Preparation of injection esomeprazole sodium

Abstract

The invention discloses preparation of injection esomeprazole sodium. The preparation comprises the following steps of: (a) adding partial injection water into a basic liquid, adding edetate disodium, dissolving and cooling to a temperature of between 10 and 20 DEG C, introducing nitrogen and adding esomeprazole sodium, stirring until the mixture is completely dissolved, adding activated carbon, stirring, decarbonizing and filtering; (b) adding injection at a temperature of between 10 and 20 DEG C to account for 80 to 95 percent of the preparation amount, introducing nitrogen, regulating pH value to be between 11.0 and 11.8 with alkali, adding injection water at a temperature of between 10 and 20 DEG C to the total preparation amount, filtering by using a filter with filter element of 0.22mu m, subpackaging in penicillin bottles, partly covering rubber plugs, and lyophilizing. The finished product prepared by the preparation is more stable in quality, and the production cost is remarkably reduced, so that the preparation is advantageous to mass production, and is good in market prospect, and worthy of popularization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation process of esomeprazole sodium. Background technique [0002] Esomeprazole sodium, whose chemical name is S-5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl} -1H-benzimidazole sodium is the world's first isomer proton pump inhibitor (PPI), which reduces gastric acid secretion by specifically inhibiting the proton pump of gastric parietal cells. It has been confirmed by a large number of clinical experiments and drug research that the therapeutic effect of esomeprazole is better than that of omeprazole. Esomeprazole showed superior metabolic function. Esomeprazole has higher bioavailability. [0003] As a new generation of PPI, it has been widely used in clinical treatment of many acid-related diseases. [0004] [0005] At present, oral esomeprazole can obtain good clinical effect, but in some patients, such as dysphagia, vomiting, ac...

AI Technical Summary

Problems solved by technology

[0007] Esomeprazole sodium can be prepared into injections, but according to the traditional production process of injection preparations, the raw and auxiliary materials are dissolved together to prepare esomeprazole sodium injections. The content of azole raw materials has dropped to 8%-10%, and the color of the liquid medicine is prone to change during the preparation process, and a small amount of medicine is oxidized and decomposed in the air, making some finished products unqualified

Directly lead to high production finished products, and there are certain safety hazards

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