基于体外染色体畸变试验评价纳米银敷料遗传毒性的研究

目的:通过体外染色体畸变试验来检测纳米银敷料引起遗传毒性的可能性,为临床前安全性评价提供资料与提示。方法:根据《GB/T16886.3-2008/ISO 1099-3:2014》中推荐的方法选用中国仓鼠肺细胞(CHL)进行体外哺乳动物细胞染色体畸变试验(CAT),在代谢活化系统(+S9)与非代谢活化系统(-S9)条件下,检测纳米银敷料浸提液在+S9/6h、-S9/6h、-S9/24h三种处理条件下诱发CHL细胞的染色体畸变率。结果:纳米银敷料各处理组的染色体畸变率与阴性对照组相比无显著性差异(P>0.05)。在与CHL接触24h后,细胞出现了明显形态改变。结论:在该试验条件下,纳米银敷料浸提液对CHL细胞的染色体无明显损伤作用,在24h接触组中出现了明显的细胞毒性。

Study on the Genotoxicity of the Nanometer Silver Dressing Evaluated by in Vitro Chromosome Aberration Test

Objective:Testing the possibility of genotoxicity from nanometer silver dressing based on in vitro chromosome aberration test to provide reference for its preclinical safety evaluation.Methods:The study was based on the requirements of the GB/T16886.3-2008/ISO 1099-3:2014.Using Chinese hamster lung fibroblasts cells(CHL)with and without metabolic activation to treat with the extraction of nanometer silver dressing.The percentage of chromosome aberration induced by nanometer silver dressing were calculated and assayed with+S9/6h,-S9/6h,-S9/24h.Results:There was no significant difference(P>0.05)between the sample group with the negative control group under all test conditions.Morphology changes were found after the 24h-treatment.Conclusion:Under the conditions of this study,the extraction of nanometer silver dressing didn’t show obvious damage effect on chromosome,but showed significant cytotoxicity in CHL after 24h-treatment.