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使用无水乙醇为浸提介质进行血液灌流器的遗传毒性试验研究 被引量:1

The Genotoxicity of Hemoperfusion Apparatus was Studied by Using Absolute Ethanol as Extraction Medium
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摘要 目的:通过试验探索无水乙醇作为血液灌流器遗传毒性试验浸提介质的可行性。方法:将无水乙醇作为浸提介质使用灌注的方式充满灌流器,使用浸提液分别进行细菌回复突变试验、体外哺乳动物细胞基因突变试验和体外哺乳动物细胞染色体畸变试验。结果:细菌回复突变试验中与阴性对照组相比5种菌株自发回复突变菌落数均无显著性差异;体外哺乳动物细胞基因突变试验中所有组的总突变频率与阴性对照组相比在统计学上无显著性差异;体外哺乳动物细胞染色体畸变试验中染色体畸变率与阴性对照组相比无显著性增加。结论:无水乙醇作为浸提介质时对试验体系中的细菌、细胞生长无影响,且在本试验条件下无致突变性,选择无水乙醇作为浸提介质进行试验是可行的。 Objective:To explore the feasibility of anhydrous alcohol as an extractant for genotoxicity test of hemoperfusion apparatus.Methods:Absolute ethanol was used as extraction medium to fill the lavage device with perfusion,and the extraction solution was used for bacterial recovery mutation test,gene mutation test and chromosome aberration test of mammalian cells in vitro.Results:Compared with the negative control group,there was no significant difference in the number of spontaneous recovery mutant colonies in the bacterial recovery mutation test.In vitro mammalian cell gene mutation test,the total mutation frequency of all groups had no significant difference compared with the negative control group.The chromosome aberration rate of mammalian cells in vitro showed no significant increase compared with the negative control group.Conclusion:Absolute ethanol as extraction medium has no effect on the growth of bacteria and cells in the experimental system,and has no mutagenicity under the experimental conditions,so it is feasible to choose absolute ethanol as extraction medium.
作者 陆金健 王嘉铭 南方 杨文润 LU Jin-jian;WANG Jia-ming;NAN Fang;YANG Wen-run(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510080)
出处 《中国医疗器械信息》 2022年第21期20-23,共4页 China Medical Device Information
基金 广东省药品监督管理局科技创新项目(项目名称:体外循环器械重点实验室项目研究,项目编号:2021ZDZ01)。
关键词 遗传毒性 血液灌流器 浸提介质 无水乙醇 genetic toxicity hemoditoxifier extraction medium absolute ethyl alcohol
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