EP4003386A1 - Composition destinée à être utilisée dans la prévention et/ou le traitement de symptômes liés à la fatigue et à l'épuisement - Google Patents

Composition destinée à être utilisée dans la prévention et/ou le traitement de symptômes liés à la fatigue et à l'épuisement

Info

Publication number
EP4003386A1
EP4003386A1 EP20764153.1A EP20764153A EP4003386A1 EP 4003386 A1 EP4003386 A1 EP 4003386A1 EP 20764153 A EP20764153 A EP 20764153A EP 4003386 A1 EP4003386 A1 EP 4003386A1
Authority
EP
European Patent Office
Prior art keywords
extract
fatigue
physical
cola
tiredness
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Withdrawn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
EP20764153.1A
Other languages
German (de)
English (en)
Inventor
Umberto DI MAIO
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.)
Neilos SRL
Original Assignee
Neilos SRL
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
Application filed by Neilos SRL filed Critical Neilos SRL
Publication of EP4003386A1 publication Critical patent/EP4003386A1/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Withdrawn legal-status Critical Current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)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/746—Morinda
    • 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)
    • A61K36/577—Malvaceae (Mallow family)
    • 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)
    • A61K36/79—Schisandraceae (Schisandra family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals

Definitions

  • composition for use in the prevention and/or treatment of symptoms related to tiredness and fatigue Composition for use in the prevention and/or treatment of symptoms related to tiredness and fatigue
  • the present invention relates to a composition of substances effective in the prevention and/or treatment of symptoms related to mental or physical tiredness and fatigue .
  • the mental fatigue is a very common psychobiological state in the daily life.
  • Such physio-pathological condition is characterized by a general sensation of tiredness, fatigue and lack of energies and it has consequences affecting, almost immediately, the correct operation of the primary cognitive functions.
  • the appearance of this general fatigue sensation is accompanied by difficulty in concentration and in keeping the normal attention levels and, in some cases, it can jeopardize the normal daily activities, the working performances as well as the physical performances.
  • Many studies have underlined that the attention, which is one of the fundamental features in the development of a dynamic behaviour and the main tool for selecting information, is negatively influenced by the mental fatigue.
  • the free radicals can attack the polyunsaturated fatty acids of the membranes (by causing a chain of peroxidation reactions), proteins and enzymes (by damaging the functionality thereof) , the nucleic acids (by causing the filament rupture and alteration of nitrogenous bases) and, above all, the mitochondrial DNA which is not protected by the histones. Then, they can alter physiological cellular mechanisms even at central level.
  • the connection between oxidative stress and damage of the cognitive functions was demonstrated.
  • the mental fatigue might affect even physical performances and, then, be associated to a sensation of physical tiredness.
  • the physical fatigue can be defined, independently from the mental fatigue, as fatigue and tiredness deriving from a performed effort and can be re connected to lack of sleep, lack of energies and to a temporary malfunction of the muscles, in turn caused by a tissue damage which can be ascribed to more or less intense physical activity.
  • a tissue damage which can be ascribed to more or less intense physical activity.
  • composition which composition comprises an association of at least an extract of Schisandra chinensis, at least an extract of Morinda citrifolia (commonly called Noni), inositol and at least an extract of a plant belonging to the genus Cola.
  • Such composition is particularly effective in the prevention and/or treatment of symptoms related to mental or physical tiredness and fatigue .
  • Schisandra chinensis is a climbing shrub belonging to the family of Schisandraceae, which can reach sizes ranging from 0.5 to 25 m of length.
  • the plants belonging to this species are little resistant both to extremely humid and dry environments, therefore they prefer tropical or subtropical environments, with light and humidity moderate conditions and a humus-rich soil.
  • Schisandra chinensis is endemic in North-East of China and in Korea wherein it has always been used for its beneficial properties; in particular in the Chinese popular medicine it is used as stimulant in tiredness and sexual impotence and as tonic in indolence and physical tiredness.
  • the subjects were asked to transmit the Morse code for five minutes at the maximum speed and the error frequency was evaluated.
  • the error frequency is in a range between 84 and 103% with respect to the control group, treated with placebo (130%) .
  • the results show that Schisandra improves the mental performances and the working capabilities by reducing the errors related to tiredness.
  • Morinda citrifolia also known as Noni, is an evergreen plant having small sizes belonging to the family of Rubiaceae. It can reach a height of 3 - 6 m as far as a maximum of 10 m. The ripe fruits are yellow and can reach sizes of 10 - 12 cm. The plant has a wide adaptability and it is widespread in all countries of the tropical area. Morinda is widely present in Indonesia and Polynesia and here it has been consumed by the local population for over 200 years for its several beneficial properties. The traditional medicine attributes Noni beneficial effects in many disorders such as osteoarthritis, rheumatisms, inflammation, diabetes, haemorrhoids, menstrual disturbance, infections, pain reduction, increase in the energy levels and well-being improvement.
  • Noni has a very high antioxidant power and it results to be useful in the states of physical and mental tiredness wherein the oxidative stress plays a predominant role.
  • - Placebo group grape and blackberry juice
  • Group A 29.5 mL of Noni juice
  • Group B 118 mL of Noni juice.
  • SARS superoxide anionic radical
  • LOOH hydroperoxide lipid
  • Inositol or Myo-Inositol
  • Myo-Inositol is a six-carbon-atom cyclitol containing five hydroxyl groups in equatorial position and one in axial position. It is a substance essential for the growth and the well-being of cells since it is involved in important cellular pathways: it is the precursor of phosphatidylinositol , component of the biological membranes having a central role in the cellular signalling. It is broken down by phospholipase C into Diacylglycerol , involved in the adjustment of the family of protein kinase C, and inositol triphosphate, involved in several transcriptional pathways.
  • Inositol belongs to the vitamins of group B and it is also known as vitamin B7.
  • the vitamins of group B favour the normal operation of the nervous system since they contribute in maintaining the normal levels of homocysteine; it is demonstrated that the excess in homocysteine is a potential risk factor of the cognitive decline and it linked to loss of attention and concentration. Therefore, vitamin B7 helps in overcoming the states of physical and psychical stress by safeguarding the health of the nervous cells.
  • a diet low in vitamins of group B is associated to high levels of oxidative stress, homocysteine and neural inflammation.
  • the vitamins of group B reduce oxidative stress and inflammation by increasing the oxidative metabolism at the brain level and by favouring myelination.
  • Cola The plants of genus Cola belong to the family of Malvaceae and include several species, thereamong the most known and used ones are Cola nitida and Cola acuminata. They are evergreen trees originally coming from Western Africa which can reach a height of 10 - 20 meters. Cola has always been used for its stimulating properties: for thousands of years it has been chewed by the populations of Western Africa and by travellers, in the long distances, in order to exploit its effect in reducing hunger, thirst and fatigue. Cola includes phenolic compounds having antioxidant action such as catechins and procyanidins .
  • the tonic and stimulating effect is due to the presence of caffein and theobromine which produce a strong sensation of euphoria and well being, by increasing the levels of attention, concentration and physical energy.
  • the effects of caffein on SNC are mainly related to its action on the receptors of adenosine Ai and A2, presynaptic receptors mediating the inhibition of transmission of the nervous stimuli.
  • Caffein blocks adenosine receptors and increases the nervous transmission.
  • Several studies highlighted the co-localization of adenosine receptors and of dopaminergic receptors in many brain areas, by demonstrating that caffein strengthens the post-synaptic transmission of dopamine.
  • Group B 100 mg/kg of Cola nitida
  • Group C 200 mg/kg of Cola nitida
  • Group D 400 mg/kg of Cola nitida.
  • composition of the present invention is effective in the prevention and/or treatment of symptoms related to physical and/or mental tiredness and fatigue.
  • the present invention allows to obtain at the same time an antioxidant effect, a stimulating effect of the cognitive functions and a stimulating effect of the muscle functions.
  • the present invention allows to obtain:
  • the present composition constitutes a valid support in the periods of intense stress thanks to its capability of alleviating both physical and mental fatigue and sustaining the attention levels, by means of the combined action of its active principles.
  • Schisandra thanks to its high content in polyphenols, exerts antioxidant action and strengthens and sustains the cholinergic system involved in learning processes and memory and in conducting neuro muscle stimuli.
  • Noni is a very powerful antioxidant which increases the mental well-being, reduces the physical tiredness and increases resistance.
  • Inositol, or vitamin B7 helps in fighting the states of physical and mental stress by safeguarding the nervous cells.
  • the extracts of plants belonging to the genus Cola thanks to the content in caffein and other metabolites, increase the levels of attention and concentration and increase the physical energy by stimulating the nervous transmission.
  • the composition of the present invention is prepared as pharmaceutical dosage form comprising from 1 mg to 5000 mg of at least an extract of Schisandra chinensis, preferably from 10 mg to 1000 mg; from 1 mg to 5000 mg of at least an extract of Morinda citrifolia, preferably from 10 mg to 2000 mg; from 0.5 mg to 50000 mg of inositol, preferably from 5 to 2500 mg; and from 1 mg to 5000 mg of at least an extract of a plant belonging to the genus Cola, preferably from 10 mg to 1000 mg apart from the usual excipients used in the preparation of the selected dosage form.
  • the preferred administration route of the composition of the present invention is oral.
  • the preferred pharmaceutical dosage forms to this purpose are capsules, tablets, sachets, orosoluble sachets, solutions, suspensions, powders, orosoluble powders, granules, syrups, bottles, vials.
  • composition vials for oral administration
  • composition powder for oral solution
  • composition The effectiveness of the composition, the present invention relates to, was evaluated according to experimental protocols known to the person expert in the art. In particular for the evaluation of the several activities of the composition according to the present invention in vitro and/or in vivo assays, known in the scientific literature, can be used.
  • Rotarod test evaluates the strength time and the holding force of the mice placed on a rotor set to a determined rotation speed.
  • mice The effect on the cognitive functions, learning and spatial memory can be evaluated in vivo on mice by means of:
  • the mouse is inserted at the centre of an eight-arm maze. In some of them a reward is placed and the mouse capabilities of storing the place in which there is food are evaluated;
  • ex-vivo biochemical analyses can be performed on tissue homogenates after having induced stress or cognitive alteration in the animal; by means of spectrophotometric method the levels of Glutathione and MDA (Malondialdehyde, product of the lipidic peroxidation) are evaluated. Moreover, the plasmatic levels of SAR, LOOH and homocysteine (markers of the oxidative stress) and of N- acetylaspartate, creatine and choline (markers of the oxidative metabolism and of myelination) can be evaluated.
  • composition of the present invention In order to demonstrate in vivo the antioxidant effectiveness of the composition of the present invention, even assays result to be suitable which consist in determining in animals the levels of endogenous substances such as, for example, reduced glutathione, glutathione peroxidase, glutathione S-transferase, superoxide dismutase and catalase, after administration of the active elements of interest. Even the measurement of the lipidic peroxidation is a valid method for estimating the antioxidant activity of the present composition.
  • the antioxidant effectiveness of the composition, the present invention relates to, can be evaluated by means of in-vitro essays such as for example: DPPH test, radical scavenging activity on the nitric oxide or on the peroxynitrile radical, TEAC (Total radical-trapping antioxidant parameter), FRAP (Ferric reducing-antioxidant power) , HORAC (Hydroxyl radical averting capacity) , ORAC (Oxygen radical absorbance capacity) tests and the like.
  • in-vitro essays such as for example: DPPH test, radical scavenging activity on the nitric oxide or on the peroxynitrile radical, TEAC (Total radical-trapping antioxidant parameter), FRAP (Ferric reducing-antioxidant power) , HORAC (Hydroxyl radical averting capacity) , ORAC (Oxygen radical absorbance capacity) tests and the like.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une composition de principes actifs qui s'est révélée être particulièrement efficace dans la prévention et/ou le traitement de symptômes liés à la fatigue mentale ou physique et à l'épuisement. La composition de l'invention comprend la combinaison synergique d'au moins un extrait de Schisandra chinensis, d'au moins un extrait de Morinda Citrifolia, d'inositol et d'au moins un extrait d'une plante appartenant au genre Cola.
EP20764153.1A 2019-07-29 2020-07-28 Composition destinée à être utilisée dans la prévention et/ou le traitement de symptômes liés à la fatigue et à l'épuisement Withdrawn EP4003386A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT201900013050 2019-07-29
PCT/IB2020/057099 WO2021019434A1 (fr) 2019-07-29 2020-07-28 Composition destinée à être utilisée dans la prévention et/ou le traitement de symptômes liés à la fatigue et à l'épuisement

Publications (1)

Publication Number Publication Date
EP4003386A1 true EP4003386A1 (fr) 2022-06-01

Family

ID=68733518

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20764153.1A Withdrawn EP4003386A1 (fr) 2019-07-29 2020-07-28 Composition destinée à être utilisée dans la prévention et/ou le traitement de symptômes liés à la fatigue et à l'épuisement

Country Status (2)

Country Link
EP (1) EP4003386A1 (fr)
WO (1) WO2021019434A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2586532B1 (fr) * 1985-09-03 1989-05-05 Note Druon Procede de preparation d'un extrait atomise de graines fraiches stabilisees de cola.
KR100522579B1 (ko) * 2004-04-30 2005-10-19 (주) 한약마을 항스트레스 효과를 갖는 황금 및 오미자 혼합 추출물을함유하는 약학조성물
JP2009149562A (ja) * 2007-12-20 2009-07-09 Oppen Keshohin Kk 皮膚外用剤
KR101668447B1 (ko) * 2009-03-17 2016-10-24 (주)아모레퍼시픽 숙취 해소용 조성물 및 이를 포함하는 건강기능 식품
CN102894366A (zh) * 2012-11-01 2013-01-30 中国医学科学院药用植物研究所云南分所 一种具有抗疲劳功效的海巴戟粉及制备方法
CN103859521B (zh) * 2014-04-08 2016-06-08 杜道林 一种海巴戟天然功能饮料及其制备方法
CN108851089A (zh) * 2018-09-12 2018-11-23 沈方雄 缓解体力疲劳的片剂及其制备工艺

Also Published As

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WO2021019434A1 (fr) 2021-02-04

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