摘要
目的评价不同pH值条件下奥硝唑注射液灭菌稳定性。方法根据奥硝唑注射液的制备方法,分别制备pH为3.0、3.5、4.0、4.5的奥硝唑注射液,115℃、30 min灭菌后,评价有关物质的变化情况。结果灭菌以后,奥硝唑输液的有关物质均有所增加,其有关物质含量随着溶液的pH值升高而增加,当pH值>4.0时,其有关物质限量已经超过相关规定。结论奥硝唑注射液的pH值在较低情况下时,灭菌较稳定。
Objective To evaluate the sterilization stability of ornidazole injection under different pH value conditions.Methods The ornidazole injection with different pH value of 3.0,3.5,4.0,4.5 was prepared based on its standard file.The related material of ornidazole injection was evaluated after sterilization.Results The related material of ornidazole injection increased after sterilization.And the related material increased when upgraded the pH value of injections.Conclusion Ornidazole injection is sterilization stable under low pH value.
出处
《医学综述》
2010年第19期3026-3027,共2页
Medical Recapitulate
基金
江苏省企业博士创新基金项目(BK2008522)
江苏省企业院士工作站专项引导资金(BM2009523)
关键词
奥硝唑
PH值
稳定性
Ornidazole
pH value
Stability
