摘要
目的:对囊型宫内节育器避孕材料的细胞毒性的潜在性作出评价。方法:采用研制的硅橡胶材料与高密度聚乙烯材料作为对照,根据GBT 16886.5―2003医疗器械生物学评价第5部分标准,设立空白对照组、阴性对照(高密度聚乙烯)浸提液组、阳性对照液(含6.3%苯酚的RPMI1640完全培养液)组、100%、50%和25%材料(硅橡胶)浸提液组共6个组;用RPMI 1640完全培养液培养L-929细胞,每组加入100μL的空白对照液、阴性对照浸提液和25%、50%、100%的材料浸提液及阳性对照液,观察细胞形态和增值率。结果:空白对照组、阴性对照浸提液组、阳性对照组、100%、50%和25%浓度材料浸提液组的细胞毒性级别分别为:0级、1级、4级、2级、2级、1级。100%、50%和25%材料浸提液组培养72 h后细胞增值率分别是(66.2±4.3)%、(72.4±6.1)%、(81.1±4.2)%;阴性对照浸提液组、100%、50%、25%材料浸提液组和阳性对照浸提液组OD(optical density)值与空白对照组比较差异有统计学意义(P<0.05);空白对照组、100%、50%材料浸提液和阳性对照液组OD值与阴性对照浸提液组差异有统计学意义(P<0.05);25%材料浸提液OD值和与阴性对照浸提液组差异无统计学意义(P>0.05)。结论:根据GBT 16886.5―2003医疗器械生物学评价第11部分标准,所测硅橡胶材料细胞毒性评价符合要求。
Objective：To evaluate the cytotoxicity of contraceptive materials of scrotiform intrauterine device（IUD）. Method：Make a cytotoxicity experiment with the additional liquid silicone rubber newly developed（formula：vinyl silicone oil,hydrogen silicone oil,and 1- ethynylcyclohexanol）in accordance with Part 5 of GBT 16886.5 ― 2003 Biological Evaluation of Medical Devices. Six groups in total including blank control group（with no RPMI1640 complete culture solution of the experimental material）,negative control extract solution group（high density polyethylene material）,positive control solution group（with RPMI1640 complete solution of 6.3 % phenol）,100 %,50 % and 25 % material extract group were set. Cultivate L-929 cell with RPMI1640 complete culture medium;add 100 μL blank control solution,negative extract solution and 25 %,50 % and 100 % material extract solutions,and observe cellular morphology under the microscope;and measure OD（optical density）value with a microplate reader and observe proliferation rate of the cells. Results：Blank control group,negative control extract solution group,positive control solution group,100 %,50 %,25 % material extract group＇s cell cytotoxicity of experimental materials are in level 0,1,4,2,2 and 1 respectively. After 72 hours,25 %,50 % and 100 % material extract solution had（66.2 ±4.3）%,（72.4 ± 6.1）%,and（81.1 ± 4.2）% cell proliferation. The OD value differences of negative control extract solution group,100 %,50 %,25 % material extract solution group and positive control extract solution group own statistical significance（P〈0.05）,the OD value differences of blank control group,100 %,50 %,25 % material extract solution group and negative control extract solution group own statistical significance（P〈0.05）;the OD value difference of 25 % material extract solution group and negative control extract solution group does not own statistical significance（P〉0.05）. Cell cytotoxicity of experimental materials are in level 2,2
出处
《中国工程科学》
北大核心
2015年第6期8-12,共5页
Strategic Study of CAE
基金
广东省科技厅基金资助项目(2010B031600175)
广东省人口与计划生育委员会基金资助项目(2010201)
关键词
宫内节育器
硅橡胶材料
细胞毒性
动物实验
鼠
intrauterind device
silicone rubber material
cytotoxicity
animal experiment
mouse
