碳纤维复合材料人工颅骨板急性期生物相容性的研究

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rhBMP-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。

Acute study of biocompatibility of carbon fiber composite artificial skull plate

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. Results ①The 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. ② The 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.