双层人工皮肤的生物相容性研究

目的 考察一种新型的皮肤替代物双层人工皮肤的生物相容性.方法 依据GB/T16886医疗器械生物学评价标准规定的细胞毒性、急性毒性试验、皮内刺激试验、致敏试验、亚慢性毒性试验、植入试验和遗传毒性试验方法,评价双层人工皮肤的生物相容性,以验证其安全性和有效性.结果 显示双层人工皮肤无急性毒性、无皮内刺激作用、无致敏作用,细胞毒性不超过1级；皮下植入后1周、4周和12周后,植入组织样品的炎症反应和纤维囊形成与对照无明显差别；遗传毒性采用鼠伤寒沙门氏菌回复突变试验（Ames试验）、体外哺乳动物细胞染色体畸变试验、哺乳动物细胞体外基因突变试验,结果均为阴性,说明双层人工皮肤无遗传毒性.结论 双层人工皮肤具有良好的生物相容性,没有观察到不良反应,符合临床使用要求.

Biocompatibility Study of Bilayer Artificial Skin

Objective To investigate the biocompatibility of bilayer artificial skin, a new skin substitution. Methods The bilayer artificial skin biocompatibility was studied using the cytotoxicity, acute toxicity, subcutaneous reactivity, sensitization, subchronic toxicity, intramuscular implantation and genotoxicity tests as described in GB/T16886. Results The experimental results showed that the bilayer artificial skin had no acute reaction, no subcutaneous reactivity, no sensitization, and the cytotoxicity did not exceed 1 grade, And there was no obvious inflammatory reaction and fibrous capsule difference between artificial skin and control group at 1, 4 and 12 weeks after implantation. The negative results of Ames test and mammalian cell chromosome aberration, as well as the mammalian cell gene mutation test, demonstrated the bilayer artificial skin had no genotoxicity. Conclusion The bilayer artificial skin has excellent biocompatibility and meets the requirement for clinical application.