氟化钠护齿涂剂的体外细胞毒性和家兔皮肤刺激性研究

摘要

Objective Sodium Fluoride Varnish was used for caries prevention .Its cytotoxicity in vitro and rabbit skin irritation were evaluated in this study .Methods According to the experimental principle of national biological appraising standard on medical ap‐paratus ,the in vitro cytotoxicity was tested by a filter membrane diffusion method and the safety of Sodium Fluoride Varnish was evaluated by rabbit skin irritation test .Results Sodium Fluoride varnish had mild cell toxicity and no obvious skin irritation was observed on rabbits .Conclusion Sodium Fluoride Varnish had a relatively low toxicity and was appropriate for caries prevention .%目的：氟化钠护齿涂剂是用于口腔龋齿预防的制剂，本文对其体外细胞毒和对家兔皮肤的刺激性进行了评价。方法遵照GB／T 16886．5‐2003《医疗器械生物学评价第5部分：体外细胞毒性实验》中华人民共和国国家标准的实验原则，采用滤膜扩散法进行氟化钠护齿涂剂的体外细胞毒性评价；遵照GB／T 16886．10‐2005《医疗器械生物学评价第10部分：刺激与迟发型超敏反应实验》，采用家兔对氟化钠护齿涂剂进行皮肤刺激性评价。结果体外细胞毒性实验结果显示，氟化钠护齿涂剂细胞毒性为1级，具有轻度细胞毒性；对家兔皮肤无明显刺激。结论氟化钠护齿涂剂具有相对较低的毒性，可用于口腔龋齿的预防。