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Dexibuprofen injection composition

A composition and injection technology, applied in the field of medicine, can solve the problems of low bioavailability, low solubility, inconvenience to patients, etc., and achieve the effects of good stability, easy production control, and stable and safe preparations

Inactive Publication Date: 2014-04-16
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, common preparations such as Dexibuprofen tablets, capsules, dispersible tablets, and oral suspensions in clinical practice, like other non-steroidal anti-inflammatory drugs, have low solubility, slow absorption, low bioavailability, and relatively slow onset of action. and other disadvantages, and it brings inconvenience to the elderly and patients who cannot swallow solid preparations

Method used

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  • Dexibuprofen injection composition
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  • Dexibuprofen injection composition

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0027] According to the formulation and preparation conditions in Table 1, different proportions of the dextroibuprofen compositions of Examples 1-6 (the content of dextrobuprofen in the formula is 100 mg / ml) were prepared by the following preparation methods.

[0028] Formulation and preparation conditions of table 1 embodiment 1-6 Dexibuprofen composition

[0029] test

Raw materials

The molar ratio of

concentration

Sterilization conditions

Example 1

Dexibuprofen: Arginine

1：0.82

100mg / ml

121℃ damp heat

Example 2

Dexibuprofen: Arginine

1：1.03

100mg / ml

121℃ damp heat

Example 3

Dexibuprofen: Arginine

1：1.30

100mg / ml

121℃ damp heat

Example 4

Dexibuprofen: Arginine

1：0.82

100mg / ml

121℃ damp heat

Example 5

Dexibuprofen: Arginine

1：1.03

l00mg / ml

121℃ damp heat

Example 6

Dexibuprofen: Arginine

1：1.30

100mg / ml

121℃ damp hea...

Embodiment 7-8

[0045] Formulation and preparation conditions of table 3 embodiment 7-8 Dexibuprofen composition

[0046] test

Raw materials

The molar ratio of

concentration

Sterilization conditions

Whether to fill nitrogen

Example 7

Dexibuprofen: Arginine

1：1.30

100mg / ml

121℃ damp heat

N

[0047] Example 8

Dexibuprofen: Arginine

1：1.30

100mg / ml

121℃ damp heat

Y

[0048] 1. Weigh the prescribed amount of arginine and ibuprofen;

[0049] 2. Dissolve arginine with an appropriate amount of water for injection (about 80ml) until it is clear and transparent, add the prescribed amount of Dexibuprofen, and stir until it is completely dissolved;

[0050] 3. Add an appropriate amount of activated carbon, stir for 15 minutes, and decarbonize by filtering with a 0.45 μm filter membrane.

[0051] 4. Dilute to full volume, filter with 0.22μm filter membrane, fill, 4ml / bottle, and seal.

[0052] 5. Steri...

Embodiment 8-10

[0059] Formulation and preparation conditions of table 5 embodiment 8-10 Dexibuprofen composition

[0060] test

Raw materials

The molar ratio of

Sterilization conditions

Whether to fill nitrogen

Example 8

Dexibuprofen: Arginine

1：1.30

121℃ damp heat for 15min

Y

Example 9

Dexibuprofen: Arginine

1：1.30

121°C damp heat for 8 minutes

Y

[0061] Example 10

Dexibuprofen: Arginine

1：1.30

115°C damp heat for 30min

Y

[0062] 1. Weigh the prescribed amount of arginine and ibuprofen;

[0063] 2. Dissolve arginine with an appropriate amount of water for injection (about 80ml) until it is clear and transparent, add the prescribed amount of Dexibuprofen, and stir until it is completely dissolved;

[0064] 3. Add 0.5% activated carbon, stir for 15 minutes, and remove carbon by filtering with a 0.45 μm filter membrane.

[0065] 4. Dilute to full volume, filter with 0.22μm filter ...

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PUM

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Abstract

The invention provides a dexibuprofen injection composition which comprises dexibuprofen, arginine and water for injection, wherein other regulating agents and organic solvents do not need to be added; the dexibuprofen can be fully dissolved to form a stable medicament composition by regulating the ratio of the arginine to the dexibuprofen. The dexibuprofen injection composition provided by the invention is higher in stability; the pH of the injection is in a blood tolerance range of a human body, so that a requirement on clinical medication can be met.

Description

technical field [0001] The invention belongs to the technical field of medicine and provides a safe and stable Dexibuprofen injection composition, which can be used to relieve pain, inflammation, fever or other diseases. Background technique [0002] Non-steroidal anti-inflammatory drugs (NSAIDs) have good anti-inflammatory, antipyretic and analgesic effects, and are widely used to treat arthritis (especially RA, OA) and pain caused by various inflammations. Dexibuprofen was first launched in the UK in 1968. Due to its significant antipyretic and analgesic effects and low toxicity, it is better than aspirin and paracetamol, so the market has expanded rapidly. Due to the better curative effect and less adverse reactions of Dexibuprofen, the U.S. and the U.K. have successively approved the conversion of its same prescription drug to an over-the-counter drug. By the early 1990s, the sales of dextroibuprofen preparations in the world market had exceeded the US$1 billion mark, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
Inventor 施猛杨欣刘恩桂张俊珺
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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