摘要
目的对聚乙二醇-聚乳酸-聚谷氨酸共聚物材料进行体内生物相容性研究,为该材料作为冠状动脉内支架涂层材料的临床应用提供实验依据。方法通过急性全身毒性试验、皮内刺激试验、溶血试验、细胞毒性试验、热源试验、过敏试验、体内植入试验综合评价聚乙二醇-聚乳酸-聚谷氨酸共聚物的生物相容性。结果聚乙二醇-聚乳酸-聚谷氨酸共聚物浸提液无溶血反应和急性全身毒性反应,无热源反应,材料中不存在致敏性物质。复合材料体内植入在初期有轻度的炎症反应,12周后炎症反应基本消失,未见巨噬细胞积聚现象,材料在16周基本完全降解。结论聚乙二醇-聚乳酸-聚谷氨酸共聚物具有良好的生物相容性,其作为冠状动脉内支架涂层材料或载体应用于临床具有可行性和安全性。
Objective To investigate the biocompatibility and biological safety of PFG-PLA-PGL polymer in vivo so as to provide experimental reference for clinical application.Methods Acute systemic toxicity test, intracutaneous stimulation test, hemolysis test, cytotoxicity test, pyrogen test, sensitivity test and muscle embedding test were performed in order to evaluating the biocompatibility and biological safety of PEG-PLA-PGL polymer. Results There was no potential allergic substance in PFG-PLA-PGL polymer, and no hemolytic reaction,acute systemic toxicity effect or pyrogen reaction was observed. Mild inflammatory reaction was seen in the surrounding tissues in the early implantation stage, which completely disappeared after 12 weeks. Macrophage aggregation was not noted. The polymer was almost degraded after 16 weeks. Condusion PFG-PLA-PGL has fine biocompatihility, which is feasible and safe for clinical reconstruction of material as carrier of coronary drug during stent.
出处
《中国实验诊断学》
2006年第9期975-978,共4页
Chinese Journal of Laboratory Diagnosis
