The invention discloses a dapoxetine
hydrochloride tablet pharmaceutical composition and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The composition comprises dapoxetine
hydrochloride,
sodium bicarbonate, a filler, a disintegrating agent and a
lubricant. Aiming at the problems of low
dissolution rate, poor stability, complex preparation process and the like of dapoxetine
hydrochloride tablets in the prior art,
sodium bicarbonate is introduced as a key auxiliary material, a
raw material pretreatment process is optimized, a traditional
adhesive is omitted, and the
dissolution rate and the preparation stability are remarkably improved. The preparation method comprises the following steps: pre-
drying the filling agent (
microcrystalline cellulose) until the
water content is less than or equal to 2.0%, sieving
sodium bicarbonate with a
sieve of more than 100 meshes, mixing the
sodium bicarbonate with dapoxetine hydrochloride and the
lubricant, directly tabletting, and then
coating. The preparation method is simple in process, low in cost and suitable for industrial production, and the obtained tablet is high in
dissolution rate and excellent in stability under the conditions of high temperature,
high humidity and illumination.