Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (8): 458-461.

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Special Safety Evaluation on Ibuprofen Injection

CAO Chong1, GAO Mei1, YANG Lin-ke2, ZHANG Ting-ting2   

  1. 1. Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Chemical Drug, Shandong Jinan 250101, China;
    2. Shandong Cancer Hospital and Institute, Shandong Jinan 250000, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

Abstract: Objective To evaluate safety of ibuprofen for injection based on the special safety experiments of ibuprofen injection, Methods Three experiments were used, including hemolysis and blood cell agglutination test in vitro and stimulation test in blood vessel, allergic test induced by ibuprofen injection in guinea pigs, to observe whether ibuprofen injection could induce hypersensitive response, vascular stimulation response, hemolytic reaction and agglutination or not. Results Ibuprofen injection caused no hemolysis and blood cell agglutination when its concentration was 4 mg·mL-1, neither vascular stimulation in rabbits nor allergic reaction in guinea pigs were observed when its concentrations were 4 mg·mL-1 and 25 mg·mL-1 respectively. Conclusion Ibuprofen injection is safe for intravenous injection.

Key words: ibuprofen injection, hemolysis, vascular stimulation, allergic reaction

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