Omeprazole sodium freeze-dried powder injection and preparing method thereof

Abstract

The invention provides an omeprazole sodium freeze-dried injection and a preparation method which is simple and feasible and the prepared freeze-dried injection is high in drug contents and low in related substances content. The method comprises the following steps: (1) the raw materials of the recipe quantity are stirred with injection water until the omeprazole sodium is completely dissolved to get omeprazole sodium solutions; sodium citrate solutions are put into the solutions got from step (1) and the pH value of the solutions is adjusted to 10.0 to 11.0; the injection water is put into the prepared products got from step (2) to the recipe quantity and then pin activated carbon is put into the prepared products, and filter decarburization is carried out after stirring to get filtrates; the filtrates got from step (3) are fine filling filtered by 0.22Mum removal bacteria microporous membrane, and the filtrates after fine filling filtering are put into a bottle which is partially stoppered, and then the filtrates are freeze-dried to get the freeze-dried injection.

Description

technical field [0001] The invention belongs to the field of biomedicine, and what relates to is a kind of preparation method of lyophilized powder injection, more specifically, what the present invention relates to is a kind of preparation method of omeprazole sodium lyophilized powder injection. Background technique [0002] Omeprazole Sodium for Injection (Omeprazole Sodium for Injection, molecular formula: C 17 h 18 N 3 NaO 3 S·H 2 O, molecular weight: 385.41), its chemical name is: 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridyl) monomethyl]-sulfinyl] - 1H-benzimidazole sodium monohydrate. Chemical Structure: [0003] [0004] In the prior art, the auxiliary materials of this product are: mannitol and water for injection. This product is white or off-white loose lump or powder. As an alternative therapy for the following conditions when oral therapy is not appropriate: duodenal ulcer, gastric ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. [0005]...

AI Technical Summary

Problems solved by technology

[0010] Prior art shows, omeprazole sodium lyophilized powder injection has poor clarity, poor stability, main drug content is low, and the defective of related substance content height, because in the omeprazole sodium lyophilized powder injection , in order to prevent metal ions from catalyzing the oxidation of the drug itself, a certain amount of metal ion chelating agent is added to reduce the concentration of metal ions. At the same time, a pH regulator must be added to make the pH value in the range suitable for the human body. Due to the preparation process The addition of different chelating agents and pH value regulators in the omeprazole sodium freeze-dried powder injection of the prior art has the problems of poor clarity, low content of the main ingredient, and a relatively cumbersome preparation process. In view of this, The present invention adjusts the pH by selecting a suitable metal ion chelating agent as a pH regulator, and then cooperates with a suitable freeze-drying step to prepare a freeze-dried powder injection with high content of the main drug, good clarity, and good stability. propose the invention

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