【摘要】 丝素/纳米SiO2凝胶共混膜是透气性、稳定性和力学性能更符合人工皮肤要求的膜状材料。为了评估丝素/纳米SiO2凝胶共混膜的生物安全性,利用实验动物对其进行与人体皮肤创伤愈合直接相关的过敏性试验、细胞毒性试验、热原试验、迟发型超敏反应试验、皮内刺激试验、急性(单剂量)毒性试验和溶血试验等。各项试验结果初步表明,实验动物对丝素/纳米SiO2凝胶共混膜无不良反应,细胞相对增殖率大于90%,符合国颁标准对医疗器械的生物安全性要求,预示其有望作为人工皮肤材料应用于临床医学。更多还原

【Abstract】 Silk fibroin/nano-SiO2 gel blend membrane is a kind of membrane material with fine air permeability,stability and mechanical properties,which meets the requirements of artificial skins better than other materials.In this study,a series of tests including allergic test,cytotoxicity test,pyrogen test,delayed hypersensitive test,hypodermic stimulation test,acute(single dose) toxicity test and hemolysis test were performed to evaluate the biological safety of silk fibroin/nano-SiO2 gel blend membrane.Results of each test preliminarily showed that the experimental animals had no adverse reactions to silk fibroin/nano-SiO2 gel blend membrane.The relative cell proliferation rate was higher than 90%,meaning that the silk fibroin/nano-SiO2 gel blend membrane could meet the biological safety requirements stipulated in the national standard on medical equipment and could be a promising material for artificial skins to be applied in clinical medicine.更多还原