生物医学工程研究Issue(1)：52-55,4.
雷帕霉素药物洗脱支架的生物安全性评价
The Biological Safety Evaluation of Rapamycin Drug-eluting Stent
陈斌 1祝君梅 1程鹏 1程琳 1李毅敏1
作者信息
- 1. 天津市医药科学研究所 天津市医用生物材料监测中心，天津300020
- 折叠
摘要
Abstract
To evaluate the biological safety of Rapamycin drug-eluting stent.10 experiments were conducted to evaluate biological safety according to the national standard GB/T16886.There was no hemolysis,systemic acute toxicity,cytotoxicity,genotoxicity,or intra-cutaneous irritation.The result of muscle implant test showed that the samples had local tissue mild irritation on 1 ,4 and 12 weeks after implantation,and no irritation on 26 weeks.The drug-related hepatotoxicity ,cardiotoxic,immune toxicity and abnormal lipid metab-olism were found in sub-chronic systemic toxicity.The medication of sub-chronic systemic toxicity test may not be applicable to such materials.The programs should be further adjusted.The samples possess biological safety in other tests.关键词
生物安全性/医疗器械/雷帕霉素/全身毒性/肌肉植入试验Key words
Biological safety/Medical devices/Rapamycin/Systemic toxicity/Muscle implant test分类
医药卫生引用本文复制引用
陈斌,祝君梅,程鹏,程琳,李毅敏..雷帕霉素药物洗脱支架的生物安全性评价[J].生物医学工程研究,2014,(1):52-55,4.
