黄体酮乳膏皮肤安全性及初步药效学研究

A study on the cutaneous safety and initial pharmacodynamics of progesterone cream

目的:观察黄体酮乳膏对新西兰白兔皮肤的刺激性及毒性反应及豚鼠皮肤对此药的过敏反应,并评价黄体酮软膏的主要药效学作用。方法:不同剂量的黄体酮乳膏用于白色新西兰兔,观察其产生急性毒性反应及刺激性情况;用健康豚鼠进行皮肤过敏试验;采用兔子宫内膜转化试验来检测孕激素的活性。结果:局部应用黄体酮乳膏后,它对新西兰白兔无毒性,对完整皮肤无刺激性,对破损皮肤有轻度刺激性,并且对豚鼠也不起过敏反应;新西兰雌性未成年白兔空白对照组、阳性对照组及黄体酮乳膏剂高、中、低剂量组的Mcphail指数分别为0、2.88±0.64、2.50±0.53、2.12±0.64、1.38±0.52。结论:外用黄体酮乳膏是安全的,不产生任何毒性反应,并有一定的孕激素活性。

Objective：To evaluate the irritation,toxicity,hypersensitive on animal skin and the pharmacodynamics function of progesterone cream.Methods：To observe acute toxicity and irritation of progesterone cream,which smearing on the alba-New Zealand rabbits with different dosage,the cutaneous hypersensitivity test was performed on the skin of cavia cobaya;detecting progestational activity by proliferation of rabbit endometrium.Results：Progesterone cream had no remarkable toxicity to the intact or damaged skin of rats,and had no irritation to the intact skin of rabbits,but the mild irritation to the damaged skin was observed.progesterone cream had no hypersensitive effects on the intact skin of cavia cobaya.The mephail index in young female rabbits of different dosagegroups were：0,2.88±0.64,2.50±0.53,2.12±0.64,1.38±0.52 respectively.Conclution：It is safe to use progesterone cream which no any toxic reaction,and possess invariable progestational activities.