The invention provides a
tandospirone citrate film-coated tablet and a preparation method thereof.The film-coated tablet comprises a tablet core and a
coating, and the tablet core is prepared from
tandospirone citrate,
pregelatinized starch,
corn starch,
calcium carboxymethyl cellulose,
polyvinyl alcohol EG-05P and
magnesium stearate; according to the present invention, the
coating powder comprising hydroxypropyl methylcellulose, concentrated
glycerol,
titanium dioxide and
carnauba wax is adopted to coat the obtained tablet core, the use amount of each component and the
coating weight gain ratio are controlled, the hygroscopicity of the
tandospirone citrate is covered, and the
fluidized bed granulation mode is adopted to substantially reduce the batch-to-batch difference, and simultaneously control the particle size of the
bulk drug, according to the present invention, the
dissolution rate of the sample can be always maintained within a certain range, and the
dissolution RSD in the
phosphate medium with the pH value of 6.8 for 5 min is far less than the
dissolution RSD in the original development agent, such that the intra-batch uniformity is ensured, and the problems of non-uniform
granulation, large inter-batch difference, and
lactose intolerance due to the long-term use of
lactose during the preparation process are solved.