烯丙孕素口服液对靶动物猪的安全性研究

Study on the Saffty of Altrenogest Oral Solution to Sows

关键词:  猪  烯丙孕素  靶动物安全性

Key words:  sows  altrenogest  safety of target animals

摘要:

本试验将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20mg烯丙孕素(相当于每次5ml)、2倍最大推荐剂量每头动物每日40mg烯丙孕素(相当于每次10ml)和3倍最大推荐剂量每头动物每日60mg烯丙孕素(相当于每次15ml)三个剂量组；另设一空白对照组,每头动物每日15ml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,其它各指标并无显著差异。试验结果说明,宁波第二激素厂生产的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。

Abstract:

This test will reach 24 heads Sujiang sows were randomly divided into 4 groups with 6 head, the dose level of drug safety research animal tested drug target, which is the maximum recommended dose per animal daily 20mg altrenogest (equivalent to 5ml each time, 2 times the maximum recommended dose) each animal daily 40mg altrenogest (equivalent to 10ml each time) and 3 times the maximum recommended dose per animal daily 60mg altrenogest (equivalent to every three 15ml) dose group; another control group, each animal daily 15ml 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 pigs in each group did not die during the trial period and were in good health. During the period, the clinical manifestations were normal. The pathological changes were not found in the tissues of 3 times the maximum recommended dose groups. Compared with the blank control group, there were no significant differences in the physiological indexes and biochemical indexes of the blood, the recommended dose group, 2 times the recommended dose group, and the 3 times the maximum recommended dose group. The test results show that the second hormone factory in Ningbo produced by the use of the recommended dose in the target animals with high safety.