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| 石墨烯人工神经鞘管遗传毒性的试验研究 |
| Study on the Genotoxicity of Graphene Artificial Nerve Sheath Conduit |
| 投稿时间：2025-03-11 修订日期：2025-03-11 |
| DOI： |
| 中文关键词: 石墨烯 医疗器械 遗传毒性 生物学评价 |
| 英文关键词: Graphene Medical devices Genotoxicity Biological evaluation |
| 基金项目:国家重点研发计划(2022YFC2409702)；山东省医疗器械和药品包装检验研究院项目(NB202216) |
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| 中文摘要: |
| 目的：系统评价石墨烯人工神经鞘管的遗传毒性风险，为其临床安全应用提供科学依据，并为应用纳米材料医疗器械的安全性评价提供方法学参考。方法：通过整合体外染色体畸变试验、小鼠淋巴瘤细胞TK基因突变试验及哺乳动物红细胞Pig-a基因突变试验，分析石墨烯人工神经鞘管对基因和染色体等不同终点的潜在影响。结果: 试验组的染色体畸变、小鼠淋巴瘤细胞的突变频率、哺乳动物红细胞的突变频率显著低于阳性对照组，与阴性对照组相比无显著性差异。结论：石墨烯人工神经鞘管在试验条件下未表现出遗传毒性，其临床应用安全性得到支持，本研究首次将Pig-a基因突变试验应用于纳米材料医疗器械的遗传毒性评价，验证了其在灵敏度和可靠性方面的优势，为纳米材料医疗器械的生物学评价提供了新的方法学思路。 |
| 英文摘要: |
| 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 safety assessment of nanomaterial medical devices. Method(s): The potential effects of graphene artificial nerve sheath conduit on genetic and chromosomal endpoints were analyzed by integrating in vitro chromosome aberration assays, mouse lymphoma cell TK gene mutation tests, and mammalian erythrocyte Pig-a gene mutation assays. Result(s): In the treatment group, frequencies of chromosome aberrations, mouse lymphoma cell mutations, and mammalian erythrocyte mutations were significantly lower than those in the positive control group, while no significant differences were observed compared to the negative control group. Conclusion(s): Under the tested conditions, graphene artificial nerve sheath conduit exhibited no detectable genotoxicity, supporting their safety for clinical applications. This study is the first to apply the Pig-a gene mutation assay to the genotoxicity evaluation of nanomaterial medical devices, validating its advantages in sensitivity and reliability. These findings provide a novel methodological framework for the biological evaluation of nanomaterial medical devices. |
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