RU2491948C1 - Composition for prevention of iron deficiency anemia - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical industry, and namely to composition for prevention of iron deficiency anemia. Composition for prevention of iron deficiency anemia, which contains source of iron, source of copper, vitamins B₁, B₃, B₆, B₉, B₁₂, ascorbic acid, extract from nettle leaves, extract from strawberry leaves, pantohematogen and auxiliary substances, with specified component ratio.

EFFECT: composition makes it possible to extend arsenal of methods for prevention of iron deficiency anemia and is effective.

4 cl, 3 ex

Description

The invention relates to the food industry and can be used for the production of biologically active additives (BAA) to food and food products aimed at the prevention of iron deficiency anemia (IDA).

Anemia is a group of clinical and hematological syndromes, the common point for which is a decrease in the concentration of hemoglobin in the blood, more often with a simultaneous decrease in the number of red blood cells (or the total volume of red blood cells).

Among the various anemic conditions, IDA is the most common and accounts for about 80% of all anemia.

IDA is hypochromic microcytic anemia that develops as a result of an absolute decrease in iron stores in the body, in which the synthesis of heme and proteins containing iron is disrupted. It occurs, as a rule, with chronic blood loss, insufficient intake of iron in the body or its poor absorption.

Any anemia, including iron deficiency, leads to a decrease in the respiratory function of the blood and the development of oxygen starvation of tissues, which is most often expressed by symptoms such as pallor of the skin, increased fatigue, weakness, headaches, dizziness, heart palpitations, shortness of breath and more.

It is difficult to overestimate the role of iron in the life of the body. This is an essential trace element involved in cell division, biosynthesis of DNA, collagen, and the functional activity of various parts of the immune system.

But first of all, the role of iron is determined by its active participation in tissue respiration, which is an indispensable condition for the existence of any living cell. Iron is contained in the structure of a number of proteins, and, above all, hemoglobin, which carries oxygen from the lungs to cells, tissues and organs. Having given oxygen to the cell, hemoglobin “takes” carbon dioxide from the cell. Thus, red blood cells that contain hemoglobin “supply” oxygen to the tissue and rid them of carbon dioxide.

Thanks to iron, cells are not only supplied with oxygen. At the same time, iron protects organs from the harmful effects of toxic hydrogen peroxide produced by white blood cells - white blood cells.

Thus, the two main "duties" of iron are to maintain a normal level of hematopoiesis and provide the body and tissues with oxygen. In cases where iron is not enough, these functions are inferior, as a result of which various organs and tissues, and the whole organism as a whole, experience a lot of negative consequences.

The adult human body contains approximately 4 grams of iron. More than half of this mass, about 2.5 grams, is accounted for by hemoglobin. A certain amount of iron is stored in the human body in the spleen, liver, and also in the bone marrow. About 1 mg per day "leaves" due to the natural peeling of cells from the surface of the skin and mucous membranes, including the surface of the gastrointestinal tract. In women, iron loss with menstrual blood is added to this.

Therefore, the human body needs an adequate intake of iron throughout life. Children, women during menopause, pregnancy (when redistribution of iron in the body occurs and its additional losses: to build the placenta, fetal needs, to increase hemoglobin) and lactating mothers are among the population with an increased need for iron.

However, no matter how necessary and “right” one or another mineral may be, it will not work by itself. He always needs helpers that facilitate his assimilation, increase his effectiveness, level out possible side effects.

A complex biologically active preparation “Ferrogem” (altaipant.ru/ferrogem) is known from the prior art, which contains pantohematogen — dry Altai blood extract, ferrous sulfate, ascorbic acid (vitamin C) and glucose as an auxiliary component with an appropriate component ratio. The drug makes up for iron deficiency in the body and improves its absorption.

Known complex iron-containing preparation "Ferropan" (catalog / yug / ferropan.html) containing pantohematogen - dry blood extract of Altai maral, iron sulfate and ascorbic acid with an appropriate ratio of components. The product is used for iron deficiency in the body.

A known formulation of dragee enriched and prophylactic action according to the patent of the Russian Federation No. 2257094, which contains pantogematogen, ascorbic acid (vitamin C), iron sulfate, rosehip extract, blackcurrant extract, red rowan extract and excipients with an appropriate ratio of components.

This dragee is called "Mini-Ferropan" and is recommended for insufficient intake of iron with food.

The objective of the present invention is to expand the range of products that make up for iron deficiency by creating a new composition aimed at the prevention of iron deficiency anemia.

The problem is solved in that the composition for the prevention of iron deficiency anemia, which contains a source of iron, a source of copper, vitamins B ₁ ; ₃ , ₆ , ₉ , ₁₂ , ascorbic acid, nettle leaf extract, strawberry leaf extract, pantohematogen and excipients in the following ratio of components, wt.%:

Source of iron 0.08-1.8

Source of copper 0.0045-0.1

Vitamin B ₁ 0.007-0.153

Vitamin B ₃ 0.05-2.0

Vitamin B ₆ 0.007-0.2

Vitamin B ₉ 0.00125-0.04

Vitamin B ₁₂ 0.000011-0.00031

Ascorbic acid 0.45-9.0

Nettle Leaf Extract 0.4-20.0

Strawberry Leaf Extract 0.25-15.0

Pantohematogen 0.15-6.0

Excipients rest

Wherein:

- as a source of iron, the composition contains mineral or organic salts of iron, or amino acid complexes of iron;

- as a source of copper, the composition contains mineral or organic salts of copper, or amino acid complexes of copper;

- made in the form of tablets, dragees or capsules.

Excipients are standard excipients that are widely used in the food and pharmaceutical industries in the manufacture of solid formulations in quantities that provide known manufacturing techniques.

In the preparation of tablets, calcium or magnesium stearate, aerosil, talc, fructose, molasses, microcrystalline cellulose, gum arabic, milk powder, etc., in quantities that determine the tablet technology can be used as auxiliary substances. Tablets are made in a known manner on tablet presses.

When performing the composition in the form of a dragee, sugar, molasses, powdered sugar, microcrystalline cellulose, cocoa powder, etc. can be used as auxiliary substances. in quantities that determine the technology of pelleting.

Another more modern preparative form of the claimed composition is gelatin capsules containing the powder of the claimed composition. To eliminate changes in hygroscopicity during encapsulation, the following auxiliary substances can be used as auxiliary substances: microcrystalline cellulose, talc, calcium stearate, etc.

The execution of the composition in the form of tablets, dragees or capsules gives an extension of the range of the drug in form and choice for customers the most convenient, acceptable form of the drug for him.

The inventive composition makes up for iron deficiency. This is due to its constituent components and their quantitative ratio.

Copper is one of the most important substances and is an indispensable trace element. In the body, copper is concentrated in the bones and muscles, in the brain, blood, kidneys and liver. It is not surprising that with its shortage, the work of all vital organs is disrupted. Copper is necessary for the normal process of blood formation and the functioning of the immune system. Without copper, it is difficult and even impossible for the body to turn iron into hemoglobin, which carries oxygen, which is so necessary for all body tissues. Chemically, this is achieved due to the bivalence of iron atoms. Copper activates iron because also has bivalence.

In patients with anemia, it actively contributes to the restoration of hemoglobin. It can be said that copper stimulates the therapeutic function of iron, which turns the blood red. It greatly increases the body's iron benefits.

The quantitative ratio of minerals was calculated on the basis of “Norms of physiological requirements for energy and nutrients for various groups of the population of the Russian Federation MP 2.3.1.2432-08”, taking into account their influence on metabolic processes. For food products (to which the claimed composition relates), the average daily intake should contain 10-50% of vitamins and minerals from the normal physiological needs of a person (SanPin 2.3.2.2804-10 (change No. 22 to SanPin 2.3.2.1078-01) and GOST P 52349-2005

Vitamin B ₁ (thiamine chloride) is one of the most important vitamins of group B. Its deficiency leads to a violation of the oxidation of carbohydrates, inhibition of the exchange of vital functions, to the accumulation in the blood and tissues of unoxidized metabolic products, which, in turn, leads to pathophysiological changes in nervous and cardiovascular systems. In addition, thiamine improves blood circulation and is involved in hematopoiesis.

Vitamin B ₃ (nicotinic acid or niacin or nicotinamide) is a component of the P complex, which is crucial for energy production and maintaining well-being at many levels, especially for heart health and optimal blood circulation. This vitamin provides normal blood circulation, participates in the processes of enrichment of cells with oxygen, carbohydrate metabolism, normalizes the immunological reactivity of the body and cholesterol in the blood.

Vitamin B ₆ (pyridoxine) - refers to the most important water-soluble vitamins, since it plays an important role in the metabolism, is necessary for the normal functioning of the central and peripheral nervous system, and also plays an important role in the metabolism of fats and proteins.

Pyridoxine is a bio-substance with universal properties. Without vitamin B ₆ blood formation is impossible. He takes part in the production of red blood cells and their coloring pigment - hemoglobin.

In addition, this vitamin is necessary for the normal utilization of copper and iron in the human body, and it also helps the absorption of vitamin B ₁₂ .

Vitamin B ₉ (folic acid) is a deficient substance in our body. Nowadays, probably, there will not be a person who would have enough of this substance in full.

Vitamin B _{9 is} necessary for the normal process of cell division, indispensable for the work of the brain and spinal cord, participates in the synthesis of proteins, stimulates the production of gastric hydrochloric acid.

Folic acid is involved in the process of hematopoiesis. It is necessary for the synthesis of hemoglobin. With its deficiency, the production of red blood cells suffers - in addition, each red blood cell somewhat increases in size and contains an increased amount of hemoglobin, but taking into account the decrease in the number of red blood cells, its total number is also reduced.

Folic acid also plays a significant role in hematopoiesis. Adequate intake of this vitamin in the body is one of the conditions for the successful absorption of iron. It should be noted that folic acid is paired with vitamin B ₁₂ .

Vitamin B ₁₂ (cyanocobalamin) - this vitamin is not only useful, but also vital. It participates in the normal functioning of the nervous system, plays an important role in the functioning of the immune system. But its main function is the anti-anemic effect. Based on a number of works, it was found that the liver contains a substance that regulates blood formation and has a therapeutic effect in case of malignant anemia in humans. A single injection of several millionths of a gram of this substance causes an improvement in hematopoietic function. This substance is called vitamin B ₁₂ or antianemic vitamin. Vitamin B ₁₂ promotes the production of red blood cells. It is necessary for the full functioning of the hemoglobin-red blood cell system. In addition, this vitamin “revives” the reserves of iron in our body, which we always lack.

Vitamin B _{12 also} contains cobalt, which stimulates the production of red blood cells by the bone marrow, affects blood formation and metabolism.

It should be noted that vitamins of group B are always desirable to take in combination, because they have a synergy of action, i.e. reinforce each other's action.

Ascorbic acid (vitamin C) - activates all dynamic life processes.

Vitamin C:

- participates in redox processes, tissue respiration, the formation and metabolism of nucleic acids. This vitamin promotes carbohydrate metabolism and normalizes cholesterol metabolism, prevents the accumulation of peroxides and free radicals in tissues, ensures the normal permeability of capillaries, increases the elasticity and strength of blood vessels, increases the body's resistance to infectious diseases, toxic substances, and oxygen starvation. He also participates in the regulation of iron metabolism, significantly improving its absorption in the body.

When introducing iron into the body, it is necessary to take into account the peculiarities of its metabolism, mainly the peculiarity of its absorption in the gastrointestinal tract. For the successful utilization of iron, ascorbic acid is necessary, which forms a soluble chelate compound with iron, which is well absorbed into the digestive tract. In addition, in iron-deficient individuals, the release of iron from reticulandothelial cells is impaired, and vitamin C leads to a rapid increase in the content of iron in blood serum, leading to the restoration of its normal concentration in the body.

Vitamin C acts comprehensively on the stability of other vitamins in the human body. For example, vitamins B ₁ , A, E, folic and pantothenic acids remain viable longer in the presence of this vitamin.

The effect of ascorbic acid is enhanced in the presence of bioflavonoids, organic acids found in large quantities in extracts of nettle leaves and strawberries.

The quantitative ratio of vitamins as well as minerals was calculated on the basis of “Norms of physiological requirements for energy and nutrients for various groups of the population of the Russian Federation MP 2.3.1.2432-08” taking into account their influence on metabolic processes. For food products (to which the claimed composition relates), the average daily intake should contain 10-50% of vitamins and minerals from the normal physiological needs of a person (SanPin 2.3.2.2804-10 (change No. 22 to SanPin 2.3.2.1078-01) and GOST P 52349-2005

Nettle is a valuable multivitamin plant, a kind of natural concentrate of vitamins. Ascorbic acid in it is twice as much as in fruits of blackcurrant and lemon, carotene content is higher than in berries of sea buckthorn, carrots and sorrel, and only 20 nettle leaves provide our body with the daily norm of vitamin A.

In addition, nettle is rich in vitamins B ₁ , B ₂ , B ₅ , B ₆ , B ₉ , E, K and macro- and microelements, including iron, copper, calcium, cobalt, magnesium and others. Nettle leaves also contain flavonoids, tannins, tannins, volatile, organic acids, chlorophyll and others. Such a rich set of biologically active elements and explains a wide range of restorative and therapeutic properties of nettle. Improving the overall course of all energy processes, nettle has a stimulating effect on carbohydrate and protein metabolism, so it is often recommended for chronic diseases, when the overall resistance of the body is noticeably reduced.

Vitamin K saturates nettle with a powerful hemostatic property. It increases blood coagulability and has an anti-inflammatory effect, which allows the use of nettle as a wound healing agent both for external use and for internal uterine, pulmonary, renal, intestinal and other internal bleeding.

Nettle helps well with heavy periods - the plant reduces blood loss and has a powerful anti-inflammatory effect.

Nettle contains a large amount of vitamin A, which, along with B vitamins and ascorbic acid, is necessary for normal iron metabolism in the body. It has been scientifically established that nettle stimulates hematopoietic functions, therefore nettle treats anemia because it helps to increase the hemoglobin content and increase the number of red blood cells.

Strawberries - in folk medicine the healing properties of not only these amazing berries, but also its leaves have long been known.

Strawberry leaves contain vitamin C, and its leaves are 5 times more than in berries. They also have tannins, flavonoids, traces of alkaloids. Minerals in strawberry leaves are not less than in berries. These are potassium, calcium, copper, iron, cobalt, iodine and others. The beneficial properties of strawberry leaves include their general strengthening effect with weak immunity, cardiovascular diseases, and diuretic effects. They are used for diseases of the kidneys, liver, spleen, uterine bleeding, heavy menstruation, as well as anemia of various origins.

Cobalt contained in the leaves of wild strawberries, as mentioned above, along with iron and copper, takes an active part in hematopoiesis and other vital processes of the human body.

Pantohematogen is a substance crushed to a powdery state from the blood of antler deer (red deer, red deer, sika deer). The millennial use of antlers and blood of antlers is described in many ancient recipes of Tibet, Korea, and China. The characteristics of the organism of antler deer associated with the specifics of the habitat and physiology cause unusually high concentrations of biologically active substances (BAS) in the blood. Not a single tissue, not a single organ of these animals has such fast, powerful growth as antlers. Collected during the period of their rapid growth (before the start of ossification), the blood contains the maximum amount of biologically active substances, and has a unique therapeutic effect on the human body.

In the future, the blood is subjected to a special treatment - defibrinization, low-temperature drying, sterilization. This technology for producing pantohematogen allows preserving the entire complex of biologically active substances: macro- and microelements, amino acids, proteins, enzymes, hormones, nucleic acid bases, etc., which are contained in proportions close to the composition of human blood.

Dry blood of antler deer fully preserves the biological activity inherent in fresh blood, and does not lose it during 2.5-3 years of storage. This environmentally friendly product is an effective adaptogen of a new generation.

It is recognized that along with a restorative, tonic, immunostimulating, adaptogenic effect, pantohematogen has pronounced anti-anemic properties. It heals the blood, increases its volume, improves blood circulation, stimulates the formation of red blood cells, i.e. significantly enhances hematopoietic function.

Plant extracts provide significant support and enhance the indicated properties of pantohematogen, due to the content of flavonoids, vitamins and minerals in them.

The inventive composition is optimized by the quantitative indicators of additives of plant and animal origin.

An increase or decrease in the amount of any component of the additive compared with the claimed leads to an imbalance of the complex of biologically active substances and a violation of the taste and aromatic properties of the finished product.

An increase in the total number of additives of plant and animal origin in excess of the declared impractical, because on the one hand, according to the total number of biologically active substances, the composition will approach drugs in action, and on the other hand, the processes of tabletting, drazhirovany, and encapsulation are more difficult.

The decrease in the number of additives below the stated is also impractical, because entails a decrease in biological value and actually negates their positive effect on the composition as a whole.

Thus, the components included in the composition of the claimed composition and their quantitative ratio, allows to obtain a new product aimed at the prevention of iron deficiency anemia, i.e. solve the problem.

The composition is enhanced by a specially selected complex of biologically active substances, vitamins, and minerals. All these factors facilitate the assimilation of iron, increase its efficiency and thereby allow its biological activity to be increased by almost 100%, just as it happens in nature.

In more detail, the proposed solution is described using an example of a specific implementation, not limiting the invention.

Example 1 (tablets)

Loading rates per 100 kg:

Iron carbonyl (source of iron) 0.16 Copper asparaginate (source of copper) 0.009 Vitamin B ₁ 0.0153 Vitamin B ₃ 0.117 Vitamin B ₆ 0.0153 Vitamin B ₉ 0.0025 Vitamin B ₁₂ 0.000022 Ascorbic Acid (Vitamin C) 0.9 Strawberry leaf extract 0.5 Nettle leaf extract 0.8 Pantohematogen 0.3 Fructose 8.0 Syrup twenty Microcrystalline cellulose 2,5 Gum arabic 0.6 Natural flavor 0.5 Talc 0.2 Calcium stearate 0.5 Aerosil 1,0 Powdered milk up to 100 kg

The preparation of the composition in the form of tablets is carried out according to known technology using standard excipients. In this example, it can be: fructose, molasses, microcrystalline cellulose, gum arabic, natural flavoring, talc, calcium stearate, aerosil, milk powder.

Ingredients sieved through a sieve with a hole diameter of 1.0 mm are loaded into the mixer. The mass is stirred for at least 30 minutes. Next, the resulting material is poured into special containers and sent for tabletting. Tableting is carried out on tablet presses.

Example 2 (dragee)

Loading rates per 100 kg:

Iron carbonyl (source of iron) 0.16 Copper asparaginate (source of copper) 0.009 Vitamin B ₁ 0.0153 Vitamin B ₃ 0.117 Vitamin B ₆ 0.0153 Vitamin B ₉ 0.0025 Vitamin B ₁₂ 0.000022 Ascorbic Acid (Vitamin C) 0.9 Strawberry leaf extract 0.5 Nettle leaf extract 0.8 Pantohematogen 0.3 Sugar and syrup 23.3 Sugar Enclosures 3.3 Microcrystalline cellulose 2,5 Gum arabic 0.6 Cocoa powder 5,0 Natural flavor 0.5 Talc 0.2 Powdered sugar up to 100 kg

The preparation of the composition in the form of dragees is carried out according to known technology using standard excipients. In this example, it can be: sugar-syrup syrup, sugar shells, microcrystalline cellulose, gum arabic, cocoa powder, natural flavoring, talc, icing sugar.

Sugar casings are loaded into the pan. Then, during rotation, sugar-syrup syrup is applied and rotated until the entire surface of the bodies is completely wetted. Then, in stages, through watering with syrup and topping, vitamins, pantohematogen, plant extracts, iron carbonyl, and copper asparaginate are mixed with powdered sugar. Each layer is rolled 12-15 minutes. The last three layers take a mixture of powdered sugar and cocoa powder. Processing is carried out until a dragee of a given size is obtained. The finished semi-finished product is unloaded into trays and stand in the workshop for at least 12 hours. After curing, the semi-finished product is glossy, i.e. coated with gloss to give the surface dragee shine and its stability during storage. Panning boilers are used for glossing. As a gloss, a wax-fat mixture is used. Ready dragees are packed and packaged in accordance with regulatory documents.

Example 3 (capsules)

Loading rates per 100 kg:

Iron carbonyl (source of iron) 0.16 Copper asparaginate (source of copper) 0.009 Vitamin B ₁ 0.0153 Vitamin B ₃ 0.117 Vitamin B ₆ 0.0153 Vitamin B ₉ 0.0025 Vitamin B ₁₂ 0.000022 Ascorbic Acid (Vitamin C) 0.9 Strawberry leaf extract 0.5 Nettle leaf extract 0.8 Pantohematogen 0.3 Microcrystalline cellulose fifty Talc 0.2 Calcium stearate 0.5 Fructose up to 100 kg

The preparation of the composition in the form of capsules is carried out according to known technology using standard excipients. In this example, it can be: microcrystalline cellulose, talc, calcium stearate, fructose.

The estimated amount of ingredients is loaded into a micromill, crushed and mixed to obtain a homogeneous bulk material, which is then Packed in gelatin capsules.

Industrial applicability

The components included in the composition are manufactured by industry. The method of preparing dragees is simple, technological, does not require the use of additional equipment, i.e. the proposed technical solution has industrial applicability.

The effect obtained from the use of the invention consists in expanding the range of domestic functional products aimed at preventing iron deficiency anemia.

Claims (4)

1. Composition for the prevention of iron deficiency anemia, containing a source of iron, a source of copper, vitamin B ₁ , vitamin B ₃ , vitamin B ₆ , vitamin B ₉ , vitamin B ₁₂ , ascorbic acid, nettle leaf extract, strawberry leaf extract, pantohematogen, excipients in the following ratio of components, wt.%:
Source of iron 0.08-1.8 Copper source 0.0045-0.1 Vitamin B ₁ 0.007-0.153 Vitamin B ₃ 0.05-2.0 Vitamin B ₆ 0.007-0.2 Vitamin B ₉ 0.00125-0.04 Vitamin B ₁₂ 0.000011-0.00031 Vitamin C 0.45-9.0 Nettle leaf extract 0.4-20.0 Strawberry leaf extract 0.25-15.0 Pantohematogen 0.15-6.0 Excipients Rest 2. The composition according to claim 1, characterized in that, as a source of iron, it contains mineral, or organic salts of iron, or amino acid complexes of iron. 3. The composition according to claim 1, characterized in that as a source of copper it contains mineral, or organic salts of copper, or amino acid complexes of copper. 4. The composition according to claim 1, characterized in that it is made in the form of tablets, dragees or capsules.