JPH0767936A - Infusion solution container - Google Patents

Abstract

PURPOSE:To prevent the oxidation decomposition of an infusion solution material over a long period by enveloping a gas-permeable plastic infusion solution container storing an infusion solution with a gas barrier outer container, and forming the outer container with a plastic laminated material having an oxygen absorbing resin layer on the inside of a gas barrier layer. CONSTITUTION:A gas-permeable plastic infusion solution container containing an infusion solution containing a constituent easily decomposed by oxygen is enveloped with a gas barrier outer container, and at least part of the outer container is formed with a plastic laminated material having an oxygen absorbing resin layer 3 on the inside of a gas barrier layer 1. A polyolefin flexible bag is used for this infusion solution container. The infusion solution containing a constituent easily decomposed by oxygen contains tryptophan and/or cysteine, or contains reducing sugar and amino acid, or is a fatty emulsion.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention relates to an infusion container, in particular, an infusion solution containing components such as amino acid infusion solutions and fat emulsions which are easily deteriorated by oxygen, and can be stably stored for a long time without causing oxidative decomposition. The present invention relates to an infusion container which is packaged in a package.

[0002]

2. Description of the Related Art At present, infusion preparations are generally contained in flexible plastic containers (bags) in order to enhance sterility during administration. Among them, physiological saline or Ringer's solution is used. In the case of a formulation that is not subject to oxidation, it can be distributed and sold as it is, but in the case of an infusion formulation that is easily deteriorated by oxygen such as amino acid infusions and fat emulsions, the plastic container body that contains it Since the container itself has oxygen permeability, the container body is usually packaged with a gas barrier exterior container, and a means for allowing an oxygen scavenger or the like to be stored in the space between the main body container and the exterior container for circulation is usually adopted. Has been done.

However, the use of the above means has the following drawbacks.

(1) Since the oxygen scavenger is locally present, the oxygen in the outer container cannot be completely absorbed, and there is a risk of partial oxidation.

(2) An oxygen absorber storage step is indispensable for manufacturing a product, and an extra complicated operation for increasing the product cost is required for that purpose, and there is a risk that the oxygen absorber may be leaked. I'm worried.

(3) The oxygen scavenger may be mistakenly used or may not be properly disposed of.

(4) During transportation of the product, the stored oxygen absorber may move in the space to damage the container body or the outer container.

Therefore, the object of the present invention is to replace all the conventional infusion containers having the above-mentioned adverse effects, and to eliminate all of the above-mentioned adverse effects, and also to obtain a sufficient long-term storage effect, especially the oxidative decomposition of the infusion agent for a long time. The point is to provide a new infusion container that can be prevented.

As a result of earnest research, the present inventors have found that the above object can be achieved by the following specific packaged infusion solution container, and have completed the present invention.

[0010]

That is, according to the present invention,
An infusion solution containing a component that is easily deteriorated by oxygen is housed in a gas-permeable plastic infusion vessel, and the infusion vessel is packaged in a gas barrier exterior container, and at least a part of the exterior container absorbs oxygen inside the gas barrier layer. Provided is an infusion container having an exterior, which is characterized in that it is composed of a plastic laminated material having a functional resin layer.

The infusion container of the present invention is preferably molded into a flexible bag made of polyolefin, and the infusion contained in the container is not particularly limited as long as it contains a component which is easily deteriorated by oxygen. Examples thereof include amino acid infusion containing tryptophan and / or cysteine, infusion containing reducing sugar and amino acid, fat emulsion and the like.

As one form of the packaged infusion container of the present invention, a packaged outer package can be mentioned, and a preferred embodiment thereof is a pillow-packaged bag-shaped container. The outer container is a bag-shaped container formed by sealing the peripheral portions of two gas barrier plastic films, and at least one of the gas barrier plastic films has an oxygen-absorbing resin layer inside the gas barrier layer. It is also a preferred embodiment of the present invention to be made of a plastic laminated material, and the outer container further seals the gas barrier tray having a flange portion at the periphery of the opening and the opening portion by easily peeling off the seal. It is another preferable embodiment of the present invention that the gas barrier lid material is used, and at least one of the tray and the lid material is made of a plastic laminated material having an oxygen absorbing resin layer inside the gas barrier layer.

Other embodiments of the packaged infusion container of the present invention include, for example, (1) a package having an oxygen-permeable sealant layer as the innermost layer, and (2) a plastic laminated material constituting the package. Has a protective layer as its outermost layer, and (3) the plastic laminated material constituting the outer container has a gas barrier plastic film layer as its outermost layer, and the layer has a silica vapor-deposited polyethylene terephthalate resin layer and a silica vapor-deposited surface. Those placed inside,
(4) A protective layer is a polyethylene terephthalate, polypropylene or polyamide layer, and a gas barrier layer is a polyvinyl alcohol, ethylene vinyl alcohol copolymer, polyvinylidene chloride or aluminum layer, (5) the oxygen absorbing resin inner layer is iron , A polyolefin resin layer mixed with an iron compound or a sulfite, and the like.

The structure and manufacturing method of the infusion container of the present invention will be described in detail below. The infusion container body of the present invention can be manufactured using the following materials.

That is, the infusion container body can be made of a gas-permeable plastic material that is commonly used for this type of infusion body. Specific examples of the material include polypropylene, linear low-density polyethylene, ethylene / α-olefin elastomer, and the like, and mixed resins thereof and the like. It can also be used in multiple layers. The oxygen permeability of the infusion container body is usually 1000 ml / m.
^It is suitable that it is ² · 24 hr · 25 μ · atm or more.

The infusion container body is preferably molded into a flexible bag as described above, and its manufacture is
It can be carried out by a general method, for example, a method using an inflation film, a method using a T die film, a blow molding method, or the like. In addition, the container can be filled with an infusion solution by a commonly used general method, and if necessary, the space is replaced with an inert gas such as nitrogen gas, and then sealed by a means such as welding a cap. .
Incidentally, the sterilization of the container body may be carried out according to the present invention before it is housed in the outer container, or may be carried out together with the outer container in a form housed in the outer container, and the operation itself follows a conventional method. be able to.

It is essential that the outer container constituting the outer container for infusion according to the present invention has a gas barrier property, and in particular, a container having a gas barrier property in which at least a part thereof uses the specific plastic laminate material. To do. The material for the gas-barrier outer container may be any material as long as it includes a layer similar to the gas barrier layer in the plastic laminate described later,
It can also be multi-layered. The oxygen permeability is usually 10 ml / m ² · 24 hr · 25 μ · atm or less, preferably 1 ml / m ² · 24 hr · 25 μ · atm or less.

The following can be used as the plastic laminate having an oxygen-absorbing resin layer inside the gas barrier layer used in at least a part of the outer container.

That is, it is appropriate that the oxygen-absorbing resin layer constituting the laminated material is, for example, a synthetic resin layer in which an oxygen-absorbing substance is dispersed. Examples of the oxygen-absorbing substance used in the layer include metal-based substances such as iron, zinc, ferrous oxide, and sodium chloride-iron; and sulfites such as sodium hydrogen sulfite and sodium sulfite; pyrogallol and ascorbic acid. Various known oxygen-absorbing substances such as organic compounds may be used, and among them, iron and sodium sulfite are particularly preferable because their safety and stability are guaranteed. Further, the above sodium sulfite has an advantage that the transparency of the laminated material can be maintained by utilizing it, while iron is hydrogen sulfide which is a decomposition product which may be slightly generated when cysteine is contained in the infusion solution. It has the advantage of reacting with and eliminating the offensive odor.

As the above-mentioned oxygen-absorbing substance, water-dependent substances such as iron and sodium sulfite can be preferably used. That is, by using such a moisture-dependent oxygen-absorbing substance, when the outer container is heat-sterilized, the oxygen-absorbing ability can be exerted by the water that comes out of the infusion container body during the heat-sterilization. It is particularly effective in the case of an infusion solution that is susceptible to oxidation during heat sterilization of the infusion solution. The amount of the above oxygen-absorbing substance dispersed in the synthetic resin can be appropriately determined depending on the type of oxygen-absorbing substance used and its oxygen-absorbing ability. The amount can be such that about 90% by weight of an oxygen-absorbing substance is mixed, and the optimum amount can be selected from this range. The optimum amount is also the layer structure of the laminated material formed by using the oxygen-absorbing resin layer, the thickness of each layer, the mode of use as an outer container, and the infusion body container that is covered with the laminated material. As such, it can be appropriately determined depending on the volume of the space between the infusion container body and the outer container, the type of infusion solution contained in the container body, and the like. The oxygen-absorbing resin layer has a thickness of about 40 to about that of the entire laminated material formed by utilizing the same.
It is preferably about 80%.

On the other hand, an oxygen permeable resin is preferably used as the synthetic resin forming the oxygen absorbing resin layer,
In particular, polyolefins such as polyethylene, polypropylene, ionomers and maleic anhydride modified polyethylene are
It is advantageous in terms of flexibility, moldability, compatibility with resins forming other layers, and the like.

The above oxygen absorbing resin can be produced by melting the above resin and mixing the above oxygen absorbing substance therein.

The gas barrier layer arranged outside the oxygen-absorbing resin layer generally has an oxygen permeability of 10 ml.
/ M ² · 24 hr · 25μ · atm or less, preferably 1
ml / m ² · 24 hr · 25μ · atm or less, which is more specifically polyvinyl alcohol,
Ethylene-vinyl alcohol copolymer, vinyl chloride-vinylidene chloride copolymer, films such as polyethylene terephthalate and those obtained by vapor deposition of silica on such films, aluminum film, aluminum laminate film and the like can be used as a material, and It may be a laminate of films. In particular, when the gas barrier layer is arranged as the outermost layer of the laminated material, it is preferable to arrange the silica vapor deposition film with the silica vapor deposition surface facing inward.
The thickness of the gas barrier layer can be appropriately determined according to the degree of oxygen permeability of the material used, and is not particularly limited, but generally 3 to 30 of the entire laminated material to be formed.
It is preferably in the range of about%.

The above laminated material can be manufactured by a known method. Examples of the method include dry laminating method, hot melt laminating method, extrusion laminating method, coating method (solution type or emulsion type), coextrusion inflation method, coextrusion T-die method,
Various methods such as a hot pressing method can be exemplified. Each method may be selected as appropriate depending on the adhesiveness of each adjacent layer and a single method may be adopted, or two or more methods may be used in combination. Further, when the hot pressing method is adopted, another resin layer, for example, an adhesive resin layer such as polyethylene can be interposed between the respective layers in order to enhance the adhesiveness of the respective layers of the laminated material.

In the laminated material used in the present invention, two layers, that is, the oxygen-absorbing resin layer and the gas barrier layer arranged outside the oxygen-absorbing resin layer are essential layers, and further, a sealant layer as the innermost layer is used. It can also be provided. As the resin forming the sealant layer, for example, polyethylene (medium or low density) or polypropylene which is easily heat-welded and has oxygen permeability is preferable. Furthermore, when a hygroscopic resin such as polyvinyl alcohol or ethylene-vinyl alcohol copolymer or aluminum is used for the gas barrier layer, it is preferable to provide a protective layer for the gas barrier layer as the outermost layer. Examples of the resin forming the protective layer include polyethylene terephthalate, polypropylene, polyamide, and the like, including unstretched film, uniaxially stretched film,
Any of biaxially stretched films may be used. By appropriately selecting the kind of resin constituting the layers other than the essential layer and the thickness of the layer, the flexibility or rigidity of the outer container using the obtained laminated material is changed to an appropriate one. can do.

The outer container of the infusion container of the present invention is manufactured by using the laminated material thus obtained as a part or the whole. The manufacture of the outer container or the storage of the infusion container body by the
As described above, it can be carried out by an appropriate means depending on the form of the outer container itself, and accordingly, the range of use (part or all) of the laminated material as an outer container should be appropriately selected. You can That is, for example, when the outer container is in the form of a bag, the infusion container body is wrapped with the above-mentioned laminated material (film), and the upper and lower ends and the back portion of the laminated material are heat-sealed to form a pillow, or the infusion container body. Is placed between two laminated materials (films) to seal the peripheral edge of the film, or the three peripheral edges of the two laminated materials (films) are sealed first, and then the infusion container is inserted from the non-sealed area. A method of inserting the main body and sealing the non-sealed portion can be adopted.

In the first method, however, the entire outer container is made of a laminated material, but in the second and third methods, one of the two films to be sealed is replaced by another. By substituting the gas barrier film of
An outer container, half of which is made of a laminated material, is manufactured, and the intended effect of the present invention can be sufficiently exerted even when such an outer container is used.

The ratio of the laminated material to be used in the outer container can be appropriately determined depending on the oxygen absorption capacity of the oxygen-absorbing resin, the volume of the space between the infusion container body and the outer container, etc. It is preferably 50% or more of the total area.

The outer container of the present invention may also be of a tray type. In this case, for example, the infusion container body is housed in a tray manufactured by normal thermoforming, and a lid member is placed on the container to open the container. The infusion container housed in a desired outer container can be obtained by easily peeling and sealing at the peripheral edge flange portion with heat welding or an adhesive. Further, in this case, by using the laminated material for either one of the tray and the lid material, it is possible to manufacture the intended container having the intended effect of the present invention.

In the thus packaged infusion solution container of the present invention, the space between the infusion solution container body and the exterior container may be replaced with an inert gas such as nitrogen gas, if necessary. As described above, it is possible to sterilize the outer container together with the outer container if necessary after the outer packaging.

[0031]

EXAMPLES In order to explain the present invention in more detail, a production example of the packaged infusion container of the present invention will be given as an example, and then a test example showing its effect will be given.

[0032]

Example 1 (1) Production of Film for Outer Container 10 g of reduced iron powder having an average particle diameter of 15 μ, average particle diameter of 8 μ
0.5 g of sodium chloride powder and 50 g of melted linear low-density polyethylene (LLDPE; density 0.910, manufactured by Mitsui Petrochemical Co., Ltd.), and Labo Plastomill (manufactured by Toyo Seiki Co., Ltd.)
Was mixed in a nitrogen gas atmosphere, and a film having a thickness of 100 μ was formed by a press molding machine. On one side of this film, silica-deposited polyethylene terephthalate (1
2μ; with silica deposition surface inside; oxygen permeability = 0.1
ml / m ² · 24 hr · 25μ · atm) and LLDPE
(30μ) dry lamination film, LLD
The PE layer was placed inside and fused by hot pressing, and the LLDPE film (30μ) was similarly fused on the other surface of the film to obtain a laminated film having a layer structure shown in FIG. 1 and a thickness of about 170μ. .

In FIG. 1, (1) is a gas barrier layer,
(2) is an LLDPE layer, (3) is an oxygen-absorbing resin layer, and (4) is an LLDPE layer as a sealant layer.

(2) Manufacture of infusion solution Each component weighed according to the following formulation was distilled water for injection 800 m.
l, and the pH of the solution was adjusted to 4.7 by adding lactic acid,
Further, distilled water for injection was added to make the total amount 1 liter.
Next, the above liquid is filtered with a Millipore filter to obtain 50
0 ml of polyethylene infusion bag (Otsuka Pharmaceutical Factory, oxygen permeability = 8000 ml / m ² , 24 hr, 25
μ · atm) and the space was replaced with nitrogen gas and sealed.

Glucose 75.0 g L-arginine 2.2 g L-histidine 1.0 g L-methionine 2.4 g L-phenylalanine 2.9 g L-threonine 1.8 g L-valine 2.0 g aminoacetic acid 3.4 g L- Lysine hydrochloride 6.2 g N-acetyl-L-tryptophan 0.7 g L-leucine 4.1 g L-isoleucine 1.8 g Sodium lactate 3.3 g Sodium hydrogen sulfite 0.5 g (3) Outer packaging with the infusion solution (2) The bag was pillow-wrapped using the film produced in (1) above with the LLDPE layer on the inside to obtain a package in the form shown in FIG.

In FIG. 2, (5) shows an infusion solution containing bag, and (6) shows a pillow packaging bag.

The pillow packaging bag has a length of 28 inches.
The width was 0 mm and the width was 180 mm, and the space was replaced with nitrogen gas. Next, the whole was heat-sterilized at 105 ° C. for 40 minutes to obtain a final product.

[0038]

Example 2 (1) Production of Film for Outer Container Sodium sulfite was pulverized by a jet mill to an average particle size of about 8 μm, and 5 g of this product and an ethylene / 1-butene copolymer (density 0.885, Mitsui Oil Co., Ltd. 50)
g in a nitrogen gas atmosphere with a Labo Plastomill (manufactured by Toyo Seiki Co., Ltd.) and a thickness of 100 μm with a press molding machine.
Was formed into a film. Polyethylene terephthalate (12μ), polyvinyl alcohol (12μ; oxygen permeability = 0.3 ml / m ² · 24h) on one surface of this film
r · 25μ · atm) and LDDPE (30μ) are dry-laminated by hot pressing with the LLDPE layer inside and the LLDPE film (30μ) is similarly fused to the other surface of the film. A laminated film having a thickness of about 180 μ was obtained.

(2) Preparation of infusion solution Each component weighed according to the following formulation was distilled water for injection 800 m.
l, and the solution pH was adjusted to 7.0 by adding acetic acid,
Further, distilled water for injection was added to make the total amount 1 liter.
Next, the solution is filtered through a Millipore filter to
A polyethylene infusion bag (manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) was filled with 0 ml, and the space was replaced with nitrogen gas, sealed, and further heat sterilized at 105 ° C. for 40 minutes.

L-leucine 14.0 g L-isoleucine 8.0 g L-valine 8.0 g L-lysine acetate 14.8 g L-threonine 5.7 g L-tryptophan 2.0 g L-methionine 3.9 g L-phenylalanine 7.0 g L-cysteine 1.0 g L-tyrosine 0.5 g L-arginine 10.5 g L-histidine 5.0 g L-alanine 8.0 g L-proline 5.0 g L-serine 3.0 g aminoacetic acid 5.9 g L-Aspartic acid 1.0 g L-Glutamic acid 1.0 g Sodium bisulfite 0.2 g (3) Outer packaging The infusion solution bag of (2) above with the LLDPE layer inside using the film produced in (1) above. Pillow wrapped. The pillow packaging bag is 280 m in length.
m, horizontal 180 mm, and the space was replaced with nitrogen gas to obtain a final product.

[0041]

[Example 3] Sodium sulfite-containing ethylene-1 produced in the production of the film for outer container of Example 2 (1)
A butene copolymer and LLDPE (density 0.920; manufactured by Mitsui Petrochemical Co., Ltd.) were used in the same manner to produce a three-layer coextruded film having a thickness of 120 μ and using LLDPE as the inner and outer layers (each 10 μ). . A dry lamination film of silica vapor-deposited polyethylene terephthalate (12μ, silica vapor-deposited surface inside) and polyethylene terephthalate (12μ) was adhered to one surface of this film by dry lamination to obtain a laminated film having a thickness of about 140μ. It was

Using the film for outer packaging obtained above,
In the same manner as in (2) and (3) of Example 2, the bag containing the infusion agent was packaged by pillow packaging to obtain the product of the present invention.

[0043]

Example 4 (1) Production of Film for Exterior Container The iron-containing LLDPE film (50 μ) and LDDPE film (density 0.920, manufactured by Mitsui Petrochemical Co., Ltd., 30 μ) prepared in the production of the film of Example 1 (1) ) And a hot-press laminated film with aluminum film (8μ; oxygen permeability = 0.05 ml / m ² · 24 hr · 25 μ · a
tm) and polyethylene terephthalate film (12
and μ) were adhered in this order by dry lamination to obtain a laminated film having a thickness of about 100 μ.

(2) Production of infusion solution The same procedure as in (2) of Example 1 was carried out.

(3) Outer packaging Polyethylene terephthalate (12 μ), ethylene / vinyl alcohol copolymer (25 μ; oxygen permeability = 1.0 ml / m ² · 24 h) was added to the film produced in the above (1).
A three-layer dry lamination film composed of r · 25 μ · atm) and LLDPE (30 μ) was laminated so that the LLDPE faces each other, and the left and right side edges and the lower edge were heat-sealed to produce a bag. The size of the bag is 2 vertical.
The width was 80 mm and the width was 180 mm. An infusion bag prepared in the same manner as in Example 1 was inserted into the bag, the space was replaced with nitrogen gas, and the upper edge was heat-sealed.
The final product was obtained by heat sterilization at 105 ° C for min.

[0046]

Example 5 (1) Manufacture of Tray 500 g of reduced iron powder having an average particle size of 15 μ and 25 g of sodium chloride powder having an average particle size of 8 μ were melted by a Banbury mixer in a nitrogen gas atmosphere using a maleic anhydride-modified polyethylene (commercial product). (“Admer”, manufactured by Mitsui Petrochemical Co., Ltd.). Using this product, a 5-layer coextrusion sheet having the following constitution was manufactured according to the coextrusion T-die method, and this was plug-assisted vacuum-molded to give a vertical length of 290.
A tray having a size of mm, a width of 160 mm and a depth of 30 mm was obtained.

Outer layer: polypropylene (thickness 200 μ) Adhesive resin layer: maleic anhydride modified polypropylene (thickness 20 μ) Gas barrier layer: ethylene-vinyl alcohol copolymer (thickness 50 μ; oxygen permeability = 1.0 ml / m) ^2, 24
hr · 25μ · atm) Oxygen-absorbing resin layer: iron-containing maleic anhydride-modified polyethylene (thickness 50μ) Inner layer: polypropylene (thickness 200μ).

(2) Production of Infusion Solution The same procedure as in Example 2 was carried out.

(3) Outer packaging The infusion solution bag of (2) above is stored in the tray obtained in (1) above, the space is replaced with nitrogen gas, a lid is placed, and the peripheral flange is heat-sealed. As a result, the product of the present invention was obtained. The following three-layer film was used as the lid material.

Outer layer: polyethylene terephthalate (thickness 12 μ) Intermediate layer: biaxially stretched polyvinyl alcohol (thickness 12 μ;
Oxygen permeability = 0.3 ml / m ² · 24 hr · 25 μ · a
tm) Inner layer: 2: 1 mixed resin of LLDPE and polypropylene (thickness 40μ)

[0051]

Example 6 (1) Production of Film for Outer Container Instead of using LLDPE as a resin for dispersing an oxygen absorbing substance, an ethylene / 1-butene copolymer (density: 0.
885; manufactured by Mitsui Petrochemical Co., Ltd.)
A laminated film was obtained in the same manner as in.

(2) Manufacture of infusion solution Each component excluding sodium sulfite from the formulation of the infusion solution of Example 2 was dissolved in 800 ml of distilled water for injection, and acetic acid was added to adjust the pH to 7.0, followed by injection. Distilled water was added to bring the total volume to 1 liter. Then, this was filtered with a Millipore filter, 400 ml of the polyethylene infusion bag (manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) was filled, and the space was replaced with nitrogen gas and then sealed.

(3) Outer packaging Two films produced in the above (1) were stacked so that the LLDPEs face each other, and the left and right side edges and the lower edge were heat-sealed to produce a bag. The size of the bag is 28
The width was 0 mm and the width was 180 mm. The infusion bag obtained in (2) above was inserted into the bag, the space was replaced with nitrogen gas, the upper edge was heat-sealed, and then the whole was heat-sterilized at 105 ° C. for 40 minutes to obtain the final product. It was

[0054]

Comparative Example 1 A final product was obtained in the same manner as in Example 1 except that LLDPE was used instead of iron-containing LLDPE.

[0055]

Comparative Example 2 Sodium hydrogen sulfite-containing ethylene-1-
A final product was obtained in the same manner as in Example 2 except that an ethylene / 1-butene copolymer (density 0.885; manufactured by Mitsui Petrochemical Co., Ltd.) was used instead of the butene copolymer.

[0056]

Comparative Example 3 Instead of the iron-containing ethylene / 1-butene copolymer, an ethylene / 1-butene copolymer (density 0.88
5; manufactured by Mitsui Petrochemical Co., Ltd.) was used to obtain a final product in the same manner as in Example 6.

[0057]

[Test Example 1] The products produced in Example 1 and Comparative Example 1 were stored under the conditions of 40 ° C. and 75% relative humidity, and the light of each product content liquid after 1 month, 3 months and 6 months was stored. The transmittance (%) (wavelength = 445 nm) was measured to determine the degree of coloring of the liquid. The results are shown in Table 1.

[0058]

[Table 1]

From Table 1, according to the use of the infusion container of the present invention obtained in Example 1, the content liquid showed almost no coloration even after 6 months and was excellent in storage stability. Example 1
The light transmittance of each of the samples was decreased with time, and the liquid after storage for 6 months was visually confirmed to be colored.

[0060]

[Test Example 2] The products produced in Example 2 and Comparative Example 2 were stored under the conditions of 40 ° C. and a relative humidity of 75%, and stored in each product content liquid after 1 month, 3 months and 6 months. The residual amount (%) of cysteine was measured. The measurement was performed by the 4-PDS method. The obtained results are shown in Table 2.

[0061]

[Table 2]

From Table 2, it can be seen that by using the infusion container of the present invention obtained in Example 2, the cysteine content in the content liquid hardly changed even after 6 months, and the storage stability was excellent. In contrast, the product of Comparative Example 2 has about 10% after being stored for 6 months.
It was found that the content was low and the stability was poor.

[0063]

[Test Example 3] For the products manufactured in Example 6 and Comparative Example 3, respectively, immediately after the manufacture and at 40 ° C. and a relative humidity of 75
% Hydrogen sulfide in each content liquid after storage for 3 months and after storage for 6 months was collected in an aqueous solution of zinc acetate by nitrogen gas flow and quantified by the methylene blue method. The results obtained are shown in Table 3.

[0064]

[Table 3]

From Table 3, according to the use of the infusion container of the present invention obtained in Example 6, almost no generation of hydrogen sulfide was observed even after 6 months in the content liquid, and its odor was hardly sensed. While the storage stability was excellent, the one of Comparative Example 3 was inferior in stability because it had a strange odor from the moment when the outer bag was opened and generated a large amount of hydrogen sulfide, which was inferior in stability. became.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view showing the layer structure of a film for an outer container (bag) of the infusion solution container of the present invention produced in Example 1.

FIG. 2 is a schematic partial cross-sectional view showing an infusion solution container that is packaged using a pillow packaging type packaging bag of the present invention.

[Explanation of symbols]

 (1) ... Outermost layer (gas barrier layer) (2) ... LLDPE layer (3) ... Oxygen absorbing resin layer (4) ... LLDPE layer (5) ... Infusion container body (6) ... Outer bag (a) ... Silica vapor deposition surface

─────────────────────────────────────────────────── ───

[Procedure amendment]

[Submission date] June 24, 1994

[Procedure Amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0038

[Correction method] Change

[Correction content]

[0038]

Example 2 (1) Production of Film for Outer Container Sodium sulfite was pulverized by a jet mill to an average particle size of about 8 μm, and 5 g of this product and an ethylene / 1-butene copolymer (density 0.885, Mitsui Oil Co., Ltd. 50)
g in a nitrogen gas atmosphere with a Labo Plastomill (manufactured by Toyo Seiki Co., Ltd.) and a thickness of 100 μm with a press molding machine.
Was formed into a film. Polyethylene terephthalate (12μ), polyvinyl alcohol (12μ; oxygen permeability = 0.3 ml / m ² · 24h) on one surface of this film
r · 25 μ · atm) and L L DPE (30 μ) are dry-laminated by hot pressing with the LLDPE layer inside and the LLDPE film (30 μ) is also fused to the other surface of the film in the same manner. Then, a laminated film having a thickness of about 180 μ was obtained.

Claims (13)

[Claims] 1. An infusion solution containing a component that is easily deteriorated by oxygen is contained in a gas-permeable plastic infusion container, and the infusion container is packaged in a gas barrier exterior container, and at least a part of the exterior container is a gas barrier layer. An infusion container having an exterior, which is composed of a plastic laminated material having an oxygen-absorbing resin layer inside thereof. 2. The packaged infusion container according to claim 1, wherein the infusion container is a polyolefin flexible bag. 3. The packaged infusion container according to claim 1 or 2, wherein the infusion solution containing a component which is easily deteriorated by oxygen contains tryptophan and / or cysteine. 4. The infusion solution containing a component which is easily deteriorated by oxygen contains a reducing sugar and an amino acid.
A packaged infusion container described in. 5. The packaged infusion container according to claim 1, wherein the infusion solution containing a component which is easily altered by oxygen is a fat emulsion. 6. The packaged infusion container according to claim 1, wherein the package is a pillow-shaped bag-shaped container. 7. An outer container is a bag-shaped container formed by sealing the peripheral portions of two gas-barrier plastic films, and at least one of the gas-barrier plastic films is an oxygen-absorbing resin inside the gas barrier layer. The packaged infusion container according to any one of claims 1 to 5, which is composed of a plastic laminated material having layers. 8. An outer container comprises a gas barrier tray having a flange portion at the periphery of the opening and a gas barrier lid member that is easily peeled off and sealed at the flange portion to seal the opening. At least the tray and the lid member. The packaged infusion container according to any one of claims 1 to 5, wherein one is made of a plastic laminated material having an oxygen-absorbing resin layer inside a gas barrier layer. 9. The packaged infusion container according to claim 1, wherein the package has an oxygen-permeable sealant layer as the innermost layer. 10. The plastic laminated material constituting the outer container has a protective layer as the outermost layer.
The infusion container with an exterior according to any one of 1. 11. A plastic laminated material constituting an outer container has a gas barrier layer as an outermost layer thereof, and the layer has a silica vapor-deposited polyethylene terephthalate resin layer arranged with the silica vapor-deposited surface inside. An exterior infusion container according to any one of to 8. 12. The protective layer is polyethylene terephthalate,
The packaged infusion container according to claim 10, which is a polypropylene or polyamide layer, and the gas barrier layer is a polyvinyl alcohol, ethylene / vinyl alcohol copolymer, polyvinylidene chloride or aluminum layer. 13. The packaged infusion container according to claim 1, wherein the oxygen absorbing resin inner layer is a polyolefin resin layer mixed with iron, an iron compound or a sulfite salt.