Gel plaster matrix containing dexketoprofen or pharmaceutical salt thereof and preparation method of gel plaster matrix

A technology of dexketoprofen and medicinal salt, which is applied in the field of biomedicine and can solve the problems of poor moisture retention, increase of related substances, and decrease of content

Active Publication Date: 2020-10-23
HUNAN JIUDIAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a kind of gel plaster base containing dexketoprofen or its medicinal salt and preparation method thereof, to solve the problem that gel plaster base and main components react to related substances in the prior art Problems of increase, decrease in content, and poor moisture retention

Method used

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  • Gel plaster matrix containing dexketoprofen or pharmaceutical salt thereof and preparation method of gel plaster matrix
  • Gel plaster matrix containing dexketoprofen or pharmaceutical salt thereof and preparation method of gel plaster matrix
  • Gel plaster matrix containing dexketoprofen or pharmaceutical salt thereof and preparation method of gel plaster matrix

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Experimental program
Comparison scheme
Effect test

Embodiment 1~2

[0053] Embodiment 1~2 preparation method

[0054] Add the prescribed amount of pH regulator into an appropriate amount of purified water, stir to dissolve, and set aside;

[0055] Slowly add the prescribed amount of cross-linking regulator, surfactant, sorbitol, and the first macromolecular hydrophilic gel skeleton material into the remaining purified water, stir and disperse evenly for later use as an aqueous phase mixture;

[0056] Add the prescribed amount of API (dexketoprofen) into ethanol to dissolve, respectively add the prescribed amount of cross-linking agent, thickener, filler, and second polymer hydrophilic gel skeleton material into polyethylene glycol, and stir to disperse evenly , as an oil phase mixture;

[0057] Stir and mix the above pH regulator solution, water phase mixture, and oil phase mixture evenly, coat, punch out, and package.

Embodiment 3～4

[0058] Embodiment 3~4 preparation method

[0059] Add the prescribed amount of pH regulator into an appropriate amount of water, stir to dissolve, and set aside;

[0060] Slowly add the prescribed amount of cross-linking regulator, surfactant, API (dexketoprofen trometamol), sorbitol, and the first polymer hydrophilic gel skeleton material into the remaining water, stir and disperse evenly for later use as water phase mixture;

[0061] Add the prescribed amount of cross-linking agent, tackifier, filler, and the second polymer hydrophilic gel skeleton material into polyethylene glycol, stir and disperse evenly, and use it as an oil phase mixture;

[0062] Stir and mix the above pH regulator solution, water phase mixture, and oil phase mixture evenly, coat, punch out, and package.

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Abstract

The invention discloses a gel plaster matrix containing dexketoprofen or pharmaceutical salt thereof and a preparation method of the gel plaster matrix. The gel plaster matrix comprises the followingraw materials in percentage by weight: 0.3-1.2% of dexketoprofen or pharmaceutical salt thereof, 5-10% of a polymer hydrophilic gel skeleton material, 20-40% of a humectant, 1-5% of a tackifier, 2-5%of a filler, 0.5-2% of a surfactant, 0.2-1% of a pH regulator, 0.01-0.6% of a cross-linking agent, 0.01-0.2% of a cross-linking regulator and 40-55% of a solvent, wherein the humectant is polyethyleneglycol and sorbitol. According to the invention, a system of the gel plaster matrix is improved, the polyethylene glycol and the sorbitol are combined to serve as the humectant, so that the risk thatrelated substances are increased and the content of the related substances is reduced due to esterification reaction of glycerol serving as a common humectant and acrylic acid non-steroidal anti-inflammatory drugs is reduced, and meanwhile, the moisture retention performance of the gel plaster matrix and the storage stability of the preparation are improved.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, in particular to a gel plaster base containing dexketoprofen or a medicinal salt thereof and a preparation method thereof. Background technique [0002] Dexketoprofen (Dexketoprofen) is the optically pure (s)-enantiomer of ketoprofen, a non-steroidal anti-inflammatory drug produced and marketed by Menarini; Phetmethamine is sold as a prescription drug, and its indications are short-term treatment of mild to moderate pain, including dysmenorrhea, but it has large gastrointestinal reactions, short half-life, and poor oral compliance. However, dexketoprofen tromethamine The physical and chemical properties are very suitable for gel plasters. After local application, the drug concentration in skeletal muscle, joint cavity, and synovial fluid of the application site can be significantly higher than that of oral administration. [0003] Dexketoprofen and dexketoprofen trometamol gel patch are loca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/10A61K47/26A61K31/192A61P29/00
CPCA61K9/7023A61K9/0004A61K47/10A61K47/26A61K31/192A61P29/00A61K47/32
Inventor 徐华庚殷报云肖稳定谢超君贺娇容卢娟
Owner HUNAN JIUDIAN PHARMA
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