聚乳酸-乙醇酸复合中药自然铜活性骨修复支架生物学评价

摘要

目的：评价新型骨修复材料聚乳酸-乙醇酸复合中药自然铜活性骨修复支架的生物安全性。方法根据医疗器械生物学评价标准的要求，选取了溶血试验、细胞毒性试验、遗传毒性试验、刺激与致敏试验、全身毒性试验、植入试验等，全方位评价该新型材料的生物安全性。结果聚乳酸-乙醇酸复合中药自然铜活性骨修复支架的血液相容性良好，无全身毒性和细胞毒性，未发现短期遗传毒性，无皮肤刺激和致敏作用，材料植入骨后周围组织反应正常，骨修复情况良好。结论聚乳酸-乙醇酸复合中药自然铜活性骨修复支架是一种生物相容性好的骨修复材料，可安全应用于临床。%Objective To evaluate biological safety of poly lactic-co-glycolic acid( PLGA )/pyrite composite active bone repalr scaffold. Methods According to biological evaluation criterion of medical devices, we selected hemolytic test, cytotoxicity test, genotoxicity test, tests for irritation and delayed-type hypersensitivity,general toxicity test and implantation test,to evaluate biological safety of the new materials. Results PLGA /pyrite composite active bone repalr scaffold had good blood compatibility,without general toxicity,cell toxicity,skin irritation and sensitization. The tissue reaction was normal after planting to the bone and the bone repalring was in good condition. Conclusions PLGA/ pyrite composite active bone repalr scaffold was one kind of bone repalr material with good biocompatibility and could be safely applied to clinical use.