RU2126682C1 - Bioactive substance obtained from turf, method of its preparing and pharmaceutical and cosmetic compositions - Google Patents

Abstract

FIELD: bioactive compounds. SUBSTANCE: bioactive substances obtained from turf have 70 weight%, not above, preferably, 60 weight%, not above, inorganic salts, especially sodium chloride, of dry matter. Method of these products preparing involves dilution of highly concentrated an aqueous solution of inorganic salts, especially sodium chloride, with demineralized water followed by reverse osmosis to desalt a solution. Inorganic salts are removed, obtained solution is concentrated and cleared and sterilized by at least a single the following stage and/or dried by pulverization. Pharmaceutical composition containing bioactive product obtained from turf as gel is prepared by combination of sterile alcoholic plant extract with sterile glycerol, sterile an aqueous solution of preliminary powdered bioactive product obtained from turf and sterile menthol solution. Obtained mixture is combined gradually with colloidal silica to convert a liquid composition to gel at preferable weight ratio of a liquid mixture to silica = (90:10)-(94: 6). Cosmetic preparation (gel, ointment, balsam, shampoo, salt composition for bath and others) has an active component as a soluble bioactive turf product in the amount 0.01-10 wt.%, preferably, 0.05-1 wt.% and more preferably 0.05-1 wt.%. The end stable product can be added easily to pharmaceutical and veterinary preparations. EFFECT: improved method of preparing, high quality of the end product. 23 cl, 23 tbl

Description

 The invention relates primarily to new bioactive products obtained from peat, and to methods for producing such products. The invention also relates to pharmaceutical and cosmetic compositions containing these products, and to methods for producing pharmaceutical and / or cosmetic compositions containing the above bioactive products derived from peat.

 Various methods are known for extracting peat using various extraction media, as well as the use of such extracts containing bioactive ingredients derived from peat for pharmaceutical and cosmetic purposes.

 One such known method is described in the Polish patent specification No. 124110 (Chemical Abstract 101 (10), 78854e). In accordance with this known method, bioactive products are obtained from peat using primary and secondary alkaline hydrolysis of air-dried crude peat material, then the hydrolyzate obtained in this way is acidified and the insoluble solid is separated, followed by second alkalization, acidification of the pure (transparent) liquid phase and removal of ballast substances by alcohol or ether extraction. In this method, the aqueous phase of organic extraction is a liquid bioactive product obtained from peat.

 A well-known liquid product, which is a solution of peat derived active ingredients in a highly concentrated, almost saturated sodium chloride solution, obtained in accordance with the above reference to the Polish patent specification, is unstable during storage for a long time and, in addition, contains - as for the biological activity of the composition is a large excess of inorganic neutral substances. Being a bulk product, it is not convenient to handle, it is difficult to store and produce.

 The main objective of the present invention is to develop a product that does not have these disadvantages, i.e. a product that is stable and can be easily incorporated into pharmaceutical or veterinary products, as well as into cosmetic preparations, both in solid form and in the form of any convenient solution.

 In particular, with regard to the use of peat derived bioactive product for pharmaceutical purposes, i.e. to obtain pharmaceutical compositions, there was an urgent need to develop a solid form that was well suited for these purposes. Since preliminary attempts related to the concentration of a known aqueous solution of bioactive substances obtained from peat and its desalination did not give positive results due to the occlusion of the active ingredients into a crystallizing solid phase, causing a decrease in the biological activity of the composition, it was very difficult to find a suitable method for converting liquid composition into powder. It was unexpectedly found that a positive result can be achieved if, before concentration, the liquid composition is first diluted several times, i.e. dilute one volume of the composition with several volumes of water.

 Accordingly, the present invention develops a method by which it is possible to obtain a bioactive product isolated from peat, characterized by the above advantageous characteristics, from a highly concentrated aqueous solution of an inorganic salt, mainly sodium chloride, containing bioactive ingredients obtained from peat by diluting the solution with demineralized water, t .e. distilled water, followed by reverse osmosis, concentration and purification. The solution thus obtained can be easily converted into a sterile and solid product suitable for the required purpose by sterilization and spray drying. Dilution with amounts of water is preferably carried out several times, preferably 5 to 8 times, from the amount of concentrated solution to be diluted.

 This method used to process the product obtained in accordance with the description of the invention to Polish patent N 124110 consists in removing residual organic solvents from the post-extraction aqueous phase, separating insoluble parts by filtration under reduced pressure through a sintered ceramic material, diluting the solute in several times the volume of distilled water and its processing by desalination using reverse osmosis to separate excess mineral salts, mainly sodium chloride, in the form of permeate. Then, the desalted solution is concentrated, purified by centrifugation and sterilized by filtration through a membrane filter, for example, a millipore filter.

 The resulting microbiological pure solution may optionally be spray dried. From a sterile product, liquid or solid, a cosmetic, pharmaceutical or veterinary composition may be formulated. Optionally, a concentrated and purified solution can be used — without sterilization and spray drying — in any suitable dilution as a component in many cosmetic compositions.

Preferably, in the spray drying step, the inlet temperature is set to about 180 ^° C. and the outlet temperature is about 90 ^° C.

In accordance with Polish patent N 124110, an acidified hydrolyzate obtained from peat, characterized by an ash content of 8-30%, a degree of decomposition of 30-70% and a pH value of 3.5-7.0, is subjected to secondary hydrolysis in water a solution of alkaline substances at pH values from 9.0 to 14.0 and a temperature of 16-60 ^o C. After separation of the precipitate, the filtrate is acidified again to a pH value of 3.0-1.0, after which it is concentrated, neutralized and concentrated again to dryness. The dry mass thus obtained was then extracted with 40-80% aqueous ethanol at a temperature of 30-60 ^° C. After separation of the ballast substances from the extract, it was concentrated to obtain half of the original value. The residue was extracted with ethanol mixed with another organic solvent, such as ether, chloroform, benzene, ethyl acetate, in a ratio of 1: 1 to 1: 3. Then the aqueous layer is concentrated to half of the initial volume, centrifuged and separated on columns with cellulose or biogel using water or 5-10% aqueous ethanol, methanol or acetone as the separating system.

 Selective removal of excess salts or acids is carried out using an ion-exchange technique.

 The product obtained in accordance with the said patent contains, in addition to polysaccharides, certain mineral salts.

 The final product obtained in this way differs from the corresponding known product both in chemical composition and in a wider range of anticancer activity.

 An example of obtaining a product according to the patent of Poland N 124110.

 One kilogram of air-dried peat is crushed and extracted using 8 l of 0.1-8.0% aqueous NaOH solution for 36 hours at room temperature and with constant stirring. Then the alkaline extract is centrifuged to separate the solid parts, after which it is acidified with hydrochloric acid to a pH of about 2 and left for 12 hours. The precipitate formed in this case is separated, and the clear solution is treated with sodium hydroxide until a pH of 9 is reached, and then filtered again. Then the filtrate is again acidified with hydrochloric acid and concentrated under reduced pressure to reach 1/5 of the original volume. The concentrated solution was neutralized with sodium hydroxide and evaporated to dryness. Dry mass is extracted with aqueous ethanol. The extract is separated from the fat residue and inorganic salts. Then the extract is concentrated until the salt begins to precipitate. The precipitate was separated, and the filtrate thus obtained was extracted with a 1: 1 mixture of ethanol and ether, chloroform, benzene or ethyl acetate. The inorganic salt precipitated a second time is again filtered off, and the aqueous filtrate is concentrated to half the volume relative to its initial value, centrifuged and filtered. The clear filtrate is subjected to column chromatography with R-2 Biogel minus 400 mesh (crude) using water or 10% aqueous ethanol as eluent, and fractions having anti-cancer activity are collected.

The resulting preparation is a hygroscopic, amorphous brownish substance containing about 10% water. It is water soluble and insoluble in organic solvents. After acid hydrolysis, it gives a positive reaction when interacting with a group of reagents used to determine the presence of sugars - glucose, galactose, arabinose, glucuronic acid, ramnose, xylose, 6-deoxyglucose and 2-deoxyglucose. The IR spectrum is typical of polysaccharides. After calcining at 700 ^o C, ash is obtained, constituting up to 6-10% of the initial mass and containing metal oxides, among which are found such as oxides of Mo, Cd, Co, N, Mn, Mg, C, V, as well as nonmetallic oxides among which should be noted oxides of Si and P.

 Although the method according to the invention is described in combination with the method according to the description of the invention to Polish patent N 124110, its use is not limited to such a combination, but is usually applicable in the context of the method for producing a bioactive product isolated from peat from a highly concentrated liquid solution of inorganic salts, mainly sodium chloride, containing bioactive ingredients isolated from peat.

 Obtained from peat bioactive products referred to in this invention do not contain more than 70 wt.%, Preferably not more than 60 wt.%, Inorganic salts, mainly sodium chloride. Since the concentration of sodium chloride in the optimum product is desirable, as low as possible, mainly for pharmaceutical use and such cosmetic use where higher concentrations are needed, i.e. for face care, lower concentrations of sodium chloride, such as 55% or even lower, are most preferred, especially if possible through dilution and reverse osmosis steps. If the method is limited to the stages of concentration and purification, the product is a concentrated or thickened solution. The "concentrated peat extract" referred to in this description of the invention is a dark brown liquid with a density of 1.02-1.09 g / ml and contains at least 5 wt.% Dry solids. The chloride ion content in dry solids, calculated as NaCl, is not higher than 70%, preferably not higher than 60%, and the pH value of a 1% aqueous solution is 5.0-6.5, usually 6.0. The absence of the next stage of sterilization in some cases does not harm, for example, for a certain cosmetic use of the aforementioned concentrated peat extract.

On the other hand, the sterilization step may be necessary, in particular if the product is intended for the preparation of pharmaceutical compositions. In this case, an additional spray drying step, if not mandatory, is particularly preferred. The product obtained after this spray drying step is in powder form and is therefore particularly suitable for the preparation of certain pharmaceutical compositions. The most preferred product of this type is the product sold under the name "ToLPA ^® . Torf Preparation" ToLPA ^® is a registered trademark of Torf Corporation, Mydlana 2, Wroclaw, Poland.

 In this description of the invention, the abbreviation TTP will be used to refer to the above product.

 The present invention also relates to pharmaceutical compositions containing, as an active ingredient, the bioactive product obtained from peat described above, in particular a product containing not more than 70 wt.%, Preferably not more than 60 wt.%, Inorganic salts, mainly sodium chloride, dry solids, together with a pharmaceutically acceptable carrier. The bioactive product obtained from peat contained in such pharmaceutical compositions is preferably the TTP indicated above. The pharmaceutical preparations contain a peat derived bioactive product and a pharmaceutically acceptable carrier, preferably in a weight ratio of from about 1: 5 to 1:25, and most preferably between 1: 9 and 1: 19.

 In addition, the present invention relates to a method for preparing a pharmaceutical composition comprising a peat derived bioactive product in the form of a gel. This method is characterized in that a sterile alcoholic herbal extract is combined with sterile glycerin, a sterile aqueous - preferably concentrated - solution of a bioactive product obtained from peat and a sterile menthol solution, and the resulting mixture is gradually combined with colloidal silica to transform the liquid composition into a form gel, while the weight ratio of the liquid mixture to silica is from 90:10 to 94: 6. It is preferable to use TTP as a powder or concentrated peat derived bioactive product.

 The present invention also relates to a method for preparing a pharmaceutical composition comprising a peat bioactive product in the form of an ointment. This method is characterized in that the sterile herbal extract is gradually combined with a sterile solution of a powdery peat derived bioactive product, the resulting mixture is gelled by adding colloidal silica, and the gel thus obtained is ground into powder with a pre-sterilized mixture of fatty components such as eucerin (eucerine) and petroleum jelly, preferably with a weight ratio of liquid components to silica of about 30:20 and gel to fat components of 32:68 to 34:66. It is also preferable here to use TTP as a powdery or concentrated peat derived bioactive product.

 Cosmetic preparations, which may include herbal extracts, as well as other additive and enriched components, flavoring components and carriers acceptable for cosmetic purposes, contain peat derived bioactive product in accordance with the present invention in an amount of 0.01-10 weight. %, preferably 0.05-1.00 wt.%, and most preferably 0.05-0.10 wt.%.

 Carriers can be aqueous solutions of alcohols, all types of emulsions, gels, foaming compositions and fatty carriers. The use of one particular carrier selected from the group of the substances mentioned above allows the preparation of various types of cosmetic preparations in accordance with the invention, such as tonic agents, creams, balms, cleansing milk, etc. for everyday body care, as well as shampoos, hair balms, bath detergents, all with the addition of bioactive products derived from peat.

 Bioactive products isolated from peat (abbreviated peat extracts) obtained from the original raw peat material, such as (among others) therapeutic mud, contain well-balanced amounts of mineral or organic compounds, such as mineral salts of the following elements: B, Si, Ab, Fe Mg, Mn, Cu, Si, Ni, Ca, Ag, and Na; organic compounds such as amino acids in free form and in the form of salts; partially decomposed / reactive polysaccharides, in the case of hydrolysis, to deoxysaccharides and / or amino saccharides. Peat, in particular therapeutic mud, is known and studied as a material of biological plant and microbiological origin; due to the content of nutritious and stimulating components in it, it has a healing effect on the human body and mammal; therefore, bioactive compositions obtained from peat contain the above substances in proportions characteristic of living organisms; this can be considered as an explanation of the beneficial effects of cosmetic and pharmaceutical preparations containing active products and compositions derived from peat. A particularly good effect when using new cosmetic compositions is observed when herbal extracts are also present in the composition. The selection of a suitable herbal extract is based on the well-known usual use of such extracts in cosmetics with a change in the activity of drugs and thereby allowing the content of cosmetic preparations to be adapted to the requirements and needs of patients.

 The present invention is characterized in more detail and explained by the following examples.

 Example 1

 Based on 1000 kg of air-dried crude peat material, then processed, for example, according to the technology according to Polish patent N 124110, a solution of bioactive ingredients isolated from peat in a saturated aqueous solution of sodium chloride in an amount of about 10 l is obtained. The solution is filtered through sintered ceramic material under reduced pressure in order to clean it before desalting. Thus obtained pure solution contains about 95% NaCl dry weight. The dry weight is about 32 wt.% Solution. The volume of the pure solution is approximately 7 liters.

The pure solution is diluted 5-6 times with distilled water, and in diluted form is subjected to desalination, which is carried out using the reverse osmosis method and using a DDS device. Desalination is carried out for 3-4 hours, whereby the excess of mineral salts - mainly NaCl - is separated in the form of permeate. The desalted composition contains approximately 65-70% solid sodium chloride. The 6-7 L solution thus obtained was concentrated 4-5 times in a Bucchi rotary evaporator to obtain a concentrated solution containing about 20% solids. The resulting concentrated solution was purified using a Biotuga-Herabus centrifuge (flow separator) and then sterilized by filtration through a Millipore ^® filter.
The resulting microbiologically pure solution is dried by spray drying in an Anhydro dryer at an outlet temperature of 90 ^o C and an inlet temperature of 180 ^o C. The yield of dry powder is approximately 200 g.

 Example 2

The product obtained in example 1 is used to prepare pharmaceutical compositions in the form of a gel and ointment, which also contain herbal extracts, which synergistically enhance the effect of the treatment of certain diseases. For example, a gel and ointment for varicose leg ulcers is prepared as follows: 20 g of horse chestnut extract (hippocastanaceous), 10 g of calendula extract, 60 g of glycerin, 0.1 g of TTP in the form of a powder obtained as described above in example 1, 0, 1 g of salicylic acid, 1.0 g of distilled water and 8.8 g of Aerosil ^® colloidal silica are used to obtain the preparation in the form of a gel.

 Liquid (non-volatile) ingredients are sterilized before use by heating under reflux for two hours. The herbal extracts are combined with glycerol and an aqueous solution of TTP, as well as menthol, and silica is gradually added to the resulting mixture with constant stirring.

Similarly, to obtain a composition in the form of an ointment, the following ingredients are used: 20 g of horse chestnut extract (hippocastanaceous), 10 g of calendula extract, 0.1 g of salicylic acid, 0.1 TTR in powder form, obtained as described above in example 1, and 2.0 g of Aerosil ^® (colloidal silica).

 A mixture of the following substances is used as fatty components: 22 g of eucerine (eucerine) and 45.8 g of petroleum jelly. Herbal extracts are sterilized by heating under reflux for about 2 hours. The liquid ingredients are carefully combined with silica to form a gel, which in turn is triturated with sterile liquid components cooled to room temperature. A stable ointment is obtained which does not separate upon storage.

 The gel and ointment obtained as described above are simultaneously used to treat varicose leg ulcers. Ulcers are treated with a gel preparation, while unaffected skin around them is treated with ointment. It is believed that the addition of colloidal silica promotes rapid drying, while the herbal and peat derived ingredients are responsible for the therapeutic effect of the drug. Fatty components help maintain the elasticity of the crust on the wound (scab) and skin. The results obtained are compared with the results obtained in the control group of patients who are treated with the new method, were selected from the group of patients suffering from the disease for many months (sometimes years) without noticeable improvement. Patients treated with the compositions of the invention show better results within the first few weeks as compared to the control group of patients.

 Example 3

 The products obtained in example 1 are used for the preparation of pharmaceutical compositions in the form of tablets or granules, which are placed in capsules.

The sterile peat-derived bioactive composition in powder form is combined with a carrier in a weight ratio of 1: 9. MYVATEX ^® (trade name of Eastman-Kodak product), a mixture of lactose and lubricants in a weight ratio of 44: 1, is used as a carrier. Lactose with a particle size of 50 mesh and MYVATEX ^® TL are finely ground so that approximately 70% of their weight passes through a 100 mesh sieve. From a portion of the resulting mixture of the active composition and the carrier, tablets containing 5 mg of active ingredients are formed. The total weight of each tablet is 50 mg. Another part of this mixture of active composition and carrier is granulated using ds ethanol (40 vol.%). The granules are sieved through a sieve and, if necessary, ground, and then placed in capsules in such an amount that each capsule contains 5 mg of active ingredients by using TTP mixed with a carrier in a ratio of 1:19.

The tablets obtained as described above are tested to measure their disintegration time in artificial gastric juice at a temperature of 37 ^° C ± 2 ^° C using ErweKa equipment. Artificial gastric juice is prepared as follows: 2.0 g of sodium chloride, 3.2 g of pepsin are dissolved in 7 ml of hydrochloric acid and adjusted with distilled water to a total volume of 1000 ml. The pH of the resulting solution is approximately 1.2. The disintegration time of the tablet having a diameter of 5.1 mm and a total mass of 0.0498 g is 6 minutes.

 The following examples relate to numerous cosmetic preparations according to the present invention, having various compositional forms and designed for various applications, containing medicinal additives of bioactive ingredients derived from peat. Among others, such preparations as tonic agents, balms, creams, milk, shampoos, foaming agents for baths, etc. are described.

 Example 4

 In a reaction vessel equipped with a stirrer, 150 g of chamomile extract obtained by extracting chamomile inflorescences with ethanol: water solution 1: 1, as well as 1 g TTP, as described above, are placed. To the resulting mixture was added 50 g of glycerol. Three substances are mixed to obtain a homogeneous mixture. Then, a second pre-prepared mixture is poured into the same vessel. It includes 340 g of a solution of ethanol: water 95: 5, 1 g of salicylic acid and 0.5 g of menthol. The two mixtures are mixed to form a homogeneous solution. Then add 3 g of flavoring composition TILIANA H4308. TILIANA H 4308 is a product of Fabryka Syntetykow Zapachowych Pollena-Aroma (Pollena-Arema synthetic fragrance factory, Warsaw, Poland). The solution is then adjusted to a total volume of 1000 ml by adding 454.5 g of distilled water, stirring is continued until a homogeneous mixture is formed. In the above methodology, 86% glycerol, menthol and water are used in accordance with the requirements of Polish Pharmacopea FPIV and ethanol at a concentration of 95% in accordance with Polish industrial standards BN-75 / 6193-01.

 The concentrated peat extract used is a dark brown liquid with a density of 1.020-1.090 g / ml, and the dry solids content is at least 5%, the pH value of a 1% aqueous solution is 5.0-6.5. Chamomile extract is a red-brown liquid with a density of 0.9160-0.9503 g / ml and an ethanol content of 52-56 vol.%.

 Tonic preparations obtained as described above are suitable for all skin types. They are pure (clear) liquids without any solids. They have a yellow color. The pH value is 4.28 and the ethanol content is 45.92 vol.%. The total acidity, which is considered by the content of salicylic acid, is not less than 0.1 wt.%, Namely 0.23 wt. % When stored for 12 months, the drug did not change any of its above characteristics.

 Example 5

 Repeat the procedure described in example 4 above, with the only difference that instead of chamomile extract and flavoring composition TILIANA H4308, marigold flower extract and FINUS H4625 composition (also Fabryka Syntetykow Zapachowych Pollena-Aroma) are used in the same way and in the same molar and volumetric ratios. The resulting tonic preparation is suitable for dry and delicate skin. It is also a pure liquid without any particulate matter. The pH value is 4.30; the total ethanol content is 45.82 vol. % and total acidity of 0.27 vol.%. When stored for 12 months, the drug does not change its properties, as well as the drug obtained according to example 4.

 Example 6

The procedure from Example 4 is repeated, except that instead of chamomile extract, sage leaf extract is selected, and instead of TILIANA H4308, the flavoring composition LELIA 90368 (Pollena-Aroma, Warsaw) is chosen. Sage leaf extract is obtained by extraction of dry sage leaves with ethanol at 50 ^° C. and it has a brown color, a characteristic smell of sage and a density of 0.9160-0.9503, it contains 52-56% ethanol. The resulting skin care agent is particularly suitable for oily skin. It is a clean and homogeneous liquid with a dark yellow color; the pH value, ethanol content and acidity are similar to the values of the skin care agent according to example 4.

 Example 7

The following composition is a particularly effective gel for the prevention or treatment of periodontal disease, g:
Chamomile Extract - 34.0
Sage Leaf Extract - 3.0
Salicylic acid - 0.3
Menthol - 0.2
TTR - 0.1
The total mass of industrial gel as a base is 100.0
Example 8

Carefully weighed components are introduced into 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 reddish brown liquid having a density of 0.9160-0.9503 g / ml and an ethanol content of about 55% by volume;
50 g of glycerin, 86%, according to the requirements of Polish Pharmacopea FPIV;
30 g of the soapwort extract obtained by extracting the roots of the soapwort with 70% ethanol, the extract is a reddish-brown liquid, the density is 0.9630-0.9810 g / ml, and the ethanol content is about 75 vol.%;
1.0 g of the invented concentrated peat extract, which is a dark brown liquid with a density of 1.02-1.09 g / ml, contains no more than 2% chloride ions, which are calculated by sodium chloride, the dry solids content is at least 5 %, the pH value of a 1% aqueous solution of the extract is 6.0.

 The above ingredients are thoroughly mixed. A pre-prepared solution of 1 g of salicylic acid in 260 g of 95% ethanol is added there. 383 g of distilled water and 5 g of TILIANA H4308 flavoring composition are added to the mixed solution and mixed until a homogeneous solution is obtained. The drug is analyzed and stored in 200 ml retail bottles. The resulting preparation is suitable for hair care. It is a clear, slightly opalescent liquid containing approximately 45 vol.% Ethanol; the pH value is 4.5; the total acidity, which is calculated by salicylic acid, is not less than 0.1 wt.%. The drug is suitable for fair hair. The quality of the drug for 12 months of storage remains unchanged.

 Example 9

 The procedure described in Example 8 is repeated, except that instead of chamomile extract and TILIANA H4308 composition, the same sequence and ratio are used: horsetail herbal extract and PINUS H4625 flavoring composition. Horsetail herbal 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 types of hair. It is a clean and transparent liquid without any yellow-brown solid parts, the pH value, ethanol content, total acidity, and stability after storage for 12 months remain unchanged and have the same values as in the preparation described in the example 6.

 Example 10

 The procedure described in example 8 is repeated with similar results. The only difference is that instead of chamomile extract and TILIANA H4308 composition, stinging nettle leaf extract and LELTA 90368 flavoring composition (a product of the same Fabryka Syntetykow Zapachowych Pollena-Aroma) are used in the same sequence and in the same ratio. The herbal extract used has an olive green color, a density of 0.9160-0.9503 g / ml and an ethanol content of approximately 55% by volume. The drug is suitable for all types of hair.

 Example 11

Typically, cosmetic milk is a dispersion of fatty substances that act both chemically and mechanically on the skin. In fact, due to the convenient method of application and better interaction of the liquid and the skin, it is advisable to use a liquid, in particular emulsion creams. They easily penetrate into the deeper layers of the skin and thus prevent skin changes due to age. Cosmetic milk is mainly used to cleanse dry and delicate skin. Accordingly, it should not contain aggressive volatile oils, and at the same time it often contains suitable herbal extracts, such as chamomile extract or wheat germ extract. Adding bioactive products obtained from peat to such a cosmetic milk further enhances its positive effect. In particular, the composition of the new tool is as follows, g:
TTR - 0.05
Aloe Vera Extract - 20.00
Glycerin - 3.00
Eucerin - 2.00
White paraffin oil - 1.00
Triethylamine - 1.00
Aerosil ^(R) (colloidal silica) - 4.00
Example 12

 Improved recovery results are observed when using TTP and carefully selected fatty carriers in classic nutritional and regenerative creams. TTR is used in an amount of 0.01-1.00 wt.% In combination with a herbal extract (the choice depends on the type of skin for which the cream is intended) in an amount of at least 0.05-1.00 wt.%, An antibacterial drug in an amount of 0.05-1.00 wt.%, a synthetic flavoring composition in an amount of 0.01-0.05 wt.% and a fatty carrier in the form of an aqueous emulsion comprising 97.00-99.50 wt.% of the entire composition. It is essential that the fat composition is a good carrier for the active ingredients and that it is acceptable to the skin. Preferably, it is an emulsion (all amounts are given in wt.%) 35-45 eucerin, 8-14 petrolatum, 2.5-4 olive oil, 6-10 glycerol and 35-40 water. Preferred herbal extracts are marigold flower extract, chamomile extract, thyme extract and the like.

Preferred recipes are the following, parts by weight:
1 recipe
Eucerin - 39.00
Vaseline - 11.50
Olive Oil - 3.13
Glycerin - 7.80
Water - 38.00
NIPAGINA (antibacterial drug) - 0.40
TTR - 0.05
Marigold Extract - 0.10
Synthetic flavoring agent - 0.02
Total - 100.00
2 recipe
Eucerin - 42.00
Vaseline - 8.50
Olive Oil - 3.08
Glycerin - 7.90
Water - 38.00
NIPAGINA (antibacterial drug) - 0.40
TTR - 0.05
Chamomile Extract - 0.02
Synthetic flavoring agent - 0.05
Total - 100.00
Example 13

The preparation for use after shaving contains TTR as peat extract in an amount of 0.01-1 wt.%, Herbal extracts in an amount of 1-30 wt.%, Glycerin in an amount of 1-8 wt.%, Salicylic acid and menthol in water alcohol solution. Preferred herbal extracts are: extracts of chamomile, marigold, thyme, aloe and similar extracts of medicinal plants. Glycerin supplementation is also beneficial due to its effect on skin elasticity. It accelerates the application of the drug to the face, as well as its penetration into the deeper layers of the skin, thereby enhancing the healing effect of active peat composition and herbal extracts. The preferred recipe is the following, parts by weight:
TTR - 0.10
Chamomile Extract - 15.00
Glycerin - 5.00
Menthol - 0.10
Salicylic acid - 0.10
Ethanol (conc. 95%) - 10.00
Flavoring composition - 0.30
Distilled water adding up to - 100.00
Example 14

The composition of the shampoo is prepared in accordance with the following recipe, g (wt.%):
Fuller Herbal Extract - 15.0 (7.5)
Stinging Nettle Leaf Extract - 20.0 (10.0)
GAMAL SBS-11 (detergent) - 30.0 (15.0)
GAMAL NO-3 (detergent) - 20.0 (10.0)
Aseptina (aseptina) - 0.4 (0.2)
Ethanol - 1.6 (0.8)
BRONOPOL (preservative) - 0.04 (0.02)
Sodium Chloride - 6.0 (3.0)
Water - 106.96 (53.48)
Total: - 200.0 (100.0)
To 92 parts by weight of the above shampoo composition, 8 parts by weight of TTP are added to obtain 100 parts by weight of the shampoo according to the invention. Instead of an extract of stinging nettle leaves, other herbal extracts may be used.

 Example 15

Prepare the following shampoo composition, g:
Horse Chestnut Extract - 13.00
Marigold Extract - 22.00
GAMAL SBS-11 - 30.00
GAMAL NO-3 - 20.00
Aseptina (aseptina) - 0.40
Ethanol - 1.60
BPONOPOL - 0.04
Sodium Chloride - 6.00
Water - 106.96
Total: - 200.00
Example 16

 Toothpaste contains TTR as a concentrated peat extract in an amount of 0.01-0.10 weight. %, essential oils or their compositions or other fruit essences in an amount of 1-10 wt.%, glycerin in an amount of 5-10 wt. %, herbal extracts in an amount of 0.10-10 wt.% and cleaning substances in an amount of 20-35 wt.%, dyes and bleaching agents in an amount of 1-2 wt.%.

 Titanium dioxide can be used as a whitening component; TTP itself can serve as an antibacterial supplement; extracts of sage leaves, chamomile, or marigold flowers are used as useful preferred herbal extracts.

A preferred recipe is as follows, g:
Precipitated Calcium Carbonate - 150.00
Magnesium Carbonate - 60.00
Glycerin - 70.00
Herbal Extract - 5.00
TTR - 0.50
Titanium Dioxide - 10.00
Essential oils (or peppermint, lemon, etc. essence) - 5.00
Water - 400.00
Dye - Trace
Example 17

 Preparation of bath salts. In the method for producing the bioactive product isolated from peat according to the present invention, in particular when the liquid form is converted into powder, a desalination step is present in which sodium chloride is separated as a by-product. In the above by-product, 95% is sodium chloride; other mineral salts that are separated are calcium salts, magnesium salts, mainly chlorides and sulfates; these salt products also contain some organic low-molecular-weight compounds derived from peat, which are excluded within the crystalline structure of these inorganic salts. These organic compounds are components of TTP and are, among others, polysaccharides, amino acids, fulvic acids, etc. The presence of these components in salt by-products is useful when using salt as a bath salt, since they can provide an additional beneficial effect to the standard activity of bath salts. This by-product is tested appropriately for its chemical and physical properties at the Balneological Institute in Poznan, Poland, to find out if it can be used in cosmetic baths. Since these studies did not reveal any undesirable properties of this product, it was allowed to use it for cosmetic purposes.

Preferred is the following recipe, g:
Salt (NaCl) containing occluded TTP - 97.00
Coniferous essential oil or composition of essential oils - 3.00
Example 18

 The new hair balm contains TTR in an amount of 0.01-1 wt.%, Herbal extract in an amount of 0.01-10 wt.%, Anti-electrostatic components in an amount of 3-4 wt.%, Components that prevent excessive drying of hair and skin in up to 2 wt.%, glycerin in an amount of 1-5 wt.%, preservative and stabilizers in an amount of 0.05-0.50 wt.% and water - up to a total of 100 wt.%.

 As an anti-electrostatic component, this balm contains an alcohol solution of trimethylamine and a salt of ammonium chloride, obtained from fatty amines of animal origin; as a thickener, which also plays the role of a stabilizing agent, cosmetic alcohol; as an agent that prevents excessive drying of hair and skin, vegetable oils, which are simultaneously a coemulsifying agent; and glycerin - to facilitate the application and absorption of the balm, especially its active ingredients, i.e. TTR and herbal extracts. Since the acidic medium inhibits the growth of bacteria, the balm in accordance with the invention contains citric or fumaric acid in an amount of 0.1%, as well as a preservative known as BRONOPOL and a flavoring composition.

Preferred is the following recipe, wt.%:
Alcohol solution of trimethylamine and salts of ammonium chloride - 3-4
Cosmetic alcohols - 3-4
TTR - 0.01-10
Condensed Herbal Extracts - 0.01-10
Glycerin - 1.5
Vegetable Oils - Up to 2
Citric or fumaric acid - 0.1
BRONOPOL - 0.1
Flavoring composition - 0.3
Distilled Water - Up to 100
Example 19

 Cosmetic masks are well-known cosmetic products that serve many purposes. Due to the fact that therapeutic mud has a beneficial effect on the skin and body, it is also possible to use peat remaining after extraction, which is obtained using the method of separation of bioactive compositions extracted from peat for cosmetic purposes. Peat remaining after extraction contains a solution of active bodies that are released during alkaline hydrolysis due to the unusually high sorption capacity of peat after neutralization. Therefore, it can be used as a useful component of cosmetic masks. In order to enrich the peat remaining after extraction with a large number of valuable components, natural therapeutic muds and fractions of humic acid, which are present in natural peat, are added, and they are separated in the process of obtaining bioactive compositions extracted from peat from an alkaline hydrolyzate. This composition is tested in the above Balneological Institute and find it suitable for cosmetic use.

Preferred is the following composition, g:
Peat obtained after extraction - 100.00
Natural healing mud or peat - 20.00
Humic acid fraction - 10.00
Magnesium Carbonate - 10.00
Zinc oxide - 5.00
Citric acid or the like 0.1
Herbal extract or plant material in powder form - 5.0
Distilled water -
The following points and explanations relate to the biological aspect of the products of the present invention, i.e., their bioactive characteristics and the compatibility of these products, in particular from the point of view of their use as pharmaceuticals. The following abbreviations will be used:
TTp ToLPA ^® - peat preparation (trademark Peat Corporation, Wroclaw, Mydlana 2, Poland).

 IFN - interferon, exists as a ubiquitous cytokine (tissue hormone). IFN genes are present in all cells. IFN is mainly induced by proteins or glycoproteins. Substances that stimulate IFN genes to produce IFN are called inducers. The IFN induction process is a highly accurate complex biochemical process; negative and positive regulatory genes that control IFN production have been detected. Small amounts of IFN can be produced spontaneously, without any detectable inducer. Such IFNs are sometimes referred to as “physiological IFNs”.

IFN exists in nature in three molecular forms:
IFN-α (or leukocyte),
IFN-β (fibroblast) and
IFN-γ (immune).

 IFN-α and IFN-β are of type I-IFN, and IFN-α of type II-IFN. The main biological actions of IFN are antiviral, antiproliferative (anticancer) and immunomodulatory activity. There are various forms of IFN in the form of natural and recombinant drugs, and they are used as a medicine for the treatment of tumor, viral and some other diseases.

 CTL = cytolytic T-lymphocyte.

 NK cells = natural killer cells.

 IL-1, IL-2 are well-known interleukins that stimulate the proliferation of T cells and other lymphoid cells, including B cells.

 RPMI 1640 - tissue culture (medium) for the growth of human leukocytes and others (abbreviation Roswell Park Memorial Institute, Buffalo).

 PCS = fetal calf serum (for analysis with white blood cells it must be checked beforehand, as it may contain mitogenic substances that mimic the effect of interleukins).

 EMCY = encephalomyocarditis virus, mouse virus (Mouse picorna virus), non-pathogenic for humans, it is often used as a virus for infection control in biological tests.

 A-549 = human adenocarcinoma cell line — used in biological IFN assays because of its high sensitivity to IFN α β and γ. The line is recommended for such use by WHO experts (World Health Organization, Geneva), IFN-standardization.

 MTT = 3- [4,5-dimethylthiazol-2-yl] -2,5-diphenyl-tetrazolium bromide. The reagent is used to measure cell lysis or cell growth in some biological assays using an ELISA scanner (Hansen et al., Immunol, Meth, 1980, 119, 203-210).

 L 929 = mouse cell line commonly used for analysis of mouse IFN and TNF of a human or mouse.

 TNF = tumor necrosis factor, cytokine (a relatively small protein very sensitive to proteolytic enzymes) produced by monocytes and macrophages (TNF-α is also known as tumor necrosis factor cachectin, causing cachexia (depletion) in humans and animals), produced after LPS stimulation (lipopolysaccharides) viruses, bacteria and many other agents, very toxic to many virus-infected cells and neoplasm cells; may also play the role of a growth factor for fibroblasts. Associated with inflammatory reactions. A related form of TNF-β (lymphotoxin) is produced by T cells and some other cells.

 PBL = leukocytes of peripheral blood isolated from the light layer of a blood clot (honey. - leukocyte film) (intermediate phase between red (blood) cells and plasma). The reactivity of PBL of individual donors to various cytokine inducers appears to be dependent on the genetic system of donors. Highly responsive responders and lowresponsive responders have been identified. This also applies to PBL sensitivity on TTP.

 Variations of individual responses to IFN or TNF inducers are more apparent when using weak inducers rather than very strong inducers such as viruses. This is due to the fact that reactions to weak inducers are an all-or-nothing type, while viruses almost always induce detectable amounts of cytokines.

 Tolerance to an inducer - also called a hyporeactive state. Occurs after administration of a single dose of an inducer, for example, after 20 hours of exposure of an PBL to an inducer (e.g. virus) cells stop further IFN production. Hyporeactive state usually lasts about 7 days. It can be full or partial. Such reactivity complicates the therapeutic use of strong inducers and / or makes it ineffective. Weak IFN inducers either do not induce a hyporeactive state, or tolerance is negligible.

 Some natural medicines isolated from medicinal plants have immunomodulatory properties. TTR gives the impression of one of them. TTP alters many different immune functions in vitro and in vivo. It initiates balanced immunostimulation by the ability of non-specific activation of all effector pathways (CD4 helper, weakly CD8 suppressor, CTL, NK cells and activated macrophage) without cytotoxicity for normal tissues.

 TTR has a tonic effect on the healing of conventional wounds. Low doses of TTP weakly stimulate the production of IL-1 and IL-2. High doses may inhibit cytokine synthesis.

With TTR, appropriate experiments are carried out using the following methods:
PBLs from the blood of healthy donors are purified by treatment with ammonium chloride. The culture medium is RPMI 1640 plus 10% FCS. About 8 x 10 ⁶ cells / ml were cultured for 20 hours at 37 ^° C, 5% CO ₂ . The antiviral activity of interferon is analyzed by the cytopathic effect of inhibition of EMCY in human A549 cells. The MTT method is also used to measure cell lysis.

 TNF activity was measured in L 929 cells. To determine the type of IFN, individual IFN samples were treated with various anti-IFN sera for 1 hour. Their antiviral activity is compared with untreated drugs.

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

 The seven studied production packages (batches) of TTP have comparable biological activity as immunostimulating and cytokine inducers. Significant deviations are observed in the response to the TTR of the leukocytes of each blood donor. several donors were immunologically tolerant. This may be a reflection of the genetic background.

 Use potent polyclonal antisera, such as anti-IFN-α (Cantell), anti-IFN-α Ly (Hamaiwa) from K. Fantes and anti-IFN-γ (Cantell) to neutralize antiviral activity in PBL supernatants treated for 20 hours TTR.

 The results of neutralization tests are similar to the fingerprints of each individual blood donor. In other words, the proportions of IFN types induced by each individual are significantly different. Separation of PBL into viscous (adherent) and inviscid (non-adherent) fractions can enhance induced cytokine synthesis.

 Hyporeactivity (tolerance) to IFN induction by NDY, observed within 20 hours after the initial stimulation of PBL with TTP, is either minimal or absent.

 All seven packs of batches of TTP tested in human PBL as IFN and TNF inducers were active in inducing IFN and / or TNF. The optimal concentration of TTP for the induction of IFN is 30-100 μg / ml and for the induction of TNF is 100-200 μg / ml. A dose of 200 μg / ml may be subtoxic for pBL, however, TNF synthesis is much faster than IFN synthesis, and faster than an increase in slight cytotoxicity.

From the foregoing, it can be concluded that the active principle of TTP-based pharmaceuticals is the immunoactive fraction of peat extract containing organics mainly related sugars, amino acids, uronic acids, humic acid substances, and mineral salts, including trace elements. The LD ₅₀ for animals is> 2400 mg / kg per OS.

 Neither mutagenic, nor genotoxic, nor embryotoxic, nor teratogenic or carcinogenic activity of TTP was detected. TTR does not show any allergenic properties, nor does it have any local irritating properties.

 Therapeutic indications include chronic and recurrent inflammation of the respiratory tract and varicose ulcers of the lower legs, adjunctive treatment of vaginal erosion and periodontal disease.

 From clinical observations, it follows that TTR can be used as an immunomodulator in the maintenance treatment of certain tumor diseases. TTP is taken orally (5 mg tablets) or locally.

Particularly relevant and important is the fact that PBL treated with TTP for 20 hours at 37 ^° C does not produce a hyporeactive state, since they retain the ability to produce IFN after induction by NDV (Newcastle Desease Virus), a very strong inductor IFN.

 The attached tables 1-23 relate to various biological, for example, toxicological, hematological and immunological experiments. These tables are quite clear and can serve as a source of information for the biologist related to the compatibility and biological activity of TTP.

 It should be noted that the concentration of active ingredients in pharmaceutical preparations, as indicated in paragraph 13 of the claims, may be higher than in cosmetic compositions (as indicated in paragraph 14) for the following reasons.

 Pharmaceutical preparations are prepared in unit dosages, where the content of active ingredients is strictly controlled, for example, in tablets, where the concentration is selected according to the size of the tablet containing the effective daily dose (or part thereof) of the active ingredient.

 The concentration of the active ingredient, for example, TTP, in the granules that the capsules are filled with, is preferably only 5 wt.% In order to obtain a sufficient tablet size and for the convenience of the corresponding operations on the apparatus that makes the capsules.

 Another reason is that most pharmaceuticals are taken orally and the active ingredient is distributed throughout the body. Although it reaches skin cells in very low concentrations, the therapeutic effect is significant.

 In addition, cosmetic compositions - as opposed to pharmaceuticals - are used in uncontrolled concentrations, applied locally, with varying degrees of penetration to various cells.

 Some compositions, such as shampoo, which are washed off almost immediately, are in contact with the body or hair for a short period of time and may contain correspondingly more healing component; others are used several times a day and therefore should have a lower content of active ingredient.

 Finally, as in the case of toothpaste, which is in contact with the oral mucosa, where the penetration of the active ingredients is much easier than when in contact with the skin, the concentration of the active ingredients may be lower.

Claims (23)

 1. A bioactive product obtained from peat, used for non-specific immunostimulation, which is a mixture of active peat ingredients and inorganic salts obtained by a method involving primary alkaline hydrolysis of raw peat material, acidification of the hydrolyzate, separation of the insoluble part, followed by secondary alkalization, and then acidification liquid phase, removal of ballast substances using extraction with an organic solvent and subsequent processing of the remaining liquid a dry phase containing inorganic salts and bioactive ingredients extracted from peat, characterized in that it contains not more than 70 wt.% inorganic salts, especially sodium chloride, calculated on the dry matter, and this salt content is provided by diluting the liquid phase with demineralized water followed by reverse osmosis to reduce the salt content in the product.  2. The product according to claim 1, characterized in that it is in the form of an aqueous solution or dried powder.  3. The product according to claim 1 or 2, characterized in that the content of inorganic salts in it does not exceed 60%.  4. The product according to any preceding paragraph, characterized in that when the product is in the form of a 1% aqueous solution, it has a pH from 5.0 to 6.5, preferably about 6.  5. The product according to any preceding paragraph, characterized in that when the product is in the form of a concentrated solution, this solution is a dark brown liquid with a specific gravity of 1.02 to 1.09 g / ml, and its content solids is at least 5 wt.%.  6. A method of producing a bioactive product from peat, involving primary alkaline hydrolysis of the raw peat material, acidification of the hydrolyzate, separation of the insoluble part, followed by secondary alkalization, and then acidification of the pure liquid phase, removal of ballast substances using extraction with an organic solvent and subsequent processing of the remaining liquid phase, containing inorganic salts and extracted from peat bioactive ingredients, characterized in that it provides the following supplement Steps: diluting said liquid phase with demineralized water, preferably in a ratio of 1: 5 to 1: 8, desalting the diluted solution by reverse osmosis, wherein inorganic salts are removed to a concentration of not more than 70 wt.%, preferably not more than 60 wt. %, based on dry matter, concentration and purification of the desalted solution, and, possibly, sterilization and / or spray drying of the concentrated purified solution, to obtain the specified bioactive product.  7. The method according to claim 6, characterized in that after said extraction with an organic solvent, residual amounts of solvent are removed from the aqueous phase, which for this is passed through a sintered ceramic filter under reduced pressure to obtain a pure filtrate of the indicated liquid phase containing inorganic salts and bioactive peat ingredients.  8. The method according to claim 6 or 7, characterized in that the sterilization is carried out by means of a membrane filter. 9. The method according to any one of claims 6 to 8, characterized in that the spray drying of the solution at the specified stage of sterilization and / or drying is carried out at an inlet temperature of about 180 ^o C and at the outlet about 90 ^o C.  10. A method of manufacturing a pharmaceutical composition in the form of a gel capable of inducing cytokines and useful for the therapeutic treatment of external wounds or varicose ulcers, especially varicose ulcers of the lower legs, comprising combining a cytokine-inducing bioactive material with herbal extract (s), flavoring (and ) compound (s) and a gelling agent and, possibly, other ingredients, characterized in that the sterile aqueous solution of a bioactive product obtained from peat according to one of .1 - 5, containing not more than 70 wt.% Inorganic salts, especially sodium chloride, based on dry matter, combined with a sterile alcoholic herbal extract and a sterile solution of a flavoring compound, after which a gelling agent, preferably colloidal silica, is added to transfer the resulting the liquid mixture into a gel form, and the ratio of the liquid mixture to the gelling agent is 90-94: 10-6.  11. The method according to claim 10, characterized in that the flavoring compound is selected from the group consisting of menthol, thymol, mint, lemon and eucalyptus, the herbal extract is selected from the group consisting of horse chestnut (hippocastanaceous) extracts, calendula, chamomile, sage , marigold, soapwort (saponaria officinalis), horsetail, stinging nettle leaf extract, wheat germ extract, aloe, thyme, herbal extract Fuller, and the gelling agent contains colloidal silica, to which glycerin is possibly added.  12. The method according to claim 10 or 11, characterized in that the bioactive product obtained from peat is the TTP ("Peat Preparation MOLDS") described herein.  13. A method of manufacturing a pharmaceutical composition in the form of an ointment capable of inducing cytokines and useful for the therapeutic treatment of external wounds or varicose ulcers, especially varicose ulcers of the lower legs, comprising combining the bioactive material with herbal extract (s), flavoring compound (s) (compounds), gelling agent, ointment base and, possibly, other ingredients, characterized in that the sterile aqueous solution of a bioactive product obtained from peat, according to one of claims 1 to 5, contains not more than 70 wt.% inorganic salts, especially sodium chloride, based on dry matter, are gradually combined with a sterile herbal extract, after which the resulting mixture is gelled by adding a gelling agent, preferably colloidal silica, and the gel thus obtained is triturated with a pre-sterilized ointment base containing a mixture of fat components, such as eucerin and petrolatum, in a weight ratio of liquid components to a gelling agent of about 30: 2, and the gel to fat to Components 32-34: 68-66.  14. The method according to p. 13, characterized in that the flavoring compound is selected from the group consisting of menthol, thymol, mint, lemon and eucalyptus, the herbal extract is selected from the group consisting of horse chestnut (hippocastanaceous) extracts, calendula, chamomile, sage , marigolds, soapwort (saponaria officinalis), horsetail, stinging nettle leaf extract, wheat germ extract, aloe, thyme, herbal extract Fuller, and the gelling agent contains colloidal silica, possibly with the addition of glycerol.  15. The method according to item 13 or 14, characterized in that the bioactive product of peat, is described here as "Peat Preparation MOLDS" (TTP).  16. A composition capable of inducing non-specific immunostimulation containing a pharmaceutically active ingredient and a physiologically acceptable carrier, excipient and / or additive, characterized in that the active ingredient is a bioactive peat product according to one of claims 1 to 5, containing not more than 70 weight. % inorganic salts, especially sodium chloride, based on dry matter, and the bioactive product is able to induce cytokines and is present in the composition in an amount of from 0.01 to 10 wt.%.  17. The composition according to p. 16, characterized in that the carrier is a mixture of lactose and lubricants, and the weight ratio of the active ingredient to the carrier is 1: 9-19.  18. The composition according to p. 16 or 17, characterized in that it is in the form of tablets or capsules for oral administration.  19. The composition according to one of paragraphs.16 to 18, characterized in that it can be used for non-specific immunomodulation, preferably for the prevention of infections or for the treatment of external wounds and varicose ulcers.  20. The composition according to p. 16, characterized in that it contains carriers and / or other additives usual for cosmetic preparations, and the specified bioactive product is present in the composition in an amount of 0.01 to 1 wt.%, And the composition is intended for body care namely for skin, hair or teeth.  21. The composition according to claim 20, characterized in that the bioactive product is present in it at a concentration of 0.05 to 1 wt.%, And the carriers and / or additives are selected from the group consisting of aqueous solutions of alcohols, all types of emulsions, gels , foaming compositions and fat carriers.  22. The composition according to claim 20 or 21, characterized in that it further comprises at least one herbal extract and / or at least one flavoring substance.  23. The composition according to clause 16, wherein the additives include a sterile alcoholic herbal extract and a sterile solution of a flavoring compound, and the carrier contains a gelling agent, and the weight ratio of the liquid mixture to the gelling agent is from 90-94: 10-6. Priority on points:
07/15/91 according to claims 1 to 23;
03/16/91 according to claims 11, 14 and 20 - 22;
05/17/91 according to claims 11, 14 and 20 - 22;
06/03/91 according to paragraphs 11, 14 and 20 - 22;
06/10/91 according to claims 20-22;
06/17/91 according to claims 20-22.

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