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A kind of esomeprazole sodium sodium chloride injection and preparation method thereof

A technology of esomeprazole sodium sodium chloride and esomeprazole sodium, which is applied in the field of injections, can solve the problems of drug liquid pollution and storage time, and achieve the effects of not easy to degrade, avoid pollution, and have good stability

Active Publication Date: 2020-06-16
湖北华仁同济药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides an esomeprazole sodium sodium chloride injection and a preparation method thereof, which solves the problem that the esomeprazole sodium for injection in the prior art is prone to produce liquid pollution during the preparation process and the storage time after preparation shorter question

Method used

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  • A kind of esomeprazole sodium sodium chloride injection and preparation method thereof
  • A kind of esomeprazole sodium sodium chloride injection and preparation method thereof
  • A kind of esomeprazole sodium sodium chloride injection and preparation method thereof

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Embodiment 1

[0015] A kind of preparation method of esomeprazole sodium sodium chloride injection of the present invention is as follows:

[0016] 1) The prescription of esomeprazole sodium and sodium chloride injection is: esomeprazole sodium 350mg, edetate disodium 15.0mg, sodium hydroxide 60.0mg, sodium bicarbonate 40.0mg, sodium chloride 9.0g , Appropriate amount of water for injection;

[0017] 2) In the clean concentrated compounding tank, when the concentrated compounding tank is turned on and stirred, take 25% of the prescribed amount of water for injection, and slowly pour it into the concentrated compounding tank, and then add sodium chloride to make it Dissolve to prevent sinking and agglomeration. The powder adhered to the tank wall should be washed with water for injection, and stirred evenly to obtain a concentrated material;

[0018] 3) In the dilute dispensing tank, turn on the stirring of the dilute dispensing tank, add the above-mentioned concentrated material into the d...

Embodiment 2

[0023] A kind of preparation method of esomeprazole sodium sodium chloride injection of the present invention is as follows:

[0024] 1) The prescription of esomeprazole sodium and sodium chloride injection is: esomeprazole sodium 400mg, edetate disodium 25.0mg, sodium hydroxide 80.0mg, sodium bicarbonate 60.0mg, sodium chloride 9.0g 1. Appropriate amount of water for injection is about 1000mL;

[0025] 2) In the clean concentrated mixing tank, when the concentrated mixing tank is turned on and stirred, take 35% of the prescription water for injection, and slowly pour it into the concentrated mixing tank, and then add sodium chloride to make it Dissolve to prevent sinking and agglomeration. The powder adhered to the tank wall should be washed with water for injection, and stirred evenly to obtain a concentrated material;

[0026] 3) In the dilute dispensing tank, turn on the stirring of the dilute dispensing tank, add the above-mentioned concentrated material into the dilute ...

Embodiment 3

[0031] A kind of preparation method of esomeprazole sodium sodium chloride injection of the present invention is as follows:

[0032] 1) The prescription of esomeprazole sodium and sodium chloride injection is: esomeprazole sodium 450mg, edetate disodium 45.0mg, sodium hydroxide 100mg, sodium bicarbonate 80.0mg, sodium chloride 9.0g, About 1000mL of water for injection;

[0033] 2) In the clean concentrated compounding tank, when the concentrated compounding tank is turned on and stirred, take 30% of the prescribed amount of water for injection, and slowly pour it into the concentrated compounding tank, and then add sodium chloride to make it Dissolve to prevent sinking and agglomeration. The powder adhered to the tank wall should be washed with water for injection, and stirred evenly to obtain a concentrated material;

[0034] 3) In the dilute dispensing tank, turn on the stirring of the dilute dispensing tank, add the above-mentioned concentrated material into the dilute di...

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Abstract

The invention discloses an esomeprazole sodium and sodium chloride injection and a preparation method thereof, and belongs to the technical field of an injection. Every 100 mL of the injection includes: 35-45 mg of esomeprazole sodium, 1.5-4.5 mg of edetate disodium, 6-10 mg of sodium hydroxide, 4-8 mg of sodium bicarbonate, 0.9 g of sodium chloride, and a proper amount of injection water. The invention further provides a preparation method of the injection. Through prescription optimization, sodium bicarbonate, sodium chloride and injection water are added in the prescription, wherein sodiumbicarbonate has an effect of buffering and adjusting the pH value and makes the pH value of the injection always maintain in an effective pH value range of a medicine. The injection can be directly used, so that pollution during a preparation process is prevented. The injection is good in stability and not prone to degrade. According to an accelerated test, the injection can be stored for 6 monthswith the efficacy only reduced by 5.5%. The injection can be stored for 12 months at the room temperature with the efficacy being 98% of the original efficacy, and meets the quality standard.

Description

technical field [0001] The invention belongs to the technical field of injections, in particular to an esomeprazole sodium chloride injection and a preparation method thereof, in particular to an esomeprazole for treating acute gastric or duodenal ulcer bleeding Zolium sodium chloride injection and preparation method thereof. Background technique [0002] At present, esomeprazole sodium for injection marketed at home and abroad are all powder injection preparations, and the prescriptions are esomeprazole sodium, edetate disodium and sodium hydroxide; Use; by dissolving in 0.9% sodium chloride for intravenous use. The preparation method of the liquid for injection is: add 5mL of 0.9% sodium chloride solution to the powder injection vial, shake well, and after fully dissolving, it is used for intravenous injection; the preparation method of the liquid for infusion is: mix 1 tube of powder The injection preparation is dissolved into 100mL of 0.9% sodium chloride solution for ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4439A61K47/18A61K47/02A61P1/04
CPCA61K9/0019A61K9/08A61K31/4439A61K47/02A61K47/183
Inventor 马爽逄婧孙玮
Owner 湖北华仁同济药业有限责任公司
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