Process for preparing pantoprazole sodium for injection

Abstract

The invention relates to a preparation process (preparation method) for pantoprazole sodium for injection, overcomes the defect of the traditional preparation process for the pantoprazole sodium for injection, and provides a preparation process with low cost, high yield and more stable finished product quality. The process comprises the following steps of: (1) feeding materials according to 100 percent of formula quantity, adding mannitol into injection water in an amount which is about 15 percent of preparation quantity, dissolving the materials with stirring, adding medicinal carbon in an amount which is 0.2 percent (weight / volume) of preparation quantity into the solution, boiling the solution for 30 minutes, removing carbon and filtering the solution, cooling the filtered solution to between 10 and 20 DEG C, and introducing nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the solution for later use; (2) introducing the nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the 10-20 DEG C injection water in an amount which is about 60 percent of preparation quantity, adding the medicinal carbon in an amount which is 0.1 percent (weight / volume) of preparation quantity into the solution, stirring the solution uniformly, standing the solution for 20 minutes, removing carbon and filtering the solution; and (3) mixing the filtered solution, introducing the nitrogen (the pressure of the nitrogen is 0.3 to 0.5MPa) into the solution for protecting, adjusting the pH value of the solution to between 10.0 and 10.8 by using 10 percent sodium hydroxide solution, adding 10-20 DEG C injection water to the preparation quantity, stirring the solution uniformly, retesting the pH value which should be between 10.0 and 10.8, filtering the solution by using filters with a 0.45mum filter element and a 0.22mum filter element respectively, and filling the product after the submitted semi-finished products are qualified.

Description

1. Technical field [0001] The present invention relates to a kind of preparation technology of injection, particularly relate to a kind of new preparation technology of pantoprazole sodium for injection which is superior to traditional technology. 2. Background technology [0002] The main ingredient of pantoprazole sodium for injection is pantoprazole sodium, and its chemical name is 5--difluoromethoxy-2{[(3,4-dimethoxy-2. pyridyl)-methyl] .sulfinyl}.1H-benzimidazole sodium salt monohydrate is a new type of anti-ulcer drug, which directly acts on the parietal cells of the gastric mucosa, thereby inhibiting gastric acid secretion, and is suitable for the treatment of gastric ulcer, duodenal Ulcers etc. It is mainly used clinically for obliterative syndrome, thrombophlebitis, capillary hemorrhage, etc. Because of its good curative effect and few side effects, the market demand is large. [0003] There are several domestic enterprises producing it, and the preparation and pr...

AI Technical Summary

Problems solved by technology

The production process generally adopted in China dissolves the metal complexing agent and the excipients together. The temperature control of the water for injection and the liquid medicine for preparation is relatively high. The preparation process and the liquid medicine delivery process are not protected by nitrogen filling, so the raw material content in the preparation process generally drops to 8 %-10%, it must be fed according to 110% of the prescription amount; and due to the oxidative decomposition of a small amount of medicine in the air during the preparation process, there are 2%-5% of the lamp inspection black spot waste products in each batch of lamp inspection freeze-dried products; the above two Items directly lead to high production costs, and there are certain potential hidden dangers, which directly affect the mass production of this product