Biocmpatibility research of a hemostatic agent-ZSM-5 zeolite / 医疗卫生装备

ABSTRACT

Objective To evaluate the biocompatibility of ZSM-5 zeolite and provide an experimental basis for developing the first-aid hemostatic agent.Methods According to Chinese evaluation standards on medical devices and biological tests,the cytotoxicity in vitro,hemolysis test,acute toxicity of system,pyrogen test,intracutaneous stimulation,sensitization and micronucleus test were studied in ZSM-5 zeolite.In order to find out the side-effect of the zeolite granules' remains left in the wounds to body,muscle implantation test was studied.Results There were no obvious cytotoxity,hemolysis reaction.Acute tocicity,pyrogen reaction,intraeutaneous stimulation,sensitization and potential mutagenesis in themicronucleus test were observed.Their results were a11 consistent with the Chinese biological evaluation of medical devices.Obvious inflammatory reaction was observed when ZSM-5 zeolite was implanted in muscle for 12 weeks.Conclusion The ZSM-5 zeo1ite has reliable biocompatibility.But zeolite can cause inflammatory reaction when it is remained in the wound surface for long term.