摘要
目的:探讨泮托拉唑钠冻干粉针剂的生产工艺研究。方法:通过调节pH及加入适当比例的依地酸二钠(EDTA-2Na)使泮托拉唑钠冻干粉针达到良好的物理性质。结果:加入0.2%EDTA-2Na及配制好的泮托拉唑钠药液pH调到10.8~11,制成的粉针剂外观及溶液稳定性良好。结论:该方法较好地解决了泮托拉唑钠冻干粉针剂生产过程中出现的问题。
Objective: To explore the improved preparation methods of pantoprazole sodium freeze-dried powder injections. Method : Adjusting pH and adding appropriate proportion of EDTA-2Na were employed to improve the physical properties of pantoprazole so- dium freeze-dried powder injections. Result: When the pH was 10. 8-11 and the concentration of EDTA-2Na was 0. 2% , the freeze- dried powder showed better appearance and stability in solution. Conclusion: Both of the two methods can solve the problems in prepar- ing pantoprazole sodium freeze-dried powder injections.
出处
《中国药师》
CAS
2011年第11期1600-1601,共2页
China Pharmacist
关键词
泮托拉唑钠
冻干粉针剂
生产工艺
Pantoprazole
Freeze-dried powder injections
Preparation process