Sodium rabeprazole composition for injection

A technology of rabeprazole sodium and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of low production efficiency, shortened freeze-drying time, and long freeze-drying time, and achieve low production cost, shortened freeze-drying time, and low water content Effect

Active Publication Date: 2014-02-26
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to overcome the technical defects of long freeze-drying time, low production efficiency and high energy consumption of the rabeprazole sodium composition in the production process, the present inventor has carried out a large number of experiments and found that unexpectedly, in the composition preparation process without adding Filling agent, which can greatly shorten the freeze-drying time, avoiding additional sublimation time, and the resulting composition has a plump appearance and low water content

Method used

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  • Sodium rabeprazole composition for injection
  • Sodium rabeprazole composition for injection
  • Sodium rabeprazole composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] prescription:

[0089]

[0090] Weigh rabeprazole sodium and edetate disodium into the preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 10.5~12.5 with sodium hydroxide; use a 0.22um filter for the prepared medicinal solution Sterilize and filter to a sterile room, dispense into vials, and half stoppered with rubber. The product was first pre-frozen to -45°C, kept warm for 2 hours, started vacuuming, raised the temperature to 0°C, kept for 4 hours, then raised to 40°C, kept for 5 hours, and kept at 30°C for 3 hours to obtain the composition needle.

Embodiment 2

[0092] prescription:

[0093]

[0094] Weigh rabeprazole sodium and edetate disodium into the preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 10.5~12.5 with sodium hydroxide; use a 0.22um filter for the prepared medicinal solution Sterilize and filter to a sterile room, dispense into vials, and half stoppered with rubber. The product was first pre-frozen to -45°C, kept warm for 2 hours, started vacuuming, raised the temperature to 0°C, kept for 4 hours, then raised to 40°C, kept for 5 hours, and kept at 30°C for 3 hours to obtain the composition needle.

Embodiment 3

[0096] prescription:

[0097]

[0098] Weigh rabeprazole sodium and edetate disodium into the preparation tank, add water for injection, stir to dissolve and mix evenly, adjust the pH value of the solution to 10.5~12.5 with sodium hydroxide; use a 0.22um filter for the prepared medicinal solution Sterilize and filter to a sterile room, dispense into vials, and half stoppered with rubber. The product was first pre-frozen to -45°C, kept warm for 2 hours, started vacuuming, raised the temperature to 0°C, kept for 4 hours, then raised to 40°C, kept for 5 hours, and kept at 30°C for 3 hours to obtain the composition needle.

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Abstract

The present invention provides a sodium rabeprazole composition for injection. The composition comprises sodium rabeprazole and disodium edetate, wherein a weight ratio of the sodium rabeprazole to the disodium edentate is 1:0.15-1. The sodium rabeprazole composition does not contain mannitol and other fillers. According to the sodium rabeprazole composition, under a certain premise, freeze drying rate of the product is significantly improved so as to avoid additional sublimation time, such that production efficiency is improved, and production energy consumption is reduced, wherein the premise comprises that a product appearance is ensured and reconstituting property meets injection requirements. In addition, the method is suitable for industrial mass production.

Description

technical field [0001] The invention relates to a rabeprazole sodium composition for injection, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of Rabeprazole sodium is 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-1H- Benzimidazole sodium salt, the structural formula is [0003] [0004] Rabeprazole sodium is a new product developed by Japan's Eisai Company. It was first launched in Japan in 1997. In 1999, this product was launched in the United States and Sweden. The dosage form is enteric-coated tablets. For the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zoller-Ellison syndrome and other indications. As a new generation of proton pump inhibitors, rabeprazole sodium has a high pKa value, is rapidly activated in the body, and combines with proton pumps to exert an acid-suppressing effect. Compared with the first-generation proton pump inhibitors, ra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04A61P31/04
Inventor 陈庆财宗在伟杨奇珍郦江平
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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