RU2435567C2 - Method of obtaining hemodialysing solution for bicarbonate hemodialysis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine and deals with method of obtaining solution for hemodialysis. Method of obtaining hemodialysing solution for bicarbonate hemodialysis, which includes preparation of concentrated hemodialysing solution by formation sets of dry salts (SDS) of definite composition and quantitative content, following dissolution of SDS at room temperature in purified water and obtaining concentrated solution of hemodialysis (CDS) supplied into apparatus "Artificial kidney", which in automatic mode carries out CDS dilution according to ratio specified in program.

EFFECT: method simplifies obtaining acidic component and its composition ensures natural biochemical metabolite of patient's organism.

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Description

The invention relates to medicine and relates to a method for producing a solution for hemodialysis used in extracorporeal blood purification for the treatment of patients with acute and chronic renal failure.

The composition of hemodialysis 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 (1), which consists in the fact that NaCl, KCl, CH ₃ OONa · 3H ₂ O salts are dissolved in purified water heated to 80-90 ° C, 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 to a 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 COO ^- , Cl ^{- is} monitored osmolality. 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 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, as well as a high content of acetate ions in the dialysis solution - 5-6 mmol / l, which causes in patients with renal failure, acidosis.

The ability to maintain stable hemodynamics during bicarbonate hemodialysis and fewer complications have virtually determined the predominant use of bicarbonate dialysis over acetate.

A known method of treating renal failure, in which a bicarbonate dialysis solution is used (2). The dialysis solution consists of two parts - components "A" and "B". 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), which should be produced and stored under aseptic conditions.

Known methods for the preparation of dialysis solutions in the form of liquid and dry (powder) concentrates (3). Liquid bicarbonate concentrate is prepared in the form of two components: bicarbonate and acid, which contains lactic, acetic or citric acids, 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. However, the presence of a pungent odoriferous volatile acetic acid in the composition requires expensive precautions when working with it, both at the stage of preparation of dialysis solutions and at the stage of use in the hemodialysis procedure (installation of fume hoods and supply and exhaust ventilation).

The objective of the described invention is to simplify the method of obtaining the acid component and its composition by replacing part of acetic acid with succinic acid, as well as providing a natural biochemical metabolite of the patient's body.

The problem is solved by the method of obtaining a hemodialysis solution for bicarbonate hemodialysis, including the preparation of a concentrated hemodialysis solution by forming sets of dry salts (HCC), subsequent dissolution of HCC at room temperature in purified water and obtaining a concentrated solution for hemodialysis (CDR), which enters the device "Artificial kidney ", Which automatically dilutes the CRC in accordance with the specified program ratio, characterized in that gemodializiruyuschy solution contains the following components in mmol / l:

Sodium Chloride NaCl 137.3-140.3 Calcium chloride CaCl ₂ · 2H ₂ O 1.2-1.75 Magnesium chloride MgCl ₂ · 6H ₂ O 0.5-1.0 Potassium chloride KCl 0.3-4.0 Glucose, g / l 1.0-5.0 Acetic acid 0.1-2.9 Succinic acid C ₄ H ₆ O ₄ 0.1-2.9 Bicarbonate of soda 32,0

Succinic acid is a colorless non-toxic crystals, odorless when dissolved, and is an intermediate product of the Krebs cycle, i.e. physiological.

The introduction of succinic acid into the patient’s body accelerates and stimulates the tricarboxylic acid cycle, increasing the energy output necessary for ATP synthesis, increasing tissue oxygen consumption and improving tissue respiration by enhancing electron transport in mitochondria.

The chemical mechanisms of action of succinic acid lead to a decrease in the intensity of acidosis, including cellular acidosis. In patients receiving hemodialysis treatment, there is a decrease in the severity of chronic inflammatory and oxidative stresses underlying protein-energy deficiency and accelerated ateregenesis in patients with terminal uremia. There is a significant improvement in liver function, which is especially important because up to 80% of patients on hemodialysis suffer from chronic viral hepatitis B and C.

Succinic acid preparations are widely used in toxicology and resuscitation. The daily dose of succinic acid when administered intravenously to the patient is 1.5%. The dialysis solution used contains 0.05% succinic acid.

A mixture of acetic and succinic acids has undeniable advantages over using each acid separately.

EXAMPLE 1

To prepare 100 g of a concentrated acid component, a set of dry salts is used. In a tank filled with 70 l of purified water for hemodialysis, salts are loaded from a set of dry salts, a mixing device is turned on, the solution is mixed until the salts are completely dissolved and a hemodialysis solution is obtained with the following components, mmol / l:

Sodium Chloride NaCl 137.3 Calcium chloride CaCl ₂ · H ₂ O 1,2 Magnesium chloride MgCl ₂ · 6H ₂ O 0.5 Potassium chloride KCl 0.3 Glucose g / l 5,0 Acetic acid 0.1 Succinic acid C ₄ H ₆ O ₄ 2.9 Bicarbonate of soda 32,0

Then the volume of the resulting solution was adjusted to 100 l.

In the resulting solution, the content of ions Na ⁺ , Ca ⁺⁺ , Mg ⁺⁺ , K ⁺ , CH ₃ COO ^- , Cl ^- , pH, osmolality is controlled. Before serving the prepared acid component in the apparatus "Artificial kidney" produce its filtration through a filter with a pore size of 100 microns.

EXAMPLE 2

Perform the same actions as in example 1 and get a solution with

the following content of components, mmol / l:

Sodium Chloride NaCl 140.3 Calcium chloride CaCl ₂ · H ₂ O 1.75 Magnesium chloride MgCl ₂ · 6H ₂ O 1,0 Potassium chloride KCl 4.0 Glucose g / l 1,0 Acetic acid 2.9 Succinic acid C ₄ H ₆ O ₄ 0.1 Bicarbonate of soda 32,0

EXAMPLE 3

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

Sodium Chloride NaCl 140.3 Calcium chloride CaCl ₂ · 2H ₂ O 1.75 Magnesium chloride MgCl ₂ · 6H ₂ O 1,0 Potassium chloride KCl 4.0 Glucose g / l 1,0 Acetic acid 2.2 Succinic acid C ₄ H ₆ O ₄ 0.8 Bicarbonate of soda 32,0

Using this solution does not present any technical non-clinical problems.

The introduction of succinic acid into the patient’s body accelerates and stimulates the tricarboxylic acid cycle, increasing the energy output necessary for ATP synthesis, increasing tissue oxygen consumption and improving tissue respiration due to increased electron transport in mitochondria.

The use of the invention positively affects the dynamics of the hemodialysis process, reduces the number of complications in the form of acidosis that occur when significant amounts of acetate ions enter the body, and provides hemodynamic stability in patients at risk and cardiac resuscitation profile.

Information sources

1. RF patent №2200543, 2001

2. RF patent No. 2154499, 1998

3. Dialysis Manual, ed. Triad, Tver, 2003, Third Edition, Lippincott Williams & Wilkins.

Claims (1)

A method of obtaining a hemodialysis solution for bicarbonate hemodialysis, including the preparation of a concentrated hemodialysis solution by forming sets of dry salts (HSS), subsequent dissolution of the HSS at room temperature in purified water and obtaining a concentrated solution for hemodialysis (CDD), which enters the device "Artificial kidney", which in automatic mode, dilutes the CDD in accordance with the ratio specified by the program, characterized in that the hemodialysis solution win following components mmol / l:
Sodium Chloride NaCl 137.3-140.3 Calcium chloride CaCl ₂ · 2H ₂ O 1.2-1.75 Magnesium chloride MgCl ₂ · 6H ₂ O 0.5-1.0 Potassium chloride KCl 0.3-4.0 Glucose, g / l 1.0-5.0 Acetic acid 0.1-2.9 Succinic acid C ₄ H ₆ C ₄ 0.1-2.9 Bicarbonate of soda 32,0