In order to evaluate the safety of altrenogest oral solution to sows, 24 heads Sujiang sows were randomly divided into 4 groups with 6 head in this test, objective is to study the safety of target animals by multi dose administration, which is the maximum recommended dose per animal daily 20 mg altrenogest ( equivalent to 5 mL each time) , 2 times the maximum recommended dose each animal daily 40 mg altrenogest ( equivalent to 10 mL each time) and 3 times the maximum recommended dose per animal daily 60 mg altrenogest ( equivalent to 15 mL each time) ;another control group, each animal gave 15 mL clean tap water, the volume is equivalent to 3 times the recommended drugs dose volume. Through the clinical observation, the weight of each group of animals, hematology and blood biochemical parameters and histopathological examination or observation, to evaluate the safety of clinical use of altrenogest. The results showed that the sows in each group did not die and were in good health during the trial period. The clinical manifestations were normal. The pathological changes were not found in the tissues of 3 times the maximum recommended dose groups. The recommended dose group, 2 times the recommended dose group and the 3 times the maximum recommended dose group compared with the blank control group, there were no significant differences in the hematology and blood biochemical parameters. The test results show that altrenogest oral solution has high safety at the recommended dose for sows.%为评价烯丙孕素口服液对猪的安全性,将24头达到性成熟的苏姜母猪随机分为4组,每组6头,采用多剂量水平给药进行靶动物安全性研究,其中受试药物设最大推荐剂量每头动物每日20 mg烯丙孕素(相当于每次5 mL)、2倍最大推荐剂量每头动物每日40 mg烯丙孕素(相当于每次10 mL)和3倍最大推荐剂量每头动物每日60 mg烯丙孕素(相当于每次15 mL)三个剂量组;另设一空白对照组,每头动物每日15 mL洁净自来水,体积相当于3倍受试药推荐剂量的体积.通过一般临床观察、各组动物体重、血液学和血液生化学参数等指标及组织病理学检测或观察,评价烯丙孕素在临床用药的安全性.结果表明,试验期间各组猪均未死亡且健康良好,期间临床表现正常,3倍最大推荐剂量组剖检动物各组织器官未发现病理变化.在血液生理指标及生化指标方面,推荐剂量组、2倍推荐剂量组、3倍最大推荐剂量组与空白对照组相比,除少部分指标外,其他各指标并无显著差异.试验结果说明,烯丙孕素在推荐剂量下使用在靶动物猪上具有较高的安全性.
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