医用钛合金Ti-6Al-4V基体/羟基磷灰石涂层复合材料的生物安全性评价  

The Biological Safety Evaluation of Medical Titanium Alloy Ti-6Al-4V Matrix/Hydroxyapatite Compound

作　　者：陈斌[1,2] 祝君梅[1,2] 程琳[1,2] 史梦柔 李毅敏[1,2] 

机构地区：[1]天津市医药科学研究所 [2]天津市医用生物材料监测中心,天津300020

出　　处：《生物医学工程研究》2012年第3期195-197,200,共4页Journal Of Biomedical Engineering Research

摘　　要：评价新型医用钛合金Ti-6Al-4V基体/羟基磷灰石涂层复合材料的生物安全性。通过遗传毒性试验、细胞毒性试验、骨植入实验和迟发型超敏试验,对Ti-6Al-4V基体/HA涂层复合材料进行安全性研究。该复合物试样在Ames实验中无诱变性,对体外CHL细胞不诱发染色体畸变,不引起体外V79细胞的基因突变,无体外细胞毒性。该检品在骨植入试验中,对局部组织无刺激。最大剂量试验法迟发型超敏试验显示,该检品无致敏性。该复合材料有良好的生物安全性。To evaluate the biological safety of the new medical titanium alloy Ti-6Al-4V matrix / hydroxyapatite compound.Biosafety of the compound samples were assessed according to study of genetictoxicology,cytotoxicity,bone implantation and delayed-type hypersensitivity.The result of Ames test showed that the compound samples had no mutagenicity.The samples did not induce chromosomal aberrations of CHL cells or gene mutations of V79 cells.The samples had no cytotoxicity in vitro.The result of the bone implantation experiments showed that the samples hade no local tissue irritation.The result of the maximum dose of delayed-type hypersensitivity test show that the samples have no allergenicity.The new compound possesses good biological safety.

关 键 词：羟基磷灰石 钛合金 遗传毒性 骨植入 免疫毒性 

分 类 号：R318[医药卫生—生物医学工程]