自制光固化型可塑性纤维桩材料生物安全性的初步评价

Primary evaluation of biological safety of light-curable plastic fiber reinforced composite for dental post

目的:初步评价自制光固化型可塑性纤维桩材料的生物安全性。方法:分别通过溶血试验、口腔黏膜刺激试验和短期全身毒性试验(经口途径),评价自制材料的生物安全性。结果:材料溶血率为1.76%,小于中华人民共和国医药行业标准(YY)规定的5%,认为该材料未引发溶血现象,对凝血功能无影响;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,根据标准(YY)认为该材料无黏膜刺激性;短期全身毒性实验的受试小鼠无一死亡,其体质量相对增长率和食物利用率与对照组无统计学差异(P>0.05),心、肾、肝等重要器官肉眼观察无异常改变,其组织切片未见病理改变。结论:自制光固化型可塑性纤维桩材料具有较好的生物安全性。

AIM： To evaluate the biological safety of the light - curable plastic fibre reinforced composite synthetized independently. METHODS： The experimental study was carryied out with hemolytic test in vitro,oral mucous membrane irritation test and acute general toxicity test according to the relative standards. RESULTS： The hemolytic rates of the samples is 1.76%, which is less than 5% stated by medical standard of the PRC（YY） , so the material is considered to be no hemolysis phenomena and no influences on the function of coagulation. There is no abnormal- ities on the mucous membrane contacted with samples. The grade of tissue slices were all less than 4. So the material is considered to be no mucous membrane irritations according to medical standard of the PRC （YY）. All of the tested mice survive the acute general toxicities, and there is no statistic differences of the relative increasing rates of weight and the utilizing rates of foods between the experimental and control groups（ P 〈0.05 ）. Threr is no abnormalities observed by naked eye on the heart, kidney, liver and so on, and no pathological change on the tissue slices of these organs. CONCLUSION： The material synthetized independently possesses good biological safety for dental application.