注射用乳糖酸阿奇霉素安全性的再评价

目的评价用精制国产乳糖酸阿奇霉素原料药生产的注射用乳糖酸阿奇霉素 (AZL)的安全性。方法采用了血管刺激性实验、豚鼠致敏性实验、溶血实验。结果兔耳缘静脉滴注AZL未见对血管有明显的变性和坏死等严重刺激反应 ;豚鼠致敏试验未引起豚鼠的过敏反应 ;药物质量浓度为 10 g·L-1时 3h内未引起溶血现象。结论国产注射用乳糖酸阿奇霉素按临床常用剂量给药是安全的

Safety re-evaluation of azithromycin lactobionate for injection

Objective To re-evaluation safety of azithromycin lactobionate (AZL) for injection produced by refined raw material drug.Methods Some experiments were used,including allergic test induced-by AZL and MSR in guinea pigs,haemolysis test in vitro and stimulation test to blood vessel in rabbits.Results Serious stimulation such as denaturation and necrosis was not seen in rabbits' ear-rim auricular vein after given AZL. Allergic reaction was not occurred in guinea pigs. In vitro,AZL 10 g·L -1 didn't cause haemolysis within 3 h. Conclusion AZL made in China can be safe when it is used according to clinical dosage.