摘要
目的:通过体外和动物实验评价涂覆CD34抗体层药物洗脱冠脉支架的生物相容性,为该支架临床应用提供参考资料。方法:制备涂覆CD34抗体层的药物洗脱冠脉支架的浸提液,用该支架浸提液进行如下生物相容性试验研究:细胞毒性试验、溶血试验、皮内刺激试验、皮肤致敏试验、急性全身毒性试验及热原试验。结果:该支架细胞毒性分级为0级,无皮内刺激反应,无皮肤致敏反应,无急性全身毒性作用;溶血率为0,小于5%;支架材料无溶血作用;热原试验结果表明,3只实验家兔升温幅度均为0.1℃,低于0.6℃,且升温总和为0.3℃,低于1.3℃,无热原反应。结论:根据GB/T 16886医疗器械生物学评价的相关标准评定,该支架具有良好的生物相容性。
Objective： To evaluate the biocompatibility of drug eluting stents coated with anti-CD34 antibody using both in vitro test and animal experiment,so as to provide a reference for clinical application of the stents.Methods： Using extracts of drug eluting stents coated with anti-CD34 antibody,series of biocompatibility evaluation experiment was performed,including cytotoxic test,hemolysis test,intracutaneous irritation test,skin sensitization test,acute systematic toxicity test and pyrogen test.Results： Cytotoxicity of the stents was grade 0.There was no obvious intracutaneous irritation and acute systematic toxic reaction as well as skin sensitization reaction.The hemolysis rate of stents materials was 0,showing that the stents had no hemolysis.Pyrogen reaction was not found in three experimental rabbits,and the temperature increase of each rabbit was less than 0.6 ℃（0.1 ℃,0.1 ℃,and 0.1 ℃）,and the total temperature increase was 0.3 ℃,less than 1.3 ℃.Conclusion： It shows that when referring to GB / T 16886 standard,drug eluting stents coated with anti-CD34 antibody are biocompatible.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第8期1326-1330,共5页
Chinese Journal of Pharmaceutical Analysis
基金
国家科技支撑计划:新型药物缓释冠脉支架(2011BAZ03243)
国家科技支撑计划:新型及高风险医疗器械检测与安全性评价技术研究(2012BAI22B01)
