| 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. |
