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WO2017091413A1 - Extraits aqueux de rhizoma coptidis et de radix astragali - Google Patents

Extraits aqueux de rhizoma coptidis et de radix astragali Download PDF

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Publication number
WO2017091413A1
WO2017091413A1 PCT/US2016/062292 US2016062292W WO2017091413A1 WO 2017091413 A1 WO2017091413 A1 WO 2017091413A1 US 2016062292 W US2016062292 W US 2016062292W WO 2017091413 A1 WO2017091413 A1 WO 2017091413A1
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Prior art keywords
subject
radix astragali
water extract
coptidis
effective amount
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Ceased
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PCT/US2016/062292
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English (en)
Inventor
Nanzheng Cheng
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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)
    • A61K36/48—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)
    • A61K36/71—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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • This invention relates to a combination composition
  • a combination composition comprising a water extract of Rhizome Coptidis and a water extract of Radix Astragali.
  • the combination composition enhances insulin sensitivity and/or provides an insulin-like action in a synergistic matter.
  • Diabetes meilitus is a major public health problem. In the United States, there are over 10 million patients with diabetes. Diabetes is a syndrome that is caused by a relative or an absolute lack of insulin. Clinically, it is characterized by symptomatic glucose intolerance as well as alterations in lipid and protein metabolism. The maintenance of normal blood sugar levels is achieved by the actions of several hormones, most notably insulin, but also glucagon, epinephrine, corticosteroids, and growth hormone. On the other hand, hyperglycemia is exemplified by higher than normal concentrations of glucose in the blood. The pancreas produces insulin which is released in response to increased blood glucose concentrations. Insulin works to lower the blood sugar levels by stimulating the uptake of glucose by cells. Glucose is used in cellular metabolism to produce energy, or is converted to glycogen for stora e in the liver and muscles, or is used in the production of triglycerides and fats.
  • the present invention is directed to a method for increasing glucose uptake in a subject.
  • the method comprises administering to a subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the present invention is also directed to a method for regulating blood glucose level in a subject.
  • the method comprises administering to a subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the present invention is further directed to a method for decreasing blood glucose level in a hyperglycemic subject.
  • the method comprises administering to a hyperglycemic subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • FIG. l shows glucose uptake results of different test materials relative to control (normalized to 100%), by measuring the fluorescent intensity produced by cells.
  • Glucose transport is the rate-limiting step for glucose utilization in muscle at most physiologic glucose and insulin levels, as well as in type 2 and type 1 diabetes. Progressive defects in insulin sensitivity and insulin secretion contribute to the development of diabetes.
  • This invention relates to methods and compositions for providing improved insulin- sensitivity and/or enhanced insulin-like action, which leads to improved glucose uptake and utilization.
  • Increased insulin sensitivity i.e., decreased insulin resistance
  • Increased insulin sensitivity lowers the risk to the development to type 2 diabetes in a normal subject or a pre-diabetes subject.
  • Increased insulin sensitivity also leads to lowering total cholesterol, LDL-cholesterol, and triglycerides, which are associated with decreased risk of type 2 diabetes and cardiovascular diseases.
  • Rhizoma Coptidis also known as Huang Li an or Coptis Rhizome, is the dried rhizome of Coptis chinensis Franch, Coptis deltoides C.Y. Cheng et Hsiao, Coptis japonica Makino (Ranunculaceae), or other berberine-containing species of the same genus.
  • Radix Astragali is the dried root of perennial herbs, Astragalus
  • Radix Astragali is also named Astragalus root, Astragalus propinquus, huang-chi, huangqi, hwanggi, membranous milkvetch, milkvetch, Mongolian milk-vetch, neimeng huangqi, ogi, ougi, zhongfengnaomaitong.
  • Major chemical constituents in Radix Astragali are triterpene saponins (astragal osides I-X and isoastragalosides I-IV), and polysaccharides (e.g.
  • Rhizoma Coptidis and Radix Astragali used in this invention are natural substances derived from herbs, and are safe for human consumption.
  • Water extracts of Rhizoma Coptidis and Radix Astragali can be prepared according to the following procedures.
  • the source tissue is obtained either as a ground powder or is prepared by cutting the plant tissue into small pieces, pulverizing it, grinding it or otherwise increasing the surface area of the pieces of tissue to facilitate extraction.
  • Hydrophilic solvents such as water are used for extraction. Because it is safe, easy to use, and economic, water is a preferred solvent for extraction, A small amount of buffer can be added to water to maintain the pH. A small amount of ethanol or methanol also can be added to water as a solvent for extraction.
  • the amount of solvent added to the raw material for extraction is, in general, in a volume ranging from 2-200 times per unit weight of the raw material, and preferably 20-100 times per unit weight.
  • Dilute acids such as acetic acid and hydrochloric acid also can be used: the acid concentration should be less than about 1 N, and preferably less than 0.5 N, For example, 0.1 N acetic acid or 0.1 N
  • hydrochloric acid can be an effective solvent
  • Dilute bases for example, ammonium hydroxide or sodium hydroxide
  • the concentration of the base should be less than about 1 N and preferably less than 0.5 N, For example, 0. 1 N NH 4 OH can be used as an effective solvent to extract insulin potentiating activity.
  • the extraction can be performed at a wide range of temperatures, but preferably at a temperature range from room temperature to about 00°C, for from about 15 minutes to overnight.
  • the liquid which contains the insulin-like activity is separated from any solid debris by centrifugation or filtration. If acid or base is used as the solvent for extraction, the extract usually is neutralized before further usage.
  • the water extract which is free of solid debris, can be used directly, or the water extract can be lyophilized or dried (e.g., by spray drying) to form a powder.
  • the liquid or the powder can be incorporated into a variety of basic materials in the form of a liquid, powder, tablets, or capsules to provide an insulin-like activity.
  • the insulin sensitivity or insulin-like activity can be determined by increased glucose uptake by cells such as adipocytes or muscle cells.
  • Glucose uptake can be determined by measuring the amount of fluorescent labelled glucose taken up in the cells.
  • the present invention is directed to a method for increasing insulin sensitivity in a subject.
  • the present invention provides a method for increasing glucose uptake in a subject.
  • the present invention also provides a method for regulating blood glucose level in a subject.
  • the present invention provides a method of decreasing blood glucose level and/or glycosylated hemoglobin level in a hyperglycemic subject.
  • the present invention also provides a method for preventing a normal subject or a pre-diabetic subject from developing type 2 diabetes.
  • the present invention provides a method of lowering triglycerides, lowering total cholesterol, and/or lowering LDL- cholesterol in a subject such as Type 2 diabetic subject.
  • the method comprises administering to a subject an effective amount of a water extract of Rhizoma Coptidis and an effective amount of a water extract of Radix Astragali, wherein said water extracts are administered in an amount effective to increase insulin sensitivity or cause an insulin-like action in the subject.
  • An effective amount refers to an amount that is effective to increase insulin sensitivity or provide an insulin-like action in a subject.
  • this method does not contain a step of administering to a subject an additional active ingredient (other than Rhizoma Coptidis or Radix Astragali) that provides an insulin-like action.
  • the two water extracts of Rhizoma Coptidis and Radix Astragali can be administered simultaneously in one
  • compositions or in two separate compositions can be administered sequentially.
  • the method comprises administering to a subject active ingredients consisting essentially of an effective amount of a water extract of Rhizoma Coptidis and an effective amount of a water extract of Radix Astragali, wherein said water extracts are administered in an amount effective to cause an insulin-like action and to increase glucose uptake in the subject.
  • active ingredients consisting essentially of an effective amount of a water extract of Rhizoma Coptidis and an effective amount of a water extract of Radix Astragali, wherein said water extracts are administered in an amount effective to cause an insulin-like action and to increase glucose uptake in the subject.
  • Consisting essentially of, as used herein refers that the active ingredients only contain Rhizoma Coptidis and Radix Astragali, and do not contain any other active ingredient that increases insulin sensitivity or provides insulin-like action.
  • the weight ratio of the water extract of Rhizome Coptidis and the water extract of Radix Astragali used in the present methods is in general from about 5: 1 to 1 :5, or 3 : 1 to 1 :3; or 2: 1 to 1 :2.
  • About equal weight ratio (1 : 1) of Rhizoma Coptidis to Radix Astragali is preferred.
  • "About” as used herein, refers to ⁇ 10% of the recited value.
  • Chromium generally in the form of chromium picolinate or chromium chloride, is optionally administered to the subject in addition to the water extract of Rhizome Coptidis and the water extract of Radix Astragali.
  • water extract of Cinnamomum (U.S. Patent No. 6,200,569), is optionally administered to the subject in addition to the water extract of Rhizome Coptidis and the water extract of Radix Astragali.
  • the present invention is useful in treating mammalian subjects, such as humans, dogs and cats.
  • the present invention is particularly useful in treating humans.
  • the subject can be a normal subject, a pre-diabetic subject, or a subject suffering from a disease or a disorder, such as a hyperglycemia subject or a type 2 diabetic subject.
  • the water extracts of Rhizome Coptidis and Radix Astragali can be formulated as a pharmaceutical or neutraceutical formulation.
  • the formulation may include diluents or excipients such as fillers, binders, wetting agents, disintegrators, surface-active agents, lubricants and the like.
  • Typical unit dosage forms include tablets, pills, powders, solutions, suspensions, emulsions, granules, capsules, suppositories.
  • Each carrier is compatible with other ingredients in the formulation and is biologically acceptable to the subject and inert.
  • Formulations include those suitable for oral and parenteral (including subcutaneous, intramuscular, intravenous and intradermal) administration, with oral formulations being preferred.
  • a preferred oral formulation is an encapsulated dry powder of a water extract of Rhizome Coptidis, a water extract of Radix Astragali, or a mixture of both water extracts.
  • the formulations can be conveniently prepared in unit dosage form and can be prepared by any method known in the art.
  • solutions and suspensions are sterilized and are preferably isotonic to blood.
  • carriers which are commonly used in this field are used, for example, water, ethyl alcohol, propylene glycol, ethoxyiated isostearyl alcohol, polyoxylated isostearyi alcohol, poiyoxyethyiene sorbitol and sorbitate esters.
  • isotonicity adjusters such s sodium chloride, glucose or glycerin can be added to make the preparations isotonic.
  • the aqueous sterile injection solutions may further comprise oxidants, buffers, bacteriostats, and like additions acceptable for parenteral formulations.
  • the formulation according to the invention can be administered by any suitable routes, including oral and parenteral (including intraperitoneal, subcutaneous, intramuscular, intravenous and intradermal) routes. It will be appreciated that the preferred route will vary with the condition and age of the patient, and how long-lasting the treatment is.
  • the present invention provides a method for increasing glucose uptake or regulating blood glucose levels in a subject, by administering to a subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the present invention provides a method for lowering blood glucose levels in a hyperglycemic subject, by administering to a hyperglycemic subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the present invention also provides a method for preventing a subject from developing type 2 diabetes, by administering to a normal or pre-diabetic subject active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the present invention also provides a method for lowering total cholesterol, LDL- cholesterol and triglyceride levels in a subject, by administering to a subject an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali, or by administering active ingredients consisting essentially of an effective amount of a water extract of Rhizome Coptidis and an effective amount of a water extract of Radix Astragali.
  • the effective amount will vary depending upon several factors, including, but not limited to, the age and weight of the patient, the type of the disease state treated, how- advanced the disease state is, the general health of the patient, and the severity of the symptoms.
  • a human subject may take 1-10 capsules per day, preferably 1-2 or 1-3 capsules per day, containing the water extract of Rhizome Coptidis and the water extract of Radix Astragali for treatment.
  • Each capsule contains 100-1000 mg of dry powder of a water extract of Rhizome Coptidis alone, a water extract of Radix Astragali alone, or a mixture thereof.
  • daily use in a human subject is 500-5000 or 500-2500 mg total of water extracts of Rhizome Coptidis and Radix Astragali.
  • Chromium in an amount of about 100-300 ⁇ ig, usually about 200 ⁇ g, also can be added into the capsule.
  • a capsule contains a mixture of a water extract of Rhizome Coptidis and a water extract of Radix Astragali
  • the weight ratio of Rhizome Coptidis extract to Radix Astragali extract is in general from about 5 : 1 to 1 :5, or about 2: 1 to :2, or about 3 : 1 to 1 :3
  • About equal weight ratio (1 : 1 ⁇ 10%) of Rhizome Coptidis to Radix Astragali is preferred.
  • the amount of total active ingredients i.e., the dry powder of both water extracts of Rhizome Coptidis and Radix Astragali (free of solid debris), administered to a human subject per day, ranges from 25-10,000 mg, preferably 200-2500 mg, 200-1000 mg, 500-1500, or 500-2500 mg.
  • chromium of 100-3000 g, or 100-300 g per day is optionally administered to the subject.
  • cinnamon water extract of 100-1000 mg, 200-1000 mg, 50-250 mg, or 50-500 mg is optionally administered to the subject.
  • 2-DG 2-deoxyglucose
  • 2-DG-6-phosphate (2-DG6P) 2-DG-6-phosphate
  • 2-DG6P cannot be further metabolized, and thus it accumulates in the cells.
  • the accumulated 2-DG6P is directly proportional to 2-DG (or glucose) uptake by cells.
  • Rat L6 myoblasts (CRL-1458) were purchased from ATCC, Manassas, VA and were maintained in DMEM medium supplemented with 1.0% fetal bovine serum and 5% penicillin- streptomycin-glutamine in a humidified atmosphere containing 5% C0 2 and 95% air at 37°C, Cells were subcultured by trypsinization of subconfluent cultures using 0.05% trypsin with EDTA. L6 myoblasts were seeded at a density of 0.5 x 10 6 cells per well in 2mL culture medium in a 35mm dish, and cultured until 100% confluent for two days.
  • the dishes were centrifuged for 5 minutes at 400xg at room temperature and the supernatants were aspirated. Then 2 mi of cell-based assay buffer was added to each dish and the dishes were centrifuged for 5 minutes at 400xg at room temperature and the supernatants were aspirated.
  • Roots of Radix Astragali (A) plus Rhizoma Coptidis (B) provides a synergistic activity (21 1% over control) in comparison with Radix Astragali (A, 17% over control) and Rhizoma Coptidis (B, 106% over control) alone.
  • the results indicate that the combination of Radix Astragali (A) and Rhizoma Coptidis (B) enhanced the glucose uptake activities of Radix Astragali and Rhizoma Coptidis in a synergistic manner and provided improved insulin sensitivity and/or enhanced an insulin-like action.
  • C6 glioma cells (CCL-107) were purchased from American Type Culture Collection (ATCC; Manassas, VA, USA). Cell cultures were grown in F-12 K medium
  • Roots of Radix Astragali (A) plus Rhizoma Coptidis (B) provides a synergistic activity (218% over control) in comparison with Radix Astragali (A, 26% over control) and Rhizoma Coptidis (B, 89% over control) alone.
  • the results indicate that the combination of Radix Astragali (A) and Rhizoma Coptidis (B) enhanced the glucose uptake activities of Radix Astragali and Rhizoma Coptidis in a synergistic manner and provided improved insulin sensitivity and/or enhanced an insulin-like action in glioma cells.
  • Example 3 Case Study A of Water Extracts of Radix Astragali and Rhizoma Coptidis A 70 years old female patient has type 2 diabetes. After the patient took 250 mg (125 mg of water extract of radix astragali and 125 mg of water extract of rhizoma coptidis) twice a day for 4 months, the patient's HbAlC decreased from 6.9% to 6.1%, triglyceride decreased from 1.63 to 1.4 mmoi/L, and body weight decreased from 53 to 52.5 Kg.
  • a 64 years old male patient has type 2 diabetes. After the patient took 500 mg (250 mg of water extract of radix astragali and 250 mg of water extract of rhizoma coptidis) twice a day for 4 months, the patient's postprandial glucose decreased from 11.42 to 9.7 mmol/L, postprandial insulin decreased from 15.4 to 11 Uu/mL, and body weight decreased from 75 to 74.5 Kg.
  • Each of seven groups of patients each take different capsules. There are 3-5 patients in each group and they are each treated for 1-3 months with 2 capsules per day each containing 500, 1000, or 2000 mg dry extract powder per day administered orally.
  • the capsules taken by each group contain dried powder of water extract of Rhizoma Coptidis and water extract of Radix Astragali in 1 : 1 weight ratio.
  • a control group take placebo capsules.
  • Blood glucose, hemoglobinA lc , insulin, total cholesterol, HDL cholesterol and triglycerides are measured in each patient at time zero, one, two and three months.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention concerne des méthodes et des compositions permettant d'améliorer la sensibilité à l'insuline et/ou de stimuler une action analogue à l'insuline, ce qui conduit à une meilleure absorption et utilisation du glucose. L'invention concerne une méthode permettant d'accroître l'absorption du glucose chez un sujet. La présente invention concerne également une méthode permettant de réguler la glycémie chez un sujet ou d'abaisser la glycémie chez un sujet hyperglycémique. Les méthodes comprennent l'administration à un sujet d'une quantité efficace d'un extrait aqueux de Rhizome Coptidis et d'une quantité efficace d'un extrait aqueux de Radix Astragali. Un rapport en poids Rhizome Coptidis à Radix Astragali préféré est d'environ 1:1.
PCT/US2016/062292 2015-11-24 2016-11-16 Extraits aqueux de rhizoma coptidis et de radix astragali Ceased WO2017091413A1 (fr)

Applications Claiming Priority (2)

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US201562259180P 2015-11-24 2015-11-24
US62/259,180 2015-11-24

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WO2017091413A1 true WO2017091413A1 (fr) 2017-06-01

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1686238A (zh) * 2005-04-04 2005-10-26 四川科伦药业股份有限公司 用于治疗糖尿病的药物组合物
US9089577B1 (en) * 2014-07-28 2015-07-28 Nanzheng Cheng Water extracts of cinnamon and Radix Astragali

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1686238A (zh) * 2005-04-04 2005-10-26 四川科伦药业股份有限公司 用于治疗糖尿病的药物组合物
US9089577B1 (en) * 2014-07-28 2015-07-28 Nanzheng Cheng Water extracts of cinnamon and Radix Astragali

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HU ET AL.: "Anti-Diabetic activities of jiaotaiwan in db/db mice by augmentation of AMPK Protein Activity and upregulation of GLUT4 expression", EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE., vol. 2013, 2013, pages 1 - 9, XP055384971 *

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