硫酸头孢喹肟脂质体的毒理学试验及安全性评价

Toxicology Test and Safety Evaluation of Cefquinome Sulfate Liposomes

采用急性毒性试验、局部刺激性试验和亚慢性毒性试验对硫酸头孢喹肟脂质体安全性进行评价,以期为临床用药提供参考。小鼠腹腔注射硫酸头孢喹肟脂质体半数致死量(LD50)为639.73mg/kg,95%可信限为573.06~714.17mg/kg;该制剂对家兔股四头肌未见明显刺激作用;各给药剂量组家兔的体重、血液学指标、生化指标与对照组比较均无显著差异(P>0.05);对肝脏和肾脏病理学观察表明,正常治疗剂量和中剂量组肝脏和肾脏组织结构清晰,但高剂量组出现肝细胞排列紊乱,肝血窦间出血,肾小球、肾间质有散在出血。以上结果表明硫酸头孢喹肟脂质体安全可靠,可应用于兽医临床。

The purpose of this study was to evaluate the safety of the cefquinome sulfate liposomes by using the acute toxicity test,local irritation test and chronic toxicity test.The results showed that the LD_（50） of cefquinome sulfate liposomes was 639.73mg/kg after intramuscular injection of its suspension and 95% confidence interval was 573.06 to 714.17mg/kg.There was no significant stimulation to muscle.Subchronic toxicity test showed that the weight,haematological indexes and biochemical criterion of rabbits in variety dose had no significant difference compared with normal group（P〈0.05）.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.All results proved that the cefquinome sulfate liposomes was safe and reliable based on the animal experiments.