JPH06172191A - Glucose-containing electrolyte infusion solution - Google Patents

Abstract

PURPOSE:To provide the glucose-containing electrolyte infusion solution useful as a maintenance infusion solution preparation used for the positive supply of calorie in addition to the supply of electrolytes and water. CONSTITUTION:The glucose-containing electrolyte infusion solution comprises glucose and electrolytes in specific amounts, respectively, and further contains acetic acid as an alkalinizing agent and is subjected to the adjustment of pH with citric acid. Since the electrolyte infusion solution contains the glucose and the electrolyte components in a good balance and is excellent in the stability of the preparation and further since the acetic acid used as the alkalinizing agent is efficiently metabolized and utilized in the muscle of the whole body, the electrolyte infusion solution can be administered into severe hepatic patients, etc., and can supply calorie in addition to the electrolytes and the water by virture of the glucose contained therein.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to electrolyte infusion compositions. More specifically, the present invention relates to a glucose-added electrolyte infusion solution containing a specific amount of glucose and electrolyte useful as a maintenance infusion formulation for the purpose of active calorie supplementation in addition to electrolyte and water supplementation.

[0002]

2. Description of the Related Art In order to maintain life, it is indispensable to ingest various electrolytes and vitamins as well as carbohydrates, proteins, fats and water. Conventionally, in the life support of patients, oral nutrition and tube feeding are incapable or inadequate, or even if they are possible, the digestive and absorption function of the patient is remarkably poor, and food is digested. In cases where passage through the tube leads to aggravation of the underlying disease, intravenous administration of the above-mentioned nutrient-containing infusion formulation is widely performed. Among them, glucose-electrolyte infusion for the purpose of supplementing electrolytes, water and calories is highly useful as a maintenance infusion formulation, and is parenterally administered to a patient either alone or in combination with an amino acid infusion, an infusion such as a fat emulsion, or a drug. Will be given to you.

[0003]

However, the glucose-electrolyte infusion solution has a problem in the formulation stability as shown below. That is, glucose is the safest calorie source, but when heat sterilized, it causes problems such as coloring and the generation of decomposition products. Also, phosphorus, calcium and magnesium are
It is an essential and indispensable electrolyte component in the maintenance infusion together with sodium, potassium and chlor, but when these components coexist, calcium phosphate and magnesium phosphate are produced, and turbidity and precipitation are caused based on them. This tendency is further enhanced by increasing the pH of the preparation and heat sterilization. In addition to solving such problems of formulation stability, a better glucose-added electrolyte infusion solution has been earnestly desired from the viewpoint of electrolyte supplementation and calorie supplementation. The present invention has been made to solve the above problems, and an object of the present invention is to provide a glucose-electrolyte infusion solution which can effectively supplement electrolytes, water and calories and is stable in terms of formulation.

[0004]

Means for Solving the Problems The glucose-electrolyte infusion solution of the present invention made to overcome the above problems contains glucose and an electrolyte in the following range, and contains glucose 8.0 to 12.0 w / v. % Sodium 28.0-42.0 mEq / l Potassium 16.0-24.0 mEq / l Calcium 4.0-6.0 mEq / l Magnesium 2.4-3.6 mEq / l Crawl 22.4- 33.6 mEq / l phosphorus 8.0-12.0 mmol /
l Acetate ion 16.0 to 24.0 mEq / l Citric acid is characterized in that the pH is adjusted to 4.0 to 6.0.

In the electrolyte infusion solution of the present invention having the above constitution, commercially available Nikkei glucose can be used as glucose. Further, sodium chloride, sodium acetate, etc. as a source of sodium, potassium chloride, potassium dihydrogen phosphate, etc. as a source of potassium, calcium chloride, calcium gluconate, etc. as a source of calcium, magnesium as a source of supply. Magnesium chloride and the like can be used as sources of chlor, sodium chloride, potassium chloride, magnesium chloride and the like, and sources of phosphorus can be potassium dihydrogen phosphate, potassium glycerophosphate and the like. They can also be used as hydrates.

The glucose-electrolyte infusion solution of the present invention is adjusted to pH 4.0 to 6.0 with citric acid. Citric acid is a free acid, salt (for example, sodium salt),
It can be used in any of the hydrate forms.

By the way, extracellular fluid contains bicarbonate ion as a main constituent (about 27 m in healthy plasma).
Eq / l), and in order to improve metabolic acidosis, it is necessary to add a bicarbonate or a substance that is metabolized in vivo to form bicarbonate ion (so-called alkalizing agent) in order to improve metabolic acidosis. . In general, it is difficult to formulate bicarbonate together with other electrolyte components in terms of stability, etc. Therefore, an alkalizing agent that is metabolized to generate bicarbonate ion is usually used. There is. In the electrolyte infusion solution of the present invention, acetic acid is used as an alkalizing agent. Lactic acid is generally used as an alkalizing agent, but since lactic acid is mainly metabolized in the liver, lactic acid is based on a decrease in lactic acid metabolism in the liver during severe liver disease and bleeding shock when hepatic blood flow decreases. Acidosis may occur, which is not preferable. On the other hand, since acetic acid is efficiently metabolized not only in the liver but also in the muscles of the whole body, it has an advantage that it can be administered even in patients with severe liver disease or in hemorrhagic shock. Acetic acid may be used in any form of a free acid, a salt (for example, sodium salt, etc.) and a hydrate.

The electrolyte infusion solution of the present invention can be prepared by various methods. For example, each component is weighed, dissolved in a corresponding amount of water for injection, and then pH adjusted with citric acid.
Can be adjusted to 4.0 to 6.0, preferably 4.5 to 5.5. The preferred composition range of the electrolyte infusion solution of the present invention is as follows. Glucose 8.0 to 12.0, preferably 9.0 to 11.0 w / v% sodium 28.0 to 42.0, preferably 31.5 to 38.5 mEq / l potassium 16.0 to 24.0, preferably 18.0 to 22.0 〃 calcium 4.0 to 6.0, preferably 4.5 to 5.5 〃 magnesium 2.4 to 3.6, preferably 2.7 to 3.3 〃 chlor 22.4 to 33.6, preferably 25.2 to 30.8 〃 phosphorus 8.0 to 12.0, preferably 9.0 to 11.0 mmol / l acetic acid 16.0 to 24.0, preferably 18.0 to 22.0 mEq / l

The electrolyte infusion solution of the present invention can be sterilized by heating. For example, the infusion solution can be sterilized by subjecting the infusion solution to a glass container or plastic (eg, polypropylene, polyethylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, etc.). ) After filling a container (for example, bag, bottle, etc.) and sealing the container, it can be carried out according to a conventional method. In particular,
It can be carried out by a method such as high-pressure steam sterilization, hot water immersion sterilization, hot water shower sterilization and the like.

The glucose-electrolyte infusion solution of the present invention is stable and does not discolor, even if it is sterilized by heating, without the formation of a decomposition product of glucose or calcium phosphate and the like; acetic acid used as an alkalizing agent is Since it is efficiently metabolized and utilized not only in the liver but also in the muscles of the whole body, it can be administered to patients with severe liver disease; contains phosphorus, calcium and magnesium which are components necessary for maintaining the function of the living body. Therefore, it is possible to prevent disorders caused by diminished body fluids when infusions are administered and the concentrations of these components are reduced; glucose, which is the safest sugar, is used as a sugar. As a maintenance infusion formulation for the purpose of active calorie supplementation, in addition to electrolyte and water supplementation, it has the following characteristics: It is a use. The glucose electrolyzed electrolyte infusion solution of the present invention having the above-mentioned characteristics is parenterally administered to a patient alone or in combination with other amino acids, an infusion solution such as a fat emulsion, or a drug, if necessary.

[0011]

EXAMPLES In order to explain the present invention in more detail, examples will be given below, but the present invention is not limited thereto. Example 1 In 900 ml of water for injection, glucose 100.00 g, sodium chloride 0.88 g, potassium chloride 0.75 g, calcium gluconate 1.12 g, magnesium chloride hexahydrate 0.31 g, sodium acetate trihydrate 2 0.72 g and potassium dihydrogen phosphate 1.36 g were sequentially added and dissolved, and the pH was adjusted to 5.0 with citric acid, and the total amount was adjusted to 1 liter with water for injection. The glucose and electrolyte concentrations are shown in the table below. Component Concentration ━━━━━━━━━━━━━━━━━━━━━ Glucose 10.0 w / v% Sodium 35.0 mEq / l Potassium 20.0 〃 Calcium 5.0 〃 Magnesium 3.0 〃 Chlor 28.0 〃 Phosphorus 10.0 mmol / l Acetic acid 20.0 mEq / l This solution was filtered using a 0.22 µm membrane filter and dispensed into 500 ml glass bottles in 250 ml aliquots. Then, hot water static sterilization was performed at 115 ° C. for 30 minutes. The stability of this infusion formulation is 70 ° C for 6 days and 40 ° C 3
I examined it for a month. As a result, the pH was not lowered and the coloring did not occur, and the formation of precipitates was not observed, which proved that the infusion preparation was extremely stable.

Example 2 Instead of the glass bottle in Example 1, a PE bag (polyethylene soft bag) was dispensed, and hot water shower sterilization was performed at 115 ° C. for 30 minutes. The infusion preparation thus obtained was also extremely stable, like the preparation of Example 1.

[0013]

INDUSTRIAL APPLICABILITY The electrolyte infusion solution of the present invention contains glucose and an electrolyte component in a well-balanced manner and is excellent in pharmaceutical stability, and can suppress the coloring due to heat sterilization and the generation of decomposition products and precipitates. Further, since it contains acetic acid as an alkalizing agent and is efficiently metabolized and utilized not only in the liver but also in the muscles of the whole body, it can be administered to patients with severe liver disease and the like. Furthermore, since it contains glucose, it is useful as a maintenance infusion formulation for the purpose of active supplementation of calories in addition to supplementation of electrolytes and water.

Continuation of the front page (51) Int.Cl. ⁵ Identification number Internal reference number of the agency FI Technical display area A61K 33/42 8314-4C // (A61K 33/14 33:42 31:19 9283-4C 31:70) ( 72) Inventor Kazumasa Yokoyama 2-25-1 Otani, Hirakata-shi, Midori Central Research Institute

Claims (1)

[Claims] 1. Glucose and an electrolyte are contained in the following ranges, glucose 8.0-12.0 w / v% sodium 28.0-42.0 mEq / l potassium 16.0-24.0 mEq / l Calcium 4.0-6.0 mEq / l Magnesium 2.4-3.6 mEq / l Crawl 22.4-33.6 mEq / l Phosphorus 8.0-12.0 mmol /
l Acetate ion 16.0 to 24.0 mEq / l pH adjusted to 4.0 to 6.0 with citric acid, a glucose-added electrolyte infusion solution.