新型生物可降解材料聚丁二酸丁二醇酯的生物安全性评价  

Biological safety assessment of novel biodegradable material——polybutylene succinate

作　　者：周建[1] 王小微[2] 张维[2] 华琨[1] 段长恩[1] 季君晖[2] 杨秀滨[1] 

机构地区：[1]北京协和医学院中国医学科学院阜外心血管病医院,北京100037 [2]中国科学院理化技术研究所,北京100190

出　　处：《生物医学工程与临床》2011年第5期403-407,共5页Biomedical Engineering and Clinical Medicine

基　　金：国家自然科学基金项目(30870620)

摘　　要：目的通过对可降解材料聚丁二酸丁二醇酯(PBS)刺激和迟发超敏反应及血液相容性的研究,进一步评价PBS材料的生物安全性。方法选用新西兰白兔,通过单次接触实验法,研究原发刺激指数,以确定材料的刺激性。在实验用豚鼠上,采用最大剂量法,判定材料的迟发超敏反应性。采取新鲜兔血,通过溶血实验和血小板黏附实验,研究材料的血液相容性。结果 PBS局部刺激反应极轻微,无迟发超敏反应,材料的溶血率小于5.0%,血小板黏附性与聚乳酸材料相当。结论 PBS材料生物安全性良好,与皮肤接触无不良反应,溶血率低,血小板黏附性与聚乳酸材料相当。Objective To assess the biological safety of biodegradable material——polybutylene succinate（PBS） by studying PBS irritation,delayed hypersensitivity and blood compatibility.Methods The irritation index of material was determined in New Zealand white rabbits with single exposure test.The delayed hypersensitivity of material was assessed in guinea pigs with the maximum doses method.The blood compatibility of material was studied in rabbit blood by hemolysis test and platelet adhesion experiment.Results PBS induced no irritation and delayed hypersensitivity.The hemolysis rate was lower than 5.0 % and platelet adhesiveness showed good hemocompatibility.Conclusion It is demonstrated that PBS material is biocompatible and hold a great potential for biomedical application.

关 键 词：生物可降解 聚丁二酸丁二醇酯 生物安全性 

分 类 号：R318.08[医药卫生—生物医学工程]