JP2003246731A - Infusion preparation - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an infusion preparation which enables a plurality of infusion ingredients to be administered stably and safely for a long time enables accidents caused by mistaking infusion ingredients to be structurally avoided. <P>SOLUTION: The infusion bag of the infusion preparation has a plurality of sections for filling the infusion ingredients, the sections are isolated so that they can not communicate with each other, and each of the sections has an opening for discharging the infusion ingredient and may have a plurality of rooms separated by partitions allowing the communication with each other. The infusion preparation is prepared by filling a section with an ingredient which receives a chemical or physical change when it is brought into contact with other ingredients and filling another section with another ingredient which unstabilizes the above ingredient. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an infusion preparation capable of stably and safely administering a plurality of infusion components over a long period of time.

[0002]

2. Description of the Related Art Conventionally, a method of dissolving and mixing various liquid and powder drugs and administering them intravenously has been adopted for the purpose of life support and treatment of diseases of patients.
Furthermore, as medical technology has advanced in recent years, techniques for administering high-concentration infusion components have been developed, and therefore all components necessary for the life support of patients are administered intravenously, and thus more Infusion preparations that can simultaneously administer different kinds of infusion components are being studied. However, the conditions under which each drug can exist in a stable manner are different, and various problems may occur due to the mixing of these drugs, resulting in a state in which the drug cannot be applied to a patient.

For example, fat emulsions are unstable formulations,
When mixed with other infusion components, fat particles become coarse,
There is a problem that phase separation (creaming) occurs,
In particular, there is a problem in that the presence of divalent metal ions contained in the infusion preparation causes aggregation of the fat emulsion and disintegration of oil particles. Further, when the amino acid infusion solution and the sugar infusion solution are mixed, there is a problem that a Maillard reaction occurs over time, causing discoloration, turbidity, and the like. Further, a diuretic such as potassium canrenoate has a problem that when the pH is lowered by mixing with an infusion solution, it is precipitated as a non-dissociated canrenoic acid having low solubility. When an antibiotic such as amphotericin B is mixed with an amino acid infusion solution, an amino acid salting-out effect is produced, and amphotericin B is precipitated over time, resulting in turbidity. As described above, mixing various infusion solutions causes various problems such as decomposition, precipitation, deterioration, and coloring,
It was difficult to mix and store these infusions.

Recently, various vitamins have been intravenously administered. Since such vitamins are chemicals lacking in stability, they are formulated individually in the form of mixed vitamin preparations or multivitamin preparations, and are added and mixed in an infusion solution before use. However, when a trace element is contained in the infusion solution to which vitamins are added, there is a problem that the added vitamins are decomposed between mixing and administration.

Various attempts have been made to solve the above problems. For example, an infusion solution bag in which two private chambers are formed by a separable partition wall is used, and the infusion solutions in the first chamber and the second chamber are mixed by communicating at the time of use to solve the above problems (for example, Japanese Patent Laid-Open No. 5-311
No. 51). Furthermore, in order to administer various vitamins, it has been attempted to divide vitamins into a two-chamber container type infusion into each chamber (see, for example, JP-A-6-
209979, JP-A-8-709).

However, according to such means, since the administration of the infusion solution to the patient is started in a state where the infusion components are mixed in the bag, a part of the mixed infusion solution may take a long time exceeding 10 hours after the mixing. It will be administered to the patient after a lapse of time. In such a situation, in order to reduce the pain of the patient, prevent the accidental infusion of the infusion solution and alleviate the burden on the medical staff, etc. It arises from the reality of the medical field that a patient is infused with infusion for a long time (for example, for about 24 hours) using one infusion bag filled with the required daily amount of infusion components. Therefore, there has been a problem that a part of the infusion components mixed in the infusion bag is decomposed during administration.

[0007] On the other hand, Compleven (registered trademark) of Fresenius Kabi, etc. is an infusion preparation having three chambers formed by separable partition walls. The bag of this formulation consists of two chambers with one mixing inlet for mixing different infusion components and one chamber with one opening for discharging the mixed infusion components. Therefore, there is only one mouth as a bag. Even in such a bag, after all, since the infusion components are mixed in the bag and supplied to the patient, the above problem cannot be solved.

[0008]

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to provide an infusion preparation which can stably and safely administer a plurality of infusion components for a long period of time, and which can structurally avoid mistransfusion accidents. To provide.

[0009]

That is, the gist of the present invention is
[1] A plurality of compartments for filling infusion components are provided, the compartments are isolated from each other so that they cannot communicate with each other, and each of the compartments has an opening for discharging the infusion components,
Then, each of the compartments may have a plurality of chambers separated by separable partition walls, and a trace element coexists in one compartment of the infusion bag, and coexistence with the trace element in a compartment different from that causes chemical change. An infusion preparation in which each of the acceptable components is filled, [2] one or more additional components selected from the group consisting of amino acids, electrolytes, saccharides and fat emulsions are not distributed in the same chamber for amino acids and saccharides. And the electrolyte and the fat emulsion are not distributed in the same chamber, each chamber is filled with the infusion preparation described in [1], [3] The amount of each infusion component filled in the infusion bag is The infusion preparation according to the above [1] or [2], which is the daily required amount of the infusion component, [4] the compartment of the infusion bag is two compartments, compartment A and compartment B, and compartment A contains trace elements. ,
The compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element, [1] to
[3] The infusion preparation according to any one of [1], [5] the section A
Trace elements, amino acids and fat emulsions in compartment B
The infusion preparation according to [4] above, which is filled with a component, an electrolyte and a saccharide that can undergo a chemical change when coexisting with the trace element.

[6] The compartment A is filled with a trace element, an electrolyte and a saccharide, and the compartment B is filled with a component, an amino acid and a fat emulsion which can undergo a chemical change when coexisting with the trace element, respectively. [4] the infusion preparation,
[7] The compartment A is filled with a trace element, a fat emulsion and a saccharide, and the compartment B is filled with a component, an amino acid and an electrolyte capable of undergoing a chemical change when coexisting with the trace element, [4] Infusion formulation described in [8] the section A
The infusion preparation according to [4] above, which is filled with a trace element, an amino acid and an electrolyte, and the compartment B is filled with a component, a fat emulsion and a saccharide that can undergo a chemical change when coexisting with the trace element.

[9] The compartment of the infusion bag is two compartments, compartment A and compartment B, and compartment A is divided into compartments a ₁ and compartment a ₂ by compartments, and compartment B is 1 compartment.
The compartment A of the infusion bag consisting of a chamber is filled with a trace element, and the compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element, and further selected from the group consisting of amino acids, electrolytes, sugars and fat emulsions. The above-mentioned [2] or [2] or [1] in which one or more kinds of additive components are filled in each chamber so that the amino acid and the saccharide are not distributed in the same chamber and the electrolyte and the fat emulsion are not distributed in the same chamber. infusion preparation of 3] above, [10] the chamber a electrolyte and amino acids and trace elements in _1, fat emulsion and sugars into the chamber a ₂ is a chemical change by coexisting with fine quantity element compartment B Each of the components that can be received is filled,

[9] infusion preparation according, is [11] the chamber a ₁ in trace elements and sugars, fat emulsion said chamber a _2, may undergo chemical changes by coexisting with fine quantity element compartment B component, The amino acid and the electrolyte are respectively filled,

[9] the infusion preparation,
[12] The chamber a ₁ is filled with trace elements and fat emulsions, the chamber a ₂ is filled with amino acids, and the compartment B is filled with components, sugars and electrolytes that can undergo chemical changes due to the coexistence with the trace elements. The above

[9] the infusion preparation,

[13] Trace elements and electrolytes in the chamber a ₁
The chamber a ₂ is filled with a saccharide, and the compartment B is filled with a component, an amino acid and a fat emulsion, which can undergo a chemical change when coexisting with the trace element.

[9] The infusion preparation according to [9], wherein [14] the chamber a ₁ contains trace elements and an electrolyte.
₂ , the amino acids are filled in the compartment B with components, sugars and fat emulsions that can undergo chemical changes when coexisting with the trace elements,

[9] the infusion preparation,
[15] trace elements and amino acids in said chamber a ₁ is the chamber a ₂
A saccharide and a fat emulsion, and the compartment B is filled with a component and an electrolyte that can undergo a chemical change when coexisting with the trace element.

[9] The infusion preparation described in [16]
The chamber a ₁ is filled with a trace element and an amino acid, the chamber a ₂ is filled with a saccharide and an electrolyte, and the compartment B is filled with a component capable of undergoing a chemical change by coexistence with the trace element and a fat emulsion. The above

[9] The infusion preparation according to [17], wherein the chamber a ₁
A trace element and a saccharide, the chamber a ₂ is filled with an amino acid and a fat emulsion, and the compartment B is filled with a component and an electrolyte capable of undergoing a chemical change by coexisting with the trace element,
The above

[9] infusion preparation according, [18] the chamber a ₁ in trace elements and sugars, amino acids and electrolytes into the chamber a _2, may undergo chemical changes by coexisting with fine quantity element compartment B Ingredients and fat emulsion are respectively filled,

[9] The infusion preparation described in [9], [19] The compartment of the infusion bag is two compartments, compartment A and compartment B, and compartment A is divided into compartments a ₁ and a ₂ by a partition that can communicate with each other, and compartments B is divided into chambers b ₁ and b ₂ by a partition wall capable of communicating with each other, and a trace element in the chamber a ₁ and a component capable of undergoing a chemical change by coexisting with the trace element in the chamber b ₁ In order to prevent the amino acids and the saccharides from being distributed in the same chamber, the electrolyte and the fat emulsion should be distributed in the same chamber, and at least one additive component selected from the group consisting of amino acids, electrolytes, saccharides and fat emulsions should not be distributed in the same chamber. The infusion preparation according to the above [2] or [3], which is filled in each chamber so as not to be distributed into

[20] The chamber a₁Trace elements and electrolyte,
The room a₂Sugar in the chamber b₁Coexist with the trace element
Amino acids and components that can undergo chemical changes due to
The room b₂Each of which is filled with a fat emulsion,
[19] The infusion preparation described in [21], [21] the chamber a.₁Trace elements
But the room a₂Sugar and electrolyte in the chamber b₁To the trace element
The component that can undergo a chemical change by coexisting with
The room b₂Filled with fat emulsion and amino acids
[22] The chamber a
₁Trace elements in the chamber a₂Fat emulsion and amino acids
But the room b ₁When it coexists with the trace element,
A component that can undergo oxidization, and ₂Sugars and electrolytes
Infusion solution according to the above [19], each filled
Agent, [23] the chamber a₁Trace elements in the chamber a₂In fat milk
Agent and sugar₁To coexist with the trace element
Components that can undergo more chemical changes, and the chamber b₂To electrolyze
The above [1], which is filled with quality and amino acids, respectively.
9] The infusion preparation described in [24], the chamber a₁Trace elements in
The room a₂Electrolyte and amino acids are stored in the chamber b₁To the trace amount
The components that can undergo chemical changes when coexisting with the element are
Then the room b₂Filled with fat emulsion and sugar
[25] The infusion preparation according to the above [19],
There are three sections, section A, section B and section C
Of the infusion bag containing compartment A containing trace elements and compartment C containing
Components that can undergo chemical changes when coexisting with trace elements
Respectively filled with amino acids, electrolytes, sugars
And at least one additive selected from the group consisting of fat emulsions
Amino acids and sugars are not distributed in the same chamber
And that electrolyte and fat emulsion are not distributed in the same chamber
In the above [2] or [3], each chamber is filled with
[26] Trace element, sugar and electrolysis in compartment A
Quality, the compartment B with a fat emulsion, and the compartment C with the trace element.
Components and amino acids that can undergo chemical changes when coexisting
Infusion solution according to the above [25], which is filled with each type
Preparation, [27] Trace element and fat emulsion in the section A
The sugar and the electrolyte coexist in the area B in the compartment C together with the trace element.
The components and amino acids that may undergo chemical changes due to
The infusion preparation according to the above [25], each of which is filled
[28] Trace elements, fat emulsions and sugars in the compartment A are
Electrolyte in compartment B may coexist with the trace element in compartment C
Amino acids and components that can undergo chemical changes due to
The infusion preparation according to [25] above, which is filled and filled, [2
9] Trace elements and fat emulsions in the compartment A,
Nonoic acid and electrolyte may coexist in the compartment C with the trace element.
Filled with saccharides and components that can undergo chemical changes due to
The infusion preparation according to [25] above,

[30] Trace elements and electrolytes in the section A
[31] The infusion preparation according to [25] above, wherein the compartment B is filled with a saccharide and a fat emulsion, and the compartment C is filled with a component and an amino acid that can undergo a chemical change when coexisting with the trace element. The compartment A is filled with a trace element and an electrolyte, the compartment B is filled with an amino acid and a fat emulsion, and the compartment C is filled with a component and a saccharide that can undergo a chemical change when coexisting with the trace element, respectively. 25] The infusion preparation described in
[32] Trace elements and amino acids in the compartment A are contained in the compartment B
The infusion preparation according to [25] above, wherein the saccharide and the fat emulsion are respectively filled in the compartment C with a component that can undergo a chemical change by coexisting with the trace element and an electrolyte.
3] The compartment A is filled with a trace element and an amino acid, the compartment B is filled with a saccharide and an electrolyte, and the compartment C is filled with a component capable of undergoing a chemical change by coexistence with the trace element and a fat emulsion. [34] The infusion preparation according to the above [25], [34] A chemical change may be caused by coexistence of trace elements and saccharides in the section A, amino acids and fat emulsion in the section B, and trace elements in the section C. [25] The infusion preparation according to the above [25], wherein the component and the electrolyte are respectively filled.
[25], wherein the trace element and saccharide are filled in the compartment B, the amino acid and the electrolyte are filled in the compartment B, and the component which can be chemically changed by coexisting with the trace element in the compartment C and the fat emulsion are filled. Infusion preparation according to any one of [1] to [35] above, wherein the component capable of undergoing a chemical change by coexisting with [36] trace element is [37] trace element. The infusion preparation according to any one of [1] to [35] above, wherein the component capable of undergoing a chemical change upon coexistence is a vitamin containing Vitamin C, and a chemical change upon coexistence with the [38] trace element [1] to [3, wherein the component capable of receiving vitamin C is vitamin C
5] The infusion preparation according to any one of the above items,

[39] It has a plurality of compartments for filling the infusion component, the compartments are isolated from each other so that they cannot communicate with each other, and each of the compartments has a mouth for discharging the infusion component. The compartments of the infusion bag, which have two compartments, compartment A and compartment B, each of which has a plurality of chambers separated by separable partition walls, are amino acids, electrolytes, sugars, vitamins. And at least one additional component selected from the group consisting of the group A and the fat emulsion so that the amino acid and the saccharide are not distributed in the same compartment and the electrolyte and the fat emulsion are not distributed in the same compartment. Infusion preparation filled in compartment B, [40] having a plurality of compartments for filling infusion components, the compartments being isolated so as not to communicate with each other, and each of the compartments containing infusion components To discharge There are two compartments of the infusion bag, compartment A and compartment B, each of which has a mouth portion and may have a plurality of chambers separated by partition walls which can communicate with each other. Chamber a ₁ and chamber a
_{In the} infusion bag fractionated in ₂ , amino acids,
One or more additive components selected from the group consisting of electrolytes, sugars, vitamins and fat emulsions are used so that amino acids and sugars are not distributed in the same compartment of compartment A or compartment B and the electrolytes and fat emulsions are compartment A. Of the infusion preparation filled in each compartment or each compartment of the same compartment so as not to be distributed to the same compartment or compartment B of [41], and a plurality of compartments for filling the infusion component. Each of the compartments has an opening for discharging an infusion component, and each of the compartments has a plurality of chambers separated by a separable partition wall. In the infusion bag compartment A, which may consist of three compartments, compartment A, compartment B and compartment C, amino acids,
One or more additional components selected from the group consisting of electrolytes, sugars, vitamins and fat emulsions are used so that amino acids and sugars are not distributed in the same compartment, and electrolytes and fat emulsions are not distributed in the same compartment. , An infusion preparation filled in each compartment.

[0015]

BEST MODE FOR CARRYING OUT THE INVENTION 1. Infusion Component The infusion component of the infusion preparation of the present invention will be described below. (1) Trace element The trace element in the present invention refers to an element that improves various deficiency symptoms that may occur when a human is subjected to high-calorie infusion therapy. Specific examples include iron, copper, zinc, manganese, iodine, selenium, molybdenum, chromium and fluorine. These trace elements may be used alone or in combination of two or more, depending on the condition of the target patient. In the present invention, the trace element is filled in a compartment different from the component that may undergo a chemical change by coexisting with the trace element.

The filling amount of each trace element is not particularly limited as long as it is within the general range as a daily dose (required daily amount) of each trace element described in various documents in the infusion field. . An example of a suitable range of the amount of the trace element filled is as follows. Iron: 0.9 to 224 μmol is preferable, 9 to 70 μm
ol is more preferred. Copper: 0.9 to 55 μmol is preferable, 1 to 10 μmo
l is more preferred. Zinc: 3.85 to 210 μmol is preferable, and 38.5
˜61.5 μmol is more preferred. Manganese: 0-51 μmol is preferable, 1-14.5
μmol is more preferred. Selenium: 0.025 to 5.0 μmol is preferable, and 0.
25 to 2.5 μmol is more preferable. Iodine: 0-11 μmol is preferable, 0.6-1.1
μmol is more preferred. The trace element preparation of the present invention may optionally contain other elements such as chromium, molybdenum, cobalt and fluorine.

A water-soluble compound of each of these elements is dissolved in water for injection or another aqueous component and filled in an infusion bag. Examples of water-soluble compounds that are the source of each element are:
The following compounds may be mentioned. Iron source: iron sulfate, ferrous chloride, ferric chloride, iron gluconate. Copper source: copper sulfate. Zinc source: zinc sulfate, zinc chloride, zinc gluconate, zinc lactate, zinc acetate. Manganese source: manganese sulfate. Also, with respect to iodine, selenium, molybdenum, chromium, fluorine, etc., the water-soluble compounds thereof may be used.

[0018] At present, preparations containing a plurality of trace elements are commercially available and easily available, and thus such commercially available products may be used. Specific examples of commercially available products include “Mineralin Injection” (registered trademark) containing iron, copper, zinc, manganese and iodine (trade name, Nippon Pharmaceutical Co., Ltd./
Takeda Pharmaceutical Co., Ltd.) and "Elemental Note"
(Registered trademark) (trade name, manufactured by Ajinomoto Pharma Co.), iron,
"Palmyrin Injection" (registered trademark) (trade name, manufactured by Nippon Pharmaceutical Co., Ltd./Takeda Pharmaceutical Co., Ltd.) and "Elemate Injection" (registered trademark) (trade name, manufactured by Ajinomoto Pharma Co.) containing copper, zinc and iodine are Can be mentioned.

(2) Component capable of undergoing chemical change by coexistence with a trace element In the present invention, a component capable of undergoing chemical change by coexistence with a trace element is filled in a compartment different from the trace element. This is because the decomposition of the component, the formation of precipitate in the infusion, the coloring of the infusion and the like due to the chemical change of the component are suppressed. Specific examples of such ingredients include, for example, vitamins, antipyretic and analgesic and anti-inflammatory agents, psychiatric agents, antispasmodics, cardiotonics, diuretics, circulatory agents, expectorants, peptic ulcer agents,
Adrenal hormones, hormones, calcium, mineral preparations, organ preparations, blood substitutes, hemostatics, anticoagulants,
Examples include one or more components selected from the group consisting of agents for liver diseases, antidotes, antimetabolites, antitumor antibiotic preparations, antibacterial agents, and anticancer agents. The filling amount of these components excluding vitamins may be appropriately selected according to the patient's symptoms and the like, and the daily required amount is preferable.

As the vitamins, various vitamins regardless of water solubility / fat solubility can be mentioned without particular limitation. For example, vitamin A, provitamin A, vitamin D, provitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacin, vitamin B6
Group, pantothenic acid, biotin, myo-inositol, choline, folic acid, vitamin B12, vitamin C, vitamin P, vitamin U and the like. Commercially available vitamin preparations containing these vitamins may be used, and examples of such preparations include “Maltamine” (registered trademark) (trade name, manufactured by Sankyo Co., Ltd.). In particular, the content of vitamin C is greatly reduced by coexisting with trace elements. Therefore, it is a typical example of components that can undergo a chemical change when vitamins including vitamin C, especially vitamin C coexist with trace elements.

The filling amount of vitamins is not particularly limited as long as it is within the general range of the daily dose of vitamins (daily required amount) described in various documents in the field of infusion. An example of a suitable range of the amount of vitamins to be filled is as follows. Vitamin A: 1000 to 5000 IU is preferable, Vitamin D: 2.5 to 15 μg is preferable, Vitamin E: 5 to 20 mg is preferable, Vitamin K: 0.5 to 3 mg is preferable, Vitamin B 1: 1.0 to 50 mg is preferable. Vitamin B2: 1.0 to 10 mg is preferable, Vitamin B6 group: 0.5 to 5.5 mg is preferable, Pantothenic acid: 4.5 to 25 mg is preferable, Biotin: 10 to 200 μg is preferable, Folic acid: 100 to 500 μg , Vitamin B12: 2.5 to 25 μg is preferable, and vitamin C: 25 to 130 mg is preferable. If necessary, niacin, myo-inositol,
It may contain choline, vitamin P, vitamin U and the like.

(3) Fat emulsion As the fat emulsion, it is preferable to use an oil-in-water emulsion prepared by dispersing fats and oils in water using an emulsifier. The fat emulsion can be prepared by a conventional method. In the present invention, the fat emulsion is filled in a compartment different from the electrolyte. Further, depending on the purpose, fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K may be filled together with the fat emulsion.

As the fats and oils, the fats and oils known as edible oils can be used without particular limitation. For example, vegetable oils (soybean oil, cottonseed oil, safflower oil, corn oil, olive oil, coconut oil, perilla oil, perilla oil, etc.), fish oils (cod liver oil, etc.), medium-chain fatty acid triglycerides (for example, panasate (trade name, NOF Company), ODO (trade name, manufactured by Nisshin Oil Co., Ltd.)) and chemically synthesized triglycerides (for example,
Chemically defined trigl such as 2-linoleoyl-1,3-dioctanoylglycerol (8L8), 2-linoleoyl-1,3-didecanoylglycerol (10L10)
One or more fats and oils selected from the group consisting of ycerides, structure lipids, etc.) are mentioned as preferable fats and oils.

As the emulsifier, any emulsifier used in pharmaceutical preparations can be used. For example, egg yolk phospholipids, hydrogenated egg yolk phospholipids, soybean phospholipids, hydrogenated soybean phospholipids and nonionic surfactants (eg Pluronic F68 (Asahi Denka Kogyo KK), HCO-6
One or more emulsifiers selected from the group consisting of 0 (manufactured by Nippon Chemical Co., Ltd.) are preferred as emulsifiers.
A particularly preferred fat emulsion is a fat emulsion using soybean oil as an oil and fat and egg yolk phospholipid as an emulsifier.

The filling amount of the fat emulsion is within the general range as the daily dose (daily required amount) of the fat emulsion described in various documents in the infusion field,
There is no particular limitation. For example, a range of 5 to 50 g of oil and fat and 0.5 to 10 g of emulsifier is preferable.

(4) Sugars As saccharides, those conventionally used for various infusions can be used without particular limitation. Specific examples include monosaccharides such as glucose and fructose, disaccharides such as maltose, polyhydric alcohols such as glycerol, sugar alcohols such as xylitol, sorbitol and mannitol. These may be used alone or in combination of two or more. In the present invention, the saccharide is packed in a compartment or chamber different from the amino acids.

The amount of saccharides to be filled is not particularly limited as long as it is within the general range as the daily dose of saccharides (daily required amount) described in various documents in the field of infusion. For example, 50 to 500 g is preferable.

(5) Electrolyte Examples of the electrolyte include various water-soluble salts conventionally used for infusion. For example, various inorganic components (sodium, potassium, calcium, magnesium, etc.) required to maintain the function of the living body and the electrolyte balance of body fluids.
Water-soluble salts of phosphorus and the like (for example, chloride, sulfate, acetate, gluconate, lactate, etc.). These water-soluble salts may be hydrates. In the present invention, from the viewpoint of stabilizing the oil and fat particles, the electrolyte, particularly the divalent metal ion, is filled in a compartment different from that of the fat emulsion.

The following compounds may be mentioned as preferred specific examples of the electrolyte. Sodium source: sodium chloride, sodium lactate,
Sodium acetate, sodium sulfate, sodium glycerophosphate is preferable, potassium source: potassium chloride, potassium lactate, potassium acetate, potassium sulfate, potassium glycerophosphate is preferable, calcium source: calcium chloride, calcium lactate,
Calcium acetate, calcium glycerophosphate, calcium gluconate and calcium pantothenate are preferred, and magnesium source: magnesium sulfate, magnesium chloride, magnesium lactate, magnesium acetate, magnesium glycerophosphate is preferred.

As the phosphorus supply source, phosphoric acid esters of saccharides and salts thereof are preferably used. Specifically, glycerophosphate, mannitol-1-phosphate, sorbitol-
1-phosphate, glucose-6-phosphate, fructose-
6-phosphoric acid, mannose-6-phosphoric acid and the like can be mentioned.
Further, as salts of these esters, alkali metal salts such as sodium salt and potassium salt are preferable. More specifically, the sodium salt and potassium salt of glycerophosphoric acid are preferable.

The electrolyte filling amount is not particularly limited as long as it is within the general range as the daily dose of electrolyte (daily required amount) described in various documents in the field of infusion. For example, sodium: 15 to 70 mEq is preferable, potassium: 10 to 35 mEq is preferable, calcium: 3 to 15 mEq is preferable, magnesium: 2 to 15 mEq is preferable, and phosphorus: 1 to 20 mmol is preferable.

(6) Amino Acids The amino acids are not particularly limited as long as they are various amino acids (essential amino acids, non-essential amino acids) contained in conventional amino acid infusions for the purpose of nutritional supply and supply of nitrogen source. Can be used without. In the present invention, the amino acids are packed in a compartment or chamber different from the sugar. Specifically, L-isoleucine, L-leucine, L-valine,
L-lysine, L-methionine, L-phenylalanine,
L-threonine, L-tryptophan, L-arginine, L-histidine, glycine, L-alanine, L-proline, L-aspartic acid, L-serine, L-tyrosine, L-glutamic acid, L-cysteine and the like can be mentioned. .

Such amino acids do not necessarily have to be used in the form of free amino acids, and include inorganic acid salts (L-lysine hydrochloride etc.), organic acid salts (L-lysine acetate, L-lysine malate etc.), Ester that can be hydrolyzed in vivo (L
-Tyrosine methyl ester, L-methionine methyl ester, L-methionine ethyl ester, etc.), N-substituted product (N-acetyl-L-tryptophan, N-acetyl-
L-cysteine, N-acetyl-L-proline, etc.) and the like. Furthermore, dipeptides (L-tyrosyl-L-tyrosine, L-alanyl-L-tyrosine, L-arginyl-L-tyrosine, L-tyrosyl-L-arginine, etc.) in which the same or different amino acids are peptide-bonded, etc. It may be used in the form.

The mixing ratio of these amino acids is not particularly limited, but usually, it is an index known in this technical field (Vuj-N formulation, FAO formulation, FO formulation based on the required amount of essential amino acids).
The ratio of various essential amino acids to non-essential amino acids (so-called E / N ratio), or the ratio of essential amino acids to all amino acids (so-called E / T), according to the AO / WHO prescription or the Fisher amino acid prescription according to plasma)
It is preferable to use a mixture in which the ratio) is changed variously, or one in which the branched chain amino acid is appropriately contained in consideration of the ratio to the essential amino acid or the non-essential amino acid.

The filling amount of amino acids is not particularly limited as long as it is within the general range as the daily dose (daily required amount) of amino acids described in various documents in the infusion field. An example of a suitable range of the amount of amino acids to be filled is as follows.

L-isoleucine: preferably 0.5 to 5.0 g, L-leucine: 0.5 to 7.0 g, L-valine: 0.5 to 7.0 g, L-lysine: 0 0.5-7.0 g is preferable, L-methionine: 0.1-4.0 g is preferable, L-phenylalanine: 0.3-5.0 g is preferable, L-threonine: 0.2-4.0 g is preferable. , L-tryptophan: 0.1-1.0 g is preferable, L-arginine: 0.3-7.0 g is preferable, L-histidine: 0.2-4.0 g is preferable, glycine: 0.2-7 0.0 g is preferable, L-alanine: 0.3 to 7.0 g is preferable, L-proline: 0.2 to 5.0 g is preferable, L-aspartic acid: 0.03 to 2.0 g is preferable, L- Serine: 0.2-4.0 g Mashiku, L- tyrosine: 0.03 to 1.0 g preferably, L- glutamic acid: 0.03～2.0G preferably, L- cysteine: 0.03 to 1.0 g is preferable.

2. Infusion Bag An infusion bag used in the infusion preparation of the present invention will be described below. The infusion bag has a plurality of compartments for filling an infusion component, the compartments are isolated from each other so that they cannot communicate with each other, and each of the compartments has an opening for discharging the infusion component. It has a structure. Further, each of the compartments may have a plurality of chambers separated by a partition that can communicate with each other. Then, a specific infusion component and a component capable of undergoing a chemical change or a physical change when coexisting with the component are filled in different compartments.

A specific mode of the infusion bag having such a structure will be described below with reference to the drawings. The infusion bag used in the present invention has a plurality of compartments for filling infusion components. The number of sections is not particularly limited, but from the viewpoint of practical use and the manufacturing cost, any one selected from the group consisting of 2, 3 and 4 is preferable.

1 and 2 are schematic views showing the basic structure of an infusion bag. In FIG. 1, the infusion solution bag has two compartments A and B, A and B are separated by a separating means 6 so that they cannot communicate with each other, and A and B are mouths for discharging the infusion solution. It has 3 and 4 respectively.
Then, the mixed injection port 12 for mixing and injecting another infusion component is B
It is provided in.

Further, in FIG. 2, the infusion bag has three compartments A, B and C, which are isolated by the isolation means 6 and 7 so that they cannot communicate with each other.
Each of A, B, and C has one mouth portion 3, 4, and 5 for discharging the infusion solution. A filling section 11 is provided in each section as needed, and each section is filled with an infusion component via the filling section 11. Further, although not shown, A, B,
4 compartment type infusion bag consisting of C and D,
Infusion bags with five or more compartments can also be used in the present invention.

In the infusion bag used in the present invention, the compartments are isolated so that they cannot communicate with each other. The isolation means shall be one that does not allow communication between compartments. For example,
By performing the heat welding under the same conditions as the heat welding of the peripheral edge of the bag to form the isolation means, the communication between the compartments becomes impossible. Since such an infusion bag cannot communicate between compartments, the infusion ingredients filled in different compartments are mixed in the infusion bag at any time of filling, storage and administration to a patient. There is nothing to do. Only a few minutes before injection into the patient's body, the mixture should be mixed for several minutes, even if the infusion formulation contains multiple components that may cause chemical changes even at room temperature if left in contact for a long time. As long as it is filled in the compartment, it can be stably injected into the body.

Further, it is also possible to use a bag in which at least one of the compartments of the infusion bag is divided into a plurality of chambers by a partition wall which can communicate with each other. In this way, by providing multiple chambers in one compartment, it is possible to avoid reactions between each component during heat sterilization during the manufacturing process of infusion preparations, and to diversify the combination of infusion components. Can correspond to.

FIG. 3 is a schematic diagram showing the basic structure of the infusion bag. The infusion bag shown in FIG. 3 is a two-compartment type infusion bag, and a plurality of chambers (two chambers: a and b) are provided by a partition wall (weak seal portion 8) capable of communicating at least one (A) of the compartments. ) Is fractionated. And each division has the mouth parts 3 and 4, respectively.

In order to provide a chamber in the compartment, the compartment may be weakly sealed and fractionated. By applying a stress to the weakly sealed portion (weakly sealed portion) from the outside of the bag, the weakly sealed portion is released from the seal and communication between the chambers is established.
Then, the infusion components can be mixed easily and aseptically in the bag.

The weak seal portion can be formed by a method conventionally used for forming the weak seal portion in a known infusion bag or the like. For example, a method of heat-welding the weak seal portion weaker than the peripheral edge of the bag where a strong seal is required, a method of forming the weak seal portion from a material that is more easily separated than the peripheral edge of the bag, and the like can be adopted.

Such a weak seal portion can be used as a partition that can communicate with each other. In addition, the body portion of the infusion bag is pinched from the outside by using a pinch member to divide the internal space into a plurality of chambers for administration. A method in which the pinch member is removed to mix the infusion solution in each chamber, or a boundary portion that divides each chamber of the infusion bag is closed, and a port member that can be opened by breaking is attached to a part of the boundary portion. Also, means for mixing the infusion solution in each chamber by folding the port member at the time of administration and the like can be mentioned.

The number of chambers is not particularly limited, but from the viewpoint of practical use and the manufacturing cost, 2 to 5 is preferable, 2 to 4 is more preferable, and 2 to 3 is further preferable.

Preferred embodiments of such an infusion bag having a plurality of chambers in the compartment are as follows. 1) An infusion bag in which the number of compartments is 2, and at least one of the compartments is divided into two chambers, three chambers, or four chambers by a partition wall which can communicate with each other. 2) An infusion bag in which the number of compartments is 3, and at least one of the compartments is divided into two chambers, three chambers, or four chambers by a partition that can communicate with each other. 3) An infusion bag in which the number of compartments is 4, and at least one of the compartments is divided into two chambers, three chambers, or four chambers by a partition wall which can communicate with each other.

An example of the infusion solution bag of the aspect 1) is a bag having the basic structure shown in FIG. The compartment A of the bag shown in FIG. 3 is divided into two chambers a and b by the weak seal portion 8. A, b, and B will be filled with the infusion component via the respective filling portions 11. In addition, one mouth portion (mouth portions 3 and 4) is provided for each section.

A further example of the infusion bag of the aspect 1) is:
It is a bag which has the basic structure shown in FIG. Figure 4
In the bag shown in FIG. 1, the compartment A is divided into two chambers a and b by the weak seal portion 8, and the compartment B is further divided into the weak seal portion 9
It is divided into two chambers, c and d. The a, b, c and d will be filled with the infusion component via the respective filling portions 11. In addition, one mouth portion (mouth portions 3 and 4) is provided for each section.

A further example of the infusion bag of the aspect 1) is:
6 is a bag having the basic structure shown in FIG. Figure 5
In the bag shown in FIG. 3, the compartment A is divided into three chambers a, b and c by the weak seal portions 8 and 9. a, b, c
And B are filled with the infusion component via the respective filling portions 11. In addition, one mouth portion (mouth portions 3 and 4) is provided for each section.

A further example of the infusion bag of the aspect 1) is:
It is a bag which has the basic structure shown in FIG. Figure 6
In the bag shown in FIG. 3, the compartment A is divided into three chambers a, b and c by the weak seal portions 8 and 9. a, b, c
And B are filled with the infusion component via the respective filling portions 11. In addition, one mouth portion (mouth portions 3 and 4) is provided for each section.

As shown in FIGS. 5 and 6, the shape of the chamber is not particularly limited, and may be appropriately set according to the amount of the infusion components, the order of mixing the infusion components, and the like.

Further, specific examples of the infusion solution bag of the present invention include those provided with a member such as a handle or a hole for hanging the bag.

For example, the infusion bag having the basic structure shown in FIGS. 7 and 8 is provided with a handle 21 which is used when it is installed on a column. Here, handle 21
Is not limited, but is preferably provided in contact with the isolation means 6. The mouths 3 and 4 are preferably provided at positions facing each other, and the isolation means 6 for separating the sections A and B and the handle 21 are preferably provided between the mouths 3 and 4, but are not limited thereto. Not done.

As an example of the relative positional relationship among the mouth portion, the handle and the separating means in the case where the shape of the bag is rectangular, A) the mouth portion 3 on one side of the bag and the mouth portion on the side relative to that side. 4 is provided, and the handle 21 and the separating means 6 are provided in parallel with the side provided with the mouth (FIG. 7), or B) the mouth 3 at one apex of the bag and the mouth at the apex relative to the apex. 4 is provided, and an example (FIG. 8) in which the handle 21 and the separating means 6 are provided on a diagonal line connecting the vertices other than the vertices provided with the mouth portion is given.
With the structure shown in FIGS. 7 and 8, the handle 2
When 1 is installed on the column, the bag is bent at the location of the separating means 6 and the mouth portions 3 and 4 face vertically downward, which is convenient in that the infusion line can be easily connected.

Further, the infusion solution bag having the basic structure shown in FIG. 9 is provided with a hole 23 for hanging the bag which is used when it is installed on a support. Further, in order to reinforce the hole 23 for suspending the bag, a close contact seal portion 22 is provided. In FIG. 9, the hole 23 for suspending the bag is provided with the mouth portions 3 and 4 when the bag is suspended.
Is provided in a position so as to face vertically downward. And the isolation | separation means 6 which isolate | separates division A and B is provided in the position parallel to this vertical direction.

With the structure shown in FIG. 9, when the hanging hole 23 of the bag is attached to the column, the bag can be bent at the location of the separating means 6, so that the infusion line can be easily connected. It is convenient in that

As a material for the infusion bag, a flexible resin which has been conventionally used for an infusion container or the like is preferable. More preferred resins include soft synthetic resins having a certain degree of heat resistance (polyolefins (polyethylene, polypropylene, ethylene-propylene copolymer, a mixture of polypropylene and polyethylene or polybutene, a partially crosslinked product of the polyolefin, ethylene-vinyl acetate). Copolymer,
Ethylene- (meth) acrylic acid ester copolymer, ethylene- (meth) acrylic acid copolymer, ethylene-maleic anhydride copolymer, etc.), polyvinyl chloride, vinyl chloride-
Vinyl acetate copolymer, fluorinated ethylene-vinylidene chloride copolymer, polyester (polyethylene terephthalate, polybutylene terephthalate), nylon, styrene elastomer (styrene-ethylene-butylene-styrene block copolymer, hydrogenated styrene-ethylene- Butadiene copolymer, hydrogenated styrene-isoprene-styrene copolymer, etc.)).

A resin sheet is formed from a mixture obtained by mixing these polymers alone or appropriately, or a multilayer sheet is formed by laminating these resin sheets, and a bag-like material is formed from this resin sheet. Create. An infusion bag is obtained by providing a mouth for discharging the infusion and a filling section for filling the infusion component. A preferable example of the heat-resistant soft synthetic resin used in the infusion bag is a mixture of polypropylene and a styrene elastomer.

The infusion bag can be manufactured by appropriately applying the conventional general method for manufacturing an infusion bag. For example, a method of heat-welding the peripheral portions of two resin sheets (sheet method), a method of extruding a resin by an inflation molding machine to form a tubular shape and heat-welding the openings at both ends (inflation method), parison It can be manufactured by using a method (blow molding method) or the like in which a part of the above is sandwiched between molds and blown with gas.

The air permeability of the infusion bag is preferably high in airtightness. For example, when airtightness is expressed by oxygen permeability, it is 5 mL (STP) / 20 ° C. and 60% RH.
m ³ · 24 hours or less is preferable, 1 mL (ST
P) / m ³ · 24 hours or less is more preferable.

The total volume of each compartment depends on the patient to which it is applied, but cannot be generally stated. For example, 500 to 40
00 mL is preferable, 1000-3000 mL is more preferable, and 1500-2000 mL is particularly preferable. If such an infusion bag is used, it is possible to fill the bag with the required amount of all infusion components per day. As a result, continuous administration for a long time, for example, over 12 hours, is possible without replacing the infusion bag.

The volume ratio between the compartments can be appropriately set according to the type of infusion component filled in the compartments. For example, in the case of a two-compartment (A, B) type infusion bag, A: B =
1: 0.05-20 are preferable, 1: 0.1-10 are more preferable, 1: 0.5-2 are especially preferable. For example, in the case of a three-compartment (A, B, C) type infusion bag, A:
B: C = 1: 0.05-20: 0.05-20 is preferable, 1: 0.1-10: 0.1-10 is more preferable,
It is particularly preferably 1: 0.5 to 2: 0.5 to 2. For example, in the case of a four-compartment (A, B, C, D) type infusion bag,
A: B: C: D = 1: 0.05-20: 0.05-2
0: 0.05-20 is preferable, and 1: 0.1-10:
0.1-10: 0.1-10 are more preferable, and 1: 0.
5: 2: 0.5 to 2: 0.5 to 2 is particularly preferable.

The volume ratio between the chambers provided in the compartment cannot be generally stated because it depends on the type of infusion component filled in each chamber, but in the case of two chambers (a, b), for example ,
a: b = 1: 0.05 to 20 is preferable, and 1: 0.1
10 is more preferable, and 1: 0.5 to 2 is particularly preferable.
Further, for example, in the case of three rooms (a, b, c), a: b: c =
1: 0.05 to 20: 0.05 to 20 are preferable, and 1:
0.1-10: 0.1-10 are more preferable, and 1: 0.
5-2: 0.5-2 is particularly preferable. Further, for example, in the case of four rooms (a, b, c, d), a: b: c: d = 1: 0.
05-20: 0.05-20: 0.05-20 is preferable, 1: 0.1-10: 0.1-10: 0.1-10 is more preferable, 1: 0.5-2: 0. 0.5-2: 0.5-
2 is particularly preferred.

Each section of the infusion solution bag used in the present invention has a mouth for discharging the infusion solution. By providing such a mouth portion for each compartment, the infusion components filled in the compartments are not mixed in the infusion bag, and the respective infusion components are discharged to the outside of the infusion bag and immediately before being injected into the patient's body. It can be mixed. As a method for connecting the bag body and the mouth portion, a known method, for example, a method such as heat welding can be mentioned. Also, the number of mouths per compartment is usually 1
However, it can be increased to 2 to 4 if necessary.

The structure and material of the mouth portion are not particularly limited, and may be the structure and material conventionally used in infusion bags. As an example of the mouth portion, a tubular member made of a semi-rigid material such as polyethylene, polypropylene, etc., polystyrene, polycarbonate, etc., and a needle pierceable sealing member disposed in or at the end of the tubular member. Examples of the structure include a structure made of, and a structure obtained by further laminating such a structure with plastic. Here, as the material of the needle-pierceable sealing member, an elastic material (for example, various rubber materials such as isoprene rubber, natural rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber (particularly vulcanized), Polyurethane-based, polyamide-based, polyester-based, olefin-based, styrene-based various thermoplastic elastomers, and mixtures thereof).

At the time of administration to a patient, the infusion line 10 is connected to each mouth. Each infusion line is connected to each other, for example, as shown in FIG. 1, and the infusion component is administered to the patient.
The infusion components that are divided and filled in the respective compartments come into contact with each other only in the infusion line. Since the infusion solution stays in the infusion line for a relatively short period of time, the infusion solution can be stored with almost no effect (for example, decomposition, precipitation, alteration, coloring, etc.) due to contact and mixing of the infusion components. Will be administered to the patient.

If necessary, the filling section 11 for filling the infusion component may be provided in the compartment (in the case of having a chamber, the chamber). In this case, the transfusion component is filled via the filling section. On the other hand, the infusion component can be filled in the compartment (or the room) without providing such a filling section. In this case, a portion which is not heat-welded is provided at the time of manufacturing the bag, and the infusion component is filled from there. Then, after that, the portion may be heat-welded. As a method for connecting the bag body and the filling portion, a known method, for example, heat welding or the like can be mentioned.

The structure and material of the filling portion are not particularly limited,
The structure and material conventionally used in the infusion bag can be used. For example, the same material as the mouth may be used. However, in order to prevent an accident due to incorrect connection, it is usually preferable that the structure of the filling portion is different in shape from the mouth portion.

Further, a member (so-called mixed injection port) for mixing and pouring another infusion component into the compartment (or the room) as needed may be provided in the bag. The structure and material of the mixed injection port are not particularly limited, and may be the structure and material conventionally used in the infusion bag. For example, the same material as the mouth may be used. However, in order to prevent an accident due to incorrect connection, it is usually preferable that the structure of the mixed injection port is different in shape from the mouth portion.

The infusion solution bag can be sterilized by a conventional method. For example, any of electron beam sterilization method, ultraviolet ray sterilization method, γ-ray sterilization method, autoclave sterilization method, gas sterilization method and the like, or a combination thereof may be used.

3. Infusion Preparation The infusion preparation of the present invention can be produced by filling the above infusion bag with each infusion component. Filling and sealing each infusion component in each compartment (or room) of the infusion bag
It can be performed according to a conventional method. For example, a method of aseptically filling / sealing infusion components that have been sterilized in advance by filtration sterilization, heat sterilization, etc., or filling / sealing infusion components in each compartment etc., and then with the contents together with the infusion bag A method of sterilization according to a conventional method (for example, high-pressure steam sterilization method, hot water immersion sterilization method, hot water shower sterilization method) can be employed.

Further, as the infusion bag used for the infusion preparation, the above-mentioned infusion bag can be mentioned. Next, specific embodiments of the infusion preparation of the present invention will be described.

(1) Trace element coexists with the trace element
It is filled with components that can undergo chemical changes by
Infusion formulation In the infusion formulation of this embodiment, different compartments of the infusion bag are filled with trace elements and components capable of undergoing a chemical change when coexisting with the trace elements, as infusion components.

The infusion solution bag may be further filled with other kinds of infusion ingredients as additional components, as long as they do not affect the trace elements and the components that may undergo chemical changes when coexisting with the trace elements. Such an additive component may be one kind or two or more kinds.

Specific additives include amino acids,
One or more components selected from the group consisting of electrolytes, sugars and fat emulsions can be mentioned. However, it is not necessary to fill all types of these additive components in the infusion preparation, and it may be appropriately selected depending on the purpose of the infusion preparation. Regarding the combination of packing, the amino acid and the saccharide are not packed in the same compartment or the same chamber from the viewpoint of suppressing the Maillard reaction. further,
From the viewpoint of stabilizing fat particles, the electrolyte and the fat emulsion are not packed in the same compartment. Therefore, as one mode of preferable distribution when the additive component is filled, amino acids, electrolyte,
Fill each chamber with one or more additive components selected from the group consisting of sugars and fat emulsions so that amino acids and sugars are not distributed in the same chamber and electrolyte and fat emulsion are not distributed in the same chamber. The embodiment which is carried out is mentioned.

The amount of each transfusion component filled in the transfusion bag is preferably the daily required amount of the transfusion component. Since the infusion preparation of the present invention can be stably and safely administered without change of each component even when the administration time is long, it is possible to fill a larger amount of infusion component than before. .

Preferred infusion bags that can be used in this embodiment are, for example, a two-compartment bag as shown in FIG. 1 and two compartments as shown in FIG. 3 in which one compartment is divided into two compartments. A bag (two compartments and two chambers), Figure 4
Examples include a bag in which each compartment is divided into two compartments (two compartments and four compartments) as shown in Fig. 2, a three compartment bag as shown in Fig. 2, and the like.

When a two-compartment bag is used, the trace element is divided into one compartment (compartment A), and the component which can undergo a chemical change by coexistence with the trace element is divided into another compartment (compartment B). Is filled.

If necessary, additional components may be filled in the infusion bag. In this case, as an example of the combination of filling the respective infusion components, 1) a mode in which the compartment A is filled with an amino acid and / or a fat emulsion, and a compartment B is filled with an electrolyte and / or a saccharide, 2) a compartment A Embodiment in which electrolyte and / or saccharide is filled, and compartment B is filled with amino acid and / or fat emulsion, 3) compartment A is filled with fat emulsion and / or saccharide, and compartment B is filled with amino acid and / or electrolyte Examples of the filling method are as follows: 4) The section A is filled with amino acids and / or electrolytes, and the section B is filled with a fat emulsion and / or sugar. These aspects are not all combinations of two compartment bags. For example, an embodiment in which a fat emulsion is not filled is a combination included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When a two-compartment, two-compartment bag is used, that is, the compartment of the infusion bag is two compartments, compartment A and compartment B, and compartment A is divided into compartments a ₁ and a ₂ by a partition that can communicate. In the case of using an infusion bag in which the compartment B is composed of one chamber, the compartment A is filled with a trace element, and the compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element, and one or more additional components. Is filled in the infusion bag. The additive component is filled in each chamber so that the amino acids and the sugars are not distributed in the same chamber and the electrolyte and the fat emulsion are not distributed in the same chamber.

As an example of the combination of filling the respective infusion components in the above case, 1) the trace element and the fat emulsion are placed in the chamber a ₁ and the chamber a ₂
Saccharides in compartment B are filled with components that can undergo a chemical change by coexisting with the trace elements, amino acids and electrolytes, 2) chamber a ₁ containing trace elements and fat emulsions,
A chamber a ₂ is filled with amino acids, and compartment B is filled with components, sugars and electrolytes that may undergo chemical changes when coexisting with the trace element, and 3) chamber a ₁ is filled with trace elements and electrolytes. ₂ is a saccharide, and compartment B is filled with components that can undergo chemical changes when coexisting with the trace element, amino acids and a fat emulsion, respectively. 4) Chamber a ₁ contains trace elements and electrolytes and chamber a ₂ the component amino acids, may undergo chemical changes by coexisting with fine quantity element compartment B, aspects sugars and fat emulsion are filled, 5) chamber trace elements and amino acids in a ₁ is the chamber a ₂ A mode in which saccharides and fat emulsions are filled in compartment B with components and electrolytes that can undergo chemical changes when coexisting with the trace elements, 6) Chamber a ₁ contains trace elements and amino acids, and chamber a ₂ contains saccharides. And electrolyte coexist in compartment B with the trace element. Aspects ingredients and fat emulsion capable of undergoing more chemical change are filled respectively, 7) chamber a ₁ in trace elements and sugars, amino acids in the chamber a ₂ and fat emulsions, to coexist with the fine amount element compartment B The composition in which the component and the electrolyte that can be chemically changed by the above are respectively filled, 8) Chamber a ₁
Trace elements and sugars, chamber a ₂ contains amino acids and electrolytes,
The compartment B is filled with a component that can undergo a chemical change by coexisting with the trace element and a fat emulsion, and 9) the chamber a ₁ contains the trace element and the saccharide, and the chamber a ₂ contains the fat emulsion.
Examples include a mode in which the components, amino acids, and electrolytes that can undergo a chemical change by coexisting with the trace element in the compartment B are filled.

These modes are not all combinations in the case of using a two-compartment, two-chamber bag, and, for example, a mode in which only a component capable of undergoing a chemical change by coexisting with a trace element is packed in the compartment B (for example, An infusion preparation in which the chamber a ₁ is filled with a trace element, an electrolyte and an amino acid, the chamber a ₂ is filled with a fat emulsion and a saccharide, and the compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element. Etc.), room a ₁
A combination of only trace elements, a composition not filled with a fat emulsion, and other easily conceivable embodiments are combinations included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When a two-compartment, four-compartment bag is used, that is, the infusion bag has two compartments, compartment A and compartment B, and compartment A is divided into compartments a ₁ and a ₂ by a partition that can communicate. , And when using the infusion bag divided into the chamber b ₁ and the chamber b ₂ by the partition wall that allows the compartment B to communicate, the chamber a ₁
Is filled with a trace element, and the chamber b ₁ is filled with a component capable of undergoing a chemical change by coexisting with the trace element. Further, one or more additive components are filled in the infusion bag. Such an additive component is filled in each chamber so that amino acids and saccharides are not distributed in the same chamber and electrolyte and fat emulsion are not distributed in the same chamber.

Examples of the combination of filling the respective infusion components in the above case are as follows: 1) When a trace element coexists in the chamber a ₁ , a saccharide and an electrolyte in the chamber a ₂ and the trace element coexists in the chamber b _1. A mode in which components capable of undergoing chemical changes and chamber b ₂ are respectively filled with a fat emulsion and amino acids, 2) trace elements in chamber a ₁ , fat emulsion and amino acids in chamber a ₂ , and chamber b ₁ A composition in which a component that can undergo a chemical change by coexisting with the trace element is filled in the chamber b ₂ with a saccharide and an electrolyte, and 3) a trace element in the chamber a ₁ and a fat emulsion and a saccharide in the chamber a _2. components may undergo a chemical change by coexisting with fine quantity element chamber b ₁ is, and aspects electrolyte and amino acids into the chamber b ₂ are filled respectively, and 4) chambers trace elements a ₁ is the chamber a electrolyte and amino acids to _2, chemical variations by coexisting with fine quantity element chamber b ₁ Components that may undergo is,
Then, a mode in which the fat emulsion and the saccharide are respectively filled in the chamber b ₂ can be mentioned.

[0087] but not all combinations of cases where these aspects are used bags of the two-compartment fourth chamber, for example, embodiments in which a plurality of infusion component in the chamber a ₁ is filled (e.g., trace elements and electrolytes in the chamber a ₁ is , An infusion preparation in which a sugar is filled in the chamber a ₂ , a component and an amino acid which may be chemically changed by coexisting with the trace element in the chamber b ₁ , and a fat emulsion is filled in the chamber b ₂ ), Even the mode in which the fat emulsion is not filled,
It is a combination included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When a three-compartment bag is used, the trace elements are in one compartment (compartment A), the added components are in another compartment (compartment B), and the components which may undergo chemical changes by coexisting with the trace elements. Are separately filled in the remaining compartments (compartment C). Further, if necessary, the compartment A and / or the compartment B may be filled with an additive component. Such an additive component is filled in each chamber so that amino acids and saccharides are not distributed in the same chamber and electrolyte and fat emulsion are not distributed in the same chamber.

As an example of the combination of filling of the respective infusion components in the above case, 1) the trace element and the fat emulsion are contained in the compartment A, and the compartment B is contained in the compartment B.
In which saccharides and electrolytes are filled in compartment C with components and amino acids that can undergo chemical changes by coexisting with the trace elements, 2) compartment A containing trace elements and fat emulsions, and compartment B with amino acids And the electrolyte are filled in the compartment C with a component and a saccharide that can undergo a chemical change by coexisting with the trace element, and 3) the compartment A is filled with the trace element and the electrolyte.
Section B is filled with sugars and fat emulsions, and Section C is filled with components and amino acids that can undergo chemical changes by coexisting with the trace elements. 4) Section A is filled with trace elements and electrolytes Aspects in which amino acids and a fat emulsion are filled in compartment C with components and sugars that can undergo chemical changes by coexisting with the trace element, 5) compartment A with trace elements and amino acids, and compartment B with sugars A mode in which the fat emulsion is filled with a component and an electrolyte that can undergo a chemical change by coexisting with the trace element in compartment C, 6) Compartment A containing trace elements and amino acids, and compartment B containing sugars and electrolytes, Aspects in which a component capable of undergoing a chemical change by coexisting with the trace element and a fat emulsion are respectively filled in the compartment C, 7) a trace element and a saccharide in the compartment A, an amino acid and a fat emulsion in the compartment B, and a compartment C With the trace element By the coexistence of the component capable of undergoing chemical change and the electrolyte, and 8) coexistence of trace elements and saccharides in compartment A, amino acids and electrolyte in compartment B, and trace elements in compartment C Examples include a mode in which a component capable of undergoing a chemical change and a fat emulsion are respectively filled.

These embodiments are not all combinations of cases where a three-compartment bag is used. For example, one compartment is filled with three kinds of infusion components (for example, compartment A contains trace elements, fat emulsions and sugars). But compartment B contains electrolyte and compartment C
Infusion preparation filled with components and amino acids that can undergo chemical changes by coexisting with the trace element, or in the compartment A, trace elements, sugars and electrolytes, in the compartment B, fat emulsion, in the compartment C. Combinations that are included in the present invention include infusion preparations in which components and amino acids that can undergo chemical changes due to coexistence with the trace element are each filled) and a mode in which a fat emulsion is not filled. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

(2) Being filled with amino acids and sugars
Infusion solution according to the present embodiment, in the infusion solution of this aspect, different compartments of the infusion bag are filled with amino acids and saccharides as infusion components, respectively.

The infusion bag may be further filled with other types of infusion components as additional components as long as it does not affect amino acids and saccharides. Such additional ingredients are
It may be one type or two or more types.

Specific additive components include one or more components selected from the group consisting of trace elements, electrolytes, components that can undergo chemical changes when coexisting with trace elements, and fat emulsions. However, it is not necessary to fill all types of these additive components in the infusion preparation, and it may be appropriately selected depending on the purpose of the infusion preparation. Regarding the combination of filling, the trace element and the component are not filled in the same compartment from the viewpoint of suppressing the decomposition of the component that may be chemically changed by coexisting with the trace element. Further, from the viewpoint of stabilizing oil particles, the electrolyte and the fat emulsion are not filled in the same compartment. Therefore, as one mode of preferable distribution at the time of filling the additive component, one or more additions selected from the group consisting of a trace element, an electrolyte, a component capable of undergoing a chemical change when coexisting with a trace element, and a fat emulsion are added. The components are filled in each chamber so that the trace elements and the components that may undergo chemical changes due to the coexistence of the trace elements are not distributed in the same chamber and the electrolyte and the fat emulsion are not distributed in the same chamber. Aspects can be mentioned.

As the amount of each infusion component filled in the infusion bag, the daily required amount of the infusion component is preferable. Since the infusion preparation of the present invention can be stably and safely administered without change of each component even when the administration time is long, it is possible to fill a larger amount of infusion component than before. .

Preferred infusion bags that can be used in this embodiment are, for example, a two-compartment bag as shown in FIG. 1 and two compartments as shown in FIG. 3 with one compartment divided into two compartments. A bag (two compartments and two chambers), Figure 4
Examples include a bag in which each compartment is divided into two compartments (two compartments and four compartments) as shown in Fig. 2, a three compartment bag as shown in Fig. 2, and the like.

When a two-compartment bag is used, the amino acids are packed separately in one compartment (compartment A) and the saccharides in another compartment (compartment B). If necessary, additional components may be further filled. In this case, as an example of a specific combination, 1) compartment A is filled with a fat emulsion and / or a trace element, and compartment B is filled with a component that can undergo a chemical change when coexisting with an electrolyte and / or a trace element. Embodiment, 2) a compartment A is filled with a component that can undergo a chemical change by coexisting with an electrolyte and / or a trace element, and compartment B is filled with a fat emulsion and / or a trace element, 3) compartment A In which a component capable of undergoing a chemical change by coexisting with a fat emulsion and / or a trace element is filled into the compartment, and the compartment B is filled with an electrolyte and / or a trace element, and
4) A mode in which the compartment A is filled with an electrolyte and / or a trace element, and the compartment B is filled with a component capable of undergoing a chemical change by coexisting with the fat emulsion and / or the trace element, and the like.

When a two-compartment bag is used and a trace element is not used as an additive component, a further aspect of the infusion preparation is amino acid, electrolyte, saccharide,
In order to prevent the amino acids and the saccharides from being distributed in the same compartment, and the electrolyte and the fat emulsion to be distributed in the same compartment, one or more additive components selected from the group consisting of vitamins and fat emulsions should be used. Compartment B is filled. The above embodiments are not all combinations in the case of using a two-compartment bag, and, for example, embodiments in which a fat emulsion is not filled are also included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

In the case of using a bag of two compartments and two chambers, that is, the compartment of the infusion bag is the two compartments of compartment A and compartment B, and compartment A is divided into compartments a ₁ and a ₂ by the partition which can communicate. When using an infusion bag in which the compartment B is composed of one chamber, the compartment A is filled with amino acids, the compartment B is filled with saccharides, and one or more additive components are further filled in the infusion bag. Such additive components are filled in each chamber so that trace elements and components that may undergo chemical changes due to coexistence with the trace elements are not distributed in the same chamber, and the electrolyte and fat emulsion are not distributed in the same chamber. To be done.

[0099] Examples of combinations of filling of the infusion component in the case described above, 1) room amino acids in a ₁ and a fat emulsion, chamber a
_{2) A} component that can undergo a chemical change when coexisting with a trace element is filled in the compartment B with a saccharide, a trace element, and an electrolyte, 2) The chamber a ₁ contains an amino acid and a fat emulsion,
Trace elements into the chamber a ₂ is, sugars compartment B, aspects ingredients and electrolyte may undergo a chemical change by coexisting with trace elements are filled respectively, 3) chambers a ₁ to amino acids and electrolytes, chamber a ₂ In the compartment B is filled with sugars, trace elements and a fat emulsion, and 4) chamber a ₁ contains amino acids and electrolytes and chamber a ₂ contains components that may undergo chemical changes when coexisting with trace elements. Examples include a mode in which a trace element is filled in the compartment B with a sugar and a component that may undergo a chemical change when coexisting with the trace element, and a fat emulsion.

Further, when a two-compartment, two-chamber bag is used and a trace element is not used as an additive component, a further embodiment of the infusion preparation comprises amino acids, electrolytes, sugars, vitamins and fat emulsions. 1 selected from the group
One or more additional ingredients are added to each compartment or compartment so that amino acids and sugars are not distributed in the same compartment or compartment B in compartment A and electrolyte and fat emulsion are not distributed in the same compartment or compartment B in compartment A. Each room in the same compartment is filled.

[0102] embodiments rather than all combinations in the case where the above aspects are used bags of the two-compartment two chambers, for example, and embodiments only amino acids in the chamber a ₁ is filled, the amino acids in the compartment B is filled, The embodiment in which the fat emulsion is not filled is also a combination included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When using a two-compartment, four-chamber bag, amino
Acids are stored in one of the compartments (compartment A) (compartment a)₁)
, And sugars in either compartment of another compartment (compartment B)
(Room b ₁) Are separately filled. As needed
In addition, additional components may be filled. This place
In this case, the additive components are stored in the remaining chamber₂And / or ward
Room b of picture B₂) Is filled. In this case, a concrete union
For example, 1) room a₂Fat emulsion and / or trace amount
Filled with element, chamber b₂With electrolytes and / or trace elements
Filled with components that can undergo chemical changes when present
Aspect, 2) Chamber a₂Coexist with electrolytes and / or trace elements
The chamber b is filled with a component that can undergo a chemical change.₂
In which a fat emulsion and / or a trace element is filled in, 3) chamber
a₂By coexisting with fat emulsion and / or trace elements
The chamber b is filled with components that can undergo chemical changes.₂To electrolyte
And / or a mode in which trace elements are filled, and 4) Chamber a₂To
Chamber b filled with electrolyte and / or trace elements₂In fat milk
Chemical changes due to coexistence with agents and / or trace elements
Examples include a mode in which the acceptable components are filled.

These modes are not all combinations in the case of using a two-compartment, four-chamber bag, and, for example, a mode in which an additive component is further filled in the chamber a ₁ and / or the chamber b ₁
It is a combination included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When using a three-compartment bag, the amino acids are packed in one compartment (compartment A), the additive component in another compartment (compartment B), and the saccharides in the remaining compartment (compartment C). To be done. If necessary, section A and / or
Alternatively, the compartment B may be filled with an additive component. Such additive components are filled in each chamber so that trace elements and components that may undergo chemical changes due to the coexistence of trace elements are not distributed to the same chamber and electrolyte and fat emulsion are not distributed to the same chamber. It

As an example of the combination of the filling of the respective infusion components in the above case, 1) amino acids and a fat emulsion are contained in compartment A, and components and electrolytes which can undergo chemical changes due to the coexistence of trace elements in compartment B , Section C in which saccharides and trace elements are respectively filled, 2) Chemical changes due to coexistence of amino acids and fat emulsion in section A, trace elements and electrolytes in section B, and sugars and trace elements in section C 3) Amino acids and electrolytes in compartment A, and components and fat emulsions that can undergo chemical changes due to coexistence with trace elements in compartment B, and sugars and trace elements in compartment C , 4) compartment A is filled with amino acids and electrolyte,
Section B is filled with trace elements and fat emulsions, and Section C is filled with components that can undergo chemical changes by coexisting with sugars and trace elements, 5) Section A is filled with amino acids and trace elements in Section B A component and a fat emulsion that can undergo a chemical change when coexisting with a trace element, in which compartment C is filled with saccharides and electrolytes respectively, 6) amino acids and trace elements in compartment A and trace elements in compartment B coexist The component and electrolyte that can undergo a chemical change by doing so, the aspect in which the saccharide and the fat emulsion are respectively filled in the compartment C, 7) The component that can undergo a chemical change by coexisting with the amino acids and trace elements in the compartment A,
In the section B, trace elements and fat emulsions are filled in the section C, and in the section C, sugars and electrolytes are filled, respectively. 8) In the section A, the components that can undergo chemical changes due to coexistence of amino acids and trace elements are set in the section B. Examples include a mode in which the trace elements and the electrolyte are filled in the compartment C with the sugar and the fat emulsion, respectively.

When a three-compartment bag is used and a trace element is not used as an additive component, a further aspect of the infusion preparation is amino acid, electrolyte, saccharide,
One or more additional components selected from the group consisting of vitamins and fat emulsions are added to each compartment so that amino acids and sugars are not distributed in the same compartment and electrolyte and fat emulsion are not distributed in the same compartment. Is filled.

These embodiments are not all combinations in the case of using a three-compartment bag, and, for example, an embodiment in which one compartment is filled with three kinds of infusion components, an embodiment in which a fat emulsion is not filled, and the like are also included in the present invention. It is a combination included in. Those skilled in the art can easily derive from the description of the present specification, even for combinations not described in the present specification,
Such combinations are also included in the present invention.

(3) The fat emulsion and the electrolyte are not filled.
Infusion formulation according to the present embodiment, in the infusion formulation of the present embodiment, different compartments of the infusion bag are filled with a fat emulsion and an electrolyte as infusion components, respectively.

The infusion bag may be further filled with other types of infusion components as additional components as long as it does not affect the fat emulsion or the electrolyte. Such additional ingredients are
It may be one type or two or more types.

Specific additives are amino acids,
One or more components selected from the group consisting of trace elements, saccharides, and components capable of undergoing chemical changes when coexisting with the trace elements are included. However, it is not necessary to fill all types of these additive components in the infusion preparation, and it may be appropriately selected depending on the purpose of the infusion preparation. Regarding the combination of packing, amino acids and saccharides are not packed in the same compartment from the viewpoint of suppressing the Maillard reaction. Furthermore, from the viewpoint of suppressing decomposition of components that may undergo chemical changes due to coexistence with trace elements, the same compartment is not filled with trace elements and components that may undergo chemical changes due to coexistence with trace elements.
Therefore, as one preferable mode of distribution when the additive component is filled, one or more additives selected from the group consisting of amino acids, trace elements, saccharides, and components capable of undergoing chemical changes when coexisting with the trace elements are added. The components are filled in each chamber so that the trace elements and the components that may undergo chemical changes due to the coexistence with the trace elements are not distributed in the same chamber and the amino acids and the saccharides are not distributed in the same chamber. Aspects can be mentioned.

As the amount of each transfusion component filled in the transfusion bag, the daily required amount of the transfusion component is preferable. Since the infusion preparation of the present invention can be stably and safely administered without change of each component even when the administration time is long, it is possible to fill a larger amount of infusion component than before. .

Preferred infusion bags that can be used in this embodiment are, for example, a two-compartment bag as shown in FIG. 1, two compartments as shown in FIG. 3, and one compartment divided into two compartments. A bag (two compartments and two chambers), Figure 4
Examples include a bag in which each compartment is divided into two compartments (two compartments and four compartments) as shown in Fig. 2, a three compartment bag as shown in Fig. 2, and the like.

When a two compartment bag is used, the fat emulsion is filled in one compartment (compartment A) and the electrolyte in the other compartment (compartment B). If necessary, additional components may be further filled. In this case, as an example of a specific combination, 1) compartment A is filled with trace elements and / or amino acids, and compartment B is filled with components and / or sugars that can undergo chemical changes when coexisting with trace elements. 2) Compartment A is filled with components and / or sugars that can undergo chemical changes by coexisting with trace elements,
Embodiment in which compartment B is filled with trace elements and / or amino acids, 3) compartment A is filled with trace elements and / or saccharides, and constituent B and / or components that may undergo chemical changes when coexisting with trace elements Aspects in which amino acids are filled, and 4)
Examples include a mode in which the compartment A is filled with components and / or amino acids that can undergo a chemical change when coexisting with a trace element, and the compartment B is filled with trace elements and / or saccharides.
These embodiments are not all combinations in the case of using a two-compartment bag, and, for example, embodiments in which sugar is not filled are also included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When a two-compartment, two-compartment bag is used, that is, the compartment of the infusion bag is two compartments, compartment A and compartment B, and compartment A is divided into compartments a ₁ and a ₂ by a partition that can communicate. When using an infusion bag in which the compartment B is composed of one chamber, the compartment A is filled with the fat emulsion, the compartment B is filled with the electrolyte, and one or more additive components are further filled in the infusion bag. Such added components are filled in each chamber so that amino acids and sugars are not distributed in the same chamber, and trace elements and components that may undergo chemical changes due to the coexistence of the trace elements are not distributed in the same chamber. To be done.

As an example of the combination of filling the respective infusion components in the above case, 1) the fat emulsion and the trace elements are stored in the chamber a ₁ and the chamber a ₂
In the compartment B, compartments B are filled with components capable of undergoing chemical changes by coexisting with electrolytes, amino acids and trace elements, 2) chamber a ₁ containing fat emulsion and trace elements, and chamber a ₂ containing amino acids. In the compartment B, components that can undergo chemical changes due to coexistence with electrolytes, sugars and trace elements are respectively filled, and 3) chamber a ₁ undergoes chemical changes due to coexistence with fat emulsions and trace elements. The component to be obtained is the chamber a ₂
In which compartment B is filled with electrolytes, amino acids and trace elements, 4) In chamber a ₁ , a component that can undergo a chemical change due to the coexistence of a fat emulsion and trace elements is stored in chamber a ₂ . In which compartment B is filled with electrolyte, saccharides and trace elements, 5) coexistence of fat emulsion and amino acids in compartment a ₁ , saccharides and trace elements in compartment a ₂ and electrolyte and trace elements in compartment B 6) The composition in which the fat emulsion and the amino acid are contained in the chamber a ₁ and the component which can be chemically changed by the coexistence of the saccharide and the trace element in the chamber a ₂ , Aspect where the compartment B is filled with the electrolyte and the trace element respectively, and 7) the chamber a ₁ contains the fat emulsion and the saccharide, the compartment a ₂ contains the amino acid and the trace element, and the compartment B coexists with the electrolyte and the trace element. The state in which each component that can be changed is filled And 8) chambers fat emulsion and sugars into a ₁ is mode components that may undergo chemical change by the chamber a ₂ coexists with amino acids and trace elements, electrolytes and trace elements compartment B is filled, respectively, etc. Is mentioned.

[0116] embodiments rather than all combinations of cases where these aspects are used bags of the two-compartment two chambers, for example, embodiments in which only the fat emulsion chamber a ₁ is filled, the fat emulsion in compartment B is filled, trace A mode in which elements are not filled is also a combination included in the present invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

When using a two-compartment, four-chamber bag, fat milk
The agent is stored in one of the compartments (compartment A) (compartment a)₁)
And the electrolyte is in one of the compartments of another compartment (compartment B).
(Room b ₁) Are separately filled. As needed
In addition, additional components may be filled. This place
In this case, the additive components are stored in the remaining chamber₂And / or ward
Room b of picture B₂) Is filled. In this case, a concrete union
For example, 1) room a₂Trace elements and / or amino
Chamber filled with acids₂By coexisting with trace elements in
Is filled with components and / or sugars that can undergo chemical changes
Aspect, 2) Chamber a₂Chemical change due to coexistence with trace elements in
Chamber b filled with components and / or sugars capable of undergoing oxidization₂To
Aspects in which trace elements and / or amino acids are filled, 3) chamber
a₂Is filled with trace elements and / or sugars, and the chamber b ₂Fine
Components that may undergo chemical changes when coexisting with quantitative elements
And / or amino acids, and 4) Chamber a₂To
Components that can undergo chemical changes when coexisting with trace elements
And / or filled with amino acids, chamber b₂Trace elements and
And / or sugars are included. further,
If necessary, add ingredients to chamber a₁And / or room b₁Filled in
You may. However, trace elements and trace elements may coexist.
Ingredients that can undergo chemical changes due to, and sugars and amino acids
The classes are packed in separate compartments.

[0118] but not all combinations of cases where these aspects are used bags of the two-compartment fourth chamber, for example, aspects infusion ingredient only one type into the chamber a ₂ is not filled aspect or fat emulsion to be filled and the like also present It is a combination included in the invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations not described in the present specification,
Such combinations are also included in the present invention.

When a three-compartment bag is used, the fat emulsion is packed in one compartment (compartment A), the additive component in another compartment (compartment B), and the electrolyte in the remaining compartment (compartment C). To be done. Further, if necessary, the compartment A and / or the compartment B may be filled with an additive component. Such added components are filled in each chamber so that amino acids and sugars are not distributed in the same chamber, and trace elements and components that may undergo chemical changes due to the coexistence of the trace elements are not distributed in the same chamber. To be done.

As an example of the combination of the filling of the respective infusion components in the above case, 1) the fat emulsion and the trace elements in the compartment A and the compartment B in the compartment B
The components that can undergo chemical changes due to the coexistence of saccharides and trace elements in compartment C are filled with electrolytes and amino acids, respectively, 2) fat emulsion and trace elements in compartment A, and amino acids in compartment B A component that can undergo a chemical change by coexisting with a trace element is a mode in which compartment C is filled with an electrolyte and a saccharide, respectively, and 3) a component that can undergo a chemical change by coexisting with a fat emulsion and a trace element in compartment A , A manner in which compartment B is filled with sugars and trace elements, and compartment C is filled with electrolytes and amino acids, 4) compartment A contains components that can undergo chemical changes due to the coexistence of fat emulsion and trace elements in compartment B Aspects in which amino acid and trace element are filled in compartment C with electrolyte and saccharide, respectively, 5) Coexistence of fat emulsion and amino acid in compartment A, saccharide and trace element in compartment B, and electrolyte and trace element in compartment C What to do 6) A composition in which fat emulsion and amino acids are contained in compartment A, and a component which can be chemically converted by coexistence of saccharides and trace elements in compartment B is electrolyte in compartment C And 7) a composition in which fat emulsion and sugar are contained in compartment A, amino acids and trace elements are contained in compartment B, and chemical components can be chemically changed by coexisting with electrolyte and trace elements in compartment C And 8) compartment A is filled with a fat emulsion and a saccharide, and compartment B is filled with a component capable of undergoing a chemical change by coexistence with an amino acid and a trace element, and compartment C is filled with an electrolyte and a trace element, respectively. And the like.

These embodiments are not all combinations in the case of using a three-compartment bag. For example, one compartment is filled with three kinds of infusion components, or a trace element is not filled. It is a combination included in the invention. Those skilled in the art can easily derive from the description of the present specification, even for combinations that are not described in the present specification, and such combinations are also included in the present invention.

As described above, since the infusion preparation of the present invention can provide a plurality of infusion preparations as one preparation, the infusion preparation can be filled with a desired combination of infusion preparations at the manufacturing stage of the infusion preparation at the manufacturer, and one infusion bag structure can be obtained. It can be supplied to medical sites as an infusion formulation. Therefore, it is possible to structurally avoid a misunderstanding of infusion at the medical site. Further, since the infusion solution of the present invention can arrange each infusion component in the lateral direction, the bag does not become long in the longitudinal direction. Therefore, even for a tall patient, it can be safely used without causing a problem such as backflow of blood during transfer during administration.

[0123]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited to these examples.

Production Example 1 An infusion bag having the basic structure shown in FIG. 1 was produced as follows. Two rectangular polypropylene sheets (thickness: 300 μm, size: 42 cm × 28 cm) were prepared, and these were stacked. First, both edges (m, m ') on the short side of the sheet were heat-welded with a width of 1 cm.

Next, one of the heat-welded edges (denoted by m)
1 cm in the direction parallel to m at a position approximately 13 cm from
The sheet was heat-welded in the width of. As a result, the isolation means that cannot communicate with each other was formed. This isolation means produced compartments with volume ratios of approximately 1: 2 (designated A and B, respectively).

Next, a commercially available mouth portion and a mixed injection port were placed on one of the long edges (n, n ′) (denoted as n) of the sheet so as to be sandwiched between the sheets. One mouth portion 3 was placed in A, and one mouth portion 4 and one injection port 12 were placed in B. With these members sandwiched by the sheets, the edge n was heat-welded with a width of 1 cm. As a result, mouths 3 and 4 are provided in each of the sections A and B, respectively. A mixed injection port 12 was provided in B.

A commercially available filling station was then placed on the remaining one (n ') of the long edges of the sheet, sandwiched between the sheets. One filling part 11 was placed in each of A and B. With these members sandwiched between the sheets, the edge n ′ was heat-welded with a width of 1 cm. As a result, the filling sections 11 were provided in the sections A and B, respectively. Thus, the infusion bag shown in FIG. 1 was obtained. This infusion bag was named infusion bag 1.

Example 1 Infusion bag 1 obtained in Production Example 1 was filled with infusion components as follows. One compartment (compartment A) was aseptically filled with saccharides, electrolytes and trace elements as infusion components. Table 1 shows a specific formulation of the infusion component.

[0129]

[Table 1]

The other compartment (compartment B) was filled with electrolytes, amino acids and vitamin C as infusion components. Table 2 shows a specific formulation of the infusion solution.

[0131]

[Table 2]

Test Example 1 The stability of vitamin C in an infusion preparation was examined. A polypropylene sheet infusion bag having no compartment was mixed with all of the infusion components having the same formulation as in Example 1 and aseptically filled. The infusion preparation thus obtained was designated as Comparative Product 1.

The two infusion preparations of the present invention product 1 and the comparative product 1 were allowed to stand at room temperature, and the residual ratio of vitamin C was measured with time. Vitamin C was quantified according to the ascorbic acid injection solution determination method described in the 14th revised Japanese Pharmacopoeia (14th revised Japanese Pharmacopoeia, p. 213). The results are shown in Table 3. In Table 3, the residual rate (%) of vitamin C at each measurement time is shown as the amount of vitamin C at 0 hours being 100.0.

[0134]

[Table 3]

As is clear from Table 3, the infusion preparation of the present invention has a high residual rate of vitamin C, and the infusion preparation of the present invention can be used for administration for 24 hours.

Example 2 The sugars and electrolytes shown in Table 4 were placed in chamber Aa of the container shown in FIG.
The amino acids shown in Table 5 were filled in the Ab chambers A and the fat emulsion shown in Table 6 was filled in the compartment B in an aseptic manner to give the product 2 of the present invention.

[0137]

[Table 4]

[0138]

[Table 5]

[0139]

[Table 6]

Test Example 2 The stability of the fat emulsion in the infusion preparation was examined. As a control, a polypropylene sheet infusion bag having no compartment was prepared by mixing and aseptically filling all of the infusion components having the same formulation as in Example 2, which was designated as Comparative Product 2. Two types of infusion formulations, namely Aa of product 2 of the present invention
And Ab were communicated with each other to mix the contents, and Comparative Product 2 was allowed to stand at room temperature, and the appearance of the infusion solution in the bag was observed at each observation time point. The results are shown in Table 7.

[0141]

[Table 7]

The meanings of the symbols in the table are as follows. ◯: It was a white opaque emulsion. (Triangle | delta): The floating of a few fat particles was recognized (the floating was recognized in the stationary state, but when it stirred a little, it returned to the white opaque emulsion). X: Remarkable floating of fat particles was recognized (floating was recognized in a stationary state, and it did not return to a white opaque emulsion unless strongly stirred).

As described above, when the fat emulsion and the divalent ions coexisted, the floating of the fat particles, which causes the clogging of the infusion line, was observed. In the infusion preparation of the present invention, it was proved that both components can be safely administered to a patient because the contact time of both components in the infusion bag during administration is extremely short.

[0144]

INDUSTRIAL APPLICABILITY The infusion preparation of the present invention stably and safely administers a complex infusion consisting of a plurality of infusion components including an infusion component that becomes unstable even at room temperature when it is in contact with other infusion components for a long time. It is an infusion formulation that can be.

[Brief description of drawings]

FIG. 1 is a schematic view showing an example of a basic structure of a two-compartment infusion bag.

FIG. 2 is a schematic view showing an example of the basic structure of a three-compartment infusion bag.

FIG. 3 is one of the basic structures of a two-compartment, three-component infusion bag.
It is a schematic diagram which shows an example.

FIG. 4 is one of the basic structures of a two-compartment four-chamber infusion bag.
It is a schematic diagram which shows an example.

FIG. 5 is one of the basic structures of a two-compartment four-chamber infusion bag.
It is a schematic diagram which shows an example.

FIG. 6 is one of the basic structures of a two-compartment four-chamber infusion bag.
It is a schematic diagram which shows an example.

FIG. 7 is a schematic view showing an example of the basic structure of a two-compartment infusion bag with a handle.

FIG. 8 is a schematic view showing an example of a basic structure of a two-compartment infusion bag with a handle.

FIG. 9 is a schematic view showing an example of the basic structure of a two-compartment infusion bag with a hanging hole.

[Explanation of symbols]

3 mouth 4 mouth 5 mouth 6 isolation means 7 isolation means 8 Weak seal 9 Weak seal 10 Infusion line 11 Filling section 12 mixed injection port 21 Handle 22 Hermetically sealed part 23 Holes for hanging the bag

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61K 33/00 A61P 3/02 A61P 3/02 A61J 1/00 351A 351Z F term (reference) 4C076 AA12 BB13 CC22 FF12 4C086 AA01 BA18 EA01 HA01 HA02 HA03 HA04 HA09 HA11 MA03 MA04 MA17 MA66 NA04 ZC21 4C206 AA01 FA53 MA03 MA04 MA37 MA86 NA04 ZC21

Claims (41)

[Claims] 1. A plurality of compartments for filling infusion components, the compartments being isolated from each other so that they cannot communicate with each other, and each of the compartments having a mouth for discharging the infusion components. And the trace element coexists in one compartment of the infusion bag, which may have a plurality of chambers separated by separable septa, and the coexistence with the trace element in a compartment different from that. An infusion preparation that is filled with components that can undergo changes. 2. Further, one or more additive components selected from the group consisting of amino acids, electrolytes, saccharides and fat emulsions are used so that the amino acids and saccharides are not distributed in the same chamber and the electrolytes and fat emulsions are the same. The infusion preparation according to claim 1, which is filled in each chamber so as not to be distributed in the chamber. 3. The infusion preparation according to claim 1 or 2, wherein the amount of each infusion component filled in the infusion bag is the daily required amount of the infusion component. 4. The compartment of the infusion bag is compartment A and compartment B.
4. The compartment according to any one of claims 1 to 3, wherein the compartment A is filled with a trace element, and the compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element. Infusion formulation. 5. The compartment A is filled with a trace element, an amino acid and a fat emulsion, and the compartment B is filled with a component, an electrolyte and a saccharide which can undergo a chemical change when coexisting with the trace element. 4. The infusion preparation according to 4. 6. The compartment A is filled with a trace element, an electrolyte and a saccharide, and the compartment B is filled with a component, an amino acid and a fat emulsion which can undergo a chemical change when coexisting with the trace element. 4. The infusion preparation according to 4. 7. The compartment A is filled with a trace element, a fat emulsion and a saccharide, and the compartment B is filled with a component, an amino acid and an electrolyte capable of undergoing a chemical change when coexisting with the trace element. 4. The infusion preparation according to 4. 8. The compartment A is filled with a trace element, an amino acid and an electrolyte, and the compartment B is filled with a component, a fat emulsion and a saccharide that can undergo a chemical change when coexisting with the trace element. 4. The infusion preparation according to 4. 9. The compartment of the infusion bag is compartment A and compartment B.
Of the chamber a ₁
And compartment a ₂ and compartment B of the infusion bag consisting of one compartment is filled with a trace element, and compartment B is filled with a component capable of undergoing a chemical change by coexisting with the trace element. At least one additive selected from the group consisting of amino acids, electrolytes, saccharides and fat emulsions prevents amino acids and saccharides from being distributed in the same chamber, and electrolytes and fat emulsions from being distributed in the same chamber. The infusion preparation according to claim 2 or 3, which is filled in each chamber. 10. A trace element, an electrolyte and an amino acid are contained in the chamber a ₁ , a fat emulsion and a saccharide are contained in the chamber a ₂ , and a component capable of undergoing a chemical change by coexistence with the trace element in the compartment B, respectively. The infusion preparation according to claim 9, which is filled. 11. trace elements the chamber a ₁ and sugars, the chamber a
10. The infusion preparation according to claim 9, wherein ₂ is a fat emulsion, and each of the compartments B is filled with a component, an amino acid and an electrolyte that can undergo a chemical change when coexisting with the trace element. 12. A trace element and a fat emulsion are contained in the chamber a ₁ , an amino acid is contained in the chamber a ₂ , and a component, a saccharide and an electrolyte, which can undergo a chemical change by coexisting with the trace element in the compartment B, respectively. The infusion preparation according to claim 9, which is filled. 13. A component, an amino acid and a fat emulsion, which can undergo a chemical change by coexistence of a trace element and an electrolyte in the chamber a ₁ , a saccharide in the chamber a ₂ , and the trace element in the compartment B, respectively. The infusion preparation according to claim 9, which is filled. 14. The chamber a ₁ trace elements and electrolytes, amino acids in said chamber a ₂ is, components that may undergo chemical change by coexisting with fine quantity element compartment B, and sugars and fat emulsion, respectively The infusion preparation according to claim 9, which is filled. 15. A trace element and an amino acid are contained in the chamber a ₁ .
10. The infusion preparation according to claim 9, wherein the chamber a ₂ is filled with a saccharide and a fat emulsion, and the compartment B is filled with a component and an electrolyte that can undergo a chemical change when coexisting with the trace element. 16. A trace element and an amino acid are contained in the chamber a ₁ .
The infusion preparation according to claim 9, wherein the chamber a ₂ is filled with a saccharide and an electrolyte, and the compartment B is filled with a component capable of undergoing a chemical change by coexistence with the trace element and a fat emulsion. 17. trace elements the chamber a ₁ and sugars, the chamber a
10. The infusion preparation according to claim 9, wherein the amino acid and the fat emulsion are filled in ₂ and the compartment B is filled with a component and an electrolyte that can undergo a chemical change when coexisting with the trace element. 18. trace elements the chamber a ₁ and sugars, the chamber a
Amino acids and electrolytes to _2, said compartments component and fat emulsion may undergo a chemical change by coexisting with fine amount element is formed by filling each of the B, infusion preparation according to claim 9, wherein. 19. The infusion bag has two compartments, a compartment A and a compartment B, and the compartment a is defined by a partition wall that allows the compartment A to communicate with each other.
₁ and chamber a ₂ , and compartment B is divided into chambers b ₁ and b ₂ by a partition that can communicate with compartment B. The trace elements are contained in the chamber a ₁ and trace elements in the chamber b _1. Each of them is filled with a component that can undergo a chemical change when coexisting with, and one or more additional components selected from the group consisting of amino acids, electrolytes, saccharides, and fat emulsions are distributed to the same chamber for amino acids and saccharides. Each chamber is filled so that the electrolyte and the fat emulsion are not distributed in the same chamber,
The infusion preparation according to claim 2 or claim 3. 20. A trace element and an electrolyte are contained in the chamber a ₁ , a saccharide is contained in the chamber a ₂ , and a component and an amino acid which can be chemically changed by coexisting with the trace element in the chamber b ₁ , and The chamber b ₂ is filled with a fat emulsion, respectively.
9. The infusion preparation according to 9. 21. A trace element in the chamber a ₁ , a saccharide and an electrolyte in the chamber a ₂ , a component capable of undergoing a chemical change by coexistence with the trace element in the chamber b ₁ , and the chamber b ₂ 2. A fat emulsion and amino acids are respectively filled in.
9. The infusion preparation according to 9. 22. In the chamber a ₁ , a trace element, in the chamber a ₂ , a fat emulsion and an amino acid, and in the chamber b ₁ , a component capable of undergoing a chemical change by coexisting with the trace element; The infusion preparation according to claim 19, wherein b ₂ is filled with a saccharide and an electrolyte. 23. A trace element in the chamber a ₁ , a fat emulsion and a saccharide in the chamber a ₂ , a component capable of undergoing a chemical change by coexistence with the trace element in the chamber b ₁ , and the chamber b. The infusion preparation according to claim 19, wherein ₂ is filled with an electrolyte and amino acids. Trace elements 24. The chamber a ₁ is, electrolyte and amino acids in said chamber a ₂ is, components may undergo a chemical change by coexisting with fine quantity element said chamber b ₁ is then the chamber b, ₂
20. The infusion preparation according to claim 19, wherein the fat emulsion and the saccharide are respectively filled. 25. The infusion bag compartments are compartment A and compartment B.
And a compartment C of the infusion bag consisting of three compartments, a compartment A is filled with a trace element, and a compartment C is filled with a component capable of undergoing a chemical change by coexisting with the trace element, and further amino acids, electrolytes, sugars and fats. Each chamber is filled with one or more additive components selected from the group consisting of emulsions so that amino acids and saccharides are not distributed in the same chamber and electrolyte and fat emulsion are not distributed in the same chamber. ,
The infusion preparation according to claim 2 or claim 3. 26. The compartment A is filled with a trace element, a saccharide and an electrolyte, the compartment B is filled with a fat emulsion, and the compartment C is filled with a component and an amino acid which can undergo a chemical change by coexisting with the trace element. The infusion preparation according to claim 25, which comprises: 27. The compartment A is filled with a trace element and a fat emulsion, the compartment B is filled with a saccharide and an electrolyte, and the compartment C is filled with a component and an amino acid which can undergo a chemical change by coexisting with the trace element. The infusion preparation according to claim 25, which comprises: 28. The compartment A is filled with a trace element, a fat emulsion and a saccharide, the compartment B is filled with an electrolyte, and the compartment C is filled with a component capable of undergoing a chemical change by coexistence with the trace element and an amino acid. The infusion preparation according to claim 25, which comprises: 29. The compartment A is filled with a trace element and a fat emulsion, the compartment B is filled with an amino acid and an electrolyte, and the compartment C is filled with a component and a saccharide that can undergo a chemical change by coexisting with the trace element, respectively. The infusion preparation according to claim 25, which comprises: 30. The compartment A is filled with a trace element and an electrolyte, the compartment B is filled with a saccharide and a fat emulsion, and the compartment C is filled with a component and an amino acid which can undergo a chemical change when coexisting with the trace element, respectively. The infusion preparation according to claim 25, which comprises: 31. The compartment A is filled with a trace element and an electrolyte, the compartment B is filled with an amino acid and a fat emulsion, and the compartment C is filled with a component and a saccharide that can undergo a chemical change when coexisting with the trace element, respectively. The infusion preparation according to claim 25, which comprises: 32. Trace elements and amino acids are contained in the compartment A,
26. The infusion preparation according to claim 25, wherein the compartment B is filled with a sugar and a fat emulsion, and the compartment C is filled with a component and an electrolyte that can undergo a chemical change when coexisting with the trace element. 33. Trace elements and amino acids are contained in the compartment A,
26. The infusion preparation according to claim 25, wherein the compartment B is filled with a saccharide and an electrolyte, and the compartment C is filled with a component capable of undergoing a chemical change by coexistence with the trace element and a fat emulsion. 34. The compartment A is filled with a trace element and a saccharide, the compartment B is filled with an amino acid and a fat emulsion, and the compartment C is filled with a component and an electrolyte capable of undergoing a chemical change by coexisting with the trace element. The infusion preparation according to claim 25, which comprises: 35. The compartment A is filled with a trace element and a saccharide, the compartment B is filled with an amino acid and an electrolyte, and the compartment C is filled with a component and a fat emulsion capable of undergoing a chemical change by coexistence with the trace element, respectively. The infusion preparation according to claim 25, which comprises: 36. The infusion preparation according to any one of claims 1 to 35, wherein the component capable of undergoing a chemical change when coexisting with a trace element is a vitamin. 37. The infusion preparation according to any one of claims 1 to 35, wherein the component capable of undergoing a chemical change when coexisting with a trace element is vitamins containing vitamin C. 38. The infusion preparation according to any one of claims 1 to 35, wherein the component capable of undergoing a chemical change when coexisting with a trace element is vitamin C. 39. A plurality of compartments for filling an infusion component, the compartments being isolated so as not to communicate with each other,
Each of the compartments has an opening for discharging an infusion component, and each of the compartments may have a plurality of chambers separated by a partition that can communicate with each other. It is two compartments of compartment B, and one or more additive components selected from the group consisting of amino acids, electrolytes, saccharides, vitamins and fat emulsions are used to prevent the amino acids and saccharides from being distributed in the same compartment. An infusion preparation filled in the compartment A and the compartment B so that the fat emulsion is not distributed in the same compartment. 40. Having a plurality of compartments for filling an infusion component, the compartments being isolated so that they cannot communicate with each other,
Each of the compartments has an opening for discharging an infusion component, and each of the compartments may have a plurality of chambers separated by a partition that can communicate with each other. In the infusion bag, which is two compartments of compartment B and is compartmented into compartments a ₁ and a ₂ by a partition that allows compartment A to communicate, is selected from the group consisting of amino acids, electrolytes, sugars, vitamins and fat emulsions. The one or more added ingredients are such that the amino acids and sugars are not distributed in the same compartment of compartment A or compartment B and the electrolyte and fat emulsion are compartment A.
The infusion preparation which is filled in each compartment or each compartment of the same compartment so as not to be distributed to the same compartment or compartment B. 41. A plurality of compartments for filling an infusion component, the compartments being isolated so as not to communicate with each other,
Each of the compartments has an opening for discharging an infusion component, and each of the compartments may have a plurality of chambers separated by a partition that can communicate with each other. In the compartment A of the infusion bag consisting of compartment B and compartment C, one or more additive components selected from the group consisting of amino acids, electrolytes, saccharides, vitamins and fat emulsions have the same amino acids and saccharides. An infusion preparation filled in each compartment so that the electrolyte and the fat emulsion are not distributed in the same compartment so that they are not distributed in the compartment.