Indometacin hydrogel patch

A technology of indomethacin hydrogel patch and hydrogel patch, applied in anti-inflammatory agents, non-central analgesics, medical preparations of non-active ingredients, etc., can solve the problem of uncontrollable drug release and medication Problems such as large amount and side effects

Inactive Publication Date: 2017-09-26
北京茗泽中和药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the traditional oral administration method is used to treat pain caused by trauma and inflammation of joints, soft tissues, and muscles, it needs to take a large amount of medicine, resulting in relatively large side effects, and the drug release cannot be controlled, making it difficult to provide lasting and effective analgesia on the affected area. Anti-inflammatory effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Pharmacological Example 1 In Vitro Release Experiment

[0021] According to the method provided in the third method (paddle and disk method, used for transdermal patch) in the second appendix XD of the Chinese Pharmacopoeia 2010 edition, the emergency release of the patch obtained in Examples 1 to 6 is measured . The specific method is as follows

[0022] In the test, physiological saline was used as the release medium, and the release medium was added into the dissolution cup, pre-warmed to (32±0.5°C) to remove the protective layer of the cataplasm, cut into a size of 2.5cmx7.5cm, and put it flat into a dialysis bag (molecular weight cut-off 14,000 ), with the release side facing up, placed between two layers of discs, so that the edges of the disc clamp the two ends of the dialysis bag, and then wrap and fix with rubber bands to fix the disc. Take 6mL samples from the dissolution vessel at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 2.5h, 3h and 4h respectively, a...

Embodiment 2

[0023] Pharmacological embodiment 2, in vitro transdermal experiment

[0024] The modified Franz diffusion cell method was used to conduct an in vitro transdermal test with the cataplasm patch prepared in Examples 1-6 and Comparative Examples 1-6, using the abdominal skin of isolated 3-month-old rats as a barrier. The specific experimental method is:

[0025] After 3-month-old healthy rats were anesthetized and killed, the abdominal hair was removed with scissors, the undamaged skin was removed, and the subcutaneous tissue was removed. After washing, they were respectively fixed at the release port of the Franz diffusion cell, and pH 7.4 phosphoric acid was added to the receiving chamber. The buffer is used as a release medium to keep the endothelial layer in close contact with the solution. Put the cataplasm with the protective layer removed on the skin, adjust the water bath so that the temperature of the outer layer is constant at (32±0.5)°C, and the stirring speed is 100r...

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Abstract

The invention discloses an indometacin hydrogel patch which comprises a back liner layer, a medicine storage layer and a protection layer. The indometacin hydrogel patch is characterized in that the medicine storage layer consists of the following components in percentage by weight: 0.3-0.5% of indometacin as an active component, 5-10% of an oil-phase component, 5-10% of partially neutralized sodium polyacrylate as a water-phase component, 15-20% of glycerol, 1-1.5% of carbomer 934, 1.5-2% of hydroxypropyl methyl cellulose (HPMC), a pH adjusting agent, 0.2-0.4% of dihydroxyaluminum aminoacetate, 0.1-0.3% of sodium calcium edentate, 0.3-0.5% of L-glycine, 0.5-1% of N-acetylcystein (NAC), 1-3% of a filling agent and the balance of water, wherein the oil-phase component comprises glycerol laurate and lauric acid at a ratio of 1:(0.05 to 0.06), and indometacin is dispersed in the oil phase.

Description

technical field [0001] The invention relates to an indomethacin hydrogel patch. Background technique [0002] Indomethacin (2-methyl-1-(4-chlorobenzoyl)-5-methoxy-1H-indole-3-acetic acid, CAS: 53-86-1) is a non-steroidal Anti-inflammatory drugs have antipyretic and analgesic effects, and are widely used in the analgesic treatment of osteoarthritis and rheumatoid arthritis. However, when the traditional oral administration method is used to treat pain caused by trauma and inflammation of joints, soft tissues, and muscles, it needs to take a large amount of medicine, resulting in relatively large side effects, and the drug release cannot be controlled, making it difficult to provide lasting and effective analgesia on the affected area. Anti-inflammatory effect. Compared with conventional external preparations, the hydrogel patch (cataplasm, Cataplasm) has a large drug loading capacity, promotes the percutaneous penetration of drugs, and has no allergic reaction and irritatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/405A61K47/18A61K47/14A61P29/00A61P19/02
Inventor 蔡志浩
Owner 北京茗泽中和药物研究有限公司
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