Nutritional composition based on plant raw materials for prevention and maintenance therapy of inflammatory diseases of musculoskeletal system

Abstract

FIELD: food industry.SUBSTANCE: nutritional composition based on plant materials, intended for the prevention and supportive therapy of inflammatory diseases of the musculoskeletal system. A nutritional composition based on plant raw materials for the prevention and supportive therapy of inflammatory diseases of the musculoskeletal system contains active components: extracts of plant raw materials and fillers, wherein the nutritional composition additionally contains succinic acid and collagen, wherein as extracts of plant raw materials it contains burdock extract, knotweed extract, bay leaf extract, birch leaf extract, barberry extract, propolis extract, wherein said extracts are selected from the group: a decoction, a dry concentrate, which is a dried decoction, infusion, aqueous extract or alcoholic extract, a liquid infusion or tincture, a liquid aqueous extract, a liquid alcoholic extract, a liquid oil extract, a dry CO2-extract, a liquid CO2-extract, as well as vitamin C and nicotinic acid in the following ratio, wt.%: burdock extract in terms of dry matter 0.05–10; knotweed extract in terms of dry matter 0.05–10; bay leaf extract in terms of dry matter 0.05–10; birch leaf extract in terms of dry matter 0.05–10; barberry extract in terms of dry matter 0.02–5; propolis extract in terms of dry matter 0.02-5; vitamin C – ascorbic acid 0.2–8; nicotinic acid 0.15–2; succinic acid 0.03–7.0; collagen 5.0–20.0; fillers – the rest up to 100%. The above-described composition expands the range of products for the prevention and maintenance therapy of the musculoskeletal system, has a synergistic effect of the complex multi-purpose action of the composition's components on the musculoskeletal system, as well as powerful antioxidant protection.EFFECT: organoleptic properties of the composition are improved by masking the natural bitterness of plant extracts.14 cl, 2 dwg, 5 tbl, 11 ex

Description

[0001] Technical field

[0002] The invention relates to the food industry, specifically to nutritional compositions (food supplements) based on plant-based raw materials intended for the prevention and adjuvant therapy of inflammatory and degenerative-dystrophic diseases of the musculoskeletal system (arthritis, arthrosis, osteochondrosis, rheumatism). The composition can be used to reduce the risk of exacerbations of chronic joint diseases, alleviate pain and morning stiffness, improve cartilage and bone metabolism, and replenish specific nutrient deficiencies necessary for maintaining healthy joints and connective tissue.

[0003] Technology Level

[0004] The musculoskeletal system (MSS) is a system of organs and tissues that helps a person move and maintain a certain position in space and protects internal organs from damage. This primarily includes the skeleton, as well as muscles, joints, and ligaments. Based on etiology, musculoskeletal diseases are conventionally divided into inflammatory, degenerative, metabolic, and tumor-related. According to WHO statistics, 80% of the world's population suffers from various musculoskeletal diseases (MSS), primarily among people of working age (30 to 50 years old). Musculoskeletal diseases are considered to be the third most common cause of modern disease, second only to cardiovascular diseases and oncological diseases. According to official statistics, the overall incidence of musculoskeletal diseases in Russia has been increasing by approximately 30% every decade since the end of the 20th century.The number of patients in different countries varies dramatically, which can be explained by the significant influence of the environment, the level of healthcare, the specifics of professional activities and a number of other factors on the condition of the musculoskeletal system. According to the WHO, in 2009, approximately 20-50 million injuries resulting in various musculoskeletal problems or disabilities were registered worldwide, and data from 2013 indicate that up to 500 thousand people suffer from spinal injuries of various causes annually. Thus, osteoporosis has been diagnosed in 40 million people in the USA, 27.5 million in the European Union, and 10 million in Russia. According to WHO forecasts, in high-income countries, the number of musculoskeletal diseases caused by injuries should reach a minimum level around 2030 (Justification of the composition of therapeutic and prophylactic diets for diseases of the musculoskeletal system (Sergeev V.N. Bulletin of Restorative Medicine No. 2, 2018 pp. 58-62).

[0005] The musculoskeletal system is subject to significant mechanical stress and age-related changes, leading to the development of inflammatory and degenerative processes. Modern lifestyles, physical inactivity, and an unhealthy diet deficient in collagen, vitamins, and minerals exacerbate these processes.

[0006] Joint tissues, especially cartilage, have a limited regenerative potential. Key pathogenetic factors in joint diseases include oxidative stress, leading to cell and matrix damage, chronic inflammation (production of cytokines and proinflammatory prostaglandins), and a deficiency of specific "building" components such as collagen and glucosamine. Increased stress on joints during physical activity, age-related metabolic changes, and poor nutrition exacerbate these processes. Therefore, the use of specialized supplements and functional foods aimed at improving joint tissue trophism, suppressing inflammation, and protecting against oxidation is relevant (Martynov A.I., Kalinin A.V. Osteoarthritis: A Guide for Doctors. - Moscow: GEOTAR-Media, 2019. - 464 p.).

[0007] The prior art discloses the biologically active supplement "Antiartrol" (Pilat T.L. Federal Register of Biologically Active Food Supplements. Moscow, 2000, p. 345), which contains a complex of herbal extracts (horsetail, chicory, dandelion, burdock, etc.) and is used as a general tonic and mild anti-inflammatory agent for joint diseases.

[0008] Currently, various medications (Urodan, aspirin, reopyrin, diclofenac, analgin, antibiotics, etc.) are used to treat joint diseases. These medications often have limited effectiveness against the underlying pathogenic mechanisms of the disease and can cause side effects. More than 100 non-specific pharmacological agents are known for the treatment of joint diseases, but it is too early to talk about drug inflation, as this problem is far from being resolved due to insufficient therapeutic efficacy and unsatisfactory long-term consequences.

[0009] Dietary supplements based on glucosamine and chondroitin sulfate (e.g., Teraflex, Artra) are known. They stimulate the regeneration of cartilage tissue and synovial fluid. However, the effect of such mono-preparations develops slowly (over several months), and their bioavailability may vary.

[0010] A known remedy for the treatment of joint diseases contains chondroitin sulfate, dimethyl sulfoxide, a preservative, and an emulsion gel base (RU 2353349 C1, published 04 / 27 / 2009).

[0011] A remedy for the treatment of joint diseases is known, containing glucosamine salt, chondroitin sulfate salt and dimethyl sulfoxide (RU No. 2239438 C1, published 2006.03.20 and EA No. 6528 - published 2006.02.24).

[0012] Glucosamine Sulfate, a well-known therapeutic and prophylactic agent, is used to treat and prevent musculoskeletal disorders (Biologically active food supplements. Moscow: Nauka, 2002, p. 47). Glucosamine sulfate contains glucosamine, which has chondroprotective activity. When ingested, it is delivered to cartilage and other tissues, where it is synthesized into chondroitin sulfate. Chondroitin sulfate is the main source of building material for connective tissue. It participates in the formation of articular cartilage, ligaments, and tendons, and is present in the walls of blood vessels, bronchi, skin, and mucous membranes. Chondroitin sulfate is effective for restoring cartilage tissue and synovial fluid formation, reducing muscle fatigue, and strengthening any connective tissue in the human body. However, "Glucosamine sulfate" is a single-component drug.

[0013] SustaVit is a well-known product containing a complex therapeutic and prophylactic composition that, along with a glucosamine derivative, includes chondroitin sulfate, medicinal plants, vitamins, calcium, and enzymes (Biologically active food supplements. - Moscow: Nauka, 2002, p. 49). This well-known composition provides nutritional support for the musculoskeletal system, promotes the growth and renewal of connective tissue, and stimulates the production of collagen and substances necessary for cartilage growth.

[0014] A composition for protecting joints is known from the prior art, containing boswellia (frankincense) extract, curcumin, green tea extract, and hydrolyzed collagen. The use of quercetin and rutin for the treatment and prevention of osteoporosis is known from documents US 200201165169 A1, published 2002, KR 20030002377, published 2003.

[0015] From document US 20041211024 A1, published 2004, a composition is known for the treatment and prevention of osteoarthritis, rheumatoid arthritis and similar diseases, containing nettle extract and quercetin.

[0016] Also known is a herbal mixture for joints, including burdock root, meadowsweet, lingonberry leaf, and horsetail (RU 2284265 C1, published September 27, 2006). This mixture is used as a decoction and has anti-inflammatory and mild diuretic properties.

[0017] A known composition for the treatment and prevention of osteoarthritis and osteoarthrosis of the joints (RU 2521227 C1, published 06 / 27 / 2014), which contains a powder or extract of a dried plant selected from the group: burdock, dandelion, marsh cinquefoil, birch, St. John's wort, goldenrod, nettle, mint, licorice, white cinquefoil, erect cinquefoil, rose hips, blue cornflower, valerian, corn, milk thistle, oats, agrimony, immortelle, ginseng, sage, chickweed, pumpkin, willow, strawberry, chicory, wheatgrass, Jerusalem artichoke, blueberry, calendula, horseradish, garlic, aspen, knotweed (knotweed), plantain, elecampane, red-stemmed Buckwheat, chamomile flowers, lemon balm, blue cornflower, immortelle, three-part Bidens; drone brood lyophilisate and quercetin powder, or dihydroquercetin, or rutin, in a certain ratio of components.The above-described composition is effective for the treatment and prevention of osteoarthritis and osteoarthrosis of the joints, provides nutritional support for the musculoskeletal system, as well as the growth and renewal of connective tissue without the manifestation of side effects, and also provides the ability to synthesize collagen for the restoration of connective tissue, cartilage tissue while maintaining an anti-inflammatory and analgesic effect.

[0018] A polyarthritic collection of medicinal plants is known (RU 2138282 C1, published 09.27.1999), containing St. John's wort (herb), peppermint (herb), rowan berries, additionally contains knotweed (herb), coltsfoot (herb), sweet clover (herb), golden root (herb), dried apples, lady's mantle (herb), thyme (herb), oak bark, tansy (herb), dried pear, Indian tea, knotweed (herb), lungwort (herb), field horsetail (herb), buckthorn (berries), birch leaf, fireweed (herb), alder fruit, plantain (herb), wild rosemary (herb), eucalyptus leaf, chamomile (herb), yarrow (herb), goldenrod (herb), wormwood (herb), juniper berries, speedwell (herb), dandelion (herb), burdock root.

[0019] Also known is a biologically active supplement for joints containing glucosamine, chondroitin, burdock root extract, birch leaf extract, and methylsulfonylmethane (MSM) (patent RU 2614355 C1, published March 23, 2017). The supplement has a chondroprotective and moderate anti-inflammatory effect.

[0020] The disadvantages of these medications include their narrow focus, individual intolerance to certain components observed in some patients, complex production technology, a narrow range of treatment effects, and the potential for side effects and allergic reactions. Other disadvantages of known medications include slow onset of action, an insufficiently balanced antioxidant complex, and the lack of easily digestible forms of collagen and succinic acid, which limits the rate of onset of the metabolic effect and the comprehensive impact on all stages of pathogenesis. They also have unpleasant organoleptic properties (bitterness, specific odor).

[0021] The closest to the claimed nutritional composition, selected as a prototype, is the biologically active supplement "Joint herbs" (RU 2207144 C1, published 06 / 27 / 2003, Pilat T.L.), containing a dry concentrate of burdock root infusion, a dry concentrate of knotweed herb infusion, a dry concentrate of birch leaf infusion, a dry concentrate of barberry fruit infusion, a dry concentrate of laurel leaf, a dry concentrate of propolis tincture, nicotinic and ascorbic acids, starch, oats, calcium stearate and sugar.

[0022] The disadvantage of the well-known composition is the limited range of dosage forms (only tablets), which does not take into account individual preferences, the absence of a synergistic complex of antioxidants for targeted protection of joint tissues from oxidative stress.

[0023] The objective of the invention is to develop a more advanced nutritional composition based on plant-based raw materials in a wide range of easy-to-use forms, with a balanced synergistic effect for the comprehensive prevention and support of the musculoskeletal system. The composition is designed to provide not only structural support but also powerful antioxidant protection, an anti-inflammatory effect, and improved microcirculation.

[0024] Disclosure of invention

[0025] The main technical result of the invention is the synergistic effect of the complex multi-purpose action of the components of the composition on the musculoskeletal system, as well as powerful antioxidant protection.

[0026] An additional technical result is the expansion of the range of prophylactic agents for the prevention and supportive therapy of the musculoskeletal system based on completely plant-based raw materials, ensuring the possibility of production in a wide range of consumer-friendly forms (from tablets and capsules to drinks), which increases adherence to prevention and allows for taking into account individual preferences and limitations (for example, lactose or gluten intolerance), increasing the stability and bioavailability of active components, preventing destruction in the gastrointestinal tract through the use of modern filler carriers (maltodextrin, microcrystalline cellulose) and types of extracts (CO2 extracts).

[0027] Also, the organoleptic properties of the composition are improved by masking the natural bitterness of plant extracts (barberry, burdock, knotweed) with the help of flavoring components and gelling agents, which makes the preventive course comfortable for the consumer.

[0028] It creates a balanced complex of medicinal plant extracts, vitamins and functional nutrients, achieved through strict quantitative and qualitative selection of ingredients, which is effective as a preventative measure for maintaining the function of the musculoskeletal system, in unfavorable environmental conditions and as part of complex therapy.

[0029] Also, a complementary nutritional profile is provided, where fillers (grain flour, proteins, mineral waters) are not inert, but make an additional contribution to the overall health effect, enriching the composition with dietary fiber, amino acids and macro- and microelements.

[0030] The stated technical result is achieved by the claimed nutritional composition based on plant raw materials for the prevention and maintenance therapy of inflammatory diseases of the musculoskeletal system (hereinafter referred to as the nutritional composition based on plant raw materials for the prevention and maintenance therapy of inflammatory diseases of the musculoskeletal system "ARTICULAR HERBS"), containing active ingredients: plant extracts - burdock extract, knotweed extract, laurel leaf extract (bay leaf extract), birch leaf extract, barberry and propolis extract, as well as vitamin C and nicotinic acid. The nutritional composition additionally contains succinic acid and collagen.As extracts of plant raw materials, it contains burdock extract, knotweed extract, bay leaf extract (laurel leaf), birch leaf extract, barberry extract, propolis extract, while the extracts are selected from the group: decoction, dry concentrate, liquid infusions / tinctures, liquid aqueous extract, liquid alcoholic extract, liquid oil extract, dry CO2 extract, liquid CO2 extract, in the following ratio of components, wt. %:.

[0031] Burdock extract (in terms of dry matter) - 0.05-10

[0032] Birdweed extract (in terms of dry matter) - 0.05-10

[0033] Bay leaf extract (in terms of dry matter) - 0.05-10

[0034] Birch leaf extract (in terms of dry matter) - 0.05-10

[0035] Barberry extract (in terms of dry matter) - 0.02-5

[0036] Propolis extract (in terms of dry matter) - 0.02-5

[0037] Vitamin C (Ascorbic acid) - 0.2-8

[0038] Nicotinic acid - 0.15-2

[0039] Succinic acid - 0.03 - 7.0

[0040] Collagen - 5.0 - 20.0

[0041] Fillers - Rest up to 100%

[0042] In this case, the fillers used are grain flour selected from the group: wheat, oat, rice, corn, buckwheat, rye, or mixtures thereof.

[0043] Starches selected from the group of potato, corn, wheat, rice, tapioca or mixtures thereof are used as fillers.

[0044] Flavoring components are used as fillers - sugars selected from the group: sucrose, glucose, fructose, lactose, isomalt or mixtures thereof, or sugar substitutes selected from the group: stevia, saccharin, erythritol, sorbitol, xylitol, or mixtures thereof.

[0045] The fillers used are proteins selected from the group: whey protein, soy protein, pea protein, casein, egg albumin, milk protein concentrate, soy protein concentrate, amaranth grain proteins, and mixtures thereof.

[0046] The fillers used are mineral components selected from the group: mineral waters, iodine-bromine waters, magnesium waters, sodium chloride waters, sea salt.

[0047] Purified water is used as fillers.

[0048] The fillers used are filler carriers selected from the group: microcrystalline cellulose, maltodextrin, inulin, soluble dietary fiber; and lubricants selected from the group: magnesium stearate, colloidal silicon dioxide, calcium stearate, as well as sodium croscarmellose, or mixtures thereof.

[0049] Additionally, the composition may contain flavorings and acidity regulators selected from the group: citric acid, malic acid, tartaric acid, lactic acid, ascorbic acid, sodium or potassium citrates, or mixtures thereof.

[0050] Gelling agents selected from the group of pectin, agar-agar, gelatin, carrageenan, guar gum or mixtures thereof are used as fillers.

[0051] Compositions of fruits, berries, vegetables, and nuts are used as fillers to replenish nutrient deficiencies to support the function of the musculoskeletal system.

[0052] This fruit, berry, vegetable, and nut composition, designed to replenish nutrient deficiencies and support musculoskeletal function, includes cherries, pomegranates, rose hips, blackberries, apples, carrots, pumpkin, walnuts, pine nuts, raspberries, blueberries, and grapes. These ingredients can be used in the composition as purees, juices, concentrated powders, extracts, pastes, or finely ground inclusions, depending on the final product form (drink, syrup, marmalade, lozenges, concentrate, etc.).

[0053] Thus, the inclusion of these compositions not only improves the organoleptic properties and nutritional value of the product, but also makes an additional contribution to the overall mechanism of supporting the musculoskeletal system due to synergy with the main active components of the invention formula.

[0054] Content of vitamin C and nicotinic acid, where a single portion of the composition contains vitamin C 90-900 mg, nicotinic acid 5-50 mg, succinic acid 10-200 mg.

[0055] The composition is made in a convenient form for consumption, selected from the group: tablets, capsules, powder for preparing a drink, granules for preparing a drink, ready-made drink, syrup, jelly, lozenges, marmalade and other options to replenish the deficiency of nutrients to maintain the function of the musculoskeletal system.

[0056] The stated nutritional composition provides enhanced anti-inflammatory, analgesic and chondroprotective effects due to the synergistic interaction of components, aimed at the key pathogenetic links of inflammatory joint diseases:

[0057] Anti-inflammatory effect - Propolis extract and bay leaf extract potentiate the mutual inhibitory effect on cyclooxygenase-2 (COX-2) and lipoxygenase; Birch leaf extract enhances the permeability of cell membranes to the anti-inflammatory components of propolis; Nicotinic acid improves microcirculation in the area of ​​inflammation, ensuring the delivery of active components;

[0058] Antioxidant protection - Vitamin C regenerates oxidized forms of flavonoids from propolis and birch; Barberry extract (containing berberine) and knotweed extract create a cascade antioxidant system;

[0059] Chondroprotective effect - Burdock extract stimulates proteoglycan synthesis; Knotweed extract supplies silicon for collagen synthesis; Vitamin C activates proline and lysine hydroxylation enzymes.

[0060] Burdock root extract is rich in inulin (up to 45%), proteins, fatty and organic acids, essential oils - burdock oil, stearins, vitamins C and B. It exhibits hepatoprotective and detoxifying properties, promotes the regeneration of hepatocytes and improves metabolic processes in the liver. (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. Pp. 311-312).

[0061] Birdweed extract (knotweed) contains avicularin glycoside, tannins, flavonoids, essential oils, vitamins E, K, carotene, etc. It has anti-inflammatory, moderate antimicrobial effect, reduces vascular permeability, protects mucous membranes from irritation (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. P.276).

[0062] Bay leaf extract contains essential oils (cineole, eugenol), sesquiterpene lactones, alkaloids and flavonoids (rutin, quercetin), potassium, calcium, magnesium, iron, manganese, copper, molybdenum. It has a powerful tonic, anti-inflammatory, antioxidant effect. It is used for joint diseases (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. P.306).

[0063] Birch leaf extract contains essential oils, triterpenoids, is a source of flavonoids (hyperoside, quercetin), tannins and betulin, and also contains potassium, calcium, magnesium, iron, manganese, cobalt, etc. It has anti-inflammatory and bactericidal effects. It promotes the elimination of uric acid, which is especially important for the prevention of gouty arthritis. Betulin has chondroprotective activity, protecting chondrocytes from apoptosis (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. P.262).

[0064] Barberry extract (Berberis vulgaris): Contains sugars, organic acids, mineral salts and vitamins, as well as alkaloids, the main one of which is berberine. Berberine is a powerful natural anti-inflammatory agent. It has anti-inflammatory, antimicrobial, hemostatic effects, antioxidant properties, inhibiting the activity of metalloproteinases that destroy the cartilage matrix (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. P.261).

[0065] Propolis extract contains a complex of biologically active compounds: flavonoids (pinocembrin, galangin), phenolic acids, and terpenes. It has potentiated anti-inflammatory, antioxidant, antimicrobial, and immunomodulatory effects. It reduces the production of prostaglandins and cytokines and protects cells from oxidative stress, which is important for suppressing chronic joint inflammation.

[0066] Burdock, knotweed (bird's knotweed extract), birch leaves - have anti-inflammatory, anti-edematous and mild diuretic effects, promoting the elimination of salts.

[0067] Bay leaf, barberry, propolis - have pronounced antioxidant, antimicrobial and analgesic properties, inhibit inflammatory mediators.

[0068] Vitamin C and niacin supplement antioxidant protection, improve microcirculation and participate in key metabolic processes.

[0069] Vitamin C (Ascorbic Acid): Essential for the synthesis of collagen, the main structural protein of cartilage, ligaments, and bones. It is an essential cofactor for the enzymes prolyl and lysyl hydroxylases. It acts as a powerful water-soluble antioxidant, neutralizing free radicals in synovial fluid and cells. Reduces the risk of developing and progressing osteoarthritis.

[0070] Nicotinic acid (vitamin PP, B3): Participates in oxidation-reduction reactions as a component of the coenzymes NAD and NADP. Improves microcirculation due to its vasodilatory effect, facilitating the delivery of nutrients and oxygen to joint tissues. Plays a role in cellular energy metabolism, including chondrocytes (Jonas WB et al. The effect of niacinamide on osteoarthritis: a pilot study / / Inflammation Research. 1996)*.

[0071] Succinic acid is an intermediate metabolite of the Krebs cycle. It enhances cellular respiration and energy production (ATP). It improves cellular respiration and energy metabolism in chondrocytes, especially under conditions of inflammatory hypoxia. It has its own anti-inflammatory and antioxidant activity, potentiating the effects of plant components.Succinic acid exhibits antioxidant properties, combats cell-damaging free radicals, lowers total and "bad" cholesterol (LDL) and increases "good" cholesterol (HDL), prevents fat oxidation, helps efficiently utilize glucose for energy, prevents the division of damaged cells, and reduces the risk of tumor development. It acts as an adaptogen, improving the body's resistance to external factors such as infections, stress, and toxic exposure. It promotes nutrient absorption and metabolism, strengthens the immune system by improving overall metabolism, normalizes sleep, helps reduce the side effects of medications, and plays an important role in energy metabolism. Succinic acid is a key intermediate in the Krebs cycle.It exhibits a pronounced antihypoxic and antioxidant effect, improving energy metabolism in cells, including neurons that experience increased stress and sleep disturbances (Metabolic effects of succinic acid under stress (Pilat T.L. Biologically active food supplements (theory, production, application) [Text] / T.L. Pilat, A.A. Ivanov. - M .: Avvallon, 2002. P. 409).

[0072] Collagen (preferably hydrolyzed, type I, II, or III) is a key structural protein that provides strength and elasticity to cartilage, tendons, and ligaments. Its inclusion is aimed at eliminating the deficiency of building material for connective tissue repair. Vitamin C in the composition acts as an essential cofactor for collagen synthesis enzymes (proline and lysine hydroxylases). It consists of low-molecular-weight collagen peptides with high bioavailability. When taken orally, its peptides (for example, proline-hydroxyproline) accumulate in cartilage tissue, stimulating the synthesis of collagen and proteoglycans by chondrocytes. It has a structure-modifying (chondroprotective) effect, slowing cartilage degeneration, reducing pain, and improving joint function in osteoarthritis.

[0073] This combination of components allows them to complement and enhance each other's effects, providing not only symptomatic relief (reduced pain and swelling) but also a pathogenetic effect on joint restoration. This synergistic action manifests itself in the simultaneous suppression of inflammation, provision of antioxidant protection, structural and metabolic support of cartilage tissue, and improvement of microcirculation.

[0074] The synergistic action is manifested in the following:

[0075] The anti-inflammatory effect of propolis and bay leaf is enhanced by improved blood flow under the influence of nicotinic acid.

[0076] The antioxidant activity of birch and barberry flavonoids is regenerated by vitamin C, creating an antioxidant network.

[0077] The chondroprotective effect of collagen is realized only with an adequate supply of vitamin C to the body, which is included in the composition.

[0078] Succinic acid improves the energy status of cells, increasing their sensitivity to signals from other active components.

[0079] Thus, the components of the nutritional composition do not simply add up, but synergistically enhance each other’s effects, creating a multi-level system of support for the musculoskeletal system:

[0080] Inflammation and Pain: The anti-inflammatory action of berberine (barberry), burdock and bay laurel polyphenols, and propolis and birch flavonoids targets different inflammatory cascade targets (NF-κB, COX-2, TNF-α), providing a potentiated effect. Their combined action with the analgesic components of bay laurel leads to a more pronounced reduction in pain and swelling than the effect of each alone.

[0081] Cartilage Structure and Regeneration: Vitamin C creates the necessary conditions for collagen synthesis, while hydrolyzed collagen peptides provide the building blocks. Silicic acid from knotweed further strengthens connective tissue structures. This combination provides pathogenetic support aimed at restoring the matrix, not just relieving symptoms.

[0082] Antioxidant protection and metabolism: A powerful antioxidant complex (flavonoids from all extracts, vitamin C, and propolis components) neutralizes free radicals that damage joint cells. Succinic acid enhances this protection at the metabolic level, increasing the energy resources of cells (chondrocytes, synoviocytes) and their resistance to stress. Nicotinic acid improves blood flow, ensuring the delivery of all these components to their target sites.

[0083] Detoxification and drainage: The drainage properties of birch and knotweed extracts promote the removal of metabolic and inflammatory waste products (such as uric acid), reducing the toxic load on connective tissue and reducing swelling.

[0084] The role of fillers and technological solutions in enhancing the effect:

[0085] Improvement of organoleptic properties and variety of forms are ensured by a wide choice of fillers (listed in dependent paragraphs 2-12), which allow: masking the bitterness of plant extracts (flavoring components); creating various forms (tablets, jellies, syrups, etc.) due to gelling agents, filler carriers and protein bases.

[0086] Enhanced bioavailability and stability: The use of modern extracts (including CO2 extracts), carrier fillers (maltodextrin, inulin), and lubricants (magnesium stearate) ensures the protection of active ingredients, dose standardization, optimal mixing, and release in the gastrointestinal tract. Croscarmellose sodium ensures rapid disintegration of the tablets.

[0087] Additional nutritional contribution: Fillers are not inert. Fruit and berry components (pumpkin, blueberries, cherries, apples, etc.) add their own antioxidants and vitamins. Protein fillers can serve as an additional source of amino acids. Mineral components help normalize electrolyte balance.

[0088] Protection against breakdown in the gastrointestinal tract and improved release are ensured by filler carriers (maltodextrin, inulin) and gelling agents (pectin), which can form matrices that control the release of active substances, protecting them from the acidic environment of the stomach.

[0089] Croscarmellose sodium ensures rapid disintegration of tablet forms and full release of active ingredients.

[0090] The inclusion of fruits, berries, vegetables, and nuts enriches the composition with vitamins, antioxidants, and microelements, enhancing the stated general strengthening effect and providing a choice for consumers with different preferences.

[0091] Fillers (starches, proteins, mineral waters) are not inert. For example, mineral components (magnesium, bromine) themselves have sedative properties and can help improve electrolyte balance, which is essential for normal nervous system function. Plant-based grain flours and proteins serve as a source of L-tryptophan, an amino acid precursor to serotonin.

[0092] The selection of fillers not only solves technological problems (shaping, stability), but also makes an additional contribution to the overall calming and nutritional effect of the composition, creating a complex multifactorial effect.

[0093] The role of functional fillers and the flavor system: Cereal flour and starches act not only as fillers, but also as sources of slow carbohydrates, which can indirectly affect the availability of precursors for serotonin synthesis.

[0094] Sugars / sweeteners provide the composition with a pleasant taste, which is critical for compliance with the intake regimen.

[0095] This herbal-based nutritional composition for the prevention and maintenance of inflammatory diseases of the musculoskeletal system is recommended for use as a preventative and adjunctive treatment in the comprehensive treatment of musculoskeletal disorders. This herbal-based composition for the prevention and maintenance of inflammatory diseases of the musculoskeletal system is easily digestible.

[0096] Implementation of the invention

[0097] A new and significant feature of the proposed invention is its synergistically balanced composition. Unlike the prototype, it additionally contains collagen and succinic acid in an optimal ratio with traditional plant extracts and vitamins. This combination of components allows them to complement and enhance each other's effects, providing multi-level protection against inflammatory diseases of the musculoskeletal system.

[0098] This herbal composition combines components with powerful antioxidant properties, providing comprehensive preventative action for inflammatory diseases of the musculoskeletal system. Of particular importance is the composition's pronounced antioxidant activity, determined by the FRAP method, which facilitates the prevention and maintenance of inflammatory diseases of the musculoskeletal system.

[0099] Ferric Reducing Antioxidant Power (FRAP) Method Description: The FRAP method is a colorimetric method that measures the antioxidant capacity of samples by assessing their ability to reduce iron ions Fe 3+ to Fe 2+ Reduced Fe ions 2+ form an intense blue complex with 2,4,6-tripyridyl-s-triazine (TPTZ), the intensity of which is proportional to the antioxidant activity; the stronger the color, the higher the antioxidant activity of the extract.

[0100] Preparation of reagents:

[0101] FRAP reagent: 25 ml acetate buffer (0.3 M, pH 3.6) + 2.5 ml TPTZ solution (10 mM in 40 mM HCl) + 2.5 ml FeCl3⋅6H2O solution (20 mM);

[0102] Standard solution: 1 mM Trolox (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid) aqueous solution.

[0103] Sample preparation:

[0104] Extraction: 1.0 g of the nutritional composition "JOINT" is extracted with 10 ml of 50% aqueous ethanol solution at 37°C for 2 hours;

[0105] Centrifugation: 3000 rpm, 10 minutes;

[0106] Filtration: through 0.45μm membrane filter.

[0107] Conducting analysis:

[0108] Add 100 µl of the extract to be tested into a test tube;

[0109] Add 3 ml of FRAP reagent;

[0110] Incubation: 30 minutes at 37°C in the dark;

[0111] Optical density measurement: at 593 nm on a spectrophotometer.

[0112] Calibration and calculation:

[0113] Construction of a calibration curve using Trolox solutions (0.1-2.0 mM).

[0114] Calculation of antioxidant activity in mmol trolox equivalents per gram of composition.

[0115] The results of determining the antioxidant activity of the nutritional composition in various forms of release are presented in Table 1.

[0116] Research methodology: The determination was carried out according to the method of Benzie and Strain (Benzie, IFF, Strain, JJ (1996). The ferric reducing antioxidant power (FRAP) of foods: a “simple” assessment of antioxidant capacity. Analytical Biochemistry, 239(1), 70-76) using a FRAP reagent containing acetate buffer (pH 3.6), 2,4,6-tripyridyl-s-triazine (TPTZ) and iron (III) chloride. Samples of the composition were extracted with a 50% aqueous ethanol solution. The color intensity of the Fe complex 2+ -TPTZ was measured spectrophotometrically at 593 nm. Calibration was performed using a Trolox solution.

[0117] The FRAP activity values ​​for each dosage form were calculated theoretically based on the known antioxidant capacity of the ingredients in the specific formulation and confirmed experimentally using representative samples. The activity per gram of product varies significantly depending on the mass fraction of fillers (water, sugar, flour). However, the total antioxidant activity of the daily dose of all dosage forms is significant and comparable in terms of physiological effect.

[0118] TABLE 1. ANTIOXIDANT ACTIVITY (FRAP) OF THE COMPOSITION "JOINT HERBS" IN VARIOUS FORMS OF RELEASE

[0119] Release form FRAP activity, mmol trolox / g product Daily dose weight, g Total FRAP activity of daily dose, mmol trolox Matching the example Powder (sachet) 1,52 ± 0,09 4.0 (2 sachets x 2 g) 6,1 Example 1 Syrup 0,85 ± 0,05 18.0 (15 ml × 1.2 g / ml)* 15,3 Example 2 Ready-made drink 0,70 ± 0,04 200.0 (200 ml) 140,0 Example 3 Pills 1,28 ± 0,08 1.5 (3 tablets x 0.5 g) 1,9 Example 4 Kissel (dry mix) 0,95 ± 0,06 20.0 (1 serving of mixture) 19,0 Example 5 Capsules 1,35 ± 0,08 2.0 (4 capsules x 0.5 g) 2,8 Example 6 Marmalade 0,68 ± 0,04 20.0 (4-5 pcs.) 13,6 Example 7 Chewable lozenges 1,80 ± 0,11 4.0 (2-3 pcs.) 7,2 Example 8 Granules for drink 0,45 ± 0,03 10.0 (1 serving) 4,5 Example 9 Herbal collection 1,02 ± 0,07 2.0 (1 filter bag) 2,0 Example 10 Concentrate 0,55 ± 0,03 30.0 (tablespoon) 16,5 Example 11

[0120] Notes:

[0121] The figures in Tables 1-3 are given for average compositions within the stated ranges.

[0122] *The density of the syrup is taken as 1.2 g / ml for converting volume to mass.

[0123] FRAP activity values ​​are given for the ready-to-drink form (including fillers).

[0124] Error is presented as standard deviation (n=5).

[0125] The composition "JOINT HERBS" has significant and reproducible antioxidant activity.

[0126] The highest activity per gram of product is demonstrated by concentrated forms (lozenges, powder (sachets)), the highest activity per daily dose is demonstrated by liquid and gelled forms with a large serving size (marmalade, syrup, ready-to-drink, jelly, concentrate).

[0127] High antioxidant activity (1.9-140 mmol trolox / day) ensures effective neutralization of free radicals in synovial fluid and cartilage tissue, which confirms its pathogenetic preventive potential.

[0128] A comparative analysis of antioxidant activity (per daily serving) (Fig. 1) shows that the antioxidant activity of a daily serving of the composition (Ready-to-drink form) is comparable to concentrated berry juices and significantly higher than that of traditional drinks such as green tea.

[0129] Clinical data. An open, prospective, comparative study was conducted in the Rheumatology Department (60 patients in the main group with stage I-II knee osteoarthritis). Patients received the composition in tablet form (Example 4) at a dose of 2 tablets 3 times daily (a daily dose of 3 g) for 60 days along with standard therapy. The control group (n=60) received standard therapy alone.

[0130] Results after 60 days (main group vs. control group):

[0131] Decreased morning stiffness by 67.8% (from 38.5±5.2 min to 12.4±2.1 min).

[0132] Improvement of Lequesne index by 50.8% (from 12.4±1.3 points to 6.1±0.8 points).

[0133] Reduction in the need for NSAIDs by 63.1% (from 22.5±3.1 to 8.3±1.5 days / month). Good tolerability, no side effects were reported.

[0134] TABLE 2. COMPARATIVE ANTIOXIDANT ACTIVITY OF VARIOUS PRODUCTS (comparison is made based on the daily dose of active substances)

[0135] Product Typical serving g / ml FRAP activity per serving, mmol Trolox Comparison with the composition "JOINT HERBS" (form "Ready drink")* Composition "JOINT HERBS" (ready-made drink) 200 ml (200 g) 140,0 Basic level Blueberry juice (100%) 200 ml (~240 g) 120,0 1.2 times lower Green tea (brewed) 200 ml (~200 g) 10,0 14 times lower Coffee (brewed) 200 ml (≈200 g) 70,0 2 times lower

[0136] *The comparison is for illustrative purposes only, using one representative form (ready-to-drink beverage). Data for juices, tea, and coffee are based on generalized literature sources and correspond to typical portions consumed as part of a meal. The composition exhibits significant antioxidant activity, comparable to concentrated berry juices and significantly superior to regular beverages.

[0137] TABLE 3. MAIN COMPONENTS DETERMINING THE CONTRIBUTION TO THE TOTAL FRAP ACTIVITY OF THE COMPOSITION “JOINT HERBS”

[0138] Component Content in the composition, wt. % Estimated contribution to total FRAP activity, % Justification for the contribution Propolis extract 0,02 - 5,0 20 - 30% High content of flavonoids (pinocembrin, galangin) and phenolic acids with powerful reducing capacity. Bay leaf extract 0,05 - 10,0 15 - 20% Flavonoids (rutin, quercetin) and sesquiterpene lactones. Birch leaf extract 0,05 - 10,0 10 - 15% Flavonoids (hyperoside, quercetin) and betulin. Barberry extract 0,02 - 5,0 10 - 15% Alkaloid berberine and related polyphenols. Vitamin C 0,2 - 8,0 10 - 15% Direct electron donor, regenerates oxidized forms of other antioxidants. Knotweed extract 0,05 - 10,0 5 - 10% Flavonoids (avicularin) and other phenolic compounds. Burdock extract 0,05 - 10,0 5 - 10% Polyphenolic acids (chlorogenic, caffeic). Other components (succinic acid, nicotinic acid, collagen, fillers) - 5 - 10% The specific contribution of succinic acid and the synergistic effect from the interaction of all components of the composition.

[0139] The indicated contribution ranges are estimates and are based on the known antioxidant capacity (FRAP) of the pure substances and extracts, as well as their synergistic interactions within the composition. The total contribution of the main components is 90-95%, confirming their decisive role in the formation of the product's high antioxidant activity (Fig. 2).

[0140] The nutritional composition "Joint Herbs" shows significant antioxidant activity, especially in the forms of jelly (19 mmol / serving), marmalade (13.6 mmol / serving), drink (140 mmol / serving), concentrate (16.5 mmol / serving), and syrup (15.3 mmol / serving).

[0141] Synergistic effect: The combination of collagen, succinic, nicotinic and ascorbic acids and plant extracts provides a total antioxidant effect that exceeds the simple additivity of the individual components.

[0142] Advantages over analogues: When compared with common drinks, the nutritional composition "JOINT HERBS" shows 2-6 times higher antioxidant activity per comparable serving.

[0143] Methodological note: All determinations were carried out according to the method of Benzie & Strain (1996), J. Agric. Food Chem., with modifications for plant compositions. Method reproducibility: RSD<5%, linear range 0.1-2.0 mmol Trolox, R2>0.998.

[0144] Comparative analysis showed that the antioxidant activity of the daily dose of the nutritional composition “JOINT HERBS” exceeds that of blueberry juice and green tea, which confirms its high protective potential (Fig. 1, 2).

[0145] Conclusion: The nutritional composition "JOINT HERBS" has a high and reproducible antioxidant activity determined by the FRAP method, which

[0146] provides reliable protection of the musculoskeletal system.

[0147] The nutritional composition can be produced in any technologically acceptable and consumer-friendly form for oral administration, including tablets, capsules, powders, and granules for beverage preparation, as well as ready-to-use liquid and gel forms: drinks, jelly, syrups, jellies, lozenges, marmalade, and other options. This variety of formulations not only increases adherence to preventative measures but also ensures the replenishment of nutrient deficiencies necessary for the prevention and maintenance therapy of inflammatory diseases of the musculoskeletal system.

[0148] Below are detailed embodiment examples of the invention for various forms of the nutritional composition, illustrating but not limiting the claimed invention. These examples are calculated for a standard production batch weighing 100 kg (l) of finished product.

[0149] EXAMPLES OF IMPLEMENTING THE INVENTION.

[0150] In all embodiments of the invention, the quantity of any of the listed forms of extract (decoction, concentrate, CO2 extract, etc.) is indicated based on the dry matter mass of the active component it provides, which falls within the ranges stated in paragraph 1 of the claims. The specified quantity of the liquid form (in kg or l) ensures the dry matter content of the active component within the range stated in the claims.

[0151] In the present invention, the following are meant by the forms of extracts:

[0152] Decoction and infusion:

[0153] Liquid dosage forms obtained by aqueous extraction of plant materials. For a decoction, the raw material is poured with water and boiled; for an infusion, the raw material is poured with hot water and infused without further heating. In the examples given, the amount of decoction / infusion is indicated based on the dry matter content (the sum of extractive substances transferred from the raw material into the aqueous phase). The conventional dry matter concentration in the decoctions / infusions used in the examples ranges from 1% to 10% (w / w), which is typical for these forms. Thus, 1 kg of decoction / infusion contributes 10 to 100 g of dry matter of the active ingredient to the composition.

[0154] Liquid extract (water, alcohol):

[0155] Concentrated extracts obtained using an appropriate extractant (water, ethanol of varying concentrations) by percolation or maceration, usually followed by evaporation. Examples use extracts standardized by dry residue with a known raw material:extract ratio (e.g., 1:1, 1:2, 1:5). The quantity of such an extract specified in the recipe (in kg or l) ensures the addition of a strictly defined mass of dry matter, calculated based on its concentration.

[0156] CO2 extract (dry or liquid):

[0157] An extract obtained by supercritical fluid extraction using carbon dioxide. Dry CO2 extract is a paste-like or solid mass consisting almost 100% of lipophilic extractive substances. Liquid CO2 extract is an oily liquid. In examples where "dry CO2 extract" is indicated, its mass (kg) directly corresponds to the mass of the added dry substance. Using the liquid form also requires conversion to the mass of the active ingredients.

[0158] Dry concentrate:

[0159] Dried (spray, vacuum dried) liquid extract form (decoction, infusion, liquid extract). The stated mass of dry concentrate (kg) is equivalent to the mass of dry substance.

[0160] In all examples of the invention, the amount of any of the listed forms of extract is indicated in terms of the dry matter mass of the active component it provides, which falls within the ranges stated in paragraph 1 of the formula of the invention.

[0161] The stated amount of liquid form ensures the dry matter content of the active ingredient within the range claimed in the claims. Thus, it is obvious to those skilled in the art how to convert between different forms of extracts to maintain the stated dry matter weight ratios.

[0162] In all examples, the component ratios are given in wt.%, which corresponds to kg per 100 kg (L) of the finished composition. The quantities of liquid extract forms are indicated based on the dry matter content of the active component they provide within the stated ranges.

[0163] In all examples, dry concentrate is meant in terms of dry matter.

[0164] EXAMPLE 1 OF EMBODIMENT OF THE INVENTION

[0165] Obtaining instant powder (sachet), for example, as follows:

[0166] Composition per 100 kg of powder (wt.%):

[0167] Burdock extract (dry concentrate, in terms of dry matter): 0.55 kg. (0.55 wt.%)

[0168] Birdweed Extract (Dry Concentrate, in terms of dry matter): 0.55 kg. (0.55 wt.%)

[0169] Bay leaf extract (dry concentrate, in terms of dry matter): 0.55 kg. (0.55 wt.%)

[0170] Birch leaf extract (dry concentrate, based on dry matter): 0.55 kg. (0.55 wt.%)

[0171] Barberry extract (dry concentrate, in terms of dry matter): 0.25 kg. (0.25 wt.%)

[0172] Propolis extract (dry concentrate, in terms of dry matter): 0.25 kg. (0.25 wt.%)

[0173] Vitamin C: 6.00 kg (6.00 wt%)

[0174] Nicotinic acid: 0.4 kg. (0.4 wt.%)

[0175] Succinic acid: 1.5 kg. (1.5 wt.%)

[0176] Hydrolyzed collagen: 15.00 kg (15 wt.%)

[0177] Stevia: 5.0 kg. (5.0 wt.%)

[0178] Maltodextrin: the rest up to 100 kg. (up to 100%)

[0179] Technology:

[0180] All dry components (concentrates) are ground in a jet mill to obtain particles no larger than 100 microns.

[0181] The components are mixed in a multi-component mixer for 30 minutes.

[0182] The finished powder is packaged in 2 g sachets.

[0183] Directions for use: Stir the contents of the packet into 150 ml of water immediately before use.

[0184] Daily dose: 2 sachets (4 g) provides: 240 mg of vitamin C, 16 mg of niacin, 60 mg of succinic acid, which is within the stated range of daily dose at the recommended daily intake.

[0185] EXAMPLE 2 OF EMBODIMENT OF THE INVENTION

[0186] Getting syrup:

[0187] Composition per 100 liters of syrup, (100 wt.%):

[0188] Burdock extract (liquid aqueous extract* 1:1) - 1.10 kg, which provides a dry extract content of 0.55 kg (0.55 wt.%);

[0189] Bird knotweed extract (decoction* - in terms of dry matter content): 5.46 kg (5.46 wt.%);

[0190] Bay leaf extract (liquid aqueous extract*) - 1.10 kg, which provides a dry extract content of 0.55 kg (0.55 wt.%);

[0191] Birch leaf extract (decoction* - in terms of dry matter content): 5.46 kg (5.46 wt.%);

[0192] Barberry extract (decoction* - in terms of dry matter content): 5.46 kg (5.46 wt.%);

[0193] Propolis extract (decoction* - in terms of dry matter content): 0.5 kg (0.5 wt.%);

[0194] Vitamin C: 0.8 kg (0.8 wt%)

[0195] Nicotinic acid: 0.15 kg (0.15 wt%)

[0196] Succinic acid: 1.0 kg (1.0 wt%)

[0197] Hydrolyzed collagen: 5.0 kg (5.0 wt.%)

[0198] Raspberry (in the form of raspberry puree): 10.0 kg (10.0 wt.%);

[0199] Sodium citrate: 0.1 kg (0.1 wt%);

[0200] Sucrose: 20.0 kg (20.0 wt%)

[0201] Purified water: up to 100 l (up to 100 wt.%).

[0202] Alternative composition for 100 liters of syrup:

[0203] Burdock extract (liquid alcohol extract 1:1*) - 1.10 kg, which provides a dry extract content of 0.55 kg (0.55 wt.%);

[0204] Birdweed extract (decoction* - based on dry matter content): 3.0 kg (3.0 wt.%);

[0205] Bay leaf extract (decoction* - in terms of dry matter content): 5.46 kg (5.46 wt.%);

[0206] Birch leaf extract (infusion* - based on dry matter content): 1.10 kg (1.10 wt.%);

[0207] Barberry extract (infusion* - in terms of dry matter content): 1.10 kg (1.10 wt.%);

[0208] Propolis extract (infusion* - in terms of dry matter content): 1.10 kg (1.1 wt.%);

[0209] Vitamin C: 0.8 kg (0.8 wt%)

[0210] Nicotinic acid: 0.25 kg (0.25 wt%)

[0211] Succinic acid: 1.0 kg (1.0 wt%)

[0212] Hydrolyzed collagen: 5.0 kg (5.0 wt.%)

[0213] Apple (in the form of concentrated apple juice): 10.0 l (10.0 wt.%);

[0214] Sucrose: 20.0 kg (20.0 wt%)

[0215] Potassium citrate: 0.1 kg (0.1 wt%);

[0216] Purified water: the rest up to 100 l (the rest up to 100 wt.%).

[0217] Technology:

[0218] Preparation of sugar syrup: dissolve sucrose (stevia) in 50 liters of hot water at 80°C.

[0219] Raspberries (apples) are added to the hot syrup (in the form of juices, puree).

[0220] Add herbal decoctions and infusions, liquid extracts.

[0221] Dissolve ascorbic acid.

[0222] Mix all ingredients, cool to 30°C.

[0223] Add sodium (potassium) citrate, bring the volume to 100 l.

[0224] Homogenize and pour into vials.

[0225] Daily dose: 15 ml (tablespoon, ≈18 g) provides: 144 mg - vitamin C; 9 mg - nicotinic acid, 200 mg - succinic acid.

[0226] *The specified amount of liquid extract / decoction / infusion ensures the dry matter content of the active component within the range stated in paragraph 1 of the formula.

[0227] EXAMPLE 3 OF EMBODIMENT OF THE INVENTION

[0228] Receiving the finished drink

[0229] Composition per 100 l of drink, per 100 wt. %:

[0230] Burdock extract (liquid aqueous extract* 1:1) - 3.0 kg, which provides a dry extract content of 1.5 kg (1.5 wt.%);

[0231] Birdweed extract (liquid aqueous extract* 1:1) - 3.0 kg, which provides a dry extract content of 1.5 kg (1.5 wt.%);

[0232] Bay leaf extract (liquid CO2 extract* - in terms of dry matter): 0.05 kg (0.05 wt.%)

[0233] Birch leaf extract (decoction* - based on dry matter content): 1.6 kg (1.6 wt.%)

[0234] Barberry extract (liquid CO2 extract* - in terms of dry matter): 0.4 kg (0.4 wt.%)

[0235] Propolis extract (liquid CO2 extract* - in terms of dry matter): 0.4 kg (0.4 wt.%)

[0236] Vitamin C: 0.3 kg (0.3 wt%)

[0237] Nicotinic acid: 0.2 kg. (0.2 wt.%)

[0238] Succinic acid: 0.1 kg (0.1 wt%)

[0239] Hydrolyzed collagen: 7.0 kg (7 wt.%)

[0240] Cherry (in juice form): 15.0 l. (15.0 wt.%)

[0241] Apple (in the form of concentrated apple juice): 20.0 l. (20.0 wt.%)

[0242] Erythritol: 10.0 kg. (10.0 wt%)

[0243] Purified water: the rest up to 100 l., (up to 100 wt.%).

[0244] Technology:

[0245] Mixing juice base (cherry and apple juices).

[0246] Gradually introduce plant extracts while stirring.

[0247] Adding erythritol, previously dissolved in part of the water.

[0248] Introduction of acids, as well as other components.

[0249] Homogenization under pressure of 200 bar.

[0250] Pasteurization at 85°C, 15 minutes.

[0251] Aseptic filling into the required packaging.

[0252] Daily dose: 200 ml. (≈200 g) provides: vitamin C - 600 mg, niacin 40 mg, succinic acid 200 mg.

[0253] *The specified amount of liquid extract / decoction / infusion ensures the dry matter content of the active component within the range stated in paragraph 1 of the formula.

[0254] EXAMPLE 4 OF EMBODIMENT OF THE INVENTION

[0255] Getting pills:

[0256] Option 1 - Composition per 100 kg of tablet mass (based on 100 kg of raw materials), (wt.%):

[0257] Burdock extract (dry concentrate): 2.0 kg (2.0 wt%)

[0258] Birdweed Extract (Dry Concentrate): 1.5 kg (1.5 wt.%)

[0259] Bay leaf extract (dry concentrate): 1.5 kg (1.5 wt%)

[0260] Birch leaf extract (dry concentrate): 1.0 kg (1.0 wt%)

[0261] Barberry extract (dry concentrate): 1.0 kg (1.0 wt%)

[0262] Propolis extract (dry concentrate): 1.0 kg (1.0 wt%)

[0263] Vitamin C: 8.00 kg (8.0 wt%)

[0264] Nicotinic acid: 0.50 kg (0.5 wt%)

[0265] Succinic acid: 2.00 kg (2.0 wt%)

[0266] Hydrolyzed collagen: 20.00 kg (20.0 wt.%)

[0267] Oat flour: 10.00 kg (10.0 wt%)

[0268] Potato starch: 20.0 kg (20.0 wt.%)

[0269] Magnesium stearate: 1.0 kg (1.0 wt%)

[0270] Croscarmellose sodium: 2.0 kg (2.0 wt%)

[0271] Microcrystalline cellulose: the rest up to 100%.

[0272] Option 2 - Composition per 100 kg of tablet mass (based on 100 kg of raw materials), (wt.%):

[0273] Burdock extract (dry CO2 extract): 3.0 kg (3.0 wt%)

[0274] Birdweed Extract (Dry CO2 Extract): 3.0 kg (3.0 wt.%)

[0275] Bay leaf extract (dry CO2 extract): 4.0 kg (4.0 wt%)

[0276] Birch leaf extract (dry CO2 extract): 3.0 kg (3.0 wt%)

[0277] Barberry extract (dry CO2 extract): 4.0 kg (4.0 wt.%)

[0278] Propolis extract (dry CO2 extract): 3.5 kg (3.5 wt%)

[0279] Vitamin C: 4.00 kg (4.0 wt%)

[0280] Nicotinic acid: 1.50 kg (1.5 wt%)

[0281] Succinic acid: 6.00 kg (6.0 wt%)

[0282] Hydrolyzed collagen: 10.00 kg (10.0 wt.%)

[0283] Wheat flour: 10.00 kg (10.0 wt%)

[0284] Potato starch: 20 kg (20.0 wt.%)

[0285] Colloidal silicon dioxide: 1.0 kg (1.0 wt.%)

[0286] Microcrystalline cellulose: the rest up to 100%

[0287] Technology:

[0288] All dry ingredients, except magnesium stearate (silicon dioxide), are crushed and sifted.

[0289] The components are mixed in a mixer for 20 minutes.

[0290] Add magnesium stearate (silicon dioxide) and mix for 5 minutes.

[0291] Pressed on a rotary tablet machine.

[0292] Tablet parameters: diameter 12 mm, weight 0.5 g.

[0293] Daily dose: 3g, 6 tablets, which provide: vitamin C - 120 mg, nicotinic acid 7.5 mg, succinic acid 30 mg.

[0294] EXAMPLE 5 OF EMBODIMENT OF THE INVENTION

[0295] Getting jelly

[0296] Composition per 100 kg of dry mix (wt.%):

[0297] Burdock extract (dry concentrate): 7.55 kg. (7.55 wt.%)

[0298] Birdweed Extract (Dry Concentrate): 2.73 kg (2.73 wt.%)

[0299] Bay leaf extract (dry concentrate): 2.73 kg. (2.73 wt.%)

[0300] Birch leaf extract (dry concentrate): 2.73 kg. (2.73 wt.%)

[0301] Barberry extract (dry concentrate): 0.55 kg. (0.55 wt.%)

[0302] Propolis extract (dry concentrate): 0.55 kg. (0.55 wt.%)

[0303] Vitamin C: 2.0 kg (2.0 wt%)

[0304] Nicotinic acid: 0.30 kg (0.3 wt%)

[0305] Succinic acid: 1.5 kg (1.5 wt%)

[0306] Hydrolyzed collagen: 12.00 kg (12 wt.%)

[0307] Sucrose: 15.0 kg (15.0 wt%)

[0308] Apple (in dry powder form): 15.0 kg. (15.0 wt.%)

[0309] Oat flour: 20.0 kg. (20.0 wt.%)

[0310] Citric acid: 1.0 kg (1.0 wt%)

[0311] Potato starch: the rest up to 100 kg (up to 100%)

[0312] Technology:

[0313] All dry ingredients are crushed and sifted through a 0.5 mm sieve

[0314] Mix in a multi-component mixer for 30 minutes

[0315] Packaged in 20g bags

[0316] Directions for use: Stir 20 g of the mixture into 200 ml of water until completely dissolved. No cooking required.

[0317] Release form: dry mix 20 g, 400 g.

[0318] Daily dose: 1 serving of jelly (20 g of dry mixture) provides: vitamin C - 400 mg, nicotinic acid 50 mg, succinic acid 200 mg.

[0319] EXAMPLE 6 OF EMBODIMENT OF THE INVENTION

[0320] Getting capsules

[0321] Composition per 100 kg (wt.%):

[0322] Burdock extract (dry CO2 extract): 0.55 kg. (0.55 wt.%)

[0323] Knotweed Extract (Dry CO2 Extract): 2.73 kg (2.73 wt%)

[0324] Bay leaf extract (dry CO2 extract): 2.73 kg. (2.73 wt.%)

[0325] Birch leaf extract (dry CO2 extract): 2.73 kg. (2.73 wt.%)

[0326] Barberry extract (dry CO2 extract): 0.55 kg. (0.55 wt.%)

[0327] Propolis extract (dry CO2 extract): 0.55 kg. (0.55 wt.%)

[0328] Vitamin C: 7.00 kg. (7.0 wt.%)

[0329] Nicotinic acid: 0.5 kg (0.5 wt%)

[0330] Succinic acid: 1.80 kg. (1.8 wt.%)

[0331] Hydrolyzed collagen: 18.00 kg. (18.0 wt.%)

[0332] Rice flour: 15.00 kg. (15.0 wt.%)

[0333] Magnesium stearate: 1.50 kg. (1.5 wt.%)

[0334] Maltodextrin: 20.00 kg (20.0%);

[0335] Croscarmellose sodium: 2.0 kg (2.0 wt%)

[0336] Microcrystalline cellulose: the rest up to 100%.: the rest up to 100 kg.

[0337] Technology:

[0338] All components are crushed and sifted through a 0.5 mm sieve

[0339] Mixed in a high-speed mixer-granulator for 25 minutes

[0340] Add magnesium stearate and mix for 5 minutes

[0341] Fill gelatin capsules

[0342] Polishing capsules in a perforated drum

[0343] Daily dose: 4 capsules of 0.5 g (2.0 g) provides: vitamin C - 140 mg, nicotinic acid 10 mg, succinic acid 32 mg.

[0344] EXAMPLE 7 OF EMBODIMENT OF THE INVENTION

[0345] Getting Marmalade

[0346] Composition per 100 kg, wt.%:

[0347] Burdock extract (liquid oil extract* 1:1) - 0.80 kg, which provides a dry extract content of 0.40 kg (0.40 wt.%);

[0348] Birdweed extract (liquid oil extract* 1:1) - 0.80 kg, which provides a dry extract content of 0.40 kg (0.40 wt.%);

[0349] Bay leaf extract (decoction* - in terms of dry matter content): 2.73 kg (2.73 wt.%);

[0350] Birch leaf extract (decoction* - in terms of dry matter content): 2.73 kg (2.73 wt.%);

[0351] Barberry extract (decoction* - in terms of dry matter content): 2.73 kg (2.73 wt.%);

[0352] Propolis extract (liquid infusion* - based on dry matter content): 0.55 kg (0.55 wt.%);

[0353] Vitamin C: 0.5 kg (0.5 wt%)

[0354] Nicotinic acid: 0.15 kg (0.15 wt%)

[0355] Succinic acid: 0.3 kg (0.3 wt%)

[0356] Hydrolyzed collagen: 8.0 kg (8.0 wt.%)

[0357] Apple (in the form of apple puree): 20.0 kg (20.0 wt.%)

[0358] Agar-agar: 1.5 kg (1.5 wt%)

[0359] Pectin: 2.0 kg (2.0 wt%)

[0360] Stevia: 20.0 kg (20.0 wt%)

[0361] Citric acid: 0.8 kg (0.8 wt%)

[0362] Flavour: 0.3 kg (0.3 wt%)

[0363] Purified water: the rest up to 100% (up to 100 wt.%).

[0364] Technology:

[0365] Preparing sugar syrup with agar-agar and pectin.

[0366] Introduction of fruit puree and plant extracts.

[0367] Adding flavoring.

[0368] Molding in silicone molds.

[0369] Drying at 30-35°C for 12 hours.

[0370] A 20 g serving provides: vitamin C - 100 mg, niacin 10 mg, succinic acid 60 mg.

[0371] *The specified amount of liquid extract / decoction / infusion ensures the dry matter content of the active component within the range stated in paragraph 1 of the formula.

[0372] EXAMPLE 8 OF EMBODIMENT OF THE INVENTION

[0373] Getting chewable lozenges

[0374] Composition per 100 kg of pastille mass (wt.%):

[0375] Burdock extract (dry concentrate): 10.0 kg (10.0 wt%)

[0376] Birdweed Extract (Dry Concentrate): 5.0 kg (5.0 wt.%)

[0377] Bay leaf extract (dry concentrate): 10.0 kg (10.0 wt%)

[0378] Birch leaf extract (dry concentrate): 10.0 kg (10.0 wt%)

[0379] Barberry extract (dry concentrate): 5.0 kg (5.0 wt%)

[0380] Propolis extract (dry concentrate): 0.25 kg (0.25 wt%)

[0381] Vitamin C: 2.0 kg (2.0 wt%)

[0382] Nicotinic acid: 2.0 kg (2.0 wt%)

[0383] Succinic acid: 0.7 kg (0.7 wt%)

[0384] Hydrolyzed collagen: 10.0 kg (10.0 wt.%)

[0385] Isomalt: 10.0 kg (10.0 wt%)

[0386] Pectin: 3.0 kg (3.0 wt%)

[0387] Sorbitol: 10.0 kg (10.0 wt%)

[0388] Citric acid: 1.5 kg (1.5 wt%)

[0389] Flavour: 0.5 kg (0.5 wt%)

[0390] Purified water: the rest up to 100%

[0391] Technology:

[0392] Preparation of sugar syrup (sugar substitute base) based on isomalt and sorbitol with pectin.

[0393] Dispersion of plant extracts in the base part.

[0394] Adding flavoring.

[0395] Vacuum boiling to 18% moisture.

[0396] Molding by casting method.

[0397] Dry in a convection dryer for 24 hours.

[0398] A 20g serving provides 80mg of vitamin C, 8mg of niacin, and 28mg of succinic acid.

[0399] EXAMPLE 9 OF EMBODIMENT OF THE INVENTION

[0400] Getting granules for making a drink

[0401] Composition per 100 kg of granulated mixture (wt.%):

[0402] Burdock extract (dry CO2 extract): 0.05 kg. (0.05 wt.%)

[0403] Birdweed Extract (Dry CO2 Extract): 0.05 kg. (0.05 wt.%)

[0404] Bay leaf extract (dry CO2 extract): 0.05 kg. (0.05 wt.%)

[0405] Birch leaf extract (dry CO2 extract): 0.05 kg. (0.05 wt.%)

[0406] Barberry extract (dry CO2 extract): 0.05 kg. (0.05 wt.%)

[0407] Propolis extract (dry CO2 concentrate): 0.02 kg (0.02 wt%)

[0408] Vitamin C: 3.0 kg (3.0 wt%)

[0409] Nicotinic acid: 0.2 kg (0.2 wt%)

[0410] Succinic acid: 0.5 kg (0.5 wt%)

[0411] Hydrolyzed collagen: 5.0 kg (5.0 wt.%)

[0412] Sucrose: 15.0 kg (15.0 wt%)

[0413] Flavour: 0.2 kg (0.2 wt%)

[0414] Sodium citrate: 0.3 kg (0.3 wt%)

[0415] Maltodextrin: the rest up to 100% (up to 100 wt.%).

[0416] Technology:

[0417] All dry components are ground to a fraction of 150-200 microns.

[0418] Mix in a planetary mixer for 20 minutes.

[0419] Granulated in a drum granulator.

[0420] Dried at 40°C to 3% moisture.

[0421] Packaged in 150g jars.

[0422] Daily dose: 1 serving (10 g) provides: vitamin C - 300 mg, nicotinic acid - 20 mg, succinic acid - 50 mg

[0423] *The specified amount of liquid extract / decoction / infusion ensures the dry matter content of the active component within the range stated in paragraph 1 of the formula.

[0424] EXAMPLE 10 OF EMBODIMENT OF THE INVENTION

[0425] Obtaining herbal tea for brewing

[0426] Composition per 100 kg of collection (wt.%):

[0427] Burdock extract (dry concentrate): 10.0 kg (10.0 wt%)

[0428] Birdweed Extract (Dry Concentrate): 10.0 kg (10.0 wt.%)

[0429] Bay leaf extract (dry concentrate): 10.0 kg (10.0 wt%)

[0430] Birch leaf extract (dry concentrate): 10.0 kg (10.0 wt%)

[0431] Barberry extract (dry concentrate): 5.0 kg (5.0 wt%)

[0432] Propolis extract (dry concentrate): 5.0 kg (5.0 wt%)

[0433] Vitamin C: 2.0 kg (2.0 wt%)

[0434] Nicotinic acid: 2.0 kg (2.0 wt%)

[0435] Succinic acid: 0.7 kg (0.7 wt%)

[0436] Hydrolyzed collagen: 10.0 kg (10.0 wt.%)

[0437] Sodium citrate: 0.3 kg. (0.3 wt.%)

[0438] Rosehip (in powder form): the rest up to 100 kg. (the rest up to 100 wt.%).

[0439] Technology:

[0440] All dry concentrates are crushed to a fraction of 2-5 mm and dried to a moisture content of 8-10%.

[0441] Mix in a ribbon mixer for 30 minutes.

[0442] Granulated in a drum granulator.

[0443] Stand to equalize moisture.

[0444] Packaged in filter bags of 2 g.

[0445] Daily dose: 1 serving (2 g) provides vitamin C - 20 mg, succinic acid - 20 mg.

[0446] EXAMPLE 11 OF EMBODIMENT OF THE INVENTION

[0447] Obtaining concentrate for functional nutrition

[0448] Composition per 100 kg of paste concentrate (wt.%):

[0449] Burdock extract (dry concentrate): 2.5 kg. (2.5 wt.%).

[0450] Birdweed extract (dry concentrate): 2.5 kg. (2.5 wt.%).

[0451] Bay leaf extract (dry concentrate): 3.5 kg. (3.5 wt.%)

[0452] Birch leaf extract (dry concentrate): 3.5 kg. (3.5 wt.%)

[0453] Barberry extract (dry concentrate): 3.5 kg. (3.5 wt.%)

[0454] Propolis extract (dry concentrate): 0.7 kg (0.7 wt%)

[0455] Vitamin C: 2.0 kg (2.0 wt%)

[0456] Nicotinic acid: 2.0 kg (2.0 wt%)

[0457] Succinic acid: 0.7 kg (0.7 wt%)

[0458] Hydrolyzed collagen: 10.0 kg (10.0 wt.%)

[0459] Apple (in the form of apple puree): 20.0 kg. (20 wt.%)

[0460] Whey protein concentrate: 15.0 kg. (15 wt.%)

[0461] Inulin: 10.0 kg. (10 wt.%)

[0462] Water: the rest up to 100 kg. (up to 100 wt.%).

[0463] Technology:

[0464] Mixing fruit and vegetable base.

[0465] Introduction of protein component and prebiotic.

[0466] Introduction of dry plant concentrates, collagen and other components into the base with vigorous stirring.

[0467] Emulsification of the whole mass.

[0468] Pasteurization at a temperature of 85±2°C with a holding time of 20-30 minutes

[0469] Product packaging.

[0470] Daily dose: 30 g (tablespoon) provides vitamin C - 600 mg, nicotinic acid - 60 mg, succinic acid - 200 mg

[0471] These examples are not limited to the possible forms of finished product preparation. No prophylactic effect is observed when administering these components in amounts lower than the indicated doses. Increasing the dose does not increase the therapeutic effect of the drug.

[0472] All samples provide composition stability for 24 months at temperatures not exceeding 25°C. The bioavailability of the active ingredients has been confirmed by pharmacokinetic studies.

[0473] These examples are not limited to the possible forms of finished product preparation. Experiments have shown that when administering these components in amounts below the lower limits of the stated ranges, no prophylactic or maintenance effect is observed. Exceeding the upper limits of the ranges does not result in a statistically significant increase in therapeutic effect, although the risk of individual reactions may increase.

[0474] All examples provided provide physiologically significant quantities of active ingredients within the safe range of use. The formulations are adapted for industrial production in the appropriate dosage forms.

[0475] Clinical evidence of efficacy (clinical data): Study Design: The efficacy and safety of the claimed nutritional composition was confirmed in an open, comparative, prospective study. Clinical observations conducted at the Rheumatology Department of the Rheumatology Bureau of Medical and Social Expertise, Moscow (120 patients with stage I-II knee osteoarthritis and rheumatoid arthritis) revealed the following results after 60 days of taking the nutritional composition "JOINT HERBS" in tablet form (Example 4):

[0477] Patient sample: The main group (n=60) included patients who received the composition at a dose of 2 tablets 3 times daily for 60 days along with standard therapy. The control group (n=60) received standard therapy alone.

[0478] Evaluation criteria: Visual Analogue Scale (VAS) pain index, duration of morning stiffness, Lequesne functionality index, need for non-steroidal anti-inflammatory drugs (NSAIDs).

[0479] Results: The data obtained, presented in Tables 4-6, demonstrated a statistically significant (p<0.05) superiority of the group receiving the "JOINT HERBS" nutritional composition in terms of the reduction in swelling, normalization of general urine analysis parameters, a decrease in leukocyturia, and the frequency of dysuric phenomena. Tolerability was assessed as good, and no side effects associated with the composition were recorded.

[0480] Results (main group after 60 days):

[0481] Reduction in pain intensity according to VAS by 52.9% (from 6.8±0.7 cm to 3.2±0.4 cm).

[0482] Decreased the duration of morning stiffness by 67.8% (from 38.5±5.2 min to 12.4±2.1 min).

[0483] Improvement of Lequesne index by 50.8% (from 12.4±1.3 points to 6.1±0.8 points).

[0484] Reduction in the need for NSAIDs by 63.1% (from 22.5±3.1 to 8.3±1.5 days / month).

[0485] Tolerability was assessed as good, no side effects associated with taking the composition were recorded.

[0486] TABLE 4: COMPARATIVE CHARACTERISTICS OF THE EFFICIENCY OF THE KNOWN LEVEL OF TECHNOLOGY WITH THE CLAIMED COMPOSITION FOR THE PREVENTION AND MAINTENANCE THERAPY OF INFLAMMATORY DISEASES OF THE MUSCULOSKELETAL SYSTEM

[0487] Comparison parameter Dietary supplement "Joint herbs" RU 2207144 C1 (Prototype) The declared nutritional composition "Joint herbs" in various forms of its presentation Benefits and improvements Anti-inflammatory effect (reduction of CRP) Moderate (15-20%) Expressed (35-50%) Potentiation of the effect due to synergy and a wide range of extracts Analgesic effect (pain reduction according to VAS) Moderate (35-40% after 60 days) Pronounced and more stable (50-53% after 60 days) Improved efficiency by 25-30% Reducing morning stiffness 40-45% 65-68% Increases the effect by 50% Effect on joint mobility (Lequesne index) Improvement by 20-25% Improvement by 40-50% Complex effect on cartilage metabolism and inflammation relief - Increased effect by ~70% due to complex chondroprotective action (collagen + knotweed + vitamin C). Release forms Pills Wide range (powders, syrups, capsules, marmalade) Ease of use and audience expansion Bioavailability Standard Improved through form variability and synergy More complete and rapid absorption of active substances Chondroprotective effect (according to ultrasound data) Not expressed Thickening of hyaline cartilage by 8-12% A fundamentally new quality Exchange rate efficiency A long course is required (from 60 days) A lasting effect is achieved by the 30th day. Reducing the course of treatment to achieve results

[0488] The claimed composition demonstrates statistically significant superiority in key parameters of efficacy and safety compared to known analogues.

[0489] Thus, the stated nutritional composition "JOINT HERBS," thanks to the synergistic combination of plant extracts, collagen, succinic acid, and vitamins, has pronounced anti-inflammatory, analgesic, and chondroprotective effects, confirmed by high FRAP activity and clinical data. A wide range of dosage forms makes it a convenient and effective remedy for the prevention and comprehensive support of musculoskeletal disorders.

[0490] TABLE 5: COMPARATIVE CHARACTERISTICS OF THE EFFICIENCY OF THE KNOWN LEVEL OF TECHNOLOGY IN COMPARISON WITH THE CLAIMED NUTRITIONAL COMPOSITION FOR THE PREVENTION AND MAINTENANCE THERAPY OF DISEASES OF THE MUSCULOSKELETAL SYSTEM

[0491] Comparison parameter Prototype (dietary supplement "Joint herbs" RU 2207144 C1) The declared nutritional composition "JOINT HERBS" in its various forms of presentation Benefits and improvements Composition of active ingredients Plant extracts (burdock, knotweed, birch, barberry, laurel, propolis) + Vitamin C + Nicotinic acid. Plant extracts + Collagen + Succinic acid + Vitamin C + Nicotinic acid. A fundamentally expanded composition: the introduction of hydrolyzed collagen (building substrate) and succinic acid (metabolic activator) provides structural and metabolic support that is absent from the prototype. Mechanism of action Anti-inflammatory + Mild diuretic (drainage). Anti-inflammatory + Antioxidant + Chondroprotective + Metabolic (energy supply) + Draining. Complex multi-level action: the synergy of components is aimed at all key links in pathogenesis (inflammation, oxidative stress, deficiency of building materials, trophic disorders). Bioavailability of active substances Standard, determined by the form of dry concentrates. Enhanced through the use of modern forms of extracts (CO₂), carrier fillers (maltodextrin) and synergistic interactions that enhance absorption (e.g. vitamin C for collagen). More complete and rapid absorption of key components. Onset of sustained effect (according to clinical data) 30-40 days from the start of treatment. 20-30 days from the start of treatment. The onset of a pronounced effect is accelerated by 30-40%, which is confirmed by data on the dynamics of pain and stiffness reduction. Chondroprotective effect (according to ultrasound data) Not expressed or weakly expressed. Structural-modifying effect: thickening of hyaline cartilage by 8-12% after the course. A fundamentally new quality: the composition not only relieves symptoms, but also promotes the restoration of cartilage tissue structure. Anti-inflammatory and analgesic efficacy (decrease according to VAS) 35-40% in 60 days. 50-53% in 60 days. The therapeutic effect is enhanced by 25-30% due to the potentiation of the action of plant extracts by succinic acid and the improvement of microcirculation. Antioxidant protection (FRAP activity of daily dose) Weak or moderate (not standardized). Potent: 1.4 to 140 mmol Trolox / day depending on the formulation. Activity comparable to concentrated berry juices. Reliable protection of joint tissues from oxidative stress, a key factor in damage in arthritis and arthrosis. Release forms Limited selection (tablets only). A wide range of technological forms: powders (sachets), syrups, ready-made drinks, capsules, marmalade, lozenges, jelly, concentrates. Convenience and personalization: increasing adherence to treatment by taking into account individual preferences and restrictions (diabetes, gluten / lactose intolerance). Organoleptic properties The pronounced bitterness of plant extracts causes an unpleasant taste. Improved, adapted for long-term use: bitterness is masked by flavoring components, fruit and berry components, and gelling agents. Psychological comfort when undergoing a preventive or maintenance course.

[0492] The claimed composition demonstrates statistically significant superiority in key efficacy and safety parameters compared to the prototype. The resulting synergistic effect is not obvious and is achieved through rigorous quantitative and qualitative selection of components, as well as modern technological solutions.

[0493] Justification of non-obviousness and synergy:

[0494] The obtained expressed technical result is not obvious because:

[0495] Multi-target effect: The components of the composition simultaneously and synergistically affect various pathogenesis targets (oxidative stress, inflammation, deficiency of building substrates, impaired microcirculation and energy metabolism), which is not achieved by known single-component or narrowly targeted analogues.

[0496] Bioavailability enhancement: There is a mutual enhancement of absorption and bioavailability of active substances (for example, propolis and birch flavonoids against the background of nicotinic acid).

[0497] Prolonged action: The creation of a flavonoid depot in connective tissue and long-term normalization of metabolism in chondrocytes under the influence of succinic acid are noted.

[0498] Structural and metabolic support due to the introduction of hydrolyzed collagen (a source of amino acids for the synthesis of its own collagen) and succinic acid (an activator of cellular energy metabolism, improving tissue trophism).

[0499] Enhances microcirculation and drainage thanks to the properties of extracts (barberry, propolis, birch leaf), which help improve blood supply to the joints and remove metabolites.

[0500] Thus, the claimed composition ensures the creation of a synergistic effect of complex multi-level impact on the musculoskeletal system, which is manifested in the simultaneous achievement of:

[0501] Anti-inflammatory and antioxidant effects confirmed by high FRAP activity and reduction of inflammation markers in the clinic.

[0502] Structural-metabolic support, confirmed by ultrasound data on increased cartilage thickness and significant improvement in joint function.

[0503] Improved trophism and drainage, confirmed by accelerated onset of effect and reduced swelling.

[0504] Thus, the claimed composition demonstrates pronounced synergism, ensuring the achievement of a technical result - increased effectiveness in diseases of the musculoskeletal system.

[0505] In conclusion, it should be noted that the stated technical result is achieved through the specified qualitative composition (a combination of 6 specific plant extracts, collagen, succinic, ascorbic, and nicotinic acids) and quantitative ratios of the components, as well as a wide selection of technologically advanced dosage forms, each of which, as demonstrated in the examples, provides a significant physiological dose of active ingredients. The synergy between the antioxidant properties of the extracts, the collagen-forming function of vitamin C and collagen, and the metabolic effects of succinic and nicotinic acids creates the basis for comprehensive and effective support of musculoskeletal health.

[0506] The declared nutritional composition demonstrates statistically significant superiority in key parameters of efficacy and safety compared to known analogues, which is confirmed by clinical studies.

[0507] The developed plant-based food composition is intended for mass production in the food and pharmaceutical industries. This plant-based food composition is effective for the prevention and maintenance of inflammatory diseases of the musculoskeletal system and can be used as a composition for the prevention and maintenance of inflammatory diseases of the musculoskeletal system for a wide range of consumers.

[0508] FIG. 1: COMPARATIVE ANALYSIS OF ANTIOXIDANT ACTIVITY (PER DAILY SERVING).

[0509] FIG. 2: CONTRIBUTION OF COMPOSITION COMPONENTS TO OVERALL FRAP ACTIVITY.

Claims

1. A nutritional composition based on plant raw materials for the prevention and maintenance therapy of inflammatory diseases of the musculoskeletal system, containing active components: extracts of plant raw materials and fillers, characterized in that the nutritional composition additionally contains succinic acid and collagen, while as extracts of plant raw materials it contains burdock extract, knotweed extract, bay leaf extract, birch leaf extract, barberry extract, propolis extract, wherein said extracts are selected from the group: a decoction, a dry concentrate, which is a dried decoction, infusion, aqueous extract or alcoholic extract, a liquid infusion or tincture, a liquid aqueous extract, a liquid alcoholic extract, a liquid oil extract, a dry CO2 extract, a liquid CO2 extract, as well as vitamin C and nicotinic acid in the following ratio, wt.%: Burdock extract in terms of dry matter 0,05-10 Knotweed extract in terms of dry weight substance 0,05-10 Bay leaf extract (dry basis) substance 0,05-10 Birch leaf extract in terms of dry substance 0,05-10 Barberry extract in terms of dry matter 0,02-5 Propolis extract in terms of dry matter 0,02-5 Vitamin C - ascorbic acid 0,2-8 Nicotinic acid 0,15-2 Succinic acid 0,03-7,0 Collagen 5,0-20,0 Fillers The rest up to 100% 2. The composition according to claim 1, characterized in that the fillers used are grain flour selected from the group: wheat, oat, rice, corn, buckwheat, rye or mixtures thereof.

3. The composition according to claim 1, characterized in that the fillers used are starches selected from the group: potato, corn, wheat, rice, tapioca or mixtures thereof.

4. The composition according to claim 1, characterized in that flavoring components are used as fillers - sugars selected from the group: sucrose, glucose, fructose, lactose, isomalt or mixtures thereof, or sugar substitutes selected from the group: stevia, saccharin, erythritol, sorbitol, xylitol or mixtures thereof.

5. The composition according to claim 1, characterized in that the fillers used are proteins selected from the group: whey protein, soy protein, pea protein, casein, egg albumin, milk protein concentrate, soy protein concentrate, amaranth grain proteins, or mixtures thereof.

6. The composition according to claim 1, characterized in that the fillers used are mineral components selected from the group: mineral waters, iodine-bromine waters, magnesium waters, sodium chloride waters, sea salt.

7. The composition according to claim 1, characterized in that purified water is used as a filler.

8. The composition according to claim 1, characterized in that the fillers used are filler carriers selected from the group: microcrystalline cellulose, maltodextrin, inulin, soluble dietary fiber; and lubricants selected from the group: magnesium stearate, colloidal silicon dioxide, calcium stearate, as well as sodium croscarmellose or mixtures thereof.

9. The composition according to claim 1, characterized in that the composition may additionally contain flavorings and acidity regulators selected from the group: citric acid, malic acid, tartaric acid, lactic acid, ascorbic acid, sodium or potassium citrates, or mixtures thereof.

10. The composition according to claim 1, characterized in that the fillers used are gelling agents selected from the group: pectin, agar-agar, gelatin, carrageenan, guar gum or mixtures thereof.

11. The composition according to paragraph 1, characterized in that fruits, berries, vegetables, and nuts are used as fillers.

12. The composition according to claim 11, characterized in that it contains cherries, pomegranates, rose hips, blackberries, apples, carrots, pumpkins, walnuts, pine nuts, raspberries, blueberries, and grapes as fruits, berries, vegetables, and nuts.

13. A composition according to any one of paragraphs 1-12, characterized in that a single portion of the composition contains 90-900 mg of vitamin C, 5-50 mg of nicotinic acid, and 10-200 mg of succinic acid.

14. A composition according to any one of paragraphs 1-13, characterized in that it is made in a convenient form for use, selected from the group: tablets, capsules, powder for preparing a drink, granules for preparing a drink, ready-made drink, syrup, jelly, lozenges, marmalade.

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