Safety evaluation of Parecoxib Sodium for Injection / 药物评价研究

ABSTRACT

Objective To evaluate the safety of Parecoxib Sodium for Injection.Methods Systemic active anaphylaxis testGuinea pigs were injected respectively with Parecoxib Sodium for Injection (test sample,20 mg/mL),primary control,sodium chloride injection or human serum albumin,once every other day,continuously for three times.After 14 and 21 d from the end time of sensitization,to stimulation and to observe whether allergic reactions occurred within 30 mins.Passive cutaneous anaphylaxis testGuinea pigs were received 0.1 mL antiserum injection for inducing passive sensitization,after 24 h of that we stimulated the guinea pigs,and the guinea pigs were sacrificed after 30 mins to examine the diameter of blue spots.Blood vessel irritation testAfter continuous ear Ⅳ test sample for 5 d,HE staining was performed at the end of the administration and recovery period,and the stimulation of the blood vessel at the site of injection was observed.Hemolysis or agglutination of Parecoxib Sodium for Injection was examined by in vitro methods.Results Under the dosage of 20 mg/mL,guinea pigs showed no systemic allergy and passive skin allergy,and no hemolysis,agglutination,and irritation of vascular was observed.Conclusion Under the present experimental conditions,20 mg/mL Parecoxib Sodium for Injection shows no obvious allergic reactions,irritation and hemolysis,is safe.