立体光固化成型氧化锆陶瓷的生物安全性评价

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...

Biocompatibility of zirconia ceramic fabricated by stereolithography

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.