【摘要】 目的:比较国产缬沙坦胶囊与进口原研药在4种不同的溶出介质中的溶出曲线的相似性。方法:RC806溶出仪进行溶出试验,用高效液相色谱法定量,以pH1.2的盐酸溶液,pH4.0醋酸盐缓冲溶液,pH6.8的磷酸盐缓冲溶液和水为溶出介质,分别测得4种胶囊的溶出曲线,并采用相似f2来考察其相似性。结果:缬沙坦胶囊的溶出曲线有很强的pH值依赖性,在pH1.2的盐酸溶液中溶出不完全。国产缬沙坦胶囊在pH1.2的盐酸溶液,pH4.0醋酸盐缓冲溶液和水中的溶出曲线与原研制剂有很大的差异。结论:国内外不同厂家的缬沙坦胶囊在多种溶出介质中溶出曲线存在差异,临床应用时应加以注意;有必要加强多介质溶出曲线的监控,保证不同厂家同一品种质量的均一性和稳定性。更多还原

【Abstract】 OBJECTIVE To compare the dissolution profiles of brand name drug and generics of valsartan capsules in four different mediums.METHODS The dissolution profiles of four sorts of valsartan capsules in four different mediums(pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer,pH 6.8 phosphate buffer and water) were determined by means of HPLC used in quantitative analysis and RC806 dissolution and the similarity was investigated according to the similarity factors(f2).RESULTS The obvious pH dependence dissolutions of valsartan capsules were observed,which was incomplete dissolution in pH 1.2 hydrochloric acid solution.The dissolution profiles of brand name drug were different from generics in pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer and water.CONCLUSION There are significant differences in the dissolution profiles of brand name drug and generics of valsartan capsules in four different mediums,which should be given attention in clinical application.It is necessary to strengthen monitoring of drug dissolution profiles in different mediums,to ensure homogeneous and stability of the quality for the same product of different manufacturers.更多还原