US20130337089A1 - Composition for preventing or treating hearing loss - Google Patents

Composition for preventing or treating hearing loss Download PDF

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Publication number
US20130337089A1
US20130337089A1 US14/002,763 US201214002763A US2013337089A1 US 20130337089 A1 US20130337089 A1 US 20130337089A1 US 201214002763 A US201214002763 A US 201214002763A US 2013337089 A1 US2013337089 A1 US 2013337089A1
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rehmannia glutinosa
cuscuta
extract
purpurea makino
glutinosa libschitz
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Tong Ho Kang
Bin Na Hong
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Industry Academic Cooperation Foundation of Kyung Hee University
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Industry Academic Cooperation Foundation of Kyung Hee University
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    • 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)
    • A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
    • 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)
    • A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
    • A23L1/3002—
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/64—Orobanchaceae (Broom-rape 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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Definitions

  • the present invention relates to a composition for preventing or treating hearing loss, comprising Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • Ear can be classified into external ear from auricle to external auditory canal, middle ear with ear drum and auditory ossicle, and internal ear with cochlear canal and auditory nerve. Since sound is acoustic energy, it can be transmitted from auricle through external auditory canal to vibrate ear drum. The vibration of ear drum is transmitted to auditory ossicle comprised of 3 small bones connected to ear drum via mechanical energy. Strapes, the distal bone of auditory ossicle is connected to cochlear canal thereby transmitting the energy to lymph in cochlear canal. Transmitted energy can induce wave in lymph by which hair cells inside of cochlear canal can be stimulated.
  • Sound transmitting organs such as external ear and middle ear can be recovered from diseases such as inflammation by treatment or surgery in most cases, and the hearing loss therefrom can be improved after treatment as well.
  • Such hearing loss is called conductive hearing loss.
  • hearing loss caused by cochlear canal, the organ sensing sound, auditory nerve transmitting sound via electric energy, and the brain area participating in comprehensive roles such as distinction and understanding of sound is called sensorineural hearing loss.
  • auditory organ is one of the most basic and important sense for communication enabling to learn language, acquire knowledge, take part in social activities, and enjoy human life. Since most cases of hearing loss correspond to sensorineural hearing loss without current therapeutic methods available except prevention, once occurred, utilization of assistant means such as hearing aid or implantation of mechanical devices in the body are adopted to help hearing.
  • Sensorineural hearing loss can be classified by the origin or time of outbreak, for example, innate hearing loss and acquired hearing loss depending on the time thereof. Innate hearing loss corresponds to the damage caused before birth from genetic, fetal or embryonic problems. Most cases of innate hearing loss are extremely severe in degree and impossible to learn language without separate training or education.
  • hearing aid or cochlear implant the device to stimulate auditory nerve by electric stimulus to be implanted in the body and separate external device to be worn to listen
  • hearing aid or cochlear implant with high output is adopted to help hearing.
  • the degree of hearing loss is severe, the effectiveness of assistant devices such as hearing aid or cochlear implant is low with huge difference from normal hearing ability, thereby lots of inconvenience in daily lives remains.
  • acquired hearing loss it can be caused by diseases, noise, drugs or accidents after birth, with causative agents such as noise, drugs, aging, trauma, and viruses.
  • hearing loss caused by noise and aging is appreciably increasing recently. Development of science and technology results to the extension of life span, which in turn leads to the worldwide increase of elderly population rapidly.
  • the noise level not less than 75 dB corresponds to that of roadside with driving cars
  • everyone in the industrial society can be regarded as living under the noise harmful to auditory organs.
  • environment noise compelled there are many cases of teenagers' exposure to loud sound such as leisure activity using MP3. Therefore, recent noise-induced hearing loss is seen in various age groups.
  • Noise-induced hearing loss due to MP3 utilization and the likes from young age can damage hearing so that conversation can be held only with the help of hearing aid in their 40's.
  • the degree of hearing loss gets more severe when accompanied with physical aging. As the degree of hearing loss gets severe, the effectiveness of assistant devices such as hearing aid is lowered. High degree of hearing loss will finally cause serious problems in communication. That is, the young generation experiencing current noise-induced hearing loss will suffer more severe hearing loss in their elderly.
  • Hearing loss plays important roles in determining the quality of lives of various generations from the old to the young.
  • NAC N-acetyl cysteine
  • MET methionine
  • the present inventors searched various active substances among natural substances with high safety to prevent or treat hearing loss. Surprisingly, it was found that Cuscuta japonica Choisy extract inhibited the shift of hearing threshold induced by noise effectively, and further the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy showed superior effects than individual extracts, thereby completing the present invention.
  • the present invention provides a pharmaceutical composition for preventing or treating hearing loss, comprising Cuscuta japonica Choisy extract.
  • the present invention provides a pharmaceutical composition for preventing or treating hearing loss, comprising the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • the present invention provides a food composition for preventing or ameliorating hearing loss, comprising Cuscuta japonica Choisy extract.
  • the present invention provides a food composition for preventing or ameliorating hearing loss, comprising the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • composition of the invention can be preferably adopted to the prevention or treatment of hearing loss induced by various causes, in particular noise-induced hearing loss.
  • Said Cuscuta japonica Choisy extract can be obtained by extract process comprising the extraction step of Cuscuta japonica Choisy with the extraction solvent selected from the group consisting of water, C 1 ⁇ C 4 alcohol, and the mixed solvent of water and C 1 ⁇ C 4 alcohol, preferably with aqueous ethanol.
  • Said extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy can be obtained by extract process comprising the extraction step of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy respectively with the extraction solvent selected from the group consisting of water, C 1 ⁇ C 4 alcohol, and the mixed solvent of water and C 1 ⁇ C 4 alcohol, preferably with aqueous ethanol, and then the mixing step of respective extracts, or the extraction step of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy together with the above mentioned extraction solvent.
  • the extraction solvent selected from the group consisting of water, C 1 ⁇ C 4 alcohol, and the mixed solvent of water and C 1 ⁇ C 4 alcohol, preferably with aqueous ethanol
  • Said Rehmannia glutinosa Libschitz var. purpurea MAKINO can be at least one selected from the group consisting of raw Rehmannia glutinosa Libschitz var. purpurea MAKINO, dried Rehmannia glutinosa Libschitz var. purpurea MAKINO and steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO, and said Cuscuta japonica Choisy can be at least one selected from the group consisting of Cuscuta chinensis Lam., Cuscuta pentagona Engelm., Cuscuta japonica Choisy, and Cuscuta australis R. Br.
  • composition according to the present invention can effectively inhibit the shift of hearing threshold induced by noise and the likes thereby inhibiting hearing loss, in particular, acoustic trauma, temporary or permanent noise-induced hearing loss. Therefore, the composition according to the present invention is useful for preventing or treating hearing loss. In addition, it can be administered orally, thereby drug compliance of patients can be enhanced.
  • FIG. 1 shows the measurement of Cuscuta japonica Choisy extract in transient evoked otoacoustic emission (TEOAE) test after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • FIG. 2 shows the measurement of Cuscuta japonica Choisy extract in hearing threshold test by auditory brainstem response (ABR) with click stimulation tone after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • ABR auditory brainstem response
  • FIG. 3 shows the measurement of Cuscuta japonica Choisy extract in hearing threshold test by auditory brainstem response (ABR) with 3 kHz TB stimulation tone after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • FIG. 4 shows the measurement of Cuscuta japonica Choisy extract in hearing threshold test by auditory brainstem response (ABR) with 4 kHz TB stimulation tone after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • FIG. 5 shows the measurement of Cuscuta japonica Choisy extract in hearing threshold test by auditory brainstem response (ABR) with 6 kHz TB stimulation tone after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • FIG. 6 shows the measurement of Cuscuta japonica Choisy extract in hearing threshold test by auditory brainstem response (ABR) with 8 kHz TB stimulation tone after exposure to noise (control: not treated group, T 100 : test group treated with Cuscuta japonica Choisy extract).
  • FIG. 7 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in transient evoked otoacoustic emission (TEOAE) test after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • TOAE transient evoked otoacoustic emission
  • FIG. 8 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in hearing threshold test by auditory brainstem response (ABR) with click stimulation tone after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • ABR auditory brainstem response
  • FIG. 9 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in hearing threshold test by auditory brainstem response (ABR) with 3 kHz TB stimulation tone after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • ABR auditory brainstem response
  • FIG. 10 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in hearing threshold test by auditory brainstem response (ABR) with 4 kHz TB stimulation tone after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • ABR auditory brainstem response
  • FIG. 11 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in hearing threshold test by auditory brainstem response (ABR) with 6 kHz TB stimulation tone after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • ABR auditory brainstem response
  • FIG. 12 shows the measurement of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy in hearing threshold test by auditory brainstem response (ABR) with 8 kHz TB stimulation tone after exposure to noise (control: not treated group, S 100 : comparative test group treated with steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract, TS 100 : test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy).
  • ABR auditory brainstem response
  • hearing loss used in this specification comprises conductive hearing loss and sensorineural hearing loss.
  • it comprises conductive hearing loss induced by various causes such as noise, drugs, aging, trauma, and viruses.
  • sensorineural hearing loss comprises noise induced hearing loss (NIHL) representing symptoms of damage in cochlear canal and auditory nerve due to various noises.
  • NIHL noise induced hearing loss
  • Said noise-induced hearing loss comprises acoustic trauma hearing loss, temporary threshold shift (TTS) due to short-term noise and permanent threshold shift (PTS) due to long-term noise.
  • TTS temporary threshold shift
  • PTS permanent threshold shift
  • the present invention provides a pharmaceutical composition for preventing or treating hearing loss, comprising Cuscuta japonica Choisy extract.
  • the present invention provides a pharmaceutical composition for preventing or treating hearing loss, comprising the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • Cuscuta japonica Choisy of the invention is the seed in egg-shaped fruit of annular plant Cuscuta japonica Choisy (name of herb medicine: Cuscuta japonica Choisy) belonging to Convolvulaceae, and can be at least one selected from the group consisting of Cuscuta chinensis Lam., Cuscuta pentagona Engelm., Cuscuta japonica Choisy, and Cuscuta australis R. Br.
  • Rehmannia glutinosa Libschitz var. purpurea MAKINO of the invention can be at least one selected from the group consisting of raw Rehmannia glutinosa Libschitz var. purpurea MAKINO, dried Rehmannia glutinosa Libschitz var. purpurea MAKINO and steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO, of which steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO is preferably used. Steamed Rehmannia glutinosa Libschitz var.
  • purpurea MAKINO represents the product obtained by steaming and drying raw Rehmannia glutinosa Libschitz var. purpurea MAKINO nine times, whereas raw Rehmannia glutinosa Libschitz var. purpurea MAKINO represents the root peeled with cuticular layer of perennial plant Rehmannia glutinosa Libschitz var. purpurea MAKINO (name of herb medicine: Rehmannia glutinosa Libschitz var. purpurea MAKINO) belonging to Scrophulariaceae, and dried Rehmannia glutinosa Libschitz var. purpurea MAKINO represents the product prepared by drying Rehmannia glutinosa Libschitz var. purpurea MAKINO.
  • the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy represents not only the extract prepared by extracting Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy together (mixed extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy) but also the mixture of extracts prepared by extracting them respectively (the mixture of Rehmannia glutinosa Libschitz var. purpurea MAKINO extract and Cuscuta japonica Choisy extract).
  • the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy of the invention comprises about 1:1.8 to about 1:9 ratio of Rehmannia glutinosa Libschitz var. purpurea MAKINO to Cuscuta japonica Choisy.
  • the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy blended within the above-mentioned ratio can present preferable preventive or therapeutic effects on hearing loss.
  • Said Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy can be obtained by extract process comprising the extraction step of Cuscuta japonica Choisy, or Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy with the extraction solvent (first extraction solvent) selected from the group consisting of water, C 1 ⁇ C 4 alcohol, and the mixed solvent of water and C 1 ⁇ C 4 alcohol.
  • Said first extraction solvent is preferably aqueous ethanol.
  • purpurea MAKINO and Cuscuta japonica Choisy can be also obtained by extracting Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy respectively as above, obtaining Rehmannia glutinosa Libschitz var. purpurea MAKINO extract and Cuscuta japonica Choisy extract, and then mixing them.
  • Said extraction process can be performed with about 1 to 20 w/w, and preferably about 3 to 10 w/w of said first extraction solvent, preferably the mixed solvent of water and ethanol based on the weight of Cuscuta japonica Choisy, or Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • said mixed solvent about 70% aqueous ethanol can be preferably used.
  • Extraction can be conducted by extracting methods known in the art, including but not limited to maceration, extraction with hot water, ultrasonic extraction, and reflux extraction. The person in the art can employ various extraction temperature appropriate to the extraction method selected, for example, including but not limited to from 20 to 100° C.
  • extraction time can vary depending on the extraction method and can be appropriately selected by the person in the art, for example, including the range of about 1 hour to 10 days for single or multiple times, but not limited thereto.
  • said extraction can be performed 2 or 3 times with said first extraction solvent at room temperature for about 2 days.
  • the extract obtained by extraction with said first extraction solvent can be filtered by conventional method to give liquid form wherein impurities are removed, or the extract in liquid form can be further concentrated under reduced pressure and/or dried to give powder form.
  • said extraction process can optionally further comprise the selection stage to obtain the fraction with high proportion of active ingredient. That is, the extract obtained by extraction with said first solvent is dispersed in water, and then is extracted with second extraction solvent, such as water-saturated C 4 alcohol to raise the proportion of active ingredient in the resulting extract.
  • second extraction solvent such as water-saturated C 4 alcohol
  • the pharmaceutical composition of the invention can comprise 1 to 80 weight % of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy based on the total weight of the composition.
  • the pharmaceutical composition of the invention can comprise pharmaceutically acceptable carriers, and can be formulated into the form of oral preparation such as powder, granule, tablet, capsule, suspension, emulsion, syrup, and aerosol, and external preparation, suppository preparation and sterile injection according to the conventional methods therefor.
  • said pharmaceutically acceptable carriers can comprise conventionally used carriers in the art, including but not limited to lactose, dextrose, sucrose, sorbitol, Mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrollidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oils.
  • the pharmaceutical composition of the invention comprises diluents, excipients and other pharmaceutically acceptable additives such as fillers, expanders, binders, humectants, disintegrants, and surfactants.
  • the pharmaceutical composition of the invention when formulated into oral solid preparation, it comprises tablet, pillet, powder, granule, capsule and the likes, wherein such solid preparation can comprise but not limited to at least one excipient, such as starch, calcium carbonate, sucrose or lactose, and gelatin, and lubricant, such as magnesium stearate, and talc.
  • excipient such as starch, calcium carbonate, sucrose or lactose, and gelatin
  • lubricant such as magnesium stearate, and talc.
  • the pharmaceutical composition of the invention when formulated into oral liquid preparation, it comprises suspension, drink, emulsion and syrup, wherein such preparation can comprise but not limited to diluent such as water, and liquid paraffin, humectant, sweetening agent, odorant and preservative.
  • diluent such as water, and liquid paraffin, humectant, sweetening agent, odorant and preservative.
  • the pharmaceutical composition of the invention when formulated into parental preparation, it comprises sterile solution, non-aqueous solution, suspension, emulsion, lyophilized preparation and suppository, wherein such preparation can comprise but not limited to non-aqueous solvent or suspending agent such as propylene glycol, polyethylene glycol, vegetable oil like olive oil and injectable esters like ethylolate.
  • the base for suppository can comprise but not limited to witepsol, macrogol, Tween 61, cacao butter, laurine butter, and glycerogeletain.
  • the dosage of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy to be contained in the pharmaceutical composition of the invention can vary depending on the status, weight and age of patient, severity of disease, formulation, administration route and period, but it can be properly selected by the person in the art.
  • said Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy can be administered with dosage of 1 to 2000 mg/kg/day, and preferably 10 to 2000 mg/kg/day, which can be given once a day or divided into several times a day.
  • composition of the invention can be given by various routes, for example oral, intraperitoneal or intravenous, intramuscular, subcutaneous, intrauterine, intrathecal or intracerebroventricular injection to mammal including rat, mouse, livestock, and human.
  • the pharmaceutical composition of the invention is effective in preventing or treating hearing loss including conductive hearing loss and sensorineural hearing loss, and particularly effective in preventing or treating noise-induced hearing loss including acoustic trauma hearing loss, temporary threshold shift due to short-term noise and permanent threshold shift due to long-term noise.
  • the present invention comprises the food composition for preventing or ameliorating hearing loss, preferably noise-induced hearing loss, which comprising Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • hearing loss preferably noise-induced hearing loss, which comprising Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy.
  • the food composition of the invention can be used as health functional food.
  • health functional food means the food manufactured and processed by using materials and substance with useful functionality for human body in accordance with the Health Functional Food Act No. 6727, wherein “functionality” means that it is taken for the purpose of obtaining useful health use such as controlling nutrients or influencing physiology for body structure and function.
  • the food composition of the invention can comprise conventional food additives, and the acceptability of said “food additives” shall be judged by specifications and standards for relevant items in accordance with general principles and test methods of Korean Food Additives Codex, unless there is no other regulation thereto.
  • Items listed in said “Korean Food Additives Codex” include, for example, chemically synthesized additives such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamic acid, natural additives such as persimmon color, licorice extract, crystalline cellulose, kaoliang color, and guar gum, and compound additives such as sodium L-glutamate, alkali additives for noodle, preservative additives, and tar color.
  • chemically synthesized additives such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamic acid
  • natural additives such as persimmon color, licorice extract, crystalline cellulose, kaoliang color, and guar gum
  • compound additives such as sodium L-glutamate, alkali additives for noodle, preservative additives, and tar color.
  • the food composition of the invention can comprise 0.01 to 95 weight %, preferably 1 to 80 weight % of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy based on the total weight of composition, for the purpose of preventing and/or ameliorating hearing loss, particularly noise-induced hearing loss.
  • Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy to be contained to the food composition of the invention can be obtained by the same method mentioned in the preparation of above pharmaceutical composition.
  • the food composition of the invention can be prepared and processed into the forms of tablet, capsule, powder, granule, liquid, pillet and the likes for the purpose of preventing and/or ameliorating hearing loss.
  • said health functional food in tablet form can be prepared by granulating the mixture of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy, and excipients, binders, disintegrants and other additives according to conventional method, then adding lubricants and the likes and compress-molding them, or directly compress-molding the said mixture.
  • said health functional food in tablet form can optionally comprise tasty acids and the likes, and can be optionally coated with appropriate coating agents.
  • hard capsule can be prepared by filling the mixture of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy, and additives such as excipients, or granules thereof or coated granules thereof into conventional hard capsule
  • soft capsule can be prepared by filling the mixture of steamed extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy, and additives such as excipients into capsule base such as gelatin.
  • Said soft capsule can optionally comprise plasticizers such as glycerin or sorbitol, coloring agents and preservatives.
  • the health functional food in the form of pillet can be formulated by compacting the mixture of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy, and excipients, binders, disintegrants and the likes with appropriate method, and optionally coating with white sugar or other proper coating agents or glidant-coating with starch, talc or appropriate substances.
  • the health functional food in the form of granule can be prepared with the mixture of Cuscuta japonica Choisy extract or the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy, and excipients, binders, disintegrants and the likes by proper methods, and optionally comprise fragrance, tasty acids and the likes.
  • the residual amount through sieves can be none with No. 12 sieve, and not more than 5.0% with No. 14 sieve whereas the passing amount with No. 45 sieve can be not more than 15.0% based on the total amount thereof.
  • Example 2 50 g of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy obtained from above Example 2 was suspended into 1 L of distilled water and dissolved by adding 1 L of water-saturated butanol, and then only the fraction soluble in water-saturated butanol layer was separated from funnel to vacuum dry. This procedure was repeated 5 times to obtain 9.8 g of fraction.
  • TOAE transient evoked otoacoustic emission
  • Transient evoked otoacoustic emission (TEOAE) experiment is to measure the sound developed in hair cells of cochlea from outside based on the fact that healthy hair cells develop sound as a response to acoustic stimulus. On the other hand, such response in damaged hair cells tends to diminish or disappear. Since noise-induced stimulus can cause serious damage on hair cells of cochlea, transient evoked otoacoustic emission (TEOAE) experiment was conducted to identify the effect on noise-induced hearing loss of Cuscuta japonica Choisy extract.
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • Auditory brainstem response (ABR) experiment is to test the response to sound by measuring the electric energy transmitted from auditory nerve by sound stimulus. Since the response obtained by sound from external ear through middle ear and cochlear canal to auditory nerve reflects the total condition of external ear, middle ear, and cochlear canal, it demonstrates actual auditory energy reaching to brain. Hearing threshold means the minimal point of hearing sense to hear, and normal mouse can show response with as small sound as 20 dB on average.
  • control group showed increased hearing threshold at 24 hours after exposure to noise and maintained similar threshold for 7 days which suggesting permanent hearing damage.
  • Cuscuta japonica Choisy extract (T 100 ) treated group showed the decrease in threshold since 4 days after exposure to noise, and 17 dB decrease than before administration shown at 7 days after exposure identified significant ameliorating effects compared to control group. From high ameliorating effects on hearing threshold with Cuscuta japonica Choisy extract (T 100 ) treated group, it can be verified that Cuscuta japonica Choisy extract (T 100 ) is effective in preventing and treating noise-induced hearing loss.
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • control group showed increased hearing threshold at 24 hours after exposure to noise and maintained similar threshold for 7 days which suggesting permanent hearing damage.
  • Cuscuta japonica Choisy extract (T 100 ) treated group showed the decrease in threshold since 4 days after exposure to noise, and 7 dB decrease than before administration shown at 7 days after exposure identified significant ameliorating effects compared to control group.
  • high ameliorating effects on hearing threshold with Cuscuta japonica Choisy extract (T 100 ) treated group was found to identify that Cuscuta japonica Choisy extract (T 100 ) is effective in preventing and treating noise-induced hearing loss.
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • control group showed increased hearing threshold at 24 hours after exposure to noise and maintained similar threshold for 7 days which suggesting permanent hearing damage.
  • Cuscuta japonica Choisy extract (T 100 ) treated group showed the decrease in threshold since 4 days after exposure to noise, and 15 dB decrease than before administration shown at 7 days after exposure identified significant ameliorating effects compared to control group.
  • ameliorating effects on hearing threshold with Cuscuta japonica Choisy extract (T 100 ) treated group was found to identify that Cuscuta japonica Choisy extract (T 100 ) is effective in preventing and treating noise-induced hearing loss.
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • control group showed increased hearing threshold at 24 hours after exposure to noise and maintained similar threshold for 7 days which suggesting permanent hearing damage.
  • Cuscuta japonica Choisy extract (T 100 ) treated group showed the decrease in threshold since 4 days after exposure to noise, and 13 dB decrease than before administration shown at 7 days after exposure identified ameliorating effects compared to control group.
  • ameliorating effects on hearing threshold with Cuscuta japonica Choisy extract (T 100 ) treated group was found to identify that Cuscuta japonica Choisy extract (T 100 ) is effective in preventing and treating noise-induced hearing loss.
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • control group showed increased hearing threshold at 24 hours after exposure to noise and maintained similar threshold for 7 days which suggesting permanent hearing damage.
  • Cuscuta japonica Choisy extract (T 100 ) treated group showed the decrease in threshold since 4 days after exposure to noise, and 20 dB decrease than before administration shown at 7 days after exposure identified ameliorating effects compared to control group.
  • ameliorating effects on hearing threshold with Cuscuta japonica Choisy extract (T 100 ) treated group was found to identify that Cuscuta japonica Choisy extract (T 100 ) is effective in preventing and treating noise-induced hearing loss.
  • TOAE transient evoked otoacoustic emission
  • hearing threshold experiment was conducted by using auditory brainstem response (ABR).
  • hearing threshold was measured by using auditory brainstem response (ABR).
  • the test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica showed higher ameliorating effect on hearing threshold than the group treated with Steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract (S 100 ), thereby preventive and therapeutic effects of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy (TS 100 ) on noise-induced hearing loss was identified.
  • hearing threshold was measured by using auditory brainstem response (ABR).
  • the test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica showed higher ameliorating effect on hearing threshold than the group treated with Steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract (S 100 ), thereby preventive and therapeutic effects of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy (TS 100 ) on noise-induced hearing loss was identified.
  • hearing threshold was measured by using auditory brainstem response (ABR).
  • the test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica showed higher ameliorating effect on hearing threshold than the group treated with Steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract (S 100 ), thereby preventive and therapeutic effects of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy (TS 100 ) on noise-induced hearing loss was identified.
  • hearing threshold was measured by using auditory brainstem response (ABR).
  • the test group treated with the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica showed higher ameliorating effect on hearing threshold than the group treated with Steamed Rehmannia glutinosa Libschitz var. purpurea MAKINO extract (S 100 ), thereby preventive and therapeutic effects of the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy (TS 100 ) on noise-induced hearing loss was identified.
  • Cuscuta japonica Choisy extract, and the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy are useful to prevent and treat hearing loss such as noise-induced hearing loss by protecting hair cells from damage and decreasing hearing threshold measured from auditory nerve. Therefore, Cuscuta japonica Choisy extract, and the extract of Rehmannia glutinosa Libschitz var. purpurea MAKINO and Cuscuta japonica Choisy can be used for preventing and treating sensorineural hearing loss.
  • Purified water was added to make 1000 ml.
  • the above ingredients were mixed and filled into amber bottles according to conventional methods to prepare solution.

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CN104337951A (zh) * 2013-08-10 2015-02-11 李谊 一种治疗噪声性耳聋的中药组合物
CN107846850A (zh) * 2016-01-04 2018-03-27 葡萄王生技股份有限公司 预防听力退化的活性物质、含其的组合物、及其制备方法
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