STABLE CRYSTAL X-FORM AGOMELATINE TABLET AND PREPARATION METHOD THEREOF

摘要

Disclosed are a stable crystal X-form agomelatine tablet and a preparation method thereof. The method comprises the following steps: selecting one or more protective agents, adding the protective agents into pure water, stirring, heating the mixture to 35-40°C, dissolving them until the solution is clear, cooling the solution to room temperature, adding crystal X-form agomelatine, stirring the mixture until homogeneous, and obtaining the protective agents containing the crystal X-form agomelatine for use; and then, after mixing a part of the pharmaceutical excipient until homogeneous, again adding the protective agents containing the crystal X-form agomelatine, mixing and pelletizing them according to a wet method and drying to obtain particles containing the crystal X-form agomelatine; and finally, adding the other pharmaceutical excipients into the particles according to a proportion, mixing them until homogeneous and tabletting them.