Stable crystalline X-form agomelatine tablet and preparation method thereof

摘要

Disclosed are stable crystalline Form X agomelatin tablets and methods for their preparation. The method is: select one or more protective agents, add the protective agent into pure water, stir, heat the mixture to 35-40 ° C., dissolve them until the solution is clear, bring the solution to room temperature Cooling to room temperature, adding crystalline form X agomelatin and stirring the mixture until uniform to obtain a protective agent containing crystalline form X agomelatin for use; After mixing to the extent that the protective agent containing crystalline X form agomelatine is added again, they are mixed and pelletized according to the wet method and dried to obtain particles containing crystalline X form agomelatine; and finally others Of pharmaceutical additives according to a certain ratio, mixing them until uniform and tableting them. [Selection figure] None