中文摘要：

背景：异种骨形态、结构与组成类似于人体骨组织,经理化处理后的异种骨抗原性降低,具有天然的多孔结构,被认为是解决自体骨与同种异体骨来源不足的有效方法。目的：检测3种不同方法制备羊椎骨异种骨材料的生物相容性。方法：将经过物理、化学和物理结合化学3种处理方法制备的羊椎骨异种骨材料,制成材料浸提液,植入新西兰大白兔体内,通过急性毒性实验、热源实验、皮内刺激实验和细胞毒性实验,初步评价不同处理组羊椎骨异种骨材料的生物相容性。结果与结论：物理组和物理结合化学组羊椎骨异种骨材料无急性毒性、无热源反应、无刺激性与细胞毒性;化学组羊椎骨异种骨材料有急性毒性反应、有致热源作用、有轻度刺激性及存在细胞毒性。结果提示经过物理、物理结合化学处理的异种骨材料具有良好的生物相容性;单纯经过化学处理的异种骨材料生物相容性较差,不符合生物材料安全性标准。

英文摘要：

BACKGROUND： Xenogeneic bone morphology, structure and composition are similar to human bone tissue, and the antigenicity of xenogeneic bone can be decreased after physicochemical treatment, with a natural porous structure. Xenogeneic bone is considered to be an effective way to solve the shortage of the autogenous bone and allograft bone. OBJECTIVE： To detect the biocompatibility of xenogenic bone materials prepared by three different ways. METHODS： Three sheep vertebral bone xenograft materials were prepared through physical, chemical and physical combined with chemical methods, and they were made extracted liquid and transplanted into the New Zealand white rabbits in vivo. Acute toxicity test, pyrogen test, intramuscular stimulation test and cytotoxicity test were used to evaluate the biocompatibility to sheep vertebral bone xenograft materials of different treatment groups. RESULTS AND CONCLUSION： There was no acute toxicity, pyrogen reaction, irritation reaction or cytotoxicity of sheep vertebral bone xenograft materials prepared through physical, physical combined with chemical methods; While there was acute toxicity, pyrogen reaction, mild irritation and cytotoxicity of sheep vertebral bone xenograft materials prepared through chemical methods. The xenogeneic bone materials prepared in the study showed the good biocompatibility through physical, physical combined with chemical methods. However, xenogeneic bone materials prepared through chemical methods, which had poor biocompatibility, could not qualify for the safety standards of the biological materials.