重组人尿激酶型纤溶酶原激活剂的冻干及活性贮存时间估计  

The lyophilization process of recombinant human urinary plasminogen activator and the observation of its stability

作　　者：郭志霞[1] 肖成祖[1] 张正光[1] 于芳[1] 孙彦洵[1] 胥照平[1] 

机构地区：[1]军事医学科学院生物工程研究所,北京100071

出　　处：《生物技术通讯》1999年第2期118-120,124,共4页Letters in Biotechnology

摘　　要：研究重组人尿激酶型纤溶酶原激活剂 ( u- PA)的冻干工艺 ,并对冻干产品的稳定性进行了观察。产品放置在 - 70℃和 4℃一年 ,活性和纯度未见明显变化。同时 ,通过在 80℃、70℃和 60℃的加速贮存试验 ( MIS) ,观察了 u- PA冻干产品的热稳定性 ,并对其活性的热降解速度和贮存寿命进行了估算。结果在 37℃、2 5℃、4℃和 0℃贮存时 ,活性单位损失 5 0 %所需时间分别为 1 73天、2 .78年、70 .8年和 1 1 8年 ;活性损失 1 0 %所需时间分别为 2 0天、1 0 0天、7.6年和 1 1年。说明 u- PA经冷冻干燥后保存 。In this study we explored the lyophilization process for recombinant urinary plasminogen activator (u PA) and investigated the stability of these freeze dried products. Using accelerated storage test (MIS) at 60, 70 and 80℃, we had got the rates of thermal degradation (K1), and we could predict the storage life. Both the activity and purity of them kept at 70℃ and 4℃ were not affected during one year. We predicted that the dried u PA kept at 37, 25, 4 and 0℃ will lost 50% of its activity in 173 days, 2.78 years, 70.8 years and 118 years respectively, or it will lost 10% of its activity in 20 days, 100 days, 7.6 years and 11 years kept at the same temperatures respectively. The activity and lyophilizied u PA is stable.

关 键 词：U-PA 加速贮存试验 热降解速度 贮存寿命 

分 类 号：R954[医药卫生—药学]