医疗卫生装备2018，Vol.39Issue(1)：23-26,4.DOI:10.7687/j.issn1003-8868.2018.01.023
骨外固定支架材料的生物学评价
Biological evaluation of scaffold materials for external skeletal fixation
张磊 1叶小惠 1章亚兵 1周宙1
作者信息
- 1. 安徽省食品药品检验研究院,合肥230051
- 折叠
摘要
Abstract
Objective To provide integral biological assessment on carbon fiber,aluminum alloy (6061)and stainless steel (05Cr17Ni4Cu4Nb)for external skeletal fixation.Methods According to biological evaluation criterion of medical devices, four tests in vitro and vivo were selected on the basis of the GB/T 14233.2—2005 and GB/T 16886 serial standards. The cytotoxicity test determined with MTT method. Acute general toxicity test, tests for irritation and delayed -type hypersensitivity were to evaluate biological safety by two leaching media of polar solvent (sodium chloride) and nonpolar solvent (cottonseed oil).Results The scaffold materials of external skeletal fixation had no cell toxicity in vitro.The three materials had none of acute general toxicity, skin irritation and sensitization in sodium chloride and cottonseed oil. Conclusion Carbon fiber,aluminum alloy (6061)and stainless steel (05Cr17Ni4Cu4Nb)are kinds of bone external scaffold materials with high biocompatibility and can be safely applied for clinical use.关键词
骨外固定支架材料/生物学评价/生物相容性/细胞毒性/皮内反应Key words
scaffold materials for external skeletal fixation/biological evaluation/biocompatibility/cytotoxicity/intradermal reaction分类
医药卫生引用本文复制引用
张磊,叶小惠,章亚兵,周宙..骨外固定支架材料的生物学评价[J].医疗卫生装备,2018,39(1):23-26,4.
