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A low irritation ibuprofen injection

A irritating and injection technology, applied in the direction of organic active ingredients, non-central analgesics, medical preparations of non-active ingredients, etc., can solve problems such as strong irritation and improper formulation

Inactive Publication Date: 2011-12-07
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

[0006] A common problem with injection administration is strong irritation, which may be caused by the active substance of the drug itself and improper formulation of the preparation

Method used

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  • A low irritation ibuprofen injection
  • A low irritation ibuprofen injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Ibuprofen 100.0g

[0017] Arginine 84.5g

[0018] Add water for injection to 1000mL

[0019] Take the prescribed amount of arginine and add it to about 800mL of water for injection. After stirring and dissolving, add the prescribed amount of ibuprofen, continue to stir until it is completely dissolved, and add water for injection to 1000mL; activated carbon adsorption, decarbonization, and microporous membrane filtration Detect the solution content, fill, melt seal, and sterilize to obtain a solution with a molar ratio (ibuprofen: arginine) of 1:1.0, a pH of about 7.3, and a concentration of 100 mg / mL.

Embodiment 2

[0021] Ibuprofen 100.0g

[0022] Arginine 101.3g

[0023] Add water for injection to 1000mL

[0024] Take the prescribed amount of arginine and add it to about 800mL of water for injection. After stirring and dissolving, add the prescribed amount of ibuprofen, continue to stir until it is completely dissolved, and add water for injection to 1000mL; activated carbon adsorption, decarbonization, and microporous membrane filtration Detect the solution content, fill, melt seal, and sterilize to obtain a molar ratio (ibuprofen: arginine) of 1:1.2, a pH of about 8.5, and a concentration of 100 mg / mL solution.

Embodiment 3

[0026] Ibuprofen 100.0g

[0027] Arginine 115.6g

[0028] Add water for injection to 1000mL

[0029] Take the prescribed amount of arginine and add it to about 800mL of water for injection. After stirring to dissolve, add the prescribed amount of ibuprofen and continue to stir until it is completely dissolved. Detect the solution content, fill, melt seal, and sterilize to obtain a molar ratio (ibuprofen: arginine) of 1:1.4, a pH of about 9.0, and a concentration of 100 mg / mL solution.

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Abstract

The invention discloses a low-irritation ibuprofen injection and a preparation method thereof. In the ibuprofen injection, the drug active ingredient is ibuprofen, and the auxiliary materials are amino acid and water for injection. The molar ratio of ibuprofen to amino acid ranges from 1:1.0 to 1:1.4. The ibuprofen injection of the present invention mainly adopts amino acid as a solubilizer and a pH regulator, which reduces the types of auxiliary materials used in the preparation process of the injection, thereby preparing a low-irritation ibuprofen injection beneficial to clinical application. The injection described in the invention is mainly used for treating pain, inflammation, fever and / or other diseases relieved by ibuprofen.

Description

technical field [0001] The invention relates to a low-irritation ibuprofen injection and a preparation method thereof, in particular, a low-irritation injection made of active ingredient ibuprofen and auxiliary materials for injection into the body and a preparation method thereof , belongs to the field of pharmaceutical preparations. Background technique [0002] Ibuprofen (Ibuprofen) is a phenylpropionic acid non-steroidal anti-inflammatory analgesic drug (NSAID), the chemical name is 2-(4-isobutylphenyl) propionic acid, the molecular weight is 206.28, and the molecular structural formula is as follows: [0003] [0004] In 1966, ibuprofen was first marketed as a prescription drug in the UK and in the US in 1974. In the UK, ibuprofen became the first non-steroidal anti-inflammatory drug that could be sold over-the-counter in 1983; ibuprofen also became an over-the-counter drug in the United States in 1984. Ibuprofen has strong anti-inflammatory, anti-rheumatic and ant...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/16A61P29/00
Inventor 李亚玲马占芝丁百莲杨吉宁李志强
Owner 沈阳双鼎制药有限公司
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