the preparation was studied by accelerated test. RESULTS： The optimum preparation technology for cefixime suspension was as follows： the proportions of sodium dodecylsulfate, xanthan gum, and hydroxypropyl methyl cellulose （HPMC） were 10%, 20%, and 15%, respectively. The prepared suspension had simple formula and good stability, with all indexes up to the quality specification for suspension. CONCLUSION： The suspension prepared in accordance with this formula was able to meet the requirements of Chinese Pharmacopoeia on dry suspension.