注射用头孢唑肟钠用药安全评价的试验研究

目的：评价注射用头孢唑肟钠制剂用药的安全性。方法：按照国家SFDA颁发的《化学药物刺激性、过敏性和溶血性研究技术指导原则》进行了局部血管刺激性、肌肉刺激性、溶血性和全身主动过敏性试验。结果：①注射用头孢唑肟钠耳缘静脉点滴给药浓度为0.04g/ml,给药容积为2ml/kg时,对试验兔血管无刺激性;②注射用头孢唑肟钠肌肉注射给药浓度为0.25g/ml,给药容积为0.5ml/只时,对试验兔肌肉无刺激性;③注射用头孢唑肟钠药物浓度为0.04g/ml,在体外试验条件下无溶血反应及红细胞凝聚反应;④注射用头孢唑肟钠致敏剂量为0.067和0.133g/kg,激发剂量为0.067和0.133g/kg时,对豚鼠无主动全身过敏性反应。结论：注射用头孢唑肟钠试验条件下无血管和肌肉刺激性、无溶血性及过敏性反应。

Experiment for Security Evaluation of Ceftizoxime Sodium for Injection

Objective To evaluate the safety of Ceftizoxime sodium for injection.Methods According to ＂irritant chemicals,allergic and hemolytic technical research guidelines＂issued by the state SFDA,author did vascular stimulation,muscle stimulation,haemocytolysis and anaphylaxis test.Result ①Ceftizoxime sodium for injection at concentrations of 0.04g/ml and dose of 2ml/kg showed no vascular stimulation ② Ceftizoxime sodium for injection at concentrations of 0.25g/ml and dose volume of0.5ml/only showed no muscle stimulation ③ Ceftizoxime for injection drug concentration 0.04g/ml,no evidences of hemolyzation and aggregation on rabbit erythrocyte in vitro were observed.④Ceftizoxime sodium for injection at the sensitization concentration of 0.067and 0.133g/kg,stimulate concentration of 0.067 and 0.133g/kg,no hypersensitive action was found on Guine pig.Conclusion It was showed that the Ceftizoxime sodium for injection had no vascular stimulation and muscle stimulation effect on rabbit.No evidences of hemolyzation and aggregation on rabbit erythrocyte in vitro were observed.No hypersensitive action was found on Guine pig.