氟涂层镁铝合金的体外生物相容性研究

In vitro study on the biocompatibility of magnalium with fluorine coating

目的研究氟涂层镁铝合金的体外生物相容性。方法实验分为空白对照组(N组)、镁铝合金组(M组)、氟涂层镁铝合金组(F组)和阳性对照组(P组)4组。细胞毒性实验:将L929细胞在各组的DMEM浸提液中培养,光学显微镜下观察细胞生长状况,应用WST-1法测量光密度(OD)值。溶血实验:按GB-T 16175-2008《医用有机硅材料生物学评价实验方法》第13部分《溶血试验》进行实验。测量各样本的OD值,计算溶血率。豚鼠最大剂量致敏实验,按照GB-T 16886.10-2005《医疗器械生物学评价》第10部分《刺激与迟发型超敏反应试验》进行实验。观察激发阶段去除贴附片后24、48、72h豚鼠皮肤致敏情况。结果各观察期F组的形态分级为0级,M组为4级。各组各观察期内OD值差异均有统计学意义(F=312.96,P=0.000)。第3天,实验组OD值均高于P组(1.050±0.065 vs 0.292±0.010)(P<0.05)。第5天、第7天,F组与N组OD值(1.429±0.096 vs 1.622±0.156,0.928±0.040 vs 0.995±0.070)处于同一水平(P>0.05),均高于P组(0.270±0.015,0.281±0.006)(P<0.05)。M组溶血率为68.3%,F组为0.8%。24 h、48 h和72 h后N组、M组、F组皮肤均无红斑。结论氟涂层镁铝合金体外实验显示具有良好的生物相容性。

Objective To study the biocompatibility of magnalium with fluorine coating in vitro. Methods The experiment included 4 groups： group blank control（group N）, group magnalium（group M）, group magnalium with fluorine coating（group F） and group positive control （group P）. WST-1 assay was employed to evaluate the cytotoxicity of the material against L929 cells. Haemolysis experiment was performed in accordance with the 13th part of GB-T 16175 - 2008 Experiment Method of Biology Evaluation of Medical Organosilicon. The maximal dose sensitization experiment of Cavia was performed in accordance with the lOth part of GB-T 16886.10-2005 Experiment of Irritate and Delayed Hypersensitivity in Experiment Method of medical apparatus and instrument, and the conditions of Cavia skin sensitization was observed at 24-hour, 48-hour and 72-hour after sticking removal. Results The morphological grade of group F at each observation period was O, and that of group M was 4. The OD values of each group at each observation period were statistically different（F = 312.96, P = 0.000）. At the 3rd day, the ODs of the experimental groups were higher than that of group P （1.050 ± 0.065 vs 0.292 ± 0.010）（P 〈 0.05）. At the 5th and 7th day, the OD of group F and group N（1.429 ± 0.096 vs 1.622 ± 0.156, 0.928 ± 0.040 vs 0.995 ± 0.070） was at the same level（P 〉 0.05）, but higher than that of group P （0.270 ± 0.015, 0.281 ± 0.006）（P 〈 0.05）. The haemolysis rate of group M was 68.3 %, and that of group F was 0.8 %. The skin erythema were not found in group N, group M and group F at 24-hour, 48-hour and 72-hour. Conclusion It is demonstrated that favorable biocompatibility is observed in the in vitro experiment.