Study on the Genotoxicity of Graphene Artificial Nerve Sheath Conduit
10.13241/j.cnki.pmb.2025.14.002
- VernacularTitle:石墨烯人工神经鞘管遗传毒性研究
- Author:
Ling-xiao SUN
1
;
Bing-bing SUN
;
Yue QIN
;
Guo-wei WANG
;
Luan-luan WANG
;
Zi-yi YANG
;
Zi-ye WANG
;
Xiao-tian ZHAO
;
Xiao-jing LI
;
Cheng-hu LIU
Author Information
1. 山东省医疗器械和药品包装检验研究院 山东济南 250101;生物材料器械质量评价共性技术山东省工程研究中心 山东济南 250101
- Publication Type:Journal Article
- Keywords:
Graphene;
Medical devices;
Genotoxicity;
Biological evaluation
- From:
Progress in Modern Biomedicine
2025;25(14):2250-2258
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The genotoxicity risk of graphene artificial nerve sheath conduit was systematically evaluated to provide scientific evidence for their clinical safety and to establish methodological references for the genotoxicity assessment of nanomaterial medical devices.Methods:The potential effects of graphene artificial nerve sheath conduit on genetic and chromosomal endpoints were analyzed by integrating bacterial reverse mutation assays,in vitro chromosome aberration assays,mouse lymphoma cell TK gene mutation tests,and mammalian erythrocyte Pig-a gene mutation assays.Results:In the bacterial reverse mutation assay,all plates showed good background growth.There was no significant difference in the average number of revertant colonies between the test group and the negative control group,with a ratio around 1.0.In the in vitro chromosome aberration assay,the chromosomal aberration rate in the test group was less than 5％,showing no significant increase compared to the negative control group.In the mouse lymphoma cell TK gene mutation assay,the mutation frequency in the test group was less than twice that of the negative control group,with no significant difference.In the mammalian erythrocyte Pig-a gene mutation assay,the mutation frequencies of erythrocytes and reticulocytes in the test group were both less than 3× 10-6,showing no significant difference compared to the negative control group.Conclusions:Graphene artificial nerve sheath conduit exhibited no detectable genotoxicity under the tested conditions,the research results can provide reference and guidance for the genotoxicity evaluation of nanomaterial medical devices.
