不同浸提方法对一次性使用注射器细胞毒性的影响  

Effect of Different Extraction Methods on Cytotoxicity of Disposable Syringes

作　　者：郑洋滨 洪燕 邵红英 刘宁 ZHENG Yangbin;HONG Yan;SHAO Hongying;LIU Ning(Jiangxi Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Jiangxi Nanchang330029,China;Nanchang Qingshan Lake Area Medical Insurance Management Center,Jiangxi Nanchang330029,China)

机构地区：[1]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]南昌市青山湖区医疗保险管理中心,江西南昌330029

出　　处：《中国医药导刊》2017年第11期1226-1229,共4页Chinese Journal of Medicinal Guide

基　　金：江西省科技厅立项课题(项目编号:20142BBG70020;项目名称:对一次性使用输注器具类医疗器械产品生物安全性评价的研究)

摘　　要：目的:比较两种浸提方法对一次性使用注射器细胞毒性试验结果的影响。方法:分别采用公称容量法和克重法用含血清的1640完全培养基对一次性使用注射器进行浸提,37℃、24h加入含细胞的96孔板中继续培养,72h后通过MTT比色法进行吸光度检测,采用细胞增殖度比较两种浸提方法对细胞毒性试验结果的影响。结果:1mL一次性使用注射器用两种浸提方法进行细胞毒性试验结果均为1、2级,两种浸提方法的相关系数R为0.704,P为0.034;5mL一次性使用注射器用两种浸提方法进行细胞毒性试验结果均为1、2级,两种浸提方法的相关系数R为0.689,P为0.040;10mL一次性使用注射器用两种浸提方法进行细胞毒性试验的结果有6批为1、2级,有3批为4级,两种浸提方法的相关系数R为0.956,P为0.000。结论:用两种浸提方法对3种规格的注射器进行细胞毒性试验,3种规格一次性使用注射器的细胞毒性试验结果均具有良好的相关性,两种浸提方法对一次性使用注射器细胞毒性的结果基本无影响。Objective:To compare the effects of two extraction methods on the cytotoxicity test results of disposable syringes.Methods:Using nominal capacity method and gram weight method with1640complete medium containing serum medium for disposable syringe was extracted37℃and24h containing to culture in96cells plates,72h by MTT colorimetric method with absorbance detection,cell proliferation effects of two extraction methods of the cell toxicity test.Results:1mL disposable syringe with two kinds of extraction methods of cytotoxicity test results were grade1,2,two extraction methods of the correlation coefficient R is0.704,P is0.034;5mL disposable syringe with two kinds of extraction methods of cytotoxicity test results were grade1,2,two kinds of extraction methods the correlation coefficient R is0.689,P is0.040;10mL disposable syringe with two kinds of extraction methods of cell toxicity test results were6batches of1,2grade,3batches of4grade,two extraction methods of the correlation coefficient R is0.956,P is0.Conclusion:The cytotoxicity test of the syringe3specifications by both extraction methods and cytotoxicity test results of3kinds of specifications of syringes have good correlation,both extraction methods of disposable syringe cytotoxicity results has no effect.

关 键 词：细胞毒性 一次性使用注射器 公称容量法 克重法 相对增殖度 

分 类 号：TH77[机械工程—仪器科学与技术]