摘要
目的探讨抗氧剂对注射用奥美拉唑钠药液稳定性的影响。方法用奥美拉唑钠原料进行碱度试验,结合制剂工艺筛选过程中不同的pH值对药液稳定性的影响,考察抗氧剂与奥美拉唑钠配伍后药液的外观和pH值变化。结果加入抗氧剂后,奥美拉唑钠药液的外观和pH值均符合要求,稳定性提高。结论pH值高低是影响注射用奥美拉唑钠稳定性的主要因素,在一定pH值条件下加入抗氧剂可进一步提高药液稳定性。
Objective To study the effect of antioxidant on the stability of Omeprazole sodium for injection's solution. Methods The Omeprazole sodium was used to carry out the alkalinity experiment. According to the impact of different pH value on the stability of the solution in the process of preparation by screening, the solution's outward appearance and the change of its pH value were inspected after the antioxidant was mixed with the Omeprazole sodium. Results After added the antioxidant, the outward appearance and pH value of Omeprazole Sodium are accordant with request, and its stability was improved. Conclusion The value of pH is the major factor that can affect the stability of Omeprazole sodium for injection, and to add an antioxidant under certainpH value condition can further improve its stability.
出处
《现代食品与药品杂志》
2007年第5期48-50,共3页
JOurnal of Modern Food and Pharmaceuticals
关键词
奥美拉唑钠
抗氧剂
稳定性
Omeprazole Sodium
antioxidant
stability