新型聚醚醚酮复合材料生物安全性的初步检测

Preliminary Evaluation of Biocompatibility of New PEEK Composite Materials

目的:通过体内及体外试验,初步检测自行合成的聚醚醚酮(Polyetheretherketone,PEEK)复合材料的生物安全性。方法:采用MTT、急性全身毒性试验、黏膜刺激试验和溶血试验检测PEEK复合材料的体内和体外生物安全性。结果:MTT结果显示:PEEK复合材料浸提液对细胞生长及形态没有影响;急性全身毒性试验显示:试验组大鼠在观察期内均无死亡、中毒反应,饮食正常,精神状态良好。试验组大鼠心脏、肝脏、肾脏、脾脏重要器官肉眼及镜下观察无异常,组织切片与对照组无明显差异,未见病理改变。可以认为PEEK复合材料不会引起中毒反应;黏膜刺激试验显示:经肉眼观察试验组黏膜组织正常,无红斑、糜烂、溃疡现象;镜下观察,与对照组无明显差异,镜下评分<4。综合肉眼及镜下观察结果显示,PEEK复合材料对口腔黏膜无刺激性;溶血试验显示:试验组测得溶血率为0.663%,满足中华人民共和国医药行业标准(YY)规定的溶血率小于5%的要求,所以PEEK复合材料不会引起溶血反应。结论:PEEK复合材料具有良好的生物安全性。

Objective： To evaluate the biological safety of newly synthesized composite material PEEK. Methods： MTT assay, acute systemic toxicity test, hemolysis test, and mucosa irritation test were employed to detect the bi- ological safety of PEEK composite materials in vitro and in vivo. Results.. The results of cytotoxicity test showed that cells grew well in the extract fluids of PEEK composite and there was no significant difference between experi- mental group and control group. The results of acute systemic toxicity test showed that all rats in the experimental group were alive, with normal diet and good mental state during the observation period. After the rats were injected with the extract fluids, there were no pathological changes in their hearts, livers, kidneys and spleens organs when observed by naked eye and microscopes. The results of mucous membrane irritation test showed that PEEK com- posite had no irritation to oral mucosa membrane. The result of hemolysis test showed that the PEEK composite did not cause hemolytic reaction. Conclusion： PEEK composite has biological safety.