摘要
目的:建立苯磺酸氨氯地平片体外溶出曲线评价方法,为仿制药一致性评价提供参考。方法:在4种不同介质(水、pH1.2、pH 4.0、pH 6.8)中的溶出度,采用桨板法,转速分别为75转/min和50转/min,HPLC法,在波长237 nm检测。结果:桨板法50转/min区分力好于75转/min,自制品与原研品在四种溶出介质中溶出曲线相似,与体内生物等效试验结果一致。结论:体外溶出曲线法可用于苯磺酸氨氯地平片的仿制药一致性评价。
Objective： Study in vitro dissolution profiles of genetic Amlodipine Besylate Tablets. The data generated can be used to aid the re-valuation of genetics equivalency of the product. Methods： Dissolution profiles of Amlodipine Besylate Tablets were determined in four different media （ water, pH 1.2, pH 4.0, pH 6. 8 ） using paddles at 75rpm and 50rpm. The concentrations of samples in different media were determined by HPLC with UV detector （237 nm）. Results： For Amlodipine Besylate Tablets, dissolution experiments using paddles at 50rpm is more discriminating than that of 75rpm. The dissolution profiles （ in four different media） of the genetic product is similar to that of the reference drug, which is consistent with the BE results. Conclusion： In vitro dissolution profiles can be used for ReEvaluation of Generic Amlodipine Besylate Tablet Equivalency.
出处
《中国药物评价》
2013年第4期199-203,共5页
Chinese Journal of Drug Evaluation
关键词
苯磺酸氨氯地平片
溶出曲线
一致性评价
Amlodipine besylate tablets
Dissolution profiles
In-Vitro genetic equivalency re-evaluation
