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复方美托洛尔-氨氯地平双层片体外释放度方法研究
引用本文:沈淑媛,吴赟,王成港,王杏林.复方美托洛尔-氨氯地平双层片体外释放度方法研究[J].中国医药导报,2012,9(27):118-120.
作者姓名:沈淑媛  吴赟  王成港  王杏林
作者单位:天津中医药大学;天津药物研究院释药技术与药代动力学国家重点实验室
摘    要:目的建立复方美托洛尔-氨氯地平双层片中缓释层酒石酸美托洛尔与速释层苯磺酸氨氯地平的体外释放度测定方法。方法考察不同溶出方法、溶出介质和搅拌速度对缓释层酒石酸美托洛尔体外释放度的影响,以HPLC法测定酒石酸美托洛尔和苯磺酸氨氯地平的溶出度。结果速释层在45 min内释放达到90%以上,缓释层在12 h内释放达到90%以上,缓释层释药速率符合零级动力学方程。结论建立的复方酒石酸美托洛尔-苯磺酸氨氯地平双层片体外释放度测定方法准确。

关 键 词:苯磺酸氨氯地平  酒石酸美托洛尔  双层片  体外释放度

Study of the release rate of compound Metoprolol and Amlodipine Bilayer Tablets in vitro
SHEN Shuyuan,WU Yun,WANG Chenggang,WANG Xinglin.Study of the release rate of compound Metoprolol and Amlodipine Bilayer Tablets in vitro[J].China Medical Herald,2012,9(27):118-120.
Authors:SHEN Shuyuan  WU Yun  WANG Chenggang  WANG Xinglin
Institution:1.Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;2.State Key Laboratory of Drug Technology and Pharmacokinetics Tianjin Institute of Pharmaceutical Research,Tianjin 300193,China
Abstract:Objective To establish determination method for release rate of Tartaric acid Metoprolol in the slow-release layer and Amlodipine bilayer in the quick-release layer of Metoprolol and Besylate Amlodipine bilayer Tablets.Methods The different dissolution methods,dissolution mediums and rotating speeds which effected the release of sustained release layer were studied on.The release of the bilayer tablets were determined by HPLC.Results Release of the quick-release layer was up to more than 90% within 45 min,the release of the slow-release layer was up to more than 90% within 12 h which met the requirements of the zero level dynamics equation.Conclusion The method which established for in vitro dissolution rate determination is exact.
Keywords:Amlodipine besylate  Metoprolol tartrate  Bilayer tablets  Release in vitro
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