硬组织修复材料碳纤维增强聚烯烃的生物安全性评价  

EVALUATION OF BIOLOGICAL SAFEFY OF CONTINUOUS CARBON-FIBER REINFORCED POLYOLEFIN AS HARD TISSUE REPAIR

作　　者：侯春林[1] 薛锋[1] 陈庆泉[1] 张伟[1] 杨桂生[2] 孙皎[3] 

机构地区：[1]第二军医大学附属长征医院骨科,上海200003 [2]中国科学院上海化学所 [3]上海生物材料研究测试中心

出　　处：《中国修复重建外科杂志》2005年第1期45-47,共3页Chinese Journal of Reparative and Reconstructive Surgery

摘　　要：目的　通过对连续碳纤维增强聚烯烃复合材料的毒理学试验 ,鉴定其作为硬组织修复材料的生物安全性 ,为临床应用提供依据。　方法　采用标准的毒理学试验方法将实验材料分别进行 7个方面检测 :1溶血试验 ;2热源试验 ;3致敏试验 ;4细胞毒性试验 ;5鼠伤寒沙门氏菌回复突变试验 ;6哺乳动物培养细胞染色体畸变试验 ;7骨髓微核试验。　结果　所有实验样品各项检测指标的结果显示其材料无溶血性、无热源性、无致敏性、无细胞毒性 ,以及不导致染色体畸变。　结论　连续碳纤维增强聚烯烃复合材料具有良好的生物安全性 ,满足作为硬组织修复材料生物安全性要求。Objective To evaluate the biological safety of continuous carbon fiber reinforced polyolefin as hard tissue repair material. Methods Biocompatibility of the material was evaluated through hemolysis test, pyrogen test,skin irritation test, cytotoxicity test, ames test, in vitro chromosome aberration test, and bone marrow cells Micronuclei test. Results No obvious hemolysis, pyrogenic characteristics, sensitivity, cytotoxxicity, and mutagenicity were observed. Conclusion The continuous carbon fiber reinforced polyolefin composite material is of good biological safety. It meets all the demand made by biological safety as hard tissue repair material.

关 键 词：硬组织 修复材料 临床应用 生物安全性 致敏性 骨髓微核试验 毒理学试验 回复突变 哺乳动物 实验材料 

分 类 号：R318.08[医药卫生—生物医学工程]