RU2517217C1 - Agent for preventing chronic fatigue syndrome in males - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, namely to an agent for preventing chronic fatigue syndrome in males. The agent for preventing chronic fatigue syndrome in males is presented in the form of suppositories containing male red deer's blood plasma, dry sweetvetch extract, L-arginine and additives in certain proportions.

EFFECT: agent is effective to prevent chronic fatigue syndrome in males; it corrects the psychoemotional status, and also promotes the activation of testosterone synthesis.

Description

The invention relates to the pharmaceutical industry, and in particular to agents that can be used to prevent chronic fatigue syndrome in men.

If you carefully monitor the changes in the health of our population in recent decades, it becomes apparent the steady growth of patients suffering from the so-called "diseases of civilization", which includes chronic fatigue syndrome (CFS). At the moment, this problem is beginning to be global in nature, which speaks of the importance of correcting this pathology in the development of modern society. The formation of this disease, which is quite common today, is connected, first of all, with the peculiarities and pace of life of people in big cities. The reasons also include the excessive emotional and psychological stress that a person often experiences in the modern world, as well as the adverse conditions of the surrounding urban environment. It is noted that more often it occurs in energetic young people who are concerned about the structure of their business and career. The causes of this disease include social factors, due to which CFS is called a “middle class disease”.

Manifestations of CFS are very different. The main symptom is constant fatigue, a feeling of “overwork”, which leads to a decrease in working capacity, both mental and physical. Often noted emotional instability of sleep, poor mood up to depression, memory impairment, a sense of anxiety, fear. In men with CFS, the concentration, motility, and the number of morphologically normal forms of spermatozoa are reduced, testosterone deficiency is noted, which leads to a decrease in sexual potency, and it is generally known how important his sexual activity is in a man’s life. Unfortunately, in the modern rhythm of life, many members of the stronger sex suffer from erectile dysfunction.

Chronic fatigue syndrome is a heterogeneous state with a multifactorial etiology based on disorders in the psycho-endocrine-immune system that adversely affect a man’s erectile function, therefore it is necessary to restore all the leading systems of the body.

Known in the art is the gel concentrate “Tea penny” produced by ArtLife (dvo.artlife.com.ru/customers/catalog/element.php?ID=11259), which contains tea penny extract, sorbitol, citric acid, acusel, grinstead, potassium sorbate, water with an appropriate ratio of components. The gel-concentrate helps to strengthen the general tone of the body, improves immunity, physical endurance, and helps prevent specific diseases in men.

The drug of the Bulgarian company Sopharma "Tribestan" (www.tribestan.biz/fatigue.shtml) is known in the art. It is made in the form of tablets containing dry extract of Tribulus terrestris and auxiliary substances with an appropriate ratio of components. The drug is used for chronic fatigue syndrome in men, has a positive effect on their psycho-emotional and physical condition and has an effect on the level of the hormone testosterone.

The closest to the claimed technical solution is the document - (Red root - The use of red root - Reviews of the red root, (www.babyblog.ru/user/endedemik/2338303), which discloses the use of the red root to maintain male strength, relieve fatigue. However, just the red root is a single drug, so it does not have a wide enough spectrum of action.

The objective of the present invention is to expand the range of tools aimed at the prevention of chronic fatigue syndrome in men, by creating a new tool with immunomodelling effect, which has a corrective effect on the psychological status of men, as well as promoting the activation of testosterone synthesis.

The technical result is the implementation of the declared purpose.

The problem is solved by the proposed recipe for the prevention of chronic fatigue syndrome in men, made in the form of suppositories containing the blood plasma of a maral male, dry red root extract, L-arginine and excipients in the following ratio of components in grams per suppository weighing 2.0 g :

Blood plasma of a male deer 0.05-0.2 Dry Red Root Extract 0.01-0.05 L-arginine 0.05-0.2 Excipients rest

As excipients, a base, emulsifier and other standard excipients are used, which are widely used in the pharmaceutical industry in the manufacture of soft formulations in the form of suppositories and provide well-known technologies for their manufacture. As a base, either a fatty or hydrophilic base may be used.

As a fat base for the manufacture of suppositories, you can use cocoa butter, cocoa butter alloys with paraffin and hydrogenated fats, vegetable and animal hydrogenated fats, solid fat, lanolin, alloys of hydrogenated fats with wax, hard paraffin and other bases approved for medical use in production suppositories in an amount determined by the technology of manufacturing suppositories.

As a hydrophilic base, gelatin-glycerin gels, alloys of polyethylene oxides with various molecular weights and other substances in an amount determined by the technology of manufacturing suppositories are used.

As emulsifiers in the manufacture of suppositories, emulsifier No. 1, emulsifier T-1, emulsifier T-2, tween-80, wax alcohols, aerosil and others in an amount determined by the technology for manufacturing suppositories can be used.

The suppository form is promising and preferred due to the simplicity and painlessness of the introduction, the speed of the onset of the pharmacotherapeutic effect due to the easy release of the active substances from the base and its very rapid entry into the blood (bypassing the gastrointestinal tract) due to the high absorption capacity of the rectal mucosa. Rectally administered drugs help to achieve a high concentration in the blood, prolong their circulation in the bloodstream and the loss of the barrier function of the liver, due to which the bioavailability of the active substances is 70-80%.

The inventive tool has an immunomodulating effect, has a corrective effect on the psychoemotional status, and also promotes the activation of testosterone synthesis. This is due to the specially selected composition of the components and their quantitative ratio.

Blood plasma of a maral male. The millennial use of antlers and blood of antlers, in particular deer, is mentioned in many ancient recipes of Tibet, Korea, and China. The characteristics of the organism of antler deer, associated with the specifics of the environment and physiology, cause unusually high concentrations in the blood of biologically active substances (BAS), which are not found in other animals. Not a single tissue, not a single organ of these animals has such fast, powerful growth as antlers. Blood taken during their rapid growth, i.e., during the period of greatest physiological activity, blood has a unique therapeutic effect on the human body. This environmentally friendly product is an effective adaptogen of a new generation.

Made by the unique technology of maral blood plasma, it preserves the entire complex of the most valuable biologically active substances as much as possible, which determines the variety of its amazing healing properties. Plasma contains a huge amount of chemicals necessary for human life. It consists of amino acids, proteins (albumin, globulins, fibrinogen), phospholipids, macro, and trace elements), which are contained in proportions close to the composition of human blood.

The blood plasma of a maral male enhances the energy supply of transport processes involved in the intake of most biologically active substances and ions. An important property of male maral blood plasma is also its stabilizing effect on the autonomic nervous system and an increase in the concentration of adrenocorticotropic hormone in the blood. This eliminates the effect of stress on the body.

Thus, the blood plasma of the maral male, thanks to the biologically active substances contained in it: positively affects the metabolism, activates cellular metabolism, enhances erythropoiesis, has pronounced immunostimulating properties, increases mental and physical performance, sexual activity. It eases the burden on the cardiovascular system, increases the body's own protective functions.

Plant extracts, in particular, red root extract, provides significant support and enhances the indicated properties of the blood plasma of a maral male due to its flavonoids and anthocyanins.

L-Arginine - an essential amino acid that is a carrier and donor of nitrogen, is of great importance for various functions of the human body. L-Arginine not only positively affects the cardiovascular system, but also participates in all human metabolic processes, thanks to nitric oxide, which is formed from it during the complex oxidative reaction. Without it, the normal functioning of the nervous and immune systems, the production of hormones and enzymes, sexual activity and the development of muscle tissue are impossible. L-arginine makes a person more resilient and active, well raises mood and vitality, physical and mental activity, initiative and endurance, kind of increases “mental energy”, correcting a person’s behavior in a positive way. It can rightfully be called the "Molecule that carries the positive." The amazing effect of L-arginine lies in the fact that it has a beneficial effect on the function of the prostate gland, as causes an increase in sperm, improves blood formation in the genitals of men and creates the prerequisites for a stable and prolonged erection. L-arginine is responsible for the concentration of sperm in the semen and boosts the immune response. Nitric oxide, which is formed from L-arginine, activates the blood supply to tissues and organs and enhances erection, due to the better filling of the cavernous bodies. L-arginine dramatically increases the activity of NK cells - the main component in our body’s immune system.

Dry red root extract. Red root or tea penny is a relic plant of the environmentally friendly Alpine belt of Altai. It grows at an altitude of at least 1700 m above sea level. This plant has a powerful brownish root from the surface, with a decoction and tinctures giving a beautiful pink-red color. In folk medicine, tea penny has been widely used as an anti-inflammatory, restorative, enhancing performance and stimulating the sexual activity of men tool. The composition of the red root includes phenolic components of the catechin and leukoanthocyanine structure, which belong to the group of flavonoids, which are known to have high P-vitamin activity. It is catechins and leukoanthocyanins that determine the tonic and anti-inflammatory properties of this plant.

The red root contributes to the healing of the body as a whole: it normalizes the activity of the gastrointestinal tract, strengthens the cardiovascular and respiratory systems, effectively relieves fatigue, increases physical endurance, helps to improve psycho-emotional status, and restores male sexual activity.

The inventive formulation of the drug is optimized by the quantitative indicators of the additives of plant (red root extract) and animal (blood plasma of the male of maral) origin included in it. An increase or decrease in any component compared with the declared one leads to an imbalance of biologically active substances (BAS).

An increase in the total amount of additives in excess of the declared is impractical, because on the one hand, this can cause unwanted side effects, and on the other hand, the technology for obtaining this formulation is difficult.

The decrease in the number of additives below the stated is also impractical, because entails a decrease in the biological value of the drug and, as a consequence, a decrease in its effectiveness.

Due to the fact that the daily dose of amino acids, as well as vitamins, should be regulated, the quantitative composition of L-arginine is limited by the proposed formulation.

Thus, the blood plasma of the maral male, red root extract (tea penny) and L-arginine are well combined, complementing the action of each other, enhance the positive effect of the supplement as a whole, activating key enzymes in the body, as a result of which the claimed agent:

- promotes the activation of testosterone synthesis;

- has an immunomodulating effect;

- corrects the psycho-emotional status,

which allows us to recommend it for the prevention of chronic fatigue syndrome in men, that is, to solve the problem.

The study of the clinical effectiveness of this drug was conducted at the bases of the Federal State Budgetary Institution of Science "Tomsk Scientific Research Institute of Balneology and Physiotherapy of the Federal Medical and Biological Agency" (FSBIH TNIIKiF FMBA of Russia) and the Federal State Budgetary Institution of Health Clinical Hospital No. 81 (Seversk) in the leadership of the doctor of medical sciences, professor Popkov A.V.

Research objectives

1. To assess the safety of the drug in males with chronic fatigue syndrome based on the dynamics of the state of the cardiovascular and hematopoietic systems, metabolic, hormonal, immune and psychoemotional status.

2. To study the effect of the drug on the state of hematopoiesis, carbohydrate and hormonal spectrum, the immune system in men with chronic fatigue syndrome.

3. To evaluate the clinical effectiveness of the drug when prescribed in males with CFS.

The studies were performed using measuring instruments approved for use in the Russian Federation (State Register of Measuring Instruments).

The study group included male volunteers with chronic fatigue syndrome aged 27 to 50 years (40 people), who complained of increased fatigue, anxiety, headaches, decreased libido over the past 5-6 months. All patients had an irregular schedule of work with frequent stressful situations (surgeons, ambulances, anesthesiologists, reniamotologists, ambulance drivers. Men received rectally 1 suppository per night for 10 days.

As a result of clinical trials, most patients noted an improvement in their general condition (91%), relief of headaches (66.7%), while the total score of the questionnaire was positive, which was characterized by increased libido, spontaneous and adequate erections. While taking the drug, a statistically significant increase in hematocrit, the total number of red blood cells and the percentage of reculocytes was noted. After using the drug, the level of testosterone increased significantly. The dynamics of cellular immunity indicators indicated the stimulation of the immune response. Against the background of the use of the drug, a positive trend in the indicators of situational anxiety was observed. Accordingly, the examined men became less anxious, the degree of goal setting decreased, which helps to reduce emotional stress. The data obtained in the course of the study suggest that the integrated use of this tool has an effect on the psychoemotional state of the subjects, and also helps to reduce the severity of psychological manifestations of CFS.

Based on clinical trials, the following conclusion was made:

The use of the drug contributed to the stimulation of erythropoiesis (increased hemacritis, the total number of red blood cells and the percentage of reticulocytes), increased testosterone levels. The results of the study indicate a pronounced stimulating effect of the drug on the erythrocyte germ of hematopoiesis. The use of this drug affects hormonal regulation, contributing to the activation of testosterone synthesis. The tool has the ability to exert an immunomodulating effect on the functional state of the immune system, stimulating the activity of the regulatory element of cellular immunity, which is responsible for the adequacy of the immune response. The course administration of the drug helps to increase the adaptive capabilities of the body (according to the method of L.Kh. Garkavi, 1990), reduce psychological stress by reducing situational anxiety, positive dynamics and improving the sexual health of men.

Using the product is safe because It does not adversely affect the clinical, biochemical, immunological parameters of the examined men, the cardiovascular system, and increases the integral health indicator by 15%.

Thus, the use of the drug can be recommended for use by men with chronic fatigue syndrome.

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

Concrete example

Loading rates for 30.0 kg of finished products:

1. Blood plasma of a male deer 2,250 kg 2. L-arginine 2,250 kg 3. Dry red root extract 0.300 kg 4. Aerosil A-380 0.255 kg 5. Solid fat 24.945 kg

The preparation of suppositories is carried out according to known technology using standard excipients. In this example, it can be Aerosil A-380 and solid fat.

L-arginine is ground in a ball mill to a particle size of not more than 200 microns. Solid fat is charged into the reactor and heated with stirring to a temperature of 40-45 ° C until the mass is completely melted. Next, Aerosil A-380 is introduced into the reactor and homogenized for 10-15 minutes. Then the contents of the reactor are cooled to a temperature of 38 ± 2 ° C and when the stirrer is turned on, the blood plasma of the maral male, crushed L-arginine and dry red root extract are introduced. Then continue stirring with simultaneous evacuation for 30 minutes. Then the mass is transferred to the packaging. Packing is carried out at a temperature of 35 ± 2 ° C in a polymer container of 2.0 g.

Suppositories (candles) have a torpedo-shaped cream color with a pinkish or brownish tint of a uniform consistency.

Industrial applicability

The components that make up the claimed funds are manufactured by industry. The manufacture of the product is carried out in a manner known in the art using known equipment. The proposed tool is intended for the prevention of chronic fatigue syndrome in men.

The beneficial effect of using the invention is that the range of domestic drugs aimed at the prevention of chronic fatigue syndrome in men is expanding.

Claims (1)

An agent for the prevention of chronic fatigue syndrome in men, characterized in that it is made in the form of suppositories containing the blood plasma of a maral male, dry red root extract, L-arginine and excipients in the following ratio of components in grams per suppository weighing 2.0 g :
male maral blood plasma 0.05-0.2 L-arginine 0.05-0.2 dry red root extract 0.01-0.05 Excipients rest