目的 研究新型复合纤维蛋白胶的磷酸钙骨水泥的生物相容性和生物安全性,探讨其用于临床修复骨缺损的可行性。方法 制备新型复合纤维蛋白胶的磷酸钙骨水泥,获取材料浸提液。选择急性毒性试验、溶血试验、微核试验、细胞毒性试验,对新型复合人工骨材料进行生物相容性和安全性评价。结果 该磷酸钙骨水泥材料浸提液未引起小鼠急性毒性反应;各实验组肉眼下未见明显溶血反应,溶血率0.05);浸提液对小鼠MC3T3成骨细胞的生长分化无明显影响,细胞毒性分级为Ⅰ级。结论新型复合纤维蛋白胶的磷酸钙人工骨材料具有良好的生物相容性和生物安全性。

Objective To explore the biocompatibility and biosafety of new compound of fibrin glue and calcium phosphate bone cement, and to investigate the clinical feasibility for bone reconstruction. Methods The new compound of fibrin glue and calcium phosphate bone cement was prepared and the extract liquid was obtained. The acute toxicity test, hemolysis test, micronucleus test, the cytotoxic test were used for the biocompatibility and biosafety evaluation of the new compound. Results The CPBC extract liquid did not cause acute toxicity in mice; No hemolytic reaction was observed in experimental groups by visual inspection and the hemolytic rate was less than 5%; Micronucleus test showed no significant differences between experimental group and negative control group; The extract liquid had no significant impact on growth and differentiation of mice MC3T3 osteoblasts, and the cell toxicity classification was class I. Conclusion The new compound of fibrin glue and calcium phosphate bone cement have good biocompatibility and biosafety.