中文摘要：

目的对制作人工气管的相关组分材料进行生物相容性评价。方法皮肤致敏实验：雄性豚鼠分5组（n=8），纳米碳纤维组、胶原蛋白-羟基磷灰石组、混合材料组、阳性对照组（甲醛）和阴性对照组（生理盐水），观察各组的材料浸渍液是否引起豚鼠皮肤过敏反应。热原实验：新西兰兔分4组（n=3），纳米碳纤维组、胶原蛋白-羟基磷灰石组、混合材料组和阴性对照组（生理盐水），观察各组的材料浸渍液是否含有热原物质。以及通过溶血实验观察各组的材料浸渍液对兔血细胞溶血率的影响。结果本实验涉及的生物材料致敏率均为0，与阴性对照组的皮肤致敏反应差异均无统计学意义（P〉0．05）。各材料组动物注射材料浸渍液后体温升高分别为（0．3±0．2）、（0．2±0．1）、（0．3±0．2）℃，均在0．6℃以下，且升高总数均在1.4℃以下。各组浸渍液溶血率分别为（0．1301±0．0004）％、（0．2004±0．0004）％、（0．1502±0．0004）％．均〈5％。结论人工气管的组分材料均符合生物相容性评价实验的安全标准，可为建立进一步动物实验模型提供相关依据。

英文摘要：

Objective To evaluate the biocompatibility of the composite materials for making artificial airtube. Methods Skin hypersusceptibility test： 40 male guinea pigs were divided into 5 groups （n= 8） , including nano- carbon fibers group, collagen protein/nano- hydroxyapatite （HAC） group, mixed materials group, positive control （formaldehyde） group and negative control （normal saline） group. Skin allergic response induced by the leaching liquor of each material was observed. Pyrogen test： 12 New Zealand rabbits were divided into 4 groups （n=3） , including nano-carbon fibers group, collagen protein/nano-HAC group, mixed materials group and negative control （normal saline） group. Pyrogen in the leaching liquor of each material was examined. Hemolysis test was used to investigate the effect of the leaching liquor of each material on rabbit＇ s blood cells hemolysis rate. Results Sensibilization rate of each material was 0. There was no significant difference in statistics compared with negative control group （P〉0.05）. In pyrogen test, the fervescence of the animals in each group were （0.3±0.2）, （0.2±0.1） and （0.3±0.2）℃, respectively （all less than 0.6℃ ） , and the sum total of fervescence was less than 1.4℃. The hemolysis rates of all groups were （0.130 1±0.000 4）%, （0.200 4±0.000 4）% and（0.150 2±0.000 4）% （all〈5%）. Conclusions Consistent materials for new artificial airtube are conformed to safety standard by biocompatibility test. The results provide evidences to further study of animal experimental model establishment.