BG61501B1 - Bioactive substances obtained from peat and pharmacetical and cosmetic compositions thereof - Google Patents

Abstract

The bioactive substances obtained from peat contain no more than 70 wt.%, preferably less than 60% by weight.% inorganic salts, especially sodium chloride, calculated on the basic of dry solid matter. According to the method, highly concentrated aqueous solution of inorganic salts, especially sodium chloride, containing bioactive substances extracted from peat, is diluted with demineralized water and is subjected to reverse osmosis for removing inorganic salts. The obtained solution is concentrated and purified, and optionally at least in a further stage is sterilized or subjected to spray drying. A pharmaceutical formulation, containing a bioactive substance extracted from peat, in gel form, is prepared by mixing sterile alcohol plant extract with sterile glycerol, sterile aqueous solution of presputtered bioactive peat extract substance and sterile menthol solution. The obtained mixture is mixed with colloidal silicagel to convert the liquid composition into gel form, the weight ratio between the liquid mixture and the silicagel is preferably from 90:10 to 94:6. The cosmetic preparation such as gel, ungvent, balsam, shampoo, lotion for salt bath, etc. contains, as an active ingredient, an easily soluble bioactive substance extracted from peat in amount from 0.01 to 10 wt.%, preferably from 0.05 to 1 wt.%, the best being from 0.05 - 0.1 wt.%.

Description

(54) BIOACTIVE PRODUCTS OF PEAT AND PHARMACEUTICAL AND COSMETIC COMPOSITIONS CONTAINING THEM

The invention relates to new peat products, biologically active products and a method for their preparation. The invention also relates to pharmaceutical and cosmetic compositions containing these products and to a method for the preparation of pharmaceutical and / or cosmetic forms containing the peat derived bioactive products.

Methods for extracting peat using various extraction media are known and the use of such extracts containing peat derived bioactive ingredients for cosmetic and pharmaceutical purposes.

One known method is described in patent PL 124110 (Chemical Abstracts 101/1). According to this method of the prior art biologically active peat products are obtained by primary and secondary alkaline hydrolysis of air-dried crude peat material, followed by acidification of the hydrolyzate thus obtained and separation of insoluble solids with subsequent re-alkalisation, acidification of the clear liquid phase and removal of ballast substances by alcohol and ether extraction. In the said process, the aqueous phase of the organic extraction is a liquid peat-derived biologically active product.

The known liquid product, which is a solution of the peat-derived active ingredients in a highly concentrated, almost saturated sodium chloride solution prepared according to the cited patent PL 124110, is unstable for a long time and more, contains a large excess in terms of the biological activity of the composition. of neutral inorganic substances. As a whole product, it is difficult to obtain, store and process.

The main object of the invention is to provide a product that does not suffer from these disadvantages, i. a product which is stable and which can be readily processed into pharmaceutical and veterinary forms, and may be incorporated either in the solid state, or in the form of a suitable solution, in cosmetic preparations.

In particular, as regards the use of peat derived bioactive product for pharmaceutical purposes, for example for the manufacture of pharmaceutical compositions, there is an urgent need to provide a solid form that is perfectly suitable for such purposes. Since earlier attempts at the concentration of the known aqueous solution of peat derived bioactive substances and desalination of the peat did not produce positive results, due to occlusion of the active ingredients in crystallizing solid phase, it is difficult to reduce the biological activity of the composition. a suitable method for converting the liquid composition into powder form was found.

It has been found that a positive result is obtained if, before concentration, the liquid composition is first diluted several times, for example with water volumes several times the volume of the composition.

According to the invention there is provided a method in which a biologically active product derived from peat having the described progressive characteristics is obtained from a highly concentrated aqueous solution of an inorganic salt, in particular sodium chloride containing peat derived bioactive ingredients, by diluting said a solution with demineralized water, for example distilled water, followed by reverse osmosis, concentration and clarification. The solution thus obtained can easily be converted into a sterile and solid product, very suitable for the intended purposes, by sterilization and spray drying. Dilution is carried out with water quantities several times (preferably 5 to 8 times) greater than the amount of concentrated solution to be diluted. The present method applied to the treatment of the product obtained according to patent PL 124110 consists in the removal of the organic solvents from the post-extraction aqueous phase, the separation of the insoluble parts by filtration under reduced pressure through a sintered ceramic material, the dilution of the permeate with several times the volume of distilled water and subjecting it to desaltation by reverse osmosis to remove excess mineral salts, mainly sodium chloride. The desalinated solution is then concentrated, clarified by centrifugation and sterilized by filtration through a membrane filter, for example Millipore (R). The resultant microbiologically pure solution may optionally be spray dried. The sterilized product (liquid or solid) may be processed into cosmetic, pharmaceutical or veterinary compositions. Optionally, the concentrated and clarified solution can be used (without sterilization and spray drying) at any suitable dilution as a component in numerous cosmetic compositions. Preferably, at the spray drying stage, the inlet air temperature is about 180 ° C until the temperature is the outgoing air is about 90 ° C.

Because the method of the invention is described above in combination with the method according to patent PL 124110, its use is not limited to such a combination, but is generally applied in the context of a method of obtaining a biologically active peat product from a highly concentrated solution of inorganic salts, in particular sodium chloride containing peat derived bioactive ingredients.

The biologically active product derived from the peat created according to the invention should not contain more than 70% by weight, preferably not more than 60% by weight. inorganic salts, in particular sodium chloride. As a possible low concentration of sodium chloride may be desirable for the optimum product, in particular for pharmaceutical applications and such cosmetic applications in which higher concentrations are required, such as for face care, lower concentrations of sodium chloride such as 55% and even lower are most preferred especially if obtained through the dilution and reverse osmosis steps.

When the process is completed with the concentration and clarification step, the product is concentrated / or compacted / solution. The "concentrated peat extract" mentioned in this specification is a dark brown liquid with a density of 1.02-1.09 g / ml and has a solids content of not less than 5% by weight. The content of chloride ion in the dry solid, calculated as sodium chloride, is not more than 70%, preferably not more than 60% and the pH of a 1% aqueous solution of 5.0-6.5, generally about 6 , 0. The absence of a further sterilization step may in some cases not be detrimental, for example in some cosmetic applications of said concentrated peat extract.

On the other hand, the sterilization step will be mandatory, in particular when the product is intended for the preparation of pharmaceutical compositions. In particular, in such cases, a further step of spray drying is most preferred, although optional. The product obtained after such a spray drying step is in powder form and is therefore particularly suitable for the preparation of known pharmaceutical compositions. The most preferred product of this type is the product commercialized under the name "Crowd ^{/ K /} peat preparation", with KOLPA ^{/ K /} being a registered trademark of Peat Corporation, Poland. The abbreviation TTP is used throughout the description to refer to the said product.

The invention also relates to pharmaceutical compositions containing, as an active ingredient, a peat bioactive product as described above, in particular a product containing not more than 70% by weight, preferably not more than 60% by weight. inorganic salts, in particular sodium chloride, calculated on the basis of the dry solid, together with a pharmaceutically acceptable carrier. The peat biologically active product contained in such pharmaceutical compositions is preferably TTP as defined above. The pharmaceutical composition comprises a peat derived biologically active product and a pharmaceutically acceptable carrier material, preferably in a weight ratio between about 1: 5 and 1:25, and most preferably between 1: 9 and 1:19.

The invention also relates to a method for the preparation of pharmaceutical forms containing a peat derived bioactive product in gel form. This method is characterized in that the sterile plant extract is combined with sterile glycerol, sterile aqueous, preferably concentrated, solution of pre-dusted, peat-derived biologically active product and sterile menthol solution, and the resulting mixture is gradually mixed with colloidal silica gel to convert the liquid composition into gel form, the weight ratio of the liquid mixture to the silica gel being from 90:10 to 94: 6. Preferably, TTP is used as the powdered or concentrated peat-derived bioactive product.

The invention also relates to a method for preparing a pharmaceutical composition comprising a peat bioactive product in the form of ointment. This method is characterized by the fact that a sterile vegetable extract is gradually mixed with a sterile solution of powdered peat-derived biologically active product, the resulting mixture is gelled by the addition of colloidal silica gel and the resulting gel is triturated with a pre-sterilized fat mixture components such as eucherin and petrolatum, preferably at a weight ratio of liquid components to silica gel of about 30:20 and gel to fat composition between 32:68 and 34:66. Also here, as a triturated or concentrated peat-derived bioactive product, TTP is preferably used.

Cosmetic preparations which may contain plant extracts, as well as other similar additives and enrichment ingredients, flavoring compositions and carriers authorized for cosmetic use, contain from 0.01 to 10% peat biologically active product according to the invention, preferably 0.05-1% by weight, and most preferably 0.05-0.10% by weight.

Carriers may be aqueous solutions of alcohols, all types of emulsions, gels, foamable compositions and oily carriers. The use of a specific carrier selected from the group of the above substances allows the manufacture of various types of cosmetic preparations according to the invention such as tonics, creams, conditioners, cleansing milk and others for daily body maintenance, as well as shampoos, hair conditioners, foams bath compositions, all with the addition of peat derived bioactive product.

Peat-derived biologically active products (truncated peat extracts) derived from the original crude peat material, such as therapeutic mud, contains well-balanced amounts of mineral and organic compounds as mineral salts of the following elements: B, Si, Al, Fe, Mg , Μη, Cu,

Sm, Ni, Ca, Ag in Na; organic compounds such as free-form amino acids and salts; polysaccharides, in particular degraded / reacted in the course of hydrolysis, to de5 zoxysaccharides and / or aminosaccharides. Peat, in particular therapeutic mud, is known and appreciated as a material of biological plant and microorganism origin, due to its content of nutritional 10 and stimulating components it has a beneficial effect on humans and mammals. Therefore, the peat-derived biologically active compositions contain said substances in proportions specific to the living 15 organisms. This is considered to be an explanation of the beneficial effects of cosmetic and pharmaceutical preparations containing peat-derived active products and compositions. Particularly good effects of the new cosmetic compositions are observed when plant extracts are also included in the forms. The selection of a suitable herbal extract is based on the known typical application of such extracts in cosmetics, modifying the action of the preparations and thus allowing the content of the cosmetics to be tailored to the specific requirements and needs.

The invention is better characterized and explained by the following examples.

Example 1. Starting from 1000 kg of air-dried peat material and following the known method according to literature (1), a solution of peat-derived bioactive constituents in a saturated aqueous solution of sodium chloride is obtained, in an amount of about 101. The solution is filtered through a sintered ceramic filter under reduced pressure to clarify the solution before desalination. The clear solution thus obtained contains about 95% sodium chloride as a dry mass. The dry matter is about 32% by weight. from the solution. The volume of this clear solution is about 7 l.

The clear solution is diluted with 5 to 8 times the amount of distilled water and in diluted form is subjected to desalination, which is carried out by reverse osmosis technique using a DDS apparatus. The desalination lasts from 3 to 4 hours, whereby the excess mineral salts, mainly sodium chloride, are released in the form of permeate. The desalinated composition contains approximately 65-70% of sodium chloride in the solid. The solution thus obtained, with a volume of 6 to 7 l, was concentrated 4-5 times in a rotary Buchhi evaporator to obtain a concentrated solution containing approximately 20% dry weight. The resulting concentrated solution was clarified using a centrifuge apparatus / liquid separator / Biofuga-jereus and then sterilized by filtration through a Millipore filter *.

The resulting microbiologically pure solution was dried by spraying an Anhydro spray dryer at an exhaust air temperature of 90 ° C and an inlet air temperature of 180 ° C. The yield of dry powder is approximately 200 g.

Example 2. The product of Example 1 was used to prepare a gel and ointment, pharmaceutical compositions also containing herbal extracts, synergistically improving the therapeutic effect of known diseases.

For example, gel and ointment for the treatment of varicose veins of the ankle are prepared as follows. To obtain the gel form of the preparation, 20 g of wild chestnut extract, 10 g of calendula extract, 60 g of glycerol, 0.1 g of TTP in powder form obtained as described in Example 1 above, 0, are used. 1 g salicylic acid, 1.0 g distilled water and 8.8 g aerosol (colloidal silica gel).

The liquid / non-volatile / ingredients are sterilized before use by refluxing for 2 hours. The plant extracts were mixed with glycerol and the aqueous solution of TTP and with methanol, and the silica gel was added gradually to the resulting mixture with continuous stirring.

To obtain the ointment composition, the following ingredients are similarly used: 20 g of wild chestnut extract, 10 g of calendula extract, 0.1 g of salicylic acid, 0.1 g of TTP in powder form obtained as described in Example 1, and 2 g Aerosol ^(K) (colloidal silica gel).

A mixture of the following substances is used as oily components: 22 g of eucrine and 45.8 g of petrolatum. The plant extracts were sterilized by reflux for approximately 2 hours. Eucerin and petroleum jelly are also sterilized. The liquid ingredients are carefully mixed with silica gel to give a gel, which in turn is triturated with sterilized and oily components cooled to room temperature. A stable ointment is obtained which does not stratify upon storage.

The gel and ointment obtained above are applied simultaneously for the treatment of varicose veins of the ankle. The ulcers are treated with the gel preparation, while the surrounding area of the intact skin is treated with ointment. The addition of colloidal silica gel is thought to cause rapid drying, while the herbal and peat components are considered to determine the therapeutic effect of the preparation. The oily components help maintain the elasticity of the scab and skin. The results obtained were compared with a control group of patients treated in the classic way. Those receiving the new treatment are selected from the group of patients suffering from the disease for many months (sometimes years) with no noticeable positive effect. Patients treated with the compositions according to the invention showed better results from the first few weeks than the control patients.

EXAMPLE 3 The products of Example 1 were used to formulate tablets or granules into capsule form.

A sterile, peat-derived biologically active composition in powder form is mixed with a carrier by weight of 1: 9. The carrier used was Mevatex ^{/ K /} TL (trade name Yistman-Kodak), a mixture of lactose and lubricants in a weight ratio of 44: 1. The lactose with 50 mesh size particles and the Mitexa are finely ground so that 70% of their mass passes through a 100 mesh sieve. Part of the resulting mixture of active ingredients and carrier was processed to tablets containing 5 mg of active substance. The total weight of each tablet is 50 mg. The remainder of the mixture of active composition and carrier was granulated using ethanol (40% vol). The granules are sieved and, if necessary, milled and then filled into capsules in such a quantity that each capsule contains 5 mg of active ingredients, using TTP in admixture with the carrier at a ratio of 19: 1.

The tablets obtained above were analyzed to determine the time of disintegration in artificial gastric juice at 37 ° C ± 2 ° using a Hervek apparatus. The artificial gastric juice was prepared as follows: 2.0 g of sodium 5 chloride and 3.2 g of pepsin were dissolved in 7 ml of hydrochloric acid and distilled water was added to a volume of 1000 ml. The pH of the resulting solution is approximately 1.2. The disintegration time of a tablet with a diameter of 10 5.1 mm and a total weight of 0.0498 g is 6 min.

The following examples refer to numerous cosmetic preparations according to the invention, which have different formulations and are intended for various applications and contain a favorable additive of bioactive ingredients derived from peat. They are described among other preparations such as tonics, conditioners, creams, milks, shampoos, foaming compositions 20 for bath and others.

Example 4. A reaction vessel equipped with a stirrer was charged with 150 g of chamomile extract obtained by extracting chamomile flowers with 1: 1 ethanol-water solution as well as 1 g of 25 TTP as described above. To the resulting mixture was added 50 g of glycerol. The three substances are stirred to give a homogeneous mixture. A second mixture, prepared in advance, is then placed in the same vessel. It contains 30 340 g ethanol: water 95: 5 solution, 1 g salicylic acid and 0.5 g menthol. The two mixtures are combined under stirring to form a homogeneous mixture. The Tiliana H4308 flavoring composition was then added. The latter is 35 products from the factory for synthetic fragrances Polena-Aroma, Poland. The solution was then brought to a total volume of 1000 ml by the addition of 454.5 g of distilled water. Stirring was continued until a homogeneous mixture of 40 was obtained.

The above procedure uses 86% glycerol, menthol and water according to the requirements of the Polish Pharmacopoeia IV and 95% ethanol according to Polish Industrial Standard BN-75 / 6193-01.

The concentrated peat extract used is a dark brown liquid with a density of 1,0201,090 g / ml and a solids content of not less than 5%; The pH value of 50 per 1% aqueous solution is from 5.0 to 6.5. Chamomile extract is a reddish-brown liquid with a density of 0.9169-0.9503 g / ml and an ethanol content of 52-56% vol.

The tonic preparation obtained as above is suitable for all skin types. It is a clear liquid without any solids. Its color is yellow. the pH is 4.28 and the ethanol content is 45.92% vol. The total acidity, calculated as the salicylic acid content, is not less than 0.1% by weight, namely 0.23% by weight. The preparation, stored for 12 months, does not lose any of the described characteristics.

EXAMPLE 5 The procedure described in Example 4 was repeated only with the difference that instead of chamomile extract and Tiliana H4308 aroma extract was used, and the Finus H4625 calendula and also a product of the Pollen-Aroma synthetic fragrance factory. the same way and in the same mole and volume ratios. The resulting tonic is suitable for dry and brittle skin. Likewise, it is a clear liquid without any solid particles. The pH of the solution is 4.3, the total ethanol content is 45.82% vol. and the total acidity is 0.27% by weight. On storage, the preparation does not change after 12 months, similar to the preparation obtained according to example 4.

EXAMPLE 6 The procedure of Example 4 was repeated, except that lychee leaf extract was used instead of lychee extract and Lelya 90368 (Polena-Aroma, Warsaw) fragrance was used instead of Tiliana H4308. The tea leaf extract is obtained by extracting dry tea leaves with ethanol at 50 ° C and has a brownish color, a characteristic salvia odor and a density of 0.916 to 0.9503; contains 52 to 56% ethanol. The resulting li-face support is especially suitable for oily skin. It is a clear and homogeneous liquid with a dark yellow color; The pH, ethanol content and acidity were comparable to the preparation of Example 4.

Example 7. The following composition is a particularly effective gel for the prevention or treatment of periodontal disease and contains the following ingredients in g: 24.0 chamomile extract, 3.0 sage leaf extract, 0.3 salicylic acid, 0.2 menthol, 0.1 TTP and up to 100.0 commercially available gel base.

Example 8. The following components in g were placed in a 2000 ml reaction vessel equipped with a mechanical stirrer:

270 g of chamomile extract obtained by extracting chamomile flowers with 50% ethanol; The extract is a red-brown liquid with a density of 0.9160-0.9503 g / ml and an ethanol content of about 55% vol.

g glycerol, 86% as required by the Polish Pharmacopoeia, 30 g saponarium officialis extract obtained by extraction of soap roots with 70% ethanol; the extract is a red-brown liquid with a density of 0.9630-0.9810 g / ml and an ethanol content of about 75% vol.

1.0 g of concentrated peat extract according to the invention, which is a dark brown liquid with a density of 1.02-1.09 g / ml; not more than 2% of chloride ions calculated as sodium chloride; a dry matter content of not less than 5%; The pH of the 1% aqueous solution of the extract is 6.0.

The ingredients listed above are mixed with care. To these were added a pre-prepared solution of 1 g of salicylic acid in 260 g of 95% ethanol. 383 g of distilled water and 5 g of Tiliana H3408 flavoring composition were added to the total solution and stirred until a homogeneous solution was obtained. The preparation is analyzed and stored in 200 ml retail bottles. The resulting detergent is suitable as a hair care detergent. It is a clear, slightly opalescent liquid containing about 45% v / v ethanol; pH is 4.5; the total acidity, calculated as salicylic acid, is not less than 0.1% by weight. The preparation is suitable for blond hair. For 12 months, the preparation does not change its characteristics.

EXAMPLE 9 The procedure described in Example 8 was performed except that chamomile extract and the Tiliana H4308 composition were used in the same sequence and proportions; horsetail extract and flavoring composition Finus H4625. Horsetail extract is a green-brown liquid with a density of 0.9160-0.9503 g / ml and an ethanol content of 55% vol.

The resulting preparation is suitable for all hair types. It is a clear, clear, solid, yellow-brown liquid. The pH, ethanol content, total acidity, and stability after a storage period of 12 months were the same as for the preparation described in Example 6.

Example 10 The procedure described in Example 8 was repeated with comparable results. The only difference is that instead of chamomile extract and H4308 composition, nettle leaf extract and aroma composition Lelya 90368 (a product of the same Polena-Aroma Synthetic Flavor Factory) in the same sequence and proportions is used. The plant extract used is olive green in color, has a density of 0.9160-0.9503 g / ml and an ethanol content of about 55% vol. The preparation is suitable for all hair types.

Example 11. In general, cosmetic milk is a dispersion of fatty substances that act both chemically and mechanically on the skin. In fact, due to the convenient route of administration and the improved interaction of liquid and skin, it is very appropriate to use liquid, especially emulsion creams. They can easily penetrate deeper layers of the skin and thus protect the skin from age-related changes. Cosmetic milk is mainly used to clean dry and brittle skin. Accordingly, they should not contain volatile volatile oils, but often contain suitable vegetable extracts such as chamomile extract or germ extract. The addition of peat-derived biologically active products to such cosmetic milk further enhances their positive effects. The new recipe contains in g as follows:

TTR 0.05 Aloe extract 20,00 Glycerol 3.00 Eucerin 2.00 White paraffin oil 1.00 Triethylamine 1.00 Aerosol ^(R ) colloidal silica gel / 4,00 Example 12. Improved results of re-

generation are observed when • U are used. '

TTP and carefully selected oily carriers with the classic formula for nourishing and regenerating cream. TTP is used from 0.01-1.00% by weight. in combination with the plant extract / selection depends on the type of skin for which the cream is intended / from at least 0.05-1.00% by weight, antimicrobial preparation from 0.05-1.00% by weight, synthetic flavoring composition in the amount of 0.01-0.05% by weight. and oily noses Preferred plant extracts are: chamomile, calendula, thyme, aloe extract and similar useful plant extracts. The addition of glycerol is also beneficial because of its effect on skin elasticity.

It accelerates the spread of the preparation on the face, as well as the penetration into the deep layers of the skin, thus increasing the beneficial effects of the acellel in the form of a water emulsion, making up 97,00-99,50% by weight. of the entire cast. The oily composition should be a good carrier for the active ingredients and be well received by the skin. Preferably, it is an emulsion of (all amounts are in percent by weight) 3545 eucerin, 8-14 petrolatum, 2.5-4 olive oil, 6-10 glycerol and 35-40 water. Preferred plant extracts are calendula extract, chamomile extract, thyme extract and the like. Preferred recipes by weight are the following:

The composition of peat and plant extracts.

The preferred recipe is in parts by weight as follows:

TTP0.10

Chamomile extract15,00

Glycerol 5.00

Menthol0.10

Salicylic acid 0,10

Ethanol / conc.95% / 10.00

Flavoring composition 0,30

Distilled water up to 100,00

1. Eucerin 39,00 Petrolatum 11.50 Olive oil 3.13 Glycerol 7.80 Water 38.00 Nipagin / antibacterial tool / 0.40 TTR 0.05 Calendula extract 0.10 Synthetically flavored remedy 0.02 Total 100.00 2. Eucerin 42.00 Petrolatum 8.50 Olive oil 3.08 Glycerol 7.90 Water 38.00 Nipagin / antibacterial drug / 0.40 TTR 0.05 Chamomile extract 0.02 Synthetically flavored substance 0.05 Total 100.00

Example 13 After-shave preparation contains TTP as a peat extract 0.01-1% by weight, plant extracts from 1 to 30% by weight, glycerol from 1 to 8% by weight, salicylic acid and menthol in aqueous-alcoholic solution.

EXAMPLE 14 Shampoo formulation was prepared according to the following recipe in g, respectively

% by weight: Vegetable extract to Fuller 15,00 7.50 Leaf extract tart nettle 20,00 10,00 Gamal SBS-11 / detergent / 30,00 15,00 Gamal N0-3 / detergent / 20,00 10,00 Aseptin 0.40 0.20 Ethanol 1.60 0.80 Bronpol / preservative / 0.04 0.02 Sodium chloride 6,00 3.00 Water 106.96 53.48 Total 200,00 100.00

To 92 parts by weight 8 parts by weight of the above shampoo composition are added. TTP to obtain 100 wt.h. shampoo according to the invention. Instead of leafy nettle extract, other plant extracts may be used.

Example 15. The following shampoo formulation was prepared in g:

Horse chestnut extract 13,00 Calendula extract 22,00 HAMAL SBS-11 30,00 HAMAL N0-3 20,00 Bronopol 0.04 Sodium chloride 6,00 Water 106.96 Total 200,00

To 95 parts by weight of the above composition was added 5 parts by weight of TTP to obtain 100 parts by weight of TTP. shampoo according to the present invention.

Example 16. Toothpaste contains TTP as a concentrated extract derived from peat in an amount of 0.01-0.10% by weight, essential oils or compositions of such or fruit essences of 1-10% by weight, glycerol in an amount of 5 to 10, plant extracts in an amount of 0.10 to 10 and detergents 20 to 35, dispersed in water from 45 to 60% by weight, and dyes and whitening components 1-2% by weight.

Titanium dioxide can be used as a bleaching component. The TTP itself can be used as an antibacterial supplement. Extracts of sage leaves, chamomile or calendula flowers can be used as favorable, preferred extracts.

The preferred recipe in g is the following:

Precipitated calcium carbonate 150.00 Magnesium carbonate60.00

Glycerol70,00

Vegetable extract 5.00

TTP0.50

Titanium dioxide10.00

Essential oil / or peppermint, lemon, etc. / 5,00 Water 400,00

The dye tracks

Example 17. Salt bath preparation. In the course of the peat extraction process of the bioactive products according to the invention, especially when converting the liquid form to a solid, there is a desalination step in which sodium chloride is released as a by-product. This by-product consists of 95% of sodium chloride, the other salts separated are calcium and magnesium salts, mainly chlorides and sulfates. These salt products also contain some organic peat-derived low molecular weight compounds included in the crystalline structure of these inorganic salts. These organic compounds are components of TTP and are, among others, polysaccharides, amino acids, fulvic acid and the like. The presence of these components in salt by-products is advantageous when the salt is used as a bath salt, since it can give additional beneficial effects to the standard activity of a bath salt. Accordingly, this by-product was examined for its chemical and physical properties at the Balneological Institute in Poznan, Poland, to determine whether it could be used in cosmetic baths. As the Institute did not detect any unwanted ingredients in the salt, it was approved for cosmetic use.

The preferred recipe in g is the following: Salt / sodium chloride / containing TTP included 97.00

Pine essential oil or composition of essential oil 3.00

Example 18. A new hair conditioner contains the following ingredients by weight: TTP 0.01-1, plant extracts 0.01 to 10, anti-electrostatic components 3-4, ingredients to prevent excessive drying of hair and skin, up to 2, glycerol from 1 to 5, preservatives and stabilizers 0.05-0.50 and water to 100.

As an anti-electrostatic component, this balm contains an alcoholic solution of trimethylamine and ammonium chloride salt derived from animal fat from animal amines, as a sealant, which also acts as a stabilizing agent-cosmetic alcohol, as a substance that protects against excessive drying, which act simultaneously as emulsifying agents and glycerol to facilitate the spread and penetration of balsam, in particular its TTP active ingredients and plant extracts. Because the acidic environment stops the bacteria from growing, the conditioner according to the invention contains citric or fumaric acid in amounts of 0.1%, as well as a preservative known as Bronnopol, and an aromatic composition.

The preferred composition in% by weight is the following:

Alcoholic solution of salts of trimethylamine and ammonium chloride 3-4

Cosmetic alcohols3-4

TTP 0.01-10

Compacted Plant Extract 0.01-10 Glycerol 1.5

Vegetable oils up to 2

Citric acid or fumaric acid 0,1 Bronopole 0,1

Aromatic composition0.3

Distilled water up to 100

EXAMPLE 19 Cosmetic masks are well-known cosmetics for various purposes. Because therapeutic mud has a beneficial effect on the skin and body, it is believed that, after extraction, peat can be used for cosmetic applications in the process of the release of bioactive compositions. Peat after extraction contains a solution of active substances released in the alkaline hydrolysis process due to the extremely high sorption properties of peat after neutralization. It has been found to be a valuable component of cosmetic masks. To enrich the post-extraction peat with more valuable components, natural therapeutic mud and humic acid fraction are added, which are present in the natural peat and are separated by the method of producing bioactive peat compositions from alkaline hydrolyzate. Such a composition was tested at the Balneological Institute mentioned above and found to be suitable for cosmetic use.

The preferred recipe in g is the following:

Peat after extraction 100.0

Natural therapeutic mud or peat20.0

Humic acid fraction 10,0

Magnesium carbonate 10.0

Zinc oxide5.0

Citric acid or the like 0,1

Vegetable extract or powdered vegetable material5.0

Distilled water as needed The following statements and explanations relate to the biological aspect of the products of the invention, for example the characteristics of biological activity and the compatibility of these products, in particular with regard to their usefulness as medicines. The following abbreviations are hereinafter used:

TTR Crowd ^{/ K /} peat preparation / Trademark of Peat Corporation, Wroclaw, 2 Midlana Street, Poland

1FN Interferon existing as a common cytokine (tissue hormone). IFN genes are found in all cells. IFN is mainly induced by proteins or glycoproteins. Substances that stimulate IFN genes to produce 1FN are called inducers. The IFN induction process is a highly regulated, complex biochemical process; negative and positive regulatory genes governing IFN production are distinguished. Small amounts of IFN can be obtained spontaneously without detecting an inducer. Such interferons are sometimes referred to as "physiological IFNs". Interferon exists in nature in three major molecular forms: IFN α (or leukocyte IFN); IFN-β (fibroblast IFN); IFN-γ (immune IFN), with IFN-α and IFN-β being type I IFN, IFN-γ being type II IFN.

The major biological activities of interferons are antiviral, antiproliferative (anti-cancer) and immunomodulatory action.

Various forms of IFN are manufactured industrially as natural and recombinant preparations and are used as medicines for the treatment of neoplasmic, viral and several other diseases. CTL stands for cytotoxic T lymphocyte; ΝΚ cells are natural killer cells; 1L-1, IL-2 are well-known interleukins that stimulate the proliferation of T cells and other lymphoid cells, including B cells: KPM1 1640 is a tissue culture medium for the development of human and other leukocytes / abbreviation of Roswell Park Memorial Institute, Buffalo /; FCS means calf fetal serum (for leukocyte testing it must be pre-tested as it may contain mitogenic substances resembling the action of interleukins); EMCV stands for encephalomyocarditis virus, a mouse picoric virus, non-pathogenic to humans, often used as an infection virus in IFN bioassay; A-549 is a human adenocarcinoma cell line used in IFN bioassay because of their high sensitivity to IFN-α β and γ. The line is recommended for such use by WHO experts in IFN standardization; MTT is 3- (4-, 5-dimethylthiazol-2-yl) -2,5-diphenyltetrazolibromide. A reagent used to measure cell killing or cell growth in several bioassays using ELISA scanners (2).

L 929 mouse cell line commonly used for the study of murine IFN and human or murine TNF; TNF is a tumor necrosis factor, a cytokine, (a relatively small protein very sensitive to proteolytic enzymes), produced by monocytes and a macrophage, and (TNF- is also known as cachectin, a cause of cachexia in humans and animals;)

It is produced after stimulation with LPS (lipopolysaccharides); viruses, bacteria and many other agents, it is very toxic to many infected with virus and non-plasma cells; may also act as a growth factor for fibroblasts. Associated with inflammatory reactions. The related form is TNF-? (lymphotoxin) is produced by T cells and some other cells.

PBLs are peripheral blood leukocytes, normal human leukocytes from healthy blood donors isolated from the yellow layer (the intermediate phase between red cells and plasma). The ability to respond to PBLs from individual donors to different cytokine inducers appears to be dependent on donor genetic attitudes. Non-responders and high response ability have been identified. This also applies to PBL's response to TTP.

The variation in the individual response of IFN inducers or TFN is more apparent when weak inductors are used than when very strong inducers such as viruses are used. This is due to the fact that the response to weak inducers is of the "all or nothing" type, whereas viruses almost always induce detectable amounts of cytokines.

Inducer tolerance, also called hypereactive state. (Occurs after receiving a single dose of inducer, for example, after 20 hours of PBL exposure to an inducer (eg, virus); cells stop producing more IFN. The state of hypereactivity usually lasts about seven days. It may be complete or partial. Such reactivity makes the therapeutic application of strong inducers difficult and / or ineffective. Weak inducers of 1FN either do not induce a state of hypereactivity or the tolerance is low.

Several natural remedies that are extracted from medicinal plants have immunomodulatory properties. TTP seems to be one of them. TTP alters many different immune functions in vitro and in vivo. It excites balanced immunostimulation, with the ability to nonspecifically activate all effector pathways / CD ₄ -helpsr, weak CD8 suppressor, CTL, NK cells and activated macrophage / without cytotoxicity for normal tissues.

TTP has a restorative effect in normal wound healing. Low doses of TTP slightly stimulate 1L-1 and IL-2 production. High doses can inhibit cytokine synthesis.

The appropriate tests were performed using the following methods.

PBLs from healthy blood donors are purified by treatment with ammonium chloride. The culture medium is RPMI 1640 plus 10% FCS. Approximately 8 x 10 ⁶ cells / ml were cultured for 20 h at 37 ° C, 5% CO ₂ . The antiviral action of interferon is tested by inhibiting the EMCV cytopathic effect in human A549 cells. The MTT method is also used to measure killed cells.

TNF activity was measured in L ₉₂₉ cells. To define the type of 1FN, individual IFN samples were treated with different anti-IFN sera for 1 h. Their antiviral activity is compared to untreated preparations.

Tests show that TTP stimulates the production of endogenous interferons and tumor necrosis factor (TNF). The answer is dose dependent.

Seven commercial batches of TTP after testing showed comparable biological activity as immunostimulators and cytokine inducers. There are significant variations in the response to TTP in leukocytes of individual blood donors. PBLs from several donors have been found to be incapable of responding. This may reflect a genetic background.

Powerful polyclonal antisera such as anti-IFN-α (Cantel), anti + IFN-αLy (Reduced by K.Fantes) and antiIFN-γ (Cantel) are used to neutralize antiviral activity in PBL supernatant treated with TTP for 20 h.

The results of the neutralization trials have been found to resemble the fingerprints of individual blood donors. In other words, the ratio of IFN types produced by individuals varies considerably. Separation of PBL into a cohesive and non-cohesive fraction can potentiate induced cytokine synthesis.

The hyporeactivity (tolerance) to IFN induction by NDV observed 20 h after initial stimulation of PBL with TTP is either minimal or absent.

All seven TTP batches tested for human PBL as inducers of IFN and TNF were found to be active for inducing IFN and / or TNF. The optimal concentration of TTP for induction of IFN is 30-100 / g / ml and for TNF induction 100-200 g / ml. The dose of 200 µg / ml may be subtoxic to PBL, but TNF synthesis occurs much faster than IFN and faster than the development of moderate cytotoxicity.

The conclusion is that the active principle in TTP drugs is the immunoactive fraction of peat extract containing organic primary sugars, amino acids, uronic acids, humic acid substances and mineral salts, incl. trace elements. LD ₅₀ in animals is greater than 2400 mg / kg, per axis.

No mutagenic, genotoxic, embryotoxic, teratogenic or carcinogenic activity of TTP has been identified. TTP does not exhibit allergenic properties and has no local irritant effect.

Therapeutic indications include chronic and recurrent airway inflammation and varicose veins of the lower leg, complementary treatment for vaginal erosion and periodontal disease.

There are clinical observations suggesting that TTP may be useful as an immunomodulator in the maintenance therapy of several neoplasmic diseases. TTP is used orally (5 mg tablets) or topically.

Particularly important is the fact that TTPs treated with TTP for 20 h at 37 ° C do not develop a state of hypereactivity, which is why they retain their capacity to produce interferon after induction with NDV (a very potent IFN inducer). .

The attached Tables 1 to 24 refer to various biological, for example toxicological, hematological and immunological tests. These tables provide ongoing information on biologists regarding the compatibility and biological activity of TTP.

It should be noted that the concentration of the active ingredients in the drugs as claimed in claim 13 may be higher than in the cosmetic compositions (as indicated in claim 14) for the following reasons.

The dosage forms are formulated in single doses in which the concentration of the active ingredients is strictly controlled, for example in tablets the concentration is adapted to the size of the tablet containing the effective daily dose / or part thereof / of the active ingredient. The concentration of the active ingredient, such as TTP, in capsules to be filled with capsules is preferably only 5% by weight to achieve sufficient tablet size and allow proper operation of the capsule machine.

Another reason for most oral dosage forms is that the active ingredient is distributed throughout the body. Even when it reaches skin cells at a very low concentration, the therapeutic effect is noticeable.

In addition, cosmetic compositions, unlike pharmaceutical compositions, are used in very uncontrolled amounts, applied topically, with varying degrees of penetration in different cells.

Such formulations as shampoos, which are washed almost immediately, have short contact time with the body or hair and may contain relatively more of the beneficial components. Others are given several times a day and therefore should have a lower active ingredient content.

When incorporated into toothpaste, since they are in contact with the mucous membrane of the mouth, the penetration of the active ingredient is much easier than through the skin, and the concentration of the active ingredient may be lower.

Table 1

Acute toxicity. The effect of orally administered TTP on the biochemical parameters of rabbit blood

Paul Dose of TTP g / kg Day of tried Parameters studied Creatinine (mg%) Total protein (g / 1) y-globulin (g 7o) 0.0 0 1.09 ± 0.03 65.0 ± 3.49 0.53 ± 0.00 7 1.03 ± 0.02 62.0 ± 0.33 0.56 ± 0.01 J. 2.0 0 1.06 ± 0.01 58.0 ± 1.46 0.50 ± 0.02 7 1.14 ± 0.38 57.8 ± 1.54 0.54 ± 0.01 5.0 0 0.96 ± 0.12 70.3 ± 3.52 0.55 ± 0.00 7 0.94 ± 0.13 60.0 ± 2.34 0.57 ± 0.00 0.0 0 0.80 ± 0.11 73.8 ± 3.23 0.72 ± 0.06 7 0.82 ± 0.13 75.3 ± 1.02 0.79 ± 0.03 M 2.0 0 0.88 ± 0.05 64.6 ± 2.86 0.62 ± 0.10 7 1.24 ± 0.34 64.6 ± 2.03 0.57 ± 0.07 5.0 0 0.85 ± 0.03 58.5 ± 3.19 0.57 ± 0.02 7 1.04 ± 0.12 57.6 ± 4.68 0.56 ± 0.01

Table 2 Acute toxicity. Effect of orally administered TTP on the activity of transaminases in rabbit serum

Paul Dose of TTP g / kg Experiment Day Parameters studied Alanine Aminotransferase Asparagine Aminotransferase 0.0 0 8.67 ± 1.20 22.33 ± 2.60 7 9.67 ± 0.33 28.67 ± 3.75 J. 2.0 0 10.33 ± 1.76 18.33 ± 4.09 7 12.33 ± 3.52 20.00 ± 5.03 5.0 0 11.33 ± 1.66 22.33 ± 3.52 7 11.00 ± 3.05 20.67 ± 4.66 0.0 0 10.33 ± 1.76 23.00 ± 3.05 7 12.00 ± 2.64 25.67 ± 4.17 M 2.0 0 9.00 ± 1.00 18.00 ± 1.52 7 9.00 ± 0.57 20.66 ± 3.52 5.0 0 8.00 ± 1.00 18.00 ± 1.00 7 11.33 ± 1.66 23.00 ± 1.99

Table 3

Acute toxicity. The effect of orally administered TTP on the haematological parameters of rabbits

Paul Dose of TTP g / kg Experiment Day Parameters studied Hemoglobin (mg%) Hematocrit (%) Leukocytes x 10 ³ Erythrocytes x 10 ' ⁶ 0.0 0 12.4 ± 0.44 38.3 ± 1.85 7.32 ± 0.43 5.21 ± 0.20 7 11.8 ± 0.63 37.7 ± 1.20 6.30 ± 0.66 5.11 ± 0.11 J. 2.0 0 11.5 ± 0.31 36.7 ± 0.88 5.69 ± 0.58 5.86 ± 0.55 7 12.3 ± 0.48 38.3 ± 0.66 5.74 ± 0.76 5.69 ± 0.11 5.0 0 12.3 ± 0.14 40.7 ± 2.6 7.35 ± 0.99 5.42 ± 0.20 7 11.6 ± 0.23 37.3 ± 0.33 8.55 ± 1.79 5.08 ± 0.19 0.0 0 12.0 ± 0.85 37.3 ± 1.20 11.10 ± 0.63 4.53 ± 0.26 7 11.9 ± 0.61 35.7 ± 1.85 10.80 ± 0.94 4.54 ± 0.19 M 2.0 0 12.8 ± 0.26 43.7 ± 4.80 9.94 ± 2.00 4.46 ± 0.55 7 11.8 ± 0.39 34.7 ± 2.02 11.06 ± 1.08 5.37 ± 0.56 5.0 0 12.7 ± 0.63 38.7 ± 2.40 9.52 ± 1.36 4.59 ± 0.16 7 10.6 ± 1.04 4.0 ± 2.08 8.87 ± 1.73 5.72 ± 0.66

Table 4

Chronic toxicity. The effect of orally administered TTP on the weight of rabbit organs

TTR dose (mg / kg) 150 0.0 50 150 0.0 50 Paul J. m Organ Organ weight in% of total mass Lung 0.72 ± 0.08 0.61 ± 0.17 0.67 ± 0.07 0.56 ± 0.05 0.54 ± 0.09 0.71 ± 0.14 Heart 0.23 ± 0.01 0.22 ± 0.02 0.25 ± 0.03 0.24 ± 0.02 0.23 ± 0.01 0.23 ± 0.02 Dalak 0.057 ± 0.01 0.051 + 0.00 0.079 ± 0.02 0.05 ± 0.01 0.06 ± 0.01 0.04 ± 0.01 Black fraction 2.85 ± 0.15 3.02 ± 0.08 3.22 ± 0.37 2.82 ± 0.09 2.77 ± 0.28 3.12 ± 0.06 Kidneys 0.59 ± 0.03 0.52 + 0.02 0.50 ± 0.01 0.48 ± 0.03 0.55 ± 0.01 0.49 ± 0.03 Adrenal gland- on the gland 0.016 ± 0.01 0.015 + 0.01 0.020 ± 0.01 0.013 ± 0.01 0.013 ± 0.02 0.012 ± 0.0 Ovaries and the uterus 0.58 ± 0.04 0.39 ± 0.02 0.60 ± 0.04 Testing- or - - - 0.30 ± 0.01 0.32 ± 0.03 0.36 ± 0.02

Table 5

Chronic toxicity. The effect of orally administered TTP on the haematological parameters of rabbits

Sex Dose Week _____________________ Parameters studied ______________

TTP of the test Hemoglobin Hematocrit Leukocytes Erythrocytes g / kg (mg%) (%) x IO ³ x ΙΟ ⁶

m 0.0 0 12.2 ± 0.05 38.2 ± 1.71 9.33 ± 0.79 5.10 ± 0.56 3 12.3 ± 0.15 40.7 ± 0.33 9.39 ± 1.18 6.34 ± 0.23 6 3.0 ± 0.35 41.7 ± 1.30 9.58 ± 1.12 7.32 ± 0.70 12 13.5 ± 0.19 40.7 ± 0.67 11.23 ± 1.10 6.30 ± 0.46 50 0 12.9 0.55 35.7 ± 1.82 7.52 ± 0.78 5.14 ± 0.47 m 3 - - - - 6 13.3 ± 0.35 41.0 ± 2.10 8.08 ± 1.17 6.38 ± 0.11 12 13.7 ± 0.11 39.3 ± 0.94 9.36 ± 1.01 6.19 ± 0.19 150 0 14.20 ± 0.21 36.7 ± 1.81 8.19 ± 0.16 5.34 ± 0.16 m 3 11.05 ± 0.26 38.5 ± 1.53 8.83 ± 0.78 5.68 ± 0.40 6 12.40 ± 0.63 37.3 ± 1.45 8.18 ± 0.06 6.84 ± 0.10 12 13.70 ± 0.32 39.0 ± 0.68 8.24 ± 0.04 6.54 ± 0.54 0.0 0 12.6 + 0.27 40.2 ± 0.83 7.07 + 1.16 5.63 ± 0.17 w 3 12.1 ± 0.23 39.8 ± 0.72 8.16 ± 1.01 5.74 ± 0.12 6 12.4 ± 0.86 42.3 ± 1.20 9.78 ± 1.69 5.86 ± 0.24 12 12.5 ± 0.87 37.7 ± 2.18 10.90 ± 2.16 4.60 ± 0.29 50 0 13.2 ± 1.20 35.0 ± 1.70 7.44 ± 0.98 5.47 ± 0.50 w 3 - - - - 6 13.0 ± 0.55 39.3 ± 1.20 7.25 ± 0.96 7.08 ± 0.94 12 12.8 ± 0.21 37.7 ± 4.33 9.31 ± 0.35 6.02 ± 0.32 150 0 15.2 ± 1.15 38.3 ± 1.40 8.50 ± 0.54 6.09 ± 0.08 w 3 13.1 ± 1.10 47.0 ± 2.80 8.10 ± 0.76 5.85 ± 0.57 6 12.5 ± 0.82 41.0 ± 1.15 6.85 ± 0.31 5.61 ± 0.30 12 13.1 ± 0.70 41.0 ± 1.00 8.15 ± 1.68 5.92 ± 0.13

Table 6

The effect of TTP on the phagocytic activity of neutrophils in rabbit peripheral blood

The group η Neutrophils Neutrophils,% Phagocytic activity (1000/1 mm ³ ) NBT + L.H L.W 0 3 6 0 3 6 0 3 6 0 3 6

Control 1 ml PBS 6 1.9 2.3 2.4 14.3 15.1 17.6 54.5 60.6 59.8 7.53 7.53 7.61 i.v. ± 0.9 ± 1.1 ± 0.4 ± 4.6 ± 4.6 ± 3.0 ± 9.4 ± 4,8 ± 6.8 ± 0.77 ± 0.86 ± 0.4 TTR (Experiment 1) * 0 ♦ oh • Fr. * * * 5 mg / kg 15 2.0 1.2 1.7 18,4 26,8 27.2 59,2 69,3 74.9 8.75 10.3 9.88 i. ν. ± 0.9 ± 0.7 ± 7.1 ± 7.1 ± 6.7 ± 7.0 ± 6,7 ± 7.0 ± 7.8 ± 1.18 ± 1.25 ± 1.0 TTR (Experiment 2) 8 * 0 * oh ♦ oh * 0 * oh 5 mg / kg 2.8 1.6 1.6 15.5 22.1 26.5 63.0 69.5 76.5 7.76 8.52 8.56 i. ν. ± 0.8 ± 0.6 ± 1.0 ± 4.9 ± 7.0 ± 9.1 ± 7.0 ± 7.1 ± 8.9 ± 0.83 ± 1.04 ± 1.0

η - number of experimental animals

PBS - phosphate buffer solution

- before applying TTP

3-3 days after TTP administration

6-6 days after application of TTP * - statistically significant change at p <0.05 in relation to the value before application of TTP o - statistically significant change at p <0.05 compared to the control group

Table 7

Effect of TTP on lymphocyte counts and on% of t-lymphocytes (E-rosettes) and of Vlimfocytes (EAS-rosettes) in rabbit peripheral blood

The group Lymphocytes x 10 ^-3 / mm ³ % E-rosettes% EAS rosettes η 0 6 0 6 0 6 Control 1 ml PBS 6 6.6 6.0 19,0 20.1 42.1 42.3 i. v. ± 2.0 ± 1.9 ± 5.7 ± 5.5 ± 6.3 ± 2.05 TTP (Experiment 1) * 0 5 mg / kg 15 6.6 5.4 19,2 27.1 43.7 47.7 i. v. ± 1.5 ± 1,4 ± 4.1 ± 3.2 ± 2.6 ± 4.9 TTP (Experiment 2) * 0 5 mg / kg 8 6.0 6,8 17,0 24.8 41.6 41.0 i. v. ± 1.0 ± 0.6 ± 1.9 ± 2.9 ± 1.3 ± 2.1

η - number of experimental animals

PBS - phosphate buffer solution

- before applying TTP

6-6 days after application of TTP * - statistically significant change at p <0.05 in relation to the value before application of TTP o - statistically significant change at p <0.05 compared to the control group

Table 8

Number of splenocytes after long-term TTP therapy

Control TTP 10 mg / kg.day η = 10 TTP 50 mg / kg.fleH η = 10 Time of PFC / 10 ⁶ splenocytes TTP doses Day 4 Day 7 Day 4 Day 7 Day 4 Day 7 per week 3 367 ± 157 156 ± 41 1120 ± 328 * 336 ± 240 * 772 ± 236 * 151 ± 57 5 572 ± 134 138 ± 47 1528 ± 346 * 292 ± 62 * 1239 ± 280 * 232 ± 90 7 518 ± 45 133 ± 40 699 ± 136 * 1 59 ± 44 722 ± 258 * 141 ± 63 9 466 ± 185 175 ± 75 395 ± 94 132 ± 36 412 ± 138 167 ± 62 12 287 ± 18 153 ± 30 287 ± 131 156 ± 39 376 ± 130 167 ± 69

* - statistically significant change at p <0.05 compared to the control group

Table 9

Concentration of aHTH-SRBC (19S + 7S) antibodies with long-term TTP therapy

Time Control of TTP

TTP 10 mg / kg-day η = 10

TTP 50 mg / kg-day η = 10 doses in hemagglutinin - log, from tiger weeks day 4 day 7 day 4 day 7 day 4 day 7

3.75 ± 1.78 7.12 ± 1.36 8.80 ± 0.97 *

5.82 ± 1.40 6.50 ± 1.00 7.70 ± 0.84 *

3.60 ± 0.48 5.20 ± 0.74 4.40 ± 1.11 *

3.20 ± 1.40 4.66 ± 1.24 3.50 ± 1.28

4.80 ± 0.74 4.40 ± 1.01 5.11 ± 1.09

9.20 ± 1.46 * 8.20 ± 0.40 * 6.90 ± 1.37 9.10 ± 2.02 * 7.70 ± 0.64 * 9.33 ± 2.90 * 4.10 ± 0.83 * 3.50 ± 0.83 * 3.55 ± 1.21 4.00 ± 0.81 2.90 ± 1.22 6.33 ± 1.52 5.50 ± 1.51 5.11 ± 1.19 6.10 ± 1.74

* - Statistically significant change at p <0.05 compared to control group

Table 10

Concentration of anti-SRBC (7S) antibodies on long-term TTP therapy

Time of TTP

Control

TTP 10 mg / kg η = 10

TTP 50 mg / kg π = 10 doses per week Day 4 Day 7 Day 4

1.75 ± 0.60 6.37 ± 0.85 3.20 ± 0.87 *

2.50 ± 0.70 6.12 ± 1.16 2.20 ± 0.97

1.00 ± 0.89 3.80 ± 1.09 0.60 ± 0.80

0.40 ± 0.48 3.66 ± 1.24 0.30 ± 0.64

0.80 0.97 3.80 ± 0.76 1.11 ± 0.99

Hemagglutinin - log of titer

Day 7 Day 4 Day 7 5.90 ± 1.70 3.80 ± 0.87 * 4.90 ± 0.74 * 5.70 ± 1.10 2.30 ± 1.41 5.33 ± 0.74 * 2.50 ± 1.11 * 0.55 ± 0.83 2.55 ± 0.68 * 3.25 ± 0.96 0.00 4.33 ± 1.24 4.40 ± 1.35 1.55 ± 1.49 4.30 ± 1.26

* - Statistically significant change at p <0.05 compared to control group

Table 11

Immunomodulatory effect of TTP (± SD)

Dose of TTP mg / kg η n PFC / 10 ⁶ flushes day 4 % E-socket- you Day 4 Hemagglutinin * Type 19S + 7S Day 4 Hemagglutinin ¹ Type 7S 7th day Control 30 469 13.6 5.4 8.2 ± 111 ± 3.2 ± 1.1 ± 1,8 X X 0.5 10 997 15.6 6,8 8.4 ± 139 ± 1,4 ± 1.0 ± 1.1 X X X X 2.5 10 839 20.3 6,9 9.7 ± 177 ± 4.1 ± 1.0 ± 1,4 X X X X 5.0 10 746 23,2 7.2 9,8 ± 129 ± 4.7 ± 0.6 ± 1,4

X X X X 10,0 10 795 18,4 8.3 10.4 ± 129 ± 4.0 ± 1.8 ± 1.1 X X 25,0 10 560 16.3 6,1 9.3 ± 145 ± 2.5 ± 1.1 ± 1.1 50.0 10 400 14.7 5,3 6,7 ± 57 ± 4.0 ± 1.0 ± 1.9 X X X 100,0 10 375 11.3 5.1 5.7 ± 67 ± 2.2 ± 0.8 ± 1.6 X X X 250,0 10 305 9.3 4,8 5,3 ± 67 ± 2.0 ± 1.1 ± 1.7

χ - Statistically significant change on overall comparison 0.05 (Student - t-test) * - log ₂ of titer

Table 12

TTP administration daily in 3 doses

The dose P. Day 4 after immunization with SRBC 10th day after immunization with SRBC % E - PFC / 10 ⁶ Hemagglutinin Hemagglutinin rosettes splen- -log ₂ of titer -log ₂ by titer To quote 19 S + 7S 7 S 19 S »7 S 7 S Control I 15 13.7 469 5.7 0.8 9,8 8.4 1x0,3 ml ± 3.0 ± 125 ± 1.3 ± 1.0 ± 1.3 ± 1.6 Control I 15 15.3 579 6,1 0.6 9.0 8.6 3x0,1 ml ± 4.0 ± 143 ± 1.1 ± 0.9 ± 1.7 ± 1,8 2.5 mg / kg 15 19,4 * 864 * 7.4 * 1.1 10,4 * 9.5 * 1x0,3 ml ± 3.8 ± 190 ± 1.1 ± 1.1 1.6 ± 1,2 2.5 mg / kg 15 19,0 * 769 * 7.1 * 0.5 9.3 9.0 3x0,1 ml ± 5.0 ± 132 ± 0.8 ± 0.3 1.0 ± 2.0 10 mg / kg 10 15 19,3 * 795 * 7.0 * 0.8 10,4 * 9,4 * 1x0,3 ml ± 4.1 ± 102 ± 0.7 ± 1.0 1.5 ± 1.0 10 mg / kg 15 17.5 656 7.3 * 1.3 8.9 8.8 3x0,1 ml ± 3.7 ± 128 ± 1,4 ± 1,2 1.8 ± 1.5

Table 13

Effect of TTP orally administered for 12 weeks on the immunological response of SRBC immunized mice

4th day after 10th day after Sed- PFC / 10 ⁴ hemagglutinin PFC / 10 ⁶ hemagglutinin sinks % E- Splen- -log, by titer 0 / sec / about b- Splen- -log, by titer rosettes quotes 19S + 7S 7 S rosettes quotes 19S + 7S 7 S 15.2 565 6.0 1.6 14.7 256 8.7 7.9 3 ± 3.8 ± 56 ± 0.9 ± 1.3 ± 3,4 ± 67 ± 1.0 ± 1.0 23,7 * 1035 * 7.5 * 2.9 * 23.5 * 406 * 10,4 * 9.7 * ± 7.8 ± 177 ± 0,5 ± 0.2 ± 3.7 ± 88 ± 1,2 ± 1.0 13,8 422 5.1 0 12.7 209 7.1 6,7 5 ± 2,4 ± 63 ± 0.9 0 ± 2,1 ± 41 ± 1,4 ± 1.6 23,0 * 933 * 7.6 * 2.7 * 20,5 * 430 * 11,0 * 11,0 * ± 6.1 ± 248 ± 1.5 ± 1.5 ± 2.7 ± 86 ± 1,2 ± 1.0 12,8 495 4.6 0.5 14,0 245 8.8 7.9 7 ± 2.9 ± 85 ± 1.1 ± 0.9 ± 5.1 ± 48 ± 1.6 ± 1.6 20,5 * 1120 * 7.9 * 2.1 * 26,9 * 437 * 11,3 * 10,3 * ± 5,3 ± 214 ± 0.6 ± 1.5 ± 7.7 ± 117 ± 1.0 ± 0.4 15.0 531 6.2 0.5 14.1 294 8.7 8.4 9 ± 2,1 ± 67 ± 0.8 ± 0.9 ± 2.8 ± 58 ± 1.5 ± 1.5 18,6 * 1049 * 7.7 * 1.9 18,2 * 515 * 11,9 * 10,5 * ± 2.8 ± 184 ± 0.7 ± 1,2 ± 3,4 ± 530 ± 0.8 ± 1.0 15.0 573 7.2 1.4 16.5 266 7.5 7.1 12 ± 2.6 ± 143 ± 1.0 ± 1,2 ± 2.6 ± 58 ± 1.1 ± 0.8 14.1 770 7.2 1.7 19,0 294 11,8 * 10,5 * ± 2.7 ± 132 ± 1,4 ± 1.7 ± 4.1 ± 65 ± 0.4 ± 1.0

* - Statistically significant change at P = 0.05 compared to control group. There are 40 animals in each group

Table 14

Influence of storage conditions on TTP activity with respect to E-rosette formation ability

% E-rosettes The dose Π Output activity After 2 months storage Temperature + 4 ° C At room temperature with access to light At room temperature in the dark Control 8 13.6 ± 2.4 12.8 ± 2.3 12.8 ± 2.3 12.8 ± 2.3 0.1 mg / kg 8 15.8 ± 1.7 16.1 ± 3.04 15.1 ± 2.9 16.0 ± 5.5 1 mg / kg 8 18.0 ± 0.8 * 19.8 ± 4.1 *  15.3 ± 2.8 19,8 ± 2,7 * 10 mg / kg 8 20.4 ± 4.2 * 18.0 ± 4.5 * 16,8 ± 2,4 * 16.9 ± 3.5 *

* - A statistically significant change at α = 0.5 compared to the control group

Table 15

Effect of storage conditions on the activity of TTP in view of the number of 19S antibody producing cells

PFC / 10 ⁶ splenocytes

After 2 months storage

The dose η Output activity Temperature + 4 ° C At room temperature with access to light At room temperature in the dark Control 8 571 ± 69 514 ± 128 514 ± 128 514 ± 128 0.1 mg / kg 8 747 ± 144 1039 ± 326 * 718 ± 135 1002 ± 210 * 1 mg / kg 8 1204 ± 155 * 1026 ± 314 * 793 ± 186 * 1046 ± 331 * 10 mg / kg 8 1075 ± 232 * 1070 ± 249 * 869 ± 160 * 848 ± 137 *

* - Statistically significant change at o = 0.5 compared to the control group

Table 16

Influence of storage conditions on the activity of TTP with a view to influencing the formation of antibodies of the anti-SRBC 19S + 7S type

After 2 months storage Output Temperature- At room- At room- The dose η activity tour at a pace- at a pace- + 4 ° C nature and nature access to in the dark light Day 4 Utah 4 Utah 4 Utah 4th Utah Control S 5,6 9,8 5.0 9.5 5.0 9.5 5.0 9.6 ± 0.9 +0.6 ± 1.1 ± 2,1 ± 1.1 ± 2,1 ± Μ ± 2.1 0.1 mg / kg 8 7.4 11.4 7.8 10.5 5.4 10.8 6.5 12.6 ± 0,4 * ± 1,3 * ± 1,0 * ± 1,7 * ± 0.8 ± 0.7 * ± 0.7 * ± 2.2 * 1 mg / kg 8 6,8 12.2 6,7 13,8 6.2 13,2 6.5 13.1 ± 6,3 * ± 1,1 * ± 0,4 * ± 2,1 * ± 0,3 * ± 0,4 * ± 1.3 * ± 1.3 * 10 mg / kg 8 6.4 11,0 6.2 12,0 4,8 10.6 6.0 13.6 ± 1,2 ± 1,4 * ± 0.6 ± 2,3 * ± 1.3 ± 2,4 * ± 0.5 ± 1.3 *

* - Statistically significant change at α = 0.5 compared to the control group

Table 17

Influence of storage conditions on the activity of TTP with a view to influencing the formation of anti-SRBC 7S antibodies

The dose η Output activity After 2 months storage Temperature + 4 ° C At room temperature and access to light At room temperature in the dark Day 4 Utah 4 Utah 4 Utah 4 Utah Control 8 0.4 9.2 0.3 8.1 0.3 8.1 0.3 8.1 ± 0.8 0.7 ± 0.7 ± 1,4 ± 0.7 ± 1,4 ± 0.7 ± 1,4 0.1 mg / kg 8 0 10.8 0.7 9,8 0.8 10,0 0.7 11.3 ± 1,0 * ± 0.9 ± 0.9 * ± 0.9 ± 0.6 * ± 0.9 ± 1,4 * 1 mg / kg 8 0.8 10.6 0.3 11.5 0.7 10.3 0.7 11,0 ± 0.9 ± 0,4 * ± 0.7 ± 1,8 * ± 0.9 ± 0.7 * ± 0.9 ± 1,0 * 10 mg / kg 8 0 10.2 0.3 9,8 0.3 10.7 0.7 yu, with ± 1,3 * ± 0.7 ± 1.0 ± 0.7 ± 2,0 * ± 0.9 ± 0.9 *

* - A statistically significant change at α = 0.5 compared to the control group

Table 18

Haematological parameters of healthy volunteers before and after two weeks of administration

TTP at a dose of 1 mg / day

Parameter Placebo η - 5 TTP η = 5 0 14 days 0 14 days Erythrocytes x 10 ⁶ / u 1 4,44 ± 0.46 4.32 ± 0.45 4.32 ± 0.32 4,18 ± 0.32 Hemoglobin g / dl 12,4 ± 2.5 11.9 ± 2.8 12,8 ± 0.8 11,8 ± 0.6 Hematocrit% 38,1 ± 6,7 38 ± 6.9 38,7 ± 2,1 38,1 ± 1.6 Leukocytes x 10 ³ / μ 1 5,25 ± 0.59 5.27 ± 0.8 5,23 ± 0.6 4.86 ± 0.6 Neutrophils% 52.6 ± 12 57.6 ± 11 54,2 ± 2.5 55 ± 3.6 Lymphocytes% 26 ± 7.5 30.4 ± 8.3 34 ± 4.1 32,4 ± 5,3 Platelets x W / μ 1 220 ± 40,4 214 ± 35.8 221 ± 38 214 ± 39.6 Blood sediment mm / lh 7,6 ± 9 5.6 ± 1.9 7.8 ± 2.7 6,8 ± 3.1

Table 19

Biochemical parameters of healthy volunteers before and after two weeks of administration of TTP at a dose of 1 mg / day

Parameter Placebo n = 5 TTP n = 5 0 14 days 0 14 days Total protein g / i 72.8 ± 1.76 68.42 ± 3.2 73.8 ± 1.92 70 ± 5.5 Albumin% 63.2 ± 2.5 63.8 ± 2.3 63.6 ± 1.8 64.4 ± 2.1 Globulin a1 ° / , 3.1 ± 0.4 3 ± 0.5 2.8 ± 0.5 2.8 ± 0.45 A2% globulin 5.95 ± 1.9 6.8 ± 1.5 6.93 ± 0.9 6.9 ± 0.9 Globulin β% 14.4 ± 2.2 14.2 ± 1.5 13.3 ± 1.9 13.2 ± 1.3 Globulin γ% 12.2 ± 1.5 12.1 ± 1.3 13.7 ± 0.9 12.3 ± 1 IgG g / l 10.3 ± 1.1 10.2 ± 1 11.7 ± 1.6 11.1 ± 1.4 IgA g / l 1.8 ± 0.6 1.9 ± 0.5 1.8 ± 0.5 1.9 ± 0.5 IgM g / l 1.4 ± 0.3 1.4 ± 0.2 1.1 ± 0.2 1.1 ± 0.4 Compliment C3 g / l 1.1 ± 0.1 1.1 ± 0.1 1.1 ± 0.2 0.2 ± 0.2 Compliment C4 g / l 0.2 ± 0.5 9.3 ± 0.04 0.2 ± 0.0 0.2 ± 0.03 Alanine U / l 34.2 ± 0.05 0.3 ± 0.04 30.2 ± 8.2 31.2 ± 3.2 Asparagine U / l 32.8 ± 4.4 40.2 ± 6.6 30.4 ± 7.1 39.6 ± 6.6

Table 20

Comparison of the incidence of acute respiratory tract infections in the last quarter of 1989 and 1990 compared with two groups of patients treated with TTP and placebo respectively in October 1990

TTR

Implementation in Q4 1990

And 4th trim. 1989 (without TTP) average number of infections per patient 4th trim. 1990 (with TTP) average number of infections per patient Statistical reliability "P" Colds 20 4.0 ± 1.3 1.0 ± 0.5 <0.01 Angina 20 3.3 ± 1.3 0.8 ± 0.6 <0.01 Herpes 20 2.1 ± 2.2 0.3 ± 0.4 <0.01 Cough 20 1.4 ± 1.1 0.3 ± 0.6 <0.01 Bronchitis 20 0.3 ± 0.5 0 Pneumonia 20 0.2 ± 0.9 0

Placebo

Application in the 4th trim.1990

4th trim. 4th trim. Statist- 1989 1990 Czech (without TTP) (with TTP) Evaluation of medium number average number of difference infections infections “P” for a patient for a patient

Colds 20 3.9 ± 1,4 3.1 ± 1.5 > 0.05 Angina 20 2.3 ± 2.0 2.6 ± 1.7 > 0.05 Herpes 20 2.3 ± 1,8 1.7 ± 2,1 > 0.05 Cough 20 1.5 ± 1.5 1.9 ± 2.0 > 0.05 Bronchitis 20 0.1 ± 0.3 0.1 ± 0.3 Pneumonia 20 0.1 ± 0.3 0.1 ± 0.3

Claims (15)

Claims 1. A bioactive peat product for responding to non-specific immunostimulation, characterized in that it contains no more than 70, preferably not more than 60% by weight. inorganic salts, in particular sodium chloride, with respect to a solid, preferably in the form of a concentrated solution or a dry powder; in the case of concentrated solution, it is a dark brown liquid with a specific gravity of from 1.02 to 1.09 g / ml and contains a dry solid of not less than 5% by weight; and has a pH of from 0.5 to 6.5, in particular about 6, when in the form of a 1% aqueous solution. Peat bioactive product according to claim 1, characterized in that it is obtained by a method in which a highly concentrated aqueous solution of inorganic salts, especially sodium chloride containing peat bioactive ingredients, is diluted with demineralized water, the diluted solution is optimized by reverse osmosis, in order to remove the inorganic salts during the desalination of the solution, and then to concentrate and purify, and more preferably sterilize and / or spray dry, to yield a so-called bioactive product from ORF. Peat bioactive product according to claim 2, characterized in that the concentrated saline solution containing peat bioactive ingredients is treated by a method comprising primary and secondary alkaline hydrolysis of air-dried crude peat material, followed by acidification of the hydrolysis, after this separation of insoluble parts and removal of ballast by extraction with organic solvents, followed by removal of residual organic solvents from the post-extractive aqueous phase, and filtration of residues the aqueous phase by a limestone ceramic filter under reduced pressure to obtain a pure filtrate from a concentrated saline solution containing bioactive ingredients. Bioactive peat product according to any one of claims 1 to 3, characterized in that it is included in a pharmaceutical composition for non-specific immunostimulation comprising the induction of cytokines, preferably for topical administration, the composition additionally containing pharmaceutically acceptable excipients , preferably a carrier, the carrier being preferably a mixture of lactose and lubricants, and the weight ratio of the bioactive product to the carrier is from 1: 5 to 1:25, in particular from 1: 9 to 1:19. 5. A bioactive peat product according to claim 4, wherein the pharmaceutical composition is in the form of a tablet or capsule. Bioactive peat product according to claim 4, characterized in that the pharmaceutical composition is in the form of a gel and further comprises a sterile alcoholic vegetable extract, a sterile solution of flavoring agents, preferably selected from the group consisting of menthol, thymol, mint, lemon and eucalyptus and a gel-forming agent, preferably sterile glycerin with colloidal silicon, the weight ratio of the liquid mixture to silicon being from 90:10 to 94: 6. A bioactive peat product according to claim 4, characterized in that the pharmaceutical composition is in the form of liment and further comprises a sterile plant extract, a gel-forming agent, preferably colloidal silicon, and a sterilized mixture of fatty components, such as eucrin and petrolatum. preferably by weight ratio of liquid components to silicon of 30: 2 and gel to fat components 32:68 to 34:66. Bioactive peat product according to any one of claims 1 to 3, characterized in that it is included in a composition for treating skin, hair and / or teeth, in which the composition optionally contains additional carriers and / or other additives, customary for cosmetic preparations, preferably selected from the group consisting of aqueous solutions of alcohols, all types of emulsions, gels, aromatic compositions and oily carriers, in which the bioactive product is in an amount of 0.01 to 10% by weight, preferably 0, 05 to 1%, in particular 0.05 to 0.1% by weight. A bioactive peat product according to claim 8, characterized in that the composition further comprises at least one plant extract and / or at least one aromatic substance. 10. A method for the preparation of bioactive peat products used for non-specific immunostimulation, involving the treatment of a highly concentrated solution of inorganic salts, in particular sodium chloride containing bioactive peat components, and additional steps of the method, characterized in that the additional steps include the dilution step in which the solution is diluted with demineralized water, preferably in a ratio of 1: 5 to 1: 8; a further desolvation step in which the diluted solution is subjected to reverse osmosis to desolvate the solution and compress to a concentration of not more than 70%, preferably not more than 60%, by weight, of the dry matter; a concentration and purification step in which the desolvated solution is concentrated and purified, and optionally, a sterilization and / or drying step, in which the concentrated and purified solution is sterilized and / or spray dried to yield the bioactive peat product. A method according to claim 10, characterized in that the concentrated solution is obtained by a method comprising the steps of primary and secondary alkaline hydrolysis of dry crude peat material, acidification of hydrolysis, separation of insoluble moieties and elimination of ballast substances by extraction with organic solvents to obtain a post-extraction aqueous phase, subsequent removal of residual organic solvents from the post-extraction aqueous phase and filtering and separation of the aqueous phase by limestone ceramic iltar under reduced pressure to give the pure filtrate of the highly concentrated solution of inorganic salts containing bioactive peat ingredients. The method of claim 10, wherein the sterilization is carried out by membrane filtration. A method according to claim 10, characterized in that the concentrated solution is spray dried at an initial temperature of 180 ° C and an exit temperature of 90 ° C. 14. A method of producing a gel pharmaceutical form for non-specific immunostimulation comprising the induction of cytokines, in particular for the treatment of wounds, in particular for wounds of the feet, containing as an active ingredient a bioactive peat product combined with plant extracts, flavor enhancers and gel-forming agents, and optionally additional components, characterized in that the sterile aqueous solution of the pre-powdered bioactive peat product is not more than 70% by weight. inorganic salts, in particular sodium chloride, are combined with a sterile alcoholic vegetable extract and a sterile flavoring solution, preferably selected from the group consisting of menthol, thymol, mint, lemon, and eucalyptus, followed by a gel-forming agent, glycerin, preferably sterile colloidal silicon, to convert the liquid mixture into a gel form, the weight ratio of the liquid mixture to silicon being preferably from 90:10 to 94: 6. 15. A method for the preparation of a liniment pharmaceutical formulation comprising, as an active ingredient, a bioactive peat product for non-specific immunostimulation, including cytokine induction, preferably for the treatment of wounds, in particular in wounds of the foot, which involves combining a bioactive product of peat with vegetable extract, gel-forming agent, fat components and optionally additional components, characterized in that the sterile solution of powdered bioactive peat preparation of at least 70% by weight inorganic salts, in particular sodium chloride, are combined with a sterile plant extract, after which the resulting mixture is gelled by the addition of a gel-forming component, in particular colloidal silicon, and the resulting gel is ground to a powder with a pre-sterilized mixture of fat components, such as eucerin and petrolatum, preferably the weight ratio of the liquid components to silicon is about 30: 2 and the gel to the fat composition is 32:68 to 34:66.