Lyophilized powder containing esomeprazole

A technology of esomeprazole sodium and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of poor stability of esomeprazole sodium, failure to guarantee human safety, complicated methods, etc., and achieve good quality, less impurities, The effect of prescription simplicity

Active Publication Date: 2013-05-01
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Esomeprazole sodium has poor stability and is sensitive to light, heat, oxygen, water, etc. CN 102746273 A discloses esomeprazole polymorph freeze-dried powder injection, but the method needs to prepare polymorphs, The method is complicated; several world patents (WO 94 / 027988, WO 01 / 014367, WO 03 / 089408, WO 04 / 052882, WO 07 / 013743, WO 06 / 001755, US2007 / 0259921, WO 10 / 003974) and its drawbacks are described
The method described in CN 102657622 A uses excipients and anhydrous sodium sulfite antioxidants, which cannot guarantee the safety to the human body. This patent briefly describes the preparation methods of several Chinese patents (CN 102357082 A, CN 102319223 A) and explained its shortcomings
[0004] Although there are many existing methods, they all have defects in product quality, safety or stability. This method has simple prescription, no antioxidant, no nitrogen protection in the preparation process of the medicinal solution, and can maintain its stability, good quality and less impurities. , good resolubility, low cost, suitable for large-scale industrial production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0014] prescription:

[0015] Esomeprazole Sodium 40g Edetate disodium 2g meglumine 5g Polyvinylpyrrolidone 5g sodium hydroxide 7-10g water Add to 2000ml

[0016] Made 2000 pieces

[0017] Preparation:

[0018] Add 1600ml of water for injection into the batching bucket, add the prescribed amount of edetate disodium and meglumine, stir to dissolve, add the prescribed amount of polyvinylpyrrolidone, stir until it dissolves, and adjust the pH value with sodium hydroxide solution To 11-12, add the prescribed amount of esomeprazole sodium, stir until dissolved, adjust the pH value to 11-12 with sodium hydroxide solution, and set the volume to the prescribed amount with water for injection and let it stand for 20 minutes; add 0.1% ( g / ml) activated carbon was stirred and adsorbed at room temperature for 20 minutes, and then filtered to remove the activated carbon; the liquid was sterilized by 0.45 μm and 0.22 μm polyethersulfone filter...

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PUM

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Abstract

The invention provides lyophilized powder containing esomeprazole sodium and a preparation method thereof, and belongs to the technical field of medicines. The esomeprazole sodium is an effective drug for treating acid-related diseases like peptic ulcer and gastroesophageal reflux diseases, and a lyophilized powder preparation containing the esomeprazole sodium is an alternative preparation for treating reflux esophagitis when an oral therapy is not applicable. The lyophilized powder has the advantages of stable sample quality, less impurities, good compound solubility and low cost, and is applicable to industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a freeze-dried preparation of esomeprazole sodium and a preparation method thereof. The invention provides a freeze-dried powder preparation of esomeprazole sodium for injection with stable quality and low cost. Background technique [0002] Esomeprazole (Esomeprazole) is the S-configuration isomer of Omeprazole (Omeprazole). It is an isomer proton pump inhibitor isolated and synthesized by AstraZeneca. It is used for the treatment of acid-related diseases such as peptic ulcer , gastroesophageal reflux disease and other effective drugs, and its freeze-dried powder preparation is an alternative dosage form for the treatment of reflux esophagitis when oral therapy is not applicable. Esomeprazole is a second-generation proton pump inhibitor. Compared with the first-generation proton pump inhibitors such as omeprazole and lansoprazole, it has the advantages of better acid suppression e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/32A61P1/04
Inventor 王明刚任莉陈阳生孙桂玉翟翠云刘晓霞
Owner CP PHARMA QINGDAO CO LTD
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