加米霉素注射液对靶动物猪的安全性试验研究

加米霉素(gamithromycin)是一种新型动物专用大环内酯类半合成抗生素,目前国内暂无加米霉素在靶动物猪的相关用药研究。为了研究加米霉素注射液按照临床推荐剂量(6mg/kg·B·W)用于靶动物猪的安全性,试验选用24头健康二元断奶仔猪(70日龄左右),随机分为4组,每组6头,设1组为对照组,其余为1倍剂量组(6mg/kg·B·W),3倍剂量组(18mg/kg·B·W)和5倍剂量组(30mg/kg·B·W)。猪颈部肌肉注射给药,连续3d,每天1次,持续至最后1次给药后第15天。结果显示：与未给药前相比,加米霉素各剂量组和对照组猪精神状态、呼吸特征、采食、饮水和粪尿排泄均正常,未表现异常反应。与对照组相比,加米霉素注射液各剂量组猪给药前(第0天)、最后一次给药后的第8天、第15天的增重和增重率无显著差异;且给药前(第0天)、最后1次给药后的第1天、第8天、第15天血常规和血液生化指标差异均不显著;宰杀后经肉眼观察,加米霉素注射液各剂量组猪的心、肝、脾、肺、肾、胰腺、胃、十二指肠、空肠、回肠、直肠、淋巴结、肾上腺和脑组织表面未出现显著的病理变化。HE染色,与对照组相比,5倍剂量组猪的上述组织均未发生显著病理变化。表明加米霉素注射液在临床使用中按“肌肉注射,每千克体重,猪6mg,每天1次,连续给药3d”的用法和用量使用,安全、无明显不良反应。

Study on the target animal safety of gamithromycin injection on pigs

Gamithromycin is a new kind of animal specific semi-synthetic antibiotic of macrolides. There was no study on the application of gamithromycin in target pigs. In order to investigate the clinical recommended dose of gamithromycin used for the safety of target pig, 24 healthy binary weaned piglets (about 70 days age) were chosen. These piglets were randomly divided into 4 groups, the control group, the one time dose group (6mg/kg·B·W), the three times dose group (18 mg/kg·B·W), and the five times dose group (30mg/kg·B·W). The drug was injected into neck muscles for 3 consecutive days, then the experiment lasted for 15 days after the last injections. The results showed that there were no abnormal reactions and no significant differences in mental state, respiratory characteristics, feeding, drinking, and fecal and urine excretion among the four groups. Gamithromycin did not influence the body weight, the blood routine, and the blood biochemical indexes. Compared with the control group, no significant pathological changes were observed on the surface of the heart, liver, spleen, lung, kidney, pancreas, stomach, duodenum, jejunum, ileum, rectum, lymph node, adrenal gland, and brain of the pigs among the four groups, and the HE staining also showed no significant pathological changes in the five times dose group. The results indicated that the usage and dosage of gamithromycin injection in clinical use were safe and did not lead to obvious adverse