Pharmaceutical composition containing esomeprazole sodium, and preparation method thereof

Abstract

The invention relates to a pharmaceutical composition containing esomeprazole sodium, and a preparation method thereof. Among the active components of the pharmaceutical composition provided by the invention, the amount of 5-(-)-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfonyl]-1H-benzimidazole sodium is lower than 0.3%. The invention also provides a method for producing a target product through a salt forming reaction and recrystallization of esomeprazole. With the controlling over reaction conditions and reaction solvents, advantages such as simple process, low cost, high yield, and suitability for industrialized productions are realized, and the esomeprazole sodium provided by the invention can be obtained. The invention also provides prescriptions and a preparation method of the pharmaceutical composition.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition of esomeprazole sodium and a preparation method thereof. Background technique [0002] The chemical name of Esomeprazole sodium is (S)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl] Sulfinyl-1H-benzimidazole) sodium. Esomeprazole sodium for injection is used as an alternative therapy for gastroesophageal reflux disease when oral therapy is not applicable. On March 31, 2005, FDA approved AstraZeneca's application for esomeprazole sodium for injection. In 2007, China Food and Drug Administration approved AstraZeneca's esomeprazole sodium freeze-dried powder The import of needles, whose trade name is Nexium, which is packaged in a 5ml vial, is used by adding 5ml of 0.9% sodium chloride solution to the vial for intravenous injection. Nexium’s prescription contains the main drug Exome In addition to prazole sodium, it also contains auxiliary m...

AI Technical Summary

Problems solved by technology

The applicant of the present invention finds in actual test, this method will consume a large amount of industrial raw materials acetonitrile, and the esomeprazole sodium final product yield that this method refines is lower than 20%, in the product of refining gained repeatedly , the content of sulfone is still greater than 0.3%

Images