人D-二聚体的制备及冻干性质的分析.pdfVIP

生物技术通报 ·研究报告· BIOTECHNOLOGY BULLETIN 年第 期 2014 11 人 D-二聚体的制备及其冻干性质的分析 武建伟  才蕾  王继华  唐时幸 （广州万孚生物技术股份有限公司 自检型快速诊断国家地方联合工程实验室，广州 510663） 摘 要 ： 以人源纤维蛋白原为原材料制备D-二聚体，将其制成冻干品并分析其冻干性质。使用凝血酶、Factor XIIIa 酶解纤 维蛋白原，获得交联纤维蛋白。经纤溶酶降解交联纤维蛋白，生成纤维蛋白降解产物。超滤除去纤维蛋白降解产物中的小分子物质， 可获得较高纯度的D-二聚体。通过筛选和优化冻干方案，将D-二聚体制备成冻干品。经检测可知，D-二聚体冻干品可在37℃稳定 保存 12 d ；复溶后在25℃稳定保存8 d ；复溶后在4℃稳定保存30 d ；复溶时，常用复溶溶剂对其复溶后的活性检测无明显影响。 关键词 ： 纤维蛋白 纤维蛋白原 D-二聚体 血栓 冻干品 Preparation and Analysis of Lyophilization Characterization of - Human D dimer Wu Jianwei Cai Lei Wang Jihua Tang Shixing （ ， ， 510663 ） National Engineering Laboratory of Rapid Diagnostic Test Guangzhou Wondfo Biotech Co. Ltd. Guangzhou ， Abstract: D-dimer is formed by sequential action of 3 enzymes from fibrinogen. After producing D-dimer, we did the research on its lyophilization process. To produce cross-linked fibrin, fibrinogen was digested by thrombin and Factor XIIa. Then, fibrin degradation products （FDP）was prepared from cross-linked fibrin being degraded by plasmin. D-dimer was purified from FDP through ultrafiltration and prepared into lyophilized powder. By optimizing the lyophilization program, lyophilized D-dimer was stable for at least 12 days at 37℃, stable for at least 8 days at 25℃ and 30 days at 4℃ after reconstitution, and not different when being dissolved by different solvent.The p