Ibuprofen injection and preparation method thereof

A technology for injection and water for injection, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as hidden dangers and turbidity in clinical use.

Inactive Publication Date: 2011-08-24
付正香
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in clinical application, if it is added to 0.9% sodium chloride or 5% glucose, it will appear turbid or be dissolved first and then placed to precipitate, which will bring hidden dangers to clinical use.

Method used

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  • Ibuprofen injection and preparation method thereof
  • Ibuprofen injection and preparation method thereof
  • Ibuprofen injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1 Arginine is used as a cosolvent, and the molar ratio with ibuprofen in the prescription is 1:1.

[0057] Prescription: Ibuprofen 40g

[0058] Arginine 33.8g

[0059] Add water for injection to 4000ml

[0060]

[0061] A total of 1000 pieces (or 500 pieces) were made

[0062] Preparation method: Weigh the prescribed amount of arginine, add 3200ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of ibuprofen, add gradually in portions, and stir while adding. Stirring was continued for 20 minutes after addition to fully dissolve. The measured pH value was 7.7-8.5. Use 0.15% (w / v) activated carbon for needles, adsorb for 15 minutes, decarbonize and filter; add water for injection to 4000ml. Continue to filter with a 0.22 μm microporous membrane, and carry out semi-finished product inspection on the obtained clear filtrate. Fill the qualified semi-finished liquid medicine. E...

Embodiment 2

[0063] Embodiment 2 Arginine is a cosolvent, and the molar ratio with ibuprofen in the prescription is 1.03:1.

[0064] Ibuprofen 40g

[0065] Arginine 34.8g

[0066] Add water for injection to 4000ml

[0067]

[0068] A total of 1000 pieces (or 500 pieces) were made

[0069] Preparation method: Weigh the prescribed amount of arginine, add 3200ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of ibuprofen, add gradually in portions, and stir while adding. Stirring was continued for 20 minutes after addition to fully dissolve. The pH value of the drug solution was 7.7-8.5. Use 0.15% (w / v) activated carbon for needles, adsorb for 15 minutes, decarbonize and filter; add water for injection to 4000ml. Continue to filter with a 0.22 μm microporous membrane, and carry out semi-finished product inspection on the obtained clear filtrate. Fill the qualified semi-finished liquid medicine. E...

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Abstract

The invention relates to an ibuprofen injection and a preparation method thereof. The ibuprofen injection is characterized in that the concentration of ibuprofen in the injection is 100mg/ml, arginine is used as a cosolvent, and the molar ratio of the arginine to the ibuprofen is greater than or equal to 1:1. The invention also provides a method for preparing the injection. The prepared injection which has good dissolvability is added into a 0.9% sodium chloride injection or a 5% glucose injection, the concentration of the ibuprofen is 4mg/ml or less than 4mg/ml, and the solution is clear and is stabilized for a long time. The ibuprofen injection is suitable for intravenous drip for patients for whom the oral administration is not suitable.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to ibuprofen injection and a preparation method thereof. Background technique [0002] Ibuprofen is a phenylpropionic acid non-steroidal anti-inflammatory analgesic, which has strong anti-inflammatory, anti-rheumatic, antipyretic and analgesic effects. Its curative effect is clear, with mild gastrointestinal side effects and good tolerance , is currently widely used antipyretic analgesics. Prostaglandins are substances related to heat, pain and inflammation in the human body. Ibuprofen inhibits the synthesis of prostaglandins in the human body, thereby exerting antipyretic, analgesic and anti-inflammatory effects. At present, the ibuprofen dosage forms of domestic clinical use include oral solid preparations such as tablets, capsules, granules, and suspensions, and external dosage forms such as ointments and gels. [0003] Oral and external dosage forms of ibuprofen are widely used ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/16A61P29/00
Inventor 付正香
Owner 付正香
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