EP1626729A2 - Compositions et methodes permettant de soulager des symptomes de diverses maladies - Google Patents

Compositions et methodes permettant de soulager des symptomes de diverses maladies

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Publication number
EP1626729A2
EP1626729A2 EP04753399A EP04753399A EP1626729A2 EP 1626729 A2 EP1626729 A2 EP 1626729A2 EP 04753399 A EP04753399 A EP 04753399A EP 04753399 A EP04753399 A EP 04753399A EP 1626729 A2 EP1626729 A2 EP 1626729A2
Authority
EP
European Patent Office
Prior art keywords
present
spec
composition
sinensis
symptomatic relief
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04753399A
Other languages
German (de)
English (en)
Other versions
EP1626729A4 (fr
Inventor
Terri Lee Holcomb-Halstead
Zhenguo Wang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HOLCOMB-HALSTEAD TERRI
Original Assignee
Bio Defense Nutritionals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2003/017131 external-priority patent/WO2003101389A2/fr
Application filed by Bio Defense Nutritionals Inc filed Critical Bio Defense Nutritionals Inc
Publication of EP1626729A2 publication Critical patent/EP1626729A2/fr
Publication of EP1626729A4 publication Critical patent/EP1626729A4/fr
Withdrawn legal-status Critical Current

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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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • A61K36/066—Clavicipitaceae
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/074—Ganoderma
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
    • 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)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315—Isatis, e.g. Dyer's woad
    • 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)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A61K36/428—Trichosanthes
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481—Astragalus (milkvetch)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489—Sophora, e.g. necklacepod or mamani
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/638—Ligustrum, e.g. Chinese privet
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716—Clematis (leather flower)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/748—Oldenlandia or Hedyotis
    • 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
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed

Definitions

  • new nucleoside-type inhibitors may be administered (alone or in combination with other nucleoside-type inhibitors), and exemplary alternative drugs include Stavudine (d4T), Didanosine (ddl), Combivir (a combination of Lamivudine and Zidovudine), and Trizivir (a combination of 3TC, AZT, and Abacavir).
  • exemplary alternative drugs include Stavudine (d4T), Didanosine (ddl), Combivir (a combination of Lamivudine and Zidovudine), and Trizivir (a combination of 3TC, AZT, and Abacavir).
  • non-nucleoside-type inhibitors e.g., Nevirapine, Delavirdine, Efavirenz
  • Nevirapine Delavirdine
  • Efavirenz a structurally relatively inhomogeneous group of compounds and are thought to bind in a non-nucleoside pocket of the reverse transcriptases, thereby significantly increasing antiviral efficacy where nucleoside-type inhibitors is employed.
  • use of non- nucleoside-type inhibitors seems to provide a promising new class of antiviral drugs, several disadvantages still remain.
  • the cost for currently known non-nucleoside-type inhibitors is relatively high, and a single mutation in the viral reverse transcriptases can induce a cross resistance against a wide class of non-nucleoside reverse transcriptase inhibitors.
  • a patient may receive a protease inhibitor (e.g., sequinavir, indinavir, nelfmavir, etc.), to reduce or even block viral protein processing within the cell.
  • a protease inhibitor e.g., sequinavir, indinavir, nelfmavir, etc.
  • certain protease inhibitors are less effective in a single treatment, and are therefore often administered in combination with other anti retroviral agents (e.g., combination of nucleoside reverse transcriptase inhibitors with protease inhibitors, nucleoside reverse transcriptase inhibitors with non-nucleoside reverse transcriptase inhibitors, and even combinations of nucleoside reverse transcriptase inhibitors with non-nucleoside reverse transcriptase inhibitors and protease inhibitors).
  • combination therapies of protease inhibitors with nucleoside reverse transcriptase inhibitors are often poorly tolerated and frequently lead to premature termination of that therapy.
  • viral fusion inhibitors e.g., enfuvirtide
  • enfuvirtide may be employed to attack viral propagation in yet another route. While such approach appears at present relatively promising, cost and availability are often limiting the factors. Moreover, currently available fusion inhibitors must be injected, adding to the inconvenience to the patient. Still further, fusion inhibitors tend to interfere with at least some antiviral medication and are therefore either poorly tolerated and/or limited in their use.
  • AIDS associated symptoms often aggravate a patients subjective condition.
  • AIDS associated symptoms include development of and pain associated with peripheral neuropathy and/or Kaposi's sarcoma, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, depression, and insomnia.
  • compositions and methods for symptomatic relief in a patient diagnosed with a disease and especially in a patient diagnosed with AIDS/ARC.
  • Contemplated composition comprise an herbal component and a non-herbal component, and may further include at least one of a reverse transcriptase inhibitor, a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, a chelator, and a fusion inhibitor.
  • compositions may further include at least one of a mineral supplement, a vitamin supplement, a probiotic supplement, and an enzyme supplement.
  • a composition for treatment of symptoms associated with a disease includes (1) an herbal combination comprising at least a part of at least four plants selected from the group consisting of Panax ginseng, Angelica sinensis, Astralagus membranaceus, Ligustrum lucidum, Sophora flavescens, Trichosanthes ldrilowii, Agrimonia pilosa, Ganoderma lucidum, Rehmannia glutinosa, Cordiceps sinensis, Oldenlandia diffusea, Isatis spec, Polyporus umbellatus, Pogostemon cablin, Solanum nigrum, Atractylodis macrocephalae, Clematis spec, and Glycyrrhiza spec, and (2) at least one of calculus bovis, concha pteriae powder, and borneolum syntheticum.
  • an herbal combination comprising at least a part of at least four plants selected from the group consisting of Panax
  • the herbal combination comprises at least a part of Panax ginseng, Angelica sinensis, Astralagus membranaceus, Ligustrum lucidum, Sophora flavescens, Trichosanthes kirilowii, Agrimonia pilosa, Ganoderma lucidum, Rehmannia glutinosa, and Cordiceps sinensis, and further comprises at least one of calculus bovis and borneolum syntheticum.
  • the herbal combination comprises at least a part of Cordiceps sinensis, Oldenlandia diffusea, Isatis spec, Polyporus umbellatus, Astralagus membranaceus, Panax ginseng, Pogostemon cablin, Solanum nigrum, Atractylodis macrocephalae, Trichosanthes kirilowii, Clematis spec, Ligustrum lucidum, and Glycyrrhiza spec, and further comprises at least one of calculus bovis and concha pteriae powder.
  • symptomatic relief particularly includes reduction of pain associated with a neuropathy or Kaposi's sarcoma, and/or reduction of peripheral neuropathy, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, oral candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme value, depression, and/or insomnia.
  • symptomatic relief particularly includes reduction of pain associated with a neuropathy or Kaposi's sarcoma, and/or reduction of peripheral neuropathy, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, oral candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme value, depression, and/or insomnia.
  • contemplated compositions may be marketed in a manner in which such compositions are provided, and in which information is further provided that the composition provides symptomatic relief to a patient diagnosed with a disease.
  • compositions having an herbal component and a non-herbal component demonstrated significant improvement in a patient's well-being and are thought to be effective in a wide range of symptoms associated with a wide range of diseases.
  • ARC and "Aids-Related Complex” are used interchangeably herein and refer to a condition in which antibody tests for an HIV virus in a patient are positive, and in which a patient may exhibit enlarged lymph nodes, fatigue, fever, night sweats, weight loss, and/or unexplained diarrhea, but do not have any of the more serious complications of ADDS.
  • ADRS Adstrength swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine swine s, etc.
  • CD4 cell count e.g., a CD4 cell count of less than 200 along with serological confirmation (e.g., by antibody determination or PCR) of an infection by an HIV virus.
  • treatment of symptoms associated with a disease refers to a treatment that attempts to ameliorate symptoms associated with that disease.
  • treatment of symptoms is distinct from the treatment of the disease.
  • contemplated treatments may provide improved energy level, appetite, and/or reduction in pain (e.g., due to peripheral neuropathy or Karposis's sarcoma), the viral load and/or number of T4 helper-cells may not change.
  • the term "at least a part of a plant” refers to plant extracts (e.g., prepared by liquid extraction, which may or may not include a step of concentration of the extract), portions of plants (root, leaves, etc.), which may or may not be further processed (e.g., by drying, liquid extraction, etc.), and whole plants, wherein the term “plant” broadly encompasses monocots, dicots, yeasts, fungi, and associated microorganisms.
  • compositions may include Glycyrrhiza spec., which specifically includes Glycyrrhiza glabra, and Glycyrrhiza lepidota.
  • the term "about" in conjunction with a numeral refers to a range of ⁇ 10% of that numeral, inclusive. For example, where a component is present in an amount of about 10 wt%, a range of 9-11 wt%, inclusive, is contemplated.
  • compositions of selected plants and/or plant parts exhibit especially potent pharmaceutical properties when used for treatment of symptoms associated with a variety of diseases.
  • Particularly potent herbal combinations can be prepared from plants, including Abies webbiana, Acacia spec, Acacia Arabia, Agrimonia eupatoria, Ajuga decumbens, Allium cepa, Allium sativum, Aloe vera, Alternanthera philoxeroides or sessiles, Ammi maius, Andographis paniculata, Apium graveolens, Apiurn leptophyllum, Arachis hypogaea, Arctium lappa, Amebia euhcroma, Asparagus racemosus, Astragalus spinosus, Astragalus lentingosis swainsonine, Buchenavia capita, Biyonia cretica ssp.,
  • herbal combinations are prepared from Radix Glycyrrhizae, Folium Isatidis, Rhizoma Smilacis Glabrae, Flos Lonicerae, Rhizoma Atractylodis Macrocephalae, Fructus Ziziphi Jujubae, Ganoderma Lucidum Japonicum, Polygonum multiflorum Thunb, Radix Paeoniae Alba, Fructus Lycii, Rhizoma Polygonati, Radix Ophiopogonis, Poria, Herba Ecliptae, Fructus Schisandrae, Aconitum camiichaeli Debx, Radix Morindae Officinalis, Herba Epimedii, Fructus Comi, Radix Isatidis, Radix Ginseng, Radix Angelicae Sinensis, Radix Astragali seu Hedysari, Fructus Ligustri Lucidi, Radix Sophor
  • herbal combinations are prepared from Radix Ginseng, Radix Angelicae Sinensis, Radix Astragali seu Hedysari, Fructus Ligustri Lucidi, Radix Sophorae Flavescentis, Radix Trichosanthis, Herba Agrimoniae, Ganoderma Lucidum seu Japonicum, Radix Rehmanniae, Cordyceps, and Borneolum Syntheticum.
  • the herbal composition n ⁇ ay comprise Cordyceps Sinensis, Olenlandia Dijfusae, Natural Indigo, Polyporous Umbellatus, Astragalus Membranaceous, Panax Ginseng, Solanum Nigrum L, Pogostemon Cablin, Atractylodes Macrocephalae, Trichosanthis Radix, Clematidis Radix, Ligustrum Lucidum AIT, and Glycyrrhizae Radix. It should be recognized that contemplated herbal combinations may be prepared from numerous parts of the plant (or the whole plant), including root, leaf, stem, and flower, including extracts thereof.
  • an herbal combination may be obtained through numerous known procedures, including extraction (e.g., aqueous or non-aqueous solvent, triple point extraction using carbon dioxide, etc), and grinding, etc., and combination of one or more extracts and/or macerates to the final product.
  • extraction e.g., aqueous or non-aqueous solvent, triple point extraction using carbon dioxide, etc
  • grinding etc.
  • all extracts and other plant products may be dried (e.g., freeze dried, distilled, etc.) before use in the combination.
  • non-herbal component of contemplated compositions it is generally contemplated that all known medically active non-herbal components are suitable.
  • especially preferred non-herbal components include at least one of calculus bovis, borneolum syntheticum (isoborneol), and concha pteriae powder.
  • contemplated compositions include the herbal component (typically comprising at least four, and even more typically at least eight plant or plant portions) and the non-herbal component together in a single dosage, however, separate dosage forms are also deemed suitable.
  • Contemplated composition may therefore be administered in numerous forms and dosages, and most typically as oral composition. For example, where the composition is in powdered form, a capsule, dragee, or tablet may be used.
  • the composition may be administered as a syrup, elixir, etc.
  • supplemental agent e.g., a reverse transcriptase inhibitor, a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor, a chelator, and/or a fusion inhibitor
  • various protocols are suitable, and especially contemplated protocols include substantially simultaneous administration of the supplemental agent (e.g., coadministration in a single tablet), or administration of the supplemental agent (or herbal composition) while there is a measurable concentration of the herbal composition (or supplemental agent) in the patient.
  • suitable herbal compositions may be orally administered, while the supplemental agent is parenterally administered (e.g., via injection or mucosal presentation). Consequently, the dosage and formulation of contemplated herbal compositions and supplemental agent may vary substantially. However, it is preferred that the extract is administered in approved and/or known dosages and formulations. Similarly, it is preferred that dosages and formulations of appropriate supplemental agent are identical or similar to those known in the art.
  • various nutritional supplements i.e., over-the-counter products
  • contemplated supplements include mineral supplements (coral minerals, Ca/Mg, etc.), vitamin supplements (e.g., antioxidants), probiotic supplements (e.g., for restoration of intestinal flora), and/or enzyme supplements (e.g., papain, bromelain).
  • contemplated compositions include mineral supplements (coral minerals, Ca/Mg, etc.), vitamin supplements (e.g., antioxidants), probiotic supplements (e.g., for restoration of intestinal flora), and/or enzyme supplements (e.g., papain, bromelain).
  • the inventors also contemplate a method of providing symptomatic relief to a patient diagnosed with a disease, in which in one step contemplated compositions are provided, hi especially preferred aspects, the compositions are formulated for administration to the patient in a daily amount of between 250 mg and 10 g, and even higher (e.g., multiples thereof).
  • symptomatic relief may be provided for diseases including ADDS,
  • the symptomatic relief provided by contemplated compositions includes reduction in peripheral neuropathy, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, oral candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme value, depression, and insomnia. Further contemplated symptomatic relief also comprises improved energy level and/or mental clarity.
  • compositions provide symptomatic relief to a patient diagnosed with a disease (and especially AIDS/ARC).
  • a disease and especially AIDS/ARC.
  • reduction of peripheral neuropathy, fever, cough, night sweat, diarrhea, nausea, lymph swelling, weight loss, loss of appetite, oral candidiasis, secondary bacterial infection, secondary viral infection, elevated liver enzyme values (e.g., AST, ALT, GGT), depression, and/or insomnia is particularly contemplated. Examples
  • Exemplary Extract #1 Herbal Component: (1) An aqueous extract is prepared from a combination of cleaned and dried Radix Angelicae Sinensis, Radix Astragali seu Hedysari, Fructus Ligustri Lucidi, Radix Sophorae Flavescentis, Radix Trichosanthis, Herba Agrimoniae, and Ganoderma Lucidum seu Japonicum as follows (exemplary amounts of the individual plant parts for a 1 kg formulation are provided in Table 1 below). All plant parts are placed into an extracting tank and four parts of water are added to one part of the herbal composition (wt/wt). The mixture is then boiled for approximately two hours and separated from the herbal composition as a first aqueous extract.
  • Water is again added, now at a ratio of three parts water to one part of herbal composition, and boiled for about 1 hour.
  • the so obtained second aqueous extract is combined with the liquid, filtered, and concentrated (typically between 3:1 and 10:1, most typically about 6:1).
  • a powder is prepared from cleaned Radix Ginseng, Radix Rehmanniae, and Cordyceps.
  • the so obtained powder is dried using a vacuum cold drying process (e.g., freeze- drying), preferably at or below a temperature of about 48 degree Celsius.
  • a vacuum cold drying process e.g., freeze- drying
  • the dried plant material is ground into a fine powder and mixed with the extract (1) from the herbal component. This mixture is further dried (e.g., using vacuum cold drying process), and once dried, ground to a powder and sifted.
  • Non-Herbal Component Calculus Bovis and Borneolum Syntheticum are ground to a fine powder and added to the herbal component mixture and mixed well. The so obtained mixed powder is then filled into capsules with each capsule containing about 0.25 grams of powder. ,
  • the approximate raw material to end material ratio for the following ingredients Radix Angelicae Sinensis; Radix Astragali seu Hedysari; Fructus Ligustri Lucidi; Radix Sophorae Flavescentis; Radix Trichosanthis; Herba Agrimoniae; and Ganoderma Lucidum seu Japonicum is 6:1 (due to the concentration step) while the other ingredients (Radix Ginseng, Calculus Bovis, Radix Rehmanniae, Cordyceps; and Borneolum Syntheticum) are unconcentrated.
  • Table 2 below lists ingredients, genus, species, and percentage of each ingredient present (relative to weight of plant (part) before extraction) within the composition.
  • Herbal Component (1) An aqueous extract is prepared from a combination of cleaned and dried Radix Astragali Membranaceous, Fructus Ligustri Lucidi, leaves of Oldenlandia diffusea and Isatis spec, Polyporus umbellatus, Pogostemon cablin, Solanum nigrum, Atractylodis macrocephalae rhizome, Radix Clemetidi, Radix Trichosanthis, and Radix Glycyrrhiza spec, essentially as described above in (1) of the herbal component of the ARF-1 extract. However, after combination of the aqueous extracts, the extract is reduced to a volume of about 10 ml in which the plant ingredients are present in amounts as indicated in Table 3 below.
  • a powder is prepared from cleaned Radix Ginseng and Cordyceps sinensis.
  • the so obtained powder is dried using a vacuum cold drying process (e.g., freeze-drying), preferably at or below a temperature of about 48 degree Celsius. After drying, the dried plant material is ground into a fine powder and mixed with the extract (1) from the herbal component.
  • a vacuum cold drying process e.g., freeze-drying
  • Non-Herbal Component Calculus Bovis and Margarite (Concha pteriae) are ground to a fine powder and added to the herbal component mixture and mixed well. The so obtained mixed concoction is then filled into ampoules with each ampoule containing about 10 ml of liquid.
  • the percentages and amounts represented here may vary depending on various factors, including pureness of herbal compositions available, severity of symptoms, weight and age of patient, and various other factors. Therefore, the relative weight ratios of the herbal component may vary considerably, and it should be understood that the above exemplary formulations are provided only for guidance. In other contemplated aspects, the non-herbal composition may also vary considerably, as well as the weight ratio between the herbal component and the non-herbal component.
  • extraction processes are also deemed suitable, and especially preferred extraction processes include extractions with aqueous solvents, mixtures of aqueous solvents with non-aqueous solvents, and even non-aqueous solvents.
  • liquid extracts may also.be fractionated using a two- solvent system, or chromatographic methods (e.g., size exclusion, ion exchange, hydrophobic interaction, etc.) to enrich one or more extracts in a desirable component (or to remove undesirable components).
  • the extracts may be prepared as dissolved or dispersed liquids, as dried preparations, or admixed to an edible carrier.
  • ARF-1 Patients were chosen according to the following criteria: Patients tested positive to HJN using ELISA and/or Western Blot, T-lymphocyte count was abnormal (e.g., T4 to T8 ratio was below 1, the number of T4 cells was below 400/mm 3 ), pregnancy was excluded, and all patients agreed to, use treatment with herbal medicine. Total number of patients was 10, with 5 men and 5 women. Average age was about 31 years, with the oldest being 35, and the youngest being 25. According to the CDC classification, the 10 cases all had HIV associated symptoms (4 diagnosed as ARC and 6 diagnosed as ADDS). Two capsules of the ARF-1 composition as described above were given three times a day over a course of 3 months.
  • Treatment was evaluated using ELISA test to indicate the presence of the HIV virus, flow cytometry (FACSCA ⁇ ) every three months before or after treatment to calculate the rate of T4 to T8, and the quantity of T4 (in cubic centimeters) as the index to measure the immune function of treated patients. Diagnostic records were prepared, including physical sign or appearance, appearance of the tongue, and pulse condition. The following symbols were used: evident: (+++); general, (++); slight (+); fluctuant ⁇ ); and negative (-). A numeric score was based on the conversion table shown below:
  • Criteria for Immune Function The ratio of T4 to T8 and number T4 cells was observed and used as criteria to measure the state of the immune system: if both of the items increase or either of them increase without a change in the other, there is an improvement in immune function; if both of the items decrease or either of them decrease without a change in the other, the immune system worsens; if neither of the items change, then there is no change in the immune system; if one of them increases while the other decreases, the immune system is judged according to the increase or decrease in the quantity of T4 cells.
  • Curative Effect was categorized as (a) recovery, (b) evident effect, (c) with effect, and (d) no effect.
  • Tien Xien Patients were chosen according to the following criteria: Patients tested positive to HIN using ELISA and/or Western Blot, T-lymphocyte count was abnormal (e.g., T4 to T8 ratio was below 1, the number of T4 cells was below 400/mm 3 ), pregnancy was excluded, and all patients agreed to use treatment with herbal medicine. Patients were on various HAART (Highly Active Anti-Retroviral Therapy) treatment and continued such treatment throughout the observation. Depending on severity of symptoms and overall condition, patients were advised to take two Tien Xien vials (10 ml each) per day.
  • HAART Highly Active Anti-Retroviral Therapy
  • Patient (1) (Taking one vial of Tien Xien/day): Quality of life: Reports ongoing improvement in quality of life indicators including increased mental clarity, decreased fatigue, increased ability to exercise. Any difficulty sleeping resolved many months ago during previous trial.
  • Peripheral neuropathy Symptoms of this are a sensation of inflamed feet by the end of the day. These symptoms have continued to decrease. Patient began to report normal sensation in his feet. Diarrhea: Over the last month diarrhea has decreased or almost stopped. No change in HAART reported.
  • Patient (3) (Taking 3 vials of Tien Xien per day): No change in medication, lab history, and weight. Slight decrease in quality of sleep (waking up frequently but able to return to sleep quickly). Energy level: no change. Pain: The rib cage pain has resolved. Has increased discomfort while sitting due to loss of muscle mass in the buttocks. Peripheral neuropathy: Pain is a 4/10 and off and on with decreased swelling in the left ankle and foot that is chronic since severe KS. Stools: They have darkened to a more normal color from clay colored, has 3 formed stools a day, had 1-2 days of diarrhea last month. Work/activity: very active and continues to increase the workload.
  • Patient (4) (Talcing six vials of Tien Xien per day, 2 vials each morning, noon, night): No weight change and good appetite. Pain/peripheral neuropathy: Leg or hand cramps of short duration at night, no pain in the feet, no episodes of dropping things as previously. Stools: normal stools every three days.
  • Patient (5) (Taking 3 vials of Tien Xien): No change in weight, with improved sleep and energy level. Pain: Has increased pain in the buttocks when sitting. Peripheral neuropathy showed improvement. Stools: No diarrhea, normal color, consistency and frequency. Work/activity: More active over last month. Karposi's sarcoma: Continues to fade.
  • Patient (6) (Takes three Tien Xien vials at 2AM and again at 2 PM): No change in medication, gained weight (6 pounds). Sleep: Good, 7-8 hours per night; Energy level: Good; Pain: Only some sinus pressure; Peripheral neuropathy: A few leg cramps/muscle spasms for one to one and a half weeks, hands much improved; Stools: A normal stool every 3 days, has had some bloating.

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
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  • Medicinal Chemistry (AREA)
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  • Alternative & Traditional Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une formule à base d'herbes médicinales qui permet de soulager les symptômes de diverses maladies, notamment chez des patients pour lesquels un diagnostic de AIDS/ARC a été posé. Les formules préférées sont issues d'au moins une partie d'au moins quatre plantes choisies dans le groupe constitué de Panax ginseng, Angelica sinensis, Astralagus membranaceus, Ligustrum lucidum, Sophora flavescens, Trichosanthes kirilowii, Agrimonia pilosa, Ganoderma lucidum, Rehmannia glutinosa, Cordiceps sinensis, Oldenlandia diffusea, Isatis spec., Polyporus umbellatus, Pogostemon cablin, Solanum nigrum, Atractylodis macrocephalae, Clematis spec. et Glycyrrhiza spec. et d'au moins l'un des éléments suivants : calculus bovis, concha pteriae powder et borneolum syntheticum.
EP04753399A 2003-05-29 2004-05-26 Compositions et methodes permettant de soulager des symptomes de diverses maladies Withdrawn EP1626729A4 (fr)

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PCT/US2003/017131 WO2003101389A2 (fr) 2002-05-29 2003-05-29 Soulagement des symptomes du sida
PCT/US2004/016568 WO2004105701A2 (fr) 2003-05-29 2004-05-26 Compositions et methodes permettant de soulager des symptomes de diverses maladies

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AP2130A (en) * 2004-08-12 2010-05-13 Shengxun Tian An antiviral pharmaceutical product and manufacture thereof
DE102005031364A1 (de) * 2005-06-30 2007-01-11 Ernst-Moritz-Arndt-Universität Greifswald Nahrungsergänzungsmittel mit verbesserten antioxidativen Eigenschaften
CN102861168A (zh) * 2012-09-07 2013-01-09 李承平 一组黄芪敛阴药片
CN103656281A (zh) * 2013-11-29 2014-03-26 当涂县科辉商贸有限公司 一种治疗盗汗症的中药组合物
CN104208455A (zh) * 2014-07-30 2014-12-17 严中明 一种用于失眠盗汗的阴虚内热型的大牲畜兽药其制备方法
CN104352841B (zh) * 2014-10-17 2018-03-02 青岛市市立医院 一种治疗小儿盗汗的中药组合物及其制备方法
CN104474343A (zh) * 2014-12-11 2015-04-01 丁大双 一种用于治疗自汗的中药
CN104491528A (zh) * 2014-12-11 2015-04-08 丁大双 一种用于治疗自汗的中药
CN107296858B (zh) * 2017-08-18 2020-07-28 中国热带农业科学院热带生物技术研究所 一种抗细菌感染药物组合物及其应用
CN108355077A (zh) * 2018-04-27 2018-08-03 荆明明 一种用于治疗慢性肠炎的中药方剂
CN108403996A (zh) * 2018-06-20 2018-08-17 韦雄悬 一种用于治疗艾滋病的中药组合物

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