表面改性聚对苯二甲酸乙二醇酯纤维的生物安全性评价  

Biosafety of Surface Modified Polyethylene Terephthalate Fiber

作　　者：黄兆松[1] 毕龙[1] 张振宇[1] 张东宪[1] 孙鹏霄[1] 韩一生[1] 

机构地区：[1]第四军医大学西京医院全军骨科研究所,西安710032

出　　处：《中国生物制品学杂志》2011年第5期586-589,共4页Chinese Journal of Biologicals

摘　　要：目的评价表面改性聚对苯二甲酸乙二醇酯(Polyethylene terephthalate,PET)纤维的生物安全性。方法参照相关国家标准对表面改性PET纤维进行细胞毒性试验,比较改性前后PET纤维的细胞毒性;对该表面改性PET纤维材料的浸提液进行急性毒性试验、溶血试验、热原试验和致敏试验,评价其生物安全性。结果与阴性对照组相比,改性前PET纤维的细胞毒性为Ⅲ～Ⅳ级(P<0.05),表面改性PET纤维无细胞毒性(P>0.05);表面改性PET纤维无全身急性毒性反应,溶血率为0.07%,<5%(P<0.05),热原反应符合规定,对豚鼠皮肤无致敏反应。结论表面改性PET纤维无毒性,生物相容性合格,达到了国家规定的生物安全性标准,为进一步进行人工韧带组织工程的研究提供了依据。Objective To evaluate the biosafety of surface modified polyethylene terephthalate（PET） fiber.Methods Surface modified PET fiber was subjected to cytotoxicity test according to the relevant national requirements,and the cytotoxicities before and after modification were compared.The extract of surface modified PET fiber was subjected to acute toxicity,haemolysis,pyrogen and sensitization tests,based on which its biosafety was evaluated.Results Compared with those in negative control group,the cytotoxicity of PET fiber before modification was judged as Ⅲ ～ Ⅳ（P 0.05）,while the PET after modification showed no cytotoxicity（P 0.05）.Surface modified PET fiber showed no systemic acute toxicity,and was qualified in pyrogen test as well as skin sensitization test in guinea pigs,of which the haemolysis rate was 0.07%（ 5%,P 0.05）.Conclusion Surface modified PET showed no toxicity,and was biocompatible,which met the relevant national standard for biosafety and provided a basis for further study on artificial ligament tissue engineering.

关 键 词：聚对苯二甲酸乙二醇酯 表面改性 生物相容性 药物评价 

分 类 号：R392-33[医药卫生—免疫学]