人羊膜脱细胞基质填充材料的生物相容性及动物有效性研究

Research of biocompatibility and effectiveness in animals of human amniotic membrane acellular matrix filler material

目的探讨人羊膜脱细胞基质填充材料的生物相容性及动物有效性。方法通过生物学评价实验对羊膜脱细胞基质填充材料的刺激性、致敏性、细胞毒性等进行检测,并通过大鼠皮内植入实验检测材料的动物有效性(以上市产品双美胶原蛋白作为对照)。结果羊膜脱细胞基质填充材料无致敏性、无刺激性,且细胞毒性不大于1级;大鼠皮内植入有效性实验显示,羊膜脱细胞基质填充材料于植入后20周依然有肉眼可观察到的材料保留。双美胶原植入剂降解完全,肉眼和HE染色均未见材料。且两种材料在体内降解期间的炎症反应和免疫排斥反应均为轻度反应。结论人羊膜脱细胞基质填充材料具有良好的生物相容性,无明显炎症及免疫排斥反应。其在大鼠皮内耐降解性强,保留时间较长,可作为一种安全有效的填充注射产品应用于临床。

Objective To investigate the biocompatibility and effectiveness in animals of human amniotic membrane acellular matrix filler material.Methods Irritation,sensitivity,and cell toxicity were detected by biological assessment experiments,and the efficacy of the material in animals was also inspected by a rat subcutaneous implantation experiment （Control group for Sunmax Ⅱ collagen implant agent）.Results Amaiotic membrane acellular matrix filler material was not sensitive or irritative,and the cytotoxicity of the cells was less than 1 degree.The results of the rat implant experiment showed the amniotic membrane matrix implants still retained visiblity at 20 weeks,while the Sunmax Ⅱ collagen implant agent degraded completely to detection by the naked eye and HE staining.The inflammatory reaction and immune rejection reaction of the two materials in vivo were both mild.Conclusion Human amniotic membrane acellular matrix material has excellent biocompatibility without obvious inflammation and immune rejection.The acellular amniotic matrix can be used as a safe and effective filling injection in clinical application because of its strong resistance to degradation and longer retention time.