RU2760674C1 - Use of preparations of polyscias filicifolia plant or its fragments for treatment of elementoses and their consequences - Google Patents

Abstract

FIELD: pharmaceutics.

SUBSTANCE: proposed group of inventions relates to the pharmaceutical industry, namely to the use of a preparation for the treatment of elementoses in a subject. The use of a preparation of lateral shoots or leaves of Polyscias filicifolia plant, obtained by alcohol extraction of the plant or by a biotechnological method for plant cell culture, for the treatment of elementoses in a subject in need of it is proposed, where elementoses are induced by ingestion of an extraneous chemical compound to the organism of the subject deviations in the content in one or several internal organs of the subject of at least one essential element selected from a group: Ca, Cr, I, Mn, Cu, Mg, Fe, Zn without the need to use sources or chelators of essential elements, the content of which is violated. The use of a preparation of lateral shoots or leaves of Polyscias filicifolia plant, obtained by a biotechnological method for plant cell culture, for the treatment of elementoses in a subject in need of it is proposed, where elementoses are induced by ingestion of an extraneous chemical compound and/or an infectious disease to the organism of a subject deviations in the content in one or more internal organs of the subject of at least one essential element selected from a group: Ca, Cu, Mg, Fe, Zn without the need to use sources or chelators of essential elements, the content of which is violated.

EFFECT: above-described use of the preparation obtained from lateral shoots or leaves of Polyscias filicifolia plant is effective for the treatment of elementoses in the subject.

10 cl, 10 dwg, 4 tbl, 6 ex

Description

TECHNICAL FIELD OF THE INVENTION

The present invention relates to the use of preparations of the plant Polyscias filicifolia or its fragments, including those obtained by biotechnological methods, for the treatment and prevention of elementoses and their consequences in a subject in need thereof. The present invention also relates to a medicament that contains preparations of the plant Polyscias filicifolia or its fragments for the treatment and prevention of elementoses and their consequences. In particular, such elementoses can be induced by the ingestion of an extraneous chemical compound into the subject's body or by an infectious disease.

BACKGROUND OF THE INVENTION

Maintaining homeostasis (constancy of the internal environment), including the content of essential (vital) elements necessary for life, is the basic function of the body. Elementoses, which are deviations in the content of essential elements from the levels required for normal life, lead to the occurrence of a significant number of diseases [1].

Such elementoses can be caused by both internal causes (for example, genetic disorders or infectious diseases), and external influences (for example, stress or ingestion of an extraneous chemical compound). For the purposes of the present description, the term "elementoses induced by external or internal factors" or "induced elementoses" will refer to such deviations in the content of essential elements in one or more internal organs that have occurred as a result of a time-limited and definable effect of external or internal factors or their combinations and led to a significant (statistically significant) deviation of the content of one or more essential elements from the levels characteristic of a given organism before the onset of exposure to such factors.

The negative impact of induced elementoses especially increases during pregnancy and determines both the woman's own health and the health and development of the unborn child [1, 2, 3]. Elementoses increase the risk of premature birth, various types of intrauterine pathology, up to malformations and increase infant mortality [4, 5]. The influence of induced elementoses during pregnancy is comparable or even superior to the role of genetic factors [6]. Induced elementoses have a particularly strong effect on hematopoiesis (including the formation of cells of the immune system), which is carried out with the participation of a number of essential elements (Fe, Mn, Ca, Mg, I, Cu, Zn) [7].

Also, the consequences of induced elementoses include, but are not limited to: dysbiosis, anemia, fatigue, mental and physical development disorders in children, metabolic syndrome; disorders associated with insulin deficiency or insulin resistance; diabetes mellitus, including type 2 diabetes; glucose intolerance; violation of lipid metabolism; atherosclerosis; arterial hypertension; hyperglycemia; liver disease; dysfunction of the immune system; inflammatory bowel disease, in particular irritable bowel syndrome; cardiovascular diseases; high cholesterol; increased triglycerides; asthma; osteoarthritis; neurodegeneration and oncological diseases [1].

At the same time, it is important that the induced elementoses in the body are manifested in multidirectional changes in the content of individual essential elements in various organs and tissues [8, 9]. This complicates the prevention and treatment of elementosis with preparations containing compounds of individual essential elements, since an excess of vital elements in the body is just as dangerous as their deficiency [10, 11].

There are various preparations containing high concentrations of essential elements intended for the prevention and treatment of elementosis, for example, preparations containing organic salts of copper [12], zinc [13], iron [14], magnesium [15] or calcium [16].

However, an attempt to prevent and treat elementosis by simply adding compounds containing one or another element to food leads to side effects. For example, an attempt to restore iron balance in anemic women leads to an increase in the level of oxidative stress (lipid peroxidation, high risk of diabetes and atherosclerosis) [17, 18]. Consumption of this trace element can be complicated by the accumulation of iron ions in the brain, which leads to neurodegenerative consequences [19]. With an excess of iron in the body, the liver takes on a protective function, accumulating iron ions, and such diseases as steatohepatitis, fibrosis, liver cirrhosis and hepatocellular carcinoma can develop [20]. In addition, it should be borne in mind that taking iron-containing drugs is associated with a risk of lowering the consumption of copper and, especially, zinc [11], which can cause the development of a number of diseases. In turn, the increased zinc content causes the risk of diseases associated with the reproductive system [21].

Also known are various drugs (chelators) that reduce the level of a particular element in the body, such as iron [22, 23, 24, 25] or copper [26, 27]. However, a decrease in the iron content in the body leads to numerous immune disorders [28]. A decrease in the content of copper in the body leads to a decrease in the synthesis of holo-ceruloplasmin and a weakening of ferrooxidase activity, which in some cases leads to a decrease in the release of iron from tissues and the development of anemia [29]. Antioxidant deficiency of the body is also associated with a low copper content, which leads to an increased susceptibility to infectious diseases and impaired embryogenesis [30, 31, 32, 33, 34].

There are many examples of other methods that are used to treat and prevent induced elementoses. All of them have certain disadvantages that limit the possibilities of their use in medicine.

Since the metabolic and transport pathways of essential elements in the body are closely intertwined, there is a need for such a method of treating elementosis, which are deviations in the content of several essential elements in one or more internal organs of the subject, induced by external or internal factors, in which the obligatory use of sources or chelators is not required. essential elements, the content of which is violated.

The authors of the present invention, as a result of a large number of experiments and clinical observations, unexpectedly found that preparations of the plant Polyscias filicifolia or its fragments can be used to treat induced elementosis in a subject in need, without the need for sources or chelators of essential elements, the content of which is disturbed.

In particular, the present inventors have found that such preparations can preferably be obtained using the biotechnological method of plant cell culture.

At the same time, the insignificant content of essential elements and / or their chelators in preparations of the Polyscias filicifolia plant or its fragments makes it possible not to consider such preparations as sources of essential elements, the content of which is disturbed, or their chelators [35].

SUMMARY OF THE INVENTION

The present invention relates to the use of preparations of the plant Polyscias filicifolia or fragments thereof for the treatment of elementoses and their consequences in a subject in need thereof, where elementoses are externally or internally induced deviations in the content of at least one essential element in one or more internal organs of the subject, selected from the group: Ca, Cr, I, Mn, without the need to use sources or chelators of essential elements, the content of which is disturbed.

In another general aspect, the present invention relates to the use of preparations of the plant Polyscias filicifolia or fragments thereof for the treatment of elementoses and their consequences in a subject in need thereof, where elementoses are externally or internally induced deviations of the content in one or more internal organs of the subject at least one essential element selected from the group: Ca, Cr, I, Mn, and, in addition to these elements, deviations of the content in one or more internal organs of the subject of at least one essential element selected from the group: Cu, Mg, Fe, Zn, without the need to use sources or chelators of essential elements, the content of which is violated.

In a specific embodiment, Example No. 1 illustrates a Polyscias filicifolia preparation in the form of a water-ethanol extract of the shoots of the Polyscias filicifolia plant.

In another aspect, the present invention relates to the use of preparations of the Polyscias filicifolia plant or fragments thereof for the treatment of the previously listed elementosis and their consequences, where the fragment of the Polyscias filicifolia plant is obtained by a biotechnological method of plant cell culture.

In some embodiments, the invention proposes the use of preparations of the Polyscias filicifolia plant or its fragments for the treatment of the previously listed elementoses and their consequences, where a fragment of the Polyscias filicifolia plant is obtained by a biotechnological method of plant cell culture based on the BFT 01-95 strain, No. 58 VKKK BP.

In a specific embodiment of the invention, example No. 2 illustrates the preparation of Polyscias filicifolia in the form of a water-ethanol extract of plant biomass obtained by the method of suspension culture of cells of higher plants based on the strain obtained from the leaf of the plant Polyscias filicifolia (MOORE EX ROUNIER) BAILEY BFT 01-95 and deposited in the All-Russian collection of plant cells and organs of higher plants for No. 58 dated June 5, 1995

In some embodiments, the invention provides the use of preparations of the Polyscias filicifolia plant or its fragments for the treatment of the previously listed elementoses and their consequences, where the preparation is a fragment of the Polyscias filicifolia plant fermented by probiotic microorganisms, obtained by a biotechnological method of plant cell culture.

In a specific embodiment of the invention, example No. 3 illustrates the preparation of Polyscias filicifolia in the form of a suspension of plant biomass fermented by probiotic microorganisms, obtained by the method of suspension culture of cells of higher plants based on the strain obtained from the leaf of the plant Polyscias filicifolia (MOORE EX ROUNIER) BAILEY BFT 01-95 and deposited in the All-Russian collection of plant cells and organs of higher plants for No. 58 dated June 5, 1995

In another aspect, the present invention relates to the use of preparations of the Polyscias filicifolia plant or fragments thereof for the treatment of the previously listed elementoses and their consequences, where the preparation is used in a pharmaceutical composition that contains at least one preparation of the Polyscias filicifolia plant or fragments thereof in combination with a pharmaceutically acceptable an excipient selected from the group consisting of a solvent; a pH adjusting agent; isotonicity agent; preservative; antioxidant; surfactant; thickener; an absorption enhancer, or a combination thereof.

In a specific embodiment, Example No. 4 illustrates a pharmaceutical composition that comprises a Polyscias filicifolia plant preparation in combination with a combination of pharmaceutically acceptable excipients including a solvent; a pH adjusting agent; isotonicity agent; preservative; antioxidant; surface-active substance; thickener; absorption enhancer.

In some embodiments, the invention provides the use of preparations of the plant Polyscias filicifolia or fragments thereof for the treatment of the previously listed elementoses and their consequences, where the elementoses are induced by the ingestion of an extraneous chemical compound or an infectious disease into the subject's body.

In specific embodiments of the invention, examples of the use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of elementosis and their consequences induced by the ingestion of an extraneous chemical compound (Example 5) and an infectious disease (Example 6) are given.

In some embodiments, the invention proposes the use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of the previously listed elementosis and their consequences, where elementosis is a deviation of the content of one or more essential elements in at least one of the internal organs selected from the group: liver, spleen , blood.

In specific embodiments of the invention, examples of the use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of elementosis are given, where elementosis is a deviation in the content of one or more essential elements in at least one of the internal organs selected from the group: liver, spleen, blood. (Examples 5 and 6).

In some embodiments, the invention provides the use of preparations of the Polyscias filicifolia plant or fragments thereof for the treatment of the previously listed elementoses and their consequences, where the preparation is administered orally or sublingually.

In specific embodiments of the invention, examples of the use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of the previously listed elementoses and their consequences are given, where the preparation is administered orally (Example 5) or sublingually (Example 6).

In another general aspect, there is proposed a drug for the treatment of the previously listed elementoses and their consequences, which contains preparations of the plant Polyscias filicifolia or its fragments in the composition of a pharmaceutical composition, where the consequences of elementoses are dysbiosis, anemia, fatigue, mental and physical development disorders in children, metabolic syndrome ; disorders associated with insulin deficiency or insulin resistance; diabetes mellitus, including type 2 diabetes; glucose intolerance; violation of lipid metabolism; atherosclerosis; arterial hypertension; hyperglycemia; liver disease; dysfunction of the immune system; inflammatory bowel disease, in particular irritable bowel syndrome; cardiovascular diseases; high cholesterol; increased triglycerides; asthma; osteoarthritis; neurodegeneration and oncological diseases.

In a specific embodiment of the invention, example No. 6 illustrates an agent for the treatment of the previously listed elementoses and their consequences, which contains a preparation of the plant Polyscias filicifolia in a pharmaceutical composition, where the consequence of elementoses is dysfunction of the immune system.

Details of one or more embodiments of the invention are set forth in the description below. Other features, objects and advantages of the invention will be apparent from the description.

BRIEF DESCRIPTION OF THE FIGURES

The drawings are illustrative only and are not required to implement the invention disclosed herein.

Figures 1 (a) ÷ (d) - change in the content of essential elements in the liver of animals for different experimental groups in% to the average value of the content of the corresponding element in the control group, where:

Fig. 1 (a) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T1 - (glyphosate (150 μg / kg) + Polyscias filicifolia preparation according to Example 1 (300 μl / kg)) x 7 days, * p≤0.05, ** p≤0.01, *** p≤0.001;

Fig. 1 (b) - K - control, P2 - glyphosate (750 μg / kg x 7 days), T2 - (glyphosate (750 μg / kg) + Polyscias filicifolia preparation according to Example 2 (900 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 1 (c) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T3 - (glyphosate (150 μg / kg) + Polyscias filicifolia preparation according to Example 3 (3 ml / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 1 (d) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T4 - (glyphosate (150 μg / kg) + pharmaceutical composition according to Example 4 (300 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001.

Figures 2 (a) ÷ (c) - change in the content of essential elements in a clot of formed elements of blood of animals for different experimental groups in% to the average value of the content of the corresponding element in the control group, where:

Fig. 2 (a) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T1 - glyphosate (150 μg / kg) + Polyscias filicifolia preparation according to Example 1 (300 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 2 (b) - K - control, P2 - glyphosate (750 μg / kg x 7 days), T2 - glyphosate (750 μg / kg) + Polyscias filicifolia preparation according to Example 2 (900 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 2 (c) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T4 - glyphosate (150 μg / kg) + pharmaceutical composition according to Example 4 (300 μL / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001.

Figures 3 (a) ÷ (c) - change in the content of essential elements in the spleen of animals for different experimental groups in% to the average value of the content of the corresponding element in the control group, where:

Fig. 3 (a) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T1 - glyphosate (150 μg / kg) + Polyscias filicifolia preparation according to Example 1 (300 μL / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 3 (b) - K - control, P2 - glyphosate (750 μg / kg x 7 days), T2 - glyphosate (750 μg / kg) + Polyscias filicifolia preparation according to Example 2 (900 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001;

Fig. 3 (c) - K - control, P1 - glyphosate (150 μg / kg x 7 days), T4 - glyphosate (150 μg / kg) + pharmaceutical composition according to Example 4 (300 μl / kg)) x 7 days, * p≤0.05, ** p≤0.005, *** p≤0.001.

DETAILED DESCRIPTION OF THE INVENTION

It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, as various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art. A person skilled in the art, based on the definitions provided herein, can make full use of the present invention. The following specific embodiments are to be construed as merely illustrative and in no way limiting the rest of the disclosure.

Unless otherwise indicated, all terms used in this document, including technical and scientific terms, have the meaning commonly understood by one of ordinary skill in the art to which the present invention belongs.

For purposes of disclosure, the following are definitions of various terms used to describe the present invention. Unless otherwise indicated, these definitions apply to terms used in the description and the appended claims, individually or as part of a broader group. They should not be interpreted literally. They are not general definitions and are only relevant for this description.

As used herein, the term “or” is generally used in its meaning, including “and / or,” unless the content clearly dictates otherwise.

As used herein, the term "about" means approximately and can be construed to estimate a value that is ± 10% of the specified value or range.

As used herein, the term "treating" means preventing (ie, preventing the occurrence of), reducing or ameliorating at least one adverse effect or symptom of a disease, disorder, or condition. Thus, this term refers to both therapeutic treatment and prophylactic measures, where the goal is to prevent or slow down (reduce) the target pathological condition or disorder.

The term "amount sufficient for treatment" or "effective amount" as used herein refers to an amount of preparations of the Polyscias filicifolia plant or fragments thereof that, without causing significant negative or adverse side effects, when administered to a subject to treat a disease, disorder or other undesirable pathological condition sufficient to provide a beneficial effect on the disease, disorder, or condition.

An effective amount can be administered prior to the onset of the disease or disorder for prophylactic action. Alternatively or additionally, an effective amount can be administered after the onset of the disease or disorder for therapeutic effect.

As used herein, the term "preparation of a plant or its fragments" means a substance or mixture of substances of plant origin obtained both from the whole plant and from its parts, including but not limited to: leaves, stem, shoots, seeds, fruits, bark, roots, as well as from fragments of plant parts, up to an individual plant cell, including those obtained by biotechnological methods.

As used herein, the term "plant cell culture" means a biotechnological process by which fragments of a plant: individual cells (or a single cell), tissues or parts of a plant are artificially grown under controlled conditions.

A preparation of a plant or its fragments can be made, including, but not limited to, in the form of an infusion, decoction, tincture, extract, extract, juice, syrup, suspension, powder, ointment, paste, fatty or essential oil, including fermented with probiotic microorganisms in the form, by methods well known to the person skilled in the art.

As used herein, the term "probiotic microorganism" refers to non-pathogenic and beneficial to the subject live microorganisms, which may be selected, but are not limited to, from Bifidobacterium adolescentis, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium animalis thermveophilium, Bifidobacterium Lactobacillus fermentum, Lactobacillus helveticus, Lactobacillus salivarius, Lactobacillus casei, Lactobacillus brevis, Lactobacillus delbrueckii, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus, Lactobacillus acidobacillus curl Lactococcus lactis; Escherichia coli; Enterococcus Faecalis, Enterococcus faecium; Streptococcus salivarius, Streptococcus thermophilus; Bacillus subtilis, Bacillus cereus, Bacillus licheniformis, or combinations thereof.

As used herein, the term "pharmaceutical composition" or "composition" means a single dose or multiple dose of one or more preparations of the Polyscias filicifolia plant or fragments thereof in combination with pharmaceutically acceptable excipients, which can be obtained by the methods described in one or more embodiments of the present invention.

For the purposes of the present invention, the pharmaceutical composition is preferably placed in a suitable container. This container can also be part of a device in which the pharmaceutical composition is prepared immediately prior to administration to a patient.

Various types of pharmaceutical composition for the purposes of the present invention can be selected from the group which includes, but is not limited to: solution, suspension, syrup, liquid, gel, hydrogel, emulsion, liposome, aerosol, mist, film, polymer, implant or delayed composition. release.

The method of administration to a subject of preparations of the plant Polyscias filicifolia or its fragments in pharmaceutical compositions according to the present invention can be selected from the group which includes, but is not limited to: oral, sublingual, buccal, rectal, transdermal, dermal, subcutaneous, nasal, inhalation.

A preferred embodiment of the invention is a method when the preparation is administered orally or sublingually.

In some embodiments, an effective amount of a Polyscias filicifolia plant preparation or fragments thereof in a pharmaceutical composition of the present invention is administered to a subject once a day, twice a day, three times a day, or more often. In other embodiments, the invention is administered every other day or less.

Preferably, the pharmaceutical composition of the present invention contains preparations of the plant Polyscias filicifolia or fragments thereof in an amount sufficient to treat elementoses and their consequences when the pharmaceutical composition is administered to a subject in need thereof.

As used herein, the term "subject" means an animal, preferably a mammal and most preferably a human. In the context of the present invention, the term "subject" is used interchangeably with the term "patient".

In the context of the present invention, the phrase "subject in need thereof" includes those who already have a disease or disorder, as well as those who are prone to have a disease or disorder, or those whose disease or disorder should be prevented, and for whom drugs Polyscias filicifolia plants or fragments thereof or the pharmaceutical composition of the present invention can be suitably used.

As used herein, the term "pharmaceutically acceptable" means suitable for normal pharmaceutical use, that is, without causing side effects in patients.

As used herein, the term "excipient" refers to a pharmaceutically acceptable substance or group of substances that can be administered to a patient together with preparations of the Polyscias filicifolia plant or fragments thereof according to the present invention, which does not reduce the pharmacological activity of preparations of the Polyscias filicifolia plant or its fragments, and are included in a pharmaceutical composition for the purpose of stabilizing or for imparting a therapeutic enhancement to the active ingredient, or to reduce the viscosity or to increase solubility, or for other purposes well known to the person skilled in the art.

For the purpose of carrying out the present invention, such a pharmaceutically acceptable excipient is selected from the group consisting of a solvent; a pH adjusting agent; isotonicity agent; preservative; antioxidant; surfactant; thickener; an absorption enhancer, or a combination thereof.

The term "solvent" as used herein means a substance selected from the group which includes, but is not limited to: water, ethylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, polyethylene glycol, propylene glycol, dipropylene glycol, tripropylene glycol, propylene glycol, propylene glycol, propylene glycol, propylene glycol, propylene glycol, propylene glycol isopropyl alcohol, benzyl alcohol, benzyl benzoate, glycofurol, or a combination thereof. The preferred amount of solvent that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 90.0% (w / w).

As used herein, the term "pH adjusting agent" means a substance that adjusts the pH of pharmaceutical compositions to a desired pH. PH adjusting agents can include pharmaceutically acceptable acids, bases, or buffering agents. For example, acids can include, but are not limited to, one or more inorganic mineral acids such as citric, fumaric, gluconic, lactic, malic, metatartaric, tartaric, ascorbic and benzenesulfonic acids, and the like. The bases can be one or more inorganic bases or organic bases, including, but not limited to, alkali carbonate, alkaline bicarbonate, alkaline earth metal carbonate, alkali metal hydroxide, alkaline earth metal hydroxide, or amine. For example, the inorganic or organic base may be an alkaline hydroxide such as lithium hydroxide, potassium hydroxide, cesium hydroxide, sodium hydroxide, or the like; alkaline carbonate such as calcium carbonate, sodium carbonate or the like; or an alkaline bicarbonate such as sodium bicarbonate or the like; the organic base can also be sodium acetate. The buffering agent can be, but is not limited to, an alkali metal salt of an amino acid, aluminum hydroxide, aluminum hydroxide, magnesium glycinate, calcium acetate, calcium bicarbonate, calcium borate, calcium carbonate, calcium citrate, calcium gluconate, calcium glycerophosphate calcium hydroxide, calcium lactate , calcium phthalate, calcium phosphate, calcium succinate, calcium tartrate, sodium phosphate dibasic, hydrogen phosphate dibasic, potassium phosphate. The preferred amount of pH adjusting agent that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 2.0% (w / w).

Used herein, the term "pH" is a measure of the concentration of hydrogen ions, which is usually used in this field. Typically, pH provides a measure on a scale of 0 to 14 for the acidity or alkalinity of a solution. In the context of the present invention, the pH of the pharmaceutical composition is from about 2.0 to about 11.0.

As used herein, the term "isotonicity agent" as used refers to a substance in a pharmaceutical composition that serves to alter the osmotic pressure of the pharmaceutical composition so that the osmotic pressure becomes closer to that of human plasma. Examples of isotonicity agents include, but are not limited to, sodium chloride or potassium chloride, or a physiologically tolerable polyol such as, for example, a sugar alcohol, in particular sorbitol or glycerol, at a concentration necessary to render isotonic. The preferred amount of isotonicity agent that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 1.0% (w / w).

As used herein, the term "preservative" refers to a substance that is added to a pharmaceutical composition to prevent or slow down microbial activity (growth and metabolism). Examples of preservatives that can be used in the pharmaceutical composition may be selected, but are not limited to, phenylcarbinol, benzalkonium chloride, thimerosal, benzyl alcohol, ethyl alcohol, phenylethyl alcohol, methylparabens, ethylparabens, propylparabens, and butylparabens. or a combination of both. The preferred amount of preservative that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 2.0% (w / w).

Examples of suitable antioxidants that can be used in the pharmaceutical composition of the present invention may be selected, but are not limited to, ascorbic acid, alpha-tocopherol (vitamin e), butylated hydroxyanisole, butylated hydroxytoluene, glutathione, and the like. The preferred amount of antioxidant that may be present in the pharmaceutical composition of the present invention may be from about 0.001 to about 1.0% (w / w).

Examples of suitable surfactants that can be used in the pharmaceutical composition of the present invention may be selected, but are not limited to, from polysorbates, their ethoxylates obtained by reacting sorbitol esters with ethylene oxide, polyoxyethylene alkylphenol, polyoxyethylene acetyl ether, polyoxyethylene alkylaryl ether, polyoxyethylene monolaurate, polyoxyethylene vegetable oil, polyoxyethylene ester or mixed fatty and resin acids, polyoxyethylene sorbitol-lanolin derivatives, polyoxyethylene tridecyl ether esters, polyoxyethylene lanolin derivatives, sodium oleate ammonium oleate, sodium oleate ammonium quaternary sulfate derivatives The preferred amount of surfactants that may be present in the pharmaceutical composition of the present invention may be from about 0.001 to about 5.0% (w / w).

Examples of suitable thickening agents that can be used in the pharmaceutical composition of the present invention may be selected, but are not limited to, water insoluble polymers, acrylic polymers, polyoxyethylene polyoxypropylene block copolymers, xanthan gum, gum tragacanth, alginates, agar-agar, gelatin , sorbitol. The preferred amount of thickening agent that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 2.0% (w / w).

Examples of suitable absorption enhancers that can be used in the pharmaceutical composition of the present invention may be selected, but are not limited to, disodium edetate, benzyl alcohol, ethanol, thiamine or a salt thereof, capric acid or a salt thereof, malic acid or a salt thereof, pyrophosphoric acid or its salt, citric acid or its salt, salicylic acid or its salt, pyrophosphoric acid or its salt, or combinations thereof. The preferred amount of absorption enhancer that may be present in the pharmaceutical composition of the present invention may range from about 0.001 to about 2.0 wt%.

The invention is further illustrated by the following examples, which are presented as an example of the invention and do not limit the scope of the invention. Although the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.

Example 1. Preparation of lateral shoots of the plant Polyscias filicifolia.

To obtain the preparation, the collected lateral shoots of the Polyscias filicifolia plant were crushed and dried in a drying oven at a temperature of 35 ± 1 ° C for 48 hours. The dried shoots were extracted with a 40% aqueous solution of ethyl alcohol (GOST R 51786), based on a weight / volume ratio of 1:30 - 1:32 by the percolation method. For this, the dried shoots were poured with a 40% aqueous solution of ethyl alcohol at the rate of 20 ml per 1 g of dried shoots and left for 48 hours. The resulting solution was centrifuged (3000 rpm, 5 min), the supernatant was poured into a collection tank, and the sediment was filled with a new portion of a 40% aqueous solution of ethyl alcohol (at the rate of 10 ml per 1 g of the original weight of dried shoots) and left for 48 hours. The resulting solution was centrifuged (3000 rpm, 5 min), the second portion of the supernatant was poured into the same collection vessel, and the resulting mixture was kept in a refrigerator for 3 days, decanted and filtered using Millipore 0.45 μm * 25 mm filters. The resulting extract was characterized by HPLC.

Example 2. Preparation of plant biomass Polyscias filicifolia, obtained by the biotechnological method of plant cell culture.

The biomass of Polyscias filicifolia was grown in a bioreactor by the method of suspension culture of cells of higher plants based on the strain obtained from the leaf of the plant Polyscias filicifolia (MOORE EX ROUNIER) BAILEY BFT 01-95, deposited in the All-Russian collection of plant cells and organs of higher plants under No. 58, in accordance with by the method described in Patent RU 2 337 138 "The cell culture strain of Polyscias filicifolia (MOORE EX ROUNIER) BAILEY for the production of drugs, dietary supplements and cosmetics" [36]. Drying of biomass was carried out on trays in a drying cabinet in a stream of hot air at 45 - 50 ° C for 12 - 18 hours. Extraction of air-dry cell biomass was carried out with a 40% aqueous solution of ethyl alcohol (GOST R 51786), based on a weight / volume ratio of 1:10 - 1:12 by the percolation method. The biomass was placed in a percolator and poured with a 40% aqueous solution of ethyl alcohol so that the latter completely covered the biomass (at the rate of 5300 ml per 1 kg of biomass) and left overnight. The next day, the extract was poured through the bottom tap into a collecting tank, and the biomass was poured with a new portion of a 40% aqueous solution of ethyl alcohol (at the rate of 3300–3400 ml per 1 kg of the initial biomass) and, after stirring, left overnight. On the third day, the extract was poured into the same collection container and the biomass was again poured with a new portion of a 40% aqueous solution of ethyl alcohol in such an amount to eventually obtain 10 L of the extract. The third portion of the extract was poured the next morning into the same collection container, combining all three extracts. The combined extract was kept in a refrigerator for 3 days, decanted and filtered. The resulting preparation was characterized in accordance with the requirements of TU 9154-001-89061833-2011 with amendments No. 1 to the Vitagmal dietary supplement, SGR No. RU 77.99.29.003.E.003414.02.15 dated 12.02.2015.

Example 3. Preparation of biomass of the plant Polyscias filicifolia fermented by probiotic microorganisms.

The plant biomass of Polyscias filicifolia was grown in a bioreactor by the method of suspension culture of cells of higher plants in accordance with the method described in Patent RU 2 337 138 [36]. Then 10 g of the obtained air-dry biomass of Polyscias filicifolia and 0.1 g of vitamin C were suspended in 100 ml of pre-sterilized milk. The resulting suspension was inoculated with 1 ml (about 10 ⁹ CFU / ml) of the culture liquid of Bifidobacterium longum, followed by fermentation for 24 hours at 37 ± 1 ° C, with constant stirring. The resulting preparation was characterized by HPLC.

Example 4. A pharmaceutical composition that contains a preparation of the plant Polyscias filicifolia.

The preparation of a pharmaceutical composition for the purposes of the present invention included the following steps:

(a) preparing a Polyscias filicifolia plant preparation in accordance with Example 1;

(b) adding to the preparation with constant stirring pharmaceutically acceptable excipients, including a solvent; a pH adjusting agent; isotonicity agent; preservative; antioxidant; surface-active substance; thickener; absorption enhancer;

(c) filling the pharmaceutical composition into 25 ml sterile glass vials and closing.

A pharmaceutical composition was prepared containing a preparation of the plant Polyscias filicifolia, the composition of which is indicated in Table 1:

Table 1

Excipient type Excipient Number in composition,
% (mass) pH of the pharmaceutical composition Polyscias filicifolia
PH regulating agent
Preservative
Isotonicity agent
Absorption enhancer
Antioxidant
Surface-active substance
Thickener
Solvent Polyscias filicifolia preparation according to Example 1
Acetic acid
Benzalkonium chloride
Sodium chloride
EDTA
Vitamin C
Polysorbate TWEEN 20
Gelatin
Polyethylene glycol 97.0
0.22
0.01
0.5
0.005
0.02
0.01
1.0
up to 100% 3.7 ± 0.1

Example 5. The use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of elementoses induced by the ingestion of an extraneous chemical compound.

Rodents are standard subjects for pharmacological research in accordance with the recommendations of the Guidelines for Preclinical Investigation of Potential Drugs [37, 38, 39].

The number of animals used in the study of the use of preparations of the plant Polyscias filicifolia for the treatment of elementosis is the minimum possible in each experimental group, and sufficient to obtain reliable research results and complete statistically significant registration of the studied effects.

In the experiment, 60 specially bred, previously not involved in research, white outbred male Wistar rats, about two months old and weighing 200-220 g, were used.

The animals were kept in controlled conditions at an air temperature of 20-26 ° C and a relative humidity of 30-70% with a regular change of the light cycle (12 hours of light / 12 hours of darkness), water and food ad libitum. All animals went through a 30-day quarantine before being sent to the territory of the nursery. After the arrival, the animals underwent a 48-hour adaptation in the vivarium. During the adaptation period, the animals were visually monitored for clinical signs of health (general condition, mobility, neatness, fatness, appetite, absence of disease symptoms). Before the start of the study, animals meeting the criteria for inclusion in the experiment (body weight, clinical health) were divided into 10 animals per group. The distribution was made so that the average weights of groups of animals of the same species differed by no more than 10%. Each animal was assigned a unique number.

Experiments with the use of laboratory animals were carried out in compliance with humane treatment and ethical standards for the use of animals in the experiment in accordance with the rules [40, 41, 42, 43].

To simulate elementosis in animals, it was decided to use glyphosate (N-phosphonomethylglycine), which is a chelator for a number of essential elements, including iron, copper, zinc, and magnesium [44].

Oral administration of the prepared solutions in the doses indicated in Table 2 was carried out for 7 days.

Table 2 - Study design for various experimental groups of animals.

Group name Method of administration and amount of injected solution,
solution volume / animal weight The composition of the injected solution,
weight or volume of ingredient /
solution volume Number of animals in each test TO Intragastric, once a day in the morning at 3 ml / kg for 7 days Purified water - 100% 10 P1 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 50 μg / ml
Purified water - up to 100% 10 P2 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 250 mcg / ml
Purified water - up to 100% 10 T1 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 50 μg / ml
Polyscias filicifolia preparation (Example 1) - 100 μl / ml
Purified water - up to 100% 10 T2 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 250 mcg / ml
Polyscias filicifolia preparation (Example 2) - 300 μl / ml
Purified water - up to 100% 10 T3 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 50 μg / ml
Polyscias filicifolia preparation (Example 3) - up to 100% 10 T4 Intragastric, once a day in the morning at 3 ml / kg for 7 days Glyphosate - 50 μg / ml
Pharmaceutical composition
(Example 4) - 100 μl / ml
Purified water - up to 100% 10

On the eighth day, 5 ml of blood was taken from the animals. The obtained samples were divided into plasma and a clot of blood cells and frozen at -18 ° C. The liver and spleen were also removed for further research, weighed and frozen at -18 ° C. The frozen samples were transported for quantitative analysis of trace elements. The analysis of the content of essential elements in the samples was carried out in accordance with MUK 4.1.1483 by atomic emission spectrometry on an Agilent 7900 ICP-MS inductively coupled plasma mass spectrometer.

Statistical processing of the obtained data was carried out in the IBM SPSS Statistics 24 program. To describe the groups with homogeneous data or having a distribution close to normal, the mean values (X) and standard deviations (S) were used, and the comparison of the groups was carried out by the method of analysis of variance (F-test ), pairwise comparison by the a posteriori Scheffe test in the case of homogeneous variance in the compared groups or a posteriori Tamhein test in the case of inhomogeneous variance. The test for normality of distribution was carried out by the Shapiro-Wilk test, the test for homogeneity of dispersion was carried out by the Livigne test. Comparison of groups was carried out by nonparametric Kruskal-Wallis analysis of variance (H-test), and pairwise comparison by nonparametric Mann-Whitney test. The critical level of significance for significant differences was taken as p≤0.05.

Checking the data for normal distribution showed that most of the indicators have a distribution that differs from normal, which means that the differences should be assessed using nonparametric criteria. The Kruskal-Wallis test revealed significant differences between the experimental groups in the content of a number of essential elements in the liver, spleen and blood clot. The experimental results are presented in Table 3 (the content of essential elements in the organs of animals for different experimental groups (μg / g)) and in Figures 1 - 3.

Table 3

Organ Group Mg Al Ca Cr Mn Fe Cu Zn I Liver TO The average 324,895 8.627 415,976 0.975 2,215 106,138 3.685 42,844 0.403 N 10 10 10 10 10 10 10 10 10 Standard deviation 86,550 8,392 135,284 0.518 0.811 36.183 2,275 10.417 0.551 Median 366,655 6.145 455,445 1,230 2,425 113,780 4.165 45,670 0.127 Р1 The average 208,829 5,923 272,288 0.307 1,362 66,386 0.696 24,588 0.182 N 10 10 10 10 10 10 10 10 10 Standard deviation 22,782 0.436 38,544 0.233 0.194 14.972 0.457 4.295 0.282 Median 211,885 6,005 282.405 0.220 1.395 67,870 0.570 24.505 0.093 P2 The average 204,392 2.969 508,411 0.025 0.474 56,295 0.468 26,644 0.157 N 10 10 10 10 10 10 10 10 10 Standard deviation 12,640 1,048 13,871 0.079 0.145 25,187 0.554 6,230 0.108 Median 206,000 2.735 510,070 0.000 0.520 50.205 0.275 25.010 0.133 T1 The average 186,781 2,648 178,797 0.300 1,425 79,011 1,674 32.404 0.155 N 10 10 10 10 10 10 10 10 10 Standard deviation 21,572 0.919 46,144 0.070 0.159 19,486 0.908 5.264 0.069 Median 179,725 2.415 167,915 0.315 1.415 81,730 1.345 31,845 0.137 T2 The average 189,179 2,482 178,234 0.373 1.283 63,243 1.498 33.625 0.120 N 10 10 10 10 10 10 10 10 10 Standard deviation 13.657 0.440 33,495 0.039 0.338 27.967 0.413 5.810 0.025 Median 186,255 2,355 175,440 0.370 1,385 58,510 1,435 31,085 0.121 T3 The average 200,550 2.635 148,755 0.316 1.588 76,833 1,500 31,499 0.238 N 10 10 10 10 10 10 10 10 10 Standard deviation 20.022 1.083 65,083 0.071 0.297 21,738 0.606 4.475 0.089 Median 190,695 2,330 129.245 0.320 1,480 78,240 1,280 31.285 0.218 T4 The average 189,027 2,660 140,192 0.663 1,824 85,670 1,824 33,358 0.194 N 10 10 10 10 10 10 10 10 10 Standard deviation 22,126 0.735 50,717 0.982 1,375 28,521 2,297 16,071 0.067 Median 191.405 2,390 126,135 0.305 1,430 81,830 1,130 28,935 0.189 Clot
uniform
elements
blood TO The average 59.620 2,059 97,900 0.646 606,533 0.006 0.504 5.683 0.060 N 10 10 10 10 10 10 10 10 10 Standard deviation 7.16 0.713 4,321 0.253 247,376 0.015 1.412 0.694 0.013 Median 58,750 2,015 99,200 0.680 540,850 0.000 0.005 5.565 0.058 Р1 The average 61,320 1,556 101,480 0.635 527,968 0.007 0.013 6.461 0.049 N 10 10 10 10 10 10 10 10 10 Standard deviation 12,830 0.501 20,524 0.208 94,910 0.016 0.020 1.052 0.012 Median 62,700 1,660 97,700 0.660 494,700 0.000 0.000 6,280 0.048 P2 The average 69,991 0.904 101,485 0.695 758,530 0.052 0.082 7.073 0.041 N 10 10 10 10 10 10 10 10 10 Standard deviation 12,149 0.311 16.621 0.244 103,141 0.141 0.205 0.821 0.026 Median 66,890 0.845 99,750 0.860 738,300 0.000 0.010 6.985 0.032 T1 The average 45,481 1.801 126,889 0.850 764,961 0.032 0.049 8,586 0.079 N 10 10 10 10 10 10 10 10 10 Standard deviation 3.603 0.742 25.039 0.066 120,441 0.027 0.028 0.773 0.010 Median 45,850 1,890 122,295 0.860 732,900 0.040 0.040 8.925 0.081 T2 The average 61.617 1.181 89,063 0.691 846,815 0.008 0.970 8,049 0.060 N 10 10 10 10 10 10 10 10 10 Standard deviation 10,154 0.434 17,199 0.244 100,599 0.016 2.089 1,658 0.017 Median 65,900 0.965 90,850 0.725 803,175 0.000 0.070 7,895 0.058 T4 The average 47,748 1.111 131,878 0.718 621,560 0.009 0.136 7.135 0.068 N 10 10 10 10 10 10 10 10 10 Standard deviation 6.176 0.435 10,841 0.112 47,161 0.009 0.191 0.729 0.017 Median 47.070 0.965 130,995 0.710 607,650 0.010 0.065 7,090 0.068 Spleen TO The average 210.623 1,237 1032,300 0.085 0.398 307,419 0.751 18,235 0.000 N 10 10 10 10 10 10 10 10 10 Standard deviation 110,059 1.025 270,510 0.186 0.658 55,973 0.421 5.297 0.000 Median 176,245 0.885 169,600 0.015 0.210 305,300 0.610 17,750 0.000 Р1 The average 165,878 1.147 147,792 0.029 0.175 330,920 0.592 14,587 0.000 N 10 10 10 10 10 10 10 10 10 Standard deviation 27,859 1.1851 40,642 0.050 0.045 53.925 0.099 3.819 0.000 Median 169,000 0.745 134,140 0.000 0.170 337,425 0.625 14,660 0.000 P2 The average 173,109 0.843 142,154 0.005 0.186 335,748 0.697 13,714 0.056 N 10 10 10 10 10 10 10 10 10 Standard deviation 27.621 0.158 17,701 0.007 0.051 118,167 0.259 2.967 0.098 Median 166,940 0.860 138,550 0.000 0.180 331,870 0.620 12,450 0.000 T1 The average 192.019 0.932 140.019 0.141 0.186 383,093 1.148 14,757 0.035 N 10 10 10 10 10 10 10 10 10 Standard deviation 47.389 0.315 27,000 0.118 0.040 103,226 0.351 2.799 0.110 Median 192,770 0.860 129.195 0.095 0.175 320,450 1,140 13,700 0.000 T2 The average 216,080 0.827 210,557 0.183 0.216 334,110 1.011 20,814 0.000 N 10 10 10 10 10 10 10 10 10 Standard deviation 18,030 0.313 168,258 0.135 0.036 110,063 0.297 12,342 0.000 Median 217,530 0.760 162,220 0.150 0.215 320,320 0.975 16,870 0.000 T4 The average 214,181 0.704 154,689 0.180 0.231 409,315 0.898 15,848 0.079 N 10 10 10 10 10 10 10 10 10 Standard deviation 28.044 0.338 38,725 0.175 0.045 108,644 0.277 2,260 0.249 Median 210,495 0.605 149,535 0.130 0.235 390,500 0.865 15,750 0.000

The results of the experiment show that preparations of the plant Polyscias filicifolia or its fragments can be used to treat elementoses and their consequences in a subject in need of it, where elementoses are deviations in the content of at least one an essential element selected from the group: Ca, Cr, I, Mn, and, in addition, deviations in the content in one or more internal organs of the subject of at least one essential element selected from the group: Cu, Mg, Fe, Zn, without the need to use sources or chelators of essential elements, the content of which is violated.

Example 6. The use of preparations of the plant Polyscias filicifolia or its fragments for the treatment of elementoses induced by an infectious disease.

Infectious diseases, in particular of the oral cavity, primarily periodontitis, are the cause of many systemic diseases, including cardiovascular, bacterial pneumonia, diabetes, osteoporosis, arthritis, cognitive impairment, thrombosis, and other diseases [45].

A clinical study of the use of the plant biomass preparation Polyscias filicifolia, obtained by the biotechnological method of plant cell culture (Example 2), was carried out at the Medical Center No. 18 (St. acad. I.P. Pavlov under the guidance of Associate Professor of the Department of Internal Medicine, Faculty of Dentistry, St. acad. I.P. Pavlova, Dr. honey. Sciences IA Gorbacheva, and with the participation of therapists and dentists of the city periodontal center PAKS and medical unit No. 18.

We selected patients with manifestations of periodontitis in combination with various pathologies of internal organs. In total, 27 people were examined, including 22 women and 5 men aged 20 to 50 years. The treatment was carried out according to the scheme: 10-12 drops of the biomass preparation of the plant Polyscias filicifolia "Vitagmal" sublingually 40 minutes before meals in the morning for 30 days. In addition, the patients treated their gums with Vitagmal after the evening dressing of the oral cavity.

Laboratory studies recorded an improvement in immunological parameters (p <0.001) in patients from the experimental group: the mobilization of mononuclear phagocytes in the focus of aseptic inflammation increased from (52.1 ± 0.7)% to (62.8 ± 1.5)% (at normal (69.3 ± 0.61)%); the number of monocyte precursor cells circulating in the blood from (0.35 ± 0.08) to (0.58 ± 0.09) ⋅109 / l (at a rate of (0.6 ± 0.05) ⋅109 / l); with a pronounced desensitization of the body: a decrease in the level of lymphocyte blast transformation from (5.9 ± 0.9)% to (1.5 ± 0.09)%; the level of γ-globulins from (24.5 ± 0.5)% to (20.0 ± 0.6)%.

All patients noted the disappearance of gingival hypersensitivity and bleeding. The results of laboratory studies of the content of essential elements in the blood of patients are shown in Table 4 (dynamics of the content of essential elements in the blood of patients with periodontitis before and after treatment with the biomass preparation of the plant Polyscias filicifolia).

Table 4

Element Study period Healthy before treatment after the course of treatment Mg (mMol / L)
in plasma
in erythrocytes 0.80 ± 0.03
1.82 ± 0.09 0.83 ± 0.03
2.29 ± 0.09 0.82 ± 0.02
2.3 ± 0.52 Ca (mMol / L)
in plasma
in erythrocytes 1.93 ± 0.09
0.34 ± 0.05 2.10 ± 0.09
0.38 ± 0.05 2.3 ± 0.05
0.38 ± 0.03 Zn (μMol / L)
in plasma
in erythrocytes 5.98 ± 0.9
79.61 ± 0.30 14.7 ± 0.3
112.48 ± 0.5 16.38 ± 0.75
258.45 ± 1.22 Cu (μMol / L)
in plasma
in erythrocytes 10.29 ± 0.51
2.85 ± 0.5 15.48 ± 0.35
14.8 ± 1.5 15.74 ± 0.60
26.75 ± 2.68 Fe (μMol / L)
in plasma 11.7 ± 0.8 19.2 ± 0.6 18.61 ± 0.96

The results of the experiment show that preparations of the plant Polyscias filicifolia or its fragments can be used to treat elementoses and their consequences in a subject in need of it, where elementoses are deviations in the content of at least one an essential element selected from the group: Ca, Cr, I, Mn, and, in addition, deviations in the content in one or more internal organs of the subject of at least one essential element selected from the group: Cu, Mg, Fe, Zn, without the need to use sources or chelators of essential elements, the content of which is violated.

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Claims (10)

1. The use of a preparation of lateral shoots or leaves of a plant Polyscias filicifolia, obtained by alcohol extraction of a plant or by a biotechnological method of plant cell culture, for the treatment of elementosis in a subject in need thereof, where elementoses are deviations in the content of one or several internal organs of the subject of at least one essential element selected from the group: Ca, Cr, I, Mn, Cu, Mg, Fe, Zn without the need to use sources or chelators of essential elements, the content of which is disturbed. 2. The use of a preparation of lateral shoots or leaves of the plant Polyscias filicifolia, obtained by the biotechnological method of plant cell culture, for the treatment of elementoses in a subject in need of it, where elementoses are deviations of the content in one or several internal organs of the subject of at least one essential element selected from the group: Ca, Cu, Mg, Fe, Zn without the need to use sources or chelators of essential elements, the content of which is disturbed. 3. Use according to claim 1 or 2, wherein the biomass of the Polyscias filicifolia plant is obtained by a biotechnological method of plant cell culture. 4. The use according to claim 3, where the biomass of the plant Polyscias filicifolia was obtained by the biotechnological method of plant cell culture based on the strain BFT 01-95, No. 58 VKKK BP. 5. Use according to claim 3, wherein the preparation is a Polyscias filicifolia plant biomass fermented by probiotic microorganisms, obtained by a biotechnological method of plant cell culture. 6. Application according to any one of paragraphs. 1-5, where the preparation is used in a pharmaceutical composition that contains at least one preparation of the Polyscias filicifolia plant in combination with a pharmaceutically acceptable excipient selected from the group consisting of a solvent; a pH adjusting agent; isotonicity agent; preservative; antioxidant; surfactant; thickener; an absorption enhancer, or a combination thereof. 7. Use according to claim 1, wherein the elementoses are induced by the ingestion of an extraneous chemical compound glyphosate (N- (phosphonomethyl) -glycine) into the subject's body. 8. Application according to any one of paragraphs. 1-7, where elementosis is a deviation in the content of one or more essential elements in at least one of the internal organs selected from the group: liver, spleen, blood. 9. Application according to any one of paragraphs. 1-8, where the drug is administered orally or sublingually. 10. The use according to any one of paragraphs. 1-9, where the drug is part of a drug for the treatment of elementoses.

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