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Loxoprofen sodium gel paste matrix without transdermal penetration enhancer and preparation method thereof

A technology of loxoprofen sodium and transdermal penetration enhancer, which is applied in the field of pharmaceutical preparations and can solve the problems of gel plasters being prone to mildew and other problems

Active Publication Date: 2020-04-03
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At the same time, ethyl p-hydroxybenzoate (also known as ethyl hydroxybenzoate) is added to the base of the plaster as a preservative, which solves the disadvantage that the gel plaster is easy to mildew

Method used

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  • Loxoprofen sodium gel paste matrix without transdermal penetration enhancer and preparation method thereof
  • Loxoprofen sodium gel paste matrix without transdermal penetration enhancer and preparation method thereof
  • Loxoprofen sodium gel paste matrix without transdermal penetration enhancer and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription:

[0026] materials Proportion materials Proportion Loxoprofen Sodium 1 purified water 52.8 glycerin 33 Sodium polyacrylate 6 Sodium carboxymethyl cellulose 2 Titanium dioxide 1 silica 1 Polysorbate 80 1 Ethanol 1 L-tartaric acid 0.6 Aluminum hydroxide 0.5 Disodium Edetate 0.1

[0027] Preparation method: add 0.6 part of L-tartaric acid to 2.8 parts of water, stir to dissolve, and set aside. Add 1 part of loxoprofen sodium and 0.1 part of disodium edetate to 50 parts of water, stir to dissolve, and add 1 part of silicon dioxide and 1 part of polysorbate 80, stir and disperse evenly. A mixture of 0.5 part of sodium carboxymethyl cellulose and 2 parts of glycerol was added, stirred and dispersed evenly and used as an aqueous phase mixture. Add 0.5 part of aluminum hydroxide to 31 parts of glycerin, disperse evenly, add 6 parts of sodium polyacrylate, 1.5 parts of sodium carboxymethyl cel...

Embodiment 2

[0029] prescription:

[0030] materials Proportion materials Proportion Loxoprofen Sodium 1 purified water 52.6 glycerin 33 Sodium polyacrylate 6 Sodium carboxymethyl cellulose 2 Titanium dioxide 1 silica 1 Polysorbate 80 1 Ethanol 1 L-tartaric acid 0.6 Aluminum hydroxide 0.5 ethyl paraben 0.2 Disodium Edetate 0.1

[0031] Preparation method: add 0.6 part of L-tartaric acid to 2.6 parts of water, stir to dissolve, and set aside. Add 1 part of loxoprofen sodium and 0.1 part of disodium edetate to 50 parts of water, stir to dissolve, and add 1 part of silicon dioxide and 1 part of polysorbate 80, stir and disperse evenly. A mixture of 0.5 part of sodium carboxymethyl cellulose and 2 parts of glycerol was added, stirred and dispersed evenly and used as an aqueous phase mixture. Add 0.5 parts of aluminum hydroxide to 31 parts of glycerin, disperse evenly, add 6 parts of sodium polyacrylate, 1.5 part...

Embodiment 3

[0033] prescription:

[0034] materials Proportion materials Proportion Loxoprofen Sodium 1 purified water 52.4 glycerin 33 Sodium polyacrylate 6 Sodium carboxymethyl cellulose 2 Titanium dioxide 1 silica 1 Polysorbate 80 1 Ethanol 1 L-tartaric acid 0.6 Aluminum hydroxide 0.5 ethyl paraben 0.4 Disodium Edetate 0.1

[0035]Preparation method: add 0.6 part of L-tartaric acid to 2.4 parts of water, stir to dissolve, and set aside. Add 1 part of loxoprofen sodium and 0.1 part of disodium edetate to 50 parts of water, stir to dissolve, and add 1 part of silicon dioxide and 1 part of polysorbate 80, stir and disperse evenly. A mixture of 0.5 part of sodium carboxymethyl cellulose and 2 parts of glycerol was added, stirred and dispersed evenly and used as an aqueous phase mixture. Add 0.5 parts of aluminum hydroxide to 31 parts of glycerin, disperse evenly, add 6 parts of sodium polyacrylate, 1.5 parts...

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Abstract

The invention discloses a loxoprofen sodium gel paste matrix and a preparation method thereof. The gel paste matrix comprises, by weight, 0.5 to 2.0 parts of loxoprofen sodium, 40 to 60 parts of purified water, 5 to 10 parts of framework material, 25 to 45 parts of humectant, 1 to 10 parts of tackifier, 1 to 8 parts of filler, 1 to 5 parts of surfactant, 0.4 to 2.0 parts of pH regulator, 0.1 to 2.0 parts of aluminum hydroxide, 0.2 to 1.0 part of preservative, 1 part of ethanol and 0.05 to 0.5 part of edetate disodium. The gel paste matrix provided by the invention does not contain transdermalpenetration enhancers such as N-methyl pyrrolidone, crotamicin and azone. The purpose of an ideal transdermal effect is achieved by improving the release behavior of the matrix. The risk of potentialharm of an organic solvent to a human body is reduced. Ethyl p-hydroxybenzoate is added into the matrix of the plaster as a preservative, which overcomes the defect that a gel plaster is easy to mildew.

Description

technical field [0001] The invention relates to a novel external use gel patch base with anti-inflammatory and analgesic non-steroidal anti-inflammatory drug loxoprofen sodium and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Loxoprofen sodium is a new type of non-steroidal anti-inflammatory drug. Different from other drugs, the drug is a prodrug, which has no activity by itself. It is only active after it is rapidly converted into trans-OH form by the liver. Co., Ltd. was first developed, and in July 1986, it was launched in Japan in tablet form. Anti-inflammatory and analgesic for rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, neck-shoulder-wrist syndrome; analgesia and anti-inflammatory after surgery, trauma and tooth extraction; acute upper respiratory tract inflammation antipyretic and analgesic. Compared with similar clinical drugs, its clinical features are faster (...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/14A61K31/192A61P29/00
CPCA61K9/0014A61K9/7046A61K31/192A61K47/14A61P29/00
Inventor 殷报云何莉肖稳定
Owner HUNAN JIUDIAN PHARMA
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