复方地麻滴鼻剂的稳定性考察

Stability Observation of Co Dexamethasone-Ephedrine Nartistillae

目的:建立二阶导数光谱法和使用微生物检定法测定复方地麻滴鼻剂中地塞米松和庆大霉素的含量,考察复方地麻滴鼻剂的稳定性。方法:应用二阶导数光谱法和微生物检定法,不经分离,直接测定滴鼻剂中地塞米松和庆大霉素的含量,并用经典恒温加速实验法对复方滴鼻剂的稳定性进行研究。结果:地塞米松和庆大霉素在复方地麻滴鼻剂中比较稳定。结论:本法准确、灵敏、简便,适用于制剂常规检测。复方地麻滴鼻剂比较稳定,符合医院制剂所规定的贮存期限的要求。

Objective:To establish second order derivative spectroscopy and use microbial method to determine the con- tent of Dexamethadsone and Gentamycin in Co Dexamethasone-Ephedrine naristillae.To examine the stability of this preparation.Methods:Without separation,the content of Dexamethadsone and Gentamycin in Co Dexamethasone-Ephedrine naristillae were directly determined with second order derivative spectroscopy and microbial method,respectively.And the stability of Co Dexamethasone-Ephedrine naristillae also be examined with classic constant temperature accelerated tests.Results:Dexamethadsone and Gentamycin were stable in this preparation.Conclusion:This method is accurate,sensitive and simple.It is suitable for routine determination of prepartions.Co Dexamethasone-Ephedrine naristillae is rather stable in the room temperature,which is according with the request of the limit time of storage for the hospital preparations.