氟涂层镁铝合金的体外生物相容性研究简

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-T16175-2008《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GBJ16886.10-2005（（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 50.995±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％。24h、48h和72h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。

In vitro study on the biocompatibflity of magnalium with fluorine coating

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.