Study On The Preparation Of Amlodipine Besylate And Isosorbide Mononitrate Compound Bilayer Tablets

Objective:Optimize the optimal prescription and preparation process of amlodipine besylate monolayer tablet of diphenyl sulfonate,establish its quality standard and explore the release mechanism?Methods:The in vitro analysis method of amlodipine besylate and isosorbide mononitrate was established.The single factor method and response surface test method were used to optimize the prescription of the two-layer tablet by using dissolution and release as the indicators.Preparation process;according to the"Chinese Pharmacopoeia"2015 edition of the four general principles 0101"tablet",9013"slow release,controlled release and delayed release preparation guidelines",establish a two-layer quality standard;use mathematical models to fit,explore bilayer release mechanism of the sustained release layer?Results:The determination of amlodipine besylate and isosorbide mononitrate was stable and feasible by high performance liquid chromatography.A double layer tablet of amlodipine besylate mononitrate was prepared by wet granulation tableting method.The best prescription for amlodipine besylate is:lactose as a filler,the amount is 95%;1%HPMC_K15M15M aqueous solution as a binder;granulation mesh is 16 mesh;isosorbide mononitrate sustained release layer The best prescription is:the sustained release material is HPMC_K15M,the dosage is 12.9%;the filler is lactose,the dosage is 73.8%;the binder is 9%PVP_K30-70%ethanol solution,the meshing number is 16 mesh;the tableting pressure is12kgf;compound bilayer tablet specification is 0.4g/tablet,wherein 0.1ml of amlodipine besylate layer and 0.3g of isosorbide mononitrate release layer,verification test shows that the process is stable and feasible,in line with 2015 edition The"Chinese Pharmacopoeia"four general principles 0101 tablets and the"Chinese Pharmacopoeia"2015 version of the four general rules 0913 release degree measurement method.The interaction between amlodipine besylate monoisosorbide compound bilayer was further studied,and the release medium of compound bilayer was investigated.Amlodip besylate monoisosorbide compound double was established.Ply quality standard;In the study of drug release mechanism,the release behavior accords with the Higuchi model equation and belongs to the effect of the skeleton sustained-release system.Conclusion:The preparation process of amlodipine besylate monosorbate monohydrate tablets is simple,stable and feasible?...