厄贝沙坦片在多种溶出介质中溶出曲线的比较研究

Evaluation of Irbesartan Tablets by Dissolution Profiles in Different Mediums

目的比较国产厄贝沙坦片仿制药与进口原研药在4种不同的溶出介质中的溶出曲线的相似性。方法 RC806溶出仪进行溶出实验,用高效液相色谱法定量,以pH1.2的盐酸溶液,pH4.0乙酸盐缓冲溶液,pH6.8的磷酸盐缓冲溶液和水为溶出介质,分别测得4种片的溶出曲线,并采用相似因子f2来考察其相似性。结果厄贝沙坦片的溶出曲线有很强的pH值依赖性,在pH1.2的盐酸溶液中溶出完全,而在pH4.0乙酸盐缓冲溶液、pH6.8的磷酸盐缓冲溶液和水中,国产厄贝沙坦片仿制药与进口原研药的溶出曲线有很大差异。结论国内外不同厂家的厄贝沙坦片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。

Objective To compare the dissolution profiles of three brand name drugs and generics of irbesartan tablets in 4 different mediums. Methods The dissolution profiles of 4 sorts of irbesartan tablets in 4 different mediums （pill. 2 hydrochloric acid solution, pH4.0 acetate buffer, pH6.8 phosphate buffer and water） were determined by means of HPLC used in quantitative analysis and RC806 dissolution. The similarity was investigated according to the similarity factors （f2）. Results The obvious pH dependence dissolutions of irbesartan tablets were observed, which was complete dissolution in pill. 2 hydrochloric acid solution. The dissolution profiles of brand name drug are different from generics in pH4.0 acetate buffer, pH6. 8 phosphate buffer and water. Conclusion There are significant differences in the dissolution profiles of brand name drug and generics of irbesartan tablets in 4 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.