CN107951866A - Loxoprofen sodium patch - Google Patents
Loxoprofen sodium patch Download PDFInfo
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- CN107951866A CN107951866A CN201711274661.3A CN201711274661A CN107951866A CN 107951866 A CN107951866 A CN 107951866A CN 201711274661 A CN201711274661 A CN 201711274661A CN 107951866 A CN107951866 A CN 107951866A
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- Prior art keywords
- patch
- loxoprofen sodium
- emulsion
- tween
- lotion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Loxoprofen sodium patch, it is characterized in that the patch includes the lotion being coated on support layer, the percentage of weight formula of the lotion is as follows:4%~6% loxoprofen sodium, 4%~6% diethanol amine, 1.8~2.2% propane diols, 2.5~3.5% azone, 2.5~3.5% menthol, 0.5%~0.7% Tween 80,0.2~0.3% ascorbic acid, 0.2%~0.3% superfine silica gel powder and 0.2%~0.3% alumina powder, and the matrix prepared with emulsion-type polyacrylate pressure sensitive adhesive of surplus, the loxoprofen sodium area fraction of the patch is 0.6~1.0mg/cm2。
Description
Technical field
The present invention relates to loxoprofen sodium patch.
Background technology
Loxoprofen sodium (CAS:80382-23-6, Monosodium
2- { 4- [(2-oxocyclopentyl) methyl] phenyl } propanoatedihydrate, 2- [4- (2- oxygen
For pentamethylene -1- ylmethyls) phenyl] sodium propionate dihydrate) belong to phenylpropionic acid nonsteroidal anti-inflammatory drug, its molecular formula is as follows:
Loxoprofen sodium is succeeded in developing first by Japanese Sankyo Co., is listed in Japan within 1986, clinically can be wide
General anti-inflammatory and antalgic for rheumatoid arthritis, pain in the back, scapulohumeral periarthritis, neck shoulder wrist syndrome etc. etc..The external application of loxoprofen sodium
Preparation is mainly the one or three patch and cataplasm produced altogether, its specification is 100mg (in terms of loxoprofen)/2g lotions/10cm
× 14cm, its major auxiliary burden are as follows:As the atoleine of softening agent, as the alicyclic petroleum resin of adhesive, as base
The styrene-isoprene-styrene block copolymer (SIS) and polyisobutene of matter, and the silicic acid anhydride as adsorbent,
As the Menthol of aromatic, three fat of medium chain fatty acid as solvent and the two fourth hydroxyl first as antioxidant
Benzene.Patch easily allows user to produce skin mistake in itself using rubber matrix as pressure sensitive adhesive, but in actual use
Quick reaction, have impact on the compliance of patch.Development (Wang Fei, the Chongqing medical courses in general of Chinese document --- loxoprofen sodium transdermal patch
University's M Sc thesis, in May, 2012) disclose and a kind of use development of Acrylate Emulsion Pressure-Sensitive Adhesive to the addition of for matrix
The loxoprofen sodium patch of diethanol amine, azone and menthol, and point out it with good therapeutic effect and pierced without skin
Swash property.But traditional skin irritation test uses healthy animal model, but in actual use, due to loxoprofen sodium in itself
Belong to nonsteroidal anti-inflammatory drug, in its indication, the patient of the disease such as rheumatoid arthritis, scapulohumeral periarthritis is often inherently in
Among delayed type hypersensitivity, DTH, therefore in actual application, there are the contact dermatitis such as red swelling of the skin, itch, fash
Symptom is commonplace, therefore provides a kind of loxoprofen sodium that can reduce the skin irritation to delayed type hypersensitivity, DTH patient
The problem of patch becomes in the prior art urgently.
The content of the invention
To solve aforementioned technical problem, the present invention adopts the technical scheme that:
Loxoprofen sodium patch is provided, it is characterized in that the patch includes the lotion being coated on support layer, the cream
The percentage of weight formula of body is as follows:4%~6% loxoprofen sodium, 4%~6% diethanol amine, the third of 1.8~2.2%
Glycol, 2.5~3.5% azone, 2.5~3.5% menthol, 0.5%~0.7% Tween-80,0.2~0.3% it is anti-
Bad hematic acid, 0.2%~0.3% superfine silica gel powder and 0.2%~0.3% alumina powder, and surplus with emulsion-type poly- third
Matrix prepared by olefin(e) acid ester type pressure sensitive adhesive, the loxoprofen sodium area fraction of the patch is 0.6~1.0mg/cm2。
The loxoprofen sodium patch, it is characterized in that the Tween-80, ascorbic acid, superfine silica gel powder and aluminium oxide
Weight ratio is 2.3~2.6:0.9~1.1:0.9~1.1:0.9~1.1, the D90 particle diameters of the alumina powder are 5~10 μm.
The loxoprofen sodium patch, it is characterized in that the loxoprofen sodium area fraction of the patch for 0.75~
0.85mg/cm2。
The loxoprofen sodium patch, it is characterized in that the emulsion-type polyacrylate pressure sensitive adhesive is selected from YBJ-02 types
Medicinal acrylate emulsion-type pressure-sensitive.
The loxoprofen sodium patch, it is characterized in that the content of azone is 2.8%~3.2% in the lotion, it is thin
Lotus alcohol content is 2.8%~3.2%.
Present invention also offers the manufacture craft of the loxoprofen sodium patch, it is characterized in that comprising the following steps
1) loxoprofen sodium is scattered in propane diols, addition diethanol amine, after ultrasonic disperse, adds azone and peppermint
Alcohol continues ultrasonic disperse to uniformly obtaining mixed liquor (1);
2) ascorbic acid, superfine silica gel powder and alumina powder of recipe quantity are added in Tween-80, ultrasonic disperse is obtained to uniform
To mixed liquor (2),
3) mixed liquor (1) and mixed liquor (2) are separately added into emulsion-type polyacrylate pressure sensitive adhesive, are mixed and are stood to glue
It is coated in liquid after bubble-free on support layer, loxoprofen sodium patch is obtained after dry at 50 ± 2 DEG C.
Loxoprofen sodium patch provided by the invention, in the existing Luo Suo using development of Acrylate Emulsion Pressure-Sensitive Adhesive as matrix
On the basis of ibuprofen sodium patch, by increasing the auxiliary materials such as a small amount of Tween-80, ascorbic acid, superfine silica gel powder and aluminium oxide in prescription,
The skin irritation for the patch that can unexpectedly reduce.Compared with being added without the patch of above-mentioned a small amount of auxiliary material, the present invention carries
The patch of confession shows lower irritation, explanation in the skin irritation test to delayed hypersensitive reaction experimental animal
By optimization formulation, the incidence of side effects to tardy super quick patient can be reduced, so as to improve the compliance of preparation, and is contrasted
Experiment shows that the generation of the effect above, which is depended in prescription, increases a small amount of Tween-80, ascorbic acid, superfine silica gel powder and aluminium oxide
Deng the synergistic effect of auxiliary material, change any of Tween-80, ascorbic acid, superfine silica gel powder and aluminium oxide component or proportioning, its
The effect of the skin irritation of delayed hypersensitive reaction animal can be decreased obviously by reducing.
Embodiment
Loxoprofen sodium patch in the embodiment of the present invention is prepared in accordance with the following methods
1) loxoprofen sodium is scattered in propane diols, addition diethanol amine, after ultrasonic disperse 30min, adds azone
Continue ultrasonic disperse 30min to uniformly obtaining mixed liquor (1) with menthol;
2) ascorbic acid, superfine silica gel powder and alumina powder of recipe quantity are added in Tween-80, ultrasonic disperse is obtained to uniform
To mixed liquor (2),
3) mixed liquor (1) and mixed liquor (2) are separately added into emulsion-type polyacrylate pressure sensitive adhesive, are mixed and are stood to glue
Be coated in liquid after bubble-free on support layer, the dry 1h at 50 ± 2 DEG C, after obtain loxoprofen sodium patch.
In all embodiments and reference examples, the support layer that is made is stretch fabric, and the loxoprofen sodium is 2- [4- (2-
Oxo-cyclopentane -1- ylmethyls) phenyl] sodium propionate dihydrate, molecular formula is as follows
The D90 particle diameters of the alumina powder are 5~10 μm.The emulsion-type polyacrylate pressure sensitive adhesive is selected from YBJ-02
Type medicinal acrylate emulsion-type pressure-sensitive (is purchased from Tangshan Hua Chang medical sanitary dressing Industrial Co., Ltd.).The menthol is
Menthol.
The proportioning accounts for the weight percent content of lotion for each component, and the loxoprofen sodium area of obtained patch contains
Measure as 0.81mg/cm2(equivalent 0.714mg loxoprofens/cm2)
The formula of embodiment 1~6 see the table below
The formula of the reference examples 1~6 obtained after constituent part in 1~6 prescription of embodiment is adjusted see the table below (with reality
Apply 1~6 identical entry of example not arrange)
Compared with embodiment 1~6, by the patch to embodiment and comparative example into investigation, it is known that its uniformity of dosage units, release
Degree of putting, initial adhesion force, hold viscous force and peel strength and meet relevant regulations in two annex IV patches of Chinese Pharmacopoeia 2010 edition.
New zealand rabbit animal model skin irritation test of the Pharmacological Examples 1 to delayed type hypersensitivity, DTH
1st, experimental animal:New Zealand White Rabbit is selected, 2.0~2.5kg of weight, male and female are unlimited, every group 10.
2nd, model, model group potassium bichromate (K2Cr2O7) be immunized, every rabbit muscle injects 1%K2Cr2O7+ Fu Shi
Freund's complete adjuvant mixed liquor (volume ratio 1:1)0.5ml.It is continuous to inject 7d back with each 0.1ml of intracutaneous injection mixed liquor at the time-division 4
Portion K2Cr2O7/ 40% dimethyl sulphoxide solution applies skin.3rd week intramuscular injection 0.5%K2Cr2O7 solution 0. after injecting first
5ml is to strengthen hypersensitivity.
3rd, experimental method
Most of rabbit hair of backbone both sides is first cut after final injection with scissors, and the suede of skin surface is removed with depilatory cream
Hair, per side, depilation area is about 5cm × 7cm for backbone both sides.Normal raising was administered for one day in second day, and administration group patch is given in left side
Blank patch is given on agent, right side, and patch is removed after fixing 6h with nonirritant bandage and cleans administration skin with warm water.Even
Continue administration 7d, and the erythema and oedema feelings of skin surface is administered in observation in 6,24,48 and 72h small after last time is administered
Condition, to investigate skin irritation as index situations such as skin surface erythema and oedema.
Packet see the table below with administrations
Blank patch is the blank patch (being not added with loxoprofen sodium) made according to 1 prescription of embodiment, and blank group both sides are equal
Stick blank patch, commercially available patch for the one or the three loxoprofen sodium patch produced altogether (Chinese medicines quasi-word J20150124, trade name,
Happy pine, specification is 100mg loxoprofens/10cm × 14cm).
Standards of grading are referring to following table
The skin irritation average score (being added scores of erythema with oedema scoring) of each group is as follows after the last administration
Test result indicates that for delayed hypersensitive reaction animal, commercially available loxoprofen sodium patch is also shown slightly
Stimulation row, and use 1~6 patch of the embodiment of the present invention experimental group 1~6 without obvious skin irritation, experimental group 7
The patch of~12 comparative examples 1~6 used, its skin irritation illustrate what is used in embodiment apparently higher than experimental group 1~6
The auxiliary materials such as Tween-80, ascorbic acid, superfine silica gel powder and aluminium oxide generate synergistic effect, reduce the irritation of patch, make it
It is particularly suitable for the use to tardy super quick type patient.
Claims (6)
1. loxoprofen sodium patch, it is characterized in that the patch includes the lotion being coated on support layer, the weight of the lotion
Percentage formula is as follows:4%~6% loxoprofen sodium, 4%~6% diethanol amine, 1.8~2.2% propane diols, 2.5
~3.5% azone, 2.5~3.5% menthol, 0.5%~0.7% Tween-80,0.2~0.3% ascorbic acid,
0.2%~0.3% superfine silica gel powder and 0.2%~0.3% alumina powder, and surplus with emulsion-type polyacrylate
Matrix prepared by pressure sensitive adhesive, the loxoprofen sodium area fraction of the patch is 0.6~1.0mg/cm2。
2. loxoprofen sodium patch as claimed in claim 1, it is characterized in that the Tween-80, ascorbic acid, superfine silica gel powder and
The weight ratio of aluminium oxide is 2.3~2.6:0.9~1.1:0.9~1.1:0.9~1.1, the D90 particle diameters of the alumina powder are 5
~10 μm.
3. loxoprofen sodium patch as claimed in claim 1, it is characterized in that the loxoprofen sodium area fraction of the patch is
0.75~0.85mg/cm2。
4. loxoprofen sodium patch as claimed in claim 1, it is characterized in that the emulsion-type polyacrylate pressure sensitive adhesive selects
From YBJ-02 type medicinal acrylate emulsion-type pressure-sensitives.
5. loxoprofen sodium patch as claimed in claim 1, it is characterized in that in the lotion content of azone for 2.8%~
3.2%, menthol content is 2.8%~3.2%.
6. the manufacture craft of loxoprofen sodium patch as described in Claims 1 to 5 is any, it is characterized in that comprising the following steps
1) loxoprofen sodium is scattered in propane diols, adds diethanol amine, after ultrasonic disperse, add azone and menthol after
Continuous ultrasonic disperse is to uniformly obtaining mixed liquor (1);
2) ascorbic acid, superfine silica gel powder and alumina powder of recipe quantity are added in Tween-80, ultrasonic disperse is to uniformly being mixed
Close liquid (2);
3) mixed liquor (1) and mixed liquor (2) are separately added into emulsion-type polyacrylate pressure sensitive adhesive, are mixed and are stood into glue
It is coated on after bubble-free on support layer, loxoprofen sodium patch is obtained after dry at 50 ± 2 DEG C.
Priority Applications (1)
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CN201711274661.3A CN107951866A (en) | 2017-12-06 | 2017-12-06 | Loxoprofen sodium patch |
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CN201711274661.3A CN107951866A (en) | 2017-12-06 | 2017-12-06 | Loxoprofen sodium patch |
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CN107951866A true CN107951866A (en) | 2018-04-24 |
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CN201711274661.3A Withdrawn CN107951866A (en) | 2017-12-06 | 2017-12-06 | Loxoprofen sodium patch |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113069437A (en) * | 2020-12-29 | 2021-07-06 | 北京湃驰泰克医药科技有限公司 | External gel emplastrum containing loxoprofen and medicinal salt thereof and preparation method thereof |
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JP2008100939A (en) * | 2006-10-18 | 2008-05-01 | Nichiban Co Ltd | Percutaneous absorption preparation having little skin irritation |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113069437A (en) * | 2020-12-29 | 2021-07-06 | 北京湃驰泰克医药科技有限公司 | External gel emplastrum containing loxoprofen and medicinal salt thereof and preparation method thereof |
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Application publication date: 20180424 |