糠酸莫米松凝胶用药皮肤过敏性及刺激性评价研究

摘要

[目的]观察糠酸莫米松凝胶给药后产生的过敏和刺激性反应及严重程度,客观评价该药物可能存在的毒性反应.[方法]按照国家食品药品监督管理总局颁发的《药物刺激性、过敏性和溶血性研究技术指导原则》,进行了皮肤过敏性和刺激性试验.[结果]WingdingsAB@u000f糠酸莫米松凝胶皮肤给药未对豚鼠产生过敏反应.WingdingsBB@u000f糠酸莫米松凝胶皮肤给药未对实验兔产生刺激反应.[结论]在本实验条件下,由华润三九(南昌)药业有限公司生产的批号为1409001J的糠酸莫米松凝胶对豚鼠无皮肤过敏反应,对兔无皮肤刺激性反应.%[Objective]To observe the cutaneous allergic and irritant reaction and severity after administration of mometasone furoate gel,and objectively evaluate of the toxic reaction of the drug may exist.[Method]The cutaneous allergy and irritation test were carried out in accordance with the State Food and Drug Administration issued the "guiding principles for the study of drug irritation,allergy and hemolysis".[Results]There was no allergic reaction in guinea pigs on skin that caused by Mometasone furoate gel.There was no irritant reaction in rabbits on skin that caused by Mometasone furoate gel.[Conclusion]At this experimental conditions,there were no shin allergic and irritant reaction after administration of mometasone furoate gel(the lot number was 1409001J)produced by Huarun three nine(Nanchang)Pharmaceutical Co.,Ltd..