瑞舒伐他汀钙片的制备与质量考察评价

摘要

制备瑞舒伐他汀钙片,用HPLC建立溶出度测定方法,考察样品质量稳定性及不同pH条件下的溶出度,并与原研药进行对比评价.经处方筛选,利用直压法制备瑞舒伐他汀钙片,采用高效液相色谱法检测溶出度,计算相似因子,同时绘制三维曲面图,对比自制样品与原研药的溶出特性.自制的三批样品,在不同溶出介质中的相似因子均在50以上.自制片剂与原研药体外溶出相似,自制产品质量稳定,接近原研药水平.%Rosuvastatin calcium tablets were prepared, and a HPLC method for the dissolution determination was established.The sample quality stability and the release of different pH conditions were investigated and compared with the original product to evaluate its performance.Direct compression technique was used to prepare rosuvastatin calcium tablets after the prescription screening.HPLC was used for testing the releasing, and the similarity factor method was applied for its comparison, simultaneously, drawing three-dimensional releasing spectrogram to compare the dissolution characteristics of the self-made samples and the original drugs.The similarity factor between the self-made tablet and the original product was above 50%.It was relevant between the two tablets in vitro dissolution.The self-made rosuvastatin calcium tablets were stable in quality, close to the level of the original drugs.