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Preparation method of diclofenac sodium transdermal patch

A technology of diclofenac sodium and transdermal patch is applied in the directions of sheet delivery, non-central analgesics, antipyretics, etc., which can solve the problems of thick thickness, affecting product quality, and appearing bubbles, and achieves the effect of simple preparation process

Inactive Publication Date: 2012-01-18
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the product is thicker, and bubbles will appear during the coating process, which will affect the quality of the product

Method used

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  • Preparation method of diclofenac sodium transdermal patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 1) Weigh 5g of azone, 7g of propylene glycol and 10g of absolute ethanol and add them to 50g of diclofenac sodium and stir evenly;

[0021] 2) Weigh 270g of acrylic pressure-sensitive adhesive, add 1) to item 2), stir for 20 minutes, and homogenize twice with a homogenizer at 18mpa;

[0022] 3) The drying temperature of the coating machine is 60°C, and the thickness is controlled to 55um. Cut into 5*10cm with a slicer 2 size;

[0023] 4) Inspection results: no air bubbles, no wire drawing (adhesion).

[0024] Take 6 pieces of test results: standard: 1 hour (10%-30%); 4 hours (20%-45%); 24 hours (greater than 50%). Measured results: 1 hour: 23.5%, 24.8%, 26.1%, 21.8%, 26.7%, 22.7%; 4 hours: 37.6%, 29.5%, 29.3%, 35.2%, 32.6%, 33.8%; 24 hours: 65.0% , 62.7%, 67.7%, 65.2%, 62.8%, 61.4%.

Embodiment 2

[0026] 1) Weigh 3g of azone, 9g of propylene glycol and 15g of absolute ethanol and add them to 50g of diclofenac sodium and stir evenly;

[0027] 2) Weigh 250g of acrylic pressure-sensitive adhesive, add 1) to item 2), stir for 25 minutes, and homogenize twice with a homogenizer at 15mpa;

[0028] 3) The drying temperature of the coating machine is 50°C, and the thickness is controlled to 60um. Cut into 5*10cm with a slicer 2 size;

[0029] 4) Inspection results: no air bubbles, no wire drawing (adhesion).

[0030] Take 6 pieces of test results: standard: 1 hour (10%-30%); 4 hours (20%-45%); 24 hours (greater than 50%). Measured results: 1 hour: 24.7%, 24.3%, 22.3%, 25.8%, 22.6%, 24.9%; 4 hours: 35.4%, 27.7%, 27.5%, 33.4%, 34.8%, 32.1%; 24 hours: 63.8% , 60.9%, 65.5%, 62.7%, 63.6%, 60.5%.

Embodiment 3

[0032] 1) Weigh 4g of azone, 4g of propylene glycol and 15g of absolute ethanol and add them to 50g of diclofenac sodium and stir evenly;

[0033] 2) Weigh 240g of acrylic pressure-sensitive adhesive, add 1) to item 2), stir for 30 minutes, and homogenize twice with a homogenizer at 14mpa;

[0034] 3) The drying temperature of the coating machine is 65°C, and the thickness is controlled to 50um. Cut into 5*10cm with a slicer 2 size;

[0035] 4) Inspection results: no air bubbles, no wire drawing (adhesion) phenomenon.

[0036] Take 6 pieces of test results: standard: 1 hour (10%-30%); 4 hours (20%-45%); 24 hours (greater than 50%). Measured results: 1 hour: 25.1%, 25.6%, 23.8%, 22.7%, 24.6%, 21.5%; 4 hours: 38.4%, 39.1%, 39.3%, 36.4%, 37.4%, 38.3%; 24 hours: 66.1% , 64.5%, 63.8%, 66.4%, 63.9%, 64.2%.

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Abstract

The invention relates to a preparation method of a diclofenac sodium transdermal patch. The method comprises the following steps: 1) weighing 2 to 10 weight parts of azone, 2 to 10 weight parts of propylene glycol and 5 to 15 weight parts of absolute ethanol, uniformly stirring, and adding the mixture into 50 weight parts of diclofenac sodium for uniformly stirring; 2) weighing 200 to 300 weight parts of pressure-sensitive adhesive; 3) adding the mixture in step 1) into the substance in the step 2), stirring for 10 to 30 minutes, and homogenizing by using a homogenizer; and 4) uniformly coating a medicinal base layer to a release film, controlling the thickness to be between 40 and 60 mu m, and coating a medical elastic cloth. The preparation method has simple preparation process, and no bubbles are generated after the medicaments are applied.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing diclofenac sodium transdermal patches. Background technique [0002] Diclofenac sodium has excellent anti-inflammatory and analgesic effects, and its tablets, capsules, and suppositories have been widely used clinically. Like other non-steroidal anti-inflammatory drugs, it will inevitably cause gastrointestinal damage and serious adverse reactions such as headache and dizziness, and patients have to interrupt treatment. [0003] Recently, diclofenac sodium ointment and gel are on the market, and there is a glimmer of hope. However, since the skin has a stratum corneum with keratin as the main component, it still contains a large amount of fat-soluble components such as fat, wax and cholesterol, forming a strong barrier function on the skin. Salt drugs such as diclofenac sodium are difficult to effectively dissolve in ointment or gel bases, resul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/196A61P29/00
Inventor 陈鹏刘兆祥王超薛世静
Owner 蚌埠丰原涂山制药有限公司