The effect of compatible stability and safety of Omeprazole Sodium for Injection with Coenzyme Q10 Sodium Chloride Injection
WEI Xia
LIU Na
XIE Qiangsheng
GENG Xue
ZHU Qingfen
Abstract：Objective To evaluate the compatible stability and safety of Omeprazole Sodium for Injection with Coenzyme Q10 Sodium Chloride Injection,provide basis for clinical application.Methods Omeprazole Sodium for Injection was dissolved in Coenzyme Q10 Sodium Chloride Injection and Sodium Chloride Injection respectively according to the clinical dose 0.4 mg·mL-1,stay for 4 h,HPLC method was used to determine the content of main component and related substances,investigate the stability of the drug.Allergy test,in vitro hemolysis test,vascular irritation test studies were performed to investigate the safety of the drug.Results The HPLC assay showed no significant difference in the content of the principal component and the related substances.Futhermore,the allergy test and vascular stimulation test are all showed negative results of two test articles at concentration of 0.4 mg·mL-1 solution.In vitro hemolysis test showed negative results of test articles both in concentration of 0.6 mg·mL-1 and 0.24 mg·mL-1.Conclusion Coenzyme Q10 Sodium Chloride Injection had no significant effect on the stability and safety of Omeprazole Sodium for Injection compared to Sodium Chloride Injection.
Keywords：Omeprazole Sodium for InjectionCoenzyme Q10 Sodium Chloride InjectionStabilitySafety
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 215-218,239 )