氟轻松维B6乳膏制剂皮肤用药安全评价的实验研究

目的：评价氟轻松维B6乳膏制剂皮肤用药的安全性。方法：按照国家SFDA颁发的《化学药物刺激性、过敏性和溶血性研究技术指导原则》（第二稿）[1]进行豚鼠皮肤致敏试验与实验兔皮肤刺激性试验。结果：氟轻松维B6乳膏1.0g/只对豚鼠皮肤平均反应值为0,致敏率为0;氟轻松维B6乳膏乳膏0.5g/只对实验兔局部皮肤刺激性平均反应积分值为0,实验兔局部皮肤刺激的累积刺激指数为0。结论：氟轻松维B6乳膏局部皮肤用药对豚鼠皮肤无过敏反应,对实验兔皮肤无刺激性反应。

Experimental Studies on Enepidermic Safety Evaluation of Fluocinolone Acetonide-dimensional B6 Cream

Objective：to elevate the enepidermic safety of fluocinolone acetonide-dimensional B6 cream.Method：according to ＂irritant chemicals,allergic and hemolytic technical research guidelines＂（second draft） issued by the state SFDA,author did guinea pig skin sensitization test and the rabbit skin irritation test.Result：guinea pig skin average response value was 0 and guinea pig skin sensitized rate was 0 in allergic test of 1.0g of fluocinolone acetonide-dimensional B6 cream.Rabbit local skin irritation reaction average score was 0 and the Cumulative irritation index was 0 in irritation test of 0.5g of fluocinolone acetonide-dimensional B6 cream.Conclusion：there was no anaphylaxis effect on local skin after fluocinolone acetonide-dimensional B6 cream in guinea pig.There was no irritation reaction to skin after fluocinolone acetonide-dimensional B6 cream in rabbit.