JP2811035B2 - Bicarbonate blended liquid and its container - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention
More specifically, bicarbonate ion (H
CO ₃ ^-) only infusion using, for artificial kidneys perfusate, filtered artificial kidney for replenisher, container containing a bicarbonate formulation solution of peritoneal dialysis fluid and the like, are especially packaged in packaging material having a gas barrier property, The present invention relates to a gas-permeable plastic container in which a space between a container and a packaging material has a carbon dioxide gas atmosphere, and to the bicarbonate-containing liquid.

[0002]

2. Description of the Related Art Lactate and acetic acid are exclusively used in Ringer's lactate solution, Ringer's acetate solution, perfusion solution for artificial kidney, replenisher for filtration-type artificial kidney, peritoneal dialysate, etc., which have been used for body fluid correction. It is formulated as a blood alkalizing agent (buffer for blood). This is because lactate and acetate are metabolized to bicarbonate in the body to exert a buffering action. However, liver damage, diabetes, patients with metabolic abnormalities during major surgery such as during surgical invasion, when using a solution containing the above lactate or acetate, there is a disadvantage that blood pressure drop and poor mood tend to occur, Its use requires careful consideration.

[0003] On the other hand, a solution utilizing bicarbonate instead of lactate or the like as the above-mentioned blood alkalizing agent is also partly marketed or studied as a dialysis perfusate or replenisher for artificial kidneys (for example, see Japanese Patent Application Laid-Open No. H11-163873). No. 61-22865). However, each of these solutions is divided into two agents from the viewpoint of preventing the formation of precipitates and the coloring due to the decomposition of the compounded reducing sugar.
Housed separately in one container. Such preparations, of course, require complicated aseptic mixing operations when used, and at the time of mixing, the risk of bacterial contamination cannot be avoided. In addition, at present, it is inevitable to mix organic acids such as lactic acid and acetic acid to adjust the pH of the solution, and this type still uses bicarbonate alone as a blood alkalizing agent and does not contain organic acid salts. Infusions, perfusion solutions for artificial kidneys, replenishers, and the like have not been developed, and research and development of such solutions are strongly desired in the art.

[0004]

Accordingly, it is an object of the present invention to provide a bicarbonate blend containing no organic acid salts, as required in the art.

The inventors of the present invention have conducted intensive studies for the above purpose, and as a result, when selecting a bicarbonate blended liquid composition and specifying a container for accommodating the liquid and packing the container by a specific means, A mixed solution meeting the above purpose is obtained,
In addition, it was found that the composition did not change over time and was stable even after long-term storage, and the present invention was completed.

That is, according to the present invention, a bicarbonate solution as a blood alkalizing agent and an electrolyte solution containing calcium ions or magnesium ions are separately accommodated in a gas-permeable plastic container having at least two chambers. And the reducing sugar is housed in the same chamber as the electrolyte solution as needed, or is housed in a third chamber separate from the chambers, and the container is packaged with a packaging material having gas barrier properties. In addition, there is provided a bicarbonate-containing liquid container, wherein a space between the container and the packaging material has a gas atmosphere containing carbon dioxide gas.

According to the present invention, there is also provided a container containing a bicarbonate-containing liquid, wherein the bicarbonate-containing liquid contained in the plastic container has the following composition and pH by mixing at the time of use, and the bicarbonate-containing liquid: Is provided.

Sodium ion 50-150 mEq / l potassium ion 0-25 mEq / l calcium ion 2-5 mEq / l magnesium ion 0-3 mEq / l chloride ion 40-150 mEq / l bicarbonate ion 20-40 mEq / l reducing sugar 0 30 w / v% pH 7.0-7.5 The bicarbonate-containing solution contained in the container of the present invention utilizes bicarbonate as a blood alkalizing agent and does not contain organic acids such as lactic acid and acetic acid. There is no risk of adverse effects due to the use of such an organic acid, and this has the advantage of not significantly changing the blood composition even when it is directly injected into a blood vessel.

Further, according to the present invention, since the bicarbonate solution and the electrolyte solution containing calcium ions or this and magnesium ions are accommodated in two separate chambers, calcium carbonate or magnesium carbonate is stored over time. There is no danger of precipitation of the precipitate, and the reducing sugar is also housed in a separate room from the bicarbonate solution, so that there is no risk of decomposition and coloring due to the high pH of the bicarbonate solution.

Further, in the present invention, the bicarbonate-containing liquid is contained in a gas-permeable container, the container is packaged with a packaging material having gas barrier properties, and the space between the container and the packaging material contains carbon dioxide. Based on the gas atmosphere, the generation and volatilization of carbon dioxide due to the decomposition of bicarbonate over time can be prevented tremendously, and the resulting increase in the pH of the solution and the loss of commercial value of the blended solution itself can be ensured. Can be avoided. In addition, according to this requirement, there is no risk of increasing the pH of the solution, and there is no need to mix conventional lactic acid, acetic acid or the like as a pH adjuster.

The bicarbonate compound liquid used in the container of the present invention desirably has a composition range and a pH range of the following electrolyte ions (and reducing sugar).

Sodium ion 120-150 mEq / l potassium ion 0-10 mEq / l calcium ion 2-5 mEq / l magnesium ion 0-3 mEq / l chloride ion 100-120 mEq / l bicarbonate ion 25-40 mEq / l reducing sugar 0 10 w / v% pH 7.0 to 7.5 The bicarbonate compounding liquid may appropriately contain, for example, a trace element such as phosphate ion, copper, or zinc in addition to the above ions.

As the raw material compound for providing the above-mentioned electrolyte ion (and reducing sugar) composition, any of various usual compounds may be used, and typically, sodium hydrogen carbonate (NaHC) is used.
O _3), sodium chloride (NaCl), potassium chloride (KCl), calcium chloride dihydrate (CaCl ₂ · 2
H ₂ O), magnesium chloride hexahydrate (MgCl ₂ .6)
H ₂ O), magnesium sulphate heptahydrate (MgSO ₄ · 7
H ₂ O), etc. and glucose, a reducing sugar such as maltose can be exemplified.

According to the present invention, the bicarbonate-containing liquid contains a bicarbonate solution as a blood alkalizing agent and calcium ions or magnesium ions in each chamber of a gas-permeable plastic container having at least two chambers. It is important that the electrolyte solution and the electrolyte solution are housed separately, and the reducing sugar may be housed in the same room as the electrolyte solution, or may be housed in a third room separate from each of the rooms. With this configuration, generation of precipitation of calcium carbonate and magnesium carbonate, decomposition of reducing sugar, and coloring can be prevented. A bicarbonate solution (hereinafter referred to as solution A) as the blood alkalizing agent,
Electrolyte solution containing calcium ion or calcium ion and magnesium ion and, if necessary, reducing sugar (referred to as solution B)
And the concentration of the solution A and the solution B are not particularly limited, and the above composition may be obtained when both are mixed. Also, sodium ion, potassium ion,
Chloride ion may be contained in any of the above-mentioned liquids A and B, and may be contained in both liquids.

The above-described air-permeable plastic container having at least two chambers may be any of various types of known plastic containers. As a specific example, for example, a device provided with a means for closing a communicating portion of two rooms (Japanese Patent Publication No. 63-63)
No. 20550, Japanese Utility Model Publication No. Sho 63-17474) and those in which a seal portion for dividing two chambers is easily communicated by pressing (Japanese Patent Application Laid-Open Nos. 63-309263 and 2-467).
No. 1) and the like. Examples of the material of the container include, for example, polyethylene, polypropylene, polyvinyl chloride, cross-linked vinyl acetate, and the like.
In particular, it is desirable to be able to withstand high-pressure steam sterilization or hot water sterilization.

According to the present invention, the container containing the solution A and the solution B is packaged with a packaging material having gas barrier properties, and the space between the container and the packaging material is set to a gas atmosphere containing carbon dioxide gas. Is required.

Here, the packaging material having gas barrier properties may be a conventional one, and specific examples thereof include polyethylene terephthalate (PET), ethylene vinyl alcohol copolymer (EVOH), and polyvinylidene chloride (PVDC). Examples thereof include those made of a material and those made of a multilayer film made of a combination of these materials. The shape, size, and the like of the packaging material are not particularly limited on the premise that the plastic container can accommodate the above-mentioned plastic container and that there is a sufficient space between the container and the container after which the plastic container can be filled with a carbon dioxide-containing gas. . Usually, it is appropriate that the space is about 0.1 to 0.8 times the volume of the liquid content of the container.

In order to set the space between the container and the packaging material to a gas atmosphere containing carbon dioxide, a gas containing carbon dioxide such as a mixed gas of carbon dioxide and air or a mixed gas of carbon dioxide and nitrogen is used. Can be adopted in the space. Further, a method of enclosing a carbon dioxide-generating type oxygen scavenger, which absorbs oxygen gas existing in the space portion and releases carbon dioxide gas of the same volume as the oxygen gas, can be similarly employed. As the carbon dioxide-generating type oxygen scavenger, for example, "Ageless G" manufactured by Mitsubishi Gas Science Co., Ltd., and a freshness retaining agent C type manufactured by Toppan Printing Co., Ltd. can be advantageously used.

Thus, according to the present invention, a bicarbonate solution as a blood alkalizing agent is separated and contained from calcium ions, magnesium ions, and further reducing sugars in an air-permeable plastic container having at least two chambers as described above, and The container is wrapped with a packaging material having gas barrier properties, and the space between the container and the packaging material is made to have a gas atmosphere containing carbon dioxide gas. Thus, it is possible to provide an ideal bicarbonate-containing solution having a composition and a pH particularly suitable as the intended infusion solution, dialysis perfusion solution for artificial kidney, peritoneal dialysis solution, and the like.

However, if, for example, the above-mentioned liquid A and liquid B are separately accommodated in a container and mixed only when used, the bicarbonate in the liquid A will be reduced without taking the above-mentioned structure of the present invention. According to the formula (1), the disadvantage of partially decomposing during sterilization and storage to generate carbon dioxide gas and increasing the pH of the solution is inevitable.

2HCO ₃ ⁻ → CO ₃ ⁻ + H ₂ O + CO ₂ (1) According to the adoption of the above configuration of the present invention, carbon dioxide present in the space between the container and the packaging material is removed from the wall of the gas permeable plastic container. , And is absorbed by the liquid A, the carbon dioxide partial pressure in the liquid A reaches equilibrium with the carbon dioxide partial pressure in the space, and the pH is 7.0.
所 定 7.5 falls within a predetermined range. That is, carbon dioxide is p
Since it acts as an H adjuster, it does not require any pH adjustment with lactic acid, acetic acid, or the like.

However, at this time, the pH of the solution A is adjusted to 7.0 to 7.0.
In order to set the value to 5, the relationship between the carbon dioxide concentration in the space, the volume of the space and the amount of the liquid content needs to satisfy the following equation (2).

[0023] _{k = N co2 √V R, k} = 16~30 (2) where, N _{of co2} is the carbon dioxide concentration in the space (%), V _R is the space volume / content liquid amount (liquid contents volume and Is the total amount of the solution A and the solution B).

[0024] The V _R is not particularly limited, approximately 0.1 to 0.8 from the utility of the packaging, preferably preferably about 0.3 to 0.6.

Normally, in order to prepare and produce a bicarbonate-containing solution at a pH of 7.0 to 7.5, p.
It is customary to carefully prepare H to 7.0 to 7.5 and pressurize the inside of the sterilization vessel with carbon dioxide gas so that carbon dioxide gas does not evaporate from the contents during sterilization. Does not require pH adjustment during the preparation of solution A,
Don't have to worry at all. Sterilization may also be performed by ordinary high-pressure steam sterilization without using nerves for pH fluctuation. That is,
If the bicarbonate and an electrolyte containing neither calcium ions nor magnesium ions are dissolved in water for injection, the pH becomes 8.0.
~ 8.3 A solution is obtained. This liquid A is filled in a plastic container and subjected to normal high-pressure steam sterilization (100 to 121 ° C.).
For 20 to 60 minutes), the pH is usually 8.2 to 8.
Liquid A of 4 is obtained. A plastic container for accommodating the liquid A thus obtained separately from the liquid B may be accommodated in a gas barrier film, and a gas containing carbon dioxide may be sealed in the space, and the k value at that time is 16 to 30. If so, the carbon dioxide gas sealed in the space is absorbed by the solution A through the container wall containing the solution A, and according to the following formula (3) CO ₂ + CO ₃ ⁻ + H ₂ O → 2HCO ₃ ⁻ (3) The pH drops to a physiological pH range of 7.0 to 7.5. When the k value is less than 16, the pH drop of the solution A is small and becomes higher than a predetermined range. If the k value is greater than 30, the pH drop of the solution A is large and lower than a predetermined range. A preferable range of the k value is 18 to 27. When the solution A and the solution B of the product of the present invention thus obtained are mixed, A
The solution has a buffering action by bicarbonate, but the solution B has no buffering action, so that the pH of the mixed solution is 7.0 to 7.0.
7.5.

There are no particular restrictions on the method for preparing the above-mentioned solutions A and B, and any method can be used as long as the mixture has the above-mentioned composition. As a typical method, for example, sodium bicarbonate is dissolved in water for injection to prepare solution A. Sodium chloride and / or potassium chloride can be further dissolved in the solution A. On the other hand, calcium chloride, magnesium chloride and, if necessary, reducing sugar are dissolved in water for injection to obtain solution B. In the solution B, sodium chloride and / or potassium chloride can be further dissolved. The solution A and the solution B thus obtained were prepared by adding 0.45
After filtration through a μ-membrane filter, it can be stored in each chamber of the air-permeable plastic container.

Thus, according to the present invention, a desired bicarbonate blended liquid can be easily produced without the need for pH adjustment, which was conventionally required. In addition, this does not cause a decrease in blood pressure, poor mood, etc., even for patients with metabolic abnormalities during major operations such as liver injury, diabetes, and surgical invasion. Therefore, in the medical field, this is a dialysis perfusate for artificial kidneys,
It is very useful as a replenisher, an infusion, a peritoneal dialysis solution, etc. for a filtration type artificial kidney. Upon use, the bicarbonate blended liquid in the container of the present invention can be administered and applied in various dosage forms depending on the purpose. The composition of the solution can be appropriately determined from the above range according to the state of the patient to be administered and applied, the degree of the disease, the age, and the like.

[0028]

The present invention will be described in more detail with reference to the following examples.

The schematic drawing of the container of the present invention used in the examples is shown in the accompanying drawings.

In the figures, (1) is a packaging material having gas barrier properties, (2) is a gas permeable plastic container having at least two chambers, and (3) is a seal portion which easily communicates and partitions the two chambers of the container. Show.

[0031]

Example 1 5.04 g of sodium bicarbonate was dissolved in water for injection to make 1 liter, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 0.44
0 g, 11.688 g of sodium chloride and 0.596 g of potassium chloride were dissolved in water for injection to make 1 liter, which was used as solution B.

A polyethylene container having two chambers shown in FIG. 1 (2), each containing 250 ml of the solution A and the solution B, each of which can be mixed with the solution immediately before use, was filtered with a 0.45 μm membrane filter. Approximately 40
0 cm ³ ), the obtained container was subjected to high-pressure steam sterilization (105 ° C., 40 minutes), and then a gas barrier film (multilayer film made of polyvinyl alcohol, product shown in (1) of FIG. 1) (Name: Boblon, manufactured by Nichigo Film Co., Ltd.). At this time, the secondary side space was replaced with carbon dioxide gas mixed air. That is, the carbon dioxide concentration is 30%
Of the mixed gas of 250 ml was sealed. Volume ratio V _R is 0.
5. The k value was calculated to be 21.2. P of solution A of the present invention
When H was measured over time, it was as follows.

PH 8.30 (immediately after production) → 7.30
(Room temperature 10 days) → 7.33 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
The composition and pH of 500 ml of a bicarbonate-containing liquid obtained by mixing the liquid and the liquid B are as follows, and can be provided as a stable bicarbonate-containing Ringer's liquid.

The ^{Na + 130mEq / l K + 4mEq} / l Ca ++ 3mEq / l Cl - 107mEq / l HCO 3 - 30mEq / l pH 7.30

[0036]

Example 2 59.61 g of sodium chloride, 2.98 g of potassium chloride, and 23.52 g of sodium carbonate were dissolved in water for injection to make 6 liters, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 2.21
g and maltose (500 g) were dissolved in water for injection to make 4 l, and used as solution B.

Thereafter, in the same manner as in Example 1,
ml and 400 ml of solution B were filled in a polyethylene container ((2) in FIG. 1) partitioned into two chambers, and sterilized by high-pressure steam.
It was packaged with a gas barrier film ((1) in FIG. 1). 2
0.2 l of 50% carbon dioxide gas mixed air was sealed in the secondary space to obtain k = 50 × √0.2 = 22.4. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.32 (immediately after production) → 7.35
(Room temperature 10 days) → 7.39 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
Liquid and liquid B, the composition of 1 l of bicarbonate compounded liquid obtained and p
H is as follows, and can be provided as an infusion or replacement fluid.

The ^{Na + 130mEq / l K + 4mEq} / l Ca ++ 3mEq / l Cl - 109mEq / l HCO 3 - 28mEq / l maltose 5w / v% pH 7.35

[0041]

Example 3 35.06 g of sodium chloride and 15.12 g of sodium hydrogen carbonate were dissolved in water for injection to make 4 liters, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 1.32
g, potassium chloride (4.47 g) and glucose (60 g) were dissolved in water for injection to make 2 liters.

The same operation as in Example 1 was carried out using 400 ml of the solution A and 200 ml of the solution B filtered through a 0.45 μm membrane filter. However, 35% in the secondary space
300 ml of carbon dioxide mixed air was sealed. k is 24.7
Was asked. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.35 (immediately after production) → 7.21
(Room temperature 10 days) → 7.30 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
The composition and pH of 600 ml of the bicarbonate compounded liquid obtained by mixing the liquid and the liquid B are as follows, and can be provided as an infusion.

The ^{Na + 130mEq / l K + 10mEq} / l Ca ++ 3mEq / l Cl - 113mEq / l HCO 3 - 30mEq / l glucose 1w / v% pH 7.21

[0046]

Example 4 25.20 g of sodium bicarbonate was dissolved in water for injection to make 3 liters, which was used as solution A.

On the other hand, 61.36 g of sodium chloride, 1.86 g of potassium chloride, and 2.2 of calcium chloride (dihydrate)
1 g and 1.52 g of magnesium chloride (hexahydrate) were dissolved in water for injection to make 7 l, which was used as solution B.

The same operation as in Example 1 was carried out using 300 ml of the solution A and 700 ml of the solution B filtered through a 0.45 μm membrane filter. However, 40% in the secondary space
About 250 ml of carbon dioxide mixed air was sealed. k is 40√
0.25 = 20 was calculated. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.27 (immediately after production) → 7.40
(Room temperature 10 days) → 7.42 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
Liquid and liquid B, the composition of 1 l of bicarbonate compounded liquid obtained and p
H is as follows, and can be provided as a stable replenisher for a filtered artificial kidney.

The ^{Na + 135mEq / l K + 2.5mEq} / l Ca ++ 3mEq / l Mg ++ 1.5mEq / l Cl - 112mEq / l HCO 3 - 30mEq / l pH 7.40

[0051]

EXAMPLE 5 122.72 g of sodium chloride, 2.98 g of potassium chloride and 58.81 g of sodium hydrogen carbonate were dissolved in water for injection to make 10 liters, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 4.41
g, 2.03 g of magnesium chloride (hexahydrate) and 40.0 g of glucose were dissolved in water for injection to make 10 liters, which was used as solution B.

The same procedure as in Example 1 was repeated for 1 liter of Solution A and 1 liter of Solution B filtered through a 0.45 μm membrane filter to obtain a product of the present invention. However, 3 in the secondary space
Approximately 800 ml of 5% carbon dioxide mixed air is enclosed, and k = 3
It was calculated as 5２．１0.4 = 22.1. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.29 (immediately after production) → 7.25
(Room temperature 10 days) → 7.30 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
The composition and pH of 2 l of the bicarbonate mixture obtained by mixing the liquid and the liquid B are as follows, and can be provided as a perfusion solution for continuous hemodiafiltration.

[0055] ^{Na + 140mEq / l K + 2mEq} / l Ca ++ 3mEq / l Mg ++ 1mEq / l Cl - 111mEq / l HCO 3 - 35mEq / l glucose 0.2w / v% pH 7.25 The present In the production, (1) about 900 ml of 25% carbon dioxide gas mixed air was sealed in the secondary space. The k value at this time was calculated to be 16.8, and the pH of the solution A was
Is 8.29 (immediately after production) → 7.48 (room temperature 10 days) →
7.50 (room temperature 12 months).

(2) About 900 m of 44% carbon dioxide mixed air
1 was enclosed. The k value at this time is calculated as 29.5,
Solution A pH 8.29 (immediately after production) → 7.13 (room temperature 10
Day) → 7.15 (room temperature 12 months).

[0057]

Example 6 74.22 g of sodium chloride, 3.73 g of potassium chloride and 16.80 g of sodium hydrogen carbonate were dissolved in water for injection to make 2 liters, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 2.94
g and 500.0 g of glucose in water for injection to 8 l
And used as solution B.

The same procedure as in Example 1 was carried out on 200 ml of solution A and 800 ml of solution B filtered with a 0.45 μm membrane filter to obtain a product of the present invention. However, the secondary space was filled with 150 ml of 50% carbon dioxide gas mixed air, and k = 50√0.15 = 19.4. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.13 (immediately after production) → 7.42
(Room temperature 10 days) → 7.48 (room temperature 12 months) Solution A and B of the product of the present invention obtained from the above and passed for 10 days
The composition and pH of 1 liter of the bicarbonate blended liquid obtained by mixing the liquids are as follows, and can be provided as an infusion.

[0061] ^{Na + 147mEq / l K + 5mEq} / l Ca ++ 4mEq / l Cl - 136mEq / l HCO 3 - 20mEq / l glucose 5w / v% pH 7.42

[0062]

Example 7 29.40 g of sodium bicarbonate was dissolved in water for injection to make 5 liters, which was used as solution A.

On the other hand, 11.69 g of sodium chloride, 18.64 g of potassium chloride, and calcium chloride (dihydrate)
21 g, 2.03 g of magnesium chloride (hexahydrate) and 2500.0 g of glucose were dissolved in water for injection to make 5 l,
Solution B was used.

The same procedures as in Example 1 were carried out on 500 ml of solution A and 500 ml of solution B filtered through a 0.45 μm membrane filter to obtain a product of the present invention. However, about 300 ml of 40% carbon dioxide gas mixed air was sealed in the secondary space, and k = 40√0.3 = 21.9. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.21 (immediately after production) → 7.35
(Room temperature 10 days) → 7.39 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
The composition and pH of 1 liter of the bicarbonate blended liquid obtained by mixing the liquid and the liquid B are as follows, and can be provided as a high calorie infusion.

[0066] ^{Na + 55mEq / l K + 25mEq} / l Ca ++ 3mEq / l Mg ++ 2mEq / l Cl - 50mEq / l HCO 3 - 35mEq / l glucose 25w / v% pH 7.35

[0067]

Example 8 111.0 g of sodium chloride and 58.8 g of sodium bicarbonate were dissolved in water for injection to make 10 liters, which was used as solution A.

On the other hand, calcium chloride (dihydrate) 5.15
g, 3.05 g of magnesium chloride (hexahydrate) and 300 g of glucose were dissolved in water for injection to make 10 liters to obtain a solution B.

The same procedures as in Example 1 were carried out on 1 liter of solution A and 1 liter of solution B filtered through a 0.45 μm membrane filter to obtain a product of the present invention. However, 3 in the secondary space
Approximately 800 ml of 5% carbon dioxide mixed air is enclosed, and k = 3
It was calculated as 5２．１0.4 = 22.1. When the pH of the solution A of the product of the present invention was measured over time, it was as follows.

PH 8.30 (immediately after production) → 7.28
(Room temperature 10 days) → 7.32 (room temperature 12 months) A of the product of the present invention obtained by the above-mentioned production and having passed 10 days.
The composition and pH of 2 l of the bicarbonate blended solution obtained by mixing the solution and the solution B are as follows, and can be provided as a stable peritoneal dialysis solution.

[0071] ^{Na + 130mEq / l Ca ++ 3.5mEq} / l Mg ++ 1.5mEq / l Cl - 100mEq / l HCO 3 - 35mEq / l glucose 1.5w / v% pH 7.28

[0072]

Ninth Embodiment In the first embodiment, the secondary side space is set to 350
The operation was carried out in the same manner except that an air atmosphere of ml was used, and one carbon dioxide-generating type oxygen scavenger, Ageless G (manufactured by Mitsubishi Gas Science Co., Ltd.), was sealed therein. Thus, the oxygen of the secondary-side space is replaced with carbon dioxide gas equal volume, thus the secondary side space becomes approximately 20% of the carbon dioxide concentration, the volume ratio V _R is 0.
7. The K value was calculated to be 16.7. P of solution A of the present invention
When H was measured over time, it was as follows.

PH 8.31 (immediately after production) → 7.43
(Room temperature for 2 weeks) → 7.45 (room temperature for 12 months)
The composition and pH of 500 ml of a bicarbonate-containing liquid obtained by mixing the liquid and the liquid B are as follows, and can be provided as a stable bicarbonate-containing Ringer's liquid.

[0074] ^{Na + 130mEq / l K + 4mEq} / l Ca ++ 3mEq / l Cl - 107mEq / l HCO 3 - 30mEq / l p H 7.40

[0075]

Effects of the Invention By changing lactate, acetate, etc. as an alkalizing agent contained in an infusion, a perfusion solution for an artificial kidney, and a replenisher for a filtration-type artificial kidney to bicarbonate, severely ill patients and metabolic disorders It is no longer necessary to carefully administer to patients with illness.

[Brief description of the drawings]

FIG. 1 is a schematic view of a container containing a bicarbonate-containing liquid according to the present invention.

[Explanation of symbols]

(1) A packaging material having a gas barrier property (2) A gas-permeable plastic container having at least two chambers (3) A seal portion which divides two chambers and is easily communicated.

──────────────────────────────────────────────────続 き Continued on front page (58) Field surveyed (Int.Cl. ⁶ , DB name) A61M 1/14 511,520

Claims (4)

(57) [Claims] A bicarbonate solution as a blood alkalizing agent and an electrolyte solution containing calcium ions or this and magnesium ions are separately contained in a gas-permeable plastic container having at least two chambers, and a reducing sugar is further contained. Is housed in the same chamber as the electrolyte solution as needed, or is housed in a third chamber separate from each of the chambers, the container is wrapped with a packaging material having gas barrier properties, and the container and the packaging material are A bicarbonate-containing liquid storage container characterized in that a space portion of the container is a gas atmosphere containing carbon dioxide gas. 2. The container according to claim 1, wherein the bicarbonate-containing liquid contained in the air-permeable plastic container has the following composition and pH by mixing at the time of use. Sodium ion 50 to 150 mEq / l potassium ion 0 to 25 mEq / l calcium ion 2 to 5 mEq / l magnesium ion 0 to 3 mEq / l chloride ion 40 to 150 mEq / l bicarbonate ion 20 to 40 mEq / l reducing sugar 0 to 30 w / v % PH 7.0 to 7.5 3. A gas atmosphere in a space between a container and a packaging material,
Carbon dioxide concentration (%) x √ (volume of space / volume of liquid content) = 1
The container according to claim 1, wherein the number is 6 to 30. 4. A bicarbonate-containing liquid which is contained in the container according to claim 1 or 2, and has the following composition and pH by mixing at the time of use. Sodium ion 50 to 150 mEq / l potassium ion 0 to 25 mEq / l calcium ion 2 to 5 mEq / l magnesium ion 0 to 3 mEq / l chloride ion 40 to 150 mEq / l bicarbonate ion 20 to 40 mEq / l reducing sugar 0 to 30 w / v % PH 7.0 to 7.5