NaHCO3促凝氧化硅涂层的动物活体毒性评价

The toxicity evaluation of sol-gel silica coating coagulated by NaHCO_3 in vivo

目的:评价NaHCO_3促凝氧化硅凝胶的动物活体毒性。方法:根据YY/T 0244-1996标准对受试样本进行SD大鼠经口途径短期全身毒性试验评价;根据T16886.10-2005/ISO 10993-10:2002标准,对受试样本进行白色豚鼠刺激与迟发型超敏反应试验评价;根据YY/T 0127.13-2009标准对受试样本进行金黄地鼠口腔黏膜刺激试验评价。结果:经口途径短期全身毒性试验中,试验组与对照组大鼠食物利用率差小于对照组食物利用率的20%;试验组与对照组的体重相对增长率无差异;试验组大鼠在试验期间未观察到明显毒性体征。刺激与迟发型超敏反应试验中,试验组和对照组豚鼠在激发接触后24 h和48 h皮肤均未见红斑及水肿,致敏率为0%。口腔黏膜刺激试验中,肉眼观察和组织病理学观察结果均显示对试验组与对照组金黄地鼠的口腔黏膜的刺激指数为0。结论:NaHCO_3促凝的氧化硅凝胶对活体动物不具有明显毒性。

Objective：To evaluate the toxicity of NaHCO3 coagulated silica gel for coating on the zirconia bonding surface in vivo.Methods：The silica gel was subjected to short term systemic toxicity test by delayed-type hypersensitivity test by oral route and oral mucosa irritation test according to the YY/T 0244-1996 standards,T16886.10-2005/ISO 10993-10：2002 standards and YY/T 0127.13-2009 standards respectively.Results：In the short term systemic acute toxicity tested mice there was no significant difference in the weekly food utilization rate and relative body weight growth rate between the experimental and control groups.No abnormality and pathological change were observed.The delayed-type hypersensitivity test showed that no ery-thema and edema reaction presented in all the test cavies after 24 and 48 h of stimulation contact,and the sensitization rate was 0.There was no local or systemic pathological change in all the oral mucosa irritation test animals.Conclusion：NaHCO_3 procoagulant silica gel has no in vivo toxicity.