柔性陶瓷材料的体内安全性评价  

In Vivo Safety Evaluation of Flexible Ceramic Materials

作　　者：孙倩 冯丽芳 李敬东[2] 王武良 韩子文 梁锐英 SUN Qian;FENG Lifang;LI Jingdong;WANG Wuliang;HAN Ziwen;LIANG Ruiying(North China University of Science and Technology, School of Stomatology, Tangshan 063000, China;Department of Oral and Maxillofacial Surgery, Tangshan Union Medical College Hospital, Tangshan 063000, China)

机构地区：[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

出　　处：《口腔医学研究》2022年第3期268-274,共7页Journal of Oral Science Research

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。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.

关 键 词：柔性陶瓷材料 生物安全性 国家标准 

分 类 号：TQ1[化学工程]