The invention discloses a preparation method of a
tolvaptan tablet. The preparation method comprises the following steps: 1, mixing
tolvaptan with high-substituted hydroxylpropyl
cellulose according to a
mass ratio of 1:0.2-0.6, crushing them, and sieving by a 60-100 mesh
sieve; 2, dissolving throughs in a
mixed solution of waterless
ethanol and
dichloromethane with a volume ratio of 1:1-4, carrying out
spray drying to form
powder, carrying out reduced pressure
drying at 70-90DEG C until that the content of solvents residual in the sprayed
powder is qualified; 3, crushing the sprayed
powder, sieving by a 180-220 mesh
sieve, accurately weighing the sprayed powder,
lactose,
microcrystalline cellulose and hydroxypropyl methylcellulose according to prescription amounts, uniformly mixing them, and adding a proper amount of water to prepare a soft material; and 4, sieving the soft material by a 15-25 mesh
sieve, preparing a wet particle,
drying the wet particle at 50-70DEG C until that the content of water in the wet particle is 2-4%, sieving the dried wet particle by a 15-25 mesh sieve, granulating, adding a prescription amount of
magnesium stearate, uniformly mixing, and tabletting. The preparation method of the invention has the advantages of ingenious conception, low production cost, high
in vitro dissolubility of the prepared
tolvaptan tablet, and good
biological availability and clinic
curative effect of the tolvaptan tablet.