WO2007021008A1

WO2007021008A1 - Process for producing plaster, apparatus for producing the same, and liner for plaster

Info

Publication number: WO2007021008A1
Application number: PCT/JP2006/316266
Authority: WO
Inventors: Shinji Morikane; Daizo Morikane
Original assignee: Dia Pharmaceutical Co., Ltd.
Priority date: 2005-08-19
Filing date: 2006-08-18
Publication date: 2007-02-22
Also published as: JP4913738B2; JPWO2007021008A1

Abstract

An active ingredient is efficiently incorporated in or fixed to a pressure-sensitive adhesive layer without lowering the activity of the active ingredient. A process for producing a plaster comprising a substrate, a pressure-sensitive adhesive layer formed thereon which has an active ingredient incorporated therein or fixed thereto, and a liner superposed on the adhesive layer is provided. It comprises forming a pressure-sensitive base adhesive layer on a substrate or liner based on the melting of the pressure-sensitive adhesive itself or the evaporation of a solvent used while heating the pressure-sensitive adhesive according to the kind thereof, and incorporating or fixing the active ingredient to the pressure-sensitive base adhesive layer to continuously obtain a plaster, wherein the incorporation or fixation of the active ingredient to the pressure-sensitive base adhesive layer is conducted after the pressure-sensitive base adhesive layer which was heated in the formation thereof has been cooled to a temperature at which the activity of the active ingredient does not decrease.

Description

Specification

Manufacturing method of blaster, manufacturing apparatus thereof, and liner for plaster

Technical field

TECHNICAL FIELD [0001] The present invention relates to a plaster manufacturing method and a manufacturing apparatus therefor, and more specifically, a support, a pressure-sensitive adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order. The present invention relates to a plaster manufacturing method and a manufacturing apparatus for manufacturing a plaster.

Background art

[0002] Plaster is known as a medical pressure-sensitive adhesive tape, adhesive bandage, patch, and the like. Typical examples of the plaster include a support, a pressure-sensitive adhesive layer spread on one surface, and the pressure-sensitive adhesive. And a liner that is releasably adhered to the layer. Examples of the pressure-sensitive adhesive include natural rubber, synthetic rubber and a mixture thereof, an acrylic polymer solution emulsion type, a hot melt type, and an electron beam curable type. Further, when producing a plaster containing a pharmaceutical ingredient, a cosmetic ingredient, etc. as an active ingredient in the adhesive, a method of mixing the active ingredient in the adhesive and applying it to a support is common (for example, Patent Document 1). reference).

[0003] However, most of the active ingredients are organic solvent-based adhesives, solvent removal with hot air after coating (about 60-110 ° C) · drying process, and hot-melt adhesives are adhesive groups Heating at the time of mixing in the agent (about 170-180 ° ○) · There is a problem that in the mixing process, the active ingredient volatilizes and the chemical loss · thermal degradation such as decomposition occurs. On the other hand, a permeable support such as a woven fabric or a non-woven fabric is often used. However, since the temperature is high, there is a problem that if a highly fluid pressure-sensitive adhesive is applied, it oozes out to the back side.

Patent Document 1: JP-A-8-295624

Disclosure of the invention

Problems to be solved by the invention

[0004] The present invention has been made in order to solve the above-described problems, and can be efficiently contained or supported in an adhesive layer without reducing the activity of an active ingredient. Further, the present invention provides a method for producing a plaster and an apparatus for producing the same, which can prevent the seepage of the adhesive base even if a permeable support is used.

Means for solving the problem

[0005] The inventors of the present invention have made extensive studies to solve the above problems, and obtained the knowledge that the active ingredient can be contained in the adhesive base layer even after formation of the adhesive base layer. Based on this knowledge, an adhesive base layer that does not contain an active ingredient is first formed, and then the adhesive base layer is brought to a temperature condition that does not reduce the activity of the active ingredient and then the active ingredient is contained. Has been found to be able to solve the problem, and the present invention has been completed.

[0006] That is, one feature of the present invention is a method for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order, the support or liner The adhesive base layer is formed by heating according to the type of the adhesive and melting the adhesive itself or evaporating the solvent used, and containing or carrying the effective component in the adhesive base layer. Consisting of continuously obtaining plaster,

In the method for producing a plaster, the active ingredient is contained or supported on the adhesive base layer in a state where the heating temperature at the time of forming the adhesive base layer is lowered to a temperature that does not reduce the activity of the active ingredient. . In addition, a further feature of the present invention is that when the adhesive base layer is formed on the support or liner, and the active ingredient is contained or supported on the adhesive base layer, the heating temperature of the adhesive base layer is determined as the active ingredient. However, it does not reduce the temperature of the adhesive base layer unilaterally, but the active ingredient is contained in the adhesive base layer at a higher temperature. Or by supporting (effectively preventing leaching of the adhesive base layer to the permeable support) and effectively containing or supporting the active ingredient in the adhesive base layer (high at high temperatures) The use of permeability) and the ability of the liner and support (especially the liner) to be firmly bonded in the process of forming the adhesive base layer, and the waste of lowering the temperature unnecessarily in industrial production. Save time and save time To, is to improve the quality and productivity of plaster.

Here, the temperature of the active ingredient contained or supported in the adhesive base layer should not be lowered, the temperature Is a force depending on the active ingredient, for example, about 130 ° C or less, preferably about 35 to about 100 ° C, and more preferably about 35 to about 80 ° C. The temperature at which the activity of the active ingredient is not lowered can be obtained by temperature detecting means for detecting the temperature of the adhesive base layer. Although not particularly limited, for example, it can be obtained by a non-contact infrared thermosensor that detects the temperature of the surface of the adhesive base layer.

In the present invention, the active ingredient is contained or supported in the adhesive base layer means that the active ingredient is contained (impregnated or penetrated) in the adhesive base layer, or the active ingredient is completely supported on the surface of the adhesive base layer. In addition to the above, the case where a part of the active ingredient is contained in the adhesive base layer and the rest is supported on the surface of the adhesive base layer is also included.

[0007] Formation of the pressure-sensitive adhesive layer containing or carrying the active ingredient according to the present invention includes (1) forming an adhesive base layer on the support and forming an active ingredient-containing layer containing the active ingredient on the liner, The active ingredient-containing layer is bonded together in a state where the temperature of the adhesive base layer formed on the support is lowered to a desired temperature, or (2) of the adhesive base layer formed on the support It is obtained by applying a solution in which an active ingredient is dissolved or dispersed on the adhesive base layer in a state where the temperature is lowered to a desired temperature.

[0008] According to another aspect, the present invention provides an apparatus for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order. A support conveying means for conveying the carrier, a liner conveying means for conveying the liner, an adhesive base layer forming means for forming an adhesive base layer on one of the conveyed support and liner, and An active ingredient supporting layer forming means for forming an active ingredient supporting layer by forming an active ingredient containing layer on either the support or the liner, and a temperature detecting means for detecting the temperature of the adhesive base layer. In the state where the temperature detected by this temperature detecting means has been lowered to a temperature that does not decrease the activity of the active ingredient, the active ingredient carrying layer is bonded to the surface of the adhesive base layer, and the active ingredient is attached to the adhesive base. Contained in the layer Possible to provide a manufacturing apparatus of plaster comprising a bonding means to the adhesive base layer and the effective component carrying layer is to be carried.

[0009] According to yet another aspect, the present invention is an apparatus for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order. A support transporting means for transporting the carrier; a liner transporting means for transporting the liner; an adhesive base layer forming means for forming an adhesive base layer on one of the transported support and liner; and the adhesive Effective when the temperature detected by the temperature detecting means detects the temperature of the base layer and the temperature detected by the temperature detecting means drops to a temperature at which the activity of the active ingredient does not decrease. Applying a solution in which an ingredient is dissolved or dispersed and applying or containing an active ingredient in or on an adhesive base layer, either a support or a liner on an adhesive base layer containing or carrying an active ingredient It is possible to provide a device for manufacturing a plaster comprising a shell-dividing means for attaching the other.

The invention's effect

[0010] According to the present invention, an adhesive base layer is formed in advance on the support or liner by melting or evaporating the solvent according to the type of the adhesive, and thereafter, an effective component is formed on the adhesive base layer. By containing or carrying the active ingredient under temperature conditions that do not reduce the activity, the active ingredient can be efficiently contained in the pressure-sensitive adhesive layer without reducing its activity.

Furthermore, in the present invention, when the active ingredient is contained or supported in the adhesive base layer, the heating temperature of the adhesive base layer is lowered to a temperature condition that does not reduce the activity of the active ingredient. The temperature of the adhesive base layer is not lowered. Among those conditions, the active ingredient is contained or supported on the adhesive base layer at a higher temperature, thereby effectively containing the active ingredient in the adhesive base layer. Support (use high permeability at high temperature), and make sure that the liner and support force can be firmly bonded in the process of forming the adhesive base layer. Unnecessarily reducing waste and reducing time, and improving the quality and productivity of plasters.

Brief Description of Drawings

FIG. 1 is a schematic configuration explanatory view showing a first embodiment of a plaster manufacturing apparatus according to the present invention.

2 is a cross-sectional view illustrating a schematic configuration of the plaster manufactured in Embodiment 1 of FIG.

FIG. 3 is a schematic configuration explanatory view showing Embodiment 2 of a plaster manufacturing apparatus according to the present invention. is there.

4] FIG. 4 is a cross-sectional view illustrating the schematic configuration of the plaster manufactured in the second embodiment shown in FIG. Explanation of symbols

1 Plaster production equipment

2 Support

3 liner

4 Adhesive layer

4a Adhesive base layer

5 Pharmaceutical component carrier layer

6 Support roll

7 Supply roll

8 Guide roll

9 First roll

10 Liner feed roll

11 Guide roll

12 Second roll

13 Cooling roll

14 Main roll

15 containers

16 Gravure Ronole

17 Rubber roll

18 Secondary roll

19 Nmalone

20 Plaster culling roll

21 Guide roll

22 Guide roll

23 Doctor blade

PI plaster BEST MODE FOR CARRYING OUT THE INVENTION

[0013] In the method for producing a plaster according to the present invention, a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order, and the liner is peeled off during use from the adhesive layer side. The plaster to be attached to the surface to be applied is the manufacturing target.

In the present invention, an adhesive base layer (meaning an adhesive layer not containing an active ingredient) is first formed on a support or liner, and the activity of the active ingredient is reduced in the adhesive base layer. The active ingredient is contained or supported under temperature conditions that do not.

Here, as the material and shape of the support, those known in the art can be used. More specifically, as the raw material for producing the plaster, a sheet or a film is used, which is cut into an appropriate size after the plaster is formed. The material may be any of non-woven fabrics and woven fabrics made of natural fibers, synthetic resin fibers, and other synthetic resin films. For example, non-woven fabrics formed into a cloth using one or more types of fibers such as polyester, polypropylene, or rayon. Preferable examples include woven fabric made of polyester fiber, sufumuslin, a chlorinated bure film, a polyethylene film, a polyurethane / vinyl chloride copolymer film, and a polyurethane film that are woven using soot. In addition, cellophane, cellulose acetate, polyvinylidene chloride, nitrile rubber, polypropylene homo or copolymer, polyamide, polytetrafluoroethylene, and other synthetic resins, and blends with other polymers can also be listed as preferred materials. S, a support that is not limited to these, is selected depending on the application.

[0015] Examples of the liner include paper and films processed on both sides having releasability, crepe paper, embossed films, and films coated with other release agents. Examples of the film include a vinyl chloride film, a polyethylene film, a polypropylene film, a polyester film, and a polyethylene terephthalate film. Of particular importance are silicone release liners wherein the film is silicone treated.

[0016] Examples of the pressure-sensitive adhesive forming the pressure-sensitive adhesive base layer include natural rubber, synthetic rubber and a mixture thereof, a solution-based emulsion type of acrylic polymer, a hot melt type, and an electron beam curable type ( Published by Nikkan Kogyo Shimbun, “Adhesion Technology No. Book” pages 774-775). These pressure-sensitive adhesives have different methods for forming a pressure-sensitive adhesive base layer depending on their types. In any of these methods, the adhesive base layer is formed through a high temperature. Therefore, in the present invention, when the adhesive base layer does not decrease the activity of the active ingredient, (when the temperature is high) The active ingredient is contained or supported after adjusting to a temperature condition that does not reduce the activity of the active ingredient.

When the active ingredient is contained or supported on the adhesive base layer under such temperature conditions, the penetration of the active ingredient into the adhesive base layer can be made effective, or the other liner can be supported or supported. In consideration of sufficient adhesion to the body, it is desirable to adopt the following method for each type of adhesive.

[0017] (1) Hot melt adhesive

Hot-melt adhesives are heated to a high temperature (for example, 120 to 180 ° C) and melted, and an adhesive base layer is formed on either the support or liner by spreading or coating (coating). To do. The adhesive base layer contains or carries the active ingredient under temperature conditions that do not reduce the activity of the active ingredient, but the temperature is higher than the temperature conditions that do not reduce the activity of the active ingredient. The active ingredient is contained in the adhesive base layer under certain conditions, whereby the active ingredient is effectively infiltrated into the adhesive base layer (use of high permeability at high temperature), and either the support or the liner (especially (Liner) can be tightly bonded (use of high tack at high temperatures), and in particular, in industrial production, unnecessary waste of temperature reduction can be eliminated.

[0018] Here, examples of the hot-melt rubber-based pressure-sensitive adhesive include a combination of the following elastomer and a tackifier. That is, as an elastomer, natural rubber, synthetic polyisoprene rubber, styrene-butadiene rubber, styrene-isoprene block copolymer, polyisobutylene, butyl rubber, styrene-isoprene-styrene block copolymer (abbreviated as SIS). The same applies hereinafter), styrene butadiene rubber (SBR), hydrogen additive of styrene butadiene rubber (SBRS), and the like.

[0019] Tackifiers include rosin, hydrogenated rosin, rosin ester, hydrogenated rosin ester, polytenolene, terpene phenol, phenol resin, xylene resin, coumarone indene resin, and other aliphatic resins (C5 resin). , Petroleum resins, alicyclic hydrocarbon resins (hydrogenated aromatic resins), and the like. [0020] A rubber-based pressure-sensitive adhesive in which these elastomers and a tackifier are combined can be made into a solid block at room temperature, and heated by heating to a high temperature (for example, 120 to 180 ° C). And then spread (apply) directly on the support or liner to form an adhesive base layer. Separately spread (apply) on a roll or the like to form an adhesive base layer. After pressing, the adhesive base layer may be attached (transferred) on the support or liner.

The thickness of the pressure-sensitive adhesive layer is generally set to 10 to 1000 zm, preferably 20 to 200 zm in consideration of securing the adhesive strength of the plaster and the retention strength of the active ingredient.

[0021] (2) Solvent-type adhesive

With solvent-type adhesives, the adhesive is spread or applied (coating) by dissolving it in a solvent, and then the solvent is evaporated at a high temperature (for example, 120 ° C) to either the support or the liner. An adhesive base layer is formed. The adhesive base layer contains or carries the active ingredient under a temperature condition that does not reduce the activity of the active ingredient, but the temperature condition does not reduce the activity of the active ingredient at a higher temperature condition. Before the solvent is completely evaporated, the active ingredient is contained or supported on the adhesive base layer, so that the active ingredient can effectively penetrate into the adhesive base layer (use of high permeability at high temperature) and support It is possible to firmly attach either the body or the liner (especially the liner) in the process of forming the adhesive base layer, and it is possible to eliminate the waste of lowering the temperature unnecessarily, especially in industrial production. .

Here, examples of the solvent-type acrylic pressure-sensitive adhesive include combinations of the following main monomers and submonomers. That is, as the main monomer, ethyl acrylate, butyl acrylate, 2-ethylhexyl acrylate, octyl acrylate, isooctyl acrylate, decyl acrylate, decyl methacrylate, dodecyl acrylate, dodecyl methacrylate, etc. Is mentioned. In addition, examples of the secondary monomer include acrylic acid, butyl acetate, methyl acrylate, methyl methacrylate, maleic anhydride, and 2-hydroxyethyl acrylate.

[0023] The acrylic pressure-sensitive adhesive combining the main monomer and the submonomer is appropriately added with an additive, dissolved in a specific solvent, coated (spread or coated) on a support or liner, and then heated (for example, 120). ° C) through a drying tunnel to properly evaporate the solvent and An agent layer is formed.

[0024] A softener (plasticizer), an absorption accelerator, polyhydric alcohols, silicone oils, inorganic fillers, antioxidants (ultraviolet absorbers) and the like are appropriately used for the adhesive base layer. In particular, it is preferable to use an active ingredient together with a softening agent (plasticizer) of a low molecular compound that can dissolve or disperse the active ingredient and penetrate into the adhesive base layer.

[0025] Examples of the softener (plasticizer) include polybutene, polyisobutylene, dioctyl phthalate, dibutyl phthalate, jetyl phthalate, liquid rosin ester, chlorinated paraffin, process oil, lanolin, IPM, silicone, petrolatum, solid Paraffin, liquid paraffin, plastic pace, beeswax, mentholenole, limonene, binene, piperiton, terpinol, carveol, almond oil, olive oil, camellia oil, persic oil, hearth oil, sesame oil, soybean oil, mink oil, Cottonseed oil, corn oil, safflower oil, grape oil, macadamia nut oil, egg yolk oil, safflower oil, crotamiton, pyrrolidone, liquid polyisoprene, medium chain fatty acid triglyceride, polyethylene glycol, benzyl alcohol, oleyl alcohol, dimethyl alcohol Tyramide, diisopropyl adipate, linolenic acid, force puric acid, oleic acid, stearic acid, maristynic acid, linoleic acid, olephinic acid, propylene glycol, butylene glycol, squalene, squalene, eucalyptus oil, palm oil, coconut oil, Examples include laccase oil, propylene carbonate, dioctyl phthalate, dibutyl phthalate, lauryl alcohol, triisopropanolanolamine, diisopropanolamine, and polyoxyethylene sorbitan monooleate. These may be used alone or in combination of two or more depending on the active ingredient.

[0026] Examples of the polyhydric alcohol include glycerin, propylene glycol, octanediol, polyethylene glycol, D-sorbit, crotamiton and the like.

Examples of the silicone oil include methylsiloxane, methylphenylpolysiloxane, dodecamethylpolysiloxane, and the like.

Examples of the inorganic filler include zinc oxide, titanium oxide, and calcium carbonate. Examples of the antioxidant (ultraviolet absorber) include BHT and DTBHQ.

[0027] Effective composition suitable for inclusion or support in the adhesive base layer of the plaster according to the present invention. Examples of the ingredients include the following pharmaceutical ingredients (pharmaceuticals), cosmetic ingredients (cosmetics), and fragrances. Pharmaceutical components (pharmaceuticals) include anti-inflammatory analgesics, hormonal agents, local anesthetics, nitrates for heart disease, therapeutic agents for motion sickness, therapeutic agents for menopause, antihypertensive agents, cancer pain relieving agents, bronchodilators, smoking cessation aids , Urinary incontinence treatment, etc., and specific examples include ferpinac, indomethacin, ketoprofen, flurbiprofen, methyl salicylate, glycol salicylate, mentholore, betamethasone valerate, insulin, lidocaine ( MT66 ~ 6 9 ° C, BT159 ~: 160 ° C), isosorbide nitrate, nitroglycerin (stable at 50 ° C or less), scopolamine, estradiol, clonidine, fentanyl, fentanyl citrate, lobbuterol, nicotine, hydrochloric acid Oxybutynin, diclofenac sodium, eperisone hydrochloride, loxoprofen sodium, cap Isin (ΜΤ 65.7-66.3 ° C), tranisol hydrochloride, ketorolata, suprofen, zaltoprofen, dibu force in, testosterone, piroxicam, salicylic acid, progesterone, camphor, edaravone, valdecoxib, celecoxib, oral fuecoxib, estrogen, Progestogen, Clondin, Theophylline, Nonyl oxynitrylamide, Pepper extract, Aspirin, Salbutamol sulfate, Isoprotenol hydrochloride, Arylestrenol, Hyde mouth cortisone, Prednisolone, Methylprezidolone, Triamcinolone, Dexamethasone, Parameterzone and these cortisones Powers that can include derivatives and salts of these are not limited to these.

[0028] In addition, examples of cosmetic ingredients (cosmetics) include vitamins, moisturizers, whitening agents, blood circulation promoting ingredients, antioxidant ingredients, cell activation ingredients, antiallergic ingredients, and the like. Examples include, but are not limited to, C, vitamin E, arbutin, and ubidecarenone. The temperature at which the activity of the active ingredient is not reduced is, for example, 45 ° C. or less for the cell activation ingredient ubidecaren.

Examples of the fragrance include sweet orange, lemon, bergamot, peppermint, lavender, geranium, rose, jasmine, basil, eucalyptus, and the like, but are not limited to these.

[0029] When the active ingredient as described above is applied, it is used in a solution in which the active ingredient is dissolved or dispersed in an appropriate medium. The medium is selected mainly considering the physical properties such as solubility in organic solvents and water depending on the type of active ingredient, but in addition, it is compatible with the adhesive base layer. Alternatively, the use of a compatible medium is preferable for containing or penetrating the active ingredient in the adhesive base layer at a high concentration. A person skilled in the art can easily select the medium without the need for special experimentation.

As the above medium, the above-mentioned softeners (plasticizers) can be used singly or in combination according to the active ingredient. For example, crotamiton is preferably used for pharmaceutical ingredients such as ketoprofen, ibuprofen, lidocaine, flurbiprofen, aspirin, felbinac, and pyrrolidone is used for ketoprofen, ibuprofen, lidocaine, felpinac, diclofenac sodium Isopropanolamine is preferably used for pharmaceutical ingredients such as ketoprofen, ibuprofen, lidocaine, flurbiprofen, and aspirin. It is preferably used for pharmaceutical ingredients such as oral fen, lidocaine, flurbiprofen and the like. However, it is not limited to these.

In addition, the active ingredient-containing layer used for bonding with the adhesive base layer allows the active ingredient to be supported uniformly and at an appropriate concentration on an appropriate liquid or solid carrier (a solvent is added if necessary). Let it form. The liquid or solid carrier is preferably one that is inert to the active ingredient and can be easily removed after bonding with the adhesive base layer or does not substantially remain. This is also the softener (plasticizer) described above. Can be used alone or as a mixture of two or more thereof depending on the active ingredient.

Next, in order to set the temperature of the adhesive base layer to a temperature that does not specifically reduce the activity of the above-described pharmaceutical ingredients and cosmetic ingredients, the following temperature adjusting means can be appropriately employed.

(1) A temperature adjusting means for adjusting the adhesive base layer to a temperature that does not reduce the activity of the active ingredient, for example, a mouthpiece for forming the adhesive base layer.

(2) Adhesive base layer forming means comprising: an adhesive base layer forming roll in which the supplied high-temperature adhesive is spread on the roll surface to form an adhesive base layer; It is composed of a laminating roll for laminating the pressure-sensitive adhesive base layer on either one, and a cooler for lowering the temperature of the pressure-sensitive adhesive base layer to a temperature that does not decrease the activity of the active ingredient is heated on this laminating roll. Provide interchangeably.

(3) One of the support and liner to be conveyed, one of them, and the adhesive base formed thereon A cooling chamber is provided by passing through the layer to lower at least the temperature of the adhesive base layer to a temperature that does not decrease the activity of the active ingredient.

Of course, if the temperature of the adhesive base layer is naturally at a temperature that does not decrease the activity of the pharmaceutical ingredient or cosmetic ingredient, the temperature adjusting means is unnecessary.

[0031] And, in order to contain the active ingredient in the preformed adhesive base layer, specifically, the adhesive base layer is formed on the support and the active ingredient-containing layer is formed on the liner, respectively. The active ingredient-containing layer is bonded to the adhesive base layer formed on the body. An adhesive base layer may be formed on the liner, an active ingredient-containing layer may be formed on the support, and the active ingredient-containing layer may be bonded to the adhesive base layer formed on the liner.

[0032] Alternatively, an adhesive base layer may be formed on a support or liner, and a solution in which an active ingredient is dissolved or dispersed may be spread or applied (coated) on the adhesive base layer. Examples of the application include roll method and spray method.

In the present invention, as a matter of course, an active ingredient that can permeate (transfer or impregnate) the adhesive base layer by the above-mentioned bonding or coating, and can be contained or supported is selected and used.

The active ingredient permeates and diffuses into the adhesive base layer from the active ingredient carrying layer brought into contact with the adhesive base layer by bonding or coating, thereby forming an adhesive layer containing the active ingredient almost evenly. . For example, active ingredients applied or bonded to a 50 to 200 μm adhesive base layer:! To diffuse and penetrate uniformly into the adhesive base layer in 2 weeks.

In the present invention, the obtained plaster has a structure in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order. The liner is peeled off during use, and the plaster is peeled off. It is applied to the desired skin surface from the coated surface side (adhesive layer). Further, if necessary, the concentration distribution of the active ingredient in the adhesive base layer can be increased with the liner 佃 J.

[Embodiment 1]

FIG. 1 is a schematic structural explanatory view showing Embodiment 1 of a plaster manufacturing apparatus according to the present invention, and FIG. 2 is a schematic structural explanatory sectional view of a plaster.

First, in FIG. 2, plaster P1 includes a support 2 and an adhesive layer 4 containing an active ingredient. The liner 3 is laminated in this order, and the liner 3 is peeled off during use, and the adhesive layer 4 can be applied to the surface to be applied (skin surface) (for example, the overall size: approximately 70 mm). X about 100mm).

[0034] The support 2 is made of a non-woven fabric made of polyester (support thickness: approximately 1 mm). Liner 3 is made of a peelable synthetic resin sheet with appropriate release agent applied to PET (liner thickness: about 30-60 111).

Adhesive layer 4 contains a hormonal agent (insulin) (about 400 μg) as an active ingredient in styrene-isoprene-styrene resin (SIS), which is a rubber adhesive as a hot-melt adhesive. (The thickness of the pressure-sensitive adhesive layer: about 100 to 200 μm).

In FIG. 1, the plaster manufacturing apparatus 1 includes a support transport means for transporting the support 2 from the support feed roll 6, a liner transport means for transporting the liner 3 from the liner feed roll 10, and Adhesive base layer forming means for forming the adhesive base layer 4a on the transported support 2; Pharmaceutical component support layer forming means for forming the pharmaceutical ingredient supporting layer 5 on the liner 3 to be transported; 2 on the adhesive base layer 4a formed on 2 is bonded from the side of the pharmaceutical component support layer 5 to the liner 3 and the pharmaceutical component support layer 5 formed thereon, and is a plaster P1; And plaster removing means for scraping the plaster P1 obtained by the bonding means.

[0036] The support transport means includes a no-tension transport roll 7 for supplying the support 2 fed from the support feed roll 6 to an adhesive base layer forming main roll 14 described later with no tension, and the transport roll. It consists of a guide roll 8 between the main roll 14.

The liner conveying means includes a guide roll 11 that feeds the liner 3 from the liner feed roll 10 and guides and feeds it to a rubber roll 17 described later.

[0037] The adhesive base layer forming means includes a comma coater 19 having a first roll 9 and a second roll 12 having a temperature control function, a cooling roll 13 having a roll-coated silicon surface, and the cooling roll. And a main base 14 for forming an adhesive base layer which is in contact with the surface of the roll and is anti-slip processed. The cooling roll 13 is provided with a cooler (not shown) that is attached in a heat exchange manner and reduces the temperature of the adhesive base layer 4a formed on the roll surface to a temperature that does not reduce the activity of the pharmaceutical ingredients. Yes. [0038] The medicinal component-supporting layer forming means comprises a container 15 for storing a medicinal component solution, a gravure roll 16 partially immersed in the medicinal component solution in the container, and a gravure roll in contact with the gravure roll. It comprises a rubber roll 17 that forms a medicinal component-supporting layer 5 on a liner 3 that passes through the gap. Reference numeral 23 denotes a gravure roll 16 scraper.

The laminating means comprises a sub roll 18 that contacts the main roll 14.

The plaster scraping means includes a scraper opening 20 for scraping the plaster P1 by a torque motor (not shown), and two guide rolls 21 and 22.

The operation of the plaster manufacturing apparatus 1 having the above configuration will be described.

First, the support feeding roll 6 supplies the support 2 to the main roll 14 for forming the adhesive base layer with no tension via the no tension conveying roll 7 and the guide roll 8.

The first roll 9 and the second roll 12 are supplied with the SIS pressure-sensitive adhesive that has been heated to 160 to 180 ° C. from the solid state to become a molten state, and the molten SIS pressure-sensitive adhesive 120 to 160: 160 While adjusting the temperature to ° C, supply it to the cooling roll 13 and spread it at a thickness of about 100 μΐη. The cooling roller 13 forms an adhesive base layer 4a on the support 2 supplied to the main roller 14 while lowering the temperature of the spread SIS resin to about 2 to 8 ° C. An infrared sensor (not shown) that detects the surface temperature of the adhesive base layer 4a formed on the support 2 is provided, and a temperature signal detected by this sensor is sent to the temperature of the cooler via a controller (not shown). It is comprised so that it may control.

[0040] On the other hand, the liner feeding roll 10 supplies the liner 3 to the rubber roll 17 through the guide roll 11, and the gravure roll 16 transfers the pharmaceutical ingredient solution (insulin dissolved in lanolin) in the container 15 onto the rubber roll 17. The medicine component carrying layer 5 is formed by spreading on the surface of the liner 3.

The main roll 14 and the sub-roll 18 are bonded to the adhesive base layer 4a on the support 2 with the liner 3 and the pharmaceutical component support layer 5 thereon from the side of the pharmaceutical component support layer 5, and the support 2 and the pharmaceutical component as a whole. The pressure-sensitive adhesive layer 4 and the liner 3 are laminated in this order, and the liner 3 is peeled off during use to make the pressure-sensitive adhesive layer 4 a plaster P1 that can be attached to the surface to be applied (skin surface). The obtained plaster P1 is scraped off by a scraping roll 20.

[0041] The adhesive base layer 4a of the plaster P1 is formed in advance before containing a pharmaceutical ingredient, Thereafter, the adhesive base layer 4a is allowed to contain the pharmaceutical ingredient under a temperature condition that does not reduce the activity of the pharmaceutical ingredient. Therefore, the adhesive base layer 4a can be efficiently used without reducing the activity of the pharmaceutical ingredient. Can be contained (penetrated). Further, since the obtained plaster is penetrated from the side where the adhesive layer 4 is applied, the concentration distribution of the pharmaceutical component is large on the side where the adhesive is applied, so the effect of the pharmaceutical component is fast and large.

[0042] [Embodiment 2]

FIG. 3 is a schematic structural explanatory view showing Embodiment 2 of the plaster manufacturing apparatus according to the present invention, and FIG. 4 is a schematic structural explanatory sectional view of the plaster. The same components as those in Embodiment 1 are given the same numbers.

In FIG. 4, the plaster P2 includes a support 32, an adhesive layer 34 containing an active ingredient, and a liner 33, which are laminated in this order, and the liner 33 is peeled off during use to cover the adhesive layer 34. It is configured so that it can be attached to the application surface (skin surface) (for example, overall size: about 70 mm × about 100 mm).

The support 32 is made of a non-woven fabric made of polyester (support thickness: about 1 mm). The liner 33 is made of a peelable synthetic sheet in which a sealing agent or a release agent is appropriately immersed in a synthetic paper (liner thickness: about 30 to 60 μm).

Adhesive layer 34 contains SIS-based adhesive as a hot-melt adhesive containing cell activation component ubidecaren (approximately 300 μg) as an active ingredient (adhesive layer thickness: approximately 100–200 xm). ).

In FIG. 3, the plaster manufacturing apparatus 31 includes a support transport means for transporting the support 32 from the support feed roll 6, a liner transport means for transporting the liner 33 from the liner feed roll 10, and a transport. An adhesive base layer forming means for forming an adhesive base layer 34a on the support 32, a pharmaceutical ingredient applying means for applying a pharmaceutical ingredient solution on the formed adhesive base layer 34a, and a pharmaceutical ingredient are applied. A liner 33 is bonded to the adhesive base layer 34a thus formed to form a plaster P2, and a plaster scraping unit for scraping the plaster P2 obtained by the bonding means.

[0045] The support conveying means and the adhesive base layer forming means are the same as in the first embodiment, and a description thereof will be omitted. The liner conveying means includes a liner winding roll 10, which feeds out the liner 33 and guides and supplies it to a rubber roll 38 to be described later.

The medicinal component application means includes a container 15 for storing the medicinal component solution, and an adhesive base formed on the support 32 by the adhering base layer forming means by partially immersing the medicinal component solution in the container. It consists of a gravure roll 16 for applying a pharmaceutical component solution on the surface of the layer 34a, and a rubber roll 36 that comes into contact with this daravia roll. 23 is a gravure roll 16 scraper.

[0046] The laminating means is composed of a pair of rubber rollers 37 and 38 that are in contact with each other, and the liner 33 is pasted onto the adhesive base layer 34a coated with the pharmaceutical component solution.

The plaster scraping means comprises a scraping roll 20 that scrapes the plaster P2 by a torque motor (not shown). Reference numeral 35 denotes a cooling chamber serving as a cooling section that allows a laminate in which the adhesive base layer 34a is formed on the support 32 to pass therethrough and lowers the temperature of at least the adhesive base layer 34a.

The operation of the plaster manufacturing apparatus 31 having the above configuration will be described.

First, the support feeding roll 6 supplies the support 32 to the main roll 14 for forming the adhesive base layer with no tension via the no tension conveying roll 7 and the guide roll 8. The first roll 9 and the second roll 12 are supplied with the SIS pressure-sensitive adhesive that has been heated to 160 to 180 ° C from the solid state to become molten, and the SIS pressure-sensitive adhesive in the molten state is 120 to 160 °. While adjusting the temperature to C, it is supplied onto the cooling roll 13 and spreads at a thickness of about 100 xm. The cooling roller 13 forms an adhesive base layer 34a on the support 2 supplied to the main roller 14 while lowering the temperature of the spread SIS resin to about 45 ° C.

[0048] The gravure roll 16 applies the pharmaceutical component solution in the container 15 to the surface of the adhesive base layer 34a on the support 32.

A pair of rubber rollers 37 and 38 that are in contact with each other are bonded to a liner 33 on an adhesive base layer 34a coated with a pharmaceutical component solution, and as a whole, a support 32 and an adhesive layer 34 containing a pharmaceutical component The liner 33 and the liner 33 are laminated in this order, and the liner 33 is peeled off during use, and the adhesive layer 34 is a plaster P2 that can be attached to the surface to be applied (skin surface). The obtained blaster P2 is scraped off by a scraping roll 20. The adhesive base layer 34a of this plaster P2 is formed in advance before containing the pharmaceutical ingredient, and then the adhesive base layer 34a is added with the pharmaceutical ingredient under a temperature condition that does not reduce the activity of the pharmaceutical ingredient. Therefore, the medicinal component can be contained (permeated / diffused) almost evenly and efficiently in the adhesive base layer 34a without reducing its activity. In addition, since the medicinal components permeate from the side where the adhesive layer 34 is applied as necessary, the concentration distribution of the medicinal components can be increased on the adhering side, so that the effect of the medicinal components is fast and large. The power to make S.

Claims

The scope of the claims

[1] A method for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order,

An adhesive base layer is formed on the support or liner by heating depending on the type of the adhesive to melt the adhesive itself or evaporating the solvent used, and the adhesive base layer contains the effective component or Consisting of continuously obtaining plaster by carrying,

A method for producing a plaster, wherein the active ingredient is contained or supported on the adhesive base layer in a state where the temperature of heating performed at the time of forming the adhesive base layer is lowered to a temperature that does not reduce the activity of the active ingredient.

[2] The formation of the pressure-sensitive adhesive base layer on the support or the liner is performed in a state where the heating temperature at the time of forming the pressure-sensitive adhesive base layer is lowered to a temperature that does not decrease the activity of the active ingredient. A method for producing the plaster according to 1.

[3] The active ingredient is contained in or supported on the adhesive base layer by pasting a liner on which the active ingredient-containing layer has been formed in advance to the adhesive base layer formed on the support. 2. A method for producing a plaster according to 2.

[4] The plaster according to claim 1 or 2, wherein the active ingredient is contained or supported on the adhesive base layer by applying a solution in which the active ingredient is dissolved or dispersed on the adhesive base layer. Production method.

5. The method for producing a plaster according to claim 4, wherein the solution is obtained by dissolving or dispersing an active ingredient in a medium having affinity or compatibility with the adhesive base layer.

[6] The method for producing a plaster according to any one of [1] to [5], wherein the adhesive base layer is composed of a hot-melt adhesive.

[7] The adhesive base layer according to any one of claims 1 to 6, wherein the thickness of the adhesive base layer is 10 to 1000 / im.

The manufacturing method of the plaster as described in one.

[8] The method for producing a plaster according to any one of [1] to [7], wherein the support is a woven fabric made of polyester fiber, and the liner is a polyethylene terephthalate film.

[9] The method for producing a plaster according to any one of [1] to [8], wherein the temperature at which the activity of the active ingredient is not lowered is about 35 to about 100 ° C.

[10] The method for producing a plaster according to any one of [8] to [8], wherein the temperature at which the activity of the active ingredient is not lowered is about 35 to about 80 ° C.

[11] A plaster obtained by the method for producing a plaster according to any one of claims 3 to 10, wherein the concentration distribution of the active ingredient in the adhesive layer is large on the liner side.

[12] An apparatus for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order,

A support transport means for transporting the support;

Liner conveying means for conveying the liner;

An adhesive base layer forming means for forming an adhesive base layer on either the support or the liner to be conveyed;

An active ingredient-carrying layer forming means for forming an active ingredient-carrying layer by forming an active ingredient-containing layer on the other of the carrier and the liner to be conveyed;

Temperature detecting means for detecting the temperature of the adhesive base layer;

In a state where the temperature detected by the temperature detection means has dropped to a temperature that does not reduce the activity of the active ingredient, the active ingredient-supporting layer is bonded to the surface of the adhesive base layer, and the active ingredient is then added to the adhesive base layer. Means for adhering the adhesive base layer to be contained or carried in the active ingredient and the active ingredient carrying layer;

A plaster manufacturing apparatus comprising:

[13] An apparatus for producing a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order,

A support transport means for transporting the support;

Liner conveying means for conveying the liner;

On the formed adhesive base layer, a solution in which the active ingredient is dissolved or dispersed is applied in a state where the temperature detected by the temperature detecting means has decreased to the temperature without reducing the activity of the active ingredient. Active ingredient coating containing or supporting active ingredient in adhesive base layer Cloth means;

A laminating means for laminating either the support or the liner on the adhesive base layer containing or carrying the active ingredient;

A plaster manufacturing apparatus comprising:

[14] The device according to claim 12, further comprising temperature adjusting means for adjusting the pressure-sensitive adhesive layer to a temperature that does not decrease the activity of the effective component before the pressure-sensitive adhesive base layer and the active ingredient-carrying layer are bonded to each other. Production equipment for plaster.

[15] The apparatus of claim 13, further comprising a temperature adjusting means for adjusting the pressure-sensitive adhesive layer to a temperature that does not decrease the activity of the active ingredient before applying a solution in which the active ingredient is dissolved or dispersed in the pressure-sensitive adhesive base layer. The manufacturing apparatus of the plaster of description.

[16] The plaster manufacturing apparatus according to any one of [12] to [15], wherein the temperature detection means is a non-contact infrared thermosensor.

[17] An adhesive base layer forming roll in which the adhesive base layer forming means spreads the supplied high-temperature adhesive on the roll surface to form an adhesive base layer; It consists of a laminating roll for laminating the adhesive base layer on one side,

15. The plaster manufacturing apparatus according to claim 14, wherein the temperature adjusting means is a cooler that is attached to the laminating roll in a heat exchange manner and reduces the temperature of the adhesive base layer to a temperature that does not decrease the activity of the active ingredient. .

[18] The temperature adjusting means allows at least the temperature of the adhesive base layer to be an effective component by passing either the support to be conveyed or the liner and the adhesive base layer formed thereon. 16. The apparatus for producing a plaster according to claim 14, wherein the apparatus is a cooling section that lowers the temperature to a temperature that does not decrease the activity.

[19] A liner used for a plaster in which a support, an adhesive layer containing or carrying an active ingredient, and a liner are laminated in this order,

A plaster liner in which an active ingredient-containing layer is formed on a liner in advance for containing or carrying an active ingredient by bonding to an adhesive base layer.

[20] The coating formed by applying a solution in which the active ingredient is dissolved or dispersed in a medium having an affinity or compatibility with the adhesive base layer on the liner. The plaster liner according to claim 19.