结合雌激素阴道软胶囊初步药效学及局部毒性研究

Studies on pharmacodynamics and local toxicity of conjugated estrogen soft vaginal capsules

目的研究结合雌激素阴道软胶囊的局部毒性及初步药效学。方法家兔阴道给药后考察结合雌激素软胶囊内容物的急性毒性和对阴道黏膜的刺激性;小鼠阴道给药后考察结合雌激素软胶囊内容物对未成年雌性小鼠子宫指数的影响。结果家兔阴道给药7 d后,家兔阴道外观及家兔阴道组织病理切片未见异常;一次性给予家兔相当于人体临床用量75倍剂量时未见家兔出现死亡及饮食、自主活动、行为改变,皮肤、眼睛、黏膜、毛色均无异常,呼吸、心率等指标与对照组比较差异无统计学意义(P>0．05);按低、中、高不同剂量软胶囊内容物小鼠阴道给药后,受试物中剂量组与阳性对照组之间小鼠子宫指数差异无统计学意义(P>0．05),各组与阴性对照组之间差异有统计学意义(P<0．01)。结论结合雌激素阴道软胶囊无局部毒性,具有雌激素活性。

bjective To test conjugated estrogen soft vaginal capsule pharmacodynarnics and local toxicity and its vaginal stimulation. Method The acute toxicity test and stimulation test were carried out on rabbit by vaginal administration. The effect of conjugated estrogens soft vaginal capsules on uterus weight of mice was observed . Result The rabbit vagina given medicine for 7 d, pathology slices abnormality was not observed. The independent activity, skin and hair color of rabbits are normal, meanwhile their respiration, heart rate and body weight have no notable difference between test and control groups （P〉0.05）. Uterus weight was increased after taking low,middle,high dose （P〈0.05）,and middle dose group has no difference compared with positive groups （P〉0.05）. Condusion The results showed that conjugated estrogen soft vaginal capsuls are safe and effective.