人工气管材料体外细胞毒性和生物相容性研究

目的 :对自行研制的人工气管材料进行体外细胞毒性和生物相容性研究 ,以便为该植入材料应用于临床提供实验依据。方法 :参照 ISO10 993- 1:1992医疗器械生物学评价标准和要求 ,对人工气管材料进行了体外细胞与材料共培养试验、细胞毒性试验、溶血试验、急性全身毒性试验、致敏和热源试验。 结果 :(1)人工气管材料表面的细胞黏附生长良好 ,该材料对体外培养的细胞形态不构成损害 ,对细胞的生长和增殖均无明显抑制作用 ,细胞增殖指数和增殖指数百分率与空白对照组比较无显著性差异 (P>0 .0 5 ) ,而与阳性参照材料组比较差异具有显著性 (P<0 .0 1) ;(2 )溶血率均低于 5 %的国家标准 ,在体外不引起溶血反应 ;(3)该组分材料也无急性全身毒性反应、致敏和热源作用。结论 :该人工气管材料无细胞毒性和热源作用 ,不引起溶血反应和急性全身毒性反应 ,对细胞形态、生长和增殖不构成损害 ,具有良好的生物相容性。

In vitro toxicology and biocompatibility of compos ite materials of tracheal prosthesis

Objective: To evaluate the cytotoxicity,biocompatibility and biological safety of composite materials of tracheal prosthesis in vitro , providing scientific basis for clinical application.Methods: According to standard of ISO10993 1:1992 documents,the cellular cultivation and cytotoxicity test in vitro were conducted to evaluate the composite materials influence on the morphology,growth and proliferation of cultured cells. The hemolysis test was done to assess the impact on the function and metabolism of erythrocyte.Moreover, the acute systemic toxicity test,sensitivation test and pyrogen test were also performed. Results:(1)There was no obvious changes in cultured cells attachment to the surface of the composite materials;(2)The growth and proliferation of the cultured cells was not significantly inhibited by the composite materials;(3)The composite materials had no hemolytic reation and their hemolysis rates were no more than 5%;(4)It had no acute systemic toxicity,no sensitivity,and no pyrogen reaction in vitro .Conclusion:The composite materials of tracheal prosthesis have excellent biocompatibility and biological safety for the clinical application in the future.