CN106267245A - A kind of gel combination, patch and preparation method thereof - Google Patents
A kind of gel combination, patch and preparation method thereof Download PDFInfo
- Publication number
- CN106267245A CN106267245A CN201610843594.1A CN201610843594A CN106267245A CN 106267245 A CN106267245 A CN 106267245A CN 201610843594 A CN201610843594 A CN 201610843594A CN 106267245 A CN106267245 A CN 106267245A
- Authority
- CN
- China
- Prior art keywords
- transparent carrier
- gel combination
- patch
- described transparent
- carrier
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 239000000758 substrate Substances 0.000 claims abstract description 18
- 239000000499 gel Substances 0.000 claims description 66
- 239000000203 mixture Substances 0.000 claims description 20
- 239000000853 adhesive Substances 0.000 claims description 19
- 230000001070 adhesive effect Effects 0.000 claims description 19
- 238000007789 sealing Methods 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 12
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical group COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 12
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 claims description 11
- -1 tragakanta Polymers 0.000 claims description 11
- HSHXDCVZWHOWCS-UHFFFAOYSA-N N'-hexadecylthiophene-2-carbohydrazide Chemical compound CCCCCCCCCCCCCCCCNNC(=O)c1cccs1 HSHXDCVZWHOWCS-UHFFFAOYSA-N 0.000 claims description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 239000000080 wetting agent Substances 0.000 claims description 9
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 8
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 8
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- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 8
- QIGBRXMKCJKVMJ-UHFFFAOYSA-N Hydroquinone Chemical compound OC1=CC=C(O)C=C1 QIGBRXMKCJKVMJ-UHFFFAOYSA-N 0.000 claims description 7
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- 239000011796 hollow space material Substances 0.000 claims description 6
- KMUONIBRACKNSN-UHFFFAOYSA-N potassium dichromate Chemical compound [K+].[K+].[O-][Cr](=O)(=O)O[Cr]([O-])(=O)=O KMUONIBRACKNSN-UHFFFAOYSA-N 0.000 claims description 6
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 6
- OOCCDEMITAIZTP-QPJJXVBHSA-N (E)-cinnamyl alcohol Chemical compound OC\C=C\C1=CC=CC=C1 OOCCDEMITAIZTP-QPJJXVBHSA-N 0.000 claims description 4
- ZRMMVODKVLXCBB-UHFFFAOYSA-N 1-n-cyclohexyl-4-n-phenylbenzene-1,4-diamine Chemical compound C1CCCCC1NC(C=C1)=CC=C1NC1=CC=CC=C1 ZRMMVODKVLXCBB-UHFFFAOYSA-N 0.000 claims description 4
- GLZPCOQZEFWAFX-UHFFFAOYSA-N Geraniol Chemical compound CC(C)=CCCC(C)=CCO GLZPCOQZEFWAFX-UHFFFAOYSA-N 0.000 claims description 4
- 239000002390 adhesive tape Substances 0.000 claims description 4
- 125000003118 aryl group Chemical group 0.000 claims description 4
- WSFSSNUMVMOOMR-UHFFFAOYSA-N formaldehyde Natural products O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims description 4
- 150000002596 lactones Chemical class 0.000 claims description 4
- LGQLOGILCSXPEA-UHFFFAOYSA-L nickel sulfate Chemical compound [Ni+2].[O-]S([O-])(=O)=O LGQLOGILCSXPEA-UHFFFAOYSA-L 0.000 claims description 4
- 229910000363 nickel(II) sulfate Inorganic materials 0.000 claims description 4
- 239000003960 organic solvent Substances 0.000 claims description 4
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- 239000011593 sulfur Substances 0.000 claims description 4
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- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 claims description 3
- UTGQNNCQYDRXCH-UHFFFAOYSA-N N,N'-diphenyl-1,4-phenylenediamine Chemical compound C=1C=C(NC=2C=CC=CC=2)C=CC=1NC1=CC=CC=C1 UTGQNNCQYDRXCH-UHFFFAOYSA-N 0.000 claims description 3
- RSWGJHLUYNHPMX-ONCXSQPRSA-N abietic acid Chemical compound C([C@@H]12)CC(C(C)C)=CC1=CC[C@@H]1[C@]2(C)CCC[C@@]1(C)C(O)=O RSWGJHLUYNHPMX-ONCXSQPRSA-N 0.000 claims description 3
- GVPFVAHMJGGAJG-UHFFFAOYSA-L cobalt dichloride Chemical compound [Cl-].[Cl-].[Co+2] GVPFVAHMJGGAJG-UHFFFAOYSA-L 0.000 claims description 3
- 229940097267 cobaltous chloride Drugs 0.000 claims description 3
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- 239000001923 methylcellulose Substances 0.000 claims description 3
- 235000010981 methylcellulose Nutrition 0.000 claims description 3
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 3
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 3
- 229960003415 propylparaben Drugs 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- OWRCNXZUPFZXOS-UHFFFAOYSA-N 1,3-diphenylguanidine Chemical compound C=1C=CC=CC=1NC(=N)NC1=CC=CC=C1 OWRCNXZUPFZXOS-UHFFFAOYSA-N 0.000 claims description 2
- CBCKQZAAMUWICA-UHFFFAOYSA-N 1,4-phenylenediamine Chemical compound NC1=CC=C(N)C=C1 CBCKQZAAMUWICA-UHFFFAOYSA-N 0.000 claims description 2
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- QHPQWRBYOIRBIT-UHFFFAOYSA-N 4-tert-butylphenol Chemical compound CC(C)(C)C1=CC=C(O)C=C1 QHPQWRBYOIRBIT-UHFFFAOYSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
- A61K49/0006—Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
Abstract
The present invention provides a kind of gel combination, patch and preparation method thereof, tests, for solving patch in prior art, the problem that cannot intuitively, quickly obtain testing result.The gel combination that the present invention provides, patch and preparation method thereof, gel combination is owing to using transparent substrate so that experimenter, generally in transparent state, is conveniently tested, and can observe testing result intuitively, rapidly by gel combination；Meanwhile, enable a physician to simply, carry out patch experiment efficiently, reduce patient's sense of discomfort in testing.
Description
Technical field
The present invention relates to diagnostic techniques field, in particular it relates to a kind of gel combination, patch and preparation method thereof.
Background technology
Contact hypersensitivity is one of Dermatology Clinic commonly encountered diseases, and it refers to that skin, mucosa expose or contact some thing
After matter, the allergic inflammation reaction mainly produced in contact site, cause tissue injury, referred to as contact dermatitis
(ACD).Contact dermatitis is as the most modal contact dermatitis type, generally by contact animal sources material
(secretions, venom, hair), botanical components (leaf, stem, flower, pollen, fruit) cause with chemical substance.Wherein chemical substance
It is to cause the topmost anaphylactogen of contact dermatitis, generally includes metal and goods, rubber, plastics, spice, cosmetics, food
Thing additive etc. itself or micromolecular compound contained by it.The clinical characters of contact dermatitis is fresh at generation edge, contact site
Bright infringement, the lighter is that edematous erythema, relatively severe one have pimple, water lump, big scar, more severe patient to have epidermolysis, even downright bad.
If finding to cause the material of patient's inflammatory reaction early, removing the cause of disease and suitably processing, contact dermatitis can speed heal,
Otherwise may be converted into eczema-like dermatitis.
Patient is carried out by contact dermatitis diagnosis and induction contact dermatitis anaphylactogen screening most straightforward approach exactly
Skin wrinkle is sturdy to be tested, and it is used clinically for diagnosing the existing over one hundred year history of contact dermatitis.
Patch experiment is to be placed on applicable carrier by anaphylactogen to be measured, is adhered to experimenter's skin by cohesive material
Skin surface, by inducing the IV allergic reaction type of patient artificially, as there is erythema, pimple, water with the skin of allergen exposure
The inflammatory reaction such as bleb, incrustation, then this material can induce experimenter's contact dermatitis, it may be determined that experimenter is to this material mistake
Quick, and then take measure targetedly.
Along with development and the raising of living standards of the people of society, people contact various chemical industry with natural prodcuts probability year by year
Increasing, the probability simultaneously contacting anaphylactogen contained therein is also increasing, and the sickness rate which results in contact dermatitis also presents
Ascendant trend.Find which kind of material can induce patient and produce scytitis, instruct patient to evade this material in life and work,
Reduce or be not in contact with it, it is to avoid the recurrence of scytitis and deterioration, being that prevention patient produces contact dermatitis the most directly, effectively
Measure.
Traditional patch experiment is with medical ventolin or distilled water as substrate, product to be measured or compound is carried out necessarily
Dilution, make into patch reagent by oneself and carry out patch experiment.The speckle Han contactant is prepared traditionally with medical ventolin substrate
Reagent transparency is low, is unfavorable for the observation of testing result, and is not suitable for some water solublity contactants；Simultaneously because
Vaseline is more greasy, easy pollution clothes when removing.
Summary of the invention
Solve the problems referred to above and be employed technical scheme comprise that a kind of gel combination, patch and preparation method thereof.
The gel combination that the present invention provides, includes by percentage to the quality:
Contactant: 0.01-20%；
Residuite: 0.5-50%；
Wetting agent: 1-30%；
Organic solvent: 0-80%；
The water of surplus.
Preferably, residuite: 0.5-20%；
Wetting agent: 5-20%.
Preferably, residuite: 2-10%；
Wetting agent: 10-15%.
Described residuite includes: polyvinylpyrrolidone, carbomer, methylcellulose, ethyl cellulose, hydroxypropyl
Cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, sodium polyacrylate, tragakanta, xanthan gum, gelatin, starch,
One or more in sodium alginate, chitosan；
Described wetting agent includes: one or more in glycerol, propylene glycol, sorbitol；
Described organic solvent includes one or more in acetone, ethanol；
Described contactant includes: potassium dichromate, p-phenylenediamine, Nipagin ester, Kazon, cobaltous chloride, nickel sulfate, pine
Perfume, aromatic, formaldehyde, bronopol, ethylendiamine dihydrochloride, thimerosal, mercaptobenzothiazoler, kappa mixture,
One in rubber composition, quart 15, p tert butylphenol formaldehyde resin, N-cyclohexyl sulfur peptide lactones, hydroquinone, epoxy resin
Or it is several.
Preferably, described Nipagin ester is in methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, butoben
One or more；
Described aromatic is amyl cinnamic aldehyde, cinnamyl alcohol, isoeugenol, geraniol, hydroxycitronellal, Cortex Cinnamomi
One or more in aldehyde, eugenol, oak moss extract；
Described kappa mixture is diphenylguanidine, (DDC)2Zn, dibutyl dithiocaarbamate
One or more in zinc；
Described rubber composition be N-isopropyl-N '-diphenyl-para-phenylene diamine, CPPD N cyclohexyl N' phenyl p phenylene diamine,
One or more in DPPD N,N' diphenyl p phenylene diamine.
Above-mentioned contactant content in gel combination is according to " cosmetic dermatosis diagnostic criteria and process former
Then general provisions " GB17149.1-1997, " the diagnosis general provisions of dermatergosis " GBZ18-2013, and SmartPractice with
Chemotechnique Diagnostics company commercialization patch reagent, and related experiment document and inventor test number
According to determining, under conditions of safely and effectively, determine corresponding content.
The present invention also provides for a kind of patch, including: there is the transparent substrate of adhesive faces and be arranged on described adhesive faces extremely
A few transparent carrier, described transparent carrier is used for carrying gel combination；
It is arranged on the sealing coat on described transparent carrier, described sealing coat and described transparent carrier and part not by transparent load
The adhesive faces contact that body covers.
Preferably, described transparent carrier includes: housing and be positioned at the hollow space within described housing；And it is arranged on described
The transparent slide of hollow space, described transparent slide is used for carrying gel combination；
Described sealing coat is release paper.
Preferably, described transparent carrier on described transparent substrate in matrix arrangements；
Described transparent carrier is polyvinyl chloride sheet and/or non-woven fabric plate；Described transparent substrate is medical adhesive tape；
Described transparent carrier is generally circular in shape, rectangle, square or polygon；
Distance 0.2-2cm between described transparent carrier；
The area of described transparent carrier is 0.2-5cm2；
Described outer width of frame 1-6mm；
Described housing thickness 0.05-3mm；
Described gel combination is 10-50 μ L at the consumption of described transparent slide.
Preferably, described housing is polyvinyl chloride sheet；Described transparent slide is non-woven fabric plate；
Distance 0.5-1.5cm between described transparent carrier；
The area of described transparent carrier is 0.6-3cm2；
Described outer width of frame 2-4mm；
Described housing thickness 0.1-1.5mm；
Described gel combination is 15-30 μ L at the consumption of described transparent slide.
Preferably, the area of described transparent carrier is 0.8-1cm2；
Described outer width of frame 2.5-3.5mm；
Described housing thickness 0.2-0.5mm；
Described gel combination is 20-25 μ L at the consumption of described transparent slide.
The present invention also provides for the preparation method of a kind of patch, comprises the following steps:
The adhesive faces of transparent substrate arranges at least one transparent carrier；
Described transparent carrier arranges sealing coat, described sealing coat and described transparent carrier and part not by transparent carrier
The adhesive faces contact covered, forms patch.
Preferably, be additionally included in sealing coat is set before by gel combination point sample step on described transparent carrier.
The gel combination that the present invention provides, patch and preparation method thereof, gel combination owing to using transparent substrate,
Make gel combination generally in transparent state, conveniently experimenter is tested, and inspection can be observed intuitively, rapidly
Survey result；Meanwhile, enable a physician to simply, carry out patch experiment efficiently, reduce patient's sense of discomfort in testing.
Accompanying drawing explanation
Fig. 1 is the picture that in embodiments of the invention 11, patch experiment carries out 0h.
Fig. 2 is that in embodiments of the invention 11, patch experiment carries out 48h picture.
Fig. 3 is that in embodiments of the invention 11, patch experiment removes the picture after speckle tries device.
Detailed description of the invention
For making those skilled in the art be more fully understood that technical scheme, below in conjunction with the accompanying drawings and specific embodiment party
The present invention is described in further detail by formula.
Gel combination and preparation method thereof is introduced below in conjunction with specific embodiment 1-8:
Its core procedure is:
1) contactant is dissolved in water and is configured to aqueous solution, or contactant is dissolved in organic solution is configured to
Organic solution；Above-mentioned process for preparation is that the dissolution properties according to contactant selects to make aqueous solution or organic solution.
2) gel-type vehicle, wetting agent, water are configured to gel；Described gel is mixed with described aqueous solution or organic solution
Close uniform, degassing, it is thus achieved that gel combination.
Component and constituent content needed for table 1 embodiment 1-8
The preparation of embodiment 1. thimerosal gel combination
Thimerosal (INN:Thiomersal), is a kind of organomercurial compound, and purposes is antibacterial and antifungal, is used for
Vaccine, skin test agent, the anticorrosion of the liquid such as liquid medicine of tatooing, be the common contactant of China.
Quality as described in table 1 weighs sodium carboxymethyl cellulose 0.75g, adds glycerol 2.5g, mix homogeneously, adds purified water
10g, stirs to all dissolving, and swelling 12h obtains sodium carboxymethyl cellulose gel.Weigh merthiolate 0.025g, be dissolved in 5g purification
In water, filter away insoluble matter.Potassium dichromate aqueous solution is joined in sodium carboxymethyl cellulose gel, add purified water to gross weight
Amount 25g, stirs, and de-bubbled obtains colorless transparent gel compositions.
Load in 10mL syringe, loading amount 5mL, obtain thimerosal gel.
The preparation of embodiment 2. Nipagin complex esters gel combination
Nipagin complex esters is a kind of broad spectrum activity efficient food preservative, is widely used in flavoring agent, cakestuffings in the world
The anti-corrosive fresh-keeping of the food such as material, Semen Arecae, milk product, bean product, meat products, beverage, fish product, fruit and vegerable.Nipagin ester series
Product has: methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, butoben, and they all have good antiseptic effect, are
The common contact allergy of China is former.
Quality as described in table 1 weighs hydroxypropyl methyl cellulose 0.5g, adds glycerol 3.75g, mix homogeneously, adds purification
Water 10g, stirs to all dissolving, obtains hydroxypropyl methyl cellulose gel.Weigh methyl hydroxybenzoate, methyl hydroxybenzoate, nipalgin
The each 0.75g of methyl ester, methyl hydroxybenzoate, is dissolved in 5g dehydrated alcohol, filters away insoluble matter.Nipagin complex esters alcoholic solution is added
Enter in hydroxypropyl methyl cellulose gel, add dehydrated alcohol ad pond om 25g, stir, de-bubbled, obtain water white transparency and coagulate
Glue composition.
Load in 10mL syringe, loading amount 5mL, obtain parabens gel.
The preparation of embodiment 3. cobaltous chloride gel combination
Compared with Example 1, differ only in and replace merthiolate with 0.25g cobalt chloride hexahydrate, use polyvinyl pyrrole
Alkanone 1g replaces sodium carboxymethyl cellulose, obtains pale red clear gel compositions.Other material, quality as described in table 1 claims
Take.
The preparation of embodiment 4. nickel sulfate gel combination
Compared with Example 1, differ only in and replace merthiolate with 1.25g six hydration nickel sulfate, use methylcellulose
Replace sodium carboxymethyl cellulose, obtain light green clear gel compositions.Other material, quality as described in table 1 weighs.
The preparation of embodiment 5. hydroquinone gel combination
Compared with Example 1, differ only in 0.25g substituting hydroquinone merthiolate, use hydroxypropyl methyl cellulose generation
For sodium carboxymethyl cellulose, obtain colorless transparent gel compositions.Other material, quality as described in table 1 weighs.
The preparation of embodiment 6. mercaptobenzothiazoler gel combination
Compared with Example 2, differ only in and replace Nipagin complex esters with 0.5g mercaptobenzothiazoler, use polyethylene pyrrole
Pyrrolidone 1g replaces hydroxypropyl methyl cellulose, replaces ethanol as solvent with acetone, obtains colorless transparent gel compositions.
The preparation of embodiment 7.N-cyclohexyl sulfur peptide lactones gel combination
Compared with Example 2, differ only in and replace Nipagin complex esters with 0.25gN-cyclohexyl sulfur peptide lactones, use first
Base cellulose replaces hydroxypropyl methyl cellulose, obtains colorless transparent gel compositions.Other material, as described in table 1, quality is carried out
Weigh.
The preparation of embodiment 8. Colophonium gel combination
Compared with Example 2, differ only in and replace Nipagin complex esters with 5g Colophonium, use hydroxypropyl methyl cellulose generation
For hydroxypropyl methyl cellulose, purified water consumption is 5g, obtains yellow transparent gel combination.Other material, quality as described in table 1
Weigh.
Specifying by under the 4th 0114 gel item of " Chinese Pharmacopoeia " version in 2015, gel typically should detect pH value.Skin
Skin surface p H is generally 4-7, average out to 5.75.The gel combination preparing above-described embodiment 1-8 carries out pH value detection.
Therefore, specify by under the 4th 0631pH pH-value determination pH method item of " Chinese Pharmacopoeia " version in 2015, to described in embodiment 1-8
Gel combination carries out detection detection for the first time；At 30 ± 2 DEG C, after placing 6 months under the conditions of relative humidity 65 ± 5%, carry out
Second time detection；The pH value of twice detection the results are shown in Table 1, its pH is all between 4-7, qualified.
The pH value testing result of gel combination in table 2 embodiment 1-8
Embodiment 9
The present embodiment provides a kind of patch, including: there is the transparent substrate of adhesive faces and be arranged on described adhesive faces extremely
A few transparent carrier, described transparent carrier is used for carrying gel combination；
It is arranged on the sealing coat on described transparent carrier, described sealing coat and described transparent carrier and part not by transparent load
The adhesive faces contact that body covers.
So due to patch, there is transparent substrate, transparent carrier and clear gel compositions so that patch removes isolation
After Ceng, testing result after being labelled on the skin of the experimenter, can be observed intuitively, rapidly；Meanwhile, enable a physician to simple, fast
Prompt carries out patch experiment, reduces patient's sense of discomfort in testing.
Preferably, transparent substrate can be transparent medical proof fabric, the most transparent medical hypoallergenic adhesive plaster.
Preferred described sealing coat is release paper, it should be appreciated that release paper can be selected commercially available, as long as can make
Patch is isolated, and will not damage patch when removing release paper.
Preferably, described transparent carrier includes: housing and be positioned at the hollow space within described housing；And it is arranged on described
The transparent slide of hollow space, described transparent slide is used for carrying gel combination；
Described transparent carrier is polyvinyl chloride sheet and/or non-woven fabric plate；Described transparent substrate is medical adhesive tape；Tool
Body ground, transparent carrier can be polyvinyl chloride sheet；Transparent slide can be non-woven fabric plate；It is to say, it is thin by polrvinyl chloride
Sheet forms housing, non-woven fabrics form transparent slide.
Preferably, described transparent carrier on described transparent substrate in matrix arrangements；It should be appreciated that transparent carrier can
To be configured according to the actual needs, form different shape, area and location intervals.
Specifically, described transparent carrier is generally circular in shape, rectangle, square or polygon；
Distance 0.2-2cm between preferred described transparent carrier；Distance between preferred described transparent carrier
0.5-1.5cm。
Preferably, the area of described transparent carrier is 0.2-5cm2；It is furthermore preferred that the area of described transparent carrier is 0.6-
3cm2；Most preferably, the area of described transparent carrier is 0.8-1cm2。
Preferably, described outer width of frame 1-6mm；It is furthermore preferred that described outer width of frame 2-4mm；Most preferably, described housing
Width 2.5-3.5mm.
Preferably, described housing thickness 0.05-3mm；It is furthermore preferred that described housing thickness 0.1-1.5mm；Most preferably,
Described housing thickness 0.2-0.5mm.
Preferably, described gel combination is 10-50 μ L at the consumption of described transparent slide.It is furthermore preferred that described gel
Compositions is 15-30 μ L at the consumption of described transparent slide.Most preferably, described gel combination is in the use of described transparent slide
Amount is 20-25 μ L.
Embodiment 10
The present embodiment provides a kind of patch and preparation method thereof, comprises the following steps:
1) at least one transparent carrier is set in the adhesive faces of transparent substrate；
Preferably, by gel combination point sample on described transparent carrier；
Specifically, polyvinyl chloride sheet is cut into interior length of side 0.8cm, the square of outer length of side 1.5cm, is pasted onto transparent
In the adhesive faces of medical low sensitive tape；Nonwoven carrier is cut into the square of length of side 0.8cm, is inlaid into polrvinyl chloride frame
In, it is pasted onto in the adhesive faces of transparent medical low sensitive tape, every piece of medical adhesive tape is stained with 10 groups of transparent carriers；Preferably,
By the gel combination point sample of preparation on described transparent carrier.
2) arranging sealing coat on described transparent carrier, described sealing coat and described transparent carrier and part be not by transparent load
The adhesive faces contact that body covers, forms patch.
Specifically, transparent carrier with transparent medical low sensitive tape adhesive faces cover strippable release paper, encapsulate shape
Become patch.
When the above-mentioned patch being to be understood that can also be prepared, point sample does not adds gel combination, when carrying out patch experiment,
Remove sealing coat, the gel combination needed for point sample addition.
Skin wrinkle is sturdy tests for the diagnosis of embodiment 11. contact dermatitis
Totally 40 example experimenter, 28 years old mean age, male 25 example, women 15 example, determine thimerosal allergy clinically
Contact dermatitis experimenter 20 example, as positive group；Non-thimerosal allergy experimenter 20 example, as negative group.
Use that embodiment 1 gel combination and embodiment 9 form can the patch of fluoroscopic observation dermoreaction be subject to above-mentioned
Examination person carries out patch experiment, amount of gel 20-25 μ L.Experimenter removes patch after sticking 48h, interpretation experiment knot in 72-96h
Really.Listed by basis for estimation table 3, phenomenon carries out classification to experimenter.
Table 3 patch experimental result
| Classification | Differentiate | Basis for estimation |
| - | Negative reaction | Skin is not any change |
| ？+ | Suspicious reaction | Only have slight erythema |
| + | Weak positive reaction | Erythema, infiltration, can there is a small amount of pimple |
| ++ | Strong positive reaction | Erythema, infiltration, pimple, vesicle |
| +++ | Extremely strong positive reaction | Erythema, infiltration substantially, can have a small amount of pimple, vesicle, bulla occur |
| IR | Irritative response | Erythema, eschar, edema |
| NT | Not test |
The result of table 3 shows:
In 20 example positive subjects, 11 examples are had to occur ++ above strong positive reaction, there are 8 example appearance+weak positive reactions, have 1
Example occurs？+ suspicious reaction；
In 20 example negative subject, 17 example appearance-negative reaction reactions, 3 examples occur？+ suspicious reaction.
Calculating patch experimental result:
Susceptiveness %=positive findings number/positive group number=(11+8)/20=95%
Specificity %=negative findings number/feminine gender group number=17/20=85%
The patch that the present invention provides, can intuitively observe subjects skin's change (Fig. 1 and Fig. 2) after sticking, and observe knot
Fruit with remove speckle examination device after result highly consistent.The patch of the present invention has high sensitivity (95%) and high specific
, and easy to use (85%), docile sense is good, waterproof can shower, do not affect normal learning life.
It is understood that the principle that is intended to be merely illustrative of the present of embodiment of above and the exemplary enforcement that uses
Mode, but the invention is not limited in this.For those skilled in the art, in the essence without departing from the present invention
In the case of god and essence, can make various modification and improvement, these modification and improvement are also considered as protection scope of the present invention.
Claims (12)
1. a gel combination, it is characterised in that include by percentage to the quality:
Contactant: 0.01-20%；
Residuite: 0.5-50%；
Wetting agent: 1-30%；
Organic solvent: 0-80%；
The water of surplus.
2. gel combination as claimed in claim 1, it is characterised in that
Residuite: 0.5-20%；
Wetting agent: 5-20%.
3. gel combination as claimed in claim 1, it is characterised in that
Residuite: 2-10%；
Wetting agent: 10-15%.
4. gel combination as claimed in claim 1, it is characterised in that described residuite includes: polyvinylpyrrolidine
Ketone, carbomer, methylcellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose,
One or more in sodium polyacrylate, tragakanta, xanthan gum, gelatin, starch, sodium alginate, chitosan；
Described wetting agent includes: one or more in glycerol, propylene glycol, sorbitol；
Described organic solvent includes one or more in acetone, ethanol；
Described contactant includes: potassium dichromate, p-phenylenediamine, Nipagin ester, Kazon, cobaltous chloride, nickel sulfate, Colophonium,
Aromatic, formaldehyde, bronopol, ethylendiamine dihydrochloride, thimerosal, mercaptobenzothiazoler, kappa mixture, rubber
One or several in mixture, quart 15, p tert butylphenol formaldehyde resin, N-cyclohexyl sulfur peptide lactones, hydroquinone, epoxy resin
Kind.
5. gel combination as claimed in claim 4, it is characterised in that described Nipagin ester is methyl hydroxybenzoate, Ni Bo
One or more in gold ethyl ester, propylparaben, butoben；
Described aromatic is amyl cinnamic aldehyde, cinnamyl alcohol, isoeugenol, geraniol, hydroxycitronellal, cinnamic aldehyde, fourth
One or more in fragrant phenol, oak moss extract；
Described kappa mixture is in diphenylguanidine, (DDC)2Zn, zinc dibutyl dithiocarbamate
One or more；
Described rubber composition be N-isopropyl-N '-diphenyl-para-phenylene diamine, CPPD N cyclohexyl N' phenyl p phenylene diamine, N, N '-
One or more in diphenyl-para-phenylene diamine.
6. a patch, it is characterised in that including: there is the transparent substrate of adhesive faces and be arranged at least the one of described adhesive faces
Individual transparent carrier, described transparent carrier is used for carrying gel combination；
Being arranged on the sealing coat on described transparent carrier, described sealing coat is not covered by transparent carrier with described transparent carrier and part
The adhesive faces contact of lid.
7. patch as claimed in claim 6, it is characterised in that described transparent carrier includes: housing and be positioned at described housing
The hollow space in portion；And it being arranged on the transparent slide of described hollow space, described transparent slide is used for carrying gel combination；
Described sealing coat is release paper.
8. patch as claimed in claim 7, it is characterised in that described transparent carrier on described transparent substrate in matrix cloth
Put；
Described transparent carrier is polyvinyl chloride sheet and/or non-woven fabric plate；Described transparent substrate is medical adhesive tape；
Described transparent carrier is generally circular in shape, rectangle, square or polygon；
Distance 0.2-2cm between described transparent carrier；
The area of described transparent carrier is 0.2-5cm2；
Described outer width of frame 1-6mm；
Described housing thickness 0.05-3mm；
Described gel combination is 10-50 μ L at the consumption of described transparent slide.
9. patch as claimed in claim 8, it is characterised in that
Described housing is polyvinyl chloride sheet；Described transparent slide is non-woven fabric plate；
Distance 0.5-1.5cm between described transparent carrier；
The area of described transparent carrier is 0.6-3cm2；
Described outer width of frame 2-4mm；
Described housing thickness 0.1-1.5mm；
Described gel combination is 15-30 μ L at the consumption of described transparent slide.
10. patch as claimed in claim 9, it is characterised in that
The area of described transparent carrier is 0.8-1cm2；
Described outer width of frame 2.5-3.5mm；
Described housing thickness 0.2-0.5mm；
Described gel combination is 20-25 μ L at the consumption of described transparent slide.
The preparation method of 11. 1 kinds of patches, it is characterised in that comprise the following steps:
The adhesive faces of transparent substrate arranges at least one transparent carrier；
Arranging sealing coat on described transparent carrier, described sealing coat is not covered by transparent carrier with described transparent carrier and part
Adhesive faces contact, formed patch.
The preparation method of 12. patches as claimed in claim 11, it is characterised in that being additionally included in before arranging sealing coat will be solidifying
Glue composition point sample step on described transparent carrier.
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| CN109999205A (en) * | 2019-02-28 | 2019-07-12 | 北京三立慧评化妆品科技有限公司 | Gel combination, patch and its application |
| CN110018161A (en) * | 2019-02-28 | 2019-07-16 | 北京三立慧评化妆品科技有限公司 | The detection method of the irritating detection method of cosmetic material and the anti-irritation of anti-irritant product |
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| CN103480005A (en) * | 2012-06-11 | 2014-01-01 | 浙江我武生物科技股份有限公司 | Dermatitis diagnostic patch and preparation method thereof |
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| CN106924760A (en) * | 2017-03-29 | 2017-07-07 | 三明市和众生物技术有限公司 | A kind of Skin photosensitization patch test diagnosis base composition and preparation method thereof |
| CN109999205A (en) * | 2019-02-28 | 2019-07-12 | 北京三立慧评化妆品科技有限公司 | Gel combination, patch and its application |
| CN110018161A (en) * | 2019-02-28 | 2019-07-16 | 北京三立慧评化妆品科技有限公司 | The detection method of the irritating detection method of cosmetic material and the anti-irritation of anti-irritant product |
| CN109999205B (en) * | 2019-02-28 | 2022-02-11 | 三立慧评(北京)检测技术有限公司 | Gel composition, spot patch and application thereof |
| CN113101378A (en) * | 2021-04-13 | 2021-07-13 | 黑龙江省医院 | Cosmetic allergen detection method and allergen patch kit |
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