The invention discloses a galanthamine
hydrobromide enteric-coated tablet and a preparation method thereof. The tablet is composed of a tablet core, an
isolation layer and an enteric layer, the tablet core contains 5.0%-16.0% of galanthamine
hydrobromide, and auxiliary materials such as
mannitol, a mixture of
magnesium stearate and
sodium stearyl fumarate in a specific proportion,
colloidal silicon dioxide and the like are matched; the isolating layer adopts an opadry II type
film coating, and the enteric-coated layer adopts an opadry Acryl-EZE II type enteric-coated
coating. The
dissolution rate of the tablet in an acidic medium with the pH value of 1.2 for 2 hours is less than 5%, the release rate of the tablet in a medium with the pH value of 5.5 or 6.8 for 45 minutes is more than or equal to 80%, the tablet is sealed and placed at 40 DEG C + / -2 DEG C / 75% + / -5% RH for 6 months, the stability is good, and the pharmacokinetic parameters are excellent. The preparation method comprises the steps of raw and auxiliary material pretreatment, graded premixing, total mixing and lubricating, tabletting, two-step
coating and the like, and the process is stable and controllable. The enteric-coated tablet disclosed by the invention is strong in
targeted release property, high in stability and good in
bioavailability, and can guarantee the effectiveness and safety of medication.