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Freeze-dried powder injection containing dextrogyrate rabeprazole and salts thereof, preparing technology thereof

A technology for dex-rabeprazole and dex-rabeprazole sodium is applied in the field of freeze-dried powder injection preparations and their preparation, and can solve the problems of slow onset of action and inability to achieve therapeutic effects and the like

Inactive Publication Date: 2008-07-30
BEIJING RUNDEKANG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Dexrabeprazole currently used in the market is mainly film-coated tablets, but the onset of effect is slow and cannot achieve a good therapeutic effect

Method used

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  • Freeze-dried powder injection containing dextrogyrate rabeprazole and salts thereof, preparing technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Dexrabeprazole hydrochloride freeze-dried powder injection

[0027] prescription:

[0028] components

Dosage

Dexrabeprazole Sodium

Mannitol

sodium bisulfite

4% sodium hydroxide solution

Water for Injection

Co-made

10g

50g

5g

Appropriate amount

Add to 5000ml

1000 bottles

[0029] Preparation:

[0030] The sodium bisulfite and dex-rabeprazole sodium of the prescribed amount were weighed and dissolved in 80% water for injection to make a dex-rabeprazole sodium solution, and the mannitol of the prescribed amount was added to adjust the pH value to 3.0-9.5. Heat the medicinal solution to about 60°C, add 0.1% activated carbon for needles according to the prepared amount, stir for 30 minutes, filter and decarbonize, and then use a 0.22 μm microporous membrane for fine filtration. In the bottle (theoretical amount of each bottle is 5ml), put the medicinal ...

Embodiment 2

[0031] Example 2: Dex-rabeprazole hydrochloride freeze-dried powder injection

[0032] prescription:

[0033] components

Dosage

Dexrabeprazole Sodium

Dextran

Sodium thiosulfate

1% sodium hydroxide solution

Water for Injection

Co-made

10g

50g

4g

Appropriate amount

Add to 2000ml

1000 bottles

[0034] Preparation:

[0035] Weigh the prescribed amount of sodium thiosulfate and dex-rabeprazole sodium and add them to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of dextran, adjust the pH value to 3.0-9.5, and add 0.1% according to the prepared amount Activated carbon for needles was incubated and stirred for 30 minutes, filtered, decarbonized, and finely filtered with a 0.22 μm microporous membrane. After the intermediate was tested and passed, it was aseptically filled in a 5ml vial (theoretical amount of each bottle was 2ml), ...

Embodiment 3

[0036] Example 3: Dex-rabeprazole hydrochloride freeze-dried powder injection

[0037] prescription:

[0038] components

Dosage

Dexrabeprazole Potassium

Glycine

Sodium metabisulfite

Sodium Calcium EDTA

1% sodium hydroxide solution

Water for Injection

Co-made

20g

25g

2g

1g

Appropriate amount

Add to 2000ml

1000 bottles

[0039] Preparation:

[0040]Weigh the prescribed amount of dex-rabeprazole potassium and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of glycine, sodium metabisulfite, sodium calcium edetate, stir to dissolve and adjust the pH value to 3.0 ~9.5, add 0.1% activated carbon for needles according to the prepared amount, heat and stir for 30min, filter, decarbonize, and then fine filter with a 0.22 μm microporous membrane. After the intermediate is qualified, it is aseptically filled in...

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PUM

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Abstract

The invention relates to a freeze-dry powder injection containing dextral rabeprazole and salt of the dextral rabeprazole and a preparation technique thereof. The dextral rabeprazole and the salt thereof are taken as medical active components and mixed with a plurality of pharmaceutically acceptable supplements to form a medical composition. The preparation method is that the dextral rabeprazole and the salt thereof are taken as raw materials, a plurality of supplements with special type and proportion are added, and the freeze-dry powder injection preparation for intravenous injection are prepared and developed according to the technical method described by the invention. The invention can be applied in urgent treatments of tachycardia type arrhythmia (including the atrial fibrillation, atrial flutter and sinus tachycardia) happened during operation.

Description

technical field [0001] The invention relates to a freeze-dried powder preparation containing dex-rabeprazole and its salt and a preparation process thereof, belonging to the technical field of medicine. Background technique [0002] The chemical name of rabeprazole is [0003] 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl[1H]-benzimidazole [0004] Its chemical structure is [0005] [0006] In practical applications, we often use its medicinal salts, most commonly sodium and potassium salts. Rabeprazole sodium is a drug that inhibits secretion and is a substitute for benzimidazole. It has no anticholinergic and anti-H2 histamine properties, but it can attach to the surface of gastric parietal cells and inhibit gastric acid production by inhibiting H+ / K+-ATPase secretion. This enzyme system is regarded as an acid proton pump, so rabeprazole sodium acts as a proton pump inhibitor in the stomach to block the production of gastric acid, and this effect i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/19A61K47/10A61K47/12A61K47/16A61K47/26A61K47/36A61P1/04
Inventor 路洪书
Owner BEIJING RUNDEKANG MEDICAL TECH CO LTD
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