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Flurbiprofen axetil injection and preparation method thereof

A technology for flurbiprofen axetil and injection, applied in the field of pharmaceutical preparations, can solve the problems of unstable light and high temperature, poor batch-to-batch stability, harsh processing conditions, etc. Action-promoting effect

Active Publication Date: 2014-12-03
HEBEI YIPIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these injection emulsions have the disadvantages of harsh processing conditions, poor stability between batches, instability to strong light and high temperature, and poor solubility. Therefore, preparing a water-soluble flurbiprofen axetil injection with good quality is still an urgent need to solve The problem

Method used

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  • Flurbiprofen axetil injection and preparation method thereof
  • Flurbiprofen axetil injection and preparation method thereof
  • Flurbiprofen axetil injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: flurbiprofen axetil injection, specification: 5ml (50mg)

[0050] prescription:

[0051]

[0052] Preparation:

[0053] a) Weigh 500g (1.5mol) of flurbiprofen axetil, 264g (1.5mol) of arginine, 2.64g of nicotinamide, and 250g of disodium hydrogen phosphate, and set aside;

[0054] b) Take arginine and nicotinamide, add 10000ml of water for injection to dissolve them completely, and prepare the obtained solution for later use;

[0055] c) Add flurbiprofen axetil and the solution obtained in step b) into a 100L reaction tank, fully stir and dissolve at a speed of 60 rpm for 1 hour, add disodium hydrogen phosphate, then add 35000ml water for injection, and use 0.1M hydrogen Adjust the pH value of sodium oxide solution to 8.0, add water for injection to 50000ml;

[0056] d) Add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane;

[0057] e) Fill the filtr...

Embodiment 2

[0058] Embodiment 2: flurbiprofen axetil injection, specification: 5ml (50mg)

[0059] prescription:

[0060]

[0061] Preparation:

[0062] a) Weigh 500g (1.5mol) of flurbiprofen axetil, 396g (2.25mol) of arginine, 10g of nicotinamide, and 250g of disodium hydrogen phosphate, and set aside;

[0063] b) Take arginine and nicotinamide, add 10000ml of water for injection to dissolve them completely, and prepare the obtained solution for later use;

[0064] c) Add flurbiprofen axetil, the solution obtained in step b) into a 100L reaction tank, fully stir and dissolve at a speed of 60 rpm for 1 hour, add disodium hydrogen phosphate, add 35000ml water for injection, and oxidize with 0.1M hydroxide Adjust the pH value of sodium solution to 7.5, add water for injection to 50000ml;

[0065] d) Add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane;

[0066] e) Fill the filtrate i...

Embodiment 3

[0067] Embodiment 3: flurbiprofen axetil injection, specification: 5ml (50mg)

[0068] prescription:

[0069]

[0070] Preparation:

[0071] a) Weigh 500g (1.5mol) of flurbiprofen axetil, 396g (2.25mol) of arginine, 10g of nicotinamide, and 250g of disodium hydrogen phosphate, and set aside;

[0072] b) Take arginine and nicotinamide, add 10000ml of water for injection to dissolve them completely, and prepare the obtained solution for later use;

[0073] c) Add flurbiprofen axetil, the solution obtained in step b) into a 100L reaction tank, fully stir and dissolve at a speed of 60 rpm for 1 hour, add disodium hydrogen phosphate, add 35000ml water for injection, and oxidize with 0.1M hydroxide Adjust the pH value of the sodium solution to 7.0, add water for injection to make the volume 50000ml;

[0074] d) Add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane;

[0075] e)...

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Abstract

The invention relates to flurbiprofen axetil injection and a preparation method thereof and belongs to the technical field of pharmaceutic preparations. The flurbiprofen axetil injection contains flurbiprofen axetil and a cosolvent in a mole ratio of 1:(1-1.8), has the advantages of good solubility, stable quality and the like, can be used for avoiding drug-induced risks, probably caused by other products, of patients suffering from heart disease, hypertension and kidney disease and avoiding adverse effects such as nausea and stomachache.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a flurbiprofen axetil injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Flurbiprofen, a non-steroidal anti-inflammatory drug, is a propionic acid non-selective cyclooxygenase inhibitor, which has antipyretic, anti-inflammatory and analgesic effects, and is clinically used for the treatment of pain and inflammatory diseases. Flurbiprofen axetil is an injection form (Kaifen) prepared from flurbiprofen after emulsifying liposome microspheres. It has a high affinity with inflammatory tissues and has targeted analgesic effect. Its mechanism of action is mainly to inhibit the activity of arachidonic acid epoxidase, thereby inhibiting the synthesis of prostaglandins that cause pain and inflammation, and play an analgesic effect. Flurbiprofen axetil injection sold on the market has pr...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/216A61K47/18A61K47/22A61P29/00
Inventor 武玉洁郧海丽常明程瑶张晓彩董文弟啜振华
Owner HEBEI YIPIN PHARMA
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