“环丙-林可霉素长效注射液”毒理学试验研究  

Study on particial toxicology of long-acting ciprofloxacin and lincomycin compound injection

作　　者：叶兆伟 吴海港 李尽哲 刘锦妮 姬万民 YE Zhaowei;WU Haigang;LI Jinzhe;LIU Jinni;JI Wanmin(Xinyang College of Argriculture and Forestry,Xinyang,Henan Province 464000,China;Research and Creation of New Veterinary Drug Preparations Engineering Technology Research Center of Xinyang,Xinyang,Henan Province 464000,China;Tianjin Ringpu Bio-Technology,Airport Economic Zone,Tianjin 300308,China)

机构地区：[1]信阳农林学院生物与制药工程学院,河南信阳464000 [2]信阳市兽药新制剂研究与创制工程技术研究中心,河南信阳464000 [3]瑞普(天津)生物科技股份有限公司,天津空港经济区300308

出　　处：《中国饲料》2020年第17期44-47,共4页China Feed

摘　　要：为评价新制剂环丙-林可霉素长效注射液的安全性,本研究采用急性毒性试验、溶血性试验、局部刺激性试验和亚慢性毒性试验对兽药新制剂环丙-林可霉素长效注射液安全性进行评价。结果表明:环丙-林可霉素长效注射液小鼠肌肉注射LD_(50)为4.81 mg/kg,LD_(50)的95%可信限为4.50~5.53 mg/kg;该注射液在4 h内不产生溶血现象;肌肉注射部位及周围组织均未见充血、水肿、出血和坏死;肌肉注射部位充血范围0.5 cm×1 cm;以相当于临床用量2倍的剂量涂抹皮肤,停药后1、24、48、72 h观察均未见明显异常变化;对肝脏和肾脏组织学观察表明,治疗剂量和中剂量组肝脏和肾脏组织结构清晰,而高剂量组肾小球内有大量出血,肾间质出现坏死,肝细胞排列紊乱,肝细胞肿胀融合,肝血窦间有大量出血。综上,环丙-林可霉素长效注射液按照治疗剂量在本试验条件下是安全的。The purpose of this study was to evaluated the safety of long-acting ciprofloxacin and lincomycin compound injection by using the acute toxicity test,local irritation test and chronic toxicity test.The results showed that LD50 of long-acting ciprofloxacin and lincomycin compound injection by intramuscrular adminstration in mice was 4.81 mg/kg of its suspension and 95%confidence interval was 4.50 to 5.53 mg/kg,hemolysis or coaeervation in the red blood cells in rabbits did not occur of the injection in 4 h.Pathological changs such as hyperaemia,edema or hemorrhage were not examined in the veins where were injected intravenousiy and their surrounding tissues the hyperaemia ranged below 0.5 cm×1 cm.On the intramuscular injection site,double dose of the clinical doage of the injection was smeared on the rabbit skin,obvious pathological changes were not observed after the drug withdrawal for 1,24,48 h and 72 h.There was no visible pathological changes on the liver,kidney histology.According to pathological observation,the structure of liver and kidney were clear in treated and middle dose groups,but there existed disorganized hepatic cell cord in the liver and hemorrhag between glomerulopathy,tubulointerstitial and hepatic sinusoids in high dose group.

关 键 词：环丙-林可霉素长效注射液 急性毒性 刺激性 安全性评价 

分 类 号：S859[农业科学—临床兽医学]