雷马Ⅱ型贴膏皮肤给药毒性实验研究

目的]观察雷马Ⅱ型贴膏对动物皮肤给药的毒性作用,探讨其皮肤用药的安全性。方法]对健康家兔进行皮肤刺激实验并进行评分,对健康家兔进行皮肤急性毒性实验并观察有无急性毒性反应出现,对健康豚鼠进行皮肤过敏实验并进行评分,对wistar大鼠进行慢性毒性实验并观察其一般状态、体重、血常规及生化指标、脏器指数、组织病理变化。结果]雷马Ⅱ型贴膏对家兔完整皮肤无刺激性,对破损皮肤有轻度刺激性,但在给药后24小时消失;对家兔完整皮肤及破损皮肤未引起急性毒性反应;对豚鼠完整皮肤无致敏作用;对wistar大鼠一般状态、体重、血常规及生化指标、脏器指数、组织病理变化均未产生明显影响,未出现慢性毒性反应。结论]雷马Ⅱ型贴膏用于皮肤给药安全、无毒。

Toxicity Study of TDD of Leima Path Ⅱ in Experimental Animals

Objective]By observing the toxicity of transcutaneous drug delivery(TDD) of Leima PathⅡon experimental animals,to explore the safety of TDD of Leima PathⅡ.Methods]Dermal irritation and acute dermal toxicity experiment were performed on healthy rabbits by marking and observing the acute toxic reaction of rabbits;to investigate the allergic reaction value on guinea pigs by performing dermal sensitivity experiment;Long-term toxicity test was performed on Wistar rats by examining general conditions,body weight,blood and urine routines,blood biochemistry indices,weight coefficients of organs and pathological changes.Results]Leima PathⅡhad no irritation to the integral skin and low-grade irritation to the damaged skin of rabbits,but it was disappeared after 24h;no acute toxicity on the integral or damaged skin of rabbits was observed and no hypersensitive effects to the skin of guinea pigs.It had no chronic toxicity on Wistar rats and no significant effect on general conditions,body weight,blood and urine routines,blood biochemistry indices,weight coefficients of organs and pathological changes.Conclusion]Leima PathⅡ used in TDD shows safe and nontoxic.