JP2001157705A - Infusion packaging material and infusion packaging body using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical infusion packaging material and an infusion packaging body using it, which keeps out gas and prevents a low molecular weight component of an adhesive resin from eluting into the content even if the infusion packaging body goes through a full sterilization process. SOLUTION: In the infusion packaging body using a packaging material laminated by using an adhesive, as an inner layer 11, a copolymer between cyclic olefin and either one or two or more of ethylene, α-olefin and other olefinic monomer or a polymer obtained by ring opening of a cyclic olefin or its hydrogenated substance is used.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a packaging material used for filling and sealing an infusion of pharmaceuticals, and in particular, has a gas barrier property (oxygen / steam) and a sufficient heating / heating property. The present invention relates to an infusion packaging material that can be sterilized by pressurization and an infusion packaging using the same.

[0002]

2. Description of the Related Art Packaging materials for infusion of pharmaceuticals are made of polyolefin alone or a multilayer film of polyolefin and polyolefin containing a material having gas barrier properties. Manufactured using packaging materials.

[0003] Then, for example, the strength,
When the impact resistance such as buffering property and the barrier properties such as moisture proofness, gas barrier property and light-shielding property are insufficient, multiple outer bags such as secondary packaging or tertiary packaging should be placed in this infusion package. Equipped with supplemented impact resistance and barrier properties. This is because the infusion packaging material used for the infusion packaging of pharmaceuticals is a laminated packaging made by laminating various films using an adhesive according to the regulations of the Japanese Pharmacopoeia in order to ensure the safety of the pharmaceuticals. No material was found.

In recent years, the revision of the standards of the Japanese Pharmacopoeia has allowed the use of adhesives for packaging materials for infusion of pharmaceuticals. Therefore, the use of an adhesive is necessary for the lamination. For example, if a transparent glass vapor-deposited film is used, the infusion package manufactured using the laminated infusion packaging material has gas barrier properties (oxygen / oxygen). Water vapor) and can be an excellent transfusion package that can be sterilized by sufficient heat and pressure.

However, for an infusion solution prepared by using a multilayer film using an adhesive, such a transparent glass-deposited film and a polyolefin alone or a multilayer film of a polyolefin and a polyolefin containing a material having gas barrier properties. The package is sterilized by heating and pressurizing, and the low molecular weight components derived from the printing ink used for decorating and the resin of the adhesive used for laminating elute to the contents side, exceeding the standards of the Japanese Pharmacopoeia. As a result, safety as a pharmaceutical cannot be ensured. Ensuring the safety of this drug is a major problem.

[0006]

SUMMARY OF THE INVENTION The present invention has been made in order to solve the above-mentioned problems, and is directed to a transfusion package using a laminate packaging material in which various films are laminated in a multilayer using an adhesive. , Gas barrier properties (oxygen
A package for infusion of pharmaceuticals, which has water vapor and is capable of suppressing the dissolution of low-molecular-weight components derived from the resin of printing inks and adhesives into the contents even if sterilization treatment is performed by applying sufficient heat and pressure. It is an object of the present invention to provide a packaging material for infusion which enables the following. Another object of the present invention is to provide a package for infusion using the packaging material for infusion.

[0007]

SUMMARY OF THE INVENTION The present invention provides an ethylene, α
-An infusion packaging material characterized in that a copolymer of one or more of olefins and other olefinic monomers and a cyclic olefin is used for an inner layer.

The present invention is also a packaging material for infusion, characterized in that a ring-opened polymer of a cyclic olefin or a hydrogenated product thereof is used for an inner layer.

Further, the present invention provides the infusion packaging material according to the present invention, wherein the outer layer of the inner layer is provided with a gas barrier layer composed of a polyethylene terephthalate film layer and a transparent glass vapor-deposited layer laminated using an adhesive. A packaging material for infusion characterized by the following.

Further, the present invention is characterized in that the infusion packaging material according to the present invention is provided with a heat-sealing seal portion formed by laminating two sheets with the inner layer as an inner surface and heating and pressing the periphery. It is a package for infusion.

[0011]

Embodiments of the present invention will be described below. FIG. 1 is an enlarged sectional view showing a part of an embodiment of a packaging material for infusion according to the present invention. As shown in FIG. 1, an infusion packaging material (10) according to the present invention comprises an inner layer (11), an adhesive layer (12), and a gas barrier layer (1).
3) are formed by laminating in this order.

The inner layer (11) is made of a copolymer (21) of one or more of ethylene, α-olefin and other olefin monomers, a cyclic olefin and a linear low-density polyethylene (31). It is composed. The gas barrier layer (13) is composed of a polyethylene terephthalate film layer (23) and a transparent glass deposition layer (33) as a gas barrier material.
The surface of the transparent glass vapor deposition layer (33) of 3) is laminated on the surface of the copolymer (21) of the inner layer (11) via the adhesive layer (12).

FIG. 2 shows a packaging material for infusion (1) according to the present invention.
1 is a plan view of a four-side seal pouch showing an example of a package using (0). FIG. 3 is a cross-sectional view showing the XX ′ cross section of the four-side seal pouch (20) in FIG. As shown in FIGS. 2 and 3, a four-sided seal pouch (20) using the infusion packaging material (10) according to the present invention has two sheets with the inner layer (11) of the infusion packaging material (10) as the inner surface. They are overlapped, filled with contents (not shown), heated and pressurized on the four sides (14) of the rectangular shape, and heat-sealed together to form a bag and hermetically sealed.

The infusion packaging material according to the present invention has the above-mentioned structure. In the four-side seal pouch (20) using such an infusion packaging material, the copolymer (21) of the present invention is contained in the inner layer. Since it is used, it has gas barrier properties (oxygen and water vapor), and even if it is sterilized by sufficient heating and pressurization, the elution of low molecular weight components derived from the resin of printing inks and adhesives into the contents will not occur. It becomes a package for infusion of pharmaceuticals to be suppressed.

In the present invention, as shown in FIG. 1, a gas barrier layer (13) composed of a polyethylene terephthalate film layer (23) and a transparent glass vapor deposition layer (33) as a gas barrier material is used. Is preferable. This is the gas barrier layer (13)
By using, the gas barrier property is strengthened, and the sterilization treatment by heating and pressurizing can be performed more sufficiently on the infusion package, and the infusion package can be subjected to multiple packaging such as secondary packaging or tertiary packaging. This is because there is no need to equip the outer bag.

In FIG. 1, an infusion packaging material (10) is formed by an inner layer (11), an adhesive layer (12) and a gas barrier layer (13). Has various functions in the outer layer of the gas barrier layer (13), for example, biaxially stretched film such as polyethylene terephthalate, nylon, biaxially stretched polypropylene, poval, or ethylene-poval copolymer, unstretched polypropylene, An unstretched film such as polyethylene may be used by further laminating it in multiple layers. As the transparent glass deposition layer (33), an inorganic oxide such as silicon oxide or aluminum oxide can be used. Its thickness is 50
It only has to be about 0 to 2000 mm.

In FIG. 1, the gas barrier layer (13) is adjacent to the inner layer (11) via the adhesive layer (12), but the gas barrier layer (13) is not necessarily required to be adjacent. Alternatively, another film may be laminated between the inner layer (11) and the gas barrier layer (13).

As a method of producing a packaging material for infusion, a film-formed product of the copolymer of the present invention may be dry-laminated, or a knee lam method in which the film is formed and then laminated in-line. Furthermore,
It can also be produced by laminating the copolymer by melt extruding the film and laminating another resin from above after extruding the copolymer.

The cyclic olefin of the copolymer in the present invention
As a component, for example, cyclohexene or its derivative
Body, cycloheptene or derivatives thereof, cyclooctene
Or a derivative thereof, cyclononene or a derivative thereof,
Clodecene or a derivative thereof, bicyclo [2.2.1]
Hept-2-ene or a derivative thereof, tetracyclo
[4.4.0.1^2.5. 1^7.10] -3-dodecene or
Its derivative, hexacyclo [6.6.1.1].^3.6. 1
^10.13. 0^2.7. 0^9.14-4-heptadecene or its
Octacyclo [8.8.0.1]^2.9.
1^4.7. 1^11.10. 1^13.16. 0^3.8. 0^12.17] -5
-Dococene or a derivative thereof, pentacyclo [6.6.
1.1^3.6. 0^2.7. 0^9.14] -4-hexadecene or
Is a derivative thereof, pentacyclo [6.5.1.1.^3.6. 0
^2.7. 0^9.13-4-pentadecene or a derivative thereof,
Heptacyclo [8.7.0.1^2.9. 1^4.7.
1^11.17. 0^3.8. 0^{12 .16}] -5-eicosene or
Its derivative, heptacyclo [8.8.0.1^2.9. 1
^4.7. 1^11.16. 0^3.8. 0^12.17] -5-Hen Eiko
Sen or its derivative, tricyclo [4.4.0.1
^2.5-3-undecene or a derivative thereof, tricyclo
[4.3.0.1^2.5] -3-Decene or derivatives thereof
Body, tricyclo [4.3.0.1^2.5] -3,7-deca
Diene, pentacyclo [6.5.1.1^{3. 6}. 0^2.7.
0^9.13] -4,10-pentadecadiene or derivatives thereof
Body, pentacyclo [4.7.0.1^2.5. 0^8.13. 1
^9.12] -3-pentadecene or a derivative thereof, heptacy
Black [7.8.0.1^3.6. 0^2.7. 1^10.17. 0
^11.16. 1 ^12.15-4-Eicosene or its induction
Body, nonacyclo [9.10.1.1]^{Four. 7}. 0^3.8. 0
^2.10. 0^12.21. 1^13.20. 0^14.19. 1^15.19] -5
-Can include pentasecon or its derivatives
In this case, one component or two or more components may be used.

Further, ring-opened products of the above monomers or derivatives thereof other than cyclohexene or derivatives thereof, cycloheptene or derivatives thereof, cyclooctene or derivatives thereof, cyclononene or derivatives thereof, cyclodecene or derivatives thereof, and hydrogenated products thereof, etc. These may be one component or two or more components.

The olefin component for copolymerizing the cyclic olefin component includes, for example, ethylene, propylene, 1-butene, 1-pentene, 4-methyl-pentene, 3-methyl-pentene, 1-hexene, and 1-hexene. Examples thereof include butene, 1-octene, 1-nonene, 1-decene and the like, and these may be one component or two or more components.

In the copolymer of the present invention, the structural unit derived from an olefin component such as an ethylene component is 5 to 60.
In the range of mol%, the structural unit derived from the cyclic olefin component is usually in the range of 40 to 95 mol%.

Further, as the cyclic olefin (co) polymer in the present invention, a ring-opened (co) polymer obtained by ring-opening (co) polymerizing a cyclic olefin and a hydrogenated product thereof can be used. Examples of the cyclic olefin that can be used here include cyclohexene or a derivative thereof, cycloheptene or a derivative thereof, cyclooctene or a derivative thereof, cyclononene or a derivative thereof, cyclomonene or a derivative thereof, and the above-described monomers or derivatives thereof other than the cyclodecene or a derivative thereof. These are ring-opened homopolymers or ring-opened copolymers of two or more components, and hydrogenated products thereof.

[0024]

The present invention will be described in detail with reference to the following examples. <Example 1> A coextruded film of a linear low-density polyethylene and a copolymer of the present invention was used as an inner layer, and a transparent glass vapor-deposited film obtained by vapor-depositing aluminum oxide on a polyethylene terephthalate film was used as a gas barrier layer. Was. The co-extruded film and the transparent glass evaporated film were dry-laminated to obtain a packaging material for infusion.

Using this packaging material for infusion, a two-sided seal pouch (120 mm × 170 mm;
0 mm), and filled with distilled water as a content.
A retort sterilization treatment was performed at 0 ° C. for 60 minutes. The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposition layer / adhesive layer / co-extruded film layer (40 μm) Co-extruded film layer (40 μm) is composed of 10 μm of cyclic olefin copolymer and 30 μm of linear low density polyethylene.
It is.

The layer structure is shown below by abbreviations. PET12μm * / ad / COC10μm / LLDP
E: 30 μm PET: polyethylene terephthalate film layer (same below) *: transparent glass deposited layer (same below) ad: adhesive layer (same below) COC / LLDPE: co-extruded film of cyclic olefin copolymer and linear low-density polyethylene Layer (the same applies hereinafter) COC: ethylene-tetracyclododecene copolymer (hereinafter the same applies to Example 4) The layer constitutions of Examples 1 to 10 are shown in Table 1 by abbreviated symbols. The adhesive layer used was A-515 / A-50 manufactured by Takeda Pharmaceutical Co., Ltd., and the coating amount was 3.
5 g / m ² .

The distilled water after the retort sterilization treatment was analyzed. 1) As a quantitative analysis of a compound eluted in distilled water, distilled water was directly measured with UV absorption spectrum (wavelength range: 200
４００400 nm). 2) As the supersaturated state of the insoluble substance eluted in the distilled water, the number of the insoluble fine particles (2 to 5 μm) is measured using the light shielding fine particle measuring apparatus with the distilled water as it is. 3) As quantitative analysis of organic compounds eluted in distilled water,
The residue obtained by liquid-liquid extraction and concentration using distilled water in a solvent was measured by gas chromatography. Table 3 shows the measurement results of Examples 1 to 10.

Example 2 A coextruded film of high-density polyethylene and the copolymer of the present invention was used as the inner layer, and a transparent glass vapor-deposited film obtained by vapor-depositing aluminum oxide on a polyethylene terephthalate film was used as the gas barrier layer. Was. The co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer structure of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposition layer / adhesive layer / co-extruded film layer (40 μm) The co-extruded film layer (40 μm) is a cyclic olefin copolymer of 10 μm and a high-density polyethylene of 30 μm. The layer constitution is shown below by abbreviations. PET12μm * / ad / COC10μm / HDPE
30 μm HDPE: High-density polyethylene layer (same below) COC / HDPE: Co-extruded film layer of cyclic olefin copolymer and high-density polyethylene (same below)

Example 3 A multi-layer coextruded film of low-density polyethylene, linear low-density polyethylene and the copolymer of the present invention was used as an inner layer, and aluminum oxide was used as a gas barrier layer in a polyethylene terephthalate film. A deposited transparent glass deposited film was used. The multilayer co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer structure of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposited layer / adhesive layer / multilayer co-extruded film layer (40 μm) The multilayer co-extruded film layer (40 μm) is composed of a cyclic olefin copolymer 10 μm, a linear low density polyethylene 10
μm, low-density polyethylene 20 μm. The layer constitution is shown below by abbreviations. PET12μm ・ * / ad / COC10μm // LLD
PE 10 μm // LDPE 20 μm LDPE: Low density polyethylene layer (the same applies hereinafter)

Example 4 A multi-layer coextruded film of low-density polyethylene, high-density polyethylene and the copolymer of the present invention was used as the inner layer, and a transparent film was formed by depositing aluminum oxide on a polyethylene terephthalate film as the gas barrier layer. A glass evaporated film was used.
The multilayer co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposited layer / adhesive layer / multilayer co-extruded film layer (40 μm) Multi-layer co-extruded film layer (40 μm) is composed of 10 μm of cyclic olefin copolymer, 10 μm of high density polyethylene,
Low density polyethylene 20 μm. The layer constitution is shown below by abbreviations. PET12μm * / ad / COC10μm // HDP
E10μm // LDPE20μm

Example 5 A multi-layer co-extruded film of low-density polyethylene, the copolymer of the present invention and low-density polyethylene was used as the inner layer, and a transparent film was formed by depositing aluminum oxide on a polyethylene terephthalate film as a gas barrier layer. A glass evaporated film was used.
The multilayer co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposited layer / adhesive layer / multilayer coextruded film layer (40 μm) The multilayer coextruded film layer (40 μm) is made of low-density polyethylene 15 μm, cyclic olefin copolymer 5 μm, and low-density polyethylene 20 μm. The layer constitution is shown below by abbreviations. PET12μm * / ad / LDPE15μm // CO
C5 μm // LDPE 20 μm COC: hydrogenated polymer of dicyclopentadiene ring-opening polymer (hereinafter the same as in Example 12)

Example 6 A multilayer coextruded film of a linear low-density polyethylene, a copolymer according to the present invention, and a linear low-density polyethylene was used as an inner layer, and a polyethylene terephthalate film was used as a gas barrier layer. A transparent glass evaporated film on which aluminum oxide was evaporated was used. The multilayer co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer structure of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposited layer / adhesive layer / multilayer coextruded film layer (40 μm) Multilayer coextruded film layer (40 μm) is composed of linear low density polyethylene 15 μm and cyclic olefin copolymer 5 μm.
m, linear low density polyethylene 20 μm. The layer constitution is shown below by abbreviations. PET12μm ・ * / ad / LLDPE15μm // C
OC5μm // LLDPE20μm

<Example 7> A multi-layer coextruded film of high-density polyethylene, a copolymer according to the present invention and a linear low-density polyethylene was used as an inner layer, and aluminum oxide was used as a gas barrier layer in a polyethylene terephthalate film. A deposited transparent glass deposited film was used. The multilayer co-extruded film and the transparent glass-deposited film were dry-laminated with the same adhesive layer as in Example 1 to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 1, and the distilled water after the retort sterilization treatment was analyzed.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposited layer / adhesive layer / multilayer coextruded film layer (40 μm) Multilayer coextruded film layer (40 μm) is composed of linear low density polyethylene 15 μm and cyclic olefin copolymer 5 μm.
m, high-density polyethylene 20 μm. The layer constitution is shown below by abbreviations. PET12μm ・ * / ad / LLDPE15μm // C
OC5μm // HDPE20μm

Example 8 A low-density polyethylene film and a cyclic olefin copolymer were used as the inner layer, and a transparent glass vapor-deposited film obtained by vapor-depositing a transparent glass on a polyethylene terephthalate film was used as the gas barrier layer. An anchor coat agent was applied to this transparent glass vapor-deposited film, and a low-density polyethylene film was sand-laminated with a cyclic olefin copolymer to obtain a packaging material for infusion.

Using this packaging material for infusion, a two-sided seal pouch (120 mm × 170 mm;
0 mm), and filled with distilled water as a content.
A retort sterilization treatment was performed at 0 ° C. for 60 minutes.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposition layer / anchor coating agent layer / coextruded film layer (45 μm) The coextruded film layer (45 μm) is a cyclic olefin copolymer 15 μm and a low density polyethylene 30 μm. The layer constitution is shown below by abbreviations. PET12μm * / AC / COC15μm / LDPE
30 μm Further, the anchor coat agent layer is manufactured by Takeda Pharmaceutical Co., Ltd .: A-
Using 3210 / A-3070, the coating amount is 0.5 g / m
² The distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 1.

Example 9 A linear low-density polyethylene and a cyclic olefin copolymer were used as the inner layer, and a transparent glass vapor-deposited film obtained by vapor-depositing aluminum oxide on a polyethylene terephthalate film was used as the gas barrier layer. The same anchor coating agent as in Example 8 was applied to this transparent glass-deposited film, and a low-density linear polyethylene film was sand-laminated with a cyclic olefin copolymer to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 8, and the distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 8.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposition layer / Anchor coating agent layer / Co-extruded film layer (45 μm) Co-extruded film layer (45 μm) is composed of a cyclic olefin copolymer 15 μm and a linear low-density polyethylene 30 μm.
It is. The layer constitution is shown below by abbreviations. PET12μm * / AC / COC15μm / LLDP
E30μm

Example 10 A high-density polyethylene and a cyclic olefin copolymer were used as an inner layer, and a transparent glass vapor-deposited film in which aluminum oxide was vapor-deposited on a polyethylene terephthalate film was used as a gas barrier layer. The same anchor coating agent as in Example 8 was applied to this transparent glass-deposited film, and a high-density polyethylene film was sand-laminated with a cyclic olefin copolymer to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 8, and the distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 8.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposition layer / anchor coating agent layer / co-extruded film layer (45 μm) The co-extruded film layer (45 μm) is a cyclic olefin copolymer 15 μm and a high-density polyethylene 30 μm. The layer constitution is shown below by abbreviations. PET12μm * / AC / COC15μm / HDPE
30 μm

<Example 11> As an inner layer, a multilayer coextruded film of polypropylene, an adhesive layer and low-density polyethylene and a cyclic olefin copolymer, and as a gas barrier layer, a transparent glass obtained by depositing a transparent glass on a polyethylene terephthalate film A vapor deposition film was used.
The adhesive layer used was a polypropylene graft-modified with maleic anhydride. The same anchor coating agent as in Example 8 was applied to this transparent glass vapor-deposited film, and a multilayer co-extruded film was sand-laminated with a cyclic olefin copolymer to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 8, and the distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 8.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposition layer / Anchor coating agent layer / Cyclic olefin copolymer layer (15 μm) Multi-layer co-extruded film layer (30 μm) Co-extruded film layer (30 μm) is polypropylene layer 10 μm, adhesive layer 10 μm, low density polyethylene 10
μm.

The layer structure is shown below by abbreviations. PET12μm ・ * / AC / COC15μm // LDP
E10 μm // adhesive layer 10 μm // PP10 μm Table 2 shows the layer configurations of Examples 11 to 12 and Comparative Examples 1 and 2 by abbreviations. Further, Examples 11 to 12 and Comparative Examples 1 to
Table 4 shows the measurement results of No. 2.

Example 12 A multi-layer coextruded film of polypropylene, an adhesive layer and a linear low-density polyethylene and a cyclic olefin copolymer were deposited as an inner layer, and aluminum oxide was deposited on a polyethylene terephthalate film as a gas barrier layer. A transparent glass evaporated film was used. The adhesive layer used was a polypropylene graft-modified with maleic anhydride. The same anchor coating agent as in Example 8 was applied to this transparent glass vapor-deposited film, and a multilayer co-extruded film was sand-laminated with a cyclic olefin copolymer to obtain a packaging material for infusion. Further, a four-sided seal pouch was prepared in the same manner as in Example 8, and the distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 8.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposition layer / Anchor coating agent layer / Cyclic olefin copolymer layer (15 μm) Multi-layer co-extruded film layer (30 μm) Co-extruded film layer (30 μm) is polypropylene layer 10 μm, adhesive layer 10 μm, linear low density polyethylene 10 μm. The layer constitution is shown below by abbreviations. PET12μm * / AC / COC15μm // LLD
PE 10 μm // adhesive layer 10 μm // PP10 μm

Comparative Example 1 Comparative Example 1 is a material and a layer structure according to a conventional method. A linear low-density polyethylene film was used as the inner layer, and a transparent glass vapor-deposited film in which aluminum oxide was vapor-deposited on a polyethylene terephthalate film was used as the gas barrier layer. The linear low-density polyethylene film and the transparent glass vapor-deposited film were dry-laminated to obtain a packaging material for infusion.

Using this packaging material for infusion, a two-sided seal pouch (120 mm × 170 mm, seal width 1 mm) was superposed with the inner layer on the inner surface and the periphery was heated and pressurized and heat-sealed.
0 mm), and filled with distilled water as a content.
A retort sterilization treatment was performed at 0 ° C. for 60 minutes.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass deposition layer / adhesive layer / linear low density polyethylene film (40 μm) The layer constitution is shown below by abbreviations. PET 12 μm * / ad / LLDPE 40 μm The adhesive was manufactured by Takeda Pharmaceutical Co., Ltd .: A-515 / A-
50, and the coating amount is 3.5 g / m ² . The distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 1.

<Comparative Example 2> Comparative Example 2 is a material and a layer structure according to a conventional method. As the inner layer, a co-extruded film of linear low density polyethylene and low density polyethylene,
Further, as a gas barrier layer, a transparent glass vapor-deposited film obtained by vapor-depositing aluminum oxide on a polyethylene terephthalate film was used. The co-extruded film and the transparent glass evaporated film were dry-laminated to obtain a packaging material for infusion.

Using this packaging material for infusion, a two-sided seal pouch (120 mm × 170 mm, seal width 1 mm) was superposed by heat-pressing and heat-sealing the periphery with the inner layer as the inner surface.
0 mm), and filled with distilled water as a content.
A retort sterilization treatment was performed at 0 ° C. for 60 minutes.

The layer constitution of the packaging material for infusion is shown below. Polyethylene terephthalate film layer (12 μm)
Transparent glass vapor deposition layer / anchor coating agent layer / co-extruded film layer (45 μm) The co-extruded film layer (45 μm) is low-density polyethylene 15 μm and linear low-density polyethylene 30 μm. The layer constitution is shown below by abbreviations. PET12μm * / AC / LDPE15μm / LLD
PE 30 μm Further, the anchor coating agent layer is manufactured by Takeda Pharmaceutical Co., Ltd .: A-
Using 3210 / A-3070, the coating amount is 0.5 g / m
² The distilled water after the retort sterilization treatment was analyzed in the same manner as in Example 1.

[0058]

[Table 1]

[0059]

[Table 2]

[0060]

[Table 3]

[0061]

[Table 4]

As shown in Tables 3 and 4, Examples 1 to 7 in Table 3 and Comparative Example 1 in Table 4 are compared. Elution of the low-molecular-weight components into the contents is significantly suppressed. Examples 8 to 12 shown in Tables 3 and 4
In comparison with Comparative Example 2 in Table 4, in Examples 8 to 12, the elution of the low molecular weight component derived from the resin into the contents was all significantly suppressed.

[0063]

According to the present invention, ethylene, α-olefin,
Since it is a packaging material for infusion using a copolymer of any one or more of other olefinic monomers and a cyclic olefin for the inner layer, it can be used in a state where various films are laminated in multiple layers using an adhesive. It has gas barrier properties (oxygen and water vapor), and even if it is sterilized by applying sufficient heat and pressure, elution of low molecular weight components derived from resin of printing inks and adhesives into the contents is suppressed. Infusion packaging material that enables infusion packaging of pharmaceutical products.

Since the present invention is a packaging material for infusion using a ring-opened polymer of a cyclic olefin or a hydrogenated product thereof for the inner layer, it can be used in a state where various films are laminated in a multilayer using an adhesive. Also has gas barrier properties (oxygen and water vapor) and suppresses the elution of low molecular weight components derived from resin of printing inks and adhesives into the contents even if sterilization treatment is performed with sufficient heat and pressure. It becomes a packaging material for infusion which enables a packaging for infusion of a drug to be used.

Further, the present invention provides the above-mentioned packaging material for infusion,
A heat-sealed portion formed by superposing two layers with the inner layer as the inner surface and heating and pressurizing the periphery is provided, so it has gas barrier properties (oxygen and water vapor) and sterilization by sufficient heat and pressure This makes it possible to provide a pharmaceutical transfusion package in which the elution of low molecular weight components derived from the resin of the printing ink or the adhesive into the contents is suppressed.

[Brief description of the drawings]

FIG. 1 is an enlarged sectional view showing a part of an embodiment of a packaging material for infusion according to the present invention.

FIG. 2 is a plan view of a four-side seal pouch showing an example of a package using the packaging material for infusion according to the present invention.

FIG. 3 is a cross-sectional view showing a cross section XX ′ of the four-side seal pouch in FIG. 2;

[Explanation of symbols]

10 packaging material for infusion according to the present invention 11 inner layer 12 adhesive layer 13 gas barrier layer 14 square around 20 20 square sealing pouch using packaging material for infusion 21 according to the present invention 21 Copolymer in the present invention 23 {polyethylene terephthalate film layer 31} linear low density polyethylene 33} transparent glass deposited layer

Claims (4)

[Claims] An infusion packaging material characterized by using a copolymer of a cyclic olefin and any one or more of ethylene, α-olefin and other olefin monomers in an inner layer. 2. A packaging material for infusion, wherein a ring-opened polymer of a cyclic olefin or a hydrogenated product thereof is used for an inner layer. 3. A gas barrier layer comprising a polyethylene terephthalate film layer and a transparent glass vapor-deposited layer laminated on an outer layer of the inner layer using an adhesive. The packaging material for infusion according to the above. 4. A heat-sealing seal portion formed by laminating two infusion packaging materials according to claim 1 with the inner layer as an inner surface and heating and pressing the periphery. Infusion packaging.