CN103480005A - Dermatitis diagnostic patch and preparation method thereof - Google Patents
Dermatitis diagnostic patch and preparation method thereof Download PDFInfo
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- CN103480005A CN103480005A CN201210190082.1A CN201210190082A CN103480005A CN 103480005 A CN103480005 A CN 103480005A CN 201210190082 A CN201210190082 A CN 201210190082A CN 103480005 A CN103480005 A CN 103480005A
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- nickel sulfate
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Abstract
The invention discloses a dermatitis diagnostic patch and a preparation method thereof. The dermatitis diagnostic patch comprises a gel layer containing nickel sulfate, a carrier, and a viscous material.
Description
Technical field
The invention belongs to the biochemical technology field, be specifically related to a kind of dermatitis diagnosis patch and preparation method thereof.
Background technology
Contact dermatitis refers to that skin is due to the contact external substance, the inflammatory reaction occurred as metal, cosmetics and medicine etc., and the antigenicity power of its clinical symptoms and contactant and the sensitivity of individual body constitution are relevant.The lighter only shows vasodilation, congestive erythema and edema, and pimple, vesicle, bulla occur in severe one on the erythema basis, sample Epidermal necrosis, the common obscure boundary of skin lesion even occur scalding.The material that can cause contact dermatitis has a lot, and some material shows as sensitization when low concentration, and irritant and toxicity when high concentration can be divided three classes by its character: the first kind, animality source: zootoxin, insecticide secretions, poison hair etc.; Equations of The Second Kind, vegetalitas source: pollen, leaves of plants, stem, flower and fruit etc.; The 3rd class, chemical substance: be also the main sensitinogen that causes contact dermatitis, mainly comprise metal and goods thereof, plastics, rubber and spice etc.
Usually the contact dermatitis of saying refers to allergic contact dermatitis, is that body enters a kind of adaptive immunity reaction of the chemical substance in body to seeing through skin, belongs to the IV allergic reaction type.It is divided into two stages: initial sensitization stage and excitation phase subsequently.In the initial sensitization stage, enter the micromolecule hapten material (molecular weight is generally less than 500Da) in body, be combined with the memebrane protein of epidermis cell and form complete antigen as paint, fuel, pesticide, cosmetics and some drugs (sulfanilamide and penicillin) etc., through antigen presenting cell (as Langerhans cell) " picked-up " and by being offered the cell to T, make its activation and be divided into the effector T cell of allergen specificity.Excitation phase: if by the body of sensitization again the contact allergy principle show the skin allergic reaction symptom, i.e. allergic contact dermatitis symptom.Clinical symptoms: redness, erythra, vesicle appear in local skin, and exfoliative dermatitis can appear in severe patient.Reaction mechanism: this is a kind of T cellullar immunologic response reaction of antigen induction, body contacts corresponding sensitinogen after by sensitization again, T cells with antigenic specificity is activated and recruits to the sensitization position, Skin Cell and the effector T cell release cells factor, chemotactic factor and cytotoxin, cause that local vascular stimulates, macrophage and oxyphil cell's gathering and cascade iodine subsequently.Even allergic contact dermatitis patient contacts the chemical substance of low dosage very or routine use dosage, obvious dermatitis symptom can occur, itself can not constitute a threat to the chemical substance of these low dosages to human body, the overreaction that is on the contrary body has damaged human body autologous tissue, affects the normal work of patient and life.
Data show that the incidence rate to the Contact hyper sensitization of specific sensitinogen is different between country variant, and along with surrounding and social development and change, to the incidence rate of the Contact hyper sensitization of specific sensitinogen, also can change thereupon.In surrounding, the kind of sensitinogen (for example depends primarily on weather, the chromium allergy of Nigeria is mainly because the warmer climate people often wear due to leather sandals), occupation (for example, in the farm hand of India, contact dermatitis is due to guayule allergy), cultural practices (for example, wear jewelry and easily cause nickel allergy) and legislation (for example, the regulation and control of Denmark to nickel) etc.Therefore, to the epidemiology statistics data of Contact hyper sensitization, can be subject to time and regional limitation, and can change along with the variation of time and these deciding factors of area.
Use clinically the patch test diagnosis of allergic contact dermatitis that the history of more than 100 year has been arranged, its diagnosis mechanism is exactly the IV allergic reaction type that brings out artificially the autopath, causes the obvious skin lesion of skin surface, thereby the judgement patient is to which kind of material allergy.The tradition patch test is that the clinician uses vaseline or distilled water etc. to do dilution substrate self-control patch product to be detected.Along with increasing chemical products are applied to every field, daily life contacts various sensitizers probability with people in working environment is increasing, so the sickness rate of allergic skin disease is progressively rising.Finding sensitinogen by patch test, determine and instruct itself and clinical dependency the patient to avoid contacting such material, thereby avoid recurrence and the deterioration of allergic skin disease, is the important measures of Polyglucan contact dermatitis.
Various countries, according to national situation, by the investigation and analysis to common sensitinogen in surrounding and daily life, are combined into a set of patch test standard allergen series, wherein extensive with European standard allergen series and North America standard allergen serial application.European standard allergen series contains 26 kinds and detects anaphylactogen, and North America standard allergen series contains 24 kinds and detects anaphylactogen.In these two standard allergen series, some antigen is identical, and some antigen is different because of regional difference, and China there is no standard allergen series at present.Therefore, series is detected in the urgent need to formulating the contact dermatitis allergen that is applicable to China's national situation in this area, and prepares the dermatitis diagnosis patch of corresponding allergen kind.
Nickel sulfate is one of common anaphylactogen of contact dermatitis in China, the common contact dermatitis patient who causes because of nickel sulfate allergy clinically, therefore, the dermatitis diagnosis patch that preparation contains nickel sulfate, carry out early diagnosis and impel the patient strictly to avoid the contact again of anaphylactogen just to seem particularly urgent.
Summary of the invention
The present invention aims to provide a kind of dermatitis diagnosis patch.
In a first aspect of the present invention, a kind of dermatitis diagnosis patch is provided, described patch comprises:
One gel layer that contains nickel sulfate;
One carrier; With
One cohesive material.
In another preference, described dermatitis is contact dermatitis.Specifically, described dermatitis refers to the allergic contact dermatitis caused by the IV allergic reaction type.
In another preference, the described gel layer that contains nickel sulfate comprises nickel sulfate, becomes membrane matrix and solvent; More preferably the described gel layer that contains nickel sulfate is by nickel sulfate, one-tenth membrane matrix and solvent composition.
In another preference, described one-tenth membrane matrix is polyvidone, and more preferably 30 POVIDONE K 30 BP/USP 90.
In another preference, the combination that described solvent is purified water and dehydrated alcohol.
In another preference, when the described gel layer that contains nickel sulfate of preparation, in preparation film forming liquid, the mass ratio of described polyvidone and described solvent is preferably 1:4-1:20, and that better is 1:5-1:15, and that best is 1:9; The combination of the preferred purified water of described solvent and dehydrated alcohol, the mass ratio of described purified water and described dehydrated alcohol is preferably 1:1-5:1, and that better is 2:1-4:1, and that best is 3:1.
In another preference, the thickness of the described gel layer that contains nickel sulfate is 1-50 μ m, and more preferably 2-30 μ m, most preferably be 3-10 μ m.
In another preference, the area of the described gel layer that contains nickel sulfate is 0.5-14cm
2, 0.7-3cm more preferably
2, most preferably be 0.8-1cm
2.
In another preference, the described gel layer that contains nickel sulfate be shaped as the shape with corner angle; More preferably square or rectangle.
In another preference, the square that the described gel layer that contains nickel sulfate is 0.9cm * 0.9cm.
In another preference, at least one carrier of dermatitis diagnosis patch is fixed on cohesive material, is covered with the gel layer that contains nickel sulfate at least one carrier.
In another preference, described carrier material is polrvinyl chloride.
In another preference, described cohesive material is medical adhesive tape; More preferably, described medical adhesive tape mainly is comprised of non-woven fabrics and medical pressure-sensing glue material.
In another preference, the area of described carrier is 0.5-14cm
2, 0.7-3cm more preferably
2, most preferably be 0.8-1cm
2.
In another preference, described carrier be shaped as the shape with corner angle; More preferably square or rectangle.
In another preference, the square that described carrier is 0.9cm * 0.9cm.
In another preference, the area of described carrier is more than or equal to the area of the described gel layer that contains nickel sulfate.
In another preference, the described gel layer that contains nickel sulfate is identical with the shape of described carrier, area equates, and both fully overlap and be close together.
In another preference, be coated with release paper on the described gel layer that contains nickel sulfate, the part of described release paper contacts and fixes with described cohesive material; Preferred described release paper is release paper.
In another preference, in the described gel layer that contains nickel sulfate, the concentration of nickel sulfate is calculated as 20-100 μ g/cm with nickel
2.
In another preference, in the described gel layer that contains nickel sulfate, the concentration of nickel sulfate is calculated as 40-50 μ g/cm with nickel
2; 45 μ g/cm more preferably
2.
In another preference, described nickel sulfate is selected from anhydrous nickel sulfate, six hydration nickel sulfate, single nickel salts.
In a second aspect of the present invention, a kind of preparation method of dermatitis diagnosis patch provided by the invention as above is provided, described method comprises step:
(1), by solvent, nickel sulfate with become membrane matrix to mix, dissolve, obtain film forming liquid after bubble removing;
(2) film forming liquid is filmed on carrier, drying, make on carrier to be covered with the gel layer that contains nickel sulfate; With
(3) section, be assembled on cohesive material, obtains dermatitis diagnosis patch provided by the invention as above.
In another preference, in step (1), the mass ratio of described one-tenth membrane matrix and solvent is 1:4-1:20; 1:5-1:15 more preferably; Most preferably be 1:9; The quality of described nickel sulfate is generally described solvent and the 1%-10% that becomes membrane matrix quality sum, and more preferably 2%-5%, most preferably be 3%-4%.
In another preference, described nickel sulfate is selected from anhydrous nickel sulfate, six hydration nickel sulfate, single nickel salts.
In another preference, described one-tenth membrane matrix is polyvidone, and more preferably 30 POVIDONE K 30 BP/USP 90.
In another preference, the combination that described solvent is purified water and dehydrated alcohol.More preferably, the mass ratio of described purified water and described dehydrated alcohol is preferably 1:1-5:1, and that better is 2:1-4:1, and that best is 3:1.
In another preference, described carrier material is polrvinyl chloride.
In another preference, described cohesive material is medical adhesive tape.
In another preference, described medical adhesive tape mainly is comprised of non-woven fabrics and medical pressure-sensing glue material.
In another preference, in step (3), described section is that to be divided into area be 0.5-14cm by being covered with the carrier that contains the nickel sulfate gel layer
2, 0.7-3cm more preferably
2, most preferably be 0.8-1cm
2the shape with corner angle; Be more preferably square or rectangle.
In another preference, in step (3), described section is to be covered with the carrier that contains the nickel sulfate gel layer and to be divided into the square of 0.9cm * 0.9cm.
In another preference, in step (2), described coating thickness is 50-500 μ m; More preferably 70-200 μ m, most preferably be 100 μ m.
In another preference, the thickness of the described gel layer that contains nickel sulfate is 1-50 μ m, and more preferably 2-30 μ m, most preferably be 3-10 μ m.
In another preference, in the described gel layer that contains nickel sulfate, the concentration of nickel sulfate is calculated as 20-100 μ g/cm with nickel
2, 40-50 μ g/cm more preferably
2; Most preferably be 45 μ g/cm
2.
Accordingly, the invention provides a kind of dermatitis diagnosis patch that contains nickel sulfate, in order to carrying out early diagnosis, impel the patient strictly to avoid contacting again of anaphylactogen.
The specific embodiment
The inventor, through extensive and deep research, has found a kind of dermatitis diagnosis patch that contains nickel sulfate, and described patch is to be fixed on cohesive material by least one carrier, wherein, at least one described carrier, is covered with the gel layer that contains nickel sulfate.
The dermatitis diagnosis patch that contains nickel sulfate of the present invention is applied to patch test, but adopted " gel layer that contains nickel sulfate ", nickel sulfate distributes more even, and removed the difference sense that traditional speckle examination device brings to the patient, carrier also can reach the same partial closure's effect of same speckle examination device simultaneously.
Herein, " at least one " refers to that dermatitis diagnosis patch of the present invention can have a plurality of carriers, can be covered with respectively on it containing allergenic gel layer.Described allergen includes but not limited to, nickel sulfate, lanonol, polygynax, potassium dichromate, benzocaine, flavor compounds (comprises geraniol, hydroxycitronellal, cinnamic aldehyde, eugenol, the amyl group cinnamic aldehyde, isoeugenol, cinnamic alcohol or its combination), Colophonium, bisphenol A type epoxy resin, quinoline compound (comprises nioform, chlorquinaldol or its combination), Peruvian balsam, ethylenediamine, cobaltous chloride, budesonide, bacitracin, nickel sulfate, the p-tert-butylphenol formaldehyde resin, the p-Hydroxybenzoate compound (comprises methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate or its combination), the kappa compound (comprises 1,3-diphenylguanidine (DPG), diethyl-dithiocarbamate zinc (ZDC), dibutyl two sulfur ammonia zinc formate (ZBC) or its combinations), the black rubber compound (comprises N-isopropyl-N '-phenyl-p-phenylenediamine (PPD) (IPPD), N, N '-diphenyl-p-phenylenediamine (PPD) (DPPD), N-cyclohexyl-N '-phenyl-p-phenylenediamine (PPD) (CPPD) or its combination), quart 15, mercaptobenzothiazoler, p-phenylenediamine (PPD), formaldehyde, sulfhydryl compound (comprises cyclohexyl benzo thiazole sulfenamide (CBS), bisbenzothiazole disulphide (MBTS), morpholine plug mercaptobenzothiazoler (MOR) or its combination), thimerosal, thiuram compound (comprises tetramethylthiuram monosulfide (TMTM), tetramethylthiuram disulfide (TMTD), tetraethylthiuram disulfide (TETD), dipentamethylene thiuram disulfide (PTD) or its combination), imidazolidinyl urea, the diazonium imidazolidinyl urea, hydrocortisone butyrate, bronopol etc.
In a preferred embodiment of the present invention, the described gel layer that contains nickel sulfate comprises nickel sulfate, becomes membrane matrix and solvent.In a preferred embodiment, the described gel layer that contains nickel sulfate is by nickel sulfate, one-tenth membrane matrix and solvent composition.
As used herein, " nickel sulfate " (English name: Nickelous sulfate), three kinds of anhydride, six water things and seven water things are arranged.Preferred six water things.Two kinds of variants of α-type and β-type are arranged, and the former is blue cubic crystallization, and the latter is green monoclinic crystal.Lose six water of crystallization while being heated to 103 ° of C.Water-soluble, it is acid that aqueous solution is; Be soluble in alcohol and ammonia.
In certain areal extent, the area difference, even the accumulated dose of chemistry lifetime killer differs many times of several times to ten, but, as long as in unit are, the dosage (being described concentration of nickel sulfate of the present invention) of chemical sensitizer is consistent, the sensitization effect of human body skin do not had to difference.Therefore, the present invention in preferred embodiments, defines the concentration range of areal extent and the nickel sulfate of gel layer, can guarantee to detect effect.
As used herein, " contact dermatitis " is that body enters a kind of adaptive immunity reaction of the chemical substance in body to seeing through skin, belongs to the IV allergic reaction type.Its clinical characters is the infringement at generation edge, contact site distinctness, and the lighter is edematous erythema, than severe one, pimple, the even large scar of water lump is arranged, and more severe patient can have epidermolysis, even downright bad.
Carrier on dermatitis of the present invention diagnosis patch has when a plurality of, the interference for fear of contiguous different allergens to the testing result interpretation, and the spacing of adjacent carrier should be more than or equal to 0.2cm, preferably is more than or equal to 0.5cm, the better 1cm that is more than or equal to.
In the present invention, the nickel sulfate after dissolving evenly is blended in to for example, in polyvidone (30 POVIDONE K 30 BP/USP 90) drying and forming-film (gel layer), makes the anaphylactogen in gel layer be crystallization, micronize state, reach the highest uniformity and release.Described polyvidone is to be obtained by the vinyl pyrrolidone polymerization, English PVP, the molecular weight 5000-700000 of being called for short.Polyvidone is a kind of non-ionic macromolecule compound; it is a kind of synthesizing water-solubility macromolecular compound; general aspects with water-soluble high-molecular compound, colloid protective effect, film property, caking property, hygroscopicity, solubilising or cohesion, excellent solubility property and physiological compatibility.Polyvidone is white or milky, odorless or almost odorless, runny amorphous powder, and hygroscopicity is arranged.There is good dissolubility, water soluble, chloride kind solvent, ethanol, amine and low-molecular-weight fatty acid, compatible with most inorganic salts and various kinds of resin, be insoluble to ether and acetone.Polyvidone has good physiology inertia and biocompatibility, to skin, eyes, mucosa is non-stimulated or irritated, nontoxic (LD
50>13000mg/kg).It does not participate in the human body metabolism, has again good biocompatibility, and skin, mucosa, eye etc. are not formed to any stimulation, and skin, without anaphylaxis, is widely used as to the adjuvant of pharmaceutical preparation.
Polyvidone has K15, K25, K30, K60, K90 equal-specification by its mean molecule quantity, and the K value is larger, and molecular weight is larger, and different K values represents respectively corresponding polyvidone average molecular weight range.The K value is actually the eigenvalue relevant with the relative viscosity of polyvidone aqueous solution, and viscosity is the physical quantity relevant with molecular weight of high polymer, therefore can characterize by the K value mean molecule quantity of polyvidone.Usually the K value is larger, and its viscosity is larger, and cementability is stronger.In one embodiment of the invention, selected 30 POVIDONE K 30 BP/USP 90 as becoming membrane matrix.From embodiments of the invention 4, can find out, adopted 30 POVIDONE K 30 BP/USP 90 as becoming membrane matrix, film forming (gel layer) is effective, film (gel layer) uniform surface, and be difficult for demoulding (gel layer).
In the gel layer that contains nickel sulfate of the present invention, the concentration of described nickel sulfate is calculated with nickel, is preferably 20-100 μ g/cm
2, that better is 40-50 μ g/cm
2, that best is 45 μ g/cm
2.In a preferred embodiment, when the preparation gel layer that contains nickel sulfate of the present invention, in preparation film forming liquid, described polyvidone (preferably 30 POVIDONE K 30 BP/USP 90) is preferably 1:4-1:20 with the mass ratio of described solvent (the preferably combination of purified water and dehydrated alcohol), that better is 1:5-1:15, and that best is 1:9; The combination of the preferred purified water of described solvent and dehydrated alcohol, the mass ratio of described purified water and described dehydrated alcohol is preferably 1:1-5:1, and that better is 2:1-4:1, and that best is 3:1.The quality that described nickel sulfate (preferably six hydration nickel sulfate) adds is generally described solvent (the preferably combination of purified water and dehydrated alcohol) and the 1%-10% that becomes membrane matrix (preferred 30 POVIDONE K 30 BP/USP 90) quality sum, and more preferably 2%-5%, most preferably be 3%-4%.
In the present invention, the thickness of the described gel layer that contains nickel sulfate is generally 1-50 μ m, is preferably 2-30 μ m, and that better is 3-10 μ m.The area of the described gel layer that contains nickel sulfate is generally 0.5-14cm
2, be preferably 0.7-3cm
2, that better is 0.8-1cm
2.
Carrier of the present invention should not comprise any material that may stimulate the skin generation, and carrier can reach the partial closure effect identical with traditional speckle examination device.In a preferred embodiment of the invention, the material of described carrier is polrvinyl chloride.In addition, the shape for carrier does not have too many restriction, general consistent with the shape of the gel layer that contains nickel sulfate (both are close together).Yet the shape that irritant skin reaction focus presents is how identical with the support shapes touched, and the contact hypersensitivity erythra position really caused by anaphylactogen generally all presents circle, if select round carrier, easily obscures, and affects interpretation as a result.Therefore, the preferred square of shape of carrier and the gel layer that contains nickel sulfate on it or rectangle etc. are with the shape of corner angle.In one embodiment of the invention, selected the square of 0.9cm * 0.9cm.
Preferably in embodiment, on the described gel layer that contains nickel sulfate, also be coated with release paper at one, the part of described release paper contacts and fixes with described cohesive material.Mainly consider its sealing, do not react with nickel sulfate, do not adsorb nickel sulfate and affect its content when tearing off for the selection of release paper.In a better embodiment, described release paper is release paper.Described release paper (preferably release paper) is to remove before patch is applied to patient skin.
For the ease of preserving and transportation, dermatitis diagnosis patch of the present invention can seal preservation, preferably can seal and be stored in medical clad aluminum foil bag.In order to prevent the impact on described dermatitis diagnosis patch of air, moisture and light, suitably evacuation, add noble gas, or add desiccant (sheet) etc., and these are also well-known to those skilled in the art.
The present invention also provides a kind of method for preparing described dermatitis diagnosis patch, comprises the steps:
(1), by solvent, nickel sulfate with become membrane matrix to mix, dissolve, obtain film forming liquid after bubble removing;
(2) film forming liquid is filmed on carrier, drying, make on carrier to be covered with the gel layer that contains nickel sulfate;
(3) section, be assembled on cohesive material, obtains described dermatitis diagnosis patch.
At one, preferably in embodiment, described preparation method, comprise the steps:
1) prepare film forming liquid
By solvent, nickel sulfate with become membrane matrix to mix, dissolve, obtain film forming liquid after bubble removing.Wherein, described nickel sulfate is selected from anhydrous nickel sulfate, six hydration nickel sulfate, single nickel salts.The combination of the preferred purified water of described solvent and dehydrated alcohol, the mass ratio of described purified water and described dehydrated alcohol is preferably 1:1-5:1, and that better is 2:1-4:1, and that best is 3:1.Described polyvidone (preferably 30 POVIDONE K 30 BP/USP 90) is preferably 1:4-1:20 with the mass ratio of described solvent (the preferably combination of purified water and dehydrated alcohol), and that better is 1:5-1:15, and that best is 1:9.It is preferably 2%-5% with the 1%-10%(of described polyvidone (preferably 30 POVIDONE K 30 BP/USP 90) quality sum that the quality that described nickel sulfate (preferably six hydration nickel sulfate) adds is generally described solvent (the preferably combination of purified water and dehydrated alcohol), and that better is 3%-4%).In addition, mixing time is preferably more than at least 1 hour, more preferably more than 2 hours, most preferably more than 3 hours.For the method for bubble removing, can adopt standing (being generally 5-10 minute) bubble removing, centrifugal (being generally 5,000-10,000rpm, 5-10 minute) bubble removing, or evacuation bubble removing method etc.
2) film and drying
By film forming liquid on carrier, film, drying, make on carrier to be covered with the gel layer that contains nickel sulfate.To those skilled in the art, can use automatic film applicator operation coating device to film, also can use manual coating device to film.Wherein, described coating thickness is preferably 50-500 μ m, and more preferably 70-200 μ m, most preferably be 100 μ m.Preferably 0 ℃-60 ℃ of dry temperature, more preferably 20 ℃-40 ℃, also will be preferably 25 ℃-37 ℃; The preferred 40%-70% of humidity, more preferably 45%-65%; Preferred 10-60 minute of time, more preferably 20-60 minute, also want preferred 30-60 minute, most preferably 45 minutes.After drying and forming-film (gel layer that contains nickel sulfate), the thickness of the described gel layer that contains nickel sulfate is generally 1-50 μ m, is preferably 2-30 μ m, and that better is 3-10 μ m.
3) section and assembling
Section, be assembled on cohesive material, obtains described dermatitis diagnosis patch.Described section is that to be divided into area be 0.5-14cm by being covered with the carrier that contains the nickel sulfate gel layer
2, 0.7-3cm more preferably
2, most preferably be 0.8-1cm
2the shape with corner angle; Be more preferably square or rectangle.In one embodiment of the invention, selected the square of 0.9cm * 0.9cm.Finally, by being covered with the carrier that contains the nickel sulfate gel layer, for example be fixed in, on cohesive material (medical adhesive tape).Preferably, also be coated with release paper (for example release paper) on the described gel layer that contains nickel sulfate, the part of described release paper (for example release paper) contacts and fixes with described cohesive material.More preferably, can seal and be stored in medical clad aluminum foil bag.
It should be noted that, carrier on dermatitis of the present invention diagnosis patch (can be covered with respectively it on and contain different allergenic gel layers) has when a plurality of, when preparation dermatitis of the present invention diagnosis patch, comprise the steps: 1. to prepare respectively and contain different allergenic film forming liquid; 2. film forming liquid is filmed respectively on carrier, drying, make on carrier to be covered with and contain allergenic gel layer; 3. section, be contained in a plurality of vehicle group that contain the allergen gel layer that are covered with on cohesive material.Interference for fear of contiguous different allergens to the testing result interpretation, the spacing of adjacent carrier should be more than or equal to 0.2cm, preferably is more than or equal to 0.5cm, the better 1cm that is more than or equal to.
The above-mentioned feature that the present invention mentions, or the feature that embodiment mentions can combination in any.All features that this case description discloses can with any composition forms use, each feature disclosed in description, can anyly provide the alternative characteristics of identical, impartial or similar purpose to replace.Therefore except special instruction is arranged, the feature disclosed is only the general example of equalization or similar features.
Major advantage of the present invention is:
1, provide first the dermatitis diagnosis patch that contains nickel sulfate.
2, provide first the dermatitis that contains nickel sulfate diagnosis patch highly sensitive, high specificity.
3, provide first film (gel layer) uniform surface, and be difficult for the dermatitis that the contains nickel sulfate diagnosis patch of demoulding (gel layer).
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only are not used in and limit the scope of the invention for the present invention is described.The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition or the condition of advising according to manufacturer.Unless otherwise indicated, otherwise all percent, ratio, ratio or umber by weight.
Unit in percent weight in volume in the present invention is well-known to those skilled in the art, for example refers to the weight of solute in the solution of 100 milliliters.
Unless otherwise defined, the same meaning that all specialties of using in literary composition and scientific words and one skilled in the art are familiar.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.The use that better implementation method described in literary composition and material only present a demonstration.
The preparation of the dermatitis diagnosis patch that embodiment 1 contains nickel sulfate
(1) prepare film forming liquid
1. according to aforementioned proportion, take purified water, add six hydration nickel sulfate, be stirred to fully and dissolve;
2. add dehydrated alcohol again, slowly add while stirring 30 POVIDONE K 30 BP/USP 90, after sealing, stir about is 3 hours;
3. after dissolving fully, the standing, gas removal bubble, the nickel sulfate film forming solution.
(2) film and drying
Polyvinyl chloride hard sheet is affixed on the horizontal glass plate, confirms smooth without bubble.Glass plate is fixed on film applicator, 100 μ m coating devices are placed on polyvinyl chloride hard sheet, pour film forming liquid into, the operation film applicator.
The environment that the above-mentioned film coated is placed in to room temperature, humidity 45%-65% is dried to the not sticky mould release membrance in film surface and gets final product (approximately 45 minutes).
(3) section and assembling
The film prepared (gel layer that contains nickel sulfate) is close on polyvinyl chloride hard sheet, and it is cut into to the square diaphragm (being covered with the carrier that contains the nickel sulfate gel layer) of 0.9cm * 0.9cm together.
Above-mentioned 0.9cm * 0.9cm square diaphragm is fixed on the medical adhesive tape adhesive faces of (mainly being comprised of non-woven fabrics and medical pressure-sensing glue material), covers on it by the air-locked release paper of waterproof, and by medical clad aluminum foil bag enclosed package.
Embodiment 2 nickel ion (Ni
2+) detection of concentration (content)
Principle: in alkaline solution, under the condition that oxidant (Ammonium persulfate .) exists, nickel and developer (diacetyldioxime) form the soluble complexes of claret, at wavelength 465nm place, characteristic absorption peak are arranged, and utilize spectrophotomelric assay nickel ion (Ni for this character
2+) concentration (content).
(1) reagent preparation
A) 20% potassium sodium tartrate solution: take the 20g sodium potassium tartrate tetrahydrate, add after a small amount of purified water is dissolved and be settled to 100ml, mix.
B) 3% ammonium persulfate solution: take the 1.5g Ammonium persulfate., be settled to 50ml after adding a small amount of purified water to dissolve, mix.Keep in Dark Place, need preparation on the same day.
C) 5%NaOH solution: take 5g NaOH, be settled to 100ml after adding a small amount of purified water to dissolve, mix.
D) 1% diacetyldioxime solution: take the 0.5g diacetyldioxime, be settled to 50ml after adding a small amount of 5%NaOH solution to dissolve, mix.Need preparation on the same day.
(2) preparation of standard substance series concentration
Pipette nickel ion standard solution (1mg/ml) 1ml and, in the 25ml volumetric flask, by purified water, be diluted to scale.Mix rear getting respectively in 4ml, 3ml, 2ml, 1ml, 0.5ml to 10ml centrifuge tube, mend to 4ml by purified water.Standard substance (Ni
2+) series concentration is followed successively by 40 μ g/ml, 30 μ g/ml, 20 μ g/ml, 10 μ g/ml, 5 μ g/ml.
(3) preparation of need testing solution
Randomly draw 10 dermatitis that contain nickel sulfate of taking from embodiment 1 preparation and diagnose the nickel sulfate diaphragm (being covered with the carrier that contains the nickel sulfate gel layer) on patch, be placed in respectively the 5ml centrifuge tube, every adds the 2ml purified water, soak 1 hour, intermittent oscillation 2 times, each 10-15 second, make it to dissolve fully, i.e. test liquid.
(4) assay method
A) the accurate product series concentration solution of label taking and each 1.0ml of test liquid are in 15ml tool plug scale test tube.Take purified water as blank, do to process equally.
B) add respectively 20% potassium sodium tartrate solution 1.0ml, 5%NaOH solution 0.4ml, 3% ammonium persulfate solution 0.5ml, mix.
C) add again 1% diacetyldioxime solution 0.3ml, then add purified water 6.8ml, mix room temperature reaction 15-20 minute.
D) measure its absorbance with quartz colorimetric utensil in 465nm wavelength place.With blank school zero.
(5) result of the test
A) drawing standard curve
The absorbance that the standard substance series concentration solution of take detects is abscissa (x), and corresponding standard substance concentration is vertical coordinate (y), drawing standard curve y=ax+b.
B) calculate nickel ion (Ni
2+) concentration (content)
According to absorbance and the standard curve y=ax+b of test liquid, calculate nickel ion (Ni in test liquid
2+) concentration, and be converted into the nickel ion (Ni in single nickel sulfate diaphragm
2+) content.
C) testing result
Nickel ion (Ni in the single nickel sulfate diaphragm of result of calculation
2+) content be the meansigma methods that 36.75 μ g(10 time detects), i.e. in the dermatitis that the contains nickel sulfate diagnosis patch of embodiment 1 preparation, nickel ion (Ni in the gel layer that contains nickel sulfate
2+) concentration be 45.37 μ g/cm
2.(area of single diaphragm is 0.9cm * 0.9cm=0.81cm
2, therefore, nickel ion (Ni in the gel layer that contains nickel sulfate
2+) concentration be 36.75 μ g ÷ 0.81cm
2=45.37 μ g/cm
2.）
Embodiment 3 patch tests
Totally 44 routine experimenters, year mean age (40.5 ± 9.6), male's 25 examples, women's 19 examples, wherein be diagnosed as contact dermatitis patient's 22 examples (positive group) of nickel sulfate allergy, contact dermatitis patient's 22 examples (negative group) of non-sulfuric acid nickel allergy clinically.Use the dermatitis that the contains nickel sulfate diagnosis patch of embodiment 1 preparation to carry out patch test to above-mentioned patient, the patient must continue to paste at least 48 hours, notes keeping trial zone dry and comfortable.Interpretation as a result should be carried out during 72-96 hour, if assessed when taking patch off, should after 30 minutes, carry out interpretation, and supplemented interpretation during 72-96 hour.Interpretation standard is as shown in the table:
Result shows: 22 in routine positive group, have 2 examples " extremely strong positive reaction " (+++) to occur, " strong positive reaction " (++) appears in 9 examples, and " weak positive reaction " (+) appear in 9 examples, " suspicious reaction " () appears in 1 example, and " negative reaction " (-) appears in 1 example.22, in routine negative group, have 2 examples " weak positive reaction " (+) to occur, " suspicious reaction " () appears in 3 examples, and " negative reaction " (-) appear in 19 examples.Diagnostic criteria and exclusion standard that as take, clinical diagnosis is the contact dermatitis of nickel sulfate allergy, the result of meter sensitivity and specificity is as follows:
The ÷ 22=90.91% of the positive number of sensitivity (%)=patch test results/positive group total number of persons=(2+9+9)
The negative number of specificity (%)=patch test results/feminine gender group total number of persons=19 ÷ 22=86.36%
Therefore, use the dermatitis diagnosis patch that contains nickel sulfate of the present invention to carry out that patch test is highly sensitive, high specificity.The testing result of the contact dermatitis group of the contact dermatitis group that is nickel sulfate allergy according to clinical definite and non-sulfuric acid nickel allergy, this assay sensitivity 90.91% and specificity 86.36%, with clinical diagnosis, good coincidence rate is arranged, and untoward reaction is few, can be well tolerable.
Embodiment 4 is different, and the one-tenth membrane matrix is filmed (gel layer) relatively
According to embodiment 1(1), the method for (2) prepares respectively 4 kinds of diaphragms (being covered with the carrier that contains the nickel sulfate gel layer), do not cut into slices, the formula of 4 kinds of film forming liquid is as follows:
Diaphragm one:
Diaphragm two:
Diaphragm three:
NiSO
4·6H
2O 3.1g
Hyprolose (HPC-HF) 5g
Purified water 95g
Diaphragm four:
NiSO
4·6H
2O 3.8g
Methylcellulose 10g
Purified water 90g
Annotate: by methylcellulose join be preheated to high temperature (80 ℃ of left and right) purified water high speed dispersed with stirring evenly after, then add rapidly the NiSO dissolved by purified water
46H
2o also stirs.
Observe film-formation result, result is as follows:
Diaphragm one: film-formation result is good, and film (gel layer) uniform surface, be difficult for demoulding (gel layer);
Diaphragm two: film-formation result is good, and film (gel layer) uniform surface, be difficult for demoulding (gel layer);
Diaphragm three: film-formation result is poor, and there is decorative pattern on film (gel layer) surface, easily demoulding (gel layer);
Diaphragm four: film-formation result is poor, and there is decorative pattern on film (gel layer) surface, easily demoulding (gel layer).
From above-mentioned film forming (gel layer) effect, adopt the film forming liquid film forming (gel layer) of 30 POVIDONE K 30 BP/USP 90 effective, film (gel layer) uniform surface, and be difficult for demoulding (gel layer).
The foregoing is only preferred embodiment of the present invention, not in order to limit essence technology contents scope of the present invention, essence technology contents of the present invention is broadly to be defined in the claim scope of application, any technology entity or method that other people complete, if defined identical with the claim scope of application, also or a kind of change of equivalence, all will be regarded as being covered by among this claim scope.
Claims (10)
1. a dermatitis diagnosis patch, is characterized in that, described patch comprises:
One gel layer that contains nickel sulfate;
One carrier; With
One cohesive material.
2. dermatitis diagnosis patch as claimed in claim 1, is characterized in that, the described gel layer that contains nickel sulfate comprises nickel sulfate, becomes membrane matrix and solvent; Preferably the described gel layer that contains nickel sulfate is by nickel sulfate, one-tenth membrane matrix and solvent composition.
3. dermatitis diagnosis patch as claimed in claim 1, is characterized in that, at least one carrier is fixed on cohesive material, is covered with the gel layer that contains nickel sulfate at least one carrier.
4. patch according to claim 3, is characterized in that, on the described gel layer that contains nickel sulfate, is coated with release paper, and the part of described release paper contacts and fixes with described cohesive material; Preferred described release paper is release paper.
5. described dermatitis diagnosis patch as arbitrary as claim 1-4, is characterized in that, in the described gel layer that contains nickel sulfate, the concentration of nickel sulfate is calculated as 20-100 μ g/cm with nickel
2.
6. dermatitis diagnosis patch as claimed in claim 5, is characterized in that, in the described gel layer that contains nickel sulfate, the concentration of nickel sulfate is calculated as 40-50 μ g/cm with nickel
2; Be preferably 45 μ g/cm
2.
7. dermatitis diagnosis patch as claimed in claim 5, is characterized in that, described nickel sulfate is selected from anhydrous nickel sulfate, six hydration nickel sulfate, single nickel salts.
8. the preparation method of a described dermatitis diagnosis patch as arbitrary as claim 1-7, is characterized in that, described method comprises step:
(1), by solvent, nickel sulfate with become membrane matrix to mix, dissolve, obtain film forming liquid after bubble removing;
(2) film forming liquid is filmed on carrier, drying, make on carrier to be covered with the gel layer that contains nickel sulfate;
(3) section, be assembled on cohesive material, obtains described dermatitis diagnosis patch as arbitrary as claim 1-7.
9. preparation method as claimed in claim 8, is characterized in that, in step (1), the mass ratio of described one-tenth membrane matrix and solvent is 1:4-1:20; Be preferably 1:5-1:15; 1:9 more preferably; The quality of described nickel sulfate is generally described solvent and the 1%-10% that becomes membrane matrix quality sum, and more preferably 2%-5%, most preferably be 3%-4%.
10. method according to claim 9, is characterized in that, in step (2), described coating thickness is 50-500 μ m; Be preferably 70-200 μ m, more preferably 100 μ m.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210190082.1A CN103480005A (en) | 2012-06-11 | 2012-06-11 | Dermatitis diagnostic patch and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210190082.1A CN103480005A (en) | 2012-06-11 | 2012-06-11 | Dermatitis diagnostic patch and preparation method thereof |
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ID=49820813
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267245A (en) * | 2016-09-23 | 2017-01-04 | 何韶衡 | A kind of gel combination, patch and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4836217A (en) * | 1984-10-01 | 1989-06-06 | Fischer Torkel I | Hypersensitivity test means |
| CN1243518C (en) * | 2001-03-13 | 2006-03-01 | Dbv技术公司 | Patch for screening sensitivity state of subject with respect to allergen and use thereof |
| CN101484075A (en) * | 2006-04-26 | 2009-07-15 | Dbv技术公司 | Patches and uses thereof |
-
2012
- 2012-06-11 CN CN201210190082.1A patent/CN103480005A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4836217A (en) * | 1984-10-01 | 1989-06-06 | Fischer Torkel I | Hypersensitivity test means |
| CN1243518C (en) * | 2001-03-13 | 2006-03-01 | Dbv技术公司 | Patch for screening sensitivity state of subject with respect to allergen and use thereof |
| CN101484075A (en) * | 2006-04-26 | 2009-07-15 | Dbv技术公司 | Patches and uses thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267245A (en) * | 2016-09-23 | 2017-01-04 | 何韶衡 | A kind of gel combination, patch and preparation method thereof |
| CN110013558A (en) * | 2016-09-23 | 2019-07-16 | 何韶衡 | A kind of transparent patch and preparation method thereof |
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