骨水泥的遗传毒性研究  

Genotoxicity Study of Bone Cement

作　　者：宋捷[1] 胡燕平[1] 马锐[1] 王欣[1] 郭隽[1] 王雪[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,北京100176

出　　处：《中国医药指南》2012年第3期8-9,13,共3页Guide of China Medicine

摘　　要：目的检测医疗器械进口产品骨水泥的遗传毒性。方法以骨水泥粉体浸提液与其液体混合液为供试液,采用细菌回复突变试验(Ames试验)和小鼠淋巴瘤细胞试验(MLA),在非代谢活化(-S9)和代谢活化(+S9)条件下检测。Ames试验检测了25、50、100μL/皿3个剂量组诱发鼠伤寒沙门氏菌(his-)TA98、TA100、TA1535、TA1537及大肠杆菌(trp-)WP2uvrA的回变菌落数;MLA检测了0.125、0.25、0.5%(V/V)3个浓度组,在+S9/3 h、-S9/3 h、-S9/24 h三种处理条件下诱发的L5178Y细胞tk-+/-基因突变频率(MF)和小集落突变百分率(SC%)。结果 +/-S9条件下,剂量组诱发五株菌的回变菌落数对比DMSO溶媒(阴性)对照组均无明显增加;-S9/24 h处理条件下0.5%(V/V)浓度组诱发的MF明显增加(P<0.01),但未达到阳性评判标准。结论骨水泥对试验菌的his-/trp-无明显诱变作用,对测试细胞的tk+/-及染色体无明显损伤作用。Objective To investigate the genotoxicity of bone cement.Methods Test article was the powder extract of bone cement.Using bacterial reverse mutation test（Ames test） and mouse lymphoma Assay（MLA） with and without metabolic activation S9.Ames test was performed by the plate incorporation method for its ability to induce reverse mutations in three treatment dosage groups;25μL/plate,50μL/plate,100μL/plate usingS.typhimurium TA98,TA100,TA1535,TA1537 and E.coli WP2 uvrA;In MLA,the mutation frequency（MF） and the percentage of small colony mutants（SC%） of L5178 tk-＋/-cells induced by bone cement at final concentration of 0.125%,0.25% and 0.5%（V/V） were calculated and assayed with ＋S9/3 h,-S9/3 h,-S9/24 h.Results The mean number of revertant induced by three groups did not increase compared with negative control（DMSO） in Ames test.There was a significant MF increases（P0.01） with-S9/24 hat 0.5%（V/V） in MLA which didn’t satisfy the positive standard.Conclusions The bone cement did not induce point mutation at his-/trp-and there was no obvious damage effect to gene tk-＋/-or chromosome under this study condition.

关 键 词：骨水泥 细菌回复突变试验 小鼠淋巴瘤细胞试验 遗传毒性 

分 类 号：R733[医药卫生—肿瘤]