CAJ | 학술논문

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<5%；微核实验显示，各实验组微核率与阴性对照组无差别（P>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。
목적：연구신형복합섬유단백효적린산개골수니적생물상용성화생물안전성，탐토기용우림상수복골결손적가행성。방법제비신형복합섬유단백효적린산개골수니，획취재료침제액。선택급성독성시험、용혈시험、미핵시험、세포독성시험，대신형복합인공골재료진행생물상용성화안전성평개。결과해린산개골수니재료침제액미인기소서급성독성반응；각실험조육안하미견명현용혈반응，용혈솔<5%；미핵실험현시，각실험조미핵솔여음성대조조무차별（P>0.05）；침제액대소서MC3T3성골세포적생장분화무명현영향，세포독성분급위Ⅰ급。결론신형복합섬유단백효적린산개인공골재료구유량호적생물상용성화생물안전성。
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.