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Ibuprofen-containing pharmaceutical composition and preparation method and application thereof

A composition and drug technology, applied in the field of pharmaceutical preparations, to achieve the effect of excellent effect

Active Publication Date: 2012-10-17
北京爱力佳医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to find a reasonable and effective ibuprofen-containing formula and process to overcome the existing problems of the existing preparations, expecting to produce stable and controllable small-volume injection preparations, especially water injection dosage forms

Method used

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  • Ibuprofen-containing pharmaceutical composition and preparation method and application thereof
  • Ibuprofen-containing pharmaceutical composition and preparation method and application thereof
  • Ibuprofen-containing pharmaceutical composition and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Ibuprofen 800g Arginine 675.6g

[0050] Propylene Glycol 200g Sodium Hydroxide Appropriate amount

[0051] Add water for injection to 8000ml

[0052] Process: Take 6000ml of water for injection, add the prescribed amount of propylene glycol and arginine in sequence, and stir to dissolve. Add the ibuprofen raw material of the prescribed amount in portions again, and stir to make it dissolve completely. Supplement water for injection to 7200ml, adjust pH to 8.0 with 0.1 mole of sodium hydroxide, supplement water for injection to 8000ml, filter with 0.22um filter membrane, fill, melt seal, and sterilize at 121°C for 15 minutes. The molar ratio of ibuprofen to arginine is 1:1.

[0053] After full-wavelength ultraviolet scanning, it has absorption at 230nm and 264.50nm.

Embodiment 2

[0055] Ibuprofen 800g Arginine 743.2g

[0056] Appropriate amount of sodium hydroxide

[0057] Add water for injection to 8000ml

[0058] Process: Take 6000ml of water for injection, add arginine, and dissolve. Add ibuprofen and let it dissolve. Supplement water for injection to 7200ml, adjust pH to 7.6-8.1 with 0.1 mole of sodium hydroxide, supplement water for injection to 8000ml, filter through membrane, fill, melt seal, and sterilize at 121°C for 15 minutes. The molar ratio of ibuprofen to arginine is 1:1.1. This technique has difference with embodiment 1 sterilization temperature, and drug effect is identical, and related substance is slightly different.

Embodiment 3

[0060] Ibuprofen 800g Arginine 743.2g

[0061] Propylene Glycol 200g Sodium Hydroxide Appropriate amount

[0062] Add water for injection to 8000ml

[0063] Process: Take 6000ml of water for injection, add propylene glycol and arginine, and dissolve. Then add the ibuprofen raw material to make it dissolve completely. Supplement water for injection to 7200ml, adjust pH to 7.4 with 0.1 mole sodium hydroxide, supplement water for injection to 8000ml, membrane filter, and sterilize at 121°C for 8 minutes. The molar ratio of ibuprofen to arginine is 1:1.1.

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Abstract

The invention provides an ibuprofen-containing pharmaceutical composition, which also comprises arginine and preferably propylene glycol. The invention also provides a preparation method and an application of the pharmaceutical composition. The composition provided by the invention is mainly used to treat patients with pains from light to moderate degree, and can be also used as an auxiliary treatment drug of anesthetic sedative agents to alleviate pains from moderate to severe degree or febrile diseases emerged in patients.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to the formulation, preparation process and application of a small-capacity preparation of an injection composition containing ibuprofen. Background technique [0002] In 1968, ibuprofen began to be marketed in the UK. Because of its anti-inflammatory and anti-rheumatic effects, and its curative effect and adverse reactions were comparable to aspirin and acetaminophen, it soon became a pillar product in the market. Ibuprofen, as one of the pillar drugs in the antipyretic and analgesic market, has this ingredient in many compound preparations such as anti-inflammatory pain relief and cold. The three major advantages of ibuprofen are that it is relatively safe and is recommended by the World Health Organization for children; it has a strong analgesic effect, 16-32 times stronger than aspirin; it has a good effect on controlling persistent high fever and is mostly...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/192A61K47/16A61K9/08A61P29/00
Inventor 袁璐
Owner 北京爱力佳医药科技有限公司
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