HRP20110559A2 - Medicinal syrup-form preparation suitable for oral administration based on homogenous aqueous solution of dry extract of propolis, honey in a solvent and medicinal herbal extracts - Google Patents

Abstract

The present invention relates to syrup preparations based on a homogeneous mixture of an aqueous solution of dry propolis extract, honey in solvent and glycerin extracts of herbs wherein the aqueous dry propolis solution is standardized to flavonoids and contains at least 0.18 g flavonoids. Honey is sage or acacia honey, and glycerin extracts are obtained from the following medicinal plants: rudbekia, basil, rosemary, broccoli, spruce, thyme, ivy, cane, anise fruits. A special feature of the preparation is the use of an aqueous solution of propolis, where the process of its preparation is carried out by pouring the dry propolis extract with 10 l of demineralized water and by thermally guided process at a temperature of 55Â ° C to 95Â ° C with continuous ultrasonic mixing, propolis extraction is carried out . Propolis extraction is carried out continuously for 18 h followed by stabilization of the propolis aqueous solution at 30 ° C for 5 h.

Description

The field of technology

The subject invention generally belongs to the field of medicinal preparations in the form of syrup based on a homogeneous mixture of an aqueous solution of dry propolis extract, honey in a solvent and extracts of medicinal plants, whereby the aqueous solution of dry propolis is standardized for flavonoids and contains the least flavonoids.

Technical problem

The technical problem that is solved by the present invention consists in the fact that the active substances, in this case a mixture of honey and propolis with extracts of certain medicinal plants, while preserving their active characteristics in the best way, conditioned by their synergistic action, which all together enables a simple application to strengthen the body's natural resistance, calm the stimulus to cough, relieve inflammation of the upper and lower respiratory tract, relieve dry and irritating cough, dilute bronchial mucus, which promotes expectoration in case of productive cough.

State of the art

There are well-known preparations for strengthening the body's natural resistance, calming the stimulus for coughing, alleviating inflammation of the upper and lower respiratory tract, alleviating dry and irritating coughs, thinning bronchial mucus, which promotes expectoration in productive coughs, which contain active substances containing preparations such as essential oils, extracts, tinctures, or medicinal parts of herbal drugs.

It is known that propolis works against viruses, bacteria and fungi. Its specialty is that bacteria do not develop resistance to it. Another advantage of propolis is that it has no harmful side effects, which is a disadvantage of synthetic antibiotics, and as a natural antibiotic it also acts as an antiviral.

In medicine, propolis is also used for anemia, respiratory problems, care of the oral cavity, in dermatology, to increase the body's immunity, for infections of the digestive tract, to protect the liver, and in cosmetics because it affects rapid tissue regeneration.

As a powerful antioxidant, it effectively acts against free radicals, which today are considered the cause of many, even the most serious diseases, such as atherosclerosis, cataracts, aging, Parkinson's and Alzheimer's diseases.

Propolis is also used in dentistry as an agent in the treatment of periodontitis and to strengthen the gums. It has a preventive effect on sore throats, and achieves extremely good results in the treatment of infections, burns, open wounds and ulcers of the digestive system.

Newer research increasingly confirms that it strengthens the immune system and has an immediate anti-cancer effect. Therefore, many experts consider it the golden product of the beehive and the medicine of the 21st century.

By the way, propolis is a medicinal product with a resinous consistency, yellow to dark brown in color, with a weak smell, which honey bees (Apis mellifera L.) collect from the buds and bark of trees. Bees use it to close cracks inside the hive, polish the combs that are used to receive honey, pollen and as a cradle for larvae, then for temperature regulation and embalming intruders that they cannot remove from the hive.

Its evaporation in the bee colony creates unfavorable conditions for the development of bacteria and fungi that can threaten the health of the colony. Between 150 and 400 grams of propolis is collected from one bee colony per year.

The origin of the substance in propolis comes from three sources - plant secretions, secretory substances of bee metabolism and substances added during its processing. The chemical composition of propolis has not yet been fully elucidated. In one analysis of propolis in England, 150 constituents were detected in just one sample (Greenaway, 1990), but soon 180 were isolated.

The composition of propolis depends on the types of plants in the bees' habitat. Propolis differs in color, smell and possibly medicinal properties, depending on its composition and season. It is known that propolis contains various resins and resin-like substances, balms and essential oils, wax, pollen, flavonoids, mineral substances and so-called plant hormones.

Flavonoids are widely distributed in the plant world, and their role is to protect plants from pathogens from the environment. Propolis contains numerous flavonoids: galangin, quercetin, chrysin, kaempferol, apigenin, pinocembrin, pinobaxin.

At a temperature between 25 and 45°C, propolis is soft, malleable and sticky. At a temperature lower than 15°C it becomes rigid and brittle, and at a temperature above 45°C it becomes rubbery and sticky. It usually turns into a liquid state at a temperature between 60 and 70°C. For some samples, the melting point is above 100°C.

Products based on propolis come to the market in different forms:

• alcoholic solutions

• oil drops

• sprays for the oral and nasal cavity

• ointments and creams

• tablets and capsules

Alcoholic solution of propolis is the most common form of propolis solution. However, the alcoholic solution of propolis cannot be mixed with a solution of honey and water, or honey syrups. By mixing an alcoholic solution of propolis and honey syrup, propolis coagulation occurs, the color changes from dark to light brown, such propolis settles on the walls and cannot be homogenized with honey syrup.

Rudbeckia (Echinacea) is by far the most popular antiviral medicinal plant. She fights the virus in two ways. First of all - caffeine, chicory acid and echinacin. It is about three ingredients with specific antiviral activity.

In addition, root extracts of this plant act like interferon, an antiviral substance produced by the body itself. Rudbeckia therefore strengthens the immune system and thus helps the body to defend itself more effectively against viral infections.

Numerous studies have confirmed the healing properties of the plant, and some of the most common benefits include strengthening immunity. According to research published in the journal Immunopharmacology, rudbeckia supports the immune system by activating white blood cells. When microorganisms invade the body, the cells secrete chemicals that attract white blood cells that fight the invaders. Rudbeckia enhances their ability to destroy microorganisms. Although the plant does not directly kill the virus, it stimulates the immune system so that it can better defend itself against infection.

Basil (Ocimum basilicum L.) is an aromatic annual plant, a well-known spice, but also a medicine. The original homeland of basil is India and Iran, where it thrives as a perennial plant.

Basil is a scientifically tested plant and its spicy, fragrant, and medicinal effects have been proven. This means that basil is not only a spice for food and an ornamental plant, but also helps our health. Basil leaves contain 0.3-0.8 percent essential oil with the main ingredient methyl avicol, which resembles aniseed, saponins, thymol, bitter substances, tannins.

In terms of medicinal properties, basil in food or as a tea drink helps with inflammation of internal organs, that is, it stimulates digestion, opens appetite, removes inflammation, spasms and catarrh of the stomach and intestines, and digestive gases. Basil tea also helps with colds, coughs, asthma and general respiratory diseases because the essential oils have a disinfecting and antibacterial effect.

Rosemary (rosmarinus officinalis) is a bushy plant that grows up to two meters in height, with a pleasant and intense smell. Rosemary branches are woody and densely covered with leathery leaves without petioles. The flowers are light blue, small and in the upper parts they are collected in inflorescences. The active substances of rosemary are essential oils, resins, tannins, flavonoids, various organic acids and saponins.

Rosemary is known as a plant that stimulates blood circulation and balances the nervous system. It is also good for preventing upper abdominal cramps, gout and rheumatism. It is also used for various forms of weakness, where rosemary's ability to raise excessively low blood pressure comes to the fore.

Broccoli (also: broccoli, broccoli and broccoli, lat. bracchium) is a vegetable from the cabbage family, which also includes brussels sprouts, cabbage, korab, cauliflower, kale and others. Broccoli contains various biologically active ingredients (phytochemicals), whose antioxidant properties have a positive effect on health. In addition to the abundance of nutrients, broccoli also contains various biologically active ingredients (phytochemicals), whose antioxidant properties have a positive effect on health, reducing the risk of some forms of cancer and heart disease. Thanks to its specific composition and nutraceutical properties, broccoli has become the focus of scientific research - it contains active substances that contain sulfur - indole carbinol and sulforaphane. Sulforaphane stimulates the body's natural defense mechanisms in the fight against some types of cancer (stomach and colon cancer). Likewise, sulforaphane destroys Helicobacter pylori bacteria, which can contribute to the appearance of ulcers and stomach cancer even when it is resistant to common antibiotics. Preliminary laboratory research has shown that a compound known as indole-3-carbinol (I3C) found naturally in broccoli, cabbage and Brussels sprouts can attack the Herpes simplex virus and prevent factors that help the virus reproduce.

Acting as a sensitive modulator of certain key components of the cell cycle, indole-3-carbinol proved to be a promising starting compound for the synthesis of possible new drugs that could be used in the future in the treatment of early detected malignant processes. As an excellent source of vitamin C, it helps protect LDL cholesterol from oxidative damage. Vitamin C is needed for the formation of collagen, the "glue" that strengthens many parts of the body such as muscles and blood vessels. It also has an important role in wound healing and has an anti-allergic effect. This vitamin stimulates the formation of bile, helps in defense against viruses and detoxification of the body. Although vitamin C has little effect in preventing the common cold, it shortens the duration and relieves the symptoms of a cold.

Spruce is an evergreen up to 7 m tall, with very narrow, pointed, prickly leaves or needles, a very resistant, densely and irregularly branched dioecious shrub. Ripe fruits are round and black-purple, have a resinous and aromatic smell and a bitter-sweet taste. The whole plant is medicinal, but the fruits are most often used. It is used against urinary retention, for densification of the urinary tract, improving digestion, expectoration, against stomach and kidney diseases, but also for the treatment of many other diseases, for external and internal use. In small doses, juniper essential oil, among other things, facilitates expectoration, is used for incense, inhalation in case of diseases of the respiratory organs. Spruce has a bactericidal effect, and is used in the treatment of infectious lung diseases.

Description of the solution to the technical problem with examples of preparation

Pharmaceutical preparation in the form of syrup based on a homogeneous mixture of an aqueous solution of dry propolis extract, honey in a solvent and extracts of medicinal plants, whereby the aqueous solution of dry propolis is standardized for flavonoids and contains at least 0.18 g of flavonoids.

The characteristic of the syrup is that, in addition to containing non-alcoholic extracts of medicinal plants, it also contains propolis-aqueous solution of propolis, which means a unique composition-product without ethyl alcohol.

To make honey-propolis syrup, it was necessary to produce an aqueous solution of propolis, you cannot produce honey-propolis syrup with an alcoholic solution of propolis. Propolis is a mixture of plant resins, balsams, flavones and flavonoids, essential oils, minerals, enzymes and wax. Propolis resin is removed from the hives by scraping or shaking the hive parts. In addition to propolis, such propolis resin contains wax, wood, bees, nails, wire and other impurities, so it needs to be purified, which is done mechanically or with water. Purified propolis is dissolved (extracted) for a certain amount of time in an alcohol solution that is optimal in terms of volume and amount of alcohol. The resulting alcoholic solution of propolis is then completely evaporated in a thermally controlled process in order to obtain a dry propolis extract. Dry extract of propolis is used to make an aqueous solution of propolis.

An aqueous solution of propolis, with a higher level of dry matter (>4%), and thus total flavonoids (>4mg/ml) can only be produced from dry propolis extract in a continuous, guided, thermal process and ultrasonic mixing. The procedure for obtaining an aqueous solution of propolis is carried out by pouring 2 kg of dry propolis extract with 10 l of demineralized water and extracting propolis using a thermally controlled process at a temperature from to with continuous ultrasonic mixing. The process is carried out continuously for 18 hours, followed by stabilization of the aqueous propolis solution for 5 hours. After stabilization and filtration, the aqueous solution of propolis is used in the production of honey-propolis syrups.

QUANTIFICATION AND STANDARDIZATION OF FLAVONOIDS

Pharmacologically, the most important component of propolis is flavonoids. Flavonoids are plant pigments that protect plants from pests and ensure the taste and color of fruits and vegetables. Flavonoids are responsible for the biological activity of propolis, i.e. the therapeutic effect of propolis because they have antibacterial, antiviral, antioxidant, anti-inflammatory, antitumor effects.

Quantification

The two most common methods for determining flavonoids are the spectrophotometric method (UV/Vis spectrophotometry) and the chromatographic method (HPLC). The spectrophotometric method determines groups of flavonoids (eg flavones, flavonols, flavanones, flavanonols), while the chromatographic method determines individual flavonoids (eg galangin, quercetin, naringenin, apigenin, chrysin, pinocembrin).

Through the Farmakol project, in cooperation with the Faculty of Pharmacy and Biochemistry, we determined total flavonoids using the spectrophotometric method - UV/Vis spectrophotometric method. The UV/Vis spectrophotometric method is carried out on the principle of the reaction of the appropriate reagent with the functional groups of flavonoids, whereby a colored product is formed. The intensity of the color depends on the concentration of flavonoids in the sample, and the amount of total flavonoids is determined using the horizontal line.

Standardization

The standardization of propolis for total flavonoids begins with the extraction of propolis in an alcoholic solution, where it is important that the amount of purified propolis that dissolves in the alcoholic solution is as large as possible (at least 100 kg) and that the origin of the propolis is from different parts of Croatia. In this way, alcoholic solutions of propolis are obtained, that is, in the end, dry extracts of propolis with a very stable composition of total flavonoids.

The subject invention relates to a syrup, added honey diluted with demineralized water, a preparation with medicinal properties in the form of a juice suitable for oral administration, wherein said syrup contains a homogeneous mixture of an aqueous solution of a dry extract of propolis, honey in a solvent suitable for oral administration, and additionally contains extracts medicinal herbs. The aqueous solution of dry propolis is standardized for flavonoids and contains the least flavonoids.

The syrup contains 5.2 – 5.6% by weight / 7.0 – 7.4% by volume of an aqueous solution of dry propolis extract. According to the preferred way of carrying out the invention, the syrup preferably contains 5.4% by weight / 7.2% of the aqueous solution of the dry extract of propolis.

The mixture of aqueous solution of dry extract of propolis and honey amounts to 90.2 - 90.6% by weight or 88.1 - 88.5% by volume of syrup. In one embodiment of the invention, the mixture of the aqueous solution of the dry extract of propolis and honey in the syrup preferably amounts to 90.4% by weight or 88.3% by volume of the syrup. The weight/volume percentage of honey in the syrup is 85% / 81.1%.

The syrups according to the present invention, each according to its composition, contain glycerine extract of the rudbeckia plant, glycerine extract of the basil plant, glycerine extract of rosemary leaves, glycerine extract of broccoli flowers, royal jelly, glycerine extract of spruce thistle, glycerine extract of the thyme plant, glycerine extract of ivy leaves, glycerine extract of plantain leaves and glycerine extract of anise fruits. All individual extracts of medicinal plants in the syrup are present in the same percentage by weight in the amount of 2% by weight, except for broccoli extract which is present in the amount of 1.1% by weight. The syrup is based on honey, where the honey is acacia or sage honey. The solvent for honey is demineralized water.

The syrup also contains royal jelly. Frozen fresh royal jelly is melted at room temperature and mixed with 20% of the total honey. The homogenized mixture of royal jelly and honey is added to the rest of the syrup solution.

The invention will be further illustrated through the following examples, which do not limit the invention.

Example 1.

Honey-propolis syrup with royal jelly - strengthening the body's natural resistance. Royal jelly and propolis in synergy with echinacea stimulate the work of the immune system. It helps with general exhaustion of the body, giving it strength and vitality. It is recommended to be taken preventively and in acute conditions of viral and bacterial infections, colds and allergies.

The ingredients of honey-propolis syrup are as follows: acacia honey, glycerine extract of rudbeckia plant (Echinacea angustifolia) 4g, glycerine extract of basil plant (Ocimum basilicum) 4g, glycerine extract of rosemary leaves (Rosmarinus officinalis) 4g, glycerine extract of broccoli flowers (Brassica oleracea) 2 ,2g, royal jelly 2.0g, aqueous solution of dry extract of propolis, standardized for flavonoids, with at least 0.18g of flavonoids, demineralized water, orange aroma.

Example 2.

Honey-propolis syrup for calming cough stimuli, easing inflammation of the upper and lower respiratory tract and thereby enabling easier breathing. It helps to overcome colds, flu, bronchitis, bacterial and viral infections faster.

The ingredients of the honey-propolis syrup are as follows: sage honey 170.9g, glycerine extract of spruce tops (Picea abies) 4g, glycerine extract of the thyme plant (Thymus serpyllum) 4g, glycerine extract of the rudbeckia plant (Echinacea angustifolia) 4g, aqueous solution of dry propolis extract , standardized for flavonoids, with at least 0.18g of flavonoids, demineralized water, menthol aroma.

Example 3.

Honey-propolis syrup for alleviating dry and irritated coughs and thinning bronchial mucus, which promotes expectoration in productive coughs. Having an anti-inflammatory and antimicrobial effect, respiratory problems are reduced.

The ingredients of honey-propolis syrup are as follows: sage honey 170.9g, glycerine extract of ivy leaves (Hedera helix) 4g, glycerine extract of plantain leaves (Plantago major) 4g, glycerine extract of anise fruits (Pimpinella anisum) 4g, aqueous solution of dry propolis extract, standardized for flavonoids, with at least 0.18 g of flavonoids, demineralized water, orange flavor.

Claims (26)

1. A preparation with medicinal properties in the form of a syrup suitable for oral administration, characterized by the fact that said syrup contains a homogeneous mixture of an aqueous solution of a dry extract of propolis and honey in a solvent suitable for oral administration. 2. Syrup according to claim 1, characterized by the fact that it additionally contains extracts of medicinal plants. 3. Syrup according to claim 1, characterized in that the aqueous solution of dry propolis is standardized for flavonoids and contains at least 0.18 g of flavonoids. 4. Syrup according to claim 3, characterized by the fact that it is a 5.2 - 5.6% by weight / 7.0 - 7.4% by volume aqueous solution of dry extract of propolis. 5. Syrup according to claim 4, characterized in that it is a 5.4% by weight / 7.2% aqueous solution of dry propolis extract. 6. Syrup according to any of the previous requirements, characterized in that the mixture of the aqueous solution of the dry propolis extract and honey is 90.2-90.6% by weight. 7. Syrup according to any of the preceding claims, characterized in that the mixture of the aqueous solution of the dry extract of propolis and honey is 90.4% by weight of the syrup. 8. Syrup according to any of the previous requirements, indicated that the weight percentage of honey in the syrup is 85%, that is, the volume percentage of honey in the syrup is 81.1%. 9. Syrup according to claim 2, characterized in that it contains a glycerine extract of the rudbeckia plant. 10. Syrup according to claim 9, characterized in that it additionally contains glycerine extract of basil plant, glycerine extract of rosemary leaves, glycerine extract of broccoli flowers. 11. Syrup according to claim 10, characterized in that it additionally contains royal jelly. 12. Syrup according to claim 2, characterized in that it contains a glycerine extract of spruce tops, a glycerine extract of the thyme plant. 13. Syrup according to claim 2, characterized in that it additionally contains glycerine extract of ivy leaves, glycerine extract of plantain leaves, glycerine extract of anise fruits. 14. Syrup according to claim 1, characterized in that the honey is acacia honey. 15. Syrup according to claim 1 characterized in that the honey is sage honey. 16. Syrup according to any of the preceding claims, characterized in that it additionally contains orange flavoring. 17. Syrup according to claim 1, characterized in that the solvent is demineralized water. 18. Syrup according to claim 2, characterized by the fact that all individual extracts of medicinal plants are present in the syrup in the same percentage by weight in the amount of 2% by weight, except for broccoli extract which is present in the amount of 1.1% by weight. 19. Syrup according to claim 11, characterized in that the frozen fresh royal jelly is melted at room temperature and mixed with 20% by weight of honey, after which the homogenized mixture of royal jelly and honey is added to the rest of the syrup solution. 20. Syrup according to claims 1-11, and 14, characterized in that it is used to stimulate the work of the immune system. 21. Syrup according to claim 20, characterized in that it is used in the prevention and treatment of viral and bacterial infections and allergies. 22. Syrup according to claims 1-8, 12 and 15, characterized by the fact that it is used to calm cough stimuli, relieve inflammation of the upper and lower respiratory tract, in the treatment of colds, flu, bronchitis. 23. Syrup according to claims 1-8, 13 and 15, characterized in that it is used to alleviate dry and irritating coughs, and to promote expectoration in productive coughs. 24. The procedure for obtaining an aqueous solution of propolis for the production of honey-propolis syrups indicated that the dry extract of propolis is poured with 10 l of demineralized water and the extraction of propolis is carried out by a thermally controlled process at a temperature of 55°C to 95°C with continuous ultrasonic mixing. 25. The procedure according to claim 24, characterized in that it is carried out continuously for 18 hours, followed by stabilization of the aqueous solution of propolis at 30°C. 26. The method according to claim 25, characterized in that the stabilization of the aqueous solution of propolis is carried out for 5 h.