外用人纤维蛋白粘合剂凝胶性能研究

Research on gelation ability of fibrin sealant

目的开发生产人纤维蛋白粘合剂产品,并对其成胶速度、持续时间、弹力及抗张强度等凝胶性能指标进行研究。方法通过乙醇沉淀,离子交换层析等分离纯化方法和多重病毒灭活工艺制备产品;体外拉伸试验和小鼠试验研究其凝胶性能指标。结果所制得纤维蛋白原及凝血酶各项性能指标均优于中国药典标准,纤维蛋白粘合剂成品成胶时间均在2 s以内,具有较快的成胶速度;37℃下凝胶持续时间在600-700 min内,使用牛抑肽酶试液溶解纤维蛋白原的试验组成胶速度有所降低,而凝胶的持续时间有所延长;纤维蛋白粘合剂平均单位面积拉伸高度6.4-7.4 mm,具有较好的弹性指数,而抗张强度差异较大,最佳抗张强度为80 g/cm2,抗张强度方面有所不足。结论所开发的人纤维蛋白粘合剂制品具有高强度、高弹力、成胶速度快,持续时间久的凝胶性能。

Objective To development and produce fibrin adhesive products. Gel performance indicators such as gel speed, duration, elasticity and tensile strength were studied. Methods Product was prepared by separation of ethanol precipi- tation, ion exchange chromatography and multiple virus inactivated process. Tensile test in mice were used to study in vitro on gel performance indicators.Results All performance indicators of fibrinogen and thrombin were superior to Chinese pharma- copoeia standards. The bonding time of the binder is within 2 s and gel with fast speed ; the gel duration within 600-700 rain at 37℃. Using bovine test solution, the fibrinogen dissolution decreased, while the duration of the gel was extended. The av- erage per unit area stretching height for fibrin glue was 6.4-7.4 mm, the best tensile strength was 80 g/cm2, which was insufficient. Conclusion Human fibrin sealant products were developed with gel properties, such as increased strength, high elasticity, fast gel and long duration.