RU2410080C1 - Method for producing bicarbonate dialysis fluid - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: dialysis solution contains the following components, in mmol/l: Sodium chloride NaCl 137.0-139.3; Calcium chloride CaCl22H2O 1.2-2.5; Magnesium chloride MgCl26H2O 0.5-1.0; Potassium chloride KCl 0.3-4.0; Hydrochloric acid 2.0-4.0; Sodium acetate 0-0.3; Glucose, g/l 0-5.0; Sodium bicarbonate 32.0. ^ EFFECT: possibility to clean a hemodialysis fluid from acetate ions to substituted by chlorine and hydrogen ions, that has a positive effect on dynamics of a hemodialysis process, and to eliminate complications in the form of acidosis observed if significant amounts of acetate ions are delivered to a body. ^ 4 ex

Description

The invention relates to medicine, relates to a method for producing a bicarbonate dialysis solution and will find application in extracorporeal blood purification for the treatment of patients with acute and chronic renal failure.

The composition of the dialysis solutions corresponds to human blood in terms of osmolality, the concentration of basic ions and the value of the concentration of hydrogen ions (pH). There are two main types of dialysis solutions - acetate and bicarbonate.

A known method of obtaining a concentrated acetate solution (RU 2200543, 2001.05.08, A61K 9/08). It is as follows. In purified water, heated to 80-90 ° C, the salts NaCl, KCl, CH ₃ OONa · 3H ₂ O are dissolved after complete dissolution of which the solution is cooled to 20-25 ° C. Inorganic salts of CaCl ₂ · 6H ₂ O, MgCl ₂ · 6H ₂ O are dissolved in purified water at 20-25 ° C separately from the salts NaCl, KCl, CH ₃ OONa · 3H ₂ O and added as a solution to the cooled to 20-25 ° C solution of salts of NaCl, KCl, CH ₃ OONa · 3H ₂ O. The resulting solution is stirred for 15-20 minutes and the content of ions Na ⁺ , K ⁺ , Ca ⁺⁺ , Mg ⁺⁺ , CH ₃ СОО ^- , Cl ^{- is} monitored osmolarity.

The disadvantages of this method include the fact that the operation of heating salts of NaCl, KCl, CH ₃ OONa · 3H ₂ O to a temperature of 80-90 ° C complicates the process, as it requires additional equipment, which significantly increases the cost of electricity. The ability to maintain stable hemodynamics during bicarbonate hemodialysis and fewer complications have practically determined the predominant use of bicarbonate dialysis over acetate.

Also, the disadvantages of the method include the additional operation of separately dissolving CaCl ₂ · 6H ₂ O, MgCl ₂ · 6H ₂ O, followed by mixing with other salts.

A known method of treating renal failure, in which a bicarbonate dialysis solution is used (RU 2154499, 1998.10.16, A61M 1/34). The dialysis solution consists of two parts - components "A" - the acid component and "B" - the bicarbonate component.

The acid component “A” contains an acid ion, in which component A contains acetic acid or sodium acetate (it is not an acid ion). The content of acetate ion is 3-6 mmol / l, which leads to the development of acidosis in patients receiving a chronic hemodialysis procedure.

The disadvantages of preparing the solution include the relatively complex composition of the acid component "A" containing a concentrated solution of acetic acid (2-5) meq / l, divalent cations - calcium (2.5-3.5) meq / l, magnesium (0, 5-1.0) meq / l, potassium (1.2-2.3) meq / l, sodium (135-140) meq / l, chlorides (100-120) meq / l, pH (7.2- 7.4) meq / l, pCO ₂ (40-100) mmHg and the bicarbonate component “B” - (28-38) meq / l, moreover, the above solutions should be produced and stored under aseptic conditions.

Known methods for preparing dialysis solutions in the form of liquid and dry (powder) concentrates (Dialysis Manual, ed. Triad, Tver, 2003, Third Edition, Lippincott Williams & Wilkins). Liquid bicarbonate concentrate is prepared in the form of two components: bicarbonate and acid. The latter contains lactic, acetic or citric acids, plus sodium, chlorine, potassium, if necessary, dextrose (preferably) and all the necessary amounts of calcium and magnesium. A special device of the dialysis apparatus mixes these two components simultaneously with purified water and get a dialysis solution. To reduce the cost of storage, transportation, some companies today offer bicarbonate concentrate or both bicarbonate and acetate concentrates in the form of containers with dry powder, which are diluted on the spot during dialysis.

A known method of obtaining a bicarbonate dialysis solution is adopted as a prototype. Its disadvantages include the presence of a pungent odor in the composition of concentrated volatile acetic acid, which requires expensive precautions when working with it, both at the stage of preparation of dialysis solutions and at the stage of use during the hemodialysis procedure (installation of fume hoods and supply and exhaust ventilation )

The tasks to which the invention is directed are to replace acetic acid with hydrochloric acid, which allows you to remove acetate ions from the hemodialysis solution, replacing them with chlorine and hydrogen ions, which positively affects the dynamics of the hemodialysis process, and also exclude complications in the form of acidosis, which occur when significant amounts of acetate ions enter the body.

The replacement of acetic acid in the composition of the dialysis solution with hydrochloric acid is aimed at replacing acetate ions, which opens up opportunities for high-flux hemodialysis procedures, in which the intake of acetate ions in the patient's body increases especially.

The tasks are solved as follows.

A method of obtaining a bicarbonate dialysate solution consisting of an acid and bicarbonate components involves mixing dry reagents with demineralized water and characterized in that for the preparation of the said solution, according to the recipe, sets of dry salts (HSS) are formed, for preparing the acid and bicarbonate components, then the acid component of the HSS dissolved at room temperature in purified water and get concentrated acid (CKR), and the bicarbonate component is dissolved at a temperature of 37-40 ° C.

The acidic concentrated solution is fed into the “Artificial kidney” apparatus, which automatically dilutes the KKR in the ratio specified by the apparatus program and mixes it with the bicarbonate component. The resulting dialysis solution contains the following components, in mmol / l:

Sodium Chloride NaCl 137.0-139.3 Calcium chloride CaCl ₂ · H ₂ O 1.2-2.5 Magnesium chloride MgCl ₂ · 6Н ₂ О 0.5-1.0 Potassium chloride KCl 0.3-4.0 Hydrochloric acid 2.0-4.0 Sodium Acetate 0-0.3 Glucose, g / l 0-5.0 Bicarbonate of soda 32,0

The advantages of the obtained dialysis solution include a decrease in acetate ions in it, which prevents acidosis in dialysis patients.

The implementation of the invention provides the following advantages. In well-known solutions, KKR, which contain acetic acid, is supplied to the Artificial Kidney apparatus. At the same time, technical difficulties arise - the environmental situation at the hemodialysis units worsens, because acetic acid is volatile; MAC in the air of the working area is 3 mg / m ³ . Clinical difficulties arise in many patients receiving the hemodialysis procedure using a dialysis solution with acetic acid, acidosis develops.

Technical and clinical difficulties that arise when using acetic acid significantly increase the cost of hemodialysis.

A method of preparing a bicarbonate dialysis solution is as follows. Dry chemical reagents are weighed according to the recipe and formed into sets of dry salts (HSS) for the preparation of concentrated acid and bicarbonate hemodialysis solutions.

HSS for the acid component is dissolved in purified water for hemodialysis at room temperature, HSS for the bicarbonate component is dissolved at a temperature of 37-40 ° C, while obtaining concentrated solutions for the preparation of a hemodialysis solution. KDR is fed to the “Artificial kidney” apparatus, which automatically dilutes and mixes acid and bicarbonate components in the ratio specified by the apparatus program.

EXAMPLE 1

First, an acid component is prepared, for which a necessary amount of salts from a set of dry salts is loaded into a tank filled to 1/3 of the required volume, purified for hemodialysis with water, a stirring device is turned on, the solution is mixed until the salts are completely dissolved, purified water is added to the required volume . The acid component is fed to the "Artificial kidney" apparatus, where it is mixed with diluted purified water in an automatic mode with a bicarbonate component and a bicarbonate dialysis solution is obtained with the following components, mmol / l:

Sodium Chloride NaCl 138.0 Calcium chloride CaCl ₂ · 2H ₂ O 1,5 Magnesium chloride MgCl ₂ · 6H ₂ O 0.5 Potassium chloride KCl 2.0 Hydrochloric acid 3.0 Sodium Acetate 0.2 Glucose, g / l 1,0 Bicarbonate of soda 32,0

In the solution content is controlled ions Na ^+, Ca ^{++, Mg ++, K +,} Cl -, pH, _HCO3, glucose

EXAMPLE 2

Perform the same actions as in example 1, and get a dialysis solution with the following components, mmol / l:

Sodium Chloride NaCl 138.2 Calcium chloride CaCl ₂ · 2H ₂ O 2.5 Magnesium chloride MgCl ₂ · 6H ₂ O 1,0 Potassium chloride KCl 2.5 Hydrochloric acid 3.0 Sodium Acetate 0.2 Glucose, g / l 1,0 Bicarbonate of soda 32,0

In the solution content is controlled ions ^{Na +, Ca ++, Mg ++} , K ^+, Cl ^-, pH, _HCO3, glucose

EXAMPLE 3

Perform the same actions as in example 1, and get a dialysis solution with the following components, mmol / l:

Sodium Chloride NaCl 137.2 Calcium chloride CaCl ₂ · 2Н ₂ О 2.5 Magnesium chloride MgCl ₂ · 6Н ₂ О 1,0 Potassium chloride KCl 2.5 Hydrochloric acid 2.0 Sodium Acetate 0.2 Glucose, g / l 1,0 Bicarbonate of soda 32,0

In the resulting solution control the content of ions Na ⁺ , Ca ⁺⁺ , Mg ⁺⁺ , K ⁺ , Cl ^- , pH, HCO ₃ , glucose content.

The present invention will find application in extracorporeal blood purification for the treatment of patients with acute and chronic renal failure.

EXAMPLE 4

Perform the same actions as in example 1, and get a dialysis solution with the following components, mmol / l:

Sodium Chloride NaCl 139.3 Calcium chloride CaCl ₂ · 2H ₂ O 2.5 Magnesium chloride MgCl ₂ · 6H ₂ O 1,0 Potassium chloride KCl 2.5 Hydrochloric acid 4.0 Sodium Acetate 0.2 Glucose, g / l 1,0 Bicarbonate of soda 32,0

In the resulting solution control the content of ions Na ⁺ , Ca ⁺⁺ , Mg ⁺⁺ , K ⁺ , Cl ^- , pH, HCO ₃ , glucose content.

The present invention will find application in extracorporeal blood purification for the treatment of patients with acute and chronic renal failure.

Claims (1)

A method of obtaining a bicarbonate dialysate solution consisting of an acid and bicarbonate component, comprising mixing dry acid component reagents with demineralized water, characterized in that for preparing said solution according to the recipe, sets of dry salts are formed, which are then dissolved in purified water and the resulting concentrated solution is fed into apparatus "Artificial kidney", which automatically dilutes it in the ratio specified by the program of the apparatus, and ix with bicarbonate component thus obtained dialysis solution contains the following components, mmol / l:
Sodium Chloride NaCl 137.0-139.3 Calcium chloride CaCl ₂ · 2H ₂ O 1.2-2.5 Magnesium chloride MgCl ₂ · 6H ₂ O 0.5-1.0 Potassium chloride KCl 0.3-4.0 Hydrochloric acid 2.0-4.0 Sodium Acetate 0-0.3 Glucose, g / l 0-5.0 Bicarbonate of soda 32,0