WO2022065342A1 - Specimen collection container - Google Patents

Specimen collection container Download PDF

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Publication number
WO2022065342A1
WO2022065342A1 PCT/JP2021/034711 JP2021034711W WO2022065342A1 WO 2022065342 A1 WO2022065342 A1 WO 2022065342A1 JP 2021034711 W JP2021034711 W JP 2021034711W WO 2022065342 A1 WO2022065342 A1 WO 2022065342A1
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WO
WIPO (PCT)
Prior art keywords
film
barrier film
collection container
sample collection
container body
Prior art date
Application number
PCT/JP2021/034711
Other languages
French (fr)
Japanese (ja)
Inventor
嵩也 内山
邦哉 駒井
雅敏 丹生谷
浩信 五十川
Original Assignee
積水メディカル株式会社
徳山積水工業株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 積水メディカル株式会社, 徳山積水工業株式会社 filed Critical 積水メディカル株式会社
Publication of WO2022065342A1 publication Critical patent/WO2022065342A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state

Definitions

  • the present invention relates to a sample collection container.
  • sample collection containers from which samples are collected are widely used.
  • An example of the sample collection container is a blood collection tube from which blood is collected.
  • the blood collection tube is designed so that a specified amount of blood can be collected by reducing the pressure inside (for example, Patent Document 1).
  • sample collection container When using the sample collection container, customer information and sample information such as the sample number may be entered on the outer surface of the sample collection container with a pen or the like. Further, a sample collection container to which a paper label for writing sample information with a pencil or a pen is attached is also known.
  • a sample collection container containing an internal substance such as a vacuum collection tube containing a liquid containing an anticoagulant.
  • the conventional sample collection container in which the liquid is housed has a problem that the liquid gradually evaporates.
  • a barrier film to the outer peripheral surface of the container.
  • the surface of the barrier film is a smooth surface, so that the sample information cannot be entered with a pencil or pen, or the entered sample information is touched. And rubbing occurs.
  • An object of the present invention is to provide a sample collection container in which sample information can be entered on the surface of a barrier film and the entered sample information is less likely to be rubbed.
  • the container body and the barrier film arranged on the outer surface of the container body are provided, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more, and the rough surface region of the barrier film is a sample collection container.
  • a sample collection container is provided that constitutes at least a portion of the outer surface of the.
  • the maximum height Rz of the rough surface region of the barrier film is 10.0 ⁇ m or more.
  • the arithmetic average roughness Ra of the rough surface region of the barrier film is 2.4 ⁇ m or more.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is 1.1 g / (m 2 ⁇ day) or less.
  • the barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order.
  • the outer surface of the first film has the rough surface region, and the second adhesive layer is arranged on the outer surface of the container body.
  • the first film is a barrier film main body
  • the second film is a polyethylene terephthalate film
  • the sample collection container includes a stopper attached to an opening of the container body and a liquid contained in the container body.
  • the sample collected in the sample collection container is blood
  • the liquid is a liquid containing an anticoagulant.
  • the sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container. Since the sample collection container according to the present invention has the above configuration, the sample information can be written on the surface of the barrier film, and the written sample information is less likely to be rubbed.
  • FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention.
  • FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
  • the sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g.
  • the outer surface of the barrier film is (m 2 ⁇ day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container.
  • the sample information can be entered on the surface of the barrier film, and the entered sample information is less likely to be rubbed.
  • the sample information can be entered with a pencil or a pen in the rough surface region, and the entered sample information can be entered. Even if you touch, the sample information is not easily faded. Therefore, in the sample collection container according to the present invention, the barrier performance can be enhanced, the sample information can be satisfactorily entered, and the entered sample information can be less likely to be rubbed.
  • the barrier film is arranged on the outer surface of the container body.
  • the barrier film is preferably attached on the outer surface of the container body, and is preferably wrapped.
  • the barrier film is preferably a water vapor barrier film.
  • the barrier film is preferably transparent. In the sample collection container, it is preferable that the collected sample can be visually recognized through the barrier film when the sample is collected.
  • the barrier film is preferably a transparent barrier film, and preferably a transparent water vapor barrier film.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is 0.8 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.6 g / (m 2 ⁇ day) or less, more preferably 0.3 g / (m). 2. Day) or less, more preferably 0.1 g / (m 2 ⁇ day) or less, and particularly preferably 0.05 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
  • the outer surface of the barrier film has a rough surface region having an arithmetic average roughness Ra of 1.5 ⁇ m or more.
  • the rough surface region constitutes at least a part of the outer surface of the sample collection container.
  • the arithmetic average roughness Ra of the rough surface region is preferably 2.0 ⁇ m or more, more preferably 2.4 ⁇ m or more, still more preferably 3.0 ⁇ m or more, and particularly preferably 5.0 ⁇ m or more.
  • the arithmetic average roughness Ra of the rough surface region is preferably 10.0 ⁇ m or less, more preferably 9.0 ⁇ m or less, still more preferably 8.0 ⁇ m or less, particularly preferably 7.0 ⁇ m or less, and most preferably 6.0 ⁇ m or less. Is.
  • the arithmetic average roughness Ra of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively.
  • the sample information can be satisfactorily entered with a pencil.
  • the arithmetic average roughness Ra of the rough surface region is not more than the above upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
  • the arithmetic average roughness Ra of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
  • the maximum height Rz of the rough surface region is preferably 10.0 ⁇ m or more, more preferably 15.0 ⁇ m or more, still more preferably 20.0 ⁇ m or more, particularly preferably 25.0 ⁇ m or more, and most preferably 30.0 ⁇ m or more. be.
  • the maximum height Rz of the rough surface region is preferably 70.0 ⁇ m or less, more preferably 60.0 ⁇ m or less, still more preferably 55.0 ⁇ m or less, particularly preferably 50.0 ⁇ m or less, and most preferably 45.0 ⁇ m or less. be.
  • the maximum height Rz of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively.
  • the maximum height Rz of the rough surface region is not more than the upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
  • the maximum height Rz of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
  • the arithmetic average roughness Ra of the rough surface region is 2.0 ⁇ m or more and the maximum height Rz is 20.0 ⁇ m or more. In this case, the sample information can be entered even better with a pencil and a pen.
  • Examples of the method for forming the rough surface region by adjusting the arithmetic average roughness Ra and the maximum height Rz of the outer surface of the barrier film include a method of rubbing with sandpaper and a method of projecting fine sand. Be done.
  • a sample collection container can be produced by arranging the barrier film having the rough surface region on the outer surface of the container body.
  • the thickness of the barrier film is preferably 5 ⁇ m or more, more preferably 30 ⁇ m or more, preferably 300 ⁇ m or less, and more preferably 200 ⁇ m or less.
  • the thickness of the barrier film is the thickness of the barrier film itself.
  • the barrier film is preferably arranged at 0.2 laps or more, more preferably 0.5 laps or more, and more preferably 3 laps or less in the circumferential direction of the outer surface of the container body. It is preferable that it is arranged, and it is more preferable that it is arranged in 1.5 laps or less. In this case, the barrier performance can be further improved.
  • the surface area of the portion where the barrier film is arranged is preferably 15% or more, more preferably 30% or more, still more preferably 70% or more.
  • the barrier performance can be further improved.
  • sample information can be easily entered.
  • the surface area of the portion where the barrier film is arranged may be 100%, 100% or less, or 90% or less. It may be 80% or less.
  • the surface area of the rough surface region is preferably 2% or more, more preferably 10% or more, still more preferably 20% or more. It is preferably 95% or less, more preferably 70% or less, still more preferably 40% or less.
  • the surface area of the rough surface region is at least the above lower limit, sample information can be easily entered.
  • the surface area of the rough surface region is not more than the upper limit, the visibility inside the container at the time of sample collection can be improved, and the water vapor barrier performance can be maintained high.
  • the rough surface region constitutes at least a part of the outer surface of the sample collection container.
  • the surface area is preferably 5% or more, more preferably 15% or more, still more preferably 25% or more, preferably 90% or less, more preferably 65% or less, still more preferably 45% or less.
  • the barrier film preferably has a barrier film main body and an adhesive layer.
  • the adhesive layer is arranged on the outer surface of the container body, and the barrier film body is arranged outside the adhesive layer.
  • the barrier film main body may be arranged on the outer surface of the adhesive layer.
  • the barrier film includes a first film, a first adhesive layer, a second film, and a second adhesive layer. It is more preferable to have them in order.
  • the outer surface of the first film has the rough surface region, and it is preferable that the second adhesive layer is arranged on the outer surface of the container body.
  • the first film may be the barrier film main body, and the second film may be the barrier film main body.
  • the barrier film has a portion having a first film, a first adhesive layer, a second film, and a second adhesive layer in this order.
  • the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the second film has the rough surface region. You may be doing it.
  • the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the first film has the rough surface region. You may be doing it.
  • the second adhesive layer is arranged on the outer surface of the container body.
  • the first film may be the barrier film main body
  • the second film may be the barrier film main body.
  • the first film and the first adhesive layer may be directly laminated or may be laminated via another layer.
  • the first adhesive layer and the second film may be directly laminated or may be laminated via another layer.
  • the second film and the second adhesive layer may be directly laminated or may be laminated via another layer.
  • the first film and the first adhesive layer are directly laminated, and the first adhesive layer and the second film are directly laminated. It is preferable that the second film and the second adhesive layer are directly laminated.
  • the barrier film preferably has a barrier film body.
  • the water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is preferably 0.8 g / (m 2 ⁇ day) or less, more preferably 0.6 g / (m 2 ⁇ day) or less, still more preferably. It is 0.3 g / (m 2 ⁇ day) or less, particularly preferably 0.1 g / (m 2 ⁇ day) or less, and most preferably 0.05 g / (m 2 ⁇ day) or less.
  • the water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
  • the barrier film main body preferably includes a base film, an inorganic oxide layer, and more preferably a base film, an inorganic oxide layer, and a barrier coat layer in this order.
  • the base film and the inorganic oxide layer may be directly laminated or may be laminated via another layer.
  • the inorganic oxide layer and the barrier coat layer may be directly laminated or may be laminated via another layer.
  • the base film examples include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
  • the base film is preferably transparent.
  • the inorganic oxide layer is preferably a layer having a gas barrier property or a water vapor barrier property.
  • the inorganic oxide layer is preferably an inorganic oxide-deposited layer in which an inorganic oxide is vapor-deposited on the surface of the base film.
  • Examples of the inorganic oxide contained in the inorganic oxide layer include aluminum oxide, silicon oxide, tin oxide, magnesium oxide and the like. Only one kind of the above-mentioned inorganic oxide may be used, or two or more kinds thereof may be used in combination.
  • the inorganic oxide is preferably aluminum oxide or silicon oxide.
  • the barrier coat layer is a layer having a gas barrier property. Further, by having the barrier coat layer, oxidation of the inorganic oxide can be effectively suppressed, and damage to the inorganic oxide layer due to an external impact or the like can be suppressed.
  • the material of the barrier coat layer a conventionally known material used as the barrier coat layer can be used.
  • the material of the barrier coat layer include a composition containing a hydrolysis product of alkoxysilane and a water-soluble polymer, polyethylene terephthalate, nylon and the like.
  • the material of the barrier coat layer only one kind may be used, or two or more kinds may be used in combination.
  • water-soluble polymer examples include polyvinyl alcohol-based resins and ethylene-vinyl alcohol copolymers. Only one kind of the water-soluble polymer may be used, or two or more kinds thereof may be used in combination.
  • the base film and the inorganic oxide layer it is preferable that the base film is arranged on the container body side.
  • the base film and the barrier coat layer it is preferable that the base film is arranged on the container body side.
  • the outer surface of the barrier film body is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the barrier film body has the rough surface region.
  • the first film is the barrier film main body.
  • the outer surface of the first film is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the first film has the rough surface region.
  • the above-mentioned commercial products include “GX-PF” and “GL-AEC-F” manufactured by Toppan Printing Co., Ltd., “IB-PET-PXB2” manufactured by Dai Nippon Printing Co., Ltd., and “Barrier Rocks 1011 SBR2” manufactured by Toray Film Processing Co., Ltd. , "V Barrier” manufactured by Mitsui Chemicals Tocello Co., Ltd., “Tech Barrier” manufactured by Mitsubishi Chemical Corporation, and the like.
  • a barrier film main body having the rough surface region can be obtained.
  • the second film may be the barrier film main body or not the barrier film main body.
  • the first film is a barrier film main body
  • the second film is preferably not a barrier film main body, and is preferably a resin film.
  • Examples of the second film include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
  • the second film is preferably a polyethylene terephthalate film.
  • the adhesive can be applied satisfactorily and the laminating workability can be improved.
  • the thickness of the second film is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the second film is the thickness of the second film itself.
  • the barrier film preferably has an adhesive layer.
  • the adhesive layer is a layer formed by an adhesive.
  • the first adhesive layer is arranged between the first film and the second film.
  • the second adhesive layer is arranged between the second film and the outer surface of the container body.
  • the second adhesive layer is preferably arranged on the outer surface of the container body.
  • the material of the pressure-sensitive adhesive layer is not particularly limited, and a conventionally known pressure-sensitive adhesive can be used.
  • the pressure-sensitive adhesive include silicone-based pressure-sensitive adhesives, urethane-based pressure-sensitive adhesives, acrylic-based pressure-sensitive adhesives, and the like. Only one kind of the above-mentioned pressure-sensitive adhesive may be used, or two or more kinds thereof may be used in combination.
  • the pressure-sensitive adhesive is preferably an acrylic pressure-sensitive adhesive or a silicone-based pressure-sensitive adhesive.
  • the thickness of the first adhesive layer is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the first adhesive layer is the thickness of the first adhesive layer itself. When the thickness of the first adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
  • the thickness of the second adhesive layer is preferably 1 ⁇ m or more, more preferably 10 ⁇ m or more, preferably 80 ⁇ m or less, and more preferably 50 ⁇ m or less.
  • the thickness of the second adhesive layer is the thickness of the second adhesive layer itself. When the thickness of the second adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
  • the container body preferably has an opening.
  • the shape of the container body is not particularly limited.
  • the container body is preferably a bottomed container, and more preferably a bottomed tubular container.
  • the material of the container body is not particularly limited.
  • thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyethylene naphthalate, polymethylmethacrylate, and polyacrylonitrile; and thermocurable resins such as unsaturated polyester resin, epoxy resin, and epoxy-acrylate resin.
  • Resins Modified natural resins such as cellulose acetate, cellulose propionate, ethyl cellulose, ethylchitin, etc .; Examples thereof include silicate glass such as soda lime glass, phosphoric acid glass and borosilicate glass, and glass such as quartz glass. Only one of these components may be used, or two or more of these components may be used in combination.
  • the material of the container body is preferably resin, more preferably polyethylene terephthalate or polyethylene naphthalate, and even more preferably polyethylene terephthalate.
  • the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.5 g / (m 2 ⁇ day) or less, more preferably 0. It is 2 g / (m 2 ⁇ day) or less, more preferably 0.05 g / (m 2 ⁇ day) or less.
  • the sample collection container preferably includes a stopper attached to the opening of the container body.
  • a conventionally known stopper can be used.
  • the stopper is preferably a stopper having a material and shape that can be attached to the opening of the container body in an airtight and liquidtight manner. From the viewpoint of easily collecting the sample in the sample collection container, it is preferable that the stopper is configured so that the needle can be pierced.
  • plug body examples include a plug body having a shape that fits into the opening of the container body, a sheet-shaped seal plug body, and the like.
  • the stopper body may be a stopper body including a stopper body such as a rubber stopper and a cap member made of plastic or the like. In this case, it is possible to reduce the risk of the body fluid coming into contact with the human body when the plug is pulled out from the opening of the container body after collecting the body fluid such as blood.
  • the material of the stopper body examples include synthetic resin, elastomer, rubber, metal leaf and the like.
  • Examples of the rubber include butyl rubber and halogenated butyl rubber.
  • Examples of the metal foil include aluminum foil and the like.
  • the material of the stopper body (or the stopper body) is preferably butyl rubber or halogenated butyl rubber.
  • the stopper (or the main body of the stopper) is preferably a butyl rubber stopper or a halogenated butyl rubber stopper.
  • the sample collection container may include an container contained in the container body.
  • the type and amount of the contained substance and the type and amount of the sample to be collected are not particularly limited.
  • sample examples include biological samples and the like. Specific examples of the sample include blood, plasma, urine, and cerebrospinal fluid.
  • Examples of the components contained in the contained substance include anticoagulants, enzymes, enzyme stabilizers, organic compounds, and inorganic compounds.
  • anticoagulant examples include citric acid, oxalic acid, EDTA (ethylenediaminetetraacetic acid), heparin and the like.
  • citric acid oxalic acid
  • EDTA ethylenediaminetetraacetic acid
  • heparin heparin
  • the anticoagulant only one kind may be used, or two or more kinds may be used in combination.
  • the enzyme examples include serine proteases such as trypsin, chymotrypsin, elastase, trombine, plasmin, serpentine trombine-like enzyme, subtilisin and acidic carboxypeptidase; thiol proteases such as catepsin B and phycin; carboxypeptidase A, carboxypeptidase B and leucine amino. Examples thereof include metal proteases such as peptidase and quininase I. Only one type of the above enzyme may be used, or two or more types may be used in combination.
  • the stabilizer for the enzyme examples include sugars such as dextran, peptides, and proteins such as albumin and globulin.
  • examples of the stabilizer for the enzyme include ⁇ -alanine, glycine, D-mannitol, gelatin, albumin and the like.
  • the stabilizer of the above enzyme only one kind may be used, or two or more kinds may be used in combination.
  • organic compound examples include sugar, formaldehyde free substance, citric acid and the like.
  • sugar examples include glucose, fructose, galactose, maltose, cyclodextrin and the like.
  • Examples of the inorganic compound include phosphoric acid, sodium chloride, potassium chloride, boric acid, trisphosphate and the like.
  • the contained substance may be a liquid, a dried product, or a freeze-dried product.
  • the sample collection container preferably includes a liquid contained in the container body.
  • the solvent of the liquid is preferably water. Since the sample collection container is provided with a barrier film, evaporation of the liquid can be effectively suppressed as compared with a sample collection container without a barrier film.
  • the liquid is preferably a liquid containing the anticoagulant, and more preferably a liquid containing the anticoagulant and water.
  • the anticoagulant preferably contains citric acid, EDTA, or heparin, and more preferably citric acid, EDTA, or heparin.
  • the liquid preferably contains at least one of citric acid, EDTA and heparin.
  • the amount of liquid contained in the container body may be 0.1 mL or more, or 5 mL or less.
  • the sample collection container is preferably provided with the enzyme contained in the container body, and is preferably provided with the enzyme housed in the container body and a stabilizer for the enzyme.
  • the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be.
  • the stabilizer of the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be.
  • the enzyme and the stabilizer of the enzyme may be contained in the container body in the state of a mixed solution containing the enzyme, the stabilizer of the enzyme and a solvent, and the enzyme and the stabilizer of the enzyme may be stabilized.
  • sample collection container is provided with a barrier film, it is possible to effectively suppress a decrease in enzyme activity as compared with a sample collection container without a barrier film.
  • the enzyme is preferably thrombin-like enzyme or thrombin.
  • the sample collection container is a blood collection container.
  • the sample collection container is preferably a blood collection tube, and more preferably a vacuum blood collection tube.
  • the sample collection container may contain components other than the components described above in the container body.
  • the other components include serum or plasma separating agents, serum or plasma separating jigs, Ficoll, magnetic beads and the like.
  • the amount of sample collected in the above sample collection container is not particularly limited.
  • the amount of the sample collected in the sample collection container may be 0.5 mL or more, 4.5 mL or more, or 7.6 mL or more.
  • the amount of the sample collected in the sample collection container may be 10 mL or less, 5.5 mL or less, or 2.0 mL or less.
  • FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention.
  • the sample collection container 11 shown in FIG. 1 includes a container body 1, a stopper 2, a barrier film 3, and a liquid 4.
  • the inside of the sample collection container 11 is depressurized.
  • the container body 1 is a tubular container body.
  • the container body 1 has an opening at one end and a closed bottom at the other end.
  • the stopper 2 is attached to the opening of the container body 1.
  • the barrier film 3 is arranged in the circumferential direction on the outer surface 1a of the container body 1.
  • the barrier film 3 is arranged on a part of the outer surface 1a of the container body 1.
  • the barrier film 3 is wound on the outer surface 1a of the container body 1.
  • the liquid 4 is housed in the container body 1.
  • the barrier film 3 has a first film 31, a first adhesive layer 33, a second film 32, and a second adhesive layer 34 in this order from the outside to the inside of the sample collection container 11. ..
  • a second adhesive layer 34 is arranged on the outer surface 1a of the container body 1.
  • the second film 32 is arranged on the surface of the second adhesive layer 34 opposite to the container body 1.
  • the first adhesive layer 33 is arranged on the surface of the second film 32 opposite to the second adhesive layer 34.
  • the first film 31 is arranged on the surface of the first adhesive layer 33 opposite to the second film 32.
  • the first film 31 is the barrier film body
  • the second film 32 is the polyethylene terephthalate film.
  • the outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R.
  • the rough surface region R exists on the outer surface 3a of the barrier film 3 and a part of the outer surface of the first film 31.
  • the outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 ⁇ m.
  • the rough surface region R of the barrier film 3 constitutes a part of the outer surface of the sample collection container 11.
  • FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
  • the sample collection container 11A shown in FIG. 2 includes a container body 1, a stopper 2, a barrier film 3A, and a liquid 4.
  • the inside of the sample collection container 11A is depressurized.
  • the container body 1 is a tubular container body.
  • the container body 1 has an opening at one end and a closed bottom at the other end.
  • the stopper 2 is attached to the opening of the container body 1.
  • the barrier film 3A is arranged in the circumferential direction on the outer surface 1a of the container body 1.
  • the barrier film 3A is arranged on a part of the outer surface 1a of the container body 1.
  • the barrier film 3A is wound on the outer surface 1a of the container body 1.
  • the liquid 4 is housed in the container body 1.
  • the barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. There is a part.
  • the barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. It has a portion and a portion having a second film 32A and a second adhesive layer 34A in this order.
  • the second adhesive layer 34A is arranged on the outer surface 1a of the container body 1.
  • the second film 32A is arranged on the surface of the second adhesive layer 34A opposite to the container body 1.
  • the first adhesive layer 33A is partially arranged on the surface of the second film 32A opposite to the second adhesive layer 34A. On the surface of the second film 32A opposite to the second adhesive layer 34A, there are a portion where the first adhesive layer 33A is arranged and a portion where the first adhesive layer 33A is not arranged. exist.
  • the first film 31A is arranged on the surface of the first adhesive layer 33A opposite to the second film 32A.
  • the outer surface of the first film 31A and the outer surface of the second film 32A constitute the outer surface 3Aa of the barrier film 3A.
  • the rough surface region R exists on a part of the outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A.
  • the outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 ⁇ m.
  • the rough surface region R of the barrier film 3A constitutes a part of the outer surface of the sample collection container 11A.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is preferably 1.1 g / (m 2 ⁇ day) or less, more preferably 0.9 g / (m 2 ⁇ day) or less, still more preferably. It is 0.6 g / (m 2 ⁇ day) or less. When the water vapor transmission rate is not more than the upper limit, the barrier performance can be exhibited more effectively.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH may be 0.2 g / (m 2 ⁇ day) or more, and 0.4 g / (m 2 ⁇ day) or more. You may.
  • the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is measured as follows.
  • a sample collection container (the inside is not decompressed and the inside is not decompressed) in which water is stored in the container body that does not contain liquid inside, sealed with a stopper, and a barrier film is placed on the outer surface of the container body.
  • the obtained sample collection container is stored at 40 ° C. and 0% RH.
  • the water vapor transmission rate is calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH is preferably 0.5 cc / (m 2 ⁇ day ⁇ atm) or less, more preferably 0.4 cc / (m 2 ⁇ day ⁇ atm) or less. , More preferably 0.3 cc / ( m2 ⁇ day ⁇ atm) or less.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH may be 0.1 cc / (m 2 ⁇ day ⁇ atm) or more, and 0.2 cc / (m 2 ⁇ day ⁇ atm). ) Or more.
  • the air permeability of the sample collection container at 40 ° C. and 0% RH is measured as follows.
  • the obtained sample collection container is stored at 40 ° C. and 0% RH. Water is sucked into the sample collection container, and the amount of increase in internal pressure due to storage is calculated from the calibration curve of the collected amount and internal pressure, and the air permeability is calculated.
  • the inside of the sample collection container is sterilized according to the standards described in ISO and JIS.
  • Container body The following container body having the shape shown in FIG. 1 was prepared.
  • a rubber stopper (butyl rubber stopper) having the shape shown in FIG. 1 and which can be attached to the opening of the container body was prepared.
  • Example 1 Preparation of barrier film The following materials were prepared.
  • Film X "GX-PF” manufactured by Toppan Printing Co., Ltd. (thickness 12 ⁇ m) Polyethylene terephthalate film (PET film) (thickness 25 ⁇ m) Adhesive release paper
  • the film X, the adhesive, the PET film, the adhesive, and the release paper are laminated in this order and laminated to form a film X (thickness 12 ⁇ m) / first adhesive layer / PET film (thickness 25 ⁇ m) / second adhesive.
  • a laminated film having a layer structure of a layer / release paper was obtained.
  • the obtained barrier film has a barrier film main body (first film) having a rough surface region, a first adhesive layer, a PET film (second film), and a second adhesive layer in this order. ..
  • the obtained barrier film has the following dimensions.
  • Examples 2 to 19 A barrier film and a sample collection container were prepared in the same manner as in Example 1 except that the time and area of rubbing with sandpaper were changed.
  • Example 1 The barrier was the same as in Example 1 except that the surface of the film X of the obtained laminated film was not rubbed with sandpaper (# 40) and the film X was used as the barrier film main body (first film). A film and a sample collection container were prepared.
  • Arithmetic mean roughness Ra and maximum height Rz of the barrier film In Examples 1 to 19, the arithmetic mean roughness Ra and the maximum height Rz of the portion rubbed with sandpaper were measured. In Comparative Example 1, the arithmetic mean roughness Ra and the maximum height Rz of the surface of the barrier film were measured. Arithmetic mean roughness Ra and maximum height Rz were measured according to JIS B0601: 2001. As a measuring device, a 3D measuring microscope (“VR-3100” manufactured by KEYENCE CORPORATION) was used.
  • the obtained sample collection container was stored in a constant temperature and humidity device at 40 ° C. and 0% RH.
  • the water vapor transmission rate was calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.

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Abstract

Provided is a specimen collection container that makes it possible to write specimen information on the surface of a barrier film and makes it difficult for the written specimen information to be scratched.　A specimen collection container according to this invention comprises a container body and a barrier film disposed on the outer surface of the container body. The water vapor transmission rate of the barrier film at 40° and 90% RH is less than or equal to 0.8 g/(m2/day). The external surface of the barrier film has a rough surface area where the arithmetic mean roughness Ra is greater than or equal to 1.5 μm. The rough surface area of the barrier film composes at least a portion of the outer surface of the specimen collection container.

Description

検体採取容器Specimen collection container
　本発明は、検体採取容器に関する。 The present invention relates to a sample collection container.
　臨床検査において、検体が採取される検体採取容器が広く用いられている。上記検体採取容器の一例として、血液が採取される採血管が挙げられる。採血管では、内部が減圧されていることによって、規定量の血液が採取されるように設計されている（例えば、特許文献１）。 In clinical examinations, sample collection containers from which samples are collected are widely used. An example of the sample collection container is a blood collection tube from which blood is collected. The blood collection tube is designed so that a specified amount of blood can be collected by reducing the pressure inside (for example, Patent Document 1).
特開２０１０－１５４９０９号公報Japanese Unexamined Patent Publication No. 2010-154909
　検体採取容器を使用する際、検体採取容器の外表面に顧客情報及び検体番号等の検体情報をペン等で記入することがある。また、検体情報を鉛筆又はペンで記入するための紙ラベルが貼り付けられた検体採取容器も知られている。 When using the sample collection container, customer information and sample information such as the sample number may be entered on the outer surface of the sample collection container with a pen or the like. Further, a sample collection container to which a paper label for writing sample information with a pencil or a pen is attached is also known.
　ところで、抗凝固剤を含む液が収容された真空採血管のように、内部に収容物が収容された検体採取容器が用いられている。しかしながら、内部に液体が収容された従来の検体採取容器では、液体が徐々に蒸発するという課題がある。 By the way, a sample collection container containing an internal substance is used, such as a vacuum collection tube containing a liquid containing an anticoagulant. However, the conventional sample collection container in which the liquid is housed has a problem that the liquid gradually evaporates.
　このような課題に対して、容器の外周面にバリアフィルムを貼り付けることが考えられる。しかしながら、容器の外周面にバリアフィルムを単に貼り付けた場合には、バリアフィルムの表面は平滑面であるため、検体情報を鉛筆又はペンで記入することができなかったり、記入した検体情報に触れると擦れが生じたりする。 For such problems, it is conceivable to attach a barrier film to the outer peripheral surface of the container. However, when the barrier film is simply attached to the outer peripheral surface of the container, the surface of the barrier film is a smooth surface, so that the sample information cannot be entered with a pencil or pen, or the entered sample information is touched. And rubbing occurs.
　本発明の目的は、バリアフィルムの表面に検体情報を記入することができ、かつ記入した検体情報に擦れが生じにくい検体採取容器を提供することである。 An object of the present invention is to provide a sample collection container in which sample information can be entered on the surface of a barrier film and the entered sample information is less likely to be rubbed.
　本発明の広い局面によれば、容器本体と、前記容器本体の外表面上に配置されたバリアフィルムとを備え、前記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度が０．８ｇ／（ｍ２・ｄａｙ）以下であり、前記バリアフィルムの外表面は、算術平均粗さＲａが１．５μｍ以上である粗面領域を有し、前記バリアフィルムの前記粗面領域が、検体採取容器の外表面の少なくとも一部を構成している、検体採取容器が提供される。 According to a broad aspect of the present invention, the container body and the barrier film arranged on the outer surface of the container body are provided, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g. The outer surface of the barrier film is (m 2 · day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 μm or more, and the rough surface region of the barrier film is a sample collection container. A sample collection container is provided that constitutes at least a portion of the outer surface of the.
　本発明に係る検体採取容器のある特定の局面では、前記バリアフィルムの前記粗面領域の最大高さＲｚが１０．０μｍ以上である。 In a specific aspect of the sample collection container according to the present invention, the maximum height Rz of the rough surface region of the barrier film is 10.0 μm or more.
　本発明に係る検体採取容器のある特定の局面では、前記バリアフィルムの前記粗面領域の算術平均粗さＲａが２．４μｍ以上である。 In a specific aspect of the sample collection container according to the present invention, the arithmetic average roughness Ra of the rough surface region of the barrier film is 2.4 μm or more.
　本発明に係る検体採取容器のある特定の局面では、検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度が１．１ｇ／（ｍ２・ｄａｙ）以下である。 In a particular aspect of the sample collection container according to the present invention, the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is 1.1 g / (m 2 · day) or less.
　本発明に係る検体採取容器のある特定の局面では、前記バリアフィルムが、第１のフィルムと、第１の粘着層と、第２のフィルムと、第２の粘着層とをこの順に有し、前記第１のフィルムの外表面が、前記粗面領域を有し、前記第２の粘着層が、前記容器本体の外表面上に配置されている。 In a specific aspect of the sample collection container according to the present invention, the barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order. The outer surface of the first film has the rough surface region, and the second adhesive layer is arranged on the outer surface of the container body.
　本発明に係る検体採取容器のある特定の局面では、前記第１のフィルムが、バリアフィルム本体であり、前記第２のフィルムが、ポリエチレンテレフタレートフィルムである。 In a specific aspect of the sample collection container according to the present invention, the first film is a barrier film main body, and the second film is a polyethylene terephthalate film.
　本発明に係る検体採取容器のある特定の局面では、前記検体採取容器は、前記容器本体の開口部に取り付けられた栓体と、前記容器本体内に収容された液体とを備える。 In a specific aspect of the sample collection container according to the present invention, the sample collection container includes a stopper attached to an opening of the container body and a liquid contained in the container body.
　本発明に係る検体採取容器のある特定の局面では、検体採取容器に採取される検体が、血液であり、前記液体が、抗凝固剤を含む液である。 In a specific aspect of the sample collection container according to the present invention, the sample collected in the sample collection container is blood, and the liquid is a liquid containing an anticoagulant.
　本発明に係る検体採取容器は、容器本体と、上記容器本体の外表面上に配置されたバリアフィルムとを備え、上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度が０．８ｇ／（ｍ２・ｄａｙ）以下であり、上記バリアフィルムの外表面は、算術平均粗さＲａが１．５μｍ以上である粗面領域を有する。本発明に係る検体採取容器では、上記バリアフィルムの上記粗面領域が、検体採取容器の外表面の少なくとも一部を構成している。本発明に係る検体採取容器では、上記の構成が備えられているので、バリアフィルムの表面に検体情報を記入することができ、かつ記入した検体情報に擦れが生じにくい。 The sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g. The outer surface of the barrier film is (m 2 · day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 μm or more. In the sample collection container according to the present invention, the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container. Since the sample collection container according to the present invention has the above configuration, the sample information can be written on the surface of the barrier film, and the written sample information is less likely to be rubbed.
図１は、本発明の第１の実施形態に係る検体採取容器を模式的に示す正面断面図である。FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention. 図２は、本発明の第２の実施形態に係る検体採取容器を模式的に示す正面断面図である。FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
　以下、本発明の詳細を説明する。 Hereinafter, the details of the present invention will be described.
　本発明に係る検体採取容器は、容器本体と、上記容器本体の外表面上に配置されたバリアフィルムとを備え、上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度が０．８ｇ／（ｍ２・ｄａｙ）以下であり、上記バリアフィルムの外表面は、算術平均粗さＲａが１．５μｍ以上である粗面領域を有する。本発明に係る検体採取容器では、上記バリアフィルムの上記粗面領域が、検体採取容器の外表面の少なくとも一部を構成している。 The sample collection container according to the present invention includes a container body and a barrier film arranged on the outer surface of the container body, and the water vapor permeability of the barrier film at 40 ° C. and 90% RH is 0.8 g / g. The outer surface of the barrier film is (m 2 · day) or less, and has a rough surface region having an arithmetic mean roughness Ra of 1.5 μm or more. In the sample collection container according to the present invention, the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container.
　本発明に係る検体採取容器では、上記の構成が備えられているので、バリアフィルムの表面に検体情報を記入することができ、かつ記入した検体情報に擦れが生じにくい。本発明に係る検体採取容器では、バリアフィルムの外表面に特定の粗面領域が存在するので、上記粗面領域において、検体情報を鉛筆又はペンで記入することができ、また、記入した検体情報に触れたとしても検体情報がかすれにくい。このため、本発明に係る検体採取容器では、バリア性能を高めることができ、検体情報を良好に記入することができ、かつ記入した検体情報に擦れが生じにくいという効果を発揮させることができる。 Since the sample collection container according to the present invention has the above configuration, the sample information can be entered on the surface of the barrier film, and the entered sample information is less likely to be rubbed. In the sample collection container according to the present invention, since a specific rough surface region exists on the outer surface of the barrier film, the sample information can be entered with a pencil or a pen in the rough surface region, and the entered sample information can be entered. Even if you touch, the sample information is not easily faded. Therefore, in the sample collection container according to the present invention, the barrier performance can be enhanced, the sample information can be satisfactorily entered, and the entered sample information can be less likely to be rubbed.
　（バリアフィルム）
　上記バリアフィルムは、上記容器本体の外表面上に配置されている。上記バリアフィルムは、上記容器本体の外表面上に貼り付けられていることが好ましく、巻かれていることが好ましい。上記バリアフィルムは、水蒸気バリアフィルムであることが好ましい。上記バリアフィルムは、透明であることが好ましい。上記検体採取容器は、検体を採取したときに、上記バリアフィルムを介して、採取された検体が視認可能であることが好ましい。上記バリアフィルムは、透明バリアフィルムであることが好ましく、透明水蒸気バリアフィルムであることが好ましい。 (Barrier film)
The barrier film is arranged on the outer surface of the container body. The barrier film is preferably attached on the outer surface of the container body, and is preferably wrapped. The barrier film is preferably a water vapor barrier film. The barrier film is preferably transparent. In the sample collection container, it is preferable that the collected sample can be visually recognized through the barrier film when the sample is collected. The barrier film is preferably a transparent barrier film, and preferably a transparent water vapor barrier film.
　バリア性能を高める観点から、上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度は０．８ｇ／（ｍ２・ｄａｙ）以下である。 From the viewpoint of enhancing the barrier performance, the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is 0.8 g / (m 2 · day) or less.
　バリア性能をより一層高める観点からは、上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度は、好ましくは０．６ｇ／（ｍ２・ｄａｙ）以下、より好ましくは０．３ｇ／（ｍ２・ｄａｙ）以下、更に好ましくは０．１ｇ／（ｍ２・ｄａｙ）以下、特に好ましくは０．０５ｇ／（ｍ２・ｄａｙ）以下である。 From the viewpoint of further enhancing the barrier performance, the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.6 g / (m 2 · day) or less, more preferably 0.3 g / (m). 2. Day) or less, more preferably 0.1 g / (m 2 · day) or less, and particularly preferably 0.05 g / (m 2 · day) or less.
　上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度は、ＪＩＳ　Ｋ７１２９のＢ法に準拠して測定される。 The water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
　上記検体採取容器において、上記バリアフィルムの外表面は、算術平均粗さＲａが１．５μｍ以上である粗面領域を有する。上記粗面領域は検体採取容器の外表面の少なくとも一部を構成する。 In the sample collection container, the outer surface of the barrier film has a rough surface region having an arithmetic average roughness Ra of 1.5 μm or more. The rough surface region constitutes at least a part of the outer surface of the sample collection container.
　上記粗面領域の算術平均粗さＲａは、好ましくは２．０μｍ以上、より好ましくは２．４μｍ以上、更に好ましくは３．０μｍ以上、特に好ましくは５．０μｍ以上である。上記粗面領域の算術平均粗さＲａは、好ましくは１０．０μｍ以下、より好ましくは９．０μｍ以下、更に好ましくは８．０μｍ以下、特に好ましくは７．０μｍ以下、最も好ましくは６．０μｍ以下である。上記粗面領域の算術平均粗さＲａが上記下限以上であると、本発明の効果をより一層効果的に発揮することができる。特に、上記粗面領域の算術平均粗さＲａが２．４μｍ以上であると、検体情報を鉛筆で良好に記入することができる。上記粗面領域の算術平均粗さＲａが上記上限以下であると、検体情報を鉛筆及びペンで良好に記入することができ、かつ水蒸気バリア性能を高く維持することができる。 The arithmetic average roughness Ra of the rough surface region is preferably 2.0 μm or more, more preferably 2.4 μm or more, still more preferably 3.0 μm or more, and particularly preferably 5.0 μm or more. The arithmetic average roughness Ra of the rough surface region is preferably 10.0 μm or less, more preferably 9.0 μm or less, still more preferably 8.0 μm or less, particularly preferably 7.0 μm or less, and most preferably 6.0 μm or less. Is. When the arithmetic average roughness Ra of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively. In particular, when the arithmetic average roughness Ra of the rough surface region is 2.4 μm or more, the sample information can be satisfactorily entered with a pencil. When the arithmetic average roughness Ra of the rough surface region is not more than the above upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
　バリアフィルムの外表面の算術平均粗さＲａは、ＪＩＳ　Ｂ０６０１：２００１に準拠して測定することができる。 The arithmetic average roughness Ra of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
　上記粗面領域の最大高さＲｚは、好ましくは１０．０μｍ以上、より好ましくは１５．０μｍ以上、更に好ましくは２０．０μｍ以上、特に好ましくは２５．０μｍ以上、最も好ましくは３０．０μｍ以上である。上記粗面領域の最大高さＲｚは、好ましくは７０．０μｍ以下、より好ましくは６０．０μｍ以下、更に好ましくは５５．０μｍ以下、特に好ましくは５０．０μｍ以下、最も好ましくは４５．０μｍ以下である。上記粗面領域の最大高さＲｚが上記下限以上であると、本発明の効果をより一層効果的に発揮することができる。上記粗面領域の最大高さＲｚが上記上限以下であると、検体情報を鉛筆及びペンで良好に記入することができ、かつ水蒸気バリア性能を高く維持することができる。 The maximum height Rz of the rough surface region is preferably 10.0 μm or more, more preferably 15.0 μm or more, still more preferably 20.0 μm or more, particularly preferably 25.0 μm or more, and most preferably 30.0 μm or more. be. The maximum height Rz of the rough surface region is preferably 70.0 μm or less, more preferably 60.0 μm or less, still more preferably 55.0 μm or less, particularly preferably 50.0 μm or less, and most preferably 45.0 μm or less. be. When the maximum height Rz of the rough surface region is at least the above lower limit, the effect of the present invention can be exhibited even more effectively. When the maximum height Rz of the rough surface region is not more than the upper limit, the sample information can be satisfactorily entered with a pencil and a pen, and the water vapor barrier performance can be maintained high.
　バリアフィルムの外表面の最大高さＲｚは、ＪＩＳ　Ｂ０６０１：２００１に準拠して測定することができる。 The maximum height Rz of the outer surface of the barrier film can be measured according to JIS B0601: 2001.
　上記粗面領域の算術平均粗さＲａが２．０μｍ以上でありかつ最大高さＲｚが２０．０μｍ以上であることが好ましい。この場合には、検体情報を鉛筆及びペンでより一層良好に記入することができる。 It is preferable that the arithmetic average roughness Ra of the rough surface region is 2.0 μm or more and the maximum height Rz is 20.0 μm or more. In this case, the sample information can be entered even better with a pencil and a pen.
　なお、バリアフィルムの外表面の算術平均粗さＲａ、最大高さＲｚを調整して、上記粗面領域を形成する方法としては、紙やすりで擦る方法及び微細な砂を投射する方法等が挙げられる。上記粗面領域を有するバリアフィルムを容器本体の外表面上に配置することにより、検体採取容器を作製することができる。 Examples of the method for forming the rough surface region by adjusting the arithmetic average roughness Ra and the maximum height Rz of the outer surface of the barrier film include a method of rubbing with sandpaper and a method of projecting fine sand. Be done. A sample collection container can be produced by arranging the barrier film having the rough surface region on the outer surface of the container body.
　上記バリアフィルムの厚み（上記容器本体の外表面上に配置される前のバリアフィルムの厚み）は、好ましくは５μｍ以上、より好ましくは３０μｍ以上、好ましくは３００μｍ以下、より好ましくは２００μｍ以下である。上記バリアフィルムの厚みは、バリアフィルム自体の厚みである。上記バリアフィルムの厚みが上記下限以上及び上記上限以下であると、バリアフィルムの柔軟性を高めることができ、容器本体の外表面上へバリアフィルムを良好に配置することができる。そのため、容器本体とバリアフィルムとの間に気泡が残存するリスクを低くすることができる。 The thickness of the barrier film (thickness of the barrier film before being placed on the outer surface of the container body) is preferably 5 μm or more, more preferably 30 μm or more, preferably 300 μm or less, and more preferably 200 μm or less. The thickness of the barrier film is the thickness of the barrier film itself. When the thickness of the barrier film is not less than the above lower limit and not more than the above upper limit, the flexibility of the barrier film can be enhanced, and the barrier film can be satisfactorily placed on the outer surface of the container body. Therefore, the risk of bubbles remaining between the container body and the barrier film can be reduced.
　上記バリアフィルムは、上記容器本体の外表面の周方向に、０．２周以上で配置されていることが好ましく、０．５周以上で配置されていることがより好ましく、３周以下で配置されていることが好ましく、１．５周以下で配置されていることがより好ましい。この場合には、バリア性能をより一層高めることができる。 The barrier film is preferably arranged at 0.2 laps or more, more preferably 0.5 laps or more, and more preferably 3 laps or less in the circumferential direction of the outer surface of the container body. It is preferable that it is arranged, and it is more preferable that it is arranged in 1.5 laps or less. In this case, the barrier performance can be further improved.
　上記容器本体の外表面の全表面積１００％中、上記バリアフィルムが配置されている部分の表面積は、好ましくは１５％以上、より好ましくは３０％以上、更に好ましくは７０％以上である。上記バリアフィルムが配置されている部分の表面積が上記下限以上であると、バリア性能をより一層高めることができる。また、上記バリアフィルムが配置されている部分の表面積が上記下限以上であると、検体情報を容易に記入することができる。上記容器本体の外表面の全表面積１００％中、上記バリアフィルムが配置されている部分の表面積は、１００％であってもよく、１００％以下であってもよく、９０％以下であってもよく、８０％以下であってもよい。 Of the total surface area of the outer surface of the container body of 100%, the surface area of the portion where the barrier film is arranged is preferably 15% or more, more preferably 30% or more, still more preferably 70% or more. When the surface area of the portion where the barrier film is arranged is at least the above lower limit, the barrier performance can be further improved. Further, when the surface area of the portion where the barrier film is arranged is at least the above lower limit, sample information can be easily entered. Of the total surface area of the outer surface of the container body of 100%, the surface area of the portion where the barrier film is arranged may be 100%, 100% or less, or 90% or less. It may be 80% or less.
　上記検体採取容器の外表面を構成する上記バリアフィルムの外表面の全表面積１００％中、上記粗面領域の表面積は、好ましくは２％以上、より好ましくは１０％以上、更に好ましくは２０％以上、好ましくは９５％以下、より好ましくは７０％以下、更に好ましくは４０％以下である。上記粗面領域の表面積が上記下限以上であると、検体情報を容易に記入することができる。上記粗面領域の表面積が上記上限以下であると、検体採取時の容器内部の視認性を良好にでき、水蒸気バリア性能を高く維持することができる。 Of the total surface area of the outer surface of the barrier film constituting the outer surface of the sample collection container, the surface area of the rough surface region is preferably 2% or more, more preferably 10% or more, still more preferably 20% or more. It is preferably 95% or less, more preferably 70% or less, still more preferably 40% or less. When the surface area of the rough surface region is at least the above lower limit, sample information can be easily entered. When the surface area of the rough surface region is not more than the upper limit, the visibility inside the container at the time of sample collection can be improved, and the water vapor barrier performance can be maintained high.
　上記粗面領域は、検体採取容器の外表面の少なくとも一部を構成する。上記バリアフィルムが配置されていない部分の上記容器本体の外表面の表面積と、上記検体採取容器の外表面を構成する上記バリアフィルムの外表面の表面積との合計１００％中、上記粗面領域の表面積は、好ましくは５％以上、より好ましくは１５％以上、更に好ましくは２５％以上、好ましくは９０％以下、より好ましくは６５％以下、更に好ましくは４５％以下である。上記粗面領域の表面積が上記下限以上であると、検体情報を容易に記入することができる。上記粗面領域の表面積が上記上限以下であると、検体採取時の容器内部の視認性を良好にでき、水蒸気バリア性能を高く維持することができる。 The rough surface region constitutes at least a part of the outer surface of the sample collection container. Of the total 100% of the surface area of the outer surface of the container body in the portion where the barrier film is not arranged and the surface area of the outer surface of the barrier film constituting the outer surface of the sample collection container, the rough surface region. The surface area is preferably 5% or more, more preferably 15% or more, still more preferably 25% or more, preferably 90% or less, more preferably 65% or less, still more preferably 45% or less. When the surface area of the rough surface region is at least the above lower limit, sample information can be easily entered. When the surface area of the rough surface region is not more than the upper limit, the visibility inside the container at the time of sample collection can be improved, and the water vapor barrier performance can be maintained high.
　上記バリアフィルムは、バリアフィルム本体と、粘着層とを有することが好ましい。上記検体採取容器では、上記粘着層が上記容器本体の外表面上に配置されており、上記粘着層の外側に上記バリアフィルム本体が配置されていることが好ましい。この場合に、上記検体採取容器において、上記粘着層の外表面上に上記バリアフィルム本体が配置されていてもよい。 The barrier film preferably has a barrier film main body and an adhesive layer. In the sample collection container, it is preferable that the adhesive layer is arranged on the outer surface of the container body, and the barrier film body is arranged outside the adhesive layer. In this case, in the sample collection container, the barrier film main body may be arranged on the outer surface of the adhesive layer.
　バリア性能を高める観点及び検体採取容器を良好に作製する観点からは、上記バリアフィルムは、第１のフィルムと、第１の粘着層と、第２のフィルムと、第２の粘着層とをこの順に有することがより好ましい。この場合に、上記第１のフィルムの外表面が、上記粗面領域を有することが好ましく、上記第２の粘着層が、上記容器本体の外表面上に配置されていることが好ましい。また、この場合に、上記第１のフィルムがバリアフィルム本体であってもよく、上記第２のフィルムがバリアフィルム本体であってもよい。 From the viewpoint of enhancing the barrier performance and satisfactorily producing the sample collection container, the barrier film includes a first film, a first adhesive layer, a second film, and a second adhesive layer. It is more preferable to have them in order. In this case, it is preferable that the outer surface of the first film has the rough surface region, and it is preferable that the second adhesive layer is arranged on the outer surface of the container body. Further, in this case, the first film may be the barrier film main body, and the second film may be the barrier film main body.
　上記バリアフィルムは、第１のフィルムと、第１の粘着層と、第２のフィルムと、第２の粘着層とをこの順に有する部分が存在することがより好ましい。この場合に、上記第１のフィルムの外表面と上記第２のフィルムの外表面とが、バリアフィルムの外表面を構成しており、上記第２のフィルムの外表面が上記粗面領域を有していてもよい。この場合に、上記第１のフィルムの外表面と上記第２のフィルムの外表面とが、バリアフィルムの外表面を構成しており、上記第１のフィルムの外表面が上記粗面領域を有していてもよい。また、この場合に、上記第２の粘着層が、上記容器本体の外表面上に配置されていることが好ましい。また、この場合に、上記第１のフィルムがバリアフィルム本体であってもよく、上記第２のフィルムがバリアフィルム本体であってもよい。 It is more preferable that the barrier film has a portion having a first film, a first adhesive layer, a second film, and a second adhesive layer in this order. In this case, the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the second film has the rough surface region. You may be doing it. In this case, the outer surface of the first film and the outer surface of the second film constitute the outer surface of the barrier film, and the outer surface of the first film has the rough surface region. You may be doing it. Further, in this case, it is preferable that the second adhesive layer is arranged on the outer surface of the container body. Further, in this case, the first film may be the barrier film main body, and the second film may be the barrier film main body.
　上記第１のフィルムと上記第１の粘着層とは直接積層されていてもよく、他の層を介して積層されていてもよい。上記第１の粘着層と上記第２のフィルムとは直接積層されていてもよく、他の層を介して積層されていてもよい。上記第２のフィルムと上記第２の粘着層とは直接積層されていてもよく、他の層を介して積層されていてもよい。 The first film and the first adhesive layer may be directly laminated or may be laminated via another layer. The first adhesive layer and the second film may be directly laminated or may be laminated via another layer. The second film and the second adhesive layer may be directly laminated or may be laminated via another layer.
　バリアフィルムの厚みを薄くする観点からは、上記第１のフィルムと上記第１の粘着層とは直接積層されていることが好ましく、上記第１の粘着層と上記第２のフィルムとは直接積層されていることが好ましく、上記第２のフィルムと上記第２の粘着層とは直接積層されていることが好ましい。 From the viewpoint of reducing the thickness of the barrier film, it is preferable that the first film and the first adhesive layer are directly laminated, and the first adhesive layer and the second film are directly laminated. It is preferable that the second film and the second adhesive layer are directly laminated.
　以下、バリアフィルムを構成する層について更に説明する。 Hereinafter, the layers constituting the barrier film will be further described.
　＜バリアフィルム本体、第１，第２のフィルム＞
　上記バリアフィルムは、バリアフィルム本体を有することが好ましい。 <Barrier film body, first and second films>
The barrier film preferably has a barrier film body.
　上記バリアフィルム本体の４０℃及び９０％ＲＨでの水蒸気透過度は、好ましくは０．８ｇ／（ｍ２・ｄａｙ）以下、より好ましくは０．６ｇ／（ｍ２・ｄａｙ）以下、更に好ましくは０．３ｇ／（ｍ２・ｄａｙ）以下、特に好ましくは０．１ｇ／（ｍ２・ｄａｙ）以下、最も好ましくは０．０５ｇ／（ｍ２・ｄａｙ）以下である。 The water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is preferably 0.8 g / (m 2 · day) or less, more preferably 0.6 g / (m 2 · day) or less, still more preferably. It is 0.3 g / (m 2 · day) or less, particularly preferably 0.1 g / (m 2 · day) or less, and most preferably 0.05 g / (m 2 · day) or less.
　上記バリアフィルム本体の４０℃及び９０％ＲＨでの水蒸気透過度は、ＪＩＳ　Ｋ７１２９のＢ法に準拠して測定される。 The water vapor transmission rate of the barrier film body at 40 ° C. and 90% RH is measured according to the B method of JIS K7129.
　上記バリアフィルム本体は、基材フィルムと、無機酸化物層とを備えることが好ましく、基材フィルムと、無機酸化物層と、バリアコート層とをこの順で備えることがより好ましい。上記基材フィルムと上記無機酸化物層とは、直接積層されていてもよく、他の層を介して積層されていてもよい。上記無機酸化物層とバリアコート層とは、直接積層されていてもよく、他の層を介して積層されていてもよい。 The barrier film main body preferably includes a base film, an inorganic oxide layer, and more preferably a base film, an inorganic oxide layer, and a barrier coat layer in this order. The base film and the inorganic oxide layer may be directly laminated or may be laminated via another layer. The inorganic oxide layer and the barrier coat layer may be directly laminated or may be laminated via another layer.
　上記基材フィルムとしては、ポリエチレンテレフタレートフィルム、ポリエチレンナフタレートフィルム、ナイロンフィルム、ポリエチレンフィルム、ポリプロピレンフィルム、ポリスチレンフィルム、ポリアミドフィルム、ポリカーボネートフィルム、ポリアクリルニトリルフィルム、及びポリイミドフィルム等が挙げられる。 Examples of the base film include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
　上記基材フィルムは、透明であることが好ましい。 The base film is preferably transparent.
　上記無機酸化物層は、ガスバリア性又は水蒸気バリア性を有する層であることが好ましい。上記無機酸化物層は、上記基材フィルムの表面上に無機酸化物が蒸着された無機酸化物蒸着層であることが好ましい。 The inorganic oxide layer is preferably a layer having a gas barrier property or a water vapor barrier property. The inorganic oxide layer is preferably an inorganic oxide-deposited layer in which an inorganic oxide is vapor-deposited on the surface of the base film.
　上記無機酸化物層に含まれる無機酸化物としては、酸化アルミニウム、酸化ケイ素、酸化錫、及び酸化マグネシウム等が挙げられる。上記無機酸化物は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 Examples of the inorganic oxide contained in the inorganic oxide layer include aluminum oxide, silicon oxide, tin oxide, magnesium oxide and the like. Only one kind of the above-mentioned inorganic oxide may be used, or two or more kinds thereof may be used in combination.
　ガスバリア性及び水蒸気バリア性を高める観点から、上記無機酸化物は、酸化アルミニウム又は酸化ケイ素であることが好ましい。 From the viewpoint of enhancing the gas barrier property and the water vapor barrier property, the inorganic oxide is preferably aluminum oxide or silicon oxide.
　上記バリアコート層は、ガスバリア性を有する層である。また、上記バリアコート層を有することにより、無機酸化物の酸化を効果的に抑えることができ、外部からの衝撃等により無機酸化物層が破損することを抑えることができる。 The barrier coat layer is a layer having a gas barrier property. Further, by having the barrier coat layer, oxidation of the inorganic oxide can be effectively suppressed, and damage to the inorganic oxide layer due to an external impact or the like can be suppressed.
　上記バリアコート層の材料として、バリアコート層として用いられる従来公知の材料を用いることができる。上記バリアコート層の材料としては、アルコキシシランの加水分解生成物と水溶性高分子とを含む組成物、ポリエチレンテレフタレート、及びナイロン等が挙げられる。上記バリアコート層の材料は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 As the material of the barrier coat layer, a conventionally known material used as the barrier coat layer can be used. Examples of the material of the barrier coat layer include a composition containing a hydrolysis product of alkoxysilane and a water-soluble polymer, polyethylene terephthalate, nylon and the like. As the material of the barrier coat layer, only one kind may be used, or two or more kinds may be used in combination.
　上記水溶性高分子としては、ポリビニルアルコール系樹脂、及びエチレン－ビニルアルコール共重合体等が挙げられる。上記水溶性高分子は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 Examples of the water-soluble polymer include polyvinyl alcohol-based resins and ethylene-vinyl alcohol copolymers. Only one kind of the water-soluble polymer may be used, or two or more kinds thereof may be used in combination.
　上記基材フィルムと上記無機酸化物層とのうち、上記基材フィルムが、容器本体側に配置されていることが好ましい。上記基材フィルムと上記バリアコート層のうち、上記基材フィルムが、容器本体側に配置されていることが好ましい。 Of the base film and the inorganic oxide layer, it is preferable that the base film is arranged on the container body side. Of the base film and the barrier coat layer, it is preferable that the base film is arranged on the container body side.
　ラミネート加工の観点からは、上記バリアフィルム本体の外表面が、上記バリアフィルムの外表面であることが好ましい。したがって、上記バリアフィルム本体の外表面が、上記粗面領域を有することが好ましい。 From the viewpoint of laminating, it is preferable that the outer surface of the barrier film body is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the barrier film body has the rough surface region.
　ラミネート加工の観点及びバリアフィルムの品質担保の観点からは、上記第１のフィルムが、上記バリアフィルム本体であることが好ましい。検体採取容器において、上記第１のフィルムの外表面が、上記バリアフィルムの外表面であることが好ましい。したがって、上記第１のフィルムの外表面が、上記粗面領域を有することが好ましい。 From the viewpoint of laminating and ensuring the quality of the barrier film, it is preferable that the first film is the barrier film main body. In the sample collection container, it is preferable that the outer surface of the first film is the outer surface of the barrier film. Therefore, it is preferable that the outer surface of the first film has the rough surface region.
　上記バリアフィルム本体及び上記バリアフィルム本体である上記第１のフィルムの材料として市販品を用いることもできる。上記市販品としては、凸版印刷社製「ＧＸ－Ｐ－Ｆ」、「ＧＬ－ＡＥＣ－Ｆ」、大日本印刷社製「ＩＢ－ＰＥＴ－ＰＸＢ２」、東レフィルム加工社製「バリアロックス　１０１１　ＳＢＲ２」、三井化学東セロ社製「Ｖバリア」、及び三菱ケミカル社製「テックバリア」等が挙げられる。上記市販品の表面の一部をやすり等で処理するなどして表面粗さを調整することにより、上記粗面領域を有するバリアフィルム本体を得ることができる。 Commercially available products can also be used as the material of the barrier film main body and the first film which is the barrier film main body. The above-mentioned commercial products include "GX-PF" and "GL-AEC-F" manufactured by Toppan Printing Co., Ltd., "IB-PET-PXB2" manufactured by Dai Nippon Printing Co., Ltd., and "Barrier Rocks 1011 SBR2" manufactured by Toray Film Processing Co., Ltd. , "V Barrier" manufactured by Mitsui Chemicals Tocello Co., Ltd., "Tech Barrier" manufactured by Mitsubishi Chemical Corporation, and the like. By adjusting the surface roughness by treating a part of the surface of the commercially available product with a file or the like, a barrier film main body having the rough surface region can be obtained.
　上記第２のフィルムは、バリアフィルム本体であってもよく、バリアフィルム本体でなくてもよい。上記第１のフィルムがバリアフィルム本体である場合に、上記第２のフィルムは、バリアフィルム本体ではないことが好ましく、樹脂フィルムであることが好ましい。 The second film may be the barrier film main body or not the barrier film main body. When the first film is a barrier film main body, the second film is preferably not a barrier film main body, and is preferably a resin film.
　上記第２のフィルムとしては、ポリエチレンテレフタレートフィルム、ポリエチレンナフタレートフィルム、ナイロンフィルム、ポリエチレンフィルム、ポリプロピレンフィルム、ポリスチレンフィルム、ポリアミドフィルム、ポリカーボネートフィルム、ポリアクリルニトリルフィルム、及びポリイミドフィルム等が挙げられる。 Examples of the second film include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylic nitrile film, and polyimide film.
　上記第２のフィルムは、ポリエチレンテレフタレートフィルムであることが好ましい。この場合には、粘着剤を良好に塗布でき、ラミネート加工性も高めることができる。 The second film is preferably a polyethylene terephthalate film. In this case, the adhesive can be applied satisfactorily and the laminating workability can be improved.
　上記第２のフィルムの厚みは、好ましくは１μｍ以上、より好ましくは１０μｍ以上、好ましくは８０μｍ以下、より好ましくは５０μｍ以下である。上記第２のフィルムの厚みは、第２のフィルム自体の厚みである。上記第２のフィルムの厚みが上記下限以上及び上記上限以下であると、バリアフィルムの柔軟性を高めることができ、容器本体の外表面上へバリアフィルムを良好に配置することができる。そのため、容器本体とバリアフィルムとの間に気泡が残存するリスクを低くすることができる。 The thickness of the second film is preferably 1 μm or more, more preferably 10 μm or more, preferably 80 μm or less, and more preferably 50 μm or less. The thickness of the second film is the thickness of the second film itself. When the thickness of the second film is at least the above lower limit and at least the above upper limit, the flexibility of the barrier film can be enhanced, and the barrier film can be satisfactorily placed on the outer surface of the container body. Therefore, the risk of bubbles remaining between the container body and the barrier film can be reduced.
　＜粘着層（第１，第２の粘着層）＞
　上記バリアフィルムは、粘着層を有することが好ましい。上記粘着層は、粘着剤により形成される層である。 <Adhesive layer (first and second adhesive layers)>
The barrier film preferably has an adhesive layer. The adhesive layer is a layer formed by an adhesive.
　上記第１の粘着層は、上記第１のフィルムと上記第２のフィルムとの間に配置されている。上記第２の粘着層は、上記第２のフィルムと上記容器本体の外表面との間に配置されている。上記第２の粘着層は、上記容器本体の外表面上に配置されていることが好ましい。 The first adhesive layer is arranged between the first film and the second film. The second adhesive layer is arranged between the second film and the outer surface of the container body. The second adhesive layer is preferably arranged on the outer surface of the container body.
　上記粘着層の材料（第１，第２の粘着層の材料）としては特に限定されず、従来公知の粘着剤を用いることができる。上記粘着剤としては、シリコーン系粘着剤、ウレタン系粘着剤、及びアクリル系粘着剤等が挙げられる。上記粘着剤は、１種のみが用いられてもよく、２種以上が併用されてもよい。 The material of the pressure-sensitive adhesive layer (material of the first and second pressure-sensitive adhesive layers) is not particularly limited, and a conventionally known pressure-sensitive adhesive can be used. Examples of the pressure-sensitive adhesive include silicone-based pressure-sensitive adhesives, urethane-based pressure-sensitive adhesives, acrylic-based pressure-sensitive adhesives, and the like. Only one kind of the above-mentioned pressure-sensitive adhesive may be used, or two or more kinds thereof may be used in combination.
　接着力を高める観点からは、上記粘着剤は、アクリル系粘着剤、又はシリコーン系粘着剤であることが好ましい。 From the viewpoint of enhancing the adhesive strength, the pressure-sensitive adhesive is preferably an acrylic pressure-sensitive adhesive or a silicone-based pressure-sensitive adhesive.
　上記第１の粘着層の厚みは、好ましくは１μｍ以上、より好ましくは１０μｍ以上、好ましくは８０μｍ以下、より好ましくは５０μｍ以下である。上記第１の粘着層の厚みは、第１の粘着層自体の厚みである。上記第１の粘着層の厚みが上記下限以上及び上記上限以下であると、接着力を高めることができる。 The thickness of the first adhesive layer is preferably 1 μm or more, more preferably 10 μm or more, preferably 80 μm or less, and more preferably 50 μm or less. The thickness of the first adhesive layer is the thickness of the first adhesive layer itself. When the thickness of the first adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
　上記第２の粘着層の厚みは、好ましくは１μｍ以上、より好ましくは１０μｍ以上、好ましくは８０μｍ以下、より好ましくは５０μｍ以下である。上記第２の粘着層の厚みは、第２の粘着層自体の厚みである。上記第２の粘着層の厚みが上記下限以上及び上記上限以下であると、接着力を高めることができる。 The thickness of the second adhesive layer is preferably 1 μm or more, more preferably 10 μm or more, preferably 80 μm or less, and more preferably 50 μm or less. The thickness of the second adhesive layer is the thickness of the second adhesive layer itself. When the thickness of the second adhesive layer is at least the above lower limit and at least the above upper limit, the adhesive strength can be enhanced.
　（容器本体）
　上記容器本体は、開口部を有することが好ましい。上記容器本体の形状としては、特に限定されない。上記容器本体は、有底の容器であることが好ましく、有底の管状容器であることがより好ましい。 (Container body)
The container body preferably has an opening. The shape of the container body is not particularly limited. The container body is preferably a bottomed container, and more preferably a bottomed tubular container.
　上記容器本体の材質は特に限定されない。上記容器本体の材質としては、ポリエチレン、ポリプロピレン、ポリスチレン、ポリエチレンテレフタレート、ポリエチレンナフタレート、ポリメチルメタクリレート、ポリアクリロニトリル等の熱可塑性樹脂；不飽和ポリエステル樹脂、エポキシ樹脂、エポキシ－アクリレート樹脂等の熱硬化性樹脂；酢酸セルロース、プロピオン酸セルロース、エチルセルロース、エチルキチン等の変性天然樹脂；ソーダ石灰ガラス、リンケイ酸ガラス、ホウケイ酸ガラス等のケイ酸塩ガラス、石英ガラス等のガラスが挙げられる。これらの成分は、１種のみが用いられてもよく、２種以上が併用されてもよい。 The material of the container body is not particularly limited. As the material of the container body, thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyethylene naphthalate, polymethylmethacrylate, and polyacrylonitrile; and thermocurable resins such as unsaturated polyester resin, epoxy resin, and epoxy-acrylate resin. Resins: Modified natural resins such as cellulose acetate, cellulose propionate, ethyl cellulose, ethylchitin, etc .; Examples thereof include silicate glass such as soda lime glass, phosphoric acid glass and borosilicate glass, and glass such as quartz glass. Only one of these components may be used, or two or more of these components may be used in combination.
　上記容器本体の材質は、樹脂であることが好ましく、ポリエチレンテレフタレート、又はポリエチレンナフタレートであることがより好ましく、ポリエチレンテレフタレートであることが更に好ましい。 The material of the container body is preferably resin, more preferably polyethylene terephthalate or polyethylene naphthalate, and even more preferably polyethylene terephthalate.
　上記容器本体の材質がポリエチレンテレフタレートである場合には、上記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度は、好ましくは０．５ｇ／（ｍ２・ｄａｙ）以下、より好ましくは０．２ｇ／（ｍ２・ｄａｙ）以下、更に好ましくは０．０５ｇ／（ｍ２・ｄａｙ）以下である。 When the material of the container body is polyethylene terephthalate, the water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is preferably 0.5 g / (m 2 · day) or less, more preferably 0. It is 2 g / (m 2 · day) or less, more preferably 0.05 g / (m 2 · day) or less.
　（栓体）
　上記検体採取容器は、上記容器本体の開口部に取り付けられた栓体を備えることが好ましい。上記栓体として、従来公知の栓体を用いることができる。上記栓体は、容器本体の開口部に、気密的かつ液密的に取付け可能な材質及び形状を有する栓体であることが好ましい。上記検体を検体採取容器に容易に採取する観点からは、上記栓体は、針が刺通され得るように構成されていることが好ましい。 (Plug body)
The sample collection container preferably includes a stopper attached to the opening of the container body. As the stopper, a conventionally known stopper can be used. The stopper is preferably a stopper having a material and shape that can be attached to the opening of the container body in an airtight and liquidtight manner. From the viewpoint of easily collecting the sample in the sample collection container, it is preferable that the stopper is configured so that the needle can be pierced.
　上記栓体としては、容器本体の開口部に嵌合する形状を有する栓体、シート状のシール栓体等が挙げられる。 Examples of the plug body include a plug body having a shape that fits into the opening of the container body, a sheet-shaped seal plug body, and the like.
　また、上記栓体は、ゴム栓等の栓本体と、プラスチック等で構成されたキャップ部材とを備える栓体であってもよい。この場合には、血液等の体液の採取後に、容器本体の開口から栓体を引き抜く際に、体液が人体と接触するリスクを抑えることができる。 Further, the stopper body may be a stopper body including a stopper body such as a rubber stopper and a cap member made of plastic or the like. In this case, it is possible to reduce the risk of the body fluid coming into contact with the human body when the plug is pulled out from the opening of the container body after collecting the body fluid such as blood.
　上記栓体（又は上記栓本体）の材質としては、例えば、合成樹脂、エラストマー、ゴム、金属箔等が挙げられる。上記ゴムとしては、ブチルゴム、及びハロゲン化ブチルゴム等が挙げられる。上記金属箔としては、アルミニウム箔等が挙げられる。密封性を高める観点からは、上記栓体（又は上記栓本体）の材質は、ブチルゴム、又はハロゲン化ブチルゴムであることが好ましい。上記栓体（又は上記栓本体）は、ブチルゴム栓、又はハロゲン化ブチルゴム栓であることが好ましい。 Examples of the material of the stopper body (or the stopper body) include synthetic resin, elastomer, rubber, metal leaf and the like. Examples of the rubber include butyl rubber and halogenated butyl rubber. Examples of the metal foil include aluminum foil and the like. From the viewpoint of enhancing the sealing property, the material of the stopper body (or the stopper body) is preferably butyl rubber or halogenated butyl rubber. The stopper (or the main body of the stopper) is preferably a butyl rubber stopper or a halogenated butyl rubber stopper.
　（収容物及び検体）
　上記検体採取容器は、容器本体内に収容された収容物を備えていてもよい。上記収容物の種類及び量、並びに採取される検体の種類及び量は特に限定されない。 (Contains and specimens)
The sample collection container may include an container contained in the container body. The type and amount of the contained substance and the type and amount of the sample to be collected are not particularly limited.
　上記検体としては、生体由来試料等が挙げられる。上記検体としては、具体的には、血液、血漿、尿、及び髄液等が挙げられる。 Examples of the sample include biological samples and the like. Specific examples of the sample include blood, plasma, urine, and cerebrospinal fluid.
　上記収容物に含まれる成分としては、抗凝固剤、酵素、酵素の安定化剤、有機化合物、及び無機化合物等が挙げられる。 Examples of the components contained in the contained substance include anticoagulants, enzymes, enzyme stabilizers, organic compounds, and inorganic compounds.
　上記抗凝固剤としては、クエン酸、シュウ酸、ＥＤＴＡ（エチレンジアミン四酢酸）、及びヘパリン等が挙げられる。上記抗凝固剤は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 Examples of the anticoagulant include citric acid, oxalic acid, EDTA (ethylenediaminetetraacetic acid), heparin and the like. As the anticoagulant, only one kind may be used, or two or more kinds may be used in combination.
　上記酵素としては、トリプシン、キモトリプシン、エラスターゼ、トロンビン、プラスミン、蛇毒トロンビン様酵素、サブチリシン及び酸性カルボキシペプチターゼ等のセリンプロテアーゼ；カテプシンＢ及びフィシン等のチオールプロテアーゼ；カルボキシペプチダーゼＡ、カルボキシペプチダーゼＢ、ロイシンアミノペプチターゼ及びキニナーゼＩ等の金属プロテアーゼ等が挙げられる。上記酵素は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 Examples of the enzyme include serine proteases such as trypsin, chymotrypsin, elastase, trombine, plasmin, serpentine trombine-like enzyme, subtilisin and acidic carboxypeptidase; thiol proteases such as catepsin B and phycin; carboxypeptidase A, carboxypeptidase B and leucine amino. Examples thereof include metal proteases such as peptidase and quininase I. Only one type of the above enzyme may be used, or two or more types may be used in combination.
　上記酵素の安定化剤としては、デキストラン等の糖、ペプチド、並びにアルブミン及びグロブリン等のタンパク質等が挙げられる。上記酵素がトロンビン又はトロンビン様酵素である場合に、上記酵素の安定化剤としては、β－アラニン、グリシン、Ｄ－マンニトール、ゼラチン及びアルブミン等が挙げられる。上記酵素の安定化剤は、１種のみが用いられてもよく、２種以上が併用されていてもよい。 Examples of the stabilizer for the enzyme include sugars such as dextran, peptides, and proteins such as albumin and globulin. When the enzyme is thrombin or a thrombin-like enzyme, examples of the stabilizer for the enzyme include β-alanine, glycine, D-mannitol, gelatin, albumin and the like. As the stabilizer of the above enzyme, only one kind may be used, or two or more kinds may be used in combination.
　上記有機化合物としては、糖、ホルムアルデヒド遊離物質、及びクエン酸等が挙げられる。 Examples of the organic compound include sugar, formaldehyde free substance, citric acid and the like.
　上記糖としては、グルコース、フルクトース、ガラクトース、マルトース及びシクロデキストリン等が挙げられる。 Examples of the sugar include glucose, fructose, galactose, maltose, cyclodextrin and the like.
　上記無機化合物としては、リン酸、塩化ナトリウム、塩化カリウム、ホウ酸及びトリスリン酸塩等が挙げられる。 Examples of the inorganic compound include phosphoric acid, sodium chloride, potassium chloride, boric acid, trisphosphate and the like.
　上記収容物は、液体であってもよく、乾燥物であってもよく、凍結乾燥物であってもよい。 The contained substance may be a liquid, a dried product, or a freeze-dried product.
　上記検体採取容器は、上記容器本体内に収容された液体を備えることが好ましい。上記液体の溶媒は水であることが好ましい。上記検体採取容器はバリアフィルムを備えるので、バリアフィルムを備えない検体採取容器と比べて、液体の蒸発を効果的に抑えることができる。 The sample collection container preferably includes a liquid contained in the container body. The solvent of the liquid is preferably water. Since the sample collection container is provided with a barrier film, evaporation of the liquid can be effectively suppressed as compared with a sample collection container without a barrier film.
　上記検体が血液である場合、上記液体は、上記抗凝固剤を含む液であることが好ましく、抗凝固剤と水とを含む液であることがより好ましい。 When the sample is blood, the liquid is preferably a liquid containing the anticoagulant, and more preferably a liquid containing the anticoagulant and water.
　上記抗凝固剤は、クエン酸、ＥＤＴＡ、又はヘパリンを含むことが好ましく、クエン酸、ＥＤＴＡ、又はヘパリンであることがより好ましい。上記検体が血液である場合には、上記液体は、クエン酸、ＥＤＴＡ及びヘパリンの内の少なくとも１種を含む液であることが好ましい。 The anticoagulant preferably contains citric acid, EDTA, or heparin, and more preferably citric acid, EDTA, or heparin. When the sample is blood, the liquid preferably contains at least one of citric acid, EDTA and heparin.
　上記容器本体に収容された液体の量は、０．１ｍＬ以上であってもよく、５ｍＬ以下であってもよい。 The amount of liquid contained in the container body may be 0.1 mL or more, or 5 mL or less.
　また、上記検体採取容器は、上記容器本体内に収容された上記酵素を備えることも好ましく、上記容器本体内に収容された酵素及び該酵素の安定化剤を備えることも好ましい。この場合に、上記酵素は、上記容器本体内に、溶媒と混合されて液体の状態で収容されていてもよく、乾燥物の状態で収容されていてもよく、凍結乾燥物の状態で収容されていてもよい。上記酵素の安定化剤は、上記容器本体内に、溶媒と混合されて液体の状態で収容されていてもよく、乾燥物の状態で収容されていてもよく、凍結乾燥物の状態で収容されていてもよい。上記酵素及び上記酵素の安定化剤は、上記容器本体に、上記酵素と上記酵素の安定化剤と溶媒とを含む混合液の状態で収容されていてもよく、上記酵素及び上記酵素の安定化剤が混合された乾燥物の状態で収容されていてもよく、上記酵素及び上記酵素の安定化剤が混合された凍結乾燥物の状態で収容されていてもよい。上記検体採取容器はバリアフィルムを備えるので、バリアフィルムを備えない検体採取容器と比べて、酵素活性の低下を効果的に抑えることができる。 Further, the sample collection container is preferably provided with the enzyme contained in the container body, and is preferably provided with the enzyme housed in the container body and a stabilizer for the enzyme. In this case, the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be. The stabilizer of the enzyme may be contained in the container body in a liquid state mixed with a solvent, in a dry state, or in a freeze-dried state. May be. The enzyme and the stabilizer of the enzyme may be contained in the container body in the state of a mixed solution containing the enzyme, the stabilizer of the enzyme and a solvent, and the enzyme and the stabilizer of the enzyme may be stabilized. It may be contained in a dried product in which the agent is mixed, or may be contained in a frozen dried product in which the enzyme and the stabilizer of the enzyme are mixed. Since the sample collection container is provided with a barrier film, it is possible to effectively suppress a decrease in enzyme activity as compared with a sample collection container without a barrier film.
　上記検体が血液である場合、上記酵素は、トロンビン様酵素又はトロンビンであることが好ましい。 When the sample is blood, the enzyme is preferably thrombin-like enzyme or thrombin.
　上記検体が血液である場合、上記検体採取容器は、血液採取容器である。上記検体採取容器は、採血管であることが好ましく、真空採血管であることがより好ましい。 When the sample is blood, the sample collection container is a blood collection container. The sample collection container is preferably a blood collection tube, and more preferably a vacuum blood collection tube.
　上記検体採取容器は、上記容器本体内に上述した成分以外の他の成分が収容されていてもよい。上記他の成分としては、血清または血漿分離剤、血清または血漿分離用治具、フィコール及び磁気ビーズ等が挙げられる。 The sample collection container may contain components other than the components described above in the container body. Examples of the other components include serum or plasma separating agents, serum or plasma separating jigs, Ficoll, magnetic beads and the like.
　上記検体採取容器に採取される検体量は、特に限定されない。上記検体採取容器に採取される検体量は、０．５ｍＬ以上であってもよく、４．５ｍＬ以上であってもよく、７．６ｍＬ以上であってもよい。上記検体採取容器に採取される検体量は、１０ｍＬ以下であってもよく、５．５ｍＬ以下であってもよく、２．０ｍＬ以下であってもよい。 The amount of sample collected in the above sample collection container is not particularly limited. The amount of the sample collected in the sample collection container may be 0.5 mL or more, 4.5 mL or more, or 7.6 mL or more. The amount of the sample collected in the sample collection container may be 10 mL or less, 5.5 mL or less, or 2.0 mL or less.
　（検体採取容器の他の詳細）
　以下、図面を参照しつつ、本発明の具体的な実施形態を説明する。なお、以下の図面において、大きさ、厚み及び形状等は、図示の便宜上、実際の大きさ、厚み及び形状等と異なる場合がある。 (Other details of the sample collection container)
Hereinafter, specific embodiments of the present invention will be described with reference to the drawings. In the drawings below, the size, thickness, shape, etc. may differ from the actual size, thickness, shape, etc. for convenience of illustration.
　図１は、本発明の第１の実施形態に係る検体採取容器を模式的に示す正面断面図である。 FIG. 1 is a front sectional view schematically showing a sample collection container according to the first embodiment of the present invention.
　図１に示す検体採取容器１１は、容器本体１と、栓体２と、バリアフィルム３と、液体４とを備える。検体採取容器１１の内部は、減圧されている。容器本体１は、管状の容器本体である。容器本体１は、一端に開口部を有し、他端に閉じられた底部を有する。栓体２は、容器本体１の開口部に取り付けられている。バリアフィルム３は、容器本体１の外表面１ａ上の周方向に配置されている。バリアフィルム３は、容器本体１の外表面１ａ上の一部に配置されている。バリアフィルム３は、容器本体１の外表面１ａ上に巻かれている。液体４は、容器本体１内に収容されている。 The sample collection container 11 shown in FIG. 1 includes a container body 1, a stopper 2, a barrier film 3, and a liquid 4. The inside of the sample collection container 11 is depressurized. The container body 1 is a tubular container body. The container body 1 has an opening at one end and a closed bottom at the other end. The stopper 2 is attached to the opening of the container body 1. The barrier film 3 is arranged in the circumferential direction on the outer surface 1a of the container body 1. The barrier film 3 is arranged on a part of the outer surface 1a of the container body 1. The barrier film 3 is wound on the outer surface 1a of the container body 1. The liquid 4 is housed in the container body 1.
　バリアフィルム３は、検体採取容器１１の外側から内側に向かって、第１のフィルム３１と、第１の粘着層３３と、第２のフィルム３２と、第２の粘着層３４とをこの順に有する。容器本体１の外表面１ａ上に第２の粘着層３４が配置されている。第２の粘着層３４の容器本体１とは反対側の表面上に第２のフィルム３２が配置されている。第２のフィルム３２の第２の粘着層３４とは反対側の表面上に第１の粘着層３３が配置されている。第１の粘着層３３の第２のフィルム３２とは反対側の表面上に第１のフィルム３１が配置されている。 The barrier film 3 has a first film 31, a first adhesive layer 33, a second film 32, and a second adhesive layer 34 in this order from the outside to the inside of the sample collection container 11. .. A second adhesive layer 34 is arranged on the outer surface 1a of the container body 1. The second film 32 is arranged on the surface of the second adhesive layer 34 opposite to the container body 1. The first adhesive layer 33 is arranged on the surface of the second film 32 opposite to the second adhesive layer 34. The first film 31 is arranged on the surface of the first adhesive layer 33 opposite to the second film 32.
　バリアフィルム３では、第１のフィルム３１がバリアフィルム本体であり、第２のフィルム３２がポリエチレンテレフタレートフィルムである。 In the barrier film 3, the first film 31 is the barrier film body, and the second film 32 is the polyethylene terephthalate film.
　バリアフィルム３の外表面３ａ及び第１のフィルム３１の外表面は、粗面領域Ｒを有する。粗面領域Ｒは、バリアフィルム３の外表面３ａ及び第１のフィルム３１の外表面の一部に存在する。バリアフィルム３の外表面３ａ及び第１のフィルム３１の外表面は、粗面領域Ｒと、算術平均粗さＲａが１．５μｍ未満である平滑面領域とを有する。バリアフィルム３の粗面領域Ｒは、検体採取容器１１の外表面の一部を構成している。 The outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R. The rough surface region R exists on the outer surface 3a of the barrier film 3 and a part of the outer surface of the first film 31. The outer surface 3a of the barrier film 3 and the outer surface of the first film 31 have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 μm. The rough surface region R of the barrier film 3 constitutes a part of the outer surface of the sample collection container 11.
　図２は、本発明の第２の実施形態に係る検体採取容器を模式的に示す正面断面図である。 FIG. 2 is a front sectional view schematically showing a sample collection container according to a second embodiment of the present invention.
　図２に示す検体採取容器１１Ａは、容器本体１と、栓体２と、バリアフィルム３Ａと、液体４とを備える。検体採取容器１１Ａの内部は、減圧されている。容器本体１は、管状の容器本体である。容器本体１は、一端に開口部を有し、他端に閉じられた底部を有する。栓体２は、容器本体１の開口部に取り付けられている。バリアフィルム３Ａは、容器本体１の外表面１ａ上の周方向に配置されている。バリアフィルム３Ａは、容器本体１の外表面１ａ上の一部に配置されている。バリアフィルム３Ａは、容器本体１の外表面１ａ上に巻かれている。液体４は、容器本体１内に収容されている。 The sample collection container 11A shown in FIG. 2 includes a container body 1, a stopper 2, a barrier film 3A, and a liquid 4. The inside of the sample collection container 11A is depressurized. The container body 1 is a tubular container body. The container body 1 has an opening at one end and a closed bottom at the other end. The stopper 2 is attached to the opening of the container body 1. The barrier film 3A is arranged in the circumferential direction on the outer surface 1a of the container body 1. The barrier film 3A is arranged on a part of the outer surface 1a of the container body 1. The barrier film 3A is wound on the outer surface 1a of the container body 1. The liquid 4 is housed in the container body 1.
　バリアフィルム３Ａは、検体採取容器１１Ａの外側から内側に向かって、第１のフィルム３１Ａと、第１の粘着層３３Ａと、第２のフィルム３２Ａと、第２の粘着層３４Ａとをこの順に有する部分が存在する。バリアフィルム３Ａは、検体採取容器１１Ａの外側から内側に向かって、第１のフィルム３１Ａと、第１の粘着層３３Ａと、第２のフィルム３２Ａと、第２の粘着層３４Ａとをこの順に有する部分と、第２のフィルム３２Ａと、第２の粘着層３４Ａとをこの順に有する部分とを有する。容器本体１の外表面１ａ上に第２の粘着層３４Ａが配置されている。第２の粘着層３４Ａの容器本体１とは反対側の表面上に第２のフィルム３２Ａが配置されている。第２のフィルム３２Ａの第２の粘着層３４Ａとは反対側の表面上に第１の粘着層３３Ａが部分的に配置されている。第２のフィルム３２Ａの第２の粘着層３４Ａとは反対側の表面上には、第１の粘着層３３Ａが配置されている部分と、第１の粘着層３３Ａが配置されていない部分とが存在する。第１の粘着層３３Ａの第２のフィルム３２Ａとは反対側の表面上に第１のフィルム３１Ａが配置されている。 The barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. There is a part. The barrier film 3A has a first film 31A, a first adhesive layer 33A, a second film 32A, and a second adhesive layer 34A in this order from the outside to the inside of the sample collection container 11A. It has a portion and a portion having a second film 32A and a second adhesive layer 34A in this order. The second adhesive layer 34A is arranged on the outer surface 1a of the container body 1. The second film 32A is arranged on the surface of the second adhesive layer 34A opposite to the container body 1. The first adhesive layer 33A is partially arranged on the surface of the second film 32A opposite to the second adhesive layer 34A. On the surface of the second film 32A opposite to the second adhesive layer 34A, there are a portion where the first adhesive layer 33A is arranged and a portion where the first adhesive layer 33A is not arranged. exist. The first film 31A is arranged on the surface of the first adhesive layer 33A opposite to the second film 32A.
　第１のフィルム３１Ａの外表面と第２のフィルム３２Ａの外表面とが、バリアフィルム３Ａの外表面３Ａａを構成している。 The outer surface of the first film 31A and the outer surface of the second film 32A constitute the outer surface 3Aa of the barrier film 3A.
　粗面領域Ｒは、バリアフィルム３Ａの外表面３Ａａ及び第２のフィルム３２Ａの外表面の一部に存在する。バリアフィルム３Ａの外表面３Ａａ及び第２のフィルム３２Ａの外表面は、粗面領域Ｒと、算術平均粗さＲａが１．５μｍ未満である平滑面領域とを有する。バリアフィルム３Ａの粗面領域Ｒは、検体採取容器１１Ａの外表面の一部を構成している。 The rough surface region R exists on a part of the outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A. The outer surface 3Aa of the barrier film 3A and the outer surface of the second film 32A have a rough surface region R and a smooth surface region having an arithmetic mean roughness Ra of less than 1.5 μm. The rough surface region R of the barrier film 3A constitutes a part of the outer surface of the sample collection container 11A.
　上記検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度は、好ましくは１．１ｇ／（ｍ２・ｄａｙ）以下、より好ましくは０．９ｇ／（ｍ２・ｄａｙ）以下、更に好ましくは０．６ｇ／（ｍ２・ｄａｙ）以下である。上記水蒸気透過度が上記上限以下であると、バリア性能をより一層効果的に発揮することができる。なお、上記検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度は、０．２ｇ／（ｍ２・ｄａｙ）以上であってもよく、０．４ｇ／（ｍ２・ｄａｙ）以上であってもよい。 The water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is preferably 1.1 g / (m 2 · day) or less, more preferably 0.9 g / (m 2 · day) or less, still more preferably. It is 0.6 g / (m 2 · day) or less. When the water vapor transmission rate is not more than the upper limit, the barrier performance can be exhibited more effectively. The water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH may be 0.2 g / (m 2 · day) or more, and 0.4 g / (m 2 · day) or more. You may.
　上記検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度は、以下のようにして測定される。 The water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is measured as follows.
　内部に液体が収容されていない容器本体内に水を収容し、栓体により密閉して、容器本体の外表面上にバリアフィルムが配置された検体採取容器（内部が減圧されておらず、かつ内部に水が収容された検体採取容器）を得る。得られた検体採取容器を４０℃及び０％ＲＨで保管する。保管前後の検体採取容器の重量の減衰量を水の蒸散量として、水蒸気透過度を計算する。 A sample collection container (the inside is not decompressed and the inside is not decompressed) in which water is stored in the container body that does not contain liquid inside, sealed with a stopper, and a barrier film is placed on the outer surface of the container body. Obtain a sample collection container containing water inside). The obtained sample collection container is stored at 40 ° C. and 0% RH. The water vapor transmission rate is calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.
　上記検体採取容器の４０℃及び０％ＲＨでの空気透過度は、好ましくは０．５ｃｃ／（ｍ２・ｄａｙ・ａｔｍ）以下、より好ましくは０．４ｃｃ／（ｍ２・ｄａｙ・ａｔｍ）以下、更に好ましくは０．３ｃｃ／（ｍ２・ｄａｙ・ａｔｍ）以下である。上記空気透過度が上記上限以下であると、バリア性能をより一層効果的に発揮することができる。なお、上記検体採取容器の４０℃及び０％ＲＨでの空気透過度は、０．１ｃｃ／（ｍ２・ｄａｙ・ａｔｍ）以上であってもよく、０．２ｃｃ／（ｍ２・ｄａｙ・ａｔｍ）以上であってもよい。 The air permeability of the sample collection container at 40 ° C. and 0% RH is preferably 0.5 cc / (m 2 · day · atm) or less, more preferably 0.4 cc / (m 2 · day · atm) or less. , More preferably 0.3 cc / ( m2 · day · atm) or less. When the air permeability is not more than the upper limit, the barrier performance can be exhibited more effectively. The air permeability of the sample collection container at 40 ° C. and 0% RH may be 0.1 cc / (m 2 · day · atm) or more, and 0.2 cc / (m 2 · day · atm). ) Or more.
　上記検体採取容器の４０℃及び０％ＲＨでの空気透過度は、以下のようにして測定される。 The air permeability of the sample collection container at 40 ° C. and 0% RH is measured as follows.
　容器本体に栓体を減圧した状態で取り付け、容器本体の外表面上にバリアフィルムが配置されており、かつ内部が減圧された検体採取容器を得る。得られた検体採取容器を４０℃及び０％ＲＨで保管する。検体採取容器内に水を吸引採取し、採取量と内圧との検量線から、保管による内圧の増加量を求め、空気透過度を計算する。 Attach the stopper to the container body in a depressurized state, and obtain a sample collection container in which the barrier film is placed on the outer surface of the container body and the inside is decompressed. The obtained sample collection container is stored at 40 ° C. and 0% RH. Water is sucked into the sample collection container, and the amount of increase in internal pressure due to storage is calculated from the calibration curve of the collected amount and internal pressure, and the air permeability is calculated.
　細菌感染を防止する観点から、上記検体採取容器の内部はＩＳＯ、及びＪＩＳに記載の基準に則って滅菌されていることが好ましい。 From the viewpoint of preventing bacterial infection, it is preferable that the inside of the sample collection container is sterilized according to the standards described in ISO and JIS.
　以下、実施例及び比較例を挙げて、本発明を具体的に説明する。本発明は、以下の実施例のみに限定されない。 Hereinafter, the present invention will be specifically described with reference to Examples and Comparative Examples. The present invention is not limited to the following examples.
　（容器本体）
　図１に示す形状を有する以下の容器本体を用意した。 (Container body)
The following container body having the shape shown in FIG. 1 was prepared.
　長さ１００ｍｍ×外径１６ｍｍ（長さ：一端（開口端）と他端との距離）
　材質：ポリエチレンテレフタレート（ＰＥＴ） Length 100 mm x outer diameter 16 mm (length: distance between one end (open end) and the other end)
Material: Polyethylene terephthalate (PET)
　（栓体）
　図１に示す形状を有し、容器本体の開口部に取り付け可能なゴム栓（ブチルゴム栓）を用意した。 (Plug body)
A rubber stopper (butyl rubber stopper) having the shape shown in FIG. 1 and which can be attached to the opening of the container body was prepared.
　（実施例１）
　（１）バリアフィルムの作製
　以下の材料を用意した。 (Example 1)
(1) Preparation of barrier film The following materials were prepared.
　フィルムＸ：凸版印刷社製「ＧＸ－Ｐ－Ｆ」（厚み１２μｍ）
　ポリエチレンテレフタレートフィルム（ＰＥＴフィルム）（厚み２５μｍ）
　粘着剤
　剥離紙 Film X: "GX-PF" manufactured by Toppan Printing Co., Ltd. (thickness 12 μm)
Polyethylene terephthalate film (PET film) (thickness 25 μm)
Adhesive release paper
　フィルムＸと粘着剤とＰＥＴフィルムと粘着剤と剥離紙とをこの順に積層し、ラミネート加工して、フィルムＸ（厚み１２μｍ）／第１の粘着層／ＰＥＴフィルム（厚み２５μｍ）／第２の粘着層／剥離紙の層構成を有する積層フィルムを得た。 The film X, the adhesive, the PET film, the adhesive, and the release paper are laminated in this order and laminated to form a film X (thickness 12 μm) / first adhesive layer / PET film (thickness 25 μm) / second adhesive. A laminated film having a layer structure of a layer / release paper was obtained.
　得られた積層フィルムのフィルムＸの表面を紙やすり（＃４０）で擦ることにより、フィルムＸの表面に凹凸を付与し、粗面領域を形成した。このようにして、バリアフィルムと剥離紙との積層フィルムを得た。また、後述のように、紙やすりで擦った部分（粗面領域）の表面粗さ等を測定した。 By rubbing the surface of the film X of the obtained laminated film with sandpaper (# 40), the surface of the film X was made uneven to form a rough surface region. In this way, a laminated film of the barrier film and the release paper was obtained. Further, as described later, the surface roughness of the portion rubbed with sandpaper (rough surface region) was measured.
　得られたバリアフィルムは、粗面領域を有するバリアフィルム本体（第１のフィルム）と、第１の粘着層と、ＰＥＴフィルム（第２のフィルム）と、第２の粘着層とをこの順に有する。また、得られたバリアフィルムは以下の寸法を有する。 The obtained barrier film has a barrier film main body (first film) having a rough surface region, a first adhesive layer, a PET film (second film), and a second adhesive layer in this order. .. In addition, the obtained barrier film has the following dimensions.
　＜バリアフィルム全体のサイズ＞
　縦：７５ｍｍ±０．５ｍｍ
　横：４８ｍｍ±０．５ｍｍ <Overall size of barrier film>
Vertical: 75 mm ± 0.5 mm
Width: 48 mm ± 0.5 mm
　＜粗面領域のサイズ＞
　縦：４．５ｍｍ±０．５ｍｍ
　横：６ｍｍ±０．５ｍｍ <Size of rough surface area>
Vertical: 4.5 mm ± 0.5 mm
Width: 6 mm ± 0.5 mm
　（２）検体採取容器の作製
　バリアフィルムと剥離紙との積層フィルムにおいて、剥離紙を剥離し、第２の粘着層を露出させた。バリアフィルムの縦方向が容器本体の長さ方向に対応するように、容器本体の外表面上にバリアフィルムを第２の粘着層側から１周巻き付けた。また、容器本体内に、約１．５ｍＬのＡＣＤ－Ａ水溶液（クエン酸ナトリウム水和物２．２０Ｗ／Ｖ％、クエン酸水和物０．８０Ｗ／Ｖ％，ブドウ糖２．２０Ｗ／Ｖ％）（ＪＭＳ社製）を添加した。次いで、１９．９ｋＰａに減圧し、栓体により密閉して検体採取容器を作製した。 (2) Preparation of Specimen Collection Container In the laminated film of the barrier film and the release paper, the release paper was peeled off to expose the second adhesive layer. The barrier film was wound around the outer surface of the container body from the second adhesive layer side so that the vertical direction of the barrier film corresponds to the length direction of the container body. In addition, about 1.5 mL of ACD-A aqueous solution (sodium citrate hydrate 2.20 W / V%, citric acid hydrate 0.80 W / V%, glucose 2.20 W / V%) is contained in the container body. (Manufactured by JMS) was added. Then, the pressure was reduced to 19.9 kPa and sealed with a stopper to prepare a sample collection container.
　（実施例２～１９）
　紙やすりで擦る時間及び擦った面積を変更したこと以外は実施例１と同様にして、バリアフィルム及び検体採取容器を作製した。 (Examples 2 to 19)
A barrier film and a sample collection container were prepared in the same manner as in Example 1 except that the time and area of rubbing with sandpaper were changed.
　（比較例１）
　得られた積層フィルムのフィルムＸの表面を紙やすり（＃４０）で擦らずに、フィルムＸをバリアフィルム本体（第１のフィルム）として用いたこと以外は、実施例１と同様にして、バリアフィルム及び検体採取容器を作製した。 (Comparative Example 1)
The barrier was the same as in Example 1 except that the surface of the film X of the obtained laminated film was not rubbed with sandpaper (# 40) and the film X was used as the barrier film main body (first film). A film and a sample collection container were prepared.
　（評価）
　（１）バリアフィルムの算術平均粗さＲａ及び最大高さＲｚ
　実施例１～１９では、紙やすりで擦った部分の算術平均粗さＲａ及び最大高さＲｚを測定した。比較例１では、バリアフィルムの表面の算術平均粗さＲａ及び最大高さＲｚを測定した。算術平均粗さＲａ及び最大高さＲｚは、ＪＩＳ　Ｂ０６０１：２００１に準拠して測定した。なお、測定装置としては、３Ｄ測定マイクロスコープ（キーエンス社製「ＶＲ－３１００」）を用いた。 (evaluation)
(1) Arithmetic mean roughness Ra and maximum height Rz of the barrier film
In Examples 1 to 19, the arithmetic mean roughness Ra and the maximum height Rz of the portion rubbed with sandpaper were measured. In Comparative Example 1, the arithmetic mean roughness Ra and the maximum height Rz of the surface of the barrier film were measured. Arithmetic mean roughness Ra and maximum height Rz were measured according to JIS B0601: 2001. As a measuring device, a 3D measuring microscope (“VR-3100” manufactured by KEYENCE CORPORATION) was used.
　（２）バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度
　得られたバリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度を、ＪＩＳ　Ｋ７１２９のＢ法に準拠して測定した。その結果、実施例１～１９及び比較例１で得られたバリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度は、０．８ｇ／（ｍ２・ｄａｙ）以下であった。 (2) Moisture vapor transmission rate of the barrier film at 40 ° C. and 90% RH The water vapor transmission rate of the obtained barrier film at 40 ° C. and 90% RH was measured according to the B method of JIS K7129. As a result, the water vapor transmission rate of the barrier films obtained in Examples 1 to 19 and Comparative Example 1 at 40 ° C. and 90% RH was 0.8 g / (m 2 · day) or less.
　（３）検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度
　各実施例及び比較例で用いた容器本体とバリアフィルムとの組み合わせにおいて、以下を行った。バリアフィルムと剥離紙との積層フィルムにおいて、剥離紙を剥離し、第２の粘着層を露出させた。バリアフィルムの縦方向が容器本体の長さ方向に対応するように、容器本体の外表面上にバリアフィルムを第２の粘着層側から１周巻き付けた。内部に液体が収容されていない容器本体内に水を収容し、栓体により密閉して、容器本体の外表面上にバリアフィルムが配置された検体採取容器（内部が減圧されておらず、かつ内部に水が収容された検体採取容器）を得た。得られた検体採取容器を４０℃及び０％ＲＨの恒温恒湿装置内に保管した。保管前後の検体採取容器の重量の減衰量を水の蒸散量として、水蒸気透過度を計算した。 (3) Moisture vapor transmission rate of the sample collection container at 40 ° C. and 0% RH The following was performed in the combination of the container body and the barrier film used in each Example and Comparative Example. In the laminated film of the barrier film and the release paper, the release paper was peeled off to expose the second adhesive layer. The barrier film was wound around the outer surface of the container body from the second adhesive layer side so that the vertical direction of the barrier film corresponds to the length direction of the container body. A sample collection container (the inside is not decompressed and the inside is not decompressed) in which water is stored in the container body that does not contain liquid inside, sealed with a stopper, and a barrier film is placed on the outer surface of the container body. A sample collection container containing water inside) was obtained. The obtained sample collection container was stored in a constant temperature and humidity device at 40 ° C. and 0% RH. The water vapor transmission rate was calculated by using the amount of attenuation of the weight of the sample collection container before and after storage as the amount of water evaporation.
　（４）文字の記入
　実施例１～１９では、得られた検体採取容器のバリアフィルムの粗面領域に油性ペン及び鉛筆で文字を記入した。また、比較例１では、検体採取容器のバリアフィルムの外表面に油性ペン及び鉛筆で文字を記入した。油性ペンで記入した場合には、記入してから２秒後にその部分を指で触り、文字が擦れるか否か確認した。鉛筆で記入した場合には、記入した文字の状態を確認した。 (4) Writing of characters In Examples 1 to 19, characters were written with an oil-based pen and a pencil on the rough surface area of the barrier film of the obtained sample collection container. Further, in Comparative Example 1, characters were written on the outer surface of the barrier film of the sample collection container with an oil-based pen and a pencil. When writing with an oil-based pen, two seconds after writing, the part was touched with a finger to check whether the characters were rubbed. When writing with a pencil, I checked the condition of the written characters.
　［油性ペンによる文字の記入の判定基準］
　○：文字を記入してから２秒後にその文字を指で触ったとしても、文字が擦れない
　×：文字を記入してから２秒後にその文字を指で触ると、文字が擦れる [Criteria for writing characters with an oil-based pen]
○: The character does not rub even if you touch the character with your finger 2 seconds after writing the character ×: If you touch the character with your finger 2 seconds after writing the character, the character rubs
　［鉛筆による文字の記入の判定基準］
　○：文字を記入することができ、かつ記入した文字がはっきりと認識可能
　△：文字を記入することができるが、記入した文字がやや見えにくい
　×：文字を記入することができない [Criteria for writing characters with a pencil]
○: Characters can be entered and the entered characters can be clearly recognized △: Characters can be entered, but the entered characters are a little difficult to see ×: Characters cannot be entered
　結果を下記の表１～４に示す。 The results are shown in Tables 1 to 4 below.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
　１…容器本体
　１ａ…外表面
　２…栓体
　３，３Ａ…バリアフィルム
　３ａ，３Ａａ…外表面
　４…液体
　１１，１１Ａ…検体採取容器
　３１，３１Ａ…第１のフィルム
　３２，３２Ａ…第２のフィルム
　３３，３３Ａ…第１の粘着層
　３４，３４Ａ…第２の粘着層 1 ... Container body 1a ... Outer surface 2 ... Plug body 3,3A ... Barrier film 3a, 3Aa ... Outer surface 4 ... Liquid 11,11A ... Sample collection container 31,31A ... First film 32, 32A ... Second film 33, 33A ... 1st adhesive layer 34, 34A ... 2nd adhesive layer

Claims (8)

  1. 　容器本体と、
    　前記容器本体の外表面上に配置されたバリアフィルムとを備え、
    　前記バリアフィルムの４０℃及び９０％ＲＨでの水蒸気透過度が０．８ｇ／（ｍ２・ｄａｙ）以下であり、
    　前記バリアフィルムの外表面は、算術平均粗さＲａが１．５μｍ以上である粗面領域を有し、
    　前記バリアフィルムの前記粗面領域が、検体採取容器の外表面の少なくとも一部を構成している、検体採取容器。     With the container body
    A barrier film arranged on the outer surface of the container body is provided.
    The water vapor transmission rate of the barrier film at 40 ° C. and 90% RH is 0.8 g / (m 2 · day) or less.
    The outer surface of the barrier film has a rough surface region having an arithmetic average roughness Ra of 1.5 μm or more.
    A sample collection container in which the rough surface region of the barrier film constitutes at least a part of the outer surface of the sample collection container.
  2. 　前記バリアフィルムの前記粗面領域の最大高さＲｚが１０．０μｍ以上である、請求項１に記載の検体採取容器。 The sample collection container according to claim 1, wherein the maximum height Rz of the rough surface region of the barrier film is 10.0 μm or more.
  3. 　前記バリアフィルムの前記粗面領域の算術平均粗さＲａが２．４μｍ以上である、請求項１又は２に記載の検体採取容器。 The sample collection container according to claim 1 or 2, wherein the arithmetic average roughness Ra of the rough surface region of the barrier film is 2.4 μm or more.
  4. 　検体採取容器の４０℃及び０％ＲＨでの水蒸気透過度が１．１ｇ／（ｍ２・ｄａｙ）以下である、請求項１～３のいずれか１項に記載の検体採取容器。 The sample collection container according to any one of claims 1 to 3, wherein the water vapor transmission rate of the sample collection container at 40 ° C. and 0% RH is 1.1 g / (m 2 · day) or less.
  5. 　前記バリアフィルムが、第１のフィルムと、第１の粘着層と、第２のフィルムと、第２の粘着層とをこの順に有し、
    　前記第１のフィルムの外表面が、前記粗面領域を有し、
    　前記第２の粘着層が、前記容器本体の外表面上に配置されている、請求項１～４のいずれか１項に記載の検体採取容器。     The barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order.
    The outer surface of the first film has the rough surface region and has the rough surface region.
    The sample collection container according to any one of claims 1 to 4, wherein the second adhesive layer is arranged on the outer surface of the container body.
  6. 　前記第１のフィルムが、バリアフィルム本体であり、
    　前記第２のフィルムが、ポリエチレンテレフタレートフィルムである、請求項５に記載の検体採取容器。     The first film is the barrier film body, and is
    The sample collection container according to claim 5, wherein the second film is a polyethylene terephthalate film.
  7. 　前記容器本体の開口部に取り付けられた栓体と、
    　前記容器本体内に収容された液体とを備える、請求項１～６のいずれか１項に記載の検体採取容器。     The stopper attached to the opening of the container body and
    The sample collection container according to any one of claims 1 to 6, further comprising a liquid contained in the container body.
  8. 　検体採取容器に採取される検体が、血液であり、
    　前記液体が、抗凝固剤を含む液である、請求項７に記載の検体採取容器。     The sample collected in the sample collection container is blood,
    The sample collection container according to claim 7, wherein the liquid is a liquid containing an anticoagulant.
PCT/JP2021/034711 2020-09-23 2021-09-22 Specimen collection container WO2022065342A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH091732A (en) * 1995-06-16 1997-01-07 Yodogawa Steel Works Ltd Manufacture of laminated metal plate of vinylidene fluoride film
JPH09299356A (en) * 1996-05-02 1997-11-25 Becton Dickinson & Co Blood sampling test tube assembly
JP2000023949A (en) * 1998-07-14 2000-01-25 Terumo Corp Blood drawing tube
JP2005305856A (en) * 2004-04-22 2005-11-04 Dainippon Printing Co Ltd Transparent barrier film, laminated material using the same and container for packaging
JP2013140172A (en) * 2006-09-08 2013-07-18 Becton Dickinson & Co Sample container with physical fill-line indicator
JP2018154694A (en) * 2017-03-16 2018-10-04 東洋インキＳｃホールディングス株式会社 Hot-melt adhesive for laminate and laminated film laminate using the same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH091732A (en) * 1995-06-16 1997-01-07 Yodogawa Steel Works Ltd Manufacture of laminated metal plate of vinylidene fluoride film
JPH09299356A (en) * 1996-05-02 1997-11-25 Becton Dickinson & Co Blood sampling test tube assembly
JP2000023949A (en) * 1998-07-14 2000-01-25 Terumo Corp Blood drawing tube
JP2005305856A (en) * 2004-04-22 2005-11-04 Dainippon Printing Co Ltd Transparent barrier film, laminated material using the same and container for packaging
JP2013140172A (en) * 2006-09-08 2013-07-18 Becton Dickinson & Co Sample container with physical fill-line indicator
JP2018154694A (en) * 2017-03-16 2018-10-04 東洋インキＳｃホールディングス株式会社 Hot-melt adhesive for laminate and laminated film laminate using the same

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