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目的:观察0.4%布洛芬注射液对肌肉局部及血管的刺激性。方法:将试药、对照药和生理盐水(空白对照)分别肌肉注射家兔左、右股四头肌,连续给药3 d,平行3组,肉眼观察注射部位并组织病理学检查;将试药、对照药和生理盐水(空白对照)分别静脉注入家兔耳静脉右、左耳,连续给药3 d,平行3组,肉眼观察并将给药部位的静脉血管进行病理切片观察。结果:对照组和受试药及空白组各3块股四头肌标本中,,肉眼观察均无红肿、出血等刺激反应。病理组织学观察,对照组和受试药组各标本肌组织结构完整,肌束结构清晰细胞形态未见异常;家兔静滴0.4%布洛芬注射液30 ml后,肉眼观察,血管无充血、水肿、硬结等现象,注射时动物无嘶叫和挣扎等反应,病理组织学检查受试物组与对照组兔耳组织结构比较,未见明显差异。结论:根据《化学药物研究技术指导原则》-2005判断,布洛芬注射液肌肉、血管刺激实验符合规定。
Objective: To observe the stimulation of 0.4% ibuprofen injection on muscle and blood vessels. Methods: The left and right quadriceps muscles of rabbits were intramuscularly injected with the test drug, the control drug and the saline (blank control) respectively. The rabbits were dosed continuously for 3 days with 3 groups in parallel. The injection sites were observed with the naked eye and histopathologically. The medicine, the control medicine and the saline (blank control) were injected intravenously into the right and left ear of rabbits’ ear veins for 3 consecutive days. The rabbits were randomly divided into 3 groups. The venous blood vessels of the administration site were observed by the naked eye. Results: The control group and the test drug and the blank group of three quadriceps specimens, the naked eye showed no swelling, bleeding and other stimuli. Histopathological observation, the control group and the test group of the specimens of the muscular tissue integrity, muscle structure clear cell morphology was normal; rabbit intravenous infusion of 0.4% ibuprofen 30 ml, macroscopic observation, blood vessels without congestion , Edema, induration and so on. There was no screaming or struggling reaction at the time of injection. There was no significant difference in the histological structure between the test group and the control group. Conclusion: According to “Chemical Guiding Technical Guidelines” -2005 judgment, ibuprofen injection muscle, vascular stimulation test in line with the provisions.