WO2006015556A1 - A combinaison antivirale et fabrication de celle-ci - Google Patents

A combinaison antivirale et fabrication de celle-ci Download PDF

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Publication number
WO2006015556A1
WO2006015556A1 PCT/CN2005/001254 CN2005001254W WO2006015556A1 WO 2006015556 A1 WO2006015556 A1 WO 2006015556A1 CN 2005001254 W CN2005001254 W CN 2005001254W WO 2006015556 A1 WO2006015556 A1 WO 2006015556A1
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Prior art keywords
extract
licorice
product
powder
components
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Ceased
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PCT/CN2005/001254
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English (en)
Chinese (zh)
Inventor
Shengxun Tian
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Individual
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Individual
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Priority claimed from EP04019119A external-priority patent/EP1629847B1/fr
Priority claimed from CNB2004100911468A external-priority patent/CN100371015C/zh
Application filed by Individual filed Critical Individual
Priority to AP2007003941A priority Critical patent/AP2130A/xx
Publication of WO2006015556A1 publication Critical patent/WO2006015556A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A61K36/428—Trichosanthes
    • 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
    • A61K36/068—Cordyceps
    • 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
    • A61K36/18—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)
    • A61K36/31—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)
    • A61K36/48—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
    • 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
    • A61K36/484—Glycyrrhiza (licorice)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A61K36/8888—Pinellia
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV

Definitions

  • the present invention relates to an antiviral herbal product, and more particularly to certain pharmaceutical (combination) products and/or (drug) preparations based on plant materials or plant-derived materials as components, their resistance
  • viruses in particular retroviral infections, in particular anti-HIV infections, in particular AIDS
  • plant- or plant-derived materials for the preparation of such products or preparations, which are used for the preparation of such products or preparations
  • the invention also relates to a method of treatment comprising administering to a warm-blooded animal in need thereof, in particular a human, an effective amount for treating a viral infection according to the invention Pharmaceutical product or preparation. Background technique
  • HBV hepatitis B virus
  • PI protease inhibitors
  • RT reverse transcriptase inhibitors
  • a typical treatment regimen involves two nucleoside RT inhibitors and one PI or one non-nucleoside RT inhibitor.
  • the treatment to date involves treatment after the virus has entered the cells of the immune system infected with AIDS, and thus the treatment to date has been limited to the case where the virus is already in the cell.
  • the focus is on blocking HIV entry into cells, rather than the experimental compounds that fight them only when HIV has entered the cell.
  • Roche in Switzerland and Tr imer is the US biotechnology group, the first drug of this type, called fusion inhibitors.
  • the corresponding drug Fuzeon
  • CCR5 the entry inhibitors that blocked the cell entrance and exit called CCR5 and could be administered orally as a bolus. Smi thkl ine Beecham is also working on this type of CCR5 product.
  • the problem to be solved by the present invention is to provide a novel pharmaceutical product or preparation capable of treating retroviral infections (e.g., AIDS) and exhibiting advantageous properties, such as allowing long-term and short-term treatment, which employ toxicity Not too large a component, and/or provide a further method compared to currently used known drugs based on the treatment of retroviral infections (e.g., AIDS).
  • retroviral infections e.g., AIDS
  • Another problem to be solved by the present invention is to provide new drugs and treatments with, for example, known or new (preferably new) and/or combinations thereof for the treatment of retroviral infections, such as AIDS.
  • the product of the present invention can also be used for the treatment of other viral infections, especially hepatitis B and hepatitis C virus infections, and also has certain therapeutic and preventive effects on influenza virus infection. Summary of the invention
  • a retroviral infection eg, an HIV infection, such as AIDS
  • One or more pharmaceutically acceptable carriers and/or coating materials are absent or present in the formulation.
  • the preparation is mainly prepared from at least 3 (preferably at least 6, more preferably at least 10, most preferably all) of the above components as a raw material of the active ingredient;
  • the two or more formulations of the product together are mainly composed of at least 3 (preferably at least 6, more preferably at least 10, most preferably) of the above components. All) prepared as a raw material of the active ingredient.
  • such an embodiment relates to a corresponding product, wherein the product is a single preparation, and the preparation is mainly prepared from all the components described in (A) as a raw material of the active ingredient; In the case of two or more preparations, when they are combined, two or more preparations of the product are mainly prepared by using all of the components described in (A) as a raw material of the active ingredient.
  • the products according to (A) and (B) are products containing two or more (preferably two) preparations for sequential or simultaneous (preferably simultaneous) administration.
  • the invention relates to (A), (B) and (C) A product according to any of the preceding paragraphs, wherein the preparation is prepared using an extract or powder of the active ingredient raw material, preferably a capsule or a tablet, more preferably a tablet.
  • the preparation is prepared using an extract or powder of the active ingredient raw material, preferably a capsule or a tablet, more preferably a tablet.
  • radix isatidis, licorice, melon, pinellia, dried ginger, scutellaria, salvia, and candied licorice are in the form of their extracts
  • trichosanthin, ginseng or American ginseng, angelica and cordyceps are in powder form.
  • the commercially available powdered form of trichosanthin, ginseng or American ginseng, angelica and cordyceps can also be used, and the raw material in the form of a root block can also be ground into a powder form.
  • the invention relates to the product according to (D), wherein the extract component is specific gravity (in all cases mentioned, the specific gravity relative to water) It is prepared by a concentrated solution of 1.15 to 1.35, preferably 1.2 to 1.3, in particular wherein the extract component is obtainable by water extraction (when used in the present specification, it is particularly preferred to obtain by water extraction) of).
  • the extract component is specific gravity (in all cases mentioned, the specific gravity relative to water) It is prepared by a concentrated solution of 1.15 to 1.35, preferably 1.2 to 1.3, in particular wherein the extract component is obtainable by water extraction (when used in the present specification, it is particularly preferred to obtain by water extraction) of).
  • the product of the present invention is mainly prepared from at least 3 (preferably at least 6, more preferably at least 10, most preferably all) of the following components present in the following relative parts by weight as starting material for the active ingredient.
  • the components and their relative parts by weight are:
  • the extract of licorice is 20 ⁇ 80, preferably 30 ⁇ 70, more preferably 45 ⁇ 55, and most preferably 51;
  • the extract of melon is 5 ⁇ 45, preferably 15 ⁇ 35, more preferably 20 ⁇ 30, most preferably
  • Pinellia ternata extract 0.5 ⁇ 10, preferably 1 ⁇ 6, more preferably 1.5 ⁇ 5, most preferred
  • the extract of dried ginger is preferably 1 to 6, more preferably 1.5 to 5, and most preferably 3;
  • the extract of Astragalus membranaceus is 10 ⁇ 80, preferably 20 ⁇ 70, more preferably 35 ⁇ 55, most preferably 45;
  • the extract of Salvia miltiorrhiza is 3 ⁇ 35, preferably 5 ⁇ 30, more preferably 10 ⁇ 25, most preferably
  • the extract of candied licorice is 2 ⁇ 40, preferably 5 ⁇ 30, more preferably 1G ⁇ 20, most preferably 15;
  • ginseng or American ginseng powder 3-50 preferably 5 to 35, more preferably 10 to 30, most preferably 20;
  • Angelica powder 20 ⁇ 80 preferably 30 ⁇ 70, more preferably 40 ⁇ 60, most preferably 48;
  • the Cordyceps sinensis powder is 0.05 5 , preferably 0.1 to 1, more preferably 0.25 to 0.75, most preferably 0.5.
  • the invention in another embodiment, relates to a formulation comprising two or more formulations for simultaneous, sequential and/or separate application (-administering to warm-blooded animals, in particular humans) (preferably a pharmaceutical product which is a preparation for the treatment of a retroviral infection (for example, an HIV infection, such as AIDS), wherein each preparation is prepared mainly from at least one of the following components as a raw material of the active ingredient And the product is mainly prepared by using at least 3 (preferably at least 4, most preferably all) of the following components as active ingredient raw materials; the components are: Radix, licorice, melon, half Summer, dried ginger and smallpox.
  • a pharmaceutical product which is a preparation for the treatment of a retroviral infection (for example, an HIV infection, such as AIDS)
  • each preparation is prepared mainly from at least one of the following components as a raw material of the active ingredient
  • the product is mainly prepared by using at least 3 (preferably at least 4, most preferably all) of the following components as active ingredient raw
  • One or more pharmaceutically acceptable carriers and/or coating materials may be absent or present in the pharmaceutical formulation.
  • the product is effective alone in the treatment of retroviral infections, such as HIV infections, such as AIDS.
  • (H) is preferably a product according to paragraph (G), wherein the preparation is prepared using an extract or powder of the active ingredient raw material, preferably a capsule or a tablet, more preferably a tablet.
  • the extract component is prepared from a concentrated solution having a specific gravity of from 1.15 to 1.35, preferably from 1.2 to 1.3, before the final drying, more preferably wherein the extract component is obtainable by water extraction (especially Obtained by water extraction).
  • the Radix Isatidis, Licorice, Melon, Pinellia, and Dried Ginger are in the form of an extract thereof
  • the Trichosanthin is in the form of a powder thereof.
  • the product according to any one of (G) and (H) is mainly composed of at least 3 (preferably at least 4, most preferably all) of the following components present in the following relative parts by weight; Prepared as a raw material of the active ingredient; the components and their relative parts by weight are:
  • the extract of licorice is 20 ⁇ 80, preferably 30 ⁇ 70, more preferably 45 ⁇ 55, most preferably 51;
  • the extract of melon is 5 ⁇ 45, preferably 15 ⁇ 35, more preferably 20-30, most preferably 24;
  • the extract of Pinellia ternata is 0.5-10, preferably 1 ⁇ 6, more preferably 1.5-5, most preferably 3;
  • the extract is preferably 1 to 6, more preferably 1.5 to 5, most preferably 3;
  • the trichosanthin is 5 to 45, preferably 15 to 35, more preferably 2 to 3 Q, and most preferably 24.
  • a pharmaceutical product which is a preparation for the treatment of a retroviral infection (for example, an HIV infection, such as AIDS)
  • each preparation is prepared mainly from at least one of the following components as a raw material of the active ingredient s
  • the product is mainly prepared by using at least 3 (preferably at
  • One or more pharmaceutically acceptable carriers and/or coating materials may be absent or present in the pharmaceutical formulation.
  • Said product is effective alone in the treatment of retroviral infections (e. g. HIV infection, e.g. AIDS) and is a preferred embodiment of the invention, thus forming a preferred embodiment of the invention.
  • retroviral infections e. g. HIV infection, e.g. AIDS
  • (K) is preferably a product according to paragraph U), wherein the preparation is prepared using an extract or powder of the raw material of the active ingredient, preferably a capsule or a tablet, more preferably a tablet.
  • the extract component is prepared from a concentrated solution having a specific gravity of 1.15 to 1.35, preferably 1.2 to 1.3, before the final drying, more preferably wherein the extract component is obtainable by water extraction (especially Obtained by water extraction).
  • scutellaria, salvia, and candied licorice are preferably used in the form of their extracts, and ginseng or American ginseng, angelica and cordyceps are in powder form.
  • the product according to any one of (J) and (K) is mainly composed of at least 3 (preferably at least 4, most preferably all) of the following components present in the relative weight parts described below.
  • Prepared as a raw material of the active ingredient; the components and their relative parts by weight are:
  • the extract of Astragalus membranaceus is 10 ⁇ 80, preferably 20 ⁇ 70, more preferably 35 ⁇ 55, most preferably 45; the extract of Salvia miltiorrhiza is 3 ⁇ 35, preferably 5-30, more preferably 10-25, most preferably 18; Extract 2 ⁇ 40, preferably 5 ⁇ 30, more preferably 10 ⁇ 20, most preferably 15;
  • the invention in another embodiment, relates to a product as set forth above, which comprises a combination of a pharmaceutical product with another pharmaceutical product, in particular according to paragraphs (G), (H) above And a pharmaceutical product (most preferably a tablet or capsule) given in any of (I) and a pharmaceutical product (preferably a tablet according to any of the above paragraphs (J), (K) and (L)
  • a pharmaceutical product most preferably a tablet or capsule
  • a pharmaceutical product preferably a tablet according to any of the above paragraphs (J), (K) and (L)
  • the present invention relates to the use of the following components for the preparation of various pharmaceutical products as described above for the treatment of retroviral infections (e.g., HIV infections, such as AIDS), selection
  • retroviral infections e.g., HIV infections, such as AIDS
  • the preparation is carried out according to a product of any of the above paragraphs (G) to (I), and/or a product according to any of the above paragraphs (J) to (L), wherein the product is particularly preferably in the form of a tablet or a capsule
  • the components include: Radix Isatidis, Licorice, Melon, Pinellia, Dried Ginger, Astragalus, Salvia, Candied Licorice, Trichosanthin, Ginseng or American Ginseng, Angelica and Cordyceps sinensis.
  • the product of the invention comprises a formulation or two or more formulations for simultaneous, sequential and/or separate application (-administering to warm-blooded animals, in particular humans), wherein each formulation is predominantly comprised of the above components At least one prepared as a raw material of the active ingredient, and the product is mainly prepared from at least 3 (preferably at least 6, more preferably at least 10, most preferably all) of the above components as a raw material of the active ingredient of.
  • Another embodiment of the present invention relates to the use of a pharmaceutical product according to any of paragraphs (A) to (M) for the treatment of HIV infection, particularly AIDS.
  • the product when the product consists of a plurality of formulations, the individual formulations are packaged in a single package or in a different package labeled with instructions for use together.
  • the invention also relates to a method of treating (including preventing) a warm-blooded animal, in particular a human, suffering from a retroviral infection, in particular an HIV infection, most particularly AIDS, comprising a patient in need thereof An effective amount (particularly as defined above) according to the invention is administered to the treatment of said disease.
  • the invention relates to the methods, treatment regimens, uses, products and formulations presented in the examples.
  • the product relates to kits having multiple parts, such as in one cassette (or in a plurality of cassettes characterized by being combined) including one or more formulations.
  • the formulations are selected such that they are active alone or in particular in combination against a disease to be treated (e.g., a retroviral infection, such as an HIV infection, particularly AIDS).
  • the product comprises up to three (most preferably two) formulations comprising a total of at least 3, preferably 6, more preferably 10, most preferably all of the components mentioned above.
  • At the same time means that the ingredients are administered at almost the same time (preferably within a time difference of less than one minute, especially at exactly the same time), for example after a meal.
  • “Sequence” means long-term staggered, which means that the preparations can be administered separately at regular intervals such that they preferably still exhibit (preferably synergistic) interactions in the individual to be treated (e.g., human), That is, the combination therapy is effective. Whether this is the case, in particular by tracking the level of RANTES in the blood, RANTES is a cytokine of antiretroviral activity, showing its elevation in the case of treatment with a formulation or product according to the invention. Level, indicating that at least a certain time interval, the relevant active ingredient of the component is present in the blood of the treated individual (e.g., a human).
  • Embodiments of the invention may also be (and include) any combination of two or more of simultaneous, sequential or separate applications.
  • Any combination means that each preparation which is a part of the product can be simultaneously administered at one time point, and then only one preparation is administered at a later time point, and then another preparation or two is administered at a later time point. a combination of one or more formulations, and the like.
  • the components may be present in a single formulation in a fixed combination (as a mixture).
  • formulation unit formulation
  • Possible pharmaceutical preparations are, for example, those for parenteral or parenteral (preferably parenteral) administration.
  • the components and combinations mentioned before and hereafter are particularly useful in pharmaceutically acceptable oral formulations, or in a broader aspect of the invention, in topical formulations (for example in the vagina or elsewhere where there is a risk of infection during sexual intercourse, for example) It is particularly useful in creams or lotions to be administered.
  • the pharmaceutical preparation includes one or more of the above-mentioned and below-mentioned components, preferably 4 to 8 per unit preparation, or when they are all present in one preparation, preferably with a drug Acceptable carrier binding. Any one or more suitable conventional formulation materials can be applied.
  • suitable carriers for preferred oral administration include, but are not limited to, gelatin, gum arabic, lactose, starch, magnesium stearate, talc, vegetable oils, polyalkylene glycols, petrolatum, and the like.
  • additives may be added in accordance with accepted pharmaceutical formulation production practices, such as flavoring agents, preservatives, complexing agents, pigments, dyes, stabilizers, surfactants, emulsifiers, wetting agents, solubilizers, buffers, and the like.
  • the pharmaceutical preparation may be formulated into any conventional form, and specifically includes: (a) a solid form for oral administration, such as a tablet, a capsule (such as a hard or soft gelatin capsule), a pill, a small drug, a powder, a granule. Agents; (b) Formulations for topical administration, such as solutions, suspensions, ointments, creams, hydrogels, lipogels, micronized powders and the like.
  • the pharmaceutical preparations may be sterilized and/or may contain adjuvants such as preservatives, stabilizers, wetting agents, emulsifying agents, salts for varying the osmotic pressure and/or buffers.
  • adjuvants such as preservatives, stabilizers, wetting agents, emulsifying agents, salts for varying the osmotic pressure and/or buffers.
  • one or more of the above-mentioned components are preferably prepared as ointments, elixirs, creams, gels, solutions, lotions; and dry powders for inhalation; suspensions Agents, shampoos, shampoos, perfumes, etc.
  • any conventional composition can be utilized in the present invention. Regardless of where it is used, the term treatment or therapy also includes prophylactic treatment.
  • Examples of preferred oral dosage forms include tablets (including pills), chymidines, or hard or soft gelatin capsules, thioglycols or capsules of another suitable material that is readily soluble in the digestive tract.
  • Each tablet, pill, tablet or capsule may preferably contain from about 10 to about 2000 mg, more preferably from about 20 to about 1500 mg of the above-mentioned components.
  • Oral dosages contemplated in accordance with the present invention will vary with the needs of the individual patient as determined by the prescribing physician (e.g., the condition of the patient, the size of the body, age, possible intervention with other treatments, etc.). However, in general, in the treatment of adults, regardless of being dispersed in more than one
  • a daily dose of 4 to 40 grams is applied, which is the weight of all components of the product or preparation of the invention as a whole, more preferably 20 to 35 grams per day, preferably It is administered at 2 to 6, more preferably 2 to 4 (for example, 3) different time points, especially after a patient's meal.
  • This dose can be administered according to any dosage regimen determined by the physician based on the needs of the patient. In the case of children, lower doses are generally recommended, such as half the dose used by adults.
  • the white, red and yellow tablets given in the examples can be administered three times a day (for example, after a meal), preferably 2 to 5 (especially 3) yellow tablets, 2 to 5 (especially 3) ) Red chips and 2 to 5 (especially 3) white films.
  • the course of treatment is preferably, for example, at least 3 to 12 months, more preferably greater than 6 months.
  • the dosage to be treated will generally depend on the route of administration, the age, weight and condition of the individual.
  • the preparation according to the invention is a capsule or tablet, most preferably a tablet.
  • the tablets may be coated with a coating commonly used in the practice of pharmaceutical preparations, for example, a sugar-containing coating that is colored to identify different formulations.
  • a preferred relative amount of one or more (active) components of the formulation is such that the formulation comprises from 20 to 100%, more preferably from 50 to 98%, such as from 70 to 95% of the component, The remainder is, for example, one or more additional components that are pharmaceutically acceptable, Selected from, for example, pharmaceutically acceptable carrier materials and coatings.
  • the products or preparations of the invention may be used in conjunction with known drugs (such as antibiotics or antiviral drugs), accompanied by antibiotic treatment and /
  • drugs such as antibiotics or antiviral drugs
  • the active ingredients used to practice the products and formulations of the present invention are given above.
  • the various components actually mentioned have a long tradition in the use of Chinese herbal medicines.
  • Preferably at least 10 of these components are applied or are present in the products of the invention.
  • Radix isatidis a dried root from plant indigo, can be applied to the present invention in the form of an extract.
  • Licorice which is a dried root and rhizome of leguminous licorice, licorice or licorice, can be applied to the present invention in the form of an extract.
  • the melon which is a dry ripe fruit of a plant or a mirage, can be applied to the present invention in the form of an extract.
  • the trichosanthin which is a dry root of a plant or a mortise, can be applied to the present invention in the form of a powder.
  • Pinellia ternata a dried root or tuber of Pinellia ternata, can be applied to the present invention in the form of an extract.
  • Dried ginger which is a dried rhizome of gingeraceae ginger, can be applied to the present invention in the form of an extract.
  • Astragalus a dried root of the leguminous plant Astragalus, can be applied to the present invention in the form of an extract.
  • Salvia miltiorrhiza which is a dried root and rhizome of Salvia miltiorrhiza
  • Candied licorice, licorice cooked with honey can be applied to the present invention in the form of an extract.
  • Ginseng or American ginseng which is the dried root of the ginseng of the Araliaceae plant or American ginseng, can be applied to the present invention in the form of a powder.
  • Angelica the dried root of the umbelliferous plant Angelica, can be applied to the present invention in the form of a powder.
  • Cordyceps sinensis a complex of stalks and larval carcasses of the ergot fungus Cordyceps sinensis parasitic on bat mites, can be applied to the present invention in the form of a powder.
  • W When "relative parts by weight” is referred to in the context, it means the relative weight of the components mentioned above or below which form part of the product or formulation according to the invention.
  • extract When “extract” is used in the present disclosure, it can be obtained by using a conventional solvent such as an alcohol (for example, ethanol) or an ether (for example, diethyl ether), by extraction with a liquid or an ultra-fluid gas (for example, carbon dioxide), or preferably by using an aqueous solution (
  • the extract is obtained, for example, by using a buffer or a salt, more preferably with water.
  • Each component is extracted, either alone in the form of an extract or in combination with one or more of the other plants or plant parts extracted.
  • the extraction is carried out by, for example, boiling to heat the solvent, in particular water, preferably by heating with steam.
  • the extract is then usually at least partially concentrated, preferably by evaporation (for example by applying a vacuum), by the presence of a drying agent (for example dry silica, calcium chloride, "phosphorus pentoxide” or molecular sieves or a combination of two or more of these) Evaporate, or dry with a dry gas such as nitrogen, and/or freeze-dry.
  • a drying agent for example dry silica, calcium chloride, "phosphorus pentoxide” or molecular sieves or a combination of two or more of these
  • a dry gas such as nitrogen, and/or freeze-dry.
  • the concentration is such that the corresponding extract or mixture of extracts has a specific gravity of 1.15 ⁇ 1. 35, for example 1. 2 ⁇ 1. 3 (preferably giving a relative specific gravity in grams per liter Concentrated solution.
  • the plant or plant part is used as a component in powder form.
  • the starting materials are used alone or in combination with one or more different plants (for use as one or more of the other components used in the manufacture of the products or formulations of the invention).
  • the process according to the invention is carried out such that the extract of the above-mentioned components is used as a preformed mixture (for example from the extraction of one or more starting materials in the same batch as described above) and/or as a single Component, as a single component or as a A powder component of a mixture of one or more of the components, and a pharmaceutically acceptable carrier material.
  • a further step is the formulation of a unit preparation, such as the formation of a capsule or especially a tablet (pills), which may include the step of coating with a coating, the board being dried for 4 days and a half.
  • the coating may be colored in order to be able to distinguish a part or a whole of the preparation of the preparation of the product of the invention.
  • the manufacture may further comprise the preparation of a package and/or accompanying information (eg, in the form of a package print) of one or more components, the information being recommended or described.
  • the formulation is used separately, sequentially or (not preferred in the invention).
  • the method is as described in Example 1, 2 or 3, but the range of relative weight parts is as described above in paragraph (F), (I) or (L), and The resulting tablets are allowed to have different colors. detailed description:
  • Example ⁇ "White film” for AIDS treatment
  • the tablets are prepared from the following ingredients in the following amounts (for the formulation of the pill base):
  • the liquid extraction (second batch of extract) is obtained from the extraction vessel by repeating the filtration step.
  • the first and second batches of the boiled liquid thus obtained are then collected in a deposition vessel after removing the dust formed on the first boiled liquid.
  • the liquid mixture of the two batches of extract was placed in a deposition vessel overnight. Thereafter, the uppermost water of the liquid extract was carefully removed.
  • the concentrated solution having a specific gravity of 1. 2-1. 3 is obtained by concentrating the liquid in the concentrated container. After that, the traditional Chinese medicine ingredient (3) is ground into a powder, and then added to the extract in the form of a concentrated solution having a specific gravity of 1.2-1.
  • a portion (5% by weight) of white wheat starch for tablet formation (for forming tablets and for allowing dissolution and rupture in the stomach) was added.
  • the tablets are prepared from the following ingredients in the following amounts (tablets or pills):
  • Candied Licorice 15g According to the prescription requirements discussed above, carefully selected high-quality and authentic Chinese herbal medicines are used as the constituents of the above "red tablets”.
  • the specific production method is as follows: First, the selected Chinese herbal medicine ingredients (D), (E), and (F) are put into a vacuum extraction tank according to the composition ratio.
  • the weight ratio of water to the original medicine is 10: 1, put into the tank, soak for about half an hour, then boil for 2 hours with high pressure steam, filter out the boiled liquid, and then add water to the dregs in the tank ( This time the ratio of water to medicinal material is 8: 1), boiled in steam for two hours, and the boiled second liquid is filtered out.
  • the two boiled and filtered extracts are separately removed from the precipitate (dust on the original drug, etc.), and the extracted liquid is placed in a sedimentation tank, and precipitated for 12 hours (multiple overnight storage). After the concentrating of 1. 2, the extract is concentrated to a specific gravity of 1. 2 -1. 3, the required extraction of traditional Chinese medicine wet ointment has been completed.
  • the Chinese herbal medicine ingredients (A), (B), and (C) are ground into a powder, and uniformly added to the extracted wet ointment having a specific gravity of 1.2-1.
  • An appropriate amount of maltodextrin (about 5% by weight) is added to shape the tablet or/and lyse it in the stomach.
  • the dried concentrated and dried mixture is first granulated for use in tableting. After the above various preparations are completed, the granular drug mixture is made into a tablet containing 100 mg of raw medicinal material by a standard tableting machine. After the film is made, it may be coated with sugar according to requirements or needs, such as a red icing, which is a red piece. It is also possible to carry out the final packaging and use without adding sugar. Generally, the ratio of the sugar-coated tablets to the tablets is 25:75, or the sugar coating is less than 25.
  • red tablets Dry, stored at room temperature, can be stored for three to five years; content l OO Omg / tablet, 3-5 tablets each time, three times a day, after meals, treatment for 3 - 12 months, preferably greater than 6 months, according to the condition or The patient requested three courses of treatment. No obvious side effects. Children can take 2-3 doses per dose. Tablet, three times a day.
  • the red tablets can be used alone to treat HIV/AIDS, and can also be used in combination with the white tablets or/and yellow tablets of the formulations of Examples 1 and 3, depending on the patient or by the doctor. Example 3. Compound prescription for treating HIV/AIDS "yellow tablets,
  • the prescription is a composite side of the white sheet of Example 1 and the red sheet of Example 2.
  • the composition and specific content of the tablet and the processing method thereof are as follows: First, the selected Chinese herbal medicine composition described in Example 1 (1) (2), (4), (5), (6), and the Chinese herbal medicine ingredients (D), (E), and (F) described in Example 2, in accordance with the composition ratios described in Examples 1 and 2. Vacuum extraction tank.
  • the weight ratio of water to the original medicine is 10:1, put into the tank, soak for about half an hour, then boil for 2 hours with high pressure steam, filter out the boiled liquid, and add water to the dregs in the tank ( This time, the ratio of water to medicinal material is 8: 1), boiled in steam for two hours, and the boiled sputum secondary liquid is filtered out. Then, the two boiled and filtered extracts are separately removed from the precipitate (dust on the original drug, etc.), and the extracted liquid is placed in a sedimentation tank for about twelve hours (overnight to store the precipitate). After twelve hours, the uppermost water in the sedimentation tank is removed, and the rest is the extract of the medicinal material. The medicinal material extract is placed in a concentration tank, and the extract is concentrated to a specific gravity of 1.2-1.3. The desired wet drug ointment in the extract is obtained.
  • the Chinese medicinal material component (3) described in Example 1 and the Chinese medicinal material components (A), (B), and (C) described in Example 2 are ground into a powder, and uniformly added to a specific gravity of 1.2-1.3.
  • the extract is in a wet ointment.
  • an appropriate amount of maltodextrin (about 5% by weight) is added to shape the tablet or/and lyse it in the stomach.
  • the dried concentrated and dried mixture is first granulated to prepare for tableting. use. After the above various preparations were completed, the granular drug mixture was made into a tablet containing 10,000 mg of the raw medicinal material using a standard tableting machine. After the film is made, a sugar-coated tablet may be added according to requirements or needs, for example, the tablet is a yellow sugar coating, that is, a yellow tablet. It is also possible to carry out the final packaging and use without adding sugar. Generally, the ratio of the sugar-coated tablets to the tablets is 25:75 or the sugar coating is less than 25.
  • Pack the final product (yellow tablets). Stored in dry, room temperature, can be stored for three to five years; content l OOOmg / tablet. The difference is that because the side is a compound, the therapeutic effect is stronger than that of white and red tablets alone, so the side can be used clinically alone.
  • 2-3 tablets can be administered at a time, three times a week.
  • the yellow tablets can be used alone to treat HIV/AIDS, and can also be used in combination with the white tablets or/and red tablets of the formulations of Examples 1 and 2, depending on the patient or by the doctor.
  • Example 4 White and red tablets for treatment of patients with H IV/A IDS
  • the number of CD4 cells is determined by measuring the number of immune cells using standard detection equipment.
  • the level of viral load can indicate the degree of HIV infection in patients. The higher the infection, the heavier the infection; the viral load of healthy people is zero; the number of CD4 cells is the level of immune function of patients, the lower the number, the lower the immune level. On the contrary, it is high, and the number of normal CD4 cells is 400-1500 cells/ ⁇ 1.
  • Case 1 and # 2 * are a couple from Zambia.
  • the couple were first diagnosed on April 16, 2003, and were diagnosed with HIV infection outside the clinic. The two were introduced by the other doctors to take the newly-invented anti-HIV/AIDS pure Chinese medicine preparation.
  • the treatment of the couple was based on the combination of white tablets and red tablets. / times, red tablets are also five tablets / time, three times a day, taken after meals.
  • the patient has continued to use the drug until now, and the viral load and the number of CD4 cells were measured before, during, and after treatment (August 2, 2004).
  • the following table shows the results of the test three times before, during and after treatment:
  • CD4 cell count (T helper cells) Patient and assay time Viral load (RNA copy / ml)
  • Case 3* is a male patient from Windhoek, the capital of Sun, aged 48. He was first diagnosed on December 6, 2001. He was treated with medication until March 6, 2002. He was discontinued for three months. Second consultation on May 8, 2003, medication for six months in November 2003 No. 8 and interruption of treatment. His third clinic was on April 24, 2004, and he has been taking medication until now (March 2004). The patient was also used in four tablets/times and four tablets in red, three times a day, after meals.
  • the patient's condition report fully explains the combination of white film and red film, and the clinical efficacy is particularly positive and reliable. Although the treatment was interrupted twice, the efficacy of the drug was not reduced, and the patient's response was excellent. This further confirms that the drug or therapy does not develop resistance.
  • the combination of CD4 has greatly increased, far exceeding the initial 350 cells / ⁇ ⁇ ; and the viral load has dropped to an extremely low level. It has fully confirmed the newly invented pure Chinese medicine preparation, which not only reduces the virus, but also enhances the body's immune cells. It does provide new therapeutic drugs and treatments (including preventive treatment) for antiviral treatment in the medical community, especially for anti-HIV/AIDS treatment.
  • Case 5 Infected in Africa, living in the United States Patient female, 33 years old, company employee. The patient was diagnosed at the beginning of 2000; it was an early HIV carrier. Although the physical condition is acceptable, the viral load at that time was higher than 50,000 Kaobei/ML, and the number of immune cells was about 500. The red tablets described in Example 1 were used, 8 tablets each time, 3 times a day, and migrated to the United States less than half a year after administration, and were interrupted for 14 months due to study in the United States. In May 2002, the drug was requested to continue taking it. The patient's recovery at the time of the follow-up visit in 2002 was satisfactory, but due to the interruption of the time, the HIV viral load rose to more than 58,000 kobe/ml.
  • HIV In order for HIV to enter normal human T lymphocytes, it is necessary to use the fusion reaction between the outer membrane of the virus and the host T lymphocyte membrane.
  • This virus and intercellular fusion reaction is the result of the interaction of the four proteins on the surface of the envelope.
  • the two proteins on the surface of HIV virus cell membrane are gpl20 and gp41; the two proteins on the surface of host cell (T lymphocyte) membrane are the main receptor CD4 protein and the co-receptor CXCR4 or / and CCR5 of cell fusion reaction. protein.
  • this HIV and CD4 can be clearly seen with the naked eye. Intercellular fusion reaction. If the HIV virus cells containing gpl20 and gp41 are cultured together with T lymphocytes bearing CD4 receptors or/and CXCR4 and CCR5 co-receptors in a suitable medium, the fusion reaction between the two will be Appears automatically. The continuously formed cells with gpl20 and gp41 viruses can be seen under the microscope. Due to the occurrence of the fusion reaction, typical morphological abnormalities can be seen under high magnification, and most of the nucleated fusion cells can be stained to find the number of cells after specific fusion.
  • HeLa-SX22-l carries CD4 or / and CCR5, CXCR4 cells (see 2003, Koch, E. C et al., Antiviral Therapy, VIII, 285-487; Wa lker et al., Antiviral Therapy Law, pp. 463-470; and 1998 Kl imKa if et al., «Arch. Virol» 143, 2109-2131).
  • These cells contain a downstream gene in the HIV-LTR region with a beta-Ga lacfos idase and regulated by HIV TAT. It is the presence of this gene that, when the host cell is infected, plus the reagent Ga l, can stain the infected cells blue (sometimes this experiment is also called blue cell experiment).
  • CL-4/gpl20 and gp41 cells which are well-known HIV cells with HIV envelope proteins, which are model system cells without HIV (see article by Kraus slich et al., 1993). , at 192, 605-617).
  • HeLa cells as a control group can be grown in a simple standard DMEM medium.
  • HeLa-SX22-1 cells were grown in standard DMEM medium containing 1 ⁇ g of puromycin and 1 mg of gentamicin/ml.
  • CL-4 cells can also be grown in standard, simple DMEM.
  • the HeLa/HeLa-SX22-1 cells were washed into DMEM without pyridamycin and Qingda, and the DMEM containing this HeLa or HeLa-SX22-1 cells was diluted to 100,000 cells/ Ml of DMEM solution.
  • the CL4 cells were diluted three-fold. 12 ml of CL-4 cells and 6 ml of HeLa or HeLs-SX22-1 cells were mixed in a ratio of 2:1.
  • the Humi cAcid containing HS-1500 (see article by Schneider. J et al., 1996, Virology, 218, 389-295) at a concentration of 2.2 mg/ml PBS, prepared in standard DMEM diluted ten times. Then, on this basis, dilute to 220, 110, 55, 27. 5, 13. 75 ⁇ g/ml of DMEM every 2 times. The final concentration required to be diluted to 600 at 200 ⁇ ⁇ is 27. 5, 13. 7, 6, 9, 3. 4 and 1. 7 g/ral.
  • the concentration of the desired drug extract is set to a reserve solution of 81 mg/ml (red, white, and white) And red tablets - white tablets mixed extract).
  • This mother liquor was again diluted 3 times with DMEM solution at a concentration of 27 mg/ml.
  • a solution of 13.6, 6. 8, 3. 4 and 1.7 rag/ml was obtained by a method of twice the amount of each of the dilute cesium, in addition to the concentration of 27 mg/ml.
  • the concentrations are: A. 3. 4; B. 1. 7; C. 0. 84; D. 0. 42 mg/ml (see the table below for the specific results).
  • the half effective concentration of the white, red and white red mixture tested was EC 5Q (experimentally used for HeLa cells) as shown in the following table:
  • the effective half of the effective concentration is EC 5 .
  • the invented new Chinese medicine preparation can prevent cell fusion caused by HIV, the fusion between HIV and cells is prevented (prevented). Therefore, it can be concluded that at least inhibition (prevention) is one of the potential mechanisms of this series of products or components to inhibit HIV. It has been prevented (prevented) before HIV enters the cell, and it has greater advantages than other currently used ARVs that act only on a replication link after HIV enters the cell.

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Abstract

Combinaison antivirale et fabrication de celle-ci. La combinaison est composée d’au moins trois plantes sélectionnées à partir du groupe contenant des Radix Isatidis, Radix Glycyrrhizae, Fructus Trichosanthis, Rhizoma Pinelliae, Rhizoma Zingiberis, Radix Astragali, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae Preparata, Radix Trichosanthis, Radix Ginseng or Radix Panacis Quingquefolii, Radix Angelicea Sinensis et Cordyceps et inclut au moins une, composition préparée par au moins une plante sélectionnée à partir du même groupe que ci-dessus. La combinaison est utile dans des infections ou virus résistants, particulièrement des rétrovirus ou virus d’hépatite B et virus d’hépatite C, du VIH courant, et dans le traitement du SIDA.
PCT/CN2005/001254 2004-08-12 2005-08-12 A combinaison antivirale et fabrication de celle-ci Ceased WO2006015556A1 (fr)

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EP04019119A EP1629847B1 (fr) 2004-08-12 2004-08-12 Composition à base de plantes pour le traitement du SIDA
EP04019119.9 2004-08-12
CNB2004100911468A CN100371015C (zh) 2004-11-19 2004-11-19 一种抗病毒的中草药产品
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CN102895362A (zh) * 2012-10-30 2013-01-30 张晓彤 一种治疗乙型肝炎的中药制剂
CN103768454A (zh) * 2012-10-26 2014-05-07 北京因科瑞斯医药科技有限公司 一种具有预防和治疗hiv/aids的组合物及其制备方法
CN104027751A (zh) * 2014-06-30 2014-09-10 曹健 治疗慢性胆囊炎的中药制剂
US9675652B2 (en) 2011-07-29 2017-06-13 HXLS Charity Corp. Compositions and methods to relieve chronic diseases symptoms

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CN1367003A (zh) * 2002-01-28 2002-09-04 张在春 治疗艾滋病的药
WO2004105701A2 (fr) * 2003-05-29 2004-12-09 Bio-Defense Nutritionals, Inc. Compositions et methodes permettant de soulager des symptomes de diverses maladies

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CN1212155A (zh) * 1997-09-19 1999-03-31 张发田 治疗乙型肝炎的药物
CN1367003A (zh) * 2002-01-28 2002-09-04 张在春 治疗艾滋病的药
WO2004105701A2 (fr) * 2003-05-29 2004-12-09 Bio-Defense Nutritionals, Inc. Compositions et methodes permettant de soulager des symptomes de diverses maladies

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9675652B2 (en) 2011-07-29 2017-06-13 HXLS Charity Corp. Compositions and methods to relieve chronic diseases symptoms
US10149875B2 (en) 2011-07-29 2018-12-11 HXLS Charity Corp. Compositions and methods to relieve chronic diseases symptoms
CN103768454A (zh) * 2012-10-26 2014-05-07 北京因科瑞斯医药科技有限公司 一种具有预防和治疗hiv/aids的组合物及其制备方法
CN103768454B (zh) * 2012-10-26 2018-04-13 北京盈科瑞创新医药股份有限公司 一种具有预防和治疗hiv/aids的组合物及其制备方法
CN102895362A (zh) * 2012-10-30 2013-01-30 张晓彤 一种治疗乙型肝炎的中药制剂
CN104027751A (zh) * 2014-06-30 2014-09-10 曹健 治疗慢性胆囊炎的中药制剂

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