CN104546803A - Flurbiprofen hydrogel plaster and composition thereof - Google Patents
Flurbiprofen hydrogel plaster and composition thereof Download PDFInfo
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- CN104546803A CN104546803A CN201310512076.8A CN201310512076A CN104546803A CN 104546803 A CN104546803 A CN 104546803A CN 201310512076 A CN201310512076 A CN 201310512076A CN 104546803 A CN104546803 A CN 104546803A
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Abstract
The invention provides a flurbiprofen hydrogel plaster and a composition thereof. In the composition, the content of flurbiprofen is 0.1-3wt%, and a hydrogel substrate accounts for the rest. Based on the total weight of the hydrogel substrate, the hydrogel substrate comprises the following components: 0.1-40wt% of a hydrophilic base material, 0.01-2wt% of a crosslinking agent, 0.01-4wt% of a crosslinking regulator, 10-60wt% of a humectant, 0.05-45wt% of a penetration enhancer and 10-85wt% of a solvent. According to the flurbiprofen hydrogel plaster provided by the invention, a small number of medicines are used, and the permeability and stability are good; and the flurbiprofen hydrogel plaster can be applied to various arthralgia diseases such as rheumatic arthritis, gouty arthritis, ankylosing spondylitis, tenosynovitis, muscle pain and lumbago.
Description
Technical field
The present invention relates to a kind of hydrogel plaster, particularly relate to that a kind of water content is high, stability and the good flurbiprofen hydrogel plaster of transdermal characteristic.
Background technology
Flurbiprofen (Flurbiprofen) is class arylprop acid type NSAID (non-steroidal anti-inflammatory drug) (NSAID), and relative molecular weight is 244.26g/mol, and fusing point is 114 DEG C-117 DEG C, pKa=4.2, Determination of oil-water partition coefficient is 3.86, and dissolubility is 11mg/ml, and in body, biological half-life is 3-5 hour.Flurbiprofen is non-selectivity ring oxo enzyme inhibitor, mainly through suppressing the oxidasic effect of arachidonic acid metabolic medium ring, suppress the synthesis of prostaglandin, tool is antipyretic, analgesia, antiinflammatory action, be mainly used in swelling caused by osteoarthritis, scapulohumeral periarthritis, tendon and tenosynovitis, peritendinal inflammation, external humeral epicondylitis (tennis elbow), myalgia, wound, pain.Zoopery confirms, antiinflammatory and the analgesic activity of flurbiprofen are stronger than ibuprofen, and toxicity is lower.Flurbiprofen has good toleration, and aspirin is invalid or can not resistance to receptor is optional uses this medicine, and its analgesia, antiinflammatory and refrigeration function are 250 times and 50 times of aspirin respectively.
At present, flurbiprofen mainly contains oral and external two kinds of dosage forms clinically.When flurbiprofen is with tablet, slow releasing tablet oral administration, there is first pass effect and the untoward reaction based on gastrointestinal tract disorder, and enough amounts must be had to enter blood circulation could arrive site of action, cause blood drug level too high, easily cause the toxicity of central nervous system, headache, dizziness etc., and the flurbiprofen half-life is shorter, every day needs administration 3-4 time, needs the patient of Long-term taking medicine often can not tolerate.Therefore, the first-selected dosage form that class external preparation becomes flurbiprofen is sticked.Flurbiprofen salt transdermal patch disclosed in CN102000043A, makes plaster with on the coatings such as pressure sensitive adhesive, tackifier, penetrating agent and backing; Flurbiprofen external use plaster disclosed in WO2006/092829A, with styrene/isoprene/styrene block polymer, tackifying resin and softening agent for adhesive layer substrate; And flurbiprofen transdermal patch disclosed in CN1180770C and WO97/23206A.
Hydrogel plaster is a kind of Novel external patch, and compared with conventional rubber cream, it is strong that hydrogel plaster has moisture retention, good with skin-friendliness, stimulates the advantages such as anaphylaxis is little.Hydrogel plaster is substrate with hydrophilic high molecular material, has moisturizing, ventilative, repeatedly can take off subsides, to skin irritation and the advantage such as anaphylaxis is smaller.
At present, the topmost problem that hydrogel plaster exists improves the stability of medicine and the percutaneous permeation of medicine.Flurbiprofen is insoluble drug, and its poor solubility in water have impact on the Transdermal absorption of medicine.Therefore, improving the dissolubility of flurbiprofen, improve stability, and ensure to store stability, is be made into the matter of utmost importance being easy to transdermal absorption formulation and solving.Although technical staff has carried out much research and made great efforts to solve these problems, because the research starting of China in this field is late, the data that can for consult is few, therefore, does not find one method safely and effectively at present yet.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency, Transdermal absorption, water content are high, persistent and bland flurbiprofen hydrogel plaster to provide one to be easy to.Furthermore, the object of the invention is research flurbiprofen hydrogel plaster, make it in preparation and storage, have good steady dissolution, demonstrate high-moisture and long moisture retention, to ensure the sustained release of medicine and to improve the Transdermal absorption performance of medicine.
The present invention first aspect is to provide a kind of flurbiprofen hydrogel plaster, comprise the anti-mucosa on backing, mastic and described mastic surface, wherein: in described mastic, the content of flurbiprofen is 0.1-3wt%, be more preferably 0.1-1wt%, be more preferably 0.1-0.45wt%, be more preferably 0.2-0.4wt%.
Wherein, described backing can be the hydrogel plaster common used materials such as spun rayon cloth, non-woven fabrics or stretch fabric.
Wherein, described anti-mucosa can be the thin film such as polypropylene, polyethylene, polyester (as PET, PBT).
In one preferred embodiment of the invention, described hydrogel plaster is made up of backing, mastic and anti-mucosa, described mastic constituent comprises flurbiprofen and aqueous gel substrate, hydrophilic transdermal absorbable preparation is prepared into through hydrogel plaster moulding process, wherein, be more preferably: in mastic, the content of flurbiprofen is preferably 0.1-3wt%, is more preferably 0.1-1wt%, be more preferably 0.1-0.45wt%, be more preferably 0.2-0.4wt%; Surplus is aqueous gel substrate.
The present invention second aspect is to provide a kind of flurbiprofen pharmaceutical composition for described hydrogel plaster, comprises flurbiprofen, solvent and aqueous gel substrate; Wherein, be more preferably: the content of flurbiprofen is 0.1-0.45wt%, is more preferably 0.2-0.4wt%; Surplus is aqueous gel substrate.
In foregoing of the present invention, preferably, with aqueous gel substrate gross weight for benchmark, the constituent of the above-mentioned aqueous gel substrate of the present invention comprises and preferably consists of:
Hydrophilic basis material 0.1-40wt%, more preferably 0.5-30wt%, more preferably 5-25wt%, more preferably 5-10wt%;
Cross-linking agent 0.01-2wt%, more preferably 0.02-1wt%, more preferably 0.05-0.1wt%;
Cross-linking regulator 0.01-4wt%, more preferably 0.02-2wt%, more preferably 0.08-1.5wt%, more preferably 0.08-0.12wt%, more preferably 0.08-0.10wt%wt%;
Wetting agent 10-60wt%, more preferably 19-50wt%, more preferably 20-50wt%, more preferably 25-30wt%;
Transdermal penetration enhancer 0.05-45wt%, more preferably 0.1-30wt%, more preferably 0.5-5wt%;
Solvent 10-85wt%, more preferably 20-80wt%, more preferably 30-68wt%, more preferably 38-56wt%.
Described hydrophilic basis material can be hydrophilic high molecular material, wherein, hydrophilic high molecular material can be selected from 1) cellulose and its derivates, as carboxymethyl cellulose, carboxymethyl cellulose salt, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose etc.; 2) synthesized polymer material, as poly acrylic acid-poly sodium acrylate copolymer (as NP-600), poly acrylic acid-poly sodium acrylate copolymer (as NP-700), poly acrylic acid-poly sodium acrylate copolymer (as NP-800), polyvinylpyrrolidone (PVP), polybutene, carboxylic polrvinyl, polyvinyl alcohol, carbomer, polyacrylic acid, polyacrylate or ester; 3) other comes from the hydrophilic colloid of organism, polysaccharide, polypeptide or its hydrophilic derivatives, as gelatin, locust bean gum, tragcanth, arabic gum, alginic acid, alginate, chitosan, corn starch etc., described hydrophilic high molecular material can be one or more in above-mentioned substance; Described salt can be potassium salt, sodium salt, calcium salt etc.
Described cross-linking agent can be selected from aluminium hydroxide, dihydroxyaluminum aminoacetate, aluminum chloride, aluminium citrate, synthetic aluminium silicate, dihydroxyaluminum aminoacetate, glutamic acid aluminum, aluminium potassium sulfate, calcium hydroxide, calcium chloride etc. in interior one or more.
Described cross-linking regulator can be selected from tartaric acid, citric acid, phosphoric acid, malic acid, edetic acid (EDTA), gluconic acid or its salt etc. in interior one or more, and described salt can be potassium salt, sodium salt, calcium salt etc., as EDETATE DISODIUM.
Described wetting agent is preferably polyhydric alcohol, can be selected from glycerol, propylene glycol, Polyethylene Glycol (as PEG-400, PEG-600, PEG-800), D-glucitol, polypropylene glycol, 1,3 butylene glycol, hexanediol, xylitol, liquid paraffin etc. in interior one or more.
Described transdermal penetration enhancer can be selected from volatile oil as Oleum menthae, eucalyptus oil, Oleum Anisi Stellati, Borneolum Syntheticum, Borneolum Syntheticum; And laurocapram, N-Methyl pyrrolidone (NMP), SA diethylester, diisopropyl adipate, isopropyl myristate, propylene glycol etc. are in interior one or more.
Described solvent can be selected from water, or the admixture solvent of other medicine and pharmacology useable solvents and water, and is preferably water.
In one preferred embodiment of the invention, as required, surfactant can also be added in the mastic of described flurbiprofen hydrogel plaster.
Described surfactant can be ion-type or nonionic surfactant, and be preferably anionic surfactant, any one or a few in nonionic surfactant, can be selected from sodium lauryl sulphate, dioctyl succinate disulfonate acid, Polysorbate (as tween 80), Span, Sorbitol alcohol acid anhydride sesquialter isostearate, sorbitan sesquioleate, glyceryl monostearate, isopropyl myristate, polyoxyethylene hydrogenated Oleum Ricini etc. in interior one or more.
The consumption of described surfactant, can by those skilled in the art according to its HLB(hydrophile-lipophile balance value) regulate, to make each component disperses in mastic process for preparation even.
In addition, described mastic can also comprise the additive of one or more be selected from solubilizing agent, antiseptic, viscosifier, filler, antioxidant, freshener or warming agent, spice.
The maximum ratio that described additive accounts for described mastic weight is 5%, is more preferably the 0.01-5% accounting for described mastic weight, is more preferably 0.1-2%, be more preferably 0.5-1%.
Solubilizing agent used can be crotamiton, diisopropyl adipate one or more.
Described antiseptic can be selected from parabens (as methyl hydroxybenzoate, ethyl hydroxybenzoate etc.), benzoic acid, ethylparaben, benzalkonium chloride, thymol, Fructus Foeniculi wet goods in interior one or more.
Viscosifier can be selected from polyvinylpyrrolidone (as PVPK30), polyvinyl alcohol (PVA), polybutene etc. at interior one or both.
Filler can be selected from bentonite, Bentonite, zinc oxide, titanium dioxide, micropowder silica gel, calcium carbonate, Kaolin, light anhydrous silicic acid etc. in interior one or more.
Antioxidant can be selected from sodium sulfite, sodium pyrosulfite, citric acid, dibenzylatiooluene, Butylated hydroxyanisole, ethylenediaminetetraacetic acid etc. in interior one or more.
Freshener can be Oleum menthae, Camphora, menthol etc. in interior one or more.
Warming agent can be synthesis capsaicin, Fructus Capsici fluidextract etc. one or more.
Spice can be Oleum menthae, eucalyptus oil, Fructus Foeniculi wet goods one or more.
Flurbiprofen hydrogel plaster cream drug consumption provided by the invention is few, transdermal characteristic and having good stability, and can be used for the various arthralgia diseases such as rheumatic arthritis, gouty arthritis, tatanic myelitis, tenosynovitis, myalgia, pain in the lumbar region.
Detailed description of the invention
Referring to specific embodiment, the invention will be further described, to understand the present invention better.
Embodiment 1
The flurbiprofen hydrogel plaster that the present embodiment provides is made up of backing, mastic and anti-mucosa, and the constituent of described mastic comprises:
First sodium carboxymethyl cellulose 1.5g is dissolved in glycerol and partial purification water, obtains component A.
Get gelatin 1.5g to be dissolved in partial purification water, expand complete post-heating to 60 DEG C, stirs to translucent colloid, obtained B component.
Sodium polyacrylate part corrective (NP800) 5.0g, aluminium hydroxide 0.06g are dissolved in glycerol, are uniformly mixed, obtained component C.
In advance flurbiprofen is dissolved in crotamiton, N-Methyl pyrrolidone and makes flurbiprofen solution, add sorbitan sesquioleate 0.1g, Tween 80 0.1g, isopropyl myristate 2g again, add Oleum menthae 0.0015g, Menthol 0.10g, PEG4001.5g again, mixing, heating 40-50 DEG C, stir, obtain D component.
0.12g tartaric acid is joined in purified water, obtains component E.
Titanium dioxide 0.8g, disodium edetate 0.15g, Kaolin 0.2g are dispersed in purified water respectively, add component A, B component, component C, make its fully refine and, be uniformly dispersed, then add D component, component E, about 40-50 DEG C of insulation, mixing, stirs, makes cream.By cream even spread, section, packaging, obtained hydrogel plaster.
Embodiment 2
The flurbiprofen hydrogel plaster that the present embodiment provides is made up of backing, mastic and anti-mucosa, and the constituent of described mastic comprises:
First sodium carboxymethyl cellulose 1.5g, polyvinyl alcohol 1.0g are dissolved in glycerol and partial purification water, obtain component A.
Get gelatin 1.0g to be dissolved in partial purification water, expand complete post-heating to 60 DEG C, stirs to translucent colloid, obtained B component.
Sodium polyacrylate part corrective (NP700) 6.0g, aluminium hydroxide 0.06g are dissolved in glycerol, are uniformly mixed, obtained component C.
In advance flurbiprofen is first dissolved in crotamiton, add sorbitan sesquioleate 0.1g, Tween 80 0.1g, isopropyl myristate 2g again, add Menthol 0.10g, PEG4001.5g, D-glucitol 15g, capsaicin 0.5g again, mixing, heating 40-50 DEG C, stir, obtain D component.
0.02g phosphoric acid is joined in purified water, obtains component E.
Pulvis Talci 1g, disodium edetate 0.08g are dispersed in purified water respectively, add component A, B component, component C, make its fully refine and, be uniformly dispersed, then add D component, component E, about 40-50 DEG C of insulation, mix, stir, make cream.By cream even spread, section, packaging, obtained hydrogel plaster.
Embodiment 3
The flurbiprofen hydrogel plaster that the present embodiment provides is made up of backing, mastic and anti-mucosa, and the constituent of described mastic comprises:
First sodium carboxymethyl cellulose 1.0g is dissolved in glycerol and partial purification water, obtains component A;
Get gelatin 2.0g to be dissolved in partial purification water, expand complete post-heating to 60 DEG C, stirs to translucent colloid, obtained B component.
Sodium polyacrylate part corrective (NP600) 8.0g, dihydroxyaluminum aminoacetate 0.08g are dissolved in glycerol, are uniformly mixed, obtained component C.
Flurbiprofen is added PEG4002.0g, Oleum menthae 0.0015g, Oleum Anisi Stellati 0.0015g in advance, polyoxyethylene hydrogenated Oleum Ricini 0.5g, add Menthol 0.08g again and mix, heating 40-50 DEG C, stirs, obtains D component.
0.12g tartaric acid is joined in purified water, obtains component E.
Titanium dioxide 1g, disodium edetate 0.10g are dispersed in purified water respectively, add component A, B component, component C, make its fully refine and, be uniformly dispersed, then add D component, component E, about 40-50 DEG C of insulation, mix, stir, make cream.
By cream even spread, section, packaging, obtained hydrogel plaster.
Embodiment 4
The flurbiprofen hydrogel plaster that the present embodiment provides is made up of backing, mastic and anti-mucosa, and the constituent of described mastic comprises:
First sodium carboxymethyl cellulose 3.0g is dissolved in glycerol and partial purification water, obtains component A; Get gelatin 2.0g to be dissolved in partial purification water, expand complete post-heating to 60 DEG C, stirs to translucent colloid, obtained B component; Polyacrylate 10.0g, dihydroxyaluminum aminoacetate 0.1g are dissolved in glycerol, are uniformly mixed, obtained component C.
In advance flurbiprofen is added in PEG4002.0g, then add Menthol 0.1g and mix, be heated to 40-50 DEG C, stir, obtain D component.
Tartaric acid 0.1g is joined in purified water, obtains component E.
Titanium dioxide 1.0g, disodium edetate 0.10g are dispersed in purified water respectively, add component A, B component, component C, make its fully refine and, be uniformly dispersed, then add D component, component E, about 40-50 DEG C of insulation, mix, stir, make cream.
By cream even spread (adopting two bullet non-woven fabrics, PE antiadhesion barrier), section, packaging, obtained flurbiprofen hydrogel plaster.
Performance Detection
1, stability test
The hydrogel plaster prepared in above-described embodiment is placed in aluminium plastic packaging bag, is placed in the climatic chamber of temperature 40 DEG C, humidity 75%, under room temperature placement condition, sampled respectively 1 month, 3 months, 6 months time and carry out evaluation test.
Assessment item: separate out (polarized light microscopy spectroscopy) etc. with or without crystal in outward appearance, adhesion, content, impurity content and mastic.Result shows under placement condition, all separates out without crystal in mastic, and medicament contg is stablized, and nonwoven layer is without phenomenon of osmosis, and the fissility of antiadhesion barrier, the adhesion strength of mastic, flexibility, plastic property is all unchanged.
Table 1 result showed the present invention after 3 months, and content does not significantly reduce, and after 6 months, flurbiprofen content does not have significant change yet.
When long-time (12 months) place, this product does not find that crystal is separated out, and illustrates that subject hydrogel plaster has good stability.
Table 1 embodiment 1-4 flurbiprofen hydrogel plaster changes of contents
2, adhesion strength and plastic property test
Adhesion strength: test by method under Chinese Pharmacopoeia version in 2010 first plaster item: get test 3, sample and at room temperature remove lid lining, be placed in long 30cm, become the inclined-plane of 30 ° central authorities with horizontal plane, cream is towards upper, the mylar that top, inclined-plane 10cm and bottom 15cm 0.025mm is thick covers, central authorities reserve 5cm cream face, freely roll down from beveled top end with No. 19 steel balls.
Plastic property: check by method under Chinese Pharmacopoeia version in 2010 first plaster item, gets test 1, sample, puts in 37 DEG C of calorstats, take out, be fixed on a smooth immortal steel plate with clip by test sample, the inclination angle of steel plate and horizontal plane is 60 °, place 24h, cream face is without trickling phenomenon.Repeat adhibit quality and investigate 6 months, monthly measure once, record repeats to paste number of times.
Table 2, embodiment 1-4 flurbiprofen hydrogel plaster tackness and plastic property test result
| Standing time | Initially | 1 month | 3 months | 6 months |
| Adhesion strength | Qualified | Qualified | Qualified | Qualified |
| Plastic property | Qualified | Qualified | Qualified | Qualified |
3, Ligustrazine hydrochloride test
Adopt improved Franz diffusing cells method, be fixed on diffusion cell by rat skin (n=6), corium is towards receiving chamber, and stratum corneum side, to supply chamber, adds appropriate phosphate buffered solution in receiving chamber.By hydrogel plaster patch obtained for embodiment 1 on skin, open constant temperature (37 ± 1) DEG C water-bath circulation and magnetic stirring apparatus (250rmin
-1) different time points 2,4,6,8,12,24h sampling, utilize high phase liquid chromatography for measuring flurbiprofen content, Q is unit area Percutaneous permeability, the results are shown in Table 3.
Table 3, Ligustrazine hydrochloride result of the test
As shown in Table 3, the percutaneous abilities of the flurbiprofen hydrogel plaster that embodiment of the present invention 1-3 obtains is good, and can discharge for a long time.
4, irritation test
Get 24 SD rats, male and female half and half, body weight is about 180-200g, is equally divided into three groups, and skin of abdomen is shaved removed with being shaved a mao machine.First group of rat applies ointment or plaster in epilating area (2 × 3) cm
2the obtained flurbiprofen hydrogel plaster of embodiment 1, divest after 24, second group of tester blank hydrogel plaster of applying ointment or plaster in epilating area, divests after 24, after divesting after 3rd group of successive administration 14d, observe when divesting, divesting 24h, divest 48h after, divest 72h after to lose hair or feathers district's irriate situation.
All there is not the anaphylaxis such as erythema and edema in the skin that result shows the depilation district of three groups of rats, illustrate that this hydrogel plaster is to no skin irritation, safety is good.
In sum, provided by the invention flurbiprofen hydrophilic hydrogel plaster has good stability, water content is high, moisture retention is strong, Transdermal absorption performance good, to no skin irritation.
5, antiinflammatory action experiment
Carrageenin causes rat paw edema experiment, gets 150 ± 15gSD rat, male and female half and half, is divided into 3 groups at random.24h clipper and cream removing rat back about (4 × 4) cm that sheds before experiment
2hair, each group rat presses 2 × 2cm at depilation position
2/ only paste corresponding tested material, fix with not sensitization medical proof fabric.Inject the carrageenin 1ml of 1% concentration in every whole sole of the foot of Rat Right to ankle joint direction, after injection respectively at 30min, 1h, 2h, 3h, 4h slide gauge at same Site Determination rat left and right metapedes vola thickness, be calculated as follows swelling:
Thickness × 100% is slapped fully in swelling=(right side is slapped thickness-left side fully and slapped thickness fully)/left side
Calculate and often organize average swelling, and be calculated as follows inhibitory rate of intumesce, carry out statistical analysis: inhibitory rate of intumesce=[(the average swelling of bare substrate group-average swelling of administration the group)/average swelling of bare substrate group] × 100%.
Result shows, and causes rat paw edema experiment for carrageenin, embodiment 1-4 and bare substrate is obvious has strong inhibitory action (p < 0.01); Embodiment 1-3 does not have significant difference (p >=0.05) compared with commercially available flurbiprofen Babu cream (Japanese three large bamboo hat with a conical crown and broad brim Pharmaceutical Co., Ltd), and show equal inhibitory action, embodiment 4 has equal or more obvious inhibition.
Be described in detail specific embodiments of the invention above, but it is just as example, the present invention is not restricted to specific embodiment described above.To those skilled in the art, any equivalent modifications that the present invention is carried out and substituting also all among category of the present invention.Therefore, equalization conversion done without departing from the spirit and scope of the invention and amendment, all should contain within the scope of the invention.
Claims (10)
1. a flurbiprofen hydrogel plaster, it is characterized in that, comprise the anti-mucosa on backing, mastic and described mastic surface, described mastic constituent comprises flurbiprofen and aqueous gel substrate, is prepared into hydrophilic transdermal absorbable preparation through hydrogel plaster moulding process; Wherein, in described mastic, the content of flurbiprofen is 0.1-3wt%; Surplus is aqueous gel substrate;
The constituent of described aqueous gel substrate, with aqueous gel substrate gross weight for benchmark, comprising:
Hydrophilic basis material 0.1-40wt%;
Cross-linking agent 0.01-2wt%;
Cross-linking regulator 0.01-4wt%;
Wetting agent 10-60wt%;
Solvent 10-85wt%.
2. flurbiprofen hydrogel plaster according to claim 1, is characterized in that, in described mastic, the content of flurbiprofen is 0.1-0.45wt%.
3. flurbiprofen hydrogel plaster according to claim 1, it is characterized in that, described hydrophilic basis material is hydrophilic high molecular material, be selected from cellulose and its derivates, synthesized polymer material, other come from the hydrophilic colloid of organism, polysaccharide, polypeptide or its hydrophilic derivatives one or more.
4. flurbiprofen hydrogel plaster according to claim 1, it is characterized in that, described cross-linking agent be selected from aluminium hydroxide, dihydroxyaluminum aminoacetate, aluminum chloride, aluminium citrate, synthetic aluminium silicate, dihydroxyaluminum aminoacetate, glutamic acid aluminum, any one or a few in aluminium potassium sulfate, calcium hydroxide, calcium chloride.
5. flurbiprofen hydrogel plaster according to claim 1, is characterized in that, described cross-linking regulator be selected from tartaric acid, citric acid, phosphoric acid, malic acid, edetic acid, gluconic acid or its salt any one or a few.
6. flurbiprofen hydrogel plaster according to claim 1, it is characterized in that, described transdermal penetration enhancer be selected from volatile oil, laurocapram, N-Methyl pyrrolidone, SA diethylester, diisopropyl adipate, isopropyl myristate, propylene glycol any one or a few.
7. flurbiprofen hydrogel plaster according to claim 1, it is characterized in that, described mastic also comprises surfactant.
8. according to the flurbiprofen hydrogel plaster in claim 1-7 described in any one, it is characterized in that, described mastic also comprises additive, and described additive is selected from one or more in solubilizing agent, antiseptic, viscosifier, filler, antioxidant, freshener or warming agent, spice.
9. a R-flurbiprofen composition, is characterized in that, comprises flurbiprofen and aqueous gel substrate; Wherein, the content of flurbiprofen is 0.1-3wt%; Surplus is aqueous gel substrate;
The constituent of described aqueous gel substrate, with aqueous gel substrate gross weight for benchmark, comprising:
Hydrophilic basis material 0.1-40wt%;
Cross-linking agent 0.01-2wt%;
Cross-linking regulator 0.01-4wt%;
Wetting agent 10-60wt%;
Solvent 10-85wt%.
10. compositions according to claim 9, is characterized in that, the content of described flurbiprofen is 0.1-0.45wt%.
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| CN113181141A (en) * | 2021-04-23 | 2021-07-30 | 杭州仁德医药有限公司 | Flurbiprofen gel plaster and preparation method thereof |
| CN113262216A (en) * | 2020-02-14 | 2021-08-17 | 北京泰德制药股份有限公司 | External preparation for eliminating skin surface red swelling and easing pain |
| CN114099474A (en) * | 2021-09-17 | 2022-03-01 | 杭州上禾健康科技有限公司 | Flurbiprofen gel, preparation process of gel plaster and coating machine |
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| 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 |
| CN106822065A (en) * | 2016-12-06 | 2017-06-13 | 北京茗泽中和药物研究有限公司 | A kind of flurbiprofen cataplasms |
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| CN113041236B (en) * | 2021-03-23 | 2023-03-10 | 广州新济药业科技有限公司 | Flurbiprofen cataplasm and preparation method thereof |
| CN113041236A (en) * | 2021-03-23 | 2021-06-29 | 广州新济药业科技有限公司 | Flurbiprofen cataplasm and preparation method thereof |
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