Oxybutynin transdermal plaster and preparation method thereof

A technology of transdermal plaster and ointment, which is applied in the direction of pharmaceutical formula, medical preparations containing active ingredients, etc., which can solve the problem of limited drug effect duration of gel, slow drug release speed, Harm skin health and other problems, to achieve the effect of prolonging the duration of the drug effect, prolonging the application time, and increasing the porosity

Active Publication Date: 2021-07-23
杭州仁德药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent can avoid the dry mouth problem caused by oral medicine by making oxybutynin into the form of gel, but it also has the following problems: in the later stage of application, the content of oxybutynin in the gel decreases And water content reduction and other reasons lead to slow release of drug, weakening of drug effect, resulting in limited duration of drug effect of gel; and, although the air permeability of gel is improved compared with rubber plaster, long-term application is still Can cause skin airtightness and endanger skin health

Method used

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  • Oxybutynin transdermal plaster and preparation method thereof
  • Oxybutynin transdermal plaster and preparation method thereof

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preparation example Construction

[0038] The preparation method of described precrosslinked pectin is as follows: pectin is dispersed in water with the mass volume ratio of 1g:20-30mL, adds guava dialdehyde, and the mass ratio of described guava dialdehyde and pectin is 1: 25-35, after mixing evenly, crosslinking reaction at 50-60°C for 1-2h to obtain pre-crosslinked pectin.

[0039] The preparation method of the pectinase@ethylcellulose / chitosan microcapsules is as follows:

[0040](1) ethyl cellulose and chitosan that mass ratio is 9-12:1 are added in acetone, the mass volume ratio of described ethyl cellulose and acetone is 1g:70-80mL, after swelling, add pectin Enzymes, fully mixed to obtain a mixed solution;

[0041] (II) adding the mixed solution to the liquid paraffin containing Span-80, the volume ratio between the acetone in the step (I) and the liquid paraffin in the step (II) is 1:5-7, the Span-80 and The volume ratio of liquid paraffin is 1:60-70, stir until the acetone is completely volatilized,...

Embodiment 1

[0048] An oxybutynin transdermal plaster, comprising a backing layer and a medicated ointment, the medicated ointment includes the following raw materials in mass percentages: 3% oxybutynin hydrochloride, 15% sodium polyacrylate NP-700, pre- Crosslinked Pectin 5%, Hypromellose 1%, Aluminum Glycol 1%, Pectinase@Ethylcellulose / Chitosan Microcapsules 1.5%, Sorbitol 15%, Laurazone 1%, Ethanol 15%, water 42.5%.

[0049] A preparation method of the oxybutynin transdermal patch, comprising the following steps:

[0050] (1) Preparation of pre-crosslinked pectin: disperse pectin into water with a mass volume ratio of 1g:20mL, add guava dialdehyde, the mass ratio of guava dialdehyde to pectin is 1:25, mix well Afterwards, cross-linking reaction at 60°C for 1 hour to obtain pre-cross-linked pectin;

[0051] (2) Preparation of pectinase@ethylcellulose / chitosan microcapsules:

[0052] (2.1) Add ethyl cellulose and chitosan with a mass ratio of 12:1 into acetone, the mass volume ratio of...

Embodiment 2

[0059] An oxybutynin transdermal plaster, comprising a backing layer and a medicated ointment, the medicated ointment includes the following raw materials in mass percentages: oxybutynin hydrochloride 4%, sodium polyacrylate NP-700 13%, pre- Crosslinked Pectin 6%, Hypromellose 1.5%, Aluminum Glycol 0.8%, Pectinase@Ethylcellulose / Chitosan Microcapsules 2.5%, Sorbitol 13%, Laurazone 1.5%, Ethanol 13%, water 41.7%.

[0060] A preparation method of the oxybutynin transdermal patch, comprising the following steps:

[0061] (1) Preparation of pre-crosslinked pectin: disperse pectin into water with a mass volume ratio of 1g:25mL, add guava dialdehyde, the mass ratio of guava dialdehyde to pectin is 1:30, mix well Afterwards, cross-linking reaction at 55°C for 1.5 hours to obtain pre-cross-linked pectin;

[0062] (2) Preparation of pectinase@ethylcellulose / chitosan microcapsules:

[0063] (2.1) Add ethyl cellulose and chitosan with a mass ratio of 10:1 into acetone, the mass volume...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and discloses an oxybutynin transdermal plaster and a preparation method thereof. The oxybutynin transdermal plaster comprises a backing layer and an ointment-containing body, wherein the ointment-containing body comprises the following raw materials in percentage by mass: 3-5% of oxybutynin and / or pharmaceutically acceptable salt thereof, 10-15% of sodium polyacrylate, 5-8% of pre-crosslinked pectin, 1-2% of hydroxypropyl methylcellulose, 0.5-1% of dihydroxyaluminium aminoacetate, 1.5-3.5% of pectinase @ ethyl cellulose / chitosan microcapsule, 10-15% of sorbitol, 1-2% of laurinol azone, 10-15% of ethanol and the balance water; and the pH value of the ointment-containing body is controlled to be 5.0-6.0 by a pH regulator. The oxybutynin transdermal plaster disclosed by the invention has relatively high air permeability, and can promote the release of oxybutynin by slowly releasing pectinase in the later period of application, thereby prolonging the drug effect duration and application time of the plaster.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an oxybutynin transdermal plaster and a preparation method thereof. Background technique [0002] Oxybutynin (OB), also known as urodolin, has a chemical name of 4-(diethylamino)but-2-yn-1-ylcyclohexyl(hydroxy)phenylacetate, which is a kind of The anti-smooth muscle spasm drug with anticholinergic effect has a strong selective effect on urinary and reproductive tract smooth muscle, can increase bladder capacity and each urination volume, reduce involuntary bladder contraction and prolong the interval between two urinations. Clinical indications include various urgency, frequency, incontinence, enuresis, etc. It is most suitable for frequent urination symptoms caused by cystitis, urethritis and recurrent urinary tract infection. [0003] Oxybutynin has very little side effects on the cardiovascular system and central nervous system, but because the oral saliva...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/216A61K47/10A61K47/32A61K47/36A61K47/38A61P7/12A61P13/00A61P13/02A61P13/10A61P29/00A61P31/00A61K9/50A61K47/42
CPCA61K31/216A61K9/70A61K47/32A61K47/36A61K47/38A61K47/10A61P13/10A61P7/12A61P13/00A61P29/00A61P13/02A61P31/00A61K9/5073A61K9/5047A61K9/5036A61K47/42
Inventor 俞帮和俞洋徐明蒋志刚
Owner 杭州仁德药业股份有限公司
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