摘要
目的:研究复合支架材料——关节软骨再生支架的生物安全性。方法:采用细胞毒性、皮肤致敏性、皮内反应、急性全身毒性、溶血、遗传毒性、植入试验和亚慢毒性试验对复合材料制备的关节软骨支架样品进行检测。结果:关节软骨再生支架在细胞毒性、皮肤致敏性、皮内反应、急性全身毒性、溶血、遗传毒性、植入试验和亚慢毒性试验均符合规定。结论:复合材料制备的关节软骨再生支架样品具有良好的生物安全性。
To evaluate biosafety of articular cartilage regeneration scaffold.Methods: To evaluate the in vitro cytotoxicity test,skin sensitization test,intradermal reaction test,acute systemic toxicity test,haemolysis test,genotoxicity test,test for local effects after implantation and subchronic systemic toxicity of the articular cartilage regeneration scaffold prepared by composite materials.All the results were within the rules.Conclusion: the articular cartilage regeneration scaffold prepared by composite materials has good biosafety.
出处
《中国医疗器械信息》
2016年第5期39-44,共6页
China Medical Device Information
基金
广东省医疗产品生物安全评价科技服务平台(2012B011000003)
关键词
关节软骨再生支架
生物安全性
毒理学试验
articular cartilage regeneration scaffold
biosafety
toxicity test