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A kind of esomeprazole sodium injection freeze-dried powder composition and preparation method thereof

A technology of esomeprazole sodium and its composition, which is applied in the field of esomeprazole sodium injection freeze-dried powder composition and its preparation, and can solve the problems of excessive related substances, unqualified oxidative impurity indicators, and unqualified clarity and other issues to achieve the effect of ensuring quality and stability, and solving the problem of exceeding the standard and discoloration of related substances

Active Publication Date: 2018-03-06
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The freeze-dried composition of esomeprazole sodium is prone to quality problems such as color yellowing and related substances exceeding the standard and unqualified clarity during long-term storage or under high temperature conditions. Tests have shown that esomeprazole sodium is Relatively stable, related substances exceeding the standard are mainly due to unqualified oxidation impurity indicators

Method used

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  • A kind of esomeprazole sodium injection freeze-dried powder composition and preparation method thereof
  • A kind of esomeprazole sodium injection freeze-dried powder composition and preparation method thereof
  • A kind of esomeprazole sodium injection freeze-dried powder composition and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0044] Esomeprazole Sodium 42.5g

[0045] Sodium chloride 20g

[0046] Sodium Calcium EDTA 1.0g

[0047] Sodium hydroxide 7g

[0048] Water for injection 2L

[0049] Makes 1000

[0050] (1) The preparation method for filling with liquid is as follows:

[0051] (1) Add the prescribed amount of sodium hydroxide, esomeprazole sodium, sodium chloride, calcium sodium edetate into the water for injection, the temperature of the water for injection is at 10°C, stir to dissolve completely;

[0052] (2) Use 10% sodium hydroxide solution to adjust the pH value of the liquid medicine to 11, and add water for injection to the full amount;

[0053] (3) Add medicinal charcoal to the prepared solution according to 0.1% g / ml of the volume of the medicinal solution, and stir for 20 minutes

[0054] Finally, use a 0.45um titanium rod filter to remove carbon;

[0055] (4) Sterilize and filter with two 0.2um polyethersulfone filter elements;

[0056] (4) Determination of intermediate cont...

Embodiment 2

[0065] Esomeprazole Sodium 85g

[0066] Sodium chloride 40g

[0067] Sodium Calcium EDTA 1.5g

[0068] Sodium hydroxide 15g

[0069] Water for injection 4L

[0070] Makes 1000

[0071] (1) The preparation method for filling with liquid is as follows:

[0072] (1) Add the prescribed amount of sodium hydroxide, esomeprazole sodium, sodium chloride, calcium sodium edetate into the water for injection, the temperature of the water for injection is at 10°C, stir to dissolve completely;

[0073] (2) Use 10% sodium hydroxide solution to adjust the pH value of the liquid medicine to 11.5, and add water for injection to the full amount;

[0074] (3) Add medicinal charcoal to the prepared solution according to the volume of the medicinal solution at 0.15% g / ml, and stir for 30 minutes

[0075] Finally, use a 0.45um titanium rod filter to remove carbon;

[0076] (4) Sterilize and filter with two 0.2um polyethersulfone filter elements;

[0077] (4) Determination of intermediate co...

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Abstract

The invention relates to a composition of esomeprazole sodium freeze-dried powder for injection and a preparation method thereof. The composition is mainly used for treating stomach burning sensation caused by non-erosive gastroesophageal reflux disease, Gastrointestinal diseases such as erosive esophagitis. The main ingredients of the composition are esomeprazole sodium, sodium chloride, sodium hydroxide, and calcium sodium ethylenediamine tetraacetate. During the preparation process, low-temperature feeding, nitrogen flushing protection, and low-temperature sublimation and low-temperature analysis and drying are used to prepare the composition. craft. The freeze-dried powder compound prepared by this kind of prescription and preparation process has beautiful freeze-dried shape, stable product quality, less impurity content, good resolubility, reduced production cost, expanded production batch, convenient clinical medication, and can obtain good results. economic and social benefits.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a freeze-dried powder composition of esomeprazole sodium injection and a preparation method thereof. Background technique [0002] Peptic ulcer refers to the tissue damage of the gastrointestinal mucosa beyond the muscularis mucosa caused by the digestion of gastric digestive juice itself. It can occur in any part of the digestive tract, among which the stomach and duodenum are the most common, namely gastric ulcer and duodenum duodenal ulcer. Gastric ulcer is one of the common and frequently-occurring diseases in the Chinese population, and its occurrence is mainly related to the imbalance between the damage factors of the gastroduodenal mucosa and the self-defense repair factors of the mucosa. The protective mechanism of the gastroduodenal mucosa of normal people is sufficient to resist the erosion of gastric acid and pepsin, but when some factors damage a link in the protect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61K47/04A61P1/04
Inventor 卞建钢李成文姜绍群刘静王金宝李吉林宋晓丽
Owner DEZHOU DEYAO PHARMA
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