JPWO2010090346A1 - Film substrate for patch and patch - Google Patents

Abstract

Excellent in stretch, chemical resistance, flexibility, etc., when used as a patch, due to swelling of the film base due to the effect of the adhesive layer containing the drug, etc. Provided are a film base material for a patch and excellent in adhesion to an adhesive layer containing a drug and the like and fit to the body, and a patch using the same. A film base material for a patch made by laminating a water-swellable polyurethane layer on one surface of an elastomer layer, wherein the stress (10% modulus) at 10% elongation of the film base material for a patch is 0.2 to 3 A film base material for a patch, which has a 0.0N / 25 mm, 20% modulus of 0.3 to 4.0 N / 25 mm, and a 50% modulus of 0.5 to 5.0 N / 25 mm.

Description

  The present invention relates to a film base material for a patch and a patch material using the same, and in particular, is excellent in stretch properties, chemical resistance, flexibility, and the like, and includes an adhesive containing a drug or the like when used as a patch material. Film base material for patch materials that does not cause strength reduction or wrinkles due to swelling of the film base material due to the effect of the adhesive layer, and also has excellent adhesion to the pressure-sensitive adhesive layer containing chemicals, etc. and fit to the body And a patch using the same.

Conventionally, as a patch to be affixed to the skin for the purpose of cosmetics, treatment, etc., an adhesive layer provided on a base material for a patch is generally used. As a non-woven fabric has been used. However, since the nonwoven fabric has a large thickness and is inferior in flexibility, there is a problem that the patch using the nonwoven fabric as the patch base material is not excellent in usability. In addition, a patch using a non-woven fabric as a base material for a patch is not transparent, and there is a problem that the patch is conspicuous when it is stuck on the skin.
Therefore, it has been proposed to use a film such as a polyethylene film or a vinyl chloride film as a base material for a patch.
However, since these film base materials have low adhesion to the adhesive layer provided on the film base material when used as an adhesive material, the adhesive layer peels off from the film base material, and the adhesive material applied to the skin There was a problem that an adhesive layer remained on the skin surface when peeling.

In addition, when the film base material is used as a patch, the film base material swells due to the influence of chemicals and additives contained in the adhesive layer provided on the film base material, resulting in the strength of the film base material. In addition, there was a problem that wrinkles were generated on the film substrate.
In order to solve the above problem, for example, in Patent Document 1 (Japanese Patent Laid-Open No. 1-249719), a soft vinyl chloride resin film blended with a polymer polyester plasticizer is laminated and adhered to the surface of a polyethylene terephthalate film. Furthermore, a skin patch comprising a pressure-sensitive adhesive layer containing a drug on the polyethylene terephthalate film side is disclosed.
The patch as shown in Patent Document 1 is a film in which the polyethylene terephthalate film is excellent in chemical resistance and solvent resistance, so that the chemicals and additives in the adhesive layer do not migrate to the film base. The strength of the substrate does not decrease, and the film substrate does not wrinkle.
However, the polyethylene terephthalate film used for the film substrate has a problem that flexibility and stretchability are low, and sufficient fit to the body cannot be obtained.
In addition, the vinyl chloride resin used for the film base material is not preferably used in recent years because it may generate dioxins during incineration, and in view of environmental problems, an alternative to a non-chlorinated material is required. Yes.

  In this way, it is excellent in stretch properties, chemical resistance, flexibility, etc., and when used as a patch, strength reduction and wrinkles occur due to swelling of the film substrate due to the influence of the adhesive layer containing the drug etc. In addition, a film base material for a patch and excellent in adhesion to an adhesive layer containing a drug and the like and a fit to the body and a patch using the same have not been obtained yet.

JP-A-1-249719

  The present invention has been made in view of such a current situation, and the object of the present invention is excellent in stretchability, chemical resistance, flexibility, and the like, and when used as a patch, includes an adhesive or the like. Film base material for patch materials that does not cause strength reduction or wrinkles due to swelling of the film base material due to the effect of the adhesive layer, and also has excellent adhesion to the pressure-sensitive adhesive layer containing chemicals, etc. and fit to the body And providing a patch using the same.

As a result of intensive studies, the present inventors can solve the above problems by laminating a layer made of an elastomer resin (elastomer layer) and a layer made of a water-swellable polyurethane resin (water-swellable polyurethane layer). The present invention has been found to be possible, and the present invention has been completed based on this.
That is, the present invention relates to a film base material for a patch made by laminating a water-swellable polyurethane layer on one surface of an elastomer layer, and a stress (10% modulus) at 10% elongation of the film base material for a patch Is a film base material for a patch having a 0.2% to 3.0N / 25mm, a 20% modulus of 0.3 to 4.0N / 25mm, and a 50% modulus of 0.5 to 5.0N / 25mm.
The elastomer layer may be formed of at least one elastomer resin selected from a polyamide elastomer resin, a polyurethane elastomer resin, a polyacryl elastomer resin, a polyester elastomer resin, and a polystyrene elastomer resin. preferable.

Moreover, it is preferable that the film base material for a patch material has an elastic recovery rate of 60% or more after 60% elongation and a breaking strength of 20 MPa or more.
The water-swellable polyurethane layer preferably has a linear water swelling ratio of 1 to 30%.
Another aspect of the present invention is a patch comprising an adhesive layer provided on a water-swellable polyurethane layer of the film base for a patch.

  According to the present invention, it is excellent in stretch properties, chemical resistance, flexibility, etc., and when used as a patch, strength reduction and wrinkles occur due to swelling of the film substrate due to the influence of the adhesive layer containing the drug and the like. In addition, it is possible to provide a film base material for a patch and excellent in adhesion to a pressure-sensitive adhesive layer containing a drug and the like and excellent fit to the body, and a patch using the same.

The film base material for a patch according to the present invention (which may be simply referred to as “film base material”) is water-swelled on one side of a layer (elastomer layer) made of a resin (elastomer resin) having excellent stretch properties. A layer (water-swellable polyurethane layer) made of a conductive polyurethane resin is laminated.
In addition, when producing a patch using the film base material for a patch according to the present invention, an adhesive layer is provided on the water-swellable polyurethane layer.
Since the elastomer layer has elasticity, when used as a patch, it becomes possible to obtain the stretch properties and film strength required as a patch.
Examples of the elastomer resin used in the elastomer layer of the present invention include polyamide elastomer resin, polyurethane elastomer resin, polyacryl elastomer resin, polyester elastomer resin, polystyrene elastomer resin, and the like. One type is preferably used, and two or more types may be mixed and used. Of these, polyurethane elastomer resins are preferably used because they are excellent in flexibility, stretchability and tensile elasticity.

Here, the polyurethane elastomer resin is an elastomeric polymer obtained by reacting an isocyanate component and a polyol component.
Examples of the isocyanate component include aliphatic diisocyanates, aromatic diisocyanates, alicyclic diisocyanates, and the like, and these are used alone or in combination of two or more.
More specifically, as aliphatic diisocyanate, 1,6-hexamethylene diisocyanate and the like, as aromatic diisocyanate, xylylene diisocyanate, 4,4′-diphenylmethane diisocyanate, tolylene diisocyanate, and the like, alicyclic Examples of the diisocyanate include 1,4-cyclohexane diisocyanate, dicyclohexylmethane diisocyanate, and isophorone diisocyanate. Moreover, you may use trifunctional or more than functional isocyanate as needed.

On the other hand, as the polyol component; polyester polyol using polyethylene adipate, polybutylene adipate, polycaprolactone polyol, etc .; polycarbonate polyol using polyhexamethylene carbonate, etc .; using polyethylene glycol, polypropylene glycol, polytetramethylene glycol, etc. And polyether polyols.
Furthermore, the polyurethane elastomer resin is preferably a non-yellowing resin.
Here, the non-yellowing type resin is a resin that does not yellow due to external factors such as light, or is extremely unlikely to cause yellowing. In the case of a polyurethane elastomer resin, an aromatic isocyanate is used. A polyurethane-based elastomer resin using an isocyanate component other than (for example, 1,6-hexamethylene diisocyanate, dicyclohexylmethane diisocyanate).
By using a non-yellowing type resin, the elastomer layer swells due to the influence of the adhesive layer containing a drug, etc., and wrinkles are formed on the film substrate, compared to the case where a hardly yellowing type or yellowing type resin is used. Generation | occurrence | production can be suppressed more, and the strength fall of a film base material can be suppressed more.

In addition, the elastomer resin should essentially be an elastomer resin that does not exhibit water swellability.
When using a water-swellable elastomer resin, particularly a water-swellable polyurethane-based elastomer resin as the elastomer resin, the elastomer layer may swell due to the influence of the adhesive layer containing a drug or the like when used as a patch. There are fears that wrinkles will be generated on the film substrate, and the strength of the film substrate may be reduced.
Specific examples of the non-yellowing polyurethane-based elastomer resin preferably used in the present invention include, for example, a non-yellowing-type polycarbonate-based polyurethane resin, a non-yellowing-type polyester-based polyurethane resin, a non-yellowing-type polyether-based polyurethane resin, and a combination thereof. Polymers and the like can be mentioned, and a non-yellowing polycarbonate polyurethane resin is particularly preferably used from the viewpoint of chemical resistance and solvent resistance.
In addition, the elastomer resin may include a crosslinking agent, inorganic particles, a plasticizer, an antioxidant, an ultraviolet absorber, a smoothing agent such as an amide wax, a hydrolysis inhibitor, a pigment, an anti-yellowing agent, and a matting agent as necessary. Various additives such as may be added.

The thickness of the elastomer layer is preferably 5 to 50 μm, more preferably 10 to 30 μm.
If the thickness of the elastomer layer is less than 5 μm, the strength required as a patch cannot be obtained, and the handleability may be inferior. Moreover, when thickness exceeds 50 micrometers, the softness | flexibility of a film base material cannot fully be obtained, and when it is used as a patch, there exists a possibility that it may become inferior to a usability | use_condition.

As a method for producing the elastomer layer, the above-mentioned elastomer resin is diluted directly or with an appropriate organic solvent, and then a knife coater, comma coater, roll is formed on a substrate having release properties (release paper, release film, etc.). Examples thereof include a method of producing by coating using a coater, die coater, lip coater, etc., and a method of simultaneously producing an elastomer layer and a release film substrate by an inflation method. Among these, a method using a knife coater or a comma coater is preferably used because it has good film thickness accuracy and excellent film thinning.
Examples of the organic solvent include: ketone solvents such as methyl ethyl ketone (MEK) and acetone; dimethylformamide (DMF); aromatic solvents such as toluene; ether solvents such as tetrahydrofuran; petroleum solvents such as petroleum spirit; Alcohols, such as isopropylene alcohol (IPA), are mentioned, It can use individually or in the state which mixed 2 or more types.

The film base material for a patch according to the present invention is required to further have a layer (water-swellable polyurethane layer) made of a water-swellable polyurethane resin laminated on one surface of the elastomer layer.
Since the water-swellable polyurethane layer has high affinity with a solvent component such as water contained in the pressure-sensitive adhesive layer provided when used as a patch, the water-swellable polyurethane layer is excellent in adhesion to the pressure-sensitive adhesive layer. Therefore, it is difficult for the pressure-sensitive adhesive layer to peel off from the film base material, and it is possible to prevent the pressure-sensitive adhesive layer from remaining on the skin surface when the patch applied to the skin is peeled off. Therefore, it is preferable that the water-swellable polyurethane layer is a layer made of a polyurethane resin having a film forming property, rather than the water-swellable polyurethane particles dispersed in the binder resin layer. In particular, when the elastomer layer is made of a polyurethane resin, the use of a polyurethane resin having similar mechanical properties can improve the peeling prevention property between the elastomer layer and the water-swellable resin.

Here, the water-swellable polyurethane resin is a polyurethane resin that shows swelling of the film by water absorption when it comes into contact with water in the state of the film.
Specific examples of the water swellable polyurethane resin include water swellable polyester polyurethane resin, water swellable polycarbonate polyurethane resin, water swellable polyether polyurethane resin, and copolymers thereof. Of these, a water-swellable polyether-based polyurethane resin is preferable in that it has excellent hydrolysis resistance.
The water-swellable polyurethane layer formed of the water-swellable polyurethane resin preferably has a linear water swelling ratio of 1 to 30%, more preferably 5 to 25%.

Here, the linear water swelling rate is obtained by cutting the test piece into 5 cm × 5 cm, marking a diagonal line of 5 cm, and then immersing in water at 25 ° C. (± 5 ° C.) for 30 minutes, and then measuring the length of the marked line X [Cm] is a value calculated from the elongation of the marked line using the following formula.
Linear water swelling rate [%] = {(X [cm] -5 [cm]) / 5 [cm]} × 100
When the linear water swelling rate of the water-swellable polyurethane layer is less than 1%, when used as a patch, the adhesive with the adhesive layer provided on the water-swellable polyurethane layer is low, and the patch is affixed to the skin When peeling off, there is a possibility that problems such as an adhesive layer remaining on the skin surface may occur.
Further, when the linear water swelling ratio of the water-swellable polyurethane layer exceeds 30%, the water-swellable polyurethane layer swells greatly due to the influence of the agent contained in the adhesive layer when used as a patch, and the film substrate There is a risk that wrinkles may occur and the strength of the film substrate may be reduced.

The thickness of the water-swellable polyurethane layer is preferably 1 to 20 μm, more preferably 3 to 15 μm.
When the thickness of the water-swellable polyurethane layer is less than 1 μm, the adhesiveness between the pressure-sensitive adhesive layer and the film base material becomes insufficient, and the pressure-sensitive adhesive layer may be peeled off from the film base material. There is a possibility that an adhesive layer may remain on the skin surface when peeling. On the other hand, if the thickness exceeds 20 μm, the water-swellable polyurethane layer may be greatly swollen due to the influence of the drug contained in the adhesive layer when used as a patch, and the film base may be wrinkled. The strength of the material may be reduced.
Furthermore, the thickness of the water-swellable polyurethane layer is preferably less than 40% of the thickness of the film substrate, and more preferably less than 30%.
When the thickness of the water-swellable polyurethane layer is 40% or more of the film substrate thickness, the water-swellable polyurethane layer greatly swells due to the influence of the drug contained in the adhesive layer when used as a patch, There exists a possibility that a wrinkle may generate | occur | produce in a film base material, and there exists a possibility that the intensity | strength of a film base material may fall.

As a method of laminating the water-swellable polyurethane layer on the elastomer layer, for example, the water-swellable polyurethane resin is diluted directly or with an appropriate organic solvent, and a knife coater, comma coater, roll coater, die coater, Examples thereof include a method of applying with a lip coater and the like, and a method of forming a water-swellable polyurethane film and then laminating it on an elastomer layer and thermally fusing it. Especially, the method of apply | coating with a knife coater and a comma coater is preferable, since the precision of film thickness is good and it is excellent in film thinning.
Here, examples of the organic solvent include ketone solvents such as methyl ethyl ketone (MEK) and acetone; dimethylformamide (DMF); aromatic solvents such as toluene; ether solvents such as tetrahydrofuran; petroleum solvents such as petroleum spirit; Examples thereof include alcohols such as isopropyl alcohol (IPA), and these can be used alone or in a mixture of two or more.

The thus obtained film base material for a patch according to the present invention has a stress at 10% elongation (10% modulus) of 0.2 to 3.0 N / 25 mm and a 20% modulus of 0.3 to 4. 0.0 N / 25 mm, 50% modulus is required to be 0.5 to 5.0 N / 25 mm.
If each stress value is smaller than the above range, the film base material becomes too flexible, and when the adhesive material is applied to the skin surface or when the adhesive material is peeled off from the skin surface, the adhesive material greatly expands and contracts. Since it easily deforms, it becomes difficult to handle it as a patch.
On the other hand, when each stress value exceeds the above range, the film base material becomes hard, and when the adhesive material is used especially on the joint part of the body, the follow-up surname is lacking. Moreover, when the film base material becomes hard, a feeling of contact with the skin is given, and the feeling of use becomes extremely bad.
In addition, each stress value of a film base material can be measured with the measuring method as described in the Example mentioned later.

The film substrate according to the present invention preferably has an elastic recovery rate of 80% or more after stretching 60%, more preferably 85% in consideration of the case where the patch is used for a bent part of the body. That's it.
If the elastic recovery rate after 60% elongation is less than 80%, the patch will lack trackability especially when used on the joints of the body.
In addition, the elastic recovery factor of a film base material can be measured with the measuring method as described in the Example mentioned later.
In addition, the film substrate according to the present invention preferably has a breaking strength of 20 MPa or more, and more preferably 25 MPa or more.
When the strength of the film substrate is less than 20 MPa, when used as a patch, there is a possibility that the film substrate may be easily broken due to a load such as tension in a bent portion such as a joint.
In addition, the breaking strength of a film base material is calculated | required by the measuring method shown in the Example mentioned later.

Moreover, the patch which is another aspect of this invention can be obtained by providing an adhesive layer on the water-swellable polyurethane layer of the film base for patch.
Examples of the pressure-sensitive adhesive used in the pressure-sensitive adhesive layer include pressure-sensitive adhesives used for patch materials, such as acrylic pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives, silicone-based pressure-sensitive adhesives, and gel-type pressure-sensitive adhesives. What is necessary is just to select suitably according to a use purpose.
Moreover, you may make the said adhesive layer contain a skin absorptive chemical | medical agent etc. as needed.
Examples of the drug include, but are not limited to, acetaminophen, mefenamic acid, flufenamic acid, indomethacin, diclofenac, diclofenac sodium, alclofenac, oxyphenbutazone, phenylbutazone, ibuprofen, flurbipro Fen, salicylic acid, methyl salicylate, glycol salicylate, 1-menthol, camphor, sulindac, tolmetin sodium, naproxen, fenbufen, etc. Anesthetics, antibacterial substances, antifungal substances, vitamins, antidepressants, coronary vasodilators, antihistamines, antitussives, sex hormones, antidepressants, cerebral circulation improving agents, antiemetics, antiulcer agents and the like.
These agents may be used alone or in combination of two or more as necessary.

Moreover, you may use the said chemical | medical agent in the state melt | dissolved in the solubilizer as needed.
Examples of the solubilizer used include benzyl alcohol, butyl benzoate, isopropyl myristate, octanol, 1,3-butanediol, propylene glycol, crotamiton, polypropylene glycol, ethylene glycol, and glycerin.
The mixing ratio of the pressure-sensitive adhesive and the drug varies depending on the type of pressure-sensitive adhesive and drug used, but usually the ratio of the drug in the mixture of both is in the range of 0.1 to 30% by weight. It is preferable to prepare.
The method for providing the pressure-sensitive adhesive layer on the film base material for a patch according to the present invention is not particularly limited. For example, a method of directly applying the pressure-sensitive adhesive on the water-swellable polyurethane layer, Examples include a method in which a pressure-sensitive adhesive layer is formed on a moldable substrate, and the release layer is superimposed on the water-swellable polyurethane layer to transfer the pressure-sensitive adhesive layer.
The pressure-sensitive adhesive layer may be provided on the entire surface of the water-swellable polyurethane layer, or may be partially provided in a pattern such as a linear shape, a mesh shape, or a dot shape.

The thickness of the pressure-sensitive adhesive layer is preferably 1 to 1500 μm, and 50 to 800 μm is preferable for a drug having a relatively low diffusion rate in the pressure-sensitive adhesive layer. If the thickness of the pressure-sensitive adhesive layer is less than 1 μm, the amount of the pressure-sensitive adhesive is small, and sufficient adhesiveness may not be obtained. On the other hand, when the thickness exceeds 1500 μm, the residual rate of the drug on the skin surface is increased, and there is a risk that the drug remaining on the skin surface may cause rash and the like. In addition, there is a possibility that rash may occur due to a decrease in moisture permeability of the patch.
The patch obtained in this way may further be provided with a release paper on the pressure-sensitive adhesive layer. By providing release paper on the pressure-sensitive adhesive layer, the surface of the pressure-sensitive adhesive layer can be protected until the patch is used.
As the release paper, release paper generally used for a patch may be used, and is not particularly limited.

The adhesive material according to the present invention thus obtained is a film base material provided with a pressure-sensitive adhesive layer and allowed to stand in a 60 ° C. environment for 20 days as compared with a film base material not provided with a pressure-sensitive adhesive layer. The strength retention is preferably 60% or more, and more preferably 65% or more.
If the strength retention is less than 60%, the manufactured patch may lose sufficient strength to withstand actual use during the period from manufacture to actual use.
In addition, the strength deterioration of the film base material is caused by the quality change or deterioration of the film base material due to the influence of a drug or the like contained in the adhesive layer.
The strength retention of the film substrate is determined by the measurement method shown in the examples described later.

EXAMPLES Hereinafter, although an Example and a comparative example demonstrate this invention concretely, this invention is not limited to these at all.
In addition, each measurement and evaluation in the following examples and comparative examples were performed according to the following methods.
[Stress value of film substrate]
In accordance with JIS L 1096, a test piece having a width of 25 mm is stretched at a gripping interval of 50 mm and a tensile speed of 150 mm / min, whereby a stress value at each elongation of 10%, 20%, and 50%, that is, 10% modulus. Value, 20% modulus value and 50% modulus value were measured respectively. In addition, Shimadzu Corporation autograph AG-IS was used for the measurement.
[Elastic recovery rate of film substrate]
In accordance with JIS L 1096, a test piece having a width of 25 mm was stretched by 30 mm at a gripping interval of 50 mm and a tensile speed of 150 mm / min, and immediately recovered to the gripping interval at the same speed, and the residual elongation L [mm] at this time was increased. It was measured. In addition, Shimadzu Corporation autograph AG-IS was used for the measurement.
From the results, the elastic recovery rate at 60% elongation was calculated using the following formula.
Elastic recovery rate at 60% elongation [%]
= {(30 [mm] -L [mm]) / 30 [mm]} × 100

[Break strength of film substrate]
In accordance with JIS L 1096, a test piece having a width of 25 mm was stretched at a grip interval of 50 mm and a tensile speed of 150 mm / min, and the strength at break was measured. In addition, Shimadzu Corporation autograph AG-IS was used for the measurement.
[Linear water swelling rate]
The resin layer provided on the pressure-sensitive adhesive layer side of the elastomer layer is cut into 5 cm × 5 cm, a 5 cm marked line is marked on the diagonal line, and immersed in water at 25 ° C. (± 5 ° C.) for 30 minutes, then the marked line length X [Cm] was measured and calculated from the elongation of the marked line using the above formula.
[Strength retention rate of film base material with adhesive layer]
The strength retention of the film base material when the pressure-sensitive adhesive layer was provided on the film base material of Examples and Comparative Examples was determined by the following method.
In addition, in this specification, the intensity | strength retention rate of the film base material was calculated | required about two types of adhesive layers (the adhesive layer a and the adhesive layer b). The coating liquids a and b for providing the pressure-sensitive adhesive layer have the following formulation.
<Prescription of coating liquid a>
Glycyl salicylate 5 parts by weight 1-menthol 7 parts by weight Acrylic adhesive 40 parts by weight <Prescription of coating liquid b>
Indomethacin 1 part by weight 1-menthol 7 parts by weight Liquid paraffin Trace amount Acrylic adhesive 40 parts by weight In addition, both salicylic acid glycol contained in the coating liquid a and indomethacin contained in the coating liquid b are frequently used for the patch. It is a drug that has been.
Moreover, l-menthol is frequently used for a patch for the purpose of imparting a refreshing feeling.
The coating liquid having the above composition was directly applied to one side of the film bases produced in Examples and Comparative Examples so that the coating amount was 50 g / m ² (dry weight) to form a 50 μm thick adhesive layer.

The strength retention of each film substrate was determined by the following method.
First, based on the method for measuring the breaking strength of a film substrate described above, the breaking strength A [MPa] of a film substrate not provided with an adhesive layer was measured.
Subsequently, the adhesive material which provided the adhesive layer a or the adhesive layer b on each film base material by the said method was produced.
This was left for 20 days in an environment of 60 ° C., respectively, and then the strength at break B [MPa] of the film substrate provided with the pressure-sensitive adhesive layer based on the same measurement method as that for measuring the break strength of the film substrate. Was measured.
Using these measurement results, the strength retention of the film substrate was calculated by the following formula.
Strength retention of film base material (%) = B [MPa] / A [MPa] × 100

[Adhesion between film substrate and adhesive layer]
For each film substrate provided with the pressure-sensitive adhesive layer a or b, similar to the one used when determining the strength retention of the film base material, the ear part of the film substrate (the part where the pressure-sensitive adhesive layer is not formed) ) By hand, and the pressure-sensitive adhesive layer was peeled off with a finger to try to peel the film substrate from the pressure-sensitive adhesive layer.
From the results, the adhesion between the film substrate and the pressure-sensitive adhesive layer was evaluated based on the following criteria.
A: Cohesive failure of the pressure-sensitive adhesive layer (breakage of the pressure-sensitive adhesive layer) occurred, and no interfacial peeling between the film substrate and the pressure-sensitive adhesive layer was observed.
Δ: cohesive failure of the pressure-sensitive adhesive layer and interfacial peeling between the film substrate and the pressure-sensitive adhesive layer were observed.
X: The film base material and the pressure-sensitive adhesive layer were peeled at the interface, and cohesive failure of the pressure-sensitive adhesive layer was not observed.

[Wrinkling of the film substrate when an adhesive layer is provided]
For each film substrate provided with the adhesive layer a or b, similar to the one used when determining the strength retention of the film substrate, visually check whether the film substrate is wrinkled. Evaluation was made based on the following criteria.
○: Wrinkles were not observed on the film substrate.
(Triangle | delta): Generation | occurrence | production of some wrinkles was recognized by the film base material.
X: Generation | occurrence | production of wrinkles was recognized by the film base material.
[Usability of film base material when an adhesive layer is provided]
Each film substrate provided with the adhesive layer a or b, similar to the one used when determining the strength retention rate of the film substrate, was actually tried to be applied to the skin, and it was easy to apply and to the skin. The following property was confirmed and evaluated based on the following criteria.
○: Easy to apply to the skin and good followability to the skin.
X: Sticking to the skin is difficult or followability to the skin is poor.

[Example 1]
First, a polyurethane resin solution having the following formulation was prepared.
<Prescription of polyurethane resin solution>
Rezamin NE-8880
(Daiichi Seika Kogyo Co., Ltd.
Non-yellowing type polycarbonate-based polyurethane elastomer resin) 100 parts by weight Rezaroid LU-4007
(Surface treatment agent, manufactured by Dainichi Seika Kogyo Co., Ltd.) 40 parts by weight Toluene 70 parts by weight Isopropyl alcohol (IPA) 30 parts by weight Next, on the mat-type release paper (EV-130TPD, manufactured by Lintec Corporation), the polyurethane resin The solution was applied using a comma coater and dried at 130 ° C. for 2 minutes, and then the matte release paper was peeled off to produce an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y231
(Daiichi Seika Kogyo Co., Ltd., polyether polyurethane resin)
100 parts by weight UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight Methyl ethyl ketone (MEK) 60 parts by weight Next, the water-swellable polyurethane resin solution is added to one side of the elastomer layer with a comma. It was coated using a coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer.
Thus, the film base material for patch of Example 1 was obtained.
Each evaluation result of Example 1 is shown in Table 1. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Example 2]
First, a polyurethane resin solution having the following formulation was prepared.
<Prescription of polyurethane resin solution>
Rezamin NE-308
(Daiichi Seika Kogyo Co., Ltd.
Non-yellowing polyester polyurethane elastomer resin) 100 parts by weight Rezaroid LU-4007 (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent)
40 parts by weight Toluene 70 parts by weight Isopropyl alcohol (IPA) 30 parts by weight Next, the polyurethane resin solution was applied onto mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater, and 130 ° C. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y231
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether-based polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone (MEK) The water-swellable polyurethane resin solution is applied to one side of the layer using a comma coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. It was.
Thus, the film base material for patch of Example 2 was obtained.
Each evaluation result of Example 2 is shown in Table 1. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Example 3]
The same polyurethane resin solution as that prepared in Example 1 was used, and the polyurethane resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y208
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether-based polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone (MEK) The water-swellable polyurethane resin solution is applied to one side of the layer using a comma coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. It was.
Thus, the film base material for patch of Example 3 was obtained.
The evaluation results of Example 3 are shown in Table 1. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Example 4]
The same polyurethane resin solution as that prepared in Example 1 was used, and the polyurethane resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y611-124
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether-based polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone (MEK) The water-swellable polyurethane resin solution is applied to one side of the layer using a comma coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. It was.
Thus, the film base material for patch of Example 1 was obtained.
The evaluation results of Example 4 are shown in Table 1. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Example 5]
First, a water-swellable polyurethane resin solution having the formulation described in Example 1 was applied to one side of a polyamide-based elastomer resin film (Pebax MX1205 SP01, thickness 40 μm, manufactured by Arkema Co., Ltd.) using a comma coater. Drying for 5 minutes was performed to form a water-swellable polyurethane layer having a thickness of 5 μm.
Thus, the film base material for patch of Example 5 was obtained.
Each evaluation result of Example 5 is shown in Table 1. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Comparative Example 1]
The same polyurethane resin solution as that prepared in Example 1 was used, and an elastomer layer having a thickness of 20 μm was prepared by the same method. This was used as a film base material for a patch of Comparative Example 1.
The evaluation results of Comparative Example 1 are shown in Table 2.

[Comparative Example 2]
Using the same water-swellable polyurethane resin solution used in Example 1, the resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater, After drying at 130 ° C. for 2 minutes, the mat-type release paper was peeled off to prepare a water-swellable polyurethane layer having a thickness of 20 μm, which was used as a film base material for a patch of Comparative Example 2.
The evaluation results of Comparative Example 2 are shown in Table 2.

[Comparative Example 3]
First, a polyurethane resin solution having the following formulation was prepared.
<Prescription of polyurethane resin solution>
Crisbon 2026EL
(DIC Industrial Co., Ltd.
Hard yellowing polyester polyurethane elastomer resin) 100 parts by weight Rezaroid LU-4007 (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent)
40 parts by weight Toluene 70 parts by weight Isopropyl alcohol (IPA) 30 parts by weight Next, the polyurethane resin solution was applied onto mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater, and 130 ° C. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y231
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether-based polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone (MEK) The water-swellable polyurethane resin solution is applied to one side of the layer using a comma coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. It was.
Thus, the film base material for patch of Comparative Example 3 was obtained.
Table 2 shows the evaluation results of Comparative Example 3. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Comparative Example 4]
First, a polyurethane resin solution having the following formulation was prepared.
<Prescription of polyurethane resin solution>
Rezamin NE-8836
(Daiichi Seika Kogyo Co., Ltd.
Non-yellowing type polycarbonate-based polyurethane elastomer resin) 100 parts by weight Rezaroid LU-4007 (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent)
40 parts by weight Toluene 70 parts by weight Isopropyl alcohol (IPA) 30 parts by weight Next, the polyurethane resin solution was applied onto mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater, and 130 ° C. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyurethane resin solution having the following formulation was prepared.
<Prescription of water-swellable polyurethane resin solution>
Heimlen Y231
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether-based polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone (MEK) The water-swellable polyurethane resin solution is applied to one side of the layer using a comma coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. It was.
Thus, the film base material for patch of Comparative Example 4 was obtained.
Table 2 shows the evaluation results of Comparative Example 4. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Comparative Example 5]
The same polyurethane resin solution as that prepared in Example 1 was used, and the polyurethane resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a water-swellable polyvinyl alcohol resin solution having the following formulation was prepared.
<Prescription of water-swellable polyvinyl alcohol resin solution>
JMR-30L
(Polyvinyl alcohol-based resin, manufactured by Nippon Vineyard & Poval Co., Ltd.) 20 parts by weight Mixed solvent of 40% water and 60% IPA 85 parts by weight Next, the water-swellable polyvinyl alcohol resin solution is added to one side of the elastomer layer with a comma. It was applied using a coater and dried at 130 ° C. for 2 minutes to form a water-swellable polyvinyl alcohol layer having a thickness of 5 μm on one side of the elastomer layer.
In this manner, a film base material for patch of Comparative Example 5 was obtained.
Each evaluation result of Comparative Example 5 is shown in Table 2. In addition, an adhesive layer shall be produced on a water-swellable polyvinyl alcohol layer.

[Comparative Example 6]
The same polyurethane resin solution as that prepared in Example 1 was used, and the polyurethane resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.
Next, a water-swellable polyester resin solution (Plus Coat Z-880 (manufactured by Kyoyo Chemical Industry Co., Ltd., water-soluble polyester resin, liquid product having a solid content of 25%)) is applied to one side of the elastomer layer using a comma coater. Then, drying was performed at 130 ° C. for 2 minutes to form a water-swellable polyester layer having a thickness of 5 μm on one side of the elastomer layer.
In this way, a film base material for patch of Comparative Example 6 was obtained.
The evaluation results of Comparative Example 6 are shown in Table 2. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Comparative Example 7]
The same polyurethane resin solution as that prepared in Example 1 was used, and the polyurethane resin solution was applied onto a mat-type release paper (EV-130TPD, manufactured by Lintec Corporation) using a comma coater. After drying for 2 minutes, the mat-type release paper was peeled off to prepare an elastomer layer having a thickness of 20 μm.

Next, a hydrophilic and non-water-swellable polyurethane resin solution having the following formulation was prepared.
<Formulation of hydrophilic and non-water-swellable polyurethane resin solution>
Heimlen Y210B
100 parts by weight (manufactured by Dainichi Seika Kogyo Co., Ltd., polyether polyurethane resin) UST-392 mat B (manufactured by Dainichi Seika Kogyo Co., Ltd., surface treatment agent) 20 parts by weight 60 parts by weight methyl ethyl ketone Next, one side of the elastomer layer The water-swellable polyvinyl alcohol resin solution is applied using a comma coater and dried at 130 ° C. for 2 minutes to form a hydrophilic and non-water-swellable polyurethane layer having a thickness of 5 μm on one side of the elastomer layer. Formed.
Thus, the film base material for patch of Comparative Example 7 was obtained.
The evaluation results of Comparative Example 7 are shown in Table 2. In addition, an adhesive layer shall be produced on a water-swellable polyurethane layer.

[Evaluation]
The film bases for patch materials of Examples 1 and 2 had high strength retention even when the pressure-sensitive adhesive layer was provided, and also had good adhesion to the pressure-sensitive adhesive layer. Moreover, wrinkles were not generated on the film base material, and the usability was excellent.
Since the comparative example 1 does not have a water swelling resin layer, adhesiveness with an adhesive layer became inadequate.
In Comparative Example 2, since the elastomer layer was composed only of the water-swelled resin layer, the film substrate was swollen due to the influence of moisture contained in the pressure-sensitive adhesive, and wrinkles were generated.
In Comparative Example 3, since the resin used for the elastomer layer has a low modulus, large wrinkles are generated when laminated with the pressure-sensitive adhesive layer.
In Comparative Example 4, since the resin used for the elastomer layer had a large modulus, it was hard and inferior in usability.
In Comparative Example 5, since the elastic recovery rate of the water-swellable polyvinyl alcohol was poor, the follow-up to the elastomer layer was poor, and the film substrate had a poor elastic recovery rate.
Since Comparative Example 6 has a poor elastic recovery rate of the water-swellable polyester resin, it is a film substrate having a poor elastic recovery rate.
Since the comparative example 7 used the polyether type polyurethane which is hydrophilic but does not have water swelling property, it is inferior to adhesiveness with an adhesive layer.
The linear water swelling ratio of the first elastomer layer used in Examples and Comparative Examples other than Comparative Example 2 is 0%.

Claims (7)

A film base material for a patch made by laminating a water-swellable polyurethane layer on one surface of an elastomer layer, wherein the stress (10% modulus) at 10% elongation of the film base material for a patch is 0.2 to 3 A film base material for a patch, which has a 0.0N / 25 mm, 20% modulus of 0.3 to 4.0 N / 25 mm, and a 50% modulus of 0.5 to 5.0 N / 25 mm. The elastomer layer is formed of at least one elastomer resin selected from a polyamide elastomer resin, a polyurethane elastomer resin, a polyacryl elastomer resin, a polyester elastomer resin, and a polystyrene elastomer resin. The film base material for a patch according to claim 1, characterized in that it is a feature. The film base for a patch according to claim 1 or 2, wherein the elastomer layer is formed of a polyurethane-based elastomer resin. The film base for a patch according to any one of claims 1 to 3, wherein the film base for the patch has an elastic recovery rate of 80% or more after 60% elongation and a breaking strength of 20 MPa or more. Wood. The film base material for a patch according to any one of claims 1 to 4, wherein the water-swellable polyurethane layer has a linear water swelling ratio of 1 to 30%. The film base material for a patch according to any one of claims 1 to 5, wherein the water-swellable polyurethane layer has a linear water swelling ratio of 5 to 25%. A patch comprising an adhesive layer provided on the water-swellable polyurethane layer of the film substrate for a patch according to claim 1.