Lenaclotide preparation and preparation method thereof

The invention relates to a linaclotide preparation and a preparation method thereof, the preparation adopts a fluidized bed coating granulation process, a pellet is provided with a coating isolation layer through two-step coating, and external moisture, oxygen and the like are isolated to a certain extent. In addition, by controlling the preparation process, the pH value of the acid solution containing the active substances is in the range of 1.5-2.5, the storage time limit of the acid solution does not exceed 12 hours, the material temperature is 40-50 DEG C when the pellet is prepared in the fluidized bed, and the drying time is longer than or equal to 15 minutes. Therefore, the quality of the linaclotide preparation can be remarkably improved, the impurity content of the linaclotide preparation is low, the adverse effects of illumination, high humidity and high temperature on the preparation can be improved, the stability of the preparation in the transportation, storage and use processes is greatly improv