Safety evaluation of Parecoxib Sodium for Injection
10.7501/j.issn.1674-6376.2017.08.010
- VernacularTitle:注射用帕瑞昔布钠特殊安全性评价
- Author:
jiao Feng HUANG
1
;
Sen WU
;
hui Ping WANG
;
Ju ZHANG
;
qing Da ZHOU
Author Information
1. 湖北省食品药品监督检验研究院
- Keywords:
Parecoxib Sodium for Injection;
safety evaluation;
allergy;
irritation;
Hemolyzation
- From:
Drug Evaluation Research
2017;40(8):1090-1093
- CountryChina
- Language:Chinese
-
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.
