关节软骨替代修复材料PVA/PVP复合水凝胶的生物相容性及安全性初步研究  

The Biocompatibility of Preliminary Assessment and Preparation on Articular Cartilage Substitute Materials Poly(vinyl alcohol)/poly(vinyl pyrrolidone) Hydroge

作　　者：孙淑建[1] 赵建宁 王瑞[1] 熊党生[2] 马如银[2] 郭亭[1] 

机构地区：[1]南京军区总医院骨科,江苏省南京市210002 [2]南京理工大学材料科学与工程系

出　　处：《中国骨与关节损伤杂志》2010年第8期700-703,共4页Chinese Journal of Bone and Joint Injury

基　　金：国家自然科学基金(50575106)

摘　　要：目的通过一系列的体内、外试验对将来可能成为关节软骨损伤替代修复材料的聚乙烯醇/聚乙烯醇吡咯脘酮(PVA/PVP)复合水凝胶进行综合评定,初步探索其在动物体内的生物相容性及安全性,为进一步的人体试验提供依据。方法根据国家标准GB/T16886.1及ISO10993-1标准对医疗器械用品的评价标准要求及用于关节软骨损伤替代修复材料的要求进行:细胞毒性试验(MTT法)、溶血试验、急性全身毒性试验、慢性全身毒性试验、皮内刺激试验、肌肉植入试验。结果细胞毒性试验的试验材料细胞相对增值率为91.7%,显示无细胞毒性;血液相容性试验PVP/PVA的溶血率为0.51%,小于5%,预示该材料无溶血作用,符合医用材料的溶血试验要求;急性全身毒性试验实验组小鼠无特殊行为学表现,实验组与对照组小鼠体重增加t检验差异无统计学意义(P>0.05)。慢性全身毒性试验术后12周试验动物肝、肾均无明显病理表现,材料植入动物体内后试验组与对照组肝肾功能比较差异无统计学意义(P>0.05),实验组术前与术后肝肾功能对照差异无统计学意义(P>0.05)。肌肉植入试验术后病理组织学切片证实该材料植入兔体内后炎性细胞反应逐渐减轻,材料周围组织纤维囊壁逐渐变薄。结论该材料具有良好的生物相容性及安全性。Objective To assess polyvinyl alcohol hydrogel / polyvinyl pyrrolidine, an alternative repair material for articular cartilage injury in the future comprehensively by a series of in vivo and external tests, preliminarily explore its in vivo bioeompatibility and safety and and provide the basis for further human trials.Methods According to national standards GB/T16886.1 and ISO10993-1 standard for medical equipment supplies requirements and evaluation criteria for articular cartilage repair materials ：Cell toxicity test （MTT）,blood compatibility test, acute systemic toxicity test, chronic systemic toxicity, skin irritation test, muscle implantation test were performed.Results The relative increasing rate for test material cell eytotoxicity test was 91.7%, showing no eytotoxieity;for blood compatibility test of PVA / PVAthe hemolysis rate was 0.51% ,less than 5% ,indicating that the material has no hemolysis action,agreement with medical materials and hemolysis test requirements.Acute systemic toxicity test based on the experimental animals Kunming mice at 24 h,48 h,72 h,no chills, fever,dys pnea, exercise less, diarrhea, weight loss and other symptoms.Meanwhile the experimental group and control group mice gained weight, but t test showed no significant difference （P〉0.05）. After 12 week＇s chronic systemic toxicity test,experimental animals of New Zealand white rabbits had no obvious hyperemia and edema for liver, kidney no nodules and hardened, non-cheese-type necrosis and other inflammatory response. Materials implanted in vivo animal test group compared with the control group, indicated no significant hepatic and renal function （P〉0.05）, the experimental group showed no significant difference before and after surgery for liver and kidney function （P〉 0.05）.Muscle and bone after implantation test histopathology biopsy confirmed that afterthe material was implanted in rabbits inflammatory cells gradually reduced and surrounding tissue fibers cyst gradually thinned.Conclusion This kind

关 键 词：关节软骨 PVMPVP(聚乙烯醇/聚乙烯吡咯脘酮水凝胶) 生物相容性 

分 类 号：R684[医药卫生—骨科学]