Chemical solution bag

Abstract

To provide a chemical solution bag having excellent resistance to radiation while enhancing adhesion between a bag body and a tube port.SOLUTION: The chemical solution bag according to the present invention is a chemical solution bag including a bag main body in which a sheet member is formed into a bag shape and which accommodates a content, and a tubular port member attached to the bag main body, in which the sheet member includes an innermost layer and a base resin layer, the innermost layer includes an amorphous polymer having a cyclic hydrocarbon skeleton as a main component, the port member includes a port material, and a seal strength of the port material with respect to a base material including a cyclic olefin is 30 N / 15 mm or more.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a drug solution bag. [Background technology]

[0002] A chemical solution bag is used as a package for storing a chemical solution (medicine) used for medical treatment, disinfection, herbicides, etc. A chemical solution bag generally comprises a container formed into a bag shape using a resin film so that the chemical solution can be stored therein, and a port member for filling or discharging the chemical solution. The container is formed, for example, by stacking a laminate of multiple types of resin films with a port member sandwiched between them and joining the outer periphery by heat sealing or the like. The chemical solution bag is sterilized and sealed with radiation such as gamma rays or electron beams before or after storing the chemical solution in the container.

[0003] One such medical infusion bag has been disclosed, which includes a bag body made of polyethylene film shaped into a bag shape to accommodate the infusion, and a tube port welded to the bottom of the bag body for discharging the infusion from the bag body. In this medical infusion bag, the tube port has a multilayer structure including an outer layer made of high-density polyethylene, an inner layer made of a resin material containing random polypropylene and / or block polypropylene, and an adhesive layer joining the outer layer and the inner layer (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 5632226 Summary of the Invention [Problem to be solved by the invention]

[0005] However, the medical infusion bag described in Patent Document 1 has a problem in that the polyethylene film constituting the bag body is prone to adsorbing the contained medicinal ingredients and causing the medicinal ingredients to leach out from the bag body.

[0006] Another possible method is to use a cyclic polyolefin resin as the material for forming the bag body, which is a resin that adsorbs less pharmaceutical ingredients and causes less elution of pharmaceutical ingredients from the bag body than polyethylene film. However, because the outer layer of the tube port of the medical infusion bag described in Patent Document 1 is made of high-density polyethylene, the adhesion between the bag body and the tube port is insufficient, and pharmaceutical ingredients may elute from the joint between the bag body and the tube port.

[0007] Furthermore, because the inner layer of the tube port is made of polypropylene, it has low resistance to radiation sterilization and is easily deteriorated by radiation sterilization. When the inner layer of the tube port deteriorates due to radiation, the adhesive strength between the inner layer of the tube port and the adhesive layer decreases, which reduces the durability of the tube port and may cause the drug ingredients in the bag body to leach out.

[0008] One aspect of the present invention has been made in consideration of the above circumstances, and aims to provide a drug solution bag that has excellent resistance to radiation while improving adhesion between the bag body and the tube port. [Means for solving the problem]

[0009] In order to solve the above problems, one embodiment of the present invention has the following configuration. [1] A drug solution bag having a bag body for accommodating contents, the bag body being formed from a sheet member into a bag shape, and a cylindrical port member attached to the bag body, the sheet member includes an innermost layer and a base resin layer, the innermost layer containing an amorphous polymer having a cyclic hydrocarbon skeleton as a main component, the port member includes a port material; A drug solution bag, wherein the port material has a seal strength of 30 N / 15 mm or more with respect to a substrate containing a cyclic olefin. [2] The drug solution bag according to [1], wherein the port material has a tensile modulus of elasticity of 20 to 70 MPa. [3] The drug solution bag according to [1] or [2], wherein the port material has a MFR of 3.8 to 20 g / 10 min at 190°C. [4] The drug solution bag according to any one of [1] to [3], wherein the port material contains one or more linear low-density polyethylenes. [5] The drug solution bag according to any one of [1] to [4], wherein the port material contains linear low-density polyethylene and a resin having a tensile modulus of elasticity of 25 MPa or less. [6] The drug solution bag according to [5], wherein the linear low-density polyethylene and the resin having a tensile modulus of elasticity of 25 MPa or less are contained in a mass ratio of 60:40 to 75:25. [7] When the port material contains two types of linear low-density polyethylene, one of the linear low-density polyethylenes has a higher MFR at 190°C than the other of the linear low-density polyethylenes; The drug solution bag according to any one of [1] to [6], wherein the other linear low-density polyethylene has a lower flexural modulus than the one linear low-density polyethylene. [8] The MFR of the one linear low-density polyethylene at 190°C is 8 g / 10 min or more, The drug solution bag according to [7], wherein the other linear low-density polyethylene has a flexural modulus of 100 MPa or less. [9] The drug solution bag according to any one of [1] to [8], wherein the contents are medicines. [Effects of the Invention]

[0010] A chemical solution bag according to one aspect of the present invention has excellent radiation resistance while improving the adhesion between the bag body and the tube port. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a plan view of a chemical solution bag according to an embodiment of the present invention. FIG. [Figure 2] FIG. 2 is a cross-sectional view taken along the line II in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0012] Hereinafter, embodiments of the present invention will be described in detail. To facilitate understanding of the description, the same components in each drawing will be assigned the same reference numerals, and duplicate descriptions will be omitted. Furthermore, the scale of each member in the drawings may differ from the actual scale. In this specification, unless otherwise specified, "to" indicating a numerical range means that the numerical values ​​before and after it are included as the lower and upper limits. Furthermore, when only the upper limit value in a numerical range expressed by "to" is specified in units, it means that the lower limit value is also in the same units.

[0013] <Medicine bag> A chemical solution bag according to an embodiment of the present invention will now be described. Fig. 1 is a plan view of the chemical solution bag according to this embodiment, and Fig. 2 is a view seen from direction II in Fig. 1. As shown in Fig. 1, the chemical solution bag 1 according to this embodiment includes a bag body 10 and a tubular port member (tube port) 20 attached to the bag body 10, one end of which communicates with the interior of the bag body 10 and the other end of which is exposed to the outside of the bag body 10, and contains contents within the bag body 10. The chemical solution bag 1 is sterilized by radiation such as gamma rays or electron beams before or after the contents are contained in the bag body 10.

[0014] In this embodiment, the contents include pharmaceuticals (drugs), cells, tissues, organs, biological materials, blood, body fluids, enzymes, antibodies, beauty products, nutrients, health supplements, cosmetics, and foods. Among these, pharmaceuticals are preferred. Preferred examples of pharmaceuticals include chemically synthesized low-molecular-weight compounds (low-molecular-weight pharmaceuticals) and biopharmaceuticals (biological preparations) made using polymers such as proteins. Preferred examples of biopharmaceuticals include protein preparations.

[0015] The form of the contents is not particularly limited and may be, for example, a solid, liquid, gas, powder, granules, a mixture, a composition, a dispersion, etc. Furthermore, when the contents are liquid, the liquid may be an aqueous solution containing a drug.

[0016] [Bag body] 2, the bag body 10 is a packaging bag (pouch) formed into a bag shape by overlapping a pair of sheet members 100. The bag body 10 is manufactured by overlapping the pair of sheet members 100 so that they face each other, welding their outer peripheral edges together, and forming them into a bag shape.

[0017] The bag body 10 has a joint (sealed portion) 11 formed by overlapping a pair of sheet members 100 (see Figure 2) facing each other and welding their outer peripheral edges together, a storage chamber 12 defined by the pair of sheet members 100 and the joint 11, and openings 13A and 13B where the outer peripheral edges of the pair of sheet members 100 (see Figure 2) are not welded together and are welded to the port member 20.

[0018] The joint 11 is provided in a closed loop shape on the periphery of the bag body 10. The joint 11 has a first joint 11-1 where the sheet members 100 are joined together, and a second joint 11-2 where the sheet members 100 are joined to the port member 20. As shown in FIG. 1 , the first joint 11-1 and the second joint 11-2 are formed continuously in a plan view of the bag body 10.

[0019] The storage chamber 12 is a space to be filled with contents. Note that the specific state, shape, etc. of the contents are not shown in the drawings.

[0020] Openings 13A and 13B are unfused gaps between opposing sheet members 100, and are provided by welding or the like to port member 20. Before port member 20 is welded or the like, openings 13A and 13B may be used as filling ports for inserting contents to be stored in storage chamber 12.

[0021] Although the bag body 10 is a four-sided bag, the shape of the bag body 10 is not particularly limited, and may be, for example, a three-sided bag, a seamed bag, a gusseted bag, a self-standing bag, an inner bag for a bag-in-box, or an inner bag for a drum can.

[0022] (sheet material) The pair of sheet members 100 constituting the bag body 10 will now be described. As shown in Fig. 2, the sheet member 100 includes an innermost layer (sealing layer) 101, an adhesive resin layer (AD) 102, and a base resin layer 103, which are laminated together. The pair of sheet members 100 are stacked together with the innermost layers 101 facing each other, with the innermost layers 101 facing each other. Note that the sheet member 100 may include the innermost layer 101 and the base resin layer 103, and may be configured by laminating two or more layers.

[0023] The thickness of the sheet member 100 is not particularly limited, but is preferably 70 to 400 μm, and from the viewpoint of the strength and flexibility required for the bag body 10, more preferably 150 to 300 μm.

[0024] In this specification, the thickness of the sheet member 100 refers to the length in the direction perpendicular to the main surface of the sheet member 100. The thickness of the sheet member 100 may be, for example, the thickness measured at an arbitrary location on the cross section of the sheet member 100, or may be the average value of measurements measured at several arbitrary locations. Hereinafter, the definition of thickness is similar for other members.

[0025] The seal width of the peripheral edge of the sheet member 100 is not particularly limited, but may be, for example, 2 to 20 mm.

[0026] ((innermost layer)) The innermost layer 101 is used when the sheet members 100 are bonded together by heat sealing or the like to form a bag shape. The innermost layer 101 faces the storage chamber 12 and comes into contact with the contents.

[0027] The innermost layer 101 contains one or more types of olefin monomers, at least one of which contains, as a main component, an amorphous polymer, which is a monomer having a cyclic hydrocarbon skeleton. This makes the innermost layer 101 resistant to radiation and reduces deterioration caused by sterilizing the drug solution bag 1 with radiation.

[0028] The term "main component" means that the proportion of the amorphous polymer relative to one type of olefin monomer is 50% by mass or more. The same applies to each layer constituting the sheet member 100 and the port member 20.

[0029] The amorphous polymer that is the main component of the innermost layer 101 is an amorphous polymer composed of at least one or two or more types of olefin monomers, at least one of which is a monomer having a cyclic hydrocarbon skeleton. Examples of the amorphous polymer include cyclic olefin monomers. Examples of the cyclic olefin monomer include norbornene compounds. When the amorphous polymer is composed of only one type of cyclic olefin monomer (such as a norbornene compound), it may be a ring-opening metathesis polymer of a norbornene compound or the like, but it is preferable that the amorphous polymer does not contain a homoaddition polymer of a norbornene compound or the like.

[0030] The amorphous polymer that is the main component of the innermost layer 101 includes copolymers of two or more types of cyclic olefin monomers such as norbornene compounds, addition polymers obtained by copolymerizing a cyclic olefin monomer with an olefin monomer (acyclic olefin monomer) other than a cyclic olefin monomer such as an α-olefin, or polymers obtained by ring-opening metathesis polymerization of a cyclic olefin monomer such as a norbornene compound and hydrogenating the remaining double bonds. However, it is preferable that the polymer does not include homoaddition polymers of only one type of cyclic olefin monomer. Hereinafter, polymers obtained by copolymerizing these cyclic olefin monomers are also referred to as "cyclic olefin polymers."

[0031] Examples of such cyclic olefin polymers include the following:

[0032] Known methods for producing cyclic olefin polymers include a method in which a ring-opening metathesis polymer of a norbornene compound is hydrogenated, and a method in which a norbornene compound is copolymerized with an α-olefin.

[0033] An example of the basic structure of a cyclic olefin polymer is represented by the following formula (I). That is, the polymer of the following formula (I) is a polymer in which cyclic unit skeletons and ethylene unit skeletons are alternately arranged. The cyclic skeleton of the following formula (1) is a 1,3-cyclopentylene skeleton. However, the ring-opening metathesis polymer of a norbornene compound itself does not need to be a copolymer.

[0034] [ka]

[0035] In formula (I), n is an integer of 1 or more, and R1 and R2 are hydrogen atoms or alkyl groups, and may be the same or different. R1 and R2 may be bonded to form a ring.

[0036] The structure shown in the above formula (I) may be a homopolymer of one type of cyclic olefin monomer. That is, in the structure shown in the above formula (I), the substituents R1 and R2 of the n 1,3-cyclopentylene skeletons may be the same, and the ring-opening metathesis polymer of the norbornene compound may be a homopolymer. Note that the structure shown in the above formula (I) is not limited to a homopolymer.

[0037] The structure shown in the above formula (I) also includes a copolymer consisting of multiple cyclic olefin monomers (wherein there are two or more combinations of R1 and R2 bonded to n cyclic unit skeletons). That is, the structure shown in the above formula (I) may be a polymer obtained by hydrogenating a ring-opening metathesis polymer of two or more norbornene compounds. Examples of such polymers include the following formula (II):

[0038] [ka]

[0039] In formula (II), m and n are integers of 1 or greater, and R1 and R2 represent a hydrogen atom or an alkyl group. m and n may be the same or different. R1 and R2 may be the same or different. R1 and R2 may be bonded to each other to form a ring.

[0040] Specific examples of polymers obtained by hydrogenating ring-opening metathesis polymers of norbornene compounds include the ZEONEX (registered trademark) series and the ZEONOR (registered trademark) series manufactured by Zeon Corporation.

[0041] Furthermore, an addition polymer obtained by copolymerizing a cyclic olefin monomer and an acyclic olefin monomer can be represented by the following formula (III). The addition polymer of the following formula (III) is described as a polymer in which a cyclic skeleton and an ethylene skeleton are randomly arranged. The cyclic skeleton of the following formula (I1I) is a 2,3-norbornanylene skeleton.

[0042] [ka]

[0043] In formula (III), m and n are integers of 1 or greater, and R1, R2, and R3 represent a hydrogen atom or an alkyl group. m and n may be the same or different. R1, R2, and R3 may be the same or different. R1 and R2 may be bonded to each other to form a ring.

[0044] An example of a polymer in which R1, R2, and R3 are all hydrogen atoms is "TOPAS (registered trademark)" manufactured by Polyplastics Co., Ltd. Furthermore, an example of a polymer in which R1 and R2 are alkyl groups and R3 is a hydrogen atom is "APEL (registered trademark)" manufactured by Mitsui Chemicals, Inc.

[0045] These cyclic olefin resins have excellent water vapor barrier properties and are easily available. As described above, in the bag body 10, the sheet member 100 can use these cyclic olefin polymers as the amorphous polymer that is the main component of the innermost layer 101. The innermost layer 101 may contain one type of cyclic olefin resin, or may contain two or more types of cyclic olefin resins.

[0046] Here, the two or more cyclic olefin polymers may be two or more cyclic olefin polymers corresponding to any one of the above formulas (I) to (III), or may be one or more cyclic olefin polymers for each of two or more formulas (I) to (III). The two or more cyclic olefin polymers may further include cyclic olefin polymers that do not correspond to the above formulas (I) to (III).

[0047] Commercially available cyclic olefin polymers partially overlap with those listed above, but examples thereof include ZEONEX (registered trademark) (manufactured by Zeon Corporation, a hydrogenated polymer of a ring-opening metathesis polymer of a norbornene-based monomer), ZEONOR (registered trademark) (manufactured by Zeon Corporation, a copolymer based on the ring-opening polymerization of dicyclopentadiene and tetracyclopentadodecene), TOPAS (registered trademark) (manufactured by Polyplastics Co., Ltd., a copolymer of norbornene and ethylene), APEL (registered trademark) (manufactured by Mitsui Chemicals, Inc., a copolymer of ethylene and tetracyclododecene), and ARTON (registered trademark) (manufactured by JSR Corporation, a cyclic olefin resin containing a polar group, made from dicyclopentadiene and a methacrylic acid ester as raw materials).

[0048] The innermost layer 101 may contain other resin components in addition to the cyclic olefin resin. Examples of other resin components include one or more of polyolefin resins such as polyethylene, polypropylene, polybutene, ethylene-α-olefin copolymer, ethylene-(meth)acrylic acid copolymer, ethylene-vinyl acetate copolymer, and ethylene-(meth)acrylic acid ester copolymer; urethane resins; rubber resins; polyester resins; polyester-urethane resins; acrylic resins; amide resins; styrene resins; and silane resins. Among these, examples of styrene resins include polystyrene, styrene-acrylonitrile copolymer (SAN), and styrene elastomers. It is particularly preferred that the innermost layer 101 contain one or more components, such as styrene-butadiene copolymer, styrene-butadiene-styrene block copolymer (SBS), styrene-isoprene copolymer, styrene-isoprene-styrene block copolymer (SIS), hydrogenated products thereof (e.g., SEBS, SEPS), and styrene-butadiene random copolymer, in an amount ranging from 0.05% by mass to 20% by mass.

[0049] By containing other resin components, the innermost layer 101 can improve the performance desired for a container such as an infusion bag, such as the impact resistance of the bag body 10 at low temperatures, maintaining transparency immediately after high-pressure steam sterilization, and improving flexibility.

[0050] The innermost layer 101 preferably contains only a cyclic olefin polymer as the resin component (it may contain non-resin additives), and may contain 100% by mass of a cyclic olefin polymer (it does not contain any other additives). When it contains the other resin components, it is preferable that the innermost layer 101 contains a cyclic olefin polymer as the main component. That is, the innermost layer 101 preferably contains one type of cyclic olefin polymer or two or more types of cyclic olefin polymers in total at 50% by mass or more, and particularly preferably at 70% by mass or more. If the composition ratio of the cyclic olefin polymer is low and the contents are pharmaceutical, trace components and pharmaceutical components with high affinity for plastic may be adsorbed, which may result in insufficient storage stability of the contained pharmaceutical component.

[0051] The material constituting the innermost layer 101 may contain various additives such as antioxidants, ultraviolet absorbers, antistatic agents, lubricants, and antiblocking agents, within the range that does not impair safety and hygiene, in order to improve the appearance of the container, stabilize quality, and impart other required performance.

[0052] The thickness of the innermost layer 101 is 10 to 100 μm, and more preferably 20 to 80 μm. If the thickness of the innermost layer 101 is 10 μm or more, the innermost layer 101 will have sufficient sealing properties and sufficient welding strength with the port member 20. If the innermost layer 101 is too thin, the innermost layer 101 will thin due to heat and pressure when welding the port member 20 to the openings 13A and 13B, which may cause pinholes to form and allow the contents contained in the storage chamber 12 to leak through the pinholes. If the thickness of the innermost layer 101 is 100 μm or less, the flexibility of the bag body 10 will be easily maintained and manufacturing costs will be reduced.

[0053] ((adhesive resin layer)) The adhesive resin layer 102 is provided between the innermost layer 101 and the base resin layer 103 to bond the innermost layer 101 and the base resin layer 103 together.

[0054] A commonly used adhesive resin layer may be used as the adhesive resin layer 102, such as an adhesive resin composition containing resin components consisting of linear low-density polyethylene (LLDPE), a styrene (St)-based elastomer, and a polypropylene (PP)-based resin, with the total ratio of LLDPE to the St-based elastomer and the PP-based resin (LLDPE:(St-based elastomer + PP-based resin)) being within a range of 40:60 to 95:5 by mass. Specific examples of adhesive resin layer 102 include "ADMER (registered trademark)" manufactured by Mitsui Chemicals, Inc., and "MODIC (registered trademark)" manufactured by Mitsubishi Chemical Corporation.

[0055] The polypropylene used in the adhesive resin layer 102 is produced using a Ziegler-Natta catalyst or a metallocene catalyst. Syndiotactic polypropylene produced using a metallocene catalyst is preferred because of its excellent flexibility and transparency. The polypropylene preferably has a melting peak temperature of 110°C or higher, preferably 120°C or higher. Using polypropylene with these temperature characteristics in the adhesive resin layer 102 imparts heat resistance to the bag body 10.

[0056] ((Base resin layer)) The base resin layer 103 is a layer located on the outside of the bag body 10, and the base resin layer 103 is formed from a material such as a PP-based resin or a polyethylene (PE)-based resin.

[0057] Examples of PP-based resins that can be used include propylene homopolymers, copolymers obtained by copolymerizing a small amount (e.g., 10% by mass or less) of an α-olefin such as ethylene or 1-butene, and copolymers produced by multistage polymerization of propylene and an α-olefin. Compounds of the above homopolymers or copolymers with other polyolefins or resins may also be used. To improve the flexibility of the sheet member 100, the PP-based resin preferably has a flexural modulus of 400 to 600 MPa. Furthermore, the PP-based resin preferably has a melt flow rate (MFR) of 1 to 4 (g / 10 min) at 230°C and 21.2 N. Furthermore, the PP-based resin preferably has a peak melting temperature of 160 to 170°C. Specific examples of PP-based resins include XELAS (registered trademark) manufactured by Mitsubishi Chemical Corporation.

[0058] As the PE resin, low-density polyethylene (LDPE) or linear low-density polyethylene (linear low-density polyethylene (LLDPE)) is preferably used. The polyethylene has a density of 0.880 to 0.920 g / cm 3 The α-olefin has 12 or less carbon atoms, and examples thereof include propylene, butene-1, hexene-1, 4-methylpentene-1, and octene-1. The linear low-density polyethylene is preferably produced using a metallocene catalyst. Linear low-density polyethylene polymerized using a metallocene catalyst has little structural heterogeneity and is therefore excellent in transparency. Furthermore, since the molecular weight distribution is nearly uniform, when the LLDPE is heated, the polyethylene produces little bleeding and is less likely to become cloudy.

[0059] The polypropylene used in the base resin layer 103 is produced using a Ziegler-Natta catalyst or a metallocene catalyst. Syndiotactic polypropylene produced using a metallocene catalyst is preferred because of its excellent flexibility and transparency. The polypropylene preferably has a melting peak temperature of 110°C or higher, preferably 120°C or higher. Using a polypropylene with these temperature characteristics in the base resin layer 103 imparts heat resistance to the bag body 10.

[0060] (Other layers) The sheet member 100 may optionally include other layers between or on the surface of either the innermost layer 101 or the base resin layer 103. The types of other layers can be appropriately selected, and examples thereof include a reinforcing layer, a printed layer, a coating layer, a light-shielding layer, a vapor-deposited layer, metal foil, and synthetic paper.

[0061] Examples of the reinforcing layer include reinforcing resin layers such as biaxially oriented polyethylene terephthalate (O-PET), biaxially oriented nylon (O-Ny), and biaxially oriented polypropylene (OPP).

[0062] The printed layer or coat layer may be provided on the surface (front surface) 103 a of the base resin layer 103 opposite to the adhesive resin layer 102 .

[0063] The printed layer can impart distinctiveness and design to the drug solution bag 1 by printing ink on the surface 103a of the base resin layer 103.

[0064] The coating layer is intended to protect the base resin layer 103 or other layers such as a printed layer provided on the base resin layer 103. Examples of such a coating layer include a thin resin layer (resin film) and an ultraviolet-curable resin.

[0065] As described above, the joint portion 11 is formed by overlapping the pair of sheet members 100 so as to face each other with the port member 20 sandwiched between the pair of sheet members 100 .

[0066] The first joint 11-1 of the joint 11 is formed by fusing together the resins contained in the innermost layers 101 of the pair of sheet members 100. The first joint 11-1 has a layered structure in which the base resin layer 103 / adhesive resin layer 102 / innermost layer 101 / innermost layer 101 / adhesive resin layer 102 / base resin layer 103 are layered in this order from the surface side of one base resin layer 103 of the sheet members 100 toward the surface side of the other base resin layer 103.

[0067] The second joint portion 11-2 is formed by fusing together the resin contained in the innermost layer 101 of each of the pair of sheet members 100 and the port member 20. The second joint portion 11-2 has a layered configuration in which the base resin layer 103 / adhesive resin layer 102 / innermost layer 101 / port member 20 / innermost layer 101 / adhesive resin layer 102 / base resin layer 103 is layered in this order from the surface side of one base resin layer 103 of the sheet members 100 toward the surface side of the other base resin layer 103.

[0068] [Port parts] As shown in Figure 2, the port member 20 is sandwiched between opposing innermost layers 101 of the sheet member 100 that constitutes the bag body 10 and welded to each other. The port member 20 has a substantially cylindrical shape and has a flow path 21 therein large enough to allow the flow of contents stored in the storage chamber 12. At least a portion of the port member 20 may be contained in the storage chamber 12, with one end 20a of the port member 20 communicating with the storage chamber 12 and an opening 22 at the other end 20b exposed to the outside of the bag body 10. The shape of the port member 20 as viewed in the axial direction may be a shape other than cylindrical, and may be, for example, a polygon such as a square or hexagon, or an ellipse.

[0069] The port member 20 may contain a port material, preferably consist essentially of the port material, and more preferably consist solely of the port material. Note that "substantially" means that the port member 20 may contain impurities that are inevitably mixed in during the production of the port member 20. The port member 20 is obtained by molding a port-forming composition containing the port material into a cylindrical shape. When the port member 20 is made of the port material, the port member 20 is obtained by molding the port material.

[0070] The seal strength (hereinafter simply referred to as "seal strength") of the port material contained in the port member 20 to a substrate containing a cyclic olefin is 30 N / 15 mm or more, preferably 35 N / 15 mm or more, more preferably 40 N / 15 mm or more, and even more preferably 50 N / 15 mm or more. The upper limit of the seal strength of the port material may be 70 N / 15 mm or less. Even if the innermost layer 101 contains an amorphous polymer having a cyclic hydrocarbon skeleton, such as a cyclic olefin, as a main component, the port member 20 formed using the port material can have high adhesion to the innermost layer 101 of the sheet member 100 as long as the seal strength of the port material is 30 N / 15 mm or more.

[0071] The seal strength can be measured in accordance with ASTM F88. For example, a laminate is produced by heat-sealing a port sheet made of a port material to a substrate such as a resin film having, on its outermost surface, a layer (COP layer) containing a polymer (cycloolefin polymer; COP) composed of one or more cyclic olefins such as norbornene. The seal strength can be determined by measuring the strength when the produced laminate is peeled off at a predetermined tensile speed (e.g., 300 mm / min).

[0072] The tensile modulus of the port material is preferably 20 to 70 MPa. The tensile modulus is more preferably 25 N / 15 mm or more, and even more preferably 27 N / 15 mm or more. The tensile modulus is more preferably 65 N / 15 mm or less, and even more preferably 62 N / 15 mm or less. When the tensile modulus is within the above-mentioned preferred range, the port member 20 formed using the port material has excellent flexibility and is easily deformable, thereby preventing damage to the port member 20 due to bending and facilitating liquid stoppage by crushing the port member 20. Furthermore, a predetermined length of the port member 20 can be easily peeled off from the wound-up state during manufacturing of the port member 20. Furthermore, when a connector member or the like is connected to the tube tip on the side of the port member 20 opposite the second joint portion 11-2, adhesion with the connector member or the like can be maintained.

[0073] The tensile modulus can be measured in accordance with ISO 527-3:2018. For example, a sheet-shaped sample is prepared using the port material, and the prepared sample is cut to a predetermined size to prepare a rectangular test piece. The tensile modulus of the port material can be calculated from the slope of the graph when the cut test piece is pulled at a pulling rate (e.g., 300 mm / min) in the range of 10 to 20 N.

[0074] The melt mass flow rate (MFR) of the port material at 190°C is preferably 3.8 to 20 g / 10 min. The MFR at 190°C is more preferably 3.9 g / 10 min or more, and even more preferably 4.5 g / 10 min or more. The MFR at 190°C is more preferably 15 g / 10 min or less, and even more preferably 13 g / 10 min or less. If the MFR at 190°C is within the above preferred range, the extrusion moldability of the port material is improved, and therefore the port member 20 can be easily molded during production.

[0075] The MFR at 190°C can be measured in accordance with JIS K 7210-1:2014. For example, a sheet-shaped sample is prepared using the port material, and then cut to a specified size to prepare a rectangular test piece. The cut test piece is placed in a cylinder at a specified temperature (190°C) directly below a die, and pressed down with a piston. The test piece is preheated to 190°C for 6 minutes. After preheating, the temperature is returned to 190°C, and a specified weight (2.16 kg) is placed on the piston to extrude the molten test piece through the die. The mass of the extruded test piece is measured over the specified extrusion time, and the mass per 10 minutes [g / 10 min] is calculated to determine the MFR at 190°C. Instead of a cut sheet sample, the port material may be pelletized (powdered) and weighed out to use as the test piece.

[0076] The port material used to form the port member 20 preferably comprises a polyolefin resin.

[0077] Polyolefin resins may be homopolymers of one type of olefin or copolymers of two or more types of olefins. Examples of olefins include acyclic olefins such as ethylene, propylene, 1-butene, 1-hexene, 1-octene, and α-olefins. Specific examples of polyolefins include polyethylene, polypropylene, and ethylene-α-olefin copolymers. These polyolefins may also be copolymers containing small amounts of non-olefin vinyl monomers such as vinyl acetate, vinyl chloride, and vinyl alcohol. The olefins may be derived from petroleum-derived olefins, plant-derived olefins, or a combination of both.

[0078] When the polyolefin resin used for the port material is polyethylene, the polyethylene is preferably linear low-density polyethylene (LLDPE). If the port material is LLDPE, the port member 20 is formed from LLDPE. When the port member 20 is formed from LLDPE, the sheet member 100 that forms the bag body 10 and the port member 20 can be easily joined, and the adhesive strength between the sheet member 100 and the port member 20 is increased.

[0079] The port material may be formed from one or more LLDPEs.

[0080] The port material preferably contains LLDPE and a resin having a tensile modulus of elasticity of 25 MPa or less.

[0081] Examples of resins having a tensile modulus of elasticity of 25 MPa or less include LLDPE, styrene (St)-based elastomers, and olefin-based elastomers.

[0082] Examples of the St-based elastomer include St-based thermoplastic elastomer.

[0083] Examples of St-based thermoplastic elastomers include styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene-propylene-styrene block copolymer (SEPS), and styrene-ethylene-ethylene-propylene-styrene block copolymer (SEEPS). Among these, SEBS is preferred.

[0084] The LLDPE and the resin having a tensile modulus of 25 MPa or less are preferably contained in a mass ratio of 60:40 to 75:25, more preferably 60:40 to 75:25, and even more preferably 60:40 to 75:25. When the LLDPE and the resin having a tensile modulus of 25 MPa or less are contained in the above preferred ratio, the port material is likely to exhibit both flexibility and moldability.

[0085] When the port member 20 contains two types of LLDPE, it is preferred that the MFR at 190°C of one of the two types of LLDPE is higher than the MFR at 190°C of the other of the two types of LLDPE, and that the flexural modulus of the other LLDPE is lower than the flexural modulus of the one LLDPE, thereby allowing the port material to maintain a good balance between flexibility and formability.

[0086] On the other hand, the MFR of LLDPE at 190°C is preferably 8 g / 10 min or more, more preferably 10 g / 10 min or more, and even more preferably 12 g / 10 min or more.

[0087] On the other hand, the flexural modulus of LLDPE is preferably 100 MPa or less, more preferably 80 MPa or less, and even more preferably 70 MPa or less.

[0088] Furthermore, the drug solution bag 1 may have accessories such as an injection port, a cock, a label, an opening tab, a handle, etc. in addition to the port member 20. When the accessories are resin molded products, they may have the same configuration as the port member 20 described above.

[0089] [Method of manufacturing drug solution bags] The medicinal solution bag 1 can be manufactured using a general manufacturing method for medicinal solution bags. An example of the manufacturing method for the medicinal solution bag 1 will be described. In the manufacturing method for the medicinal solution bag 1, a resin that is a raw material for the innermost layer 101, a resin that is a raw material for the adhesive resin layer 102, and a resin that is a raw material for the base resin layer 103 are laminated in this order to form a sheet member 100 in which the innermost layer 101, the adhesive resin layer 102, and the base resin layer 103 are laminated in this order (sheet member forming process).

[0090] The sheet member 100 may be formed by laminating the resin that is the raw material for the innermost layer 101, the resin that is the raw material for the adhesive resin layer 102, and the resin that is the raw material for the base resin layer 103 using a method such as dry lamination or extrusion lamination.

[0091] Next, the port member 20 is produced by molding the port forming composition containing the port material into a cylindrical shape such as a cylinder (port member forming step).

[0092] Next, the pair of sheet members 100 and the port member 20 are joined together (joining step).

[0093] First, a pair of sheet members 100 are stacked together with the innermost layers 101 facing each other, and the port member 20 is sandwiched between the sheet members 100.

[0094] Next, the pair of sheet members 100 and the port member 20 are joined together to form the second joint portion 11-2.

[0095] Next, the pair of sheet members 100 are joined together to form the first joint portion 11-1.

[0096] In this way, the drug solution bag 1 is manufactured.

[0097] As described above, the chemical solution bag 1 includes a bag body 10 and a port member 20. The sheet member 100 constituting the bag body 10 includes an innermost layer 101 and a base resin layer 103. The innermost layer 101 contains an amorphous polymer having a cyclic hydrocarbon skeleton as a primary component, and the port material contained in the port member 20 has a seal strength of 30 N / 15 mm or greater. Because the innermost layer 101 of the sheet member 100 contains an amorphous polymer having a cyclic hydrocarbon skeleton as a primary component, it is resistant to radiation. Furthermore, because the port member 20 is formed using a port material with a seal strength of 30 N / 15 mm or greater, the port member 20 can achieve enhanced adhesion with the sheet member 100. Therefore, the chemical solution bag 1 can achieve enhanced adhesion between the bag body 10 and the port member 20 while also exhibiting excellent radiation resistance.

[0098] Furthermore, in the drug solution bag 1, deterioration of the innermost layer 101 is suppressed even when the innermost layer 101 is sterilized using radiation, which prevents a decrease in the adhesive strength between the bag body 10 and the port member 20. Therefore, the drug solution bag 1 can maintain adhesiveness between the bag body 10 and the port member 20, thereby preventing the elution of the contents in the bag body 10.

[0099] In the drug solution bag 1, the port material contained in the port member 20 preferably has a tensile modulus of elasticity of 20 to 70 MPa. The port member 20 formed using this port material can have high flexibility, which can further improve the adhesion between the bag body 10 and the port member 20.

[0100] In particular, commercially available tube ports are generally manufactured by extrusion molding, and it is important for the port member to be flexible in order to ensure adhesion to a molded product such as the bag body 10 to which the port member is connected, and to seal the port member by pressing and crushing it. By increasing the flexibility of the port member 20 formed using a port material, the port member 20 can be pressed and crushed against the innermost layer 101 of the bag body 10 to seal it, thereby further improving the airtightness of the drug solution bag 1.

[0101] In the drug solution bag 1, the port material contained in the port member 20 preferably has a MFR at 190°C of 3.8 to 20 g / 10 min. This improves the moldability, particularly extrusion moldability, of the port material, making the port member 20 easier to manufacture and reducing surface irregularities, resulting in a good appearance. This reduces the likelihood of gaps forming between the innermost layer 101 of the sheet member 100 and the port member 20 at the openings 13A and 13B of the bag body 10, ensuring more reliable adhesion. Therefore, the drug solution bag 1 can further improve the adhesion between the bag body 10 and the port member 20.

[0102] In the drug solution bag 1, the port material contained in the port member 20 preferably contains one or more types of LLDPE. The port member 20 formed using this port material is more easily joined to the sheet member 100 that forms the bag body 10, and can improve adhesion to the bag body 10. Therefore, the drug solution bag 1 can more reliably improve the sealing performance of the storage chamber 12 and improve durability.

[0103] In the drug solution bag 1, the port material contained in the port member 20 is preferably formed to contain LLDPE and a resin having a tensile modulus of elasticity of 25 MPa or less. This makes it easier for the port member 20 to maintain both flexibility and formability, and therefore the drug solution bag 1 can more easily improve the adhesion between the bag body 10 and the port member 20.

[0104] In the drug solution bag 1, the port material contained in the port member 20 preferably contains LLDPE and a resin with a tensile modulus of elasticity of 25 MPa or less in a mass ratio of 60:40 to 75:25. This makes it easier for the port member 20 formed using this port material to maintain both flexibility and formability, making it easier to further improve the adhesion between the bag body 10 and the port member 20 in the drug solution bag 1, thereby improving quality.

[0105] In the medical solution bag 1, the port material contained in the port member 20 preferably contains two types of LLDPE, with the MFR at 190°C of one LLDPE being higher than the MFR at 190°C of the other LLDPE, and the tensile modulus of the other LLDPE being higher than the tensile modulus of the one LLDPE. This allows the port member 20 to have a balanced improvement in both flexibility and formability, thereby improving the adhesion between the bag body 10 and the port member 20 in the medical solution bag 1.

[0106] In the medical solution bag 1, it is preferable that one of the LLDPEs contained in the port material of the port member 20 has an MFR at 190°C of 8 g / 10 min or more, and the other LLDPE has a tensile modulus of 100 MPa or less. This improves the flexibility and moldability of the port member 20 in a balanced manner, thereby improving the adhesion between the bag body 10 and the port member 20 in the medical solution bag 1.

[0107] As described above, the medicinal solution bag 1 has the above-mentioned properties and can therefore be suitably used as an infusion bag that contains medicines (drugs), nutrients, food, drink, etc. and is subjected to sterilization. Examples of medicines include low-molecular-weight medicines and biopharmaceuticals. The medicinal solution bag 1 can be particularly effectively used as an infusion bag that contains biopharmaceuticals.

[0108] Although the embodiments have been described above, they are presented as examples and the present invention is not limited to the above embodiments. The above embodiments can be implemented in various other forms, and various combinations, omissions, substitutions, modifications, etc. can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, and are also included in the scope of the invention and its equivalents as set forth in the claims. [Example]

[0109] The present embodiment will be described in more detail below with reference to examples, but the present embodiment is not limited to these examples. Examples 1 to 9, 12 to 16, 19 to 26, and 29 are working examples, and the other examples are comparative examples.

[0110] <Example 1 to Example 30> [Preparation of port formation sheet] Resin pellets, which are port materials, were prepared using one of the resins listed in Table 1 below, either individually or in combination. When a single port material was used, the port material was melted and processed into pellets to produce the resin pellets. When two resins were used, the two resins (Resin 1 and Resin 2) were mixed, melted in an extruder, kneaded, and processed into pellets to produce the resin pellets. The prepared resin pellets were melt-pressed using a hot press at a set temperature of 190°C and a press pressure of 15 MPa, and then cooled to produce port-forming sheets with thicknesses of 0.6 to 0.75 mm. The type and physical properties of the resins used to prepare each resin pellet are listed in Table 1. The type and ratio of the resin pellets used to prepare the port-forming sheets are listed in Table 2. In Table 2, when a port material is made of a single resin, it is indicated as "Resin 1" or "Resin 2." When a port material is made of a mixture of two resins, one resin is indicated as "Resin 1" and the other as "Resin 2."

[0111] [Table 1]

[0112] The resins used in Table 1 are as follows: LLDPE1: Metallocene-based linear low-density polyethylene (Japan Polyethylene Co., Ltd.) LLDPE2: Metallocene-based linear low-density polyethylene (Japan Polyethylene Co., Ltd.) LLDPE3: Metallocene-based linear low-density polyethylene (Japan Polyethylene Co., Ltd.) LLDPE4: Metallocene-based linear low-density polyethylene (Japan Polyethylene Co., Ltd.) LLDPE5: Metallocene-based linear low-density polyethylene (manufactured by Tosoh Corporation) LLDPE6: Metallocene-based linear low-density polyethylene (Japan Polyethylene Co., Ltd.) LLDPE7: Metallocene-based linear low-density polyethylene (manufactured by Tosoh Corporation) LLDPE8: Metallocene-based linear low-density polyethylene (manufactured by Tosoh Corporation) Styrene (St)-based elastomer: styrene-ethylene-butylene-styrene block copolymer (Kraton® G (styrene content 13% by mass, specific gravity 0.90 g / cm 3 , MFR=22g / 10min (230℃, 5kgf), manufactured by Kraton Polymers PP: MF800, manufactured by Renolit HDPE: High density polyethylene (Tosoh Corporation)

[0113] [Table 2]

[0114] [Evaluation of port formation sheets] The properties of the produced port-forming sheets were evaluated, including MFR at 190°C, tensile modulus, seal strength, and radiation resistance. The measurement results for each property are shown in Table 3. Note that the values ​​shown in gray in Table 3 satisfy or are preferable for this embodiment.

[0115] (MFR at 190°C) According to JIS K 7210, a port-forming sheet was cut to a specified size to prepare rectangular test specimens. The cut test specimen was placed in a cylinder at a specified temperature (190°C) connected directly below a die, pressed down with a piston, and preheated at 190°C for 6 minutes. After preheating, a specified weight (2.16 kg) was placed on the piston at 190°C, and the molten test specimen was extruded through the die. The mass of the extruded test specimen at the specified extrusion time was measured. The MFR at 190°C was determined by calculating the mass per 10 minutes [g / 10 min]. A port-forming sheet with an MFR at 190°C of 3.8 to 20 g / 10 min was evaluated as having a good MFR at 190°C.

[0116] (tensile modulus) In accordance with ISO 527-3:2018, the port-forming sheet was cut to a specified size (15 mm wide x 70 mm long) to prepare rectangular test specimens. The cut test specimens were pulled at a pulling rate of 300 mm / min, and the tensile modulus of the port-forming sheet was calculated from the slope of the graph in the range of 10 to 20 N. A port-forming sheet with a tensile modulus of 20 to 70 MPa was evaluated as having a good tensile modulus.

[0117] (Seal strength) In accordance with ASTM F88, a port-forming sheet and a resin film (resin film composition: PP (thickness 150 μm) / adhesive resin layer (AD) (thickness 65 μm) / COP (thickness 25 μm)) were heat-sealed under the following heat-sealing conditions to produce a laminate. The produced laminate was cut to a specified size (width 15 mm x length 70 mm) to prepare rectangular test pieces. The port-forming sheet and resin film of the cut test piece were peeled apart at a tensile speed of 300 mm / min, and the strength was measured as the seal strength. A port-forming sheet seal strength of 30 N / 15 mm or greater was evaluated as good. *Heat sealing conditions Temperature: 240℃ Time: 3sec Pressure: 0.2 MPa

[0118] In addition, in Examples 22 to 25 (the values ​​in Table 3 are * In the examples marked with "," resin pellets made of the resins shown in Table 1 were used instead of the port forming sheet, and the sealing strength was measured using a cylindrical port member (inner diameter: 6 mm, outer diameter: 8 mm, cylindrical wall thickness: 1 mm) molded into a tube by extrusion molding.

[0119] (Radiation resistance) The port-forming sheet was irradiated with gamma rays at a sterilization dose of 25 kGy, and the port-forming sheet was visually inspected for yellowing and evaluated based on the following criteria: If the port-forming sheet did not yellow upon gamma-ray irradiation, the port-forming sheet was evaluated as having good radiation resistance and suitable for radiation sterilization. *Evaluation criteria A: The port formation sheet did not yellow. B: At least a part of the port-forming sheet was yellowed.

[0120] [Table 3]

[0121] As can be seen from Table 3, the port-forming sheets of Examples 1 to 9, 12 to 16, 19 to 26, and 29 had a seal strength of 25.4 N / 15 mm or more and were also resistant to radiation (see the gray areas in Table 3).

[0122] Furthermore, among the port-forming sheets in the above examples, the port-forming sheets other than Examples 15, 16, 22, and 25 had an MFR of 3.9 g / 10 min or more at 190°C (see the gray areas in Table 3).

[0123] Furthermore, among the port-forming sheets of Examples 1 to 9, 12 to 16, 19 to 26, and 29, the port-forming sheets other than Examples 8, 9, 12 to 15, and 19 to 26 had a tensile modulus of elasticity of approximately 61 MPa or less (see the gray areas in Table 3).

[0124] On the other hand, the seal strength with the cyclic olefin was 27.4 N / 15 mm or less in the port-forming sheets of Examples other than Examples 1 to 9, 12 to 16, 19 to 26, and 29. Furthermore, the port-forming sheet of Example 28 was not resistant to radiation because PP was used to form the port-forming sheet.

[0125] Therefore, it can be said that the same effect can be achieved by manufacturing a tube port of a drug solution bag using the port material that constitutes the port-forming sheet of Examples 1 to 9, 12 to 16, 19 to 26, and 29. Therefore, it can be said that drug solution bags equipped with tube ports manufactured using the port materials used in Examples 1 to 9, 12 to 16, 19 to 26, and 29 can exhibit excellent resistance to radiation while improving adhesion between the bag body and the tube port. [Explanation of symbols]

[0126] 1 medicine bag 10 Bag body 11 Joint (seal) 12 Containment Room 13A, 13B, 22 opening 20 Port material (tube port) 100 Sheet member 101 Innermost layer (sealing layer) 102 Adhesive resin layer (AD) 103 Base resin layer

Claims

1. A drug solution bag having a bag body for accommodating contents, the bag body being made of a sheet member formed into a bag shape, and a cylindrical port member attached to the bag body, the sheet member includes an innermost layer and a base resin layer, the innermost layer containing an amorphous polymer having a cyclic hydrocarbon skeleton as a main component, the port member includes a port material; A drug solution bag, wherein the port material has a seal strength of 30 N / 15 mm or more with respect to a substrate containing a cyclic olefin.

2. 2. The drug solution bag according to claim 1, wherein the port material has a tensile modulus of elasticity of 20 to 70 MPa.

3. 3. The drug solution bag according to claim 1, wherein the port material has an MFR at 190° C. of 3.8 to 20 g / 10 min.

4. 3. The drug solution bag according to claim 1, wherein the port material comprises at least one linear low-density polyethylene.

5. 3. The drug solution bag according to claim 1, wherein the port material contains linear low-density polyethylene and a resin having a tensile modulus of elasticity of 25 MPa or less.

6. 6. The drug solution bag according to claim 5, wherein the linear low-density polyethylene and the resin having a tensile modulus of elasticity of 25 MPa or less are contained in a mass ratio of 60:40 to 75:

25.

7. When the port material contains two types of linear low-density polyethylene, one of the linear low-density polyethylenes has a higher MFR at 190°C than the other of the linear low-density polyethylenes; 3. The drug solution bag according to claim 1, wherein the other linear low-density polyethylene has a lower flexural modulus than the one linear low-density polyethylene.

8. the MFR of the one linear low-density polyethylene at 190°C is 8 g / 10 min or more; 8. The drug solution bag according to claim 7, wherein the other linear low-density polyethylene has a flexural modulus of elasticity of 100 MPa or less.

9. The drug solution bag according to claim 1 or 2, wherein the contents are medicines.

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