Antianemic agent

 

(57) Abstract:

The invention relates to medicine and veterinary medicine, namely to the treatment and prevention of iron deficiency in humans and animals. The aim of the present invention is to improve the efficiency, biological value and safety Antianemic means in comparison with existing similar products. This is achieved by introducing into the composition of Antianemic means of iron-containing component is cleaned from impurities and microorganisms of hemoglobin in the blood of farm animals, containing iron in the ferrous form, and freeze-dried beet juice, ascorbic and/or citric acids and simple sugars in the following ratio, wt. %: the hemoglobin of the blood of farm animals 20-40; freeze-dried beet juice - 30-70; ascorbic or citric acid 10-40; simple sugars (glucose, fructose, lactose) 20-60. Test Antianemic means for the prevention and treatment of anemic conditions in humans and pigs has convincingly demonstrated its advantage over foreign and domestic drugs, namely the complete absence of side effects that pozvolyauschaya (easily digestible chelate divalent heme form); rapid and pronounced therapeutic and prophylactic effect; the tool is an additional source of essential amino acids. 6 table.

The invention relates to medicine and veterinary medicine, namely, to the treatment and prevention of iron deficiency in humans and animals.

According to who, every 4 people in the world is iron deficiency, i.e. suffer from iron deficiency anemia. According to preliminary estimates in Russia up to 60 million people susceptible to this disease of varying severity. The development of this disease contributes to poor nutrition of the population (especially sharp decline in meat consumption is the main source of iron in the body).

To prevent iron-deficiency joints of humans and animals are widely used drugs on the basis of inorganic and organic salts of iron [1] They are used for food fortification (the USA, England, Sweden, Holland and others), and as medicines.

Most common in clinical practice for the treatment of anemia received medications that were created on the basis of ferric sulfate (geospan, conferon, tardyferon, activeren, ferrochrome and others ), sulfina dose of iron preparations should be 4-5 mg of elemental iron per 1 kg of body weight, it is prescribed for 1 h before meals, 3 times. Treatment continued for at least 3 months under constant control of the coefficient of transferrin iron saturation (before normalization 30-60%). Now apply a large number of drugs whose effectiveness is determined not so much by the content of iron as the extent of its absorption in the intestine. Antianemic action of many drugs is enhanced by the combination of iron with ascorbic acid (veraplex, Galatasaray, phytin (fitopatologia), copper (hemocyanin), aloe and citric acid (ferrule), phosphorus (glycerol), amino acids (such as D,L - serine - activeren). For better absorption of iron preparations should be administered in combination with the recovery or acidifying agents (ascorbic acid, gastric juice, 1% hydrochloric acid) and enzymes (pepsin, Pancreatin). In Russia for intravenous administration proposed verboven (contains saharat gluconate iron and cobalt). For intramuscular injection in foreign countries use colloidal compounds saharat iron (ferum-Lek), Zhelezobeton (astropan, imferon), farbital (sorbitol).

The main disadvantages of existing drug is th leads to the necessity of taking significant doses, causing heartburn, lack of appetite, nausea, vomiting, belching, pain in the stomach, diarrhea;

poor tolerance (irritation of the mucous membrane of the small intestine, dyspepsia) almost 10% of adult patients;

due to the binding of iron in the intestine inorganic iron sulfide, which is a physiological stimulator peristalsis, constipation, insoluble iron sulphide, colored stool in black;

the need for additional application of ascorbic acid, other vitamins, gastric juice, hydrochloric acid to enhance absorption of iron;

the fall in blood pressure, flushing of the face, neck, feeling of chest compression, back pain, headache, dizziness, frequent allergic reactions and even shock patients;

can cause darkening of the teeth;

strong likelihood of acute toxicity in overdose;

cause (injections of iron dextran) systemic lesions in the form of drug purpura, as well as local inflammatory and dystrophic changes (local liaidescribe);

there are reports of Carcinogenicity of certain drugs, for example, zhelezobetonov.

oWith sugar syrup, condensed milk and molasses until a thick mass. Then it is cooled to 65-70oAnd add under stirring black food albumin. "Hematogen" is prescribed as a therapeutic feeding drug anemia, in the postoperative period after infectious and other diseases.

Despite the absence of explicit negative effects "Hematogen" is very poorly defined therapeutic and prophylactic effect, and therefore regarded as secondary treatment and nutrient remedy for anemia.

Known effective drugs used in the treatment and prevention of iron deficiency on the composition of the components closest to the stated food Antianemic additive "Hemocyanin" (VFS - 42-153-72), which is produced in Russia. This drug is obtained from the black food albumin (dried hemolyzed blood of cattle). It uses a combination of blood proteins with the preparation of lactic acid iron and sulphate of copper. To obtain "Hemocyanine" to 25 parts of albumin are added 50 parts of lactic acid of iron, 1 part of copper sulfate. 1 tablet of Hemocyanine" sod the HB while eating, drinking diluted hydrochloric acid (10-15 drops per glass of water). The treatment lasts 3 to 6 months and over.

This drug also has some significant drawbacks:

the need for additional daily intake of 1.5-2 cups of 1% hydrochloric acid;

the manifestation of side effects as nausea, disorder of the gastrointestinal tract, etc.

the low efficiency of the drug, not allowing you to use it for the treatment of severe forms of anemia; significant disadvantages to using this form for the prevention of anemic conditions in everyday life.

The invention is directed to the creation of Antianemic agent that would have a higher efficiency, biological value and harmless than the well-known examples.

Used for this purpose is Antianemic agent based on the cleansed from impurities and microorganisms of hemoglobin in the blood of farm animals, containing iron in the ferrous form, and freeze-dried beet juice, ascorbic or citric acid and simple sugars in the following ratio, wt. hemoglobin rural-40; simple sugars (glucose, fructose, lactose) 20-60.

The hemoglobin from the blood of farm animals with a basic substance content of more than 80% (grade B) obtained by separation of blood into plasma and erythrocytes, holding hemolysis last, cleaning of ballast substances by filtration, concentration by ultrafiltration with the subsequent sterilizing filtration of the target product, and if necessary, freeze (spray) drying.

This method ensures hemoglobin, which has important advantages over existing proprietary preparations of this protein, namely the complete absence in the production technology potentially harmful to human health of chemicals (inorganic salts and organic solvents), microbiological purity and preservation of the native structure of hemoglobin, which contains iron in a high-availability of heme ferrous form.

Main indicators of hemoglobin are shown in table.1.

The hemoglobin purification from other proteins corresponds to branded drugs hemoglobin, which are used in laboratory and research work. This will assure the firs.

In table. 2 shows the extended indicators bovine hemoglobin grade "B", which was used in the preliminary tests on pigs and in the clinic for patients.

The data table. 2 indicate that the developed technology allows to produce a product with a fairly high quality indicators. This particularly applies to the lack of hemoglobin impurities of heavy metals (cadmium, mercury, lead and arsenic, as well as microbiological purity of the product.

These additional data confirm the fact that part of Antianemic means of iron-based component of hemoglobin makes it a valuable additional source of iron, other trace elements, as well as the most important essential amino acids. Moreover, the amino acid content of the product is much greater than their presence in the beef, and norms FAO needs of the person. Hemoglobin contains 0,285 g% iron, which is close to theoretical 0.34% and makes it a really natural source of iron, which is available to the body of heme chelate form.

Hemoglobin produced by foreign firms for analytical and laboratory research, not prania heavy metals and microbial contamination. In this regard, the branded preparations of hemoglobin require additional cleanup.

In addition, most corporate jet hemoglobins bad and not fully dissolved in distilled water. Hemoglobin NPF "Mobitek" dissolves quickly and completely in a minimal volume of water. Convincing evidence that the tetramer hemoglobin molecule (M. C. 6400) easily dissociate into subunits, is the electrophoretic separation of hemoglobins produced NPF "Mobitek" under denaturing conditions in the presence of sodium dodecyl sulfate and mercaptoethanol, which confirms the native characteristics of bacterial" haemoglobin supplements, compared to, for example, hemoglobin firm Reanal", which is partially denatured and, in addition, do not dissociate completely in the subunit.

As a positive fact, we can consider the lack of hemoglobin significant quantities of nucleic and fatty acids and lipids in General. Minor amounts of total lipids allow long-term storage of freeze-dried protein under normal temperature conditions with complete retention of the original properties.

Antianemic agent produces citric acids and simple sugars in the above ratio.

Properties of the obtained means are presented in table.3.

Example 1. The use of Antianemic drug for treatment and prevention of iron deficiency of parsadonov.

To study the biological value and efficiency were used Antianemic agent with the following ratio of its constituent components, wt. the hemoglobin of the blood of farm animals (TU 2423-001-10837785-96) 25; freeze-dried beet juice (TU 10.0418-71-92) 33; ascorbic acid, 10; citric acid 10; lactose (OST 49-63 - 85) 22.

Beet juice is a readily water-soluble powder dark brown color with a characteristic smell of beetroot. One part of a lyophilized powder beet juice corresponds to thirty parts of fresh beets.

The experiment was conducted in the conditions of the vivarium of the Institute of physiology, biochemistry and nutrition of farm animals (e.g. Borovsk) on 29 pigs, Sosunov from birth to 56 days (7 weeks). Piglets of the experimental group (14 goals) received in addition to the diet of the proposed tool according to the scheme given in table.4.

According to the data table.5, anemia in piglets not receiving the tool begins to develop immediately after birth and reaches the Naya dependence of the severity of the anemia from a reduction in blood levels of hemoglobin, erythrocytes and hematocrit.

In the experimental group all studied hematological parameters were significantly higher than those in the control. But, if the content of haemoglobin and iron in blood plasma of experimental piglets to seven days of age reached a physiological level, the indicators of erythrocytes and hematocrit were lower than normal (the lower limit of the normal range for hemoglobin is 8.8 g% erythrocytes 4.6 million/mm hematocrit 33%, and plasma iron 70-75 ug% These data indicate the presence of a hidden form of anemia in piglets of the experimental group. In subsequent experiments, apparently, it is necessary to increase the dose of the introduction of haemoglobin supplements 20-30% And still high levels of hemoglobin and plasma iron suggests that the body piglets able to maintain the level of oxygen consumption unchanged.

It should be noted the high content of total protein in the blood of experimental animals. This indicator is largely associated with biosynthetic processes. To the 56 th day live weight of the experimental piglets reached 160,6 kg (control 12,40,4 kg). While the average daily gain in body weight in the experimental group was 66 g more than in the control. These results confirm the position is thanks to the "cooperative" effect increases the absorption of nutrients in the diet as a whole.

In this regard, it is important to note a significant increase in blood gamma globulin, which indicates the increase of resistance of the organism of pigs. This is associated with a higher safety of piglets in the experimental group. It is necessary to note also the complete absence of negative side effects when feeding them money.

Example 2. The use of Antianemic drug for treatment and prevention of iron deficiency in patients in the clinic.

For clinical trials was made Antianemic agent with the following ratio of components, wt. the hemoglobin of the blood of farm animals 30; beet juice freeze dried 30; ascorbic acid, 10; citric acid 10; lactose 20.

Tests of means were conducted in Medical radiological research center of RAMS (,Obninsk) in 25 patients with severe syndrome of iron deficiency (20 women and 5 men) aged from 36 to 54 years old. They were given tablets containing 063 g of hemoglobin 3 times a day for 3 weeks.

Evaluating the effectiveness of funds spent on clinical signs, the condition of the blood, the content of serum albumin, total gelatos is the R in the table.6 data shows, in all groups of patients showed significant increase (P < 0,05) of hemoglobin, number of erythrocytes and serum iron while reducing TIBC (P < 0,01).

Because the bulk of patients were women, it should be considered that the increase of iron metabolism during the experiment was observed on the background of continued monthly.

Additional consumption of patients during the experiment every day about 2.6 mg of iron have also improved their overall health (82%), increased physical performance (73%) and appetite (62%). It should be noted tolerability of funds in any case was not registered negative side effects. This confirms the lack of allergenic high molecular weight compounds, low-molecular potentially toxic substances and microbiological purity of the product. All of this determines the safety of the proposed Antianemic tools.

Thus, the study of biological value and safety Antianemic funds on the basis of hemoglobin in the clinical setting has confirmed its high efficiency in the treatment and prevention of Ana the high efficiency of the proposed Antianemic drug for treatment and prevention of iron deficiency and allow to draw a conclusion about its advantages over foreign and domestic drugs, namely, the complete absence of side effects, which allows the use of high-dose funds in severe forms of anemia; high bioavailability of iron of hemoglobin (easily digestible chelate divalent heme form); rapid and pronounced therapeutic and prophylactic effect; drugs are an additional source of essential amino acids.

On the basis of these unique properties based tools hemoglobin can be concluded about the prospects of its use for the treatment and prevention of iron-deficiency anemia in medical and veterinary practice.

Antianemic agent, which includes a set of components, one of which is iron, characterized in that as the iron-containing component is used purified from impurities and microorganisms hemoglobin of the blood of farm animals, containing iron in the ferrous form, and freeze-dried beet juice, ascorbic or citric acid and a simple sugar the next time their ratio, wt.

The hemoglobin of the blood of farm animals 20 40

Freeze-dried beet juice 30 70

 

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