The invention belongs to the technical field of pharmaceutical preparations, and particularly discloses a betahistine
mesylate tablet composition and a preparation method thereof. The composition comprises a
drug-containing resin compound formed by betahistine
mesylate and high-molecular
polymer resin and pharmaceutical auxiliary materials, and the
mass ratio of the
drug to the resin is 1: 6-1: 1, preferably 1: 3-1: 2; the resin is
sodium polystyrenesulfonate. The preparation method comprises the following steps: blending the
medicine and the resin in water,
drying to obtain a compound, and mixing and tabletting with the disintegrating agent, the filling agent and the like. The core of the invention lies in that the generation of a cancerogen N-nitrosobetahistine is effectively inhibited from the source by physically isolating the
medicine through the resin compound, and the problem of stability caused by the use of oily auxiliary materials in the prior art is solved. The obtained tablet is rapid and complete in
dissolution, uniform in content, few in related substances, capable of remarkably slowing down
nitrosamine growth under the accelerated stability condition, simple and convenient in process and suitable for industrial production, and is used for treating dizziness or equilibrium disorder.