The invention relates to the technical field of
capsule preparation, and discloses a high-stability isavuconazole
sulfate capsule and a preparation method thereof.The preparation method comprises the following steps that S1, isavuconazole
sulfate, a
polymer carrier, a disintegrating agent and a surfactant are dissolved in an
organic solvent to obtain an organic phase, and a water-soluble stabilizer is dissolved in
purified water to obtain a water phase; s2, dropwise adding the organic phase into the water phase by using an
injection pump while stirring, continuously stirring after dropwise adding to form primary
emulsion, homogenizing the primary
emulsion, adding a
spray drying protective agent, stirring for dissolving, performing
spray drying, performing
cyclone separation, collecting
powder, and
drying until the
water content is less than or equal to 3.0 to obtain a pretreated
prodrug; and S3, mixing the pretreated
prodrug, a filler, an alkalizer and a
lubricant, and filling a
capsule shell with the mixture to obtain the capsule. The isavuconazole
sulfate capsule prepared by the invention has high
drug loading capacity, excellent in-vitro
dissolution performance and outstanding long-term chemical and
physical stability, and provides a high-quality oral preparation choice for clinic.