注射用帕瑞昔布钠的冻干工艺研究

Study on the freeze dryer process of parecoxib sodium for injection

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 technological conditions of Freeze- dryed Parecoxib Sodium for Injection. Methods The freeze drying process was optimized which takes the water content,related substances,content etc. as the indicators by partial factor analysis test,the following factors with three levels were considered: freeze- dryed time and drying process. Results The optimum technologies of freeze dryer were: vacuum was estimated to be 25 Pa,pre- freeze for 4 h at -40 ℃,vacuum dryer for 15 h at 0 ℃,dryer for 10 h at 35 ℃. In the accelerated stability test for 1,2,3 months,there was no significant change on character,content etc for parecoxib sodium for injection products. Conclusion The technology was feasible,the quality of infusion met the requirement of injection.