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Ibuprofen injection composition and preparation method thereof

A technology for injection preparation and injection, which is applied in the directions of drug combination, drug delivery, and pharmaceutical formulation to achieve the effect of good compliance and low irritation.

Inactive Publication Date: 2013-10-23
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In patent CN103040734, the molar ratio of ibuprofen to arginine is 1:0.85~0.95, and there is also the same compatibility problem

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Each 1000 injection preparations contains the following ingredients:

[0073] Ibuprofen 400g (1.94mol)

[0074] Arginine 365g (2.10mol)

[0075] Add water for injection to 4000ml

[0076] Weigh 400g of ibuprofen and 365g of arginine according to the prescription, add them to 3200ml of water for injection, stir at room temperature to dissolve completely; add 0.05% (W / V) activated carbon for needles, stir at 25°C for 20min, coarse filter, and filtrate Then filter with 0.22μm microporous membrane; finally add water for injection to make up to 4000ml; intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121℃, 15min high pressure steam sterilization, leak detection ; Light inspection of ampoules one by one; full sampling inspection; packaging.

Embodiment 2

[0078] Each 1000 injection preparations contains the following ingredients:

[0079] Ibuprofen 400g (1.94mol)

[0080] Arginine 372g (2.14mol)

[0081] Add water for injection to 4000ml

[0082] Weigh 400g of ibuprofen according to the prescribed quantity, add 372g of arginine into 3200ml of water for injection, stir at room temperature to dissolve completely; add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20min, coarsely filter, and re-filter the filtrate Filter with 0.22μm microporous membrane; finally add water for injection to make up to 4000ml; intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121℃, 15min high-pressure steam sterilization, leak detection; Carry out light inspection of ampoules one by one; full sampling inspection; packaging.

Embodiment 3

[0084] Each 1000 injection preparations contains the following ingredients:

[0085] Ibuprofen 400g (1.94mol)

[0086] Arginine 379g (2.18mol)

[0087] Add water for injection to 4000ml

[0088] Weigh 400g of ibuprofen according to the prescription, add 379g of arginine into 3200ml of water for injection, stir at room temperature to dissolve completely; add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20min, coarsely filter, and then re-filter the filtrate Filter with 0.22μm microporous membrane; finally add water for injection to make up to 4000ml; intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121℃, 15min high-pressure steam sterilization, leak detection; Carry out light inspection of ampoules one by one; full sampling inspection; packaging.

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Abstract

The invention relates to an ibuprofen injection. The injection consists of an active component ibuprofen and a cosolvent arginine, and is characterized in that the molar ratio of ibuprofen to arginine is 1:1.08-1.12, pH conditioning agents are not used, the amount and kind of accessories during injection preparation are reduced, irritation is low and security is higher. The prepared ibuprofen injection is substantially improved in resistance of high temperature and hard light; not only insoluble particles are obviously minimized, but also the compatibility problems of the injection with common salt and glucose injections are solved; and the product quality stability is substantially improved, and clinic compatibility demands are satisfied. Also, the invention provides a preparation method which is simple in technology and suitable for industrialized production.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an ibuprofen injection composition and a preparation method thereof. Background technique: [0002] Ibuprofen is a non-steroidal anti-inflammatory analgesic with the following structural formula, which has anti-inflammatory, analgesic and antipyretic effects. [0003] [0004] α-Methyl-4-(2-methylpropyl)phenylacetic acid [0005] Since it was developed in 1964, ibuprofen has been widely used for anti-inflammatory, analgesic, antipyretic, anti-rheumatic and so on. Because ibuprofen will produce gastrointestinal adverse reactions common to non-steroidal anti-inflammatory drugs, and its biological half-life is short, frequent medication is required to maintain the therapeutic concentration, thus further increasing the gastrointestinal reactions of the drug, such as abdominal distension , indigestion, nausea, vomiting, diarrhea, peptic ulcer, etc., eve...

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 耿海明沈恒于艳春杨波
Owner WUHAN WUYAO SCI & TECH
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