医疗器械重复接触全身毒性试验新方法的研究--大鼠胃肠外双途径接触试验  

Study on A New Method of Repeated Exposure Systemic Toxicity Test of Medical Devices—— Dual Routes of Parenteral Administration Method on Rat

作　　者：范春光[1] 侯丽[1] 展荣凯 许晶 朱福余 

机构地区：[1]山东省医疗器械产品质量检验中心,山东省医疗器械生物学评价重点实验室,济南250101

出　　处：《生物医学工程研究》2017年第4期382-386,共5页Journal Of Biomedical Engineering Research

摘　　要：为评价医疗器械极性及非极性可沥滤物同时接触人体时产生重复接触全身毒性的可能性,该研究设计了大鼠胃肠外双途径接触试验法并验证其可行性。本研究设计了空白对照组,腹腔注射玉米油组和胃肠外双途径接触组(尾静脉注射生理盐水,同时腹腔注射玉米油)。试验期间每天进行临床观察,每周称重。14 d后,取血进行临床病理检测、大体病理以及组织病理学检查并将数据进行统计学分析。与对照组相比,双途径接触组各项指标均未见毒性相关性改变。结果表明该试验法能够使大鼠同时充分接触极性及非极性浸提介质又不引起不良病理反应。In order to evaluate the potential of repeated exposure systemic toxicity of medical devices wheleachables of medical devices contact human body simultaneously, dual routes of parenteral adminand the feasibility was validated. Blank control group, intraperitoneal injection with corn oil grouption with normal saline and intraperitoneal injection with corn oil ） of parenteral administration group were cal observation was conducted everyday during the study. Animals were weighed weekly intervals. After 14 days, clinical patholog a-nalysis of the blood specimens, gross pathology and a histopathology examination were As a result, compared to the control animals, there were no toxicity - related changes in the dual routes test group on the parameters a-bove. The results show that the method can make the rat fully contact with both polar and nopolar extraction medium simultaneously but not induce adverse effect to the rat.

关 键 词：医疗器械 大鼠重复接触全身毒性试验 胃肠外双途径接触法 浸提液注射法 非极性浸提液 

分 类 号：R318[医药卫生—生物医学工程]