碳纤维复合材料人工颅骨板急性期生物相容性的研究

Acute study of biocompatibility of carbon fiber composite artificial skull plate

目的评价碳纤维复合材料人工颅骨板在急性期的生物相容性。方法制作碳纤维复合材料、含重组人骨形态发生蛋白-2(rhBMP-2)的碳纤维复合材料、钛网、MEM培养基、含有0.64%苯酚的MEM培养基的浸出液,用于测试。采用L929小鼠成纤维细胞进行细胞毒性试验,采用健康ICR小鼠进行急性毒性试验,采用新西兰大白兔耳静脉血进行急性溶血试验,采用白化豚鼠进行皮肤致敏试验。结果碳纤维复合材料、含rhBMP-2的碳纤维复合材料、钛网浸提液对L929细胞的相对增殖率均在75%以上,细胞毒性1级,无明显细胞毒性;小鼠腹腔注射相应材料的浸提液后,均活动良好,均无不良反应,均无明显急性毒性;碳纤维复合材料、含rhBMP-2的碳纤维复合材料、钛网浸提液溶血率均小于5%,均不引起溶血反应;碳纤维复合材料、含rh?BMP-2的碳纤维复合材料、钛网浸提液不引起致敏性。结论碳纤维复合人工颅骨板急性期生物相容性良好。

Objective To evaluate the biocompatibility of carbon fiber composite artificial skull plate(CFCASP)in acute phase.Methods The biocompatibility of CFCASP was observed by cytotoxicity test,acute toxicity test in mice,acute hemolysis-test in rabbits and sensitization test in guinea pigs.Results①The relative proliferation rates of L929 cells cultured in the media containing the extracts from carbon fiber composite material,recombinant human bone morphogenetic protein-2 containing carbon fiber composite material and titanium net for 24~72 hours were over 75%and,there was insignificant difference in the relative proliferation rates among the three groups(P>0.05)and the cytotoxicity was grade I,which indicated no obvious cytotoxicity.②The activities were well and no adverse reactions and obvious acute toxicity were observed in the mice 4,24,48 and 72 hours after intraperitoneal injection of the extracts of the above-mentioned three materials and physiological saline.③The acute hemolysis test showed that the hemolysis rates of the extracts from the above-mentioned materials all were less than 5%in the New Zealand white rabbits,and there was insignificant difference in the hemolysis rate among the three materials(P>0.05).④No any sensitive reactions were observed in the guinea pigs receiving intracutaneous injection of the extracts from the above-mentioned materials.Conclusions CTCASP has good biocompatibility and meets the clinical application standards of domestic medical materials.