JP7397822B2 - Oral patch sheet - Google Patents

Description

The present invention relates to an oral patch sheet.

The organs that make up the oral cavity, such as the teeth, gums, palate, and tongue, are moisturized by the saliva they secrete, and they perform functions such as chewing and swallowing food, tasting food, and speaking, which contributes to the health of the whole body. It is also an important organ involved in Therefore, when these organs become abnormal, it can lead to various diseases and functional disorders such as eating habits, and there is also a risk that aesthetics may be impaired, so care is essential to maintain, improve, and recover their functions. I can't.

Teeth are one of the organs that make up the oral cavity, and it is known that if tartar and dirt that adheres to and accumulates on the surface of the teeth are left untreated, it can cause unnecessary staining and discoloration of the gums, as well as periodontal disease and gingivitis. It is being In order to provide such appropriate care for teeth, it is necessary to take into account that the teeth are always filled with saliva, and various adhesive sheets have been developed that can act with predetermined functional ingredients.

For example, Patent Document 1 discloses a strip (dry film) for teeth whitening that contains a whitening agent and the like and is dissolved by saliva in the oral environment. Further, Patent Documents 2 and 3 disclose dry-type tooth whitening patches that have an adhesive layer and a backing layer, and when applied to the tooth, adhesive force and whitening agent start to be released due to the moisture on the tooth surface.

Special Publication No. 2007-531771 Special Publication No. 2003-526648 Special Publication No. 2006-509036

The adhesive sheets described in the above patent documents are all dry type sheets, and when applied to a desired site in the oral cavity, they dissolve with moisture such as saliva, develop adhesive properties, and contain functional ingredients. designed to emit.
Such adhesive sheets are laminated with a release sheet for the purpose of improving operability and protecting the application surface, and when used, the release sheet is peeled off and the exposed surface is applied to the desired area in the oral cavity. method may be adopted. On the other hand, in a sheet in which such an adhesive sheet and a release sheet are laminated, the production yield may decrease due to the adhesive sheet unintentionally detaching from the release sheet during the process.

However, none of the above-mentioned patent documents describes that such a problem may occur.
The present invention relates to an oral patch sheet formed by laminating a patch sheet and a release sheet, which exhibits good adhesive properties during manufacture and good releasability during use.

Therefore, after various studies, the present inventor found that in an oral patch sheet formed by laminating a release sheet and a patch sheet, by laminating a specific release sheet and a specific patch sheet, the adhesive sheet at the time of manufacture could be improved. It has been found that an oral patch sheet can be obtained that effectively prevents the patch sheet from coming off the release sheet and has good peelability from the release sheet during use.

Therefore, the present invention provides an oral patch sheet in which a patch sheet and a release sheet are laminated,
The adhesive sheet has a moisture content of 5% by mass or more and 13% by mass or less, and a thickness of 30 μm or more and 250 μm or less,
The release sheet has the following formula (I) on the surface in contact with the adhesive sheet:
Luminance difference (ΔL) = L(P) - L(X)...(I)
(In formula (I), L(P) is irradiated with 45° incident light from the left and right on the surface of the release sheet in contact with the adhesive sheet, so that the brightness of the 18% gray standard reflector becomes 120. L(X) indicates the brightness of the reflected image P of the surface in contact with the adhesive sheet when image analysis is performed.L(X) represents the brightness of the non-reflective image X of the surface in contact with the adhesive sheet when the image analysis is performed. The object of the present invention is to provide an oral patch sheet having a luminance difference (ΔL) of 4.5 or more and 19.5 or less as determined by

According to the oral patch sheet of the present invention, although it is a sheet made by laminating a patch sheet with a limited moisture content and a release sheet, it effectively prevents the patch sheet from coming off from the release sheet during manufacturing. In addition, the adhesive sheet can be easily peeled off from the release sheet when the adhesive sheet is applied to the application site during use. That is, the oral patch sheet of the present invention has the property of exhibiting good adhesion during manufacture and the property of exhibiting good releasability during use (hereinafter also referred to as "adhesion and releasability"). .
Therefore, it is possible to easily and efficiently produce oral adhesive sheets with various shapes depending on the application site.

This is an embodiment of the oral adhesive sheet of the present invention. FIG. 2 is a schematic diagram illustrating an actual use situation of an oral cavity patch sheet that is attached to the tooth periphery.

The present invention will be explained in detail below.
Here, the parts to which the oral adhesive patch sheet of the present invention is applied are the organs that make up the oral cavity, and specifically, the teeth, organs located around the teeth including the gums, the roof of the mouth, the tongue, and The floor of the mouth, etc. Note that among these parts, the teeth and the organs in the oral cavity located around the teeth, including the gums, are also particularly referred to as the "dental periphery".

The patch sheet constituting the oral patch sheet of the present invention is laminated with a release sheet, has a moisture content of 5% by mass or more and 13% by mass or less, and has a thickness of 30 μm or more and 250 μm or less. That is, in the oral patch sheet of the present invention, the patch sheet is a so-called dry type ultra-thin sheet in a dry state with a low moisture content. The oral patch sheet of the present invention is formed by laminating an adhesive sheet with specific physical properties and a release sheet having a unique uneven surface. As a result, it is stably maintained without being detached, and when the oral patch sheet of the present invention is used, it can be peeled off from the release sheet with appropriate peelability. As described above, the oral patch sheet of the present invention can exhibit good adhesive and removability, can be applied to a desired site in the oral cavity with excellent followability, and is well dissolved by moisture such as saliva. and can be closely attached.

The moisture content of the adhesive sheet can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also prevent the adhesive sheet from separating from the release sheet when it is applied to the application site during use. From the viewpoint of being able to be peeled off, being able to be applied to a desired site in the oral cavity with good tracking, and having the property of adhering well to moisture such as saliva after application, the total amount of the adhesive sheet contains: 5% by mass or more, preferably 6% by mass or more, more preferably 7% by mass or more, and 13% by mass or less, preferably 12.5% by mass or less, more preferably 12% by mass or less. % by mass or less.
The moisture content of the patch sheet is the total amount of water contained in the entire patch sheet, and means a value obtained based on a measurement method using a moisture meter using the Karl Fischer method.

The thickness of the adhesive sheet is such that it can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and it can also effectively prevent the adhesive sheet from separating from the release sheet when it is applied to the application site during use. The thickness is 30 μm or more, preferably 35 μm or more, and more preferably 50 μm, from the viewpoint of being able to adhere to the desired site and exhibiting good followability and adhesion depending on the shape of the desired site. or more, more preferably 60 μm or more, 250 μm or less, preferably 150 μm or less, and more preferably 70 μm or less.
Note that the thickness of the adhesive sheet means the average value (μm) of the thickness measured at three arbitrary locations on the adhesive sheet using a micrometer.

The strain of the adhesive sheet under a tensile stress of 20 MPa can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also prevent the adhesive sheet from peeling off when attempting to apply it to the application site during use. Preferably, from the viewpoint of being able to be peeled off well from the sheet, and from the viewpoint of preventing damage or breakage during operation while ensuring appropriate flexibility to exhibit good followability and adhesion at the application site. It is 2% or more, more preferably 3% or more, even more preferably 4% or more, preferably 12% or less, and even more preferably 11% or less.
In addition, the strain at 20 MPa tensile stress of the attached sheet is defined as the sheet to be measured using a rheometer, set in a jig for strain measurement, and the shear stress varied from 1 to 2 × 10 ⁷ Pa. This is the value obtained by measuring the strain at the time and converting the strain at a shear stress of 20 MPa into the amount of change (%) from the initial length.

The surface of the adhesive sheet that is in contact with the release sheet, that is, the surface that is exposed when the adhesive sheet is peeled off from the release sheet during use, can be applied to a desired site in the oral cavity from the viewpoint of hygiene and operability. It is preferable that the surface is

The area of the surface of the adhesive sheet that comes into contact with the release sheet can be selected as appropriate depending on the desired area in the oral cavity to which it is applied, but from the viewpoint of appropriately corresponding to the size of the desired area, and from the viewpoint of ensuring good performance during application. From the viewpoint of ensuring ease of handling, it is preferably 500 mm ² or more, more preferably 900 mm ² or more, even more preferably 1500 mm ² or more, even more preferably 1800 mm ² or more, and preferably 3000 mm ² or less. 2,500 mm ² or less, still more preferably 2,400 mm 2 or less, even more preferably 2,300 ^{mm 2 or} less.

It is preferable that the patch sheet has an active layer containing a functional component on the surface to be stuck inside the oral cavity. As a result, when the adhesive sheet of the oral adhesive sheet of the present invention is applied to a desired area, the adhesive sheet adheres to the adhesive sheet due to moisture such as saliva and dissolves, delivering and diffusing the functional ingredients contained therein to the desired area. This makes it possible to bring about the desired effects of the functional components.

The functional ingredients can be selected as appropriate depending on the desired application site and desired effect, and those commonly used as active ingredients or medicinal ingredients that can be applied to the oral cavity can be selected as appropriate. For example, anti-inflammatory/anti-inflammatory analgesics; antifungal agents/bactericidal agents; ingredients effective in preventing or treating hypersensitivity, periodontal disease, gingivitis, etc.; ingredients effective in preventing cavities; ingredients that have a whitening effect, etc. It will be done.

Specifically, anti-inflammatory/anti-inflammatory analgesics such as allantoin, ε-aminocaproic acid, tranexamic acid;
Antifungal agents/bactericidal agents such as miconazole, econazole, triclosan, isopropylmethylphenol (IPMP), benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, thymol, hinokitiol;
Fluoride ion-supplying compounds such as sodium fluoride, potassium fluoride, and ammonium fluoride, and ingredients effective in preventing tooth decay such as sodium monofluorophosphate and potassium nitrate;
Ingredients effective in preventing or treating periodontal disease, gingivitis, etc., such as glycyrrhetinic acid, glycyrrhizic acid, and salts thereof;
Examples include one or more components selected from ingredients that provide a whitening effect, such as phytic acid, pyrophosphoric acid, tripolyphosphoric acid, and salts thereof.

The content of these functional components may vary depending on the selected components, but is preferably 0.05% by mass or more, more preferably 0.07% by mass or more, and preferably 0.05% by mass or more, more preferably 0.07% by mass or more, based on the total amount of the adhesive sheet. .1% by mass or more, more preferably 30% by mass or less, more preferably 20% by mass or less, and even more preferably 15% by mass or less.

In addition to the above-mentioned functional components, the adhesive sheet can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and when trying to apply the adhesive sheet to the application site during use, the release sheet From the standpoint of being able to be peeled off well from the skin, having good followability and adhesion to the application site, and ensuring flexibility that provides good handling, it also has good solubility in moisture such as saliva. From the viewpoint of expressing this, it is preferable to contain a water-soluble polymer.
Note that the water-soluble polymer means a water-soluble polymer having a solubility in water at 25° C. of 0.1% by mass or more.

Specific examples of such water-soluble polymers include one or more selected from pullulan, hydroxyethylcellulose, guar gum, hydroxypropylcellulose, hydroxypropylmethylcellulose, gelatin, and agar.
Among these, it is possible to effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also to enable the adhesive sheet to be peeled off well from the release sheet when applying it to the application site during use. Pullulan , hydroxyethylcellulose, guar gum, hydroxypropylcellulose, hydroxypropylmethylcellulose, gelatin, and agar are preferred, and one or more are preferably selected from pullulan, hydroxypropylmethylcellulose, and gelatin. .

The water-soluble polymer content can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also prevent the adhesive sheet from separating from the release sheet when applying it to the application site during use. From the viewpoint of being able to peel off well, and from the viewpoint of imparting good followability and adhesion to the application site, good handling properties, etc., the amount is preferably 30% by mass or more, more preferably 30% by mass or more in the total amount of the adhesive sheet. is 40% by mass or more, more preferably 45% by mass or more, preferably 70% by mass or less, more preferably 65% by mass or less, even more preferably 60% by mass or less.

The adhesive sheet can effectively prevent the adhesive sheet from detaching from the release sheet during manufacture, and also allows the adhesive sheet to be easily peeled off from the release sheet when it is applied to the application site during use. It is preferable to further contain a nonionic surfactant from the viewpoint of providing good flexibility to the sheet while improving the dispersibility and diffusibility of the functional components and water-soluble polymer contained therein. Such nonionic surfactants include polyoxyethylene hydrogenated castor oil, polyglycerin fatty acid ester, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene copolymer, sucrose fatty acid ester, sorbitan fatty acid ester, glycerin fatty acid ester, polyoxy Ethylene sorbitan fatty acid ester, polyoxyethylene sorbitol fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyoxyethylene glycol fatty acid ester, polyoxyethylene phytosterol and phytostanol, polyoxyethylene lanolin and lanolin alcohol, polyoxyethylene alkylamine and fatty acid amide , polyoxyethylene alkylphenyl formaldehyde condensate, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkylphenyl ether, polyoxyethylene alkylphenyl ether, fatty acid ethanolamide, and the like. Among these, one or two selected from polyoxyethylene hydrogenated castor oil, polyglycerin fatty acid ester, sucrose fatty acid ester, and polyoxyethylene sorbitan fatty acid ester are preferred, and either polyoxyethylene hydrogenated castor oil or polyglycerin fatty acid ester It is more preferable to contain one type, and even more preferable to contain both polyoxyethylene hydrogenated castor oil and polyglycerin fatty acid ester.

The content of such a nonionic surfactant can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also prevent the adhesive sheet from separating from the release sheet when applying it to the application site during use. From the viewpoint of being able to peel off well from the adhesive sheet, and from the viewpoint of imparting good flexibility to the sheet while ensuring the dispersibility and diffusibility of the functional components, etc., the total amount of the adhesive sheet preferably contains 0.8 to 20 The content is % by mass, more preferably 2 to 10% by mass, and even more preferably 3 to 5% by mass.

In addition to the above ingredients, the patch sheet may contain, as long as the effects of the present invention are not impaired, for example, medicinal ingredients other than the above functional ingredients; surfactants other than the nonionic surfactants; fragrance; pH adjuster; wetting agent; sweetness. It may contain additives, dyes, preservatives, etc.

The patch sheet may be a sheet including only the above-mentioned working layer, but may further have a protective layer on the surface opposite to the surface on which the working layer is formed. Thereby, the ease of handling the oral adhesive sheet of the present invention can be improved. For example, if the protective layer is made of a layer having lower solubility in water such as saliva than the active layer, it becomes possible to retain or continuously release the functional components in the active layer.

Such protective layers include ethylcellulose, hydroxypropylmethylcellulose acetate succinate, cellulose acetate phthalate, hypromellose phthalate, shellac, polyvinyl acetate, polymethyl methacrylate, methacryloyl ethyl betaine/methacrylate copolymer, methacrylic acid copolymer, amino It is preferable to contain one or more water-insoluble polymers selected from an alkyl methacrylate copolymer and agar from the viewpoint of lowering the solubility in water such as saliva than in the working layer. In particular, from the viewpoint of ensuring good followability, adhesion and flexibility of the oral patch sheet of the present invention, and effectively reducing discomfort and discomfort during application to a desired area, the protective layer is One or more water-insoluble polymers selected from , ethyl cellulose, and shellac are preferred.

In addition to the above-mentioned working layer and protective layer, the patch sheet may further include an intermediate layer between the working layer and the protective layer. This makes it possible, for example, to gradually release the functional ingredient from the active layer while retaining it at the application site, and then release the desired ingredient contained in the middle layer into the oral cavity, as well as gradual and continuous dissolution. It is also easy to add gender. Desired components contained in the intermediate layer include those similar to the functional components described above, and functional components different from those contained in the working layer can also be selected.
Such an intermediate layer may be formed using the same water-soluble polymer as the working layer.

The release sheet constituting the oral patch sheet of the present invention is a sheet that exhibits a specific luminance difference (ΔL), which will be described later, on the surface in contact with the patch sheet. In this way, by laminating an adhesive sheet with specific physical properties and a release sheet that has a unique uneven surface that shows a specific luminance difference (ΔL) on the surface in contact with the adhesive sheet, there is a gap between the release sheet and the adhesive sheet. Appropriate adhesive and releasable properties can be exhibited. Therefore, when manufacturing the oral patch sheet of the present invention, even if the intraoral patch sheet is subjected to loads such as tensile stress or bending stress during tension rolls, winding, etc. The desorption of can be effectively prevented. On the other hand, when using the adhesive sheet for oral cavity of the present invention, the adhesive sheet has excellent releasability from the release sheet, and the adhesive sheet can be easily applied to a desired site.
The above luminance difference (ΔL) is expressed by the following formula (I):
Luminance difference (ΔL) = L(P) - L(X)...(I)
(In formula (I), L(P) is irradiated with 45° incident light from the left and right on the surface of the release sheet in contact with the adhesive sheet, so that the brightness of the 18% gray standard reflector becomes 120. L(X) indicates the brightness of the reflected image P of the surface in contact with the adhesive sheet when image analysis is performed.L(X) represents the brightness of the non-reflective image X of the surface in contact with the adhesive sheet when the image analysis is performed. show.)
The luminance difference (ΔL) on the surface of the release sheet in contact with the adhesive sheet is 4.5 or more and 19.5 or less.

In calculating the brightness difference (ΔL), specifically, the following image analysis method is used. First, place the release sheet horizontally on top of the non-reflective black flocked cloth with the side of the release sheet in contact with the adhesive sheet as the top surface, and then attach two lights with the polarizing axes of the linear polarizers attached in the same direction. Using illumination (LED light), 45° light (polarized light) is irradiated onto this surface from both the left and right sides. Next, using a digital single-lens reflex camera and a close-up lens equipped with a linear polarizing plate, the polarization axis of the polarizing plate attached to the lens is parallel to the polarizing plate of the illumination, and the reflected image P of the release sheet is projected onto the surface in contact with the adhesive sheet. Shoot from the normal direction. The photographed image is converted to 8-bit gray scale and used for image processing. Note that when photographing, the light amount and exposure are adjusted so that the luminance of the 18% gray standard reflector becomes 120.
Next, with the same settings as those used to obtain the reflected image P, with the polarization axis of the polarizing plate attached to the lens perpendicular to the polarizing plate of the illumination, a non-reflective image Convert to image. Image analysis is performed on the same and constant area arbitrarily selected in the reflective image P and the non-reflective image X, and the brightness (L(P)) of the reflective image P and the brightness (L(X)) of the non-reflective image X are calculated. . The obtained (L(P)) and (L(X)) are introduced into the above formula (I) to determine the luminance difference (ΔL).

The reflected image P taken by such an image analysis method is an image in which light (polarized light) specularly reflected on the surface of the release sheet and light (non-polarized light) diffusely reflected inside the release sheet are present. corresponds to On the other hand, the non-reflection image X corresponds to an image in which only light (non-polarized light) diffusely reflected inside the release sheet exists.
Therefore, the luminance difference (ΔL) obtained from the above formula (I) using these luminances (L(P)) and (L(X)) is This is an index of the intensity of light excluding diffusely reflected light, that is, a value that is an index of the intensity of surface reflected light, and is a value that depends on the shape of the surface.

On the surface of the release sheet constituting the oral cavity patch of the present invention in contact with the patch sheet, the luminance difference (ΔL) determined by the above formula (I) is 4.5 or more and 19.5 or less. Since the luminance difference (ΔL) is within such a limited range, it is possible to effectively prevent the adhesive sheet from coming off during production of the oral adhesive sheet of the present invention, It becomes possible to maintain good releasability of the release sheet during use.
On the surface of the release sheet in contact with the adhesive sheet, the luminance difference (ΔL) determined by the above formula (I) should be 4.5 or more from the viewpoint of achieving appropriate adhesive releasability between the adhesive sheet and the release sheet. and is preferably 5 or more, more preferably 7 or more, still more preferably 10 or more, and 19.5 or less, preferably 19 or less, and more preferably 18.5 or less. Yes, and more preferably 18 or less.

In order to obtain a release sheet having such a brightness difference (ΔL), it is preferable to perform sandblasting on at least one surface of the release sheet. Blasting materials used in sandblasting include nonmetallic materials such as silica sand, alumina, silicon carbide, glass beads, and ceramic beads, and metallic materials such as iron, tin, and nickel. Among these, silica sand is preferred from the viewpoint of controlling the brightness difference (ΔL) within the above range.

Therefore, the present invention provides an oral patch sheet formed by laminating a patch sheet and a release sheet, wherein the patch sheet has a moisture content of 5% by mass or more and 13% by mass or less, and a thickness of 30 μm or more and 250 μm. The release sheet is an oral patch sheet whose surface in contact with the patch sheet is sandblasted.

The area of the release sheet can be selected as appropriate depending on the area of the adhesive sheet, but from the viewpoint of ensuring good handling during application and ensuring sufficient adhesive and removability with the adhesive sheet, the area of the adhesive sheet and It is preferable that the bonding surface is a part of the release sheet. That is, the area of the release sheet is preferably larger than the area of the adhesive sheet. Specifically, the ratio (b/a) of the area of the release sheet to the area of the adhesive sheet is preferably 1.3 or more, more preferably 1.8 or more, and preferably 10 or less, More preferably it is 5 or less.
By setting the area in this way, it is possible to provide an extra area in the release sheet other than the laminated area with the adhesive sheet, so that it is possible to improve the ease of handling during application. For example, when peeling off the release sheet from the adhesive sheet when using the oral patch sheet of the present invention, by touching the excess area of the release sheet other than the laminated area with the adhesive sheet, a specific brightness difference (ΔL ) can be recognized, making it possible to easily identify and handle the adhesive sheet.

More specifically, the area of the surface of the release sheet on which the adhesive sheet is laminated can be selected as appropriate depending on the area of the adhesive sheet and the desired site in the oral cavity to which it is applied. From the viewpoint of appropriately responding to the size of the site and ensuring good handling during pasting, more specifically, it is preferably 650 mm ² or more, more preferably 1000 mm ² or more, and Preferably it is 2000 mm ² or more, even more preferably 3000 mm ² or more, preferably 30000 mm ² or less, more preferably 20000 mm ² or less, still more preferably 10000 mm ² or less, even more preferably 5000 mm ² It is as follows.

The thickness of the release sheet is such that it can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and also ensure that the adhesive sheet can be easily peeled off from the release sheet when it is applied to the application site during use. From the viewpoint of being able to do this and ensuring good followability of the adhesive sheet, the thickness is preferably 20 μm or more, more preferably 30 μm or more, even more preferably 40 μm or more, and preferably 100 μm or less, More preferably, it is 80 μm or less, and still more preferably 70 μm or less.

The release sheet can effectively prevent the adhesive sheet from detaching from the release sheet during manufacturing, and can also effectively peel the adhesive sheet from the release sheet when applying it to the application site during use. Polyethylene terephthalate (PET), polypropylene (PP), polyethylene ( It is preferably made of one or more selected from PE) and mixtures thereof, and more preferably made of polyethylene terephthalate.

It is preferable that the release sheet has a smooth surface on the opposite side from the surface in contact with the adhesive sheet. This makes it possible to distinguish between the front and back sides of the release sheet. As a result, when using the adhesive sheet for oral cavity of the present invention, when peeling the adhesive sheet from the release sheet, first of all, by touching the smooth surface of the release sheet with a finger or the like, the front and back sides are determined, and then the By touching the excess area other than the laminated area with the adhesive sheet, it is possible to recognize the unique uneven surface that shows a specific brightness difference (ΔL) and to make the boundary between the adhesive sheet and the release sheet easier. This makes it possible to more easily identify and handle the adhesive sheet.

The peeling force of the adhesive sheet from the release sheet effectively prevents the adhesive sheet from coming off during the production of the oral adhesive patch of the present invention, and also allows the release sheet to be peeled off well when the oral adhesive patch sheet is used. From the viewpoint of making it possible to It is .25N or less, more preferably 0.2N or less.
Note that the peeling force of the adhesive sheet from the release sheet means the value of the maximum pressure (N) measured when the release sheet is peeled from the adhesive sheet using a pressure gauge.

To use the adhesive sheet for oral cavity of the present invention, first, the adhesive sheet is peeled off from a release sheet. Next, the adhesive sheet is applied to the application site in the oral cavity. Specifically, for example, the oral cavity adhesive sheet 1 of the present invention has a pasting sheet 2 and a release sheet 3 laminated together, such as the oral cavity adhesive sheet 1 shown in FIG. It consists of an adhesive sheet 2a that is attached to the upper teeth and an adhesive sheet 2b that is attached to the lower teeth. In use, first, the adhesive sheet 2 is peeled off from the release sheet 3 to expose the surface 2x of the adhesive sheet 2a, and this surface 2x is applied to the tooth periphery to which it is applied.
In this case, only when the release sheet 3 is peeled off will the surface 2x of the adhesive sheet to be applied to a desired site in the oral cavity be exposed, allowing for sanitary use.

The shape of the adhesive sheet constituting the oral adhesive sheet of the present invention is selected from the tooth to be applied, the organs located around the tooth including the gums (periphery of the tooth), the roof of the mouth, the tongue, the floor of the mouth, etc. It may be determined as appropriate, taking into account the operability during use, depending on the shape.

Hereinafter, the present invention will be specifically explained based on Examples. In addition, unless otherwise indicated in the table, the content of each component indicates mass %.
In addition, each physical property of the sheet was measured by the following method.

《Moisture content of adhesive sheet》
The moisture content of the adhesive sheet was measured using an automatic moisture measuring device (AQV-300 series, manufactured by Hiranuma Publishing Co., Ltd.).

《Strain of pasting sheet at 20MPa tensile stress》
Using a rheometer (MCR502, manufactured by Anton Paar), the sheet to be measured was set in a jig for measuring strain, and the strain was measured when the shear stress was varied from 1 to 2 × 10 ⁷ Pa, The strain at a shear stress of 20 MPa was calculated by converting it into the amount of change (%) from the initial length.

《Measurement of L (P) and L (X) in release sheet, calculation of brightness difference (ΔL)》
The release sheet was placed flat on the non-reflective black flocked fabric with the surface in contact with the adhesive sheet facing upward, and measurements were performed according to the method described above.
The images were taken using a digital single-lens reflex camera (D1X, manufactured by Nikon) and a close-up lens (Ai AF ZOOM Micro Nikkor ED 70-180mm F4.5-F5.6D, manufactured by Nikon). A standard reflector manufactured by Gretag Macbeth was used as a standard reflector for % gray.
In addition, for image analysis, image analysis software (Image J, v1.53, National Institutes of Health, USA) was used to calculate each luminance (L (P) and L (X)) in the ROI of a certain area, The luminance difference (ΔL) was calculated by introducing the above equation (I).

《Measurement of peeling force of adhesive sheet from release sheet》
Using a pressure gauge (FGP-0.2, manufactured by Nidec Corporation), the maximum pressure (N) when the adhesive sheet was peeled off from the release sheet was measured.

[Examples 1 to 4]
To form the active layer shown in Table 1, prepare a stock solution by mixing each component while taking into consideration the solid content of the adhesive sheet and adjusting the amount of water appropriately, and apply the obtained stock solution onto a release sheet. After coating and drying to form a working layer, a protective layer was coated on the working layer to produce an oral patch sheet shown in Table 1.
As the release sheet, a sandblasted sheet with a brightness difference (ΔL) of 4.5 or more and 19.5 or less on the surface in contact with the adhesive sheet was used.

[Examples 5-6]
An oral patch sheet was produced in the same manner as in Example 1, except that the protective layer was not laminated on the working layer.

[Comparative example 1]
An oral patch sheet was produced in the same manner as in Example 1, except that a smooth sheet (luminance difference (ΔL) less than 4.5) whose surface in contact with the patch sheet was unprocessed was used as the release sheet.

[Comparative example 2]
An oral patch sheet was produced in the same manner as in Example 1, except that a sheet whose surface in contact with the patch sheet was sandblasted (brightness difference (ΔL) 20 or more) was used as the release sheet.

《Evaluation of peeling/falling during manufacturing》
At least 5,000 oral patch sheets shown in Table 2 were manufactured, the number of sheets that peeled or fell off was counted, and the proportion (%) of the number of sheets that peeled or fell off among the total number of sheets was determined. Evaluation was made according to the criteria.
1: None (less than 1%)
2: Almost none (1% or more but less than 5%)
3: Yes (5% or more and less than 10%)
4: Yes (10% or more)

《Evaluation of peelability during use》
Using the oral adhesive sheet shown in Table 1, we checked the degree of ease of peeling the adhesive sheet from the release sheet and the presence or absence of any effects on the sheet shape such as deformation and distortion, and met the following standards. Therefore, it was evaluated.
1: Easy to peel, no effect on product shape 2: Slightly easy to peel, no effect on product shape 3: Slightly easy to peel, but has no effect on product shape 4: Difficult to peel , has an effect on the product shape 5: Difficult to peel off

Table 3 shows prescription examples of the oral patch sheet of the present invention.

Claims (5)

An oral patch sheet comprising a layered patch sheet and a release sheet,
The adhesive sheet has a water content of 5% by mass or more and 13% by mass or less, and further contains a water-soluble polymer of 30% by mass or more and 70% by mass or less, and a nonionic surfactant of 0.8% by mass or more and 20% by mass or less. and has a thickness of 30 μm or more and 250 μm or less, the water-soluble polymer is one or more selected from pullulan, hydroxypropyl methyl cellulose, and gelatin, and the nonionic surfactant is polyoxyethylene hydrogenated castor oil, A sheet that is one or more selected from glycerin fatty acid ester, sucrose fatty acid ester, and polyoxyethylene sorbitan fatty acid ester ,
The release sheet has the following formula (I) on the surface in contact with the adhesive sheet:
Luminance difference (ΔL) = L(P) - L(X)...(I)
(In formula (I), L(P) is irradiated with 45° incident light from the left and right on the surface of the release sheet in contact with the adhesive sheet, so that the brightness of the 18% gray standard reflector becomes 120. L(X) indicates the brightness of the reflected image P of the surface in contact with the adhesive sheet when image analysis is performed.L(X) represents the brightness of the non-reflective image X of the surface in contact with the adhesive sheet when the image analysis is performed. show.)
A sheet for oral cavity, which has a brightness difference (ΔL) determined by 10 or more and 19.5 or less , and is made of one or more selected from polyethylene terephthalate, polypropylene, polyethylene, and mixtures thereof. Paste sheet. The adhesive sheet for oral cavity according to claim 1, wherein the adhesive sheet has a strain of 2% or more and 12% or less at a tensile stress of 20 MPa. The oral cavity patch sheet according to claim 1 or 2, wherein the release sheet has a thickness of 20 μm or more and 100 μm or less. The oral adhesive sheet according to any one of claims 1 to 3 , wherein the ratio ( b /a) of the area (b) of the release sheet to the area (a) of the adhesive sheet is 1.3 or more and 10 or less. . The adhesive sheet for oral cavity according to any one of claims 1 to 4 , wherein the area of the surface of the adhesive sheet in contact with the release sheet is 500 mm ² or more and 3000 mm ² or less.

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