CAJ | 학술논문

目的：观察注射用头孢他啶/他唑巴坦钠（3：1）对大鼠长期毒性作用，评价其临床用药安全性，为临床用药提供参考依据。方法长期毒性实验：SD大鼠120只，随机分为6组，分别为注射用头孢他啶/他唑巴坦钠（3：1）高、中、低剂量组，头孢他啶组，他唑巴坦钠组和阴性对照组，腹腔注射给药，每日一次，连续6周，观察大鼠长期毒性反应。结果长期毒性试验：与单组分组和对照组相比，其他剂量组各项指标均无明显异常表现；摄食量和体重增长、血液学、血液生化学检查的各项指标、脏器系数与单组分组和对照组比较，均未发现明显改变，病理组织检查亦未发现明显病理改变，且受试药无明显迟缓性毒性。结论在该实验条件下，注射用头孢他啶/他唑巴坦钠（3：1）对受试动物未见较单组分长期毒性反应增加，提示其临床用药安全性较高。
목적：관찰주사용두포타정/타서파탄납（3：1）대대서장기독성작용，평개기림상용약안전성，위림상용약제공삼고의거。방법장기독성실험：SD대서120지，수궤분위6조，분별위주사용두포타정/타서파탄납（3：1）고、중、저제량조，두포타정조，타서파탄납조화음성대조조，복강주사급약，매일일차，련속6주，관찰대서장기독성반응。결과장기독성시험：여단조분조화대조조상비，기타제량조각항지표균무명현이상표현；섭식량화체중증장、혈액학、혈액생화학검사적각항지표、장기계수여단조분조화대조조비교，균미발현명현개변，병리조직검사역미발현명현병리개변，차수시약무명현지완성독성。결론재해실험조건하，주사용두포타정/타서파탄납（3：1）대수시동물미견교단조분장기독성반응증가，제시기림상용약안전성교고。
Objective To study the long-term toxicity in rats of Ceftazidime and Tazobactam Sodium for Injection(3:1)to evaluate the clinical safety of medication and develop clinical trials dose and the observed indicators.Methods Long-term toxicity observation:120 SD rats were randomly divided into 6 groups,respectively by the name of high,middle and low dose group of Ceftazidime and Tazobactam Sodium for Injection (3:1),Ceftazidine group,tazobactam sodium group and negative control group.The drug was given by intraperitoneal injection,once daily for 6 consecutive weeks,observing the rat chronic toxicity reaction.Results Long-term toxicity observa-tion:compared with control group and single use group.The indicators are not obviously abnormal;Food intake and weight gained;Hematology,blood biochemistry exami-nation indicators,organ coefficients were not found to significantly change ,compared with single group and control group .The histopathology also found no obvious patho-logical changes,and the reagent had no significant delay toxicity.Conclusion The Ceftazidime and Tazobactam Sodium for Injection(3:1) was not found long-term tox-icity in this experiment condition ,which suggested a high clinical medication safety .