Physiolite infusion solution

FIELD: medicine.

SUBSTANCE: what is declared is an infusion solution for filling the deficiency and meeting the physiological needs for water and basic electrolytes, which contains the following ingredients: sodium (Na+) - 27.72-28.28 mmole/l; fumarate(H2C4O42-) - 13.86-14.14 mmole/l; potassium (K+) - 18.61-18.99 mmole/l; calcium (Ca2+) - 3.56-3.64 mmole/l; magnesium (Mg2+) - 2.18-2.22 mmole/l; chlorine (Cl-) - 30.0-30.6 mmole/l; glucose (C6H12O6) - 189.1-192.9 mmole/l, water for injections.

EFFECT: solution contains the basic electrolyte concentration balanced for meeting the physiological needs; it is safe for the clinical application and can be used in diseases of various aetiology for patients of any age.

1 tbl, 2 ex

 

The invention relates to medicine, namely to infusion therapy for the shortfall and ensure physiological water needs and basic electrolytes.

Known multicomponent infusion solution ringer-acetate (JSC "Firm metroliner")containing sodium acetate, sodium chloride, potassium and calcium (Griffith CA. The family of Ringer''s solutions. J Nati Intravenous Therap Assoc 1986; 9:480-483).

The use of this solution in the singular to ensure physiological needs in the basic electrolyte is invalid because its scope is limited to the body's need for sodium. The concentration of sodium per liter of solution, ringer-acetate equal to 135 mmol/L. Physiological need for sodium, for example, for a child 10 years of age is 1 to 2 mmol/l, i.e., not more than 60 mmol per day. Overdose of sodium ions causes a delay in the body of water and, consequently, to the development of edema, disturbance of microcirculation, which may adversely affect the course of the disease.

Solution volume of ringer-acetate should not exceed 450 ml, while the daily volume is within 1700-2100 ml. Missing daily volume of the liquid should not contain sodium, and it is necessary to introduce an aqueous solution of glucose. In addition, the low concentration of potassium, calcium and magnesium in solution, ringer-acetate requires additional use of the Oia their concentrated solutions, which are glucose solution.

Similar features is characterized by a known solution of Sterofundin G5 (Reference Vidal 2013. Drugs in Russia. Vidal 2013). The contents of sodium and chloride in this solution even more than the above: 140 mmol/l and 127 mmol/l, respectively.

There are several variants of child solution Monastery, but they lack magnesium ions and acetate ("Infusion therapy and clinical nutrition" / Under the editorship of Professor G. N. Habich, Fresenius AG, Germany, 1992).

Known sodium chloride 0.22% solution in combination with 5% glucose solution, which contains 20 mmol potassium (Ann G. Bailey et al. Perioperative Crystalloid and Colloid Fluid Management in Children: Where Are We and How Did We Get Here? // Anesth. Play mode display. - 2010. - Feb. - Vol.110, No. 2. - P. 375-390). This solution contains no calcium or magnesium.

A known solution of sodium chloride 0.18% in solution, 4% glucose, containing 30 mmol of sodium and chlorine (Pocket book of Hospital care for children. Geneva, WHO, 2005). The disadvantage of this solution is that it only consists of 3 components and water, and this is not enough to ensure physiological needs basic electrolytes.

Closest to the claimed infusion is a solution of Normotonic G5 containing sodium acetate, sodium chloride, potassium, calcium, magnesium and glucose (Gerasimov, L. C., frost, C. C. "Water-electrolyte and acid-base balance in patients in CR the political conditions". General reanimatology, 2008, No. 4, S. 79-85).

The disadvantage of the solution, selected as a prototype, are too high concentrations of sodium and chlorine: 100 mmol/l and 90 mmol/l, respectively. Such concentrations of sodium and chlorine limit the daily volume of the solution to one liter, while the daily fluid needs adult - an average of 2.5 liters. In result you will need to enter an aqueous solution of glucose in a volume of 1.5 l to achieve the total required amount of fluid. In children, the daily dose of this solution should be between 20 to 30 ml/kg depending on age and physiological needs in ions of sodium and chlorine, and the volume of fluid necessary to Supplement water glucose solution, containing sodium and chlorine ions.

Thus, the solution of Normotonic G5 can not only be used for total intravenous provision of physiological water needs and basic electrolytes.

Another disadvantage of the prototype is that the concentration of glucose molecules in the solution is relatively high and amounts to 55 g/l, which limits the speed of its introduction and eliminates the possibility of use in the operating room, under conditions of General anesthesia because of the risk of hyperglycemia.

You should conclude that none of the known electrolytic races the thieves can not only be used to provide physiological water needs and basic electrolytes. To perform this task we need to combine one of the sodium solution with an aqueous solution of glucose, in which, as an emergency measure, is added to concentrated solutions of potassium, calcium and magnesium.

The objective of the invention is a balanced deficit reduction and the maintenance of physiological water needs and basic electrolytes by using one multi-component solution.

According to the present invention, the technical solution of the task is achieved by the infusion solution to fill the gap and provide physiological water needs and basic electrolytes containing chlorides of potassium, calcium, magnesium and glucose, the concentration of the components is, mmol/l:

Sodium (Na+)27,72-28,28
Fumarate(H2C4O42-)13,86-14,14
Potassium (K+)18,61-18,99
Calcium (CA2+)3,56-of 3.64
Magnesium (Mg2+)2,18-2,22
Chlorine (Cl-)30,0-30,6
Glucose (C6H12O6)189,1-192,9
Water for injectionrest

Sodium concentration less than 28 mmol/l may lead to a decrease in the concentration of sodium in the blood plasma, the development of excitation, the occurrence of muscle spasms and cramps. Excess sodium concentration more than 28 mmol/l can lead to an overdose of sodium with the development of edema interstice, circulation and nutrition of the cells.

The concentration of potassium is less of 18.8 mmol/l may lead to a decrease in the concentration of potassium in the blood plasma, weakness of skeletal muscles, including respiratory, decrease intestinal motility, depression of consciousness. The excess concentration of potassium more than 18.8 mmol/l may lead to increased concentration of potassium in plasma, development of cardiac arrhythmias, the occurrence of ventricular fibrillation and asystole.

The calcium concentration of less than 3.6 mmol/l may lead to a decrease in the concentration of calcium in the blood plasma, development of muscle spasm, hypertonicity of muscles, until the development of seizures. Excess calcium concentration of 3.6 mmol/l may lead to increased concentrations of calcium in the plasma, the development of disorders in the Central nervous system (drowsiness, depression, psychosis, ataxia, stupor, and coma), muscle weak the STI, hypertension, bradycardia and asystole.

The concentration of magnesium is less than 2.2 mmol/l may lead to a decrease in the concentration of magnesium in plasma, development of persistent high blood pressure, heart rhythm problems, spasms and convulsions. The higher concentration of magnesium than 2.2 mmol/l may lead to increased concentration of magnesium in plasma, the development of arterial hypotension, respiratory depression and loss of consciousness.

The chlorine concentration of less than 30.3 mmol/l may reduce the chlorine concentration in plasma, renal failure and azotemii. The excess concentration of chlorine more than 30.3 mmol/l may lead to higher concentrations of chlorine in the plasma, the development of excitation, edema, heart rhythm and respiratory depression.

The glucose concentration less than 34 g/l can lead to a decrease in the concentration of glucose in the blood plasma, hypotonia, and coma. Excess glucose concentration of more than 34 g/l can lead to increased concentrations of glucose in plasma, the development of ketoacidosis, dehydration due to glycosuria and osmotic diuresis and impaired consciousness.

Concentration fumarata less than 14 mmol/l leads to a decrease in the content of gamma and immunoglobulin, antioxidant protection and immune responsiveness Concentration fumarata more than 14 mmol/l may cause times is the United nausea, pain in the epigastrium, vomiting, diarrhea, occurrence of dizziness, weakness, confusion and lowering blood pressure.

Thus, the claimed solution "Fazioli" is balanced by the content of electrolytes and glucose, does not violate the acid-base equilibrium and optimal for intravenous shortages and security physiological needs in the water and basic electrolytes.

In the table the values of the components of the proposed solution "Fazioli", if used to provide the daily physiological needs in the fluid (V), basic electrolytes and glucose depending on age in years (n) and body mass (MT).

Age, body weight, daily fluid volume and the amount of electrolytes in mmol/kg/day using a solution "Fazioli"
nMTV*SodiumPotassiumCalciumMagnesiumChlorineGlucose
1101000 2,81,880,360,223,03.4 g/kg
31513502,51,70,320,22,73.1 g/kg
52017002,41,60,300,192,62.9 g/kg
72520002,31,50,280,182,42.8 g/kg
103021002,01,40,250,152,12.4 g/kg
1240 25001,81,20,230,141,92.2 g/kg
145025001,41,00,180,111,51.7 g/kg
TCD.7025001,00,670,130,11,081.2 g/kg

* when calculating the volume of fluid according to the formula of Wallace - V ml/kg/day=100-3×n, where n is the age in years (but not more than 2.5 l/day).

On the current data table and on the basis of physiological norms solution "Fazioli" can be adequately satisfy a physiological need in basic electrolytes.

Example 1. Patient K. East. disease No. 6948. Age 1 year. Arrived for treatment in the clinic SPbGPU 21.04.2013. Diagnosis: Congenital malformation. Cleft hard and soft palate. The issue is Lana operation: Uranoplasty.

In the perioperative period and in the first 2 days post-operative intensive care to ensure physiological water needs and basic electrolytes used the claimed solution "Fazioli" in the amount of one liter per day.

Daily biochemical blood analysis of the patient showed that the concentrations of major electrolytes and glucose in plasma were within normal values: sodium 138-140 mmol/l, potassium 3.9 to 4.0 mmol/l; ionized calcium 2.2 to 2.3 mmol/l; magnesium is 0.9 to 0.92 mmol/l; chlorine 101-104 mmol/l; glucose 4.2 to 4.5 mmol/l

Example 2. The Patient Century. East. disease No. 7413. Age 12 years. Arrived for treatment in the clinic SPbGPU 05.04.2013. Diagnosis: Bilateral pneumonia. To fill the gap and provide physiological water needs and basic electrolytes within 3 days of intensive therapy was administered the inventive solution "Fazioli" in a volume of 2.5 liters per day.

Daily monitoring of biochemical blood analysis showed that the concentrations of major electrolytes and glucose in plasma were within normal values: sodium 139-142 mmol/l; potassium of 3.7-3.9 mmol/l; ionized calcium 2.3 to 2.4 mmol/l; magnesium 0,92-0,94 mmol/l; chlorine 103-104 mmol/l; glucose is a 4.3-4.6 mmol/L.

Benefits of the solution "Fazioli" the following:

1) solution "Visioli contains balanced to ensure the physical and the logical needs of the concentrations of major electrolytes, it does not require for this purpose several infusion solutions;

2) the solution is safe for clinical use, as it is composed of chemicals that are used in combination for many decades and in many infusion solutions;

3) the solution can be used for diseases of different etiology;

4) the solution can be used for patients of any age;

5) use of the solution "Fazioli" cannot have a limit on the duration of use;

6) solution "Fazioli" its purpose is not absolute contraindications;

7) the relatively low concentration of sodium ions in solution "Visioli allows parallel with its introduction the use of other sodium solutions special purpose;

8) practical application solution "Fazioli" will reduce the number of complications of infusion therapy, will simplify the calculations in the preparation of infusion program and will reduce the risk of potential errors of the medical staff.

Infusion solution to fill the gap and provide physiological water needs and basic electrolytes containing chlorides of potassium, calcium, magnesium and glucose, wherein the concentration of the components is in mmol/l:

Sodium (Na+)27,72-28,28
Fumarate(H2C4O42-)13,86-14,14
Potassium (K+)18,61-18,99
Calcium (CA2+)3,56-of 3.64
Magnesium (Mg2+)2,18-2,22
Chlorine (Cl-)30,0-30,6
Glucose (C6H12O6)189,1-192,9
Water for injectionrest



 

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