右旋布洛芬注射液安全药理学研究

Safety pharmacology research on Dexibuprofen injection

目的评价右旋布洛芬注射液对动物中枢神经系统、心血管系统及呼吸系统的影响。方法通过小鼠自主活动试验、运动协调试验和戊巴比妥钠催眠/睡眠试验,考察右旋布洛芬注射液对中枢神经系统的影响;通过对清醒Beagle犬遥测心电图、血压和呼吸指标的检测,考察右旋布洛芬注射液对心血管系统和呼吸系统的影响。结果右旋布洛芬注射液20、40、80 mg/kg剂量时对小鼠自主活动、爬杆行为均无显著影响,剂量为80 mg/kg时与戊巴比妥钠诱导的小鼠催眠/睡眠具有协同作用;剂量为10、20、40 mg/kg时对Beagle犬中枢神经系统、心血管系统和呼吸系统均没有显著影响。相同剂量条件下,右旋布洛芬注射液与布洛芬注射液比较,不良反应未见增加。结论右旋布洛芬注射液对自主活动、运动协调能力、心血管系统和呼吸系统没有显著影响,大剂量时与戊巴比妥钠诱导小鼠催眠/睡眠有协同作用。

Objective To study the effects of Dexibuprofen injection on the central nervous, cardiovascular and respiratory systemsin animals. Methods The effect of Dexibuprofen injection on central nervous system was observed by autonomic activitiesexperiment, mice concordant ability experiment and hypnotize experiment induced by pentobarbital. The effects of Dexibuprofeninjection on circulatory system and respiratory system were observed by measuring the implanted telemetry system, blood pressure,ECG~ respiratory rate and tidal volume of Beagle＇s dogs. Results Dexibuprofen injection （80 mg/kg） showed synergistic actionwith pentobarbital, and no significant effects on autonomic activities and concordant ability at doses of 20, 40 and 80 mg/kg in mice.Dexibuprofen injection at doses of 10, 20 and 40 mg/kg had no effect on the central nervous, cardiovagcular and respiratory systems.In the same dose, the adverse reaction of Dexibuprofen injection was not increased compared with Ibuprofen injection. ConclusionDexibuprofen injection （mice 40 mg/kg, dog 40 mg/kg） has none toxicity on cardiovascular, respiratory and central nervous systems,but at the dose of 80 mg/kg in mice has obvious effect on central nervous system.