一种新型带负电荷钙磷复合材料的生物安全性评价  

Bio-safety evaluation of a novel calcium phosphate composite with negative charge

作　　者：毛海青[1] 邹俊[1] 朱雪松[1] 许运[1] 干旻峰[1] 王根林[1] 杨惠林[1] 

机构地区：[1]苏州大学附属第一医院骨科,江苏省苏州市215006

出　　处：《中国组织工程研究与临床康复》2010年第34期6339-6341,共3页Journal of Clinical Rehabilitative Tissue Engineering Research

基　　金：江苏省普通高校研究生科研创新计划资助项目(CX09B_038Z)~~

摘　　要：背景:自20世纪80年代以来,寻求一种既具有良好生物相容性又具有成骨能力的新型骨修复和替代材料始终是材料学和骨科领域研究的热点。目的:评价一种新型带负电荷钙磷复合材料的生物安全性。方法:根据国际标准化组织所推荐的生物学试验,对其进行红细胞溶血性实验、全身性毒性实验、热源性实验、致敏性实验。结果与结论:红细胞溶解实验中红细胞溶血率为0.24%,小于阳性标准,说明材料植入体内后不会引起机体本身的溶血反应。全身毒性实验的检测结果提示无毒,不引起肝肾功能各项指标变化,说明材料本身不具有毒性。热源反应中家兔平均体温升高为0.2℃,符合医用材料的热源反应要求,说明本材料本身不具有致热源作用。致敏实验中致敏率为0,与阴性对照没有差别,说明材料没有致敏性。结果表明这种新型带负电荷的钙磷复合材料具有良好的生物安全性。BACKGROUND：Since 1980s,a bone graft for repair and placement with good biocompatibility and osteoinductivity is hot spot in the field of materials and orthopaedics.OBJECTIVE：To evaluate the bio-safety of a novel calcium phosphate composite material with negative charge.METHODS：According to the biological test recommended by International Organization for Standardization,the erythrocyte haemolysis test,systemic toxicity test,pyrogenic test and sensitization test were performed.RESULTS AND CONCLUSION：The rate of haemolysis was 0.24%,which was obviously lower than the positive standard,it was indicated that the in vivo transplantation of the materials could not cause the hemolytic reaction of the body.Systemic toxicity test results showed it was non-toxic,cannot change liver and kidney function indices,indicating the material is not toxic.In the pyrogenic reaction,the body temperature of the rabbits averagely increased by 0.2 ℃,which accorded with the demands of medical materials,it was indicated that the material has no pyrogenic effect.The rate of sensitization was 0,which had no significant difference from negative control,suggesting that the material has no sensitization.This novel calcium phosphate composite material with negative charge has a good bio-safety.

关 键 词：钙磷复合材料 生物安全性 全身毒性实验 热源实验 致敏实验 

分 类 号：R318[医药卫生—生物医学工程]