国产注射用阿莫西林钠舒巴坦钠的急性毒性研究

Study on the acute toxicity of domestic amoxicillin sodium and sulbactam sodium for injection

目的 研究国产注射用阿莫西林钠舒巴坦钠(AMSB)对小鼠的急性毒性。方法 分别用AMSB 2 500 mg/kg、5 000 mg/kg静脉注射给药和5 000 mg/kg腹腔注射给药对小鼠进行急性毒性试验,并与进口同种产品阿莫西林钠舒巴坦钠(TFM,商品名泰霸猛)、注射用阿莫西林钠(AM)、注射用舒巴坦钠(SB)进行了急性毒性比较。结果 国产AMSB、进口 TFM、AM、SB静脉注射和腹腔注射给药对小鼠的LD_(50)均大于5 000mg/kg。结论 国产AMSB毒性很低,且与进口TFM毒性相同。

Objective To investigate the acute toxicity of domestic amoxicillin sodium and sulbactam sodium for injection (AMSB) in mice.Methods The acute toxicity of AMSB was observed at the doses of 2 500 mg/kg,5 000 mg/kg (iv) and 5 000 mg/kg (ip) in mice respectively, and it was compared with that of imported trifamox (TFW),amoxicillin sodium for injection (AM) ,sulbactam sodium for injection(SB) . Results By giving mice domestic AMSB,imported TFM,AM,SB intravenously or intraperitoneally.the LD50 were all larger than 5 000 mg/kg. Conclusion Domestic AMSB has little toxicity and has the similar toxicity as imported TFM.