可塑型生物活性骨修复材料的制备及性能表征  

Preparation, performance and characterization of bioactive bone materials with plasticity

作　　者：鹿鸣[1,2] 张雪松[1] 常丽 崔新爱 刘朝 李次会 李湘杰 

机构地区：[1]解放军总医院骨科,北京市100853 [2]总参管理保障部北极寺老干部局门诊部,北京市100191 [3]北京大清生物技术有限公司,北京市100094

出　　处：《中国组织工程研究》2015年第21期3323-3328,共6页Chinese Journal of Tissue Engineering Research

基　　金：北京市科委课题项目(Z111102067311013)~~

摘　　要：背景:国外研制的可注射性硫酸钙骨替代材料具有操作简便、生物相容性好、能够注射入骨缺损处、原位固化、适应骨缺损进行塑形等优点,但价格昂贵。目的:研究以α-半水硫酸钙为主要成分可塑型骨修复材料的最佳制备参数,并对其性能进行研究和表征。方法:使用汽热法制备粉末,将α-半水硫酸钙粉末与透明质酸钠固化液分别按液固比0.2,0.25,0.3,0.35,0.4 mL/g混合,制备可注射人工骨材料,检测其注射性能、凝固时间和抗压强度;根据检测结果选择最佳液固比0.3 mL/g,在α-半水硫酸钙粉末中分别加入质量分数为1%,2%,3%的二水硫酸钙粉末,制备可注射人工骨材料,检测其注射性能、凝固时间和抗压强度,同时检测可注射骨材料的生物安全性。将液固比为0.3 mL/g并加入2%二水硫酸钙制备的可注射人工骨材料植入巴马小型猪胸骨缺损模型,植入后8,16,24周进行组织学观察。结果与结论:α-半水硫酸钙粉末与透明质酸钠固化液液固比为0.3 mL/g,加入质量分数2%二水硫酸钙粉末制备的可注射人工骨材料,初凝时间为4.0-5.0 min,终凝时间为8.0-9.0 min,抗压强度(8.93±0.23)MPa,具备良好的注射性能,符合临床要求的凝固时间及作为非负重骨缺损修复要求的抗压强度,并具有良好的生物安全性。动物植入实验表明可注射人工骨材料通过自身降解,可为新生骨的爬行替代提供空间,具有一定的成骨活性。BACKGROUND：Foreign injectable sulphate calcium has good biocompatibility, injectability and in situimmobilization, moulding based on adaptation to the shape of bone defects, but the price is expensive. OBJECTIVE：To explore the optimal fabricating parameters of bone repair materials with α-calciumsulfate hemihydrates as the main component, and to study the performance and characterization METHODS：α-Calciumsulfate hemihydrates powder was mixed with sodium hyaluronate at liquid-solid-ratios of 0.2, 0.25, 0.3, 0.35, 0.4 mL/g using vapor-heat method to prepare injectable bone materials. Performance, setting time and compressive strength of the injectable bone was detected. The best liquid-solid-ratio was 0.3 mL/g.α-Calcium sulfate hemihydrates powder was mixed with calcium sulfate dihydrate powder （1%, 2%, 3% mass fractionas） to fabricate injectable bone materials. Performance, setting time and compressive strength of the injectable bone was also detected; meanwhile, the biosafety of the injectable bone was determined. Theinjectable bone material that was made at the liquid-solid-ratio of 0.3 mL/g and by 2% calcium sulfate dihydrate was implanted into Ba-ma swine models of thoracic bone defects. At the time points of 8, 16 and 24 weeks after implantation, histological observation was done. RESULTS AND CONCLUSION： The injectable bone material was made at the liquid-solid-ratio of 0.3 mL/g and by 2% calcium sulfate dihydrate. The initial and final setting time was 4.0-5.0 minutes and 8.0-9.0 minutes, respectively. The compressive strength of the injectable bone reached （8.93±0.23） MPa. These findings indicate that the injectable boen material has good performance, initial setting time and compressive strength meeting the requirements of clinical application and good biosafety. Animal experiments show that the injectable bone can provide space for new bone in creeping substitution way by auto-degradation, with osteogenic activity.

关 键 词：生物材料 骨生物材料 可塑型 α-半水硫酸钙 注射性能 抗压强度 生物相容性 骨修复 

分 类 号：R318[医药卫生—生物医学工程]