JPH114872A - Medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical container which stores medical solutions containing carbonic acid components, such that the concentration of bicarbonate ions is held constant at any stages, say, before or after manufacture or after a long period of preservation, and that the concentration of carbonic acid gas is also held within a predetermined range. SOLUTION: In a medical container including two or more storage chambers 2 in which carbonic acid components are separately stored, with the storage chambers communicated together during use, the carbonic acid components are stored while in an alkaline state, in such a way that when the storage chambers are communicated together, the concentration of bicarbonate ions in mixed medical solutions is in the range from 10 to 30 mmol/L, and a mother liquor stored in a liquid storage chamber, other than the carbonic acid components, contains an excess gap acid so that when the storage chambers are communicated together, carbonic acid (Pco2 ) is generated in the range from 80 to 10 mmHg in the mixed medical solutions.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container containing an infusion solution, a dialysate, an organ preservation solution, and the like, and more particularly, to a medical container containing a medical solution containing a carbonic acid component that lacks stability. It relates to a container for use.

[0002]

2. Description of the Related Art Generally, when a sodium bicarbonate solution is contained in a resin container or the like, it is decomposed during heating or storage to generate carbon dioxide gas, and the carbon dioxide gas passes through the container wall and disappears. Due to such decomposition, [OH ⁻ ] increases in the solution due to ionization equilibrium, and the PH value of the solution increases. For this reason, in order to preserve the medical container for a long time, the medical container is hermetically sealed in a gas-barrier package, and carbon dioxide is introduced into the package or a carbon dioxide-generating type oxygen absorber is disposed. A technique has been proposed in which the carbon dioxide gas inside the resin container is prevented from flowing out of the resin container by setting the outside of the medical container to a carbon dioxide gas atmosphere (Japanese Patent No. 2527532, Japanese Unexamined Patent Application Publication No. Sho 6-1).
05905).

[0003]

However, the conventional method for producing a medical container containing a carbonic acid component has the following problems. Regarding the package containing carbon dioxide gas or the package containing an oxygen scavenger, the initial PH value of the solution in the medical container is set at 8 to prevent the loss of carbonate ions during steam sterilization. It is as high as .32 or 8.60. After 10 days, the PH value in the medical container shows 8.0 or less. It is considered that this is because the solution in the medical container took in carbon dioxide gas permeating the container wall. However, in such a medical container, it is clearly different from the initial composition, and it is unclear how much carbon dioxide dissolved in the solution in the medical container. Further, in a solution in which carbon dioxide gas is excessively taken in, a solution may react with calcium ions or magnesium ions in the solution to form a precipitate. Therefore, the present invention provides a medical solution containing a carbonate component in which the concentration of bicarbonate ions is kept constant and the concentration of carbon dioxide is also kept within a predetermined range at any stage before, after, or after long-term storage. It is to provide a medical container in which is stored.

[0004]

According to the present invention, there is provided a medical container comprising two or more storage chambers for storing a carbonated component in a divided manner, wherein the respective storage chambers communicate with each other during use. Is stored in an alkaline state, and the carbonic acid component is stored in the mixed medical solution when the chambers are communicated with each other so that the bicarbonate ion concentration is in the range of 10 to 30 mmol / L. The mother liquor contained in the liquid storage chamber other than the component contains 80 to 10 mm of carbonic acid (Pco ₂ ) in the mixed medical solution when the storage chambers are communicated with each other.
The above object has been attained by providing a medical container characterized by containing an excess of gap acid so as to generate in the range of Hg.

The medical container is usually a resin container having a flexible wall. The flexible wall may be any as long as the volume in the container is easily changed by bending. Further, it is desirable that the container wall has transparency to the extent that the contents can be confirmed.
This is because it is necessary to confirm the state of the medicine in the container. The above containers are blown films, tubes, sheets and those molded from films, extrusion molding,
Injection molding or blow molding. Polyolefin resin, vinyl chloride,
It is a general-purpose resin such as a vinylidene chloride resin, a polyester resin, a polyvinyl alcohol resin, a polyacrylonitrile resin, a polyacrylic resin, and a polyamide resin. Further, the resin container may be formed in a single layer or a multilayer. The innermost layer in contact with the drug in the resin container is desirably a resin layer that does not affect the drug and does not generate elutes. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene. It is desirable that a gas barrier layer is formed on the resin container wall. In particular, a layer that does not easily transmit oxygen or the like is desirable. As such a gas barrier layer, a metal layer such as aluminum or silicon oxide, magnesium oxide, which hardly or no gas permeates,
It is an inorganic vapor-deposited layer of titanium oxide or the like, or a resin layer having a high gas barrier property such as polyvinylidene chloride, polyester, nylon, an ethylene-vinyl alcohol copolymer, or a fluororesin. The oxygen permeation amount of the gas barrier layer is 40 cc · 20 μ / m ² · day · atm (temperature: 2
0 ° C) or less, especially 30 cc · 20 μ / m ² · day ·
atm or less, preferably 5 cc · 20 μ / m ² · d
ay · atm or less, further 1 cc · 20μ / m ² · da
It is desirable that it be less than y · atm. Further, it is desired that the wall of the resin container has such transparency that the medicine inside can be confirmed. For this reason, it is desirable that at least a part of the wall made of a metal layer such as the aluminum layer having an excellent function of not allowing gas to permeate at all be formed so that the metal layer can be peeled off. In the resin container having such a layer, the deterioration of the internal medicine by heat during the high-pressure steam sterilization can be sufficiently prevented.

[0006] The carbonic acid component and the mother liquor are liquid-tightly housed in separate chambers inside the medical container. To separately store the carbonate component and the mother liquor in a liquid-tight manner may use a resin container having a plurality of chambers for individually storing the carbonate component and the mother liquor. When such a container is divided into a plurality of chambers, it is desirable to form a communicating means for communicating the chambers with each other by an operation through the container wall at a portion separating the chambers from each other. Such communication means may be one in which the end of a closed tube is broken through the container wall to make the tube a communication tube, one in which an isolated portion is stopped with a clip or the like, or an operation in which the isolated portion is operated from outside. Other known means for enabling aseptic communication, such as a peel seal portion that can be peeled off. Further, the carbonic acid component and the mother liquor may be housed in separate containers, and may be composed of a plurality of containers connected to each other. The connection between the containers is such that the ends of the containers formed by the peel seal portion are connected to each other so as to be able to communicate by operation through the container at the time of use, and a communication means having a communication needle known per se between the containers. And those that can be communicated. When the container is composed of a plurality of containers, at least one of the containers may be a glass container, but it is preferable that the containers are composed of resin containers. In particular, it is desirable that the plurality of chambers are containers formed or connected by a peel seal portion capable of continuous passage through the container and the package.

[0007] Usually referred to as a peel seal portion or a weak seal portion, the chamber or the container is pressed from the outside, and the seal portion or the outer wall of the container which can be peeled off when the inside is pressurized to a certain level is gripped. And a seal that can be peeled off when pulled. The peel strength of the peel seal portion is such that the indoor pressure is 0.01 to 1.0K.
gf / cm < ² >, and in particular, peeling strength at a pressure increase of 0.05 to 0.5 kgf / cm < ² > is desirable. If the strength is lower than the above range, the safety for maintaining an isolated state at the time of production, transportation, storage and the like is lacking. If the strength exceeds the above range, there is a possibility that the communication operation between the rooms cannot be easily performed at the time of use. When the peelable seal portion is formed by thermal welding, it is desirable that the innermost wall layer of the container body is a different resin blend. In particular, different resins are desirably made of resin blends which have different heat melting onset temperatures or Picard softening points and are not very compatible.
By having such a blended material layer, it is possible to easily set the sealing temperature conditions for peel seal bonding. That is, the relationship between the seal strength required for peel seal adhesion, that is, the easy peelability due to external force during use, and the seal strength that does not cause peeling during storage can be strictly set. When a resin having different compatibility is melt-mixed in the inner layer and formed into a sheet, the inner layer surface can be microscopically separated into portions having different thermal adhesiveness. Then, by determining the thermal fusibility of the microscopic portion between the surfaces of the sheet at an arbitrary temperature, the strength of the sealing strength is accurately provided, and the above-mentioned effect is easily achieved.

[0008] The mother liquor is a component used for infusion, dialysate and organ preservation solution.
Magnesium, calcium, chlor, phosphorus, etc., other inorganic electrolytes present in the human body, acetic acid, lactic acid, citric acid, etc., and other organic electrolytes present in the human body, and, in addition to electrolytes, saccharides, amino acids, proteins, Energy such as fat and, if necessary, physiologically active substances and vitamins are also included. The mother liquor may be filled in the resin container aseptically, but is subjected to steam sterilization after being housed in a liquid-tight manner in the storage chamber of the resin container. This is because such a sterilization process ensures that the mother liquor is sterilized and can be safely administered to a patient. The carbonic acid component refers to one or both of bicarbonate and carbonic acid, and may be only bicarbonate or only carbonic acid. Further, the carbonic acid component may be present as a solid salt of bicarbonate or carbonate,
Such an alkali salt solution may be present. The salt contained in the carbonic acid component is an alkali metal salt, an alkaline earth metal salt, or the like, and particularly preferably a sodium salt or a potassium salt. Further, it is desirable that the carbonate component contains an alkali hydroxide salt. For example, sodium hydroxide or potassium hydroxide. As described above, if an excessive amount of the alkali salt is mixed in the carbonic acid component, the decomposition of carbon dioxide gas can be suppressed as much as possible.

The above-mentioned carbonic acid component has a bicarbonate ion concentration of 10 in the mixed medical solution when the above-mentioned storage chambers are communicated with each other.
It is accommodated so as to be in a range of ３０30 mmol / L. Normally, the normal range of blood bicarbonate ion concentration is 22-26.
mmol / L. Therefore, it is desirable that the amount of the carbonic acid component is filled into the compartments so that the bicarbonate ion concentration in the mixed medical solution falls within the normal range. However, since the infusion solution and the like are intended for treatment, the amount of the carbonic acid component is 10 to 3 bicarbonate ion concentrations in the mixed medical solution.
A range up to 0 mmol / L can be tolerated. If the amount of the carbonic acid component falls below the above range, the effect of the addition of the carbonic acid component may be weakened, and the conventional lactic acidosis may not be sufficiently eliminated. If the amount of the carbonated component exceeds the above range, hypercarbonated plasma may be caused.

In the mother liquor contained in the liquid storage chamber other than the above-mentioned carbonic acid component, carbonic acid (Pco ₂ ) is generated in the range of 80 to 10 mmHg in the mixed medical solution when the above-mentioned storage chambers are communicated with each other. Contains excess gap acid. Since the mother liquor is an electrolyte solution, usually, the solution contains {OH ⁻ , X ⁻ , Y ⁻ , Z ⁻ ,...} And {H ⁺ , A ⁺ ,
Various positive and negative ions with B ⁺ , C ⁺ ··· are dissociated. If the PH value is around 7, ΔX ⁻ , Y ⁻ , Z can be obtained even when hydrogen ions and hydroxyl ions are excluded.
^- · ·} and {A ^+, B ^+, positive and negative electrolyte ions of the C ⁺ ...} are equal. However, when the negative electrolyte is present in excess of the positive electrolyte, that is, when the excess gap acid is included, the excess gap acid amount ΔX ⁻ , Y ⁻ , Z ⁻ .
{A ⁺ , B ⁺ , C ⁺ ···}, and the excess gap acid amount and the hydrogen ions [H ⁺ ] in the solution are kept in equilibrium to lower the PH value.

When a weak acid such as lactic acid or acetic acid is present in the negative electrolyte containing excess gap acid, the PH value of the mother liquor is substantially determined by the ionization constant K of lactic acid or acetic acid and the excess amount C. That is, chlorine other than lactic acid or acetic acid is almost ionized,
The pH value is determined by lactic acid or acetic acid, which is difficult to ionize.
The H value approximately follows the equation of PH ≒ -1 / 2 · logK · C.
Therefore, if the ionization constant of lactic acid is K = 1.38 × 10 ⁻⁴ and the excess amount C is 1.5 mEq / L, the solution has a PH value of 3.34. Further, if acetic acid having an extremely low ionization constant is contained in the mother liquor and the amount of 1.5 mEq / L is excessive, the dissociation constant K of acetic acid is 1.85 × 10 ^-5 and the pH of the mother liquor is
The value will be 3.80. In the case of only a strong acid without a weak acid, for example, in the case of only hydrochloric acid, about 90% of the acid is dissociated, so that the excess amount C is reflected as it is, and the PH value is 2.74.
About.

[0012] [OH ^-] and [H ^+] is excessive gaps acid is mixed carbonate component comprising a bicarbonate mother liquor is carbon dioxide and carbonate ions generated present except. For example, the same amount of bicarbonate ion and sodium ion is accommodated as the carbonic acid component, the amount of bicarbonate ion is 25 mmol / L, and the excess gap acid in the mother liquor is 1 mEq / L. When these are mixed at the time of use, since bicarbonate is a weaker acid than hydrochloric acid, lactic acid, acetic acid, etc. in the mother liquor, 25 mm of sodium ion in equilibrium with bicarbonate ion in the mixed medical solution
In ol / L, the excess gap acid has an ionization relationship by 1 mEq / L. Here, when the pH value of the mixed medical fluid is maintained at around 7 due to the buffering action of the other electrolyte, both the hydroxyl ion and the hydrogen ion are in a nano unit amount, so that 1 mmol of the bicarbonate ion in 25 mEq / L of [ HCO ₃ ⁻ ] is combined with [H ⁺ ] and dissolved in the solution as carbon dioxide gas, or a part of the HCO ₃ ⁻ is released out of the solution. Therefore, the bicarbonate ion in the mixed medical solution is 24 mEq / L, and carbon dioxide is generated in the solution and a part or all of it is dissolved, and the carbon dioxide is dissolved in the solution according to the following formula of Henderson-Hasselbarch. Contributes to PH value. PH value = 6.1 + Log [HCO ₃ ⁻ ] / [0.03 × P
(CO ₂ )]

In the medical container according to the present invention, carbon dioxide gas is generated in the mixed medical solution in a range of 80 to 10 mmHg. Therefore, in theory, the excess gap acid is 80 × 0.0
3 mEq / L to 10 × 0.03 mEq / L, that is, 2.4
０．３0.3 mEq / L. However, all the carbon dioxide gas is released to the outside without dissolving in the mixed solution with respect to the excess gap acid. The amount of carbon dioxide released depends on the amount of carbon dioxide generated,
g, about 50% is released, 50 mmHg to 90 m
About 40% is released during mHg. Therefore, considering such an amount, the excess gap acid is 0.5 to 5 mE
It is desirably present at q / L. The concentration of carbon dioxide in the mixed medical solution according to the present invention is determined by the above-mentioned Henderson-Hasselbarch equation. The excess gap acid means only an acid intended to generate carbon dioxide in the mixed medical solution. For example, if the carbonated component storage chamber does not contain a salt such as sodium in an equimolar amount to the bicarbonate ion, that is, sodium hydroxide or the like is added in order to increase the alkalinity of the carbonic acid component and the sodium salt is excessively added to the bicarbonate ion. Is contained in the mother liquor, in addition to the amount of excess gap acid, an acid equivalent to the excess salt, such as hydrochloric acid, is further added.

In the medical container constructed as described above, the medical container is externally wrapped after filling with a mother liquor or the like as in the prior art, and the inside of the wrap is set to a carbon dioxide gas atmosphere.
There is no need to adjust the H value and the concentration of carbon dioxide in the medical solution, and it is not necessary to maintain the carbon dioxide atmosphere until storage. Only by allowing the excess gap acid to be present in the mother liquor, the medical solution at the time of use can contain the same amount of carbon dioxide as the concentration of carbon dioxide in the body fluid. For this reason, the medical container can be stored safely, and when the medical solution is administered to the body, it can be applied in a state close to the body fluid, so that adverse effects such as acidosis and alkali losis that occur conventionally can be prevented as much as possible. .

According to a second aspect of the present invention, there is provided the medical container according to the first aspect, wherein the carbonate component is an alkaline solution or suspension containing at least one of bicarbonate and carbonate. Further, the accommodation room for the carbonic acid component is air-tightly covered with a gas-barrier packaging material. The carbonic acid component cannot be stored for a long time unless it is in an alkaline state. As soon as the carbonic acid component is in a neutral or acidic state, it becomes carbon dioxide gas and permeates the wall of the medical container made of resin, and the carbonic acid component in the storage chamber is reduced. Therefore, if the carbonic acid component is stored in an alkaline state, loss of carbon dioxide gas in the carbonic acid component can be suppressed as much as possible. Although the carbonic acid component can be filled in the storage chamber under aseptic condition, it is preferable to perform some sterilization treatment after hermetically sealed storage in consideration of medical safety. When the carbonic acid component is stored in the form of a solution or suspension, high-pressure steam sterilization can be performed in the sealed storage chamber.
However, when the accommodation chamber is heated during the high-pressure steam sterilization, the carbonic acid component may be decomposed and permeate the container wall to be released to the outside world. Therefore, the storage chamber containing at least the carbonate component of the medical container is air-tightly covered with a gas-barrier packaging material to prevent the generation of carbon dioxide from the storage chamber during sterilization and during subsequent storage. it can.

As a specific gas barrier packaging material,
A metal layer of aluminum or the like, which has little or no gas permeation of the packaging wall, polyvinylidene chloride, polyester, nylon, ethylene-vinyl alcohol copolymer,
A resin layer with high gas barrier properties, such as a fluorine-based resin,
Or aluminum, silicon, magnesium, titanium, silver,
It has an earth metal or metal such as gold, or a vapor-deposited layer of an oxide thereof. The oxygen permeation amount of the gas barrier layer in the package is 40 cc · 20 μ / m ² · day · a
tm (temperature: 20 ° C.) or less, especially 30 cc · 20 μ /
m ² · day · atm or less, preferably 5 cc · 2
0 μ / m ² · day · atm or less, further 1 cc · 20
It is desirably not more than μ / m ² · day · atm.
The carbon dioxide gas permeation amount of the gas barrier layer in the package is
200cc ・ 20μ / m ²・ day ・ atm (Temperature: 2
5 ° C.) or less, especially 100 cc · 20 μ / m ² · day
・ Atm or less, and preferably 10 cc ・ 20 μ / m ²
・ Day ・ atm or less, 1cc ・ 20μ / m ²・
It is desirably not more than day · atm.

The medical container according to a third aspect of the present invention is the medical container according to the first aspect, wherein the carbonate component is made of a bicarbonate or a carbonate solid, and the storage compartment for the carbon dioxide component is The medical container comprises a main body of the medical container and a separate connection container, and the accommodating chamber for the carbonate component is connected to the main body after high-pressure steam sterilization of the main body. As described above, the medical container may be divided into a plurality of chambers by the separation seal portion formed by the peel seal, and the carbonated component may be stored in one chamber and the mother liquor may be stored in the other chamber. However, there are cases where it is desirable to avoid high-pressure steam sterilization of the carbonic acid component storage chamber in order to stabilize the carbonic acid component. Therefore, the storage chamber for the carbonate component is made a separate container from the storage chamber for the mother liquor, and the container containing the mother liquor is subjected to high-pressure steam sterilization, and the container for the mother liquor and the carbonate component after the treatment are aseptically filled in the storage chamber. By connecting the containers with sterilization by γ-ray or electron beam irradiation, the sterilization of the carbonate component and the mother liquor in the medical container can be surely performed.

[0018]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the medical container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a plan view of a medical container according to a first embodiment of the present invention.
FIG. 2 is a cross-sectional view of the packaging material provided in the accommodation room of the medical container of the first embodiment. FIG. 3 is a plan view when the medical container of the first embodiment is used.

The medical container 1 according to this embodiment includes two chambers 2 and 3 in which sodium bicarbonate 4 is separately stored, and the medical chambers 2 and 3 communicate with each other during use. Container. The above-mentioned sodium bicarbonate 4 contains
The mother liquor 5 is accommodated in the mixed medical solution 6 when the three are communicated with each other, so that the bicarbonate ion concentration is in the range of 10 to 30 mmol / L, and is accommodated in the liquid accommodation chamber 3 other than the sodium bicarbonate. In the mixed medical solution 6 when the accommodation chambers 2 and 3 are communicated with each other, the carbonic acid (Pco ₂ ) is 80%.
Excess gap acid is included so as to occur in the range of 〜１０10 mmHg.

The medical container 1 according to the present embodiment is a resin sheet molded container, in which an inflation sheet having a folded diameter of 120 mm is cut into a length of 400 mm, and sheets overlapping at both ends of the cut are completely heat-sealed. And molded. The resin sheet is composed of a multilayer sheet, the inner layer is composed of a blend of polyethylene and polypropylene, and the outer layer is composed of polyethylene. Both ends 1A and 1B are formed as complete non-peelable heat-sealed seals. The discharge port 7 is attached at the time of the heat sealing of the end 1A. Two isolation seal portions 9, 9 for separating the storage chamber 2 and the storage chamber 3 are formed in an intermediate portion of the cut sheet, and the separation seal portion 9 is formed. The isolation seal portion 9 is formed as a seal portion that can be peeled and opened, and is peeled and opened when the storage chamber 3 is pressed at 0.2 kgf / cm ² or more. Containment room 2
Contains sodium bicarbonate 4 as a suspension in a liquid-tight manner, and the amount of sodium bicarbonate is contained in the range of 10 to 30 mmol in Examples 1 to 8 shown in Table 1 below. A mother liquor 5 containing an electrolyte as an infusion solution is accommodated in the accommodation chamber 3 in a liquid-tight manner, and the mother liquor 5 is accommodated as an adjusting solution in the working samples 1 to 8 shown in Table 1 below.

The accommodation room 2 is packaged by a package 10, and the package 10 is formed of two sheets of gas-barrier packaging material. The packaging body 10 includes two packaging material sheets 11 and 12.
The upper, lower, left and right edges of the front sheet 11 and the front sheet 12 are hermetically sealed by heat welding, and a peripheral seal portion 10A is formed in the package 10. Further, the sealing body 10B is formed in the package 10 by a heat-sealing seal so as to sandwich the separation sealing sections 9 of the medical container 1, and the housing chamber 2 is formed.
Is airtightly wrapped. Note that a suspension hole 8 is formed in the peripheral edge seal portion 10A. Front sheet 11 as shown in FIG.
Is that the innermost layer 21 is a linear low-density polyethylene having a thickness of 100 μm, the first intermediate layer 22 is a polyvinylidene chloride layer having a thickness of 15 μm, the second intermediate layer 23 and the third intermediate layer 24 are stretched nylon layers. And the fourth intermediate layer 25 has a thickness of 9
μm aluminum layer, and the outer layer 26 has a thickness of 12 μm
Of a polyethylene terephthalate layer. A separation surface A is formed between the second intermediate layer 23 and the third intermediate layer 24, and the front sheet 11 is separated from the separation surface A by the separation surface A.
A and a separation wall 11B. The non-transparent fourth intermediate layer 25 (aluminum layer) is present on the peeling wall 11B, and the gas barrier first intermediate layer 2 is present on the peeling wall 11A.
2 (vinylidene chloride layer) is present. 6A to be peeled
Has a first intermediate layer 22 so that the carbon dioxide gas permeation amount (temperature 25 ° C., dry) is 6 to 50 cc / m ² · 24 hr.
With a water vapor permeation amount W (temperature of 25 ° C., relative humidity of 90%) of 0.5 g / m ² · 24 hr or less, the film has such transparency that the contents can be confirmed. On the other hand, the back sheet 7 is the innermost layer 2
7 is a linear low-density polyethylene having a thickness of 100 μm, the first intermediate layer 28 is a stretched nylon having a thickness of 15 μm, the second intermediate layer 29 is an aluminum layer having a thickness of 9 μm, and the outer layer 30 is a polyethylene terephthalate having a thickness of 12 μm. Consists of layers. Therefore, the innermost layer 2 of both sheets 6 and 7
Reference numerals 1 and 27 are heat-sealing seal layers, and peripheral sealing portions 10A and 10B of the package 10 are heat-sealing seal portions.

[0022]

[Table 1]

Next, a method of manufacturing the medical container 1 according to the first embodiment will be described. The resin sheet is cut into a predetermined length, and after washing and drying the inside, the isolation seal portions 9 and 9 are formed by heat-sealing and peeling at a heat sealing temperature of 140 ° C. Next, the storage chamber 2 is filled with a suspension of sodium bicarbonate shown in Table 1 below, and the cut end 1B is completely heat-sealed and sealed at a heat sealing temperature of 170 ° C. The cut end 1A of the resin sheet is heated to a heat sealing temperature of 170.
It is formed by completely heat-sealing and sealing at a temperature of ° C, and a resin discharge port 7 is attached during the formation. The storage chamber 3 is filled with the mother liquor 5 shown in the following Table 1 through the discharge port 7, and the discharge port 7 is sealed liquid-tight with a rubber stopper. Next, the container 2 of the medical container 1
The packaging material sheets 11 and 12 are placed one on top of the other, and a complete heat-sealing seal is performed at a heat sealing temperature of 140 ° C. between the peripheral edges of each other and between the isolation seal portions 9 and 9 to seal the peripheral edge portion 10A and the sealing. The seal part 10B is formed.
The medical container 1 packaged in the package 10 is subjected to high-pressure steam sterilization at a temperature of 110 ° C. to sterilize the sodium bicarbonate 4 and the mother liquor 5. After cooling, the separation wall 11A of the front sheet 11 is separated. After leaving the medical container 1 at room temperature for one week, the isolation seal portions 9 and 9 are peeled off as shown in FIG. 3 to make the accommodation room 2 and the accommodation room 3 communicate with each other. The amount of bicarbonate was determined based on the measurement method of the Japanese Pharmacopoeia, and the amount of carbon dioxide was determined from Henderson's equation. Table 2 shows the results.

[0024]

[Table 2]

From the above results, in the working samples 1 to 8, particularly the working samples 4 to 7, the PH values were close to those of blood, and the amounts of carbon dioxide and bicarbonate ions were almost close to the concentrations in blood. .

Next, a second embodiment of the medical container according to the present invention will be described with reference to FIGS. 4 and 5 of the accompanying drawings.
FIG. 4 is a plan view of another medical container according to the second embodiment, which is a container for storing a carbonated component, before another container is connected to the container body. FIG. 5 is a plan view of the medical container according to the second embodiment. The medical container 31 shown in FIGS. 4 and 5 includes two chambers 32 and 33 in which a carbonated component 34 is separately stored, and the medical containers 31 and 33 communicate with each other during use. And the bicarbonate component 34 is contained in each of the accommodation chambers 3.
The mother liquor 35 accommodated in the mixed medical solution 6 when the two and 33 are communicated with each other so that the bicarbonate ion concentration is in the range of 10 to 30 mmol / L, and is accommodated in the liquid accommodation chamber 33 other than the carbonic acid component. Contains carbonic acid (Pco ₂ ) in the mixed medical solution 6 when the accommodation chambers 32 and 33 are communicated with _{each other} .
Is similar to that of the medical container 1 of the first embodiment in that an excess gap acid is contained so that the gas is generated in the range of 80 to 10 mmHg. The medical container 31 is different from the medical container 1 of the first embodiment in that it is an anhydrous sodium carbonate tablet in which a carbonic acid component 34 is formed into a tablet, and a storage chamber for the carbonic acid component 34 is connected to the container body 33. Another point is that the mother liquor 35 is stored in the container main body 33.

The medical container 31 according to this embodiment will be further described. The container body 33 is made of the same material as the inflation resin sheet forming the medical container 1 of the first embodiment, and the discharge port 7 is made of one material. It is similarly attached to the cut end 1A by a complete heat seal. Another cut edge 1
B has a peelable peel seal portion. The container body 33 is filled with exactly 1 liter of the mother liquor 35, and the components of the mother liquor 35 are hydrochloric acid 26mEq / L, sodium chloride 76mEq / L, potassium chloride 4mEq / L, calcium chloride 1.5mEq / L, and glucose 5mEq / L. % By weight. Lactic acid in the mother liquor 35 is 2.0 mEq /
L is included as excess gap acid. Mother liquor 35
Is subjected to high-pressure steam sterilization after filling into the container body 33.

The other container 32 containing the carbonic acid component 34
It is formed by completely heat sealing the peripheral edge 32A of the sheet. The two sheets have a 200 μm linear low density polyethylene layer as the inner layer, a polyvinylidene chloride layer as the intermediate layer, and a polypropylene layer as the outer layer. First, the three peripheral edges of the two sheets are heat-sealed and sealed, and one side is opened and filled with tableted anhydrous sodium carbonate. The sodium carbonate 34 is heat-sterilized at 210 ° C. before filling. The content of sodium carbonate 34 in the tablet is 2.
Formulated based on an error standard of 76 g ± 0.12 g (26 mmol). Next, as shown in FIG.
Was inserted into the opening of another container 32 and connected by a complete heat-sealing seal to produce a medical container 31.
As a result, 10 samples of the example product were manufactured, and the sodium carbonate component in the tablet was accurately weighed in advance. After the manufacture, the peel seal portion of the medical container 31 was peeled off to remove the mixed medical solution 6. Was prepared and its bicarbonate ion amount, carbonic acid and PH values were determined. Table 3 shows the results. In preparation, instead of heat sterilization inside the tablet, γ-ray irradiation sterilization may be used. The container body 3
It is desirable to sterilize the connection between the third container 32 and the other container 32, the inside of the other container 32, and the surface of the tablet by irradiation with a low-voltage electron beam.

[0029]

[Table 3]

In this embodiment, the excess gap acid is 2.0 mm
ol, the theoretical value of bicarbonate ion after mixing is 24 mmol
/ L, but the amount of bicarbonate in the carbonic acid component 34 (26 mmol) and the amount of hydrochloric acid in the mother liquor 35 (26 mmol
The equivalence relationship between 1) and sodium (26 × 2 mmol) in the carbonic acid component was deviated, and hydrochloric acid corresponding to the weighing error was involved in 2.0 mmol / L of excess gap acid. However, it can be understood that each mixed solution 6 shows a bicarbonate ion concentration, a carbon dioxide gas amount, and a PH value which are adequately suitable for in vivo administration as a medical solution even if there is such an error of sodium carbonate. Further, it can be seen that the carbonate component according to the present invention is not limited to sodium bicarbonate, and that the mixed medical solution 6 can be sufficiently adjusted even with sodium carbonate or a mixture of sodium bicarbonate and sodium carbonate. In the above embodiment, the inflation resin sheet is used for the medical container, but a blow molded product may be used.

[0031]

As described above, in the medical container according to the present invention, which has two or more storage chambers in which the carbonic acid component is separately stored and in which the respective storage chambers communicate with each other during use,
The carbonic acid component is accommodated in an alkaline state, and the carbonic acid component is accommodated in the mixed medical solution when the chambers are communicated with each other so that the bicarbonate ion concentration is in the range of 10 to 30 mmol / L, The mother liquor stored in the liquid storage chamber other than the carbonic acid component contains 80 to 1 carbonic acid (Pco ₂ ) in the mixed medical solution when the storage chambers are communicated with each other.
Since an excess gap acid is contained so as to be generated in the range of 0 mmHg, the bicarbonate ion concentration is maintained constant at any stage before production, after production, or after long-term storage, and A medical solution containing a carbonic acid component whose gas concentration is maintained within a predetermined range can be accommodated.

[Brief description of the drawings]

FIG. 1 is a plan view of a medical container according to a first embodiment of the present invention.

FIG. 2 is a cross-sectional view of a packaging material provided in a storage chamber of the medical container of the first embodiment.

FIG. 3 is a plan view when the medical container of the first embodiment is used.

FIGS. 4A and 4B are plan views of a medical container according to a second embodiment before connecting another container, which is a container for storing a carbonic acid component, to the container main body.

FIG. 5 is a plan view of a medical container according to a second embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical container 2 Carbon dioxide component accommodation room 3 Liquid accommodation room 4 Carbon dioxide component 5 Mother liquor 6 Mixed medical solution 7 Discharge port 9 Isolation seal part 10 Package 11 Front sheet 12 Back sheet

Claims (3)

[Claims] 1. A medical container comprising two or more storage chambers for separately storing a carbonic acid component, and wherein the storage chambers communicate with each other during use, wherein the carbonic acid component is stored in an alkaline state. The carbonic acid component has a bicarbonate ion concentration of 10 to 10 in the mixed medical solution when the above-mentioned storage chambers are communicated with each other.
The mother liquor accommodated in the liquid accommodating chamber other than the carbonic acid component contains carbonic acid (Pco ₂ ) in the mixed medical solution when the accommodating chambers are communicated with each other. A medical container characterized by containing an excess gap acid so as to generate in the range of 80 to 10 mmHg. 2. The carbonate component is an alkaline solution or suspension containing at least one of bicarbonate and carbonate,
The medical container according to claim 1, wherein the accommodation room for the carbonic acid component is air-tightly covered with a gas barrier packaging material. 3. The carbonic acid component is made of a solid substance of bicarbonate or carbonate, the accommodating chamber for the carbonic acid component is composed of a connection container separate from the main body of the medical container, and the accommodating chamber for the carbonic acid component is 2. The medical container according to claim 1, wherein the main body is connected to the main body after high-pressure steam sterilization.