The invention relates to the technical field of pharmaceutical preparations, and discloses a
nifedipine controlled-release pellet
capsule and a preparation method thereof. The
nifedipine pellet is prepared from
nifedipine, a hydrophilic swelling carrier, a hydrophobic structure framework material, an interface stabilizer, namely hydrophobic
fumed silica, and a solubilizer. A step-by-step pre-dispersion and hot-melt co-
extrusion combined process is adopted, a modified lipid intermediate containing an interface stabilizer is firstly prepared, and then the modified lipid intermediate and a
drug-containing hydrophilic premix are co-extruded. According to the method, an interface pinning effect is generated by utilizing enrichment of an interface stabilizer on a two-phase interface, and a stable microcosmic bicontinuous phase skeleton structure is constructed. The structure utilizes the
physical barrier and zigzag pore effect of the lipid skeleton, and can realize zero-order stable release of the
drug without
coating. The problems of burst release risk and
ethanol-induced dosage dumping of a traditional preparation are effectively solved, the process is continuous and efficient, and the product reproducibility is good.