加速试验预测纤维蛋白止血贴稳定性

摘要

Objective To estimate the shelf life of fibrin hemostatic patch ( FHP) through accelerated storage test . Methods The activity of FHP was detected at various time points after incubation at 70℃,80℃or 90℃(1, 3, 9, 10, 12, 13, 20, 25, 29,and 32 d for 70℃samples, 1, 3, 13, 15, 16,and 17 d for 80℃samples, 1, 2, and 4 d for 90℃sam-ples).The thermal degradation rate of FHP incubated at different temperatures was calculated through an analog thermal degradation curve , which was constructed according to the activity corresponded time points .The thermal degradation curve and the shelf life curve of FHP were established , based on which the shelf time of FHP was calculated at 4℃, 25℃ and 37℃.Results The thermal degradation rate of FHP at 70℃, 80℃ and 90℃ was 0.0148,0.0247 and 0.1057, respectively,while the thermal degradation curve and the shelf life curve of FHP were y=-0.0399x+4.445 and y=-1.154x-0.376, respectively.Moreover, the shelf time of FHP at 4℃, 25℃and 37℃was calculated as 5734 d,958 d and 345 d, respectively .Conclusion FHP can be stored for more than 2 years at 25℃.%目的：通过加速试验推算纤维蛋白止血贴（ FHP）的保存期。方法根据多点等温稳定性原理，温度选择70，80和90℃，将FHP样品放入不同温度培养箱中（70、80和90℃），在不同时间点（70℃取样时间为1、3、9、10、12、13、20、25、29、32 d；80℃取样时间为1、3、13、15、16、17 d；90℃取样时间为1、2、4 d）取样测定其活性，根据活性与对应时间建立FHP的模拟一级热降解曲线，得出不同温度下FHP的热降解速度，再分别建立FHP热降解速度曲线和FHP贮存时间曲线，以此推算出FHP在4、25和37℃的保存期。结果 FHP在70、80和90℃时的热降解速度分别为0．0148、0．0247、0．1057，热降解速度曲线和FHP贮存时间曲线分别为y＝－0．0399x＋4．445和y＝－1．154x－0．376，据此推算出FHP在4、25和37℃的保存期分别为5734、958和345 d。结论 FHP在25℃条件下可以保存＞2年。