WO2021023600A1

WO2021023600A1 - Combination product for helping maintain the natural defenses of the organism and aiding with recovery

Info

Publication number: WO2021023600A1
Application number: PCT/EP2020/071443
Authority: WO
Inventors: Marilyn GENTILHOMME; France VIROUX
Original assignee: Urgo Recherche Innovation Et Developpement
Priority date: 2019-08-06
Filing date: 2020-07-29
Publication date: 2021-02-11
Also published as: FR3099698B1; FR3099698A1

Abstract

The invention relates to a combination product comprising, as active substances, at least royal jelly, spirulina, vitamin C, vitamin D3, B group vitamins, and at least one bacterial strain to help maintain the natural defenses of the organism and aid with recovery. The invention further relates to the use of a combination product as defined above for the prevention and/or treatment of infectious viral and bacterial diseases.

Description

Title of the invention: Combination product to help maintain the body's natural defenses and regain shape

[1] TECHNICAL FIELD

[2] The present invention relates to a combination product comprising as active substances, at least royal jelly, spirulina, vitamin C, vitamin D3, vitamins of group B as well as less a bacterial strain to help maintain the body's natural defenses and get back in shape. Finally, the invention relates to the use of a combination product as defined above for the prevention and / or treatment of infectious pathologies, whether of viral or bacterial origin.

[3] BACKGROUND

[4] Certain periods, such as growth, convalescence and cold stress and tire the body. Sometimes an unbalanced diet or lack of appetite does not meet your daily needs 100%. Children or adults are then more likely to show signs of fatigue and / or to contract infections, whether viral or bacterial.

[5] A viral disease, or virosis, is a disease initiated by a virus and its spread throughout the body (and at the expense of the body).

[6] RNA viruses can transform very quickly and overcome the host's defenses as shown by influenza (influenza). Viral illnesses are all illnesses, mild or severe, caused by a virus. They can be transmitted and take the form of an epidemic. There are many, many viral diseases. Among them, the common cold, angina, influenza, chickenpox, measles, smallpox, hepatitis B, AIDS ...

[7] Viral diseases are transmitted from person to person through saliva, promiscuity or sexual relations. More rarely, a viral illness can be contracted from the consumption of foods of animal origin. Each virus attacks a specific part of the body. It is this action that will allow the identification of the viral disease.

[8] A viral disease does not appear immediately after exposure. An incubation period can be noticed. This incubation lasts a few hours for an influenza and a few months for other viruses. [9] The manifestations of a viral illness are fever, headache, muscle aches, fatigue and lack of tone. Depending on the severity of the pathology, the general state of fatigue can be disabling. Some viral diseases have skin lesions as symptoms, such as chickenpox, measles, rubella or herpes.

[10] Other viral diseases such as the AIDS virus or polio cannot be cured. Early treatment of the patient ensures an optimized life expectancy and quality of life.

[11] Bacterial disease (or bacteriosis) is an infectious disease caused by bacteria. Bacterial diseases are very numerous in human pathology.

[12] Among the infectious pathologies, mention may be made, for example, of tonsillitis, nasopharyngitis, gastroenteritis, seasonal flu, colds, sinusitis, cough, bronchitis, sore throats, etc. ..

[13] The immune system is a complex system which protects the organism from external aggressions, be they viruses, bacteria or parasites. For this, it involves thousands of cells produced mainly in the bone marrow which then specialize in the thymus, spleen, lymph nodes, then circulate in the blood.

[14] Located behind the breastbone, the thymus is an extremely important gland in the development of the immune system: it positively selects cells (T lymphocytes) capable of recognizing what is foreign to the organism (the non-self. ), while it removes those that could react against our own constituents (the self).

[15] Good natural immunity makes it possible to eliminate many of these pathologies without treatment. In order to help the body maintain these natural defenses, the Applicant has developed a combination product comprising, as active substances, at least royal jelly, spirulina, vitamin C, vitamin D3. , B vitamins as well as at least one strain of bacteria.

[16] There are a number of products on the market to help maintain the body's natural defenses. Among these products, mention may be made, by way of example, of Immunité, from Bio Ponroy which contains: extract of astragalus, eleutherococcus and echinacea. Immunity Strong of Nutrigée, which contains: Andrographis, cat's claw, grapefruit seeds, maca, cola nuts and eleutherococcus, natural Vitamin C and D3, Copper and zinc. The product Defatyl Energy Plus Energy And Immunity (from Defatyl) is based on L-carnitine, taurine, vitamin B6, vitamin B12, vitamin Bl, vitamin B2, vitamin B9. Merck's Bion 3 Defense product contains ferments (Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum MF 20/5, Bifidobacterium longum SP 07/3), vitamins: A, Bl, B2, B3, B5, B6, B8, B9, B12, C, D, E and minerals : iodine, iron, zinc, selenium, chromium, manganese, magnesium.

[17] There are also products that help the body stay in shape.

[18] We can cite as an example the product Vitality 4G energizing Shot from Forté Pharma Laboratories which contains ginseng, guarana, ginger, royal jelly, acerola and vitamin C.

[19] None of the products offered contains the combination which is the subject of the present invention.

[20] These products are not entirely satisfactory in terms of helping to maintain the body's natural defenses and keeping the body in shape.

[21] The combination product of the present invention helps to maintain the body's natural defenses by stimulating and strengthening the immunity of individuals. It also helps the body to get back in shape. The product of the present invention is without side effects or addiction.

[22] Thus, the product according to the present invention makes it possible to increase resistance against fatigue, in particular thanks to the presence of royal jelly, vitamin C and spirulina, to increase the body's resistance to external aggressions. , especially thanks to spirulina and the bacterial strain, and to increase physical resistance, in particular thanks to vitamin D which participates in bone growth.

[23] The product according to the present invention therefore has the advantage of combining a bacterial strain, a “superfood”, bee products and vitamins in a single intake.

[24] The product of the present invention is preferably in the form of vials allowing optimum preservation of the composition.

[25] SUMMARY OF THE INVENTION

[26] The present invention relates to a combination product, comprising as active substances at least:

(i) royal jelly,

(ii) spirulina,

(iii) vitamin C,

(iv) vitamin D3,

(v) group B vitamins

(vi) at least one bacterial strain to help maintain the body's natural defenses and get back in shape [27] Preferably, group B vitamins are chosen from group B vitamins are chosen from vitamin B1, B2 and B6 or a combination of these vitamins.

[28] Preferably, the bacterial strain is a lactic acid bacterium, more preferably of the genus Lactobacillus rhamnosus.

[29] The present invention also relates to a combination product, comprising as active substances at least:

(i) royal jelly,

(ii) spirulina,

(iii) vitamin C,

(iv) vitamin D3,

(v) group B vitamins

(vi) at least one bacterial strain for its use in the prevention and / or treatment of infectious pathologies.

[30] In certain embodiments, the combination product according to the invention comprises, in addition to royal jelly, spirulina, vitamin C, vitamin D3, vitamins of group B as well as at least a bacterial strain, as active substances:

Plants or plant extracts, such as for example astragalus, ginseng, guarana or eleutherococcus

Vitamins and minerals, such as for example vitamin A, vitamin E, and / or zinc, iron or selenium

[31] In certain embodiments of the invention, the combination product according to the invention may be in the form of a single (or combined) composition containing at least as active substances:

(i) royal jelly,

(ii) spirulina,

(iii) vitamin C,

(iv) vitamin D3,

(v) group B vitamins

(vi) at least one bacterial strain in a physiologically acceptable medium.

[32] In certain embodiments, the combination product of the invention is characterized in that the royal jelly, spirulina, vitamin C, vitamin D3, group B vitamins as well as the bacterial strain are administered under the shape of a flask comprising (1) a dry part which comprises: from 20 to 300 mg, preferably 30 to 100 mg of vitamin C from 0.05 to 8 mg, preferably 0.2 to 6 mg of vitamin B1 from 0.05 to 8 mg of preferably 0.2 to 6 mg of vitamin B2 from 0.05 to 8 mg preferably 0.2 to 6 mg of vitamin B6 from 0.5 to 20 pg, preferably 1 to 10 pg of vitamin D3 from 0.5 to 5 billion colony forming units, preferably 0.75 to 2 billion bacterial strain colony forming units

(2) other liquid part which comprises: from 50 to 500 mg, preferably from 100 to 300 mg of royal jelly from 50 to 500 mg, preferably from 100 to 300 mg of spirulina

[33] According to a particular embodiment of the invention, the combination product is characterized in that the active ingredients (i), (ii), (iii), (iv), (v) and (vi) are in a medium suitable for oral administration. In the context of the present invention, the combination product comprises two forms, a dry and a liquid, the two forms being mixed just before ingestion. This makes it possible to improve the stability of all the active ingredients entering into the composition according to the invention.

[34] An example of a vial that can be used in the context of the present invention is described in patent EP 2 616 354. The closure device of this type of vial or container is adapted to contain a first component (in the context of the present invention, the dry part) which, when the vial is opened, will be released into the vial which contains the liquid part.

[35] The various embodiments of the invention are particularly described in the detailed description below. These embodiments can be taken separately or in combination with each other.

[36] DETAILED DESCRIPTION OF THE INVENTION:

[37] In the present invention, the Applicant has demonstrated that the combination of at least, (i) royal jelly, (ii) spirulina, (iii) vitamin C, (iv) vitamin D3, (v) group B vitamins, (vi) at least one bacterial strain, exhibited a synergistic effect to help maintain the body's natural defenses and regain shape.

[38] By synergistic effect, it is understood according to the present invention that the combination of at least (i) royal jelly, (ii) spirulina, (iii) vitamin C, (iv) vitamin D3, (v) vitamins of group B, (vi) at least one bacterial strain, has an effect on helping to maintain the body's natural defenses and on helping to regain the form, during the treatment which is superior to the cumulative effects of a treatment not comprising this association or comprising only part of this association.

[39] Royal jelly

[40] Royal jelly is the secretion product of the cephalic glandular system (hypopharyngeal glands and mandibular glands) of worker bees, between the fifth and the fourteenth day of their existence (workers who then bear the name of nurse). Royal jelly contains lipids (4.5%), carbohydrates (14.5%), proteins (13%) and water (approximately 66%).

[41] It also contains vitamins (royal jelly is the richest known natural product in vitamin B5), trace elements, acetylcholine (up to 1 mg g— 1), antibiotics particularly active against bacteria of the genus Proteus and on Escherichia coli B.

[42] Royal jelly contains a considerable proportion of protein, amino acids, lipids, vitamins and sugars, and is often considered to have various nutritional and medicinal benefits in humans. Some in vivo and in vitro experiments have made it possible to suggest vasodilator and hypotensive, anticholesterolemic and anticarcinogenic activity.

[43] The composition according to the present invention comprises from 50 to 500 mg, preferably from 100 to 300 mg of royal jelly.

[44] Spirulina

[45] Spirulina is an algae that has existed as it is for more than 3 billion years. So named because of its spiral shape, it belongs to the family of cyanobacteria or blue-green microalgae. There are nearly 1,500 species of blue algae, and 36 species of spirulina are edible. The main species currently available on the market is Spirulina platensis. First cultivated mainly in California and Hawaii, spirulina is now produced in a controlled manner all over the world where the climate allows it: Chile, China, Cuba, India, West Africa, Greece (in geothermal greenhouses), etc. In the market, spirulina is generally in the form of a dehydrated blue-green powder, in bulk or in capsules.

[46] Spirulina, low in calories, contains a wealth of nutrients in a very small volume. Its content can however vary according to its geographical origin, but also according to the cultivation, drying and grinding processes. [47] Spirulina contains 55% to 70% protein of excellent quality (proportion of amino acids and optimal digestibility), or 2.5 g to 3.5 g of protein per 5 g of powder.

[48] Spirulina is an exceptional source of various carotenoids (mainly beta-carotene, but also cryptoxanthin, lutein, zeaxanthin, etc.), ie around 22 mg / 5 g. In particular, it provides an astronomical amount of beta-carotene, ie from 12,000 III to 25,000 III per 5 g of powder.

[49] It is an excellent source of iron, from 3 mg to 8 mg per 5 g.

[50] It contains a significant amount of gamma-linolenic acid (40 mg to 50 mg / 5 g), an unsaturated fatty acid from the omega-6 family.

[51] In addition, spirulina is rich in phycocyanin, the only natural blue pigment that can serve as a food coloring and which is attributed a significant antioxidant activity. It also contains chlorophyll and small amounts of several minerals.

[52] This is why we often speak of this alga as a "superfood".

[53] The composition according to the present invention comprises from 50 to 500 mg, preferably from 100 to 300 mg of spirulina. Its quantities of spirulina represent in plant equivalent from 500 to 5000 mg, preferably 1000 to 3000 mg.

[54] Vitamin C

[55] Vitamin C is a water soluble, heat and light sensitive vitamin that plays an important role in the metabolism of humans and many other mammals. Chemically speaking, it is L-ascorbic acid, one of the stereoisomers of ascorbic acid, and its salts, the ascorbates. The most common are sodium ascorbate and calcium ascorbate.

[56] Vitamin C is an enzymatic cofactor involved in a number of physiological reactions (hydroxylation). It is required in the synthesis of collagen and red blood cells and contributes to the immune system. It also plays a role in the metabolism of iron as a promoter of its absorption; its use is therefore not recommended in patients with an iron overload and particularly hemochromatosis. In oxidized form (dehydroascorbic acid), it crosses the blood-brain barrier to access the brain and several organs with a high concentration of vitamin C.

[57] This vitamin is widely used as a self-medication for the common cold. It seems to shorten the duration of symptoms and improve them in adults. [58] The composition according to the present invention comprises 20 to 300 mg, preferably 30 to 100 mg of vitamin C.

[59] Vitamin B1

[60] Thiamine or vitamin B1 (or aneurine) is a metabolic precursor of thiamine pyrophosphate (TPP), a coenzyme essential for certain decarboxylases. In animals, thiamine is a water-soluble vitamin from the family of B vitamins that they must find in their diet. On the other hand, it is synthesized by bacteria, plants and fungi. It is essential for the transformation of carbohydrates into energy by the Krebs cycle and is necessary for the proper functioning of the nervous system and muscles. It is in fact essential for the transformation of pyruvate produced by glycolysis and toxic for the nervous system.

[61] In humans, a dietary vitamin B1 deficiency causes beriberi and can also cause Gayet-Wernicke encephalopathy.

[62] In humans, the estimated requirements are 1.3 mg to 1.5 mg per day. In healthy adults, digestive absorption is 4.5% of the ingested dose, and drops to 1.5% in cases of alcohol dependence.

[63] The composition according to the present invention from 0.05 to 8 mg, preferably 0.2 to 6 mg of vitamin B1.

[64] Vitamin B2

[65] Vitamin B2, corresponding to riboflavin, or lactoflavin, is a water-soluble vitamin required for the synthesis of flavin adenine dinucleotide (FAD) and flavin mononucleotide (FMN), two essential cofactors of flavoproteins.

[66] Vitamin B2 plays an important role in converting simple foods (carbohydrates, fats and proteins) into energy. It is involved in the repair metabolism of muscles.

[67] Riboflavin is found naturally in asparagus, popcorn, bananas, persimmons, okra, Swiss chard, cheese, milk, yogurt, meat, eggs, fish and beans. greens, each of which contains at least 0.1 mg of vitamin B per 85-300g. Other sources are green leafy vegetables, liver, kidneys, legumes, tomatoes, yeasts, mushrooms and almonds.

[68] It is also used as a disease-modifying treatment for migraine.

[69] The composition according to the present invention comprises from 0.05 to 8 mg, preferably 0.2 to 6 mg of vitamin B2.

[70] Vitamin B6 [71] Vitamin B6 is a water-soluble vitamin that exists in several forms, pyridoxal phosphate being its biologically active form, as a cofactor involved in several reactions of amino acid metabolism, including transaminations, deaminations and decarboxylations. Pyridoxal phosphate is also involved in the reaction of hydrolysis of glycogen to glucose.

[72] Vitamin B6 is known in seven different forms, interconvertible between them except the last one:

1.pyridoxine (PN), the form in which vitamin B6 is administered as a food supplement,

2.pyridoxine phosphate (PNP),

3.pyridoxal (PL),

4.pyridoxal phosphate (PLP), biologically active form (distributed as vitamin supplement "P-5-P"),

5.pyridoxamine (PM),

6.pyridoxamine phosphate (PMP),

7. 4-pyridoxic acid (PA), a catabolite excreted in the urine.

[73] Vitamin B6 participates in the transformation of tryptophan into vitamin B3, and in the metabolism of lipids and amino acids (decarboxylation and transamination). Pyridoxal phosphate allows the conversion of glycogen into glucose (Glucose-1-Phospate) by Glycogen phosphorylase.

[74] Vitamin B6 also participates in the biosynthesis of serotonin.

[75] It is present in large quantities in poultry, livers (beef, lamb, veal), bananas, various forms of cabbage, tomatoes, spinach, potatoes ...

[76] Associated with cystine, it is administered to facilitate the development of integuments (hair, nails, etc.).

[77] The composition according to the present invention comprises from 0.05 to 8 mg, preferably 0.2 to 6 mg of vitamin B6.

[78] Vitamin D3

[79] Cholecalciferol is a form of vitamin D, also called vitamin D3. Vitamin D3 is a secosteroid rather related to testosterone, cholesterol and cortisol.

[80] Vitamin D has a dual origin: it is provided by food and synthesized by the body in the skin under the action of UVB rays from the sun. [81] People with very little exposure to the sun may have varying degrees of vitamin D deficiency. People with fair skin synthesize vitamin D faster than those with dark skin, and therefore need a long period of time. shorter exposure to convert vitamin D precursors produced by the liver into vitamin D. The amount of vitamin D that the skin can produce is limited; prolonged exposure to sunlight (more than 30 minutes for a fair-skinned person, up to three hours for a dark-skinned person) does not increase the amount of cholecalciferol produced by the body. For a person with fair skin, an exposure of 10 to 15 minutes a few times a week is enough to cover the needs in vitamin D3. Vitamin D produced by the skin is stored in the liver, muscle and fatty tissue and used on demand during winter periods.

[82] Two forms of vitamin D exist: vitamin D2 or ergocalciferol produced by plants and vitamin D3 or cholecalciferol produced by animals, as well as by certain lichens. In humans, these two forms are converted to 1,25-dihydroxyvitamin D (commonly known as vitamin D), their main active metabolite.

[83] The essential function of vitamin D is to increase the absorption capacity of the intestine for calcium and phosphorus which allows:

1. ensure optimal mineralization of mineralized tissues, in particular bone, cartilage and teeth;

2. contribute to the maintenance of plasma concentrations of calcium and phosphorus.

[84] The clinical signs of vitamin D deficiency are: osteomalacia and rickets in the bone, decreased muscle tone, tetany attacks and convulsions (related to hypocalcemia) and sometimes anemia. In the elderly, vitamin D deficiency constitutes a favorable ground for bone loss (therefore osteoporosis), and depression (as confirmed by a Dutch study mentioned in Archives of General Psychiatry (May 2008)) .

[85] Several age groups constitute populations at risk of vitamin D deficiency: they are newborns, infants, pregnant women and the elderly, particularly those placed in institutions, who are not exposed to the sun much. and / or have increased needs. Other factors may worsen these risks of deficiency, the strong skin pigmentation, specific diets (vegetarian, macrobiotic), pathologies inducing intestinal malabsorption.

[86] The recommended nutritional intake of vitamin D was defined considering that endogenous production covers 50 to 70% of the daily requirements of this vitamin. [87] A limited number of foods contain significant amounts of vitamin D. Indeed, these levels are closely linked to the presence of fat in foods. The best sources of vitamin D are fatty sea fish, whatever their method of preparation and conservation (boiling, smoking, canning, grilling): herring, salmon, sardines, mackerel for example. Egg yolks, dairy products, soy and its derivatives (tofu and soy milk for example) and certain mushrooms (with great differences depending on the variety) are also sources of vitamin D. Low amounts of vitamin D are also provided by meats, offal and pâtés. Lean fish (ray, sole, hake ...) do not have them. Some lichens also produce cholecalciferol (vitamin D3), and are used to produce plant food supplements with this vitamin.

[88] The composition according to the present invention comprises from 0.5 to 20 pg, preferably 1 to 10 pg of vitamin D3.

[89] The bacterial or probiotic strain

[90] Initially, probiotics are living microorganisms (bacteria or yeasts) which, added as a supplement to certain food products such as yogurt or cereals, and ingested in adequate quantities, are believed to confer a health benefit on the body. the healthy host.

[91] In 2001, the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) gave an official definition of probiotics which are "living microorganisms that , when ingested in sufficient quantity, exert positive effects on health, beyond the traditional nutritional effects ”.

[92]

[93] The human gut microbiota (preferred term to that of microflora) comprises 800 to 1000 known microbial species15 and its diversity in dominant species is unique to each. Quantitatively, it is very stable over time (for a given individual over 2 months to 2 years), although it is not possible to define an intestinal microbiota of the human species by the profile of dominant species. . It is a consortium adapted to the host, stable, that is to say resistant to modification.

[94] Among the microorganisms used, lactic acid bacteria are the most widely used. They are natural hosts for the human gut microbiota.

[95] The most studied probiotics belong to two genera:

1. Bifidobacterium spp. more particularly the species Bifidobacterium bifidum (bifidus), Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breve ... 2. Lactobacillus spp. more particularly Lactobacillus reuteri, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus ...

[96] The most recent studies show that depending on the strain and the animal species tested, the effects differ. They can decrease the duration of acute infectious diarrhea or persistent diarrhea in children. Probiotics tend to reduce inflammation in the gut.

[97] They showed an interest in a number of intestinal pathologies of infectious or inflammatory origin: gastroenteritis; peptic ulcer; Crohn's disease; for type 2 diabetes and obesity, specific intestinal flora are also observed; infant health (by preventively improving the immune system, which thus better blocks certain neonatal sepsis).

[98] The mechanisms of action of probiotics are based on a symbiosis effect by allowing the intestinal microbiota to retain a predominantly non-pathogenic dominance. They modulate the activity of the intestinal immune system, strengthening general immunity when it is weak, for example in children, immature (newborns) or the elderly. Conversely, they could decrease the over-activation of the immune system, in the event of allergies or inflammatory bowel diseases, thus improving the barrier function of the intestinal mucosa by increasing the production and quality of mucus and / or IgA-type antibodies. They have a direct anti-pathogenic effect (by competition) by limiting the adhesion of pathogens to the intestinal walls.

[99] Preferably, the bacterial strain is a lactic acid bacterium, more preferably of the genus Lactobacillus rhamnosus.

[100] In the context of the present invention, the Lactobacillus Rhamnosus strain (ATCC n. 53103) will be preferred.

[101] The composition according to the present invention comprises from 0.5 to 5 billion colony-forming units, preferably from 0.75 to 2 billion colony-forming units of a bacterial strain. Physiologically acceptable medium

[102] A physiologically acceptable medium is a medium having no toxic or detrimental effect under the conditions of use and inert with respect to the active ingredients of the combination product. Such a medium can, for example, comprise different adjuvants according to its therapeutic or cosmetic purpose, such as, without limitation, flavors, colorants, fillers, diluents, wetting or suspending agents, etc. Such media can also allow immediate, modified or delayed release of one or other of the active ingredients. [103] The physiologically acceptable medium can be composed of texturizers, colorants, flavors, sugar or sugars.

[104] The term “texturizers” is understood to mean the compounds which modify the texture of the products in which they are incorporated. Examples of texturizers are: guar and carob flour; gum arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; gelatin; pectin; alginates (E400 to E405); agar-agar; and their mixtures. The term “dyes” is understood to mean compounds of natural or synthetic origin capable of conferring on themselves a coloring on the composition. Examples of food colors are known in Europe under the codes E100 to E180. In the context of the present invention, only the liquid part contains a dye. Preferably this colorant is a caramel colorant.

[105] The term “aromas” is understood to mean compounds of natural or synthetic origin which are capable on their own of modifying the taste of the composition. Examples of flavors are apricot, pineapple, banana, black currant, cherry, lemon, lime, strawberry, raspberry, passion fruit, tangerine, mint, orange , pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, currant, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, essential oils and mixtures thereof. In the context of the present invention, only the liquid part contains an aroma. Preferably, this aroma is a white peach aroma.

[106] For the purposes of the present invention, the term “sugar or sugars” is understood to mean any sweetening carbohydrate or any sweetening agent, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, or theirs. mixtures. In the context of the present invention, the sugars used are fructose, honey and sucralose.

[107] The composition according to the present invention also contains preservatives.

[108] In the context of the present invention, the combination product is in the form of a vial combining a liquid form and a dry form. For the purposes of the present invention, the term “dry form” is understood to mean a form free from liquid, exhibiting a residual moisture level, when it is measured by the loss on drying method, of less than 20%, preferably less than 10%, more preferably less than 5%. For the purposes of the present invention, the term “liquid form” means a syrup, an emulsion or a solution.

[109] Additional asset (s)

[110] Any additional active having a nutritional interest and / or helping to maintain the natural defenses of the organism can also be added to the products of combination of the invention in pharmaceutical or cosmetic form. The combination product may comprise, by way of example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.

[111] Advantageously, such an additional active agent can be intended to enhance the desired effect as described above.

[112] Of course, a person skilled in the art will take care to choose the additional active agents as well as their quantity in such a way that the advantageous properties of the composition in accordance with the invention are not, or substantially not, altered by the addition envisaged. .

[113] As additional usable assets, we can cite:

- water-soluble vitamins and fat-soluble vitamins. Examples of water-soluble vitamins present in the syrupy product prepared according to the invention are in particular: vitamin B3 (nicotinic acid) also called vitamin PP (Pellagra Preventive), vitamin B5 (pantothenic acid), vitamin B8 or H (biotin) , vitamin B9 (folic acid) and vitamin B12 (cobalamin). Examples of fat-soluble vitamins present in the syrupy product prepared according to the invention are in particular: vitamin A (retinol), vitamin E (mixture of tocopherols and tocotrienols) and vitamin K (phylloquinone).

- antioxidants, such as curcuminoids; carotenoids, especially chosen from beta.-carotene, astaxanthin, zeaxanthin, lutein or compounds containing them, such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidol oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; extracts of ginkgo biloba; grape extracts rich in proanthocyanidins; chilli extracts; soy extracts; Cocoa ; the grenade ; the Emblica; CoenzymeQ10; selenium,

- minerals, such as zinc, calcium, copper, iron, iodine, manganese, selenium, chromium (III),

- amino acids, in particular sulfur-containing amino acids, such as precursors of glutathione, amino acids of selenium, citrulline,

- phytosterols, resveratrol, hesperidin, neohesperidin, orthosilicic acid, monomethylsilanetriol, and mixtures thereof.

[114] Preferably, a combination product according to the invention is administered orally. [115] Preferably, the combination product according to the invention is in the form of a vial comprising two parts, one part containing the liquid form and the closure device of this type of vial is adapted to contain the dry part which , when opening the vial, will be released into the vial which contains the liquid part.

[116] The active ingredients thus preserved exhibit better bioavailability and better stability over time.

[117] Example 1 of composition according to the invention

[Table 1]

[118] Vitamins C, B1, B2, B6 and D3 are incorporated into the composition in the form of a solution. They are present in an amount of 40 mg, 0.80 mg, 1.10 mg, 0.70 mg and 5pg respectively.

[119] Manufacturing process:

All the compounds of each of the liquid and dry phases are mixed, then packaged in vials as described in patent EP 2616354.

Claims

Claims [Claim 1] Combination product comprising as active substances at least: (i) royal jelly, (ii) spirulina, (iii) vitamin C, (iv) vitamin D3, ( v) vitamins of group B (vi) at least one bacterial strain to help maintain the body's natural defenses and restore the form characterized in that royal jelly, spirulina, vitamin C, vitamin D3, the vitamins of group B as well as the bacterial strain are administered in the form of a vial comprising

(1) a dry part which comprises: from 20 to 300 mg, preferably 30 to 100 mg of vitamin C from 0.05 to 8 mg, preferably 0.2 to 6 mg of vitamin B1 from 0.05 to 8 mg of preferably 0.2 to 6 mg of vitamin B2 from 0.05 to 8 mg preferably 0.2 to 6 mg of vitamin B6 from 0.5 to 20 pg, preferably 1 to 10 pg of vitamin D3 from 0.5 to 5 billion colony forming units, preferably 0.75 to 2 billion bacterial strain colony forming units

(2) a liquid part which comprises: from 50 to 500 mg, preferably from 100 to 300 mg of royal jelly from 50 to 500 mg, preferably from 100 to 300 mg of spirulina [Claim 2] Combination product according to claiml characterized in that the bacterial strain is a lactic acid bacterium, more preferably of the genus Lactobacillus rhamnosus.

[Claim 3] Combination product according to one of the preceding claims, characterized in that the physiologically acceptable medium is suitable for oral administration.

[Claim 4] Combination product according to at least one of the preceding claims, for the prevention and / or treatment of infectious pathologies.