A kind of drug composition lyophilized powder injection containing dextrorabeprazole sodium and preparation method thereof

Abstract

The invention provides a lyophilized powder injection containing dex-rabeprazole sodium pharmaceutical composition and a preparation method thereof, which is made from a 2ml solution, and the solution contains 10-20 mg of dex-rabeprazole sodium, manna Alcohol 30-60mg, edetate disodium 0.5-1mg and a pH regulator sodium hydroxide. The stirring and dissolving process temperature of the preparation is below 30° C., and the pH value is adjusted to 11.0-12.0 with sodium hydroxide. The dex-rabeprazole sodium freeze-dried preparation prepared by the technology of the present invention has a fast reconstitution time, no obvious change in related substances during the placement process, more stable quality, convenient use, simple preparation process, and is suitable for large-scale production.

Description

A kind of freeze-dried powder injection of pharmaceutical composition containing dextro-rabeprazole sodium and preparation method thereof technical field The invention relates to a freeze-dried powder injection of a pharmaceutical composition containing dex-rabeprazole sodium and a preparation method thereof, belonging to the technical field of medicinal chemistry. Background technique The chemical name of dex-rabeprazole sodium is R-(+)-2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfite Acyl]-1H-benzimidazole sodium salt, CAS No. 171440-18-9, molecular formula: C 18 h 20 N 3 o 3 SNa, molecular weight: 381.42 The chemical structural formula is: Dexrabeprazole sodium was first developed by India's emcure pharmaceutical company, and it was launched in India in September 2007. Rabeprazole sodium is a derivative of benzimidazole. As a new type of proton pump inhibitor, it has the following characteristics: first, it strongly and rapidly inhibits gastric acid se...

AI Technical Summary

Problems solved by technology

Dexrabeprazole sodium has the disadvantages of poor aqueous solution stability and rapid degradation under acidic conditions, which brings great difficulty to the preparation of dexrabeprazole sodium freeze-dried preparations

At present, there are more studies on the lyophilized preparation of rabeprazole sodium in the published literature reports, but less research on the lyophilized preparation of dex-rabeprazole sodium