EP2605784A1 - Préparation à deux phases et son utilisation pour le traitement de l'herpès - Google Patents

Préparation à deux phases et son utilisation pour le traitement de l'herpès

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Publication number
EP2605784A1
EP2605784A1 EP11755255.4A EP11755255A EP2605784A1 EP 2605784 A1 EP2605784 A1 EP 2605784A1 EP 11755255 A EP11755255 A EP 11755255A EP 2605784 A1 EP2605784 A1 EP 2605784A1
Authority
EP
European Patent Office
Prior art keywords
phase
vitamin
preparation
extract
magnesium
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11755255.4A
Other languages
German (de)
English (en)
Inventor
Ernst-Otto Von Drachenfels
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
NUTRITEAM GmbH
Original Assignee
NUTRITEAM GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/EP2010/061912 external-priority patent/WO2012022373A1/fr
Application filed by NUTRITEAM GmbH filed Critical NUTRITEAM GmbH
Priority to EP11755255.4A priority Critical patent/EP2605784A1/fr
Publication of EP2605784A1 publication Critical patent/EP2605784A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a novel two-phase preparation.
  • the new two-phase preparation is used as a dietary supplement, as a dietetic and / or as a medicament.
  • the preparation is used to support the immune system (e.g., in acquired immunodeficiency).
  • the immune system e.g., in acquired immunodeficiency.
  • the medical use for the treatment of viral diseases especially for the treatment of herpes simplex (triggered by the herpes simplex virus), especially
  • Propagation phase of the viruses come. This usually happens at the corner of the mouth, where epithelial cells are infested and used to produce new viruses. This occurs at about 20% of the population at least once a year, with a small part every 4-8 weeks. This reactivation phase lasts 11-14 days.
  • the spread of the affected area is usually between 3 and 5 mm in size, but can also affect the entire lip.
  • a real health problem is usually not herpes cold sores. Usually it is a cosmetic problem, due to the cracking of the mouth, it is also a bit painful, but rather annoying. Especially due to the mental impairment, cold sores are not only classified as a cosmetic problem, but often as a disease.
  • Type 1 This group includes patients in whom the immune system can not prevent herpes reactivation because there is a lack of micronutrients (deficiency of the body). These include competitive athletes and risk groups, where the deficiency occurs due to diet.
  • Type 2 The so-called Ekelherpescuba does not suffer from a deficiency situation with recurrent herpes reactivations, but due to other causes (for example, psychological causes such as disgusting).
  • Object of the present invention is to provide a preparation comprising vitamins and plant components and optionally minerals and / or trace elements, which on the one hand excludes or reduces the mutual obstruction of the individual components, on the other hand favors the mutual support and so the better absorption and / or effect the individual
  • the co-administered active ingredients have a synergistic effect, i. the desired effect of the individual active substances is by the common
  • Inventive preparation can be used as a dietary supplement and / or as a dietetic.
  • Another object of the present invention is to provide a preparation for promoting and promoting the health and regeneration and / or support of the immune system.
  • the immune system Preferably, the
  • the invention provides a preparation for the treatment of herpes by means of the immune system, such as for the treatment of herpes simplex, in particular herpes labialis (cold sores) and genital herpes.
  • the present invention is directed to a two-phase preparation for temporally graduated application
  • phase (A) comprising, in addition to water-soluble vitamins and / or the associated provitamins, plant constituents and optionally minerals and / or trace elements in a first unit dosage form
  • phase (B) comprising, in addition to fat-soluble vitamins and / or the associated provitamins, plant constituents and optionally minerals and / or trace elements in a second unit dosage form,
  • phase (A) preferably contains grape-seed extract and / or cranberry juice powder as plant constituents and that phase (B)
  • phase (A) does not contain green tea extract.
  • the present invention is directed to a kit comprising
  • phase (a) a phase (A) comprising, in addition to water-soluble vitamins and / or the associated provitamins, plant constituents and optionally minerals and / or trace elements in a first unit dosage form
  • phase (B) comprising, in addition to fat-soluble vitamins and / or the associated provitamins, plant constituents and optionally minerals and / or trace elements in a second unit dosage form
  • phase (A) preferably contains grape-seed extract and / or cranberry juice powder as plant constituents and that phase (B)
  • the unit dosage forms of phases (A) and / or (B) are oral dosage forms, typically selected from the group consisting of capsules, tablets, dragees, pills, granules, effervescent tablets, powders,
  • Drinking solutions and drinking suspensions are capsules.
  • the time interval is preferably at least 2 hours and preferably at most 28 hours and may be, for example, 2, 5, 8, 12, 24 or 28 hours.
  • a time interval of more than 28 hours is only in
  • the phases (A) and (B) at the same time of day preferably taken to a meal, for example, for breakfast or dinner, on alternating days.
  • the two-phase preparation according to the invention serves in one embodiment for use as a medicament, in particular for use in the treatment and / or prevention of herpes simplex, in particular of herpes labialis.
  • the administration takes place in a time-graduated manner as described above, in particular on alternating days at the same time of day.
  • the two-pass product of the present invention can also be used to protect cells from free radicals (e.g., caused by oxidative stress) both in vivo and in vitro.
  • Fig. 1 shows the effect of the two-phase product of the invention on a
  • the present invention teaches that the active ingredients contained in the grape seed extract advantageously together with water-soluble vitamins,
  • phase (A) Trace elements are applied (hereinafter referred to as phase (A)) and that the active ingredients contained in the extract of green tea advantageously used together with fat-soluble vitamins, provitamins and any minerals and / or trace elements (hereinafter referred to as phase (B)).
  • phase (B) the phases (A) and (B) are used graduated in time.
  • Grape-seed extract contains in part similar active ingredients as cranberry juice powder.
  • grape-seed extract can in one embodiment
  • Cranberry juice powder will be replaced. Particularly preferred are the
  • Green tea extract contains in part similar active ingredients as pomegranate extract. Accordingly, green tea extract in one embodiment by
  • the fat-soluble vitamins are particularly preferably used together with green tea extract and pomegranate extract.
  • Phase (A)
  • phase (A) besides water-soluble vitamins (and / or associated provitamins) preferably comprises grape-seed extract and / or cranberry juice powder.
  • phase (A) contains no vitamin C, no biotin, no fat-soluble vitamins and / or no green tea extract.
  • phase (A) advantageously comprises both grapefruit extract and cranberry juice powder.
  • phase (A) contains grape-seed extract
  • phase (A) advantageously comprises 40 mg - 160 mg grape-seed extract, preferably 60 mg - 120 mg
  • Grape-seed extract and most preferably 75 mg - 85 mg of grape-seed extract.
  • phase (A) contains cranberry juice powder
  • phase (A) advantageously comprises 20 mg - 80 mg cranberry juice powder, preferably 30 mg - 60 mg cranberry juice powder, and most preferably 35 mg - 45 mg cranberry juice powder.
  • phase (A) examples include
  • vitamin B 5 D-pantothenic acid
  • vitamin B 3 niacin
  • vitamin B 6 preferably as pyridoxine HCl
  • riboflavin vitamin B 2
  • vitamin Bi preferably as
  • phase (A) comprises, in addition to grape-seed extract and / or cranberry juice powder, all of the said preferred vitamins, ie D-pantothenic acid (vitamin B 5 preferably as calcium D-pantothenate), niacin (vitamin B 3 , preferably as nicotinamide), Vitamin B 6 (preferably as pyridoxine HCl), riboflavin (Vitamin B 2 ), Vitamin Bi (preferably as
  • Thiamine mononitrate preferably as cyanocobalamin
  • vitamin Bi 2 preferably as cyanocobalamin
  • folic acid Thiamine mononitrate
  • the preferred water-soluble vitamins are advantageously used in the following amounts:
  • Vitamin Bi 1 mg 7 mg Vitamin Bi, preferably 2.5 mg - 4.1 mg Vitamin Bi
  • 0.1 - 1 mg folic acid preferably 0.2 - 0.6 mg folic acid.
  • free D-pantothenic acid is chemically unstable, is preferably the
  • Vitamin B 6 is usually used as pyridoxine HCl. Vitamin B is ⁇ as a rule
  • Vitamin Bi 2 is preferably used as a 1% inulin powder preparation.
  • phase (A) additionally comprises selenium and / or magnesium.
  • Selenium is preferably used as a sodium selenite, in the form of a 1% Maltodexxtnn powder formulation.
  • Magnesium is preferably used as the magnesium citrate.
  • phase (A) contains selenium
  • phase (A) advantageously comprises 20-90 ⁇ g of selenium more preferably 45-65 g of selenium, preferably in the form of sodium selenite.
  • phase (A) contains magnesium
  • phase (A) advantageously comprises 30 mg - 90 mg magnesium, more preferably 50 mg - 70 mg magnesium, preferably in the form of magnesium citrate.
  • the unit dosage forms (modes of administration) of phase (A) are typically oral dosage forms such as capsules, tablets, dragees, pills, granules, effervescent tablets, powders, drink solutions or suspensions.
  • phase (A) is administered as the capsule.
  • phase (A) is a blue-colored capsule.
  • phase (A) may additionally comprise pharmaceutical excipients, such as magnesium stearate (typically 5-15 mg), silica
  • dyes such as Indigo Carmine Blue 2.
  • phase (A) or phase (A) comprises:
  • niacin preferably in the form of nicotinic acid amide vi. 20-90 ⁇ g selenium, preferably in the form of a maltodextrin powder preparation comprising 1% sodium selenite
  • Vitamin Bi 1 mg - 7 mg Vitamin Bi, preferably in the form of thiamine mononitrate x. 3 ⁇ g - 12 ⁇ g of vitamin Bi 2 , preferably as inulin powder preparation comprising 1% cyanocobalamin
  • Excipients such as magnesium stearate, silica,
  • Titanium dioxide gelatin and / or dyes (such as Indigo Carmin-Blue 2).
  • phase (B) besides fat-soluble vitamins (and / or the associated provitamins), preferably comprises green tea extract and / or pomegranate extract.
  • phase (B) in addition to the fat-soluble vitamins (and / or associated provitamins) does not comprise any water-soluble vitamins (and / or associated provitamins) other than biotin and vitamin C.
  • Embodiment contains phase (B) no grape seed extract and / or grape skin extract.
  • phase (B) advantageously comprises both green tea extract and pomegranate extract.
  • phase (B) contains green tea extract
  • phase (B) advantageously comprises 5 mg - 160 mg green tea extract, preferably 40 mg - 120 mg green tea extract and most preferably 70 mg - 90 mg green tea extract. Tea extract.
  • phase (B) contains pomegranate extract
  • phase (B) advantageously comprises 5 mg - 80 mg pomegranate extract, preferably 20 mg - 60 mg pomegranate extract, and most preferably 30 mg - 50 mg pomegranate extract.
  • phase (B) includes vitamin E (tocopherol), vitamin D (preferably vitamin D 3 ) and beta-carotene.
  • phase (B) includes green tea extract and / or
  • the preferred fat-soluble vitamins are used (irrespective of whether all or only some of the vitamins mentioned are contained in phase (B)) in the following amounts: 2 mg - 6 mg beta-carotene, preferably 4 mg - 5.6 mg beta-carotene, preferably as a 10% preparation
  • vitamin D 0.5 ⁇ g - 10 ⁇ g of vitamin D, preferably 3 ⁇ g - 7 ⁇ g of vitamin D, preferably as cholecalciferol (vitamin D 3 ) with preferably 100,000 IU / g.
  • fat-soluble vitamins that may be included in phase (B) include retinol (vitamin A), and / or vitamin K and their provitamins.
  • phase (B) additionally comprises vitamin C, biotin and / or zinc as trace element, preferably in the form of zinc salt, for example zinc gluconate. If phase (B) contains vitamin C, phase (B) advantageously comprises 120 mg - 480 mg of vitamin C, preferably 180 mg - 300 mg of vitamin C and am
  • phase (B) contains zinc
  • phase (B) advantageously comprises 1 mg - 20 mg zinc, and more preferably 2 mg - 10 mg zinc, preferably as zinc gluconate.
  • phase (B) contains biotin
  • phase (B) advantageously comprises 20 ⁇ g - 200 ⁇ g of biotin and more preferably 50 ⁇ g - 150 ⁇ g of biotin, preferably as 1% by weight D-biotin dry glucose preparation.
  • the unit dosage forms (modes of administration) of phase (B) are typically oral dosage forms such as capsules, tablets, pills, dragees, granules, effervescent tablets, powders, drink solutions or suspensions.
  • phase (A) is administered as the capsule.
  • phase (B) is a red or orange colored capsule.
  • phase (B) may additionally comprise pharmaceutical excipients, such as magnesium stearate (typically 5-15 mg), silica
  • phase (B) or phase (B) consists of:
  • beta-carotene preferably as a 10% preparation iv. 1 mg - 20 mg zinc, preferably as zinc gluconate
  • vitamin D preferably as cholecalciferol (vitamin D 3 ) with preferably 100,000 IU / g
  • Excipients such as magnesium stearate, silica,
  • Titanium dioxide gelatin and / or dyes (such as red iron oxide).
  • phase (B) or phase (B) comprises:
  • beta-carotene preferably as a 10% preparation iv. 2 mg - 10 mg zinc, preferably as zinc gluconate
  • vitamin D preferably as cholecalciferol (vitamin D 3 ) with preferably 100,000 IU / g
  • Excipients such as magnesium stearate, silica,
  • Titanium dioxide gelatin and / or dyes (such as red iron oxide).
  • Embodiments as a capsule which are the subject of the present invention are described in Example 1A and in Example 1B.
  • the phases (A) and (B) are graduated in time, that is not taken simultaneously. Accordingly, the present invention relates in one embodiment comprising a kit
  • phase (A) comprising, in addition to water-soluble vitamins and / or the associated provitamins, plant components and optionally minerals and / or trace elements in a first unit dosage form,
  • phase (B) comprising, in addition to fat-soluble vitamins and / or the associated provitamins, plant constituents and optionally minerals and / or trace elements in a second unit dosage form,
  • phase (A) preferably contains grape-seed extract and / or cranberry juice powder as plant constituents and that phase (B)
  • phases (A) and / or (B) are oral administration forms, typically selected from the group consisting of capsules, tablets, dragees, pills, granules, effervescent tablets, powders, Drinking solutions and drinking suspensions is.
  • the phases (A) and (B) are capsules.
  • the two-phase preparation of the invention can be used to protect living cells from free radicals, e.g. as a result of oxidative stress, are used. Such use is possible in vivo (e.g., as a dietary supplement) and in vitro (e.g., by addition to cell culture).
  • the two-phase preparation according to the invention can support the immune system, e.g. in a herpes simplex infection.
  • the present invention relates to the use of the two-phase preparation according to the invention, comprising the phases (A) and (B), as
  • the present invention relates to the use of the kit according to the invention, comprising the phases (A) and (B), as a dietary supplement or dietetic.
  • the present invention relates to the use of the two-phase preparation according to the invention comprising the phases (A) and (B) as a medicament.
  • the present invention relates to the use of the two-phase preparation according to the invention comprising the phases (A) and (B) as a medicament.
  • the present invention relates to the use of the two-phase preparation according to the invention comprising the phases (A) and (B) as a medicament.
  • kit according to the invention comprising the phases (A) and (B) as medicament.
  • the present invention relates to the use of the two-phase preparation according to the invention comprising phases (A) and (B) for the treatment and / or prevention of herpes, for example herpes simplex, and in particular for the treatment of herpes labialis and / or genital herpes, especially in herpes labialis.
  • the present invention preferably relates to the use of the kit according to the invention, comprising the phases (A) and (B), for the treatment and / or prevention of Herpes, such as herpes simplex, and especially for the treatment of herpes labialis and / or genital herpes, especially in herpes labialis.
  • the present invention relates to the use of the
  • Two-phase preparation according to the invention comprising the phases (A) and (B), for the treatment and / or prevention of recurrence events in herpes, such as herpes simplex, and especially in herpes labialis and / or genital herpes, especially in herpes labialis.
  • the present invention relates in particular to the use of the kit according to the invention, comprising the phases (A) and (B), for the treatment and / or prevention of
  • herpes such as herpes simplex, and especially in herpes labialis and / or genital herpes, especially in herpes labialis.
  • the treatment and / or prevention of herpes according to the invention can be used in all patients infected with herpes, in particular with herpes simplex, ie both in patients from the group type 1 and from the group type 2.
  • Preferred in type 1 is a reduction in the number the recurrence events (herpes reactivation) reached, to a complete absence of recurrences.
  • Type 2 a reduction in the severity of
  • the immune system of the patient is supported and that the action against herpes based at least in part, but possibly also completely, on this support of the immune system.
  • a method for the treatment and / or prevention of said diseases by the administration of the two-phase preparation according to the invention to a patient is also provided by the present invention. The gift is made
  • a further subject of the present invention is the use of the two-phase preparation according to the invention for the production of a medicament for the use according to the invention as medicament as described above. It is understood that even when using the inventive
  • Two-phase product as a dietary supplement that can act against herpes.
  • the use of the two-phase product according to the invention for cosmetic purposes for reducing or avoiding the cosmetically undesirable herpes-associated lesions is therefore likewise an object of the present invention.
  • the time interval is preferably at least 2 hours and preferably at most 28 hours and may be, for example, 2, 5, 8, 12, 24 or 28 hours.
  • a time interval of more than 28 hours only makes sense in exceptional cases. It has turned out to be particularly positive if phases (A) and (B) are applied offset to each other for 24 hours. Accordingly, it is particularly advantageous if
  • N represents the non-negative integers, that is 0, 1, 2, 3, 4, etc.
  • X stands for any day, in particular, “X” is the day on which the preparation of the preparation or the kit is started. In a particular embodiment, phases (A) and (B) are taken for breakfast or dinner on alternate days.
  • the therapy, treatment or similar preferably started with the phase (A).
  • Vitamins are understood to mean all organic compounds that the human organism does not need as an energy carrier but for other vital functions, but which the metabolism can not synthesize
  • vitamins must be taken with the food.
  • vitamins can be taken up in various forms, e.g. in the form of pharmaceutical
  • vitamin B 6 can be taken as pyridoxine HCl and vitamin Bi as thiamine mononitrate.
  • Provitamins are precursors of vitamins that have yet to be converted into their respective vitamins, such as provitamin D 3 (7-dehydrocholesterol) in the skin, which is exposed to UV radiation such as sunlight D 3 (cholecalciferol) converted.
  • ß-carotene in turn, represents the provitamin of retinol (vitamin A).
  • plant constituent refers to whole plants, parts of plants, active ingredients isolated from plants and also substances obtained by chemical synthesis which are chemically identical to active substances isolated from plants
  • plant constituent in connection with the present invention whole plants or
  • Parts of plants eg flowers, leaves, seeds, bark, roots
  • unworked or comminuted substances called raw materials, or juices, tinctures, extracts, teas, which also to powders, gels and the like.
  • juices, tinctures, extracts, teas which also to powders, gels and the like.
  • an active ingredient is a
  • a substance that produces a specific effect in an organism typically in a mammal or human that is typically administered in low dose.
  • active ingredients are polyphenols, caffeine,
  • extract refers to a drug extract (also referred to as a drug extract) obtained by extraction from a raw material, for example, green tea, pomegranate or grape seed
  • a raw material for example, green tea, pomegranate or grape seed
  • liquid extracts depending on the form of preparation, tinctures or fluid extracts
  • an extract may be viscous or solid (for example
  • prepare refers to a pharmaceutical / galenic mechanical procedure typically used to improve the handling and / or dosage of low-dose drugs
  • Dosage forms is used.
  • an active ingredient is mixed one or more times with a suitable base (preferably inulin, maltodextrin, lactose or the like) to achieve homogeneity (ie uniform distribution of the active ingredient in the base) in powder form, ie "powder preparations".
  • a suitable base preferably inulin, maltodextrin, lactose or the like
  • Dietetic dietary food of food of the general Consumption by its special composition and / or by a special manufacturing process. This includes, in particular, products adapted for the dietary treatment of patients with a condition specific to certain conditions or adapted to a particular illness or disorder
  • kit refers to a set of individual parts
  • the kit according to the invention in addition to phases (A) and (B), may also comprise further individual parts, such as a leaflet and other foods and / or medicaments.
  • Green tea refers to tea leaves which, unlike black tea, are not fermented, so almost all active ingredients contained in the fresh leaf are retained.
  • Green tea extract refers to an extract of green tea as a raw material. Preferred is a green tea extract containing at least 1 wt% (preferably at least 50 wt%) polyphenols and / or at least 1 wt% (preferably at least 7 wt%) caffeine, preferably both at least 1 Wt .-% polyphenols and at least 1 wt .-% caffeine.
  • green tea extract of the species Camellia sinensis L.
  • Particularly preferred is “green tea extract” of the species Camellia sinensis L. in powder form, which has the stated amounts of polyphenol and caffeine.
  • the pomegranate is a plant, more specifically a Beerenstrauchart, the
  • Phomegranate extract is typically an extract
  • this fruit in powder form is an extract of the starting material Punica granatum L.
  • the content of ellagic acid (HPLC) in the extract is preferably at least 1 wt .-%, more preferably at least 20% by weight, more preferably at least 30% by weight, and on
  • Cranberry also known as cranberry, is a species of berry shrub of the genus Bilberry (Vaccinium) as the heather family (Ericacea).
  • the fruits of the American cranberry are widely cultivated and marketed in the USA and elsewhere. Particularly suitable is the American species Vaccinum macrocarpum, which is processed into cranberry juice concentrate.
  • the "cranberry juice powder” according to the invention is a powder produced from the juice of cranberry fruits, preferably the juice of the American species Vaccinum macrocarpum.
  • the pressed cranberry juice is applied as a concentrate to a matrix of maltodextrin, preferably in a ratio of 60% maltodextrin, 40% cranberry fruit juice concentrate.
  • the content of oligomeric proanthocyanidines (OPC, also referred to as "condensed tannins”) in cranberry juice powder is preferably at least 1 wt%, more preferably at least 10 wt%, even more preferably at least 30 wt%, and most preferably at least 70 wt .-%.
  • the "grape seed extract” according to the invention is an extract from the seeds of grapes, preferably from the vine Vitis vinifera L.
  • the extract is an extract (typically in the ratio 50: 1) in powder form.
  • the content of polyphenols (FC) in the extract is preferably at least 1 wt%, more preferably at least 10 wt%, even more preferably at least 30 wt%, and most preferably at least 95 wt%.
  • inulin preparation refers to a dosage form in the preparation of which the starting substance is distributed one or more times with inulin by a suitable method Specification "1% inulin preparation” and the like. the percentage refers to percent by weight.
  • Maltodextnn preparation refers to a dosage form which, when prepared, distributes the starting substance one or more times with maltodextrin by a suitable method, preferably a preparation based on maltodextrin in powder form, ie a maltodextrin powder preparation "1% maltodextrin preparation” and the like the percentage refers to percent by weight.
  • a suitable method preferably a preparation based on maltodextrin in powder form, ie a maltodextrin powder preparation "1% maltodextrin preparation” and the like the percentage refers to percent by weight.
  • the percentages are by weight.
  • the amount of beta-carotene in dietary supplements is also often given in "Retinol Equivalent", where 1 mg of Retinol Equivalent is equivalent to 6 mg of Beta Carotene.
  • IE International Unit.
  • concentration "IE / g” refers to the amount of vitamin D 3 per gram of the mixture containing vitamin D 3 .
  • folic acid preferably refers to pteroyl monoglutamic acid, but may refer to any folates.
  • magnesium refers to magnesium ions (typically to Mg), the term “selenium” to selenium ions (typically to Se 4+ ) and the term “zinc” to zinc ions (typically on Zn 2+ ).
  • adjuvant is understood above all to mean a pharmaceutical adjuvant which, in addition to the actual active ingredients, is or are produced in the preparation of phases (A). (B) is used.
  • Excipients may have various functions, such as shaping (excipients that carry the drug and shape the drug), manufacturability (excipients that enable or enhance certain manufacturing steps in drug manufacture), and / or control of drug release (adjuvants that cause the drug to develop) Active ingredient is rapidly, slowly, retarded or otherwise released as modified), stability enhancement (excipients containing a
  • phase (A) blue capsule (phase (A)
  • Nicotinic acid amide (vitamin B 3 ) 12-20 mg
  • Vitamin C (L-ascorbic acid) 220-260 mg
  • Example 1B two-phase system
  • Vitamin B2 (riboflavin) 4.2 mg
  • Vitamin B5 pantothenic acid 18 mg
  • Vitamin B6 (pyridoxine) 4.2 mg
  • Vitamin B9 (folic acid) 0.4 mg
  • Vitamin B12 7.5 ⁇ g
  • Vitamin A 800 ⁇ g retinol equivalent, ie 4.8 mg beta-carotene
  • Example 2 Efficacy in competitive athletes In the development of the two-phase preparation according to the invention many athletes were involved, including Olympians. Competitive athletes are known to suffer heavy competitions or hard
  • inventive two-phase preparation but recurring.
  • Example 3 Clinical examination In a clinical trial for efficacy in cold sores, the
  • Type 1 The immune system can not prevent the herpes reactivation because of a deficiency situation (for example competitive athletes).
  • the immune competence could be strengthened to such an extent by the two-phase preparation according to the invention that the herpes reactivation did not occur.
  • This group included 40% of the subjects.
  • Type 2 Recurrent herpes reactions were observed. The courses were, however, significantly shorter than without the invention
  • Two-phase preparation they shortened from 10-14 days to about 3 days. Also, the severity of the lesions was significantly lower. Personal well-being on a scale of 1-10 increased from 6-8 to 1-2. This group included 60% of the subjects.
  • the earlier countermeasures in the reactivation phase were predominantly administrations of acyclovir, but also application of toothpaste or Penatencreme.
  • Performance athletes the reduction of immune competence is not based on a pure lack of micronutrients, but could be psychologically related.
  • the consumption of the two-phase preparation according to the invention could thus improve the immunocompetence in the type 1 group in such a way that the herpes simplex viruses persisting in the body were hindered from reactivating.
  • Antioxidants act as scavengers of free radicals and therefore make important contributions to cell protection by destroying cell-damaging free radicals.
  • the two-phase product according to the invention contains antipxodants.
  • Group 1 were cell cultures with normal diet without inventive two-phase product and under oxidative stress
  • group 2 had normal diet plus two-phase product according to the invention and was under oxidative stress
  • group 3 served as a control, ie with normal diet without inventive two-phase product and without oxidative stress.
  • mice fibroblasts of the L929 cell line per measuring chamber were seeded Incubated for 22 hours serum-free with an aqueous solution of the blue capsule according to Example 1B (1 capsule per 15 liters of water) and then exposed to oxidative stress for 40 minutes by H 2 O 2 0.05 mM incubated and then measured in the analysis platform in the standard medium for 24 hours.
  • Two-phase product can significantly improve the vitality of cells in vitro and also in vivo.

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Abstract

La présente invention concerne une nouvelle préparation à deux phases destinée à être utilisée comme complément alimentaire, produit diététique et/ou médicament, plus préférentiellement à des fins médicales pour soutenir le système immunitaire lors de l'apparition d'affections virales, en particulier lors de l'apparition d'herpès. Ladite préparation comprend deux phases différentes qui sont utilisées de manière échelonnée dans le temps, les principes actifs s'inhibant mutuellement se trouvant dans des phases différentes et les principes actifs se complétant se trouvant dans la même phase.
EP11755255.4A 2010-08-16 2011-08-16 Préparation à deux phases et son utilisation pour le traitement de l'herpès Withdrawn EP2605784A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11755255.4A EP2605784A1 (fr) 2010-08-16 2011-08-16 Préparation à deux phases et son utilisation pour le traitement de l'herpès

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/EP2010/061912 WO2012022373A1 (fr) 2010-08-16 2010-08-16 Préparation à deux phases et son utilisation pour le traitement de l'herpès
EP11755255.4A EP2605784A1 (fr) 2010-08-16 2011-08-16 Préparation à deux phases et son utilisation pour le traitement de l'herpès
PCT/EP2011/004119 WO2012022466A1 (fr) 2010-08-16 2011-08-16 Préparation à deux phases et son utilisation pour le traitement de l'herpès

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EP2605784A1 true EP2605784A1 (fr) 2013-06-26

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Non-Patent Citations (1)

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See references of WO2012022466A1 *

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