摘要
目的:对壳聚糖创伤敷料进行生物学评价。方法:进行皮肤致敏以及细胞毒性试验,溶血试验,并按照国家统一标准判定。结果:细胞毒性试验:镜下见小鼠成纤维细胞生长良好,可见少量圆形细胞,偶见细胞溶解,细胞相对增值度为81%,细胞毒性总评级为1级,极轻细胞毒性。致敏试验:产品材料等级评分为0,无致敏反应。溶血试验:溶血率为0.386%,<5%,表明无溶血现象。
Purpose： To provide integral biological assessment on chitosan trauma dressing.Approach： Conduct skin sensitization and cytotoxicity tests as well as hemolysis test.Besides,the assessment according stringently to the overarching national standard is required.Results： For cytotoxicity test： the L929 grow well under the microscope,with only a small amount of round cell existing and occasional cytolysis inspected.The cell incremental validity amounts to 81%,whereas the cytotoxicity level was evaluated at the 1st level,which directs to the lowest cell toxicity.Skin sensitization test： the level grading of the material of the product equals zero,which means no sensitization reaction is practically detected.The hemolysis rate is 0.386%,5%,indicating zero hemolysis.
出处
《中国医疗器械信息》
2011年第9期40-42,共3页
China Medical Device Information
关键词
壳聚糖
敷料
生物学评价
chitosan
dressing
biological assessment
