替硝唑螺内酯乳膏的皮肤过敏性和刺激性实验

目的 对替硝唑螺内酯乳膏进行动物皮肤过敏性和刺激性实验,为其提供临床前安全性评价. 方法反复外用替硝唑螺内酯乳膏或赋形剂、2,4-二硝基氯苯(DNCB)对豚鼠多次致敏,并于第28天激发后观察豚鼠的反应;用替硝唑螺内酯乳膏、赋形剂局部涂抹家兔破损皮肤及完整皮肤,并逐日观察症状表现. 结果赋形剂、替硝唑螺内酯乳膏、阳性致敏药物(DNCB)的变态反应发生率分别为0.0%,20.0%,100.0%;替硝唑螺内酯乳膏和赋形剂的刺激评分均为0分. 结论替硝唑螺内酯乳膏对豚鼠皮肤仅轻度致敏性,对家兔皮肤无刺激性,属于安全制剂.

Skin Allergy and Irritation Tests of Tinidazole and Spironolactone Cream

Objective To evaluate the allergy and irritation of tinidazole and spironolactone cream on animals’ skin,and to provide safety evaluation of pre-clinical application.Methods Tinidazole and spironolactone cream,excipient,or 2,4-dinitrochlorobenzene was repeatedly used to sensitize guinea pigs’ skin.The guinea pigs’ reaction was observed on the 28th day.The rabbits’ damaged skin and healthy skin were locally treated with tinidazole and spironolactone cream,excipient,or 2,4-dinitrochlorobenzene,and their symptoms were observed day by day.Results The incidence rates of allergic reaction of excipient,tinidazole and spironolactone cream,and 2,4-dinitrochlorobenzene were 0,20.0%,and 100.0%,respectively.The stimulation scores of tinidazole and spironolactone cream and excipient were 0.Conclusion Tinidazole and spironolactone cream has only mild sensitization on guinea pigs’ skin and no irritation on rabbits’ skin,and it is a safe preparation.