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Flurbiprofen cataplasm

A technology of flurbiprofen and poultice, applied in the field of flurbiprofen poultice, can solve problems such as inability to apply

Inactive Publication Date: 2018-04-24
北京茗泽中和药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent application CN2017103437803 discloses a flurbiprofen cataplasm, which dissolves flurbiprofen in the oil phase components and then emulsifies and disperses it in the hydrogel to form a drug reservoir, which can not only release the drug continuously and quickly, but also control release speed, thereby significantly improving the transdermal absorption rate of the active ingredient of the cataplasm, and can achieve rapid and sustained stable release of the active ingredient. However, in the study of its technical solution, we found that although this solution can improve flurbiprofen However, its drug release performance changes rapidly with the storage time of the preparation, which makes it impossible to be used in clinical practice. Therefore, it is possible to provide a drug that can take effect quickly and achieve long-term stable drug release. Storage time can keep stable flurbiprofen cataplasm as a problem to be solved urgently in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Pharmacological Example 1 In Vitro Release Experiment

[0023] 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

[0024] 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

[0025] Pharmacological embodiment 2, in vitro transdermal experiment

[0026] 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:

[0027] 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...

Embodiment 3

[0031] Pharmacological Example 3 Detects the Influence of Storage on the In Vitro Release of Drugs

[0032] The cataplasms were prepared from the groups of Examples and Comparative Examples, sealed and packaged, stored in the dark at 40°C for 3 months, and then carried out an in vitro transdermal test according to the method of Pharmacological Example 2. The test results are as follows

[0033]

[0034] The experimental results show that the drug release properties of the groups of Examples 1 to 6 remained basically unchanged after the 3-month accelerated test, but the overall drug release properties of the cataplasms of the control examples 1 to 6 showed a significant decline. , indicating that the formulation of the cataplasm provided by the present invention can significantly improve the release performance of the cataplasm after 3 months of accelerated testing by adjusting some components.

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Abstract

The invention provides Flurbiprofen cataplasm. The Flurbiprofen cataplasm comprises a back lining layer, a drug storage cavern and a protective layer, and is characterized in that the drug storage cavern is prepared from components in percentage by weight as follows: 0.2%-0.5% of Flurbiprofen as an active component, 5%-10% of oil-phase composition and aqueous phase composition, wherein the oil-phase composition is prepared from castor oil and benzyl alcohol in a ratio of 1:(0.08-0.12), and Flurbiprofen is dissolved in benzyl alcohol firstly and then dispersed in the castor oil; the aqueous phase composition is prepared from 5%-10% of partially neutralized sodium polyacrylate, 15%-20% of glycerol, 0.2%-0.4% of aluminium glycinate, 0.1%-0.3% of sodium calcium edetate, 1%-1.5% of carbomer 934, 1.5%-3% of HPMC (hydroxypropyl methylcellulose), a pH regulator, 0.05%-0.1% of gellan gum, 1%-1.5% of L- glycine, 1%-3% of filler and the balance of water; hydrogel is formed from the aqueous phasecomposition and water, the filler is dispersed in the hydrogel in a filling manner, the oil-phase composition is emulsified and dispersed in the hydrogel, and the drug storage cavern is formed.

Description

technical field [0001] The present invention relates to flurbiprofen cataplasm. Background technique [0002] Flurbiprofen (CAS: 51543-40-9, flurbiprofen) Flurbiprofen is a fluorine-containing non-steroidal anti-inflammatory drug used for the treatment of rheumatoid arthritis and osteoarthritis. 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. Although the use of external preparations can reduce the side effects of oral administration and accelerate the speed of drug onset. However, the traditional external application method has the technical effect of continuous quantitative administration. Compared with conventional external prepa...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/18A61K47/12A61K47/02A61K47/38A61K31/192A61P29/00A61P19/02
CPCA61K9/7023A61K31/192A61K47/02A61K47/12A61K47/183A61K47/38
Inventor 李斐菲杨红伟姚永波
Owner 北京茗泽中和药物研究有限公司
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