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Dexketoprofen tromethamine gel patch and preparation method thereof

A technology of dexketoprofen trometamol gel patch and ketoprofen tromethamine, which is applied in the direction of ointment delivery, pharmaceutical formula, medical preparations of non-effective ingredients, etc., and can solve the problem of unretrieved dexketoprofen tromethamine Issues such as research reports on the preparation of profen tromethamine gel patch, etc., achieved the effects of stable transdermal absorption, high permeability, and improved curative effect

Active Publication Date: 2022-02-08
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] No research reports on dexketoprofen trometamol gel patch preparations have been retrieved so far

Method used

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  • Dexketoprofen tromethamine gel patch and preparation method thereof
  • Dexketoprofen tromethamine gel patch and preparation method thereof
  • Dexketoprofen tromethamine gel patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 preparation method

[0057] Add 0.6 parts of L-tartaric acid to 2.0 parts of water, stir to dissolve, and set aside.

[0058] Add 0.05 parts of dexketoprofen tromethamine, 5.0 parts of sorbitol, 5.0 parts of urea, 1.0 parts of polyvinylpyrrolidone, and 0.5 parts of edetate disodium into 51.0 parts of water, stir to dissolve and add 1.0 parts of silicon dioxide, 0.5 1 part of polysorbate 80, 0.5 part of polyoxyethylene hydrogenated castor oil-40, stir and disperse evenly. Add a mixture of 0.5 parts of sodium carboxymethylcellulose and 2.0 parts of glycerin, stir and disperse evenly for later use as an aqueous phase mixture.

[0059] Add 0.1 part of aluminum hydroxide, 0.2 part of aluminum glycylate, 0.5 part of talc, and 0.5 part of titanium dioxide into 18.0 parts of glycerin, and disperse evenly, add 4.0 parts of sodium polyacrylate, 1.5 parts of sodium carboxymethyl cellulose, and mix well as oil phase mixture.

[0060] Add 0.25 parts of methylparaben ...

Embodiment 2

[0062] Embodiment 2 preparation method

[0063] Add 0.6 parts of L-tartaric acid to 2.6 parts of water, stir to dissolve, and set aside.

[0064]Add 0.1 parts of dexketoprofen tromethamine, 5.0 parts of sorbitol, 5.0 parts of urea, 1.0 parts of polyvinylpyrrolidone, 0.4 parts of edetate disodium into 35.0 parts of water, stir to dissolve and add 3.0 parts of silicon dioxide, 4.0 parts Part polysorbate 80, 1.0 part polyoxyethylene hydrogenated castor oil-40, stirred and dispersed evenly. Add a mixture of 0.5 parts of sodium carboxymethylcellulose and 2.0 parts of glycerin, stir and disperse evenly for later use as an aqueous phase mixture.

[0065] Add 0.5 parts of aluminum hydroxide, 0.5 parts of talc, 1.0 parts of titanium dioxide, and 1.0 parts of carbomer to 23.0 parts of glycerin, disperse evenly, add 4.0 parts of sodium polyacrylate, 3.0 parts of polyacrylic acid, and 1.5 parts of sodium carboxymethylcellulose , mix well as an oil phase mixture.

[0066] Add 0.02 parts...

Embodiment 3

[0068] Embodiment 3 preparation method

[0069] Add 0.6 parts of L-tartaric acid to 2.7 parts of water, stir to dissolve, and set aside.

[0070] Add 0.15 parts of dexketoprofen tromethamine, 5.0 parts of sorbitol, 1.0 parts of polyvinylpyrrolidone, and 0.3 parts of disodium edetate into 39.0 parts of water, stir to dissolve and add 2.0 parts of silicon dioxide and 2.0 parts of polysorbate 80 Stir to disperse evenly. Add a mixture of 0.5 parts of sodium carboxymethylcellulose and 2.0 parts of glycerin, stir and disperse evenly for later use as an aqueous phase mixture.

[0071] Add 0.5 parts of aluminum hydroxide, 0.2 parts of aluminum glycylate, and 1.0 parts of titanium dioxide into 28.0 parts of glycerin, and disperse evenly. phase mixture.

[0072] Add 0.4 parts of ethylparaben to 5.0 parts of ethanol, dissolve and set aside.

[0073] Stir and mix the above materials evenly, coat, punch and pack.

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Abstract

The invention discloses a dexketoprofen tromethamine gel plaster and a preparation method thereof. The gel plaster contains 0.1% to 3.0% dexketoprofen tromethamine by weight percentage and gel matrix. The dexketoprofen trometamol gel plaster of the present invention is improved through the prescription of the gel matrix, does not contain a penetration enhancer, has high permeability, fast transdermal absorption, can be administered continuously for 24 hours, and has stable quality , in line with drug marketing requirements, suitable for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis, and various acute and chronic pains such as cancer pain, acute sprain, soft tissue contusion pain, etc. The product has high curative effect, less side effects, and is safe and reliable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an acrylic non-steroidal anti-inflammatory drug dexketoprofen tromethamine gel plaster and a preparation method thereof. Background technique [0002] Ketoprofen is an acrylic non-steroidal anti-inflammatory drug, mainly used for the treatment of rheumatic or rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and postoperative pain. The structural formula of ketoprofen has a chiral carbon atom, and the drug has been generally used in the form of racemate for a long time. It has been found through research that the L-form of ketoprofen is almost inactive, while the anti-inflammatory effect of the D-form is twice that of the racemic form of ketoprofen. However, dexketoprofen has low solubility and poor absorption, so it is often used as tromethamine salt. [0003] Dexketoprofen trometamol tablets were first developed by The Menarini Group and first lau...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/192A61K9/06A61K9/70A61K47/32A61K47/38A61K47/42A61P29/00A61P19/02A61P19/04
CPCA61K31/192A61K9/06A61K9/0014A61K9/7023A61K47/32A61K47/38A61K47/42A61P29/00A61P19/02A61P19/04
Inventor 殷报云肖稳定文凤谢超君徐华庚
Owner HUNAN JIUDIAN PHARMA
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