生物骨科材料与临床研究2017，Vol.14Issue(5)：1-4,4.DOI:10.3969/j.issn.1672-5972.2017.05.001
医用可降解Mg-Zn-Sr合金材料体内外生物安全性评价
Biological safety assessment of medical degradable Mg-Zn-Sr alloy in vitro and in vitro
摘要
Abstract
Objective To evaluate the biological safety of medical degradable Mg-Zn-Sr alloy in vitro and in vivo and explore the possibility of Mg-Zn-Sr alloy as a new type of orthopedic implant material.Methods According to the ISO 10993 and GB/T16886,in vivo acute systemic toxicity tests and in vitro cytotoxicity tests were performed,alloy group was injected with Mg-Zn-Sr alloy extract,and negative control group was injected with 0.9％ sodium chloride solution.Results When the Mg-Zn-Sr alloy extract was injected intravenously,the animals were in good condition,no toxic reaction and death after 0,4,24,48,72 h,respectively.There was no significant difference in the body mass relative growth rate between the two groups (P＞0.05).The cell growth condition with the addition of extracts of every concentration was good,and the number and morphology of cells were similar to those of the negative control group.There was no significant difference in the A value between the extract of every concentration group and the negative control group (P＞0.05).The value of RGR ranged from 90.98％ to 107.15％,and the toxicity was evaluated from grade 0 to grade 1.Conclusion Mg-Zn-Sr alloy has no acute systemic toxicity,no cytotoxic effect.It is the medical biological material safety requirements,is expected to become a new type of orthopedic implant material.关键词
Mg-Zn-Sr合金/生物材料/急性全身毒性/细胞毒性Key words
Mg-Zn-Sr alloy/Biological materials/Acute systemic toxicity/Cytotoxicity分类
医药卫生引用本文复制引用
甘雨,赵晶凤,马杰,刘小虎..医用可降解Mg-Zn-Sr合金材料体内外生物安全性评价[J].生物骨科材料与临床研究,2017,14(5):1-4,4.基金项目
沈阳市科技计划项目(N0:F15-139-9-42) （N0:F15-139-9-42）
