活性煅烧骨和骨水泥复合材料的生物学安全性评定

Assessment on biological safety of material combined with true bone ceramic,bBMP and bone cement

目的评定活性煅烧骨和骨水泥复合材料的生物学安全性。方法提取牛骨形成蛋白,制备活性煅烧骨颗粒,与骨水泥按不同质量比复合后植入小鼠腹腔内行急性、亚急性毒性试验,植入小鼠后腿股部肌肉内行肌肉刺激试验,体外行溶血、凝血试验等。结果急性毒性试验动物无死亡,亚急性毒性试验术前、术后动物体重、红细胞、白细胞和血红蛋白无统计学差别(t检验,P>0.05),对肌肉无刺激,无致热作用,体外对溶血、凝血功能无影响。结论该复合材料生物相容性好,易塑形,具有很强的成骨诱导活性,能满足修复不同部位、不同形状骨缺损的需要。

Objective To assess the biological safety of a composite material combined with true bone ceramic(TBC),bovine bone morphogenitic protein(bBMP) and bone cement(BC).Methods The TBC was prepared.The bBMP was extracted and mixed with TBC.Then the bBMP TBC composite was combined with BC with different weight proportion and the composite material was tested by acute and subacute toxicity test, muscle stimulation test, hemolysis and coagulation test.Results No animals died in the acute toxicity test and the body weight,red blood cells, white blood cells and hemoglobin were not affected in the subacute test.Conclusions This composite material has excellent biocompatibility and bone inductive activity.It is favorable for the repair of bone defects with different shape and different position because it can be also modeled easily.