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Diclofenac sodium pastes and preparation thereof

A technology of diclofenac sodium and patch, applied in the field of medicine, can solve problems such as insufficient adhesive force, and achieve the effects of convenient use, firm skin adhesion and good transdermal performance

Active Publication Date: 2004-04-21
BENGBU BBCA MEDICINE SCI DEV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the reported diclofenac sodium patch (diclofenac sodium transdermal controlled-release plaster, open date on February 25th, 1998, publication number 1174031A,) its adhesive force is not enough through probation, peel strength test result, joint force is 80g, It is far lower than the national standard of medical adhesive plaster in my country and the standard of the Ministry of Health

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1: Preparation of diclofenac sodium patch, content of diclofenac sodium 1mg / cm 2

[0039] Formula and ratio:

[0040] Diclofenac Sodium 5.0g

[0041] Methacrylic acid and methyl methacrylate copolymer 20.0g

[0042] Triethyl citrate 6.0g

[0043] Citric acid 0.4g

[0044] Azone 3.0g

[0045] Isopropanol 6.0g

[0046] Ethanol 59.6g

[0047] Preparation:

[0048] 1. Preparation of pressure-sensitive adhesive matrix

[0049] According to the above ratio, dissolve methacrylic acid and methyl methacrylate copolymer in a mixed solvent composed of isopropanol and ethanol; under stirring, slowly add triethyl citrate and citric acid, and stir evenly to form a pressure-sensitive adhesive matrix.

[0050] 2. Preparation of Diclofenac Sodium Patch

[0051] Add diclofenac sodium into the above-mentioned pressure-sensitive adhesive matrix, and stir to dissolve completely. Then add azone, stir well. Ultrasonic to remove air bubbles, coated on aluminum foil, dried...

Embodiment 2

[0052] Embodiment 2: preparation of diclofenac sodium patch, diclofenac sodium content 1.2mg / cm 2

[0053] Formula and ratio:

[0054] Diclofenac Sodium 5.0g

[0055] Methacrylic acid and methyl methacrylate copolymer 36.0g

[0056] Dibutyl sebacate 18.0g

[0057] Succinic acid 0.4g

[0058] Azone 3.0g

[0059] Isopropanol 2.0g

[0060] Ethanol 16g

[0061] Acetone 20g

[0062] Preparation:

[0063] 1. Preparation of matrix for pressure sensitive adhesive and plasticizer

[0064] According to the above ratio, dissolve methacrylic acid and methyl methacrylate copolymer in a mixed solvent composed of isopropanol, ethanol and acetone; under stirring, slowly add dibutyl sebacate and succinic acid, and stir well into a pressure-sensitive adhesive matrix.

[0065] 2. Preparation of Diclofenac Sodium Patch

[0066] With embodiment 1. The bonding strength of the diclofenac sodium patch is 150g.

Embodiment 3

[0067] Embodiment 3: preparation of diclofenac sodium patch, diclofenac sodium content 1mg / cm 2

[0068] Formula and ratio:

[0069] Diclofenac Sodium 5.0g

[0070] Polyisobutylene MML-100 3.6g

[0071] Polyisobutylene LM-MS 4.4g

[0072] Liquid paraffin 8.0g

[0073] Heptane 76g

[0074] Azone 3.0g

[0075] Preparation:

[0076] 1. Preparation of PSA Matrix

[0077] Dissolve polyisobutylene MML-100 and polyisobutylene LM-MS in heptane to form a pressure-sensitive adhesive matrix.

[0078] 2. Preparation of Diclofenac Sodium Patch

[0079] Diclofenac sodium is passed through a 200-mesh sieve, ground with liquid paraffin, added to the above-mentioned pressure-sensitive adhesive matrix, and stirred evenly. Add azone, stir well. Ultrasonic to remove bubbles, spread on aluminum foil, dry at 60°C for 60 minutes, cover with polyethylene film, cut into 50cm 2 / sheet, sealed package. The bonding force of the diclofenac sodium patch is 130g.

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PUM

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Abstract

A plaster of diclofenac sodium is composed of substrate, medicine layer containing diclofenac sodium, pressure sensitive adhesive and penetration promoter, and protecting film. Its advantages are high percutaneous effect and adhesion, and no irritation and sensitization to skin.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and relates to a diclofenac sodium patch and a preparation method thereof. Background technique: [0002] Diclofenac sodium is an anthranilic acid non-steroidal anti-inflammatory analgesic, its mechanism of action is similar to that of acetylsalicylic acid, it can selectively cut off the action of prostaglandin cyclooxygenase in the arachidonic acid metabolism series, and block Synthesis of prostaglandin E2 (PGF2), which in turn exerts anti-inflammatory, detumescence, antipyretic and analgesic effects. Its anti-inflammatory and antipyretic effects are 2-2.5 times stronger than indomethacin, and 26-50 times stronger than aspirin. It is mainly used clinically for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis; various soft tissue swelling and pain, including low back pain, frozen shoulder, synovitis, tendon and tenosynovitis, cervical spondylosis; soft tissue injur...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/196A61P1/02A61P15/00A61P19/02A61P19/08A61P29/00
Inventor 高申丁雪鹰管斐汪洪湖谢延丁玉娟王吟华钟延强缪春辉
Owner BENGBU BBCA MEDICINE SCI DEV
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