The invention discloses
budesonide enteric-coated sustained-release
pellets and a preparation method thereof, and belongs to the technical field of biological medicines. The
budesonide enteric-coated and sustained-release pellet sequentially comprises a
medicine-containing pellet core, a sustained-release layer and an enteric-coated layer from inside to outside, the
drug-containing
pill core comprises
budesonide, a filler, an
adhesive, an acidic agent and a
lubricant; the sustained-release layer comprises the following components: a retardant, a
plasticizer and an anti-sticking agent; the enteric-coated layer comprises the following components: an enteric-coated material, a
plasticizer and an anti-sticking agent. The budesonide enteric-coated sustained-release pellet is prepared by the following steps: preparing budesonide and auxiliary materials into a
drug-containing pellet core through an
extrusion rolling process, and then
coating the
drug-containing pellet core with a sustained-release layer and an enteric-coated layer in sequence through a
fluidized bed coating, thereby obtaining the budesonide enteric-coated sustained-release pellet. The budesonide enteric-coated and sustained-release pellet cannot be released and absorbed in the
stomach, the effect gradually starts after the budesonide enteric-coated and sustained-release pellet reaches the intestinal tract, and the budesonide enteric-coated and sustained-release pellet keeps a proper concentration level in in-vivo blood, so that targeted
continuous treatment of inflammatory intestinal diseases is facilitated.