JP5777382B2 - Laminated film and infusion bag - Google Patents

Description

  The present invention relates to a laminated film and an infusion bag using the same. In particular, the present invention relates to an infusion bag for storing a liquid drug at 25 ° C. administered subcutaneously, intravascularly, or intraperitoneally. Furthermore, it is related with the manufacturing method of an infusion bag.

  Conventionally, a laminated film obtained by laminating a gas barrier film and a resin film containing a polyethylene resin and / or a polypropylene resin has been studied (Patent Documents 1 and 2). These are preferably employed as packaging materials. However, these techniques are insufficient to produce a packaging material (for example, an infusion bag) having a high barrier property using an organic / inorganic laminated gas barrier film. This is usually heat-sealed to create a back, but in general the heat-sealed part is compressed or contracted by pressurization, heating and cooling, and the inorganic layer of the gas barrier layer is stressed and destroyed. It is because it will be done. Such destruction of the inorganic layer causes a decrease in gas barrier properties.

JP 2005-271467 A JP-A-2005-153306

  The present invention has been made to solve the above-mentioned problems, and a laminated film capable of maintaining high gas barrier properties even when pressure, heating, cooling, etc. are applied to a heat seal portion, and the laminated film. It aims at providing the used infusion bag.

  Under such circumstances, the inventor of the present application studied not to transmit stress such as compression and contraction to the inorganic layer. As a means for this, it was studied to relieve stress applied to the inorganic layer by two organic layers adjacent to each other. Specifically, it was studied to soften the upper and lower two organic layers. However, it has been found that if the organic layer film is always soft, troubles such as the film being easily scratched during production occur. Therefore, an attempt was made to adjust the film to be soft only when heat-sealed. Specifically, in the constitution of the resin film containing the first organic layer / inorganic layer / second organic layer / adhesive layer / polyethylene resin and / or polypropylene resin, the glass transition temperatures of the first and second organic layers. (Tg) is set to 70 ° C. or higher, the organic layer is softened only when heat-sealing, and from the viewpoint of maintaining the cushioning property of the organic layer, the thickness of the second organic layer is set to a certain level or more. It has been found that the stress applied to the inorganic layer can be alleviated by setting the ratio of the thickness of the organic layer and the second organic layer to a constant value, and the present invention has been completed.

Specifically, the above problems have been achieved by the following means.
(1) A laminated film in which at least a base film, a gas barrier layer, an adhesive layer, and a resin film containing a polyethylene resin and / or a polypropylene resin are laminated in this order,
The gas barrier layer has a structure in which a first organic layer, an inorganic layer, and a second organic layer are stacked in contact with each other in this order,
The second organic layer is in contact with the adhesive layer,
A / b ≧ 2 when the thickness of the second organic layer is a and the thickness of the first organic layer is b,
The laminated film whose glass transition temperature of a 1st organic layer and a 2nd organic layer is 70 degreeC or more, and is lower than melting | fusing point of the resin film containing a polyethylene resin and / or a polypropylene resin.
(2) The laminated film according to (1), wherein the first organic layer and the second organic layer are each obtained by curing a polymerizable composition containing a (meth) acrylate monomer having a phosphate ester group. .
(3) The laminated film according to (1) or (2), wherein the adhesive layer and the resin film are adjacent to each other.
(4) The laminated film according to any one of (1) to (3), wherein the gas barrier layer further includes an inorganic layer.
(5) The resin film containing the polyethylene resin and / or polypropylene resin of the laminated film according to any one of (1) to (4), wherein the outermost layer is made of a resin film containing polyethylene resin and / or polypropylene resin. Infusion bag joined by heat sealing with bag.
(6) The infusion bag according to (5), wherein the infusion bag is a duplex type.
(7) The resin film of the laminated film according to any one of (1) to (4) is bonded by heat sealing to a bag whose outermost layer is made of a resin film containing a polyethylene resin and / or a polypropylene resin. A method for producing an infusion bag.
(8) The method for producing an infusion bag according to (7), wherein the joining is performed by applying a pressure of 0.01 to 5 MPa.

  The present invention makes it possible to provide a laminated film that can maintain high barrier properties even when bonded by heat sealing. Furthermore, it became possible to make the interlayer adhesiveness of this laminated film high. And it became possible to provide an infusion bag having high drug storage stability.

It is the schematic which shows 1st embodiment of this invention.

  Hereinafter, the contents of the present invention will be described in detail. In the present specification, “to” is used to mean that the numerical values described before and after it are included as a lower limit value and an upper limit value.

Laminated film The laminated film of the present invention comprises at least a base film, a gas barrier layer, an adhesive layer, and a resin film containing polyethylene resin and / or polypropylene resin (hereinafter sometimes simply referred to as “resin film”). The gas barrier layer has a structure in which a first organic layer, an inorganic layer, and a second organic layer are in contact with each other in that order, and the second organic layer is an adhesive layer. A / b ≧ 2 when the thickness of the second organic layer is a and the thickness of the first organic layer is b, and the first organic layer and the second organic layer The glass transition temperature is 70 ° C. or higher and is lower than the melting point of a resin film containing a polyethylene resin and / or a polypropylene resin. Preferably, it is a case where it is 3-50 degreeC lower than melting | fusing point, More preferably, it is a case where it is 10-30 degreeC lower.

FIG. 1 describes the laminated film of the present invention, wherein 1 is a base film, 2 is a first organic layer, 3 is an inorganic layer, 4 is a second organic layer, and 5 is a The adhesive layer and 6 are resin films, respectively.
In this embodiment, the gas barrier layer is composed of three layers, a first organic layer, an inorganic layer, and a second organic layer. However, the gas barrier layer may further include an inorganic layer and / or an organic layer. In the present invention, it is necessary that the adhesive layer is in contact with the second organic layer, the second organic layer is in contact with the inorganic layer, and the inorganic layer is in contact with the first organic layer. Or when an inorganic layer is provided, it is provided between a base film and a 1st organic layer.
In the gas barrier layer, it is preferable that the organic layer and the inorganic layer constituting the gas barrier layer are alternately laminated one by one. The total number of gas barrier layers is preferably 3 to 20 layers.

In the present embodiment, the adhesive layer and the resin film are in contact with each other, but other layers may be included without departing from the gist of the present invention. For example, an easily bonding layer etc. are illustrated. Further, an oxygen-absorbing resin film and an adhesive layer may be included between the adhesive layer and the resin film. That is, the configuration of base film / gas barrier layer / adhesive layer / oxygen-absorbing resin film / adhesive layer / resin film is exemplified. However, since the laminated film of the present invention is also excellent in oxygen barrier properties, it is possible to maintain high oxygen barrier properties without providing an oxygen-absorbing resin layer.
Hereinafter, the base film, the organic layer, the inorganic layer, the adhesive layer, and the resin film will be described in detail.

(Base film)
The base film used in the present invention is usually a plastic film, and those described in paragraph numbers 0009 to 0012 of JP-A-2009-172993 can be preferably employed. The base film is preferably a thermoplastic resin film.
5-150 micrometers is preferable and, as for the thickness of a base film, 10-100 micrometers is more preferable.

(Organic layer)
The barrier layer in the present invention has a first organic layer and a second organic layer. The first organic layer serves as, for example, an undercoat layer serving as a base for the inorganic layer, and has a function different from that of the second organic layer. In the present invention, the first organic layer and the second organic layer can be formed of the same material, or can be formed of different materials.

The organic layer in the present invention is preferably an organic layer containing an organic polymer as a main component. Here, the main component means that the first component of the component constituting the organic layer is an organic polymer, and usually 80% by weight or more of the component constituting the organic layer is an organic polymer.
Examples of the organic polymer include polyester, acrylic resin, methacrylic resin, methacrylic acid-maleic acid copolymer, polystyrene, transparent fluororesin, polyimide, fluorinated polyimide, polyamide, polyamideimide, polyetherimide, cellulose acylate, and polyurethane. , Polyether ether ketone, polycarbonate, alicyclic polyolefin, polyarylate, polyether sulfone, polysulfone, fluorene ring modified polycarbonate, alicyclic modified polycarbonate, fluorene ring modified polyester, acryloyl compound and other thermoplastic resins, or polysiloxane, etc. Examples thereof include organosilicon polymers.

The organic layer in the present invention is preferably formed by curing a polymerizable composition containing a polymerizable compound.
(Polymerizable compound)
The polymerizable compound is preferably a radical polymerizable compound and / or a cationic polymerizable compound having an ether group as a functional group, more preferably a compound having an ethylenically unsaturated bond at the terminal or side chain, and / or A compound having an epoxy or oxetane at the terminal or side chain. Of these, compounds having an ethylenically unsaturated bond at the terminal or side chain are preferred. Examples of compounds having an ethylenically unsaturated bond at the terminal or side chain include (meth) acrylate compounds, acrylamide compounds, styrene compounds, maleic anhydride, etc., (meth) acrylate compounds and / or Styrenic compounds are preferred, (meth) acrylate compounds are more preferred, and polyfunctional (meth) acrylates are more preferred.

As the (meth) acrylate compound, (meth) acrylate, urethane (meth) acrylate, polyester (meth) acrylate, epoxy (meth) acrylate and the like are preferable.
As the styrene compound, styrene, α-methylstyrene, 4-methylstyrene, divinylbenzene, 4-hydroxystyrene, 4-carboxystyrene and the like are preferable.

  As the (meth) acrylate compound preferably used in the present invention, those described in paragraph numbers 0014 to 0019 of JP2010-22841A can be employed.

(Meth) acrylate monomer having phosphate ester group The polymerizable composition for forming the organic layer used in the present invention preferably contains a (meth) acrylate monomer having a phosphate ester group. The (meth) acrylate monomer having a phosphate ester group is more preferably a polymerizable compound represented by the following general formula (1).

［一般式（１）において、Ｚ¹は、Ａｃ²−Ｏ−Ｘ²−、重合性基を有しない置換基または水素原子を表し、Ｚ²は、Ａｃ³−Ｏ−Ｘ³−、重合性基を有しない置換基または水素原子を表し、Ａｃ¹、Ａｃ²およびＡｃ³は、それぞれ、（メタ）アクリロイル基を表し、Ｘ¹、Ｘ²およびＸ³は、それぞれ、アルキレン基、アルキレンオキシ基、アルキレンオキシカルボニル基、アルキレンカルボニルオキシ基、またはこれらの組み合わせを表す。］

[In General Formula (1), Z ¹ represents Ac ² —O—X ² —, a substituent having no polymerizable group, or a hydrogen atom, and Z ² represents Ac ³ —O—X ³ —, polymerizable. Represents a substituent having no group or a hydrogen atom, Ac ¹ , Ac ² and Ac ³ each represent a (meth) acryloyl group, and X ¹ , X ² and X ³ represent an alkylene group and an alkyleneoxy group, respectively. Represents an alkyleneoxycarbonyl group, an alkylenecarbonyloxy group, or a combination thereof. ]

  The compound represented by the general formula (1) includes a monofunctional polymerizable compound represented by the following general formula (2), a bifunctional polymerizable compound represented by the following general formula (3), and the following A trifunctional polymerizable compound represented by the general formula (4) is included.

The definitions of Ac ¹ , Ac ² , Ac ³ , X ¹ , X ² and X ³ are the same as those in the general formula (1). In the general formulas (2) and (3), R ¹ represents a substituent or a hydrogen atom having no polymerizable group, and R ² represents a substituent or a hydrogen atom having no polymerizable group.

In the general formula (1) ~ (4), X 1, the number of carbon atoms of X ² and X ³ is preferably 1 to 12, more preferably 1 to 6, 1 to 4 is more preferred. Specific examples of the alkylene group X ^1, X ² and X ³ may take, and, X ^1, alkyleneoxy groups X ² and X ³ can take an alkyleneoxy carbonyl group, specific examples of the alkylene moiety of the alkylene carbonyloxy group Includes a methylene group, an ethylene group, a propylene group, a butylene group, a pentylene group, and a hexylene group. The alkylene group may be linear or branched, but is preferably a linear alkylene group. X ¹ , X ² and X ³ are preferably an alkylene group.

In the general formulas (1) to (4), examples of the substituent having no polymerizable group include an alkyl group, an alkoxy group, an aryl group, an aryloxy group, or a group obtained by combining these. Preferred are an alkyl group and an alkoxy group, and more preferred is an alkoxy group.
1-12 are preferable, as for carbon number of an alkyl group, 1-9 are more preferable, and 1-6 are more preferable.
Specific examples of the alkyl group include a methyl group, an ethyl group, a propyl group, a butyl group, a pentyl group, and a hexyl group. The alkyl group may be linear, branched or cyclic, but is preferably a linear alkyl group. The alkyl group may be substituted with an alkoxy group, an aryl group, an aryloxy group, or the like.
6-14 are preferable and, as for carbon number of an aryl group, 6-10 are more preferable. Specific examples of the aryl group include a phenyl group, a 1-naphthyl group, and a 2-naphthyl group. The aryl group may be substituted with an alkyl group, an alkoxy group, an aryloxy group, or the like.
For the alkyl part of the alkoxy group and the aryl part of the aryloxy group, the description of the alkyl group and the aryl group can be referred to.

  In the present invention, only one type of polymerizable compound represented by the general formula (1) may be used, or two or more types may be used in combination. Moreover, when using in combination, the monofunctional polymerizable compound represented by General formula (2), the bifunctional polymerizable compound represented by General formula (3), and the trifunctional represented by General formula (4) Two or more of the polymerizable compounds may be used in combination.

In the present invention, as the polymerizable compound having a phosphoric acid ester group, commercially available compounds such as KAYAMER series manufactured by Nippon Kayaku Co., Ltd. and the Phosmer series manufactured by Unichemical Co., Ltd. may be used as they are. A newly synthesized compound may be used.
Although the specific example of the (meth) acrylate monomer which has a phosphate ester group below is shown, the polymeric compound which can be used by this invention is not limited to these.

  When the organic layer in the present invention is prepared by coating and curing a polymerizable composition containing a polymerizable compound, the content of the (meth) acrylate monomer having a phosphate ester group is 0.01 to 50 of the total polymerizable component. % By mass is preferable, and 0.1 to 30% by mass is more preferable.

(Polymerization initiator)
When the organic layer in the present invention is prepared by coating and curing a polymerizable composition containing a polymerizable compound, the polymerizable composition may contain a polymerization initiator. When using a photoinitiator, it is preferable that the content is 0.1 mol% or more of the total amount of the polymerizable compounds, and more preferably 0.5 to 2 mol%. Preferable examples of the polymerization initiator include those described in paragraph No. 0057 of JP 2010-089502 A.

(Formation method of organic layer)
A method for forming the organic layer is not particularly defined, but the method described in paragraph Nos. 0058 and 0059 of JP 2010-089502 A is preferable.

  The polymerization rate of the polymerizable monomer constituting the organic layer is preferably 85% or more, more preferably 88% or more, further preferably 90% or more, and particularly preferably 92% or more. . The polymerization rate here means the ratio of the reacted polymerizable group among all the polymerizable groups (for example, acryloyl group and methacryloyl group) in the polymerizable composition. The polymerization rate can be quantified by an infrared absorption method.

The hardness of the organic layer is preferably higher except at normal temperature, that is, when heat-sealed. The pencil hardness is preferably F or more, and more preferably H or more. There is no particular upper limit.
It is preferable that the second organic layer satisfies the pencil hardness condition, and it is more preferable that both the first organic layer and the second organic layer satisfy the pencil hardness condition.
The thickness of the second organic layer is preferably 0.1 μm or more, more preferably 0.3 to 10 μm, even more preferably 0.5 to 5 μm, since the organic layer plays a role as a cushion layer. 1 to 5 μm is more preferable, and 1.8 to 3 μm is particularly preferable.
In particular, by setting the thickness of the second organic layer to 0.3 μm or more, the cushioning property of the organic layer is excellent, and as a result, a comprehensively superior laminated film can be obtained.

On the other hand, when the first organic layer is in direct contact with the substrate film, the first organic layer is preferably a smooth layer, and the smoothness of the first organic layer is less than 1 nm as an average roughness (Ra value) of 1 μm square. Preferably, it is less than 0.5 nm. The surface of the organic layer is required to be free of foreign matters such as particles and protrusions. For this reason, it is preferable that the organic layer is formed in a clean room. The degree of cleanness is preferably class 10000 or less, more preferably class 1000 or less.
The thickness of the first organic layer is preferably 150 nm or more, more preferably 0.3 to 10 μm, further preferably 0.5 to 5 μm, and particularly preferably 0.8 to 2 μm.

  Furthermore, in the present invention, a / b ≧ 2 when the thickness of the second organic layer is a and the thickness of the first organic layer is b. By setting it as such thickness ratio, the pressure applied to an inorganic layer at the time of heat sealing can be relieved more. It is more preferable that a / b is 3 ≦ a / b.

(Inorganic layer)
The inorganic layer is usually a thin film layer made of a metal compound. As a method for forming the inorganic layer, any method can be used as long as it can form a target thin film. For example, there are a physical vapor deposition method (PVD) such as a vapor deposition method, a sputtering method, and an ion plating method, various chemical vapor deposition methods (CVD), and a liquid phase growth method such as plating and a sol-gel method. The component contained in the inorganic layer is not particularly limited as long as it satisfies the above performance. For example, it is a metal oxide, metal nitride, metal carbide, metal oxynitride, or metal oxycarbide, and Si, Al, In An oxide, nitride, carbide, oxynitride, oxycarbide, or the like containing at least one metal selected from Sn, Zn, Ti, Cu, Ce, or Ta can be preferably used. Among these, a metal oxide, nitride, or oxynitride selected from Si, Al, In, Sn, Zn, and Ti is preferable, and a metal oxide, nitride, or oxynitride of Si or Al is particularly preferable. These may contain other elements as secondary components.
The smoothness of the inorganic layer formed according to the present invention is preferably less than 1 nm, more preferably 0.5 nm or less, as an average roughness (Ra value) of 1 μm square. The inorganic layer is preferably formed in a clean room. The degree of cleanness is preferably class 10000 or less, more preferably class 1000 or less.

  Although it does not specifically limit regarding the thickness of an inorganic layer, It attaches to 1 layer, Usually, it exists in the range of 5-500 nm, Preferably it is 10-200 nm.

(Lamination of organic and inorganic layers)
The organic layer and the inorganic layer can be laminated by sequentially forming the organic layer and the inorganic layer in accordance with a desired layer structure.

Adhesive layer In the present invention, an adhesive layer is provided to bond the resin film and the gas barrier layer together. Furthermore, when it has another functional film, you may use an contact bonding layer also in order to bond this film.
Examples of the adhesive contained in the adhesive layer include an epoxy resin adhesive and a polyurethane adhesive, an ethylene vinyl acetate adhesive, an acrylic resin adhesive, and the like, and a polyurethane adhesive is preferable. Further, the adhesive layer may contain components other than the adhesive, but these components are preferably 1% by weight or less of the total.
The thickness of the adhesive layer is preferably from 0.1 to 50 μm, preferably from 1 to 30 μm, particularly preferably from 1 to 5 μm.

Resin film The resin film containing a polyethylene resin and / or a polypropylene resin in the present invention is a resin film containing a polyethylene resin and / or a polypropylene resin as a main component. Although other resins may be contained, usually, 99% by weight or more of the resin component is a polyethylene resin and / or a polypropylene resin. Various additives may be added to the resin film, but the resin film is preferably transparent. Here, the term “transparent” means that the light transmittance is 50% or more, preferably 70% or more.
The melting point of the resin film is preferably 90 to 165 ° C.
1-100 micrometers is preferable and, as for the thickness of a resin film, 2-70 micrometers is more preferable.
In this invention, the resin film which comprises the bag which consists of resin films, and the resin film joined to the bag which consists of resin films may differ, and may be the same. In the present invention, since fusion is performed by heat sealing, it is preferable that 95% by mass or more of the composition of both the resin film constituting the back made of the resin film and the resin film joined to the back made of the resin film is common. .

  The laminated film of the present invention may contain other constituent layers within a range not departing from the gist of the present invention. Other constituent layers are described in detail in paragraph numbers 0036 to 0038 of JP-A-2006-289627. Matting agent layer, protective layer, solvent-resistant layer, antistatic layer, smoothing layer, adhesion improving layer, light shielding layer, antireflection layer, hard coat layer, stress relaxation layer, antifogging layer, antifouling layer, printing A layer, an easily bonding layer, etc. are also illustrated.

  The thickness of the laminated film of the present invention can be 20 to 200 μm, and can be 25 to 70 μm. Thus, since the thickness is small, the invasion of water vapor and oxygen from the side surface can be more effectively suppressed.

Infusion Bag The infusion bag of the present invention is obtained by joining the resin film of the laminated film of the present invention with the outermost layer bonded to a bag by heat sealing. The heat seal temperature can usually be determined from the melting point of the resin film of the laminated film of the present invention. Usually, heat seal temperature is melting | fusing point of the resin film which the laminated | multilayer film of this invention has. When the resin film is polypropylene, the heat sealing temperature is preferably 160 to 220 ° C.
The time for heat sealing is usually 0.2 to 0.5 seconds. The pressure for heat sealing is preferably 0.01 to 5 MPa. In the conventional laminated film, the organic layer was damaged when heat-sealed with such pressure, but the laminated film of the present invention is significant in that there is no such problem. In the present invention, even if the heat sealing is performed on the entire laminated film, the barrier property is maintained, so that it is possible to firmly join the bag made of the resin film.

Bag made of resin film The bag made of the resin film used in the present invention is made of a resin film whose outermost layer contains a polyethylene resin and / or a polypropylene resin. Although other resins may be contained, usually, 99% by weight or more of the resin component is a polyethylene resin and / or a polypropylene resin. Various additives may be added to the resin film, but the resin film is preferably transparent. Here, the term “transparent” means that the light transmittance is 50% or more, preferably 70% or more.
For the bag made of a resin film, other detailed requirements can be appropriately determined as long as the infusion solution can be stored. As an example of a bag made of a resin film, there are a bag formed by bonding two resin films and a bag formed by bonding a single resin film in two.
Usually, the ends of the resin film are completely joined except for the liquid discharge port.
The thickness of the back resin film made of a resin film is preferably 20 to 200 μm.
In the case of a bag formed by joining two resin films, the two resin films may be different films, but are preferably the same film. In the case of the same film, it can be easily applied when it is applied by a heat seal method.
The infusion bag used in the present invention may be a single type having one bag or a multiple type having two or more bags. In the case of a duplex system, for example, a duplex bag comprising a powder storage chamber and a liquid storage chamber separated by a partition wall that can be easily separated from the powder storage chamber is exemplified. In this case, immediately before use, the partition wall is peeled off, the powder and liquid are mixed, and infusion is performed from the liquid outlet. In this case, it is preferable to use the infusion bag of the present invention in the powder container.

  Examples of the drug used for the infusion bag of the present invention include a liquid for administration by instillation or the like subcutaneously, intravascularly or intraperitoneally. In the case of a compound bag, liquids such as powdered drugs and physiological saline are exemplified. Examples of powdered drugs include nutrients such as vitamins and amino acids, antibiotics, and antibacterial agents.

The infusion bag and laminated film of the present invention can have an oxygen permeation rate of 0.1 cc / m ² / day / atm or less at a temperature of 40 ° C., 1 atm, and a relative humidity of 90%. m ² / day / atm or less.
Further, the infusion bag and laminated film of the present invention can have a water vapor transmission rate of 0.01 g / m ² / day or less at a temperature of 4 ° C., 1 atm, and a relative humidity of 90%, and further 0.001 g / M ² / day or less.
The infusion bag and laminated film of the present invention can satisfy both the oxygen transmission rate and the water vapor transmission rate.

  In addition, the techniques described in Japanese Patent Application Laid-Open Nos. 2003-230618 and 10-201818 can be considered without departing from the spirit of the present invention.

The present invention will be described more specifically with reference to the following examples. The materials, amounts used, ratios, processing details, processing procedures, and the like shown in the following examples can be changed as appropriate without departing from the spirit of the present invention. Therefore, the scope of the present invention is not limited to the specific examples shown below.
In the following, Example 7 is a reference example of the present invention.

Example 1
(Creation of gas barrier film)
A barrier laminate was formed and evaluated on one side of a polyethylene terephthalate film (PET film, manufactured by Toray Industries, Inc., trade name: Lumirror, thickness 100 μm, glass transition temperature: 78 ° C.) by the following procedure.
14.1 g of the polymerizable compound shown in Table 1 below, 1.0 g of an acrylate having a phosphate ester group (manufactured by Nippon Kayaku Co., Ltd., KAYAMER series, PM-21), KBM-5103 (Shin-Etsu) as a silane coupling agent Chemical Industry Co., Ltd.) (3.5 g) and a photopolymerization initiator (Lamberti Co., Ltd., ESACURE KTO46) (1.4 g) were prepared and dissolved in 180 g of methyl ethyl ketone to prepare a coating solution. This coating solution was applied on the smooth surface of the PET film with a wire bar using a wire bar. After drying at room temperature for 2 hours, the organic layer is cured by irradiating UV light from a high-pressure mercury lamp (accumulated dose of about ² J / cm ² ) in a chamber in which the oxygen concentration is 0.1% by the nitrogen substitution method. I let you. The thickness of the organic layer was set to the thickness shown in Table 2. The unit of thickness in the table is μm.
Next, an inorganic layer (silicon nitride layer) was formed on the surface of the organic layer using a CVD apparatus. Silane gas (flow rate 160 sccm), ammonia gas (flow rate 370 sccm), hydrogen gas (flow rate 590 sccm), and nitrogen gas (flow rate 240 sccm) were used as source gases. A high frequency power supply having a frequency of 13.56 MHz was used as the power supply. The film forming pressure was 40 Pa, and the reached film thickness was 50 nm. Thus, the inorganic layer was laminated | stacked on the surface of the organic layer.
Furthermore, it carried out similarly to the formation method of the said organic layer on the surface of the inorganic layer, and also laminated | stacked one organic layer. The thickness of the organic layer was set to the thickness shown in Table 2.
For Example 13, the organic layer was composed of 10 g of polymerizable compound EPICLON EXA-4816 (manufactured by DIC Corporation), 8.5 g of acid anhydride (MTHPA; methyltetrahydrophthalic anhydride) as a curing agent, and benzyldimethylamine as an accelerator. (BDMA) 0.1 g was prepared and dissolved in 181.4 g of methyl ethyl ketone to prepare a coating solution. This coating solution was applied on the smooth surface of the PET film with a wire bar using a wire bar, and heated at 100 ° C. for 3 hours to cure the organic layer.

(Lamination of gas barrier film and resin film)
A laminated film is obtained by laminating a gas barrier film and a resin film (polypropylene film, manufactured by Toray Film Co., Ltd., thickness: 30 μm, melting point: about 161 ° C.) using a polyurethane-based adhesive so as to have the layer configuration shown below. It was. The thickness of the adhesive layer was 3 μm.
PET / organic layer / inorganic layer / organic layer / adhesive layer / resin film

(Bonding of laminated film and resin film)
A resin film side of the obtained laminated film and a bag (polyethylene bag) made of the resin film were fused by a heat seal method to prepare an infusion bag. Heat sealing was performed by heating the entire surface at 180 ° C. and 0.1 MPa for 1 second.

(Method for measuring Tg of second organic layer)
Samples were cut into strips and measured with a dynamic viscoelastic device (EXSTAR DMS6100, manufactured by Seiko Instruments Inc.) at a rate of temperature increase of 3 ° C./min and a frequency of 1 Hz, and the temperature when tan δ peaked was defined as Tg.

(Measurement of water vapor transmission rate by the calcium method)
Among the obtained infusion bags, the water vapor transmission rate was measured by the calcium method on the side where the laminated film was provided. That is, the water vapor transmission rate (g / m ² / day) was measured using the method described in G. NISATO, PCPBOUTEN, PJSLIKKERVEER et al. SID Conference Record of the International Display Research Conference, pages 1435-1438. The temperature at this time was 40 ° C. and the relative humidity was 90%. The results are shown in the table below.
The detection limit is 0.0005 g / m ² / day or less. A practical level is 0.001 g / m ² / day or less.

(Measurement method of pencil hardness of organic layer)
For the purpose of evaluating the hardness of the gas barrier film, a pencil hardness test according to JIS K5600-5-4 was performed.
A case where the pencil hardness is F or more is a practical level.

(Adhesion evaluation method)
In order to evaluate the adhesion of the gas barrier film, a cross-cut test based on JIS K5400 was performed. The surface of the gas barrier film having the above layer structure was cut by 90 ° with respect to the film surface with a cutter knife at intervals of 1 mm, and 100 grids with intervals of 1 mm were produced. A 2 cm wide Mylar tape [manufactured by Nitto Denko, polyester tape (No. 31B)] was applied thereto, and the tape attached using a tape peeling tester was peeled off. Of the 100 grids on the laminated film, the number of cells remaining without peeling (n) was counted.
○: 70 squares or more.
Δ: 50 squares or more and less than 70 squares.
X: Less than 50 squares.

(Drug preservability)
Cefazolin sodium (manufactured by Otsuka Pharmaceutical Factory) was encapsulated as a drug in the obtained infusion bag and stored for 6 months under the condition of 40 ° C. and 75% relative humidity, and the change in color tone was evaluated.
Evaluation was made according to the following.
◎: No change in color tone ○: Partially slight change in color tone △: Changed to slightly yellow overall ×: Changed to yellow overall

  As is clear from the above results, it was found that the infusion bag of the present invention has high water vapor barrier properties and adhesion, and high drug storage stability.

Example 2
The above embodiment is such that the bulkhead mechanism of the multi-chamber container in which the specific chambers are stacked completely covers one side of the upper chamber of the polyethylene bag composed of two chambers configured by a seal having easy peel openability. Each of the laminated films 1 was superposed so that the resin film was inside and in close contact with the container body, and the periphery of the laminated film was fused with the container body by a heat seal method. Heat sealing was performed by heating at 160 ° C. and 0.1 MPa for 1 second.

<Preservability of drug>
Cefazolin sodium (manufactured by Otsuka Pharmaceutical Factory) was encapsulated in the upper chamber of the obtained infusion bag and stored for 6 months at 40 ° C. and 75% relative humidity, and the change in color tone was evaluated.
Evaluation was made according to the following.
◎: No change in color tone ○: Partially slight change in color tone △: Changed to slightly yellow overall ×: Changed to yellow overall

上記結果から明らかなとおり、本発明の複式型輸液バックも高い薬剤保存性を有していることがわかった。 The results are shown in the table below.

As is clear from the above results, it was found that the dual-type infusion bag of the present invention also has high drug storage stability.

1 Base Film 2 First Organic Layer 3 Inorganic Layer 4 Second Organic Layer 5 Adhesive Layer 6 Resin Film

Claims (8)

At least a base film, a gas barrier layer, an adhesive layer, and a laminated film in which a resin film containing a polyethylene resin and / or a polypropylene resin is laminated in the order,
The gas barrier layer has a structure in which a first organic layer, an inorganic layer, and a second organic layer are stacked in contact with each other in this order,
The second organic layer is in contact with the adhesive layer,
The first organic layer and the second organic layer are layers formed by curing a polymerizable composition containing a (meth) acrylate monomer,
The thickness of the second organic layer is 1-5 μm,
A / b ≧ 2 when the thickness of the second organic layer is a and the thickness of the first organic layer is b,
The laminated film whose glass transition temperature of a 1st organic layer and a 2nd organic layer is 70 degreeC or more, and is lower than melting | fusing point of the resin film containing a polyethylene resin and / or a polypropylene resin.   The laminated film according to claim 1, wherein the first organic layer and the second organic layer are each obtained by curing a polymerizable composition containing a (meth) acrylate monomer having a phosphate ester group.   The laminated film according to claim 1 or 2, wherein the adhesive layer and the resin film are adjacent to each other.   The laminated film according to any one of claims 1 to 3, wherein the gas barrier layer further comprises an inorganic layer.   The resin film containing the polyethylene resin and / or the polypropylene resin of the laminated film according to any one of claims 1 to 4 is heat-sealed with a bag whose outermost layer is made of a resin film containing a polyethylene resin and / or a polypropylene resin. Bonded infusion bag.   The infusion bag according to claim 5, wherein the infusion bag is a duplex type.   An infusion bag comprising: joining the resin film of the laminated film according to any one of claims 1 to 4 by heat sealing with a bag whose outermost layer is made of a resin film containing a polyethylene resin and / or a polypropylene resin. Production method.   The method for producing an infusion bag according to claim 7, wherein the joining is performed by applying a pressure of 0.01 to 5 MPa.

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