【摘要】：目的開發(fā)生產(chǎn)人纖維蛋白粘合劑產(chǎn)品,并對其成膠速度、持續(xù)時間、彈力及抗張強度等凝膠性能指標進行研究。方法通過乙醇沉淀,離子交換層析等分離純化方法和多重病毒滅活工藝制備產(chǎn)品;體外拉伸試驗和小鼠試驗研究其凝膠性能指標。結果所制得纖維蛋白原及凝血酶各項性能指標均優(yōu)于中國藥典標準,纖維蛋白粘合劑成品成膠時間均在2 s以內(nèi),具有較快的成膠速度;37℃下凝膠持續(xù)時間在600-700 min內(nèi),使用牛抑肽酶試液溶解纖維蛋白原的試驗組成膠速度有所降低,而凝膠的持續(xù)時間有所延長;纖維蛋白粘合劑平均單位面積拉伸高度6.4-7.4 mm,具有較好的彈性指數(shù),而抗張強度差異較大,最佳抗張強度為80 g/cm2,抗張強度方面有所不足。結論所開發(fā)的人纖維蛋白粘合劑制品具有高強度、高彈力、成膠速度快,持續(xù)時間久的凝膠性能。
[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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