冻干重组人白细胞介素-2结晶性状的分析

Study on crystal of lyophilized recombinant human interleukin-2

目的 对冻干重组人白细胞介素 - 2的外观结晶粗糙的原因进行分析,以改善药品的冻干质量。方法 从制品入箱时的不同板层温度、制冷速度、冻结过程等,分析对制品的外观结晶性状的影响。结果 冻干机性能好坏、冻结过程的改变和制品入箱时冻干机板层温度的变化是决定制品产生粗结晶的主要因素。结论 冻干机板层温度从常温降至 - 4 5℃以下的时间控制在 2h左右,制品在冻结过程中,应尽量避免在 - 30℃左右的区域停留,制品入箱时,板层温度控制在 6～ 15℃范围,能使制品冻干后的物理外观质量得到明显改善。

Objective This paper study the cause of rough crystal of lyophilized recombinant human Interleukin-2 (rhIL-2), and the measures of improving the quality of lyophilized rhIL-2 are introduced.Methods We analyze the impacts of temperatuer of plates,velocity of freezing and process of lyophilizing on appearance and crystal of products.Results The property of freeze dryer,the variation of lyophilized process and the change of temperature of plates may induce rough crystal of products.Conclusion The tempeature of plates should be controlled within 2h when its temperature decline from room temperature to negative 45 centigrade or below. It should be avoid lingering when its temperature is about negative 30 centigrade during the lyophilized process.the temperature of plates should be controlled form 6 centigrade to 15 centigrade befor the products are lyophilized.