The invention relates to the technical field of
medicine purification, in particular to a refining method of high-purity
Vonoprazan fumarate. The invention relates to a refining method of high-purity
Vonoprazan fumarate, which comprises the following steps: S1, adding a polar
solvent, water and lauryl
sodium sulfate into a reaction
bottle, and uniformly stirring; s2, adding a
Vonoprazan fumarate crude product, heating and dissolving, and adding
activated carbon; s3, filtering while the solution is hot, and stirring, cooling and separating out solids; s4, filtering and
vacuum drying are carried out, and the high-purity Vonoprazan fumarate is obtained. According to the refining method of the Vonoprasone fumarate, the final product is obtained through one-time recrystallization, and the purity of the product is gt; therefore, the pharmaceutical
quality standard is met. According to the refining method of the Vonoprazan fumarate, process impurities U2-U5 which are difficult to remove by a conventional recrystallization method can be removed, and the refining method is good in
impurity removal effect, high in yield, simple to operate, few in three wastes and suitable for industrial production requirements.