The invention discloses a preparation method of
bezoar ursodesoxycholic acid preparation. The preparation method of the
bezoar ursodesoxycholic acid preparation comprises the following steps: sieving a
bezoar ursodesoxycholic acid raw material and an auxiliary material for later use, wherein
particle size distribution D90 of the
raw material is required to be less than 150 microns, and the
particle size distribution D90 of the auxiliary material is required to be less than 120 microns; mixing bezoar ursodesoxycholic acid, a
diluent and a disintegrating agent, collecting a material accounting for about 10-15% of production lot size to be taken as (a) for later use; adding a lubricating agent accounting for 85-90% of the production lot size, mixing, and collecting material taken as (b) for later use; carrying out dry
granulation on the material (b); straightening the material obtained in the step 3, sieving, mixing the sieved material with the material (a), carrying out dry
granulation on the mixed material, and then straightening and sieving; adding the material obtained in the step 4 into the rest lubricating agent, mixing, and collecting a material; and preparing the preparation by adopting the material obtained in the step 5. The preparation method of the bezoar ursodesoxycholic acid preparation has the advantages that the problem of material fluidity can be solved and the phenomenon that no
initial burst release of the bezoar ursodesoxycholic acid preparation is caused under the specified
dissolution condition can be avoided.