JP2005304911A - Multi cell container for medical care and its manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a low-cost multi cell container for medical use, excellent in transparency and barrier properties against gas and water after being sterilized. <P>SOLUTION: A double cell container 1 for medical use has a plurality of cells divided with a peelable heat seal, at least one of which stores a drug product therein and the other of which stores a liquid drug to be mixed with the drug product therein so that the drug product and the liquid drug can be mixed by peeling off a part 4 of the heat seal. At least a cell 3 storing the drug product is made of a multi-layer structure material having an outer layer, an intermediate layer, and an inner layer. The outer layer comprises nylon, polybutylene terephthalate, or an acetate, the intermediate layer comprises an ethylene-vinyl alcohol copolymer, and the inner layer comprises polypropylene or polyethylene as a major constituent respectively. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a medical multi-chamber container that can separately store solutions such as physiological saline and glucose, and preparations such as antibiotics, fat emulsions, and amino acids, and can be stored for a long period of time.

  Medical containers for storing various medical drugs are manufactured after passing the prescribed physicochemical and cytotoxicity tests in the Chinese Pharmacopoeia regulations of the US FDA and China FSDA in addition to the Japanese Pharmacopoeia. Predetermined transparency is required for inspection of pharmaceuticals in a container at the time of use or use. For example, when sterilization (121 ° C.) is required after the drug is stored in the container, it is necessary to be able to see through the drug in the container even after sterilization as well as heat resistance of the container.

  As such a medical container, conventionally, a glass bottle that is stable against chemicals and sealed with a highly safe glass bottle has been used. Medical containers are used. For example, bags and bottles made of an olefin resin mainly composed of polyethylene (PE) or polypropylene (PP) have been used to store physiological saline or glucose solution.

  A simple container made of PP or PE is used to store general infusions such as electrolytes and lactic acid in addition to physiological saline and glucose, but for drugs and chemicals to be mixed, they are mixed. A medical multi-chamber container having a plurality of chambers is used because of deterioration in quality and poor storage stability. For example, what has two chambers 52 and 53 shown to FIG. 7 (A) (B) is generally called the double bag 51, and each chamber 52 and 53 is divided by the heat seal part 54 which can peel. Yes. For example, one chamber 53 stores dry antibiotics and sodium bicarbonate, and the other chamber 52 stores saline and glucose solution as a solution.

  The medical multi-chamber container 51 in which the medicine is stored is bent and circulated and stored by the heat seal part 54 of the partition. And when using it in a hospital etc., the inside of the film welded by the heat seal part 54 of the partition is peeled off by applying a load to the liquid side chamber 52, the medicine is mixed, and it is aseptic as soon as possible. It can be used after being dissolved in the state. Note that the medical multi-chamber container is not limited to two chambers, and for example, there is a so-called triple bag having three chambers, which is used for storing, for example, fatty lactic acid / amino acid / glucose.

Various types of such medical multi-chamber containers are proposed based on olefin-based resins such as polyethylene and polypropylene in order to improve heat resistance, flexibility, transparency, or peelability of the heat seal part. (See Patent Documents 1 to 3).
However, these medical multi-chamber containers made of olefinic resins are not particularly problematic when storing general infusions such as physiological saline, glucose, electrolytes, lactic acid, etc., but allow oxygen and moisture to pass through in a small amount. Therefore, a problem arises when a formulation unstable to oxygen and moisture is stored.

  For example, high-concentration high-calorie bags and bags containing amino acids, fat emulsions, etc. have the problem that ordinary PE and PP materials cannot withstand distribution and long-term storage. For this reason, usually, after storing a chemical solution in a container and sterilizing (121 ° C.), the container 61 is put together with an oxygen scavenger, for example, PET (polyester) / EVOH (ethylene-vinyl alcohol co-polymer) as shown in FIG. (Polymer) / PE or the like and put in an outer bag 62 having a high gas barrier property and completely sealed. However, in this case, pinholes are likely to occur at the bottom of the outer bag or the bent portion, and oxygen may permeate into the actual liquid bag during long-term storage, and the drug may be oxidized and become defective. Therefore, in order to prevent the occurrence of pinholes, it is general to put a PE bag on and put it in a small box 63 as shown in FIG.

  However, even if overpacking is performed in this way, there are a considerable number of cases where the chemicals in the product have been oxidized. For example, since the liquid is colored when oxidized with respect to amino acids, it can be determined at the time of use, but the fat emulsion is not colored and the liquid remains white, so it cannot be determined visually. Therefore, an oxidation judgment material (indicator) is usually attached.

  Thus, even if the medicine is stored in the olefin-based bag and then packed in another bag or box having a high gas barrier property, there is a problem that the antioxidant of the medicine is not sufficient. In addition, since an outer bag, a small box, an oxygen scavenger and an indicator are necessary, there is a problem that the cost increases.

  On the other hand, when storing unstable drugs such as antibiotics, as a multi-chamber container that prevents the deterioration of drugs due to permeation of oxygen and moisture, a cover sheet such as an aluminum foil layer is provided outside of some chambers ( Patent Document 4), and further, covered with a moisture / gas impermeable film so that a sealed space is formed around some chambers, and a desiccant or oxygen scavenger is enclosed in the sealed space Known (Patent Documents 5 and 6)

  However, if a sheet or a film for preventing the permeation of gas or moisture is provided outside a part of the chambers for storing the drug as described above, the manufacture of the container becomes complicated, and the manufacturing cost increases remarkably. In addition, if the desiccant or oxygen scavenger is enclosed, the manufacturing cost will be further increased. Furthermore, since the cover sheet such as an aluminum foil layer is low in flexibility and easily generates pinholes, there is a possibility that the quality of the drug may be changed.

JP-A-8-131515 JP 2001-226499 A JP 2003-52791 A JP-A-8-280775 Japanese Unexamined Patent Publication No. 4-364851 JP 11-1114013 A

  The present invention has been made in view of the above problems, and it is an object of the present invention to provide an inexpensive medical multi-chamber container that has excellent barrier properties against gas and moisture in addition to transparency even after sterilization. With a purpose.

  In order to achieve the above object, according to the present invention, a plurality of chambers partitioned by a peelable heat seal are provided, the formulation is stored in at least one chamber, and the liquid to be mixed with the formulation is stored in another chamber. A multi-chamber container for medical use in which the preparation and the liquid are mixed by separating and peeling off the heat-sealed portion, wherein at least the chamber for storing the preparation has an outer layer, an intermediate layer, and an inner layer The main component of each layer is that the outer layer is nylon, polybutylene terephthalate or acetate, the intermediate layer is an ethylene-vinyl alcohol copolymer, and the inner layer is polypropylene or polyethylene. A medical multi-chamber container is provided (claim 1).

  The chamber for storing a preparation such as an antibiotic was composed of, for example, a multilayer film comprising an outer layer of nylon (NY), an intermediate layer of ethylene-vinyl alcohol copolymer (EVOH), and an inner layer of polypropylene (PP). If it is a medical multi-chamber container, it exhibits excellent gas barrier properties due to the intermediate layer (EVOH), and after sterilization, moisture is efficiently diffused from the outer layer (NY) side so that high transparency is maintained. become. Further, since an excellent barrier property against gas and moisture can be exhibited without providing a cover or the like for preventing the permeation of gas and moisture, manufacturing is easy and inexpensive.

Further, the medical multi-chamber container may have two chambers for storing the preparation and one chamber for storing the liquid agent (Claim 2).
Such a so-called triple bag also exhibits excellent barrier properties and transparency, and is easy to manufacture, so it is inexpensive.

The outer layer and the intermediate layer of the chamber for storing the preparation may be bonded via adhesive nylon, polypropylene, or polyethylene (Claim 3), and the intermediate layer and the inner layer are It can be bonded via adhesive polypropylene or polyethylene (claim 4).
By interposing these adhesive layers, the adhesive strength of each main layer can be increased with almost no reduction in barrier properties and transparency, and the medical multi-chamber container can be made more stable.

A layer having a thickness of 15 μm or less made of polypropylene or polyethylene may be laminated as an outermost layer on the outside of the outer layer of the chamber for storing the preparation (Claim 5).
If a thin outermost layer made of PP or PE is provided in this way, the container can be reliably prevented from being deformed by sterilization, and there is almost no influence on the barrier properties and transparency.

The chamber for storing the liquid agent may be made of polypropylene or polyethylene.
For example, when storing a liquid agent such as physiological saline or glucose, a strict barrier property against oxygen or moisture is not required. Therefore, if the liquid side chamber is made of PP or PE, the material cost is reduced and the cost is reduced. be able to.

On the other hand, the chamber for storing the liquid medicine may have the same multilayer structure as the chamber for storing the preparation (claim 7).
That is, if the entire container is composed of the same multi-layered film, it is easy to manufacture and suitable for storing a liquid / liquid double bag for high calories.

The medical multi-chamber container may contain an amino acid, a fat emulsion, a baking soda, an antibiotic, or a Chinese medicine as the preparation (claim 8).
These preparations are required to have a high barrier property because they are easily altered by oxygen and moisture, and the medical multi-chamber container of the present invention is particularly effective.

The medical multi-chamber container may be manufactured by an inflation method, a blow method, or extrusion lamination (claim 9).
If it is manufactured by these methods, it can be easily manufactured, so that a cheaper medical multi-chamber container can be obtained.

Furthermore, according to the present invention, there is provided a method for producing a medical multi-chamber container, wherein the container according to the present invention is produced by an inflation method, a blow method, or extrusion lamination. A method of manufacturing a container is provided (claim 10).
According to these methods, medical multi-chamber containers having various shapes can be easily manufactured, and thus the medical multi-chamber container according to the present invention can be manufactured at a low manufacturing cost.

According to the present invention, a chamber for storing a preparation such as an antibiotic is composed of, for example, an outer layer of nylon (NY), an intermediate layer of ethylene-vinyl alcohol copolymer (EVOH), and an inner layer of polypropylene (PP). It is composed of a multilayer film and exhibits excellent gas barrier properties due to the intermediate layer (EVOH), and after sterilization, moisture is efficiently diffused from the outer layer (NY) side so that high transparency is maintained. become.
In addition to the outer bag and cover for preventing the permeation of gas and moisture, an oxygen scavenger and the like are unnecessary, so that it is inexpensive.
Further, since the intermediate layer exhibiting barrier properties is protected by the inner layer and the outer layer, the oxidation of the preparation due to the generation of pinholes can be extremely effectively prevented.

Prior to the completion of the present invention, the present inventor conducted the following studies.
EVOH is known as a thermoplastic resin having a high gas barrier property. For example, an oxygen permeability of 0.3 (60% RH) to 0.75% (80% RH) cc / m ² · day · atm per 20 μm thickness. What shows (OTR) is used widely. And in packaging of ordinary temperature medicines and foods, for example, it is known that if an EVOH layer is sandwiched with a thin PP or PE layer as an inner and outer layer, excellent barrier properties and transparency can be maintained. When sterilized at 121 ° C using a medical multi-chamber container, the amount of moisture that penetrates into the EVOH layer through the outer layer during sterilization increases, resulting in problems such as a marked decrease in gas barrier properties and white turbidity and wrinkle patterns. A serious problem occurs. Therefore, it may be possible to suppress the water impregnation during sterilization by making the outer layer sufficiently thick, but if the outer layer PE or PP is thickened, it becomes hard like a hard bottle, and drainage and flexibility are also required. It is not suitable as a multi-chamber container.

  In addition to these studies, the present inventor has conducted extensive experiments, and as a result, the inner layer that comes into contact with the preparation is made of PP or the like used in general medical multi-chamber containers, and can be stored for a long time with high gas barrier properties. Therefore, if an EVOH layer is provided as an intermediate layer, and a medical multi-chamber container with NY as the outer layer is used to enhance strength maintenance and drainage during sterilization, an outer bag or an antioxidant is not used in combination. However, the present inventors have found that the preparation can be prevented from being oxidized for a long period of time, and that the container can maintain high transparency and flexibility even when sterilized.

Hereinafter, the medical multi-chamber container according to the present invention will be described in detail.
FIG. 1 shows an example of a medical multi-chamber container according to the present invention. This medical multi-chamber container 1 has two chambers 2 and 3, and each of the chambers 2 and 3 is partitioned by a peelable heat seal 4.
The chamber 2 provided with the port 5 is for storing solutions such as physiological saline and glucose solution, and the other chamber 3 is for storing preparations such as antibiotics that should avoid oxygen and moisture. It is. In the medical multi-chamber container 1, the solution-side chamber 2 is made of a single-layer film of polypropylene, whereas the preparation-chamber side chamber 3 is made of a multilayer film (of course, The chamber 2 on the solution side may also be a multilayer film).

FIG. 2 schematically shows an example of the basic structure of the multilayer structure film constituting the chamber 3 on the preparation side. The multilayer structure film 10 has, as main layers, an outer layer 11 made of nylon (NY), an intermediate layer 13 made of ethylene-vinyl alcohol copolymer (EVOH), and an inner layer 15 made of polypropylene (PP). The outer layer 11 and the intermediate layer 13 are bonded through adhesive nylon 12, and the intermediate layer 13 and the inner layer 15 are bonded through adhesive polypropylene 14.
However, in the present invention, it is not always necessary to form a film having the five-layer structure as described above. The main layer is formed by omitting the adhesive NY layer 12 or the adhesive PP layer 14 and blending a resin for improving adhesiveness. 11, 13, 15 can also be directly bonded.
The outer layer 11 and the intermediate layer 13 may be bonded via adhesive polypropylene or polyethylene, and the intermediate layer 13 and the inner layer 15 may be bonded via adhesive polyethylene.

  Further, when sterilization such as a high-temperature and high-pressure retort treatment at 121 ° C. is performed, the multilayer film 10 is easily curled, which may affect the subsequent encapsulating operation of the preparation. In order to prevent such curling after sterilization, a layer having a thickness of 15 μm or less made of polypropylene or polyethylene may be laminated on the outer side of the outer layer (NY) 15 as an outermost layer. For example, if a PP layer having a thickness exceeding 15 μm is provided as the outermost layer, the effect of diverging moisture absorbed in the intermediate layer (EVOH) 13 through the outer layer (NY) 11 may be hindered. In particular, the thickness is particularly preferably 10 μm or less.

Here, each of the main layers will be described more specifically. Since the inner layer 15 comes into contact with the preparation and also comes into contact with the liquid after mixing, a soft material mainly composed of PP or PE used for a medical multi-chamber container can be suitably used. For example, PP in which a styrene elastomer having an ethylene content of 2 to 4% is dispersed in a sea-island structure, specifically, obtained by the second-stage polymerization with the following component (A) disclosed in the aforementioned Patent Document 3. A propylene-based resin composition containing the following component (B), wherein the proportion of the component (A) relative to the total amount of both components is 10 to 60% by mass, and the proportion of the component (B) is 40 to 90% by mass. Can be used.
(A) component: a polymer component mainly composed of propylene having an isotactic index of 90% or more,
(B) component: It consists of a copolymer of propylene and another α-olefin having 8 or less carbon atoms, containing propylene and ethylene as essential components,
The component that is insoluble in xylene at room temperature is more than 20% by mass and less than 70% by mass in the total polymer of the components (A) and (B), and the component that is soluble in xylene at room temperature is the component (A) and (B) The content of α-olefin other than propylene in the component soluble in xylene at room temperature is 10% by mass or more and 60% by mass or less in the total polymer combined with the component, and is less than 20% by mass. Copolymer component.
Moreover, as the inner layer 15, you may use the flexible resin which has PE as a main component generally used as a medical container.

  As the intermediate layer 13, an ethylene-vinyl alcohol copolymer containing 20 to 50 mol% of ethylene monomer units (water absorption rate (ASTM D-570-57T): 6.5%) is used.

As the outer layer 11, nylon (NY) having a moisture absorption rate of 9.0% (ASTM D-570-57T) can be suitably used. By setting the outer layer 11 to NY in this way, moisture absorbed in the EVOH layer by sterilization can easily move to the outer layer (NY) side. Therefore, it is possible to promote the diffusion of moisture through the outer layer.
In addition, as the outer layer 11, polybutylene terephthalate (PBT) or acetate can also be used suitably. If the moisture absorption rate of the outer layer 11 is too low or too high, the effect of promoting the diffusion of moisture in the EVOH layer cannot be obtained. If so, the water absorption is 4 to 10%. Therefore, if this is used as the outer layer, it is possible to obtain an effect of promoting the diffusion of moisture absorbed in the EVOH layer as in the case of NY.

  In addition, the thickness of each layer may be appropriately set according to the shape of the container, the medicine to be stored, and the like. For example, in the case of the double bag 1 as shown in FIG. There may be a problem of degradation. On the other hand, if the film is too thick, problems such as a decrease in flexibility occur. Therefore, the inner layer 15 is preferably 10 to 100 μm, and the intermediate layer 13 and the outer layer 11 are preferably 10 to 80 μm.

  As in the container 1 shown in FIG. 1, the medical multi-chamber container 1 in which the solution-side chamber 2 and the preparation-side chamber 3 are composed of different films except for the inner layer can be suitably manufactured by an inflation method. . Since only a part of the container can be made into a multilayer structure by the tubular die structure of the inflation film manufacturing machine, for example, as shown in FIG. 3 (A), the tubular half is mainly made of NY / EVOH / PP. The tube 30 is extruded from the die outlet with the multilayer film 10 serving as a working layer, and the remaining half circumference as a single-layer film 20 of PP. The extruded tube 30 is cooled and flattened so that the same films overlap each other as shown in FIG.

In this way, the chamber on the side storing the preparations that should avoid oxygen and moisture such as antibiotics is the multilayer structure film 10 of NY / EVOH / PP, while storing liquid solutions (dissolution solutions) such as physiological saline and glucose. If the chamber on the side to be constructed is composed of a single-layer film 20 of PP, the material cost of the single-layer PP film is low, so that the manufacturing cost can be kept low for the entire container, and an inexpensive bag can be obtained.
In addition, since each chamber does not necessarily need to be the same size, what is necessary is just to set the ratio of a multilayer film and a single layer film according to the magnitude | size of each chamber.

FIG. 4 shows a flow from making a medical multi-chamber container (double bag) from the inflation film 30 manufactured as described above to storing a medicine and shipping it.
First, the inflation film 30 is cut to a length corresponding to the width of the container and heat-sealed on both the left and right sides, and partitioned into chambers 2 and 3 on the single-layer film side (solution side) and the multilayer film side (formulation side). As shown, a heat seal portion (easy peel portion) 4 that can be peeled off at the intermediate portion is formed (FIG. 4A).
Next, the upper part of the chamber 2 made of the single-layer PP film 20 is heat-sealed and a port 5 is provided (FIG. 4B). Thereby, the multi-chamber container 1 is manufactured.

The medical multi-chamber container 1 made as described above is filled with a liquid agent such as physiological saline through the port 5 into the room on the single-layer PP film 20 side (FIG. 4C).
And after sealing with a cap etc., it sterilizes (FIG.4 (D)). In the preparation-side chamber 3 formed of a multilayer film (NY / EVOH / PP) by the sterilization treatment, the EVOH of the intermediate layer contains a large amount of moisture and devitrifies, and the barrier property is lowered. Then, after the sterilization, when the water in the EVOH layer is not quickly released, there is a possibility that a preparation such as an antibiotic to be filled later is denatured by oxygen or moisture permeated into the room.

  However, the inner layer (PP) of the chamber 3 on the preparation side has a very low water absorption (less than 0.1% of water absorption), whereas the outer layer NY has a suitable water absorption (water absorption of about 9.0%). Therefore, the moisture absorbed in EVOH does not permeate into the room, and evaporation through the outer layer NY is promoted. Therefore, transparency and barrier properties are promptly restored after sterilization.

  After sterilization, the bottom of the container 1 is cut to open the chamber 3, and for example, powdered antibiotics are put into the chamber 3 made of a multilayer film (NY / EVOH / PP) (FIG. 4 (E)). Is heat sealed (FIG. 4F).

The medical multi-chamber container 1 is manufactured by the above process, and the medicines are stored and shipped in the respective chambers 2 and 3, but the preparation-side chamber 3 made of a multilayer film (NY / EVOH / PP) contains oxygen and Since it has an excellent barrier property against moisture, it can effectively prevent oxidation of the preparation even when stored for a long period (several years).
Moreover, since the liquid agent side chamber 2 for storing physiological saline or the like is formed of PP, the material cost can be kept low.

  Further, in the present invention, as shown in FIG. 5, the entire medical multi-chamber container, that is, the chamber 2 for storing the liquid agent, is a film 10 having the same multilayer structure (NY / EVOH / PP) as the chamber 3 for storing the preparation. It may be configured. Such a container can be suitably used when, for example, a container (such as a high-calorie liquid / liquid double bag) containing a liquid agent that needs to prevent oxidation in both the chambers 2 and 3 is used.

  However, in any of the medical multi-chamber containers according to the present invention, the formulation to be stored is not particularly limited. For example, a formulation that needs to prevent permeation of gas or moisture, such as amino acid, fat emulsion, baking soda, or herbal medicine. It can be suitably used as a medical multi-chamber container to be stored. For example, in order to prevent oxidation, a CAPD bag that contains baking soda and glucose solution to prevent carbon dioxide permeation may be used. The form of the preparation is also arbitrary, and it may be a solid such as powder, granule, pellet or the like, or a liquid or gel.

  Moreover, although what was manufactured by the inflation construction method was demonstrated above, it is not limited to this, The other construction methods utilized by manufacture of a multi-chamber container, such as a blow construction method or extrusion lamination, can also be used suitably. For example, a shuttle or a rotary blow production machine can be used, and the whole circumference or a part of the container can have a multilayer structure by a blow die structure.

  Furthermore, the medical multi-chamber container of the present invention is not limited to a double bag, and may have more chambers. For example, as shown in FIG. 6, a so-called triple bag 41 having two chambers 42 and 43 for storing a preparation and one chamber 44 for storing a liquid agent is formed. If amino acids are stored and glucose is stored in the solution chamber 44, oxidation of the fat emulsion and amino acids can be prevented for a long period of time.

Examples of the present invention and comparative examples will be described below.
<Example 1-3 and Comparative Examples 1 and 2>
A medical multi-chamber container (double bag) made of a film having the structure shown in Table 1 below was produced by an inflation method.

Each manufactured multi-chamber container was sterilized (hot water storage type, 121 ° C., 83 minutes) using a high-temperature and high-pressure tester (RTC-40RTGN: manufactured by Nisaka Seisakusho).
Each container after sterilization was measured for carbon dioxide permeability (based on JIS K7126A) under the conditions shown in Table 2 below, and the measurement results are shown in Table 3.

  As can be seen from the results shown in Table 3, after sterilization, in the multi-chamber container (Comparative Examples 1 and 2) in which the outer layer is PP or HDPE (high density polyethylene), carbon dioxide permeability is extremely high after 1 hour after sterilization. It was. On the other hand, in the container of Example 1-3 in which the outer layer was NY, the permeability was 1/10 or less of Comparative Examples 1 and 2, and it was found that the barrier property against carbon dioxide was recovered in a short time. .

  Furthermore, oxygen permeability was also measured (based on JIS K7126B) under the conditions shown in Table 4 below, and the measurement results are shown in Table 5.

  As apparent from the results shown in Table 5, the container of Example 1-3 has an extremely low oxygen permeability as compared with the containers of Comparative Examples 1 and 2 as in the case of carbon dioxide permeability. It turns out that it is excellent in property.

<Example 4-6>
A medical multi-chamber container (double bag) made of a film having the structure shown in Table 6 below was manufactured by the inflation method.

  These medical multi-chamber containers were sterilized in the same manner as described above, and after sterilization, the carbon dioxide permeability was measured in the same manner. The results are shown in Table 7 below.

  As shown in Table 7, the permeability was relatively low in all of Examples 4-6, but the container of Example 6 was the lowest and had excellent gas barrier properties.

  Moreover, in order to evaluate the transparency of a container, haze was measured using HazeMeter NDH (made by Nippon Denshoku Industries Co., Ltd.), and the result is shown in Table 8.

  As shown in Table 8, with respect to haze, all the containers were slightly higher immediately after sterilization, but the transparency almost recovered after 3 days, and sufficient transparency as a medical multi-chamber container was maintained.

  The present invention is not limited to the above embodiment. The above embodiment is merely an example, and the present invention has the same configuration as that of the technical idea described in the claims of the present invention, and any device that exhibits the same function and effect is the present invention. It is included in the technical scope of the invention.

  For example, the medical multi-chamber container according to the present invention is not limited to a double bag or a triple bag as shown in the figure, and may be, for example, a so-called double twin bag with a complicated connection circuit.

It is the schematic which shows an example of the medical multiple-chamber container (double bag) which concerns on this invention. It is sectional drawing which shows the basic structure of the multilayer film by the side of a formulation. It is a figure which shows an example of the manufacturing process of the inflation film which concerns on this invention. It is explanatory drawing which shows an example of the flow until it makes a bag from an inflation film, and is filled with a formulation. It is explanatory drawing which shows the other example of the flow from making a bag from an inflation film to filling with a formulation. It is the schematic which shows an example of a triple bag. It is the schematic which shows an example of a double bag (CAPD bag). (A) Top view (B) Side view It is the schematic which shows the packaging example of a double bag. (A) Outer bag (B) Outer bag + small box

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Medical multi-chamber container (double bag), 2 ... Liquid side chamber, 3 ... Formulation side chamber,
4 ... Heat seal part (easy peel part), 5 ... Port, 11 ... Outer layer,
13 ... intermediate layer, 15 ... inner layer.

Claims (10)

  By having a plurality of chambers partitioned by a peelable heat seal, storing the preparation in at least one chamber, storing the liquid to be mixed with the preparation in the other chamber, and peeling the heat seal portion The medical multi-chamber container in which the preparation and the liquid are mixed, wherein at least the chamber for storing the preparation is of a multilayer structure having an outer layer, an intermediate layer, and an inner layer, and the main component of each layer is A medical multi-chamber container wherein the outer layer is nylon, polybutylene terephthalate or acetate, the intermediate layer is an ethylene-vinyl alcohol copolymer, and the inner layer is polypropylene or polyethylene.   2. The medical multi-chamber container according to claim 1, wherein the medical multi-chamber container has two chambers for storing the preparation and one chamber for storing the liquid agent.   The medical use according to claim 1 or 2, wherein an outer layer and an intermediate layer of the chamber for storing the preparation are bonded via adhesive nylon, polypropylene, or polyethylene. Multi-chamber container.   The intermediate layer and the inner layer of the chamber for storing the preparation are bonded through adhesive polypropylene or polyethylene. Medical multi-chamber container.   5. The layer according to claim 1, wherein a layer having a thickness of 15 μm or less made of polypropylene or polyethylene is laminated as an outermost layer outside the outer layer of the chamber for storing the preparation. A medical multi-chamber container according to claim 1.   The medical multi-chamber container according to any one of claims 1 to 5, wherein the chamber for storing the liquid agent is made of polypropylene or polyethylene.   The medical multi-chamber container according to any one of claims 1 to 5, wherein the chamber for storing the liquid agent has the same multilayer structure as the chamber for storing the preparation.   8. The medical multi-chamber container according to any one of claims 1 to 7, wherein the medical multi-chamber container contains an amino acid, a fat emulsion, a baking soda, an antibiotic, or a Chinese medicine as the preparation. Medical multi-chamber container.   The medical multi-chamber container according to any one of claims 1 to 8, wherein the medical multi-chamber container is manufactured by an inflation method, a blow method, or extrusion lamination.   A method of manufacturing a medical multi-chamber container, wherein the container according to any one of claims 1 to 8 is manufactured by an inflation method, a blow method, or an extrusion lamination method. Of manufacturing a multi-chamber container.

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