甲磺酸培氟沙星注射液特殊安全性试验研究

目的:观察甲磺酸培氟沙星注射液的过敏性、溶血性和血管刺激性,为其临床静脉给药的安全性提供参考。方法:过敏性采用豚鼠全身主动过敏试验(ASA)和大鼠被动皮肤过敏试验(PCA);溶血性采用常规体外试管法;刺激性采用家兔同体左右侧自身对比法。结果:甲磺酸培氟沙星注射液豚鼠全身主动过敏试验和大鼠被动皮肤过敏试验均呈阴性;对家兔红细胞无溶血和凝集反应;对家兔耳静脉给药部位无明显刺激性;结论:试验所用的甲磺酸培氟沙星注射液静脉滴注给药符合临床用药安全性要求。

Safety study on pefloxacin mesylate injection

Objective：To investigate the allergia,haemolyticus and vascular irritation of pefloxacin mesylate injection for the sake of safe clinical administration.Methods：Active systemic allergic guinea pig test（ASA） and the rat passive cutaneous anaphylaxis test（PCA） were used as sensitization testing;haemolyticus was determined by conventional haemolytic in vitro test tube method and irritation by comparing left and right side of body.Results：Pefloxacin mesylate injection showed negative results in both active systemic allergic test on guinea pig and passive cutaneous anaphylaxis test on rat.No hemolysis of rabbit red blood cells and the agglutination reaction were observed.And intravenous drip showed no obvious irritation.Conclusions：The pefloxacin mesylate injection meet the security requirement for clinical administration.