复方酮康唑乳膏的皮肤刺激性和过敏性研究

目的:为复方酮康唑乳膏的应用提供临床前安全性评价依据。方法:将复方酮康唑乳膏涂敷于豚鼠背部皮肤,3次致敏接触。隔14天后,再涂药激发接触,观察过敏反应;用复方酮康唑乳膏多次重复涂敷于家兔完整及破损皮肤。采用同体左右侧自身对比,涂药期间每日观察局部皮肤红斑及水肿情况。结果:复方酮康唑乳膏与完整皮肤及破损皮肤接触均未发现皮肤出现明显的红斑和水肿反应,刺激指数均小于0.4;复方酮康唑乳膏和基质均未引起豚鼠皮肤出现红斑、水肿等过敏反应。结论:复方酮康唑乳膏对家兔皮肤无刺激性,对豚鼠皮肤未出现过敏症状,属安全制剂。

Compound Ketoconazole Cream for Skin Irritation and Allergy Research

Objective：To evaluate the irritation and hypersensitivity of compound ketoconazole cream on animals skin and to provide the information for its applications. Methods： The skin of guinea pigs back was coated by compound ketoeonazole cream, and contacted allergens three times. Then it was stimulated by coated drug and the allergic reaction was observed after 14 days. The rabbits was coated by compound ketoconazole cream repeatedly both intact and damaged skin once a day,7 days）.By comparison rabbits＇ skin left side with right side, the erythema and edema of local skin were observed every day during trial period. Results：There were no obvious erythema and edema response after the intact skin and the damaged skin had contact with compound ketoconazole cream, the stimulus index were all below 0.4; compound ketoconazole and the excipient did not cause anaphylaxis such as erythema and edema ete on the guinea pigs＇ skin.Conclusion：Compound ketoconazole cream has no irritation on rabbits＇skin and no hypersuseeptibility on guinea pigs＇skin, it belongs to the safe preparation.