目的评价本实验室自制的丝素蛋白人工神经导管对皮肤潜在的致敏性。方法以ISO 10993-10:1995标准,采用最大剂量法,将白化豚鼠分为SF-NGC组、阳性对照(甲醛溶液)、阴性对照(生理盐水)3组,先进行预试验确定主试验各阶段的浓度,然后进行主试验。在激发阶段的敷贴物去除后24h、48h、72h,观察记录各组动物激发部位的皮肤情况,按标准进行评分,并算出致敏率。结果丝素蛋白人工神经导管的皮肤反应记分为0,致敏率为0。结论在试验条件下丝素蛋白人工神经导管无潜在的皮肤致敏性。

Objective To study the sensitization of silk fibroin-based nerve guidance conduits (SF-NGCs) in vitro. Methods According to ISO 10993-10:1995 standard, maximization test was conducted in guinea pig. The skin sensitization reactions, including erythema and oedema, induced by SF-NGCs, normal saline and formalin solution were observed and scored respectively at 24, 48 and 72 h exposure of the infusion of the materials. The allergenic rates and mean response score were calculated. Results The allergenic rates a...