JPH09110703A - Electrolyte infusion and vessel therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain an electrolyte infusion preparation which contains Na in a specified concentration among electrolytes and a specific concentration of bicarbonate among electrolytes, causes no renal disorder, diarrhea and the like and can maintain an increased pH on administration. SOLUTION: This infusion preparation contains Na among electrolytes in a concentration of 20-160meq/L, additionally bicarbonate among electrolytes in a concentration of 1-65meq/L, preferably 15-30meq/L. In this objective infusion preparation, the content of acetate or lactate is suppressed to 15-0meq/L, acidotic symptom can be inhibited, even when it is dosed to the patients with hepatopathy. In addition, when the pH is set to 5.5-8, the abdominal pain of the patient can be extremely suppressed. In addition to electrolytes, the use of at least one of saccharides such as glucose, fructose, sorbitol, xylitol or mannitol in a proportion of 1-15% gives desirably an electrolyte infusion preparation which can supply sufficient calories.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an electrolyte infusion agent and a container for the same, and more specifically, it relates to the acidosis symptoms observed in persons with hepatic impairment, which have been a problem in the past for electrolyte infusion and the like. The present invention relates to an electrolyte infusion agent and its container that alleviate vomiting, chills, etc. during infusion.

[0002]

2. Description of the Related Art The concentration of bicarbonate in human plasma is usually 24.
It is about 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, the infusion is filled in a plastic medical container,
Usually, it is provided to the 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. For this reason, bicarbonate is not used in the dialysate or the like, and a substitute for it 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.

For example, in a typical electrolyte maintenance solution, Na is 20 to 50 mEq / L and K is 20 mEq / L.
Before and after, Cl is 20 to 50 mEq / L, and lactate,
Alternatively, acetate contains 20 mEq / L, glucose,
1-1 of fructose, xylitol, sorbitol, etc.
It is contained at 0% by weight. Acetate or lactate serves to make bicarbonate in the body to supplement the bicarbonate and to maintain the glucose solution in an acidic state for stability in the container. Therefore, at present, acetate or lactate is frequently used for infusion. Further, the infusion solution is conventionally filled in a non-constant volume plastic container, and a closed system that does not require a bottle needle or the like is used. And
Such a container is generally subjected to high-pressure steam sterilization treatment after being filled with an infusion solution. However, if the transfusion contains sugars and the like and the PH value of the transfusion is high, the transfusion may be discolored during the steam sterilization. Therefore, the electrolyte transfusion agent is adjusted by reducing the PH value as much as possible.

[0004]

However, when a large amount of acetate or the like is used for the conventional electrolyte infusion, there is a patient whose acetate is not immediately decomposed in the body, for example, a patient with a liver disorder, and therefore the body of the patient suffers from acidosis. Can be seen. Further, if the pH value of the infusion solution is kept as low as possible as described above, the patient who receives the administration may have acid overdose, renal disorder, diarrhea, vomiting and the like. Especially when the PH value is 5.0 or less, such symptoms are frequently observed.

Therefore, an object of the present invention is to provide an electrolyte infusion solution and a container thereof which can prevent renal damage, diarrhea, vomiting and the like due to acidosis and can maintain a high PH value during administration.

[0006]

SUMMARY OF THE INVENTION The present invention relates to N in an electrolyte.
In the electrolyte infusion containing a in the concentration range of 20 to 160 mEq / L, bicarbonate is added to the electrolyte in the range of 1 to 65 mEq / L.
The above object is achieved by providing an electrolyte transfusion agent characterized by containing L in a concentration range. The present invention also provides an infusion agent container in which a plastic container is filled with the electrolyte infusion agent, wherein the container has a plurality of chambers, and all or a part of a partition wall between the chambers is isolated from the outside of the container. An infusion container, which is formed by an isolation opening means that can be opened and allows the chambers to communicate with each other, and wherein at least one chamber is filled with bicarbonate while maintaining its alkalinity. The above object is achieved by providing the following.

In the electrolyte infusion solution according to the present invention, the content of acetate or lactate in the electrolyte is 25.
By being characterized by being suppressed to mEq / L or less, particularly 15 to 0 mEq / L, the acidosis symptom can be suppressed even during administration to patients with liver disorders and the like. In the electrolyte infusion solution according to the present invention, the PH value is 5.5.
By being characterized as being in the range of ~ 8.0,
Abdominal pain and the like of the administration patient can be suppressed as much as possible. In the electrolyte infusion agent according to the present invention, in addition to the above electrolyte, glucose, fructose, sorbitol, xylitol, and at least one or more saccharides of mantose are contained in the range of 1 to 15%, thereby providing calories. It is possible to provide an electrolyte transfusion agent that has been sufficiently prepared.

According to the infusion solution container of the present invention, the chamber of the container comprises a mother liquor filling chamber containing the electrolyte and having a PH value of 5.5 or less, and a bicarbonate filling chamber. With the characteristics, the stability of sugars and the like in the mother liquor, particularly the stability during heating in high-pressure steam sterilization, can be sufficiently achieved. According to the infusion solution container of the present invention, since the bicarbonate is a sodium salt or a potassium salt, the stability of the container in the room can be sufficiently achieved. According to the infusion solution container of the present invention, since the container is made of a polyolefin resin, the possibility of the container affecting the infusion solution is extremely reduced. According to the infusion solution container of the present invention, the isolation / opening means is a peelable peel seal part, so that the operability and economy of the container are improved, and the electrolyte infusion agent can be easily used in the hospital. And it can be provided aseptically.

[0009]

In the above infusion solution, since bicarbonate is directly contained in the infusion solution, the PH value in the body is maintained, and unlike the conventional ones, electrolyte abnormality such as acidosis does not occur. That is, when the above infusion solution is administered, the amount of electrolyte such as acetate and lactate can be reduced depending on the addition ratio of bicarbonate, so that bicarbonate directly acts on the body and the bicarbonate concentration in the body becomes constant. Furthermore, by adding bicarbonate, the administered infusion solution can maintain the PH value in the range of 6.0 to 7.5, and can prevent abdominal pain, diarrhea and the like during dialysis.

In the above-mentioned infusion container, bicarbonate is separated from the main mother liquor chamber of the container body and filled in the other chamber, and a part of the electrolyte in the main mother liquor is used as an alkaline salt agent of bicarbonate. Allocation, bicarbonate is filled while being prevented from decomposing as carbon dioxide. Therefore, even when the entire container body is subjected to high-pressure steam sterilization, most of the bicarbonate can be present as a salt without being decomposed. Further, even when the container body is stored for a long period of time, bicarbonate is not decomposed and the interior of the room is maintained aseptically. In addition, since sodium salt or potassium salt as a bicarbonate is partially mixed in the side of the filling chamber of bicarbonate, the pH value of the main mother liquor containing the sugar solution is lowered to stabilize the glucose solution in high calorie infusion. Can be maintained. In addition, calcium salts, which are not easily dissolved once reacted with bicarbonate, are maintained in an acidic state, and precipitation or the like hardly occurs even during mixing. Therefore, in combination with the chamber being partitioned by the isolation opening means that can be opened from the outside, the bicarbonate is aseptically mixed with the main mother liquor during use and provided as an infusion.

[0011]

The preferred embodiments of the electrolyte infusion agent and the container thereof according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a half sectional view of a first embodiment of an infusion container according to the present invention, and FIG. 2 is a sectional view of the infusion container of the first embodiment when in use.

The infusion solution according to the present embodiment uses Na in the electrolyte.
In a concentration range of 20 to 160 mEq / L, wherein 1 to 65 mEq / L of bicarbonate is added to the electrolyte.
Included in the concentration range of.

The infusion solution of this embodiment will be described in more detail.
The infusion solution 11 of the present example is an electrolyte maintenance solution and is used for supplementing physiological water and electrolytes by insensitive vaporization and excretion in urine. It cannot be taken orally, and vomiting, diarrhea, abnormal sweating, etc. It is applied to patients who do not continue to lose fluid through the abnormal route. Therefore, the infusate 11 has a hypotonic osmotic pressure of 1/2 to 2/3 that of plasma, and Na in the electrolyte is 30 to 30%.
Included in the range of 60 mEq / L, K is 10 to 30 mEq
/ L and Cl in the range of 20 to 50 mEq / L. The electrolyte transfusion agent 11 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.
Bicarbonic acid is preferably in the vicinity of plasma concentration, particularly 5 to 5
It is desirable that the content is 0, more preferably 15 to 30 mEq / L. For this reason, the concentration of acetate or lactate is 25 mEq / L or less, especially for people with severe liver injury.
It is contained in the range of 15 to 0 mEq / L. Further, since the infusion solution 11 of the present embodiment also requires calorie supplementation, it contains saccharide in a range of 1 to 15% by weight. 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. Furthermore, the infusion solution 11 of the present embodiment is
The PH value is in the range of 5.5 to 8.0, especially 6.0.
It is adjusted within the range of ~ 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 infusion solution of this example is administered aseptically, but it is surely sterilized by high-pressure steam sterilization. High-pressure steam sterilization is performed based on the Japanese Pharmacopoeia standard of steam sterilization.
It is carried out in an autoclave or the like at a temperature of 10 to 130 ° C.
The infusion solution may be prepared by aseptically mixing each drug, but the above high pressure steam sterilization is preferable from the viewpoint of sterilization assurance.

In the infusion solution 11 of the present embodiment, addition of acetate, lactate or the like is suppressed as much as possible, so that acidosis of the administration patient and electrolyte abnormality due to excessive acid administration can be prevented. Further, since the pH of the infusion solution can be increased, the administration patient does not have symptoms such as abdominal pain and vomiting. In the above-mentioned example, the electrolyte infusion agent was the electrolyte maintenance liquid. However, in the present invention, the electrolyte infusion agent is physiological saline, physiological saline-sugar solution, Ringer's solution,
Ringer's solution-sugar solution, Hartmann's solution, Hartmann's solution-sugar solution and other starting solutions, small external solution replenishers, gastrointestinal fluid replenishers, etc. It may be used more than 20 to 160 mE of Na
You may use between q / L.

Next, the infusion solution container used for the electrolyte infusion solution will be described in detail. As shown in FIGS. 1 and 2, the infusion container 1 of the present embodiment is a container in which the above-mentioned electrolyte infusion agent 11 is filled in a plastic container, and the container 1 has a plurality of chambers 2,
3, a part of the isolation wall between the chamber 2 and the chamber 3 is formed by a click tip 4 which is an isolation opening means that can be separated from the outside of the container 1 and allows the chamber 2 and the chamber 3 to communicate with each other. At least one chamber 3 is filled with bicarbonate 13 while maintaining its alkalinity.

According to the infusion solution container 1 of the present embodiment, the chambers 2 and 3 of the container are filled with the mother liquor 12 and the bicarbonate 13 which contain an electrolyte and have a PH value of 5.5 or less. Chamber 3 and bicarbonate 13 is the sodium salt. Also,
According to the infusion container 1 according to the present embodiment, the container 1 is made of polyolefin resin.

The infusion solution container 1 according to this embodiment will be described in more detail. The infusion solution container 1 is a container filled with the infusion solution 11 for the electrolyte maintenance solution as described above. The infusion container 1 is made of an indefinite volume resin container whose wall surface bends. Specifically, in this embodiment, the container 1 is formed by stretching a sheet produced by extruding linear low-density polyethylene and cutting the sheet into a predetermined size. The cut sheets are stacked on top of each other, and the two sheets are completely fixed and sealed at predetermined four sides by heat welding, and the chambers 2 and 3 are separated and sealed, and the peripheral edge seal portion 1A and the separation seal portion 1B are separated from each other. It is in a non-peeling state. The click tip 4 is liquid-tightly attached between the two sheets when the isolation seal portion 1B is formed. Normally, the click tip 4 does not communicate between the chamber 2 and the chamber 3 unless it is broken and broken. That is, the click tip 4 is formed of a resin molded product, and is formed in a tubular shape with one end closed. Then, the click tip 4 becomes a completely open-ended tube by breaking off the closed end at the notch 4A on the side surface of the closed end. Peripheral seal part 1
A discharge port 5 is attached to the click tip 4 when forming A, and the discharge port 5 includes a cylindrical resin port member 6, a rubber stopper 7, and a stopper 8. The discharge port 5 will be
It is liquid-tightly attached between two sheets, and a rubber stopper 7 is arranged at the open end thereof. The rubber plug 7 is attached to the mouth member 6 via the stopper 8 in a state where the opening of the mouth member 6 is closed in a liquid-tight manner, and the stopper 8 is fixed to the mouth member 6 via the flange portions of each other.

In this example, linear low-density polyethylene (trade name: Moretech, manufactured by Idemitsu Petrochemical Co., Ltd.,
The sheet with density: 0.916 g / cm ³ , MI: 2)
The sheet is cut into a sheet having a thickness of 200 μm, a length of 400 mm and a width of 200 mm. Next, an impulse sealer (auto sealer FA-30 manufactured by Fuji Impulse Co., Ltd.) is used to stack two resin sheets and form a predetermined peripheral end of the container into a container form.
Seal with 0-5W). Sealing conditions are sealing time 1.
5 seconds, cooling time 5 seconds. The use of a general-purpose polyolefin resin for the container 1 is desirable not only for the economical aspect but also for the filling of the container. That is, since the polyolefin resin does not contain a plasticizer or the like and does not have a functional group or the like, it does not adversely affect the infusion solution composed of the bicarbonate 13 and the mother liquor 12.

In the examples, polyolefin-based linear low-density polyethylene was used for the container 1, but other resins may be used as long as a non-constant volume resin container is possible. 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 thickness of the wall of the container 1 is not particularly limited as long as it has flexibility and flexibility. Further, the container 1 may have a multilayer resin structure. In particular, it is desirable to use a resin having high permeability to carbon dioxide for the outer layer or the intermediate layer. When such a resin layer having a high carbon dioxide gas barrier property is provided, even if the bicarbonate 12 in the container 1 is slightly decomposed and carbon dioxide gas is released, the carbon dioxide gas is released from the filling chamber 4 of the container 1. It becomes extremely difficult and further guarantees long-term stable storage of the container.

The electrolyte transfusion agent 11 is divided into a bicarbonate 13 and a mother liquor 12 and filled in the container 1, and the bicarbonate 13 is filled in the filling chamber 3 of the container 1. Then, the inside of the filling chamber 3 is maintained in an alkaline state. That is, the bicarbonate 13 is filled in the filling chamber 3 in an alkaline salt state. A part of the salt to be filled in the filling chamber 2 of the mother liquor 12 is assigned to the alkali salt. The salt is preferably a salt which is easily dissolved when the bicarbonate 13 is mixed with the mother liquor 12, and such a salt is preferably a sodium salt or a potassium salt.
Therefore, in this embodiment, the filling chamber 3 is filled with sodium hydrogen carbonate or sodium carbonate, and is filled with a PH value of 7 or more, particularly in the range of 7.9 to 9.0 (1:30).
PH value as an aqueous solution. ). Further, the sodium salt in the mother liquor 12 is subtracted from the amount of sodium salt used in the filling chamber 3.

The bicarbonate 13 to be filled in the filling chamber 3 is 100 w / v% such as powder of sodium bicarbonate or the like according to the Japanese Pharmacopoeia, or sodium hydrogencarbonate injection according to the Japanese Pharmacopoeia.
It is desirable to fill it in the form of an aqueous solution (suspension) or a concentrated liquid. In the present embodiment, such a bicarbonate 13 is filled based on the above blending amount. As described above, the bicarbonate concentration (HCO ₃ ) is 1 to 65, especially 15
It is desirable that the range is ˜30 mEq / L. Therefore, in this example, 24 mEq / L of sodium bicarbonate is used. Therefore, in this embodiment, since 1000 mL of the liquid is stored in the container 1, sodium hydrogen carbonate as the bicarbonate 13 is used in the range of 2.02 g.

The mother liquor 12 is filled in the filling chamber 2 which occupies most of the container 1, and the bicarbonate 13 is separated and filled in the filling chamber 3, so that theoretical amounts of lactate, sodium salt and the like are subtracted from the relationship. It is filled as a composition liquid. Further, the mother liquor 12 to be filled in the filling chamber 2 preferably has a PH value of 5.5 or less before it is mixed with the bicarbonate 13, particularly 5.3 or even 5.0 or less. Is desirable. Such acidification of the mother liquor 12 is easily achieved by separating the bicarbonate 13 into the filling chamber 2 and removing sodium or potassium, and when the mother liquor 12 is maintained at the PH value in the above range, Even if the mother liquor 12 is heated by high-pressure steam sterilization, the possibility that glucose and the like in the mother liquor 12 will be deteriorated is extremely reduced.

The bicarbonate 13 forms the isolation seal portion 1B on two sheets, and when the peripheral seal portion 1A is formed,
The filling liquid is filled in the filling chamber 3, and the mother liquor 12 is filled in the filling chamber 2 from the mouth member 6 after the discharge port member 6 is attached to the peripheral seal portion 1A. Then, the outlet member 6 is sealed with the rubber stopper 7 and the stopper 8, and the container 1 is sterilized by high pressure steam.
As a result, the filling chamber 2 and the filling chamber 3 are sterilized. The high-pressure steam sterilization is carried out based on the high-pressure steam sterilization method of the Japanese Pharmacopoeia, and a general autoclave is used for the high-pressure steam sterilization. Done in.

In the infusion container 1 thus constructed, the bicarbonate 13 is not decomposed in the filling chamber 3 during sterilization, so that the container 1 is kept in the filled state. Further, when the container 1 is stored, the bicarbonate 13 is maintained in the container 1 without being decomposed, so that it can be provided to the hospital as it is. When using the infusion solution container 1,
As shown in FIG. 2, the closed end of the click tip 4 is broken from the outside of the container 1 to connect the filling chamber 2 and the filling chamber 3 to each other. Then, the mother liquor 12 and the bicarbonate 13 are mixed, so that an infusion having no electrolyte abnormality can be made in the container body 2. In this case, since the calcium and the like in the mother liquor 12 exist in a state of extremely low concentration, there is little possibility that the calcium carbonate and the like will precipitate when mixed with the bicarbonate 13. Further, since bicarbonate 13 exists in an alkaline state, when mixed with mother liquor 12,
It raises the PH value of the mother liquor 12, and eventually plays the role of adjusting the pH of the infusion solution.

In the above embodiment, the filling chamber 3 is an extremely large chamber, but as long as the required amount of bicarbonate 13 can be filled,
It may be a small room. In the above embodiment, the container 1 was molded using two extruded sheets, but the present invention is not limited to this, and the container body may be manufactured from an inflation-molded tubular sheet.

Next, the infusion solution container according to the second embodiment used for the electrolyte infusion agent will be described in detail. FIG. 3 is a longitudinal sectional view of the infusion container according to the second embodiment as seen from the front, FIG.
FIG. 4 is a cross-sectional view of a main part of FIG. As shown in FIG. 3 and FIG. 4, the infusion container 21 of this embodiment is the container 1 of the first embodiment.
Similarly, the electrolyte transfusion agent 11 is filled, the transfusion container 21 has two chambers 22 and 23, and the partition wall between the chamber 22 and the chamber 23 is separable from the outside of the container 21 and the chamber 22 and the chamber 23. Is formed by a peel seal portion 24 that enables communication between
3 is filled with a bicarbonate suspension 13 ', maintaining its alkalinity.

The infusion solution container 21 according to this embodiment will be described in more detail. The infusion solution container 21 is made of a resin container having an indefinite volume whose wall surface bends. Specifically, in this embodiment, the container 21 is formed by cutting a tubular sheet produced by inflation molding of a mixed composition of linear low-density polyethylene and polypropylene into a predetermined size. is there. The end portion 21A of the cut sheet is completely fixed and sealed by heat welding, and the fixed sealing portion 21 forms a container. In addition to the fixed seal portion 21A, the container 21 has a peel seal portion 2 from which the sheet inner walls can be separated from each other from the outside.
4 are formed. Then, the peel seal portion 24 divides the container 1 into a filling chamber 22 and a filling chamber 23. Therefore,
The container 21 is formed with a complete fixed seal portion 21A and a peel seal portion 24. Regarding the formation of such different seal portions, there is a medical device having a fully fixed seal portion 21A and a peelable seal portion 24 which are known per se. It can be produced by referring to the method for producing the container.

That is, in this example, linear low-density polyethylene (trade name: Moretec, manufactured by Idemitsu Petrochemical Co., Ltd., density: 0.916 g / cm ³ , MI: 2) and polypropylene (trade name: Chisso Polypro) Manufactured by Chisso Corporation, density: 0.90 g / cm ³ , MI: 0.7) 6:
Kneaded with 2 rolls (roll temperature is 175 ° C.) at a ratio of 4 and inflation molded to obtain a wall thickness of 200
A sheet having a size of μm, a length of 300 mm and a width of 150 mm is prepared. Next, in order to form the container 1 by sealing the peripheral edge, it is sealed with an impulse sealer (Fuji Impulse Corp. auto sealer FA-300-5W). The sealing conditions are a sealing time of 1.5 seconds and a cooling time of 5 seconds. On the other hand, the peel seal portion 24 is 10 mm wide with a heating die from above and below,
A section of 150 mm in length is pressed and sealed. The sealing condition was between 130 ° C. and 150 ° C. and the plate was placed in a pressed state for 12 seconds. It should be noted that a stopper is provided so that the sealing surface is not completely crushed by the press, and the pressure is adjusted so as not to apply an excessive press pressure. In addition, the container 21 has a fixed seal portion 21.
Simultaneously with the formation of A, the discharge port 5 is provided.

The electrolyte infusion agent 11 is the container 1 of the first embodiment.
As in the above, the bicarbonate 13 'and the mother liquor 12 are separately filled, but the bicarbonate 13' is a 100 w / v% aqueous solution (suspension) like sodium bicarbonate injection based on the Japanese Pharmacopoeia. Alternatively, it is filled in the form of a concentrated liquid. In this embodiment, such a bicarbonate 13 'is blended in the same manner as in the first embodiment described above. Where mother liquor 12 and bicarbonate 1
For filling 3 ', the peripheral seal portion 21A provided with the discharge port 5 of the container 21 is sealed and the peel seal portion 24 is formed. Next, the mother liquor 12 is filled from the discharge port 5 while the peel seal portion 24 is gripped by a gripping jig or the like,
The outlet 5 is sealed by the rubber plug 7. Then, the outlet 5 is sealed and the container 21 is sterilized by high pressure steam. As a result, the inside of the filling chamber 22 is sterilized together with the mother liquor 12. The high-pressure steam sterilization is carried out based on the high-pressure steam sterilization method of the Japanese Pharmacopoeia, and a general autoclave is used for the high-pressure steam sterilization. Done in.

Next, after high-pressure steam sterilization, the filling chamber 23 is filled with the bicarbonate 13 ', and the other peripheral edge sealing portion 21A is heat-sealed. Then, after removing the gripping jig, the portion of the filling chamber 23 of the container 21 is subjected to electron beam irradiation sterilization. Since the container 21 is thin, the inside of the electron beam is directly irradiated. In this case, the dose in the filling chamber 23 is 1.
If it is 6 Mrad or more, sufficient sterilization can be performed. For example,
Microbial radiation bacteria (indicator bacteria: B. pumilus (spores) E-
601) has a D value of about 0.2 Mrad. Container 21
Inner is being kept clean, the following bacteria usually 10 ⁰ order is attached. If safety is taken into consideration, 10 ²
If there is adhesion up to the order, the sterilization assurance level is 10 ^-6 % and the survival rate is 0.2 Mrad x 8
The above irradiation is required.

The electron beam permeability is determined by the acceleration voltage of the electrons, and is 1 at the maximum in the high energy type electron beam irradiation apparatus.
It is 3000 g / m ² , which is 13000 μm in thickness of water (specific gravity 1 g / m ³ ). However, in the high-energy electron beam irradiation apparatus, the generation of X-rays is large, the shielding equipment for the apparatus is excessive, and the container 21 may be affected. Therefore, it is difficult to assemble a production line with a high energy type electron beam irradiation apparatus. On the other hand, the medium and low energy type of 1 MeV or less has 1500 g / m ²
It is expected that the electron beam can be transmitted to a certain degree. Therefore, in electron beam irradiation sterilization of a drug, if both sides are irradiated and the wall thickness of the container 21 is (1600/2) μm or less, it is possible to use a compact low-medium energy type facility. On the production line, it is possible to sterilize a large amount of chemicals with certainty. Therefore, in this embodiment,
Since the wall thickness of the container wall 21 is 200 μm, electron beam sterilization is directly performed on the bonded portion by the low energy type electron beam irradiation device.

In the infusion solution container 21 thus constructed,
In sterilization and storage, the same operational effects as the first embodiment can be obtained. Further, when the infusion container 21 is used, the peel seal portion 24 is peeled off from the outside of the container 21 to connect the filling chamber 22 and the filling chamber 23. And
The mother liquor 12 and the bicarbonate 13 'are mixed to form the infusion solution 11 having no electrolyte abnormality in the container 21. In use, the peel seal portion 24 is opened, the bicarbonate 13 'and the mother liquor 12 are mixed, and then a communicating needle for drip is connected to the outlet 5 to administer the infusion. In the above embodiment, the discharge port 5
Although it is provided only on the filling chamber 22 side, the invention is not limited to this and may be provided on the filling chamber 23 side. In the above embodiment,
Although the partition wall seal between the filling chamber 22 and the filling chamber 23 is formed by the peel seal portion 24 as a whole, the partition wall may be formed by the peel seal portion 24 and the fixed seal portion. In the above embodiment, the container 21 was formed from the inflation molded sheet, but the container 21 may be manufactured using two extrusion molded sheets. The container 21 may be blow molded. In each of the above-mentioned embodiments, the click tip and the peel seal portion are used as the separating and opening means, but the separating and opening means need not be limited to these in the present invention. For example,
A gripping sealing means such as a clip or a rubber stopper may be provided on a part or the whole of the isolation wall, or a push-out communication means having a communication needle on the isolation wall may be used. However, in terms of the separability of the chamber, the opening operability, and the ease of manufacturing, the separating and opening means of the peel seal portion is particularly desirable.

[0033]

As described above, according to the electrolyte infusion solution of the present invention, since bicarbonate is blended, renal damage due to acidosis or the like can be prevented. Also, the pH of the infusion solution
When the range is 5.5 to 8.0, diarrhea, vomiting, etc. do not occur in the treated patients. According to the infusion container according to the present invention, the components of the above infusion are divided and provided in different chambers, and one chamber is filled with alkaline bicarbonate, so that the chambers can be connected from the outside. In addition, the infusion solution is stably maintained for a long period of time, and the sugar in the infusion solution is not altered even during high-pressure steam sterilization.

[Brief description of the drawings]

FIG. 1 is a half sectional view of an infusion container according to a first embodiment.

FIG. 2 is a cross-sectional view of essential parts when the container of the first embodiment is used.

FIG. 3 is a sectional view of an infusion container according to a second embodiment.

FIG. 2 is a sectional view of the container of the second embodiment during use.

[Explanation of Codes] 1,21 Infusion container 1A, 21A Peripheral seal part 2,22 Bicarbonate filling chamber 3,23 Mother liquor filling chamber 4 Click tip 5 Discharge port 11 Electrolyte transfusion agent 12 Mother liquor 13,13 'Bicarbonate 24 Peel seal part

[Procedure amendment]

[Submission date] January 19, 1996

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Brief description of drawings

[Correction method] Change

[Correction contents]

[Brief description of the drawings]

FIG. 1 is a half sectional view of an infusion container according to a first embodiment.

FIG. 2 is a cross-sectional view of essential parts when the container of the first embodiment is used.

FIG. 3 is a sectional view of an infusion container according to a second embodiment.

FIG. 4 is a sectional view of the container of the second embodiment when in use.

[Explanation of Codes] 1,21 Infusion container 1A, 21A Peripheral seal part 2,22 Bicarbonate filling chamber 3,23 Mother liquor filling chamber 4 Click tip 5 Discharge port 11 Electrolyte transfusion agent 12 Mother liquor 13,13 'Bicarbonate 24 Peel seal part

Claims (10)

[Claims] 1. Na in the electrolyte is 20 to 160 mEq /
An electrolyte infusion solution containing L in a concentration range, wherein the electrolyte contains bicarbonate in a concentration range of 1 to 65 mEq / L. 2. The electrolyte transfusion agent according to claim 1, wherein the content of acetate or lactate in the electrolyte is suppressed to 25 mEq / L or less. 3. The electrolyte transfusion agent according to claim 2, wherein the content of acetate or lactate in the electrolyte is suppressed to 15 to 0 mEq / L. 4. The electrolyte transfusion agent according to claim 1, wherein the pH value of the transfusion agent is in the range of 5.5 to 8.0. 5. The electrolyte infusion solution according to claim 4, which contains, in addition to the electrolyte, at least one or more saccharides of glucose, fructose, sorbitol, xylitol, and mantose in the range of 1 to 15%. 6. An infusion container in which a plastic container is filled with the electrolyte infusion agent according to any one of claims 1 to 5, wherein the container has a plurality of chambers, and all or part of a partition wall between the chambers. A part is formed by an isolation opening means capable of isolation opening from the outside of the container and allowing the chambers to communicate with each other, and the at least one chamber is filled with bicarbonate while maintaining alkalinity. An infusion container characterized by being. 7. The chamber of the container comprises a mother liquor filling chamber containing the electrolyte and having a PH value of 5.5 or less, and a bicarbonate filling chamber. Infusion container. 8. The infusion container according to claim 7, wherein the bicarbonate is a sodium salt or a potassium salt. 9. The infusion container according to claim 6, wherein the container is made of a polyolefin resin. 10. The infusion container according to claim 6, wherein the isolation opening means is a peelable peel seal portion.