CN1443532A - Flurbiprofenbab preparation and its preparation method - Google Patents

Flurbiprofenbab preparation and its preparation method Download PDF

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Publication number
CN1443532A
CN1443532A CN 03116441 CN03116441A CN1443532A CN 1443532 A CN1443532 A CN 1443532A CN 03116441 CN03116441 CN 03116441 CN 03116441 A CN03116441 A CN 03116441A CN 1443532 A CN1443532 A CN 1443532A
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Prior art keywords
flurbiprofen
cataplasma
acid
hydrophilic
preparation
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CN 03116441
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CN100502852C (en
Inventor
丁雪鹰
高申
王世岭
缪春辉
陈宙艳
管斐
马光大
蒋雪涛
朱全刚
张仰眉
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Shanghai Baolong Pharmaceutical Co ltd
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Second Military Medical University SMMU
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Abstract

The present invention relates to the field of medicine technology, in particular, it relates to a flurbiprofenbab preparation and its preparation method. Said preparation includes back lining layer, medicine storage layer and protecting film, said medicine storage layer is formed from flurbiprofen powder preparation or flurbiprofen emulsion, hydrophilic bab preparation matrix, osmotic accelerator and additive. Its medicine-carrying quantity is large, moisture-holidng property and air permeability are good.

Description

Flurbiprofen cataplasma and preparation method thereof
Technical field:
The present invention relates to medical technical field, is a kind of flurbiprofen cataplasma and preparation method thereof.
Background technology:
Flurbiprofen (flurbiprofen) is a kind of new NSAID (non-steroidal anti-inflammatory drug), has anti-inflammatory analgesic action, effect is the strongest in aryl alkanoic acid class antipyretic analgesic, each dosage 120mg can be effective equally with aspirin 2g, be widely used in muscle skeleton and joint disease, as rheumatic, rheumatoid arthritis, degenerative arthritis, osteoarthritis, ankylosing spondylitis; Soft tissue diseases, as sprain and strain; Alleviating pain leniently is as dysmenorrhea and postoperative pain.But it is the same with other NSAID (non-steroidal anti-inflammatory drug), oral digestive tract ulcer and the gastrointestinal side effect such as hemorrhage of easily causing.Percutaneous drug administration preparation can improve the local drug concentration of flurbiprofen at painful area, strengthens antiinflammatory action, avoids the untoward reaction of gastrointestinal administration.Now existing flurbiprofen gel, ointment, liniment, membrane, patch etc., but yet there are no flurbiprofen cataplasma and relevant report thereof so far.
Summary of the invention:
The invention provides a kind of easy to use, effect is obvious, side reaction is little flurbiprofen cataplasma, compare with other emplastrum, it is big that cataplasma has a drug loading, water conservation, preserve moisture, the advantage of good permeability, side effect such as no sensitization, stimulation.
Flurbiprofen cataplasma of the present invention comprises backing layer, drug-reservoir and protecting film, and drug-reservoir is made up of flurbiprofen powder or flurbiprofen Emulsion, hydrophilic catablasm base material, penetration enhancer and additives.Their proportioning is as follows: (%w/w)
Flurbiprofen 0.5-20
Emulsifying agent 0-15
Oil phase 0-25
Hydrophilic catablasm base material 40-95
Penetration enhancer 1-40
Additives 0.5-5
Their composition is respectively:
1. hydrophilic catablasm base material is made up of hydrophilic cohesiveness substrate, cross-linking agent, wetting agent, filler, water, wherein:
1) hydrophilic cohesiveness substrate: be selected from sodium polyacrylate, polyacrylic acid potassium, ammonium polyacrylate, polyacrylic acid monoethanol ammonium, polyacrylic acid diethanol ammonium, polyacrylic acid triethanol ammonium, sodium carboxymethyl cellulose, carboxymethyl starch, tragakanta, polyvinyl alcohol, carbopol, polyvinylpyrrolidone, polyacrylic acid, Polyethylene Glycol, arabic gum, hydroxypropyl cellulose, hydroxyethyl-cellulose, hydroxy methocel, gelatin, agar etc.
2) cross-linking agent: be selected from aluminum salt, calcium salt and magnesium salt,, can select wherein one or both polyvalent metal hydrochlorates simultaneously for use as aluminium hydroxide, aluminum chloride, aluminium potassium sulfate, aluminium carbonate, aluminum acetate, aluminum nitrate, magnesium hydroxide, magnesium aluminate, magnesium nitrate, calcium chloride etc.
3) wetting agent is selected from glycerol, mannitol, propylene glycol, sorbitol etc.
4) filler: be selected from Kaolin, zinc oxide, titanium dioxide etc.
2. flurbiprofen can be the flurbiprofen powder type or makes flurbiprofen Emulsion form, and Emulsion is made up of water, oil phase and emulsifying agent.Wherein,
1) emulsifying agent: be selected from monovalence soap that non-ionic surface active agents such as sodium lauryl sulphate, tween, span, stearic acid and sodium hydroxide or potassium hydroxide or ammonium hydroxide forms, Bian Ze, peregal, polyoxyethylene nonylphenol ether etc., hydrophile-lipophile balance value (HLB) is more than 10.
2) oil phase: flurbiprofen is dissolved in oil phase, oil phase is selected from one or both compositions in polycarboxylic acids poly alkyl ester, liquid paraffin, the silicone, polycarboxylic acids poly alkyl ester wherein, be selected from that alkyl such as phthalic acid isobutyl ester, diethyl phthalate, dibutyl phthalate, O-phthalic isopropyl propionate, diethylene adipate, ethyl sebacate, sad diethylester contain 10-25 carbon atom, carboxylic acid is aliphatic or aromatic monobasic or binary acid, can select one or both of oil phase simultaneously for use.
3. penetration enhancer: be selected from (1) organic solvent class: as ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide ex hoc genus anne thing; (2) organic acid, aliphatic alcohol: as oleic acid, linoleic acid, lauryl alcohol; (3) azone and homologue thereof; (4) surfactant: be selected from cationic, anionic and nonionic, as sodium lauryl sulphate, Tween 80; (5) cutin is preserved moisture and softening agent: as carbamide, salicylic acid and pyrrolidinone compounds; (6) terpenes: as menthol, Camphora, limonene and eucalyptole.Can select 1-3 kind wherein simultaneously for use.
4. additives: comprise various antioxidant commonly used, as vitamin C, sodium sulfite etc.; Antiseptic is as parabens, sorbic acid, benzoic acid etc.; Also comprise spice, pigment etc.
The preparation method of flurbiprofen cataplasma of the present invention comprises the following steps:
Method one: with the preparation of flurbiprofen Emulsion
1. prepare flurbiprofen Emulsion
(1) the flurbiprofen powder is added oil phase and put the heating in water bath dissolving;
(2) emulsifying agent is added in the water heating in water bath dissolving;
(3) water is slowly poured in the oil phase, be mixed into breast, be flurbiprofen Emulsion.
2. prepare hydrophilic catablasm base material
(1) hydrophilic cohesiveness substrate, glue are connected agent, wetting agent is dissolved in water, resulting mixture stirs;
(2) filler is crossed 200 mesh sieves, is added in the said mixture, stir, Hydrophillia Babu agent substrate;
3. prepare the flurbiprofen cataplasma
(1) flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, stir, the degassing is applied to backing, covered with protective film.
(2) 40 ℃ of dried overnight cut into 6-100cm as required 2, be flurbiprofen cataplasma of the present invention.
Method two: with the preparation of flurbiprofen powder
1. prepare hydrophilic catablasm base material
Hydrophilic cohesiveness substrate, glue crosslinking agent, wetting agent are dissolved in water, stir
Evenly.
2. prepare the flurbiprofen cataplasma
(1) flurbiprofen powder and filler are crossed 200 mesh sieves, be added in the hydrophilic catablasm base material, stir;
(2) degassing is applied to backing, covered with protective film.
(3) 40 ℃ of dried overnight, cutting promptly gets the flurbiprofen cataplasma.
Above-mentioned back lining materials can be selected non-woven fabrics, polyethylene, aluminium foil, polypropylene and polyester etc. for use.The protecting film material is selected from polyethylene, polypropylene etc.
Flurbiprofen cataplasma of the present invention is carried out relevant transdermal, viscosity and skin irritation test:
1. transdermal test in vitro experiment (method sees the percutaneous dosing novel form for details. the Lu Bin chief editor. and medicine is new
Dosage form and new technique. Beijing: the People's Health Publisher, 1998:375)
Adopt improvement Franz diffusion cell, mouse skin is fixed on the diffusion cell, corium is towards receiving chamber, and stratum corneum side is to supply chamber.Cataplasma sticks on stratum corneum side, adds an amount of PH7.4 phosphate buffer (PBS liquid) in the receiving chamber.32 ℃ of water bath with thermostatic control circulations and magnetic stirring apparatus (300 rev/mins), sampling in 2,4,8,12,24 hours, each 1ml, and replenish 37 ℃ of PBS solution of equal-volume, high performance liquid chromatography (HPLC) working sample concentration immediately.Experimental result: with unit are accumulation transit dose Q time t is returned: Q=13.4453t+29.3523, r=0.9956, drug transdermal speed is 13.4453 μ g/cm 2H illustrates that cataplasma transdermal of the present invention is functional.
2. the adhesion test of flurbiprofen cataplasma
According to the regulation of Chinese Pharmacopoeia (2000 editions), get three of flurbiprofen cataplasmas, all can cling maximum steel ball (6mm), adhesion test is qualified.
3. the plastic property of flurbiprofen cataplasma test
According to the operation of Chinese Pharmacopoeia (2000 editions) regulation, the cream face does not have the trickling phenomenon, the plastic property pass the test.
Skin irritation test (method sees the percutaneous dosing novel form for details. Lu Bin chief editor. novel pharmaceutical formulation and new technique. Beijing: the People's Health Publisher, 1998:375)
4.1 skin hypersensitivity experiment
Laboratory animal: 40 of Cavia porcelluss, male and female half and half, body weight 300 ± 50g is available from laboratory animal institute of The 2nd Army Medical College.
The negative control thing: be blank cataplasma, except that not containing the flurbiprofen, all the other compositions are all identical with flurbiprofen cataplasma of the present invention.
Positive sensitizer: 2, the 4-dinitro-chloro-benzene, reagent one factory in Shanghai produces, and is mixed with the concentration that excites of 0.1% sensitization concentration and 1% with 75% ethanol.
With the depilatory depilation, lost hair or feathers and distinguish the about 3 * 3cm of area in the guinea pig back left side 2, be divided into three groups at random, first group of positive matched group, 14 of animals are given positive sensitizer (0.1% sensitization concentration); Second group for being tried the thing group, and 13 of animals are given the flurbiprofen cataplasma; The 3rd group of negative matched group, 13 of animals are given the negative control thing.At the 7th and the 14th day, in kind distinguish repeat administration once, each medication depilation in preceding 24 hours.
After the last administration, (lost hair or feathers the about 3 * 3cm of area before 24 hours on the guinea pig back right side in 14 days 2), in kind be administered once respectively in depilation district, Cavia porcellus right side (positive controls is given 1% the concentration that excites) removed cataplasma after 6 hours again, at once, observed the skin allergy situation in 24,48 and 72 hours.The result shows that positive sensitizer (2, the 4-dinitro-chloro-benzene) sensitization rate is 100%, and extremely strong sensitization is arranged, and flurbiprofen cataplasma and negative control thing sensitization rate are 0, all do not have sensitization, illustrate that the flurbiprofen cataplasma is used for skin outward and does not have sensitization.
2.2 skin irritation test
Animal: 8 of adult healthy rabbit, male and female half and half, body weight 2.5-3.0kg is available from the The 2nd Army Medical College Experimental Animal Center.
Tester: blank cataplasma, except that not containing the flurbiprofen, all the other compositions are all identical with flurbiprofen cataplasma of the present invention.
Spinal column both sides, the experimental rabbit back rabbit hair is cut, and area is about 10% (about 150cm of body surface area 2), two districts about branch, the about 50cm in every district 2(5cm * 10cm), adjacent two offsets are from about 3cm.The medication after 24 hours of losing hair or feathers sticks flurbiprofen cataplasma and tester respectively in medication district and check plot, removes cataplasma in 24 hours, observes agents area and does not have situations such as erythema and edema.Continue administration, stick flurbiprofen cataplasma and tester respectively in medication district and check plot, one week of successive administration, 1,24,48 and 72 hour observation agents area behind the removal cataplasma, only the show speckle is omited in the medication district of 1 rabbit, erythema disappears after 24 hours, and the result shows that the flurbiprofen cataplasma is to the skin nonirritant.
Above-mentioned result of the test shows flurbiprofen cataplasma safety of the present invention, and viscosity is suitable, the non-stimulated and anaphylaxis to skin, and transdermal test in vitro is respond well.
The specific embodiment: now in conjunction with the embodiments, flurbiprofen cataplasma of the present invention and preparation method thereof is described in detail.
Embodiment 1: preparation flurbiprofen cataplasma, flurbiprofen content 1mg/cm 2
Prescription and proportioning:
Flurbiprofen 10g
Paraffin oil 12g
Ethyl sebacate 18g
Sodium laurylsulfate 20g
Gelatin 50g
Glycerol 230g
Sodium polyacrylate 40g
Sodium carboxymethyl cellulose 30g
Kaolin 50g
Azone 10g
Citric acid 10g
Essence 5g
Water adds to 1000g
Preparation method:
1. prepare flurbiprofen Emulsion:
By said ratio flurbiprofen is joined in the ethyl sebacate, 60 ℃ of heating for dissolving add paraffin oil, and the room temperature cooling is oil phase.Sodium laurylsulfate is dissolved in 60ml water, pours above-mentioned oil phase again into, be blended into breast.
2. prepare hydrophilic catablasm base material
Get gelatin, glycerol, sodium polyacrylate, citric acid, sodium carboxymethyl cellulose by said ratio and be dissolved in 460ml water, add the Kaolin of crossing 200 mesh sieves again and stir.
3. prepare the flurbiprofen cataplasma
Flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, adds essence again, azone stirs, mastic.Evenly be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 80cm 2/ open, pack.Embodiment 2: preparation flurbiprofen cataplasma, flurbiprofen content 1.2mg/cm 2Prescription and proportioning: Flurbiprofen 30g Tween-80 30g paraffin oil 45g diethylene adipate 55gd-sorbierite 275g gelatin 25g alum 1.8g ethylparaben 1g Sodium Polyacrylate 3.5g sodium carboxymethylcellulose 31g kaolin 16g PVP K-90 3g azone 10g essence 3g distilled water adds to the 1000g preparation method: prepare Flurbiprofen emulsion 1.:
By said ratio flurbiprofen is joined in the diethylene adipate, 60 ℃ of heating for dissolving add paraffin oil, and the room temperature cooling is oil phase.Tween 80 is added in the 200ml water, pour in the above-mentioned oil phase, be blended into breast.2. prepare hydrophilic catablasm base material
By said ratio gelatin, d-sorbitol, sodium polyacrylate, sodium carboxymethyl cellulose, aluminium potassium sulfate, polyvinylpyrrolidone K-90 are dissolved in 260ml water, add the Kaolin of crossing 200 mesh sieves again and stir.3. prepare the flurbiprofen cataplasma
Flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, add ethyl hydroxybenzoate, essence, azone again, stir, get mastic.Be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 80cm 2/ open, pack.
Embodiment 3: preparation flurbiprofen cataplasma, flurbiprofen content 1mg/cm 2
Prescription and proportioning:
Flurbiprofen 30g
Glycerol 300g
Gelatin 25g
Aluminium hydroxide 2.0g
Ethyl hydroxybenzoate 1g
Sodium polyacrylate 2.5g
Sodium carboxymethyl cellulose 19g
Kaolin 16g
Polyvinylpyrrolidone K-90 3g
N-Methyl pyrrolidone 10g
Essence 8g
Distilled water adds to the 1000g preparation method: prepare hydrophilic catablasm base material 1.
By said ratio gelatin, glycerol, sodium polyacrylate, sodium carboxymethyl cellulose, aluminium hydroxide, polyvinylpyrrolidone K-90 are dissolved in 580ml water.2. prepare the flurbiprofen cataplasma
Flurbiprofen, the Kaolin that to cross 200 mesh sieves by said ratio add hydrophilic catablasm base material, stir, and add ethyl hydroxybenzoate, essence, N-Methyl pyrrolidone again, stir, and get mastic.Be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 50cm 2/ open, pack.
Embodiment 4: preparation flurbiprofen cataplasma, flurbiprofen content 1mg/cm 2
Prescription and proportioning:
Flurbiprofen 9g
Tween 80 10g
Paraffin oil 10g
Diethylene adipate 15g
Glycerol 300g
Gelatin 25g
Aluminium potassium sulfate 1.8g
EDTA-Na 5g
Sodium polyacrylate 90g
Sodium carboxymethyl cellulose 31g
Kaolin 40g
Azone 10g
Tartaric acid 5g
Essence 10g
Distilled water adds to the 1000g preparation method: prepare flurbiprofen Emulsion 1.
By said ratio flurbiprofen is added diethylene adipate, 60 ℃ of heating for dissolving add paraffin oil again, and the room temperature cooling is oil phase.Tween 80 is added in the 60ml water, pour above-mentioned oil phase again into, be blended into breast.2. prepare hydrophilic catablasm base material
By said ratio gelatin, glycerol, sodium polyacrylate, sodium carboxymethyl cellulose, aluminium potassium sulfate are dissolved in 580ml water, add the Kaolin of crossing 200 mesh sieves and stir.3. prepare the flurbiprofen cataplasma
Flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, add EDTA-Na, tartaric acid, essence, azone again, stir, get mastic.Be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 60cm 2/ open, pack.
Embodiment 5: preparation flurbiprofen cataplasma, flurbiprofen content 0.5mg/cm 2
Prescription and proportioning:
Flurbiprofen 10g
Paraffin oil 12g
Ethyl sebacate 18g
Sodium laurylsulfate 20g
Gelatin 50g
Glycerol 230g
Ammonium polyacrylate 40g
Sodium carboxymethyl cellulose 30g
Kaolin 50g
Azone 10g
Citric acid 10g
Essence 5g
Water adds to 1000g
Preparation method:
1. prepare flurbiprofen Emulsion:
With embodiment 1.
2. prepare hydrophilic catablasm base material
Get gelatin, glycerol, ammonium polyacrylate, citric acid, sodium carboxymethyl cellulose by said ratio and be dissolved in 460ml water, add the Kaolin of crossing 200 mesh sieves again and stir.
3. prepare the flurbiprofen cataplasma
With embodiment 1.
Embodiment 6: preparation flurbiprofen cataplasma, flurbiprofen content 1.2mg/cm 2
Prescription and proportioning:
Flurbiprofen 30g
Tween 80 30g
Paraffin oil 45g
Diethyl phthalate 55g
D-sorbitol 275g
Gelatin 25g
Aluminium potassium sulfate 1.8g
Ethyl hydroxybenzoate 1g
Sodium polyacrylate 3.5g
Sodium carboxymethyl cellulose 31g
Kaolin 16g
Polyvinylpyrrolidone K-90 3g
Azone 10g
Essence 3g
Distilled water adds to 1000g
Preparation method: 1. prepare flurbiprofen Emulsion:
By said ratio flurbiprofen is joined in the diethyl phthalate, 60 ℃ of heating for dissolving add paraffin oil, and the room temperature cooling is oil phase.Tween 80 is added in the 200ml water, pour in the above-mentioned oil phase, be blended into breast.2. prepare hydrophilic catablasm base material
With embodiment 2.3. prepare the flurbiprofen cataplasma
With embodiment 2.Embodiment 7: preparation flurbiprofen cataplasma, flurbiprofen content 1mg/cm 2Prescription and proportioning: Flurbiprofen 30g glycerine 300g gelatin 25g aluminium hydroxide 2.0g
Ethyl hydroxybenzoate 1g
Sodium polyacrylate 2.5g
Polyethylene Glycol 19g
Kaolin 16g
Polyvinylpyrrolidone K-90 3g
N-Methyl pyrrolidone 10g
Essence 8g
Distilled water adds to the 1000g preparation method: prepare hydrophilic catablasm base material 1.
By said ratio gelatin, glycerol, sodium polyacrylate, Polyethylene Glycol, aluminium hydroxide, polyvinylpyrrolidone K-90 are dissolved in 580ml water.2. prepare the flurbiprofen cataplasma
With embodiment 3.
Embodiment 8: preparation flurbiprofen cataplasma, flurbiprofen content 1mg/cm 2
Prescription and proportioning:
Flurbiprofen 9g
Polyoxyethylene nonylphenol ether 10g
Paraffin oil 10g
Diethylene adipate 15g
Glycerol 300g
Gelatin 25g
Aluminium potassium sulfate 1.8g
EDTA-Na 5g
Sodium polyacrylate 90g
Tragakanta 31g
Kaolin 40g
Carbamide 10g
Tartaric acid 5g
Essence 10g
Distilled water adds to the 1000g preparation method: prepare flurbiprofen Emulsion 1.
By said ratio flurbiprofen is added diethylene adipate, 60 ℃ of heating for dissolving add paraffin oil again, and the room temperature cooling is oil phase.Polyoxyethylene nonylphenol ether is added in the 60ml water, pour above-mentioned oil phase again into, be blended into breast.2. prepare hydrophilic catablasm base material
By said ratio gelatin, glycerol, sodium polyacrylate, tragakanta, aluminium potassium sulfate are dissolved in 580ml water, add the Kaolin of crossing 200 mesh sieves and stir.3. prepare the flurbiprofen cataplasma
Flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, add EDTA-Na, tartaric acid, essence, carbamide again, stir, get mastic.Be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 60cm 2/ open, pack.
Embodiment 9: preparation flurbiprofen cataplasma, flurbiprofen content 1.2mg/cm 2
Prescription and proportioning:
Flurbiprofen 9g
Sodium lauryl sulphate 10g
Paraffin oil 10g
Diethylene adipate 15g
Glycerol 300g
Gelatin 25g
Aluminium hydroxide 1.8g
EDTA-Na 5g
Sodium polyacrylate 90g
Tragakanta 31g
Kaolin 40g
Carbamide 10g
Tartaric acid 5g
Essence 10g
Distilled water adds to the 1000g preparation method: prepare flurbiprofen Emulsion 1.
By said ratio flurbiprofen is added diethylene adipate, 60 ℃ of heating for dissolving add paraffin oil again, and the room temperature cooling is oil phase.Sodium lauryl sulphate is added in the 60ml water, pour above-mentioned oil phase again into, be blended into breast.2. prepare hydrophilic catablasm base material
By said ratio gelatin, glycerol, sodium polyacrylate, tragakanta, aluminium hydroxide are dissolved in 580ml water, add the Kaolin of crossing 200 mesh sieves and stir.3. prepare the flurbiprofen cataplasma
Flurbiprofen Emulsion is added Hydrophillia Babu agent substrate, add EDTA-Na, tartaric acid, essence, carbamide again, stir, get mastic.Be applied to after the degassing on the non-woven fabrics, go up polyethylene film again, 40 ℃ of dryings cut into 60cm 2/ open, pack.

Claims (15)

1. a flurbiprofen cataplasma comprises backing layer, drug-reservoir and protecting film, it is characterized in that drug-reservoir is made up of flurbiprofen powder or flurbiprofen Emulsion, hydrophilic catablasm base material, penetration enhancer and additives, and proportioning is as follows: (%w/w)
Flurbiprofen 0.5-20
Emulsifying agent 0-15
Oil phase 0-25
Hydrophilic catablasm base material 40-95
Penetration enhancer 1-40
Additives 0.5-5
2. by the described flurbiprofen cataplasma of claim 1, it is characterized in that said flurbiprofen Emulsion is made up of flurbiprofen, water, oil phase and emulsifying agent, emulsifying agent wherein is selected from the monovalence soap that sodium lauryl sulphate, tween, span, Bian Ze, peregal, polyoxyethylene nonylphenol ether, stearic acid and sodium hydroxide or potassium hydroxide or ammonium hydroxide form; Flurbiprofen is dissolved in oil phase, oil phase is selected from liquid paraffin, silicone and phthalic acid isobutyl ester, diethyl phthalate, O-phthalic isopropyl propionate, dibutyl phthalate, diethylene adipate, sad diethylester, ethyl sebacate, can select one or both of oil phase simultaneously for use.
3. by claim 1 or 2 described flurbiprofen cataplasmas, it is characterized in that said hydrophilic catablasm base material is by hydrophilic cohesiveness substrate, cross-linking agent, wetting agent, filler, water is formed, and wherein hydrophilic cohesiveness substrate is selected from sodium polyacrylate, polyacrylic acid potassium, ammonium polyacrylate, polyacrylic acid monoethanol ammonium, polyacrylic acid diethanol ammonium, the polyacrylic acid triethanol ammonium, sodium carboxymethyl cellulose, carboxymethyl starch, the tragakanta, polyvinyl alcohol, carbopol, polyvinylpyrrolidone, polyacrylic acid, Polyethylene Glycol, arabic gum, hydroxypropyl cellulose, hydroxyethyl-cellulose, hydroxy methocel, gelatin, agar.
4. by the described flurbiprofen cataplasma of claim 3, it is characterized in that said cross-linking agent is selected from aluminium hydroxide, aluminum chloride, aluminium potassium sulfate, aluminium carbonate, aluminum acetate, aluminum nitrate, magnesium hydroxide, magnesium aluminate, magnesium nitrate, calcium chloride, can select wherein one or both simultaneously for use.
5. by the described flurbiprofen cataplasma of claim 3, it is characterized in that said wetting agent is selected from glycerol, mannitol, propylene glycol, sorbitol.
6. by the described flurbiprofen cataplasma of claim 4, it is characterized in that said wetting agent is selected from glycerol, mannitol, propylene glycol, sorbitol.
7. by the described flurbiprofen cataplasma of claim 3, it is characterized in that said filler is selected from Kaolin, zinc oxide, titanium dioxide.
8. by claim 4,5,6 described flurbiprofen cataplasmas, it is characterized in that said filler is selected from Kaolin, zinc oxide, titanium dioxide.
9. by claim 1,2,4,5,6,7 described flurbiprofen cataplasmas, it is characterized in that said penetration enhancer is selected from ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide, oleic acid, linoleic acid, lauryl alcohol, azone, sodium lauryl sulphate, Tween 80, carbamide, salicylic acid and N-Methyl pyrrolidone, N-ethyl pyrrolidone, menthol, Camphora, limonene and eucalyptole, can select the 1-3 kind simultaneously for use.
10. by the described flurbiprofen cataplasma of claim 3, it is characterized in that said penetration enhancer is selected from ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide, oleic acid, linoleic acid, lauryl alcohol, azone, sodium lauryl sulphate, Tween 80, carbamide, salicylic acid and N-Methyl pyrrolidone, N-ethyl pyrrolidone, menthol, Camphora, limonene and eucalyptole, can select the 1-3 kind simultaneously for use.
11. by the described flurbiprofen cataplasma of claim 8, it is characterized in that said penetration enhancer is selected from ethanol, propylene glycol, fatty acid ester, dimethyl sulfoxide, oleic acid, linoleic acid, lauryl alcohol, azone, sodium lauryl sulphate, Tween 80, carbamide, salicylic acid and N-Methyl pyrrolidone, N-ethyl pyrrolidone, menthol, Camphora, limonene and eucalyptole, can select the 1-3 kind simultaneously for use.
12., it is characterized in that said additives are antioxidant, antiseptic, spice, pigment by claim 1,2,4,5,6,7,10,11 described flurbiprofen cataplasmas.
13., it is characterized in that said additives are antioxidant, antiseptic, spice, pigment by the described flurbiprofen cataplasma of claim 3.
14., it is characterized in that said additives are antioxidant, antiseptic, spice, pigment by the described flurbiprofen cataplasma of claim 8.
15., it is characterized in that said additives are antioxidant, antiseptic, spice, pigment by the described flurbiprofen cataplasma of claim 9.
CNB031164412A 2003-04-17 2003-04-17 Flurbiprofenbab preparation and its preparation method Expired - Lifetime CN100502852C (en)

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Cited By (10)

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CN104546803A (en) * 2013-10-24 2015-04-29 和心医药科技(上海)有限公司 Flurbiprofen hydrogel plaster and composition thereof
CN104784102A (en) * 2015-03-20 2015-07-22 成都汇智远景科技有限公司 Ceftezole sodium ointment
CN105078645A (en) * 2014-05-12 2015-11-25 天津卓普医疗器械有限公司 Cold-compression patch with hydrogel as substrate and method for manufacturing cold-compression patch
CN105287361A (en) * 2015-11-13 2016-02-03 北京泰德制药股份有限公司 External preparation containing non-steroid anti-inflammatory drug microemulsion and used for skin
CN106667970A (en) * 2016-12-06 2017-05-17 北京茗泽中和药物研究有限公司 Flurbiprofen cataplasm
CN107157962A (en) * 2017-05-16 2017-09-15 蔡志浩 flurbiprofen cataplasms
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CN109528693A (en) * 2018-12-20 2019-03-29 武汉科福新药有限责任公司 A kind of rapamycin cataplasm and preparation method thereof
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CN103393631B (en) * 2013-08-22 2015-04-08 北京蓝丹医药科技有限公司 Flurbiprofen axetil pharmaceutical composition
CN103393631A (en) * 2013-08-22 2013-11-20 北京蓝丹医药科技有限公司 Flurbiprofen axetil pharmaceutical composition
CN104546803A (en) * 2013-10-24 2015-04-29 和心医药科技(上海)有限公司 Flurbiprofen hydrogel plaster and composition thereof
CN105078645A (en) * 2014-05-12 2015-11-25 天津卓普医疗器械有限公司 Cold-compression patch with hydrogel as substrate and method for manufacturing cold-compression patch
CN104784102B (en) * 2015-03-20 2018-01-02 宋益兴 Cefobutazine sodium ointment
CN104784102A (en) * 2015-03-20 2015-07-22 成都汇智远景科技有限公司 Ceftezole sodium ointment
CN105287361A (en) * 2015-11-13 2016-02-03 北京泰德制药股份有限公司 External preparation containing non-steroid anti-inflammatory drug microemulsion and used for skin
CN106667970A (en) * 2016-12-06 2017-05-17 北京茗泽中和药物研究有限公司 Flurbiprofen cataplasm
CN106667970B (en) * 2016-12-06 2019-06-25 北京茗泽中和药物研究有限公司 Flurbiprofen cataplasms
CN107157962A (en) * 2017-05-16 2017-09-15 蔡志浩 flurbiprofen cataplasms
CN109432061A (en) * 2018-11-09 2019-03-08 北京德默高科医药技术有限公司 Multilayer transdermal delivery system containing brufen or its analogue
CN109528693A (en) * 2018-12-20 2019-03-29 武汉科福新药有限责任公司 A kind of rapamycin cataplasm and preparation method thereof
CN109528693B (en) * 2018-12-20 2022-03-01 武汉科福新药有限责任公司 Rapamycin cataplasm and preparation method thereof
CN111904925A (en) * 2020-04-28 2020-11-10 湖南九典制药股份有限公司 Flurbiprofen sodium gel preparation and preparation method and application thereof

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