异种肌腱基质材料生物相容性体外评价实验.docVIP

异种肌腱基质材料生物相容性体外评价实验[摘要]目的：通过对制备的异种肌腱基质材料生物相容性的体外实验研究，鉴定其作为软组织修复充填材料的可行性，为进一步试验研究和临床应用提供依据。方法：参照医疗器械生物学评价标准和要求，采用标准的毒理学方法进行急性毒性试验、致敏试验、皮内刺激实验、细胞毒性试验、遗传毒性试验，对制备的异种肌腱基质材料进行评价。结果：急性毒性实验：各组小鼠活动正常，72h 小鼠无死亡，各组动物未见中毒症状或不良反应。致敏试验显示材料组和阴性对照组的皮肤反应指数均为0,无致敏性。皮内刺激实验观察显示，材料浸提液和生理盐水处无明显红斑、水肿和皮肤坏死，极轻微刺激。材料的细胞毒性结果示该材料的相对增殖度较高，细胞毒性分级在 0-1 级。遗传毒性试验指标均达到标准要求，无遗传毒性。结论：异种肌腱基质材料具有良好的生物相容性，满足作为软组织修复充填材料的生物安全性要求，有望成为一种理想的软组织充填材料。 [关键词]异种材料；生物相容性 [中图分类号]R318.08Q813[文献标识码]A[文章编号]1008-6455（2011）05-0787-04 Experimental studies on biocompatibility of xenogenic tendon matrix materials in vitro CHEN Yuan-Liang1,JIANG Ping1,XIA Xue-ying1,CHEN Wei1,ZHANG Wei2 (1.Department of Plastic Surgery,Nanfang Hospital,Southern Medical University,Guangzhou 510515,Guangdong,China;2.National Engineering Laboratory for Regenerative Implantable Medical Devices,Guangzhou 510663,Guangdong,China) Abstract:ObjectiveTo evaluate the biocompatibility of novel manufactured xenogenic tendon matrix materials and to provide basis for further experimental study and clinical application.MethodsAccording to the standard for the biological evaluation of the medical devices,the acute toxicity test,sensitization test,skin stimulating test,cellular toxicity test,and genotoxicity test were carried out to evaluate the biocompatibility of the prepared implants.ResultsNo animal died and no toxicity symptom or adverse effects were shown within 72 hours. No obvious sensitivity were observed.Skin stimulating reactions were not found in the experimental groups and negative control group by intradermal stimulation test. The toxicity of materials leaching liquor was graded from 0 to 1,which means the material has no cytotoxicity.Ames test,chromosome aberration test,and micronucleus test of bone marrow cells in mice were negative and lacked toxicity.ConclusionThe new xenogenic tendon matrix material has good biocompatibility,and it may be served as a promising implant material. Key words:xenogeneic material;biocompatibil