WO2019114686A1 - Composition for teeating dementia and preparation method and use thereof - Google Patents

Composition for teeating dementia and preparation method and use thereof Download PDF

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Publication number
WO2019114686A1
WO2019114686A1 PCT/CN2018/120239 CN2018120239W WO2019114686A1 WO 2019114686 A1 WO2019114686 A1 WO 2019114686A1 CN 2018120239 W CN2018120239 W CN 2018120239W WO 2019114686 A1 WO2019114686 A1 WO 2019114686A1
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approximately
therapeutic composition
ingredients
weight portion
portion size
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PCT/CN2018/120239
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French (fr)
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Zhijing YAO
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Yao Zhijing
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285Aucklandia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/29Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296Epimedium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/69Polygalaceae (Milkwort family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/888Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8965Asparagus, e.g. garden asparagus or asparagus fern
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • A61K36/8984Dendrobium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • A61K36/8988Gastrodia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Definitions

  • the invention relates to the field of traditional Chinese medicine, and in particular to a therapeutic composition for preventing and treating Alzheimer's disease, a preparation method thereof, and a method of using the therapeutic composition for the prevention and/or treating of Alzheimer's disease.
  • Dementia including Alzheimer's disease (AD) , senile dementia, vascular dementia, and depression, etc.
  • AD Alzheimer's disease
  • senile dementia vascular dementia
  • depression depression
  • Dementia has remained a world-wide challenging disease that is very difficult to prevent, treat, or cure.
  • these medications have far from ideal clinical effectiveness, and often have toxicity and side effects that cannot be ignored.
  • the patients with dementia quite often still show serious symptoms such as mental retardation, disordered memory, and degraded cognitive function, etc.
  • the present invention provides a therapeutic composition for treating dementia, a preparation method thereof, and a method for treating dementia utilizing the therapeutic composition.
  • a therapeutic composition for treating dementia is provided.
  • the therapeutic composition comprises a plurality of ingredients, which include Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice.
  • Each of the plurality of ingredients is in a powder form and is together mixed with an animal fat, a vegetable oil, an edible alcohol, and an edible salt.
  • Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, Licorice, the animal fat, the vegetable oil, the edible alcohol, and the edible salt respectively have a weight portion size of approximately 1-10, approximately 3-15, approximately 3-15, approximately 1-3, approximately 3-10, approximately 1-6, approximately 1-6, approximately 1-5, approximately 1-10, approximately 350-1000, approximately 5-15, approximately 25-250, and approximately 2-10.
  • the plurality of ingredients further comprise Angelica, Gastrodia elata, Dendrobium, and Epimedium, which respectively have a weight portion size of approximately 3-10, approximately 3-10, approximately 1-3, and approximately 1-10.
  • Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 1, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, and approximately 1.
  • Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 3, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, and approximately 1.
  • the animal fat can comprise at least one of beef fat, pork fat, or goat fat
  • the vegetable oil can comprise at least one of sea buckthorn oil, walnut oil, olive oil, or palm oil.
  • the edible alcohol can comprise an alcoholic wine with a degree of alcohol of about 15-50 degrees
  • the Genseng can comprise at least one of Genseng from North East China, Korean Genseng, or American Genseng.
  • the edible salt can comprise sodium chloride.
  • the therapeutic composition can further comprise a pharmaceutically acceptable adjuvant, such as starch.
  • the therapeutic composition can have a dosage form of granules, tablets, paste, pills, or capsules.
  • the therapeutic composition can further comprise at least one of Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
  • Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, and Hawthorn pulp can respectively have a weight portion size of approximately 10-20, approximately 10-20, approximately 10-20, approximately 6-15, approximately 6-15, approximately 6-10, approximately 6-15, and approximately 6-15.
  • the present disclosure further provides a method for preparing a therapeutic composition.
  • the therapeutic composition can be based on any one of the embodiments described above.
  • the preparation method substantially comprises the following steps:
  • the plurality of ingredients further comprise at least one of Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
  • the preparation method further comprises a step of:
  • the dosage form can be selected from granules, tablets, paste, pills, and capsules.
  • the preparation method further comprises a step of:
  • the present disclosure further provides a method for treating a subject diagnosed with dementia.
  • the treating method substantially comprises:
  • the therapeutic composition can be based on any one of the embodiments described above.
  • the therapeutic composition in step a) , is orally administered to the subject on a schedule of two or three times daily for at least one treating period.
  • each of at least one treating period can be a month of at least 28 days.
  • the therapeutic composition further comprises at least one of Pueraria, Shengdi, Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
  • the dementia can be Alzheimer’s disease, vascular dementia, or depression.
  • the dementia is Alzheimer’s disease, which is combined with a Parkinson’s syndrome.
  • the subject can be a human being, or can be an animal such as a mouse, a monkey, an ape, etc.
  • the weight portion size is defined as a relative size in terms of weight, which can be a number of unit weight.
  • the unit weight can be 1 gram, 10 grams, 100 ounces, 1 kilograms, etc.
  • a composition has ingredients A, B, C, and D, and the ingredients A, B, C and D have a weight portion size of 1, 2, 3 and 4, respectively.
  • the respective weights for the ingredients A, B, C and D are 10 g, 20 g, 30 g, and 40 g.
  • the respective weights for the ingredients A, B, C and D are 100 oz, 200 oz, 300 oz, and 400 oz.
  • FIG. 1 illustrates a correspondence table for the English names and the Chinese names of certain traditional Chinese medicine ingredient.
  • FIG. 1 illustrates a correspondence table for the English names and the Chinese names of certain traditional Chinese medicine ingredient included in the therapeutic composition disclosed herein.
  • Embodiment 1 one embodiment of the therapeutic composition and its preparation method
  • one daily dose for the therapeutic composition includes: 1 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice.
  • Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder.
  • Embodiment 2 another embodiment of the therapeutic composition and its preparation method
  • one daily dose for the therapeutic composition includes: 1 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice.
  • Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder.
  • Embodiment 3 yet another embodiment of the therapeutic composition and its preparation method
  • one daily dose for the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice.
  • Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder.
  • Embodiment 4 yet another embodiment of the therapeutic composition and its preparation method
  • one daily dose for the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice.
  • Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder.
  • Embodiment 5 a granule-form therapeutic composition and its preparation method
  • Embodiment 5 the therapeutic composition obtained in Embodiment 1 can be mixed with a conventional auxiliary material to thereby obtain a granule-form therapeutic composition following a conventional granule preparation approach.
  • Embodiment 5 is substantially a granule-form of the therapeutic composition based on Embodiment 1.
  • Embodiment 6 a tablet-form therapeutic composition and its preparation method
  • Embodiment 6 the therapeutic composition obtained in Embodiment 2 can be mixed with a conventional auxiliary material to thereby obtain a tablet-form therapeutic composition following a conventional tablet preparation approach.
  • Embodiment 6 is substantially a tablet-form of the therapeutic composition based on Embodiment 2.
  • Embodiment 7 a paste-form therapeutic composition and its preparation method
  • Embodiment 7 the therapeutic composition obtained in Embodiment 3 can be mixed with a conventional auxiliary material to thereby obtain a paste-form therapeutic composition following a conventional tablet preparation approach.
  • Embodiment 7 is substantially a paste-form of the therapeutic composition based on Embodiment 3.
  • Embodiment 8 a pill-form therapeutic composition and its preparation method
  • Embodiment 8 the therapeutic composition obtained in Embodiment 3 can be mixed with a conventional auxiliary material to thereby obtain a pill-form therapeutic composition following a conventional tablet preparation approach.
  • Embodiment 8 is substantially a pill-form of the therapeutic composition based on Embodiment 3.
  • Embodiment 9 a capsule-form therapeutic composition and its preparation method
  • Embodiment 8 the therapeutic composition obtained in Embodiment 4 can be mixed with a conventional auxiliary material to thereby obtain a capsule-form therapeutic composition following a conventional tablet preparation approach.
  • Embodiment 9 is substantially a capsule-form of the therapeutic composition based on Embodiment 4.
  • Embodiment 10 a small pill-form therapeutic composition and its preparation method
  • Embodiment 10 the therapeutic composition obtained in Embodiment 4 can be mixed with a conventional auxiliary material to thereby obtain a small pill-form therapeutic composition following a conventional tablet preparation approach.
  • Embodiment 10 is substantially a small pill-form of the therapeutic composition based on Embodiment 4.
  • one or more of the following ingredients or components can be added in any of the Embodiments 1-4 described above: 10-20 g of Pueraria, 10-20 g of Shengdi, 10-20 g of Rehmannia, 6-15 g of Chinese wolfberry, 6-15 g of Bupleurum, 6-10 g of Cohosh, 6-15 g of Tuckahoe, and 6-15 g of Hawthorn pulp (i.e. Cornus Pulp) .
  • Embodiment 11 yet another embodiment of the therapeutic composition and its preparation method
  • the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 3 g of Pueraria, and 3 g of Bupleurum.
  • Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder.
  • Embodiment 12 yet another embodiment of the therapeutic composition and its preparation method
  • the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 15 g of Shengdi, 6 g of Chinese wolfberry, 8 g of Cohosh (i.e. Cimicifuga) , and 6 g of Bupleurum.
  • Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder. Then 250 g of pork fat, 5 g of walnut oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
  • Embodiment 13 yet another embodiment of the therapeutic composition and its preparation method
  • the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 10 g of Tuckahoe, 10 g of Cornus Pulp, and 16 g of Rehmannia.
  • Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder.
  • Embodiment 14 yet another embodiment of the therapeutic composition and its preparation method
  • the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, and 10 g of Tuckahoe.
  • Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder.
  • the therapeutic composition can have a dosage form of granules, tablets, paste, pills (large or small) , capsules, and can be bottled and sealed.
  • the median lethal dose (LD50) or the maximum dose is determined by evaluating the acute toxicity of the granule-form of the therapeutic composition, which can provide a safety evaluation for clinical use.
  • a total of 50 mice were used, with 25 males and 25 females, each having a weight of 18-25 g.
  • a box is configured to have 10 mice per box, and the males and females were cultured in different boxes.
  • the granules of the therapeutic composition according to Embodiment 1 are formulated into a suspension having a maximum concentration using distilled water.
  • the suspension having a maximum concentration is defined such that when the suspension is drawn in a syringe, the syringe is not clogged, and the normal gavage is not affected.
  • mice Because the LD50 was not detected in the preliminary experiment, the experiment was changed to the determination of the maximum dose.
  • a total of 40 healthy mice having 20 males and 20 females are randomly divided into 4 groups, with 10 mice in each group. These mice were fasted for 12 h before administration of the therapeutic composition.
  • mice contain a blank control group, and an administration group 130.0, 260.0, and 520.0 g/Kg (ratio of the weight of therapeutic composition relative to the body weight) , which correspond to 50, 100, and 200 folds of a clinical dose, respectively.
  • a test solution i.e. the suspension of the therapeutic composition
  • the test solution was administered according to the maximum volume of 0.4 ml/10 g.
  • the blank control group was given an equal dose of physiological saline, then was observed for appearance, behavior, activity, and Mental activity, appetite, urine and its color, fur, breath, nose, eyes, mouth, abnormal secretions, weight changes and death.
  • organ coefficient (organ weight/body weight) x 100%.
  • mice were free to move, and have no convulsions, movement disorders, salivation, tearing, runny nose, difficulty breathing, diarrhea, constipation, and flatulence. Animal fur was shiny and none of the animals died within 7 days after administration. There was no significant difference in body weight between the mice before administration, and it was comparable. After administration, the body weight of the mice in the drug-administered group did not show significant difference compared with the blank control group. The anatomical organ was observed with the naked eye. No abnormal changes such as swelling, atrophy, hemorrhage, color abnormality, adhesion, and hardening were found in the liver, kidney, spleen and other organs. There was no statistically significant difference in the organ coefficient between the drug-administered group and the control group.
  • liver function e.g. alanine aminotransferase
  • renal function e.g. serum muscle spasm and urea nitrogen
  • the therapeutic composition was orally administered to the patients two to three times a day for at least one treating period, and preferably 1-3 treating period.
  • one treating period is about one month, with 28 days counted for each month.
  • Each time each patient was administered with ⁇ 9.9 g of the therapeutic composition.
  • Other drugs and methods for treating the disease were stopped during the treatment.
  • the therapeutic composition provided by the present disclosure has a therapeutic efficiency of 73%and an effective rate of 97%for Alzheimer's disease and its combined Parkinson's syndrome, and can be used for treating Alzheimer's disease and its combined Parkinson's syndrome. No toxic side effects are observed, and thus it is suitable for long-term use.
  • Case 1 Ms. Zou, 70 years old, had suffered from Alzheimer's disease for more than 10 years. The following symptoms were observed before treatment: debilitating, sluggish, language disorder, no logic, very poor recognition, no sense of direction, yet she had normal blood pressure, blood sugar and blood lipids, her diet, urine and feces were normal. Her pulse was fine.
  • Case 3 Ms. Qiu, 76 years old, with 5 years of Alzheimer's disease. The following symptoms were observed before treatment: very poor recognition, unable to take care of herself, poor sleep at night, only remembering things decades ago, no sense of time and space, and unable to recognize any relatives.
  • Case 4 Ms. Chen, 75 years old, with a moderate cerebral infarction. The following symptoms were observed before treatment: unable to move, need care for everything, sluggish facial expression, awkward language, and cold hands and feet.
  • the therapeutic composition disclosed herein has remarkable effects in treating Alzheimer's disease and its combined Parkinson's syndrome, and the toxic and side effects are light, if any.
  • the therapeutic composition disclosed herein does not need to be prepared in a traditional manner (e.g. decoction) , and can be grinded into powder and mixed with an animal fat, a vegetable oil and an alcohol.
  • the preparation method of the therapeutic composition is relatively simple and the therapeutic composition prepared thereby is also convenient for storage.

Abstract

A therapeutic composition for treating dementia is disclosed. The therapeutic composition includes a plurality of ingredients including Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice. Each ingredient is in a powder form and the powered ingredients are together mixed with an animal fat, vegetable oil, an edible alcohol, and an edible salt. The ingredients can optionally further include at least one of Pueraria, Shengdi, Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp. The therapeutic composition can be in various dosage forms.

Description

[Title established by the ISA under Rule 37.2] COMPOSITION FOR TEEATING DEMENTIA AND PREPARATION METHOD AND USE THEREOF
CROSS-REFERENCE TO RELATED APPLICATION
The present application is a continuation of, and claims priority to Chinese Patent Application No. 201711330512.4, filed on December 13, 2017, the disclosure of which is hereby incorporated by reference in its entirety.
TECHNICAL FIELD
The invention relates to the field of traditional Chinese medicine, and in particular to a therapeutic composition for preventing and treating Alzheimer's disease, a preparation method thereof, and a method of using the therapeutic composition for the prevention and/or treating of Alzheimer's disease.
BACKGROUND
Dementia, including Alzheimer's disease (AD) , senile dementia, vascular dementia, and depression, etc., has remained a world-wide challenging disease that is very difficult to prevent, treat, or cure. At present, there are several medications that have been developed and applied in the western medical community. Generally, these medications have far from ideal clinical effectiveness, and often have toxicity and side effects that cannot be ignored. For example, after taking these western medications, the patients with dementia quite often still show serious symptoms such as mental retardation, disordered memory, and degraded cognitive function, etc.
Chinese traditional medicine, on the other hand, has shown some promises in clinical practices due to its long history, self-contained theoretical basis, and a common understanding of many complex diseases. Currently, however, there have been no such traditional Chinese medicine targeting dementia with significant therapeutic effects.
SUMMARY OF THE INVENTION
The present invention provides a therapeutic composition for treating dementia, a preparation method thereof, and a method for treating dementia utilizing the  therapeutic composition.
In a first aspect, a therapeutic composition for treating dementia is provided.
The therapeutic composition comprises a plurality of ingredients, which include Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice. Each of the plurality of ingredients is in a powder form and is together mixed with an animal fat, a vegetable oil, an edible alcohol, and an edible salt.
According to some embodiments of the therapeutic composition, Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, Licorice, the animal fat, the vegetable oil, the edible alcohol, and the edible salt respectively have a weight portion size of approximately 1-10, approximately 3-15, approximately 3-15, approximately 1-3, approximately 3-10, approximately 1-6, approximately 1-6, approximately 1-5, approximately 1-10, approximately 350-1000, approximately 5-15, approximately 25-250, and approximately 2-10.
Optionally in the therapeutic composition, the plurality of ingredients further comprise Angelica, Gastrodia elata, Dendrobium, and Epimedium, which respectively have a weight portion size of approximately 3-10, approximately 3-10, approximately 1-3, and approximately 1-10.
According to some embodiment of the therapeutic composition, Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 1, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, and approximately 1.
According to some other embodiment of the therapeutic composition, Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 3, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1,  and approximately 1.
In any one of the embodiments of the therapeutic composition described above, the animal fat can comprise at least one of beef fat, pork fat, or goat fat, and the vegetable oil can comprise at least one of sea buckthorn oil, walnut oil, olive oil, or palm oil.
Furthermore, the edible alcohol can comprise an alcoholic wine with a degree of alcohol of about 15-50 degrees, and the Genseng can comprise at least one of Genseng from North East China, Korean Genseng, or American Genseng.
Herein, the edible salt can comprise sodium chloride.
Herein, the therapeutic composition can further comprise a pharmaceutically acceptable adjuvant, such as starch.
The therapeutic composition can have a dosage form of granules, tablets, paste, pills, or capsules.
According to some embodiments of the disclosure, the therapeutic composition can further comprise at least one of Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
Optionally, for the above ingredients in the therapeutic composition, Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, and Hawthorn pulp can respectively have a weight portion size of approximately 10-20, approximately 10-20, approximately 10-20, approximately 6-15, approximately 6-15, approximately 6-10, approximately 6-15, and approximately 6-15.
In a second aspect, the present disclosure further provides a method for preparing a therapeutic composition. The therapeutic composition can be based on any one of the embodiments described above.
The preparation method substantially comprises the following steps:
i) providing a plurality of ingredients, wherein the plurality of ingredients comprise Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice;
ii) grinding each of the plurality of ingredients into a powder to thereby obtain a plurality of powders corresponding respectively to the plurality of ingredients; and
iii) mixing the plurality of powders with an animal fat, a vegetable oil, an edible alcohol, and an edible salt to thereby obtain the therapeutic composition.
According to some embodiments of the preparation method, in step i) , the plurality of ingredients further comprise at least one of Pueraria, Shengdi. Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
According to some embodiments of the disclosure, after step iii) , the preparation method further comprises a step of:
iv) processing the therapeutic composition to thereby obtain a dosage form thereof.
Herein, in step iv) , the dosage form can be selected from granules, tablets, paste, pills, and capsules.
According to some embodiments of the disclosure, after step iv) , the preparation method further comprises a step of:
v) bottling and sealing the dosage form of the therapeutic composition.
In a third aspect, the present disclosure further provides a method for treating a subject diagnosed with dementia.
The treating method substantially comprises:
a) administering a therapeutic composition orally to the subject.
Herein, the therapeutic composition can be based on any one of the embodiments described above.
According to some embodiments of the treating method, in step a) , the therapeutic composition is orally administered to the subject on a schedule of two or three times daily for at least one treating period.
Herein each of at least one treating period can be a month of at least 28 days.
According to some embodiments of the treating method, in step a) , the therapeutic composition further comprises at least one of Pueraria, Shengdi, Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
In the treating method described above, the dementia can be Alzheimer’s disease, vascular dementia, or depression.
According to some embodiments, the dementia is Alzheimer’s disease, which is combined with a Parkinson’s syndrome.
Herein the subject can be a human being, or can be an animal such as a mouse, a monkey, an ape, etc.
Herein, and throughout the disclosure, the weight portion size is defined as a  relative size in terms of weight, which can be a number of unit weight. Depending on different embodiments, the unit weight can be 1 gram, 10 grams, 100 ounces, 1 kilograms, etc. In one illustrating example, a composition has ingredients A, B, C, and D, and the ingredients A, B, C and D have a weight portion size of 1, 2, 3 and 4, respectively. Thus in the composition, if a unit weight is 10 grams, then the respective weights for the ingredients A, B, C and D are 10 g, 20 g, 30 g, and 40 g. If a unit weight is 100 ounces, then the respective weights for the ingredients A, B, C and D are 100 oz, 200 oz, 300 oz, and 400 oz.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 illustrates a correspondence table for the English names and the Chinese names of certain traditional Chinese medicine ingredient.
DETAILED DESCRIPTION
The technical solutions in the embodiments of the present invention are clearly and completely described below. It is obvious that the described embodiments are only part, but not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of the present invention.
FIG. 1 illustrates a correspondence table for the English names and the Chinese names of certain traditional Chinese medicine ingredient included in the therapeutic composition disclosed herein.
Embodiment 1: one embodiment of the therapeutic composition and its preparation method
According to Embodiment 1, one daily dose for the therapeutic composition includes: 1 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice. Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder. Then 350 g of beef fat, 5 g of sea buckthorn oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture  of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 2: another embodiment of the therapeutic composition and its preparation method
According to Embodiment 2, one daily dose for the therapeutic composition includes: 1 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice. Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder. Then 400 g of goat fat, 11g of walnut oil, 100 g of edible alcohol and 8 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 3: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 2, one daily dose for the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice. Each of the above components in the therapeutic composition is multiplied by 28 days (i.e. one treating period) , and grinded into powder. Then 350 g of pork fat, 15 g of olive oil, 50 g of edible alcohol and 5 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 4: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 4, one daily dose for the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice. Each of the above components in the therapeutic composition is  multiplied by 28 days (i.e. one treating period) , and grinded into powder. Then 350 g of goat fat, 10 g of palm oil, 50 g of edible alcohol and 5 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 5: a granule-form therapeutic composition and its preparation method
According to Embodiment 5, the therapeutic composition obtained in Embodiment 1 can be mixed with a conventional auxiliary material to thereby obtain a granule-form therapeutic composition following a conventional granule preparation approach. In other words, Embodiment 5 is substantially a granule-form of the therapeutic composition based on Embodiment 1.
Embodiment 6: a tablet-form therapeutic composition and its preparation method
According to Embodiment 6, the therapeutic composition obtained in Embodiment 2 can be mixed with a conventional auxiliary material to thereby obtain a tablet-form therapeutic composition following a conventional tablet preparation approach. In other words, Embodiment 6 is substantially a tablet-form of the therapeutic composition based on Embodiment 2.
Embodiment 7: a paste-form therapeutic composition and its preparation method
According to Embodiment 7, the therapeutic composition obtained in Embodiment 3 can be mixed with a conventional auxiliary material to thereby obtain a paste-form therapeutic composition following a conventional tablet preparation approach. In other words, Embodiment 7 is substantially a paste-form of the therapeutic composition based on Embodiment 3.
Embodiment 8: a pill-form therapeutic composition and its preparation method
According to Embodiment 8, the therapeutic composition obtained in Embodiment 3 can be mixed with a conventional auxiliary material to thereby obtain a pill-form therapeutic composition following a conventional tablet preparation approach. In other words, Embodiment 8 is substantially a pill-form of the therapeutic composition based on Embodiment 3.
Embodiment 9: a capsule-form therapeutic composition and its preparation method
According to Embodiment 8, the therapeutic composition obtained in Embodiment 4 can be mixed with a conventional auxiliary material to thereby obtain a capsule-form therapeutic composition following a conventional tablet preparation approach. In other words, Embodiment 9 is substantially a capsule-form of the therapeutic composition based on Embodiment 4.
Embodiment 10: a small pill-form therapeutic composition and its preparation method
According to Embodiment 10, the therapeutic composition obtained in Embodiment 4 can be mixed with a conventional auxiliary material to thereby obtain a small pill-form therapeutic composition following a conventional tablet preparation approach. In other words, Embodiment 10 is substantially a small pill-form of the therapeutic composition based on Embodiment 4.
It is noted that according to different conditions and symptoms associated with patients, one or more of the following ingredients or components can be added in any of the Embodiments 1-4 described above: 10-20 g of Pueraria, 10-20 g of Shengdi, 10-20 g of Rehmannia, 6-15 g of Chinese wolfberry, 6-15 g of Bupleurum, 6-10 g of Cohosh, 6-15 g of Tuckahoe, and 6-15 g of Hawthorn pulp (i.e. Cornus Pulp) .
Embodiment 11: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 11, the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 3 g of Pueraria, and 3 g of Bupleurum. Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder. Then 250 g of goat fat, 5 g of olive oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 12: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 12, the therapeutic composition includes: 3 g of  Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 15 g of Shengdi, 6 g of Chinese wolfberry, 8 g of Cohosh (i.e. Cimicifuga) , and 6 g of Bupleurum. Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder. Then 250 g of pork fat, 5 g of walnut oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 13: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 13, the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, 10 g of Tuckahoe, 10 g of Cornus Pulp, and 16 g of Rehmannia. Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder. Then 250 g of beef fat, 5 g of olive oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
Embodiment 14: yet another embodiment of the therapeutic composition and its preparation method
According to Embodiment 14, the therapeutic composition includes: 3 g of Ginseng, 3 g of Yuanzhi, 3 g of Shichangpu, 1 g of saffron, 3 g of Chuanxiong, 3 g of Angelica, 3 g of Gastrodia elata, 1 g of Dendrobium, 1 g of Rosa Banksiae, 1 g of Dry tangerine peel, 1 g of Epimedium, 1 g of Notoginseng, and 1 g of Licorice, and 10 g of Tuckahoe. Each of the above components in the therapeutic composition is multiplied by 28 days, and grinded into powder. Then 250 g of pork fat, 5 g of olive oil, 25 g of edible alcohol, and 2 g of edible salt are added to a mixture of the powder  from all the above components, which then undergoes further mixing (i.e. by stirring) to thereby obtained a well-mixed mixture of the therapeutic composition. Such a mixture is ready for patients to take orally.
It is noted that in any one of the Embodiments 1-14 of the therapeutic composition, the therapeutic composition can have a dosage form of granules, tablets, paste, pills (large or small) , capsules, and can be bottled and sealed.
In the following, a series of pharmacologic experiments have been performed over the therapeutic composition according to certain embodiments.
Acute toxicity test:
The median lethal dose (LD50) or the maximum dose is determined by evaluating the acute toxicity of the granule-form of the therapeutic composition, which can provide a safety evaluation for clinical use.
A total of 50 mice were used, with 25 males and 25 females, each having a weight of 18-25 g. A box is configured to have 10 mice per box, and the males and females were cultured in different boxes.
After purchasing, these mice were observed for one day. The granules of the therapeutic composition according to Embodiment 1 are formulated into a suspension having a maximum concentration using distilled water. Herein, the suspension having a maximum concentration is defined such that when the suspension is drawn in a syringe, the syringe is not clogged, and the normal gavage is not affected.
Because the LD50 was not detected in the preliminary experiment, the experiment was changed to the determination of the maximum dose. A total of 40 healthy mice having 20 males and 20 females are randomly divided into 4 groups, with 10 mice in each group. These mice were fasted for 12 h before administration of the therapeutic composition.
These mice contain a blank control group, and an administration group 130.0, 260.0, and 520.0 g/Kg (ratio of the weight of therapeutic composition relative to the body weight) , which correspond to 50, 100, and 200 folds of a clinical dose, respectively. A test solution (i.e. the suspension of the therapeutic composition) was administered intragastrically three times, in morning, noon and evening, respectively. The test solution was administered according to the maximum volume of 0.4 ml/10 g. The blank control group was given an equal dose of physiological saline, then was  observed for appearance, behavior, activity, and Mental activity, appetite, urine and its color, fur, breath, nose, eyes, mouth, abnormal secretions, weight changes and death.
After 7 days of administration, the mice were sacrificed by cervical dislocation after fasting for 12 hours. The appearance of the main organs was examined by abdominal cavity examination, and the changes of the internal organs of the mice were observed with the naked eye. The heart, liver, spleen, lungs and kidneys were stripped, the electronic balance was accurately weighed, the organ coefficient was calculated, with a formula: organ coefficient = (organ weight/body weight) x 100%. Statistical comparison between the groups was performed.
Results: After 7 days of continuous observation, the mice were free to move, and have no convulsions, movement disorders, salivation, tearing, runny nose, difficulty breathing, diarrhea, constipation, and flatulence. Animal fur was shiny and none of the animals died within 7 days after administration. There was no significant difference in body weight between the mice before administration, and it was comparable. After administration, the body weight of the mice in the drug-administered group did not show significant difference compared with the blank control group. The anatomical organ was observed with the naked eye. No abnormal changes such as swelling, atrophy, hemorrhage, color abnormality, adhesion, and hardening were found in the liver, kidney, spleen and other organs. There was no statistically significant difference in the organ coefficient between the drug-administered group and the control group.
The above results of the acute toxicity test showed that the therapeutic composition disclosed herein had no significant effect on the body weight of the mice, and there was no obvious damage to crucial organs, indicating that the therapeutic composition has good safety and low toxicity. This result excludes the possibility of drug toxicity effects for subsequent use of dose issues.
Efficacy determination experiment:
Case selection: According to the classification criteria of the "Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine" issued by the Chinese Drug and Food Administration in 2008, we selected 100 patients Alzheimer’s disease in combination with Parkinson's syndrome (i.e. the patients have dementia  with confusion, language, forgetfulness, and facial expression) .
These 100 patients include 50 males and 50 females, with the oldest being 81 years old, the youngest being 60 years old, and with an average of 72 years. The shortest course of disease is 10 months, and the longest course of disease is 10 years. For all cases, blood routine tests, liver function (e.g. alanine aminotransferase) , renal function (e.g. serum muscle spasm and urea nitrogen) were in the normal range before and after treatment, indicating that the therapeutic composition have toxic side effects on the human body.
Treatment method:
The therapeutic composition was orally administered to the patients two to three times a day for at least one treating period, and preferably 1-3 treating period. Herein, one treating period is about one month, with 28 days counted for each month. Each time each patient was administered with ~ 9.9 g of the therapeutic composition. Other drugs and methods for treating the disease were stopped during the treatment.
The following efficacy criteria were applied:
Completely Cured: Clear thinking, smooth language, normal communication, no forgetfulness, consciousness, and normal expression.
Significant Improvement: confusion in mind, language ambiguity, forgetfulness, and cold facial expressions have basically disappeared.
Some Improvement: confusion in mind, language, forgetfulness, and facial expressions are obviously improved.
No improvement: no significant improvement or aggravation of clinical manifestations and laboratory tests.
The following two formulas were used:
Significant efficiency = (healing cases + marked cases) /total case X 100%
Effectiveness = (healing case + marked case + effective case) /total case X 100%
The efficacy results are shown in Table 1 below:
Table 1: Efficacy results
Figure PCTCN2018120239-appb-000001
It can be seen from the results in Table 1 that the therapeutic composition  provided by the present disclosure has a therapeutic efficiency of 73%and an effective rate of 97%for Alzheimer's disease and its combined Parkinson's syndrome, and can be used for treating Alzheimer's disease and its combined Parkinson's syndrome. No toxic side effects are observed, and thus it is suitable for long-term use.
Case 1: Ms. Zou, 70 years old, had suffered from Alzheimer's disease for more than 10 years. The following symptoms were observed before treatment: debilitating, sluggish, language disorder, no logic, very poor recognition, no sense of direction, yet she had normal blood pressure, blood sugar and blood lipids, her diet, urine and feces were normal. Her pulse was fine.
After taking the therapeutic composition prepared in Embodiment 1 for 3 months, all the above symptoms were improved. After one year of continuous use, the patient's mind was greatly improved, and the doctor could communicate with the doctor normally, and the dialogue could be carried out in conjunction with the doctor's request. Thus this treatment can significantly improve the human brain and the way of thinking.
Case 2: Mr. Wang, 68 years old, with mild Alzheimer’s disease combined Parkinson's syndrome for 5 years. The following symptoms were observed before treatment: norml blood pressure, blood sugar and blood pressure, slow walking, broken steps, cold facial expressions, slow conversation, slow thinking, easily forgetting things.
After taking the therapeutic composition prepared in Embodiment 2 for 3 months, all the above symptoms were improved. After one year of continuous use, he could perform simple chores, such as cooking during the Spring Festival.
Case 3: Ms. Qiu, 76 years old, with 5 years of Alzheimer's disease. The following symptoms were observed before treatment: very poor recognition, unable to take care of herself, poor sleep at night, only remembering things decades ago, no sense of time and space, and unable to recognize any relatives.
After taking the therapeutic composition prepared in Embodiment 3 for 3 months, all the above symptoms were improved. After 1 year of continuous use, the mind was awake, many people could be identified, normal sleep, normal diet, able to cook some dishes, and able to take care of herself on certain simple matters.
Case 4: Ms. Chen, 75 years old, with a moderate cerebral infarction. The  following symptoms were observed before treatment: unable to move, need care for everything, sluggish facial expression, awkward language, and cold hands and feet.
After taking the therapeutic composition prepared in Embodiment 4 for 3 months, all the above symptoms were improved. After 1 year of continuous use, the patient's diet increased greatly, the facial expression changed, and the conversation with others was normal, the thinking was clearer than before, and the temperature of the hands and feet was clearly improved.
In summary, the therapeutic composition disclosed herein has remarkable effects in treating Alzheimer's disease and its combined Parkinson's syndrome, and the toxic and side effects are light, if any.
In addition, the therapeutic composition disclosed herein does not need to be prepared in a traditional manner (e.g. decoction) , and can be grinded into powder and mixed with an animal fat, a vegetable oil and an alcohol. Thus the preparation method of the therapeutic composition is relatively simple and the therapeutic composition prepared thereby is also convenient for storage.
Although specific embodiments have been described above in detail, the description is merely for purposes of illustration. It should be appreciated, therefore, that many aspects described above are not intended as required or essential elements unless explicitly stated otherwise.
Various modifications of, and equivalent acts corresponding to, the disclosed aspects of the exemplary embodiments, in addition to those described above, can be made by a person of ordinary skill in the art, having the benefit of the present disclosure, without departing from the spirit and scope of the disclosure defined in the following claims, the scope of which is to be accorded the broadest interpretation so as to encompass such modifications and equivalent structures.

Claims (20)

  1. A therapeutic composition, comprising a plurality of ingredients, wherein:
    the plurality of ingredients comprise Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice;
    each of the plurality of ingredients is in a powder form and is together mixed with an animal fat, a vegetable oil, an edible alcohol, and an edible salt.
  2. The therapeutic composition of claim 1, wherein Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, Licorice, the animal fat, the vegetable oil, the edible alcohol, and the edible salt respectively have a weight portion size of approximately 1-10, approximately 3-15, approximately 3-15, approximately 1-3, approximately 3-10, approximately 1-6, approximately 1-6, approximately 1-5, approximately 1-10, approximately 350-1000, approximately 5-15, approximately 25-250, and approximately 2-10.
  3. The therapeutic composition of claim 2, wherein the plurality of ingredients further comprise Angelica, Gastrodia elata, Dendrobium, and Epimedium, respectively having a weight portion size of approximately 3-10, approximately 3-10, approximately 1-3, and approximately 1-10.
  4. The therapeutic composition of claim 3, wherein Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 1, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, and approximately 1.
  5. The therapeutic composition of claim 3, wherein Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Angelica, Gastrodia elata, Dendrobium, Rosa Banksiae, dried tangerine peel, Epimedium, Notoginseng, and Licorice respectively have a weight portion size of approximately 3, approximately 3, approximately 3, approximately 1, approximately 3, approximately 3, approximately 3, approximately 1, approximately 1, approximately 1, approximately 1, approximately 1, and approximately 1.
  6. The therapeutic composition of claim 1, wherein the animal fat comprises at least one of beef fat, pork fat, or goat fat.
  7. The therapeutic composition of claim 1, wherein the vegetable oil comprises at least one of sea buckthorn oil, walnut oil, olive oil, or palm oil.
  8. The therapeutic composition of claim 1, wherein the edible alcohol comprises an alcoholic wine with a degree of alcohol of about 15-50 degrees.
  9. The therapeutic composition of claim 1, wherein the Genseng comprises at least one of Genseng from North East China, Korean Genseng, or American Genseng.
  10. The therapeutic composition of claim 1, having a dosage form of granules, tablets, paste, pills, or capsules.
  11. The therapeutic composition of claim 2, the plurality of ingredients further comprise at least one of Pueraria having a weight portion size of approximately 10-20, Shengdi having a weight portion size of approximately 10-20, Rehmannia having a weight portion size of approximately 10-20, Chinese wolfberry having a weight portion size of approximately 6-15, Bupleurum having a weight portion size of approximately 6-15, Cohosh having a weight portion size of approximately 6-10, Tuckahoe having a weight portion size of approximately 6-15, or Hawthorn pulp having a weight portion size of approximately 6-15.
  12. A method for preparing a therapeutic composition, comprising:
    i) providing a plurality of ingredients, wherein the plurality of ingredients comprise Ginseng, Yuanzhi, Shichangpu, Saffron, Chuanxiong, Rosa Banksiae, dried tangerine peel, Notoginseng, and Licorice;
    ii) grinding each of the plurality of ingredients into a powder to thereby obtain a plurality of powders corresponding respectively to the plurality of ingredients; and
    iii) mixing the plurality of powders with an animal fat, a vegetable oil, an edible alcohol, and an edible salt to thereby obtain the therapeutic composition.
  13. The method of claim 12, wherein in step i) , the plurality of ingredients further comprise at least one of Pueraria, Shengdi.Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
  14. The method of claim 12, further comprising:
    iv) processing the therapeutic composition to thereby obtain a dosage form thereof.
  15. The method of claim 14, further comprising:
    v) bottling and sealing the dosage form of the therapeutic composition.
  16. A method for treating a subject diagnosed with dementia, comprising:
    a) administering a therapeutic composition of claim 1 orally to the subject.
  17. The method of claim 16, wherein in step a) , the therapeutic composition is orally administered to the subject on a schedule of two or three times daily for at least one treating period.
  18. The method of claim 16, wherein the therapeutic composition further comprises at least one of Pueraria, Shengdi, Rehmannia, Chinese wolfberry, Bupleurum, Cohosh, Tuckahoe, or Hawthorn pulp.
  19. The method of claim 16, wherein the dementia is Alzheimer’s disease, vascular dementia, or depression.
  20. The method of claim 19, wherein the dementia is Alzheimer’s disease, combined with a Parkinson’s syndrome.
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