立体光固化成型氧化锆陶瓷的生物安全性评价  

Biocompatibility of zirconia ceramic fabricated by stereolithography

作　　者：赵祯 代康 于海 赵喆 高勃 ZHAO Zhen;DAI Kang;YU Hai;ZHAO Zhe;GAO Bao(State Key Laboratory of Military Stomatology&National Clinical Research Center for Oral Diseases&Shaanxi Provincial Key Laboratory of Stomatology&Dept,of Prosthodontics,Hospital of Stomatology,Fourth Military Medical University,Xi'an 710032,China;不详)

机构地区：[1]军事口腔医学国家重点实验室,国家口腔疾病临床医学研究中心,陕西省口腔医学重点实验室,第四军医大学口腔医院修复科,陕西西安710032 [2]嘉兴饶稷科技有限公司,浙江嘉兴314100

出　　处：《口腔医学》2022年第1期47-52,共6页Stomatology

基　　金：国家口腔疾病临床医学研究中心资助课题(LCA202011)。

摘　　要：目的评价立体光固化成型氧化锆陶瓷的生物安全性。方法依照国标GB/T 16886.5—2017、GB/T 16886.10—2017及医药行业标准YY/T 0127.14—2009、YY/T 0127.13—2018对该陶瓷材料进行实验,包括体外细胞毒性实验、皮肤致敏实验、急性经口毒实验及黏膜刺激实验。结果体外细胞毒性实验结果显示不同浓度浸提液组细胞培养24 h后存活率均>90%;皮肤致敏实验中,实验组红斑反应程度及发生率等于阴性对照组,证实陶瓷材料对皮肤无致敏作用;急性经口毒实验观察实验组大鼠大体器官及HE染色均未见明显异常;黏膜刺激实验观察金黄地鼠颊囊粘膜未见充血、糜烂等异常表现,HE染色未见角化不良、基底细胞空泡样变,证实对黏膜无刺激性。结论立体光固化成型氧化锆陶瓷的生物安全性初步满足临床要求。Objective To evaluate the biocompatibility of zirconia ceramic fabricated by stereolithography.Methods According to GB/T 16886.5—2017,GB/T 16886.10—2017,YY/T 0127.14—2009 and YY/T 0127.13—2018,samples were prepared and tested with general cytotoxicity test,skin sensitization test,acute oral toxicity test and oral mucous irritation test.Results General cytotoxicity test showed that the survival rate of cells cultured for 24 h in different concentration extract groups was>90%.The degree and incidence of erythema reaction in the skin sensitization test group were equal to those in the negative control group,which proved that the ceramic material had no sensitization effect on skin.Acute oral toxicity test of rats in the experimental group showed no obvious abnormalities in gross organs and HE staining.Results of oral mucous irritation test showed that no hyperemia and erosion were observed in the cheek pouch mucosa of hamster;no dyskeratosis and vacuolar changes of basal cells were observed in HE staining,which proved that the ceramic material had no irritation on mucosa.Conclusion The biocompatibility of zirconia ceramic fabricated by stereolithography meets elementary clinical requirements.

关 键 词：氧化锆陶瓷 立体光固化 生物安全性 

分 类 号：R783.1[医药卫生—口腔医学]