Preparation and Quality Control of Taste-masked Cefprozil Dry Suspension / 中国药房

ABSTRACT

OBJECTIVE:To prepare taste-masked cefprozil dry suspension and establish its quality control method. METHODS: The suspension was prepared with glyceryl monostearin used as taste-masked agent and cefprozil as principal agent. The content of cefprozil was determined by HPLC,meanwhile the dissolution rate of the preparation was determined. RESULTS: The preparation was off-white or yellowish granula and it was up to the relative standard specified in Chinese Pharmacopeia (2005 edition) in inspection. The linear ranges of cis-isomer and trans-isomer of cefprozil were 0.05～0.5 mg?mL-1(r=0.999 9) and 5.0～50 ?g?mL-1(r=0.999 9),respectively. The average recoveries were 99.7%(RSD=0.32%,n=6) and 100.7% (RSD=0.23%,n=6),respectively. The preparation had a good taste and its dissolution rate within 45 minutes was as high as about 100%. CONCLUSIONS: The taste-masked cefprozil dry suspension has been successfully prepared by this method mentioned above;furthermore,the quality indexes of the suspension are up to the standard.