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WO2022225984A1 - Supplément nutritif pour la régulation de la glycémie - Google Patents

Supplément nutritif pour la régulation de la glycémie Download PDF

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Publication number
WO2022225984A1
WO2022225984A1 PCT/US2022/025423 US2022025423W WO2022225984A1 WO 2022225984 A1 WO2022225984 A1 WO 2022225984A1 US 2022025423 W US2022025423 W US 2022025423W WO 2022225984 A1 WO2022225984 A1 WO 2022225984A1
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WO
WIPO (PCT)
Prior art keywords
weight
nutritional supplement
blood glucose
individual
glucose concentration
Prior art date
Application number
PCT/US2022/025423
Other languages
English (en)
Inventor
Gao SIHUA
Shaohuan SONG
Original Assignee
Spruce Health Sciences 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
Application filed by Spruce Health Sciences Inc. filed Critical Spruce Health Sciences Inc.
Publication of WO2022225984A1 publication Critical patent/WO2022225984A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
    • 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
    • A61K36/718—Coptis (goldthread)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger

Definitions

  • the field of the invention is nutritional supplements, specifically nutritional supplements useful for controlling blood sugar and/or diabetes.
  • Diabetes mellitus is a common, serious disease that is characterized by elevated blood glucose levels, the majority of them in developed countries. Diabetic disease is commonly divided into two subclasses insulin-dependent diabetes mellitus (i.e., type I diabetes) and non- insulin-dependent diabetes mellitus (i.e., type II diabetes or adult diabetes).
  • Insulin and hypoglycemic pharmaceutical compounds such as sulfonylureas, biguanides, and alpha glucosidase inhibitors
  • sulfonylureas include low blood glucose concentration (hypoglycemia), renal and hepatic disease, gastrointestinal disturbances, increase cardiovascular mortality, dizziness, drowsiness, and headache.
  • biguanides include lactic acidosis and increased cardiovascular mortality.
  • alpha glucosidase inhibitors include gastrointestinal side effects and hypoglycemia.
  • United States Patent No. 8,153,167, to Hwang et al. describes a mixture of six different plant materials as effective in treating diabetes, however it provides no evidence of hypoglycemic effect.
  • United States Patent No. 8,206,753, to Tripp et al. describes the use of compounds obtained from acacia or hops or extracts from a range of plant materials to enhance lipogenesis in adipocytes, which is cited as useful in the treatment of metabolic syndrome (which has an association with diabetes). It is not clear, however, if the described compounds and extracts can modulate blood glucose concentration. [0009] Thus, there is still a need for safe and effective plant-based formulations for the treatment of diabetes and/or pre-diabetes.
  • the inventive subject matter provides apparatus, systems and methods in which a nutritional supplement is used to control blood glucose levels or to treat a diabetic or pre-diabetic condition.
  • One embodiment of the inventive concept is a nutritional supplement that includes Curcuma long (3% to 30% by weight), Cinnamonum cassia (3% to 30% by weight), Rehmannia glutinosa (6% to 40% by weight), Astragalus membranaceus (6% to 40% by weight), Coptis chinensis (5% to 35% by weight), mulberry leaf (5% to 35% by weight), and Momordica charantia (5% to 35% by weight).
  • Curcurma longa Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia are provided in amounts that are effective to modulate (e.g., lower) blood glucose concentration upon administration to an individual in need of treatment (for example, treatment of a diabetic or pre-diabetic condition).
  • Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia are provided in relative amounts and/or relative proportions that provide a synergistic effect (i.e., greater than additive effect of the contributions of individual components) in modulating blood glucose concentration.
  • a nutritional supplement can be formulated for oral administration, such as a pill, a capsule, a powder, a lozenge, a pastille, a food additive, or a liquid. In other embodiments such a nutritional supplement is formulated for parenteral administration.
  • Another embodiment of the inventive concept is a pharmaceutical composition that includes a nutritional supplement comprising Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia, and also includes a pharmaceutical agent that is active in modulating blood glucose concentration.
  • the nutritional supplement and the pharmaceutical agent are provided in amounts effective to modulate blood glucose concentration upon administration to an individual in need of treatment (e.g., for a diabetic or pre-diabetic condition).
  • Suitable pharmaceutical agents include insulin, an insulin analog, Chlorpropamide, Glyburide, Glipizide, Glimepiride, Tolbutamide, Acetohexamide, Tolazamide, Rosiglitazone, Pioglitazone, Metformin, Acarbose, Meglitol, and Sitagliptin.
  • Such a pharmaceutical composition can be formulated such that the nutritional supplement and the pharmaceutical agent are provided as a combined formulation, or as separate formulations.
  • the nutritional supplement can include Curcuma long at 3% to 30% by weight, Cinnamonum cassia at 3% to 30% by weight, Rehmannia glutinosa at 6% to 40% by weight, Astragalus membranaceus at 6% to 40% by weight, Coptis chinensis at 5% to 35% by weight, mulberry leaf at 5% to 35% by weight, and Momordica charantia at 5% to 35% by weight.
  • Another embodiment of the inventive concept is a method of modulating blood glucose concentration in an individual with a diabetic condition by administering a composition as described above to an individual on a schedule that is effective to move the individual’s blood glucose concentration towards or maintain the individual’s blood glucose concentration at a medically acceptable normal range.
  • the diabetic condition can be type 1 diabetes, type 2 diabetes, and a pre-diabetic condition.
  • Such a schedule can include administering from 1 mg to 500 g of the composition per day to the individual, at a frequency of 4 times per day to once every 4 weeks.
  • the inventive subject matter provides compositions and methods for treating an individual with a diabetic condition, wherein the composition includes Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia.
  • a diabetic condition can be type 1 diabetes, type 2 diabetes, a pre-diabetic condition, hyperglycemia, hypoglycemia, and/or a glycosylated hemoglobin Ale value that is outside of normal clinical range.
  • Treatment of the diabetic condition can be modulation of the concentration of glucose in the blood of a treated individual, such as a reduction in blood glucose concentration, a stabilization of blood glucose concentration, an elevation of blood glucose concentration, and/or a modulation of blood glucose concentration towards a value that is within a range that is considered clinically normal.
  • treatment of the diabetic condition can be modulation of the amount of glycosylated hemoglobin in the blood of a treated individual, such as a reduction in glycosylated hemoglobin, a stabilization of glycosylated hemoglobin, an elevation of glycosylated hemoglobin, and/or a modulation of glycosylated hemoglobin towards a value that is within a range that is considered clinically normal.
  • the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
  • effects of the composition are selective for individuals with the diabetic condition (i.e., modulating effects are not observed or are observed to a reduced degree in individuals that do not have a diabetic condition).
  • Treatment with a composition of the inventive complex can be more selective in modulating blood glucose than conventional treatment with insulin, insulin analogs, medications that modulate production of insulin, and/or medication that modulate insulin receptors.
  • compositions of the inventive concept can reduce blood glucose concentration upon administration while not inducing a hypoglycemic condition in the treated individual.
  • inventive subject matter provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
  • compositions of the inventive concept can be formulation such that the amounts (e.g., weight, concentration, and/or relative amounts) of Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia provide a cumulative effect in regard to modulating blood glucose concentration and/or glycosylated hemoglobin that exceeds the sum of individual modulating effects of each of the components (when administered individually or as monotherapies). Within the context of the application this greater- than- additive effect defines a synergistic effect.
  • the composition described above is provided as a nutritional supplement that is administered in concert with a conventional pharmaceutical agent for the treatment of a diabetic condition.
  • suitable conventional pharmaceutical agents include injectable medications (e.g., insulin and/or insulin analogs) and oral medications.
  • suitable oral medications include (but are not limited to) Chlorpropamide, Glyburide, Glipizide, Glimepiride, Tolbutamide, Acetohexamide, Tolazamide, Rosiglitazone, Pioglitazone, Metformin, Acarbose, Meglitol, and Sitagliptin.
  • the nutritional supplement and one or more conventional pharmaceutical agent are provided as separate formulations, which can be applied on the same or different schedules.
  • the nutritional supplement and one or more conventional pharmaceutical agent can be provided as a combined formulation.
  • the amounts (e.g., weight, concentration, and/or relative amounts) of Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia in combination with the conventional pharmaceutical agent provide a cumulative effect in regard to modulating blood glucose concentration and/or glycosylated hemoglobin that exceeds the sum of individual modulating effects of the nutritional supplement component and the conventional pharmaceutical component (i.e., provide a synergistic effect when used in combination).
  • One embodiment of the inventive concept is a nutritional supplement that includes Curcuma long at from about 3% to about 30% by weight, Cinnamonum cassia at from about 3% to about 30% by weight, Rehmannia glutinosa at from about 6% to about 40% by weight, Astragalus membranaceus at from about 6% to about 40% by weight, Coptis chinensis at from about 5% to about 35% by weight, mulberry leaf at from about 5% to about 35% by weight, and Momordica charantia at from about 5% to about 35% by weight. Unless otherwise indicated, these amounts reflect the weight of dried materials.
  • any portion e.g., root, leaf, bark, flowering portion, etc.
  • Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia are provided in amounts and/or proportions that are effective to modulate blood glucose concentration and/or glycosylated hemoglobin upon administration to an individual in need thereof (e.g., an individual with a diabetic condition).
  • Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia can be provided in relative amounts or proportions that provide a synergistic effect in modulating blood glucose concentration and/or glycosylated hemoglobin that is greater than the sum of effects in modulating blood glucose concentration on administration of Curcurma longa, Cinnamonum cassia, Rehmannia glutinosa, Astragalus membranaceus, Coptis chinensis, mulberry leaf, and Momordica charantia individually.
  • Such a nutritional supplement can be formulated for oral administration.
  • the nutritional supplement can be formulated as a pill, a capsule, a powder, a lozenge, a pastille, a food additive, or a liquid.
  • Liquid forms include extracts (e.g., aqueous extracts, organic solvent extracts) and/or suspensions (e.g., particulate suspension, emulsions, and/or micellar suspensions).
  • Such formulations can include a pharmaceutically acceptable matrix, fillers, stabilizers (e.g., anti-oxidants), dyes, and or flavoring agents in order to improve palatability.
  • such a nutritional supplement can be formulated for parenteral administration (e.g., by subdermal, intramuscular, intravenous, and/or intraperitoneal injection) following solubilization and/or extraction.
  • Another embodiment of the inventive concept is a pharmaceutical composition that includes a nutritional supplement comprising Curcurma longa (e.g., at about at 3% to about 30% by weight), Cinnamomum cassia (e.g., at about 3% to about 30% by weight), Rehmannia glutinosa (e.g., at about 6% to about 40% by weight), Astragalus membranaceus (at about 6% to about 40% by weight), Coptis chinensis (e.g., at about 5% to about 35% by weight), mulberry leaf (e.g., at about 5% to about 35% by weight), and Momordica charantia (e.g., at about 5% to 35% by weight), and also includes a pharmaceutical agent active in modulating blood glucose concentration and/or glycosylated hemoglobin.
  • Curcurma longa e.g., at about at 3% to about 30% by weight
  • Cinnamomum cassia e.g., at about 3% to
  • the nutritional supplement and the pharmaceutical agent are provided in amounts effective to modulate blood glucose concentration and/or glycosylated hemoglobin on administration to an individual in need treatment for a diabetic condition.
  • Suitable pharmaceutical agents include (but are not limited to) insulin, an insulin analog, Chlorpropamide, Glyburide, Glipizide, Glimepiride, Tolbutamide, Acetohexamide, Tolazamide, Rosiglitazone, Pioglitazone, Metformin, Acarbose, Meglitol, and Sitagliptin.
  • the nutritional supplement and the pharmaceutical agent can be provided as a combined formulation.
  • the nutritional supplement can be provided as a first formulation and the pharmaceutical agent is provided as a second formulation.
  • the nutritional supplement and the pharmaceutical agent can be provided on the same schedule or on different schedules.
  • such separate formulations are provided on a schedule or schedules that provide overlap between periods of treatment with the nutritional supplement and the pharmaceutical agent.
  • Another embodiment of the inventive concept is a method of modulating blood glucose concentration and/or glycosylated hemoglobin in an individual with a diabetic condition, by administering a composition as described above (i.e., a nutritional supplement and/or a nutritional supplement in combination with a pharmaceutical agent effective to modulate blood glucose and/or glycosylated hemoglobin concentration) to the individual on a schedule and/or dosage that is effective to move the individual’s blood glucose concentration and/or glycosylated hemoglobin towards or maintain the individual’s blood glucose concentration and/or glycosylated hemoglobin at a medically acceptable normal range.
  • the diabetic condition can, for example, be type 1 diabetes, type 2 diabetes, or a pre-diabetic condition.
  • Suitable treatment schedules include administering from 1 mg to 500 g of the composition per day to the individual.
  • a suitable treatment schedule can include administering the composition at a frequency of 4 times per day to once every 4 weeks.
  • a treatment schedule can vary during a course of treatment.
  • an individual in need of treatment for a diabetic condition can initially treated using a combination of a nutritional supplement as described above and a pharmaceutical agent conventionally utilized to treat a diabetic condition, then transition to a treatment schedule using only the nutritional supplement.
  • a treatment schedule can include treatment with a nutritional supplement as described above under most circumstances and transition to use of a pharmaceutical agent conventionally used to treat a diabetic condition in combination with the nutritional supplement under specific circumstances (e.g., prior to a large meal).
  • dosage and frequency of administration of a nutritional supplement of the inventive concept can be adjusted based on blood glucose, glycosylated hemoglobin, and/or other clinical measurements obtained from the individual being treated or symptoms experienced by the individual (dizziness, fatigue, confusion, etc.).
  • Another embodiment of the inventive concept is a method of preparing a nutritional supplement that is useful in treating a diabetic condition.
  • a nutritional supplement can include Curcurma longa (e.g., at about at 3% to about 30% by weight), Cinnamomum cassia (e.g., at about 3% to about 30% by weight), Rehmannia glutinosa (e.g., at about 6% to about 40% by weight), Astragalus membranaceus (at about 6% to about 40% by weight), Coptis chinensis (e.g., at about 5% to about 35% by weight), mulberry leaf (e.g., at about 5% to about 35% by weight), and Momordica charantia (e.g., at about 5% to 35% by weight).
  • Curcurma longa e.g., at about at 3% to about 30% by weight
  • Cinnamomum cassia e.g., at about 3% to about 30% by weight
  • Curcurma longa can be obtained as a complete plant (e.g.., including roots, stems, leaves, flowers, and seeds), a plant portion (e.g., a root, a stem, a leaf, a flower, a seed, bark, etc.), and/or a processed powder.
  • Cinnamomum cassia also known as Chinese cinnamon
  • a plant portion e.g., a root, a stem, a leaf, a flower, a seed, bark, etc.
  • a processed powder e.g., a processed powder.
  • Rehmannia glutinosa can be obtained as a complete plant (e.g.., including roots, stems, leaves, flowers, and seeds), a plant portion (e.g., a root, a stem, a leaf, a flower, a seed, bark, etc.), and/or a processed powder.
  • Astragalus membranaceus also known as (huang qi
  • Coptis chinensis (also known as duan e huanglian ) can be obtained as a complete plant (e.g.., including roots, stems, leaves, flowers, and seeds), a plant portion (e.g., a root, a stem, a leaf, a flower, a seed, bark, etc.), and/or a processed powder.
  • Momordica charantia (commonly known as bitter melon) can be obtained as a complete plant (e.g.., including roots, stems, leaves, flowers, and seeds), a plant portion (e.g., a root, a stem, a leaf, a flower, a fruit, a seed, bark, etc.), and/or a processed powder.
  • Plant materials can be obtained in dried form, and in some embodiments different forms can be combined.
  • such materials can be dried (if not already dried) and subjected to a sizing process, such as maceration and/or grinding. Such sized materials can then be blended in proportions as indicated above.
  • a flavorant such as a sweetener, a fruit flavor, a vanilla flavor, a chocolate flavor, etc.
  • a masking agent can be added to improve palatability and patient compliance.
  • This mixture can be used directly, for example by mixing with food or suspension in a liquid.
  • the nutritional supplement can be provided already blended into a food (such as a food bar) or a beverage (such as a nutritional shake).
  • such a mixture can be further processed by packaging into a capsule or compressing into a pill or tablet suitable for oral consumption.
  • the nutritional supplement can be provided parenterally.
  • plant components can be provided in the weight proportions as described above in the form of an extract.
  • each plant material provided in dry form in an amount corresponding to a weight proportion cited above can be extracted for a suitable period of time to generate liquid plant extracts that are subsequently blended to provide a solution form of the nutritional supplement that reflects the specified weight proportions of the plant components and is suitable for parenteral administration.
  • dried plant materials as cited above can be blended in the specified weight proportions prior to extraction.
  • Extraction can be performed by any suitable process, including extraction with hot (e.g., 50° to 100°C) water, extraction with cold (e.g., less than about 20° C) water, and extraction with a suitable organic solvent (i.e., ethanol, isopropyl alcohol, acetone, etc.), and extraction with a liquified gas (e.g., carbon dioxide).
  • a suitable organic solvent i.e., ethanol, isopropyl alcohol, acetone, etc.
  • a liquified gas e.g., carbon dioxide
  • Individual plant materials can be extracted by different means, and such extracts can be dried and redissolved or resuspended prior to blending.
  • Such extracts can be further processed, for example by filtration (0.2 pm or less) to ensure sterility, and can be characterized for bacterial, fungal, and/or endotoxin contamination.
  • Nutritional supplements so provided in solution form can be provided as a stock solution (e.g., 2X, 5X, 10X, 50X, 100X) than can be diluted with a pharmaceutically acceptable diluent (e.g., normal saline) prior to use.
  • a pharmaceutically acceptable diluent e.g., normal saline

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Abstract

L'invention concerne des compositions comprenant du Curcurma Longa, du Cinnamonum Cassia, de la Rehmannia glutinosa, de l'Astragalus membranaceus, du Coptis chinensis, de la feuille de mûrier, de la Momordica charantia et leurs procédés d'utilisation dans le traitement d'un état diabétique. De telles états diabétiques comprennent le diabète de type 1, le diabète de type 2, un état pré-diabétique, l'hyperglycémie et/ou l'hypoglycémie. Le traitement de l'état diabétique peut être une modulation de la concentration de glucose dans le sang d'un individu traité, telle qu'une réduction de la concentration de glucose dans le sang, une stabilisation de la concentration de glucose dans le sang, une élévation de la concentration de glucose dans le sang, et/ou une modulation de la concentration de glucose dans le sang vers une valeur qui se situe dans une plage qui est considérée comme étant cliniquement normale.
PCT/US2022/025423 2021-04-19 2022-04-19 Supplément nutritif pour la régulation de la glycémie WO2022225984A1 (fr)

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US63/176,498 2021-04-19

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Citations (4)

* Cited by examiner, † Cited by third party
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