亚甲基水杨酸杆菌肽可溶性粉在靶动物兔的安全性试验

Target Animal Safety Test of BMD Soluble Powder in Rabbits

关键词:  亚甲基水杨酸杆菌肽  兔  靶动物  安全性试验

Key words:  bacitracin methylene disalicylate (BMD)  rabbit  target animal  safety test

摘要:

为评价亚甲基水杨酸杆菌肽可溶性粉对靶动物兔用药的安全性，32只健康成年新西兰兔随机分为4组，每组8只（公母各半）。试验采用多剂量水平给药进行靶动物安全性研究，其中受试药物分别设1倍推荐剂量组（6 mg/kg/d）、3倍推荐剂量组（18 mg/kg/d）和5倍推荐剂量组（30 mg/kg/d），另设一空白对照组。受试药经混饮给药，连用21 d。用药期间通过观察一般临床表现、体重和摄食量变化，血液学和血液相关生化指标的检测以及大体和组织病理学检查，确定受试药的靶动物安全性。结果表明，试验期间所有受试动物均存活，对照组和受试药组临床表现均正常，病理剖解主要脏器无明显眼观病理变化。与对照组相比，亚甲基水杨酸杆菌肽可溶性粉按推荐剂量给药对兔的生长性能有正性作用；3倍和5倍剂量组促进作用不明显。在血液生理指标及生化指标方面，各试验组之间无显著性差异。剖检后对主要脏器进行大体和显微病理学检查未见明显病变，个别高剂量组中的兔肝组织出现部分肝细胞肿胀现象。靶动物安全性实验结果表明，亚甲基水杨酸杆菌肽可溶性粉按推荐剂量连续给药21 d具有较大的安全性。

Abstract:

To evalutate the safety of bacitracin methylene disalicylate (BMD) soluble powder to rabbits, thirty-two healthy adult New Zealand rabbits were randomly divided into 4 groups, 8 in each group(female and male half). The safety of target animals was studied by using multiple dose levels, each group was given BMD soluble powder with water at dosage of 0 ppm，recommended dosage(6 mg·kg-1·d-1), 3 times of recommended dosage(18 mg·kg-1·d-1) and 5 times of recommended dosage(30 mg·kg-1·d-1) for 21 d continuously. During the experiment, clinical observation, weight change observation, general pathology examination, clinical hematologic studies, blood biochemistry examination and histopathological examination were undertaken. The results showed that all the tested animals survived during the test, and the clinical manifestations of the control group and the test drug group were normal. There were no obvious pathological changes in the pathological anatomy of the main organs. Compared with the control group, the recommended dose group had a positive effect on the growth performance of rabbits; the three-fold and five-fold dose groups had no obvious positive effect. There were no significant differences between the experimental groups in blood physiological and biochemical parameters. Gross and microscopic pathological examinations of major organs after necropsy showed no obvious lesions, and some liver cells in some high-dose groups showed hepatocyte swelling. The results of the safety test of the target animals showed that it was safe for rabbits to use BMD soluble powder at the recommended dose for 21 d continuously.