人工气管组分材料的毒理学评价

目的 对人工气管的相关组分材料进行毒理学评价实验.方法 本实验按照国际国内既定标准,对纳米碳纤维、胶原蛋白-纳米羟基磷灰石等组分材料进行体外毒理学实验研究,包括细胞毒性实验、遗传毒性实验、急性毒性实验.结果 本实验涉及的生物材料以及混合材料没有发现细胞毒性及遗传毒性作用.各组材料浸渍液与L-929细胞共培养7 d,细胞相对增殖率均>100%(纳米碳纤维:136.21%;胶原蛋白.纳米羟基磷灰石:135.10%;混合材料:112.05%),毒性分级均为0级.动物实验亦未见明显的全身毒性作用,均符合毒理学评价实验的安全标准.结论 利用纳米碳纤维、胶原蛋白-纳米羟基磷灰石设计制作的人工气管符合生物相容性毒理学评价实验的安全标准.

Toxicological evaluation for the composite materials of artificial trachea

Objective To evaluate the toxicity of the composite materials which composed artificial trachea by toxicological experiments. Methods According to the international and domestic standards, cytotoxieity test, genotoxicity test and acute toxicity test in vitro for the composite materials including nano-carbon fibers, collagen protein/nano-hydroxyapatite (HAC) were performed. Results All the materials and mixed materials were neither cytotoxicity nor genotoxicity. After L-929 cells and the material impregnating solution were co-cultured for 7 days, the relative growth rates of L-929 cells were all more than 100% (nano-carbon fibers: 136.21% ; collagen protein/nano-HAC: 135.10% ; mixed materials: 112.05%), and toxicity classifications were 0 grade. Systemic toxicity was not found in animal experiment. All the materials conformed to safe standards of toxicological evaluation experiment. Conclusion The artificial trachea made of nano-carbon fibers, collagen protein/nano-HAC is safe according to the biocompatibility standards of toxicological evaluation experiments.