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硬组织修复材料碳纤维增强聚烯烃的生物安全性评价
引用本文:侯春林,薛锋,陈庆泉,张伟,杨桂生,孙皎.硬组织修复材料碳纤维增强聚烯烃的生物安全性评价[J].中国修复重建外科杂志,2005,19(1):45-47.
作者姓名:侯春林  薛锋  陈庆泉  张伟  杨桂生  孙皎
作者单位: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
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。

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
修稿时间:2003年7月7日

EVALUATION OF BIOLOGICAL SAFEFY OF CONTINUOUS CARBON-FIBER REINFORCED POLYOLEFIN AS HARD TISSUE REPAIR
HOU Chunlin,XUE Feng,CHEN Qingquan,et al..EVALUATION OF BIOLOGICAL SAFEFY OF CONTINUOUS CARBON-FIBER REINFORCED POLYOLEFIN AS HARD TISSUE REPAIR[J].Chinese Journal of Reparative and Reconstructive Surgery,2005,19(1):45-47.
Authors:HOU Chunlin  XUE Feng  CHEN Qingquan  
Institution:Department of Orthopeadic Surgery, Changzheng Hospital, Second Military Medical University, Shanghai 200003, P R China. chunlin-hou@yahoo.com.cn
Abstract: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.
Keywords:Composite    Carbon fiber    Biological safety
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