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

目的评价医用可降解Mg-Zn-Sr合金材料的体内外生物安全性,初步探讨其作为骨科植入材料的可行性。方法参照国际ISO 10993标准和国内GB/T16886标准,对Mg-Zn-Sr合金进行小鼠体内急性全身毒性试验和体外细胞毒性试验研究,记为合金组,对照组自小鼠尾静脉注射0.9%氯化钠溶液。结果 Mg-Zn-Sr合金浸提液经静脉注射后,在即时、4、24、48、72 h后动物一般状态均良好,未见毒性反应及死亡情况,合金组和对照组体质量相对增长率比较,差异无统计学意义(>0.05);各浓度浸提液组细胞生长状况良好,细胞数目和形态与阴性对照组相似,各浓度浸提液组A值与阴性对照组A值比较,差异无统计学意义(>0.05),细胞相对增值率(RGR值)介于(90.98%~107.15%)之间,毒性评价为0~1级。结论 Mg-Zn-Sr合金无急性全身毒性反应,无细胞毒性作用,符合医用生物材料安全性要求,有望成为新型骨科植入材料。

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 （/〉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.