Method for preparing ibuprofen injection

An injection, alkaline technology, applied in the direction of pharmaceutical formulations, drug delivery, non-central analgesics, etc., can solve the problems of slow absorption, gastrointestinal irritation, low solubility, etc.

Inactive Publication Date: 2011-01-12
南京威尔曼药物研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The water solubility of ibuprofen is not good, so most of the oral preparations of ibuprofen are used clinically at present, such as common preparations such as tablets, capsules, dispersible tablets, and oral suspensions. Like other non-steroidal anti-inflammatory drugs, there is a small solubility , slow absorption, low bioavailability, and relatively slow onset of action, which will cause inconvenience to children, the elderly, and patients who cannot swallow solid preparations; in addition, oral ibuprofen is irritating to the gastrointestinal tract to a certain extent, and taking it for a long time cause discomfort to the patient

Method used

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  • Method for preparing ibuprofen injection
  • Method for preparing ibuprofen injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: Ibuprofen injection, 400mg specification (batch number: 100501)

[0015] Ibuprofen 400g

[0016] Arginine 312g

[0017] Sodium bicarbonate 7g

[0018] Edetate Disodium 2g

[0019] Add water for injection 4000ml

[0020]

[0021] 1000 pieces

[0022] The sodium bicarbonate and arginine that take prescription quantity are dissolved in 2800ml (70%) water for injection and dissolve completely, slowly add ibuprofen under stirring condition until fully dissolving, add prescription quantity disodium edetate and dissolve, add water to Stir well enough, add 2g (0.05%) of activated carbon, stir for 15-30min, decarbonize, filter through 0.45μm, 0.22μm microporous membrane; pack into brown ampoules according to 4ml, sterilize at 121℃ for 10 minutes to make injection liquid.

Embodiment 2

[0023] Embodiment 2: ibuprofen injection, 400mg specification (batch number: 100502)

[0024] Ibuprofen 400g

[0025] Lysine 260g

[0026] Disodium hydrogen phosphate dodecahydrate 156g

[0027] Sodium dihydrogen phosphate dihydrate 7.5g

[0028] Sodium metabisulfite 4g

[0029] Add water for injection 4000ml

[0030]

[0031] 1000 pieces

[0032] The disodium hydrogen phosphate, sodium dihydrogen phosphate and lysine that take prescription quantity are dissolved in 3200ml (80%) water for injection and dissolve completely, slowly add ibuprofen under stirring condition until completely dissolving, add prescription quantity sodium pyrosulfite to dissolve , add water to a sufficient amount and stir evenly, add 2g (0.05%) of activated carbon, stir for 15-30 minutes, decarbonize, filter through 0.45μm, 0.22μm microporous membranes; pack into brown ampoules according to 4ml, and sterilize at 121°C for 10 minutes Made into ...

Embodiment 3

[0033] Embodiment 3: ibuprofen injection, 800mg specification (batch number: 100503)

[0034] Ibuprofen 800g

[0035] Diethanolamine 360g

[0036] Borax 80g

[0037] Add water for injection 8000ml

[0038]

[0039] 1000 pieces

[0040] The diethanolamine and borax that take prescription quantity are dissolved in 6000ml (75%) water for injection and dissolve completely, under stirring condition, slowly add ibuprofen until fully dissolved, add water to sufficient amount and stir evenly, add 2g (0.05%) of activated carbon , stirred for 15-30 minutes, decarbonized, filtered through 0.45 μm and 0.22 μm microporous membranes; divided into brown ampoules according to 8ml, and sterilized at 121°C for 10 minutes to make injections.

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Abstract

The invention discloses a method for preparing an ibuprofen injection, which is characterized in that the injection is a more stable injection prepared from ibuprofen and an alkaline cosolvent, wherein the cosolvent is one or more of arginine, lysine, histidine, anhydrous ethylenediamine, diethanol amine, and the like. The process has the advantages of simple operation and easy application and is easy for industrialized scale production.

Description

technical field [0001] The invention relates to a preparation method of medicine injection, in particular to a method for dissolving ibuprofen and a preparation method of ibuprofen injection. Background technique [0002] ibuprofen: [0003] Chemical name: α-methyl-4-(2-methylpropyl)phenylacetic acid [0004] The structural formula is: [0005] [0006] Molecular formula: C 13 h 18 o 2 [0007] Molecular weight: 206.28 [0008] Ibuprofen is a non-steroidal anti-inflammatory drug (NSAIDs), which has significant anti-inflammatory, analgesic and antipyretic effects and less adverse reactions. It is widely used in the world and has become one of the best-selling over-the-counter drugs in the world. The mechanism of anti-inflammatory and antipyretic effects of ibuprofen may be related to the inhibition of prostaglandin synthesis, which inhibits prostaglandin synthesis by inhibiting cyclooxygenase (COX), and relieves inflammation, fever and pain caused by prostaglandin a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61P29/00
Inventor 任金山赵晖张瑾邹爱峰廖燕燕徐健峰魏小荣张敏
Owner 南京威尔曼药物研究所有限公司
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