The invention discloses
afatinib tablets with high stability and rapid
dissolution characteristics and a preparation method of the
afatinib tablets, and belongs to the technical field of pharmaceutical preparations. In order to solve the problems that the
dissolution rate is reduced and related substances are increased due to
moisture absorption during the storage period of the existing
afatinib tablets, afatinib dimaleate (
crystal form A, D90 is 45-55m, and BET specific surface area is 2500-3000 m / kg) with a specific
crystal form and particle size is adopted as a core and is compatible with an
anhydrous crystal form auxiliary material (such as spray-dried
mannitol), and the afatinib tablets are prepared into the afatinib tablets. Preparing a tablet core through dry
granulation and a strict
humidity control process, and then applying a damp-proof
film coating. According to the scheme, the influence of water on the
medicine is systematically blocked, the
dissolution rate of the tablet in various dissolution media within 15 minutes is ensured to be greater than or equal to 85%, the dissolution rate is reduced by less than or equal to 5% after an accelerated test, the increase of related substances is obviously lower than that of a
reference preparation, and the afatinib tablet with excellent dissolution performance and long-term stability is provided for clinic.