EP4351724A1 - Composition comprising centella extract and hippophae extract - Google Patents
Composition comprising centella extract and hippophae extractInfo
- Publication number
- EP4351724A1 EP4351724A1 EP22733576.7A EP22733576A EP4351724A1 EP 4351724 A1 EP4351724 A1 EP 4351724A1 EP 22733576 A EP22733576 A EP 22733576A EP 4351724 A1 EP4351724 A1 EP 4351724A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- range
- plant material
- material selected
- extract obtained
- family
- 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.)
- Pending
Links
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- 239000000284 extract Substances 0.000 title claims abstract description 103
- 241000167550 Centella Species 0.000 title claims description 6
- 241000229143 Hippophae Species 0.000 title claims description 5
- 235000003935 Hippophae Nutrition 0.000 title claims description 4
- 241000196324 Embryophyta Species 0.000 claims abstract description 101
- 239000000463 material Substances 0.000 claims abstract description 99
- 229930003935 flavonoid Natural products 0.000 claims abstract description 51
- 235000017173 flavonoids Nutrition 0.000 claims abstract description 51
- 241001117772 Elaeagnaceae Species 0.000 claims abstract description 50
- 241000208173 Apiaceae Species 0.000 claims abstract description 42
- -1 flavonoid compound Chemical class 0.000 claims abstract description 30
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 claims description 76
- IYRMWMYZSQPJKC-UHFFFAOYSA-N kaempferol Chemical compound C1=CC(O)=CC=C1C1=C(O)C(=O)C2=C(O)C=C(O)C=C2O1 IYRMWMYZSQPJKC-UHFFFAOYSA-N 0.000 claims description 76
- MWDZOUNAPSSOEL-UHFFFAOYSA-N kaempferol Natural products OC1=C(C(=O)c2cc(O)cc(O)c2O1)c3ccc(O)cc3 MWDZOUNAPSSOEL-UHFFFAOYSA-N 0.000 claims description 76
- 229940011658 asiatic acid Drugs 0.000 claims description 69
- JXSVIVRDWWRQRT-UYDOISQJSA-N asiatic acid Chemical compound C1[C@@H](O)[C@H](O)[C@@](C)(CO)[C@@H]2CC[C@@]3(C)[C@]4(C)CC[C@@]5(C(O)=O)CC[C@@H](C)[C@H](C)[C@H]5C4=CC[C@@H]3[C@]21C JXSVIVRDWWRQRT-UYDOISQJSA-N 0.000 claims description 69
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- CLXOLTFMHAXJST-UHFFFAOYSA-N esculentic acid Natural products C12CC=C3C4CC(C)(C(O)=O)CCC4(C(O)=O)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(CO)C CLXOLTFMHAXJST-UHFFFAOYSA-N 0.000 claims description 69
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- 235000008800 isorhamnetin Nutrition 0.000 claims description 46
- IZQSVPBOUDKVDZ-UHFFFAOYSA-N isorhamnetin Chemical compound C1=C(O)C(OC)=CC(C2=C(C(=O)C3=C(O)C=C(O)C=C3O2)O)=C1 IZQSVPBOUDKVDZ-UHFFFAOYSA-N 0.000 claims description 46
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- ZVOLCUVKHLEPEV-UHFFFAOYSA-N Quercetagetin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=C(O)C(O)=C(O)C=C2O1 ZVOLCUVKHLEPEV-UHFFFAOYSA-N 0.000 claims description 38
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- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 description 3
- NRSUOHVIKLCXEE-UHFFFAOYSA-N Isorhamnetin 3-O-beta-D-glucopyranoside Natural products CCC1OC(OC2=C(Oc3cc(O)cc(O)c3C2=O)c4ccc(O)c(OC)c4)C(O)C(O)C1O NRSUOHVIKLCXEE-UHFFFAOYSA-N 0.000 description 3
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- BNMGUJRJUUDLHW-HCZMHFOYSA-N Madecassoside Chemical compound O([C@@H]1[C@@H](CO)O[C@H]([C@@H]([C@H]1O)O)OC[C@H]1O[C@H]([C@@H]([C@@H](O)[C@@H]1O)O)OC(=O)[C@]12CC[C@H]([C@@H]([C@H]1C=1[C@@]([C@@]3(C[C@@H](O)[C@H]4[C@](C)(CO)[C@@H](O)[C@H](O)C[C@]4(C)[C@H]3CC=1)C)(C)CC2)C)C)[C@@H]1O[C@@H](C)[C@H](O)[C@@H](O)[C@H]1O BNMGUJRJUUDLHW-HCZMHFOYSA-N 0.000 description 3
- BNMGUJRJUUDLHW-HLUHVYOBSA-N Madecassoside Natural products C[C@@H]1CC[C@@]2(CC[C@]3(C)C(=CC[C@@H]4[C@@]5(C)C[C@@H](O)[C@H](O)[C@@](C)(CO)[C@@H]5[C@H](O)C[C@@]34C)[C@@H]2[C@H]1C)C(=O)O[C@@H]6O[C@H](CO[C@@H]7O[C@H](CO)[C@@H](O[C@@H]8O[C@H](C)[C@H](O)[C@@H](O)[C@H]8O)[C@H](O)[C@H]7O)[C@@H](O)[C@H](O)[C@H]6O BNMGUJRJUUDLHW-HLUHVYOBSA-N 0.000 description 3
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates to a composition for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans.
- the present invention relates particularly to a composition, in the form of an herbal remedy, comprising a mixture of plant extracts for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans
- Snoring is a worldwide problem, not only for the snorer who has a disturbed sleeping rhythm or an increased risk of developing a serious illness, such as sleep apnea and Alzheimer ' s disease, but also for the partner sleeping next to them.
- Snoring is not defined a disease per se, but it is a symptom of restricted air passage in the upper airways that millions of people suffer from. Most importantly, it is a symptom that most people are familiar with, and it is also extremely important to seek help for treatment. This is important as the snoring can cause more physiological diseases. In addition, it is often the first symptom of sleep apnea, which is a serious disease if untreated.
- Sleep apnea also spelt sleep apnoea, is a sleep disorder characterized by pauses in breathing or periods of shallow breathing during sleep. Each pause can last for a few seconds to a few minutes, and they occur several times during the night. In the most common form, this follows loud snoring. There may be a choking or snorting sound as breathing resumes. As the disorder disrupts normal sleep, those affected may experience sleepiness or feel tired during the day. In children it may cause problems in school, or hyperactivity.
- OSA obstructive
- CSA central
- mixed sleep apnea a combination of the two called mixed sleep apnea.
- OSA is the most common form. Risk factors for OSA include being overweight, a family history of the condition, allergies, a small airway, and enlarged tonsils.
- OSA breathing is interrupted by a blockage of airflow, while in CSA breathing stops due to a lack of effort to breathe.
- People with sleep apnea may not be aware they have it. In many cases, it is first observed by a family member. Sleep apnea is often diagnosed with an overnight sleep study. For a diagnosis of sleep apnea, more than five episodes an hour must occur.
- Treatment may include lifestyle changes, mouthpieces, breathing devices, and surgery. Lifestyle changes may include avoiding alcohol, losing weight, stopping smoking, and sleeping on one's side. Breathing devices include the use of a CPAP machine (Continuous Positive Airway Pressure machine). Presently, no medical treatment is available for the treatment of snoring/sleeping apnea.
- CPAP machine Continuous Positive Airway Pressure machine
- sleep apnea may increase the risk of heart attack, stroke, diabetes, heart failure, irregular heartbeat, obesity, and traffic accidents.
- an object of the present invention relates to a composition for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans.
- composition comprising a mixture of plant extracts for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans that solves the above-mentioned problems of the prior art with snoring where lifestyle changes, mouthpieces, breathing devices, and/or surgery are the presently offered treatments.
- composition comprising the combination of:
- Another aspect of the present invention relates to a nasal spray comprising a composition according to the present invention.
- compositions for use as a medication comprising the combination of:
- composition for treating, alleviating, and/or preventing snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
- a further aspect of the present invention relates to a composition for avoiding or postponing the development of snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of: (i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
- An even further aspect of the present invention relates to a method for providing a composition according to the present invention, wherein the method comprises the steps of:
- Elaeagnaceae and/or the extract obtained from the herb or combination of herbs comprising isorhamnetin, kaempferol and/or quercetin; obtained in step (a); with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b), providing the composition according to the present invention.
- sleep apnea related to all the three forms of sleep apnea : obstructive (OSA), central (CSA), and a combination of the two called mixed sleep apnea.
- OSA obstructive
- CSA central
- mixed sleep apnea a combination of the two called mixed sleep apnea.
- the present invention relates to a composition
- a composition comprising the combination of:
- the combination of ingredients in the composition according to the present invention may relate to the following combinations: an extract obtained from plant material selected from the family Elaeagnaceae; and an extract obtained from plant material selected from the family Apiaceae; one or more flavonoid compound(s); and an extract obtained from plant material selected from the family Apiaceae; or an extract obtained from plant material selected from the family Elaeagnaceae, and one or more flavonoid compound(s), and an extract obtained from plant material selected from the family Apiaceae
- extract relates to a substance made by subjecting plant material to a solvent resulting in concentrating one or more analytes from the plant material into the solvent.
- the one or more flavonoid compound may be obtained from an herb or a combination of herbs comprising the one or more flavonoids.
- the one or more flavonoid compound in particular isorhamnetin, kaempferol and/or quercetin, may be isolated from an herb or from a combination of herbs comprising the one or more flavonoid.
- the herb may be Elaeagnaceae.
- the one or more flavonoid compound may be selected from isorhamnetin, kaempferol, quercetin or a combination hereof.
- the herb or the combination of herbs may be selected from a herb or a combination of herbs comprising isorhamnetin, kaempferol and/or quercetin.
- a herb or a combination of herbs comprising isorhamnetin, kaempferol and/or quercetin.
- such herb may be a plant material selected from the family Elaeagnaceae.
- composition according to the present invention comprises one or more flavonoid compound(s) obtained from an herb or a combination of herbs
- the herb or the combination of herbs an extract of the herb or the combination of herbs may be provided in the same way as described for the extract obtained from plant material selected from the family Elaeagnaceae.
- the plant material selected from the family Elaeagnaceae may comprise a plant material selected from the Hippophae genus.
- the plant material may be selected from the family Elaeagnaceae may comprise plant material selected from the species H. rhamnoides, Hippophae rhamnoides.
- the composition may comprise isorhamnetin, preferably glycosidic bound isorhamnetin, such as isorhamnetin-3-O-glucoside; quercetin; and/or kaempferol
- composition according to the present invention may preferably be standardized according to the content of flavonoids; preferably the composition according to the present invention may preferably be standardized according to the content of the flavonoids isorhamnetin, kaempferol and/or quercetin; even more preferably the composition according to the present invention may preferably be standardized according to the content of the flavonoids isorhamnetin.
- Hippophae rhamnoides is also known as common sea buckthorn. It is normally found in the cold-temperate regions of Europe and Asia. It is a spiny deciduous shrub with fruit/berries. The plant has traditionally been used in the food and cosmetics industries, in traditional medicine, as animal fodder, and for ecological purposes. H. rhamnoides fruits have been used in the traditional Austrian medicine internally as tea, juice, or syrup for treatment of infections.
- the extract obtained from a plant material selected from the family Elaeagnaceae may be obtained from the fruits of the plant material selected from the family Elaeagnaceae, such as Hippophae rhamnoides.
- an extract obtained from a plant material selected from the family Elaeagnaceae or "an extract of the herb or the combination of herbs”
- an extract obtained from a plant material selected from the family Apiaceae relates to the process of subjecting the plant materials (or herb or combination of herbs comprising one or ore more flavonoids as described herein ) to a solvent extracting the analytes of interest and providing the extracts.
- the plant material may be selected from the family Apiaceae comprising a plant material selected from the Centella family.
- the plant material may be selected from the family Apiaceae comprising a plant material selected from the species C. asiatica, Centella asiatica.
- Centella, Centella asiatica contains pentacyclic triterpenoids, including asiaticoside, asiatic acid, and madecassic acid (brahmic acid).
- Centella asiatica C. asiatica
- Centella asiatica has been used to treat various disorders and minor wounds and to encourage lactation.
- the composition comprises asiatic acid; asiaticoside; and/or madegassic acid.
- the composition comprises isorhamnetin and asiatic acid; asiaticoside; and/or madegassic acid.
- the content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of isorhamnetin.
- the composition comprises in the range of 0.1- 5 g/l isorhamnetin, such as in the range of 0.2-4 g/l isorhamnetin, e.g. in the range of 0.3- 3 g/l isorhamnetin, such as in the range of 0.4-2.5 g/l isorhamnetin, e.g. in the range of 0.5-2 g/l isorhamnetin, such as in the range of 0.6-1.5 g/l isorhamnetin, e.g. in the range of 0.7-1 g/l isorhamnetin, such as about 0.75 g/l isorhamnetin.
- the content of the extract obtained from a plant material selected from the family Apiaceae present in the composition may be standardizing from the content of asiatic acid.
- the composition comprises in the range of 0.1- 10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid.
- the composition comprises in the range of 0.1-5 g/l isorhamnetin, such as in the range of 0.2-4 g/l isorhamnetin, e.g. in the range of 0.3-3 g/l isorhamnetin, such as in the range of 0.4-2.5 g/l isorhamnetin, e.g. in the range of 0.5-2 g/l isorhamnetin, such as in the range of 0.6-1.5 g/l isorhamnetin, e.g.
- g/l asiatic acid in the range of 0.7-1 g/l isorhamnetin, such as about 0.75 g/l isorhamnetin; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid,
- the content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of kaempferol.
- the composition comprises in the range of 0.1- 5 g/l kaempferol, such as in the range of 0.2-4 g/l kaempferol, e.g. in the range of 0.3-3 g/l kaempferol, such as in the range of 0.4-2.5 g/l kaempferol, e.g. in the range of 0.5-2 g/l kaempferol, such as in the range of 0.6-1.5 g/l kaempferol, e.g. in the range of 0.7-1 g/l kaempferol, such as about 0.75 g/l kaempferol.
- the composition comprises in the range of 0.1-5 g/l kaempferol, such as in the range of 0.2-4 g/l kaempferol, e.g. in the range of 0.3-3 g/l kaempferol, such as in the range of 0.4-2.5 g/l kaempferol, e.g. in the range of 0.5-2 g/l kaempferol, such as in the range of 0.6-1.5 g/l kaempferol, e.g.
- g/l asiatic acid in the range of 0.7-1 g/l kaempferol, such as about 0.75 g/l kaempferol; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid,
- the content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of quercetin.
- the composition comprises in the range of 0.1- 5 g/l quercetin, such as in the range of 0.2-4 g/l quercetin, e.g. in the range of 0.3-3 g/l quercetin, such as in the range of 0.4-2.5 g/l quercetin, e.g. in the range of 0.5-2 g/l quercetin, such as in the range of 0.6-1.5 g/l quercetin, e.g. in the range of 0.7-1 g/l quercetin, such as about 0.75 g/l quercetin.
- the composition comprises in the range of 0.1-5 g/l quercetin, such as in the range of 0.2-4 g/l quercetin, e.g. in the range of 0.3- 3 g/l quercetin, such as in the range of 0.4-2.5 g/l quercetin, e.g. in the range of 0.5-2 g/l quercetin, such as in the range of 0.6-1.5 g/l quercetin, e.g.
- g/l quercetin in the range of 0.7-1 g/l quercetin, such as about 0.75 g/l quercetin; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid,
- the composition may comprise flavonoids, preferably glycosidic bound flavonoids (such as isorhamnetin; preferably, glycosidic bound isorhamnetin; such as isorhamnetin-3-O- glucoside, asiatic acid; asiaticoside; and/or madegassic acid).
- flavonoids preferably glycosidic bound flavonoids (such as isorhamnetin; preferably, glycosidic bound isorhamnetin; such as isorhamnetin-3-O- glucoside, asiatic acid; asiaticoside; and/or madegassic acid).
- the composition comprises a higher content of madecassoside than asiatic acid and/or than asiaticoside.
- the composition comprises a content of madecassoside which between 1.5-10 times higher than the content of asiatic acid on a weight-by-weight basis, such as between
- the composition comprises a content of madecassoside which between 2-10 times higher than the content of asiaticoside on a weight-by-weight basis, such as between
- the composition comprises a higher content of asiatic acid than asiaticoside.
- the composition comprises a content of asiatic acid which between 1.25-5 times higher than the content of asiaticoside on a weight-by- weight basis, such as between 1.5-2.5 times higher, e.g. about 2 times higher.
- the composition may comprise a flavouring agent.
- the flavouring agent may be a menthe flavouring agent or a rosemary flavouring agent.
- the composition comprises a preservation agent.
- the preservation agent is a sorbate compound, such as potassium sorbate.
- the sorbate compound is added in a concentration in the range of 0.1-0.5% (w/w) on a dry- matter basis, such as about 0.2% (w/w) on a dry-matter basis. Potassium sorbate has shown to prevent growth of molds and microbes and to increase shelf life of products.
- the solvents used for providing the extracts according to the present invention may be an aqueous solvent, such as water, or an alcoholic solvent.
- the alcoholic solvent may be selected from methanol; ethanol, isopropanol or a mixture hereof.
- the composition comprises less than 2% alcoholic solvent; such as less than 1.5% alcoholic solvent; e.g. less than 1% alcoholic solvent; such as less than 0.5% alcoholic solvent; e.g. less than 0.3% alcoholic solvent; such as less than 0.1% alcoholic solvent, e.g. no alcoholic solvent.
- the composition may preferably have a pH value in the range of pH 4-7.5, such as in the range of pH 4.5-6.5, e.g. in the range of pH 5-6, such as in the range of pH 5.5-5.8.
- the extract obtained from a plant material selected from the family Elaeagnaceae, or from the herb or combination of herbs comprising the one or more flavonoid compounds may be an alcoholic extract.
- the extract obtained from plant material selected from the family Elaeagnaceae, or from the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a liquid, a juice, a syrup, or a powder.
- the extract obtained from a plant material selected from the family Elaeagnaceae, or the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a liquid, juice, or a syrup, even more preferably, the extract obtained from a plant material selected from the family Elaeagnaceae, or the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a syrup.
- the extract obtained from plant material selected from the family Apiaceae may be an aqueous solvent.
- the extract obtained from a plant material selected from the family Apiaceae may be provided in the form of a liquid, a juice, a syrup, or a powder.
- the extract obtained from plant material selected from the family Apiaceae may be provided in the form of a powder.
- the term "powder” relates to a composition having a moisture content of 15% (w/w) or less, such as a moisture content of 10% (w/w) or less, e.g. a moisture content of 7.5% (w/w) or less, such as a moisture content of 5% or less.
- the composition may be administered in a unit dose form.
- the composition may be administered as a pill, a tablet, a spray, or a droplet.
- the composition may be administered as a spray.
- composition according to the present invention may be formulated into an aerosol forming device, such as a nasal spray.
- a preferred embodiment of the present invention relates to a nasal spray comprising a composition according to the present invention.
- the nasal spray may be a decongestant nasal spray.
- the nasal spray may comprise a capacity in the range of 5-100 ml, such as in the range of 10-75 ml, e.g. in the range of 20-50 ml, such as about 30 ml.
- the nasal spray may be adjusted to provide a unit dose of 25-300 mI/unit dose; such as 50-200 mI/unit dose; e.g. 75-150 mI/unit dose, such as about 100 mI/unit dose.
- the unit dose and/or single unit dose may relate to the volume of the composition provided to a human, e.g. the volume of the composition expelled from a nasal spray when actuated.
- composition according to the present invention have shown to have a tightening effect on the structure of the connective tissue in the soft part of the palate and throat, creating a more open passage in the upper respiratory tract.
- composition for use as a medication wherein the composition comprises the combination of:
- a further preferred embodiment of the present invention relates to a composition for treating, alleviating and/or preventing snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
- composition an extract obtained from plant material selected from the family Apiaceae.
- the composition may be administered to humans by oral and/or nasal administration, preferably by both oral and nasal administration.
- each unit dose comprise in the range of 25-300 pi of the composition
- the unit doses may be administered nasally, preferably to each nostril.
- compositions When the composition is used as a medication and/or when the composition is used for treating, alleviating, and/or preventing snoring, cold, and/or sleep apnea in humans, 1-3, preferably two, unit doses may be nasally administered to each nostril and two unit doses may be orally administered to humans, preferably such administration is repeated three times a day.
- People suffering from snoring, cold, and/or sleep apnea may use an increased dosage of the composition according to the present invention, e.g. using two unit doses to treat and/or alleviate the snoring, cold, and/or sleep apnea as described above; whereas low incidence of snoring, cold, and/or sleep apnea; or avoiding the development of snoring, cold, and/or sleep apnea may use a reduced dosage, e.g. one unit dose, as described in the following.
- a preferred embodiment of the present invention relates to a composition for avoiding or postponing the development of snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
- the composition When the composition is used for reducing the incidence of snoring, cold, and/or sleep apnea in humans or to avoid (or substantially avoid) the development of snoring, cold, and/or sleep apnea, the composition may be administered to humans by oral and/or nasal administration, preferably by both oral and nasal administration.
- a single unit dose in the range of 25-300 pi of the composition may be administered to humans, preferably 1-5 times a day, such as 2-4 times a day, preferably three times a day; such as in the range of 50-200 pi; e.g. in the range of 75-150 pi, such as about 100 pi.
- composition When the composition is used for reducing the incidence of snoring, cold, and/or sleep apnea in humans or to avoid (or substantially avoid) the development of snoring, cold, and/or sleep apnea the composition may be administered to humans one unit dose may be nasally administered to each nostril and one unit dose may be orally administered to humans, Preferably, such administration is repeated three times a day.
- the composition according to the present invention may preferably be a medication, a natural medicinal product or a dietary supplement.
- the composition according to the present invention may be a dietary supplement.
- the composition according to the present invention is preferably an aqueous solution comprising the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising the flavonoids; and the extract obtained from a plant material selected from the family Apiaceae.
- a preferred embodiment of the present invention relates to a method for providing a composition according to the present invention, wherein the method comprises the steps of:
- step (c) mixing the extract obtained from the plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising isorhamnetin, kaempferol and/or quercetin; obtained in step (a); with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b), providing the composition according to the present invention.
- the first solvent may be an alcoholic solvent.
- the alcoholic solvent may be selected from methanol; ethanol, isopropanol or a mixture hereof.
- the concentration of the alcoholic solvent may preferably in the range of 10-50% alcohol, such as in the range of 15-40% alcohol, e.g. in the range of 17-30% alcohol, such as about 20% alcohol.
- the second solvent is an aqueous solvent.
- the second embodiment is water, or an aqueous buffer.
- the dry matter content provided in step (i) and/or (ii) during the extraction process may be in the range of 40-70% (w/w); such as in the range of 50-65% (w/w); e.g. about 60% (w/w).
- the extract obtained from plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising the flavonoids may comprise glycosidic bound flavonoids, e.g. glycosidic bound isorhamnetin, such as isorhamnetin-3-O-glucoside; kaempferol; and/or quercetin.
- glycosidic bound flavonoids e.g. glycosidic bound isorhamnetin, such as isorhamnetin-3-O-glucoside; kaempferol; and/or quercetin.
- the extract obtained from plant material selected from the family Apiaceae comprises asiatic acid; asiaticoside; and/or madegassic acid.
- the composition obtained by the present method comprises isorhamnetin (kaempferol and/or quercetin) and asiatic acid; asiaticoside; and/or madegassic acid.
- the method according to the present invention further comprises the step of adding a preservation agent to the mixed composition.
- the preservation agent is a sorbate compound, such as potassium sorbate.
- the sorbate compound is added in a concentration in the range of 0.1-0.5% (w/w) on a dry-matter basis, such as about 0.2% (w/w) on a dry-matter basis.
- the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising flavonoids may preferably be provide in the form of a liquid, a juice or in the form of a syrup, preferably in the form of a syrup.
- the extract obtained from a plant material selected from the family Apiaceae may preferably be provide in the form of a dry powder.
- the dry powder comprising the extract obtained from a plant material selected from the family Apiaceae may be dissolved in water or in the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs provided in the form of a liquid, a juice or a syrup.
- water may be added to the extract obtained from plant material selected from the family Elaeagnaceae, to the extract obtained from the herb or combination of herbs comprising flavonoids (like isorhamnetin, kaempferol and/or quercetin) (step (a)); to the extract obtained from a plant material selected from the family Apiaceae (step (b)) or to the mixture provided in step (c), where the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs obtained in step (a) are mixed with the extract obtained from a plant material selected from the family Apiaceae as obtained in step (b), to provide the desired concentration of ingredients.
- flavonoids like isorhamnetin, kaempferol and/or quercetin
- the composition according to the present invention may be provided by mixing: the extract obtained from the plant material selected from the family Elaeagnaceae, obtained in step (a); and/or one or more flavonoid compound(s) according to the present invention; with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b); providing the composition according to the present invention.
- Example 1 Preparation of the composition according to the present invention.
- An extract obtained from a plant material selected from Hippophae rhamnoides was prepared by adding 20% ethanol (solvent) to the fruits of Hippophae rhamnoides, which has been ground, to a dry matter content of about 60%.
- the solvent is evaporated, and no ethanol (less than 0.5% ethanol) remains in the syrup extract.
- the syrup is standardized from the content of isorhamnetin to a content of isorhamnetin of 65% of the syrup.
- the standardized syrup is mixed 1:5 with purified water and allowed to rest for 4 hours and organic particles and organic matter can settle, and the remaining solution is decanted to a mixing tray.
- An extract obtained from a plant material selected from Centella asiatica was prepared by adding purified water (solvent) to ground Centella asiatica, to a dry matter content of about 60%. After the extraction, the extract was standardized from the content of asiatic acid and water was evaporated and the extract was dried providing a standardized powder extract.
- the powder extract and a menthe flavouring agent was added to the mixing tray resulting in a composition having 2.77 g/l isorhamnetin, 0.75 g/l asiatic acid and the pH was adjusted to pH 5,5 using phosphate buffer.
- composition was packed in 30 ml nasal spray bottles and ready for use.
- Example 2 Demonstrating the effect of the spray developed in Example 1
- Each volunteer received a nasal spray bottle as provided in example 1 above.
- Each volunteer was treated with two unit-doses in each nostril and two unit doses was administered orally. The treatment was repeated 3 times a day and the treatment were continued for 15 days.
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Abstract
The present invention relates to a composition comprising the combination of (i) an extract obtained from plant material selected from the family Elaeagnaceae, and/or (ii) one or more flavonoid compound(s); in combination with (iii) an extract obtained from plant material selected from the family Apiaceae.
Description
COMPOSITION COMPRISING CENTELLA EXTRACT AND HIPPOPHAE EXTRACT
Technical field of the invention The present invention relates to a composition for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans. The present invention relates particularly to a composition, in the form of an herbal remedy, comprising a mixture of plant extracts for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans
Background of the invention
Snoring is a worldwide problem, not only for the snorer who has a disturbed sleeping rhythm or an increased risk of developing a serious illness, such as sleep apnea and Alzheimer's disease, but also for the partner sleeping next to them.
Snoring is not defined a disease per se, but it is a symptom of restricted air passage in the upper airways that millions of people suffer from. Most importantly, it is a symptom that most people are familiar with, and it is also extremely important to seek help for treatment. This is important as the snoring can cause more physiological diseases. In addition, it is often the first symptom of sleep apnea, which is a serious disease if untreated.
Sleep apnea, also spelt sleep apnoea, is a sleep disorder characterized by pauses in breathing or periods of shallow breathing during sleep. Each pause can last for a few seconds to a few minutes, and they occur several times during the night. In the most common form, this follows loud snoring. There may be a choking or snorting sound as breathing resumes. As the disorder disrupts normal sleep, those affected may experience sleepiness or feel tired during the day. In children it may cause problems in school, or hyperactivity.
There are three forms of sleep apnea: obstructive (OSA), central (CSA), and a combination of the two called mixed sleep apnea. OSA is the most common form. Risk factors for OSA include being overweight, a family history of the condition, allergies, a small airway, and enlarged tonsils. In OSA, breathing is interrupted by a blockage of airflow, while in CSA breathing stops due to a lack of effort to breathe. People with sleep apnea may not be
aware they have it. In many cases, it is first observed by a family member. Sleep apnea is often diagnosed with an overnight sleep study. For a diagnosis of sleep apnea, more than five episodes an hour must occur. Treatment may include lifestyle changes, mouthpieces, breathing devices, and surgery. Lifestyle changes may include avoiding alcohol, losing weight, stopping smoking, and sleeping on one's side. Breathing devices include the use of a CPAP machine (Continuous Positive Airway Pressure machine). Presently, no medical treatment is available for the treatment of snoring/sleeping apnea.
Without treatment, sleep apnea may increase the risk of heart attack, stroke, diabetes, heart failure, irregular heartbeat, obesity, and traffic accidents.
Hence, there is a need for an improved and less invasive way to deal with snoring, and in particular an efficient and/or reliable way to deal with snoring where lifestyle changes, mouthpieces, breathing devices, and/or surgery may be avoided would be advantageous.
Summary of the invention Thus, an object of the present invention relates to a composition for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans.
In particular, it is an object of the present invention to provide a composition comprising a mixture of plant extracts for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans that solves the above-mentioned problems of the prior art with snoring where lifestyle changes, mouthpieces, breathing devices, and/or surgery are the presently offered treatments.
Thus, one aspect of the invention relates to a composition comprising the combination of:
(i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(ill) an extract obtained from a plant material selected from the family Apiaceae. Another aspect of the present invention relates to a nasal spray comprising a composition according to the present invention.
Yet another aspect of the present invention relates to a composition for use as a medication, wherein the composition comprises the combination of:
(i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from a plant material selected from the family Apiaceae. Yet another aspect of the present invention relates to a composition for treating, alleviating, and/or preventing snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
(i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(ill) an extract obtained from a plant material selected from the family Apiaceae. A further aspect of the present invention relates to a composition for avoiding or postponing the development of snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
(i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from a plant material selected from the family Apiaceae.
An even further aspect of the present invention relates to a method for providing a composition according to the present invention, wherein the method comprises the steps of:
(a) subjecting a plant material selected from the family Elaeagnaceae, and/or an herb or combination of herbs comprising the one or more flavonoids, to a first solvent providing an extract obtained from the plant material selected from the family Elaeagnaceae, and/or an extract obtained from the herb or the combination of herbs;
(b) subjecting a plant material selected from the family Apiaceae, to a second solvent providing an extract obtained from the plant material selected from the family Apiaceae; (c) mixing the extract obtained from the plant material selected from the family
Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising isorhamnetin, kaempferol and/or quercetin; obtained in step (a); with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b), providing the composition according to the present invention.
The present invention will now be described in more detail in the following. Detailed description of the invention
As mentioned above millions of people suffer from snoring and most people are familiar with snoring. When snoring develops it may be extremely important to seek help for treatment, as snoring can cause more physiological diseases such as sleep apnea, which is
a serious disease if untreated. Accordingly, the inventor of the present invention surprisingly found that a combination of extracts from various plants, was shown to be effective for treating, and/or alleviating snoring, cold, and/or sleep apnea in humans.
In the present context the term "sleep apnea" related to all the three forms of sleep apnea : obstructive (OSA), central (CSA), and a combination of the two called mixed sleep apnea.
Hence, in a preferred embodiment, the present invention relates to a composition comprising the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae.
The combination of ingredients in the composition according to the present invention may relate to the following combinations: an extract obtained from plant material selected from the family Elaeagnaceae; and an extract obtained from plant material selected from the family Apiaceae; one or more flavonoid compound(s); and an extract obtained from plant material selected from the family Apiaceae; or an extract obtained from plant material selected from the family Elaeagnaceae, and one or more flavonoid compound(s), and an extract obtained from plant material selected from the family Apiaceae
In the context of the present invention the term "extract" relates to a substance made by subjecting plant material to a solvent resulting in concentrating one or more analytes from the plant material into the solvent.
In an embodiment of the present invention a composition according to the present invention consisting essentially of the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae.
In the context of the present invention, the term "consisting essentially of", relates to a limitation of the scope of a claim to the specified features or steps and those features or steps, not mentioned and that do not materially affect the basic and novel characteristic(s) of the claimed invention.
In an embodiment of the present invention the one or more flavonoid compound may be obtained from an herb or a combination of herbs comprising the one or more flavonoids.
The one or more flavonoid compound, in particular isorhamnetin, kaempferol and/or quercetin, may be isolated from an herb or from a combination of herbs comprising the one or more flavonoid. Preferably, the herb may be Elaeagnaceae.
The one or more flavonoid compound may be selected from isorhamnetin, kaempferol, quercetin or a combination hereof.
Preferably the herb or the combination of herbs may be selected from a herb or a combination of herbs comprising isorhamnetin, kaempferol and/or quercetin. Preferably such herb may be a plant material selected from the family Elaeagnaceae.
In the event the composition according to the present invention comprises one or more flavonoid compound(s) obtained from an herb or a combination of herbs, the herb or the combination of herbs, an extract of the herb or the combination of herbs may be provided in the same way as described for the extract obtained from plant material selected from the family Elaeagnaceae.
In an embodiment of the present invention the plant material selected from the family Elaeagnaceae may comprise a plant material selected from the Hippophae genus.
In a further embodiment of the present invention the plant material may be selected from the family Elaeagnaceae may comprise plant material selected from the species H. rhamnoides, Hippophae rhamnoides.
In an embodiment of the present invention the composition may comprise isorhamnetin, preferably glycosidic bound isorhamnetin, such as isorhamnetin-3-O-glucoside; quercetin; and/or kaempferol
The composition according to the present invention may preferably be standardized according to the content of flavonoids; preferably the composition according to the present invention may preferably be standardized according to the content of the flavonoids isorhamnetin, kaempferol and/or quercetin; even more preferably the composition according to the present invention may preferably be standardized according to the content of the flavonoids isorhamnetin.
Hippophae rhamnoides, is also known as common sea buckthorn. It is normally found in the cold-temperate regions of Europe and Asia. It is a spiny deciduous shrub with fruit/berries. The plant has traditionally been used in the food and cosmetics industries, in traditional medicine, as animal fodder, and for ecological purposes. H. rhamnoides fruits have been used in the traditional Austrian medicine internally as tea, juice, or syrup for treatment of infections.
In an embodiment of the present invention the extract obtained from a plant material selected from the family Elaeagnaceae may be obtained from the fruits of the plant material selected from the family Elaeagnaceae, such as Hippophae rhamnoides.
In the present context the terms "an extract obtained from a plant material selected from the family Elaeagnaceae", or "an extract of the herb or the combination of herbs" " and "an extract obtained from a plant material selected from the family Apiaceae" relates to the process of subjecting the plant materials (or herb or combination of herbs comprising one or ore more flavonoids as described herein ) to a solvent extracting the analytes of interest and providing the extracts.
In an embodiment of the present invention the plant material may be selected from the family Apiaceae comprising a plant material selected from the Centella family.
Preferably, the plant material may be selected from the family Apiaceae comprising a plant material selected from the species C. asiatica, Centella asiatica.
Centella, Centella asiatica, contains pentacyclic triterpenoids, including asiaticoside, asiatic acid, and madecassic acid (brahmic acid). In traditional medicine, Centella asiatica (C. asiatica ) has been used to treat various disorders and minor wounds and to encourage lactation. There are no records of the synergistic effect of Centella, Centella asiatica, and
herbs of the family Elaeagnaceae, or herb or combination of herbs containing the flavonoids; isorhamnetin, kaempferol and/or quercetin, on wound-healing, collagen, edema and mucosal membranes.
In an embodiment of the present invention, the composition comprises asiatic acid; asiaticoside; and/or madegassic acid.
In a further embodiment of the present invention the composition comprises isorhamnetin and asiatic acid; asiaticoside; and/or madegassic acid.
The content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of isorhamnetin.
In an embodiment of the present invention the composition comprises in the range of 0.1- 5 g/l isorhamnetin, such as in the range of 0.2-4 g/l isorhamnetin, e.g. in the range of 0.3- 3 g/l isorhamnetin, such as in the range of 0.4-2.5 g/l isorhamnetin, e.g. in the range of 0.5-2 g/l isorhamnetin, such as in the range of 0.6-1.5 g/l isorhamnetin, e.g. in the range of 0.7-1 g/l isorhamnetin, such as about 0.75 g/l isorhamnetin.
The content of the extract obtained from a plant material selected from the family Apiaceae present in the composition may be standardizing from the content of asiatic acid.
In an embodiment of the present invention the composition comprises in the range of 0.1- 10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid.
In a further embodiment of the present invention the composition comprises in the range of 0.1-5 g/l isorhamnetin, such as in the range of 0.2-4 g/l isorhamnetin, e.g. in the range of 0.3-3 g/l isorhamnetin, such as in the range of 0.4-2.5 g/l isorhamnetin, e.g. in the range of 0.5-2 g/l isorhamnetin, such as in the range of 0.6-1.5 g/l isorhamnetin, e.g. in the range of 0.7-1 g/l isorhamnetin, such as about 0.75 g/l isorhamnetin; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5
g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid
The content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of kaempferol.
In an embodiment of the present invention the composition comprises in the range of 0.1- 5 g/l kaempferol, such as in the range of 0.2-4 g/l kaempferol, e.g. in the range of 0.3-3 g/l kaempferol, such as in the range of 0.4-2.5 g/l kaempferol, e.g. in the range of 0.5-2 g/l kaempferol, such as in the range of 0.6-1.5 g/l kaempferol, e.g. in the range of 0.7-1 g/l kaempferol, such as about 0.75 g/l kaempferol.
In a further embodiment of the present invention the composition comprises in the range of 0.1-5 g/l kaempferol, such as in the range of 0.2-4 g/l kaempferol, e.g. in the range of 0.3-3 g/l kaempferol, such as in the range of 0.4-2.5 g/l kaempferol, e.g. in the range of 0.5-2 g/l kaempferol, such as in the range of 0.6-1.5 g/l kaempferol, e.g. in the range of 0.7-1 g/l kaempferol, such as about 0.75 g/l kaempferol; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid
The content of the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the one or more flavonoids present in the composition may be standardized from the flavonoid content, preferably from the content of quercetin.
In an embodiment of the present invention the composition comprises in the range of 0.1- 5 g/l quercetin, such as in the range of 0.2-4 g/l quercetin, e.g. in the range of 0.3-3 g/l quercetin, such as in the range of 0.4-2.5 g/l quercetin, e.g. in the range of 0.5-2 g/l quercetin, such as in the range of 0.6-1.5 g/l quercetin, e.g. in the range of 0.7-1 g/l quercetin, such as about 0.75 g/l quercetin.
In a further embodiment of the present invention the composition comprises in the range of 0.1-5 g/l quercetin, such as in the range of 0.2-4 g/l quercetin, e.g. in the range of 0.3- 3 g/l quercetin, such as in the range of 0.4-2.5 g/l quercetin, e.g. in the range of 0.5-2 g/l
quercetin, such as in the range of 0.6-1.5 g/l quercetin, e.g. in the range of 0.7-1 g/l quercetin, such as about 0.75 g/l quercetin; and in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid
The composition may comprise flavonoids, preferably glycosidic bound flavonoids (such as isorhamnetin; preferably, glycosidic bound isorhamnetin; such as isorhamnetin-3-O- glucoside, asiatic acid; asiaticoside; and/or madegassic acid).
In an embodiment of the present invention the composition comprises a higher content of madecassoside than asiatic acid and/or than asiaticoside.
Preferably, the composition comprises a content of madecassoside which between 1.5-10 times higher than the content of asiatic acid on a weight-by-weight basis, such as between
2-5 times higher, e.g. about 3 times higher.
Preferably, the composition comprises a content of madecassoside which between 2-10 times higher than the content of asiaticoside on a weight-by-weight basis, such as between
3-5 times higher, e.g. about 4.5 times higher.
In an embodiment of the present invention the composition comprises a higher content of asiatic acid than asiaticoside. Preferably, the composition comprises a content of asiatic acid which between 1.25-5 times higher than the content of asiaticoside on a weight-by- weight basis, such as between 1.5-2.5 times higher, e.g. about 2 times higher.
In order to improve the taste and odour experience of the product, the composition may comprise a flavouring agent. The flavouring agent may be a menthe flavouring agent or a rosemary flavouring agent.
Even both the menthe flavouring agent and the rosemary flavouring agent may have preserving effects, the composition comprises a preservation agent. Preferably, the preservation agent is a sorbate compound, such as potassium sorbate. Preferably the sorbate compound is added in a concentration in the range of 0.1-0.5% (w/w) on a dry- matter basis, such as about 0.2% (w/w) on a dry-matter basis. Potassium sorbate has shown to prevent growth of molds and microbes and to increase shelf life of products.
The solvents used for providing the extracts according to the present invention may be an aqueous solvent, such as water, or an alcoholic solvent. The alcoholic solvent may be selected from methanol; ethanol, isopropanol or a mixture hereof.
In an embodiment of the present invention the composition comprises less than 2% alcoholic solvent; such as less than 1.5% alcoholic solvent; e.g. less than 1% alcoholic solvent; such as less than 0.5% alcoholic solvent; e.g. less than 0.3% alcoholic solvent; such as less than 0.1% alcoholic solvent, e.g. no alcoholic solvent.
The composition may preferably have a pH value in the range of pH 4-7.5, such as in the range of pH 4.5-6.5, e.g. in the range of pH 5-6, such as in the range of pH 5.5-5.8.
In an embodiment according to the present invention, the extract obtained from a plant material selected from the family Elaeagnaceae, or from the herb or combination of herbs comprising the one or more flavonoid compounds may be an alcoholic extract.
Preferably, the extract obtained from plant material selected from the family Elaeagnaceae, or from the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a liquid, a juice, a syrup, or a powder. Preferably, the extract obtained from a plant material selected from the family Elaeagnaceae, or the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a liquid, juice, or a syrup, even more preferably, the extract obtained from a plant material selected from the family Elaeagnaceae, or the herb or combination of herbs comprising the one or more flavonoid compounds may be provided in the form of a syrup.
In a further embodiment of the present invention the extract obtained from plant material selected from the family Apiaceae may be an aqueous solvent.
Preferably, the extract obtained from a plant material selected from the family Apiaceae may be provided in the form of a liquid, a juice, a syrup, or a powder. Preferably, the extract obtained from plant material selected from the family Apiaceae may be provided in the form of a powder.
In the present context the term "powder" relates to a composition having a moisture content of 15% (w/w) or less, such as a moisture content of 10% (w/w) or less, e.g. a moisture content of 7.5% (w/w) or less, such as a moisture content of 5% or less.
The composition may be administered in a unit dose form. In an embodiment of the present invention, the composition may be administered as a pill, a tablet, a spray, or a droplet. Preferably, the composition may be administered as a spray.
The composition according to the present invention may be formulated into an aerosol forming device, such as a nasal spray.
Thus, a preferred embodiment of the present invention relates to a nasal spray comprising a composition according to the present invention.
The nasal spray may be a decongestant nasal spray.
In an embodiment of the present invention the nasal spray may comprise a capacity in the range of 5-100 ml, such as in the range of 10-75 ml, e.g. in the range of 20-50 ml, such as about 30 ml.
In a further embodiment of the present invention the nasal spray may be adjusted to provide a unit dose of 25-300 mI/unit dose; such as 50-200 mI/unit dose; e.g. 75-150 mI/unit dose, such as about 100 mI/unit dose.
Preferably, the unit dose and/or single unit dose may relate to the volume of the composition provided to a human, e.g. the volume of the composition expelled from a nasal spray when actuated.
The composition according to the present invention have shown to have a tightening effect on the structure of the connective tissue in the soft part of the palate and throat, creating a more open passage in the upper respiratory tract.
Thus, a preferred embodiment of the present invention relates to a composition for use as a medication, wherein the composition comprises the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae.
A further preferred embodiment of the present invention relates to a composition for treating, alleviating and/or preventing snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae. When the composition is used as a medication and/or when the composition is used for treating, alleviating and/or preventing snoring, cold, and/or sleep apnea in humans the composition may be administered to humans by oral and/or nasal administration, preferably by both oral and nasal administration. Furthermore, when the composition is used as a medication and/or when the composition is used for treating, alleviating and/or precenting snoring, cold, and/or sleep apnea in humans, two unit doses, each unit dose comprise in the range of 25-300 pi of the composition, may be administered to humans, preferably 1-5 times a day, such as 2-4 times a day, preferably three times a day; such as two unit doses, each in the range of 50- 200 pi; e.g. two unit doses, each in the range of 75-150 pi, such as two unit doses, each of about 100 pi.
In an embodiment of the present invention the unit doses may be administered nasally, preferably to each nostril.
When the composition is used as a medication and/or when the composition is used for treating, alleviating, and/or preventing snoring, cold, and/or sleep apnea in humans, 1-3, preferably two, unit doses may be nasally administered to each nostril and two unit doses may be orally administered to humans, preferably such administration is repeated three times a day.
People suffering from snoring, cold, and/or sleep apnea may use an increased dosage of the composition according to the present invention, e.g. using two unit doses to treat and/or alleviate the snoring, cold, and/or sleep apnea as described above; whereas low
incidence of snoring, cold, and/or sleep apnea; or avoiding the development of snoring, cold, and/or sleep apnea may use a reduced dosage, e.g. one unit dose, as described in the following.
A preferred embodiment of the present invention relates to a composition for avoiding or postponing the development of snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
(i) an extract obtained from a plant material selected from the family Elaeagnaceae; and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from a plant material selected from the family Apiaceae.
When the composition is used for reducing the incidence of snoring, cold, and/or sleep apnea in humans or to avoid (or substantially avoid) the development of snoring, cold, and/or sleep apnea, the composition may be administered to humans by oral and/or nasal administration, preferably by both oral and nasal administration.
Furthermore, when the composition is used for reducing the incidence of snoring, cold, and/or sleep apnea in humans or to avoid (or substantially avoid) the development of snoring, cold, and/or sleep apnea, a single unit dose in the range of 25-300 pi of the composition may be administered to humans, preferably 1-5 times a day, such as 2-4 times a day, preferably three times a day; such as in the range of 50-200 pi; e.g. in the range of 75-150 pi, such as about 100 pi.
When the composition is used for reducing the incidence of snoring, cold, and/or sleep apnea in humans or to avoid (or substantially avoid) the development of snoring, cold, and/or sleep apnea the composition may be administered to humans one unit dose may be nasally administered to each nostril and one unit dose may be orally administered to humans, Preferably, such administration is repeated three times a day.
The composition according to the present invention may preferably be a medication, a natural medicinal product or a dietary supplement. Preferably, the composition according to the present invention may be a dietary supplement.
The composition according to the present invention is preferably an aqueous solution comprising the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising the flavonoids; and the extract obtained from a plant material selected from the family Apiaceae.
A preferred embodiment of the present invention relates to a method for providing a composition according to the present invention, wherein the method comprises the steps of:
(a) subjecting a plant material selected from the family Elaeagnaceae, and/or a herb or combination of herbs comprising the one or more flavonoids, to a first solvent providing an extract obtained from the plant material selected from the family Elaeagnaceae, and/or an extract obtained from the herb or the combination of herbs;
(b) subjecting a plant material selected from the family Apiaceae, to a second solvent providing an extract obtained from the plant material selected from the family Apiaceae;
(c) mixing the extract obtained from the plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising isorhamnetin, kaempferol and/or quercetin; obtained in step (a); with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b), providing the composition according to the present invention.
In an embodiment of the present invention the first solvent may be an alcoholic solvent. Preferably, the alcoholic solvent may be selected from methanol; ethanol, isopropanol or a mixture hereof.
The concentration of the alcoholic solvent may preferably in the range of 10-50% alcohol, such as in the range of 15-40% alcohol, e.g. in the range of 17-30% alcohol, such as about 20% alcohol.
In a further embodiment of the present invention the second solvent is an aqueous solvent. Preferably, the second embodiment is water, or an aqueous buffer.
The dry matter content provided in step (i) and/or (ii) during the extraction process may be in the range of 40-70% (w/w); such as in the range of 50-65% (w/w); e.g. about 60% (w/w).
Preferably, the extract obtained from plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising the flavonoids, may comprise glycosidic bound flavonoids, e.g. glycosidic bound isorhamnetin, such as isorhamnetin-3-O-glucoside; kaempferol; and/or quercetin.
Preferably, the extract obtained from plant material selected from the family Apiaceae comprises asiatic acid; asiaticoside; and/or madegassic acid.
In an embodiment of the present invention, the composition obtained by the present method comprises isorhamnetin (kaempferol and/or quercetin) and asiatic acid; asiaticoside; and/or madegassic acid.
The method according to the present invention further comprises the step of adding a preservation agent to the mixed composition. Preferably, the preservation agent is a sorbate compound, such as potassium sorbate. Preferably the sorbate compound is added in a concentration in the range of 0.1-0.5% (w/w) on a dry-matter basis, such as about 0.2% (w/w) on a dry-matter basis.
The extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising flavonoids; may preferably be provide in the form of a liquid, a juice or in the form of a syrup, preferably in the form of a syrup.
The extract obtained from a plant material selected from the family Apiaceae may preferably be provide in the form of a dry powder. The dry powder comprising the extract obtained from a plant material selected from the family Apiaceae may be dissolved in water or in the extract obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs provided in the form of a liquid, a juice or a syrup.
In an embodiment of the present invention, water may be added to the extract obtained from plant material selected from the family Elaeagnaceae, to the extract obtained from the herb or combination of herbs comprising flavonoids (like isorhamnetin, kaempferol and/or quercetin) (step (a)); to the extract obtained from a plant material selected from the family Apiaceae (step (b)) or to the mixture provided in step (c), where the extract
obtained from a plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs obtained in step (a) are mixed with the extract obtained from a plant material selected from the family Apiaceae as obtained in step (b), to provide the desired concentration of ingredients.
In an embodiment of the present invention the composition according to the present invention may be provided by mixing: the extract obtained from the plant material selected from the family Elaeagnaceae, obtained in step (a); and/or one or more flavonoid compound(s) according to the present invention; with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b); providing the composition according to the present invention.
It should be noted that embodiments and features described in the context of one of the aspects of the present invention also apply to the other aspects of the invention.
The invention will now be described in further details in the following non-limiting examples.
Examples
Example 1 - Preparation of the composition according to the present invention.
An extract obtained from a plant material selected from Hippophae rhamnoides was prepared by adding 20% ethanol (solvent) to the fruits of Hippophae rhamnoides, which has been ground, to a dry matter content of about 60%.
The solvent is evaporated, and no ethanol (less than 0.5% ethanol) remains in the syrup extract.
The syrup is standardized from the content of isorhamnetin to a content of isorhamnetin of 65% of the syrup.
The standardized syrup is mixed 1:5 with purified water and allowed to rest for 4 hours and organic particles and organic matter can settle, and the remaining solution is decanted to a mixing tray.
An extract obtained from a plant material selected from Centella asiatica was prepared by adding purified water (solvent) to ground Centella asiatica, to a dry matter content of about 60%. After the extraction, the extract was standardized from the content of asiatic acid and water was evaporated and the extract was dried providing a standardized powder extract.
The powder extract and a menthe flavouring agent was added to the mixing tray resulting in a composition having 2.77 g/l isorhamnetin, 0.75 g/l asiatic acid and the pH was adjusted to pH 5,5 using phosphate buffer.
The composition was packed in 30 ml nasal spray bottles and ready for use.
Example 2 - Demonstrating the effect of the spray developed in Example 1
25 volunteers 11 males and 14 females suffering from sleep apnea was diagnosed by a medical doctor at a Danish hospital. The doctor observed significant changes on the mucous membranes (showing severe swelling and blood extensions) and a greatly prolonged dream in all the 25 volunteers, and everyone were referred to the Sleep Clinic at a Danish hospital.
Each volunteer received a nasal spray bottle as provided in example 1 above. Each volunteer was treated with two unit-doses in each nostril and two unit doses was administered orally. The treatment was repeated 3 times a day and the treatment were continued for 15 days.
The results showed that all 25 volunteers experienced an improved condition after the test period, relative to the condition before receiving the nasal spray bottle as provided in example 1.
80% the volunteers were after a second clinic investigations at the Sleep Clinic at a Danish hospital, diagnosed as no longer suffering from sleep apnea and only slight snoring was observed periods of a total of 15-30 minutes spread over a full night's sleep.
Claims
1. A composition comprising the combination of: (i) an extract obtained from plant material selected from the family
Elaeagnaceae, and/or
(ii) one or more flavonoid compound(s); in combination with:
(iii) an extract obtained from plant material selected from the family Apiaceae.
2. The composition according to claim 1, wherein the one or more flavonoid compound is obtained from an herb or a combination of herbs comprising the one or more flavonoids.
3. The composition according to claim 2, wherein the herb or combination of herbs comprising the one or more flavonoids is Elaeagnaceae
4. The composition according to anyone of claims 1-3, wherein the Elaeagnaceae is selected from a Hippophae genus, such as the species H. rhamnoides ( Hippophae rhamnoides).
5. The composition according to anyone of the previous claims, wherein the plant material selected from the family Apiaceae comprising a plant material selected from the Centella family, or wherein the plant material selected from the family Apiaceae comprising a plant material selected from the species C. asiatica (Centella asiatica )
6. The composition according to anyone of the preceding claims, wherein the composition has a pH value in the range of pH 4-7.5, such as in the range of pH 4.5-6.5, e.g. in the range of pH 5-6, such as in the range of pH 5.5-5.8.
7. The composition according to anyone of the preceding claims wherein the composition comprises isorhamnetin (kaempferol and/or quercetin), and wherein the composition comprises in the range of 0.1-5 g/l isorhamnetin (kaempferol and/or quercetin), such as in the range of 0.2-4 g/l isorhamnetin (kaempferol and/or quercetin), e.g. in the range of 0.3-3 g/l isorhamnetin (kaempferol and/or quercetin), such as in the range of 0.4-2.5 g/l isorhamnetin (kaempferol and/or quercetin), e.g. in the range of 0.5-2 g/l isorhamnetin (kaempferol and/or quercetin), such as in the range of 0.6-1.5 g/l isorhamnetin
(kaempferol and/or quercetin), e.g. in the range of 0.7-1 g/l isorhamnetin (kaempferol and/or quercetin), such as about 0.75 g/l isorhamnetin (kaempferol and/or quercetin); and/or wherein the composition comprises asiatic acid, and wherein the composition comprises in the range of 0.1-10 g/l asiatic acid, such as in the range of 0.3-9 g/l asiatic acid, e.g. in the range of 0.5-8 g/l asiatic acid, such as in the range of 0.7-8 g/l asiatic acid, e.g. in the range of 0.9-7 g/l asiatic acid, such as in the range of 1-6 g/l asiatic acid, e.g. in the range of 1.5-5 g/l asiatic acid, such as in the range of 1.75-4 g/l asiatic acid, e.g. in the range of 2-3 g/l asiatic acid, such as in the range of 2.25-2.8 g/l asiatic acid, e.g. about 2.77 g/l asiatic acid.
8. A nasal spray comprising a composition according to anyone of claims 1-7.
9. The nasal spray according to claim 7, wherein the nasal spray is adjusted to provide a unit dose in an amount of 25-300 mI/unit dose; such as 50-200 mI/unit dose; e.g. 75-150 mI/unit dose, such as about 100 mI/unit dose.
10. A composition for use as a medication, wherein the composition comprises the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae, and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae.
11. A composition for treating, alleviating, preventing snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of:
(i) an extract obtained from plant material selected from the family Elaeagnaceae, and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from plant material selected from the family Apiaceae.
12. A composition for avoiding or postpone the development of snoring, cold, and/or sleep apnea in humans, characterised in that the composition comprises the combination of: (i) an extract obtained from a plant material selected from the family
Elaeagnaceae, and/or
(ii) one or more flavonoid compound(s); in combination with
(iii) an extract obtained from a plant material selected from the family Apiaceae.
13. The composition according to anyone of claims 10-12, wherein two unit doses each unit dose in the range of 25-300 pi of the composition is administered to humans three times a day; such as in the range of 50-200 pi; e.g. in the range of 75-150 mI, such as about 100 mI.
14. A method for providing a composition according to anyone of claims 1-7 and 10-13, wherein the method comprises the steps of:
(a) subjecting a plant material selected from the family Elaeagnaceae, and/or a herb or combination of herbs comprising the one or more flavonoids, to a first solvent providing an extract obtained from the plant material selected from the family Elaeagnaceae, and/or an extract obtained from the herb or the combination of herbs;
(b) subjecting a plant material selected from the family Apiaceae, to a second solvent providing an extract obtained from the plant material selected from the family Apiaceae;
(c) mixing the extract obtained from the plant material selected from the family Elaeagnaceae, and/or the extract obtained from the herb or combination of herbs comprising isorhamnetin, kaempferol and/or quercetin; obtained in step (a); with the extract obtained from plant material selected from the family Apiaceae as obtained in step (b), providing the composition according to anyone of claims 1-7 and 10-13.
15. The method according to claim 14, wherein the first solvent is an alcoholic solvent and/or the second solvent is an aqueous solvent.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA202100620 | 2021-06-11 | ||
| PCT/EP2022/065613 WO2022258722A1 (en) | 2021-06-11 | 2022-06-08 | Composition comprising centella extract and hippophae extract |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4351724A1 true EP4351724A1 (en) | 2024-04-17 |
Family
ID=82214093
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP22733576.7A Pending EP4351724A1 (en) | 2021-06-11 | 2022-06-08 | Composition comprising centella extract and hippophae extract |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP4351724A1 (en) |
| WO (1) | WO2022258722A1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105616533A (en) * | 2014-11-01 | 2016-06-01 | 崔怀龙 | Traditional Chinese medicine for treating sleep-apnea syndrome |
| CN108420746A (en) * | 2016-02-17 | 2018-08-21 | 哈尔滨凝昇科技有限公司 | A kind of preparation method of moisturizing emulsion |
| KR20180075136A (en) * | 2016-12-26 | 2018-07-04 | 주식회사 퍼슨 | Composition treating and relieving of snoring and sleep-apnea comprising viscotoxin and mistletoe polysaccarides |
| CN107951966B (en) * | 2017-11-21 | 2023-01-06 | 黄晓兵 | Foot bath liquid combining traditional Chinese medicine and Tibetan medicine |
| CN108653136A (en) * | 2018-06-26 | 2018-10-16 | 戴伟 | A kind of Chinese medicine composition and its mixed extract being used for cosmetics frost breast and facial mask |
-
2022
- 2022-06-08 EP EP22733576.7A patent/EP4351724A1/en active Pending
- 2022-06-08 WO PCT/EP2022/065613 patent/WO2022258722A1/en active Application Filing
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| Publication number | Publication date |
|---|---|
| WO2022258722A1 (en) | 2022-12-15 |
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