Preparation and Quality Control of Rapid-disintegrating Oral Tablets of Indometacin / 中国药房

ABSTRACT

OBJECTIVE:To prepare rapid-disintegrating oral tablets of indometacin and establish a method for its quality control.METHODS:The formula of the oral tablets was optimized by orthogonal test with the formula quality of CMS-Na(A),L-HPC(B),MCC(C),manniton(D) as factors,and the disintegrating time as index.The content of indometacin was determined by ultraviolet spectrophotometry.RESULTS:The optimal formula of the tablets was the following,A∶B∶C∶D=5∶5∶50∶5.The preparation was white in color and its quality was up to the related standard specified in Chinese Pharmacopeia (2005 edition) in identification.The linear range of indometacin was 2.08～41.6 ?g?mL-1 (r=0.999 9).The average recovery was 99.3%.The intra-day RSD=0.53% and inter-day RSD=0.74%.CONCLUSION:The preparation is simple and feasible in preparation process,and controllable in quality.