Preparation and Quality Control of Nifuratel Vaginal Effervescent Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare nifuratel vaginal effervescent tablets(NVET)and establish a method for its quality control.METHODS:The NVET was prepared using acid or alkali effervescent by principal ingredient-separated granulation.The content of the principal ingredient was determined by UV spectrophotometry.RESULTS:The preparation was white or off-white colored tablet and its property was up to the standard stated in Chinese Pharmacopeia(2005 Edition)in identification and test.The linear concentration range of nifuratel was 100～400 ?g?mL-1(r=0.999 6)with an average recovery rate of 101.1%(RSD=0.62%,n=6).CONCLUSION:The preparation process for NVET is simple,and its quality is stable and controllable.