关键词: 埃索美拉唑, 溶媒, 稳定性

Abstract: Objective To investigate the stability influence of esomeprazole sodium for injection combined pharmacotherapy with different solvents. Methods 40 mg esomeprazole sodium for injection was respectively dissolved in 100 mL water for injection, 0.9% sodium chloride, 5% glucose, 10% glucose, 5% glucose and sodium chloride injection. The concentrations of esomeprazole in different solvents were detected by high performance liquid chromatography at the time 0, 0.5, 1, 2, 4, 6, 12, 24 hours. The pH value of the solution was measured regularly and the color/clarity change of the solution was observed. 100 mL solution was prepared by solvent with best stability above, then 10 mL levofloxacin injection, somatostatin for injection, amoxicillin and clavulanate potassium, ambroxol hydrochloride injection, compound amino acid injection, mannitol injection, fructose diphosphate sodium for injection, sodium potassium magnesium calcium glucose injection were added. The color/clarity change was observed at 0, 0.5, 1, 2, 4, 6, 12, 24 hours. Results There were no significant changes on content, pH value and color/clarity within 24 h after being mixed with 0.9% sodium chloride. But when the esomeprazole was dissolved in water for injection, 5% glucose, 10% glucose, 5% glucose and sodium chloride injection, the content, pH value, and color/clarity all had different degrees of change. Esomeprazole combined with levofloxacin and amoxicillin and clavulanate potassium, the color/clarity had no obvious change after 24 hours. Combined with compound amino acid and mannitol injection, the color was changed after 6 hours, the color and clarity changed immediately when combined with somatostatin, ambroxol hydrochloride injection, fructose diphosphate sodium for injection and sodium potassium magnesium calcium glucose injection. Conclusion The concentration, pH value, color was stable when esomeprazole sodium for injection was dissolved in 0.9% sodium chloride. The color easily changed when esomeprazole combined with compound amino acid and mannitol injection, attention should be paid in the clinic. There were incompatibilities when esomeprazole combined with ambroxol hydrochloride injection, fructose diphosphate sodium for injection, sodium potassium magnesium, calcium and glucose injection, should be avoided in the clinical use.

Key words: esomeprazole, solvent, stability