摘要
目的考察依地酸二钠对注射用艾司奥美拉唑钠质量的影响,确定处方中依地酸二钠的添加量。方法考察不同的金属离子、包材浸提液对艾司奥美拉唑钠溶液澄明度影响,考察不同用量依地酸二钠的中间体溶液稳定性,冻干成品的质量,确定注射用艾司奥美拉唑钠处方中的依地酸二钠用量。并进行注射用艾司奥美拉唑钠的加速和长期稳定性试验考察。结果依地酸二钠最佳用量为1.5mg/瓶。按照优化处方工艺制备注射用艾司奥美拉唑钠,产品质量合格,且在加速和长期试验过程中质量稳定。结论确定处方中加入依地酸二钠可改善药品的澄明度及药物的稳定性。
OBJECTIVE To investigate the influence of edetate disodium on the quality of esomeprazole lyophilized preparation and to confirm the best adding quantity of edetate disodium in esomeprazole lyophilized preparation. METHODS The influences of metal ion solutions and extracts of packing materials on the clarity of esomeprazole solution were investigated thoroughly. The amount of edetate disodium added was confirmed based on the results of stability test of the esomeprazole liquor prepared with different amount of edetate disodium. The accelerated and long term stability of esomeprazole lyophilized preparation was tested. RESULTS The best adding quantity of edetate disodium is 1. 5mg for each preparation unit. The quality of esomeprazole injections prepared according to the optimized formulation and process are qualified and stable during the accelerated and long term stability test. CONCLUSION Edetate disodium added to the formulation could improve the clarity and stability of esomeprazole preparations.
出处
《海峡药学》
2017年第1期6-9,共4页
Strait Pharmaceutical Journal
