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Ibuprofen amino acid salt injection and preparation thereof

A technology of ibuprofen lysine salt and amino acid salt is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve the problems of screening and optimization of non-injection prescriptions, and no product listing. To achieve the effect of broadening the scope of use, improving the curative effect and reducing irritation

Inactive Publication Date: 2008-07-09
航天中心医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability, hemolysis, irritation and allergy of the drug after it is made into the injection is the key to whether the injection can be applied. Although the oral preparation of ibuprofen arginine salt has been marketed, the ibuprofen amino acid salt Injection has no products on the market so far
Patent CN01823764.9 mentioned a preparation method of ibuprofen arginine salt liquid preparation, but it did not screen and optimize the prescription of its injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] prescription:

[0078] Ibuprofen arginine salt: 184.45g (calculated as ibuprofen 100g)

[0079] Sodium bicarbonate: 3g

[0080] Water for injection 1000ml

[0081] Preparation method: according to the ordinary small-volume injection process, mix the prescribed amount of ibuprofen arginine salt and sodium bicarbonate with 80-90% of the total amount of water for injection, stir to dissolve completely, add water for injection to 1000ml; Carbon adsorption, decarburization, and filtration with 0.45 micron and 0.22 micron microporous membranes in turn; after the content of the filtrate is determined to be qualified, it is filled in washed, dried and sterilized ampoules, 1ml ampoule or 2ml ampoule, and sealed; 115 ℃ autoclave for 30 minutes, and make it into a finished product.

Embodiment 2

[0083] prescription:

[0084] Ibuprofen lysine salt: 170.87g (calculated as ibuprofen, 100g)

[0085] Sodium bicarbonate: 13g

[0086] Water for injection 1000ml

[0087] Preparation method: According to the preparation process of ordinary small-volume injections, completely dissolve ibuprofen lysine salt and sodium bicarbonate with about 900ml of water for injection to make a solution, add water for injection to 1000ml; absorb by activated carbon, decarburize, Filter through microporous membranes of 0.45 microns and 0.22 microns in turn; after the content of the filtrate is determined to be qualified, fill and seal in washed, dried and sterilized ampoules, either 1ml ampoule or 2ml ampoule, and melt seal; extinguish by hot pressing at 115°C Bacteria 30min, obtains the injection finished product of the present invention.

Embodiment 3

[0089] prescription:

[0090] Ibuprofen: 100g

[0091] Arginine: 84.45g

[0092] Sodium bicarbonate: 6g

[0093] Water for injection 1000ml

[0094] Preparation method: According to the process of small-volume injection, mix ibuprofen, lysine, and sodium bicarbonate, add about 850ml of water for injection, stir while adding until completely dissolved, add water for injection to 1000ml; after activated carbon adsorption, Decarburization, followed by filtration with 0.45 micron and 0.22 micron microporous membranes; after the content of the filtrate is determined to be qualified, it is filled in a washed, dried and sterilized ampoule, 1ml ampoule or 2ml ampoule, melted and sealed; 115 ° C heat press Sterilize for 30 minutes to make a finished product.

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PUM

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Abstract

The present invention discloses ibuprofen amino acid salt injection and a preparation method thereof. In the present invention, sodium bicarbonate is used as preparation auxiliary material, which ensures the prepared injection has stable quality, little stimulation, no hypersusceptibility effect, no hemolysis effect and stable curative effect and takes effect fast. The present invention is mainly applied to antipyresis and acesodyne under the circumstance which is not fit for oral medication or is not capable of the oral medication.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to an ibuprofen amino acid salt injection and a preparation method thereof. Background technique [0002] Ibuprofen (Ibuprofen) is a phenylpropionic acid non-steroidal anti-inflammatory analgesic, which has strong anti-inflammatory, anti-rheumatic and antipyretic and analgesic effects. Similar, better than acetaminophen, with mild gastrointestinal side effects and good tolerance, it is an antipyretic and analgesic widely used at present. Ibuprofen inhibits thromboxane A in humans 2 Improve immune function, improve anti-infection ability, inhibit fibrous proliferation after injury, inhibit vasoconstriction, ischemia and vascular hyperplasia around injured tissue, restore blood pressure, correct acidosis, increase cardiac output and improve survival of endotoxin-induced shock Therefore, it has great clinical application value. The dosage forms of ibuprofen listed both at home and ab...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K47/02A61P29/00A61K31/192
Inventor 刘会臣刘金印杜玉民王涛
Owner 航天中心医院
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