胶原聚合物人体植入材料的生物相容性研究(英文)  

Biocompatibility research of the collagen-polymer as human implants

作　　者：辜臻晟[1] 盛耀华[1] 王丽天[1] 祝肇荣[1] 李增琦[1] 高金榜[1] 

机构地区：[1]上海第二医科大学附属新华医院眼科,上海市200092

出　　处：《中国临床康复》2005年第6期247-249,共3页Chinese Journal of Clinical Rehabilitation

基　　金：上海高等学校科学技术发展基金(97B06)~~

摘　　要：背景:Staar公司将IV型胶原与水凝胶(HEMA)聚合而成的新型材料Collamer,是研制眼内接触镜的良好材质。国内尚无类似材料。目的:评定胶原聚合物为主体的眼内接触镜(intraocularcontactlens,ICL)在动物体内的生物相容性。设计:随机对照实验。单位:上海生物材料研究测试中心。材料:本研究于2000-01/2000-04在上海生物材料研究测试中心完成。细胞株:传代48～72h生长旺盛的L-929细胞(小鼠成纤维细胞);白色豚鼠20只,体质量300～500g,1～3月龄,雌雄均可;健康成年新西兰白兔7只,体质量1.7～3.0kg和2.5～3.5kg,雌雄不拘(热原实验,雌兔无孕)(实验动物均由上海实验动物中心提供,为普通级)。干预:分别应用胶原材料进行以下生物学测试:①细胞毒性试验(细胞增殖度法)。②致敏试验。③热原试验。④皮下植入试验。实验数据根据标准进行分析和评估。主要观察指标:①小鼠成纤维细胞生长和增殖情况。②皮内注射和局部斑贴诱导后,每一观察时间和每一激发部位红斑和水肿反应情况。③家兔由耳缘静脉注入材料浸提液后,该兔体温升高情况。④胶原材料植入家兔皮下后4周材料周围组织反应情况。结果:①细胞毒性试验:材料组相对增殖度为99%～106%,毒性分级为0～1级。②过敏试验:材料组各时段每一激发部位均无红斑和水肿反应,结果评定?BACKGROUND:A new type of materials, Collamer, is polymerized with type IV collagen and HEMA by Staar company,which is a good material for the establishment of intraocular contact lens(ICL).There is no similar material in our country. OBJECTIVE:To evaluate the biocompatibility of ICL made mainly by collagen polymer in animals. DESIGN:A randomized controlled trial. SETTING:Testing Center of Shanghai Institute of Biomaterial. MATERIALS:Our study was conducted in the Testing Center of Shanghai Institute of Biomaterial from January 2000 to April 2000. Cell strain:hearty L 929 cells(fibroblast of mouse) after 48- 72 hours of passage;Twenty white guinea pig of either gender aged between 1 month and 3 months with a body mass between 300 g and 500 g;Seven healthy adult New Zealand rabbit of either gender(female rabbits were not required pregnant for pyrogenic reaction test) with a body mass between 1.7 kg and 3.0 kg or between 2.5 kg and 3.5 kg(experimental animals were obtained from Shanghai experimental animal center, ordinary grade). INTERVENTIONS:Collagen was used to perform the following biological tests:① cytotoxicity test (cell growth rate);② anaphylaxis test; ③ pyrogenic reactions test; ④ subcutaneous implant test.The data were analyzed and evaluated according to criteria. MAIN OUTCOME MEASURES:① Growth and proliferation of fibroblast in mice;② Reactions of erythema and edema of every provocation site and every observatory time after the induction of intradermal injection and local patch test;③ Increase of body temperature of the rabbit after the injection of the extraction of the material into auricle marginal vein;④ Reactions around the materials after 4 weeks of collagen implantation in rabbits subcutaneously. RESULTS:① Cytotoxicity test:relative growth rate of collagen group was 99% to 106% ,and the toxicity grade was level 0- 1.② Anaphylaxis test: there was no erythema or edema reaction at every provocation site at each time point of collagen group.The skin reaction to collagen po

关 键 词：胶原 晶体 人工 生物相容性材料 

分 类 号：R318[医药卫生—生物医学工程]