药学研究2017，Vol.36Issue(4)：215-218,239,5.DOI:10.13506/j.cnki.jpr.2017.04.008
注射用奥美拉唑钠配伍辅酶Q10氯化钠注射液的稳定性和安全性
The effect of compatible stability and safety of Omeprazole Sodium for Injection with Coenzyme Q10 Sodium Chloride Injection
摘要
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.关键词
注射用奥美拉唑钠/辅酶Q10氯化钠注射液/稳定性/安全性Key words
Omeprazole Sodium for Injection/Coenzyme Q10 Sodium Chloride Injection/Stability/Safety分类
医药卫生引用本文复制引用
魏霞,刘娜,谢强胜,耿雪,祝清芬..注射用奥美拉唑钠配伍辅酶Q10氯化钠注射液的稳定性和安全性[J].药学研究,2017,36(4):215-218,239,5.基金项目
山东省中医药科技发展计划项目(No.2015-161) （No.2015-161）
