摘要
目的评价注射用头孢替坦二钠的安全性。方法对注射用头孢替坦二进行了过敏性、刺激性及溶血性试验。结果豚鼠全身主动过敏性试验及大鼠被动皮肤过敏性试验未见明显过敏反应,兔耳缘静脉及周围组织均未见明显刺激性反应,未引起新西兰兔股四头肌刺激性病理变化,体外溶血试验无溶血和凝集现象。结论该药相关安全性检测结果符合新药申报要求,可供静脉或肌肉注射给药。
Objective To evaluate the safety of Cefotetan disodium for injection. Methods Allergic to cefotetan disodium for injection, hemolysis and irritation tests were studied. Results The results of active systemic anaphylaxis and passive skin allergic test rats had no obvious allergic reaction, rabbit ear vein and surrounding tissues showed no obvious irritation, and cefotetan disodium for injection did not cause the pathological changes of the rabbits unit four quadriceps stimulation, no hemolysis and coagulation phenomenon was occurred. Conclusion These results of the drug safety will fit the application requirements of new drugs. The cefotetan disodium for injection in clinic can be administered intravenously or intramuscularly to the patient.
出处
《中国医药科学》
2016年第23期52-56,共5页
China Medicine And Pharmacy
