论文部分内容阅读
目的研究注射用帕瑞昔布钠最佳冻干制备工艺条件。方法通过部分因子分析实验,以水分、有关物质、含量等为指标优化冻干工艺,其中考察因素为冻干时间和干燥工艺,每个因素取3个水平。结果注射用帕瑞昔布钠的最佳冻干工艺条件为:真空度25 Pa,-40℃预冻4 h,0℃真空干燥15 h,35℃再干燥10 h即得。所制得注射用帕瑞昔布钠粉针剂经加速1、2、3月后性状、含量等指标无明显变化。结论选定的工艺可行,产品符合药典注射剂项下的各项要求。
Objective To study the optimum preparation conditions of parecoxib sodium for injection. Methods Part of the factor analysis experiments were conducted to optimize the freeze-drying process with water, relevant substances and contents as the indexes. The factors of investigation were the freeze-drying time and the drying process, each factor taking 3 levels. Results The optimal lyophilization conditions of parecoxib sodium for injection were vacuum degree 25 Pa, pre-freeze at -40 ℃ for 4 h, vacuum drying at 0 ℃ for 15 h and drying at 35 ℃ for 10 h. The prepared parecoxib powder for injection has been accelerated 1, 2, 3 months after the traits, content and other indicators did not change significantly. Conclusion The selected process is feasible and the products meet the requirements of the Pharmacopoeia injection.