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A kind of Dexibuprofen injection and preparation method thereof

A technology of dextroibuprofen and injection, applied in the field of medicine, can solve the problems such as no obvious innovation, insignificant effect of solubilization, increase of adverse reactions, etc., and achieve significant effect of solubilization, shorten production time, and speed up dissolution. effect of speed

Active Publication Date: 2017-01-11
沈阳双鼎制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Patent CN102370615A discloses a kind of dextrobuprofen injection, the molar ratio of meglumine and ibuprofen provided by it is 0.1~2.0:1, and when the dosage of meglumine is small, the effect of solubilization is not obvious, and the dosage is large drug safety issues
[0012] At present, most of the patents on Dexibuprofen Injection focus on the discussion on the dosage of alkaline co-solvents such as arginine and meglumine. Ibuprofen exists in the form of ions to increase the solubility. The type and dosage of co-solvents are reflected in the relevant patents of ibuprofen injection, and there is no obvious innovation
And if the consumption of alkaline co-solvent is low, then when using with 5% glucose injection or 0.9% sodium chloride injection compatibility, the drug is easy to separate out, resulting in the inability to administer; However, more electrolytes are injected, which increases the chance of adverse reactions

Method used

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  • A kind of Dexibuprofen injection and preparation method thereof
  • A kind of Dexibuprofen injection and preparation method thereof
  • A kind of Dexibuprofen injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] A preparation method of Dexibuprofen injection comprises adding 640ml of water for injection into a beaker, adding 1.6g of poloxamer-188 and stirring until completely dissolved, adjusting pH 7.5 to 8.5 with sodium hydroxide, adding 80g of Dextrobuprofen Stir the ibuprofen until it is completely dissolved, add 0.16g of activated carbon for needles, keep warm at 50-70°C for 15 minutes, filter to remove the carbon, add water for injection to 800ml, stir evenly, and filter the filtrate with a 0.22μm sterile microporous filter membrane , the filtrate was filled in ampoules, each 4ml, 200 in total, filled with nitrogen and sealed, sterilized at 121°C for 15 minutes.

Embodiment 2

[0035] A preparation method of Dexibuprofen injection comprises adding 640ml of water for injection into a beaker, adding 2.4g of poloxamer-188 and stirring until completely dissolved, adjusting the pH to 7.5~8.5 with sodium hydroxide, adding 80g of Dextrobuprofen Stir the ibuprofen until it is completely dissolved, add 0.16g of activated carbon for needles, keep warm at 50-70°C for 15 minutes, filter to remove the carbon, add water for injection to 800ml, stir evenly, and filter the filtrate with a 0.22μm sterile microporous filter membrane , the filtrate was filled in ampoules, each 4ml, 200 in total, filled with nitrogen and sealed, sterilized at 121°C for 15 minutes.

Embodiment 3

[0037] A preparation method of Dexibuprofen injection comprises adding 640ml of water for injection into a beaker, adding 3.2g of poloxamer-188 and stirring until completely dissolved, adjusting the pH to 7.5-8.5 with arginine, adding 80g of Dexabuprofen Stir the ibuprofen until it is completely dissolved, add 0.17g of activated carbon for needles, keep warm at 50-70°C for 15 minutes, filter to remove the carbon, add water for injection to 800ml, stir evenly, and filter the filtrate with a 0.22μm sterile microporous filter membrane , the filtrate was filled in ampoules, each 4ml, 200 in total, filled with nitrogen and sealed, sterilized at 121°C for 15 minutes.

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Abstract

The invention relates to a dexibuprofen injection and a preparation method thereof, and particularly relates to a dexibuprofen injection prepared by using poloxamer-188 as a cosolvent and a preparation method thereof. In the injection, the weight ratio of dexibuprofen to poloxamer-188 is 100:(2-5). The invention provides the effective method which is capable of quickly dissolving dexibuprofen, the auxiliary usage is small, and the safety is high. Drug stability tests and animal safety tests indicate that the dexibuprofen product prepared by the method is safe and stable, and has a good drug effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular provides a safe and stable Dexibuprofen injection composition, which can be used to relieve pain, inflammation, fever or other diseases. Background technique [0002] The chemical structural formula of Dexibuprofen is: [0003] [0004] Chemical name: (s)-(+)-2-(4-isobutylphenyl)propionic acid. [0005] Ibuprofen is a clinically more commonly used and widely used non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is an effective PG synthase inhibitor with antipyretic, analgesic and anti-inflammatory effects. For sprains, strains, low back pain, frozen shoulder, bursitis, tendon and tenosynovitis. Toothache and postoperative pain, rheumatoid arthritis, osteoarthritis, and other seronegative (nonrheumatoid) joint diseases. It is used to relieve moderate pain, such as joint pain, muscle pain, migraine, headache, toothache, dysmenorrhea, neuralgia, and can also be use...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/34A61K31/192A61P29/00
Inventor 马占芝刘刚李皓刘宇
Owner 沈阳双鼎制药有限公司
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