Ibuprofen injection and preparation method thereof

A technology for injections and injections, applied in the direction of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., to achieve the effects of easy dosage, high bioavailability, and convenient clinical administration

Inactive Publication Date: 2011-03-30
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, the only pain-relieving injections available on the market are the opioids morphine and meperidine and the non-steroidal anti-inflammatory drug ketoprofen

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: present embodiment prepares 250 ibuprofen injections (the specification is 30mg / ml), adopts following prescription:

[0021] Material name Feed amount

[0022] Ibuprofen 75g

[0023] Hydroxypropyl-β-cyclodextrin 1000ml

[0024] Hydrochloric acid 100ml

[0025] Macrogol 400 100ml

[0026] Appropriate amount of sodium hydroxide

[0027] Add water for injection to 2500ml

[0028] Makes 250 count

[0029] Preparation method: Take hydroxypropyl-β-cyclodextrin and place it in water for injection. After dissolving, add ibuprofen, stir and ultrasonically obtain the ibuprofen inclusion compound solution, and then add the ibuprofen inclusion compound solution to the ibuprofen inclusion compound solution Add hydrochloric acid and polyethylene glycol, adjust the pH of the solution to about 6 with sodium hydroxide, filter and sterilize to obtain ibuprofen injection.

Embodiment 2

[0030] Embodiment 2: This embodiment prepares 250 ibuprofen injection powders (the specification is 300mg), adopts following prescription:

[0031] Material name Feed amount

[0032] Ibuprofen 75g

[0033] Hydroxypropyl-β-cyclodextrin 1000ml

[0034] Citric acid 150ml

[0035] Mannitol 100ml

[0036] Sodium bicarbonate amount

[0037] Add water for injection to 2500ml

[0038] Makes 250 count

[0039] Preparation method: Take hydroxypropyl-β-cyclodextrin and place it in water for injection. After dissolving, add ibuprofen, stir and ultrasonically obtain the ibuprofen inclusion compound solution, and then add the ibuprofen inclusion compound solution to the ibuprofen inclusion compound solution Add mannitol and citric acid, adjust the pH of the solution to about 6 with sodium bicarbonate, filter, sterilize, and freeze-dry to obtain ibuprofen powder for injection.

[0040] The powder for ibuprofen injection prepared by the present invention has the characteristics of good...

Embodiment 3

[0041] Embodiment 3: This embodiment prepares 250 ibuprofen injection powders (the specification is 200mg), adopts following prescription:

[0042] Material name Feed amount

[0043] Ibuprofen 50g

[0044] Hydroxypropyl-β-cyclodextrin 1000ml

[0045] Maleic acid 150ml

[0046] Glucose 100ml

[0047] Sodium citrate appropriate amount

[0048] Add water for injection to 2500ml

[0049] Makes 250 count

[0050] Preparation method: Take hydroxypropyl-β-cyclodextrin and place it in water for injection. After dissolving, add ibuprofen, stir and ultrasonically obtain the ibuprofen inclusion compound solution, and then add the ibuprofen inclusion compound solution to the ibuprofen inclusion compound solution Glucose and maleic acid are added, and then the pH of the solution is adjusted to about 6 with sodium citrate, filtered, sterilized, and freeze-dried to obtain ibuprofen powder for injection.

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PUM

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Abstract

The invention relates to ibuprofen injection and a preparation method thereof. The ibuprofen injection comprises 0.5 to 20 weight percent of ibuprofen, 10 to 60 weight percent of cyclodextrin or cyclodextrin derivatives, 1 to 40 weight percent of water soluble excipient and the balance of water, wherein ibuprofen serves as a main medicament; and the cyclodextrin or cyclodextrin derivatives and the water soluble excipient serve as medicinal auxiliary materials. In the invention, the cyclodextrin or cyclodextrin derivatives represented by hydroxypropyl-beta-cyclodextrin is used to make the ibuprofen, which used to be water insoluble, very water soluble. The stability of the medicament is improved. The clathrate compounds can be made into injection using water as a solvent or power for injection. Thus, it is very convenient to administrate the medicament in clinic and it is easy to control injection volume. Meanwhile, the drawback of the universal adoption of auxiliary materials and solvents for injection, which are very dangerous, such as organic solvents and cosolvents, of the conventional insoluble and soluble medicinal injection is overcome.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ibuprofen injection and a preparation method thereof. Background technique [0002] Rheumatoid arthritis is an allergic disease and is one of the main manifestations of rheumatic fever. It usually starts with acute fever and joint pain. The typical manifestations are mild or moderate fever and migratory polyarthritis. The affected joints are mostly large joints such as knees, ankles, shoulders, elbows, and wrists. It is common to transfer from one joint to the other. In the other joint, the lesion is locally red, swollen, burning, and severe pain. Some patients also have several joints at the same time. Atypical patients only have joint pain without other inflammatory manifestations. The acute inflammation usually subsides in 2-4 weeks. Leaving sequelae, but often recurrent. If rheumatic activity affects the heart, myocarditis can occur, and even left over heart va...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/192A61K47/40A61P29/00
Inventor 范敏华卢少林刘华方利明
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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