复方阿莫西林纳米乳制剂的安全性评价  

Safety evaluation of compound Amoxicillin and Levofloxacin hydrochloride nanoemulsion

作　　者：杨雪峰[1,2] 姜金庆[1] 孙红武[2,3] 欧阳五庆[2] 

机构地区：[1]河南科技学院动物科学学院,河南新乡453003 [2]西北农林科技大学动物医学院,陕西杨凌712100 [3]第三军医大学药学院,重庆400038

出　　处：《河南农业大学学报》2011年第5期562-567,共6页Journal of Henan Agricultural University

基　　金：国家科技支撑计划项目(2006BAD04A11)

摘　　要：通过急性毒性试验、皮肤刺激性试验和细胞毒性试验,对复方阿莫西林纳米乳(AMX-LH-NE)进行体内外安全性评价.结果表明,AMX-LH-NE毒性低,无法测出其半数致死量,小鼠的最大耐受量倍数为426倍;无论是单次给药,还是多次给药,AMX-LH-NE对完整皮肤和破损皮肤均无明显刺激性;AMX-LH-NE为10～150 mg.L-1时,对乳腺上皮细胞的生长和形态无明显影响,其毒性分级属于0或1级,即对乳腺上皮细胞无毒性作用.The safety of compound Amoxicillin and Levofloxacin hydrochloride nanoemulsion （AMX- LH-NE） was evaluated in vivo and in vitro by acute toxicity test, skin irritation test and cytotoxic test. The results showed that the toxicity of AMX-LH-NE was low and its half lethal dose was impossibly measured. The maximum tolerable dose to mice was 426 times. Obvious irritation didn＇ t appear regardless of single or multiple dosing when AMX-LH-NE was used on complete and damaged skin of rabbits respectively. There was no obvious influence of AMX-LH-NE on growth and appearance of mammary epithelial cells at the concentration of 10 to 150 mg ·L-1, and its toxicity grade was 0 or 1. In other words, AMX-LH-NE had no cytotoxicity against mammary epithelial cells.

关 键 词：复方阿莫西林纳米乳 急性毒性 皮肤刺激性 细胞毒性 安全性评价 

分 类 号：S859.83[农业科学—临床兽医学]