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Esomeprazole sodium sterile lyophilized powder for injection and preparation process of lyophilized powder

A technology for esomeprazole sodium and injection, which is applied in the field of sterile freeze-dried powder of esomeprazole sodium for injection and its preparation, can solve the problems of decreased curative effect and increased incidence of adverse reactions, and achieve guaranteed curative effect and safety, the preparation method is simple and easy to control, and the effect of low cost

Inactive Publication Date: 2014-05-07
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] It can be seen from the above table that the proportion of R-configuration isomers in the aqueous solution increases, and the increase of R-configuration isomers will lead to a decrease in curative effect and an increase in the incidence of adverse reactions

Method used

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  • Esomeprazole sodium sterile lyophilized powder for injection and preparation process of lyophilized powder
  • Esomeprazole sodium sterile lyophilized powder for injection and preparation process of lyophilized powder
  • Esomeprazole sodium sterile lyophilized powder for injection and preparation process of lyophilized powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]

[0023] Weigh 1080g of hydroxypropyl-β-cyclodextrin and place it in a clean container, add 1000ml of water for injection into it, stir to dissolve, adjust the pH to 10.0 with sodium hydroxide solution; add the active ingredient esomeprazole sodium into it, stir After 10-15 minutes, add water to 4L. , add 2g of activated carbon for needles, stir and absorb for 15 minutes, filter out the activated carbon for needles, filter for sterilization, divide the medicinal solution into vials, each bottle has a volume of 4ml, and freeze-dry to obtain.

Embodiment 2

[0025]

[0026] Weigh 1200g of sulfobutyl-β-cyclodextrin and place it in a clean container, add 1800ml of water for injection into it, stir to dissolve, adjust the pH to 11.8 with sodium hydroxide solution; add the active ingredient esomeprazole sodium into it, stir After 10-15 minutes, add water to 6L. , add 3g of activated carbon for needles, stir and absorb for 15 minutes, filter out the activated carbon for needles, filter for sterilization, divide the medicinal solution into vials, each bottle has a volume of 6ml, and freeze-dry to obtain.

Embodiment 3

[0028]

[0029]

[0030] Weigh 1600g of glucosyl-β-cyclodextrin and place it in a clean container, add 1500ml of water for injection into it, stir to dissolve, adjust the pH to 9.5 with sodium bicarbonate solution; add the active ingredient esomeprazole sodium into it, stir After 10-15 minutes, add water to 5L. , add 2.5g of activated carbon for needles, stir and absorb for 15 minutes, filter out the activated carbon for needles, filter for sterilization, divide the medicinal solution into vials, each bottle has a volume of 5ml, and freeze-dry to obtain.

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Abstract

The invention relates to sterile lyophilized powder for inhibiting esomeprazole sodium racemization and a preparation process of the lyophilized powder. The active component esomeprazole sodium is included in a molecular 'hole' structure of esomeprazole sodium by adopting beta-cyclodextrin and derivatives thereof, so that racemization of esomeprazole sodium can be stopped to guarantee the curative effect and safety of a product. The R configurational isomer of the product is less than 0.5 percent when placed for 24 months; the preparation process is simple and practical, and is suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sterile freeze-dried powder of esomeprazole sodium for injection and a preparation process thereof. Background technique [0002] Esomeprazole, the S-configuration isomer of omeprazole, inhibits the H + / K + -ATPase to reduce gastric acid secretion and prevent the formation of gastric acid. It is clinically used for the treatment of gastroesophageal reflux disease and erosive reflux esophagitis, long-term maintenance treatment for cured esophagitis patients to prevent recurrence, symptom control of gastroesophageal reflux disease, combined with appropriate antibacterial therapy Eradicate Helicobacter pylori, and heal the duodenal ulcer associated with Helicobacter pylori infection, and prevent the recurrence of peptic ulcer associated with Helicobacter pylori. Esomeprazole Sodium for Injection was approved for marketing in Europe in 2003, with...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/48A61P1/04
Inventor 赵志全赵震震吕永超
Owner SHANDONG NEWTIME PHARMA
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