RU2475050C2 - "protobiol" substances composition for impact on microbial-tissular complex of human bowel and method for microbial-tissular complex recovery in general - Google Patents

Abstract

FIELD: food industry.SUBSTANCE: invention relates to the field of medicine, biology, prevention of the human diseases and health preservation. The substances composition for impact on the microbial-tissular complex of the human bowel is represented by a complex target product. The product includes inactivated yeast cytoskeletons. The yeast is represented by Saccharomyces symbiotic races mixture immobilised on a carrier. The carrier is produced depending on the composition of a mixture of offal of cereals and/or legumes and/or nuts by way of their extrusion under a pressure up to 300 kg/cmand at a temperature of 80 - 220°C combined with drinking water in a proportion equal to 1 kg of the mixture per 0.5-2.0 l of drinking water. Additionally the complex target product includes Saccharomyces symbiotic races vital activity products biomass at a ratio of 15 - 85 % of the Saccharomyces biomass total quantity. The physical and chemical composition of the product is determined according to presence of microelements and/or enzymes and/or hormones introduced in the process of Saccharomyces biomass growth on the carrier as well as according to presence of oligosaccharides in the carrier composition equal to less than 50% of the total content of carbohydrates contained in the carrier. The vital activity products biomass combined with microelements and/or enzymes and/or hormones, produced as a result of their processing by Saccharomyces on extruded offal of cereals and/or legumes and/or nuts having a porous surface no less than 2.0 m/g and with Saccharomyces cells concentration equal to no less than 10-10cells/g, is represented by a biotransformed compound. This compound provides for presence of element compound as follows in the target product, wt %: carbon - no less than 45, hydrogen - no less than 6.4, oxygen - no less than 30, nitrogen - 7.5-10, phosphorus -1.6-3.5, calcium - 0.3-0.8, potassium - 1.5-2.5, magnesium - 0.1-0.4, sodium - 0.06-0.2, sulphur - 0.2% as well as presence of biotransformed yeast microelements in the biotransformed compound which include, mg/kg: ferrum - 90- 350, cuprum - 20-135, zinc - 100-160, molybdenum - 15-65. The biotransformed compound presence in the substances composition ensures adaptogenic, immunomodulatory, metabolic-homeostasing, enterosorption, detoxification and antiinflammatory activity under impact on the bowel microbial-tissular complex with persons suffering from acute and chronic diseases as well as persons having undergone environmental impact.EFFECT: invention allows to recover the microbial-tissular complex of the human bowel in general.4 cl, 7 dwg, 1 tbl, 12 ex

Description

The invention relates to the field of medicine, biology, disease prevention and human health. It is used in biotechnology, namely, in the production of therapeutic and prophylactic agents for humans and in health institutions, as well as in medical institutions as a concomitant, auxiliary agent for the treatment and acceleration of rehabilitation processes in acute and chronic diseases, complex surgical interventions and chemotherapy.

In particular, it can be used as a dietary supplement for influencing the state of the microbial-tissue complex of the human intestine and optimizing its functioning, leveling chronic systemic inflammation and the state of insulin resistance, removing harmful compounds from the body, as well as normalizing carbohydrate, lipid, protein metabolism, water - electrolyte, vitamin and microelement balances, hormonal background and component composition of the human body.

The purpose of the proposed method and composition of substances is their use as biologically active food additives that have eubiotic and detoxifying effects, as well as systemic homeostabilizing and immunomodulating effects. The purpose of the composition is the manufacture, for example, of bakery products with improved organoleptic and nutritional characteristics, the production of preventive food additives and compositions for therapeutic nutrition, as well as the production of drugs with a wide spectrum of action. The composition is used as a complex modulator of the state of the microbial-tissue complex of the intestine and is a source of a wide range of biologically active substances for a living organism with systemic macrobiotic activity with homeostatic and morpho-kinetic functions.

Known invention "Producer of melanin-containing biologically active additives" Astromelanin ", patent RU 2116037, publ. 07/27/1998, IPC A23L 1/054, A61K 35/72, A61K 7/00, C12N 1/16, C12P 17/10, in which a natural known strain of Antarctic black yeast is used as a producer of a melanin-containing biologically active food additive. This invention identifies a source of effective biological additives with new, previously unknown properties that are not inherent in the known properties for a similar purpose. The purpose of this strain is to use, as a producer, the melanin-containing biologically active additives "Astromelanin" with a wide spectrum of action and potential for use. In particular, it stops the destructive effect of labile free radicals. Its use in drugs allows you to enhance or modify the therapeutic effect when used together with drugs. However, the mechanism of its effect is carried out without correction of the state of the microbial-tissue complex of the human intestine. This supplement does not have systemic homeostatic and morpho-kinetic effects.

The invention is known "Method for removing organochlorine pesticides from the body", patent RU 2121352, publ. 11/10/1998, IPC A61K 35/72, the method allows the removal of organic pesticides from the body, based on the phenomenon of physicochemical sorption with direct resistance of the pesticide and sorbent, namely, it is an enterosorption method based on the possibility of extracting toxic substances in intestinal lumen, as well as blood and other biological fluids through the walls of the capillaries of intestinal villi and the removal of toxic substances in a natural way. Despite the fact that disintegrated wine yeast-saccharomycetes are used in the proposed composition of substances, however, this method does not use the capabilities and does not optimize both local and systemic regulatory and homeostatic functions of the human intestinal microbial-tissue complex.

The invention is known "A method of using a biosorbent for removing heavy metals from the body", patent RU 2137399, publ. 09/20/1999, IPC A23L 1/30, A23J 1/18, A61K 35/72, in which the biosorbent is a disintegrated wine saccharomycetes, allowing only toxic metals, in particular, cadmium and lead, to be excreted from the body. However, this method uses only the sorption properties of disintegrated wine yeast-saccharomycetes, while the microbial-tissue complex of the intestine is not restored and the optimization of water-electrolyte and vitamin-microelement and other balances in the body is not realized.

Closest to the proposed method is the invention "Biosorbent" Vitabios and the method of its manufacture ", patent RU 2127066, publ. 03/10/1999, IPC A23L 1/30, B01J 20/24, which uses inactivated yeast having antioxidant activity and electrokinetic potential and the finished product is manufactured, includes heat treatment of the yeast suspension under controlled heating. A biosorbent of a wide spectrum of action is obtained and used, as well as capable of removing radionuclides and heavy metal ions from the body, activating the immune and digestive systems. However, disintegrated cell membranes of yeast - saccharomycetes with negative surface potential must necessarily be calculated for the maximum admissible dose of administration, otherwise the incompatibility of the test organism with drugs, as well as the general state of the body and its susceptibility to stress can give an overdose of this drug. In addition, the mechanism of action of the drug is based on its sorption properties and does not include exposure to the microbial-tissue complex of the human intestine and the optimization of its systemic homeostatic effects.

Currently, there is an urgent need to develop not just a balanced supplement, administered orally, which supplements the micronutrients required for the body, regulates microflora, and also indirectly positively affects human biochemistry, hormonal levels and improves human anthropometry, but also regulates through internal regulatory mechanisms organism all types of homeostasis (balance) due to the restoration and optimization of the functioning of the microbial-tissue complex of the intestine of a person . At the same time, the microbial-tissue complex of the intestine is a complex regulatory body with a wide spectrum of positive effects on the body, based on the close symbiotic interaction of the intestinal epithelium and intestinal microflora.

The discovered beneficial properties of the proposed composition of substances were not previously known and are not described in the literature. As a producer of the target product of eubiotic action on the intestinal microbial and tissue complex, which acts as a detoxifier and regulator of the intestinal microbial and tissue complex, which alleviates chronic systemic inflammation and insulin resistance, which removes harmful compounds from the body, as well as normalizes carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and microelement balances, hormonal background and component composition of the human body The effect of this composition of substances on the microbial-tissue complex of the human intestine is a manifestation of the wide spectrum of action and potential use of the proposed composition of substances and the method of its effect on the microbial-tissue complex of the intestine.

In addition, when regulating the microelement composition in the body, namely by the following indicators: aluminum, beryllium, boron, vanadium, iron, potassium, calcium, cobalt, magnesium, manganese, copper, arsenic, sodium, nickel, rubidium, selenium, phosphorus, chrome, zinc; it is important that the amount of these trace elements in the body is in sufficient quantity, but not exceed the norm, because both of these lead to negative consequences for the body. Therefore, it is required to remove the surplus of trace elements and supplement their shortage due to the development of trace elements by the microbial-tissue complex of the intestine of the body itself. In this case, these indicators can be adjusted endogenously through exposure to the microbial-tissue complex of the intestine. The task is especially important for increased stress on the body, for example, constant, prolonged stress, heavy operations or exposure to hard radiation or in the treatment of chronic diseases, when the recovery dynamics is comparable in time with the body's ability to self-regulation and recovery.

The normal functioning of the microbial-tissue complex of the intestine is determined by the optimal state of all elements of the intestinal mucosa, its blood supply and innervation, as well as the normal qualitative and quantitative composition of the luminal and parietal microflora. Physiological restoration and optimization of the microbial-tissue complex of the intestine should be based on its own sanogenetic potential, in particular, it is necessary to restore the normal concentration of representatives of obligate microflora (for example, lactobacilli, bifidobacteria, bacteroids, E. coli with normal enzymatic activity, fusobacteria, peptostreptococcus enube, , Klebsiella, Proteus) and reduce the concentration of pathogenic and conditionally pathogenic bacteria (yeast-like fungi, Staphilos golden PCC pathogenic enterobacteria, E.coli and hemolyzing lactosonegative).

For this, it is necessary to optimize the living conditions of the obligatory microflora within the body and increase the cantominating surface of the intestinal microbial-tissue complex due to the introduced composition of substances, without disturbing the internal balance of the organism, but stimulating the own sanogenetic potential of the microbial-tissue complex to increase the number of useful representatives of the microbiota and naturally level the number of harmful microorganisms, a logical consequence of which is the optimization of its functions ionization and the implementation of its systemic homeostatic effects. In particular, the optimization of the functioning of the microbial-tissue complex of the human intestine leads to the leveling of chronic systemic inflammation and the state of insulin resistance, the elimination of harmful compounds from the body, as well as the normalization of carbohydrate, lipid, protein, purine metabolism, water-electrolyte, vitamin and microelement balances, hormonal background and component composition of the human body

And this will make it possible to successfully treat any acute and chronic human diseases that require optimization of homeostatic processes (elimination of metabolic, immunological, water-electrolyte, vitamin and other disorders).

For example, in patients with cardiovascular diseases, in particular coronary heart disease, cerebrovascular disease, hypertension, metabolic syndrome, restoration of the microbial-tissue complex of the intestine and, as a result, the leveling of chronic systemic inflammation, endothelial dysfunction and insulin resistance lead to an improvement in the course and prognosis of the disease. These effects are accompanied by an improvement in the following laboratory indicators: cholesterol, triglycerides, HDL, VLDL, CA, LDL, glucose, insulin, homocysteine, C-reactive protein, pro-inflammatory cytokines (TNF-α, IL-1β), etc .; and instrumental indicators: blood pressure, abdominal circumference, degree of fatty hepatosis, reactive hyperemia of the brachial artery, etc.

In patients with endocrine diseases, especially type 2 diabetes mellitus, restoration of the microbial-tissue complex of the intestine and, as a result, optimization of microelement and vitamin exchanges, leveling of chronic systemic inflammation can increase the sensitivity of tissues to hormonal stimuli (in particular, insulin), optimize the process synthesis and breakdown of hormones and hormone-like substances. These effects are accompanied by an improvement in the following laboratory parameters: glucose, insulin, HOMAIR, C-reactive protein, pro-inflammatory cytokines (TNF-α, IL-1β), leptin, adiponectin, ghrelin, estradiol, testosterone, thyroid-stimulating hormone, T4, T3, cortisol glucagon, growth hormone, etc .; and instrumental indicators: blood pressure, abdominal circumference, degree of fatty hepatosis, reactive hyperemia of the brachial artery, etc.

In patients with excess or underweight, restoration of the microbial-tissue complex of the intestine and, as a result, optimization of microelement and vitamin metabolism, leveling of chronic systemic inflammation and insulin resistance can increase tissue sensitivity to hormonal stimuli (in particular, to insulin), normalization of carbohydrate, lipid , protein, purine types of metabolism, water-electrolyte, vitamin and trace elements, hormonal levels allows you to normalize the composition pleasing body composition. These effects are accompanied by an improvement in the following laboratory parameters: glucose, insulin, HOMAIR, C-reactive protein, pro-inflammatory cytokines (TNF-α, IL-1β), leptin, adiponectin, ghrelin, estradiol, testosterone, thyroid-stimulating hormone, T4, T3, cortisol glucagon, growth hormone, etc .; and instrumental indicators: blood pressure, abdominal circumference, degree of fatty hepatosis, reactive hyperemia of the brachial artery, etc. total body weight, muscle mass, body fat mass.

The chain of positive effects on the body can be provided by the proposed composition of substances and the method of exposure to the microbial-tissue complex of the intestine, which is confirmed by experimental data.

Under the following terms, specialists understand the following:

The specialists call the microbial-tissue complex of the intestine a single morphofunctional system that combines the intestinal microflora, dietary fiber, mucus, glycocalyx, epithelium, cellular elements and components of the intercellular matrix of the stroma of the intestinal mucosa with its vessels, lymphoid follicles, APUD-system cells and the ends of the splet nervous system (Grinevich VB et al. // Modern ideas about the value of human intestinal microbiocenosis and methods for correcting its disorders. / New St. Pe Terburg Medical Journal: All-Russian Journal of General Practitioner, 2003. N3. - S.13-20].

The proposed method and composition of substances ensure the achievement of the following technical result:

- the impact on the microbial-tissue complex of a person with the regulation of its systemic homeostatic functions;

- leveling of chronic systemic inflammation and the state of insulin resistance, elimination of harmful compounds from the body, as well as normalization of carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and microelement balances, hormonal background and component composition of the human body directly through microbial-tissue human complex;

- optimization of the human immune status;

- the elimination of an overdose of the composition of substances and the balance of absorbed substances is ensured by the regulatory effects of the microbial-tissue complex of the intestine.

This technical result is achieved due to the fact that the proposed method of exposure, which in the proposed composition of substances consists in the fact that the composition of substances "eubiotic complex" is used as a means of restoring the microbial-tissue complex of the intestine, optimizing its functioning, leveling chronic systemic inflammation and a state of insulin resistance, removing harmful compounds from the body, as well as normalizing carbohydrate, lipid, protein metabolism, water-electro essential, vitamin and microelement balances, hormonal background and component composition of the human body through exposure to PROBIOL substances on the microbial-tissue complex of the human intestine with the aim of optimizing its functioning, leveling chronic systemic inflammation and insulin resistance, normalizing carbohydrate, lipid and protein types of metabolism, water-electrolyte, vitamin and microelement balances, excretion of harmful compounds from the body, modulation of hormonal levels on and component composition of the human body.

Thus, the method of restoring the microbial-tissue complex of the intestine as a whole in order to optimize its functioning, leveling chronic systemic inflammation and the state of insulin resistance, normalizing carbohydrate, lipid, protein metabolism, water-electrolyte, vitamin and microelement balances, hormonal background and component composition the human body and the removal of harmful compounds from the body provides for the introduction to the human composition of substances according to claim 1 in the form of a comprehensive target product a.

The method of restoring the microbial-tissue complex of the intestine as a whole according to claim 5 with the aim of exposing the human intestinal microbial-tissue complex to this complex target product by oral administration.

Thus, the method allows you to use the composition of the substances "PROTOBIOL" as a detoxifier, restoring - microbial-element homeostasis, and / or lipid homeostasis, and / or enzymatic homeostasis, and / or water-electrolyte homeostasis, and / or vitamin-microbial homeostasis, organism as a whole through exposure to the PROTOBIOL substance composition on the human microbial-tissue complex.

It was previously found that the complex, consisting of wine yeast fermented during their growth, wheat bran and minerals, has a wide range of healing effects. So, this drug restores intestinal microflora, has a detoxifying effect, activates humoral immunity in severe infectious processes (see RF patent 2102903, publ. 01.27.1998).

The effect of optimizing the functioning of the microbial-tissue complex is confirmed by the following research data obtained using PROTOBIOL on a statistically significant group of athletes exposed to increased loads. So we measured the biochemical, anthropometric and other indicators of athletes without taking PROTOBIOL for the period of their active training, then we measured the body parameters after rest and then we measured the body parameters during active training with PROTOBIOL. Inspection results see in the table. The following notation is used in the table:

GROUP 1 - before the start of the first game season, they took multivitamins without PROTOBIOL.

GROUP 2 - after the first game season, they took multivitamins without PROTOBIOL.

GROUP 3 - after the holidays, did not accept anything.

GROUP 4 - before the start of the second game season, they took multivitamins + PROTOBIOL.

GROUP 5 - after the second game season, they took multivitamins + PROTOBIOL.

The leveling of chronic systemic inflammation and the state of insulin resistance is confirmed by the following example.

EXAMPLE 1

Patient A., 45 years old, was admitted with a diagnosis of coronary heart disease, exertional angina 1 pc., Hypertension 2 tbsp. (AH 2 tbsp.), Newly diagnosed type 2 diabetes mellitus, compensated, nutritional and constitutional obesity 1 tbsp. (BMI 33.1 kg / m ² ). In addition to antihypertensive, antiplatelet therapy and dietary recommendations, prebiotic correction of the state of the microbial-tissue complex of the intestine was performed. The effectiveness of prebiotic correction was evaluated according to the microbiological examination of feces, the initial degree of intestinal dysbiosis was 3. After 21 days, against the background of the treatment, the patient showed an improvement in the main indicators of carbohydrate (HOMA-IR insulin resistance coefficient decreased from 4.2 to 1.9) and lipid (atherogenic coefficient decreased from 5.3 to 3.2) metabolism, index endothelium-dependent vasodilation (ESVD) of the brachial artery (ESVD index increased from 8.9 to 15.5), markers of chronic systemic inflammation (C-reactive protein level decreased from 8.35 mg / dl to 4.13 mg / dl; level the TNF-α cytokine decreased from 76.3 ng / ml to 26.5 ng / ml). The indicated positive dynamics on the part of laboratory and instrumental data was accompanied by a decrease in BMI (from 33.1 kg / m ² to 31.8 kg / m ² ) and an indicator of relative body fat mass (from 25.6% to 24.7%), a decrease average numbers of blood pressure (systolic blood pressure from 150 to 140 mm Hg; diastolic blood pressure from 90 to 85 mm Hg). In addition, there was a decrease in leptin levels from 11.4 to 5.9 ng / ml. According to the ultrasound examination of the abdominal organs, a decrease in the severity of fatty hepatosis from 3 degrees to 2 degrees was noted. Conducted therapy effectively contributed to improving the overall well-being of the patient and exercise tolerance. According to the microbiological study of feces, an increase in the concentration of obligate microflora (bifidobacteria, lactobacilli, E. coli with normal enzymatic activity) and leveling of the representation of pathogenic and conditionally pathogenic microbiota was noted.

The effect of elimination of harmful compounds from the body is confirmed by the following clinical example.

EXAMPLE 2

Patient K. addressed with symptoms:

tachycardia,

periodic rises in blood pressure,

fatigue, depression, restless sleep;

decreased attention;

muscle spasms;

chilliness.

An objective examination:

The condition is satisfactory. T - 36.4 ° C. BMI - 26.8 kg / m ²

Skin and visible mucous membranes of normal color.

Heart sounds: rhythmic, muffled, heart rate = 94 beats. per minute, satisfactory filling, not tense; the vascular wall outside the pulse wave is not palpable. The apical and cardiac impulse are not palpable. Epigastric pulsation is determined. The boundaries of the heart are within normal limits.

HELL 145 and 95 mm Hg

The abdomen is slightly increased in volume due to subcutaneous fat and flatulence. Liver, spleen not enlarged.

Urination is free, painless.

ECG - an increase in the duration of the QT interval by 10% from the due.

In the biochemical analysis of blood - magnesium 0.71 mmol / l, the remaining indicators without pathology.

A combination of magnesium lactate (450 mg, 46 mg in terms of magnesium) and the PROBIOL prebiotic complex 2 sachets 3 times a day were used.

Within 7 days it was possible to achieve clinical remission (elimination of symptoms), after 10 days - the restoration of the level of magnesium in the blood.

The patient received 138 mg of magnesium per day, which eliminates a possible overdose, nevertheless, an increase in the absorption of magnesium, due to the normalization of the microbial-tissue complex of the intestine, makes it possible to effectively stop magnesium deficiency.

Thus, we can conclude that the addition of a composition of PROTOBIOL substances acts as a means to normalize the level of magnesium in the body, restoring and normalizing microelement homeostasis.

This trend is confirmed by clinical studies using reliable statistical studies on athletes (see table).

EXAMPLE 3

Patient S., 60 years old, was admitted to hospital for acute ischemic cerebrovascular accident in the pool of the right middle cerebral artery. The disease developed against the background of a long time of the existing metabolic syndrome: alimentary-constitutional obesity II tbsp. BMI (35.2 kg / m ² ), arterial hypertension up to 150/100 mm Hg, impaired glucose tolerance. In addition to antihypertensive and neuroprotective therapy, the patient underwent prebiotic correction of the state of the intestinal microbial-tissue complex. The effectiveness of prebiotic correction was evaluated according to the microbiological examination of feces, the initial degree of intestinal dysbiosis was 3. After 21 days, against the background of the treatment, the patient showed an improvement in the main indicators of carbohydrate (HOMA-IR insulin resistance coefficient decreased from 5.6 to 2.45) and lipid (atherogenic coefficient decreased from 4.2 to 2.8) metabolism, index brachial artery endothelium-dependent vasodilation (ESVD) (ESVD index increased from 7.9 to 13.4), markers of chronic systemic inflammation (C-reactive protein level decreased from 10.72 mg / dl to 5.22 mg / dl; level TNF-α cytokine decreased from 82.5 ng / ml to 31.9 ng / ml). The indicated positive dynamics on the part of laboratory and instrumental data was accompanied by a decrease in BMI (from 35.2 kg / m ² to 34.6 kg / m ² ) and an indicator of relative body fat mass (from 27.55% to 25.2%), a decrease average numbers of blood pressure (systolic blood pressure from 150 to 140 mm Hg; diastolic blood pressure from 100 to 90 mm Hg). The conducted therapy effectively contributed to the leveling of the neurological deficit: the indicators of existing neurological symptoms decreased (from 9 to 2 points on the NIHSS scale) and the degree of restriction of activity in the field of everyday life (from 65 to 88 points on the Barthel scale). According to the microbiological study of feces, an increase in the concentration of obligate microflora (bifidobacteria, lactobacilli, E. coli with normal enzymatic activity) and leveling of the representation of pathogenic and conditionally pathogenic microbiota was noted.

EXAMPLE 4

Patient O. addressed with symptoms:

- weakness, fatigue;

- shortness of breath, palpitations during exercise;

- dizziness, darkening in the eyes when rising quickly and in a stuffy room;

- ripple in the temples, neck;

- headache, loss of attention, memory impairment, decreased mental performance.

An objective examination:

The condition is satisfactory. T - 36.6 ° C. BMI - 24.2 kg / m ²

The skin and visible mucous membranes are pale; draws attention to dry skin, cracks on the tips of the fingers, soles; cracks in the corners of the mouth; increased brittleness and hair loss, darker tooth enamel.

Heart sounds: rhythmic, muffled, ChS092 beats. per minute, satisfactory filling, not tense; the vascular wall outside the pulse wave is not palpable. The apical and cardiac impulse are not palpable. The boundaries of the heart are within normal limits. Weak systolic murmur with auscultation of the heart.

HELL 125 and 75 mm Hg The abdomen is soft, painless, the liver, spleen are not enlarged.

Urination is free, painless.

On the ECG, moderate repolarization disorders.

In a general clinical blood test, hypochromic microcytic anemia: hemoglobin - 86 g / l; erythrocytes 3.9 × 10 ¹² / l; color indicator - 0.78; a decrease in the average hemoglobin content in an erythrocyte (SIT) - 22 pg; microcytosis: a decrease in the average volume of the red blood cell (MCV) - 82 fl; an increase in the distribution of red blood cells by volume (RDW) - 18%.

In a biochemical blood test: a decrease in the concentration of iron in serum - 7 μmol / l; increase in OZHSS - 86 micromol / l; a decrease in the concentration of ferritin in serum is 12 μg / l.

Other indicators without pathology.

A combination of iron (II) gluconate (325 mg, 39 mg in terms of iron) and the PROBIOL prebiotic complex 2 sachets 3 times a day was used.

Within 14 days it was possible to achieve clinical remission (elimination of symptoms), after 21 days - the restoration of hemoglobin and iron levels in the blood.

In total (taking into account the prebiotic complex, the preparation of iron (II) gluconate and food), the patient received about 45 mg of iron per day, which eliminates the possibility of an overdose, while increasing the digestibility of iron, due to the normalization of the microbial-tissue complex of the intestine, allows stop iron deficiency.

Thus, we can conclude that the addition of the PROTOBIOL substance composition increases the effectiveness of iron deficiency therapy by restoring the microbial-tissue complex of the intestine and optimizing the microelement balance in iron.

Normalization of carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and trace elements, hormonal levels and component composition of the human body is confirmed by clinical studies using reliable statistical studies on athletes (see table).

The elimination of overdose and the balance of absorbed substances is provided by the regulatory effects of the microbial-tissue complex of the intestine is confirmed by the following clinical example.

The presence of regulatory and optimizing properties of the composition of substances under the general name PROTOBIOL used in the proposed method is confirmed by the graphs presented in the drawings, which demonstrate the presence of morpho-kinetic and homeostasis effects that optimize and normalize functioning, level out chronic systemic inflammation and insulin resistance, normalize carbohydrate , lipid and protein types of metabolism, water-electrolyte, vitamin and microelement of its balances, elimination of harmful compounds from the body, modulation of the hormonal background and component composition of the human body.

The graphs illustrate the results achieved in optimizing and normalizing indicators relative to the norm established by WHO documents. The following notation is used in the graphs:

1 CUT TO - before the start of the first game season, they took multivitamins without PROTOBIOL.

1 CUT AFTER - after the first game season, they took multivitamins without PROTOBIOL.

2 CPE3 - after vacation, did not take anything.

3 CUT TO - before the start of the second game season, took multivitamins + PROTOBIOL.

3 SLICE AFTER - after the second game season, they took multivitamins + PROTOBIOL.

Figure 1 shows the changes in indicators in a group of 15 people for such biochemical parameters.

Figure 2 - changes in indicators for a group of 15 people in vitamins.

Figure 3 - changes in indicators for a group of 15 people in hormones.

Figure 4 - changes in indicators for a group of 15 people on CBS (enzymes).

Figure 5 - changes in indicators for a group of 15 people in microflora.

Figure 6 - changes in indicators for a group of 15 people for trace elements.

In Fig.7 - changes in indicators in a group of 15 people according to anthropometric characteristics.

The absence of an overdose is confirmed by clinical studies, which show that when taking PROTOBIOL, the percentage in the blood of the tested athlete normalizes at high loads, providing the necessary level of microelements, but with an excess of them the same indicator decreases to normal.

(See table)

Thus, this method, using the effect of the PROBOBIOL group of substances on the microbial-tissue complex, provides a technical result: the effect on the human microbial-tissue complex with the regulation of its systemic homeostatic functions, the leveling of chronic systemic inflammation and the state of insulin resistance, elimination of harmful compounds from the body, and also normalization of carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and microelement balance , Hormonal and component composition of the human body directly through the microbe-tissue complex person, optimization of human immune status, with the exception of overdose and balance of absorbent material provides the regulatory effects of microbially-intestinal tissue complex.

The invention is known “Therapeutic prophylactic antianemic and immunocorrective yeast preparation”, patent RU 2117486, publ. 08/20/1998, IPC A61K 35/72, the production of which uses liquid-phase growth of Saccharomyces cerevisiae yeast, enrichment of yeast cells with macroelements and subsequent separation of biomass, which is the target product. This drug, when taken orally, does not optimize the functioning of the microbial-tissue complex of the intestine and does not affect its participation in the regulation of trace elements. In addition, it mainly affects only the body’s ability to assimilate nutritional iron and is enriched with only a few trace elements, while the proposed method can use the whole spectrum of trace elements due to the fact that the microbial-tissue complex of the body independently regulates the required amount of trace elements acquired by the body. , even if their intake through a food supplement is greater than required. In the case of a shortage of incoming microelements, the microbial-tissue complex of the body will regulate with the help of the proposed additive the production of the necessary amount of microelements from substances obtained with food.

Known invention "A method of obtaining a preparation enriched in selenium", patent RU 2086645, publ. 08/10/1997, IPC C12N 1/16, which consists in the cultivation of yeast of the genus Saccharomyces cerevisiae on a nutrient medium containing sources of trace elements, the purpose of this method is the production of yeast biomass on hydrocarbon-containing media to ensure the inclusion of selenium in the biopolymers of the cell. It allows you to include trace elements in the composition of cell biopolymers, but transforming the composition of the biomass cell, it does not take into account the properties and functioning conditions of the microbial-tissue complex of the human intestine, which makes it impossible to regulate its system functions.

The invention is known "A method of obtaining a food biologically active product of the processing of yeast", patent RU 2087531, publ. 08/20/1997, IPC C12N 1/06, C12N 1/16, C12N 1/18, A23J 1/18, C12P 13/00, consisting in the fact that the reaction mass containing the formed yeast autolysate is subjected to sterilization and subsequent drying, which contains a mixture of amino acids and lower peptides, nucleic components, polysaccharides, yeast cell walls. It allows partially (selectively) to ensure the introduction into the human body of protein-carbohydrate complexes in the form of cell membranes with enzymatic activity. This result is achieved due to the introduction of additional substances from outside, and not due to the activation of the morpho-kinetic function of the organism itself. This invention does not affect the microbial-tissue complex of the intestine and does not directly restore the carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and microelement balances directly due to the regulatory functions of the microbial-tissue complex.

The invention is known "Method for the use of biologically active food additives in the diet of athletes", patent RU 2156086, publ. 09/20/2000, IPC A23L 1/30, A61K 35/78, A61K 35/72, in which shells of saccharomycetes with electrokinetic potential in the calculated amount are used as a detoxicant. However, disintegrated cell membranes of yeast-saccharomycetes with negative surface potential must necessarily be calculated for the maximum admissible dose of administration, otherwise the incompatibility of the test organism with drugs, as well as the general state of the body and its susceptibility to stress can give an overdose of this drug. The invention allows to create a biologically active supplement that has the ability to overcome the state of immunodeficiency in athletes during peak loads on his body, due to the optimally selected ratio of components and their properties. However, the result is achieved due to the introduction of additional substances from outside, and not due to the impact on the microbial-tissue complex of the human intestine and the optimization of its systemic homeostatic effects.

The invention is known "Means of increasing human adaptability to extreme conditions", patent RU 2191587, publ. 10.27.2002, IPC A61K 35/72, A23L 1/30, which use the Vitabios biosorbent as a means of increasing human adaptability to extreme conditions. However, disintegrated cell membranes of yeast - saccharomycetes with negative surface potential must necessarily be calculated for the maximum admissible dose of administration, otherwise the incompatibility of the test organism with drugs, as well as the general state of the body and its susceptibility to stress can give an overdose of this drug. In addition, the mechanism of action of the drug is based on its sorption properties and does not include exposure to the microbial-tissue complex of the human intestine and the optimization of its systemic homeostatic effects.

The closest invention is "A method for producing a biologically active drug, biologically active food supplement (dietary supplement) of prebiotic action, leading to correction (leveling) of the metabolic syndrome and a drug for regulating microbiocenosis of the gastrointestinal tract", patent No. RU 2233320, publ. 07/27/2004, IPC C12N 1/16, C12N 11/02, A61K 35/72, A23L 1/05, in which the target product is obtained on the basis of Saccharomycetaeceae biomass, which is placed in the sowing mass on bran cereals extruded at a given pressure and temperature, cultivated to obtain the desired concentration of Saccharomycetaeceae cells with drinking water in a ratio of 50 vol.% to 50 vol.% and get the target product after inactivation of biomass and drying, providing elemental composition in phosphorus, potassium, sodium, magnesium, calcium. The invention allows to obtain an environmentally friendly additive. Moreover, reaching the threshold value of the number of microorganisms per unit volume of the carrier, the use of such an additive will provide a more pronounced positive effect of its effect on the body. In addition, prebiotics are the most environmentally friendly, because they stimulate the growth of their own intestinal flora without introducing alien living microorganisms that may turn out to be pathogens with respect to the endogenous flora. The proposed invention, in addition, allows for a targeted change in the endogenous intestinal flora due to an increase in the representation of the bifidobacteria and lactogenic intestinal flora used to obtain a therapeutic effect, as a result of which correction and treatment of the metabolic syndrome (synonyms - cardiovascular syndrome, X syndrome, deadly quartet, sextet , quintet, dysmetabolic syndrome). The treatment of diseases of the digestive system, endocrine system, cardiovascular system, skin diseases, acute and chronic infectious diseases is also carried out by means of targeted exposure (correction) to intestinal microbiocenosis, which was not used in the prototype and was not known. In the proposed invention, the addition of trace elements, enzymes and hormones is carried out at the stage of activation of the work of yeast cells on the basis of which, it is possible to obtain substances processed by living yeast cells, which are bio-microelements, bio-enzymes and bio-hormones having different, improved properties compared to unprocessed ones, and waste products yeast remains in the product unchanged and gives a positive result, while living yeast cells are inactivated and do not carry out negative effects on the body when taking the proposed composition of substances. However, through a directed effect on the intestinal microbiocenosis, private positive effects, for example, immunomodulation, are realized. At present, new properties of the drug have also been identified, which can be modified by the methods indicated below so that an improved modification of this drug can provide an effect not only on the intestinal microflora, but also directly on the microbial-tissue complex of the intestine as a whole (which has not been identified and used in the prototype), and therefore, could not be used to restore and optimize the microbial-tissue complex of the intestine, regulate its systemic functions, and level the chronic systemic about inflammation and the state of insulin resistance, elimination of harmful compounds from the body, as well as the normalization of carbohydrate, lipid, protein, purine types of metabolism, water-electrolyte, vitamin and microelement balances, hormonal background and component composition of the human body.

The above method is provided through the use of the following composition of substances, which has a wide range of modifications, depending on the type of trace elements introduced during immobilization onto a carrier, which are introduced during the activation of Saccharomyces. Moreover, the entire spectrum of such compositions of substances is called SANOBIOL, one of the special cases using the new open properties of the target product, which consists of biomass of waste products, in particular Saccharomyces, is EUBICOR according to RF patent No. 2233320, which is a prototype.

The importance of correcting dysbiotic disorders, which is often present in various forms of pathology in the clinic of internal diseases, is dictated by the fact that the microbiocenotic composition of the intestinal flora plays a significant role in the regulation of basic metabolic functions (the state of lipid and carbohydrate homeostasis, the formation of an antioxidant defense system that inhibits peroxidation processes) cell membrane modifications), which characterizes the systemic homeostatic functions of the body.

The technical result of the impact on the microbial-tissue complex of a person with the regulation of its systemic homeostatic functions is provided by obtaining the following composition.

The composition of the substances is “PROBIOL eubiotic complex” for exposure to the human microbial-tissue complex, which has an eubiotic effect on the human intestinal microbial-tissue complex, which is a complex target product including inactivated yeast cytoskeletons. The composition of the substances is characterized in that the composition of the substances also includes the biomass of the waste products of the symbiotic races of Saccharomyces together and / or alternately in ratios of 15 to 85%.

The composition of substances for influencing the microbial-tissue complex of the human intestine is a complex target product, including the cytoskeletons of inactivated yeast. OH differs in that the mixture of Saccharomyces symbiotic races immobilized on a carrier is taken as yeast, the carrier is obtained depending on the composition of the mixture of bran of grain and / or legumes, and / or nuts, by extrusion at a pressure of up to 300 kg / cm ² and a temperature of 80 to 220 ° С together with drinking water in the proportion of 1 kg of mixture per 0.5-2.0 l of drinking water, and the composition of the substances in the form of a complex target product additionally includes: biomass of vital products of symbiotic races Saccharomyces in ratios from 15 to 85% of the total Saccharomyces biomass, and the physicochemical composition of the complex target product is determined by the presence of trace elements and / or enzymes and / or hormones introduced during growth (activation) of the Saccharomyces biomass in the carrier in the required effective ratio of the total biomass of Saccharomyces vital products and oligosaccharides in the composition of the carrier, equal to at least 50% of the total carbohydrate content contained in the carrier, which consists of a mixture of extruded bran of cereals and / or legumes and / or nuts, and the biomass of products znedeyatelnosti together with trace elements and / or enzymes and / or hormones derived from the processing of Saccharomyces on extruded bran of cereals and / or legumes and / or nuts with the porous surface of at least 2.0 m ² / g and a concentration of Saccharomyces cells not less than 10 ⁹ -10 ¹² cells / g, is a biotransformed compound, which ensures the presence in the complex target product of elemental composition, wt.%: carbon not less than 45, hydrogen not less than 6.4, oxygen not less than 30, nitrogen 7, 5-10, phosphorus 1.6-3.5, calcium 0.3-0.8%, potassium 1.5-2.5, agnium 0.1-0.4, sodium 0.06-0.2, sulfur 0.2%, as well as the presence in the biotransformed compound of yeast biotransformed trace elements, including, mg / kg: iron 90-350, copper 20-135, zinc 100-160, molybdenum 15-65, moreover, the presence of a biotransformed compound in the composition of substances provides adaptogenic, immunomodulating, metabolic-homeostasis, enterosorption, detoxification and anti-inflammatory activity when exposed to the microbial-tissue complex of the intestines of persons with acute and chronic diseases, as well as persons n exposed to adverse environmental influences. The composition also in the particular case is characterized in that amino acids and / or macro- and / or microelements of organic and inorganic origin are added to the final product after inactivation.

The immobilized (complex) is cultivated on a carrier from a mixture of extruded bran of cereals and / or legumes, and / or nuts, which are used as a mixture with a given physicochemical composition: for oligosaccharides - at least 50% of the total carbohydrate content (and the specified physical the chemical composition is determined by the presence of trace elements and / or enzymes and / or hormones introduced during the growth (activation) of Saccharomyces on the carrier in the required effective ratio of the total biomass of Saccharomyces vital products). Next, the preparation of the nutrient medium is carried out by mixing wine or malt wort with a density of 3–42% with drinking water in a proportion of 10–90 vol.% To 90–10 vol.% With or without micronutrients, amino acids and vitamins, using a two-stream method in two stages.

Moreover, depending on the form of biotransformed compounds, extruded at a pressure of up to 300 kg / cm ² and a temperature of 80 to 220 ° C with drinking water in a proportion of 1 kg of a mixture of bran of cereal crops for 0.5-2.0 l of drinking water, providing elementary composition,%: carbon not less than 45, hydrogen not less than 6.4, oxygen not less than 30, nitrogen 7.5-10, phosphorus 1.6-3.5, calcium 0.3-0.8%, potassium 1.5-2.5, magnesium 0.1-0.4, sodium 0.06-0.2, sulfur 0.2%, with the content of biotransformed trace elements in yeast (in mg / kg): iron 90-350, copper 20-135, zinc 100-160, molybdenum 15-65.

Moreover, the carrier has a porous surface of at least 2.0 m ² / g with a concentration of Saccharomyces cells of at least 10 ⁹ -10 ¹² cells / g, and the composition of the substances affects the microbial-tissue complex of the human intestine as a drug with adaptogenic, immunomodulating, metabolic homeostatic, enterosorption, detoxification and anti-inflammatory activity for people with acute and chronic diseases, as well as people exposed to adverse environmental influences.

In addition, to obtain a composition of substances, a nutrient medium can be used to obtain a composition of substances by mixing wine or malt wort with a density of 3–42% with drinking water in a proportion of 10–90 vol.% To 90–10 vol.% With or without addition , trace elements, amino acids and vitamins, in a two-threaded way in the "n" stages. Also, for example, seed can be prepared from thermotolerant yeast races that are cultivated in a colloidal or dispersed nutrient medium, while adding trace elements, amino acids, and fatty acids in effective amounts. The nutrient medium can be prepared by mixing wine or malt wort with a density of 3–42% with drinking water in a proportion of 10–90 vol.% To 90–10 vol.%, Using the two-flow method in two stages, providing an adjustable difference in the osmotic pressure in the cells yeast and wort. In the composition of the substances, bran of cereals, legumes, and nuts can be used in the form of a mixture with the physicochemical composition of enzymes, hormones, and microelements determined depending on the required effective amount of biotransformed compounds in the final product, and biotransformed compounds are vital products of yeast. The mixture can be extruded at a pressure of up to 300 kg / cm ² and a temperature of (80-220) ° C with drinking water in the proportion of 1 kg of a mixture of bran of cereal crops per 0.5-2.0 l of drinking water. After inactivation, amino acids and / or macro- and / or microelements of organic and inorganic origin can be added to the final product. Depending on the required effective amount of biotransformed compounds, the wort can be subjected to ultrasound treatment at a frequency of 740 kHz during fermentation to increase the ergosterol content by 45-60% and / or electron paramagnetic resonance using radio spectrometers at an ac frequency of about 9000 MHz.

In the particular case receive a composition of substances, for example, the following in composition:

cytoskeletons of inactivated yeast on a carrier in a single dose - 3 g are:

- soluble dietary fiber - 0.25 g,

- dietary fiber insoluble - 1.0 g,

oligosaccharides in the composition of the carrier (for carbohydrates) are inserted - 2.06 g per 3 g of the composition of substances,

while the biomass of waste products ensures the presence in the complex target product of elemental composition, wt.%:

- amino acids: valine - 34.2 mg (1.14%); isoleucine - 19.2 mg (0.64%); lysine - 23.1 mg (0.77%); methionine - 9.6 mg (0.32%); phenylalanine - 19.8 mg (0.66%) per 3 g of the composition of substances,

- vitamins - A - 39.0 ME; D ₃ - 157.2 ME; B1 0.00294 mg; B2 - 0.01668 mg; E - 0.225 mg; C - 0.153 mg per 3 g of the composition of substances:

- carbon - 1350 mg

- hydrogen - 195 mg

- oxygen - 900 mg

- nitrogen - 225 mg

- phosphorus - 48.1 mg

- calcium-9.7 mg

- potassium - 45.1 mg

- magnesium -12.0 mg

- sodium - 1.9 mg

- sulfur - 6 mg

biotransformed trace elements, per 3 g of the composition of substances

- iron - 0.2856 mg

- copper - 0,0476 mg

- zinc - 0.16 mg

- molybdenum-0.002 mg

And the method of obtaining this composition of substances involves obtaining a complex target product by growing the seed matrix in the form of a mixture of symbiotic Saccharomyces races immobilized on a carrier in a nutrient medium and biomass of vital products of Saccharomyces symbiotic races in a nutrient medium, while the medium is taken as a carrier, prepare it by mixing wine or malt wort with a density of from 3-42% with drinking water in a proportion of 10-90 vol.% to 90-10 vol.% with or without the addition of trace elements, amines acid and vitamins, according to the two-threaded method, at least in two stages, and the seed is prepared from Saccharomyces thermotolerant symbiotic races. Then they are cultivated in a colloidal or dispersed nutrient medium, adding during the cultivation and / or enzymes and / or hormones in effective amounts, providing an adjustable difference in the osmotic pressure in yeast cells and the nutrient medium, and get the target product, which is a composition of substances that provide adaptogenic , immunomodulatory, metabolic-homeostasis, enterosorption, detoxification and anti-inflammatory activity and consisting of a mixture of symbiotic races of Saccharomyces cytoskeletons, immobility are supported on the carrier and the biotransformed compound formed in this mixture, after which the resulting complex target product is inactivated.

This combination of substances in the form of biologically active additives based on biomass Saccharomycetaeceae is obtained as follows:

prepare the nutrient medium

cultivating the seed in a nutrient medium to obtain a seed mass,

place the seed mass on the bran of crops, cultivate to obtain the desired concentration of Saccharomycetaeceae cells to obtain the target product after inactivation of the biomass and drying,

at the same time, the seed is prepared on thermo-tolerant races of yeast and cultivated in a colloidal or dispersed nutrient medium, adding micronutrients, amino acids, fatty acids, if necessary,

a colloidal or dispersed nutrient medium is prepared by mixing wine or malt wort with a density of from 3-42% with drinking water in a proportion of 10-90 vol.% to 90-10 vol.%, two-stream method in two stages, providing an adjustable difference in osmotic pressure in yeast cells and must (the larger the difference, the faster the yeast multiplies).

First, a preliminary sowing mass is obtained, and then a working sowing mass is obtained, and bran of cereals, legumes, and nuts is used in the form of a mixture with the physicochemical composition of enzymes, hormones, and microelements, determined depending on the required effective amount of biotransformed compounds that are yeast and extruded (mixture) at a pressure of up to 300 kg / cm ² and a temperature of (80-220) ° C with drinking water in a proportion of 1 kg of a mixture of bran of grain crops for 0.5-2.0 l of drinking water.

The preliminary and working seeding mass is obtained in the form of a liquid inoculum with a concentration of at least 10 ¹² cells / ml, and at both stages the inoculum is added to the liquid nutrient medium until an initial concentration of 1.10 ⁹ cells / ml is obtained and cultured to the indicated cell concentration.

Next, the working sowing mass is placed on a mixture of bran of grain crops in an amount of 20 · 10 ¹² -4 · 10 ¹² cells / kg of the mixture and cultivated for 12-48 hours at a temperature of -4-38 ° C and humidity from 30-90% to a concentration not less than 1.10 ¹² cells / ml, and biomass inactivation is carried out, for example, by infrared radiation at a density of 0.1-3.0 W / cm with a wavelength of 4.3-9.8 μm simultaneously with drying, which is carried out at a temperature of 70- 85 ° C using a combined radiation-convection method to a residual moisture content of 3-5%.

Before packing, the eubiotic complex can be treated with ultraviolet light to enrich the complex with vitamin D2 (ergocalciferol).

Depending on the physicochemical composition of the nutrient mixture for enzymes, hormones and trace elements, determined depending on the required effective amount of biotransformed compounds, the wort is subjected to ultrasonic treatment at a frequency of 740 kHz during fermentation to increase the ergosterol content by, for example, 45-60 % and / or electron paramagnetic resonance using radio spectrometers at an ac field frequency of about 9000 MHz, arising from the interaction of unpaired electrons with the magnetic field of nuclei, it allows changing unbound radicals and arrangement of atoms in a molecule.

Electron magnetic resonance provides activation of growth and a new modification of the functional activity of saccharomycetes.

The ultrasonic treatment regimen is selected depending on the physicochemical composition of the enzymes, hormones and trace elements determined depending on the required effective amount of biotransformed compounds. For example, saccharomycetes begin to synthesize vitamin D.

As a carrier, a mixture of extruded bran of cereals, legumes, and nuts is used, in which (mixture) the physical and chemical composition of oligosugars is at least 50% of the total carbohydrate content. Physico-chemical composition is determined depending on the task. For example, if you want to provide a daily requirement for magnesium, which is 300-800 mg, this need is provided by introducing into the composition of the substances at the fermentation stage, wt.% Magnesium from 0.1 to 0.4. If you want to ensure the daily requirement for iron, then this need is provided by introducing into the composition of the substances at the fermentation stage wt.% Iron mg, which is ensured by the presence of iron in the working inoculum from 90-350 mg / kg.

The properties of the composition of substances are confirmed by the type of activity of the composition, which stimulates the bifido-, lacto-, coligenic effect in the gastrointestinal tract and has the properties of water absorption and swelling, as well as sorption properties that are manifested in the human body.

The presence of the regulatory effect of such a composition of substances is confirmed in clinical studies (see table).

When cultured in a colloidal or dispersed nutrient medium, for example, various microelements are added in effective amounts based on the pathology detected or deficiency or excess in the body, amino acids based on clinical analysis, fatty acids depending on the anthropometric parameters of the body. Moreover, the composition of the substances ensures their digestibility in the required effective amounts, reducing the content with their excess and saturating the body with their lack.

Moreover, the ratio of filler and biomass, in which the ratio of immobilized micronutrients, which is the integral part of the metabolic products of the symbiotic races Saccharomyces products, is their component, is taken in amounts effective for targeted exposure to intestinal microbiocenosis based on the need to regulate systemic homeostatic body functions. For example, a medicinal product contains a biologically active substance, an excipient, and cell components, where a biomass based on biomass, including the vital products of cells of a strain of the species Saccharomyces cerevisiae, for example, Saccharomyces vini, VKPM U-511, is produced in the form of organic and inorganic bio-microelements consisting of from biotransformed microorganisms of proteins, vitamins, lipids, carbohydrates, dietary fiber and / or biotransformed microorganisms of potassium, magnesium, sodium, calcium, phosphorus, obtained in effective amounts SHALL and inactivated cells of a strain of the strain actually species Saccharomyces cerevisiae.

This ensures, for example, elemental composition,%:

carbon 47, hydrogen 6.5, oxygen 31,

nitrogen 7.5-10,

phosphorus 1.6-3.5,

calcium 0.3-0.8%,

potassium 1.5-2.5,

magnesium 0.1-0.4,

sodium 0.06-0.2, sulfur 0.2%.

In yeast, biotransformed microelements (in mg / kg), which are provided in the yeast itself, processed in this way:

iron 90-350,

copper 20-135,

zinc 100-160,

molybdenum 15-65.

The number of trace elements introduced during cultivation depends on the task.

For example, for magnesium daily requirement: in adults - 5 mg / kg / day, in children 5-10 mg / kg / day, in pregnant women and breast-feeding - 10-15 mg / kg / day, in athletes - 10-15 mg / kg / day, in the general case, the daily requirement for magnesium is 300-800 mg. This need is ensured by introducing into the composition of the substances at the fermentation stage wt.% Magnesium from 0.1 to 0.4, which ensures the assimilation of magnesium in the body in the required quantities.

These data are confirmed by clinical trials.

EXAMPLE 5

Patient K. addressed with symptoms:

tachycardia,

periodic rises in blood pressure,

fatigue, depression, restless sleep;

decreased attention;

muscle spasms;

chilliness.

A combination of magnesium lactate (450 mg, 46 mg in terms of magnesium) and the prebiotic complex SANABIL (modification) was used - 2 sachets 3 times a day.

Within 7 days it was possible to achieve clinical remission (elimination of symptoms), after 10 days - the restoration of the level of magnesium in the blood.

The patient received 138 mg of magnesium per day, which eliminates a possible overdose, nevertheless, an increase in the absorption of magnesium, due to the normalization of the microbial-tissue complex of the intestine, makes it possible to effectively stop magnesium deficiency.

Thus, we can conclude that the addition of a composition of SANABIOL substances acts as a detoxifier, restoring and normalizing microbial-element homeostasis.

Moreover, it is known that a randomized study showed high efficacy of monotherapy with magnesium in the treatment of anxiety-depressive disorders (Scharbach H. La Vie Medicale, N17, Novembre, 1988).

- Plasma magnesium levels below 0.75 mmol / L are considered an additional significant risk factor for stroke (Schimatschek HF, Rempis R. Prevalence of hypomagnesemia in an unselected German population of 16,000 individuals. // Magnes Res 2003 Dec; 14 (4 ): 283-90).

The serum magnesium content

- In adults, 0.75-1.26 mmol / L (1.87-3.15 mg / ml)

- In adolescents, 0.74-1.15 mmol / L (1.85-2.87 mg / ml)

- During pregnancy - 0.8-1.05 mmol / l (1.9-2.5 mg / ml)

In red blood cells, the level of magnesium is -1.65-2.65 mmol / l (4.125-6.625 mg / ml).

Magnesium deficiency can be observed not only with malnutrition, but also with an increase in the need for it: during physical and mental stress, stress, psycho-emotional stress, for example, if a child attends school with increased training, he goes in for sports (i.e. has an increased load on nervous system).

Other causes of magnesium deficiency are malabsorption (diarrhea, constipation), gastrointestinal diseases, and laxative abuse.

Increased excretion through the kidneys (renal acidosis, diabetes, diuretics, alcohol).

The use of drugs (birth control, estrogen, beta-blockers, ACE inhibitors, cardiac glycosides, anti-TB drugs, antibiotics, cytostatics. Lack of magnesium leads to a deficiency of zinc, copper, calcium, potassium, silicon and their further replacement with toxic heavy metals: lead, cadmium, aluminum.

Excess magnesium with increased consumption in the form of drugs can also lead to a negative result.

So the symptoms of excess magnesium in the body:

- oppression of reflexes,

- increased inhibitory processes in the central nervous system (lethargy, drowsiness),

- osteoporosis,

- paresthesia

- lowering blood pressure,

- violation of atrial ventricular conduction,

bradycardia.

For example, the daily iron requirement: children - 4-18 mg, adult men - 10 mg, adult women - 18 mg, pregnant women in the second half of pregnancy - 33 mg, for athletes - 30-50 mg. In the general case, the daily requirement for iron is 10-20 mg. This need is ensured by introducing into the composition of the substances at the fermentation stage wt.% Of the total weight of the composition, which is ensured by the presence of iron in the working sowing mass of 90-350 mg / kg, which ensures the assimilation of iron in the body in the required quantities.

EXAMPLE 6

Patient O. addressed with symptoms:

- weakness, fatigue;

- shortness of breath, palpitations during exercise;

- dizziness, darkening in the eyes when rising quickly and in a stuffy room;

- ripple in the temples, neck;

- headache, loss of attention, memory impairment, decreased mental performance.

In a general clinical blood test, hypochromic microcytic anemia: hemoglobin -86 g / l; erythrocytes 3.9 × 10 ¹² / l; color indicator - 0.78; a decrease in the average hemoglobin content in an erythrocyte (SIT) - 22 pg; microcytosis: a decrease in the average volume of the red blood cell (MCV) - 82 fl; an increase in the distribution of red blood cells by volume (RDW) - 18%.

In a biochemical analysis of blood: a decrease in the concentration of iron in serum -7 μmol / l; increase in OZHSS - 86 micromol / l; a decrease in the concentration of ferritin in serum is 12 μg / l.

Other indicators without pathology.

A combination of iron (II) gluconate (325 mg, 39 mg in terms of iron) and the PROBIOL prebiotic complex (modification) was used - 2 sachets 3 times a day.

Within 14 days it was possible to achieve clinical remission (elimination of symptoms), after 21 days - the restoration of hemoglobin and iron levels in the blood.

In total (taking into account the prebiotic complex, the preparation of iron (II) gluconate and food), the patient received about 45 mg of iron per day, which eliminates the possibility of an overdose, while increasing the digestibility of iron, due to the normalization of the microbial-tissue complex of the intestine, allows stop iron deficiency.

Thus, we can conclude that the addition of the PROTOBIOL substance composition increases the effectiveness of iron deficiency therapy by restoring the microbial-tissue complex of the intestine and optimizing the microelement balance.

It is also known that iron deficiency due to impaired oxygen transport function (hemoglobin, myoglobin, cytochromes) causes a longer and more severe course of most chronic diseases of internal organs (Dilan S. et al., 2003).

It was found that the use of iron preparations is accompanied by a significant improvement in cognitive functions in children with iron deficiency (N.A. Korovina et al., 2006).

The clinical picture of the overtraining of professional athletes is often also based on a low level of iron, despite their intake of vitamin-mineral complexes (Louise Burke et al., 2008).

The most important regulatory center of iron homeostasis in the human body is located on the apical and basolateral membranes of the duodenal epithelium (I.N. Zakharova, 2007). Violation of the microbial-tissue complex of the intestine is almost always accompanied by a violation of transport mechanisms through the membrane of intestinal epithelial cells.

A rather frequent side effect when taking iron preparations is constipation (Groond E., 2005), on the other hand, correction of the microbial-tissue complex of the intestine allows them to be leveled.

Iron deficiency can be observed not only with malnutrition, but also with an increase in the need for it: with physical and mental stress, stress, psycho-emotional stress, the presence of foci of chronic infection, heavy menstrual bleeding, and also hidden gastrointestinal bleeding.

Other causes of iron deficiency are malabsorption (diarrhea, constipation), gastrointestinal tract diseases, abuse of laxatives; increased excretion through the kidneys (renal acidosis, diabetes, diuretics, alcohol). The use of drugs (birth control, estrogen, beta-blockers, ACE inhibitors, cardiac glycosides, anti-TB drugs, antibiotics, cytostatics.

Excess iron with increased consumption in the form of drugs can also lead to a negative result.

So the symptoms of excess iron in the body:

- icteric staining of the skin, sclera, as well as palate and tongue, itching, enlarged liver;

- violation of the heart rhythm;

- most of the iron accumulates in the liver, pancreas, heart muscle, which ultimately becomes the cause of the change in the organ itself: hepatitis, cirrhosis of the liver, and diabetes mellitus develop; diseases of the joints, nervous system, cardiac pathologies, up to sudden cardiac arrest;

- excess iron complicates the course of Parkinson's and Alzheimer's diseases, can provoke cancer of the intestines, liver, lungs;

- Rheumatoid arthritis also often proceeds against the background of excess iron.

For example, the daily requirement of iodine: in adults - 150 mcg / day, in children - 180 mcg / day, in pregnant women and breast-feeding - 200 mcg / day, in athletes - 200 mcg / day.

EXAMPLE 7

Patient D. treated with symptoms:

- irritability, aggressiveness, uncontrollability;

- distraction, forgetfulness,

- drowsiness, lethargy,

- increased fatigue, headaches

- fragility of hair and nails,

- an increase in body weight of 6 kg over the past 5 months.

In a biochemical blood test:

increase in cholesterol - 7.1 mmol / l,

thyroid hormones: TSH - 4.5 mU / l (normal - 0.4 - 4.0 mU / l), free T3-2.4 pmol / l (normal - 2.6 - 5.7 pmol / l) , free T4 - 8.4 pmol / l (normal - 9.0 - 22.0 pmol / l), the remaining indicators without pathology.

Ultrasound of the thyroid gland - a diffuse increase in both lobes of the thyroid gland.

Analysis of the spectrum of chemical elements in the hair:

Iodine - 0.05 (norm 0.1-4.2 mcg / g)

Diagnosis: Endemic goiter. Subclinical hypothyroidism with iodine deficiency.

A combination of potassium iodide 200 μg and the prebiotic complex SANOBIOL (modification) was used - 2 sachets 3 times a day.

Within 20 days, clinical remission (elimination of symptoms) was achieved, the iodine level in the hair was 2.1 μg / g.

If a person does not receive enough iodine, then this usually leads to the development of a disease such as endemic goiter, characterized by impaired thyroxine synthesis, inhibition of function and an increase in the size of the thyroid gland.

When administered orally, iodine, selectively accumulating in the tissue of the thyroid gland, affects the function of the thyroid gland, participates in the synthesis of the hormone thyroxine, enhances the processes of dissimilation, favorably affects lipid and protein metabolism. With insufficient iodine content in water and food products, the synthesis of thyroxine is impaired, and iodine and its preparations are necessary to restore the normal hormonal function of the thyroid gland, which justifies the use of iodine preparations for the prevention of endemic goiter.

Small doses of iodine inhibit the formation of thyroid stimulating hormone of the anterior pituitary gland, which explains its positive effect in hyperthyroidism. The use of iodine microdoses to attenuate the goiter effect (enlargement of the thyroid gland, exfoliating eyes) in the treatment of hyperthyroidism with methylthiouracil is based on the same effect.

With frequent use, especially inside, of iodine-containing drugs, some people develop inflammation of the mucous membrane of the upper respiratory tract (runny nose, lacrimation, laryngitis, bronchitis), skin rashes, kidney irritation, etc. These phenomena are called iodism.

Iodine also has a toxic effect. So, a single oral intake of about 2-3 g of iodine or about 30 ml of iodine tincture ends, as a rule, lethally.

If a significant amount of iodine (especially concentrated solutions) enters the body, pain immediately appears as a result of a burn of the mucous membrane of the oral cavity, pharynx, larynx, esophagus and stomach. Vomiting begins with characteristic brown or blue contents. After some time, the body temperature rises, a drop in blood pressure is noted, excitement appears, convulsions and paralysis can occur, the development of toxic pulmonary edema may occur.

The size of the surface of the carrier is important to ensure effective correction of the microbial-tissue complex, since the surface area determines the concentration of the final products of yeast fermentation. So one of the main characteristics of any method of obtaining a composition of substances based on an immobilized enzyme is the maximum amount of protein that can be immobilized on a carrier unit (per 1 g, ml, cm ² , cm ³ ). When immobilizing the required hormones that are placed on a carrier unit, the amount of bioprocessed waste products produced by the yeast on the carrier also depends on whether the yeast is thermo-tolerant and their quantity on the carrier unit.

For example, if the carrier has a porous surface of not less than 2.0 m ² / g with a concentration of Saccharomyces cells of not less than 10 ⁹ -10 ¹² cells / g, then the microbial-tissue complex is controlled due to the high concentration of the final yeast fermentation products with a prebiotic effect , which allows you to effectively influence the microbial-tissue complex of the intestine and regulate its local and systemic homeostasis effects, which are characterized by indicators of the biochemistry of the body:

- cholesterol, triglycerides, HDL, VLDL, CA, LDL, glucose, insulin, homocysteine, cytokines, C-reactive protein, urea, creatinine, bilirubin, direct bilirubin, indirect bilirubin, a common protein.

This is confirmed by clinical studies using reliable statistical studies on athletes (see table).

The main characteristic of any composition of substances obtained on the basis of an immobilized enzyme is catalytic activity localized on a unit of carrier (per 1 g, ml, cm ² , cm ³ ). The unit of enzymatic activity is the amount of enzyme that catalyzes the hydrolysis of 1 μmol of substrate in one minute at 25 ° C and pH 9.0. A comparison of the enzymatic activity of different compositions of substances is carried out on paraoxon as the most widespread substrate.

The catalytic efficiency of the enzyme, which is the ratio of the maximum rate of the enzymatic reaction (Vmax) to the Michaelis constant (Km), which reflects the degree of affinity of the substrate for the enzyme, is used to compare the catalytic properties of the immobilized and native forms of the enzyme. The change in the catalytic efficiency of the enzyme action reflects the influence of the method of obtaining an immobilized enzyme on its catalytic properties.

If, during cultivation, the enzymes required for the task are immobilized, then, on the basis of the proposed composition of substances, the required enzymes and / or vitamins are added to the nutrient medium in effective amounts, which ensures the regulation of vitamin-microbial homeostasis and / or enzymatic homeostasis.

The possibility of obtaining a technical result is also confirmed by clinical examples of various variants of the declared dietary supplement according to the composition of the composition, at the intervals indicated in the formula.

EXAMPLE 8

The composition of the substances includes:

a mixture of repeatedly extruded wheat and rice bran;

wine yeast - a strain of Saccharomyces cerevisiae (vini), genetically unmodified;

succinic acid (succinate) 250 mg per 100 g of Protobiol.

The addition of succinic acid to dietary supplements is based on extensive pharmacological and clinical-biochemical data on the beneficial effects of succinic acid, its salts and esters, which are a universal intracellular metabolite.

When physiological doses of succinic acid are used, two groups of effects can be distinguished: a) direct effect of succinic acid on cellular metabolism; b) the effect of succinic acid on the transport of free oxygen in the tissue. The replenishment of the acid pool of the Krebs cycle, which is impaired by hypoxia, endotoxemia, ischemic disorders, is a necessary mechanism for maintaining energy homeostasis. To replenish the pool of all organic acids of the Krebs cycle, exogenous administration of only one succinate was sufficient. Succinate is a stimulator of the synthesis of reducing equivalents in the cell due to the phenomenon of its rapid oxidation in the cytoplasm, accompanied by rapid ATP resynthesis, which is the basis for the increase in antioxidant resistance with succinic acid and its derivatives. In addition, succinate positively affects the oxygenation of the internal environment, stabilizes the structure and functional activity of mitochondria, is an inducer of the synthesis of certain proteins, and affects ion exchange in the cell. The advantages of succinate in the oxidation rate over other substrates of cellular respiration are most pronounced under conditions of hypoxia, when the NAD-dependent transport of electrons in the respiratory chain is inhibited, and the activity of succinate dehydrogenase and production of endogenous succinate increases. Recent studies have shown the presence of succinic acid biological activity with a unique combination of manifestations: in relation to a healthy body, succinates act as adaptogens and actoprotectors, and in the presence of pathological manifestations they exhibit an atypically high therapeutic effect for adaptagens. The use of succinates in the treatment of pathology of the cardiovascular, respiratory, endocrine systems, gastro-secretory insufficiency and liver lesions of various etiologies, oncological, mental diseases, as stimulants of post-traumatic regeneration is promising; succinic acid is used in medicine to prevent a state of reduced immunological reactivity and to increase adaptogenic resistance to stress influences. In this case, the amplitude and direction of modifications under the action of succinic acid depend on the functional initial state of the tissues, and its final result is expressed in the optimization of the parameters of their functioning.

The conversion of succinic acid in the body is associated with the production of energy necessary for life support. With an increase in the load on any of the body systems, the maintenance of its work is ensured mainly due to the oxidation of succinic acid. The power of an energy production system using succinic acid is hundreds of times greater than all other energy systems in the body.

This is what provides a wide range of non-specific therapeutic effects of succinic acid and its salts. In addition, succinic acid also has effects such as actoprotective and antiviral.

EXAMPLE 9

The composition of the substances includes:

- mixtures of repeatedly extruded wheat and rice bran;

- wine yeast - a strain of Saccharomyces cerevisiae (vini), genetically unmodified;

- dry kelp extract 2.0 g per 100 g Protobiol.

The addition of dry kelp extract to dietary supplements is based on extensive pharmacological and clinical-biochemical data on its beneficial effect. Laminaria, being a natural source of organic iodine, replenishes its deficiency in the body in a natural way, prevents the development of iodine deficiency diseases, prevents the development of goiter associated with a lack of iodine in food.

In addition to iodine, kelp contains a wide range of minerals and trace elements (iron, magnesium, phosphorus, potassium, calcium, copper, zinc, bromine, sulfur, boron, fluorine, nitrogen, cobalt, manganese, sodium, etc.), organic substances and vitamins. Laminaria contains 23 amino acids (the main composition is aspartic, glutamine, folic, pantothenic and alanine). Kelp contains many proteins and salts of alginic acid, which is an effective natural sorbent and is able to neutralize and remove toxins and salts of heavy metals from the body. Laminaria inhibits the reproduction of pathogenic bacteria, being a powerful bactericidal agent (not only in the gastrointestinal tract).

In addition to filling the iodine deficiency, the biologically active substances contained in the kelp have a general strengthening effect, optimize energy exchange and increase the efficiency of the use of nutrients and oxygen by cells. The phytohormones and vitamins contained in kelp stimulate the repair of the mucous membranes of the nose, mouth, intestines, female genital organs, etc. The halide group of elements (chlorine, iodine, bromine) has a disinfecting effect. Laminaria iodine has a regulatory effect on the menstrual cycle, ovaries and thyroid gland, and reduces the pathological manifestations of preclimax.

Supplements contain cytoskeletons of inactivated cells and products of the enzymatic activity of a specially selected strain of wine yeast - Saccharomyces cerevisiae, which are adsorbed onto wheat and rice extruded bran by the original technology. Thus, dietary fiber serves as a substrate for Saccharomyces cerevisiae cells in dietary supplements. The cell membrane of Saccharomyces cerevisiae has a polysaccharide structure, their cytoplasm is rich in amino acids, enzymes, contains vitamins of the R, PP and D ₂ groups.

EXAMPLE 10

The composition of the substances includes:

- mixtures of repeatedly extruded wheat and rice bran;

- wine yeast - a strain of Saccharomyces cerevisiae (vini), genetically unmodified;

- iron lactate - 1.25 g - per 100 g of Protobiol;

- copper sulfate -0.025 g per 100 g of Protobiol.

The addition of biotransformed iron and copper compounds in dietary supplements is based on extensive pharmacological and clinical-biochemical data on the beneficial effects of these trace elements.

Iron in the human body can be divided into 2 large groups; cellular and extracellular. Iron compounds in the cell, which differ in their various structures, possess functional activity characteristic of them and a biological role for the organism. In turn, they can be divided into 4 groups:

1) hemoproteins, the main structural element of which is heme (hemoglobin, myoglobin, cytochromes, catalase and peroxidase);

2) iron-containing enzymes of the non-hemene group (succinate dehydrogenase, acetyl - coenzyme A - dehydrogenase, NADH, - cytochrome C-reductase, etc.);

3) ferritin and hemosiderin of internal organs;

4) iron, loosely bound to proteins and other organic substances. The second group of extracellular iron compounds includes iron-binding proteins transferrin and lactoferrin contained in extracellular fluids.

Hemoglobin contained in red blood cells performs an important gas transport function for the body - it transfers exogenous oxygen and endogenous carbon dioxide. The red blood cell in relation to hemoglobin plays the role of a buffer system capable of regulating the total value of the gas transport function.

Myoglobin is a respiratory protein of the cardiac and skeletal muscles. It consists of a single polypeptide chain containing 153 amino acids and connected to a hemoprosthetic group. The main function of myoglobin is the transport of oxygen through the cell and the regulation of its content in the muscle for the implementation of complex biochemical processes that underlie cellular respiration. It contains 0.34% iron. Myoglobin deposits oxygen during muscle contraction, and when they are damaged, it can enter the bloodstream and excrete in the urine.

Iron-containing enzymes and non-hememic iron cells are found mainly in mitochondria.

The most studied and important enzymes for the body are cytochromes, catalase and peroxidase.

Cytochromes are divided into 4 groups depending on the structure of the hemin group:

A - cytochromes with a heme group connecting formylporfin;

B - cytochromes with a protogem group;

C - cytochromes with a substituted mesoghem group;

D - cytochromes with a heme group connecting dehydroporphin.

Cytochrome oxidase is the final enzyme of mitochondrial electron transport, the electron transport chain, responsible for the formation of ATP during oxidative phospholation in mitochondria. A close relationship has been shown between the content of this enzyme in tissues and their utilization of oxygen.

Catalase, like cytochrome oxidase, consists of a single polypeptide chain linked to a heme group. It is one of the most important enzymes that protect red blood cells from oxidative hemolysis. Catalase has a dual function, depending on the concentration of hydrogen peroxide in the cell. At a high concentration of hydrogen peroxide, the enzyme catalyzes the decomposition reaction, and at a low concentration in the presence of a hydrogen donor (methanol, ethanol, etc.), the peroxidase activity of catalase becomes predominant.

Peroxidase is found mainly in leukocytes and mucous membranes of the small intestine in humans. It also has a protective role, protecting cells from their destruction by peroxide compounds. Myeloperoxidase, an iron-containing hemin enzyme found in azurophilic granules of neutrophilic leukocytes, is released into phagocytic vacuoles during lysis of the granules.

The appointment of iron is indicated for:

iron deficiency conditions

with sideropenic dysphagia of Rossolimo-Ankylosing spondylitis, coilonychia,

perversions of taste and smell, fetid runny nose (onesia).

Copper is a vital element that is part of many vitamins, hormones, enzymes, respiratory pigments, is involved in metabolic processes, in tissue respiration, etc. Copper is of great importance for maintaining the normal structure of bones, cartilage, tendons (collagen), elasticity of the walls of blood vessels, pulmonary alveoli, skin (elastin). Copper is part of the myelin sheaths of nerves. The effect of copper on carbohydrate metabolism is manifested by accelerating the processes of glucose oxidation, inhibiting the breakdown of glycogen in the liver. Copper is a part of many important enzymes, such as cytochrome oxidase, tyrosinase, ascorbinase, etc. Copper is present in the body's antioxidant defense system, being a cofactor of the superoxide dismutase enzyme, which is involved in neutralizing oxygen free radicals. This bioelement increases the body's resistance to certain infections, binds microbial toxins and enhances the effect of antibiotics. Copper has a pronounced anti-inflammatory property, softens the manifestations of autoimmune diseases (eg, rheumatoid arthritis), promotes the absorption of iron.

EXAMPLE 11

The composition of the substances includes:

- mixtures of repeatedly extruded wheat and rice bran;

- wine yeast - a strain of Saccharomyces cerevisiae (vini), genetically unmodified;

- chromium picolinate - 1 mg (which corresponds to 1000 μg of chromium) - per 100 g of protobiol;

- selena methionine (selena cysteine) - 250 μg per 100 g of protobiol.

The addition of biotransformed chromium and selenium compounds in dietary supplements is based on extensive pharmacological and clinical-biochemical data on the beneficial effects of these trace elements.

Chromium is found in foods in fairly low concentrations. With ordinary mixed nutrition, it enters the body in an amount only slightly exceeding the lower limit of the physiological needs of adults in this microelement. With an unbalanced construction of food rations, a uniform diet, a relative deficiency of chromium arises quite quickly. With food, a person should receive 200-250 mcg of chromium per day.

Chromium is involved in the regulation of carbohydrate and lipid metabolism, in maintaining normal glucose tolerance. So, chromium increases insulin activity, strengthens muscles (chromium picolinate helps increase muscle mass and stimulates fat burning during exercise), and also helps to normalize the metabolism of proteins, fats and carbohydrates. Chromium chelate is used in diabetes and weight loss programs. Chromium is the central link in the molecule of a hormone-like substance - glucose uptake factor (GTF), which works in conjunction with insulin, ensuring the passage of glucose through cell membranes. Chromium increases the sensitivity of cellular tissue receptors to insulin, facilitating their interaction and reducing the body's need for insulin. It is able to enhance the action of insulin in all metabolic processes regulated by this hormone. Therefore, chromium is necessary for patients with diabetes mellitus (primarily type II), since its level in the blood of such patients is lowered. Moreover, a high deficiency of this trace element can cause a diabetes-like condition. The level of chromium decreases in women during pregnancy and after birth. This deficiency of chromium can explain diabetes in pregnant women, although this is hardly the only reason. A deficiency of chromium in the body, in addition to increasing blood glucose, leads to an increase in triglycerides and cholesterol in blood plasma and ultimately to atherosclerosis. The effect of chromium on lipid metabolism is also mediated by its regulatory effect on the functioning of insulin.

Chromium is an activator of a number of enzymes (phosphoglucomutase, trypsin, etc.). A very high chromium content was found in some nucleoprotein fractions, participating in the metabolism of nucleic acids.

The main functions of chromium in the body:

- Chromium is part of a low molecular weight organic complex - glucose tolerance factor, which maintains a normal level of glucose in the blood.

- Chromium, together with insulin, acts as a regulator of blood sugar, ensures normal insulin activity.

- Chromium contributes to the structural integrity of nucleic acid molecules.

- Chromium is involved in the regulation of the heart muscle and the functioning of blood vessels.

- Chromium promotes the elimination of toxins, salts of heavy metals, and radionuclides from the body.

Selenium is a biologically active trace element indispensable for human life.

According to literature, selenium can reduce cancer incidence by almost 40% and reduce cancer mortality by 50%. Due to its direct effect on the synthesis of glutathione peroxidase, selenium prevents the risk of mutations in the epithelial cells of the bronchi, intestinal mucosa, and mammary gland.

Recommended for patients:

- with diffuse mastopathies;

- with colitis;

- for the prevention of cancer of the lungs, breast, prostate, thick and straight cat.

It should be noted the absence of contraindications for the use of selenium in pediatrics. The main point of its application in the treatment of childhood diseases is a positive effect on the immune system:

Chronic tonsillitis.

Often sick children.

Secondary immunodeficiency in immunosuppressant therapy.

Diathesis. With a deficiency of selenium is observed:

1. Decreased immunity and increased susceptibility to infection.

2. Hypersensitivity to the effects of ionizing radiation.

3. Violation of the metabolism of fatty acids and an increased risk of atherosclerosis.

4. Impaired liver function and increased sensitivity of the liver to the effects of toxins and hepatitis virus.

5. Violation of the activity of the heart muscle.

6. The development of myocardial dystrophy.

7. Inhibition of the reproductive function of women and men, up to infertility.

8. Out of control of allergic reactions.

9. Pancreatic insufficiency.

10. Exacerbation of skin diseases.

11. Premature aging.

EXAMPLE 12

The composition of the substances includes:

- a mixture of repeatedly extruded wheat and rice bran.

- wine yeast - a strain of Saccharomyces cerevisiae (vini), genetically unmodified;

- L-thyroxine sodium 125 μg per 100 g of Protobiol.

Synthetic L-thyroxine, but biotransformed, causes the same physiological effect as the natural thyroid hormone - L-thyroxine.

The drug refers to hormone replacement therapy for deficiency of L-thyroxine in the body, the factors of which can be various conditions: injuries or surgical removal of the thyroid gland, radiation injuries, functional disorders in the production of thyroid-stimulating hormone, insufficient intake of output substances (iodine, amino acids and other).

An increase in the concentration of thyroid hormones in the blood inhibits the secretion of TSH (thyroid stimulating hormone) and TSH (a hormone that releases thyrotropin). Ultimately, the administration of exogenous thyroid hormones inhibits the production of endogenous thyroid hormones.

Thyroid hormone receptors are localized inside the cells. Thyroxine penetrates cells using passive and active transport mechanisms. Triiodothyronine, which was formed from thyroxine in the cell cytoplasm, penetrates the cell nucleus and binds to thyroid receptors. Receptor binding leads to activation or inhibition of DNA transcription, which affects protein synthesis.

Thyroxine versatile affects a variety of body systems:

enhances energy processes, increases oxygen and glucose consumption in tissues, stimulates cell growth and differentiation. The effect of the drug depends on the dose: small doses enhance anabolic processes, in large doses thyroxin stimulates protein catabolism. L-thyroxine increases myocardial contractility, exhibits a systemic effect, reducing peripheral vascular counteraction.

Pharmacokinetics The areas of the most active absorption of the drug are the proximal and middle parts of the empty intestine. The degree of absorption increases with the use of the drug on an empty stomach and decreases with malabsorption in the small intestine. Absorption may be impaired in elderly patients. Meals that are rich in soy and include bile acids, iron sulfate and aluminum hydroxide supplements can impair the absorption of L-thyroxine. Depending on the above factors, the absorption of L-thyroxine can vary from 50 to 80% of the oral dose. The maximum plasma concentration is usually observed 6-7 hours after taking L-thyroxine. An obvious effect occurs 5-8 days after the start of the drug. About 99% of the circulating L-thyroxin in the blood is bound to serum proteins. L-thyroxine is slowly excreted from the body, its half-life is 6-7 days.

The inactivation and decomposition of L-thyroxine occurs mainly in the liver and kidneys, where deamination, deiodination and conjugation occur. In the liver, deamination, deiodination, and conjugation of L-thyroxine occur and its sulfate and glucuronic derivatives are formed. In all target organs of thyroid hormones, deiodination of L-thyroxine at the 5'-position occurs, which leads to the formation of more active L-triiodothyronine. If deiodination occurs in the 5-position, the so-called reversible triiodothyronine is formed, which practically has no bioactivity. Conjugated hormone in the form of glucuronide and sulfate is found in bile and intestines. Up to 40% of L-thyroxine is excreted in the feces.

Indications for use. Replacement therapy in patients with hypothyroidism of various origins (primary and secondary hypothyroidism, including after surgery for goiter and radioactive iodine therapy), except for transitional hypothyroidism in the recovery period; complex treatment of toxic goiter (after reaching the euthyroid state), autoimmune thyroiditis, benign euthyroid goiter; prevention of relapse after surgical treatment of nodular and malignant neoplasms of the thyroid gland. Conducting a differential diagnostic test of thyroid suppression.

The technical result of optimizing the parameters of the body is also confirmed by clinical studies using reliable statistical studies on athletes (see table).

As a result, through the action of the PROTOBIOL substance composition on the human microbial-tissue complex, the anthropometric parameters of the body are normalized, for example, by the following indicators: fat mass,%; fat mass, kg; muscle mass, %; muscle mass, kg; body weight, kg; height.

(see table)

During the application of the eubiotic complex (composition of substances) (trade name "PROTOBIOL") it was found that the eubiotic complex can be successfully used in preparing a person for work in an extreme situation. In particular, to work in an extreme situation include the performance of athletes in competitions, the work of rescuers, military exercises, etc. - see table. At the same time, the composition of substances provides highly selective enterosorption of heavy metals and toxic microelements and increases the effectiveness of professional athletes in missing and scored points, their efficiency, getting into a foul during the game, etc.

If it was previously known to use biosorbent as a food additive, as well as the use of biosorbent as a therapeutic drug for removing toxins and toxic substances from the human body (including radionuclides, pesticides, metal ions), then in the submitted application, a new use of biosorbent for the basis of disintegrated cell walls of yeast - saccharomycetes by exposure to the human microbial-tissue complex.

Claims (4)

1. A composition of substances for influencing the microbial-tissue complex of the human intestine, which is a complex target product including cytoskeletons of inactivated yeast, characterized in that the mixture of symbiotic races Saccharomyces is taken as a yeast, immobilized on a carrier, the carrier is obtained depending on the composition of the bran mixture cereals, and / or legumes, and / or nuts, by extrusion at a pressure of up to 300 kg / cm ² and a temperature of from 80 to 220 ° C together with drinking water in the ratio of 1 kg of the mixture to 0.5-2.0 liters of drinking water , and compo The substance in the form of a complex target product additionally includes: the biomass of vital products of Saccharomyces symbiotic races in ratios from 15 to 85% of the total amount of Saccharomyces biomass, and the physicochemical composition of the complex target product is determined by the presence of Saccharomyces biomass introduced during growth (activation) a carrier of trace elements and / or enzymes and / or hormones in the required effective ratio of the total biomass of the waste products of Saccharomyces and oligosaccharides in the carrier, at least 50% of the total content of carbohydrates contained in the carrier, which consists of a mixture of extruded bran of cereals, and / or legumes, and / or nuts, the biomass of waste products together with trace elements and / or enzymes and / or hormones, obtained by processing their Saccharomyces on extruded bran of cereals, and / or legumes, and / or nuts with a porous surface of at least 2.0 m ² / g and with a Saccharomyces cell concentration of at least 10 ⁹ -10 ¹² cells / g, is biotransformed compound that ensures the presence in the complex target product of elemental composition, wt.%: carbon not less than 45, hydrogen not less than 6.4, oxygen not less than 30, nitrogen 7.5-10, phosphorus 1.6-3.5, calcium 0.3 -0.8, potassium 1.5-2.5, magnesium 0.1-0.4, sodium 0.06-0.2, sulfur 0.2%, as well as the presence in the biotransformed compound of yeast biotransformed micronutrients, including, mg / kg: iron 90-350, copper 20-135, zinc 100-160, molybdenum 15-65, and the presence of a biotransformed compound in the composition of the substances provides adaptogenic, immunomodulating, metabolic-homeostatic , enterosorption, detoxification and anti-inflammatory activity when exposed to the microbial-tissue complex of the intestines of persons with acute and chronic diseases, as well as persons exposed to adverse environmental influences. 2. The composition of substances according to claim 1, characterized in that amino acids and / or macro and / or microelements of organic and inorganic origin are added to the final product after inactivation. 3. A method of restoring the microbial-tissue complex of the intestine as a whole in order to optimize its functioning, leveling chronic systemic inflammation and the state of insulin resistance, normalizing carbohydrate, lipid, protein types of metabolism, water-electrolyte, vitamin and microelement balances, hormonal levels and body composition a person and the removal of harmful compounds from the body, comprising administering to a person a composition of substances according to claim 1 in the form of a complex target product. 4. The method of restoring the microbial-tissue complex of the intestine as a whole according to claim 3 with the aim of exposing the microbial-tissue complex of the human intestine to this complex target product by oral administration.

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