【摘要】 目的 :评价黄体酮药膜局部应用安全性。方法 :分别用常规方法进行黄体酮药膜的大鼠急性毒性试验、家兔皮肤刺激试验、大鼠阴道局部刺激试验、豚鼠皮肤致敏性试验。结果 :大鼠阴道给予黄体酮药膜一天的最大耐受剂量为 40 0mg/kg ;家兔皮肤刺激实验结果显示 ,皮肤无红斑、红肿等刺激反应 ;大鼠阴道刺激试验结果显示 ,经阴道给药后子宫无充血、肿胀情况 ,阴道也未见充血与肿胀等炎性反应 ;豚鼠皮肤过敏试验结果未见过敏反应。结论 :黄体酮药膜大鼠一次经阴道途径给药的最大耐受量为 40 0mg/kg ,无皮肤刺激性、阴道局部刺激性与皮肤致敏性 ,临床阴道应用是安全的。更多还原

【Abstract】 Objective: To study the local application of the progesterone pellicle in animals. Methods: Studies on the acute toxicity of SD rats, the irritation on the skin of rabbits, the local irritation of the vagina on rats, and the allergic test on the skin of the guinea pigs were done in the experiment separately by regular methods. Results: The maximal tolerant dose of progesterone pellicle in one day, by vaginal injection, was 400mg/kg (LD 50>400mg/kg); Skin irritation test showed there were no erythema, red swelling and other irritative reactions; After the application of the tested paste in the rats’ vagina both uterus and vagina revealed no inflammations such as hyperaemia and tumescences etc; The allergic test on the skin of the guinea pigs showed no allergic reaction. Conclusion: The LD 50 of progesterone pellicle administed in rats’ vagina was more than 400mg/kg; The progesterone pellicle did not have irritative effect, no allergic effect on skin and local irritative effect on vagina.更多还原