TW201331032A - Sheet for PTP or blister package used to package pharmaceuticals package or blister package for pharmaceuticals package using the sheet, as well as method for manufacturing PTP for pharmaceuticals package or blister package for pharmaceuticals package - Google Patents

Abstract

The present invention provides a sheet for PTP or blister package used to package pharmaceuticals, which has a component (A) mixed by an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm and a dispersant (a2) of a number average molecular weight of 100 to 3000, and a resin component (B), therefore it has an excellent dispersion in the organic coloring pigment (the organic coloring pigment is distributed evenly in the sheet), and can obtain the sheet for forming PTP or blister package (the sheet for PTP or blister package) to reduce bleeding of the organic coloring pigment (or without the bleeding).

Description

PTP or blister packaging sheet for packaging pharmaceuticals, PTP for pharmaceutical packaging using the sheet, blister packaging for pharmaceutical packaging, and PTP for pharmaceutical packaging or blister packaging for pharmaceutical packaging

The present invention relates to a PTP or blister packaging sheet for packaging pharmaceuticals, a PTP for pharmaceutical packaging using the sheet, a blister package for pharmaceutical packaging, and a PTP for pharmaceutical packaging or a pharmaceutical packaging. A method of manufacturing a blister package. More specifically, the present invention relates to an organic coloring pigment contained in a sheet, and a PTP or blister packaging sheet for packaging pharmaceuticals which exhibits good dispersibility, and a PTP for pharmaceutical packaging using the sheet. Or a blister package for pharmaceutical packaging, and a PTP for pharmaceutical packaging or a method for producing a blister package for pharmaceutical packaging.

Conventionally, blister packs are used for contents such as packages, capsules, and the like, foods, toys, and the like (packaged articles). In particular, a PTP (press through package) which is a type of blister package is widely used for packaging tablets, capsules and the like.

Such a blister pack is formed by thermoforming a plurality of pockets on the surface of a strip-shaped resin sheet (a sheet for blister packaging, a sheet for PTP), and filling the contents in the formed pockets, and A sheet foil (cover material) having a metal foil or the like (aluminum foil or the like) is heated and then baked on the surface of the resin film to seal the contents to be filled.

Further, the blister package is required to have moldability, transparency, and various characteristics (low oxygen permeability, moisture resistance, UV barrier property, etc.) depending on the nature of the contents.

For example, Patent Document 1 discloses a resin laminated film for forming a blister package having a lower oxygen permeability than before, and a blister package using the same. The resin laminated film for forming a blister package has a support substrate of the resin laminated film; an oxygen barrier layer disposed on a side opposite to the support substrate; and a moisture barrier layer disposed not in The oxygen barrier layer supports the side opposite the substrate.

Further, Patent Document 2 discloses a practical PTP sheet which is excellent in shape and barrier properties, and which has high moisture resistance and good slipperiness on the surface of the sheet, and at the same time, even if the total thickness of the sheet is less than 250 μm in the pocket. The Ministry does not collapse. The PTP sheet is characterized in that a plurality of receiving pockets are formed in the laminated film under specific conditions, wherein the laminated film system The two-area layer of the intermediate layer composed of the polymer having a specific alicyclic structure is made of an outer layer made of a specific polypropylene resin.

In addition, in the above-mentioned patent documents, the addition of an ultraviolet absorber and a light-shielding material (organic coloring pigment, etc.) to the sheet can reduce the deterioration of the content caused by visible light and ultraviolet rays in the obtained PTP (discoloration) (deterioration) (Patent Document 1: Paragraph [0058] to [0062], Patent Document 2: Paragraph [0044])

Prior technical literature Patent literature

Patent Document 1: International Publication No. 2008/156039

Patent Document 2: JP-A-2005-263287

However, it is difficult to uniformly disperse the organic coloring pigment contained in the sheet in the resin, and the coloring pigment is easily distributed unevenly. Therefore, when a molded article such as a PTP or a blister package is produced, there is a possibility that the pigment is aggregated in the sheet or the sheet has a poor surface, and the moldability is improved. Further, the organic coloring pigment is likely to bleed out from the molded article or the sheet, and even if the organic coloring pigment has an effect of shielding, scattering, or absorbing ultraviolet rays, such a molded article has a portion having insufficient UV barrier property (having uneven UV blocking property). As a result, it is not possible to exert good UV barrier properties over the entire range.

The present inventors have concentrated on such prior issues and concluded It has been found that a good organic color pigment dispersibility can be exhibited by using a resin component and a mixture of an organic coloring pigment having a specific average particle diameter and a dispersing agent having a specific molecular weight in a sheet for blister packaging. In the sheet, the organic coloring pigment is unevenly distributed, and at the same time, the occurrence of bleeding of the organic coloring pigment (or the occurrence of the bleeding does not occur).

Further, the following knowledge has been found: when the sheet is used to produce a molded article such as PTP or blister package due to the good dispersibility, (i) the moldability is good, and (ii) the organic color pigment has a shadow, a scattering or the absorption. In the case of the action of ultraviolet rays, the obtained molded article exhibits excellent UV barrier properties in the entire molded article range (less uneven distribution), and (iii) particularly, the sheet contains organic coloring which has the effect of shielding, scattering or absorbing ultraviolet rays. The pigment, the PTP obtained by molding the sheet, and the blister package are suitable for packaging a pharmaceutical product which is easily deteriorated or deteriorated by ultraviolet rays.

That is, an object of the present invention is to provide a sheet (PTP or blister package sheet) for forming a PTP or a blister package suitable for packaging a pharmaceutical product, which exhibits good dispersibility in an organic coloring pigment (in the case of In the flakes, the organic coloring pigment is unevenly distributed, and at the same time, the organic coloring pigment can be prevented from oozing out (or the bleeding does not occur).

The PTP or blister packaging sheet for packaging pharmaceuticals of the present invention comprises: component (A) which is an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm and a number average molecular weight of 100 to 100 3000 dispersant (a2); and resin component (B).

In the sheet for PTP or blister packaging of the present invention, The component (A) is preferably contained in an amount of 0.4 to 6.0 parts by mass based on 100 parts by mass of the resin component (B).

In the sheet for PTP or blister packaging of the present invention, the mass ratio ((a1)/(a2)) of the organic coloring pigment (a1) to the dispersing agent (a2) is preferably from 30/70 to 75/25.

In the sheet for PTP or blister packaging of the present invention, the resin component (B) is preferably an ester resin or an olefin resin.

In the sheet for PTP or blister packaging of the present invention, the anti-bleed layer of at least one type of resin selected from the group consisting of polypropylene, polyethylene, and polychlorotrifluoroethylene is contained in one or two-area layers. good.

The PTP for pharmaceutical packaging of the present invention or the blister package for pharmaceutical packaging, which is obtained by molding PTP or blister packaging sheets for packaging pharmaceuticals according to any of the above.

A method for producing a PTP for pharmaceutical packaging of the present invention or a blister packaging for pharmaceutical packaging, which comprises mixing an organic colored pigment (a1) having an average particle diameter of 20 to 400 nm and a dispersing agent having a number average molecular weight of 100 to 3,000 ( A2) The component (A) is mixed and the component (A) is dispersed in the resin component (B) to prepare a resin composition, and the PTP or blister package for packaging a pharmaceutical product is molded from the resin composition. Further, PTP for pharmaceutical packaging or blister packaging for pharmaceutical packaging is produced by using the above-mentioned sheet.

The sheet for PTP or blister packaging of the present invention is attached to Among the organic coloring pigments contained in the sheet, good dispersibility (less uneven distribution of the organic coloring pigment in the sheet) can be exhibited, and at the same time, the organic coloring pigment can be prevented from oozing out (or the bleeding does not occur).

Further, when PTP or a blister package is produced by the good dispersibility, good formability can be exhibited, and when the organic coloring pigment has a function of shielding, scattering, and absorbing ultraviolet rays, it is possible to exhibit a good UV barrier over the entire range. PTP or blister packaging.

Hereinafter, the PTP or blister packaging sheet, the PTP or blister package, and the PTP or blister package production method of the present invention will be described in detail.

[PTP or blister packaging sheet]

The PTP or blister packaging sheet of the present invention is suitably used for the production of PTP or blister package sheets for packaging pharmaceuticals, and is characterized by containing an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm. The component (A) and the resin component (B) which are a dispersing agent (a2) having a number average molecular weight of 100 to 3,000 are contained as a component.

Here, the sheet for PTP or blister packaging refers to a PTP (press-through type package) or a blister package (preferably a PTP or a blister package sheet for packaging pharmaceuticals (PTP for pharmaceutical packaging) or The blister packaging sheet for pharmaceutical packaging)) The sheet used.

Further, in the following description, there is also a PTP of the present invention. The sheet for packaging by the blister is simply referred to as "the sheet of the present invention", and the organic coloring pigment (a1) and the dispersing agent (a2) are each referred to as "(a1) component" and "(a2) component".

<ingredient (A)>

The component (A) contained in the sheet of the present invention is an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm and a dispersing agent (a2) having a number average molecular weight of 100 to 3,000, and as needed. Any of the components (C) described later. That is, the component (A) is an organic coloring pigment (a1) coated with a dispersing agent (a2).

The component (a1) is not particularly limited as long as it is an organic coloring pigment having an average particle diameter of 20 to 400 nm, and is derived from the viewpoint of imparting ultraviolet barrier properties to the sheet of the present invention and the PTP or blister package obtained therefrom. It is preferable to use a pigment which shields, absorbs, and scatters ultraviolet rays (for example, 200 to 390 nm).

Specific examples of the component (a1) include cyanin, styrene, phthalocyanine, anthraquinone, perinone, and isoindolinone. An organic pigment such as a quinophthalone system, a quinacridone system, or a thioindigo system.

When considering the ease, safety, and hygiene, the (a1) component is CI Pigment Yellow 147 (1,1'-[(6-phenyl-1,3,5-three) -2,4-diyl)-diimido]bis-9,10-nonanedione) (Formula (1) below), CI Pigment Yellow 180 (2,2'-[1,2-ethane Di-bis(oxy-2,1-phenylene azo)]bis[N-(2,3-dihydro-2-oxo-1H-benzylimidazolium-5-yl)-3- side Oxy-butane decylamine] (Formula (2) below), CI Pigment Yellow 181 (N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[2,3-dihydro- 2-sided oxy-1H-benzimidazol-5-yl]amino]carbonyl]-2-oxopropyl propyl]azo)benzamide (the following formula (3)), or such The mixture is better.

C.I. Pigment Yellow 147

C.I. Pigment Yellow 180

C.I. Pigment Yellow 181

Further, from the viewpoints of improving the light-shielding property, safety, and transparency of the sheet of the present invention and the PTP or blister package obtained therefrom, the component (a1) is CI Pigment Yellow 180, CI Pigment among the above. Red 117 is preferred. Further, these compounds may be used singly or in combination of two or more kinds.

Further, the average particle diameter of the component (a1) is from 20 to 400 nm, and the average particle diameter is from 250 to 350 nm from the viewpoint of improving the light-shielding stability, safety, and transparency per unit area of the sheet of the present invention. good. Here, the average particle diameter means an average particle diameter obtained by the following measurement method.

[Method for Measuring Average Particle Size]

Measurement sample: The component (a1) was added to a dispersion medium (diethyl ether), and ultrasonically dispersed, and adhered to a film (substrate), and photographed using a transmission electron microscope (manufactured by JEOL Ltd.) (magnification: 35,000 times) The component (a1) adhered to the surface of the substrate was measured for the average value of the longest diameter of the primary particles of the component (a1) observed in the obtained microscope image.

When the average particle diameter of the component (a1) is adjusted to the above specific range, a well-known means for mechanically crushing and pulverizing the organic coloring pigment having a particle diameter larger than the upper limit of the above specific range can be used. Specific examples of such means include a vibrating mill, a vibrating ball mill, a bead mill, a turbine mill, a planetary ball mill, and the like.

The dispersing agent (a2) is not particularly limited as long as the number average molecular weight is from 100 to 3,000, but the dispersing agent is excellent in the dispersibility of the component (a1) in the film of the present invention and high in safety. A2) is preferably an olefin-based resin (polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-butene copolymer, etc.) having a number average molecular weight of 100 to 3,000. Further, various olefin-based resins may be used singly or in combination of two or more kinds.

Further, the number average molecular weight of the component (a2) is from 100 to 3,000. Since the (a2) component has such a molecular weight, it has an appropriate viscosity (for example, a viscosity at 140 ° C of 5 to 500 mPa·s). Therefore, when mixed with the component (a1), the surface of the component (a1) is covered by the component (a2) and reduced (a1). The aggregation of the components is such that the dispersibility of the component (a1) in the film becomes good.

Moreover, from the viewpoint of more excellent dispersibility of the component (a1) in the film of the present invention and high safety, the number average molecular weight is preferably from 1,500 to 2,000.

Further, the number average molecular weight of the component (a2) means a number average molecular weight measured by a vapor pressure osmometry method according to the following measurement conditions.

[Method for determining the number average molecular weight]

. Measuring sample: (a2) component

. Determination method: vapor pressure osmotic pressure method

. Measuring machine: Vapor pressure osmometer K-7000 (KNAUER company)

Further, the component (A) is obtained by mixing the above-mentioned (a1) component, (a2) component, and optionally any component (C), and can be prepared by a well-known mixing means such as a V-type mixer or a ball mill.

Further, it is also possible to use a vibrating mill, a vibrating rod mill, a vibrating ball mill, a bead mill, a turbine with an organic coloring pigment, a dispersing agent and an optional component (C) which are larger than the upper limit of the specific average particle diameter range. The mechanical pulverization and mixing means of a mill, a planetary ball mill, and the like are mixed, and the component (A) which adjusts the average particle diameter of the organic coloring pigment to a specific range (that is, at the same time as the modulation (a1) and (a2)) is prepared.

Further, the mass ratio (mixing ratio, (a1)/(a2))) of (a1) and (a2) in the component (A) may be any value, but can be improved from the film of the present invention (a1) Dispersibility of the component, transparency of the film of the present invention, shading From the standpoint of sex and safety, the mass ratio is preferably from 30/70 to 75/25, and preferably from 40/60 to 50/50.

Furthermore, the sheet of the present invention contains component (A) 0.4 to 6.0 with respect to 100 parts by mass of the resin component (B) to be described later, from the viewpoint of further improving dispersibility, transparency, light-shielding property and safety. The amount of the parts by mass is preferably from 2.0 to 5.0 parts by mass.

<Resin component (B)>

The resin component (B) contained in the sheet of the present invention is not particularly limited as long as it is a resin used for a known PTP or blister packaging sheet. Examples of such a resin include ester resins (polyester) such as polyethylene terephthalate or polyethylene naphthalate, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, and ethylene. An olefin resin such as a butene copolymer, polystyrene, polyamine, polyvinyl chloride, polycarbonate, polyacrylonitrile or polyimine. Moreover, these systems may be used singly or in combination of two or more types.

In particular, the resin component (B) is an olefin resin or an ester resin from the viewpoint of improving the dispersibility of the component (a1) in the sheet of the present invention, the transparency of the sheet of the present invention, the light blocking property, and the safety. (Polyester) is preferred.

Further, the number average molecular weight of the above olefin-based resin or ester-based resin is, for example, 50,000 to 180,000 (measured using a gel permeation chromatograph).

<arbitrary component (C)>

The sheet system of the present invention may also contain (a1) as needed. A component other than the component (a2) and the resin component (B) (optional component (C)).

Here, the optional component (C) may be contained in the component (A) together with the component (a1) and the component (a2) (that is, the components (C) and (a1) may be simultaneously mixed with (a2). The component (A)) or the resin component (B) may be contained (that is, the optional component (C) and the component (A) and the resin component (B) may be mixed at the same time to prepare the molded article. The resin composition of the sheet of the invention).

Examples of the optional component (C) include a stabilizer such as an antioxidant, a thermal stabilizer, and a light stabilizer, and an ultraviolet ray scattering agent other than the component (a1), an ultraviolet absorbing agent other than the component (a1), an inorganic pigment, and an anti- Electrostatic agent, slip agent, plasticizer, etc. In particular, in order to obtain a PTP or a blister package excellent in transparency, it is preferred to formulate an antioxidant. Examples of the antioxidant include a phenol-based antioxidant, a phosphorus-based antioxidant, and a sulfur-based antioxidant.

<PTP or blister packaging sheets, and PTP or blister packaging>

The PTP or blister packaging sheet of the present invention is a resin composition obtained by dispersing the component (A), the resin component (B), and the optional component (C), for example, by a known method such as a melt molding method. It is formed into a sheet shape.

Further, the sheet of the present invention may be a single layer, or a layer of a gas barrier layer such as one or two layers of an oxygen barrier layer, a gas absorbing layer, a moisture barrier layer, a light shielding layer, an anti-seepage layer, or the like, if necessary. (multilayer sheet). Among them, the sheet of the present invention contains a layer selected from one or two areas selected from the viewpoint of easily preventing such exudation even if a small amount of the component (a1) and the component (C) are easily exuded from the sheet of the present invention. Polypropylene, polyethyl A layer of at least one type of resin composed of a group of alkene and polychlorotrifluoroethylene is preferable as the anti-bleeding layer (multilayer sheet).

Further, a known layering means can be used in the case of one side or two area layers of the sheet of the present invention as described above. For example, the sheet of the present invention can be produced by laminating sheets of each layer on one or both sides, thermally bonding the sheets, or adhering the sheets forming the layers through an adhesive layer or the like. Here, in order to improve the adhesion between the sheet of the present invention and the above layers, corona treatment, low-temperature plasma treatment, or ion bombardment treatment may be performed on both surfaces or one of the surfaces as a pretreatment. It can be used for drug treatment and solvent treatment.

Further, the resin composition containing the component (A), the resin component (B), and optionally the component (C), and the resin composition forming each layer may be formed by a multilayer T-die method, a multilayer blow molding method, or the like. It is produced by a usual multilayer sheet forming method such as a coextrusion molding method, an extrusion coating method, a dry lamination method, a heat buildup layer, a wet casting method, a dry casting method, or the like, and a calender method.

The thickness of the sheet of the present invention (the total thickness in the case of a multilayer type) is usually from 150 μm to 400 μm, preferably from 180 μm to 350 μm. With such a thickness, the PTP and the blister package can be produced from the sheet of the present invention with good moldability.

The PTP or blister package of the present invention can be produced by using the above-mentioned PTP or blister packaging sheet. Such a PTP or blister pack exhibits good UV barrier properties over the entire range and is not easily bleed out, and thus is suitable for packaging foods and medicines (especially foods and medicines which are easily deteriorated by ultraviolet rays (discoloration and deterioration)). Things.

The method for producing a PTP or a blister package from the sheet of the present invention is not particularly limited, and for example, a well is formed on the surface of the sheet by a known forming method, and the contents are filled in the respective pockets, and the contents to be filled are sealed. A PTP or blister package is produced by following the surface of the sheet with a sealing material (cover material).

Here, a method of forming a cavity on the surface of the sheet of the present invention specifically includes the following method.

. Heating and pressure forming method: a sheet for PTP or blister packaging is sandwiched between a mold having a hole capable of supplying high-temperature, high-pressure air and a concave portion having a concave shape, and is heated and softened to supply air. A method of forming a pocket.

. Pre-heater flat plate forming method: heating and softening a sheet for PTP or blister packaging, sandwiching a mold having a hole capable of supplying high-pressure air and a mold having a recessed shape and supplying air thereto A method of forming a pocket.

. Drum-type vacuum forming method: a method in which a PTP or a blister-package sheet is partially heated and softened by a heating roller, and the recessed portion of the roller having the recessed portion of the recessed shape is evacuated to form a recess.

. Plug forming method: A method in which a sheet for PTP or blister packaging is heated and softened, and then pressed by a concave-convex mold having a concave shape.

. Pre-heater plug assisted pressure forming method: heating and softening the PTP or blister packaging sheet, sandwiching the mold with a hole capable of supplying high-pressure air, and a cavity having a recessed shape, and supplying air a method of forming a cavity in which a convex shaped plug is raised and lowered while being formed Line assisted forming.

In addition, since the film of the present invention is not only a vacuum forming method, but also a molding failure is unlikely to occur due to the pressure forming method, it is possible to form an air gap by a flat plate forming method or a plug assisting pressure forming method. Formed by law. Moreover, the shape, size, depth, number, arrangement, and the like of the pocket portion of the blister package of the present invention can be appropriately selected in accordance with the shape and use of the packaged article.

Further, since the contents to be filled can be sealed by heat sealing (heating followed), it is preferable that the sealing material (cover material) has a heat-sealable resin layer. The heat-sealable resin layer is not particularly limited as long as it can be fused to the surface of the sheet of the present invention in which the content is filled during heat sealing, and examples thereof include one or two or more kinds of low density polyethylene (LDPE). , medium density polyethylene (MDPE), high density polyethylene (HDPE), linear low density polyethylene (LLDPE), ethylene vinyl acetate (EVA), polypropylene (PP), ethylene-acrylic acid copolymer (EAA) , ethylene-methacrylic acid copolymer (EMA), ethylene-methacrylate copolymer (EMAA), ethylene-ethyl acrylate copolymer (EEAA), ethylene-methyl methacrylate copolymer (EMMA), ion polymerization Layer of matter (IO), etc.

In addition, it is preferable that the sealing material (the cover material) has a metal deposition film layer or a metal foil layer having an aluminum layer or the like.

(Example)

The present invention will be specifically described below by way of examples, but the invention is not limited thereto.

Organic coloring pigments and dispersions used in this embodiment The agent is as follows.

(1) Yellow pigment powder: A pigment having an average particle diameter of 320 nm obtained by pulverizing C.I. Pigment Yellow 180 (manufactured by CLARIANT JAPAN Co., Ltd., trade name "PV FAST YELLOW HG").

Further, the above average particle diameter is obtained by adding the pulverized CI Pigment Yellow 180 to a dispersion medium (diethyl ether), dispersing it by ultrasonic waves, adhering it to a film (substrate), and using a transmission electron microscope (Japan Electronics Co., Ltd.) The film was photographed (magnification: 35,000 times) of CI Pigment Yellow 180 adhered to the surface of the substrate, and the average value of the longest diameter of the primary particles of CI Pigment Yellow 180 observed in the obtained microscope image was measured.

(2) Polyethylene wax: Polyethylene wax (manufactured by Honeywell, trade name "A-C6A", number average molecular weight: 2000, viscosity at 140 °C: 400 cps)

Further, the measurement conditions of the number average molecular weight of the polyethylene wax and the viscosity at 140 ° C are as follows.

[Quantum average molecular weight]

Determination sample: the above polyethylene wax

Determination method: vapor pressure osmotic pressure method

Measuring machine: Vapor pressure osmometer K-7000 (KNAUER company)

[Measurement of viscosity]

The viscosity of the above polyethylene wax was measured by a B-type viscometer under conditions of No. 4 rotor, 60 rpm, 60 seconds, and 140 °C.

[Manufacture of test sheet]

The "yellow pigment powder" (coloring pigment (a1)) and "polyethylene wax" (dispersant (a2)) are mixed at the composition ratios shown in Table 1 below. The component (A1) and the component (A2) are prepared.

Next, according to the kind and ratio of the components shown in Table 2, the component A1 or the component A2 was added to the molten polypropylene of about 200 ° C and mixed by a biaxial kneading extruder to obtain a molten resin composition.

A 15 mm non-vented single-axis extruder is provided, which is provided with a hopper for inputting a resin, a cylinder, a heater for heating the cylinder, and a screw (full-screw type screw (L/D= 23)), which is disposed in the cylinder and is used for extruding the resin which is put into the hopper while heating and melting; the motor (1.5 KW) is used as a rotary power source of the screw; and the mold is set in The front end of the cylinder (the molten resin is extruded to the outside of the machine). In the cylinder of the extruder, a wire mesh (500 mesh, manufactured by Ishikawa Metal Wire Co., Ltd., "IKSCREEN" (registered trademark) MONOTYPE) is disposed between the mold and the cylinder.

1 kg of the obtained resin composition was put into a hopper of an extruder and the screw was rotated using a rotation speed of 150 rpm, and a molten resin group was allowed. The product is continuously extruded from the mold through the above-mentioned wire mesh, and continues until the extruded resin composition is used up. Here, it was confirmed by visual observation that the resin composition began to be extruded from the mold and the resin composition extruded from the mold was used up.

Further, as the screw rotates, the molten resin in the cylinder is subjected to pressure in the moving direction of the resin (from the screw to the direction in which the mold is provided).

Here, after the above pressure (P ₀ ) at the time of starting the extrusion of the resin composition from the mold, the above pressure (P ₁ ) at the time when the resin composition extruded from the mold was used up was measured.

The pressure rise difference ΔP is calculated from the obtained pressure values (P ₀ and P ₁ ) and the following formula 1. The dispersibility was evaluated using the calculated ΔP and the following evaluation criteria. Further, the unit of the above "P ₁ " and the following "P ₀ " is MPa.

△P=P ₁ -P ₀ (1)

[evaluation benchmark]

○: The value of ΔP is 3 or less.

×: The value of ΔP is more than 3.

When the dispersibility of the coloring pigment contained in the resin composition is poor, the coloring pigments are agglomerated or the coloring pigment in the resin composition is unevenly distributed, so that the value of ΔP is increased. On the other hand, when the dispersibility of the coloring pigment contained in the resin composition is good, since the coloring pigments do not easily aggregate, the coloring pigments are uniformly dispersed in the resin composition, so that the value of ΔP is made small. Further, in each of the examples, ΔP is in the range of 0.2 to 0.7 MPa.

Furthermore, the obtained resin composition was obtained using a multilayer extruder A sheet having a thickness of 250 μm in a polypropylene layer (thickness: 30 μm) was formed in a two-area layer to obtain a test sheet. The obtained test sheet was cut out to a size of 10 mm × 30 mm, and the light transmittance (%) at a wavelength of 220 to 420 nm was measured using an ultraviolet-visible spectrophotometer (V-560, manufactured by JASCO Corporation), and based on the following evaluation criteria. Evaluation of UV barrier properties.

[evaluation benchmark]

○: The light transmittance is less than 10%.

×: The light transmittance is 10% or more.

According to the present invention, good dispersibility (less uneven distribution of organic coloring pigments in the sheet) can be exhibited in the organic coloring pigment, and at the same time, it can be provided for forming to reduce the occurrence of bleeding of the organic coloring pigment (or the occurrence of the bleeding). PTP or blister-packed sheets (PTP or blister packaging sheets).

Further, according to the present invention, in the production of PTP or blister package, good formability can be exhibited and the organic coloring pigment can be shielded, scattered, When it absorbs ultraviolet light, it can provide a PTP or blister package that exhibits good UV barrier properties over the entire range.

The invention of the present application has been described above with reference to the embodiments, but the invention of the present application is not limited to the above. Various changes that can be understood by those skilled in the art can be made within the scope of the invention within the scope of the invention.

Priority is claimed on the basis of Japanese Patent Application No. 2011-268067, filed on Dec. 7, 2011, the entire disclosure of which is incorporated herein.

(industrial availability)

The present invention can be used for PTP or blister packaging because it can exhibit good dispersibility in medical organic coloring pigments and can reduce exudation of organic coloring pigments, and can be applied to packaging sheets of pharmaceuticals.

Claims (7)

A PTP or blister package for packaging pharmaceuticals, comprising: component (A), which is a mixture of an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm and a number average molecular weight of 100 to 3,000. The agent (a2); and the resin component (B). The PTP or the blister-packing sheet for packaging pharmaceuticals according to the first aspect of the invention, wherein the component (A) is contained in an amount of 0.4 to 6.0 parts by mass based on 100 parts by mass of the resin component (B). ). The PTP or blister packaging sheet for packaging pharmaceuticals according to the first or second aspect of the invention, wherein the mass ratio of the organic coloring pigment (a1) to the dispersing agent (a2) is (a1)/ (a2)) is 30/70 to 75/25. The PTP or blister packaging sheet for packaging pharmaceuticals according to any one of claims 1 to 3, wherein the resin component (B) is an ester resin or an olefin resin. The PTP or blister packaging sheet for packaging pharmaceuticals according to any one of claims 1 to 4, which is characterized in that one or both of the layers are selected from the group consisting of polypropylene, polyethylene and polychlorotrifluorocarbon. An anti-seepage layer of at least one type of resin composed of ethylene. A PTP for pharmaceutical packaging, or a blister pack for medicinal packaging, which is formed by using PTP or blister packaging sheets for packaging pharmaceuticals according to any one of claims 1 to 5. PTP for pharmaceutical packaging or blister packaging for pharmaceutical packaging a method of preparing an organic coloring pigment (a1) having an average particle diameter of 20 to 400 nm and a dispersing agent (a2) having a number average molecular weight of 100 to 3,000 to prepare a component (A); and the component (A) Dispersing the resin component (B) to prepare a resin composition; forming a PTP or blister packaging sheet for packaging a pharmaceutical product from the resin composition; and using the above-mentioned sheet to produce a PTP for pharmaceutical packaging or a blister for pharmaceutical packaging package.