JPH09193963A - Wrapping method of resin container filled with carbonate or bicarbonate - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a wrapping method of a resin container filled with a carbonate or bicarbonate which is capable of suppressing the decomposition of the carbonate or bicarbonate filled in the resin container as much as possible and suitable for applications in the medical field. SOLUTION: In a method to wrap a carbonate or bicarbonate 4 in a resin container 2 in a sealed manner, the carbonate or bicarbonate 4 is filled in a sealed manner in the resin container 2 having a flexible wall of 10 to 1,600μm in thickness, and a resin container 3 in which an aqueous solution is filled in a sealed manner is provided in a coexistent manner to further wrap the resin container 2 filled with the carbonate or bicarbonate 4 by a wrapping body in a liquid-tight manner.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a packaging method for a resin container filled with a carbonate or a bicarbonate, and more specifically, a packaging method capable of suppressing decomposition of a carbonate or a bicarbonate as much as possible. It is about.

[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,
If it is an aqueous solution, it is stored in a highly sensitive container such as a glass ampoule. Further, the carbonate and bicarbonate solutions are easily decomposed when heated to a high temperature by steam sterilization or the like. Recently, a resin container has been used as a container for chemicals, and the resin container is excellent in that it does not take much time to handle and dispose it like a glass container. But,
Since the resin container is less airtight than the glass container, even if the solid carbonate or bicarbonate is exposed to high temperature to some extent, decomposition occurs. Therefore, there is a problem in filling a container, particularly a container having a flexible wall such as a resin sheet, with a carbonate or a bicarbonate to be used as an injection, an infusion solution, a dialysis solution, and an organ preservation solution. Therefore, although the blood or tissue cells of the human body contain bicarbonate at a constant concentration, an infusion agent, an artificial dialysate, and an organ (tissue) preservation solution used for treatment of the human body, etc. Contains a predetermined electrolyte, but contains 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, the object of the present invention is to prevent the decomposition of carbonate or bicarbonate filled in the resin container as much as possible, and to fill the resin container with carbonate or bicarbonate suitable for application in the medical field. Is to provide a packaging method.

[0005]

The present invention provides a method for sealing a carbonate or bicarbonate in a resin container for packaging, wherein the carbonate or bicarbonate is added to a resin container having a flexible wall having a thickness of 10 μm to 1600 μm. It is characterized in that a bicarbonate is hermetically filled, and then a resin container in which an aqueous solution is hermetically filled is allowed to coexist, and the above-mentioned carbonate or bicarbonate-filled resin container is further liquid-tightly packaged in a package. The above object is achieved by providing a packaging method of a resin container filled with a carbonate or a bicarbonate.

In the resin container packaging method according to the present invention, the water vapor permeability is 100 cc / m ² hr (measurement method is JIS
A resin having a thickness of 30 μm (converted to Z0208) is used in a resin container filled with the aqueous solution. In the resin container packaging method according to the present invention,
The resin container filled with the carbonate or bicarbonate and the resin container filled with the aqueous solution are the same multi-chamber container having a plurality of filling chambers, and all or one of the isolation walls between the chambers. Part is a multi-chamber container that can be opened from the outside of the container and is formed by an isolation opening means that allows the chambers to communicate with each other, and one chamber of the multi-chamber container is hermetically filled with the aqueous solution containing an electrolyte. Steam sterilization is performed later, and then the other chamber of the multi-chamber container is sealed and filled with the carbonate or bicarbonate, and then the multi-chamber container is liquid-tightly packaged with the packaging body. To do.

In the method of packaging a resin container according to the present invention, the filling chamber of the carbonate or bicarbonate is sterilized by electron beam irradiation. In the packaging method of the resin container according to the present invention, the electron beam irradiation sterilization can be characterized by electron beam irradiation sterilization with a medium to low accelerating voltage having an accelerating voltage of 1 MeV or less.

[0008]

Even if the resin container filled with the above-mentioned carbonate or bicarbonate is simply liquid-tightly packaged in the airtight or carbon dioxide gas barrier package, it is temporarily exposed to 40 to 60 ° C from room temperature. When it is treated, a large amount of carbonate or bicarbonate in the resin container is seen to decompose. On the other hand, when the resin container filled with the carbonate or the bicarbonate and the resin container filled with the aqueous solution are liquid-tightly housed in the package together as in the present invention, the resin container is Since it has moisture permeability, water vapor in the container filled with the aqueous solution permeates the container wall and is released into the airtight package. Due to such release, even if the external environment temperature temporarily becomes 40 ° C. to 60 ° C., the relative humidity inside the resin package is maintained constant regardless of the temperature change. This means that the relative humidity in the resin package containing the resin container filled with carbonate or bicarbonate is maintained at 50% or more irrespective of the temperature change. Keeping high prevents the decomposition of carbonates or bicarbonates in the resin container. Although the relationship between the maintenance of humidity in the resin package and the prevention of decomposition is unknown, it is necessary not to dry the resin package in order to suppress the decomposition of carbonate or bicarbonate in the resin container as much as possible at some high temperature. I understand.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A preferred embodiment of a packaging method for a resin container filled with a carbonate or bicarbonate according to the present invention will be described in detail below with reference to the accompanying drawings. 1 is a plan view of a packaging body in a first embodiment in which a resin container filled with a carbonate or a bicarbonate is packaged by the packaging method of the present invention, and FIG. 2 is a sectional view of the packaging body in FIG. FIG. 3 is a partial cross-sectional view of a packaging body in a second embodiment in which a medical container filled with carbonate or bicarbonate is packaged by the packaging method of the present invention, and FIG. 4 is a medical container used in the second embodiment. FIG. 5 is a sectional view of the medical container according to the second embodiment, FIG. 5 is a schematic sectional view of an electron beam irradiation apparatus used for the medical container of the second embodiment, and FIG. It is sectional drawing at the time of use of the medical container in a 2nd Example.

As shown in FIGS. 1 and 2, the method for packaging a resin container filled with a carbonate or bicarbonate according to the first embodiment is a method in which a bicarbonate 4 is sealed in a resin container 2 for packaging.
A bicarbonate 4 is hermetically filled in a resin container 2 having a flexible wall with a thickness of 10 μm to 1600 μm, and then a bicarbonate 4 is allowed to coexist with a resin container 3 in which an aqueous solution 5 is hermetically filled.
The resin container 2 filled with is further liquid-tightly packed with the resin package 1.

The packaging method of this embodiment will be described in more detail. First, the bicarbonate 4 is added to a thickness of 10 μm to 1600 μm.
The resin container 2 having the flexible wall is sealed and filled. The resin container 2 in this embodiment is composed of two resin sheets 1.
1 and 12 are piled up, and a predetermined peripheral edge is heat-welded and sealed to form. The thickness of the resin sheets 11 and 12 is 10 μm
To 1600 μm, particularly 50 μm to 800 μm, and in this embodiment, the thickness is 500 μm.
The resin sheet of is used. When the thickness of the resin sheet exceeds the above range, the flexibility of the wall of the resin container 2 decreases,
The cost of the container is high, and the economical efficiency of manufacturing is deteriorated.
If the thickness of the resin sheet is below the above range, sufficient wall strength of the resin container 2 cannot be obtained. In this embodiment, the resin sheets 11 and 12 are made of linear low density polyethylene,
Since such a resin is an olefin-based resin, it is preferable in that it has no functional group in the eluate, is low in cost, and is a versatile resin.

In the present invention, it is not necessary to limit to linear low-density polyethylene as in this embodiment, and various known resins can be used as long as they are thermoplastic resins. 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. The resin sheet may be a multilayer laminate of different resins. In this case, in particular, a resin having high permeability to carbon dioxide may be used for the outer layer or the intermediate layer. Examples of resins having high carbon dioxide gas barrier properties include high-density polyethylene, vinylidene chloride, polyester, nylon, and vinylon. Although the resin container 2 is molded from two resin sheets in this embodiment, it may be an inflation molded tube, an extrusion molded product, a vacuum molded product, an injection molded product, a blow molded product or the like in the present invention.

In this embodiment, the bicarbonate 4 which is hermetically sealed in the resin container 2 is sodium hydrogen carbonate of the standard described in the Japanese Pharmacopoeia. Sodium hydrogen carbonate is a salt that easily decomposes into carbonic acid, water and sodium hydroxide when left at room temperature. In the present invention, as the bicarbonate, a chemical such as sodium hydrogen carbonate, potassium hydrogen carbonate, lithium hydrogen carbonate or the like can be used. Further, a carbonate may be mixed with the bicarbonate 4, and a carbonate may be used instead of the bicarbonate 4. Examples of carbonates include sodium carbonate and potassium carbonate.

In this embodiment, the resin container 3 filled with the bicarbonate 4 is made to coexist, and the resin container 2 filled with the bicarbonate 4 is further liquid-tightly packaged in the resin package 1.
The resin container 3 in this embodiment includes two resin sheets 11,
12 are piled up, and a predetermined peripheral edge is heat-welded and sealed to form. The same resin sheet as the resin container 2 is used for the resin sheets 11 and 12. However, the resin used for the resin sheet here has a water vapor permeability of 100 cc / m ² h
It is preferably r (measured in JIS Z0208 and converted to a thickness of 30 μm) or more, and particularly preferably 300 cc / m ² hr or more. If the water vapor permeability of the resin container 3 is above the above range, even if the external environment suddenly becomes high temperature, the water vapor from the resin container 3 easily passes through the resin wall and the relative humidity in the package is 50%. By maintaining the above, it is possible to avoid the dry state. On the other hand, if the thickness is less than the above range, it is difficult to keep the relative humidity in the package 1 constant by quickly responding to the external environment temperature even if the resin container 3 is made extremely thin. Although the resin container 3 has the same material and structure as the resin container 2, the present invention is not limited to this, and the resin sheet is a linear low-density polyethylene as described in the above-mentioned resin container 2. However, the sheet may be a multilayer sheet. Furthermore, in the present invention, the resin container 3
May be an inflation molded tube, an extrusion molded product, a vacuum molded product, an injection molded product, a blow molded product, or the like. Further, in the present invention, the aqueous solution 5 may be purified water, a mixed solvent such as alcohol, a solution in which an electrolyte is dissolved, or a solution in which carbohydrates such as sugar, proteins, fats and oils are dissolved.

A resin container 2 filled with bicarbonate 4 and a resin container 3 filled with an aqueous solution 5 are housed in a package 1 in a liquid-tight manner. As the coexistence method, the resin container 2 and the resin container 3 may be overlapped as in the present embodiment, or may be arranged so as not to overlap each other. The package 1 is formed by heat-sealing both ends of an inflation-molded tubular sheet. In the present invention, the package 1 may be any resin container as long as it seals the resin container 2 liquid-tightly. For example, the package 1 may be made of a completely airtight aluminum foil and a laminated sheet. Alternatively, it may be a semi-airtight resin sheet that is unlikely to allow water vapor to pass through like a normal resin sheet. The same resin material as the resin containers 2 and 3 is used for the package 1 in this embodiment. Further, in the present invention, the package 1 does not have to be a flexible container, and may be a resin container having regularity and shape retention. Therefore, the package 1
Is not limited to resin sheet moldings, blow moldings,
It may be an injection molded product or the like.

In the packaging method based on such an embodiment, since the resin container 3 filled with the aqueous solution has moisture permeability, the water vapor in the container 3 permeates the container wall and is discharged into the package 1. It Even if the external environmental temperature temporarily rises to 40 ° C. to 60 ° C. due to such release, the package 1
The relative humidity inside is kept constant regardless of the temperature change. Therefore, the resin container 2 filled with the bicarbonate 4 is not placed in a dry state in the package 1, and it can be clearly seen from Table 1 of the evaluation of Examples described later that the resin container 2 can withstand a high temperature.

(Evaluation of Examples) Based on the first example, the packaging bodies of Example samples 1, 2, 3 and 4 were prepared. Example sample 1 was at room temperature, Example sample 2 was at 32 ° C.
Example samples 3 and 4 were stored at a temperature of 60 ° C. for about 40 days. Sodium bicarbonate was appropriately weighed from the inside of the resin container 2 after storage, and the titration amount at the first end point and the titration amount at the second end point were determined by the neutralization titration method based on the Walder method. Calculate the content ratio with sodium bicarbonate, and determine the amount that became sodium hydroxide as the mass percentage of bicarbonate.
And The results are shown in Table 1. The measurement error range from the standard bicarbonate was ± 2%. In addition, as a comparative example, four packagings of the resin container 2 were prepared as comparative example samples by the same method as in the example except that the resin container 3 packed with the aqueous solution was packaged without coexisting with each other. The sample was stored under the same temperature conditions as those of the examples. Then, these comparative samples were evaluated in the same manner as in the examples, and the results are shown in Table 1 as comparative examples.

[0018]

[Table 1]

Next, a second embodiment of the resin container packaging method according to the present invention will be described with reference to FIGS. FIG.
As shown in FIG. 7, in the packaging method of the resin container 21 according to the present embodiment, the resin container filled with bicarbonate and the resin container filled with the above aqueous solution are the same as each other having a plurality of filling chambers 22 and 23. The multi-chamber container 21 and the peel-seal portion 24 that allows the isolation wall between the first chamber 22 and the second chamber 23 to be opened from the outside of the container 21 and allows the first chamber 22 and the second chamber 23 to communicate with each other. One chamber 2 of multi-chamber container 21
2 is hermetically filled with mother liquor 32, which is an aqueous solution containing an electrolyte, and then steam sterilized, and then another chamber 23 of the multi-chamber container 21 is hermetically filled with bicarbonate 33 and then the multi-chamber container 21 is packaged. The body 20 is liquid-tightly packaged.

As shown in FIG. 4, the multi-chamber container 21 is formed by cutting a resin sheet made of an inflation-molded tubular linear low-density polyethylene and polypropylene composition into a predetermined size. One end 21A of the cut sheet is fixedly sealed by heat welding, and the discharge port 2
5 is attached. A peel seal portion 24 that can be peeled from the outside is formed at a predetermined intermediate portion of the multi-chamber container 21 to form a first filling chamber 22 of a mother liquid 32 of an infusion agent. Specifically, linear low-density polyethylene (density: 0.916 g / cm ³ ,
MI: 2) and polypropylene (density: 0.90 g / cm
³ , MI: 0.7) was kneaded in a ratio of 6: 4 by two rolls (roll temperature is 175 ° C.), and the thickness was 2
Inflation molding is performed to a size of 00 μm and a width of 200 mm.
The formed tubular sheet is cut into a length of 500 mm, and one end 21A is fixedly sealed by heat welding with an impulse sealer (Fuji Impulse Co., Ltd. auto sealer FA-300-5W), and the discharge port 25 is attached. The sealing conditions are a sealing time of 1.5 seconds and a cooling time of 5 seconds. Next, 130 ° C. to 150 ° C. from above and below so that the peel seal part 24 can be peeled from the outside at a predetermined middle part of the cutting sheet.
Width of 10 mm and length of 200 mm is 1 with a heating mold of ℃
It was placed in the pressed state for 2 seconds. It should be noted that a stopper is provided so that the seal surface is not completely crushed by the press, and adjustment is made so as not to apply an excessive press pressure.

Next, the mother liquor 32 is discharged from the discharge port 25 into the first chamber 2.
2 is filled, the outlet 25 is sealed with a rubber stopper, and the multi-chamber container 21 is subjected to high-pressure steam sterilization. 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. After high-pressure steam sterilization, as shown in FIG. 5, the bicarbonate 33 is filled from the open opening of the other end 21B of the multi-chamber container 21, and the other end 21B is heat-welded with an impulse sealer in the same manner as the above-mentioned one end 21A. Then, the liquid-tight second chamber 23 is formed in the multi-chamber container 21.

In use, as shown in FIG. 7, when the peel seal portion 24 is opened from the outside of the multi-chamber container 21, the mother liquor 32 and the bicarbonate 33 are mixed to form the infusion solution 31. The infusion solution 31 of the present embodiment is an electrolyte maintenance solution, which is used for supplementing physiological water and electrolytes by insensitive vaporization and excretion in urine, cannot be taken orally, and causes vomiting, diarrhea, abnormal sweating, etc. It is applied to patients who have not continued to lose fluid through abnormal routes. Therefore, the infusion agent 31 has an osmotic pressure of 1/2 to 2 that of plasma.
/ 3 is hypotonic and Na in the electrolyte is 30-60 mEq
/ L, K is included in the range of 10 to 30 mEq / L, and Cl is included in the range of 20 to 50 mEq / L. The electrolyte infusion agent 31 of the present embodiment contains bicarbonate in the range of 1 to 65 mEq / L together with or instead of an electrolyte such as acetate or lactate. Bicarbonate is
The concentration is preferably around the plasma concentration, and particularly preferably in the range of 5 to 50, more preferably 15 to 30 mEq / L. Therefore, the concentration of acetate or lactate is 2
5 mEq / L or less, especially 15 to 0 mE for people with severe liver damage
It is contained in the range of q / L. In addition, the infusion solution 3 of this example
Since No. 1 requires calorie supplementation, it contains 1 to 15% by weight of saccharides. If the saccharide content is below the above range, the significance of calorie supplementation is lost, and if it exceeds the above range, normal intravenous administration may damage the blood vessel wall. The pH value of the infusion solution 31 is in the range of 5.5 to 8.0, and is adjusted particularly in the range of 6.0 to 7.5.
A PH value in this range is easily achieved by adding bicarbonate, and there is no risk of causing abdominal pain or diarrhea in the administered patient. On the other hand, when the PH value is below the above range, the bicarbonate becomes unstable during infusion.

The mother liquor 32 is filled in the filling chamber 22 which occupies most of the multi-chamber container 21, and the bicarbonate 33 is separated and filled in the filling chamber 23. Therefore, the theoretical amount of lactate and sodium salt is subtracted from the relationship. Filled as a composition liquid. Therefore, the filling chamber 22 of the mother liquor 32 is a chamber filled with the aqueous solution. Before mixing with the bicarbonate 33, the mother liquor 32 preferably has a PH value of 5.5 or less, particularly 5.3, or even 5.0 or less. Such acidification of the mother liquor 32 causes bicarbonate 33 in the filling chamber 22.
When the mother liquor 32 is maintained at the PH value within the above range by separating the liquor with sodium or potassium, and the mother liquor 32 is heated by high-pressure steam sterilization, glucose or the like in the mother liquor 32 can be heated. The risk of deterioration is extremely reduced. Bicarbonate 33 filled in the filling chamber 23
Is powder such as baking soda, tablets, etc. based on the Japanese Pharmacopoeia. In this embodiment, such a bicarbonate 33 is filled based on the above blending amount. Bicarbonate concentration (HCO ₃ ) is 1 to 6
The range of 5, especially 15 to 30 mEq / L is desirable. Therefore, in this example, 24 mEq / L of sodium bicarbonate is used. Therefore, in this embodiment, 1000 mL of liquid is contained in the multi-chamber container 21 which is a medical container.
Since it is stored, sodium hydrogen carbonate as the bicarbonate 13 is used in the range of 2.02 g.

Only the second filling chamber 23 of the multi-chamber container 21 filled with the bicarbonate 33 is externally irradiated and sterilized. In this embodiment, the irradiation sterilization in the second chamber 33 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. To ensure the sterilization by electron beam irradiation, the penetrability of the wall of the container for electron beams becomes a problem. The electron beam permeability is mainly determined by the acceleration voltage, and is 13000 g / m ² at the maximum in the high energy type, which is 13000 μm in the thickness of water (specific gravity 1 g / m ² ). However, when the accelerating voltage device is increased in size, the X-ray shielding equipment becomes large, and the resin material may be deteriorated.
For this reason, an accelerating voltage device of medium to low energy type of 1 MeV or less, particularly low energy type of 500 KV or less is desirable.
^{2. Since} the low energy type has a limit of about 800 g / m ² , the optimum 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 21 and the thickness of the second chamber 23 are preferably within the above range. Electron beam sterilization has an accelerating voltage of less than 1 MeV,
In particular, if it is a low energy type of 500 KV to 50 KV, a predetermined permeability of the electron beam can be obtained, but since there is almost no emission of X-rays or the like, no shielding facility is required,
It can be arranged compactly on the production line. That is,
Penetration of electron beam by acceleration voltage 500KV is about 8000
If it is g / m ² or less, a sufficient permeability can be obtained particularly in a resin thin portion of 800 μm or less.

As shown in FIG. 6, the electron beam irradiation apparatus 50 is
A machine frame 52 provided above the belt conveyor 51, a window frame 53 formed on the machine frame 52, a window foil 54 attached to the window frame 53, an acceleration tube 55 covering the upper side of the window frame 53,
And an electron beam generator 56 provided in the vacuum chamber in the acceleration tube 55. The electron beam generator 56 includes a grid 57, 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 5
Irradiation from 4 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 conveyor 51
The irradiation electron dose can be adjusted by the speed of 1) and the energization amount of the filament 59, and the penetrability of the electron beam can be adjusted by the acceleration voltage.

In FIG. 6, only the second chamber 23 of the multi-chamber container 21 is irradiation-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. pumilus (spor
es) 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 × 0.2 Mr.
The amount of electricity and the conveyor speed are adjusted so that sterilization is performed at a rate of at least ad, preferably at least 8 × 0.2 Mrad.

Next, a multilayer sheet obtained by laminating an aluminum foil on an inflation-molded tubular polyethylene sheet is cut into a predetermined size, and one end thereof is fixed by heat welding to be fixedly sealed. A multi-chamber container 2 that accommodates a multi-chamber container 21 and firmly seals the other end of the package 20
Complete the packaging of 1. Multi-chamber container 2 configured in this way
In the packaging method of No. 1, for example, even if the package 20 is exposed to 60 ° C. during transportation and transfer, the bicarbonate 33 is filled in the multi-chamber container 21 as a solid, and the mother liquor 32 which is an aqueous solution. Also, since it is packed by the packaging body 20 in a state of being filled in another first chamber 22, a small amount of water in the mother liquor 32 comes out of the first chamber 22 as water vapor into the packaging body 20. Therefore,
Even if the medical container, which is the multi-chamber container 21, is temporarily exposed to high temperature, the bicarbonate 33 in the multi-chamber container 21 does not decompose.

In the above embodiment, the composition mixture of linear low-density polyethylene and propylene was used for the multi-chamber container 21, but the invention is not limited to this, and other general-purpose resins and compositions may be used. In addition, the multi-chamber container 21
However, in the present invention, the peel seal portion 24 may be formed as a part of the isolation wall. In addition to the peel seal portion 24, the peel seal portion 24 may be a sandwiching member known per se. A pin and a click tip may be used as the isolation opening means. However, in terms of operability and productivity, the peel seal portion is desirable. Although the irradiation sterilization process is performed before packaging with the package 20 in the above embodiment, the irradiation sterilization process may be performed after packaging with the package 20. In the above embodiment, the filling of the multi-chamber container 21 was the electrolyte maintenance liquid, but in the present invention, the filling is physiological saline, physiological saline-sugar solution, Ringer's solution, Ringer's solution-sugar solution, Hartmann solution, It may be a starter solution such as Hartmann's solution-sugar solution, an extra-detailed solution replenisher, a gastrointestinal fluid replenisher, an electrolyte maintenance solution, a high-calorie infusion solution, etc. Further, in addition to such an infusion agent, an artificial dialysate, a peritoneal dialysate, an organ preservation solution, etc. may be separately filled in the bicarbonate 33 in the multi-chamber container 21. Although the bicarbonate powder and granules are used in the bicarbonate chamber of each embodiment of the present invention, a tableting machine or the like may be used instead. Further, the chamber may be filled with not only bicarbonate but also carbonate as long as its stability is guaranteed. The bicarbonate or carbonate is not limited to sodium salt, but may be potassium salt, lithium salt or the like.

[0029]

INDUSTRIAL APPLICABILITY As described above, in the method of packaging a resin container filled with carbonate or bicarbonate according to the present invention, the above-mentioned carbonate or bicarbonate is added to a resin container having a flexible wall having a thickness of 10 μm to 1600 μm. Since the resin container in which the carbonate is hermetically filled and then the aqueous solution is hermetically filled is made to coexist, and the resin container filled with the above carbonate or bicarbonate is further liquid-tightly packaged in a package, the resin container It is possible to provide a method for packaging a resin container filled with a carbonate or a bicarbonate, which can suppress the decomposition of the carbonate or the bicarbonate to be filled in as much as possible, and which is suitable for application in the medical field.

[Brief description of the drawings]

FIG. 1 is a partial cross-sectional view of a package in a first example in which a resin container filled with a carbonate or a bicarbonate is packaged by the packaging method of the present invention.

FIG. 2 is a sectional view of the packaging body in FIG.

FIG. 3 is a partial cross-sectional view of a package in a second embodiment in which a medical container filled with carbonate or bicarbonate is packaged by the packaging method of the present invention.

FIG. 4 is a cross-sectional view of the medical container used in the second embodiment during manufacturing.

FIG. 5 is a sectional view of the medical container according to the second embodiment during manufacture.

FIG. 6 is a schematic sectional view of an electron beam irradiation apparatus used for a medical container in the second embodiment.

FIG. 7 is a cross-sectional view of the medical container according to the second embodiment when it is used.

[Explanation of symbols]

 1, 20 Package 2 Resin container filled with bicarbonate 3 Resin container filled with aqueous solution 4 Sodium bicarbonate 5 aqueous solution 11, 12 Resin sheet 21 Multi-chamber container 22 First chamber 23 Second chamber 24 Peel seal part 25 Discharge Outlet 31 Infusion agent 32 Mother liquor 33 Sodium bicarbonate 50 Electron beam irradiation device

Claims (5)

[Claims] 1. A method for sealing a carbonate or bicarbonate in a resin container for packaging, wherein a resin container having a flexible wall with a thickness of 10 μm to 1600 μm is hermetically filled with the carbonate or bicarbonate. next,
The resin container filled with the carbonate or bicarbonate is allowed to coexist with the resin container in which the aqueous solution is hermetically filled, and the resin container is further liquid-tightly packed with a packaging body, and the carbonate or bicarbonate is filled. Packaging method for resin containers. 2. A resin container having a water vapor permeability of 100 cc / m ² hr (measurement method converted to a thickness of 30 μm according to JIS Z0208) or more is used in a resin container filled with the aqueous solution. Packaging method. 3. The resin container filled with the carbonate or bicarbonate and the resin container filled with the aqueous solution are the same multi-chamber container having a plurality of filling chambers, and the chambers are isolated from each other. A multi-chamber container in which all or part of the wall can be opened from the outside of the container and is formed by an isolation opening means that allows the chambers to communicate with each other, and one chamber of the multi-chamber container contains an electrolyte. Steam sterilization is performed after the aqueous solution is hermetically filled, and then the carbonate or bicarbonate is hermetically filled in the other chamber of the multi-chamber container, and then the multi-chamber container is liquid-tightly packed with the packaging body. The packaging method for a resin container filled with a carbonate and a bicarbonate according to claim 1 or 2, characterized in that: 4. The method of packaging a resin container according to claim 3, wherein the carbonate or bicarbonate filling chamber is subjected to electron beam irradiation sterilization. 5. The electron beam irradiation sterilization has an accelerating voltage of 1
The method for packaging a resin container according to claim 4, wherein electron beam irradiation sterilization is performed at a medium to low acceleration voltage of MeV or less.