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.