注射用门冬酰胺酶冻干工艺研究  

Study on Freeze-drying Process of Asparaginase for Injection

作　　者：谢鹏 梁淑娃 明飞平 蓝碧峰 李梅 

机构地区：[1]广州市微生物研究所,广东广州510250

出　　处：《今日药学》2010年第11期10-12,共3页Pharmacy Today

基　　金：国家创新基金项目(编号:09C26214415194)

摘　　要：目的建立适合注射用门冬酰胺酶的冻干工艺。方法 采用真空冷冻干燥法,对门冬酰胺酶冻干的各条件如装量、共晶点、预冻温度、预冻速度、升华温度、解吸温度等进行研究。结果 冻干工艺为装量1 ml/瓶,1.5℃/min的速度预冻至-40℃,在真空状态下,以-28℃进行升华干燥,25℃进行解吸干燥。结论 此工艺制备的门冬酰胺酶冻干剂符合《中国药典》的相关规定。Objective To establish a suitable freeze-drying process of Asparaginase.Methods The vacuum freeze-drying method was modified by inspecting the process conditions such as liquid volume in bottle,the eutectic point,pre-freezing temperature,pre-freezing rate,sublimating temperature and temperature of desorption.Results The acceptable freeze-drying process is that liquid volume was 1ml per bottle,pre-freezing rate was 1.5℃/min,pre-freezing temperature was-40℃,sublimating temperature was-28℃,desorption temperature was 25℃.Conclusion The lyophilized agent of asparaginase prepared by this process meet the requirement of the Chinese Pharmacopoeia.

关 键 词：门冬酰胺酶 真空冷冻干燥 冻干工艺 

分 类 号：TQ460.6[化学工程—制药化工]