The Biological Safety Evaluation of Rapamycin Drug-eluting Stent
CHEN Bin
ZHU Junmei
CHENG Peng
CHENG Lin
LI Yimin
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.
Keywords：Biological safetyMedical devicesRapamycinSystemic toxicityMuscle implant test
Publication Date：2014-01-01
Online Publishing Date：2026-09-11(First online date of this platform, not the publication date of the document)
Pages：4( 52-55 )