一次性使用精密过滤输液器的生物相容性研究  

Biocompatibility study of disposable precise filtering infusion apparatus

作　　者：叶小惠 周宙 章亚兵 张磊 YE Xiao-hui;ZHOU Zhou;ZHANG Ya-bing;ZHANG Lei(Anhui Institute for Food and Drug Control,Hefei 230051,China)

机构地区：[1]安徽省食品药品检验研究院,合肥230051

出　　处：《医疗卫生装备》2019年第5期38-42,共5页Chinese Medical Equipment Journal

摘　　要：目的:评价一次性使用精密过滤输液器的生物相容性,为其在临床上的安全应用提供依据。方法 :按照医疗器械生物学评价标准选择以下试验:细胞毒性试验采用MTT比色法;急性全身毒性试验、皮内反应试验和致敏试验分别以0.9%氯化钠注射液和棉籽油为浸提介质;血液相容性试验测定体外溶血率和凝血酶原时间;热原试验观察家兔体温升高情况。结果:该输液器的细胞毒性反应分级为1级;在氯化钠介质和棉籽油介质中,该输液器均无致敏反应、皮内反应、急性全身毒性反应;该输液器的溶血率为1.17%,凝血酶原时间所得结果与阴性对照和同类型产品对照比较,差异均无统计学意义。家兔体温升高总和为0.4℃。结论:一次性使用精密过滤输液器无细胞毒性、致敏反应、皮内反应、急性全身毒性反应、热原反应、溶血反应和凝血反应,具有良好的生物相容性,为其临床的安全应用提供了可靠保障。Objective To study the biological compatibility of the disposable precise filtering infusion apparatus in order to provide evidence for the safety of clinical application.Methods According to biological evaluation criterion of medical devices,seven tests were selected in vitro and vivo.The cytotoxicity test was determined with MTT method in vitro;acute systemic toxicity test as well as the tests for irritation and sensitization were executed with sodium chloride injection and cottonseed oil as the leaching media;blood compatibility test detected hemolysis rate in vitro and prothrombin time;rabbit fervescence was measured during pyrogen test.Results The filtering infusion apparatus gained Grade 1 cytotoxicity,and had no sensitization response,intracutaneous reaction,acute systemic toxicity found during the tests.The hemolysis rate was 1.17%,and there were no statistical differences between the results of prothormbin time of the apparatus,negative control and like products.The rabbit had the body temperature increased by 0.4℃.Conclusion The disposable precise filtering infusion apparatus has no cytotoxicity,sensitization response,intracutaneous reaction,acute systemic toxicity,pyrogen reaction,hemolytic reaction and coagulation effect,and thus proves its high biocompatibility for clinical application.

关 键 词：精密过滤输液器 生物相容性 细胞毒性 溶血率 凝血反应 

分 类 号：R318.6[医药卫生—生物医学工程] TH789[医药卫生—基础医学]