生物医学工程研究2017，Vol.36Issue(4)：382-386,5.DOI:10.19529/j.cnki.1672-6278.2017.04.22
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
范春光 1侯丽 1展荣凯 1许晶 1朱福余1
作者信息
- 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
- 折叠
摘要
Abstract
In order to evaluate the potential of repeated exposure systemic toxicity of medical devices when both polar and nonpolar leachables of medical devices contact human body simultaneously , dual routes of parenteral administration method on rat was designed and the feasibility was validated .Blank control group , intraperitoneal injection with corn oil group and dual routes ( intravenous injec-tion with normal saline and intraperitoneal injection with corn oil ) of parenteral administration group were designed in the study .Clini-cal observation was conducted everyday during the study .Animals were weighed weekly intervals .After 14 days, clinical pathology a-nalysis of the blood specimens , gross pathology and a histopathology examination were conducted and data were analyzed statistically . 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Key words
Medical devices/Repeated exposure systemic toxicity test on rat/Dual routes of parenteral administration method/Extracts injection method/Nonpolar extracts分类
医药卫生引用本文复制引用
范春光,侯丽,展荣凯,许晶,朱福余..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[J].生物医学工程研究,2017,36(4):382-386,5.
