Preparation and Quality Control of Sterilized Neomycin Sulfate Solution / 中国药房

ABSTRACT

OBJECTIVE:To optimize the optimal formulation of sterilized neomycin sulfate solution and to study its quality stability.METHODS:Sterilized neomycin sulfate solutions of various formulations were prepared;the alteration of color,pH value and content were taken as the index to optimize the optimal preparation;the stability of which was determined before comparing with the determination results of the reserved samples.RESUITS:The solution would not turn yellow after steril-ization at100℃if its pH value was adjusted to the range of4～5by HCl;the quality of which was stable after acceleration for6months and sample storage observation at room temperature for9months.CONCLUSION:The preparation was rational in formulation design,stable in quality and controllable in quality.