JJ- 磁性固位体金属材料的生物相容性评价

Biocompatibility of JJ- Magnetic Retainer Metal Materials

目的 了解JJ 磁性固位体金属材料的生物相容性。方法 选用细胞毒性试验、口腔粘膜刺激试验、急性经口毒性试验、溶血试验、致敏试验、Ames试验等 6个试验 ,分别对JJ 磁性固位体金属材料的毒性、致敏性和致突变性进行研究测试。结果 细胞毒性试验显示 ,试验组毒性分级为I级 ;口腔粘膜刺激试验 ,试验组无论肉眼观察还是组织切片 ,均与阴性对照无显著性差异 ;急性经口毒性试验 ,试验组属于无毒类 ;溶血试验的试验组溶血率为0 .45 % ;致敏试验显示试验组不引起致敏反应 ;Ames试验的试验组在各剂量组对TA97、TA98、TA10 0 、TA10 2 的回变菌落数与自发回变数相近 ,无致基因突变作用。结论 JJ

Objective The purpose of this study was to evaluate the biocompatibility of new JJ magnetic retainer metal materials.Methods Preliminary biocompatible tests of the metal materials were performed depending on ISO 10.993 12 standard. They were cytotoxicity test, hemolysis test, acute systemic toxicity test, sensitization test and Ames test.Results The cytotoxicity of the metal material was grade I. The hemolysis rate was 0.45%.There was no abnormal sensitization and irritation actions in the experimental group. The metal had no action of mutagenesis and carcinogenesis.Conclusion The JJ magnetic retainer metal material showed excellent biocompatibility on the preliminary tests. It would be a good material in the way of biological safety.[