Stable diclofenac diethylamine gel plaster and preparation method thereof

A technology of diclofenac diethylamine gel patch and diclofenac diethylamine, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problem of slow drug onset and skin penetration Poor sex resistance, poor skin compliance and other problems, to achieve the effect of improving skin permeability, high bioavailability, and increasing fat solubility

Pending Publication Date: 2022-01-18
CHANGSHA JINGYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both diclofenac diethylamine gel and latex are external preparations, which can avoid gastrointestinal irritation and first-pass effects, and reduce adverse reactions. However, there are some problems such as difficult control of drug dosage during use, easy staining of clothes, and limited duration. question
In addition, the reported patches are all composed of drugs, pressure-sensitive adhesives, and penetration enhancers, but the pressure-sensitive adhesives have poor water absorption, resulting in poor skin compliance, poor air permeability, water permeability, and oxygen permeability, and long-term attachment will cause damage. Cause damage to the skin and other problems, and diclofenac diethylamine gel patch can overcome the above-mentioned defects
However, due to the low oil-water partition coefficient of diclofenac diethylamine, common topical preparations have poor skin permeability, slow drug onset, and unsatisfactory bioavailability

Method used

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  • Stable diclofenac diethylamine gel plaster and preparation method thereof
  • Stable diclofenac diethylamine gel plaster and preparation method thereof
  • Stable diclofenac diethylamine gel plaster and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1: use polyvinylpyrrolidone as crystal inhibitor

[0053]

[0054] making process:

[0055] a) Put diclofenac diethylamine, propylene glycol, liquid paraffin, caprylic acid / capric fatty alcohol ester in a container to heat, then put polyvinylpyrrolidone and an appropriate amount of purified water in the container to dissolve, then mix the two, and heat Stir homogeneously to make it emulsified to obtain an O / W emulsion.

[0056] b) Disperse sodium polyacrylate, aluminum glycolate, disodium edetate, kaolin, and menthol in the prescribed amount in glycerin, and then dissolve tartaric acid and methyl hydroxybenzoate in the remaining purified water.

[0057] c) Then add the O / W type emulsion into the above-mentioned glycerin dispersion, mix well, then quickly add the remaining purified water containing tartaric acid and methyl hydroxybenzoate, stir and mix evenly to obtain a medicated patch matrix layer.

[0058] d) Evenly apply the base layer of the plaster ...

Embodiment 2

[0059] Embodiment 2: use triethanolamine as decrystallizer

[0060]

[0061]

[0062] making process:

[0063] a) Put diclofenac diethylamine, propylene glycol, liquid paraffin, caprylic acid / capric fatty alcohol ester in a container and heat, then put an appropriate amount of purified water in the container and heat to dissolve, then mix the two, stir and homogenize under heating Make it emulsified, and finally add triethanolamine to obtain an O / W emulsion.

[0064] b) Disperse sodium polyacrylate, aluminum glycolate, disodium edetate, kaolin, and menthol in the prescribed amount in glycerin, and then dissolve tartaric acid and methyl hydroxybenzoate in the remaining purified water.

[0065] c) Then add the O / W type emulsion into the above-mentioned glycerin dispersion, mix well, then quickly add the remaining purified water containing tartaric acid and methyl hydroxybenzoate, stir and mix evenly to obtain a medicated patch matrix layer.

[0066] d) Evenly apply the b...

Embodiment 3

[0067] Embodiment 3: Use polyvinylpyrrolidone as a crystal inhibitor, but do not prepare the drug into an O / W type emulsion

[0068]

[0069] making process:

[0070] a) Take an appropriate amount of purified water to dissolve polyvinylpyrrolidone, then add diclofenac diethylamine and propylene glycol and heat to dissolve to form a drug solution.

[0071] b) Disperse sodium polyacrylate, aluminum glycolate, disodium edetate, kaolin, and menthol in the prescribed amount in glycerin, and then dissolve tartaric acid and methyl hydroxybenzoate in the remaining purified water.

[0072] c) Then the drug solution is added to the above-mentioned glycerin dispersion, mixed thoroughly, and then the remaining purified water containing tartaric acid and methyl hydroxybenzoate is quickly added, stirred and mixed evenly to obtain a drug-containing plaster matrix layer.

[0073] d) Evenly apply the base layer of the plaster containing the medicine on the polyethylene terephthalate PET fi...

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PUM

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Abstract

The invention discloses a diclofenac diethylamine gel plaster and a preparation method thereof, and relates to the field of pharmaceutical preparations. The gel plaster comprises a non-woven fabric layer, a plaster matrix layer and a protective layer, wherein the plaster matrix layer comprises diclofenac diethylamine, an aqueous gel matrix and a crystal inhibitor. According to the diclofenac diethylamine gel plaster, the stability of the diclofenac diethylamine gel plaster is effectively improved by adding the crystal inhibitor, and the bioavailability is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable diclofenac diethylamine gel patch and a preparation method thereof. Background technique [0002] Non-steroidal antipyretic analgesic anti-inflammatory drugs, its mechanism of action is to cover the active center of the enzyme by combining with cyclooxygenase, thereby blocking the enzyme's metabolic process of catalyzing the conversion of arachidonic acid into prostaglandins, and then exerting anti-inflammatory effects. Inflammation, swelling and antipyretic, analgesic effect. Diclofenac belongs to phenylacetic acid non-steroidal antipyretic, analgesic and anti-inflammatory drugs. Its analgesic, anti-inflammatory and antipyretic effects are 2.0-2.5 times stronger than indomethacin, and 26-50 times stronger than aspirin. The effect is good and the elimination is fast. With few adverse reactions, it has become the drug of choice for anti-rheumatism and rheumatoi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/205A61K47/32A61K47/44A61P29/00
CPCA61K31/205A61K9/7023A61K47/32A61K47/44A61P29/00
Inventor 张海龙张小娇
Owner CHANGSHA JINGYI PHARM TECH CO LTD
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