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Dexketoprofen trometamol gel plaster and preparation method thereof

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

Active Publication Date: 2020-10-20
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 trometamol gel plaster and preparation method thereof
  • Dexketoprofen trometamol gel plaster and preparation method thereof
  • Dexketoprofen trometamol gel plaster 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 glyoxate, 0.5 part of talc, and 0.5 part of titanium dioxide into 18.0 parts of glycerin, disperse evenly, add 4.0 parts of sodium polyacrylate, 1.5 parts of sodium carboxymethyl cellulose, mix well as oil phase mixture.

[0060] Add 0.25 parts of methylparaben and 0.25 parts of ...

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 trometamol gel plaster and a preparation method thereof. The dexketoprofen trometamol gel plaster comprises the following components in percentage by weight: 0.1%-3.0% of dexketoprofen trometamol and a gel matrix. According to the dexketoprofen trometamol gel plaster, the prescription of the gel matrix is improved, the plaster does not contain a permeation enhancer, has permeability with high strength, is high in transdermal absorption speed, is capable of being continuously administrated for 24 hours and stable in quality, meets medicine listing requirements, is suitable for various acute and chronic pains such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis, cancer pain, acute sprain, soft tissue contusion pain andthe like, and is high in curative effect, small in side effect, safe and reliable compared with similar products on the market.

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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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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