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

A technology of esomeprazole sodium and omeprazole sodium, which is applied in the field of esomeprazole sodium freeze-dried powder and its preparation, can solve potential safety hazards, large errors, unrealistic production operations, etc. question

Active Publication Date: 2020-01-10
LEPU PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A powder for injection uses PEG-4000 as a solubilizer and excipient, ignoring the requirements for injection, which may cause potential safety hazards”
In addition, according to the description of polyethylene glycol 4000 in the 2015 edition of the "Chinese Pharmacopoeia", "this product is a white wax-coated solid flake or granular powder", while the other two excipients, ethanol and propylene glycol, are liquid. According to the literature The "volume ratio of ethanol-propylene glycol-polyethylene glycol 4000 is 65:20:15", the liquid and solid combination will have a large error in proportioning according to volume, and the actual production operation is not realistic
The disclosed esomeprazole sodium lyophilized powder of document CN102657622A has used multiple types of auxiliary materials such as excipients, antioxidants, and esomeprazole sodium lyophilized powder directly enters the patient's blood when used, so the more types of auxiliary materials The more, the higher the security risk

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A freeze-dried powder of esomeprazole sodium (1000 freeze-dried powder injections), the composition is as follows:

[0028]

[0029] Follow the steps below to prepare:

[0030] 1. Prepare the solution

[0031] (1) Cool the water for injection to 10°C for later use;

[0032] (2) Add 80% of the prepared volume of water for injection into the dispensing tank, add the prescribed amount of disodium hydrogen phosphate and esomeprazole sodium, stir to dissolve completely;

[0033] (3) Use 0.1mol / L sodium hydroxide solution to adjust the pH value of the liquid to 10.5;

[0034] (4) Add 0.05% (g / mL) activated carbon and stir for 15 minutes;

[0035] (5) First decarbonize by filtering through a 0.8μm filter membrane, add water for injection to the full amount, then filter through a 0.22μm filter membrane, fill and fill with a half stopper.

[0036] 2. Freeze-drying

[0037] Put the above-mentioned subpackaged semi-finished products into the freeze-drying box;

[0038] ...

Embodiment 2

[0042] A freeze-dried powder of esomeprazole sodium (1000 freeze-dried powder injections), the composition is as follows:

[0043]

[0044] Follow the steps below to prepare:

[0045] 1. Prepare the solution

[0046] (1) Cool the water for injection to 12°C for later use;

[0047] (2) Add 80% of the prepared volume of water for injection into the dispensing tank, add the prescribed amount of disodium hydrogen phosphate and esomeprazole sodium, stir to dissolve completely;

[0048] (3) Use 0.1mol / L sodium hydroxide solution to adjust the pH value of the liquid to 10.8;

[0049](4) Add 0.08% (g / mL) activated carbon and stir for 15 minutes;

[0050] (5) First decarbonize by filtering through a 0.8μm filter membrane, add water for injection to the full amount, then filter through a 0.22μm filter membrane, fill and fill with a half stopper.

[0051] 2. Freeze-drying

[0052] Put the above-mentioned subpackaged semi-finished products into the freeze-drying box;

[0053] ...

Embodiment 3

[0057] A freeze-dried powder of esomeprazole sodium (1000 freeze-dried powder injections), the composition is as follows:

[0058]

[0059] Follow the steps below to prepare:

[0060] 1. Prepare the solution

[0061] (1) Cool the water for injection to 15°C for later use;

[0062] (2) Add 80% of the prepared volume of water for injection into the dispensing tank, add the prescribed amount of disodium hydrogen phosphate and esomeprazole sodium, stir to dissolve completely;

[0063] (3) Use 0.1mol / L sodium hydroxide solution to adjust the pH value of the liquid to 11.0;

[0064] (4) Add 0.1% (g / mL) activated carbon and stir for 15 minutes;

[0065] (5) First decarbonize by filtering through a 0.8μm filter membrane, add water for injection to the full amount, then filter through a 0.22μm filter membrane, fill and fill with a half stopper.

[0066] 2. Freeze-drying

[0067] Put the above-mentioned subpackaged semi-finished products into the freeze-drying box;

[0068] ...

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Abstract

The invention discloses esomeprazole sodium freeze-dried powder and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The esomeprazole sodium freeze-driedpowder is composed of esomeprazole sodium, disodium hydrogen phosphate and sodium hydroxide, wherein the mass of the esomeprazole sodium is 42.5mg; the addition amount of the disodium hydrogen phosphate is 0.3-0.8% of the mass of the esomeprazole sodium; and the sodium hydroxide is a pH regulator, so that the pH value of the solution of the freeze-dried powder is 10.5-11.0 before freeze frying. The technical scheme of the invention is mainly characterized in that the preparation formula is simple, excipients, antioxidants and other auxiliary materials are not needed, disodium hydrogen phosphate can achieve effects of a complexing agent and can also achieve pH buffering effect, and the stability of the finished preparation is ensured. According to the technical scheme in the invention, excessive dosing is not needed, and the content of main ingredients has extremely small fluctuation after the finished product is re-dissolved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried esomeprazole sodium powder and a preparation method thereof. Background technique [0002] Esomeprazole, also known as esomeprazole, is the S-isomer of omeprazole, and esomeprazole sodium for injection is clinically used for "when oral therapy is not applicable, gastroesophageal reflux Alternative therapies for diseases". Esomeprazole is a proton pump inhibitor anti-ulcer drug. Proton pump inhibitors are highly effective drugs for the treatment of ulcer disease. It inhibits H in gastric parietal cells. + , K + -ATPase to achieve the inhibition of gastric acid secretion in the digestive tract. Digestive system diseases are one of the common frequently-occurring diseases. Due to the development of society and the accelerated pace of life, the incidence of gastrointestinal diseases is still increasing year by year. The drug market for such di...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K9/19A61K47/02A61P1/04
CPCA61K9/0019A61K9/19A61K31/4439A61K47/02
Inventor 王庆鹏骆献丽尚云飞杨永霞王玉拓
Owner LEPU PHARMACEUTICAL CO LTD
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