摘要
目的:研究不同浸提介质对医用护理垫体外细胞毒性评价的影响。方法:根据ISO 10993-5:2009的试验原则和评价标准,采用不同的浸提介质制备医用护理垫浸提液,小鼠成纤维细胞L929与浸提液共培养24h,MTT法评价浸提液对细胞生长的影响,并计算细胞存活率(Viab.%)。结果:医用护理垫不同浸提液的细胞毒性结果有统计学差异,含血清浸提介质使细胞生长抑制,Viab.%值为68.6%,而其余三种浸提介质细胞生长状态良好,Viab.%均>80%。结论:不同的浸提介质对医用护理垫细胞毒性结果有直接影响,因此在评价医用材料的细胞毒性时,必须明确所使用的浸提介质。
Objective: To evaluate the effects of different extraction vehicle on cytotoxicity of medical under pad. Methods:According to experiment principle and criterion of ISO 10993-5:2009, a series of extracts of medical under pad were prepared by different extraction vehicle. L929 mouse fibroblasts were evaluated by MTT assay after inculation with different extracts for 24h, and then cellviability was calculated. Results:Cytotoxicity showed statistical y significant in different extraction vehicle made from medical under pad. The growth of L929 cells was inhibited when using MEM with serum as extraction vehicle, with cellviability of 68.6%, while there was almost no difference in the cellgrowth among the other 3 extraction vehicle, with cellviability of greater than 80%. Conclusion:There’s a direct impact on cytotoxicity of medical under pad made by different extraction vehicle, so the extraction vehicle should be clearly determined in evaluation of cytotoxicity of medical materials.
出处
《中国医疗器械信息》
2014年第2期65-68,共4页
China Medical Device Information