KR100740508B1 - Double-chamber Container for Transfusion and Laminated Film Adapted Thereto - Google Patents

Abstract

The present invention relates to a double chamber fluid container and a transparent gas barrier multi-layer film, and more specifically to a liquid formulation, dry formulations such as powder formulations and solid formulations separately contained, and when used in combination with a liquid formulation and a dry formulation for the sap The present invention relates to a flexible double chamber infusion container that can be used as a multilayer film and a polymer laminate film composed of multilayers having excellent transparency of water and gas barrier properties and high transparency.

Sap containers, antibiotics, diluents, multilayer films

Description

Double-chamber Container for Transfusion and Laminated Film Adapted Thereto}

1 is a front view showing a double chamber infusion container according to one embodiment of the present invention;

2 is a schematic side cross-sectional view of a dual chamber infusion container according to one embodiment of the present invention;

3 is a partial cross-sectional view showing a compartment seal of a dual chamber infusion container according to one embodiment of the present invention;

4 is a schematic cross-sectional view showing a state in which a double chamber infusion container according to one embodiment of the present invention is accommodated in a pouch;

5 is a structural cross-sectional view of a multilayer film according to an embodiment of the present invention;

6 is a structural cross-sectional view of a multilayer film according to another embodiment of the present invention;

7 is a structural cross-sectional view of a multilayer film for a pouch according to an embodiment of the present invention; And

8 is a schematic view of a multilayer film manufacturing apparatus according to an embodiment of the present invention.

<Explanation of symbols for the main parts of the drawings>

100: sap container

110: container body 112: powder pharmaceutical chamber

112a and 112b: first and second sheet portions 114: liquid chamber

114a, 114b: third and fourth sheet portions 116: compartment sealing portion

116a: junction 116b: non-junction

120: drug outlet 130: hanger hole

212: front cover sheet 214: rear cover sheet

214a: Handle 400: Pouch

410 desiccant 420 deoxidant

The present invention relates to a dual chamber fluid container and a gas barrier layered film applied thereto, and more particularly, to a dual chamber having high transparency while being able to effectively prevent oxidation or deterioration of a drug and having excellent transparency. An infusion container and a multilayer film applied thereto.

The infusion container should be able to maintain the quality of the stored medication by protecting the stored medication from external environmental factors until it is administered to the patient, and should be convenient for administration to the patient.

In other words, the infusion container protects the stored medicine from the influence of external factors such as temperature, moisture, gas, vibration, shock, etc. in order to maintain the quality, efficacy and safety of the medicine during the storage period until administration to the patient. This is essential.

Conventionally, medical fluid containers having a plurality of chambers have not been able to effectively block permeation of moisture, gas, and the like. For this reason, during long-term storage, there was an unavoidable drawback of denaturation of the dry powder formulation. In order to compensate for this drawback, a separate storage space is provided in the chamber to double package the desiccant and / or the oxygen scavenger, but this causes the production process to be complicated and the production cost increases.

In addition, although a transparent film is used as the container material to visually observe the medicine inside the infusion container, the drug itself may be deteriorated by light passing through the film during storage, and the container itself should be stored in the dark.

Japanese Patent Laid-Open No. 3-277365 includes an outer layer composed of linear low density polyethylene having a density of at least 0.920 g / cm 2, an intermediate layer composed of linear low density polyethylene having a density of at least 0.915 g / cm 2, and a side chain low density polyethylene having a density of at least 0.918 g / cm 2. Disclosed is a three-layer film comprising a constructed inner layer. However, the film according to Japanese Patent Laid-Open No. 3-277365 is excellent in terms of flexibility, but there is a problem in that transparency is degraded at high temperature sterilization at 121 ° C.

In Japanese Patent Laid-Open No. 9-52328, an aqueous solution in which a polypropylene resin layer composed of a syndiotactic polypropylene and a propylene-ethylene copolymer and a polyethylene resin layer composed of an ethylene-alpha olefin copolymer using a metallocene catalyst are laminated. A container for use is disclosed. Such a film according to Japanese Patent Laid-Open No. 9-52328 has improved transparency, flexibility, and heat resistance, but there is a problem in that transparency is lowered due to whitening of a part during high temperature sterilization at 121 ° C.

Japanese Patent Laid-Open No. 9-59455 discloses a composition for use in a medical bag comprising a propylene-based propylene-alphaolefin copolymer, a hydrogenated styrene-butylene rubber, and a nucleating agent. Such a composition according to Japanese Patent Laid-Open No. 9-59455 has excellent transparency and impact resistance, and there is no whitening phenomenon after sterilization, but lacks flexibility.

Accordingly, the present invention provides a medical multilayer film not only excellent in moisture and gas barrier properties but also excellent in transparency, flexibility, heat resistance, and the like, and a double chamber infusion container having storage safety and convenience of use using the above film. It is for that purpose.

The present invention to achieve the above technical problem,

In a double chamber fluid container formed so as to separate the powdered first drug and the liquid second drug during storage, and to mix the first and second drugs during use, formed by a predetermined base sheet and First and second chambers for separately receiving the first and second agents, respectively; And a non-junction disposed between at least two junctions and adjacent junctions to partition the first and second chambers, wherein the junction is opened by external pressure to seal the compartment formed to allow communication between the chambers. It provides a dual chamber infusion container comprising a portion.

In addition, in order to achieve the above technical problem, the present invention can be used for the storage and storage of medicines, having a gas barrier property of moisture and oxygen impermeability and at the same time ensure transparency, the material of the double chamber fluid container It provides a transparent gas barrier multilayer film that can also be used.

Hereinafter, the present invention will be described in detail.

The dual chamber fluid container of the present invention comprises a powder pharmaceutical chamber; Liquid chamber; A compartment seal opened by external pressure to allow communication between the chambers; And it is configured to include a drug discharge port attached to the lower portion of any one of the chambers for discharging the chemical liquid.

A coating sheet is attached to both outer surfaces of the chamber for powder medicament, and the covering sheet on the front side thereof is fixedly bonded to the base sheet of the chamber without close space, and the covering sheet on the back side of the chamber can be peeled off on the base sheet of the chamber. To form a lung space.

It is preferable to use an opaque film for accommodating the powdered drug which may be denatured by moisture, gas, and light, and in particular, the coated sheet is preferably a sheet film in which polyethylene terephthalate is laminated on aluminum foil or aluminum foil. Do.

The compartment seal is preferably weakly hermetically sealed to be easily openable by manually pressing the chamber to increase the internal pressure. To this end, the compartment seal may be sealed in a configuration comprising a plurality of bonded portions that are heat sealed and one or more non-bonded portions disposed therebetween.

The liquid chamber is delivered by a sheet made of the same material as the base sheet of the powdered medicine chamber. All of the base sheets have moisture and gas (particularly oxygen) barrier properties, and are preferably formed of a transparent thermoplastic resin film for visual observation of a storage state or a mixed state of the contents. In particular, the base sheet is preferably a transparent gas barrier multilayer film composed of an outer layer, an intermediate layer, and an inner layer.

The transparent gas barrier multi-layer film should have sufficient moisture and gas barrier properties to prevent the deterioration of the contents, easy to observe inside, flexible and flexible. In addition, the heat resistance at the time of radiation or heat sterilization is required, and should have a property that can be properly sealed.

In a preferred configuration of the multilayer film, aluminum oxide (AlOx; integer of x = 1-4) or silicon oxide (SiOx; integer of x = 1-4) contains a polyethylene terephthalate homopolymer coated on the bottom. Outer layer; An intermediate layer containing a polymer of a polyolefin-based polymer; And an inner layer containing a mixture of a polyolefin-based polymer and an elastomer.

Optionally, a mixture layer of polyolefin-based polymer and elastomer may be additionally interposed between the intermediate layer and the inner layer.

The outer layer coated on at least a portion of the aluminum oxide or silicon oxide is preferably a layer for imparting high barrier properties such as moisture and oxygen, usage, capacity, printability, protection of other layers, heat resistance, etc. to the primary film. Preferably, polyethylene terephthalate homopolymer is used in which aluminum oxide is coated on the bottom.

The polymer film or sheet laminated to the outer layer is not particularly limited as long as it has excellent transparency, flexibility, heat resistance, machinability, impact resistance, and chemical stability, but as the intermediate layer, possibility of sterilization at a high temperature of 121 ° C., In consideration of the stability of the drug, a polymer of a polyolefin-based polymer is used.

The inner layer is preferably a mixture of a polyolefin-based polymer and an elastomer in consideration of reactivity with the drug, that is, drug stability and heat adhesion. Herein, the mixture of the polyolefin-based polymer and the elastomer is considered to be sterilizable, high transparency and drug stability at 121 ° C. of the polyolefin-based polymer, and the elastomer is to consider flexibility and drug stability.

In this case, the elastomer is preferably a polymer of at least one polymer selected from the group consisting of styrene, ethylene, propylene, and copolymers thereof.

In another preferred configuration of the multilayer film, a polyethylene terephthalate homopolymer coated with silicon oxide (SiOx; integer of x = 1-4) or aluminum oxide (AlOx; integer of x = 1-4) underneath An outer layer containing; An interlayer containing a polymer of engineering plastics; And an inner layer containing a polymer of the polyolefin-based polymer or a mixture of the polyolefin-based polymer and the elastomer. Optionally, an adhesive resin may be additionally interposed between these layers. The adhesive resin can be used as long as it is conventional in the field of the present invention, it is preferable to use a resin configured to maintain a low peel (peel) bonding force.

The outer layer coated with at least a portion of the silicon oxide or aluminum oxide is a layer for imparting high barrier properties such as moisture and oxygen, printing capacity and the like, protection of other layers, heat resistance, etc. to the primary film. Preferably, polyethylene terephthalate homopolymers having silicon oxide coated thereon are used.

The polymer film or sheet which can be laminated on the outer layer is not particularly limited as long as it has excellent transparency, heat resistance, machinability, and chemical stability.

As the intermediate layer, polymers containing homopolymers and engineering plastics of engineering plastics, which are excellent in barrier properties and thermal stability such as moisture and gas, are preferably used.

The engineering plastics are not particularly limited as long as they are high functional polymer resins having high impact resistance, abrasion resistance, heat resistance, cold resistance, and chemical resistance, but are not limited to polyamides, polyacetyls, polycarbonates, polyesters, and modified polys. General-purpose engineering plastics such as phenylene oxide resin; High performance engineering plastics such as U polymer, polysulfone, polyphenylene sulfide, polyetherimide, polyethersulfone, polyarylate, polyetheretherketone, and tetrafluoroethylene resin; Super heat-resistant engineering plastics, such as polyimide, can be used.

The inner layer is preferably a polymer of a polyolefin-based polymer, or a mixture of a polyolefin-based polymer and an elastomer in consideration of drug stability and heat adhesion.

The thickness of the above-mentioned multilayer film is normally performed by selecting suitably in the range of 0.1-50 micrometers, Preferably it is 10-30 micrometers. If the thickness of the multi-layer film is thinner than 0.1㎛, the gas barrier properties are insufficient, if the thickness of the multilayer film is thicker than 50㎛ because cracks are likely to occur, there is a problem of inhibiting transparency.

The transparent gas barrier multilayer film can be used not only as a medical infusion container for administering drugs, but also to collect urine or other feces of patients.

The dual chamber infusion containers of the present invention are usually housed in half folded pouches and transported and stored. The infusion container is folded along the compartment seal and stored in the pouch. In this case, at least one of a desiccant and an oxygen scavenger may be additionally stored in the pouch in order to prevent moisture penetration and increase the oxygen scavenger effect.

As the overlap pouch film that can be used as the storage bag, an engineering plastic-containing layer and a polymer of a polyolefin-based polymer or a mixture-containing layer of a polyolefin-based polymer and an elastomer are sequentially stacked on both sides of an ethylene vinyl alcohol copolymer-containing intermediate layer, respectively. It is preferable that it is a multilayer film.

The intermediate layer formed of the ethylene vinyl alcohol copolymer has high oxygen barrier property.

The engineering plastic containing layer has high oxygen and moisture barrier properties and heat resistance, and protects the intermediate layer which is weak to moisture.

The polyolefin-based polymer-containing layer is formed of a polymer of a polyolefin-based polymer having excellent sterilization potential, high transparency, drug stability and sealability at 121 ° C., or a mixture of a polyolefin-based polymer and an elastomer.

Hereinafter, with reference to the accompanying drawings to help the understanding of the present invention will be described in more detail the present invention.

1 is a front view showing an embodiment of a dual chamber infusion container according to the present invention, and FIG. 2 is a side cross-sectional view of an embodiment of a dual chamber infusion container according to the present invention.

1 and 2 , the infusion container 100 is a rectangular container body 110 formed by heat-sealing the peripheral edge portions of the two films constituting the base sheet, combined with the body 110 and the inside It comprises a drug outlet 120 having a rubber plug and a hanger hole 130 formed to hang a hanger or the like at the other end of the drug outlet 120 of the body 110.

The container body 110 has a powder pharmaceutical chamber 112 and a liquid chamber 114 arranged in a row therein, and the two chambers 112 and 114 are partitioned by a compartment seal 116. . The drugs contained in the two chambers 112 and 114, respectively, are drugs that need to be stored separately from each other because the Maillard reaction or similar changes may occur over time when they are stored in a mixed state. . In the present embodiment, the powdered pharmaceutical chamber 112 is housed in a powdery antibiotic (eg, imipenem, cell thiam, ceftazidime, etc.), the liquid chamber 114, physiological saline solution, glucose Diluents such as injections and the like are accommodated. In this case, the drug outlet 120 is installed below the liquid chamber 114.

In the present specification, the base sheet forming the body 110 may include the first and second sheet portions 112a and 112b forming the powder pharmaceutical chamber 112 and the third and forming the liquid chamber 114. It is divided into 4th sheet part 114a, 114b. In this case, all of the first to fourth sheet portions 112a, 112b, 114a, and 114b have the same properties, and in particular, have transparency and flexibility while having moisture and gas barrier properties.

The base sheet of the body 110 is preferably composed of a multilayer film formed by laminating a plurality of film layers having predetermined characteristics. In this embodiment, the multilayer film as an outer layer containing a polyethylene terephthalate homopolymer coated on at least a portion of aluminum oxide or silicon oxide; An intermediate layer containing a polymer of a polyolefin-based polymer; And an outer layer using a multilayer film comprising an inner layer containing a mixture of polyolefin and elastomer (see FIG. 5 ) or containing a polyethylene terephthalate homopolymer coated on at least a portion of silicon oxide or aluminum oxide; Interlayers containing engineering plastic polymers; And an inner layer containing a polymer of a polyolefin-based polymer or a mixture of a polyolefin-based polymer and an elastomer (see FIG. 6 ). When the base sheet is formed in this manner, the base sheet may have a high tear strength and may prevent tearing and the like.

And, as shown in Figure 2, the outer surface of the first and second sheet portion (112a, 112b) of the powder pharmaceutical chamber 112 on the front and rear covering sheets having excellent light shielding properties as well as moisture and oxygen barrier properties ( 212 and 214 are attached respectively. At this time, the front cover sheet 212 is tightly fixed to the first sheet portion 112a, and the back cover sheet 214 is only weakly bonded to the edge portion so that it can be peeled from the second sheet portion 112b in use. Such front and rear cover sheets 212 and 214 can effectively prevent the drug contained in the powdered medicine chamber 112 from being exposed to moisture, gas or light.

On the other hand, the back cover sheet 214 is formed so that the handle 214a is protruded at one end can be easily peeled off by the user. And, when the back cover sheet 214 is peeled off, the user can visually check the preservation state of the received drug or the mixed state of the drug and the diluent.

3 is an enlarged cross-sectional view of a compartment seal 116 showing a state in which two chambers 112 and 114 are in communication with each other so that pressure may be applied to a dual chamber fluid container according to the present invention so that two drugs may be mixed with each other.

The partition seal 116 in the present embodiment includes two junction portions 116a and one non-junction portion 116b formed to cross the body 110, and as shown in FIG. 3 by external pressure. It is formed to be openable. That is, the compartment sealing portion 116 is opened when the user presses any one of the two chambers 112 and 114, and the powdered medicine and the liquid medicine contained in each of the chambers 112 and 114 are mixed with each other.

The non-junction 116b is formed at the center of the two junctions 116a and functions to buffer a load generated from the outside. For example, when an unintentional external pressure (for example, a shock during transportation, etc.) is applied to the container body 110, the remaining joint is opened by the non-junction 116b even if any one joint is opened. Can be prevented. In other words, in the case where the non-junction 116b is not present, that is, when only one junction is present, a concentrated load acts on the junction, and eventually the junction is opened so that unintentionally received drugs are mixed. Can be.

On the other hand, the compartment sealing portion 116 is not limited to the configuration of the embodiment shown, two or more non-bonding portion 116b between the junction portion 116a may be formed.

The multi-chambered fluid container configured as above is used in the manner described below.

When the user presses either of the two chambers 112 and 114 manually (for example, by hand, etc.), the room pressure of the pressed chamber is increased, so that the two junction portions 116a are sequentially peeled off. The powdered medicine chamber 112 and the liquid medicine chamber 114 communicate with each other. In this state, the user shakes the container body 110 to mix the medicine contained in both chambers 112 and 114. That is, the chemical | medical agent to be administered to a patient is prepared by dissolving the chemical | medical agent accommodated in the powdered chemical | medical agent chamber 112 with the diluent liquid accommodated in the liquid chemical chamber 114. At this time, the injection needle penetrates the rubber plug of the drug outlet 120, and the mixed drug solution can be administered to the patient.

The dual chamber infusion container of the present invention as described above is typically folded around the compartment seal 116 and then sealed and wrapped with an Over Wrap pouch for transport and storage.

Figure 4 is a cross-sectional view showing a storage state of the dual chamber infusion container according to the present invention, as shown, the dual chamber infusion container 100 of the present invention is a desiccant 410 and deoxidant 420 in the overlap pouch 400 ) May be stored together with one or more of them. Preferably, the pouch 400 is also formed of a multilayer film having a high barrier against moisture, gas, and the like.

FIG. 5 is a structural cross-sectional view showing an embodiment of a gas barrier multilayer film according to the present invention. Referring to FIG. 5, the multilayer film of the present invention is a polyethylene terephthalate homopolymer coated with at least a portion of aluminum oxide or silicon oxide, respectively. An outer layer 510 containing; An intermediate layer 520 containing a polymer of a polyolefin-based polymer; And an inner layer 530 containing a mixture of a polyolefin-based polymer and various elastomers.

6 is a structural cross-sectional view showing another embodiment of a gas barrier multilayer film according to the present invention. Referring to FIG. 6, the multilayer film of the present invention is polyethylene terephthalate alone coated with at least a portion of silicon oxide or aluminum oxide. Outer layer 610 containing a polymer; An intermediate layer 620 containing polymers of engineering plastics; And an inner layer 630 containing a polyolefin-based polymer or a mixture of a polyolefin-based polymer and an elastomer.

7 is a structural cross-sectional view showing an embodiment of the gas barrier overlap pouch film of the present invention. Referring to FIG. 7, the film for overlap pouches of the present invention is formed on both sides of an intermediate layer 710 of ethylene vinyl alcohol copolymer. It has a multilayer structure in which the containing layer 720 and the polymer of the polyolefin-based polymer or the mixture containing layer 730 of the polyolefin-based polymer and the elastomer are sequentially laminated.

Hereinafter, the manufacturing process of the medical multilayer film and the double chamber infusion container according to the present invention will be described, but is not limited thereto.

< Production Example  1> double chamber  Fabrication of Sap Containers

1-1. Preparation of Multilayer Film

An ultrasonic cleaning device was used to remove foreign substances adhering to the surface of the synthetic resin film. In this case, when the synthetic resin film has sufficient cleanliness for vacuum electron beam coating, ultrasonic cleaning may be omitted.

Using the electron beam lamination apparatus shown in FIG. 8 , the 12 μm synthetic resin, ie, polyethylene terephthalate film, is rolled up and rolled into a roll laminator, and a ceramic or aluminum material, i.e., SiO or After Al was installed, the SiO or Al was irradiated with an electron beam at a low temperature of 100 ° C. or lower to condense the evaporated silicon oxide material or aluminum oxide material onto the polyethylene terephthalate film, thereby providing 0.4 μm thick SiOx (x = 1.8) or AlOx (x = 1.8) film was formed.

The polyethylene terephthalate homopolymer coated on the lower part of the obtained silicon oxide or aluminum oxide is used as an outer layer, an intermediate layer is formed of a polymer of engineering plastic, and an inner layer is formed of a polyolefin-based polymer, thereby depending on the heat resistance of the laminated film. Although it can set suitably, Preferably the transparent flexible gas barrier sheet film as shown in FIG . 6 was manufactured using the roll laminator which heat-processes from room temperature to 150 degrees C or less.

1-2. double chamber  Fabrication of Sap Containers

In order to form the compartment seal 116 on the manufactured flexible multilayer film, heat seal is performed such that a junction / non-junction / junction is formed at an interval of 4 mm in the central portion of the film. Then, a tubular rubber plug for discharging the medicine is placed at the center of one end of the liquid chamber 114, and the edge of the container is strongly heat-compressed sealed at a temperature of 170 to 200 DEG C at a pressure of 5 bar, and then The missing part was cut out to form the container body. Glucose solution was injected and filled through the rubber plug conduit of the container body, sealed, and sterilized for 1 hour at 1.2 at 120 ° C. in an autoclave. Rotating the container body up and down 180 degrees to position the powder medicament chamber to be placed up, and then open the top of the powder medicament chamber, therein powder imipenem / cilastatin, sepoxitine, cephmetazole, Cefataxime, ceprerazone / sulbactam, ceftriaxone, cetifaxim, promoseph, ceftazidime, ceftminox, ceftyramide, cethetane, celanide, cefepime, meropenem, phanypenem / betamipronone Alternatively, the cepuroxime is charged and charged in an appropriate amount, and the powdered pharmaceutical chamber is hermetically sealed by heat compression sealing. Subsequently, a film in which polyethylene teretralate is laminated on an aluminum foil is formed on the rear surface of one side of the chamber for powder medicine, and an adhesive resin (Rohm and Haas, ADCOTE 40-65E) attached to the other side of the powder pharmaceutical chamber was bonded to the polyethylene teretralate laminated film on a high-shielding aluminum foil of the same material as above to prepare a double chamber fluid container. .

When storing and transporting the sap container, as shown in FIG . 7 , a multilayer film in which engineering plastics and polyolefin-based polymers were sequentially stacked on both sides of an intermediate layer of ethylene vinyl alcohol copolymer was stored in a pouch made of an overlap film. .

< Production Example  2> double chamber  Fabrication of Sap Containers

2-1. Preparation of Multilayer Film

An ultrasonic cleaning device was used to remove foreign substances adhering to the surface of the synthetic resin film. In this case, when the synthetic resin film has sufficient cleanliness for vacuum electron beam coating, ultrasonic cleaning may be omitted.

Using the electron beam lamination apparatus shown in FIG. 8 , the 12 μm synthetic resin, that is, polyethylene terephthalate film was rolled up in a roll laminator, and aluminum or silicon was installed in an atmosphere of Ar gas in a 5 mtorr vacuum chamber. By irradiating and evaporating aluminum or silicon with electron beam at a low temperature below 100 ° C., the evaporated aluminum oxidized material was condensed on the polyethylene terephthalate film and cold rolled to give 0.4 μm of AlOx (x = 1.8) or SiOx (x = 1.8). A film was formed.

The polyethylene terephthalate homopolymer coated on the bottom with the obtained aluminum oxide or silicon oxide is used as the outer layer; Forming a first intermediate layer and a mixture of the polyolefin-based polymer and the elastomer into a second intermediate layer with the polymer of the polyolefin-based polymer; A mixture of a polyolefin-based polymer and a polyolefin-based elastomer including styrene or ethylene or butadiene and a composite polymer thereof may be used as an inner layer, and the temperature may be appropriately set according to the heat resistance of the laminated film, but preferably 150 ° C. or less from room temperature. The transparent flexible gas barrier multilayer film as shown in FIG . 5 was manufactured using the roll laminator which heat-processes at.

2-2. double chamber  Fabrication of Sap Containers

A double chamber infusion container was manufactured in the same manner as in Example 1, except that the flexible multilayer film prepared in 2-1 was used as the base sheet film.

< Experimental Example >

1. Moisture permeability test of multilayer film

Dual chamber fluid containers using a film coated with aluminum oxide at 38 ° C., 100% RH under the measurement conditions ASTM F 1249 of the American Society for Testing and Materials using a measuring instrument (PERMATRAN-W 3/33, MOCON) The water vapor transmission rate for the double chamber infusion vessel (hereinafter referred to as "Example 2") using "Example 1" and a film coated with silicon oxide was measured. 2, and 2 g (water) / day / m 2, respectively, to meet 5 g (water) / day / m 2 required in the art.

2. Oxygen permeability test of multilayer film

Oxygen permeability for the double chamber infusion vessels according to Examples 1-2 under 25 ° C., dry, under the measurement conditions ASTM D 3985 of the American Material Testing Association, using a measuring instrument (OX-TRAN MODEL 2/21, MOCON) Measured. 4 cc / m 2 / day / atm and 5 cc / m 2 / day / atm, respectively, indicating that they meet the 10 cc / m 2 / day / atm or less required in the art.

3. Tensile test of multilayer film

Tensile tests of the double chamber infusion vessels according to Examples 1 and 2 were carried out using a tensile tester (UNIVERSAL TESTING MACHINE TIRA TEST MODEL 2810, TIRA WPH LEIPZING GmbH) under the measurement conditions ASTM D 88 of the American Society for Testing and Materials.

All properties described are averaged for at least five measurements so that they can be statistically representative.

4. Appearance test of multilayer film

The coloring state and transparency were visually determined.

division Water vapor transmission rate (mg / day / ㎡) Oxygen transmittance (cc / ㎡ / day / atm) Tensile Strength (kgf / ㎠) Exterior Example 1 <2 below instrument measuring range <4 below instrument measuring range 220 transparent Example 2 <2 below instrument measuring range <5 or less 350 transparent

As shown in Table 1, the infusion container using the prepared multilayer film is colorless, transparent, it can be seen that satisfies the physical properties of gas barrier properties such as excellent moisture and oxygen at the same time.

According to the medical multilayer film and the double chamber fluid container using the same according to the present invention having the above configuration, a separate manufacturing space is not required for the desiccant and the deoxidizer, and the manufacturing process is simplified and the manufacturing cost is reduced, as well as the prior art. Compared to the above, transparency, flexibility and heat resistance are greatly improved. In addition, it can be used as a material for various containers and packaging materials requiring excellent water and gas barrier properties, in addition to containers for fluids, in place of glass containers having weaknesses due to their weakness, high density, and heavy weakness.

Claims (10)

In a double chamber fluid container formed so as to separate the powdered first drug and the liquid second drug during storage, and to mix the first and second drugs during use, formed by a predetermined base sheet and First and second chambers for separately receiving the first and second agents, respectively; And a non-junction disposed between at least two junctions and adjacent junctions to partition the first and second chambers, wherein the junction is opened by external pressure to seal the compartment formed to allow communication between the chambers. A dual chamber fluid container comprising a portion, Wherein the predetermined base sheet comprises an outer layer containing polyethylene terephthalate homopolymer coated on at least a portion of aluminum oxide or silicon oxide; An intermediate layer containing a polymer of a polyolefin-based polymer; And an inner layer containing a mixture of a polyolefin-based polymer and an elastomer, or An outer layer containing polyethylene terephthalate homopolymer coated on at least a portion of silicon oxide or aluminum oxide; Polyamide resin, polyacetyl resin, polycarbonate resin, polyester resin, modified polyphenylene oxide resin, U polymer resin, polysulfone resin, polyphenylene sulfide resin, polyetherimide resin, polyethersulfone An intermediate layer containing an engineering plastic polymer selected from the group consisting of resins, polyarylate resins, polyetheretherketone resins, tetrafluoroethylene resins, and polyimide resins; And a multilayer film comprising an inner layer containing a polymer of a polyolefin-based polymer or a mixture of a polyolefin-based polymer and an elastomer. According to claim 1, The front covering sheet is fixed to the outer side of the first chamber; And a back cover sheet detachably attached to the other outer surface of the first chamber. The double chamber fluid container according to claim 2, wherein the front cover sheet and the back cover sheet are aluminum foil or a film laminated with polyethylene terephthalate on an aluminum foil. delete delete An outer layer containing polyethylene terephthalate homopolymer coated on at least a portion of aluminum oxide or silicon oxide; An intermediate layer containing a polymer of a polyolefin-based polymer; And an inner layer containing a mixture of a polyolefin-based polymer and an elastomer. The multilayer film of claim 6, further comprising a mixture layer of a polyolefin-based polymer and an elastomer interposed between the intermediate layer and the inner layer. An outer layer containing polyethylene terephthalate homopolymer coated on at least a portion of silicon oxide or aluminum oxide; Polyamide resin, polyacetyl resin, polycarbonate resin, polyester resin, modified polyphenylene oxide resin, U polymer resin, polysulfone resin, polyphenylene sulfide resin, polyetherimide resin, polyethersulfone An intermediate layer containing an engineering plastic polymer selected from the group consisting of resins, polyarylate resins, polyetheretherketone resins, tetrafluoroethylene resins, and polyimide resins; And a polymer of polyolefin-based polymer, or a mixture of polyolefin-based polymer and elastomer. The dual chamber infusion vessel of claim 1; At least one of a desiccant and a deoxidizer; And An infusion kit comprising the dual chamber infusion container and an overlap pouch for containing one or more of the desiccant and deoxygenation agent. 10. The method of claim 9, wherein the overlap pouch is an intermediate layer containing an ethylene vinyl alcohol copolymer; Polyamide-based resin, polyacetyl-based resin, polycarbonate-based resin, polyester-based resin, modified polyphenylene oxide-based resin, U-polymer resin, polysulfone resin, polyphenylene sulfide sequentially stacked on both outer surfaces of the intermediate layer Polymers of polyolefin-based polymers and engineering plastic-containing layers selected from the group consisting of resins, polyetherimide resins, polyethersulfone resins, polyarylate resins, polyetheretherketone resins, tetrafluoroethylene resins, and polyimide resins, or polyolefins An infusion kit consisting of a multilayer film comprising a mixture containing layer of a polymer and an elastomer.

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