The invention discloses an eluxadoline
enteric coated tablet and a preparation method thereof. The preparation method includes: mixing eluxadoline with a solubilizer evenly, then dissolving the mixture in a 95%
ethanol solution, mixing the substances evenly, then adding an appropriate amount of
lecithin, conducting
drying at 50DEG C for 45min to obtain dry particles, performing sieving by a 80-mesh
sieve, then mixing the product with a filling agent and a disintegrating agent evenly, adding a
lubricant tablet, and finally carrying out isolating
coating and
enteric coating. The eluxadoline
enteric coated tablet provided by the invention does not contain basic ingredients, reduces
stomach discomfort and other side effects,
glyceryl monostearate is added in the
enteric coating to significantly improve the
dissolution degree of eluxadoline and its stability in gastric juice.
Dissolution experiments find that the eluxadoline
dissolution degree increases significantly and no burst release phenomenon occurs, the 6h
dissolution degree is above 99%, acceleration tests find that the eluxadoline
enteric coated tablet has good stability during preparation and storage, the preparation process is simple, has no need for complex preparation equipment, and is easy to realize industrial
mass production.