摘要
目的:对ZSM-5沸石进行生物相容性评价,为开发其作为急救止血材料提供实验室依据。方法:参照我国医疗器械生物学评价标准和所推荐的生物学试验,对ZSM-5沸石进行体外细胞毒性、溶血、急性全身毒性、热原、皮内反应、致敏、微核试验研究。为了解沸石颗粒残留伤口内对机体的影响,行肌肉内植入试验研究。结果:ZSM-5沸石无明显细胞毒性;无溶血反应;急性全身毒性、热原、皮内反应、致敏试验结果均符合我国医疗器械生物学评价标准:沸石植入肌肉后12周局部组织有明显的炎症反应。结论:ZSM-5沸石细胞生物相容性好,但长期存留于创面内可引起炎症反应。
Objective To evaluate the biocompatibility of ZSM-5 zeolite and provide an experimental basis for developing the first-aid hemostatie agent. Methods According to Chinese evaluation standards on medical devices and biological tests, the eytotoxicity in vitro, hemolysis test, acute toxicity of system, pyrogen test, intraeutaneous 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 all 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 zeolite has reliable biocompatibility. But zeolite can cause inflammatory reaction when it is remained in the wound surface for long term.
出处
《医疗卫生装备》
CAS
2007年第1期22-25,共4页
Chinese Medical Equipment Journal
基金
军队"十一"科技攻关项目资助。
