中文摘要：

背景：生物反应器膜材料不仅具备双向物质交换、良好的理化特性，还要具有良好的生物相容性。目的：评价人肝细胞／微孔聚丙烯杂化界面，即接枝改性微孔聚丙烯超滤膜的生物相容性。设计、时间及地点：动物实验观察，于2005—09-007-10在上海交通大学医学院附属瑞金医院器官移植中心（上海消化外科研究所）实验室和浙江大学高分子材料研究所共同完成。材料：选用孔径为0．2um，分子截流量为M50000～100000的微孔聚丙烯超滤平面薄膜为实验模型，利用光化学接枝聚合改性技术，在聚丙烯超滤膜表面通过化学键的形式接枝亲水性丙烯酰胺基冈，成功地构建一种人肝细胞／微孔聚丙烯杂化界面，即新型的生物人工肝生物反应器膜——接枝改性微孔聚丙烯超滤膜。方法：参照国际标准化组织ISO10993-1：1992医疗器械生物学评价标准和要求进行溶血试验、细胞毒性试验、全身急性毒性试验、热原试验、皮肤和皮内刺激试验，评价接枝改性微孔聚丙烯超滤膜的生物相容性。主要观察指标：接枝改性微孔聚丙烯超滤膜浸提液的溶血试验、细胞毒性试验、全身急性毒性试验、热原试验、皮肤和皮内刺激试验结果。结果：接枝改性微孔聚丙烯超滤膜的溶血率为1．90％〈5％，表明其无致溶血性；其浸提液对L929细胞增殖活性无明显的抑制作用；注射接枝改性微孔聚丙烯超滤膜浸提液后24，48，72h，所有小鼠无死亡，体质量无明显变化，未观察到眼睑下垂、呼吸困难、发绀、腹部刺激症、腹泻、运动减少、震颤等全身急性毒性反应。热原试验中兔体温变化范围-0．2～0．4，符合生物医学材料无热原的评价标准。皮肤刺激实验中仅1例有极轻微的红斑，积分1分，其原发刺激指数为0．25〈0．4，皮内刺激试验结果原发刺激指数为0．2，平均原发刺激指数?

英文摘要：

BACKGROUND： Membrane materials of bioreactor have exchange of substance and good physiochemical characteristics as well as good biocompatibility. OBJECTIVE： To evaluate the biocompatibility of interface of human hepatocyte/microporous polypropylene, i.e. graft modified microporous polypropylene semipermeable ultrafiltration membrane （MPP）. DESIGN, TIME AND SETTING： Animal observation was performed at the Organ Transplantation Center, Ruijin Hospital of Shanghai Jiao Tong University Medical School and Polymers Institute of Zhejiang University between September 2005 and October 2007. MATERIALS： The microporous polypropylene ultrafiltration plane thin membranes, 0.2 μm diameter, Mt 50 000- 100 000 molecular blockage, were used. Photochemical graft polymerization modification technique was adopted to graft hydrophilic acrylamide group through chemical bonds on MPP surface and succeeded in constructing an interface of human hepatocyte/microporous polypropylene, i.e. bioreactor membrane of bioartificial liver, graft modified MPP. METHODS： The biocompatibility Of modified MPP was evaluated by hemolysis test, cytotoxicity test, acute systemic toxicity test, pyrogen test, skin sensitization and percutaneous stimulation test according to the requirements and biological evaluation criteria of medical device of ISO 10993-1：1992. MAIN OUTCOME MEAURES： The experimental results of hemolysis, cytotoxicity, general acute toxicity, pyrogen, skin sensitization and percutaneous stimulation of modified MPP. RESULTS： The hemolytic rate of modified MPP was 1.90% （〈 5%）, which showed that modified MPP did not lead to hemolysis. The extract solution of modified MPP exhibited no significant inhibition on the proliferative activity of L929 cells. At 24, 48 and 72 hours after MPP injection, no mice death, significant changes in body mass, or acute systemic toxicity were observed, such as ptosis, dyspnea, cyanosis, abdominal stimulation, diarrhea, decreased movement or tremor. In rabbit pyrogen test, the body tempe