Biological Safety Evaluation Of CFR/PEEK Composites

Objective:The biological safety of carbon fiber reinforced polyetheretherketone composites with different contents was evaluated by cytotoxicity test,hemolysis test and acute systemic toxicity test.It provides guidance for further experimental direction.Thus,the possibility of clinical application is discussed,and the biological basis for clinical application is provided.Methods:PEEK、25%CFR/PEEK、30%CFR/PEEK、35%CFR/PEEK、40%CFR/PEEK were prepared,and their overall biosafety was evaluated in the following three parts:1.In vitro cytotoxicity test was carried out by CCK-8 method.The third generation mouse fibroblasts L-929 were cultured in different material extracts.On the first,third,5th and 7th days,the morphologic changes of the cells were observed.The relative proliferation rate(RGR)of the cells was calculated by optical density value(OD value),and the cytotoxic grade of each group was evaluated.2.In the hemolysis experiment,the diluted human venous blood was put into the extract of different materials for 1 hour,centrifuged,observed the difference of the liquid color with naked eye,and the hemolysis rate was calculated by OD value of the supernatant.3.In acute systemic toxicity tests,ICR mice were perfused with material extract for one week to observe the symptoms of clinical poisoning,to calculate the food utilization rate and the relative growth rate of body weight,to prepare histopathological section,and to evaluate the histopathological changes of important organs.Results:1.The cytotoxicity test showed that on the first day,the third day,5th day,7th day,the cell morphology of each experimental group was basically fusiform or polygonal,and there was no difference between the experimental group and the negative control group,the relative cell proliferation rate was 88.33%~103.33%,and the cytotoxicity grade was 0 ~ 1.2.Hemolysis experiment: the supernatant of each experimental group and negative control group was colorless and transparent,and a large amount of red precipitate accumulated on the bottom of the tube.The supernatant of the positive control group was pink and there was almost no red precipitate on the bottom of the tube.The hemolysis rate of each experimental group ranged from-0.38 to 0.06,which was lower than 5%.3.Acute systemic toxicity test: ICR mice in each group had no clinical toxicity signs.There was no significant difference in the food utilization rate and the relative growth rate of body weight between the experimental group and the negative control group.There was no abnormal pathological manifestation in heart,liver,spleen,stomach and kidney.Conclusion:The cytotoxicity test,hemolysis test and acute systemic toxicity test of PEEK 、25%CFR/PEEK、30%CFR/PEEK、35%CFR/PEEK、40%CFR/PEEK all meet the criteria of biosafety evaluation,which is worthy of clinical application.