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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 observe the irritant and toxic effects of progesterone cream on the skin of New Zealand white rabbits and the allergic reaction of guinea pig skin to the drug, and to evaluate the main pharmacodynamic effects of progesterone ointment. Methods: Different doses of progesterone cream were applied to white New Zealand rabbits to observe their acute toxicity and irritation. Skin allergy test was conducted in healthy guinea pigs and the activity of progesterone in rabbit endometrial transformation test. RESULTS: Topical progesterone creams were non-toxic to New Zealand white rabbits, non-irritating to intact skin, slightly irritating to damaged skin, and not allergic to guinea pigs. New Zealand white female rabbits The Mcphail indexes of high, medium and low dose groups of control group, positive control group and progesterone cream were 0, 2.88 ± 0.64, 2.50 ± 0.53, 2.12 ± 0.64 and 1.38 ± 0.52, respectively. Conclusion: External progesterone cream is safe, does not produce any toxic reaction, and has some progesterone activity.