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作 者:张俊明[1] 余华[1] 黄永红[2] 郑国安[1] 丁琦[1] 李良[1]
机构地区:[1]江西省药物研究所,江西南昌330029 [2]南昌大学医学院,江西南昌330029
出 处:《科技广场》2010年第10期122-124,共3页Science Mosaic
摘 要: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。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.
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