JPH09226842A - Package structure of plastic container receiving bicarbonate or the like - Google Patents

Abstract

PROBLEM TO BE SOLVED: To suppress decomposition of a bicarbonate or the like as much as possible by packaging in a liquid-tight package so that relative humidity outside a plastic container is kept at a specific value or higher. SOLUTION: A bicarbonate 3 is filled in a package structure 1 for packaging a plastic container 2, and the plastic container 2 is packaged by a liquid-tight package 1A so that relative humidity outside the container 2 is kept at 50% or higher. The package 1A is filled with water 4 thereby keeping the relative humidity outside the container 2 at 50% or higher. Electrolytic solution in the package 1A is liquid-tightly filled in the plastic container 2 having a moisture- permeable wall, while the moisture-permeable plastic container 2 is a resin container having an elastic wall. The plastic container 2 is formed by overlaying resin sheets 6, 7 and heat-weld-sealing peripheries 2A, 2B. Thus, decomposition of bicarbonate or the like filled in the plastic container can be suppressed as much as possible, thereby preferably being applicable to a medical field.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a package structure of a plastic container filled with bicarbonate or the like. More specifically, decomposition of bicarbonate or the like is suppressed as much as possible, and long-term storage is possible. It concerns a possible packaging structure.

[0002]

2. Description of the Related Art Carbonates or bicarbonates are widely used in medicine in the medical field as sodium carbonate, potassium carbonate, sodium hydrogen carbonate and potassium hydrogen carbonate. In addition, these carbonates and bicarbonates are provided as solids such as powders and tablets or as an aqueous solution, and are used for injections, infusions, dialysis solutions, organ preservation solutions, and the like. Carbonates and bicarbonates are extremely unstable and readily release carbon dioxide and decompose. For this reason,
Even if it is limited to an aqueous solution, even if it is powder etc., most of the storage containers are glass containers. This is because the glass container has airtightness that does not allow gas to permeate through its wall. On the other hand, in a plastic container, particularly a thin-walled flexible plastic sheet container, gas such as air and water vapor permeates through the wall, so that the inside cannot be kept completely airtight. Therefore, even if the bicarbonate or the like is stored in a plastic container in a confidential manner, carbon dioxide gas is released from the container over time, and it cannot endure long-term storage. In particular, if the plastic container containing the bicarbonate powder is kept at room temperature or higher, the water of crystallization in the bicarbonate inside the container will separate,
Bicarbonate easily decomposes to generate carbon dioxide gas.

Recently, as a container for chemicals, a resin container has been used instead of a glass container, and the resin container is excellent in that it is easy to handle and dispose like a glass container. However, since the resin container is not airtight as compared with the glass container as described above, even a solid carbonate or bicarbonate is decomposed when exposed to a high temperature to some extent. For this reason, a carbonate or bicarbonate is filled in a container, particularly a container having a flexible wall such as a resin sheet, and an injectable agent,
There is a problem in using it as an infusion solution, a dialysis solution, and an organ preservation solution. Therefore, despite the fact that the human body blood or tissue cells contain bicarbonate at a constant concentration,
Although the infusion solution, artificial dialysate solution, and organ (tissue) preservation solution used for treatment of the human body and the like contain a predetermined electrolyte, they contain little or no bicarbonate.

For example, the concentration of bicarbonate in human plasma is usually about 24 to 27 mEq / L. When bicarbonate is directly administered to the body by infusion or indirectly administered by hemodialysis or peritoneal dialysis, it is desirable to adjust the bicarbonate concentration of each solution according to the concentration in plasma. However, an infusion solution or the like is filled in a plastic medical container and usually provided to a hospital in a completely sterilized state by high-pressure steam sterilization. Therefore, if bicarbonate is preliminarily prepared in the liquid in the container, the bicarbonate is almost decomposed into carbon dioxide during high-pressure steam sterilization. Further, even if conventional plastic medical containers are not filled with bicarbonate and subjected to high-pressure steam sterilization, in a diluted solution, bicarbonate is decomposed into carbon dioxide and disappears. Therefore, bicarbonate is not used as an infusion agent, a dialysate, etc., but a substitute for this is added in the body. In order to keep the bicarbonate concentration in plasma or the like constant, acetate or lactate is prepared as an alternative to bicarbonate. However, when a large amount of an organic acid such as acetate or citric acid is used in the conventional electrolyte solution,
Since there are patients whose acetate and the like are not immediately decomposed in the body, for example, patients with liver damage, there is a tendency for acidosis in the body of the patients. In addition, as described above, P
If the H value is kept as low as possible, acid overdose, renal damage, diarrhea, vomiting and the like may occur in the administered patient. Especially when the PH value is 5.0 or less, such symptoms are frequently observed. Therefore, an object of the present invention is to provide a packaged structure of a plastic container filled with bicarbonate or the like, which can suppress decomposition of the bicarbonate or the like filled in the plastic container as much as possible and is suitable for application to the medical field. Especially.

[0005]

The present invention is a packaging structure for packaging a plastic container filled with carbonate or bicarbonate, and the relative humidity outside the plastic container can be maintained at 50% or more. The above object is achieved by providing a packaging structure characterized in that the above plastic container is packaged in a liquid-tight packaging body.
In the package structure according to the present invention, the package body is filled with water, and the water maintains the relative humidity outside the plastic container at 50% or more. In the package structure according to the present invention, the water in the package is
Further, it is characterized in that it is liquid-tightly filled in a container having a moisture permeable wall. The moisture-permeable container has a thickness of 10
It can be characterized in that it is a resin container having a flexible wall of μm to 1600 μm. Further, the resin container has a moisture permeability of 100 cc / m ² hr (measurement method is JIS
It can be characterized by using a resin having a thickness of 30 μm (converted to Z0208).

In the packaging structure according to the present invention, the plastic container filled with the carbonate or bicarbonate and the moisture permeable container filled with water are the same container, and the inside of the container is a partition wall. A multi-chamber container isolated from the above, wherein all or part of the partition wall between the carbonate or bicarbonate filling chamber and the water filling chamber can be opened from the outside of the container. It is characterized in that it is a multi-chamber container formed by an isolation-opening means capable of communicating with each other. Further, the filling chamber filled with water may be a mother liquid chamber for an infusion liquid containing an electrolyte, and the multi-chamber container may be an infusion liquid container. Further, the filling chamber of the carbonate or the bicarbonate can be sterilized by electron beam irradiation.

In the package structure according to the present invention, the water is directly contained in the package. Further, in the package structure according to the present invention, the water is contained in the package by a water-absorbing carrier.

[0008]

Even if a plastic container filled with the above-mentioned bicarbonate or the like is simply air-tight or liquid-tightly packed with a carbon dioxide gas barrier package, it is temporarily exposed to 40 to 60 ° C. from room temperature. In some cases, it is seen that a large amount of bicarbonate and the like in the plastic container is decomposed. On the other hand, as in the present invention, the package structure is provided so that the relative humidity thereof is 50% or more even if the atmosphere around the plastic container filled with the carbonate or bicarbonate is in a high temperature state. When,
Crystal water such as bicarbonate in the plastic container does not separate,
Bicarbonate does not decompose by releasing carbon dioxide gas even when the external environment temperature reaches 40 ° C to 60 ° C. The structure of the package may be a structure in which water is directly filled in the package, a structure in which water is infiltrated into a water-absorbent carrier, or a structure in which water is further stored in a resin container, and these filled waters are contained in the package. Relative humidity of 50% or more can be maintained. The water may be pure water alone, or may be an aqueous solution in which other solutes are dissolved, or may be a mixed aqueous solution with alcohol or the like, if necessary. In particular, if the aqueous solution is used as a medical electrolyte solution, an infusion solution containing a bicarbonate, a dialysate, an organ preservation solution, etc. can be aseptically provided to a plastic container.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A preferred embodiment of the packaging structure of a plastic container containing a bicarbonate or the like according to the present invention will be described in detail below with reference to the accompanying drawings. FIG. 1 is a plan view of a first embodiment of the packaging structure of a plastic container containing bicarbonate or the like according to the present invention. FIG. 2 is a sectional view of the package structure taken along the line II in FIG. FIG. 3 is a schematic diagram of an electron beam irradiation apparatus used in the package structure of FIG. FIG. 4 is a plan view of a second embodiment of the packaging structure of a plastic container containing bicarbonate and the like according to the present invention. FIG. 5 is a cross-sectional view of the package structure taken along the line II-II in FIG. FIG. 6 is a cross-sectional view of a third embodiment of the packaging structure of a plastic container containing bicarbonate and the like according to the present invention.

A package structure 1 for packaging a plastic container 2 filled with a bicarbonate 3 as shown in FIGS. 1 and 2, so that the relative humidity outside the plastic container 2 can be maintained at 50% or more. The plastic container 2 is packed in a liquid-tight package 1A. In the package structure 1, water (hereinafter, referred to as an electrolyte solution) is contained in the package 1A.
4 is filled, and the relative humidity outside the plastic container 2 is maintained at 50% or more by the water 4. In the package structure 1, the electrolyte solution in the package 1A is liquid-tightly filled in the plastic container 2 having a moisture permeable wall, and the moisture permeable plastic container 2 has a thickness of 10 μm.
It is a resin container having a flexible wall of 1 to 1600 μm.
Further, the plastic container 2 has a water vapor permeability of 100 cc / m ²
A resin having an hr (measurement method converted to a thickness of 30 μm according to JIS Z0208) or more is used.

That is, in the package structure 1 according to the present embodiment, the plastic container 2 filled with the bicarbonate 3 and the moisture permeable container filled with the electrolyte solution 4 are the same container 2 and the inside thereof is the isolation wall. 5 is a multi-chamber container isolated into a plurality of chambers. The plastic container 2 can be opened from the outside of the container 2 with a partition wall 5 between the filling chamber 3A for the bicarbonate 3 and the filling chamber 4A for the electrolyte solution 4 and has a peel seal portion for communicating the chamber 3A with the chamber 4A. It was formed. Further, the moisture-permeable filling chamber 4A filled with the electrolyte solution serves as a mother liquor chamber for the infusion liquid containing the electrolyte, and the plastic container 2 serves as the infusion container. Further, the filling chamber 3A for the bicarbonate 3 is subjected to electron beam irradiation sterilization.

The structure of the wrapping body of this embodiment will be described in more detail. As shown in FIGS. 1 and 2, the wrapping body 1A cuts an inflation sheet into a predetermined length to form a predetermined edge 8A,
It is formed by heat-sealing 8B. The package 1A may have some gas permeability and water vapor permeability, but the package 1A itself is kept airtight by the seal, and the moisture vapor permeates from the filling chamber 4A of the plastic container 2 described later. The internal relative humidity of 50% or more,
In particular, it can be maintained at 70% or more. In this embodiment, the sheet is made of linear low density polyethylene. In addition to the resin sheet of this embodiment, aluminum foil, a resin laminate having an aluminum layer, or a resin having a high gas barrier property can be used in order to give the package 1A a function of preventing moisture permeation. . For example, there are high-density polyethylene, vinylidene chloride, polyester, nylon, vinylon and the like. In the present invention, the package 1A may be an extrusion molded product, a vacuum molded product, an injection molded product, a blow molded product, or the like.

As shown in FIGS. 1 and 2, the plastic container 2 has two resin sheets 6 and 7 stacked on each other and has a predetermined peripheral edge 2.
The plastic used is formed by heat-sealing A and 2B, and the plastic used is a linear low density polyethylene and polypropylene composition. The resin used for the resin sheet here has a water vapor transmission rate of 100 cc / m ² hr (measurement method: JI
Converted to a thickness of 30 μm with S Z0208) or more, especially 30
It is preferably 0 cc / m ² hr or more. If the moisture vapor transmission rate is above the above range, water vapor from the plastic container 2 easily passes through the resin wall to maintain the relative humidity inside the package at 50% or more even when the external environment suddenly becomes high in temperature. The dry condition can be avoided. On the other hand, if the thickness is less than the above range, it is difficult to keep the relative humidity in the package 1A constant by quickly responding to the external environmental temperature even if the plastic container 2 is made extremely thin.

The plastic container 2 is divided into a chamber 3A and a chamber 4A, and a partition wall 5 separating the chamber 3A and the chamber 4A is entirely formed by a peel seal portion which can be opened from the outside of the container 2. A filling and discharging port 9 is attached to the heat-sealing seal portion 2A, an electrolyte solution 4 serving as a mother liquid of an infusion agent is stored in the filling chamber 4A and steam sterilized, and irradiation filling sterilization is performed in the filling chamber 3A after filling. Bicarbonate 3 is contained. In the present invention, the plastic of the container 2 does not have to be a linear low-density polyethylene and polypropylene composition, and other resins can be used as long as they have the above-mentioned moisture permeability and can be peel-sealed. For example, a highly flexible material such as a low-density polyethylene resin, a high-density polyethylene resin, a polypropylene resin, a soft polyester resin, a chlorinated polyethylene resin, a vinyl chloride resin, and an ethylene-vinyl acetate copolymer can be used. However, it is desirable to use the olefin resin as in the present embodiment as the resin that has little adverse effect on the four components of the electrolyte solution. Further, in the present invention, the container 2 may be an extrusion molded product, a vacuum molded product, an injection molded product, a blow molded product, or the like.

The plastic container 2 of this embodiment has a length of 5
The width is 200 mm and the width is 00 mm, and the thickness of the container wall is 200 μm. In the present invention, the thickness of the container wall of the medical container 1 is 1600 to 10 μm.
m, especially 800 to 30 μm is desirable. If the thickness of the container wall exceeds the above range, it becomes difficult to sterilize the bicarbonate 12 by irradiation with an electron beam irradiation device of a simple facility to be described later, and it becomes difficult to put it on a mass production line. Further, when the ratio is below the above range, there is a problem that the chance of breaking the container wall increases.

The bicarbonate 3 in the plastic container 2 and the electrolyte solution 4 are mixed to form an infusion agent. The bicarbonate 3 is kept alkaline in the filling chamber 3A. Bicarbonate 3
Is contained as a strongly alkaline salt, which is the sodium salt. As the alkaline salt of bicarbonate,
The salt is not limited to the salt of this embodiment as long as a part of the salt to be used in the electrolyte solution 4 which is the mother liquor is assigned. For example, potassium salt may be used in addition to sodium salt. Therefore, powdered sodium bicarbonate (including sodium carbonate if necessary) is stored as the bicarbonate 3 in the filling chamber 3A. The amount of bicarbonate 3 contained is such that the bicarbonate concentration when the bicarbonate 3 is dissolved in the electrolyte solution 4 is 1 to 1.
A range of 65, especially 5 to 50 mEq / L is desirable. Therefore, in this example, since the storage amount of the electrolyte solution 4 was 500 mL, the bicarbonate 3 was used in the range of 0.042 to 2.73 g as sodium hydrogen carbonate. In addition, depending on the addition of bicarbonate 4, electrolyte solution 4
It is desirable to add a reduced amount of acetate or lactate therein.

The electrolyte solution 4 is a hypertonic sugar solution and is a high-calorie infusion solution to be administered via the central venous route. Such infusions are performed for the purpose of nutritional supplementation for patients with massive excision of the intestinal tract, small intestinal lesions, severe diarrhea, and the like. Glucose is mainly used for carbohydrates, but in addition to glucose,
Fructose, xylitol, sorbitol and the like are also used. The electrolyte solution 4 appropriately contains an electrolyte in addition to sugar, and as the electrolyte, Na (sodium), K (potassium), Cl (crawl), Ca (calcium), Mg
(Magnesium) and the like. Also, if necessary,
Trace metals such as Zn (zinc), P (phosphorus), Fe (iron), Cu (copper), and organic acids such as citric acid, gluconic acid, acetic acid (acetates), lactic acid (lactates), etc. are also added. It These electrolytes and organic acids include hydrochloride, lactate,
It is used as an acetate, a sulfate, a phosphate, a gluconate, and a glycerophosphate, and in Ca, it is used as a glycerophosphate. In order to supply P sufficiently so as not to cause precipitation or the like, a polyhydric alcohol or a phosphoric acid ester of sugar is used.

Na is 0 to 160, especially 20 to 80 mEq.
Used in the electrolyte solution 4 at a concentration of / L. However, the amount obtained by subtracting the sodium salt used in bicarbonate 3 is added. K is used in the electrolyte solution 4 at a concentration of 0 to 80, particularly 10 to 70 mEq / L. Cl is 0-16
It is used in the electrolyte solution 4 at a concentration of 0, particularly in the range of 20 to 80 mEq / L. Ca is 0 to 20, especially 4 to 15 mEq
Used in the electrolyte solution 4 at a concentration of / L. Mg is 0
˜25, especially 6 to 20 mEq / L in the concentration range used for the electrolyte solution 4. P is 0 to 500, especially 120 to 35
Used in the electrolyte solution 4 at a concentration of 0 mg / L. Z
n is used in the electrolyte solution 4 in a concentration range of 0 to 40, especially 5 to 30 μmol. The concentration of acetate or lactate is 28 mEq / L or less, especially 1
It is contained in the range of 5 to 0 mEq / L.

The PH value of the electrolyte solution 4 in the filling chamber 4A is
It can be lowered to 5.5 or less, and particularly in this embodiment, the PH value is 5.
It is prepared in the range of 0 to 3.0. If the PH value of the electrolyte solution 4 exceeds the above range, the sugar may be discolored or deteriorated during the high-pressure steam sterilization treatment. Further, the PH value of the whole high calorie infusion solution in which the electrolyte solution 4 and the bicarbonate 3 are mixed is preferably in the range of 6.0 to 8.0, particularly 6.5 to 7.5. If the pH value of the infusion solution is below the above range, diarrhea, abdominal pain, etc. often occur in the patient. The electrolyte solution 4 is sterilized by high-pressure steam in the filling chamber 4A. The high-pressure steam sterilization treatment is performed based on the Japanese Pharmacopoeia standard of steam sterilization, and in this embodiment, it is performed in an autoclave or the like at a temperature of 100 to 130 ° C. In the present invention, steam sterilization known per se can be adopted.

The bicarbonate 3 is irradiated and sterilized in the filling chamber 3A. In this embodiment, irradiation sterilization in the filling chamber 3A is performed by electron beam irradiation sterilization. The irradiation sterilization treatment of the present invention may be irradiation sterilization treatment using gamma rays, electron beams, and ultraviolet rays. However, the following electron beam irradiation sterilization is desirable from the viewpoint of the certainty of sterilization, its economic efficiency, and adaptability to mass production.

In order to ensure the irradiation sterilization, the transparency of the container wall for electron beams becomes a problem. The transmittance of the electron beam is mainly determined by the accelerating voltage.
g / m ² , which is 13000 μm in water (specific gravity 1 g / m ² ) thickness. However, when the accelerating voltage device is increased in size, the X-ray shielding equipment becomes large, and the resin material may be deteriorated. Therefore, 1 MeV or lower energy type in about particularly low energy type 500KV following acceleration voltage device is desirable, from about 1500 g / m ² in medium energy type in such a device, a low energy type 80
Since the limit is 0 g / m ^{2, the} optimal thickness of the electron beam transmission is 1600 μm for the resin material. Therefore, as described above, the thickness of the wall of the container 2 and the thickness of the filling chamber 3A are preferably within the above range. Electron beam sterilization has an accelerating voltage of less than 1 MeV, especially low energy type 500K
With a voltage of V to 50 KV, a predetermined permeability of an electron beam can be obtained, but there is almost no emission of X-rays or the like. Therefore, shielding equipment is not required and the device can be arranged compactly on a production line. That is, the penetrability of an electron beam at an acceleration voltage of 500 KV is about 8000 g / m ² or less, particularly 800 μm.
Sufficient permeability is obtained in the resin thin portion of m or less.

As shown in FIG. 3, the electron beam irradiation apparatus 50 is provided above the belt conveyor 51, a machine frame 52, a window frame 53 formed on the machine frame 52, and a window foil 54 attached to the window frame 53. The acceleration tube 55 covering the window frame 53 and the electron beam generator 56 provided in the vacuum chamber inside the acceleration tube 55. The electron beam generator 56 is connected to the grid 5
7, a gun frame 58, and a filament 59. The filament 59 is energized and heated to generate thermoelectrons. The thermoelectrons are accelerated between the filament 59 to which a predetermined voltage is applied and the grid 57, and the window foil 54
Irradiates the light onto the conveyor 51. Note that the machine casing 52 is shielded with lead to prevent external leakage of X-rays and the like generated secondary by irradiation with electron beams. Therefore, the irradiation electron dose can be adjusted by the speed of the conveyor 51 and the amount of current supplied to the filament 59, and the permeability of the electron beam can be adjusted by the acceleration voltage.

In FIG. 3, only the filling chamber 3A of the plastic container 2 is irradiated and sterilized by the electron beam irradiation device 50. Also, electron beam irradiation is performed from both sides of the container 1. In the sterilization of microorganisms, as described in JP-A-7-16286, B.
Milus (spores) E-601 has a D value of about 0.2 Mrad (2 kGy). 1 cm ² per Although bacteria typically 10 ⁰ order is attached, if sufficiently considering safety versa assumption that there is attached to the 10 ^two orders. The sterilization assurance level (SAL) has a survival rate of 10 ^-6 %. Therefore, in the electron beam irradiation apparatus 50 of this embodiment, the inside of the second chamber 3 is 6
The amount of electricity and the speed of the conveyor are adjusted so that the sterilization is performed at × 0.2 Mrad or more, preferably 8 × 0.2 Mrad or more.

Next, the assembly of the package structure 1 will be described. As shown in FIG. 1, the plastic container 2 is formed by cutting an inflation-molded tubular linear low-density polyethylene sheet into a predetermined size. One end portion of the cut sheet is fixedly sealed by a heat welding seal, and the discharge port 9 is attached at this time. Next, the isolation wall 5 consisting of a single strip seal portion is formed at a predetermined position of the container 2, and the filling chamber 3A and the filling chamber 4A are divided in the container 2. Specifically, linear low-density polyethylene (density: 0.916
The sheet of g / cm ³ and MI: 2) has a wall thickness of 200μ.
m, length 500 mm, width 200 mm. Next, in order to form a container, an impulse sealer (Fuji Impulse Co., Ltd. auto sealer FA-30
Both ends are heat-sealed with 0-5 W). The sealing conditions are a sealing time of 1.5 seconds and a cooling time of 5 seconds. The peel seal portion 5 is 120 to 140 ° C. so that it can be peeled off.
It is formed by sandwiching for a long time with the sandwiched body preheated in.
In the present invention, a method of forming a peel seal portion known per se other than the above method may be used.

Next, the filling chamber 4A is filled with the electrolyte solution 4 through the discharge port 9, and the discharge port 9 is sealed with the rubber stopper 9A. In this state, the high-pressure steam sterilization is applied to the plastic container 2 to sterilize the electrolyte solution 4. Next, the bicarbonate 3 is filled into the filling chamber 3A from the other end 2B of the plastic container 2 which is not closed. Then, after the opening of the other end 2B is heat-sealed, the plastic container 2 is transported to the electron beam irradiation device 50, and both surfaces of the filling chamber 3A are irradiation-sterilized. Next, the plastic container 2 is inserted from one end opening of the package 1A, and the end opening is heat-sealed and sealed to form the confidential package structure 1.

In the package structure 1 of the present embodiment thus constructed, even if the external environment becomes hot and the outside is dried, part of the water content of the electrolyte solution in the filling chamber 4A of the plastic container 2 is packed as water vapor. Released into the body 1A, the package 1A
The inside is not dried and the relative humidity is maintained at 50% or more. Therefore, the bicarbonate 3 in the filling chamber 3A of the plastic container 2
Does not release crystal water due to drying, and there is no risk of decomposition into carbon dioxide gas and release. Therefore, the bicarbonate 3 does not decompose even when exposed to a high temperature to some extent, and can be stored for a long period of time. Further, in this embodiment, the filling chamber 4A contains the electrolyte solution 4 serving as an infusion agent, and the bicarbonate 3 can be aseptically mixed through the isolation wall 5 of the peel seal portion. Therefore, it becomes possible to stably administer bicarbonate ions, which has not been achieved by conventional infusion agents, and as a result,
Infusion can be administered without electrolyte abnormality. Further, in the present embodiment, the bicarbonate 3 is subjected to irradiation sterilization such as high-pressure steam sterilization while avoiding high temperatures as much as possible.
Is difficult to decompose, and particularly powder and granules hardly decompose in the filling chamber 3A. In particular, since the bicarbonate 3 is a substance that is not likely to be altered during electron beam irradiation, irradiation sterilization can be carried out through the container wall without any problem, and reliable sterilization is achieved.

Next, the structure of the package of the plastic container containing the bicarbonate according to the present invention will be described in detail with reference to FIGS. 4 and 5. 4 and 5 in the present embodiment, the members used in the first embodiment are designated by the same reference numerals, and detailed description thereof will be omitted. In this embodiment, the package 11 having the package structure itself directly accommodates the electrolyte solution 4,
The package 11 itself is an infusion container. The package 11 is two resin sheets (linear low-density polyethylene sheet)
Is formed by heat-sealing the periphery thereof, and a discharge port 9 is attached to the seal portion 11A. Package 1
Relative humidity in 1 is always maintained at 70% or more by the electrolyte solution 4.

In the package 11, a plastic container 12 containing the bicarbonate 3 is placed. The plastic container 12 is a container formed by inflation-molding linear polyethylene and cutting it into a predetermined length. One end 12B of the plastic container 2 is sealed at the same time as the heat-sealing seal of the peripheral edge of the package 11,
Is in the package 11 and is fixedly placed on the peripheral seal portion 11B. In addition, the other end 1 of the plastic container 12
2A has a peel seal portion that can be opened from the outside. Even in such a configuration, the bicarbonate 3 in the package 11 does not decompose even when exposed to high temperature or the like as in the first embodiment. Further, since the plastic container 12 accommodating the bicarbonate 3 can be easily opened from the outside, it is possible to provide an infusion solution similar to that of the first embodiment. In addition, in the above embodiment, the package 11 is
Although molded from a single resin sheet, known molded products such as blow molded products and injection molded products can be appropriately used in the present invention.

Next, the third embodiment of the packaging structure according to the present invention will be described in detail with reference to FIG. As shown in FIG. 6, in the packaging body structure of this embodiment, the packaging body 21 is provided with the water absorbing carrier 23 under the net member 24. Plastic drug containers 22 and 22 are stacked on the upper surface of the net member 24. The packaging body 21 is a rectangular plastic injection-molded product, and has an opening 25 and a handle / opening knob 26 on the upper surface. Further, the inside of the package 21 is in a sealed state. The net member 24 in the package 21 is made of plastic and has air permeability, and divides the package 21 into upper and lower chambers. The water absorbent carrier 23 is made of a super absorbent polymer,
Sufficient water is retained to maintain the relative humidity inside the package 21 at 70% or more. The drug container 22 is formed of a linear low-density polyethylene resin sheet (thickness: 200 μm) and contains the bicarbonate 3.

Even in such a structure, the bicarbonate 3 in the drug container 22 which is a plastic container does not decompose even when exposed to high temperature. That is, the water-absorbent carrier 23
Are placed, and water vapor is released into the package 21.
Due to such release, the external environmental temperature is temporarily 40 ° C.
Even if the temperature rises to 60 ° C., the relative humidity inside the package 21 is maintained at 50% or more regardless of the temperature change. Therefore, the drug container 22 filled with bicarbonate 3
It can be seen from Table 1 of the evaluation of the examples described later that it can withstand a high temperature, without being placed in a dry state in the package 21.

(Evaluation of Examples) Based on the first example, Example Samples a and b were manufactured, and in Example Sample b, the filling chamber 3A of the plastic container 2 was irradiated with an electron beam of 4 Mrad. Further, as a comparative sample, a sample was prepared in which the electrolyte solution 4 was not filled in the filling chamber 4A of the plastic container 2 of the first embodiment. The working samples a and b and the comparative sample were stored at a temperature of 60 ° C. for 70 days. The weight change of these samples and the weight change of bicarbonate along with the standard samples were measured by the Winkler titration method. The results are shown in Table 1. In addition, the measurement of the variable mass of bicarbonate is
The measurement error range from the standard product was ± 2%.

[0032]

[Table 1]

[0033]

INDUSTRIAL APPLICABILITY As described above, the present invention provides a package structure for packaging a plastic container filled with carbonate or bicarbonate, in which the relative humidity outside the plastic container is maintained at 50% or more. Since the plastic container is packaged in a liquid-tight package so that the plastic container can be prevented from decomposing the bicarbonate and the like as much as possible, it is filled with bicarbonate and the like suitable for application in the medical field. A package structure for a plastic container can be provided.

[Brief description of drawings]

FIG. 1 is a plan view of a first embodiment of a package structure of a plastic container accommodating a bicarbonate or the like according to the present invention.

2 is a cross-sectional view of the package structure taken along the line I-I in FIG.

FIG. 3 is a schematic diagram of an electron beam irradiation apparatus used in the package structure of FIG.

FIG. 4 is a plan view of a second embodiment of the packaging structure of the plastic container containing the bicarbonate or the like according to the present invention.

5 is a cross-sectional view of the package structure taken along the line II-II in FIG.

FIG. 6 is a cross-sectional view of a third embodiment of the packaging structure of the plastic container containing the bicarbonate or the like according to the present invention.

[Explanation of symbols]

 1 Packaging Structure 1A, 11, 21 Packaging 2, 12, 22 Plastic Container 3 Bicarbonate 3A Filling Chamber 4 Electrolyte Solution 4A Filling Chamber 5 Isolation Wall

Claims (10)

[Claims] 1. A packaging structure for packaging a plastic container filled with carbonate or bicarbonate, wherein the plastic container is liquid-tight so that the relative humidity on the outside of the plastic container can be maintained at 50% or more. A package structure characterized by being wrapped in a simple package. 2. The package structure according to claim 1, wherein the package body is filled with water, and the relative humidity on the outside of the plastic container is maintained at 50% or more by the water. 3. The package structure according to claim 2, wherein the water in the package is liquid-tightly filled in a container having a moisture permeable wall. 4. The package structure according to claim 3, wherein the moisture-permeable container is a resin container having a flexible wall with a thickness of 10 μm to 1600 μm. 5. The resin container has a water vapor transmission rate of 100 cc /
m ² hr (measurement method is JIS Z0208 and thickness is 30 μm
5. The package structure according to claim 4, characterized in that a resin of the above (converted to) is used. 6. A multi-chamber container in which the plastic container filled with the carbonate or bicarbonate and the moisture-permeable container filled with water are the same container, and the inside of which is separated into a plurality of chambers by a separating wall. A partition wall for separating the carbonate or bicarbonate filling chamber and the water filling chamber from the outside of the container in whole or in part so that the chamber and the chamber can communicate with each other. 6. A multi-chamber container formed by opening means.
Package structure described. 7. The package structure according to claim 6, wherein the filling chamber filled with water is a mother liquor chamber for an infusion liquid containing an electrolyte, and the multi-chamber container is an infusion liquid container. 8. The package structure according to claim 7, wherein a filling chamber of the carbonate or the bicarbonate is sterilized by electron beam irradiation. 9. The package structure according to claim 2, wherein the water is directly contained in the package. 10. The package structure according to claim 2, wherein the water is contained in the package by a water absorbent carrier.