JP2003095312A - Packaging structure using shading packaging material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a packaging structure which can prevent any photolysis or photo-oxidation of a plaster agent for medical use containing medicines which has an aromatic ring with primary, secondary and tertiary amines as substituents within a chemical structure thereof, and causes photolysis or photo- oxidation in the wavelength range of 400-450 nm, and inspect the appearance after the packaging. SOLUTION: The packaging structure can prevent any photolysis or photo- oxidation of the plaster agent for medical use containing the above medicines, and inspect the appearance after the packaging by a packaging material having a layer containing a disazo-yellow pigment.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a packaging structure in which a medical patch preparation containing a drug that is oxidized or decomposed (hereinafter referred to as photodegradation) by light in a specific wavelength region is packaged. More specifically, a package using a light-shielding packaging material having a characteristic that the light transmittance of the drug contained in the medicated patch preparation is suppressed by the wavelength region so as to suppress the photodegradation and have transparency. It is about structure.

[Prior art]

Many drugs are unstable to light,
If no measures are taken for these, serious problems such as photo-deterioration during storage and use, resulting in a reduction in effect, and causing side effects occur. Therefore, conventionally, drugs have been put to practical use by devising measures such as providing a light-shielding property in terms of packaging materials and preparations.

Drugs that are unstable to light are generally 290
Photodegradation is promoted by absorbing light in the wavelength region of up to 450 nm, but it is also known that the wavelength region in which the reaction is promoted is slightly different due to the difference in chemical structure. Among them, drugs having an aromatic ring having a primary, secondary or tertiary amine as a substituent in its chemical structure such as lidocaine, methoxamine and tulobuterol (hereinafter referred to as a specific drug) have a near-purple wavelength of 400 to 450 nm. External visible light significantly promotes photodegradation, but these are often used in medical patch preparations. Therefore, in order to expect the pharmacological effect of such a medicated patch preparation, it is important to block the light in the above near-ultraviolet visible region.

Conventionally, a light-shielding packaging material for packaging such a medicated patch preparation is generally provided with an aluminum layer or the like to suppress photodegradation of a drug. The medical patch preparation packaged with such a light-shielding packaging material having an aluminum layer has sufficient light-shielding property, but it becomes impossible to visually select the packaged product. Therefore, the foreign material inspection after packaging and the dropout inspection of the formulation (hereinafter referred to as appearance inspection) are performed by methods such as measuring the weight before and after packaging, but if the packaging material is transparent enough to be visually confirmed. If it has the property, not only the appearance inspection after packaging can be performed more easily, but also the equipment for the appearance inspection becomes unnecessary. Therefore, it is very convenient if the packaging material for packaging the medicated patch preparation has both transparency and light shielding properties.

As a packaging material having transparency and light shielding properties,
Japanese Unexamined Patent Publication No. 2000-280394 discloses a transparent light-shielding packaging material used for packaging foods, in which a transparent gas barrier film, a printing ink layer, and a heat-fusible resin layer are laminated. And, in the publication, the wavelength range of 300 to 400 nm and 600 as described in the scope of claims are provided.
~ Packaging material that blocks light in the 700 nm wavelength range, 300 ~
Packaging material that blocks light in the wavelength range of 800 nm, and 30
A packaging material that blocks light in the wavelength range of 0 to 500 nm is disclosed. As described above, the light-shielding packaging material of the above publication has a very wide wavelength range to be blocked, and no pigment or the like to be contained in the light-shielding packaging material is specified at all. And, as mentioned above, this publication relates to a light-shielding packaging material for packaging foods and the like, and does not disclose any use for packaging a medical patch preparation containing a specific drug.
The specific drug contained in the medical patch preparation is 400 to 4
Since the photodegradation can be sufficiently suppressed by blocking the light in the wavelength region of 50 nm, the packaging material for packaging the medicated patch preparation containing the drug is required to block the above wavelength region in a focused manner. It However, conventionally, in such a light-shielding packaging material, what kind of pigment is used to shield light in the wavelength region of 400 to 450 nm more accurately has not been specified at all. .

[0006]

SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and maintains the effects of a medicated patch preparation containing a specific drug, while keeping the contents after packaging. It is an object of the present invention to provide a packaging structure capable of confirming the above.

[0007]

[Means for Solving the Problems]

Therefore, the inventors of the present invention have conducted extensive studies on a light-shielding packaging material suitable for packaging medical patch preparations, and as a result, the packaging material containing a disazo yellow compound as a pigment has a wavelength of 400 to 450 nm. It has been shown that it exhibits an absorption capacity in the wavelength region of 1, and exhibits an effect of remarkably suppressing the photodegradation of the medicated patch preparation. Further, it has been found that the packaging material containing the above-mentioned disazo yellow pigment has a transparency that allows the packaged preparation to be clearly selected from the outside by exhibiting almost no absorption capacity in the wavelength region of 600 nm or more, and the present invention. Has been completed.

That is, according to the present invention, a light-shielding property is obtained by laminating at least a base film, a layer containing a disazo yellow pigment, and a heat-sealing resin layer so that the heat-sealing resin layer is the outermost layer. A packaging structure in which a medical patch preparation is packaged with a packaging material, wherein the medical patch preparation has a plaster layer containing a drug formed on one side of a support, and the drug is 1
The present invention provides a packaging structure characterized by having an aromatic ring having a secondary, secondary or tertiary amine as a substituent in its chemical structural formula.

[0010]

DETAILED DESCRIPTION OF THE INVENTION

The structure of the light-shielding packaging material used in the packaging structure of the present invention comprises a base material film, a layer containing a disazo yellow pigment, and a laminated material in which a heat-sealing resin layer is essential. As long as the light-shielding property according to claim 1 of the present invention and the transparency to the extent that the contents after packaging can be confirmed can be maintained, the above three layers can be laminated or other layers (for example, an intermediate base material layer, etc.). ) Can be stacked. Also,
The order of lamination is not particularly limited as long as the heat-sealing resin layer is the outermost layer, but it is preferable that a layer containing a disazo yellow pigment is laminated on the inside in view of pigment retention.

Specific examples of the light-shielding packaging material used in the packaging structure of the present invention are shown in FIGS. 1 to 4 are schematic cross-sectional views showing an example of the light-shielding packaging material used in the packaging structure of the present invention, and FIGS. 5 to 6 are schematic diagrams showing an example of the packaging structure of the present invention.

First, as shown in FIG. 1, a light-shielding packaging material A in which a substrate film 3, an adhesive layer 2 containing a disazo yellow pigment, and a heat-sealing resin layer 1 are laminated can be exemplified. Also,
As shown in FIG. 2, printing containing a disazo yellow pigment between the base film 3 and the adhesive layer 2 ′ in the laminate of the base film 3, the adhesive layer 2 ′, and the heat-sealing resin layer 1. An example is a light-shielding packaging material A ′ with the ink layer 4 interposed. Further, as shown in FIG. 3, a light-shielding packaging base material A ′ having an intermediate base material layer 5 provided between the adhesive layer 2 ′ of the light-shielding packaging material B shown in FIG. 2 and the heat-sealing resin layer 1. 'Can be illustrated. In addition, as shown in FIG. 4, between the base film 3 and the heat-sealing resin layer 1,
An example is a light-shielding packaging material A ′ ″ with a printing ink layer 4 containing a disazo yellow pigment interposed. Figure 1 above
4 to 4 exemplify typical configurations of the packaging material used in the present invention, and the light-shielding packaging material of the present invention is not limited to these. Further, the intermediate base material layer and the printing ink layer may be interposed at any position.

Next, regarding the packaging structure of the present invention, FIG.
This will be described with reference to FIG. As shown in FIG. 5, two light-shielding packaging materials are prepared and cut into a substantially rectangular shape, and after heat-sealing resin layers are overlapped with each other, heat-sealing is applied to four sides of the peripheral end portions thereof to provide medical treatment. 2 is a packaging structure of the present invention in which the packaging product 7 for packaging is packaged and a notch 8 for opening is provided. FIG. 6 is a schematic view of the packaging structure of the present invention in which the package is opened by using the opening notch of FIG. 5 and the medicated patch preparation is taken out. In addition,
The packaging structure of the present invention is not limited to these.

The base film layer of the packaging material used in the present invention supports the layer containing the disazo yellow pigment and the heat-sealing resin layer, and heats, pressurizes, and humidifies during production and storage. Use a sheet or film that has heat resistance and strength that can withstand such factors, and is transparent enough to confirm the contents after the packaging material is completed.
Examples of the material for the base film include polyester resin, polyamide resin, polyaramid resin, polyolefin resin such as polyethylene and polypropylene, polystyrene resin, polyacrylic resin, polycarbonate resin, polyacetal resin, fluorine resin. , Polyacrylonitrile-based resin, polyvinyl alcohol-based resin and the like can be used.

It is preferable from the standpoint of strength that the base film is a film which is stretched about 2 to 10 times in either the longitudinal direction or the transverse direction. As this stretching method, a known method such as a flat method or an inflation method can be used. The thickness of the substrate film is not particularly limited, but is preferably 5 to 100 μm from the viewpoint of operability and followability at the time of sticking, and further 10 to 50 μm.
μm is more preferable. If the thickness is less than 5 μm, the packaging material is more likely to be damaged. Further, if it is thicker than 100 μm, it is difficult to cut the packaging material at the time of manufacturing and it is costly. In addition,
A desired printing pattern such as letters, figures, symbols, patterns, etc. can be applied to the above-mentioned base film by front printing or back printing by a usual printing method.

In the present invention, the layer containing the disazo yellow pigment suppresses the photodegradation of the drug of the medical patch preparation packaged in the light-shielding packaging material, and can be sorted from the outside after packaging. Such a light-shielding property and transparency are imparted. The layer containing the disazo yellow pigment is preferably a printing ink layer containing the disazo yellow pigment or an adhesive layer containing the disazo yellow pigment. The content of disazo yellow pigment is preferably those which are 0.03~5g / m ^2, further 0.05 to 3 g / m ² is more preferable. If it is less than 0.03 g / m ² , the expected effect of suppressing photodegradation of the medical patch preparation may not be obtained after packaging. Also, 5 g / m ²
If the amount is larger, it will be difficult to identify it in the packaged state, and it will be difficult to include it in the layer of the light-shielding packaging material.

The method for forming the printing ink layer containing the above-mentioned disazo yellow pigment may be a usual method such as gravure coating, roll coating, knife coating, spray coating, gravure printing, flexographic printing, screen printing, offset printing, etc. , A heat-fusible resin layer, a substrate film layer, and other printable layers are printed and dried. The position where the printing ink layer is formed is not particularly limited, but when the printing ink layer is formed on the outermost layer, the pigment may elute, so it is formed on the inner side after the packaging material is completed. Is preferred.

The composition of the printing ink used in such a printing ink layer is a vehicle in which a disazo yellow pigment is dispersed and various additives are added. The vehicle plays a role of uniformly transferring and fixing the pigment to the material to be printed, and is composed of a resin, a solvent, an auxiliary agent and the like. Specifically, for example, as the resin, camrosin,
Wood rosin, tall oil rosin, lime rosin, rosin ester, maleic acid resin, polyamide resin, vinyl resin, nitrocellulose, cellulose acetate, ethyl cellulose, ethylene-vinyl acetate copolymer resin, urethane resin, polyester resin, alkyd resin, gilsonite,
Examples thereof include resin mixtures such as dammar and shellac.
As the solvent, hydrocarbons, alcohols, ketones,
Examples thereof include ethers and esters. In addition, the auxiliary agent plays a large role in the vehicle, and affects the improvement of the functionality of the pigment or resin, the reinforcement of the printed film, the electrostatic property, and the like. Specific examples of such auxiliaries include printability improving agents such as dispersants, antifoaming agents, antistatic agents, and antisettling agents, and print film stability improving agents such as low-molecular polyethylene wax and fatty acid amides. , Plasticizers for giving flexibility, isocyanates and organotitanium compounds for the purpose of curing, and other metal soaps for improving various performances,
Phenolic compounds, epoxy resins, benzotriazole and the like can be used.

Layers having no self-adhesiveness in the packaging material used in the present invention are preferably laminated with an adhesive. The material for this adhesive is not particularly specified as long as it does not impair the characteristics of the light-shielding packaging material of the present invention, and a general-purpose material can be used. For example, as a two-component organic solvent mixed curing type, polyester urethane polyol / aromatic polyisocyanate system, polyether polyurethane / epoxy system, polyether urethane polyol / aliphatic polyisocyanate system, polyester / aliphatic isocyanate system, polyester / aromatic isocyanate System, etc.

The adhesive containing the disazo yellow pigment is prepared from a solution prepared by adding the disazo yellow pigment to an adhesive similar to the above and diluting and dispersing it with a solvent or the like. The light-shielding packaging material of the present invention can also be produced by laminating the adhesive layer containing the disazo yellow pigment as described above on a laminate having at least a base film layer and a heat-sealing resin layer. The stacking position is also not particularly limited,
It is preferably laminated on the inside for pigment retention.

Regarding the coating amount of the adhesive layer, the coating amount is 0.2 regardless of whether the pigment is contained or not.
5-30g / m ^{2 is} good, and the coating amount is 1.0-20g /
m ² is more preferable. When the coating amount is less than 0.5 g / m ² ,
In some cases, the glued layers may come off,
When the coating amount exceeds 30 g / m ² , not only transparency is deteriorated but also cost is not preferable.

The disazo yellow pigment contained in the printing ink layer and the adhesive layer has a color index registration name (hereinafter, referred to as C.I.) Pigment Yellow 1
2, 13, 14, 16, 17, 55, 81, and 83
At least one of the above can be used, but CI Pigment Yellows 13, 14, 17, and 83 are more preferably used as the light-shielding packaging material of the present invention having a remarkable light transmittance. Further, a pigment or dye other than the disazo yellow pigment may be added as long as it does not deviate from the range of the light transmittance described in claim 1 of the present invention. Examples of the above-mentioned pigments or dyes include yellow pigments such as fast yellow, titanium yellow, yellow iron oxide, and lead, red pigments such as toluidine red, lake red, red iron oxide, molybdenum red, and vermilion, and orange to brown pigments. Pigments, dark blue, cobalt titanate green, blue or green pigments such as chromium oxide, white pigments such as titanium oxide, zinc white, zinc sulfide, black pigments such as carbon black, calcium carbonate, barium sulfate precipitated, clay, Examples include extender pigments such as talc, azo dyes / pigments, phthalocyanine pigments, quinacridone pigments, isoindolinone pigments, dioxane pigments, thioindigo pigments, and anthraquinone dyes / pigments.

The packaging structure of the present invention is obtained by heat-sealing heat-sealing resins. The material of the heat-sealing resin layer is not particularly limited, but specifically, low density polyethylene, medium density polyethylene, high density polyethylene, linear low density polyethylene, polypropylene, ethylene-vinyl acetate copolymer, ionomer resin, Ethylene-acrylic acid copolymer, ethylene-ethyl acrylate copolymer, ethylene-
Methacrylic acid copolymer, ethylene-methyl methacrylate copolymer, ethylene-propylene copolymer, methylpentene polymer, polybutene polymer, polyolefin resin such as polyethylene or polypropylene, acrylic acid, maleic acid, fumaric acid, maleic anhydride Acid-modified polyolefin resin modified with unsaturated carboxylic acid such as acid, polyvinyl acetate resin, poly (meth) acrylic resin, polyvinyl chloride resin, polystyrene resin, polyacrylonitrile resin, acrylonitrile-styrene copolymer Polymers, acrylonitrile-butadiene-styrene copolymers, and other resins can be used. The heat-fusible resin layer of the present invention can be formed of a film or sheet of the above resin or a coating film of the above resin composition containing the resin as a main component. The thickness is preferably 1 to 200 μm, and further 5 to
100 μm is more preferable. If it is less than 1 μm, the heat sealability is insufficient and the heat-sealing resin layers are likely to peel off from each other during storage. If it exceeds 200 μm, it becomes difficult to cut the packaging material.

The packaging material used in the present invention may be provided with an intermediate base material layer, if necessary, as long as it does not impair the light transmittance range described in claim 1. The purpose of providing the intermediate base material layer is various, but for example, as the intermediate base material layer provided for the barrier property against water vapor, water, gas, etc., a resin film having a vapor deposition film of an inorganic oxide such as silicon oxide , And a film or sheet such as a polyamide film, a polyolefin film, a polyvinyl chloride film, a polycarbonate film, a polyvinylidene chloride film, a polyvinyl alcohol film, and a saponified ethylene-vinyl acetate copolymer film can be used. These may be used alone or in combination of two or more kinds. In addition, the position and thickness of the above-mentioned intermediate base material layer are not particularly specified, and are appropriately determined according to the intermediate base material layer, the base material film layer, the heat-sealing resin layer, and other properties and thickness. it can.

The light-shielding packaging material used in the present invention has a layer containing a disazo yellow pigment,
It exhibits absorption ability in the wavelength region of 400 to 450 nm and can prevent photodegradation of the contents due to the above wavelength region, and at the same time, has a high light transmittance on the longer wavelength side than 600 nm and is excellent in transparency. Therefore, you can check the contents. The light transmittance of the light-shielding packaging material having such a property is 10% or less in the wavelength region of 400 to 450 nm and 40% or more at 600 nm, but further 400 to 450 nm in light shielding property and transparency. Light transmittance is 1%
It is preferably 50% or more below and at 600 nm. If the light transmittance in the wavelength region of 400 to 450 nm exceeds 10%, the light-shielding property is insufficient, so that the packaged contents are deteriorated by near-ultraviolet visible light in this wavelength region. Further, if the light transmittance at 600 nm is less than 40%, it may be difficult to clearly select the packaged medical patch preparation from the outside, or it may be difficult to perform an appearance inspection in a packaged state.

Since the light-shielding packaging material used in the present invention exhibits the above-mentioned light transmittance, it contains a drug which causes remarkable photodegradation in the visible light region of 400 to 450 nm.
Used for packaging medical patch preparations. Such a medicated patch preparation is applied to the skin or mucous membranes for the purpose of treating or preventing a disease, etc., and a plaster layer containing a drug or a plaster layer and a support layer containing a drug. It consists of

The above-mentioned plaster layer is composed of an adhesive base or the like containing a specific drug, and plays a role of sticking to the human body to administer the drug when the medicated patch preparation is used. As the adhesive base in such a plaster layer, depending on the purpose of use, it exhibits adhesiveness under normal conditions, wet conditions, or under heating, and can be applied to the skin or mucous membrane for a certain period of time. If so, there is no particular designation. In addition, the tacky base is blended with a known additive such as a tackifier for improving tackiness, a plasticizer, an absorption promoter, a surfactant, a filler, and water, if necessary. May be.

The support layer of the medicated patch preparation supports the plaster layer containing the drug. As such a support layer, a flexible sheet-like or film-like one which is easy to handle and has good operability and which does not give an uncomfortable feeling when applied is used. In addition, this medical patch preparation is manufactured,
In order to prevent deterioration of the preparation during transportation or storage, it is desirable to cover and protect the exposed surface of the plaster layer with a release liner just before use.

In the medicated patch preparation in which the above-mentioned support layer or release liner has a light-shielding property, the photodegradation of the specific drug contained can be suppressed to some extent, and therefore the effect of the packaging structure of the present invention is remarkable. This can be observed when the support layer or the release liner does not have a light-shielding property. However, an advantage of the packaging structure of the present invention is that the photodegradation of a specific drug can be reliably prevented regardless of whether or not the medical patch is light-shielding. Therefore, the materials for the support layer and release liner of the medicated patch to be packaged in the present invention are not limited to the presence or absence of light-shielding property and can be appropriately determined according to the site to be used and the purpose.

The drug contained in the plaster layer of the above medicated patch preparation causes remarkable photodegradation in the visible light region of 400 to 450 nm, and therefore, the photodegradation is suppressed by packaging with the packaging material. To be done. Specifically, one having an aromatic ring having a primary, secondary or tertiary amine as a substituent in its chemical structural formula is selected. For example, corticosteroids having the above chemical structure, analgesic / antiinflammatory agent, hypnotic analgesic, tranquilizer, antihypertensive agent, antihypertensive diuretic, antibiotic, general anesthetic, antibacterial agent, antifungal agent, vitamin agent, crown Drugs classified into vasodilators, antihistamines, antitussives, sex hormones, antidepressants, cerebral circulation improving agents, antiemetics, antitumor agents, biopharmaceuticals and the like can be used. Specific examples of such a drug include amphetane, levodopa, methyldopa, dopamine, baclofen, midodrine, methoxamine, dimethoxyphenyl-, in the case of a drug having an aromatic ring having a primary amine as a substituent in its chemical structural formula. 2-aminoethanol, and pharmacologically acceptable salts thereof, and the like, in the case of secondary amines, fluoxetine, prilocaine, methamphetamine, desipramine, epinephrine, propranolol, tulobuterol, and their pharmacologically acceptable salts. Examples thereof include salts, and in the case of tertiary amines, lidocaine, procaine, tetracaine,
Examples thereof include dibucaine, biperidene, chlorpromazine, haloperidol, cyrnadefil, and pharmacologically acceptable salts thereof. The content of the drug as described above can be appropriately determined depending on the drug species, but 1 to 80% by weight in the plaster layer of the medical patch preparation is an appropriate amount, and further 2 to
70% by weight is more preferred. When the content is less than 1% by weight, it is not possible to expect an effective amount of drug release for treatment or prevention, and when it is more than 80% by weight, the adhesiveness of the plaster decreases and the medicated patch formulation is used. It is no longer possible to expect sufficient attachment on the part to be used.

[0032]

EXAMPLES The present invention will be described in detail below with reference to Examples and Comparative Examples, but the present invention is not limited thereto. In the following description, “part” means “part by weight”.

[Preparation of Medical Preparation Patch A] Acrylic acid 2-ethylhexyl ester 95 in an inert gas atmosphere
Parts and 5 parts of acrylic acid were copolymerized in ethyl acetate to prepare an adhesive base solution. The adhesive base solution 40
To 60 parts (as solid content), 60 parts of lidocaine was added, mixed and dissolved, and the resulting solution was mixed with a polyester separator (7
(5 μm thick) so that the thickness after drying was 20 μm, and dried to form a plaster layer. Next, this plaster layer was bonded to a polypropylene and polyester composite fiber non-woven fabric (thickness 0.5 mm, basis weight 90 g / m ² ) to prepare a medical patch preparation.

[Preparation of medical patch preparation B] Acrylic acid 2-ethylhexyl ester 50 in an inert gas atmosphere
Part, 25 parts acrylic acid 2-methoxyethyl ester, and 25 parts vinyl acetate are copolymerized in ethyl acetate,
An adhesive base solution was obtained. 5 parts of methoxamine were added to 95 parts of the above-mentioned adhesive base solution (as a solid content), mixed and dissolved, and the resulting solution was made into a polyester separator (75 μm thick).
A plaster layer was formed by coating the composition on the top so that the thickness after drying was 40 μm and drying. Then, this plaster layer was treated with ethylene-
It was stuck to a vinyl acetate copolymer film (50 μm thick) to prepare a medicated patch preparation B.

[Preparation of medical patch preparation C] Acrylic acid 2-ethylhexyl ester 65 under an inert gas atmosphere
Part, 30 parts vinylpyrrolidone and 5 parts acrylic acid,
An adhesive base solution was prepared by copolymerization in ethyl acetate.
To 70 parts (as a solid content) of the adhesive base solution, 20 parts of isopropyl myristate and 10 parts of biperidene were added and mixed and dissolved, and the resulting solution was dried on a polyester separator (75 μm thickness) to have a thickness of 40 μm. Was applied and dried to form a plaster layer. Next, this plaster layer was laminated on a polyester film surface of a film obtained by laminating a polyester non-woven fabric (about 600 μm thickness, weight per unit area 100 g / m ² ) on a polyester film (2 μm thickness) to prepare a medicated patch preparation C.

[Preparation of medicated patch preparation D] 50 parts of polyisobutylene (viscosity average molecular weight 120,000), 30 parts of polyisobutylene (viscosity average molecular weight 60,000), and alicyclic petroleum resin (softening point 100 ° C.) 20 The parts were uniformly mixed in hexane to obtain a rubber-based polymer solution. To 90 parts (as solid content) of the rubber-based polymer solution, 10 parts of tulobuterol was added and mixed and dispersed, and the resulting dispersion was dried on a polyester separator (75 μm thick) to have a thickness of 40 μm.
It was applied so as to be m and dried to form a plaster layer. Then, the plaster layer was applied to a polyester film (25 μm
To prepare a medical patch preparation D.

[Preparation of Adhesive Base Solution E] 72 parts of polyester urethane polyol resin, 8 parts of aromatic polyisocyanate, and 240 parts of ethyl acetate were mixed and dissolved to obtain an adhesive base solution E.

Example 1 Polyester film (12 μm) as a base film
20) CI Pigment Yellow 17 on one side
Parts, 72 parts of polyester urethane polyol resin, 8 parts of aromatic isocyanate, and 300 parts of ethyl acetate were mixed and dispersed, and then dried to form an adhesive layer containing a disazo yellow pigment having a thickness of 10 μm. next,
A polyacrylonitrile-based copolymer film (20 μm thick) as a heat-sealing resin layer was laminated on the adhesive layer surface containing the disazo yellow pigment to prepare a yellow light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material and used as Example 1.

Example 2 Polyester film (12 μm) as a base film
CI Pigment Yellow 17 on one side of (thickness) 19.5
Parts, 0.5 parts of phthalocyanine blue, 72 parts of polyester urethane polyol resin, 8 parts of aromatic polyisocyanate, and 300 parts of ethyl acetate are mixed and dispersed, and then dried to obtain a disazo yellow pigment having a thickness of 10 μm. An adhesive layer containing was formed. Next, a polyacrylonitrile-based copolymer resin film (20 μm thick) was formed as a heat-sealing resin layer on the adhesive layer surface containing the disazo yellow pigment.
Was laminated to produce a yellowish green light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material and used as Example 2.

Example 3 Polyester film (12 μm) as a base film
Thickness), solid printing of 5% CI Pigment Yellow 83 on one side, followed by drying to apply a coating weight of 2 g
A printed layer containing a disazo yellow pigment of / m ² was formed.
Next, the adhesive base solution E is applied to the surface of the printing ink layer containing the above-mentioned disazo yellow pigment and then dried to obtain a thickness of 10
A μm adhesive layer was formed. Further, a polyacrylonitrile-based copolymer resin film (thickness of 30 μm) was laminated as a heat-sealing resin layer on the surface of the adhesive layer to prepare a yellow-orange light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material and used as Example 3.

Example 4 Polyester film (12 μm) as a base film
CI Pigment Yellow 17 on one side of
Parts, 81 parts of polyester urethane polyol resin, 9 parts of aromatic isocyanate, and 300 parts of ethyl acetate were mixed and dispersed, and then dried to form an adhesive layer containing a disazo yellow pigment having a thickness of 10 μm. next,
A polyacrylonitrile-based copolymer film (thickness 20 μm) as a heat-sealing resin layer was laminated on the surface of the adhesive layer containing the disazo yellow pigment to prepare a yellow light-shielding packaging material. The above medicated patch preparation A was packaged with this light-shielding packaging material, and this was designated as Example 4.

Example 5 Polyester film (12 μm) as a base film
Thickness), solid printing of 5% CI Pigment Yellow 17 on one side, followed by drying to apply a coating weight of 2 g
A printed layer containing a disazo yellow pigment of / m ² was formed.
Next, the adhesive base solution E is applied to the surface of the printing ink layer containing the above-mentioned disazo yellow pigment and then dried to obtain a thickness of 10 μm.
m adhesive layer was formed. Furthermore, on the adhesive layer surface,
A polyacrylonitrile-based copolymer resin film (20 μm thick) was laminated as a heat-sealing resin layer to produce a yellow light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material, and this was referred to as Example 5.

Example 6 Polyester film (12 μm) as a base film
CI Pigment Yellow 17 on one side (thickness) of 4.9
%, 0.1% phthalocyanine blue was solidly printed and then dried to form a printing ink layer containing a disazo yellow pigment having a coating weight of 2 g / m ² . Next, the adhesive base solution E was applied to the surface of the printing ink layer containing the disazo yellow pigment and then dried to form an adhesive layer having a thickness of 10 μm. Furthermore, a polyacrylonitrile-based copolymer resin film (20 μm thick) was laminated as a heat-sealing resin layer on the adhesive layer surface to prepare a yellow-green light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material to give Example 6.

Example 7 Polyester film (12 μm) as a base film
20) CI Pigment Yellow 14 on one side
Part, 72 parts of polyurethane polyol resin, 8 parts of aromatic polyisocyanate, and 300 parts of ethyl acetate were mixed and dispersed, and then dried to form an adhesive layer containing a disazo yellow pigment having a thickness of 10 μm. Next, a polyacrylonitrile-based copolymer resin film (20 μm thick) was laminated as a heat-sealing resin layer on the adhesive layer surface to prepare a yellow light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material, and this was referred to as Example 7.

Example 8 Polyester film (12 μm) as a base film
(Thickness) solid-printing a printing ink layer containing 5% of CI Pigment Yellow 14 on one side, and then drying to apply a coating weight of 2
A printing ink layer containing a g / m ² disazo yellow pigment was formed. Next, the adhesive base solution E was applied to the surface of the printing ink layer containing the disazo yellow pigment and then dried to form an adhesive layer having a thickness of 10 μm. Further, a polyacrylonitrile-based copolymer resin film (20 μm thick) was laminated as a heat-sealing resin layer on the surface of the adhesive layer to prepare a yellow light-shielding packaging material. The patch preparation for medical use A was packaged in this light-shielding packaging material, and this was referred to as Example 8.

Example 9 Polyester film (12 μm) as a base film
20) CI Pigment Yellow 83 on one side
Part, 72 parts of polyurethane polyol resin, 8 parts of aromatic polyisocyanate, and 300 parts of ethyl acetate were mixed and dispersed, and then dried to form an adhesive layer containing a disazo yellow pigment having a thickness of 10 μm. Next, a polyacrylonitrile-based copolymer resin film (20 μm thick) was laminated as a heat-sealing resin layer on the adhesive layer surface to produce a yellow-orange light-shielding packaging material. The patch preparation for medical use A was packaged with this light-shielding packaging material, and this was referred to as Example 9.

Example 10 A medical patch preparation B was packaged in a light-shielding packaging material prepared in the same manner as in Example 1 to give Example 10.

Example 11 A medical patch preparation C was packaged in a light-shielding packaging material produced in the same manner as in Example 1 to give Example 11.

Example 12 A medical patch preparation D was packaged in a light-shielding packaging material prepared in the same manner as in Example 1 to give Example 12.

Comparative Example 1 Polyester film (12 μm) as a base film
Thickness) / polyester urethane polyol / aromatic polyisocyanate-based dry laminate adhesive layer (10 μm
(Thickness) / polyacrylonitrile-based co-heavy resin film (20 μm thick) as a heat-sealing resin layer was prepared, and the medicated patch preparation A was packaged in this laminate to give Comparative Example 1.

Comparative Example 2 Polyester film (12 μm) as a base film
Thickness) / polyethylene (15 μm thickness) / aluminum foil (7 μm thickness) / polyester urethane polyol / aromatic polyisocyanate adhesive layer (10 μm thickness) / polyacrylonitrile copolymer resin film (20 μm thickness) as a heat-sealing resin layer Was prepared, and the medicated patch preparation A was packaged in this laminate to give Comparative Example 2.

Comparative Example 3 Instead of C.I Pigment Yellow 17 of Example 1,
Comparative Example 3 was prepared by preparing a light-shielding packaging material containing 20 parts of CI Pigment Yellow 3 which is a monoazo yellow pigment, and packaging the medical patch preparation A in this light-shielding packaging material.

Comparative Example 4 Instead of CI Pigment Yellow 17 of Example 1,
A blue light-shielding packaging material was prepared by adding 20 parts of CI Pigment Blue 15, and the medical patch preparation A was packaged in this light-shielding packaging material to give Comparative Example 4.

[Measurement of Light Transmittance of Visible Light] The packing materials used in the above Examples and Comparative Examples were measured with a spectrophotometer to measure 400
The light transmittances in the visible light region of ˜450 nm and 600 nm were measured, and the results are shown in Table 1.

[0055]

【table 1】

[Transparency of Packing Material] The transparency of the packing materials of the above Examples and Comparative Examples was evaluated and is shown in Table 2. Regarding the evaluation method, the one in which the medical patch preparation for contents in the packaged state can be visually selected was evaluated as ○, and the one in which it was not possible was evaluated as ×. In addition, ○ indicates that the medical preparation inside the package can be inspected for dropout or contamination with foreign matter, and × indicates that it is not possible.
And

[0057]

[Table 2]

[Photooxidation Inhibitory Effect of Drug] Regarding the photooxidation inhibitory effect of the drug in the packaging structures of the above-mentioned Examples and Comparative Examples, the photooxidation reaction is promoted by supplying sufficient white light and air and heating. An accelerated test was performed using the apparatus described above, and the results are shown in Table 3. The test method is a white fluorescent lamp (color comparison-inspection D65 fluorescent lamp FL20S-D-EDL-D6
520W Toshiba Lightec) Illumination 3500Lx, air supply 2ml / sec, ambient temperature 50 ° C for 48 hours light irradiation test, and the reaction products 1 and 2 produced by photooxidation of drug Shall be measured by high performance liquid chromatography (HPLC method). The photo-oxidation reaction product production rate is the ratio (%) of the initial drug content to the peak area. HPLC method condition Detector: UV absorptiometer (measurement wavelength 230 nm) Column: A stainless tube having an inner diameter of about 4.6 mm and a length of about 25 cm packed with 5 μm octadecylsilylated silica gel for liquid chromatography. Column temperature: 45 ° C. Flow rate: 1.4 ml / min Mobile phase: Anhydrous sodium monohydrogen phosphate (9.15 g) and phosphoric acid (9.15 g) were dissolved in water (1700 ml), and acetonitrile (300 ml) was added thereto. Retention time for Reactant 1 5.0 minutes Retention time for Reactant 2 5.8 minutes

[0059]

[Table 3]

As can be seen from the above results, Examples 1 to 4 have 40
Since the light transmittance in the wavelength region of 0 to 450 nm is as low as 10% or less, the drug (primary, secondary, or tertiary amine contained as a substituent in the plaster layer of the packaged medical patch preparation is used as a substituent. (Having an aromatic ring in the chemical structure) can be sufficiently prevented. In the wavelength region of 600 nm, 4
Since it is larger than 0%, it is easy to confirm the contents in the packaged state. In contrast, in Comparative Examples 1 to 4, it is not possible to prevent the photodegradation of the drug, or even if the photodegradation can be prevented, it is not possible to confirm the contents in the packaged state. Although the results of Examples 5 to 12 are not described above, similar experiments were performed, and good results were obtained, which was equivalent to those of Examples 1 to 4.

The light-shielding packaging material used in the packaging structure of the present invention has a layer containing a disazo yellow pigment, so that the light transmittance in the wavelength region of 400 to 450 nm is remarkably low. It has excellent light-shielding properties. Further, since the present invention has a packaging structure in which a medical patch preparation containing a drug that causes photooxidation in the above wavelength range is packaged, photooxidation of the drug can be favorably suppressed. Furthermore, the light-shielding packaging material used in the packaging structure of the present invention,
Since the light transmittance of 600 nm is high and the transparency is excellent, it is possible to identify the package contents, inspect the appearance, and the like.

[0061]

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view showing an example of a laminated structure of a light-shielding packaging material used in the packaging structure of the present invention.

FIG. 2 is a schematic cross-sectional view showing an example of a laminated structure of a light-shielding packaging material used in the packaging structure of the present invention.

FIG. 3 is a schematic cross-sectional view showing an example of a laminated structure of a light-shielding packaging material used in the packaging structure of the present invention.

FIG. 4 is a schematic cross-sectional view showing an example of a laminated structure of a light-shielding packaging material used in the packaging structure of the present invention.

FIG. 5 is a schematic perspective view showing an example of the packaging structure of the present invention.

FIG. 6 is a schematic view showing an example of a packaging structure of the present invention.

[Explanation of symbols]

A, A ′, A ″, A ′ ″ Light-shielding packaging material B Layer containing disazo yellow pigment (adhesive layer) B ′ Layer containing disazo yellow pigment (printing ink layer) 1 Heat Fusing resin layer 2 Adhesive layer (containing disazo yellow pigment) 2'Adhesive layer 3 Base film 4 Printing ink layer 5 Intermediate base layer 6 Heat seal part 7 Medical patch preparation (with separator) 8 Notch for opening 9 Separator 10 Medical patch preparation

   ─────────────────────────────────────────────────── ─── Continued front page    F term (reference) 3E067 AA12 AB81 BA12A BB14A                       BB25A BB26A CA11 CA12                       CA24 EA06 FA01 FC01 GD01                 3E086 AB01 AD01 BA04 BA15 BA24                       BB22 BB51 CA28                 4C076 AA72 BB31 DD48U EE24A                       FF70                 4F100 AH03H AK01C AK27 AK42                       AK51 AL01 AR00B AT00A                       BA03 BA07 BA10C CA13B                       CA13H CB00B GB16 HB31B                       JL10B JL12C JN02 YY00B

Claims (4)

[Claims] 1. A light-shielding packaging material obtained by laminating at least a base film, a layer containing a disazo yellow pigment, and a heat-sealing resin layer so that the heat-sealing resin layer is the outermost layer. 1. A packaging structure in which a medical patch preparation is packaged, wherein the medical patch preparation has a plaster layer containing a drug formed on one surface of a support, and the drug is a primary, secondary or tertiary amine. A packaging structure having an aromatic ring having as a substituent in its chemical structural formula. 2. Disazo yellow pigments whose color index registration names are Pigment Yellow 12, 13, 1
The packaging structure according to claim 1, wherein the packaging structure is selected from at least one of 4, 16, 17, 55, 81, and 83. 3. A layer containing a disazo yellow pigment is a printing ink layer containing a disazo yellow pigment,
Alternatively, in the adhesive layer containing a disazo yellow pigment, the content of the disazo yellow pigment is 0.03 to 5
The packaging structure according to claim 1, wherein the packaging structure is g / m ² . 4. The packaging structure according to claim 1, wherein the heat-fusible resin layers are heat-sealed to package a medical patch preparation.