人D-二聚体的制备及其冻干性质的分析

生物技术通报 ›› 2014, Vol. 0 ›› Issue (11): 219-224.

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

收稿日期:2014-05-12 出版日期:2014-11-07 发布日期:2014-11-07
作者简介:武建伟,男,硕士,研究方向：免疫诊断
基金资助:
国家高技术研究发展计划（“863”计划）（2011AA02A103）,广东省战略新兴产业核心技术攻关项目（2012A080800007）

Preparation and Analysis of Lyophilization Characterization of Human D-dimer

Wu Jianwei ,Cai Lei ,Wang Jihua, Tang Shixing

National Engineering Laboratory of Rapid Diagnostic Test, Guangzhou Wondfo Biotech Co., Ltd., Guangzhou 510663

Received:2014-05-12 Published:2014-11-07 Online:2014-11-07

摘要/Abstract

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

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 preparation system established in this research is feasible and efficient. Depend on its stability, lyophilized D-dimer could be provided as biological raw materials for further research.

Key words: Fibrin , Fibrinogen , D-dimer, Thrombus , Lyophilized power

武建伟,才蕾,王继华,唐时幸. 人D-二聚体的制备及其冻干性质的分析[J]. 生物技术通报, 2014, 0(11): 219-224.

Wu Jianwei ,Cai Lei ,Wang Jihua, Tang Shixing. Preparation and Analysis of Lyophilization Characterization of Human D-dimer[J]. Biotechnology Bulletin, 2014, 0(11): 219-224.

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