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Ibuprofen injection preparation and preparation method thereof

A technology for injection preparations and modulators, applied in anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., can solve problems such as insufficient stability of products and potential safety hazards in medication, and achieve a strong effect of stability

Active Publication Date: 2012-03-14
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] As a solution of ibuprofen, the above-mentioned patent No. ZL 01823764.9 uses arginine to effectively dissolve ibuprofen, but the resulting product has different appearance, content, pH, etc. under light and high temperature conditions. Obvious changes, the product is not stable enough, and there are potential safety hazards in medication

Method used

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  • Ibuprofen injection preparation and preparation method thereof
  • Ibuprofen injection preparation and preparation method thereof
  • Ibuprofen injection preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0052] Embodiment 1: the preparation of injection

[0053] The meglumine of 468g is added into the water of 6L, stirs and makes dissolving completely, then meglumine by molar ratio: ibuprofen=0.49: 1.00, add (R) ibuprofen, (S) ibuprofen or ( RS) ibuprofen 1009g, stir to make ibuprofen dissolve completely, add water to 10L, make the solution that contains ibuprofen concentration and be 100g / L, adjust pH to 7.5 with sodium carbonate solution, and guarantee that the solution is clear and colorless, add Activated carbon, the dosage is 0.02%, boiled for 30 minutes, cooled to 60°C, left for 10 minutes, decarbonized and filtered, filled with ampoules, and obtained.

Embodiment 2

[0054] Embodiment 2: the preparation of injection

[0055] The meglumine of 950g is added into the water of 6L, stirs and makes dissolving completely, then is meglumine: ibuprofen=1: 1 by molar ratio, adds (R) ibuprofen, (S) ibuprofen or ( RS) ibuprofen 1004g, stir and make ibuprofen dissolve completely, add water to 10L, make the solution that contains ibuprofen concentration and be 100g / L, the solution is clear and colorless, adjust pH to 6.5 with sodium carbonate solution, and Ensure that the solution is clear and colorless, add activated carbon at a dosage of 0.45%, boil for 5 minutes, cool to 40°C, stand for 30 minutes, decarbonize and filter, fill with ampoules, and get ready.

Embodiment 3

[0056] Embodiment 3: the preparation of injection

[0057] Add 1420g of meglumine to 6L of water, stir to dissolve completely, then meglumine: ibuprofen=1.5:1.0 in molar ratio, add (R) ibuprofen, (S) ibuprofen or (RS) ) ibuprofen 1000g, stir to make the ibuprofen dissolve completely, add water to 10L, make a solution containing ibuprofen concentration of 100g / L, the solution is clear and colorless, adjust the pH to 8.5 with citric acid solution, and ensure that the solution Clear and colorless, add activated carbon at a dosage of 0.3%, boil for 10 minutes, cool to 45°C, stand for 25 minutes, decarbonize and filter, fill with ampoules, and get ready.

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Abstract

The invention relates to an ibuprofen injection preparation and a preparation method thereof, and especially relates to an ibuprofen injection preparation with meglumine as a cosolvent and a preparation method thereof, wherein the molar ratio of meglumine and ibuprofen is 0.1-2.0:1. The invention provides a new effective method which allows ibuprofen to be dissolved, the drug effect of ibuprofen to be rapidly and fully performed, and the solution formed by ibuprofen to be used for preparing a solution for injection or freeze-dried powder for injection. By carrying out pharmic stability tests,animal safety tests, pharmacokinetics and the like to realize the multitime investigation of the stability, the safety and the effectiveness of the ibuprofen injection preparation, results show that the ibuprofen injection preparation has a strong stability. So compared with the prior part, the preparation method of the invention allows the safety and the effectiveness of drugs to be guaranteed.

Description

technical field [0001] The invention relates to an ibuprofen injection preparation and a preparation method thereof, in particular to an ibuprofen injection preparation using meglumine as a cosolvent and a preparation method thereof. Background technique [0002] Ibuprofen, chemical name 2-(4-isobutylphenyl)propanoic acid, alpha-methyl-4-(2-methylpropyl)phenylacetic acid or 2-methyl-4-(2-methyl Propyl) phenylacetic acid, the molecular formula is C 13 h 18 0 2 , the chemical structural formula is: [0003] [0004] 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 mode...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/192A61K47/18A61P29/00
Inventor 赵同华王利春梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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