JPH10201818A - Double cell container made of plastic film - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a double cell container which exhibits a long-term preservation effect capable of preventing the oxidation decomposition of the powder agent housed in the container for a long period. SOLUTION: The powder agent which is liable to be changed in properties by oxygen is housed in at least one cell of the container made of plastic films segmented to a plural number of cells having a barrier mechanism communicatable at the time of use and the cell is tightly packaged by an external film having a gas barrier property. The external film is at least partly composed of the laminated materials of the plastic films having an oxygen absorptive resin layer on the inner layer of the bas barrier layer.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a multi-chamber container, and more particularly to a gas-barrier outer film, which can stably store powders which are easily degraded by oxygen such as antibiotics without causing oxidative decomposition. The present invention relates to a multi-chamber container made of plastic film.

[0002]

2. Description of the Related Art In general, powders such as antibiotics, which are easily deteriorated by oxygen, are stored in a glass container in order to remove the influence of oxygen. Etc. Flexible plastic film container (bag)
In order to further avoid adverse effects of oxygen, the container body is externally packaged (packaged) with a gas-barrier outer container, and a deoxidizer is stored in the space between the main container and the outer container and circulated. (Multi-chamber container)
No. 64850).

[0003]

However, the adoption of this means, however, necessitates a step of accommodating the oxygen absorber in the production of the product, which necessitates an extra complicated operation which raises the cost of the product. There is a concern that there is a danger of the oxygen agent leaking out of storage, or the oxygen absorbing ability may vary depending on the storage conditions of the oxygen absorber, and further improvement has been demanded.

[0004] Accordingly, an object of the present invention is to replace the above-mentioned double-chambered container with a solution to the harmful effects observed therewith, and to provide a sufficient long-term preservation effect, in particular, oxidative decomposition of powders such as antibiotics for a long period of time. And to provide a new multi-chamber container which can be prevented.

As a result of intensive studies, the present inventors have found that the above objects can be achieved by the following specific double-chamber container, and have completed the present invention.

[0006]

That is, according to the present invention,
At least one of the plastic film containers divided into a plurality of chambers having a partition mechanism capable of communicating at the time of use contains a powder agent easily deteriorated by oxygen, and the chamber is tightly packaged with a gas barrier outer film, A multi-chamber container made of a plastic film, wherein at least a part of the film is formed of a plastic film laminate having an oxygen-absorbing resin layer inside a gas barrier layer, and a plurality of chambers having a partition mechanism capable of communicating in use. At least one chamber of a plastic film container partitioned into a container stores a powder agent that is easily degraded by oxygen, at least the chamber is made of a plastic film laminate having an oxygen-absorbing resin layer, and the chamber is a gas barrier exterior film. The present invention provides a plastic film double-chamber container characterized in that it is tightly packaged.

Further, according to the present invention, it is easy for oxygen to deteriorate in one room adjacent to the hanging part of the plastic film bag having the hanging part, which is divided into two chambers having a partition mechanism capable of communicating at the time of use. The powder agent is stored, the chamber and the hanging part are covered with a gas barrier outer film,
A plastic film double-chamber bag, wherein the chamber and the hanging part are covered with a gas barrier exterior film, and an oxygen-absorbing resin layer is formed inside the gas barrier exterior film for the chamber or the hanging part. A powder material which is easily deteriorated by oxygen is stored in a room adjacent to the hanging portion of a plastic film bag having a hanging portion, which is divided into two rooms having a partition mechanism capable of communicating at the time of use; A plastic film laminated material having an oxygen-absorbing resin layer, and a room for accommodating a powder agent which is easily degraded by oxygen and a hanging part are tightly packaged with a gas barrier outer film. A bag is provided.

The multi-chamber container of the present invention can prevent the deterioration of the powder agent due to oxygen until the powder agent such as an antibiotic is used, and can surely guarantee its stability. It is extremely convenient at the time of manufacture, transportation, storage, and disposal.

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The container of the present invention is preferably made of a gas-permeable plastic film, and is particularly preferably in the form of a polyolefin flexible bag. The partition mechanism that enables communication between the multiple chambers of the container when in use is not particularly limited, and any of various known mechanisms can be employed. As a specific example thereof, for example, a seal having an easy peel open property (Japanese Unexamined Patent Application Publication No.
No. 4671, Japanese Utility Model Laid-Open No. 5-5138, etc.)
And a hollow plug welded to the partition (JP-B 63-20
550) or a clip sandwiched from the outside (see Japanese Patent Application Laid-Open No. 63-309263). In any case, it is preferable that the separating means can be broken or opened by an external operation during use so that the multiple chambers can communicate with each other, whereby the contents can be easily mixed without exposing the contents to the outside air.

The powder contained in the container is not particularly limited as long as it contains at least one component containing a component that is easily degraded by oxygen, and contains the component that is easily degraded by oxygen. Examples thereof include antibiotics such as antibiotics, anticancer agents, steroids, thrombolytic agents, vitamins and the like.

A preferred embodiment of the multi-chamber container according to the present invention is a gas-barrier outer film provided on both sides of the front and back sides so as to completely cover the entirety of a specific chamber containing a powder agent which is easily deteriorated by oxygen. In a state in which the gas barrier layer is overlapped, the peripheral portion thereof is adhered to the container body, and at least one of the gas barrier outer films is made of a plastic film laminate having an oxygen-absorbing resin layer inside the gas barrier layer. Can be mentioned.

Other preferred embodiments of the multi-chamber container of the present invention include, for example, (1) an outer film having an oxygen-permeable sealant layer in the innermost layer thereof, and (2) a plastic film laminate constituting the outer film. Has a protective layer on its outermost layer, and (3) the plastic film laminate constituting the exterior film has a gas-barrier plastic film layer on its outermost layer, and this layer has a silica-deposited polyethylene terephthalate resin layer on a silica-deposited surface. (4) The protective layer is a polyethylene terephthalate, polypropylene or polyamide layer, and the gas barrier layer is polyvinyl alcohol, ethylene.
Examples thereof include a vinyl alcohol copolymer, a polyvinylidene chloride or aluminum layer, and (5) a layer in which the oxygen-absorbing resin inner layer is a polyolefin resin layer mixed with iron, an iron compound or a sulfite.

Further, another preferred embodiment of the multi-chamber container of the present invention is a plastic film bag having a hanging part, the container being divided into two chambers having a partition mechanism capable of communicating when used. A powder agent that is easily deteriorated by oxygen is stored in a chamber adjacent to the hanging part, and the chamber and the hanging part are tightly covered with a gas barrier outer film, and an oxygen-absorbing resin layer is provided inside the gas barrier layer of the hanging part. Can be exemplified.

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

That is, the main body of the multi-chamber container can be made of a gas-permeable plastic film material. Specific examples of the material include, for example, polypropylene, linear low-density polyethylene, ethylene / α-olefin-based elastomer, electron beam-crosslinked ethylene / vinyl acetate copolymer, and a mixed resin thereof. They can also be used as a multilayer. When the partition mechanism of the multi-chamber container of the present invention is a seal having an easy peel open property, it is preferable that the resin directly involved in the seal is a resin mixture composed of at least two kinds of polyolefin resins. The oxygen permeability of the container body is usually 1000 ml /
It is suitable that m ² · 24 hr · 25 μ · atm or more. The container body is preferably formed in a flexible bag form as described above, and is manufactured by a general method, for example, a method of manufacturing with an inflation film, a method of manufacturing with a T-die film, a blow molding method, and the like. Can be performed.

As a partition mechanism of the container and a communication means at the time of use, a seal having an easy peel open property is provided, and at the time of use, a method of peeling off the seal portion by an operation from the outside to allow communication, a hollow portion at the partition portion. A method of connecting the stopper by welding the stopper from the outside when using it, opening the partition part partially, sandwiching the opening from the outside with a clip and isolating it and using this clip at the time of use A method of allowing communication by removing is suitably used.

The exterior film constituting the multi-chamber container of the present invention in which the specific chamber is externally provided must have gas barrier properties. The material of the gas-barrier exterior film is the same as the gas-barrier layer described later, and it may be a multilayer. Its oxygen permeability is usually 10 ml / m ² · 2
4 hr · 25 μ · atm or less, preferably 1 ml / m ²
It is good to be set to 24 hrs 25 μatm or less.

A chamber for accommodating a plastic film laminated material having an oxygen-absorbing resin layer inside a gas barrier layer and a suspending portion or a powder agent which is liable to be deteriorated by oxygen, which is used for at least a part of the exterior film. The following can be used as the plastic film laminate having the oxygen-absorbing resin layer.

That is, it is appropriate that the oxygen-absorbing resin layer 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; sulfites such as sodium hydrogen sulfite and sodium sulfite; pyrogallol; and ascorbic acid. Various known oxygen-absorbing substances such as organic substances may be used, and among them, iron and sodium sulfite are particularly preferable because their safety and stability are guaranteed. Further, the sodium sulfite has an advantage that the transparency of the laminated material can be maintained by its use.

The optimum amount of the oxygen-absorbing substance dispersed in the synthetic resin can be appropriately determined according to the type of the oxygen-absorbing substance used and its oxygen-absorbing ability. The amount in which about 1 to 90% by weight of the oxygen-absorbing substance is mixed can be used, and the above-mentioned optimum amount can be selected from this range.

The optimum amount is the layer structure of the laminated material formed using the above-mentioned oxygen-absorbing resin layer, the thickness of each layer, the mode of its use as an exterior film, and the exterior of the laminated material. The container itself can be appropriately determined according to the volume of the space between the container body and the exterior film, the type of powder stored in the container body, and the like.

It is preferable that the thickness of the oxygen-absorbing resin layer is about 20 to 90% of the entire laminated material formed by using the layer.

On the other hand, it is preferable to use an oxygen-permeable resin as the synthetic resin constituting the oxygen-absorbing resin layer.
In particular, polyethylene, polypropylene, ionomer, polyolefins such as maleic anhydride-modified polyethylene,
This is advantageous in terms of flexibility, moldability, affinity with a resin constituting another layer, and the like.

The oxygen-absorbing resin can be produced by melting the above-mentioned resin and mixing the above-mentioned oxygen-absorbing substance therewith.

The gas barrier layer disposed outside the oxygen-absorbing resin layer generally has an oxygen permeability of 10 ml.
/ M ² · 24 hr · 25 µ · atm or less, preferably 1
ml / m ² · 24 hr · 25 μ · atm or less, and more specifically, polyvinyl alcohol,
Ethylene-vinyl alcohol copolymer, vinyl chloride-vinylidene chloride copolymer, films of polyethylene terephthalate and the like and those obtained by depositing silica on such films, aluminum films, aluminum laminate films, etc. These films may be laminated. In particular, when the gas barrier layer is disposed as the outermost layer of the laminated material, it is preferable that the silica-deposited film is disposed with its silica-deposited surface inside.

The thickness of the gas barrier layer can be appropriately determined according to the degree of oxygen permeability of the material to be used, and is not particularly limited, but is generally about 3 to 30% of the total thickness of the formed laminate. It is preferable to set it in the range.

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

The laminated material used in the present invention may be, for example, two layers of the above-described oxygen-absorbing resin layer and a gas barrier layer disposed outside thereof, and further provided with a sealant layer as the innermost layer. it can. As the resin constituting the sealant layer, for example, polyethylene (medium, low density) or polypropylene, which is easily heat-sealed and has oxygen permeability, is preferable.

Further, 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 constituting the protective layer include polyethylene terephthalate, polypropylene, polyamide and the like, and these may be any of an unstretched film and a biaxially stretched film.

The kind of resin constituting the layers other than the above-mentioned layers and the thickness of the layer are appropriately selected so that the flexibility or rigidity of the exterior film using the obtained laminated material is appropriately adjusted. Can be changed to something.

As a preferred method of exteriorizing a specific chamber of the multi-chamber container of the present invention, the following method can be exemplified.

That is, the gas barrier layers are provided on both sides of the front and back sides of the chamber (in the case of a bag having a hanging tool and the hanging tool portion and the chamber), the two gas barrier outer films and the container are provided. By superimposing the main body and heat sealing the peripheral portion of the exterior film with the container main body,
There is a method of exteriorizing a specific chamber of a multi-chamber container.

At this time, the two gas barrier exterior films on the front and back may be the same material or different materials. Although it is preferable that the container body and the exterior film are in close contact with each other, a space may be present between them, and the space may be replaced with an inert gas such as nitrogen.

In the case where the chamber including the hanging part is exteriorized, only the hanging part or the hanging part and the chamber are formed of an oxygen-absorbing resin layer, and the exterior has a gas barrier layer outside thereof. It is also possible to heat seal the periphery by laminating films. In this case, the oxygen-absorbing resin layer does not need to be a synthetic resin layer, but may be a sheet-like form containing an oxygen-absorbing substance in an appropriate bag-like material. It is preferable that the space between the specific chamber and the hanging part is heat-sealed in a point-like manner for the fixing.

When the powder is stored in one chamber of the multi-chamber container of the present invention and the liquid is stored in the other chamber, for example, 5% glucose solution, physiological saline, distilled water for injection, etc., the production is as follows. For example, it can be implemented as follows. That is, one room of the multi-chamber container manufactured according to the above method is filled with the liquid agent,
The sterilization under high pressure is performed under the condition of 0 minutes. At this time, the chamber accommodating the powder agent is kept in a sealed state. After the above sterilization,
The chamber containing the powder is opened, filled and sealed under aseptic conditions. Thus, a desired multi-compartment container product of the present invention can be obtained.

[0036]

EXAMPLES Hereinafter, in order to explain the present invention in more detail, a production example of the multi-chamber container of the present invention will be described as an example, and then a test example showing its effect will be described.

[0037]

Example 1 (1) Production of Gas Barrier Outer Film Having Oxygen Absorbing Resin Layer 10 g of reduced iron powder having an average particle diameter of 15 μm, average particle diameter of 8 μm
Of sodium chloride powder and 50 g of molten linear low-density polyethylene (LLDPE; density 0.910, manufactured by Mitsui Petrochemical Co., Ltd.)
And a film having a thickness of 50 μm was formed by a press molding machine.

A hot-press laminated film of this film and an LLDPE film (density 0.920, manufactured by Mitsui Petrochemical Co., Ltd., 30 μ) and an aluminum film (7 μ, oxygen permeability = 0.05 ml / m ² · 24 hr · 25 μ · atm) ) And a polyethylene terephthalate film (12μ) in this order by a polyurethane-based adhesive,
A laminated film having a layer structure shown in FIG. 1 and having a thickness of about 110 μ was obtained.

In FIG. 1, (1) is a protective layer of polyethylene terephthalate, (2) is a gas barrier layer of aluminum,
(3) is an oxygen-absorbing resin layer and (4) is an LLDPE sealant layer.

(2) Manufacture of a multi-chamber container equipped with a specific chamber exterior A polyethylene bag (Otsuka Pharmaceutical Factory Co., Ltd., oxygen permeability) consisting of two chambers in which the partition wall mechanism of the container is constituted by a seal having an easy peel open property = 8000 ml / m ²
・ 24hr ・ 25μ ・ atm) so that one side of the upper chamber (including the hanging part) is completely covered, and the exterior film obtained in the above (1) is brought into close contact with the container body with the LLDPE layer inside. And the peripheral portion of the exterior film was fused to the container body by heat sealing.

The silica-evaporated polyethylene terephthalate (12
μ, manufactured by Oike Industry Co., Ltd.) / Polyethylene terephthalate (1
A gas barrier film composed of 2 μ) / LLDPE (40 μ) is overlapped with the LLDPE layer inside so as to be in intimate contact with the container body, and similarly fused by heat sealing to the container body to form a specific chamber. The obtained multi-chamber container was obtained.

(3) Production of a multi-chamber container containing an antibiotic and an infusion agent 5% glucose solution 1 was placed in the lower chamber of the multi-chamber bag obtained in (2) above.
After filling the bag and sealing the bag,
Heat sterilization was performed for minutes.

Further, under aseptic conditions, after opening the upper chamber (outer chamber) of the double-chamber bag, 2 g of cefazolin was added thereto.
Cefazolin sodium was filled to a titer and sealed to obtain the final product of the present invention shown in FIG. 2 (front view) and FIG. 3 (cross-sectional view).

In each of the figures, (5) shows an exterior room,
(6) is a room without exterior, (7) is a container body,
(8) is an exterior film having an oxygen-absorbing resin layer,
(9) shows a powder (antibiotics), (10) shows a liquid (5% glucose), and (11) shows a hanging part.

(4) Production of a multi-chamber container containing an antibiotic and physiological saline or distilled water for injection In the above (3), instead of the infusion in the lower chamber, physiological saline and distilled water for injection were used. , And 1
After heat sterilization at 18 ° C. for 40 minutes, a final product of the present invention was obtained in which one room was filled with an antibiotic and the other room was filled with a physiological saline or distilled water for injection.

[0046]

Example 2 A polyethylene bag (Otsuka Pharmaceutical Factory Co., Ltd., oxygen permeability = 8000 ml / m ² · 24 hr ·) made of two chambers in which the partition wall mechanism of the container in Example 1 is constituted by a seal having an easy peel open property. 25μ ・ at
m), the oxygen-absorbing resin layer of Example 1 was adhered to the hanging member portion with a polyurethane-based adhesive, and a gas-barrier exterior film without the oxygen-absorbing resin layer of Example 1 was used. Similarly, the final product of the present invention shown in FIG. 4 was obtained.

[0047]

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

The bag thus obtained was sterilized by heating at 118 ° C. for 40 minutes under a nitrogen atmosphere to obtain a final product.

[0049]

Test Example 1 The products prepared in Example 1 and Comparative Example 1 were stored under the conditions of 40 ° C. and 75% relative humidity, respectively, and immediately after the production, 1 month, 3 months, and 6 months after each powder preparation Was determined. Table 1 shows the results.

[0050]

[Table 1]

From Table 1, it can be seen that, according to the use of the double-chambered container of the present invention obtained in Example 1, the antimicrobial agent shows almost no coloring even after 6 months, and has excellent long-term storage stability. It was found that the powder of Comparative Example 1 was oxidatively decomposed with the passage of time, and that the powder after storage for 6 months was colored by the naked eye.

[Brief description of the drawings]

FIG. 1 is a schematic cross-sectional view showing a layer configuration of a gas barrier exterior film used in a multi-chamber container of the present invention produced in (1) of Example 1.

FIG. 2 is a front view of the multi-chamber container of the present invention manufactured in (3) of Example 1.

FIG. 3 is a longitudinal sectional view of the multi-chamber container of the present invention manufactured in (3) of Example 1.

FIG. 4 is a schematic view of the multi-chamber container of the present invention manufactured in Example 2.

[Explanation of symbols]

 (1) Protective layer of polyethylene terephthalate (2) Gas barrier layer of aluminum (3) Oxygen-absorbing resin layer (4) Sealant layer of LLDPE (5) Exterior room (6) Exterior Room (7): Multi-chamber infusion container main body (8): Exterior film having oxygen-absorbing resin layer (9) Powder (10) Liquid (11) Hanging part

Claims (14)

[Claims] 1. A plastic film container which is divided into a plurality of chambers having a partition mechanism capable of communicating with each other when a powder agent which is easily deteriorated by oxygen is stored in at least one of the chambers, and the chamber is closely adhered to a gas barrier outer film. A multi-chamber container made of plastic film, wherein at least a part of the packaging film is formed of a plastic film laminate having an oxygen-absorbing resin layer inside a gas barrier layer. 2. A plastic film container which is divided into a plurality of chambers having a partition mechanism capable of communicating with each other during use, contains a powder agent which is easily deteriorated by oxygen in at least one chamber, and at least said chamber is formed of an oxygen-absorbing resin layer. A multi-chamber container made of a plastic film, wherein the multi-chamber container is made of a plastic film laminate having the following properties, and the chamber is tightly packed with a gas barrier exterior film. 3. A plastic film container partitioned into a plurality of chambers having a partition mechanism capable of communicating when in use, comprising a gas permeable plastic film.
2. The multi-chamber container according to 1. 4. The multi-chamber container according to claim 1, wherein the plastic film container partitioned into a plurality of chambers having a partition mechanism capable of communicating when used is a polyolefin flexible bag. 5. The partition mechanism is selected from a seal having an easy peel-open property, a hollow plug welded to a partition, and a clip inserted from the outside.
5. The multi-chamber container according to any one of items 1 to 4, 6. The multi-chamber container according to claim 1, wherein the powder easily deteriorated by oxygen contains an antibiotic. 7. A plastic film container divided into a plurality of chambers having a partition mechanism capable of communicating at the time of use, at least one chamber of which is tightly covered with two gas barrier exterior films, and at least one of the gas barrier exterior films. 2. A sheet comprising a plastic film laminate having an oxygen-absorbing resin layer inside a gas barrier layer.
7. The double-chamber container according to any one of claims 6 to 6. 8. The multi-chamber container according to claim 1, wherein the outer film has an oxygen-permeable sealant layer for tight outer packaging on its innermost layer. 9. The multi-chamber container according to claim 1, wherein the exterior film has a protective layer on its outermost layer. 10. The exterior film has a gas barrier layer as an outermost layer, wherein the layer is provided with a silica-deposited polyethylene terephthalate resin layer as a protective layer with the silica-deposited surface inside. 9. The double-chamber container according to any one of 8. 11. A protective layer comprising polyethylene terephthalate,
The multi-chamber container according to claim 9, which is a polypropylene or polyamide layer, and wherein the gas barrier layer is a polyvinyl alcohol, ethylene / vinyl alcohol copolymer, polyvinylidene chloride or aluminum layer. 12. The multi-chamber container according to claim 1, wherein the oxygen-absorbing resin inner layer is a polyolefin resin layer in which iron, iron compound or sulfite is mixed. 13. A plastic film bag having a hanging part, which is divided into two chambers having a partition mechanism capable of communicating with each other, and containing a powder agent which is easily deteriorated by oxygen in one room adjacent to the hanging part. A plastic film double-chamber bag, wherein the chamber and the hanging part are covered with a gas barrier exterior film, and an oxygen-absorbing resin layer is formed inside the gas barrier exterior film with respect to the chamber or the hanging part. 14. A plastic film bag having a hanging part, which is divided into two chambers having a partition mechanism capable of communicating with each other, and containing a powder agent which is easily deteriorated by oxygen in one room adjacent to the hanging part. The hanging part is made of a plastic film laminated material having an oxygen-absorbing resin layer, and the room containing the powder agent which is easily deteriorated by oxygen and the hanging part are tightly packed with a gas barrier outer film. Plastic film double-chamber bag.