盐酸左氧氟沙星缓释滴眼液的毒性及刺激性反应  

Toxicity and Irritation of Levofloxacin Hydrochloride Delayed-release Eye Drops

作　　者：张娜[1] 高萍[1] 王文彤[1] 陶遵威[1] 郑夺[1] 

机构地区：[1]天津市医药科学研究所,天津市300020

出　　处：《中国药房》2010年第33期3095-3097,共3页China Pharmacy

基　　金：天津市应用基础研究计划基金资助项目(07JCZDJC05200)

摘　　要：目的:进行盐酸左氧氟沙星缓释滴眼液的安全性评价。方法:采用琼脂扩散法,以褪色指数和溶解指数为指标得到的细胞反应级数评价该滴眼液的体外细胞毒性;20只小鼠一次性静脉注射盐酸左氧氟沙星缓释滴眼液(15mg·kg-1)进行急性毒性实验,观察14d内小鼠死亡数和体质量变化;12只兔敷贴滴眼液(1.5mg·d-1,连续用药7d)进行皮肤刺激性实验,观察末次用药24h后1、24、48、72h的红斑和水肿评分。结果:盐酸左氧氟沙星缓释滴眼液体外细胞毒性反应为1级;14d内小鼠无死亡且体质量变化没有明显差异;兔皮肤红斑和水肿评分均小于0.05,评价均为无刺激性。结论:盐酸左氧氟沙星缓释滴眼液具有良好的生物安全性。OBJECTIVE： To evaluate the safety of Levofloxacin hydrochloride delayed-release eye drops. METHODS： Agar diffusion method was used to evaluate the in vitro cytotoxicity of eye drops according to cellular reaction scale using fading index and dissolving index as index. 20 mice were intravenous injection of drops （15 mg·kg-1） to carry out acute toxicity test. The number of dead mice and the change of body weight were observed in 14 days. 12 rabbits were pasted eye drops （1.5 mg·d-1, lasting for 7 d） to carry out skin irritation test. 24 h after last administration, the score of erythema and edema were observed at 1h, 24 h, 48 h and 72 h. RESULTS： The in vitro cytotoxicity reaction of eye drops was first grade. There was no death and significant difference in body weight in 14 d. The scores of erythema and edema were all lower than 0.05. No irritation was observed. CONCLUSION： Levofloxacin hydrochloride delayed-release eye drops has good biosafety.

关 键 词：盐酸左氧氟沙星缓释滴眼液 体外细胞毒性 急性毒性 皮肤刺激反应 安全性 

分 类 号：R988.1[医药卫生—药品] R318[医药卫生—药学]