菌癣灵乳膏的制备和皮肤变态反应及刺激性实验

Preparation of Junxianling Cream and Its Skin Allergy and Irritation Reaction Study

目的 :制备菌癣灵乳膏剂并考察其外用的安全性。方法 :拟订菌癣灵乳膏剂处方与制备工艺。进行家兔完整与破损皮肤接触后产生的皮肤刺激性实验 ,豚鼠皮肤变态反应实验。结果 :该乳膏剂白色、细腻、均匀、涂展性强。家兔完整皮肤、破损皮肤涂药后未发现明显红斑和水肿反应 ,未出现皮肤局部刺激反应。豚鼠皮肤变态反应实验结果显示 :给药 6～ 72h未见红斑和水肿。结论 :菌癣灵乳膏剂处方合理 ,制备工艺可靠。经动物实验证实 ,该药无皮肤变态反应性和刺激性 ,为临床应用提供了可靠的安全性保证。

Objective:To prepare the junxianling cream and to observe its safety in external use. Methods:The prescription of junxianling cream and its preparation skill were established. Then its irritation reaction on normal and damage skin of rabbits and its allergy reaction on guinea pigs were carried out. Results:Junxianling cream had a white, fine and smooth and easy-to-daub quality. There were no swollen, red speckles or local skin irritation reaction observed on rabbits. There were no allergy reaction found on guinea pigs during 6-72 h after use. Conclusion:The prescription of junxianling is rational and the preparation has a good quality.