骨质宁凝胶的皮肤刺激性及皮肤致敏性实验研究

Experimental study on skin stimulation and hypersensitivity of Guzhining gel

[目的]考察骨质宁凝胶的刺激性及过敏性,以评价该制剂临床用药的安全性。[方法]采用家兔同体左右侧自身比较法研究皮肤刺激性和用豚鼠研究皮肤致敏性。[结果]在皮肤刺激性实验中,受试品骨质宁凝胶对家兔的正常皮肤未见刺激性,但对破损皮肤见有轻微刺激性;在致敏性实验中,骨质宁凝胶对豚鼠未见致敏作用,而阳性药2,4-二硝基氯苯见有极强致敏性。[结论]在实验条件下,受试品骨质宁凝胶对受试家兔正常皮肤无刺激性,对豚鼠无致敏性,符合外用制剂的安全性要求,故可供涂布外用给药;对家兔破损皮肤有轻度刺激性,所以应慎用或避免用于破损皮肤。

[Objective] For evaluating the safety of the drug we investigate the skin irritation and hypersensitiveness of Guzhining gel. [Methods] The skin irritation experiment was carried out by comparing the irritation on skin of both sides of rabbits, and the skin hypersensitive experiment was carried out on guinea pigs. [Results] Guzhining gel had no irritation effect on the integral skin of rabbits, but a little irritation on damaged skin of rabbits was observed. Hypersensitive effect on the skin of guinea pig was not found, but the positive vehicle drug 2, 4-dichloronitrobenzene had strong hypersensitiveness. [ Conclusion] Guzhining gel has no irritation on normal skin of rabbits and hypersensitiveness on guinea pigs, thus it may be used topically. However, it should be curious or avoided to use on damaged skin because of a little irritation on injured skin.