Formula Improvement and Quality Control of Urea Cream / 中国药房

ABSTRACT

OBJECTIVE:To improve the formula of urea cream and establish its quality control methods.METHODS:The matrix component of formula was adjusted to prepare O/W matrix.Prednisone was added into matrix to prepare urea cream;UV spectrophotometry was applied to determine the content of urea and evaluate the quality of preparation and the stability of 3 batches of samples setting for 40 days under different conditions.RESULTS:The preparation was white cream and its inspection results were in line with the standards stated in Chinese Pharmacopoeia(2005 edition).The linear range of urea was 30.5～180.2 ?g?mL-1(r=0.999 0) with an average recovery of 99.68%(RSD=0.49%).The quality of 3 batches of samples kept stable during observation.CONCLUSION:Improved formula is reasonable,simple in preparation technology and quality control.