CZ2014517A3 - Pharmaceutical composition exhibiting virucidal and antibacterial activity - Google Patents

Abstract

A pharmaceutical composition with virucidal and antibacterial activity comprising iodine, potassium iodide, sodium iodide, a synthetic water-soluble polymer, carbohydrates and halogenated carbohydrates and water, and additionally rutin and ascorbic acid, as follows: iodine 1 - 25 g / l, potassium or sodium iodide 1.5 - 25 g / l, water-soluble synthetic polymer 1 - 10 g / l, carbohydrates 10 - 200 g / l, halogenated saccharides 0.01 - 100 g / l, rutin 1 - 10 g / l, ascorbic acid 1 - 10 g / l with water up to 1 liter. The water-soluble synthetic polymer is preferably polyvinylpyrrolidone.

Description

(54) Title of the application for the invention:

Pharmaceutical agent with virucidal and antibacterial effect (57)

Pharmaceutical composition with virucidal and antibacterial action comprising iodine, potassium or sodium iodide, water-soluble synthetic polymer, carbohydrates and halogenated carbohydrates and water and additionally rutin and ascorbic acid, in the following composition: iodine 1 - 25 g / l, potassium or sodium iodide 1.5-25 g / l, water-soluble synthetic polymer 1-10 g / l, carbohydrates 10-200 g / l, halogenated carbohydrates 0.01-100 g / l, rutin 1-10 g / l, ascorbic acid 1 - 10 g / 1 supplemented with water up to 1 liter. The water-soluble synthetic polymer is preferably polyvinylpyrrolidone.

PHARMACEUTICAL PRODUCT WITH VIRUCID AND ANTIBACTERIAL EFFECT

Field of technology

The present invention relates to a pharmaceutical composition having virucidal and antibacterial activity and to its use. The composition can be used in pathological conditions such as bacterial and viral mono- or mixed infections, cancer, systemic connective tissue diseases, certain skin diseases, conditions after radiation damage, radiation therapy and chemotherapy, after injuries caused by external causes. The composition can be used to treat diseases against mono- and mixed infections, including HIV-associated infections, has overt anti-inflammatory, antioxidant, antiseptic, regenerative, detoxifying, immunomodulatory, cytostatic, antitumor, and also exhibits antineoplastic properties without toxic effects on the body. This pharmaceutical composition can be used on its own or in combination with traditional combination therapy.

Prior art

The invention relates to a pharmaceutical preparation intended for the treatment and prevention of infectious diseases, including socially dangerous: brucellosis, hepatitis, anthrax and other viral and bacterial diseases.

These diseases reduce the immunoreactive, adaptogenic properties of humans and mammals, increase stress, complicate conventional therapies against viruses and microbes that can be transformed into new strains.

Currently, there are a large number of antibacterial agents - antibiotics, both natural, polysynthetic and synthetic.

Antiviral therapy, unlike antibiotic therapy, has a significantly smaller arsenal of drugs. The efficacy of many virucidal chemicals and antivirals has been established in experimental studies and as a result of numerous clinical trials, however, few are approved for widespread practical use (The International Pharmacopoeia. 4-th ed., Vol. 1-2, including First Suppl (WHO, Geneva, 2008).

Research into antibacterial and virucidal substances from the group of carbohydrates and proteins has a long history. In this application, only publications directly related to the subject matter of the invention are mentioned, and references are also made to several basic publications (Advances in protein chemistry. V. 1-39. New York, San Francisco, London: Academie Press, 1976; Methods in carbohydrate chemistry (V. 1-15. New York: Academic Press, 1980).

U.S. Pat. No. 5,846,951 discloses a pharmaceutical composition comprising polysaccharides having at least five sialic acid residues in their composition. As polysaccharides, bacterial polysaccharides are proposed, e.g., from E. coli K1, N. meningitidis, Moraxella liquefaciens or others.

International application WO9722346 describes the use of alkylated and / or acylated mono and / or oligosaccharides as antimicrobial, antifungal and / or antiviral agents.

International application WO9700689 describes antiviral agents which contain as active ingredient an effective amount of a red microalgae polysaccharide or a mixture of two or more of said polysaccharides.

Antimicrobial antibiotics are known - aminoglycosides (neomycin, monomycin, kanamycin, gentamicin, etc.) (The International Pharmacopoeia. 4-th ed., Vol. 1-2, including First Suppl. WHO, Geneva, 2008), which vary according to activity , spectrum and duration of action, toxicity. The disadvantages of all aminoglycoside-containing antibiotics are nephrotoxicity and ototoxicity. U.S. Pat. No. 5,646,119 A discloses the use of D-aminogistatin-based peptides as antifungal and antibacterial agents. The composition comprises a peptide with an amino acid sequence of at least eight amino acids.

U.S. Patent No. 5,869,457 discloses modified proteins and their use in combating viral infection, including influenza and immunodeficiency. The compositions are used in vitro to inhibit the fusion of virus-infected and non-virus-infected cells and contain modified proteins and / or polypeptides as carriers for the active ingredients.

U.S. Pat. No. 5,622,933 A discloses known branched chain peptide constructs which are used to treat HIV.

Fr2729858 discloses a compound based on iodinated polyvinylpyrrolidone and its use for disinfection. The compound may be in the form of a powder, granules or tablets.

U.S. Pat. No. 6,045,787 for disinfecting a protein contained in a plasma-type solution describes the use of an iodinated resin containing 5 to 80 parts of iodine. This resin effectively disinfects solutions, minimally damages unstable proteins and saves red blood cells and platelets.

Utility Model No. 5435, Patent No. PK 6730, discloses a pharmaceutical composition of iodomidol having a bactericidal and virucidal effect, comprising iodine, potassium iodide or sodium iodide, a synthetic water-soluble polymer which acts as a base polymer, and water. This preparation is characterized in that it additionally contains a natural polymer, for example polysaccharides in the following ratio, g / l: iodine - 6-10; potassium or sodium iodide - 9-15; water-soluble synthetic polymer - 2; natural polymer (polysaccharides- 80-120; the rest is water).

The pharmaceutical composition may further contain trace elements, such as zinc, manganese, iron, copper, cobalt, in an amount of 0.1 g / liter of the total. The disadvantage of this preparation is its relatively high toxicity.

EP Patent No. 0978289 and the Republic of Armenia Patent No. 659 describe a pharmaceutical preparation with antiviral activity, comprising iodine, potassium iodide or sodium iodide, a synthetic water-soluble polymer, a mixture of natural mono-, oligo- and polysaccharides, and lithium chloride in a ratio of components , g / 1: iodine - 0.8-25; potassium or sodium iodide - 1,2-38; lithium chloride - 0.1-20; water-soluble synthetic polymer - 0.01-6; mixture of mono-, oligo- and polysaccharides - 8-400; water - residue This product can be used to treat humans, but like the above products has high toxicity.

Patent of the Republic of Armenia No. 949, describes a pharmaceutical preparation Armenikum with virucidal and bactericidal effect, which contains iodine, potassium or sodium iodide, sodium chloride, lithium chloride, synthetic water-soluble polymer, mono-, oligo- and polysaccharides and water, and other halogenated organic compounds in such content (g / l): iodine - 8-25, potassium or sodium iodide - 1,2-38, sodium chloride - 9, lithium chloride - 0,1 - 20, synthetic water-soluble polymer - 0,01- 6, mono-, oligo- and polysaccharides - 8-400, halogenated organic compounds 0.001 - 0.01, water - residue. The disadvantage of this drug is its low virucidal effect, including the effect on HIV infection.

A common disadvantage of said medicinal products (patent PK No. 6730, patent RF No. 2130312, UV of the Czech Republic No. 5435, European Patent EP0978289 patent of the Republic of Armenia No. 659, Patent of the Republic of Armenia No. 949) is also the lack of bactericidal effect against mycobacteria and low bactericidal activity against spores, spore-forming bacteria and fungi (Armenicum Experimental Studies. Yerevan; Gitutyun Publishing House NAS RA, 2000, 176 p.).

Other biologically active preparations containing iodine in one form or another are also known (RF Patent No. 2160090 C2, RF Patent Application No. 991191 A; RF Patent Application No. 93005225 A, RF Patent No. 21755 C2), but all also have the above disadvantages.

A comparison of the composition of the applied preparation and the most similar ones mentioned in the above-mentioned patent applications is given in Table 1.

(33) Table No. 1 - Comparison of the composition of preparations in the mentioned documents and the composition of the composition according to the invention (g / 1)

Patent of the Republic Armenia no 949 Utility model of the Czech Republic No. 5435 In prehistoric times Jodinol European Patent No. 0978289 Patent of the Republic of Kazakhstan No. 6730 Eurasian Patent No. 004203 Utility model of the Czech Republic No. 8277 Patent CZ 295765 composition of the composition according to the invention Iodine 0.8-25 6-10 0.1% 0.8-25 6-10 0.8-25 0.8-25 0.8-25 1-25 Potassium or sodium iodide 1,2-38 9-15 0.3% 1,2-38 9-15 1,2-38 1,2-38 1,2-38 1.5-25 Sodium chloride 9 9 Lithium chloride 0.1-20 0.1-20 0.1-20 0.1-20 0.1-20 Synthetic polymer 0.01-6 2-4 0.9% 0.01-6 2-4 0.01-6 0-6 0-6 1-10 (low molecular weight polyvinylpyrrolidone medical 8000-2000) Carbohydrates (mono, oligo, poly) 8-400 8-120 8-400 80-120 8-400 8-400 8-40 10-200 (of natural origin) Halogenated natural carbohydrates 0.001-0.01 0.001-0.01 0.01-100 Trace elements (Zn, Mn, Fe, Cu. Co) 0.1 Routine - - - - 1-10 Ascorbic acid • - 1-10 Water to 1 1 to 1 1 to 1 1 to 1 1 to 1 1 to 1 1 to 1 1 to 1 1 - Saline or 5% glucose solution - - - to I 1

The essence of the invention

These disadvantages of the known solutions are eliminated by a pharmaceutical composition with virucidal and antibacterial action, which contains iodine, potassium or sodium iodide, a water-soluble synthetic polymer, carbohydrates and halogenated carbohydrates, according to

of the present invention, the essence of which is that it additionally contains rutin and ascorbic acid, with the following composition G/· Iodine 1-25 potassium or sodium iodide 1.5-25 water-soluble synthetic polymer 1-10 carbohydrates 10-200 halogenated carbohydrates 0.01-100 routine 1-10 ascorbic acid 1-10 water the rest to 1 liter.

The water-soluble synthetic polymer is preferably polyvinylpyrrolidone. The saccharides may be monosaccharides, oligoaccharides and / or polysaccharides of natural origin. The water present is supplied in the form of saline or 5% glucose solution.

The pharmaceutical composition of the present invention has a antiviral, antibacterial antioxidant, antiseptic, regenerative, detoxifying, immunomodulatory, cytostatic, antitumor effect, and is used to treat burns, purulent wounds, anal and rectal fissures, acute upper respiratory tract infections, autoimmune diseases, psoriasis, viral diseases caused by viruses: influenza, human papillomavirus poliomyelitis, herpes simplex, hepatitis B and C, HIV; treatment of cancer, supportive treatment after irradiation and chemotherapy, treatment of the consequences of radiation damage.

The concentration ranges of the components are not selected at random. All the properties included in the proposed composition are necessary and sufficient to achieve the desired effect. None of them can be excluded or replaced. Otherwise, the technical result will not be achieved. The choice of qualitative and quantitative components contained in the present pharmaceutical composition was based on numerous research data of the authors (Tables 2-8, Figures 1-7), confirming the high therapeutic efficacy of the applied preparation, and the absence of toxicity.

The advantage of the present composition is minimal toxicity, due to the addition of the strong antioxidant rutin and vitamin C-ascorbic acid, which bind to each other free radicals caused by exposure to sunlight. These substances reduce excessive toxicity, slow down lipid peroxidation processes as well as oxidative DNA damage, as well as eliminated excessive amounts of NaCl, LICI, heavy metal salts (Zn, Mn, Fe, Cu, Co), which increase the toxicity of the compared preparations. To further reduce the toxicity of the present composition compared to EP 0978289, as well as Czech UV No. 5435, polymethyl methacrylate, which has chronic toxicity, has been replaced in the present formulation by non-toxic low molecular weight polyvinylpyrrolidone contained in a number of other approved pharmaceutical formulations (e.g. iodine)

Iodine is an effective virucidal, antibacterial, antiseptic agent. As shown by experimental studies, at iodine concentrations below 0.8 g / l it hydrolyzes and the shelf life of the product is reduced. If the iodine concentration is above 25 g / l, jelly-like systems are formed. The use of preparations containing iodine affects the metabolism, increases the function of the thyroid gland. Iodine affects the metabolism of fats and proteins. The use of iodine-containing products lowers blood cholesterol levels and reduces blood clotting. Iodine products are used as disinfectants in the treatment of inflammatory and other diseases. High doses of iodine are used to treat polio, viral diseases and some diseases of the central nervous system. The reflexive increase in mucus secretion by the airway glands and the proteolytic effect explain the use of iodine preparations as expectorants and mucolytics. Iodine is approved for medical use in various dosage forms (including oral, in the form of injectable solutions, etc.) and is a component of many approved pharmaceuticals (e.g., lodinol, Joks, Betadine, etc.).

Potassium or Sodium Iodide - Provides the composition of ionized potassium or sodium cations, as well as iodine anions. In aqueous drug interaction solutions, just ionized forms of substances have a higher bioavailability. In the present preparation, molecular iodine stabilizes and prevents (together with the polymer matrix polyvinylpyrrolidone) undesirable processes such as iodine peroxidation and the formation of toxic iodine radicals.

Upon entering the body in physiological amounts, iodides normalize the ratio of T3 / T4 thyroid hormones triiodothyronine (T3) and thyroxine (T4), damaged due to iodine deficiency. In thyroid follicle epithelial cells, iodide is oxidized to elemental iodine under the influence of thyroperoxidase, which provides iodination of tyrosine residues on the side chains of the thyroglobulin molecule to form precursors of thyroid hormones - monoiodothyrosines (MIT) and diiodothyrosines (DIT).

Due to the action of oxidative enzymes MIT and DIT, they condense with the formation of thyronines, the main ones being triiodothyronine (T3) and thyroxine (T4). The complex of thyroglobulin with thyronine by endocytosis passes from the colloid to the follicular cell, where it is deposited.

Iodides of various metals (potassium, sodium, calcium, etc.) are part of many pharmaceutical preparations (eg iodine vitamin, iodine, iodobalans, iodide 100, iodide 200, iodomarin 100, iodomarin 200, iodostin, potassium iodide 200 Berlin-Chemie, Potassium iodide tablets, etc.).

The water-soluble polymer (low molecular weight polyvinylpyrrolidone) serves as an iodophor, an immobilization matrix that provides the body with active iodine sorption / desorption processes, and when added to the blood, performs a gelling function, a plasma replacement function and an active iodine prolonging function. It stabilizes molecular iodine and prevents (together with potassium and sodium iodide) undesirable processes of peroxidation of molecular iodine and the formation of toxic iodine radicals. Polyvinylpyrrolidone is also involved in increasing the solubility of the composition in liquid and semi-solid dosed forms, and is also an inhibitor of iodine crystallization.

Natural carbohydrates act as immunoregulators determining the energy potential of the body. Carbohydrates may be present in the form of mono-, oligo- and / or polysaccharides. It is known that carbohydrates, together with proteins and lipids, are part of the biological membranes that divide the space between the cell contents and the external environment. The mono-, oligo- and polysaccharides contained in the preparation play an important role in intracellular cognition. The polysaccharides contained in the composition have a positive effect on inflammation, on exposure to ionizing radiation, enhance the regeneration of nerve and muscle tissues, suppress the growth of connective tissue, have a certain antitumor activity. The specific antitumor effects of polysaccharides are associated with the activation of macrophages and T-lymphocytes, the stimulation of interferon and the immunomodulatory effect at the cellular level.

By using natural carbohydrates with low toxicity (containing no toxic synthetic impurities), it was possible to remove excess (higher than the maximum permissible concentrations) sodium chloride and lithium chloride, as well as heavy metal salts without losing the qualitative properties of the composition. Natural carbohydrates are among the permitted excipients of medicines.

Halogenated carbohydrates - increase the solubility of iodine, supply iodide ions, adjust pH, and also have the effect of prolonging the effectiveness of the composition during storage.

Rutin is an antioxidant, adaptogen, a vascular protective agent that increases the solubility and bioavailability of the components of the composition; strengthens the walls of blood vessels (vitamin P). Strengthens capillary walls, adjusts their permeability; increases the effects of ascorbic acid. It is recommended in cases accompanied by increased capillary permeability, capillary toxicosis, radiation sickness, viral bacterial endocarditis, rheumatism, glomerulonephrosis, hypertension, allergic diseases, to normalize blood function, as an anti-inflammatory agent.

Ascorbic acid - vitamin C is a pH regulator. Ascorbic acid is involved in the conversion of cholesterol to bile acids. Vitamin C is also essential for detoxification in hepatocytes involving cytochrome P450. Restores ubiquinone and vitamin E. It participates in immunomodulation by stimulating interferon synthesis. An important function of ascorbic acid in the present preparation is also that it slows down the glycosylation process of hemoglobin, slows down the conversion of glucose (from carbohydrates, in their natural form, after hydrolysis in the body) to sorbitol, and thus allows the use of the product to treat children and diabetics. It supports the production of collagen, serotonin from tryptophan, the formation of catecholamines, the synthesis of corticosteroids. Ascorbic acid is involved in the conversion of cholesterol to bile acids.

Rutin reacts with enzymes and proteins, increases their biological functions, and thanks to this property has antimicrobial, antimutagenic, antineoplastic and antirachitic effects.

Rutin and ascorbic acid in the composition of the proposed drug act as potent antioxidants to ensure the destruction of toxic free radicals formed by prolonged exposure to direct sunlight, to prevent lipid peroxidation processes determining the excessive toxicity of the comparators, and such oxidative DNA damage. Rutin also regulates the pH of the environment and removes waste products from the body due to the reaction of C = C bonds and alcoholic OH groups.

Saline or 5% glucose solution dissolves all the components of the pharmaceutical composition of the invention, providing the water solubility of the preparation and the softness of its use. Saline is used to cleanse the blood and the body in general, reduces toxicity, in medicine it is used to dissolve and dilute drugs, as well as in large loss or lack of extracellular fluid or its insufficient influx, hyponatremia and hypochloraemia with dehydration, intoxication, etc. .

A pharmaceutical composition according to the invention with a broad spectrum of action is an aqueous solution of a dark blue color of molecular and ionic complexes of iodine with associates of water-soluble gelling synthetic polymers and natural mono-, oligo- and ***; · Polysaccharides. The pharmaceutical composition has a pH of 6-7. All its components are dissolved in isotonic sodium chloride solution or 5% glucose solution.

The pharmaceutical composition has low toxicity and poor cumulative properties. All studies were performed in triplicate on 10-day-old chicken embryos. The preparation, diluted from the initial to 1: 256, was injected into the allantoic cavity of the embryo in a volume of 0.2 ml. The control group injected phosphate buffer without the addition of agent. Embryotoxicity was calculated according to the number of dead embryos. During the embryotoxicity study of the composition, it was found that embryo death was 10% in the control group. It has been shown that the value of embryotoxicity depends on the dilution of the product. The embryotoxicity of the composition was found to be 0% at a dilution of 1: 4 to 1: 256. When increasing the concentration of the composition to 1: 2, the toxicity increases up to 50%, when using the starting solution - up to 70%. In this way, the preparation was found to have toxic properties in the starting solution and at a dilution of 1: 2; at a dilution of 1: 4 and more it does not show toxic effects on chicken embryos, see tab. 2.

Table No.2 - Determination of embryotoxicity of the device

Dilution of the agent Starting solution (51.7 mg / kg) 1: 2 1: 4 1: 8 1:16 1:32 1:64 1: 128 1: 256 Proportion of dead embryos 70% 50% 0 0% 0% 0% 0% 0% 0% Effective treatment concentrations for (Example A, B, L AT) other means R, S, T,

Note:

1. The stock solution was prepared according to standard embryotoxicity methods.

2. The concentration of the starting solution was greater than the minimum concentration of the composition (Example A) - 33.3 times; at a therapeutic dose of 0.2 ml / kg (Example A, B, L, R, S) - 16.7 times; at a therapeutic dose of 0.3 ml / kg (Example 1, R, S, T, U) - 11.1 times.

Any changes in the condition of the animals, the overall appearance and behavior were not registered. Achieving the upper limit of toxicity or absolute lethal effect by administration of gradually increasing doses of the substance (including the maximum possible dose) failed due to the low toxicity of the composition and its cut-off volume for administration. This means that the test substance is a safe substance due to the parameters of acute toxicity (LD 50> 500 mg / kg).

The pharmaceutical composition has antibacterial and virucidal activity against mono- and mixed infections, including HIV-associated infections, with marked anti-inflammatory, antioxidant, antiseptic, regenerative, detoxifying, immunomodulatory, cytostatic, antitumor effect, and exhibits antineoplastic properties without toxic effect on the organism.

A pharmaceutical composition of a broad spectrum of pharmacological action is used in mammals, including humans, orally, topically, subcutaneously, intramuscularly, intravenously and intraperitoneally.

Overview of figures in the drawings

The solution is explained in more detail in the drawings, where:

Giant. 1 shows the inhibitory activity of an anti-A / H INI influenza virus composition.

Figure 2 shows the inhibitory activity of the composition against influenza A / H3N2 virus.

Giant. 3 shows the inhibitory activity of the composition against influenza virus, type B.

Giant. 4 shows the inhibitory activity of the composition against influenza A / H5N3 and A / H7N1

Giant. No. 5 shows a fluoroscopic study of the antiviral efficacy of an anti-HPV16 agent

Giant. No. 6 shows a Western Blot method for determining the ability of an injectable composition to inhibit HPV16 in cells

Giant. No. 7 shows a Western Blot method for determining the ability of an oral preparation to inhibit HPV16 in cells.

Examples of embodiments of the invention

Examples of the composition of the composition according to the invention (g / l):

Example 1 (minimum concentration)

1. Iodine 1 2. Potassium or sodium iodide 1.5 3. Water-soluble synthetic polymer 1 4. Carbohydrates 10 5. Halogenated carbohydrates 0.01 6. Routine 1 7. Ascorbic acid 1 8. Saline or 5% glucose solution to 1 1 Example 2 (maximum concentration) 1. Iodine 25 2. Potassium or sodium iodide 25 3. Water-soluble synthetic polymer 10 4. Carbohydrates 200 5. Halogenated carbohydrates 100 6. Routine 10 7. Ascorbic acid 10 8. Saline or 5% glucose solution to 1 1

____ · · ···· ** · ·· · * * · · ·

II

Note: examples of therapeutic use of the present composition in minimum and maximum concentrations, as well as in comparison with known preparations are given in Tables 4, 5.

Use of the product in veterinary medicine

Example A

The composition was used in animals (pigs) with Aujeszky's disease at a dose of 0.1-0.2 ml of the composition according to Example 1 per 1 kg of body weight. After a single injection of this dose, the clinical manifestations of the disease and the death of the animals stopped.

Example B

The composition was used in animals (cattle and sheep) infected with foot-and-mouth disease, parenterally with a double dose of 0.1 ml of the composition according to Example 1 per 1 kg of body weight at intervals of 24 hours. After treatment, a positive clinical effect was observed in 100% of cases of foot-and-mouth disease in animals.

Study of antibacterial properties of the composition

Example C

Laboratory tests of the bactericidal activity of the composition in relation to strains of anthrax microorganisms (Bacillus anthracis) in guinea pigs and strains of brucellosis microorganisms (Brucella melitensis, Brucella abortus, Brucella suis) in white mice were performed. Investigation of the bactericidal activity of the product showed positive results in vitro at a dilution of 1:64 of the anthrax pathogen and 01:16 of the brucellosis pathogen. The therapeutic effect of the composition was observed in 60% of brucellosis-infected animals and in 75% of anthrax-infected animals.

Example D

In in vitro laboratory studies, the composition of Example 1 at a dilution of 1:10 to 1: 100 showed a marked bactericidal effect against gram-positive and gram-negative bacteria, which disappeared within 5-10 minutes after the onset of action. The bactericidal effect of the drug was comparable to the potency of broad-spectrum antibiotics in the control sample.

Use of the product for burns, festering wounds, anal and rectal fissures

The pharmaceutical composition of the invention was used to treat burns, wounds, shin ulcers, in the form of a hydrophilic gel having the composition as in Example 1. After application to the wound surface, formed a protective film, which shortened treatment time due to faster cleansing and healing of burns, absence of irritants and side effects of the drug. The gel did not spread over the surface, but covered the wound like a film that prevented further infection of the wound and also did not delay the regeneration of the damaged tissue. The use of the gel did not require additional loading of the aseptic dressing, i.e. the treatment was performed in an open manner. The gel was particularly effective on fresh wounds caused by heat, chemical and sunburn.

The gel gel pharmaceutical composition of the invention acts on burns as a potent anti-inflammatory, antioxidant, overt sorbent and regenerating agent. The gel also forms a surface film, which is a mechanical protection against infection of the wound from the outside. The gel softens the scab, which reduces the tension of the scab and new epithelium. Thanks to the action of the composition in the form of a gel, the healing of burns takes place without complications and the formation of scars.

Example F

Patient, 37 years old, II. degree of burns by flame of hands, arms 5% of the body surface. Treatment was started in the first days after the trauma. Every day, 3 times a day, a hydrophilic gel of the composition according to Example 1 was applied to the affected areas of the skin. The course of the wound healing process without complications;

Example G

Patient, 29 years old, 1-11. degree of leg burns in the legs 4%, of which III. And a degree of 2% of the body surface. Gel treatment of the composition of Example 1 was started from the first day after the injury. During the treatment, mechanical scab removal was performed. On day 11, superficial burns were completely epithelialized. The remaining granulation wounds continued to be treated with gel. Complete recovery occurred on the 32nd day after the injury. No gross scarring was detected immediately after treatment and 3 months after injury.

Example H

Patient, 25 years old, thermal burns of the forearm I.-II. st. 2% of the body surface. Treatment was started from the first day after trauma, the hydrophilic gel according to Example 1 was applied twice a day. The course of wound healing without complications, on the 8th day from the day of the injury there was a complete epithelialization of the skin.

Good tolerability was determined during treatment, without allergic reactions and local irritation.

The composition has been used in patients with inflammatory rectal disease

Example I

Patient, 44 years old, anal fissure. The composition was administered in an oral dosage form in a dose of 0.3 ml of the composition of Example 1 per 1 kg of body weight, and in a form for external use as an application twice a day. Complete healing and epithelialization of the wound surface occurred 10 days after the start of treatment. There were no recurrences.

Example J

Patient, 39 years old, hemorrhoids. Treatment was prescribed: a liquid form of the composition according to Example 1 was administered in the form of a microclyme 7 ml of the composition according to Example 1 12 times a day and application of a hydrophilic gel to the anal area 2 times a day. During treatment three days later, the patient's health was improved, the pain and bleeding completely disappeared during defecation. Complete recovery occurred 7 days after the start of treatment.

Effect of the product on influenza virus and acute upper respiratory tract infections

The virucidal effect of the composition according to the invention of the composition according to Example 1 was studied on chicken embryos infected with the following viruses and viral antigens: A / New Jersey / 8/76 (H1N1), A / Solomon Islands / 03/06 (H1N1), A / Swine / Iowa / 15/30 (H _Sw lNl), A / Wisconsin / 67/05 (H3N2), A / Brisbane / 10/06 (H3N2), B / Shandong / 07/07 (Victorian Line), B / Florida / 09 / 06 (Yamagata Line), A / tern / South Africa / 1/61 (H5N3) and A / FPV / Rostock / 67/05 (H7N1).

To study the virucidal effect of the composition according to the invention with the composition according to Example 1 against influenza A and B viruses, its infectious activity was determined (Table 3).

Table 3 - Infectious activity of viruses

C. Strain Antigenic formula IgEID 50 value / 0.2 ml 1 A / New Jersey / 8/76 H1N1 6.78 2 A / Solomon lslands / 03/06 H1N1 5.63 3 A / Wisconsin / 67/05 H3N2 6.75 4 A / Brisbane / 10/06 H3N2 5.25 5 B / Shandong / 07/07 Victorian line 7.5 6 B / Florida / 09/06 Yamagata line 4.33 7 A / Swine / Iowa / 15/30 HswlNl 8.78 8 A / tern / South Africa / 1/61 H5N3 8.0 9 A / FPV / Rostock / 67/05 H7N1 8.75

...... ·· ···: Λ.

• · · · · _e »· ·

·. ϊ i · · * · *; ··; * t · · · · a J ···

The results of the study of the virucidal activity of the composition according to the invention against influenza A / New Jersey / 8/76 (H1N1), A / Solomon Islands / 03/06 (H1N1) and A / Swine / Iowa / 15/30 (HswlN1) are shown in FIG. 1. Shown that the composition of the invention is able to completely inhibit the reproduction of 100 infectious doses of influenza A / H1 virus at dilutions from the initial dilution to 1: 8, maintaining the inhibitory effect until a dilution of 1:64.

The effect of the composition on influenza virus serotype H3 (A / Wisconsin / 67/05 and A / Brisbane / 10/06) is shown in Figure 2. The maximum inhibitory activity (100%) of the composition according to the invention of the composition according to Example 1 was demonstrated from the initial dilution. to 1: 4, the effect decreased to 0% at a 1:64 dilution.

Suppression of influenza B virus reproduction (B / ShALSEdong / 07/07 and B / Florida / 09/06) by the composition of Example 1 is shown in Figure 3. The composition showed inhibitory activity to a dilution of 1:16, completely suppressing the virus in dilution from initial to 1: 4 dilution.

Figure 4 shows the effect of a composition according to the invention of the composition according to Example 1 on the influenza A / H5N3 and A / H7N1 viruses. This composition was found to be effective against these viruses up to a dilution of 1:16, and approaches 100% inhibition at a maximum dilution of 1: 2.

Studies of antiviral activity have shown that the composition of Example 1 has significant inhibitory properties against both influenza A and B viruses. The best results are against influenza A / H1N1 viruses at dilutions from initial to 1:64. Against the A / H3N2 influenza virus, these numbers dropped from initial to 1:32. For influenza B, A / H5N3 and A / H7N1 viruses, the effect of the composition was observed to a dilution of 1:16.

Effect of the agent on the hepatitis B virus

Example K

Laboratory tests of blood samples from patients' serum containing hepatitis B antigen (HBsAg) were performed. A decrease in the serological activity of the blood serum was noted, and it was also found that the preparation according to the invention of the composition according to Example 1 at a dilution of 1:20 with an incubation time of 2 hours has an inhibitory effect on HBsAg.

Effect of the agent on the hepatitis C virus

Exclusion tests for antiviral activity against the hepatitis C virus were performed. This agent effectively protects cells in vitro from the cytopathogenic effect of hepatitis C virus.

Example L

In patients with chronic hepatitis C, the composition of the invention of the composition of Example 1 was administered as follows: one course of treatment contained a daily oral dose of 0.2 ml of the composition of the composition of Example 1 per kg of body weight, divided into two doses, morning and evening. , for 45 days. The break between courses was 15 days. It can be said that the whole period of treatment consisted of 3 to 5 courses depending on the severity of the disease, the basal level of transaminases, viral load and the amount of antibodies. The pharmaceutical composition shortened the treatment time by improving the effectiveness of the antiviral effect without increasing the toxic effect on the patient's body. Treatment with the product reduced the level of infection caused by the hepatitis C virus. In a significant number of patients treated during the course, health status, working capacity improved significantly for 4-6 weeks, asthenic vegetative syndrome disappeared, pain in the right upper quadrant was alleviated (Table 4). . The method of treatment with the composition according to the invention ensured clinical and laboratory remissions, as well as the elimination of the hepatitis C virus and the normalization of biochemical parameters after the end of the treatment. The rate at which liver function tests (transaminases and bilirubin) decreased in patients taking this medicine was rapid. SVR was observed in 86% of patients (Tables 5, 6). During antiviral treatment, none of the patients experienced symptoms that could be considered a side effect of the product.

(87) Table No. 4 - Occurrence of clinical difficulties before and after treatment with a composition according to the invention of the composition according to Example 1

Index Study group (n = 60) Control group (n = 60) Before treatment After treatment Before treatment After treatment Abs. ReL (%) Abs. ReL (%) Abs. ReL (%) Abs. ReL (%) Weakness 30 50 5 30 50 12 20 Fatigue 34 56.7 4 ** 6.7 36 60 18 30 Impaired working capacity 20 33.3 4 ** 6.7 24 40 10 16.7 Decreased appetite 27 45 6 * 10 32 53.3 19 31.7 Nausea 11 18.3 3.3 12 20 7 11.7 Unpleasant feelings in the right upper quadrant 17 28.3 2 ** 15 25 10 16.7

Note: differences between groups * - p <0.05, ** - p <0.01

Table 5 - Comparison of the efficacy of the formulation of Example 1 and Example 2 with the interferon formulation in the treatment of hepatitis C

Clinical and laboratory parameters in patients with chronic hepatitis C, mild course

Hb (g / i) RBC xl0 ^{, 2} / l ALT (U / L) AST (U / L) Bili (pmol / L) HCV RNA (U / mL) In the treatment with a composition according to the invention (Examples 1 and 2) Before treatment 118.1 ± 7.0 4.2 ± 0.15 173.0 ± 14.1 172.0 ± 0.62 37.1 ± 2.28 1610000 ± 2700 Example 1 (min. Conc.) After 6 months of treatment 122.9 ± 10.0 4.3 ± 0.28 24.7 ± 0.7 ** 22.8 ± 1.4 ** 18.5 ± 2.52 * 0 ** Example 2 (max. Conc.) After 6 months of treatment 125.4 ± 11.0 4.4 ± 0.32 22.3 ± 0.7 ** 19.2 ± 1.6 ** 17.6 ± 2.65 * 0 ** In the treatment of interferon products Before treatment 123.8 ± 9.30 4.6 ± 0.42 195.3 ± 6.7 144.4 ± 7.1 36.3 ± 2.31 164000 ± 2900 After 6 months of treatment 1I7.4 ± l 1.0 4.1 ± 0.78 55.3 ± 9.2 ** 29.2 ± 13.5 ** 21.5 ± 2.84 * 10 ± 0.8 **

Table 6 - Comparison of the efficacy of the formulation of Example I and Example 2 with the interferon formulation in the treatment of hepatitis C

Clinical and laboratory parameters in patients with chronic hepatitis C, moderate course

1 Hb (g / i) RBC x10 ^l2 / l ALT (U / L) AST (U / L) Bili (pmol / L) HCV RNA (U / mL) In the treatment with a composition according to the invention (Ex clad 1 and 2) Before treatment 120.1 ± 6.3 3.9 ± 0.19 191.0 ± 15.4 185.2 ± 5.1 42.9 ± 2.73 1835000 ± 2150 Example 1 After 6 months of treatment 118.9 ± 3.1 4.0 ± 0.9 77.2 ± 5.1 ** 72.8 ± 4.4 ** 26.3 ± 2.4 * 2255 ± 44.8 ** Example 2 Mon 6 months of treatment 121.4 ± 3, 3 4.1 ± 1.1 73.5 ± 5.4 ** 69.3 ± 4.8 ** 25.8 ± 2.6 * 2150 ± 45.6 ** Example 1 After 9 months of treatment 122.6 ± 9.9 4.2 ± 0.65 26.9 ± 1.9 * 23.2 ± 2.1 ** 20.1 ± 1.79 * 0 ** Example 2 After 9 months 123.2 ± 10. 8 4.3 ± 0.67 25.6 ± 1.8 * 2l, 4 ± l, 9 ** 18.7 ± 1.94 * 0 **

treatment In the treatment of interferon products Before treatment 122.6 ± 7.4 4.4 ± 1.2 243.6 ± 10.7 165.9 ± 8.6 43.4 ± 4.8 1784000 ± 2830 After 6 months of treatment 120.3 ± 8.9 4, l ± l, 5 172.7 ± 9.2 * 108.6 ± 6.9 * 34.2 ± 6.5 95000 ± 1300 ** After 9 months of treatment 16.2 ± 9.3 4.0 ± 0.91 57.5 ± 7.4 ** 32.1 ± 7.1 ** 21.7 ± 2.54 * 100 ± 8.6 **

Effect of the agent on the polio virus

Example M

Laboratory tests of the antiviral activity of the composition according to the invention of the composition according to Example 1 against polio virus were carried out in vitro. Studies have shown that the composition of Example 1 at a dilution of 1:10 to 1:40 is able to suppress virus reproduction (10 ' ¹ to 10 ⁵ ). It has been found that at a dilution of 1:10 to 1:40 it has significant inhibitory properties against the polio virus.

Effect of the product on human papillomavirus

Example N

Exclusion tests for antiviral activity against human papillomavirus were performed. The cell suspension with HPV 16 was diluted with culture medium to a concentration of 2x10 ^-3 . Solutions of the composition of Example 1 at various dilutions were mixed with equal volumes of HPV16 culture medium solutions. Control (culture media + virus suspension) and dummy (culture media + culture media) samples were also generated. Figure 5 shows a fluoroscopic study of the antiviral activity of the composition according to the invention against the HPV16 virus (A - injection form of the preparation, B - oral form of the composition according to the invention, C - control sample). Injectable and oral formulations at the highest non-toxic concentration (1/24) inhibit the ability of the HPV virus to penetrate cells, whereas at other concentrations no effect was observed.

As shown in Figures 6 and 7, when diluting the composition of Example 1 in a ratio of 1/24 in injectable and oral form in HPV 16 cells, no structural protein L1 was detected, i.e. inhibition of the ability of HPV16 was observed at said concentration of the composition. penetrate the cells, while at other concentrations the effect was not observed. The obtained results are in agreement with the results of the fluoroscopic study.

The results of fluoroscopy and Western Blot study showed that the preparation in oral and parenteral form of the composition of Example 1 has a good inhibitory effect on human papillomavirus.

Effect of the agent on herpes simplex virus, type II

Example O

The virucidal effect of the drug was studied in the treatment of vaginitis in mice caused by herpes simplex virus type 11. The composition of the composition of Example 1 was administered in the form of an ointment three times a day. As a result, the concentration of the composition at the initial concentration and at 1: 2 and 1: 4 dilutions was shown to have an inhibitory effect on HSV-2.

The virucidal effect of the composition of Example 1 against HSV-2 was examined in healthy mice by introducing a mixture of test substance and virus suspension into the vagina. High therapeutic efficacy has been established, indicating its ability to prevent the entry of herpes simplex virus type II into cells.

The effect of the product on HIV

Example P

The composition of Example 1 was administered as intravenous infusions to healthy volunteers in HIV-infected patients. Blood was drawn from a vein 6 and 20 hours after administration. Biological titration of test samples (sera) was performed on a Hep-2 cell composition (a cell line derived from human laryngeal carcinoma). According to the results of the study, administration of the composition to volunteers induces weak induction of serum interferon and stimulates interferon synthesis in mononuclear cells in vitro. High baseline interferon levels in a significant number of pre-treatment patients dropped sharply after the first treatment, and remained low until the end of the study.

The use of a composition according to the invention in patients with cancer, and also in patients after irradiation and chemotherapy

An experimental study of the composition of the invention with the composition of Example 1 was performed on various human tumor cell lines: pancreatic, gastric, colon, lung, malignant melanoma, colorectal cancer or colorectal cancer, liver cancer or hepatoma cells. , group of blood cell cancers or chronic leukemia, ovarian cancer, breast cancer, human leukemia cell line, resistant strains of microorganisms related to lung cancer cell resistance to • ·· · _β ·· * »** .. * * · »· · ** '' effect of cisplatin. The results of experimental studies showed that the efficacy of maximal inhibition of IC50 in four cell lines (chronic leukemia, leukemia cells, breast cancer, hepatoma) was IC50 <1,000 ug / ml. The indicator of the efficacy of maximal IC50 inhibition in pancreatic, gastric, colon and rectal, lung, melanoma, and ovarian cancer cell lines, including drug-resistant cells, was greater than 1000 pg / ml. The dose of the composition was administered individually to cancer patients - 0.2 ml of the composition of Example 1 per 1 kg of body weight per day for parenteral administration and 0.3 ml of the composition of Example 1 per 1 kg of body weight per day for oral administration - in depending on the severity and stage of the cancer. This regimen can be recommended to patients after irradiation and chemotherapy as rehabilitation therapy.

Example R

Patient, 50 years old, cervical cancer 350 cm ³ . The composition of Example 1 was diluted in saline intravenously into the subcutaneous venous port for 6 months. During this period, the tumor shrank to 0.5 cm. Tumor reduction was monitored by ultrasound and MR1. Additionally, tampons soaked in the composition composition were inserted vaginally. As a result, after 10 days, the patient had a completely rotting odor from the vagina.

Example S

Patient, 49 years old, grade 3 rectal cancer, abdominal metastases. Weight before treatment 47 kg. After the operation, a colostomy was performed and the patient was released home. As an outpatient, the patient received the composition intravenously at a dose of 0.2 ml of the composition of Example I per 1 kg of body weight per day, alternating with the administration of the same composition in an oral dosage form at a dose of 0.3 ml per 1 kg of body weight per day. The duration of treatment was 3.5 years. She underwent an operation to close the colostomy. The patient's current weight is 72 kg. The quality of life has improved significantly, there are no complaints.

According to our observations, all cancer patients who took the composition of Example I prior to chemotherapy showed good tolerability of the treatment. In addition, patients suffering from cancer and undergoing chemotherapy were administered the composition of Example 1 for 10 days and then on the third day after chemotherapy to reduce toxicity. At the same time, a high rate of toxin excretion was observed, which was reflected in the normalization of hematological and biochemical parameters of the blood, as well as a significant reduction or absence of patient complaints. The use of the agent before and after chemotherapy allowed this therapy to be performed more often in patients. During the use of the device, the time and frequency of side effects such as vomiting, nausea, diarrhea, dizziness, headache, sleep and appetite were restored and the overall weakness disappeared, i.e. the side effects associated with chemotherapy were partially or completely compensated. The composition was well tolerated and did not cause side effects. The use of the composition made it possible to reduce toxicity, better tolerate radiotherapy and chemotherapy, and improve the quality of life of patients. The composition can be successfully used in cancer patients to alleviate the symptoms of intoxication after radiation and chemotherapy. Effective adsorption and detoxification properties were clearly observed with the composition. Due to its adsorption properties, the composition is effective against disintegration products that form during irradiation and chemotherapy. The detoxifying and adsorbing effects of the composition are presented by the direct removal of biologically active substances, xenobiotics, toxins and other pathological substances from the circulation. An equally important component of detoxification is the active dehydrating effect on the intercellular space. The composition according to the invention makes it possible to minimize the depletion of the antioxidant system and helps to restore the ability of antioxidant protection, to remove oxidative stress, and the tendency to normalize lymphocytic immunity. The polysaccharides that are part of the composition activate macrophages, improve the function of cellular and humoral immunity, which reduces the body's immune responses caused by cytotoxic drugs, radiation and chemotherapy. The composition according to the invention suppresses the acute course of cancer, has a cytostatic effect, reduces the number of mitoses in the cells.

The pharmaceutical composition according to the invention can therefore be used in groups of persons with oncological pathology, in individuals at increased risk of cancer and in persons exposed to carcinogens of a radiation and chemical nature.

Use of a composition according to the invention after radiation damage

The pharmaceutical composition according to the invention solves the problem of effective protection of humans and animals against the harmful effects of radioactive isotopes of iodine. Thanks to its composition and biochemical processes, the preparation forms biologically active complexes in the organism during its action on the cell. The composition has an effect on the induction of humoral immunity, the ability to stimulate the production of antibodies, increase the phagocytic activity of macrophages and neutrophils. The drug components improve the conductivity of cell membranes and inhibit lipid peroxidation processes. The composition makes it possible to effectively reduce the degree of endogenous intoxication in the event of radiation damage.

Example T

The efficacy of the composition of Example 1 in oral form was evaluated in individuals exposed to radiation with a thyroid pathology associated with hypertension. The composition was used in a dose of 0.3 ml of the composition of Example 1 per 1 kg of body weight in three divided doses for 10 days in patients treated with conventional therapy. Normalization of thyroid function was observed after treatment with the product, as evidenced by a decrease in elevated hormone levels. The product also affected the decrease in the originally high level of biochemical parameters of blood (cholesterol, glucose). There was a reduction in high blood pressure in patients taking this medicine.

Use of the agent for autoimmune diseases

The use of the agent for this disease allows a decrease in the level of circulating immunocomplexes, normalization of hematological and immunological parameters, recovery of the damaged by the autoimmune process of energy metabolism of lymphocytes. In autoimmune diseases, the composition is an antioxidant that is involved in inhibiting oxidative DNA damage and improving DNA repair ability.

Example U

Patient, 30 years old, Crohn's disease lasts 7 years. She previously underwent conventional treatment, without much effect. During the last 2 years, the patient lost her appetite, there was a sharp decrease in body weight to 42 kg, height 170 cm. There was a partial obstruction of the intestines, the pain appeared in connection with the development of the rectal fissure. During the last 3 months, there has been a daily increase in temperature to 39 ° C. Then the patient started to take the composition in oral dosage form in a dose of 0.3 ml of the composition of the composition according to Example 1 per 1 kg of body weight per day, and also in the form of rectal administration. During treatment, the temperature returned to normal within 2 months, and appetite appeared. At present, the patient continues to receive the treatment.

Use of the composition in the treatment of psoriasis

In exclusion tests, the efficacy of the composition of the composition according to Example 1 on the formation of a granular layer of the epidermis on the tail of mice was studied, as well as on the mitosis of the basal cells of the vaginal epithelium of mice. During the tests, oral administration of the composition for 14 days showed that the enlargement of the cells of the granular layer of the epidermis on the tail of mice compared to the control group (P <0.01), which was administered clobetasol propionate cream (Table 7).

Table No. 7 - Effect of the composition according to Example 1 on the cells of the granular layer of the epidermis after disruption of the keratinization process of the cells (x ± SD)

Group

Number of animals (pieces)

Amount of granular layer

Clobetasol propionate

9.4 ± 3.4 *

Also during the administration of the composition of Example 1 orally and vaginally for eight days, there was a decrease in the number of vaginal epithelial cells in the mitotic stage, demonstrating an inhibitory effect on mitosis of basal cells of the vaginal epithelium of mice (Table 8).

Table 8 - Effect of the composition of Example 1 on mitosis of mouse vaginal epithelial cells (x ± SD)

Group Number of animals (pieces) Mitotic index (%) Clobetasol propionate 10 15.4 ± 1.8 ** Oral administration of the composition 10 12.6 ± 1.7 **

(118) In addition, the composition according to the invention reduces the number and onset of pruritus (Table 9).

(119) Table 9 - Effect of the composition according to Example 1 on pruritus of mouse vaginal epithelial cells (x ± SD)

Group Number of animals (pieces) Itching (number of repetitions) Total stability time (s) Clobetasol propionate 10 9.2 ± 1.1 ** 235.2 ± 47.9 ** Oral administration 10 12.6 ± 3.6 * ‘ 274.7 ± 76.8 **

(120) The composition according to the invention of the composition according to Example 1 acts on pathologically horny epidermal cells, the immune system, has antineoplastic properties, acts cytostatically, which leads to a decrease in the activity of glycolytic and oxidative processes in epidermal cells. The result is a reduction in the number of mitoses in the epidermis, as well as hyperkeratosis and parakeratosis.

(121) Example V

In patients with psoriasis, the composition was administered orally in the composition of Example 1. The duration of treatment depended on the duration of the disease and the severity of the skin disease (PASI score). Thus, when the skin lesions were smaller than 3% of the body surface area, the treatment period was 3-4 months, 3-10% - 6 to 9 months, more than 10% - 12 - 24 months. When administered intravenously, the treatment time is significantly reduced. During treatment for pruritus and dry skin, patients used moisturizers and baths as symptomatic agents. The use of the product has shown high clinical efficacy in the treatment of this dermatosis. Sustained clinical remission was achieved in 100% of patients with mild psoriasis after 6 months of treatment, and in 86% of patients with moderate psoriasis intensity after 12 months of treatment. This device increases the functional capacity and quality of life of the patient. The results of the practical use of the proposed broad spectrum agent for the above diseases have shown that the composition has a strong virucidal, antibacterial and anti-inflammatory effect, apparent antioxidant, regenerative, detoxifying effect, as well as immunomodulatory, cytostatic, antitumor and antineoplastic effect due to complex drug components. .

Claims (7)

I. Pharmaceutical composition with virucidal and antibacterial action comprising iodine, potassium or sodium iodide, a water-soluble synthetic polymer, carbohydrates and halogenated carbohydrates and water, characterized in that it additionally contains rutin and ascorbic acid, in the following composition g / l iodine 1-25 potassium or sodium iodide 1.5-25 water-soluble synthetic polymer 1-10 carbohydrates 10-200 halogenated carbohydrates 0.01-100 routine 1-10 ascorbic acid 1-10 water the rest to 1 liter. The pharmaceutical composition of claim 1, wherein the water-soluble synthetic polymer is polyvinylpyrrolidone. The pharmaceutical composition of claim 1, wherein the saccharides are selected from the group consisting of monosaccharides, oligoaccharides and polysaccharides. The pharmaceutical composition of claim 1, wherein the water is contained in the form of saline. The pharmaceutical composition of claim 1, wherein the water is contained in the form of a 5% glucose solution. Pharmaceutical composition according to any one of the preceding claims, characterized in that it has a virucidal, antibacterial antioxidant, antiseptic, regenerative, detoxifying, immunomodulatory, cytostatic, antitumor effect. Pharmaceutical composition according to any one of the preceding claims for use in the treatment of burns, purulent wounds, anal and rectal fissures, acute upper respiratory tract infections, autoimmune diseases, psoriasis, viral diseases caused by viruses: influenza, human papillomavirus poliomyelitis, herpes simplex, hepatitis B and C, HIV; treatment of cancer, supportive treatment after irradiation and chemotherapy, treatment of the consequences of radiation damage.