摘要
目的考察3D打印多孔钽浸提液的细胞毒性和遗传毒性。方法参照GB/T 16886.12标准制备3D打印多孔钽浸提液,采用噻唑蓝(MTT)法检测样品浸提液的细胞毒性,分别采用体外哺乳动物细胞染色体畸变试验、细菌回复突变试验(Ames试验)、体内哺乳动物骨髓细胞微核试验检测样品浸提液的遗传毒性。结果样品浸提液作用于小鼠成纤维肌L929细胞后,细胞存活率均大于75%,细胞毒性均为1级。样品浸提液作用于中国仓鼠肺CHL细胞后,在活化(加S9试剂,下同)和非活化条件下均未引起细胞染色体畸变率增加;极性和非极性样品浸提液在活化和非活化条件下均未引起5种试验菌株(TA979,TA98,TA100,TA102,TA1535)回变菌落数增加,且极性和非极性样品浸提液均未引起小鼠骨髓嗜多染红细胞微核率升高。结论3D打印多孔钽浸提液未见细胞毒性及遗传毒性,相关评价方法可为医用增材类医疗器械生物学评价提供参考。
Objective printed porous tantalum extract was prepared according to GB/T 16886.12 standard.The cytotoxicity of the sample extract was detected by the MTT assay.The genotoxicity of the sample extract was detected by the in vitro mammalian chromosome aberration test,bacteria reverse mutation test(Ames test)and mammalian bone marrow micronucleus test in vivo.Results extract was treated on mouse fibroblast L929 cells,the cell survival rate was more than 75%and the cytotoxicity was grade one.After the sample extract was treated on Chinese hamster lung(CHL)cells,the chromosome aberration rate of cells did not increase under activated(with S9 reagent,the same below)and non activated conditions.The polar and non-polar sample extract did not increase the number of revertant colonies of five test strains(TA979,TA98,TA100,TA102,TA1535)under activated and non activated conditions,and the polar and non-polar sample extract did not raise the rate of micronucleus in bone marrow polychromatic erythrocytes(PCE)in mice.Conclusion evaluation methods can provide a reference for the biological evaluation of medical additive medical devices.
作者
蒋波
张玲
张佩
彭兰
杨柳
王旖
曾荣荣
JIANG Bo;ZHANG Ling;ZHANG Pei;PENG Lan;YANG Liu;WANG Yi;ZENG Rongrong(Chongqing Institute for Food and Drug Control,Chongqing,China 401121;Chongqing Medical and Pharmaceutical College,Chongqing,China 401331)
出处
《中国药业》
CAS
2022年第8期53-57,共5页
China Pharmaceuticals
基金
重庆市科研机构绩效激励引导专项[cstc2019jxjl130040]
重庆医药高等专科学校科研计划项目[ygz2020107]。
关键词
3D打印多孔钽
浸提液
细胞毒性
遗传毒性
体外试验
医用增材
3D-printed porous tantalum
extract
cytotoxicity
genotoxicity
in vitro test
medical additive material
