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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
【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.
【Abstract】 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.
【Key words】 compound Amoxicillin and Levofloxacin hydrochloride nanoemulsion; acute toxicity; skin irritation; cytotoxicity; safety evaluation;
- 【文献出处】 河南农业大学学报 ,Journal of Henan Agricultural University , 编辑部邮箱 ,2011年05期
- 【分类号】S859.79
- 【被引频次】4
- 【下载频次】226