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Gel plaster matrix containing dexketoprofen or its medicinal salt and preparation method thereof

A technology of dexketoprofen and medicinal salt, applied in the field of biomedicine, can solve the problems of increased related substances, poor moisture retention, decreased content and the like, and achieves the effects of prolonging storage time, relaxing storage conditions and reducing the content of impurities

Active Publication Date: 2022-04-12
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 its medicinal salt and preparation method thereof
  • Gel plaster matrix containing dexketoprofen or its medicinal salt and preparation method thereof
  • Gel plaster matrix containing dexketoprofen or its medicinal salt and preparation method thereof

Examples

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 a medicinal salt thereof and a preparation method thereof. The gel plaster matrix, by weight percentage, comprises: dexketoprofen or a medicinal salt thereof 0.3 ~1.2%, polymer hydrophilic gel skeleton material 5~10%, humectant 20~40%, thickener 1~5%, filler 2~5%, surfactant 0.5~2%, pH regulator 0.2~1%, crosslinking agent 0.01~0.6%, crosslinking regulator 0.01~0.2%, solvent 40~55%, among them, the moisturizing agent is polyethylene glycol and sorbitol. In the present invention, by improving the matrix system of the gel plaster, polyethylene glycol and sorbitol are combined as a moisturizer, which reduces the increase of related substances and the The risk of content decline, while improving the moisturizing performance of the gel patch base and the storage stability of the formulation.

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 Patents(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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