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山东大学学报(医学版) ›› 2014, Vol. 52 ›› Issue (11): 16-20.doi: 10.6040/j.issn.1671-7554.0.2014.039

• 基础医学 • 上一篇    下一篇

重组异种骨材料对神经元的安全性评价

王贤美, 李娜, 孙晓霞, 刘成虎, 侯丽   

  1. 国家食品药品监督管理局济南医疗器械质量监督检验中心, 山东省医疗器械生物学评价重点实验室, 山东 济南 250101
  • 收稿日期:2014-01-11 发布日期:2014-11-10
  • 通讯作者: 侯丽.E-mail:521keren@sina.com E-mail:521keren@sina.com
  • 基金资助:
    再生型医用植入器械国家工程室PI项目(2012NELRMD007)

Safety of reconstituted bone xenografts on neuronal cells

WANG Xianmei, LI Na, SUN Xiaoxia, LIU Chenghu, HOU Li   

  1. CFDA-Jinan Quality Supervision and Inspection Center for Medical Devices; Shandong Provincial Key Laboratory of Biological Evaluation of Medical Device, Jinan 250101, Shandong, China
  • Received:2014-01-11 Published:2014-11-10

摘要: 目的 探讨重组异种骨材料对Wistar大鼠神经元细胞活力和细胞凋亡的影响,以验证其在临床使用中对神经系统的安全性.方法 采取重组异种骨浸提液培养大鼠海马和皮层神经元(依据医疗器械生物学评价国际标准ISO10993.12-2012,进行重组异种骨浸提液的制备),分为重组异种骨样品组和阴性对照组.采用MTT掺入法和流式细胞术分别对不同接触时间、不同培养时间神经元的细胞活力和细胞凋亡进行实验.结果 重组异种骨材料对Wistar大鼠神经元细胞活力和凋亡的影响与阴性对照组相比均无显著差异(P >0.05).结论 重组异种骨材料对Wistar大鼠神经元的细胞活力和凋亡无明显影响,为重组异种骨的临床安全应用提供实验及理论依据.

关键词: 神经元, 细胞凋亡, 重组异种骨, 细胞活力

Abstract: Objective To evaluate the clinical safety of reconstituted bone xenografts on the nervous system by studying the influence on neuronal cell viability and apoptosis in Wistar rats. Methods Hippocampal and cortical neurons cells were cultured in the reconstituted bone xenograft extracts (preparation of liquid extracts was in accordance with ISO 10993.12-2002). The neuronal cells were divided into two groups: the reconstituted bone xenograft group, and the negative control group. Tests were conducted to study the viability and apoptosis of neuronal cells in different contact time and culture time with MTT incorporation assay and flow cytometry. Results There were no significant differences in neuronal cell viability and apoptosis between the two groups (P >0.05). Conclusion The reconstituted bone xenografts have no obvious influence on neuronal cell viability and apoptosis in Wistar rats. The result of this study may provide an experimental and theoretical basis for the safe clinical application of reconstituted bone xenografts.

Key words: Cell viability, Neuronal cells, Reconstituted bone xenograft, Cell apoptosis

中图分类号: 

  • R338.1
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