碱式硫酸铁溶液的稳定性考察

A Study on Inspect the Stability of the Basic Ferric Sulfate Solution

目的对更改处方后的碱式硫酸铁溶液的稳定性进行加速及长期考察。方法依据《中国人民解放军医疗机构制剂规范》中对碱式硫酸铁溶液的鉴别、检查、无菌、含量测定项及《中国药典》(2010年版二部)附录ⅪⅩC中《原料药与药物制剂稳定性试验指导原则》进行试验。结果新处方配制的碱式硫酸铁溶液,化学性质稳定,其鉴别、检查、无菌、含量测定各项结果均符合《中国人民解放军医疗机构制剂规范》要求。结论新处方配制的碱式硫酸铁溶液无需避光保存,具有很好稳定性,可在室温下保存3年。

Objective To investigate the long-term stability of the Basic Ferric Sulfate Solution after of the new prescription was changed. Methods The experiment was based on the pharmaceutical practice of medical insti- tutions of the Chinese Peopleg Liberation Army and the 2010 version of China Pharmacopoeia Appendix XIX C. Re- stilts The chemical stability, identification, inspection and asepsis of the new prescription were all up to the stand- ard. Conclusion The Basic Ferric Sulfate Solution made by the new prescription is steady in the sun, and it can be stored for three years at room temperature.