目的：评价羟基磷灰石（HA）涂层镁铝合金（AZ31B）的体外生物相容性。方法实验分为3组：HA涂层AZ31B浸提液组（H组）、阳性对照组（P组）和空白对照组（N组）。将L929细胞与各组混合液培养3、5和7 d，采用WST-1法检测细胞活力并进行细胞毒性分级。各组混合液与稀释兔血混匀，测定吸光度（OD）并计算溶血率。采用各组混合液对白化豚鼠分别进行皮内诱导、局部诱导和激发，观察去除贴敷片24、48、72 h动物激发部位皮肤情况。结果3、5和7dN组和H组细胞毒性反应分级为0级，P组部分细胞毒性反应分级为3级；各时间点H组、N组细胞活力均高于P组，差异有统计学意义（P ＜0.05）。H组、P组和N组OD值分别为（0.004±0.001）、（0.648±0.050）和（0.008±0.003）；H组溶血率为-0.6%，无溶血反应。去除贴敷片24、48、72 h H组皮肤无明显改变，P组可见中度至重度融合性红斑。结论体外实验提示HA涂层镁铝合金具有良好的体外生物相容性。%Objective To evaluate the biocompatibility of magnesium-aluminum alloy (AZ31B) with hydroxyapatite (HA) coating in vitro. Methods The experiment included three groups, group of HA-coated AZ31B leaching liquors (H group), positive control group (P group) and blank group (N group). L929 cells were cultured with mixtures in 3 groups for 3, 5 and 7 days, the cell toxicity was graded, and cell viability was measured by WST-1. Optical density (OD) was examined and hemolysis rate was then calculated after diluted cony blood mixed with mixtures in each group. Intradermally, locally induction and stimulation were underwent on the skin of Cavia Cobaya with mixtures in 3 groups. The condition of skin sensitization of Cavia Cobaya was observed 24, 48 and 72 h after sticking removed. Results Cell toxicity was graded as 0 grade in H group and N group after 3, 5 and 7 day's culture, while the cell toxicity of part of cells in P group was graded as 3 grade. Cell viability in H and N groups were higher than that in P group, the difference had statistical significance (P >0.05). OD in H group, P group and N groups was (0.004 ± 0.001), (0.648 ± 0.050) and (0.008 ± 0.003) respectively. The rate of haemolysis was -0.6% in H group, and no hemolysis reaction was found. The skin had no obvious changes in H group 24, 48 and 72 h after sticking removed, while moderate to severe cofluent erythema on the skin was found in P group. Conclusion Experimental results showed magnesium-aluminum alloy with HA coating has good biocompatibility in vitro.
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