JPH0614975A - Multi-chamber container - Google Patents

Abstract

(57) [Summary] [Purpose] Prevents moisture absorption of only substances that have hygroscopicity or easily oxidizable when storing substances that have hygroscopicity or easily oxidizable and those that do not have them in a multi-chamber container. In addition to anti-oxidation, aseptic mixing is easy and disposal of waste after use is easy. In a flexible multi-chamber container partitioned by a partition means that can communicate with each other, a moisture / gas impermeable outer wall 12 covering a part of the chamber and the chamber covered with the outer wall 12 are configured. Inner wall 14 and a space 13 inside the inner wall 14
A substance having a hygroscopic property or an easily oxidizable property is sealed in, and one or two or more weak seal portions 24 and 25 are provided as partitioning means for separating the chambers.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improvement of a flexible multi-chamber container for separately enclosing a liquid agent, a powder agent or a solid agent.

[0002]

2. Description of the Related Art When a substance having an easily oxidizable or hygroscopic property is stored in a multi-chamber container, if the entire multi-chamber container is covered with a moisture / gas barrier film, the moisture / gas barrier film is expensive and costly. Since it is expensive, cover only the necessary room with the outer wall of the moisture / gas barrier film,
A multi-chamber container is proposed in which a moisture / gas permeable film is used as an inner wall forming a chamber for storing the substance, and an oxygen scavenger or a desiccant is contained in the space between the outer wall and the inner wall. (See Japanese Patent Application No. 3-274849).
Further, when the inner wall is covered with the outer wall, the weak sealing portion (partitioning portion) of each chamber formed by welding is overlapped and welded, so that the welding strength becomes large, peeling is difficult, and it is difficult to use. Therefore, in order to avoid this, there has been proposed a multi-chamber container in which the weak seal portion (partition portion) has at least two lines and the ends of the outer wall are welded between the lines (special feature). See Japanese Patent Application No. 3-274848).

[0003]

However, in such a multi-chamber container, the oxygen scavenger and the desiccant are enclosed in the space between the outer wall and the inner wall, so that there is a problem that the cost becomes high. As the inventors of the present invention continue various researches, even when the encapsulation of the oxygen scavenger and the desiccant is omitted in the multi-chamber container, the substance contained in the chamber surrounded by the inner wall is The present invention has been completed by discovering that the double structure consisting of the outer wall of the moisture / gas barrier film has a certain effect of preventing moisture absorption and oxidation. The present invention has been made in view of such circumstances, and an object of the present invention is to store a liquid agent having a hygroscopic property, a powder agent or a solid agent, or a liquid agent having an easily oxidizable property, a powder agent or a solid agent. In addition to blocking only water from outside moisture and oxygen,
An object of the present invention is to provide a multi-chamber container capable of preventing the oxidation and moisture absorption of the substance without enclosing a deoxidizer or a desiccant.

[0004]

The present invention, which has been made to achieve such an object, is configured as follows. A A flexible multi-chamber container in which a plurality of chambers for containing a liquid agent, a powder agent, or a solid agent are partitioned by a partition means capable of communicating with each other. A water-impermeable and / or gas-impermeable outer wall covering the inner wall and an inner wall forming the chamber covered by the outer wall, and a chamber not covered by the outer wall and a wall adjacent to the outer wall and covered by the outer wall. The multi-chamber container is characterized in that the partition means for separating the separated chamber is configured by arranging one or two or more weak seal portions that can be easily peeled off by applying an external pressure to the chamber. B In the multi-chamber container according to the item A, the weak seal portion is configured by arranging at least two strips at intervals, and an end portion of an outer wall is welded to an intermediate portion between the weak seal portions. C In the multi-chamber container according to the item A or the item B,
A multi-chamber container in which a space between the outer wall and the inner wall is filled with an inert gas or a dry gas. D In the multi-chamber container according to any one of items A to C, a liquid agent, a powder agent or a solid agent having an easily oxidative property and / or a hygroscopic property is provided in a chamber inside the inner wall covered with the outer wall. A multi-chamber container designed to be stored.

[0005]

According to the present invention configured as described above, the chamber containing the liquid agent, the powder agent or the solid agent having hygroscopicity or easily oxidizable is composed of the outer wall and the inner wall of the moisture / gas barrier film. Since it has a heavy wall, it works to avoid the influence of external moisture and oxygen.

[0006]

Embodiments of the present invention will now be described in detail with reference to the drawings. In FIGS. 1 and 2, 2 is a chamber containing a substance 4 which is not hygroscopic or easily oxidizable, or a powder or solid agent, 6 is a liquid agent, hygroscopic or easily oxidizable, powder or solid agent This is the chamber on the side that houses the substance 8 of Room 2
The substance 4 is enclosed therein and the mouth 10 is attached thereto, while the chamber 6 is constituted by a double wall of the outer wall 12 and the inner wall 14, and the substance 8 is contained in the space 13 (chamber) inside the inner wall 14.
Is enclosed. As shown in FIG. 3, the inner wall 14 includes an outer layer 20 made of polyethylene (PE) and a polyethylene (P).
E) and an inner layer 22 made of a mixed resin of polypropylene (PP) and a multi-layer film, and the two multi-layer films are welded at the periphery to form the space 13.

On the other hand, the chamber 2 is constituted by the two multilayer films forming the inner wall 14 extending downward and welded. That is, two sheets of the above-mentioned multi-layered film are superposed on each other, and the peripheral portions thereof are welded together, and in the middle portion thereof, they are welded in a state in which the strength is smaller than that of the peripheral portions, and the welded portions are as shown in FIGS. As shown, two weak streaks 24, 2 as partitioning means are formed so as to form two streaks spaced apart from each other.
5 is formed, and the space portion 1 is formed with the weak seal portions 24 and 25 as boundaries.
3, chamber 2 is formed.

As shown in FIG. 5, the outer wall 12 is a multilayer film having an inner layer 26 made of polyethylene (PE) and an outer layer 28 made of a water-impermeable and gas-impermeable barrier film. Film, aluminum processed film such as aluminum vapor deposition film, and polyvinylidene chloride and polypropylene (PP)
Multiple layers are used. On the outer wall, the two multilayer films are arranged so as to cover the inner wall 14, the left and right sides and the upper part thereof are welded to each other, and the lower part is the weak seal portion 2.
It is welded to the intermediate portion between 4 and 25 and has a sealed structure. Therefore, it is possible to avoid overlapping and welding on the weak seal portions 24 and 25 at the time of welding.
The easy peel openness of can be maintained. This is because, when they are welded over the weak seal portion, the welding strength increases and the welding strength varies, and the force required for peeling the weak seal portion is large at some times and not so much at other times. However, the easy peel open property tends to be impaired, but the easy peel open property can be surely maintained by the above method. As described above, since the outer wall is heat-welded at the intermediate portion between the weak seal portions, it is separated from the adjacent chamber by the weak seal portion, so that the substance enclosed in the chamber is thermally denatured at the time of welding. Can be prevented. Further, even if an external force is erroneously applied and one weak seal portion peels off, the remaining weak seal portion can prevent communication between the chambers on both sides. Further, since the outer wall is heat-welded to the intermediate portion between the weakly sealed portions, the heat-welded portion can be prevented from contacting the weakly sealed portion, and the degree of freedom in setting the conditions for heat-welding is increased to facilitate the work. be able to.

The welding temperature for welding the various parts is
The peripheral edge of the inner wall 14 and the peripheral edge of the chamber 2 are highest, and the weak seals 24 and 25 are lower than this. On the other hand, the welding temperature of the welded portion between the inner wall 14 and the outer wall 12 depends on the weak seal portions 24, 2.
The inner layer films 22 in the middle part of No. 5 are not welded to each other,
That is, the temperature is set to be a temperature slightly higher than the welding temperature of the weak seal portions 24 and 25. As a result, the welding strengths are different from those of the inner wall 14, the chamber 2, and the outer wall 12 at the respective peripheral edge portions.
4, the adhesive portion between the outer walls 12 is almost equal, and the weak seal portion 2
4, 25 are weaker than these.

The multi-chamber container of the above embodiment is manufactured, for example, according to the manufacturing example of FIG. That is, (a) the inner layer is PE
2 is a multi-layer film with PE as the outer layer, which is a mixed resin of PP and PP.
The sheets are overlapped with each other, a three-way peripheral seal is performed at a welding temperature of about 170 to 200 ° C., and two seals for partitioning an intermediate portion are formed at a welding temperature of about 110 to 130 ° C. at predetermined intervals, and a weak seal portion 24 is formed. 25 and further the mouth 10
Attach. (B) Next, the liquid agent 4 is filled, the side (filling port) is sealed, and heat sterilization such as high-pressure steam sterilization or hot water sterilization is performed. (C) After heat sterilization, the side portion of the vacant chamber 30 is cut under aseptic conditions to provide a filling port. If necessary, dry the inside. (D) Next, a multilayer film 32 made of a moisture-impermeable and gas-impermeable barrier film having an inner layer of PE and an outer layer of a double layer of polyvinylidene chloride and PP is welded to the outside of the chamber 30. Install. The portion welded along the weak seal portions 24 and 25 is located at an intermediate position between the weak seal portions 24 and 25,
130-135 so that it does not overlap this weak seal
It is welded at ℃. (E) Thereafter, the powdered medicine 8 such as an antibiotic is put under aseptic conditions into the space inside the inner wall, and the side (filling port) is sealed. The weak seals 24, 25
Is formed by pressing a heated mold for forming a weak seal part with a cylinder device. In this mold for forming a weak seal part, two ridges at a predetermined interval can control the temperature by a power source heater. In addition, it can be moved up and down by a cylinder device.

In the embodiment constructed as described above, the inner wall 14 is made of a multi-layer film having an outer layer of PE and an inner layer of a mixed resin of PE and PP. The outer wall 1
Since 2 is composed of a moisture-impermeable and gas-impermeable barrier film, it is possible to avoid adverse effects of external moisture and oxygen. Further, the inner wall 14 and the outer wall 12 are transparent, and the internal state can be visually checked. Then, by applying a certain pressure to the chamber 2 with a finger or the like, the weak seal portions 24 and 25 are peeled off, and the chamber 2
And the space 13 are communicated with each other, and the substance 4 and the substance 8 are mixed aseptically. Examples of the substance 8 in the above examples include antibiotics, anticancer agents, steroids, urokinase, vitamins, and other easily oxidizable and heat-denatured powders, and the substance 4 is a solution or diluent thereof. For example, a liquid agent such as physiological saline or glucose solution can be mentioned.

As the inner wall, in addition to the multilayer films described in the above examples, a single layer or a multilayer film made of a combination of one or more selected from polyethylene (PE), polypropylene (PP) and mixed resins thereof is used. It is also possible. For example, as shown in FIG. 7, the outer layer 31 is linear low-density polyethylene (LLDPE), the intermediate layer 33 is LLDPE and low crystalline (amorphous) ethylene.
Mixed resin with α-olefin elastomer, inner layer 34
Is a three-layer film 3 made of a mixed resin of LLDPE and PP
5 can be mentioned. Further, depending on the drug to be encapsulated, the low molecular weight substance contained in the LLDPE used for the inner layer of the inner wall may interact with the drug over time, resulting in a reaction product that adversely affects the patient. Therefore, the LLDPE used for the inner layer 34 is pretreated by, for example, a vent pellet method at a high temperature and a reduced pressure to remove a low molecular weight substance having a carbon number of about 30 or less to a certain amount or less, thereby allowing the drug and the inner layer film to interact with each other. It can be prevented appropriately. Furthermore, if an appropriate amount of high-density polyethylene (HDPE) is added to each layer of the three-layer film 35 in order to improve the heat resistance of the film, 1
It is possible to manufacture a multi-chamber container excellent in molding stability that withstands high temperature sterilization such as high-pressure steam sterilization or hot water sterilization at 21 ° C. or higher. It is also possible to use a single-layer or multi-layer sheet of aluminum processed film, polyvinylidene chloride, polyethylene terephthalate (PET), polyvinyl alcohol (PVA), ethylene vinyl alcohol copolymer (EVOH), silica vapor deposition film for the outer wall. is there. For example, as shown in FIG. 8, PE in which the outer layer 43 is biaxially stretched
T, the intermediate layer 44 is silica vapor-deposited PVA, the inner layer 45 is low-density polyethylene (LDPE), and each layer is fixed with a urethane-based adhesive resin. The barrier film of can be mentioned. However, in order to improve the adhesion between the inner wall and the outer wall, it is desirable that at least the outer wall is a multilayer film and the material of the innermost layer of the outer wall is the same as the material of the inner wall or the outermost layer of the inner wall. In the above example, the case where the powder agent is used as the substance 8 to be enclosed in the chamber covered with the outer wall and the liquid agent is used as the substance 4 to be enclosed in the chamber not covered with the outer wall, the substance 8 is the liquid agent, Examples of the substance 4 in the form of powder include oxidizable substances such as amino acid solution to which cysteine or tryptophan is added as liquid, and sugar or electrolyte, or a mixture thereof as the powder. Substance 8 is liquid and substance 4
However, examples of other liquid agents include, for example, amino acid liquid formulations to which cysteine or tryptophan is added as the former liquid agents or substances easily oxidizable or easily heat-denatured of vitamins, and the latter liquid agents are sugar / electrolyte solutions. Is mentioned. As another example, the former liquid is an easily oxidizable substance such as a fat emulsion and the latter liquid is sugar or
An electrolyte solution and the like can be mentioned. Further, one of the substances 4 and 8 may be a solid agent and the other substance may be a liquid agent.
Furthermore, examples of the powder, liquid, and solid preparations include various nutritional and therapeutic agents for intravenous or enteral administration (tube or oral). Further, when the substance 8 has a photo-deteriorating property, a light-shielding film such as an aluminum-processed film or a colored film may be used for part or all of the outer wall to shield the inside. The aluminum processed film used for the outer wall may be partly or wholly peelable at the time of use. Further, the above-mentioned embodiment is an example of a two-chamber container in which two kinds of substances 4 and 8 are enclosed, but it is also applicable to two or more chambers. FIG. 9 shows an example thereof. Inside the outer wall 36, an inner wall having spaces 38 and 40 for enclosing two kinds of powder agents (or powder agent and solid agent) is arranged. 42 is a liquid agent. It is also possible to provide a plurality of chambers for enclosing not only the powder agent but also the liquid agent and / or the solid agent.

When the space 13 in the inner wall 14 is filled with an easily oxidizable liquid agent, powder or solid agent, nitrogen gas, carbon dioxide gas,
It is preferable to fill an inert gas such as argon gas. When a liquid agent, a powder agent, or a solid agent having a hygroscopic property is sealed in the chamber inside the inner wall 14, a dry gas such as dry air or dry nitrogen gas may be sealed in the space 15. When the inert gas is filled, the air in the space 15 is replaced with the inert gas, so that the effect of preventing oxidation is more certain. When the dry gas is filled, the air in the space 15 is replaced with the dry gas. Therefore, the effect of moisture prevention is more certain. As described above, by enclosing an inert gas in the space between the inner wall and the outer wall, or by using a barrier film having a higher barrier property used for the outer wall, it has been conventionally enclosed in the space between the inner wall and the outer wall. Stabilization of the drug over time can be achieved without the use of oxygen scavengers and / or desiccants. Note that the weak seal portion is not limited to the case of two lines and may be two or more lines. The present invention can also be applied to the case where the number of weak seals is one. Further, the weak seal portion does not necessarily have to be a straight line, and for example, the seal shape near the center of the container may be formed to have a V shape.
In this way, when pressure is applied to one of the chambers by hand during use to peel off the weak seal part, the pressure temporarily gathers in the V-shaped part, and the trigger for peeling can be given. Both drugs can be mixed. However, in this case, since there is a risk of accidental peeling during storage or transportation of the multi-chamber container of the present invention,
It is desirable to carefully examine the welding conditions.

Further, in the above embodiment, the weak seal portion is formed by a so-called direct welding method in which the inner surfaces of the two sheets forming the inner wall are directly welded to each other, but instead of this, between the sheets. You may carry out by what is called a multi-layer insert film holding welding method which forms a weak seal part by welding with a multilayer insert film pinched | interposed. Figure 1
0 indicates an example using a two-layer insert film. In this case, 48 is an inner wall made of a single-layer film, 50 is a sheet having a strong thermal adhesive force to the sheet of the inner wall 48, and 52 is a sheet having a weak thermal adhesive force to the sheet of the inner wall on the opposite side. Seal parts 54 and 56 are formed. For example, when the inner wall 48 is a single layer film of polyethylene (PE) or polypropylene (PP), 50 is the same polyethylene (PE) or polypropylene (PP) sheet, and 52 is polyethylene (PE).
Is a mixed resin of polypropylene and polypropylene (PP). The insert film may be divided into two parts for each weak seal part. Further, the outer wall 12 may be welded together with the multilayer insert film, but it is required that the inner wall has a weak sealing property.

When storing or transporting the multi-chamber container of the present invention, as shown in FIG.
It is preferable to fold the sheet in two and enclose it in the outer bag 62. By folding in two in this manner, peeling of the weak seal portion can be prevented in advance due to heavy pressure due to stacking at the time of storage, or drop (external pressure). Further, as shown in FIG. 12, a mouth portion 68 may be provided on the side of the chamber 66 that stores a powdered drug such as an antibiotic, and the side of the chamber 70 that stores a liquid agent such as a solution may be closed. If a mouth is provided in the chamber that houses the liquid such as the dissolving liquid, there is a risk of accidentally administering only the liquid such as the dissolving liquid first in an emergency. By attaching the mouth portion 68 to the side of the chamber containing the powdered medicine such as antibiotics, there is an advantage that the above danger can be avoided. Although some embodiments of the present invention have been described above, the present invention is not limited to such embodiments, and it goes without saying that the present invention can be implemented in various modes without departing from the scope of the present invention. Is.

[0016]

Since the present invention is configured as described above, it has the following effects. Storage of a substance that has hygroscopicity and oxidizability by accommodating a substance that has hygroscopicity and easily oxidizable in the room created by the inner wall of the structure that has a double wall including an inner wall and an outer wall made of a moisture and gas impermeable film At the same time, it is possible to prevent the absorption of external moisture and to combine with oxygen, and since the chamber having the double wall can be isolated from the chamber containing the substance that does not need moisture prevention or oxidation prevention, it is a multi-chamber container. A substance that does not absorb and condense water such as liquid agents that do not need to be dried as in the case where the whole is covered with a moisture / gas impermeable film, and the outer wall has hygroscopicity and oxidizable property. Since it need only be arranged around the chamber in which the water is enclosed, there is an advantage that the number of expensive moisture / gas impermeable films forming the outer wall can be reduced. Further, since it is not necessary to enclose the oxygen absorber and the desiccant in the outer wall, there is an advantage that the cost can be reduced. Furthermore, there is the advantage that sterile mixing between multiple chambers is possible and that it is not bulky due to its flexibility.
Furthermore, since glass and metal are not used, there is an advantage that disposal processing is easy.

[Brief description of drawings]

FIG. 1 is a sectional view showing an embodiment of the present invention.

FIG. 2 is a plan view of the embodiment.

FIG. 3 is an enlarged cross-sectional view of a portion A of FIG.

FIG. 4 is an enlarged sectional view of a B part in FIG.

5 is an enlarged cross-sectional view of a C portion of FIG.

FIG. 6 is an explanatory view showing the manufacturing process of the example.

FIG. 7 is a partially enlarged sectional view showing another embodiment of the present invention.

FIG. 8 is a partially enlarged sectional view showing another embodiment of the present invention.

FIG. 9 is an explanatory diagram showing still another embodiment of the present invention.

FIG. 10 is a partially enlarged cross-sectional view showing still another embodiment of the present invention.

FIG. 11 is a perspective view showing a packaged state of the multi-chamber container according to the embodiment of the present invention.

FIG. 12 is a sectional view showing still another embodiment of the present invention.

[Explanation of symbols]

 12 outer wall 13 space part 14 inner wall 15 space part 24 weak seal part 25 weak seal part 48 inner wall 54 weak seal part 56 weak seal part

Claims (4)

[Claims] 1. A flexible multi-chamber container in which a plurality of chambers for containing a liquid agent, a powder agent, or a solid agent are partitioned by a partition means capable of communicating with each other. The chamber is provided with a moisture-impermeable and / or gas-impermeable outer wall that covers the entire chamber, and an inner wall that constitutes the chamber and is covered by the outer wall, and a chamber that is not covered by the outer wall and is adjacent to the chamber. The multi-chamber container is characterized in that the partition means with the chamber covered by the outer wall is configured by arranging one or two or more weak seal portions that can be easily peeled off by applying an external pressure to the chamber. 2. The multi-chamber container according to claim 1, wherein the weak seal portions are formed by arranging at least two strips at intervals, and an end portion of an outer wall is welded to an intermediate portion between the weak seal portions. Multi-chamber container. 3. The multi-chamber container according to claim 1, wherein the space between the outer wall and the inner wall is filled with an inert gas or a dry gas. 4. The multi-chamber container according to claim 1, wherein the chamber inside the inner wall covered with the outer wall has a oxidizable property and / or a hygroscopic property.
A multi-chamber container adapted to contain a powder or solid formulation.