specimen collection container

Abstract

Provided is a specimen collection container with which it is possible to minimize a change in the mixing ratio between a collected specimen and a contained liquid, even when a long time has elapsed since production.　The specimen collection container according to the present invention is a specimen collection container into which a specimen is collected, the specimen collection container being provided with a main container body having an opening, a plug mounted on the opening, a barrier film positioned on the outer surface of the container body, and a liquid contained in the container body. The water vapor permeability of the barrier film at 40°C and 90% RH is 0.8 g / (m2 ⋅ day) or below.

Description

[Technical Field]

[0001] The present invention relates to specimen collection containers. [Background technology]

[0002] In clinical testing, specimen collection containers with reduced pressure inside, such as blood collection tubes, are widely used (for example, Patent Document 1). The specimen collection containers are designed so that a specified amount of specimen is collected by reducing the pressure inside. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-154909 Summary of the Invention [Problem to be solved by the invention]

[0004] A specimen collection container may be used that has a reduced pressure inside and is pre-filled with a liquid to be mixed with the specimen. The specimen collection container is designed so that the specimen to be collected and the liquid contained therein are mixed at a predetermined mixing ratio. An example of the specimen collection container is a vacuum blood collection tube containing a liquid containing an anticoagulant.

[0005] However, after the specimen collection container is manufactured, the internal pressure of the specimen collection container gradually increases, and the liquid contained therein gradually evaporates. Therefore, in conventional specimen collection containers, the mixture ratio of the specimen to the liquid contained therein may change over time after manufacture. While packaging the specimen collection container in an aluminum gusset bag can somewhat suppress this change in mixture ratio, the effect is not sufficient. Furthermore, this method also has the problem of increasing waste.

[0006] An object of the present invention is to provide a specimen collection container that can suppress changes in the mixture ratio between the collected specimen and the contained liquid even if a long period of time has passed since its manufacture. [Means for solving the problem]

[0007] According to a broad aspect of the present invention, there is provided a specimen collection container for collecting a specimen, the specimen collection container comprising: a container body having an opening; a stopper attached to the opening; a barrier film disposed on the outer surface of the container body; and a liquid contained in the container body, the barrier film having a water vapor transmission rate of 0.8 g / (m) at 40°C and 90% RH. 2 A specimen collection container is provided that is less than 10 days old.

[0008] In a specific aspect of the specimen collection container according to the present invention, the specimen collection container has an air permeability of 0.5 cc / (m 2 ·day·atm).

[0009] In a specific aspect of the specimen collection container according to the present invention, the specimen collection container has a water vapor transmission rate of 1.1 g / (m 2 ·day) or less.

[0010] In a specific aspect of the specimen collection container according to the present invention, the barrier film is arranged around the outer surface of the container body in a circumferential direction, the barrier film extending over 0.2 to 3 revolutions.

[0011] In a specific aspect of the specimen collection container according to the present invention, the surface area of ​​the portion where the barrier film is disposed is 15% or more and 90% or less of the total surface area (100%) of the outer surface of the container body.

[0012] In a specific aspect of the specimen collection container according to the present invention, the barrier film has a thickness of 5 μm or more and 300 μm or less before being placed on the outer surface of the container body.

[0013] In a particular aspect of the specimen collection container of 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, and the second adhesive layer is disposed on the outer surface of the container body.

[0014] In a specific aspect of the specimen collection container according to the present invention, the first film is a barrier film body, and the second film is a polyethylene terephthalate film.

[0015] In a specific aspect of the specimen collection container according to the present invention, the container body is made of polyethylene terephthalate or polyethylene naphthalate.

[0016] In a specific aspect of the specimen collection container according to the present invention, the specimen is blood, and the liquid is a liquid containing an anticoagulant.

[0017] In a specific aspect of the specimen collection container according to the present invention, the anticoagulant is citric acid, EDTA, or heparin.

[0018] In a specific aspect of the specimen collection container according to the present invention, the amount of the liquid contained in the container body is 0.1 mL or more and 5 mL or less. [Effects of the Invention]

[0019] The specimen collection container according to the present invention is a specimen collection container for collecting a specimen, and comprises a container body having an opening, a stopper attached to the opening, a barrier film disposed on the outer surface of the container body, and a liquid contained in the container body, wherein the water vapor transmission rate of the barrier film at 40°C and 90% RH is 0.8 g / (m 2 The specimen collection container according to the present invention is provided with the above-described configuration, and therefore, even if a long period of time has passed since its manufacture, it is possible to suppress changes in the mixture ratio between the collected specimen and the contained liquid. [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is a front cross-sectional view schematically showing a specimen collection container according to a first embodiment of the present invention. [Figure 2] FIG. 2 is a front cross-sectional view schematically showing a specimen collection container according to a second embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0021] The present invention will be described in detail below.

[0022] The specimen collection container according to the present invention is a specimen collection container for collecting a specimen, and comprises a container body having an opening, a stopper attached to the opening, a barrier film disposed on the outer surface of the container body, and a liquid contained in the container body, wherein the water vapor transmission rate of the barrier film at 40°C and 90% RH is 0.8 g / (m 2 ·day) or less.

[0023] The specimen collection container according to the present invention is provided with the above-described configuration, and therefore, even if a long time has passed since its manufacture, it is possible to suppress a change in the mixture ratio between the specimen to be collected and the liquid contained therein. In the present invention, it is possible to suppress a change in the mixture ratio between the specimen to the liquid when a specimen is collected using a specimen collection container that has been manufactured a long time ago, compared to when a specimen is collected using a specimen collection container that has been manufactured a long time ago.

[0024] In a specimen collection container whose interior is decompressed and which is pre-filled with a liquid, the internal pressure gradually increases after manufacture, and the liquid gradually evaporates. In conventional specimen collection containers, the rate of increase in internal pressure and the rate of evaporation of the liquid are not controlled in any way. As the internal pressure of a specimen collection container increases, the amount of specimen collected decreases. Therefore, even if a specimen is collected using a specimen collection container that has been manufactured not long ago, the specified mixture ratio of the specimen and the liquid may change when the specimen is collected using a specimen collection container manufactured long ago. If the mixture ratio changes, the accuracy of the test using the specimen may decrease.

[0025] In contrast, in the specimen collection container according to the present invention, a specific barrier film is disposed on the outer surface of the container body, so that even when a specimen collection container is used for a long period of time, the relationship between the rate of decrease in the amount of specimen collected and the rate of evaporation of the contained liquid tends to be kept constant, thereby suppressing changes in the mixture ratio between the collected specimen and the contained liquid.

[0026] The water vapor transmission rate of the specimen collection container at 40°C and 0% RH is preferably 1.1 g / (m 2 ·day) or less, more preferably 0.9g / (m 2 ·day) or less, more preferably 0.6g / (m 2 ·day) or less. When the water vapor transmission rate is equal to or less than the upper limit, the effects of the present invention can be more effectively exhibited. The water vapor transmission rate of the specimen collection container at 40°C and 0% RH is 0.2 g / (m 2 ·day) or more, and 2 ·day) or more.

[0027] The water vapor transmission rate of the specimen collection container at 40°C and 0% RH is measured as follows.

[0028] Water is placed in a container body that does not contain any liquid inside, and the container body is sealed with a stopper to obtain a specimen collection container with a barrier film disposed on the outer surface of the container body (a specimen collection container that is not decompressed and contains water inside). The obtained specimen collection container is stored at 40°C and 0% RH. The weight loss of the specimen collection container before and after storage is taken as the amount of water evaporated, and the water vapor transmission rate is calculated. It is preferable that the combination of the container body, stopper, and barrier film satisfies the preferred range of water vapor transmission rate described above.

[0029] The air permeability of the specimen collection container at 40°C and 0% RH is preferably 0.5 cc / (m 2 ·day·atm) or less, preferably 0.4cc / (m 2 ·day·atm) or less, more preferably 0.3cc / (m 2 ·day·atm) or less. When the air permeability is equal to or less than the upper limit, the effects of the present invention can be more effectively exhibited. The air permeability of the specimen collection container at 40°C and 0% RH is 0.1 cc / (m 2 ·day·atm) or more, and 0.2cc / (m 2 ·day·atm) or more.

[0030] The air permeability of the specimen collection container at 40°C and 0% RH is measured as follows.

[0031] The stopper is attached to the container body under reduced pressure, resulting in a specimen collection container with a barrier film on the outer surface of the container body and a reduced pressure inside. The resulting specimen collection container is stored at 40°C and 0% RH. Water is aspirated into the specimen collection container, and the increase in internal pressure due to storage is determined from a calibration curve of the amount collected and internal pressure, and the air permeability is calculated.

[0032] The components constituting the specimen collection container will be described in detail below.

[0033] (barrier film) The barrier film is disposed on the outer surface of the container body. The barrier film is preferably attached to the outer surface of the container body, and is preferably wound around it. The barrier film is preferably a gas barrier film. The barrier film is preferably transparent. When a sample is collected from the sample collection container, the collected sample is preferably visible through the barrier film. The barrier film is preferably a transparent barrier film, and is preferably a transparent gas barrier film.

[0034] In order to achieve the effects of the present invention, the water vapor permeability of the barrier film at 40°C and 90% RH is 0.8 g / (m 2 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 0.3g / (m 2 ·day) or less, more preferably 0.1 g / (m 2 ·day) or less, particularly preferably 0.05 g / (m 2 When the water vapor transmission rate is equal to or less than the upper limit, the effects of the present invention can be more effectively exhibited.

[0035] The water vapor permeability of the barrier film at 40° C. and 90% RH is measured in accordance with Method B of JIS K7129.

[0036] The thickness of the barrier film (the 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, and preferably 300 μm or less, 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 equal to or greater than the above lower limit and equal to or less than the above upper limit, the flexibility of the barrier film can be increased, and the barrier film can be well placed on the outer surface of the container body. This reduces the risk of air bubbles remaining between the container body and the barrier film.

[0037] The barrier film is arranged around the outer surface of the container body in the circumferential direction, preferably at least 0.2 times, more preferably at least 0.5 times, preferably at most 3 times, more preferably at most 1.5 times, in which case the effects of the present invention can be more effectively exhibited.

[0038] Of the total surface area (100%) of the outer surface of the container body, the surface area of ​​the portion where the barrier film is disposed is preferably 15% or more, more preferably 30% or more, even more preferably 50% or more, particularly preferably 60% or more, and preferably 100% or less, more preferably 95% or less, even more preferably 90% or less, and particularly preferably 80% or less. When the surface area of ​​the portion where the barrier film is disposed is not less than the above lower limit and not more than the above upper limit, the effects of the present invention can be exhibited even more effectively.

[0039] The barrier film is preferably a barrier film including a base film and an inorganic oxide layer, and more preferably a barrier film including 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 laminated directly or with another layer interposed therebetween. The inorganic oxide layer and the barrier coat layer may be laminated directly or with another layer interposed therebetween. The base film, the inorganic oxide layer, and the barrier coat layer will be described later.

[0040] The barrier film may or may not have an adhesive layer. From the viewpoint of properly positioning the barrier film on the outer surface of the container body, the barrier film preferably has a barrier film main body and an adhesive layer. In the specimen collection container, it is preferable that the adhesive layer is positioned on the outer surface of the container body, and the barrier film main body is positioned outside the adhesive layer. In this case, in the specimen collection container, the barrier film main body may be positioned on the outer surface of the adhesive layer.

[0041] The barrier film is preferably a laminated film of a first film, which is the barrier film body, and a second film.

[0042] From the viewpoint of successfully producing a specimen collection container, it is more preferable that the barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order. In this case, it is preferable that the outer surface of the first film is the outer surface of the barrier film. Also, in this case, it is preferable that the second adhesive layer is disposed on the outer surface of the container body. Also, in this case, the first film may be the barrier film body, and the second film may be the barrier film body.

[0043] The first film and the first adhesive layer may be laminated directly or via another layer. The first adhesive layer and the second film may be laminated directly or via another layer. The second film and the second adhesive layer may be laminated directly or via another layer.

[0044] 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 together, it is preferable that the first adhesive layer and the second film are directly laminated together, and it is preferable that the second film and the second adhesive layer are directly laminated together.

[0045] The layers that make up the barrier film will be further described below.

[0046] <Barrier film body, first and second films> The barrier film preferably has a barrier film main body. However, the barrier film may consist of only the barrier film main body.

[0047] The water vapor permeability of the barrier film body at 40°C and 90% RH is preferably 0.8 g / (m 2·day) or less, more preferably 0.6g / (m 2 ·day) or less, more preferably 0.3g / (m 2 ·day) or less, particularly preferably 0.1 g / (m 2 ·day) or less, most preferably 0.05g / (m 2 ·day) or less.

[0048] The water vapor permeability of the barrier film body at 40° C. and 90% RH is measured in accordance with Method B of JIS K7129.

[0049] The barrier film body preferably comprises a substrate film and an inorganic oxide layer, and more preferably comprises a substrate film, an inorganic oxide layer, and a barrier coat layer in this order. The substrate film and the inorganic oxide layer may be laminated directly or via another layer. The inorganic oxide layer and the barrier coat layer may be laminated directly or via another layer.

[0050] Examples of the substrate film include polyethylene terephthalate film, polyethylene naphthalate film, nylon film, polyethylene film, polypropylene film, polystyrene film, polyamide film, polycarbonate film, polyacrylonitrile film, and polyimide film.

[0051] The substrate film is preferably transparent.

[0052] The inorganic oxide layer is preferably a layer having gas barrier properties, and is preferably an inorganic oxide vapor-deposited layer in which an inorganic oxide is vapor-deposited on the surface of the base film.

[0053] Examples of inorganic oxides contained in the inorganic oxide layer include aluminum oxide, silicon oxide, tin oxide, magnesium oxide, etc. The inorganic oxides may be used alone or in combination of two or more.

[0054] From the viewpoint of improving the gas barrier property, the inorganic oxide is preferably aluminum oxide or silicon oxide.

[0055] The barrier coating layer is a layer having gas barrier properties, and by having the barrier coating layer, oxidation of the inorganic oxide can be effectively suppressed, and damage to the inorganic oxide layer due to external impacts or the like can be suppressed.

[0056] The barrier coat layer may be made of any of the conventionally known materials used for barrier coat layers. Examples of the barrier coat layer material include a composition containing a hydrolysis product of an alkoxysilane and a water-soluble polymer, polyethylene terephthalate, and nylon. The barrier coat layer material may be made of one material alone or two or more materials in combination.

[0057] Examples of the water-soluble polymer include polyvinyl alcohol resins, ethylene-vinyl alcohol copolymers, etc. The water-soluble polymer may be used alone or in combination of two or more.

[0058] Of the substrate film and the inorganic oxide layer, the substrate film is preferably disposed on the container body side. Of the substrate film and the barrier coat layer, the substrate film is preferably disposed on the container body side.

[0059] From the viewpoint of lamination and quality assurance of the barrier film, it is preferable that the first film is the barrier film body. In the specimen collection container, it is preferable that the outer surface of the first film is the outer surface of the barrier film.

[0060] Commercially available products can also be used for the barrier film, the barrier film main body, and the first film that is the barrier film main body. Examples of commercially available products include "GX-PF" and "GL-AEC-F" manufactured by Toppan Printing Co., Ltd., "IB-PET-PXB2" manufactured by Dai Nippon Printing Co., Ltd., "Barrierox 1011 SBR2" manufactured by Toray Advanced Film Co., Ltd., "V Barrier" manufactured by Mitsui Chemicals Tocello Inc., and "Tech Barrier" manufactured by Mitsubishi Chemical Corporation. Examples of the barrier film include films that include these commercially available films.

[0061] The second film may or may not be a 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.

[0062] Examples of the second film include a polyethylene terephthalate film, a polyethylene naphthalate film, a nylon film, a polyethylene film, a polypropylene film, a polystyrene film, a polyamide film, a polycarbonate film, a polyacrylonitrile film, and a polyimide film.

[0063] The second film is preferably a polyethylene terephthalate film, which allows for good application of the adhesive and improves lamination processability.

[0064] The thickness of the second film is preferably 1 μm or more, more preferably 10 μm or more, and preferably 80 μm or less, 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 equal to or greater than the above-mentioned lower limit and equal to or less than the above-mentioned upper limit, the flexibility of the barrier film can be increased, and the barrier film can be properly positioned on the outer surface of the container body. This reduces the risk of air bubbles remaining between the container body and the barrier film.

[0065] <Adhesive layer (first and second adhesive layers)> The barrier film preferably has an adhesive layer, which is a layer formed from an adhesive.

[0066] The first adhesive layer is disposed between the first film and the second film. The second adhesive layer is disposed between the second film and the outer surface of the container body. It is preferable that the second adhesive layer is disposed on the outer surface of the container body.

[0067] The material of the adhesive layer (material of the first and second adhesive layers) is not particularly limited, and a conventionally known adhesive can be used. Examples of the adhesive include silicone-based adhesives, urethane-based adhesives, and acrylic-based adhesives. The adhesives may be used alone or in combination of two or more.

[0068] From the viewpoint of increasing adhesive strength, the pressure-sensitive adhesive is preferably an acrylic pressure-sensitive adhesive or a silicone pressure-sensitive adhesive.

[0069] The thickness of the first adhesive layer is preferably 1 μm or more, more preferably 10 μm or more, and preferably 80 μm or less, 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 equal to or more than the lower limit and equal to or less than the upper limit, the adhesive strength can be increased.

[0070] The thickness of the second adhesive layer is preferably 1 μm or more, more preferably 10 μm or more, and preferably 80 μm or less, 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 equal to or greater than the lower limit and equal to or less than the upper limit, the adhesive strength can be increased.

[0071] (Container body) The container body has an opening. The shape of the container body is not particularly limited. The shape of the container body is preferably a bottomed container, and more preferably a bottomed tubular container.

[0072] The material of the container body is not particularly limited. Examples of the material of the container body include thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyethylene naphthalate, polymethyl methacrylate, and polyacrylonitrile; thermosetting resins such as unsaturated polyester resins, epoxy resins, and epoxy-acrylate resins; modified natural resins such as cellulose acetate, cellulose propionate, ethyl cellulose, and ethyl chitin; and glass such as silicate glass, such as soda-lime glass, phosphosilicate glass, and borosilicate glass, and quartz glass. These components may be used alone or in combination of two or more.

[0073] In order to more effectively exert the effects of the present invention, the material of the container body is preferably polyethylene terephthalate or polyethylene naphthalate, and more preferably polyethylene terephthalate.

[0074] When the material of the container body is polyethylene terephthalate, the water vapor permeability of the barrier film at 40°C and 90% RH is preferably 0.5 g / (m 2 ·day) or less, more preferably 0.2g / (m 2 ·day) or less, more preferably 0.1 g / (m 2 ·day) or less, particularly preferably 0.05 g / (m 2 ·day) or less.

[0075] (stopper) The stopper is attached to the opening of the container body. A conventionally known stopper can be used as the stopper. The stopper is preferably made of a material and has a shape that allows it to 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, the stopper is preferably configured to be pierceable with a needle.

[0076] Examples of the stopper include a stopper having a shape that fits into the opening of the container body, a sheet-like sealing stopper, and the like.

[0077] The stopper may also include a stopper body such as a rubber stopper and a cap member made of plastic, etc. In this case, the risk of the body fluid such as blood coming into contact with the human body can be reduced when the stopper body is pulled out from the opening of the container body after collection of the body fluid.

[0078] Examples of the material for the stopper (or the stopper main body) include synthetic resin, elastomer, rubber, and metal foil. Examples of the rubber include butyl rubber and halogenated butyl rubber. Examples of the metal foil include aluminum foil. From the viewpoint of improving sealing performance, the material for the stopper (or the stopper main body) is preferably butyl rubber or halogenated butyl rubber. The stopper (or the stopper main body) is preferably a butyl rubber stopper or a halogenated butyl rubber stopper.

[0079] (Specimens and fluids) The type and amount of liquid contained in the container body and the type and amount of specimen to be collected are not particularly limited.

[0080] The specimen may be a biological sample, etc. Specific examples of the specimen include blood, plasma, urine, and cerebrospinal fluid.

[0081] When the specimen is blood, the specimen collection container is a blood collection container, preferably a blood collection tube, more preferably a vacuum blood collection tube.

[0082] The liquid solvent is preferably water.

[0083] When the specimen is blood, the liquid is preferably a liquid containing an anticoagulant, and more preferably a liquid containing an anticoagulant and water.

[0084] Examples of the anticoagulant include citric acid, oxalic acid, EDTA (ethylenediaminetetraacetic acid), heparin, etc. One type of the anticoagulant may be used alone, or two or more types may be used in combination.

[0085] The anticoagulant preferably contains citric acid, EDTA, or heparin, and more preferably is citric acid, EDTA, or heparin. When the sample is blood, the liquid preferably contains at least one of citric acid, EDTA, and heparin.

[0086] The amount of liquid contained in the container body may be 0.1 mL or more, or 5 mL or less.

[0087] (Other details of specimen collection container) The inside of the specimen collection container is decompressed, and the internal pressure of the specimen collection container is appropriately changed depending on the size of the specimen collection container and the amount of specimen to be collected.

[0088] The volume of the specimen collected in the specimen collection container is not particularly limited. The volume of the specimen collected in the specimen collection container may be 0.5 mL or more, 4.5 mL or more, or 7.6 mL or more. The volume of the specimen collected in the specimen collection container may be 10 mL or less, 5.5 mL or less, or 2.0 mL or less.

[0089] Specific embodiments of the present invention will be described below with reference to the drawings. Note that in the drawings, the size, thickness, shape, etc. may differ from the actual size, thickness, shape, etc. for the sake of convenience of illustration.

[0090] FIG. 1 is a front cross-sectional view schematically showing a specimen collection container according to a first embodiment of the present invention.

[0091] The specimen collection container 11 shown in FIG. 1 comprises a container body 1, a stopper 2, a barrier film 3, and a liquid 4. The container body 1 is a tubular container. 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 portion of the outer surface 1a of the container body 1. The barrier film 3 is wrapped around the outer surface 1a of the container body 1. The liquid 4 is contained within the container body 1.

[0092] The barrier film 3 has, from the outside to the inside of the specimen collection container 11, a first film 31, a first adhesive layer 33, a second film 32, and a second adhesive layer 34, in this order. The second adhesive layer 34 is disposed on the outer surface 1a of the container body 1. The second film 32 is disposed on the surface of the second adhesive layer 34 opposite the container body 1. The first adhesive layer 33 is disposed on the surface of the second film 32 opposite the second adhesive layer 34. The first film 31 is disposed on the surface of the first adhesive layer 33 opposite the second film 32.

[0093] In the barrier film 3, the first film 31 is the barrier film body, and the second film 32 is a polyethylene terephthalate film.

[0094] FIG. 2 is a front cross-sectional view schematically showing a specimen collection container according to a second embodiment of the present invention.

[0095] The specimen collection container 11A shown in FIG. 2 comprises a container body 1, a stopper 2, a barrier film 3A, and a liquid 4. The interior of the specimen collection container 11A is under reduced pressure. 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 portion of the outer surface 1a of the container body 1. The barrier film 3A is wrapped around the outer surface 1a of the container body 1. The liquid 4 is contained within the container body 1.

[0096] The specimen collection container may contain components other than the liquid in the container body, such as a serum or plasma separating agent, a serum or plasma separating tool, a formaldehyde-releasing substance, dextran, Ficoll, and magnetic beads.

[0097] From the viewpoint of preventing bacterial infection, the inside of the specimen collection container is preferably sterilized in accordance with the standards set forth in ISO and JIS.

[0098] The present invention will be specifically described below by way of examples and comparative examples, but the present invention is not limited to the following examples. The following Examples 1 to 4, 13, and 14 are reference examples.

[0099] (Container body) The following container bodies A, B, and C having the shapes shown in FIG. 1 were prepared.

[0100] Container body A: Length 75mm x outer diameter 13mm (length: distance between one end (open end) and the other end) Material: Polyethylene terephthalate (PET)

[0101] Container body B: Length 100mm x outer diameter 16mm (length: distance between one end (open end) and the other end) Material: Polyethylene terephthalate (PET)

[0102] Container body C: Length 75mm x outer diameter 13mm (length: distance between one end (open end) and the other end) Material: Polyethylene naphthalate (PEN)

[0103] (stopper) A rubber stopper (butyl rubber stopper) having the shape shown in FIG. 1 and capable of being attached to the opening of the container body was prepared.

[0104] (barrier film) Barrier film A (a laminated film (laminated product) made by Toppan Printing Co., Ltd.'s "GX-PF" (thickness 12 μm) and polyethylene terephthalate film (PET film, thickness 25 μm)) Barrier film B (Nichiei Shinka "Transparent 50-SN", polyethylene terephthalate film (transparent PET film), thickness 50 μm) Barrier film C (Kuraray's "E105B" is a laminated film (laminated product) made of ethylene-vinyl alcohol copolymer (EVOH) film (thickness 12 μm) and polyethylene terephthalate film (transparent PET film, thickness 25 μm)) Barrier film D (prepared using the following method) Barrier film E ("IB-PET-PXB2" manufactured by Dai Nippon Printing Co., Ltd., thickness 22 μm)

[0105] Preparation of barrier film D: The following materials were prepared: Barrier film body: Toppan Printing's "GX-PF" (thickness 12 μm) Polyethylene terephthalate film (PET film) (thickness 25 μm) adhesive Release paper

[0106] A barrier film body, adhesive, PET film, adhesive, and release paper were layered in this order and laminated to obtain a laminated film (laminate film of barrier film and release paper) having a layer structure of barrier film body (thickness 12 μm) / first adhesive layer / PET film (thickness 25 μm) / second adhesive layer / release paper. The obtained barrier film D is a laminated film (laminated product) having a thickness of 66 μm and having a barrier film body (first film), first adhesive layer, PET film (second film), and second adhesive layer in this order.

[0107] The water vapor permeabilities of barrier films A to E at 40°C and 90% RH are shown in the following Table 1. The water vapor permeabilities are values ​​measured in accordance with Method B of JIS K7129.

[0108] [Table 1]

[0109] (liquid) 3.2 w / v% citric acid aqueous solution ACD-A solution (Terumo Corporation: 2.2 w / v% sodium citrate hydrate, 0.80 w / v% citric acid hydrate, 2.20 w / v% glucose)

[0110] Example 1 Specimen collection container manufacturing: A barrier film A measuring 50 mm in length and 40 mm in width was prepared. This barrier film A was wrapped around the outer periphery of the container body A once, with the vertical direction of the barrier film A corresponding to the longitudinal direction of the container body A. Approximately 0.2 mL of a 3.2 w / v % aqueous citric acid solution was added to the container body A. The pressure was then reduced to 57.8 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0111] Example 2 A specimen collection container was manufactured in the same manner as in Example 1, except that a barrier film A measuring 50 mm in length and 20 mm in width was used, in which the barrier film A was wrapped around the outer surface of the container body A by 0.5 turns.

[0112] Example 3 A barrier film A measuring 75 mm in length and 48 mm in width was prepared. This barrier film A was wrapped around the outer periphery of the container body B once so that the vertical direction of the barrier film A corresponded to the longitudinal direction of the container body B. In addition, approximately 1.5 mL of ACD-A solution was added to the container body B. Next, the pressure was reduced to 19.9 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0113] Example 4 A specimen collection container was manufactured in the same manner as in Example 3, except that a barrier film A measuring 75 mm in length and 24 mm in width was used, in which the barrier film A was wrapped around the outer surface of the container body B by 0.5 turns.

[0114] Example 5 The laminated film of barrier film D and release paper was cut to a size of 50 mm length x 40 mm width. After cutting, the release paper was peeled off from the laminated film to expose the second adhesive layer. Barrier film D was wrapped around the outer surface of container body C from the second adhesive layer side once so that the vertical direction of the barrier film corresponded to the longitudinal direction of container body C. In addition, 0.20 mL of a 3.2 w / v % citric acid aqueous solution was added to container body C. Next, the pressure was reduced to 57.8 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0115] Example 6 A specimen collection container was manufactured in the same manner as in Example 5, except that the laminated film of barrier film D and release paper was cut to a size of 50 mm length x 30 mm width, and the barrier film D obtained from the cut laminated film was used, in which the barrier film D was wrapped around the outer peripheral surface of the container body C by 0.75 turns.

[0116] Example 7 The laminated film of barrier film D and release paper was cut to a size of 75 mm length x 48 mm width. After cutting, the release paper was peeled off from the laminated film to expose the second adhesive layer. Barrier film D was wrapped around the outer surface of container body B from the second adhesive layer side once so that the vertical direction of the barrier film corresponded to the longitudinal direction of container body B. In addition, approximately 1.5 mL of ACD-A solution was added to container body B. Next, the pressure was reduced to 19.9 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0117] Example 8 A specimen collection container was manufactured in the same manner as in Example 7, except that the laminated film of barrier film D and release paper was cut to a size of 75 mm length x 24 mm width, and the barrier film D obtained from the cut laminated film was used. The specimen collection container had barrier film D wrapped around the outer peripheral surface of container body B by 0.5 turns.

[0118] Example 9 The laminated film of barrier film D and release paper was cut to a size of 50 mm length x 40 mm width. The release paper was peeled off from the cut laminated film to expose the second adhesive layer. Barrier film D was wrapped around the outer surface of container body A from the second adhesive layer side once so that the vertical direction of the barrier film corresponded to the longitudinal direction of container body A. In addition, approximately 0.2 mL of 3.2 w / v % citric acid aqueous solution was added to container body A. Next, the pressure was reduced to 57.8 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0119] Example 10 A specimen collection container was manufactured in the same manner as in Example 9, except that the laminated film of barrier film D and release paper was cut to a size of 50 mm length x 20 mm width, and the barrier film D obtained from the cut laminated film was used. The specimen collection container had barrier film D wrapped around the outer peripheral surface of the container body A by 0.5 turns.

[0120] Example 11 A specimen collection container was produced in the same manner as in Example 7, except that a barrier film D was wrapped around the outer surface of the container body B two times from the second adhesive layer side.

[0121] Example 12 A specimen collection container was produced in the same manner as in Example 7, except that a barrier film D was wrapped around the outer surface of the container body B three times from the second adhesive layer side.

[0122] Example 13 A barrier film E measuring 75 mm in length and 48 mm in width was prepared. This barrier film E was wrapped around the outer periphery of the container body B once so that the vertical direction of the barrier film E corresponded to the longitudinal direction of the container body B. In addition, approximately 1.5 mL of ACD-A solution was added to the container body B. Next, the pressure was reduced to 19.9 kPa, and the container was sealed with a stopper to produce a specimen collection container (blood collection tube).

[0123] Example 14 A specimen collection container was manufactured in the same manner as in Example 13, except that a barrier film E measuring 75 mm in length and 24 mm in width was used, in which the barrier film E was wrapped around the outer surface of the container body B by 0.5 turns.

[0124] (Comparative Example 1) A specimen collection container was produced in the same manner as in Example 1, except that no barrier film was used.

[0125] (Comparative Example 2) The specimen collection container obtained in Comparative Example 1, filter paper (manufactured by Advantec Toyo Co., Ltd.), and an oxygen absorber (manufactured by Mitsubishi Gas Chemical Company, Inc.) were placed in an aluminum gusset bag (manufactured by Dai Nippon Printing Co., Ltd.), and the aluminum gusset bag was sealed. In this way, a specimen collection container contained in an aluminum gusset bag was produced.

[0126] (Comparative Example 3) A specimen collection container was manufactured in the same manner as in Example 1, except that a barrier film B measuring 50 mm in length and 40 mm in width was used, in which the barrier film B was wrapped around the outer peripheral surface of the container body A in one turn.

[0127] Comparative Example 4 A specimen collection container was manufactured in the same manner as in Example 1, except that a barrier film C measuring 50 mm in length and 40 mm in width was used, in which the barrier film C was wrapped around the outer peripheral surface of the container body A in one turn.

[0128] (evaluation) (1) Air permeability of the specimen collection container (40°C and 0% RH) The obtained specimen collection container was stored in a thermo-hygrostat at 40°C and 0% RH. Water was suctioned into the specimen collection container, and the increase in internal pressure due to storage was determined from a calibration curve of the collected amount and internal pressure, and the air permeability was calculated. In Comparative Example 2, the specimen collection container was stored in a thermo-hygrostat while housed in an aluminum gusset bag, and the above-mentioned operation was performed.

[0129] (2) Water vapor permeability of the specimen collection container (40°C and 0% RH) In the combination of the container body and barrier film used in each Example and Comparative Example, water was placed inside the container body, which contained no liquid, and the container was sealed with a stopper to obtain a specimen collection container (a specimen collection container in which the internal pressure was not reduced and water was placed inside) with the barrier film disposed on the outer surface of the container body. The obtained specimen collection container was stored in a thermo-hygrostat at 40°C and 0% RH. The water vapor transmission rate was calculated by taking the weight loss of the specimen collection container before and after storage as the amount of water evaporation. In Comparative Example 2, the specimen collection container was stored in a thermo-hygrostat while housed in an aluminum gusset bag, and the above-mentioned procedure was performed.

[0130] (3) Storage of specimen collection containers The obtained specimen collection container was stored in a thermo-hygrostat at 40°C and 0% RH for 70 days. Storage at 40°C for 70 days corresponds to storage at 25°C for 1 year. In Comparative Example 2, the specimen collection container was stored in the thermo-hygrostat while being housed in an aluminum gusset bag.

[0131] (3-1) Amount of liquid contained The amount of liquid contained in the specimen collection container was measured immediately after production and after storage.

[0132] (3-2) Amount of sample collected Using a blood collection needle, blood was collected into the specimen collection container immediately after production and after storage. The amount of collected blood was measured.

[0133] (3-3) Mixing ratio of liquid to specimen and rate of change of the mixing ratio From the liquid volume and specimen volume measured in (3-1) and (3-2) above, the mixture ratio of the liquid to the specimen in the specimen collection container immediately after production and after storage was calculated using the following formula (1). Furthermore, from the calculated mixture ratio, the rate of change in mixture ratio was calculated using the following formula (2).

[0134] Mixing ratio = sample volume (g) / liquid volume (mL) (1) Mixing ratio change rate (%) = (YX) / X × 100 (2) X: Mixing ratio in the sample collection container immediately after production Y: Mixing ratio in the specimen collection container after storage

[0135] The configurations and results are shown in Tables 2 to 7 below.

[0136] [Table 2]

[0137] [Table 3]

[0138] [Table 4]

[0139] [Table 5]

[0140] [Table 6]

[0141] [Table 7] [Explanation of symbols]

[0142] 1...Container body 1a...Outer surface 2...Bung body 3,3A...Barrier film 4…Liquid 11, 11A...Sample collection container 31...First film 32...Second film 33...First adhesive layer 34...Second adhesive layer

Claims

1. A specimen collection container in which a specimen is collected, a container body having an opening; a plug attached to the opening; a barrier film disposed on the outer surface of the container body; a liquid contained in the container body, The water vapor permeability of the barrier film at 40°C and 90% RH is 0.8 g / (m ２ ・day) or less, the surface area of ​​the portion where the barrier film is disposed is 15% or more and 80% or less of the total surface area (100%) of the outer surface of the container body; the barrier film has a first film, a first adhesive layer, a second film, and a second adhesive layer in this order; the first film is a barrier film body, the barrier film body comprises a substrate film and an inorganic oxide layer, the second adhesive layer is disposed on the outer surface of the container body; The air permeability of the specimen collection container at 40°C and 0% RH is 0.5 cc / (m 2 ·day·atm) or less; A specimen collection container having a water vapor transmission rate of 1.1 g / (m 2 ·day) or less at 40° C. and 0% RH.

2. 2. The specimen collection container according to claim 1, wherein the barrier film is arranged around the outer surface of the container body in a circumferential direction, the barrier film extending over 0.5 to 3 revolutions.

3. 3. The specimen collection container according to claim 1, wherein the thickness of the barrier film before being placed on the outer surface of the container body is 5 μm or more and 300 μm or less.

4. The specimen collection container according to any one of claims 1 to 3, wherein the second film is a polyethylene terephthalate film.

5. 5. The specimen collection container according to claim 1, wherein the container body is made of polyethylene terephthalate or polyethylene naphthalate.

6. the sample is blood, The specimen collection container according to any one of claims 1 to 5, wherein the liquid contains an anticoagulant.

7. 7. The specimen collection container of claim 6, wherein the anticoagulant is citric acid, EDTA, or heparin.

8. The specimen collection container according to any one of claims 1 to 7, wherein the amount of the liquid contained in the container body is 0.1 mL or more and 5 mL or less.

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