【摘要】 目的:对自制炭纤维增强壳聚糖内固定棒进行生物相容性评价,为其临床应用提供实验依据。方法:采用实验动物对该内固定棒进行刺激试验与致敏试验、急性毒性试验、溶血试验,并按医疗器械生物学评价国家标准对试验结果进行生物相容性评价。结果:体内外生物相容性试验显示该材料的兔皮肤、皮内刺激未见红斑、丘疹、结节现象发生;急性全身毒性试验为阴性反应;致敏试验动物未出现过敏反应;溶血率1.64%,符合医用材料溶血率不大于5%的要求。结论:内固定棒具有良好的生物相容性,能初步满足生物内固定装置的生物相容性要求。更多还原

【Abstract】 Objective:To evaluate the biocompatibility of carbon fiber reinforced chitosan robs made by ourselves for bone fracture internal fixation both in vivo and in vitro.Method:Urgent toxicity test,skin stimulated test,sensitization test,and hemo1ysis test were performed in animals and experimental data were analyzed and evaluated according to GuoBiao/Technique(GB/T).Result:the results showed that all the tests including acute toxicity systemic test,intradermal stimulate test,sensitization test,hemolysis test were negative.Conclusion:The carbon fiber reinforced chitosan robs had good biocompatibility and can be hopefully used in bone fracture internal fixation.更多还原