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不同浸提介质对医用护理垫体外细胞毒性评价的影响 被引量:1

Effect of Different Extracting Vehicle on Cytotoxicity Evaluation for Medical under Pad
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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
关键词 医用护理垫 浸提介质 细胞毒性 MTT比色法 medical under pad extraction vehicle cytotoxicity MTT assay
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参考文献5

  • 1ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity[s].
  • 2ISO 10993-12:2009, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials[s].
  • 3中华人民共和国国家质量监督检验检疫总局.GB/T16886.5-2003医疗器械生物学评价第5部分体外细胞毒性试验[S].
  • 4Oshima H, Nakamura M. A study on reference standard for cytotoxicity assay of biomaterials[J]. Biomed Mater Eng,1994,4(4):327,.
  • 5邝辉,刘尧,曹苹,王晓炜.不同浸提介质对一次性使用球囊扩张导管体外细胞毒性评价的影响[J].生物医学工程研究,2011,30(2):113-115. 被引量:3

二级参考文献4

  • 1GB/T16886.5-2003,医疗器械生物学评价第5部分:体外细胞毒性试验[S].
  • 2ISO 10993 - 12:2002, Biological evaluation of medical devices- Part 12: Sample preparation and reference materials[ S].
  • 3GB/T14233.2-2005,医用输液、输血注射器具检验方法第二部分:生物试验方法[S].
  • 4Sgouras D, Duncan R. Methods for evaluation of biocompatibility of soluble synthetic polymers which have potential for medical use. 1. Use of the tetrazolium - based colorimetric assay (MTr) as a preliminary screen for evaluation of in vitro cytvtoxicity[ J]. Mater Med, 1990,1 : 61 - 68.

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