脱细胞骨基质材料的特性及生物安全性观察  

Characters and biological safety of acellular bone matrix

作　　者：孙新君[1] 王正国[1] 朱佩芳[1] 张猛[1] 张宇[1] 周继红[1] 

机构地区：[1]第三军医大学附属大坪医院野战外科研究所

出　　处：《中华创伤杂志》2005年第11期833-837,共5页Chinese Journal of Trauma

基　　金：国家重点基础研究发展规划资助项目(G1999054204)

摘　　要：目的对脱细胞骨基质(acellerbonematrix,ACBM)的特性及生物安全性进行评价,为进一步研究构建组织工程骨提供新型材料。方法以新鲜猪肋骨为原料制备ACBM,对材料行组织学、形态学及超微结构观察;用X线衍射及能量散射方法行成分分析并对其蛋白含量进行测定;以新鲜骨为对照,观察制备方法对ACBM生物力学的影响。按GB/T16886的有关标准制备材料浸提液,对ACBM进行生物安全性评价。结果ACBM呈乳白色,质硬,松质骨部呈蜂窝状。超微结构观察显示骨小梁结构完整,骨陷窝内无细胞及碎片残留,孔隙率、孔径大小符合要求,而且微孔之间相通。X线衍射结果显示主要成分为羟基磷灰石,钙/磷为1.66,接近人骨组织。其压缩强度、压缩极限及扭转力矩等与新鲜骨组织比较差异无统计学意义,弹性模量显著增加。急性和亚急性毒理试验、热源试验、溶血试验及肌肉埋植实验均符合GB/T16886标准。结论ACBM作为一种新型骨缺损充填物或骨组织工程基质材料,具有良好的生物安全性。Objective To observe the characters and the biological safety of acellular bone matrix （ACBM） for further research and development of new scaffolds for bone engineering. Methods ACBM was prepared using fresh pig ribs and observed by means of histology, scanning electron microscope （ SEM ） and transmission electron microscope （TEM）. The components were analysed by X-ray diffraction （XRD） and energy dispersive X-ray fluorescence （EDXRF） techniques. At the same time, protein contents were determined by tryptophan analytic method. Mechanical test was done on ACBM contrast with fresh ribs. The biological safety was evaluated aecording to standard of GB/T168886. Results ACBM was hard, with oyster white appearance and with honeycomb-framed cancellous bone. SEM showed that the frame of bone trabecula was integrated, with aperture size for （458.16 ± 117.87）μm and pori- ness for （69.9±8.8）% , without debris of cell in bone lacuna （TEM）. The X-ray diffraction showed that the major component of ACBM was Ca5 （PO4 ） 3 （OH） , with ratio of Ca/P for 1.66. Compressive strength, maximum and leverage showed insignificant difference compared with fresh ribs, while the Young＇s nlodulus increased significantly than that in fresh ribs. Evaluation of biological safety confirmed that ACBM was safe to the recipients according to the GB/T16886. Conclusion ACBM, as a new ma- terial for bone defect or scaffold for bone engineering, is safe to the recipient.

关 键 词：骨基质 脱细胞 骨折 支架材料 骨基质材料 生物安全性 脱细胞 安全性观察 急性毒理试验 骨组织工程 超微结构观 

分 类 号：R318.08[医药卫生—生物医学工程]