ABSTRACT
Objective To evaluate the safety of Parecoxib Sodium for Injection.Methods Systemic active anaphylaxis test:Guinea 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 test:Guinea 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 test:After 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.
ABSTRACT
Objective To evaluate the safety of Parecoxib Sodium for Injection.Methods Systemic active anaphylaxis test:Guinea 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 test:Guinea 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 test:After 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.
ABSTRACT
AIM To study the hemolyzation of a highly active anti complementary protein (cobra venom factor, CVF) isolated from the venom of Naja kaouthia distributed in the south of Yunnan Province, China. METHODS Guinea pig red blood cell and serum were employed to evaluate the hemolyzation of this anticomplement factor, and the effects of temperature, pH, various bivalent mental ions and EDTA on its hemolyzation were investigated. RESULTS This anticomplement factor possessed hemolytic activity of 1 391 kU?g -1 protein. It showed high stability to heat, alkalinity and acidity. Ca 2+ , Mg 2+ , Mn 2+ promoted the hemolyzation of this anticomplement factor at 1, 2 and 5 mmol?L -1 . Zn 2+ , Co 2+ also promoted the hemolyzation of this anticomplement factor at 1 and 2 mmol?L -1 , but inhibited the hemolyzation at 5 mmol?L -1 . Cu 2+ strongly inhibited the hemolyzation at 1, 2 and 5 mmol?L -1 . EDTA also strongly inhibited the hemolyzation of this anticomplement factor. CONCL- USION The anticomplement factor showed hemolytic activity. This ability could be influenced by bivalent metal ions and EDTA, but rather stable when temperature or pH value changed.