含有机锡聚氯乙烯膜作为细胞毒性试验阳性对照材料的研究  

Study of positive reference material for cytotoxicity test

作　　者：付步芳[1] 林红赛 王春仁[1] 冯晓明[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京市医疗器械检验所,北京101111

出　　处：《癌变．畸变．突变》2015年第6期480-483,共4页Carcinogenesis,Teratogenesis & Mutagenesis

基　　金：国家科技支撑计划重点专项(2012BA122B01)资助

摘　　要：目的:以医用聚氯乙烯作为基质加人马来酸二丁基锡制备细胞毒性阳性对照材料。方法:对原材料进行鉴别和杂质检查后,采用溶剂流延法来制备含有机锡聚氯乙烯膜。制备样品浸提液,并用其处理L929细胞,通过观察细胞形态和MTT试验选择适合的有机锡浓度。并对有机锡聚氯乙烯膜的均匀性和稳定性进行考察。结果:溶剂流延法制备的含0.005%有机锡聚氯乙烯膜浸提液的细胞毒性与浸提液的浓度呈明显的相关性,具有毒性梯度。均匀性试验结果显示,各组浸提液中锡元素统计量F值=1.07,小于F临界值3.22。稳定性试验结果显示,50℃老化条件下,不同老化时间样品浸提出的锡元素含量与老化前比较差异均无统计学意义(P>0.05)。结论:含0.005%有机锡聚氯乙烯膜浸提液呈现稳定的细胞毒性反应,含有机锡聚氯乙烯膜的均匀性和稳定性良好,适宜作为细胞毒性阳性对照材料。OBJECTIVE：Polyvinyl chloride（PVC） was used as matrix to prepare the positive reference material by adding dibutyl tin maleate.METHODS：Identification and impurity inspection were carried out for the matrix.The positive reference material,PVC film containing organic tin,was prepared by tape casting process.Sample extract was prepared for L929 cell culture medium.The optimal organic tin concentration was determined by cell morphology examination and MTT test.Homogeneity and stability test were performed for the positive reference material.RESULTS：Extract of PVC film containing 0.005%organic tin exhibited significant cytotoxicity in a dose-effect manner.The homogeneity test showed the statisticd F was 1.07 which was less than the threshold value F.PVC film containing0.005%organic tin exhibited stable positive reactions.Whilst the materials before and after aging test revealed that the tin contentobtained from extraction was uniform（P〉0.05）.CONCLUSION：Extract of PVC film containing 0.005%organic tin showed appropriate cytotoxicity,PVC film containing organic tin had a good uniformity and stability,so it could suitable as a cytotoxic reference material.

关 键 词：对照材料 细胞毒性试验 聚氯乙烯 有机锡 

分 类 号：R994.3[医药卫生—毒理学]