医用级硅凝胶的生物学实验研究

有机硅凝胶(GNY—514,GNY—515)具有较好的物理机械性能而被用于医学各个领域,但对该材料的毒性及生物相容性研究报道较少,作者参考了有关标准,对硅凝胶材料及制品进行了系统的毒性及生物相容性研究。结果表明红外分析制品内未查出残留单体,从细胞培养试验证实无细胞毒性,Ames试验未见致突变现象,三种刺激试验表明均无刺激反应,硅凝胶的四种介质浸提液无急性毒性反应,小鼠微核试验微核率正常,材料肌肉植入无明显的组织学改变。该研究结果证明了硅凝胶材料是无毒、无刺激、生物相容好的生物医用材料。

Biological Experiment Study of Medical Silicone Gels

Silicone gels(GNY-514,GNY-515)possess good physical and mechanical properties, and have been widely used in many fields of medicine. The toxic response and biocompatibil- ity of the silicone gels are rerely reported. According to the related standards,the toxicity and biocompatibility of the material were evaluated systematically with nine methods. The results showed that: no remaining monomers in the products by infrared analyse; cell culture with the material showed no toxic response; mutagenic phenomena were not found in Ames test; no irritant reaction were examined in three irritation tests;four extractions of these materials showed no toxic reaction;the micronucleus rate test in mice was normal as the materials im planted in muscle;and there was no significant histological reaction. The research results de monstrated that the material is no toxicity,no irritation and well biocompatible medical bio- material.