镁合金的初步生物安全性评价

Initial evaluation of biological safety of mg alloy

目的初步评价AZ31B镁合金的生物安全性。方法体外细胞毒性:L929细胞分别与实验组(M)镁合金培养基浸提液、空白对照组(N)DMEM培养基,阳性对照组(P)5%DMSO培养基培养,3 d后进行细胞毒性分级。体外溶血率:稀释兔血分别与实验组(M)镁合金生理盐水浸提液、空白对照组(N)生理盐水、阳性对照组(N)蒸馏水混合后置37℃水浴中孵育,60 min后离心,取上清液测定吸光度(OD),计算镁合金材料溶血率。体外浸提液分析:检测镁合金材料浸提液中镁离子和钠离子浓度,以及pH值。体内急性毒性:分别自小白鼠腹腔注射空白对照组(N)生理盐水和镁合金组(M)镁合金材料生理盐水浸提液,观察和记录动物的状态,72 h后计算动物体质量变化。结果 N组毒性反应分级为0级,M组为4级,P组为3级。M组溶血率为68.1%,具有溶血作用。浸提液镁离子浓度为1.33 mmol/L,钠离子浓度为134 mmol/L;浸提液pH值为10.10±0.29。所有动物注射后在各时间点无不良反应,一般情况好。M组和N组动物体质量的平均变化分别为1.97%和0.43%,小鼠体质量增加百分比差异无统计学意义(t=0.499,P=0.624)。结论体外实验显示高腐蚀率的镁合金有细胞毒性和溶血率,但体内实验并未见到急性毒性反应。

Objectives To primitively evaluate the biological safety of AZ31B Mg alloy.Methods Cytotoxicity in vitro： L929 cells were cultured in medium leaching liquor of Mg alloy as experimental group（group M）,DMEM medium as blank group（N） and 5% DMSO medium as positive control group（group P）.Cytotoxicity was detected 3 days later.Hemolysis in vitro： dilute rabbit blood mixed with leaching liquor of Mg alloy as experimental group（group M）,sodium chloride as experimental group（group N） and distilled water as positive control group（group P） were incubated at 37 ℃.The mixed solution was centrifuged 60 min later.Optical density（OD） of the supernatant was measured and hemolysis rate for Mg alloy was calculated.Analysis of leaching liquor in vitro： Ion concentrations of Na＋,Mg2 ＋ and pH were measured in leaching liquor of Mg alloy.Acute toxicity in vivo： Mus musculus albus abdominal cavities were injected into sodium chloride as experimental group（group N） or leaching liquor of Mg alloy as experimental group（group M）.The condition of Mus was observed and the change of Mus weight was measured in the third day.Results The cytotoxicity grading was 0 in group N,3 grade in group P and 4 grade in group M.Hemolysis rate was 68.1% in group M.Ion concentration was 1.33mmol / L of Mg2 ＋ and 134mmol / L of Na＋.The pH value was 10.10 ± 0.29.Percentage of Mus weight gain was（1.97 ± 6.49） % in group M and（0.43 ± 7.30） % in group N.There was no significant statistical difference between the two groups（t = 0.499,P = 0.624）.Conclusion There were cytotoxicity and severe hemolysis in vitro test,but there was no acute systematic toxic reaction in vivo for the high corrosion rate of Mg alloy.