目的:通过黏膜刺激实验和溶血试验初步评价poss(polyhedral oligomeric silsesq uioxane)复合树脂的生物安全性。方法:溶血试验:将Poss复合树脂加工成直径5mm,重量为5克的圆片3个分别装入3个装有10mL生理盐水的试管中作为实验组,以生理盐水和蒸馏水分别作为阴、阳性对照组。将0.2mL稀释新鲜抗凝人血加入所有试管中,在离心机上离心5min,分别吸取上清液,用分光光度仪在545nm波长处测定其光吸收度,计算Poss复合树脂的溶血率。黏膜刺激实验:按照国家关于口腔材料生物学试验方法,选择健康家兔10只,将实验材料(Poss复合树脂)和阴性对照材料(医用牙胶)缝合于一侧颊黏膜上,另一侧为空白对照。2周后进行肉眼观察评价和组织学评价。结果:溶血试验:poss复合树脂溶血率为0.41%,低于5%,根据ISO/TR7405-1997(E),poss复合树脂不会引起溶血。黏膜刺激试验:Poss复合树脂材料及阴性对照组均未出现局部及全身的不良反应,临床及病理反应等级属于无刺激。结论:poss复合树脂与稀释抗凝人血不会发生溶血且对试验动物颊黏膜无不良刺激反应。
Objective:To preliminery assess the biological safety of polyhedral oligomericsilsesquioxane through the oral mucous membrane irritation test and hemolysis test.Methods:Haemolysis test:the poss material was fasioned into 5mm diameter,weight for 5gram.Them were put separately in the curette with 10ml physiological saline solution as the test group,the group in distilled water and the group in physiological solution as the positive control group the negtive control group.The dilate person blood was added into each cuvette.After it was centrifugated by centrifugal,we took the serum,then mensurated the magnitude of light that was absorded in 545nm wavelengh,by spectro photometer and caculated the rate of haemolysis.Oral mucous membrane irritayion test:According to the biological test methods of dental materials,polyhedral oligomeric silsesquioxane and negative control group(gutta pertscha)were fixed on theoral membrane of 10rabbit.After two weeks,the contact parts were examined macroscopically and histologically.Results:There was no local or systemic abnormal response to polyhedral oligomeric silsesquioxane and the negative control group.The pathoeogical findings were normal.Conclusion:The poss will not bring haelysis and irritating response to the oral mucous membrane.