国产RF氧化锆全瓷材料的生物安全性初步评价  

Preliminary evaluation of the biological safety of RF Zirconia

作　　者：范天慧[1] 武天逾 何惠明[1] 冯光捷 梁猛猛[1] 

机构地区：[1]第四军医大学口腔医学院,陕西西安710032 [2]深圳市金悠然科技有限公司,广东深圳518129

出　　处：《牙体牙髓牙周病学杂志》2010年第4期208-212,共5页Chinese Journal of Conservative Dentistry

基　　金：深圳龙岗区科技计划项目(CX2008001);陕西省社发攻关项目(2009K01-87)

摘　　要：目的:初步评价实验性RF型全瓷氧化锆材料的生物安全性。方法:根据ISO7405-1997(E)/GB16886-1997标准,利用昆明小鼠、金黄地鼠实验动物对材料进行急性全身毒性、细胞毒性、口腔黏膜刺激性试验研究。结果:急性全身毒性实验中受试小鼠无一死亡,体质量增加,无中毒反应,肝,肾组织切片无明显炎性细胞。体外细胞毒性实验组A值与阴性对照组无显著性差异(P>0.05),材料毒性级别0级。且与材料接触的黏膜未见异常反应,其组织切片观察总评分<4。结论:RF型全瓷氧化锆材料具有较好的生物安全性。AIM：To preliminarily evaluate the biological safety of RF Zirconia.METHODS：According to ISO7405-1997 （EGB）16886-1997 standards,acute systemic toxicity test,vitro cytotoxicity-test and oral mucosal membrane stimulation test were carried out in Kunming mice and Mesocricetus auratus.RESULTS：In acute systematic toxicity tests all of the tested mice survived.No statistic difference was found in terms of body weight.By HE staining,no abnormality was observed in kidney and liver tissues.In cytotoxicity test,OD-values of each test group were similar to that of the negative control and significantly lower than that of the positive control group （P0.05）.The cytotoxicity was grade 0 according to the test standard.The grade of oral mucous membrane stimulation test in Mesocricetus auratus was all less than 4,which is considered to be no irritation to mucous membrane according to medical standard.CONCLUSION：RF was preliminarily proved to be safe for dental application.

关 键 词：氧化锆 全瓷材料 生物安全性 

分 类 号：R783.1[医药卫生—口腔医学]