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外用人纤维蛋白粘合剂凝胶性能研究

发布时间:2019-01-07 22:12
【摘要】: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。
[Abstract]:Objective to develop and produce human fibrin binder and to study the gel properties such as gelation speed, duration, elasticity and tensile strength. Methods the product was prepared by ethanol precipitation, ion exchange chromatography and multiplex virus inactivation, and its gel properties were studied by tensile test and mouse test in vitro. Results the properties of fibrinogen and thrombin were superior to those of Chinese pharmacopoeia standard. The gelation time of fibrin binder was less than 2 seconds, and the gelation rate of fibrinogen binder was faster than that of Chinese pharmacopoeia. When the gel duration was between 600-700 min at 37 鈩,

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