加速试验估算人凝血酶冻干品的贮存寿命

Predicting the stability of lyophilized human thrombin by accelerated storage test

目的 :为了在短时间内了解凝血酶的稳定性 ,通过加速试验对人凝血酶在不同温度下的贮存寿命进行了估算。方法 :加速试验采用多点等稳稳定性 ,温度选择 70℃ ,80℃ ,90℃。将盛有凝血酶的样品瓶放入不同温度的烘箱中 ,在实验前和实验中的不同天数 (尽量同一时间 )各取出一瓶测凝血酶的活性。 70℃取样时间为 1,3,5 ,7,9,11,2 0 ,2 8d ;80℃取样时间为 1,3,5 ,7,9,11,13d ;90℃取样时间为 1,2 ,3,4 ,5d。由人凝血酶冻干品的贮存寿命估算曲线估算出凝血酶在 37℃ ,2 5℃ ,4℃和 0℃时活性损失 10 %和 5 0 %所需要的时间。结果 :根据实验计算出凝血酶在 70℃ ,80℃ ,90℃时活性损失 10 %所需的时间为 1.4 4 ,0 .4 5 ,0 .17d ,活性损失 5 0 %所需的时间为 9.4 5 ,2 .95 ,1.14d。估算出该冻干品在 37℃ ,2 5℃ ,4℃和 0℃时活性损失 10 %所需时间为 0 .12 ,0 .4 4 ,4 .0 8,6 .2 3年 ,活性损失 5 0 %所需时间为 0 .82 ,2 .90 ,2 6 .70 ,4 0 .74年。结论 :人凝血酶在纤维蛋白止血粉中的比例可以在一个较大的范围内变化 ,凝血酶在活性损失 5 0 %时基本不影响止血效果 ,由加速试验结果可见人凝血酶冻干品完全可以满足贮存需要。

Objective:To predict the stability of lyophilized human thrombin by estimating the shelf life at different temperatures through accelerated storage test.Methods: Lyophilized human thrombin was kept at 70℃,80℃ or 90℃ and its activity was determined at different time, 0?d, 1?d, 3?d, 5?d, 7?d, 9?d, 11?d, 20?d and 28?d for 70℃ sample, 0?d, 1?d, 3?d, 5?d, 7?d, 9?d, 11?d and 13?d for 80℃ sample, 0?d, 1?d, 2?d, 3?d, 4?d and 5?d for 90℃ sample. Results:The activity of lyophilized human thrombin decreased by 10% after 0.17?d, 0.45?d, 1.44?d, 0.12 year,0.44 year,4.08 years and 6.23 years,and decreased by 50% after 1.14?d, 2.95?d, 9.45?d, 0.82 year,2.90 years,26.70 years and 40.74 years when it was kept at 90℃, 80℃, 70℃, 37℃, 25℃, 4℃ and 0℃ respectively.Conclusions:The content of thrombin in fibrin hemostatic powder can vary within a wide range and 50% decrease in its activity does not affect hemostasis,so the stability of lyophilized human thrombin is competent for the storage of fibrin hemostatic powder.