口腔医学研究

口腔医学研究 ›› 2022, Vol. 38 ›› Issue (3): 268-274.DOI: 10.13701/j.cnki.kqyxyj.2022.03.015

• 口腔修复学研究 • 上一篇    下一篇

柔性陶瓷材料的体内安全性评价

孙倩1, 冯丽芳1, 李敬东2, 王武良1, 韩子文1, 梁锐英1*   

  1. 1.华北理工大学口腔医学院 河北 唐山 063000;
    2.唐山市协和医院口腔颌面外科 河北 唐山 063000
  • 收稿日期:2021-11-04 出版日期:2022-03-28 发布日期:2022-03-25
  • 通讯作者: * 梁锐英,E-mail:lry110@126.com
  • 作者简介:孙倩(1995~ ),女,河北唐山人,硕士在读,研究方向:口腔修复学。

In Vivo Safety Evaluation of Flexible Ceramic Materials

SUN Qian1, FENG Lifang1, LI Jingdong2, WANG Wuliang1, HAN Ziwen1, LIANG Ruiying1*   

  1. 1. North China University of Science and Technology, School of Stomatology, Tangshan 063000, China;
    2. Department of Oral and Maxillofacial Surgery, Tangshan Union Medical College Hospital, Tangshan 063000, China
  • Received:2021-11-04 Online:2022-03-28 Published:2022-03-25

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摘要： 目的: 探索柔性陶瓷材料作为口腔接触类材料的生物安全性能,为临床应用提供理论支持。方法: 实验参照GB/T16886医疗器械生物学评价系列标准,制备材料浸提液或纽扣样试件进行皮肤刺激实验、皮内反应实验、迟发型超敏反应实验、口腔黏膜刺激实验及急性全身毒性实验。结果: 柔性陶瓷材料无刺激性、不引起皮内反应、无致敏性、无口腔黏膜刺激性、无短期全身毒性。结论: 柔性陶瓷材料具有良好的体内安全性,符合口腔表面接触材料的应用要求。

关键词: 柔性陶瓷材料, 生物安全性, 国家标准

Abstract: Objective: To investigate the biosafety of flexible ceramic materials. Methods: The material extract or button samples were prepared. Skin irritation test, intradermal reaction test, delayed type hypersensitivity test, oral mucosal irritation test, and acute systemic toxicity test were conducted according to GB/T16886 biological evaluation series of medical devices. Results: The flexible ceramic material had no irritation, no intradermal reaction, no sensitization, no irritation of oral mucosa, and no short-term systemic toxicity. Conclusion: Flexible ceramic materials have excellent biosafety and meet the application requirements of oral surface contact materials.

Key words: flexible ceramic materials, biosafety, national standard