WO2021172678A1 - Composition pour soulager l'hyperuricémie comprenant un extrait de dendropanax morbifera lev. - Google Patents

Composition pour soulager l'hyperuricémie comprenant un extrait de dendropanax morbifera lev. Download PDF

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WO2021172678A1
WO2021172678A1 PCT/KR2020/012420 KR2020012420W WO2021172678A1 WO 2021172678 A1 WO2021172678 A1 WO 2021172678A1 KR 2020012420 W KR2020012420 W KR 2020012420W WO 2021172678 A1 WO2021172678 A1 WO 2021172678A1
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extract
uric acid
composition
hwangchil
hyperuricemia
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PCT/KR2020/012420
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Korean (ko)
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조창수
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농업회사법인휴림황칠(주)
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Priority to CN202080097581.9A priority Critical patent/CN115135333A/zh
Publication of WO2021172678A1 publication Critical patent/WO2021172678A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/306—Foods, ingredients or supplements having a functional effect on health having an effect on bone mass, e.g. osteoporosis prevention

Definitions

  • the present invention relates to a composition containing a hwangchil tree extract as an active ingredient, and more particularly, to a medical composition or a functional food composition having a preventive, ameliorating and/or therapeutic effect of hyperuricemia.
  • Uric acid (C 5 H 4 N 4 O 3 ) is produced from hypoxanthine (C 5 H 4 N 4 O) or xanthine during purine metabolism in vivo by xanthine oxidase or xanthine dehydratase (xanthine). dehydrogenase), and about 70% of uric acid in the blood is made by endogenous purine metabolism following cell turnover, and 30% is formed from purines ingested through food and mostly excreted through the kidneys. do.
  • uric acid concentration increases.
  • Hyperuricemia is defined as 7.0 mg/dL or more in men and 6.5 mg/dL or more in women.
  • An increase in uric acid concentration is known to cause gout, which causes an inflammatory reaction as urate crystals are deposited on the joint membrane, and recently uric acid, kidney disease, cardiovascular diseases including hypertension, and metabolic syndrome and diabetes mellitus.
  • gout causes an inflammatory reaction as urate crystals are deposited on the joint membrane, and recently uric acid, kidney disease, cardiovascular diseases including hypertension, and metabolic syndrome and diabetes mellitus.
  • gout a typical disease that occurs in people with hyperuricemia, causes recurrent paroxysmal arthritis in the joints and surrounding tissues as leukocytes phagocytose uric acid crystals generated by various factors by immune response, and excessive uric acid persists. In some cases, it is a chronic systemic metabolic disease that causes joint disorders due to accumulated uric acid nodules. In summary, the formation of uric acid occurs during the decomposition of purines, and when uric acid is overproduced, it acts as a cause of gout.
  • Gout clinically causes acute gout attacks, chronic arthritis, gout nodules, etc., and also acts as a cause of various diseases such as uric acid urite and chronic nephropathy.
  • the incidence of hyperuricemia and gout is rapidly increasing due to obesity, kidney disease, high blood pressure, and increased use of diuretics such as thiazide and aspirin due to the aging population and westernization of diet. Therefore, gout patients are usually accompanied by chronic diseases such as obesity, diabetes, high blood pressure, hyperlipidemia, and metabolic syndrome, and it is known that the risk of cardiovascular disease is particularly high.
  • Such gout can be diagnosed by the presence of uric acid crystals phagocytosed by polymorphonuclear leukocytes or accumulated in tissues in the synovial fluid or tissues of the joints. . According to domestic gout medical records, the proportion of men is 10 times that of women, and it is reported that in their 30s, it is 21 times more.
  • Urolithiasis refers to a disease in which various substances, such as uric acid or calcium, are not properly excreted in the urine during the digestive process and remain in the kidneys and then crystallize to a large extent resulting in disorder symptoms. is a ureteric stone.
  • Kidney disease caused by hyperuricemia is divided into nephrolithiasis and chronic uric acid nephropathy, and uric acid-induced nephropathy accounts for 5-10% of all urolithiasis. Eighty percent of uric acid urine stone consists of only uric acid crystals, and the rest is formed by adding calcium oxalate or calcium phosphate to the uric acid crystal nucleus.
  • therapeutic agents for improving or treating hyperuricemia include xanthine oxidase inhibitors, uric acid excretion promoters (Uricosuric agents), and uric acid decomposing agents (Uricolytic drugs, urozyme).
  • a xanthine oxidase inhibitor inhibits uric acid synthesis, and when it is used, uric acid metabolism is inhibited and blood uric acid concentration is reduced, thereby treating hyperuricemia and gout.
  • Uric acid excretion promoters act on the proximal tubules of the kidneys to inhibit reabsorption of uric acid, thereby promoting excretion into urine.
  • a uric acid decomposing agent is an enzyme that oxidizes uric acid to allantoin, and allantoin has a higher solubility than uric acid, so it is easily excreted by the kidneys.
  • ROS reactive oxygen species
  • the present invention provides a composition for preventing, improving and / or treating hyperuricemia comprising a hwangchil tree extract.
  • the composition is characterized in that it can simultaneously perform xanthine oxidase inhibitory activity and uric acid excretion function.
  • the composition is characterized in that it can perform antioxidant activity.
  • the composition may exhibit the prevention, improvement and / or therapeutic function of gout, urolithiasis and kidney disease caused by hyperuricemia.
  • the composition may be a functional food composition.
  • the hwangchil tree extract may be extracted by water or a mixture of water and alcohol.
  • the present invention it is possible to obtain a new level of technology for improving hyperuricemia, a natural material that overcomes the limitations of existing products and has both xanthine oxidase inhibitory activity and uric acid excretion effect at the same time.
  • CGA is one of the indicator components, chlorogenic acid.
  • XO xanthine oxidase
  • a step is located “on” or “before” another step, this means not only a case in which a step is in a direct time-series relationship with another step, but also a step of mixing after each step and Likewise, the order of two steps may include the same rights as in the case of an indirect time series relationship in which the time series order may change.
  • Hwangchil (Dengropanas morbifera) is an evergreen broad-leaved forest belonging to the Araliaceae family, and it is a temperate tree species that grows and grows only in the southeastern coast of Jeollanam-do and island regions.
  • the resin of Hwangchil is golden in color, has strong heat resistance, durability, and water resistance, and has good adhesion and luster.
  • Hwangchil contains not only essential oil components such as sesquiterpene, but also various components such as arachidic acid, palmitic acid, and arginine. is being reported Hwangchil is registered as an edible material (leaf, stem, root) in the Food Standards of the Ministry of Food and Drug Safety, so there are no restrictions on industrial use.
  • Hwangchil is an endemic tree species in Korea and has been used in oriental medicine and modern medicine to improve blood circulation (anti-arteriosclerosis effect), liver function improvement, hard tissue (bone and tooth) regeneration effect, antidiabetic effect, antihypertensive effect, anticancer effect, antioxidant effect, skin tissue It is suitable as a new material for high value-added food, as it has been shown to have regeneration, immunity enhancement, nerve stabilization, and antibacterial activity.
  • the component research on Hwangchil is mainly focused on the analysis of essential oil and fatty acid components such as ⁇ -selinene and capnellane-8-one, which belong to sesquiterpenes having a two-ring structure, contained in Hwangchil sap, which is used as a paint. There is insufficient research in terms of the pharmacological efficacy or functionality of ingredients contained in leaves, stems, and peels, or in terms of active ingredients.
  • the present invention it is a characteristic technique to provide a composition for improving hyperuricemia using such components derived from Hwangchil tree.
  • the present inventors confirmed the inhibitory action and antioxidant efficacy of the hwangchil tree extract on xanthine oxidase, and also confirmed the blood uric acid level reduction effect of the hwangchil tree extract through a simple clinical test. In addition, the effect of lowering the blood uric acid concentration using an animal model was also confirmed. Accordingly, in the present invention, it is possible to provide a pharmaceutical and/or nutraceutical composition having the xanthine oxidase inhibitory effect, uric acid excretion effect, and antioxidant effect of Hwangchil tree extract.
  • the composition for improving hyperuricemia may include a tree of hwangchil and a leaf extract of hwangchil (hereinafter, also referred to as 'hwangchil extract').
  • the tree of hwangchil may mean the bark of the hwangchil tree.
  • the hwangchil tree may be used as it is as the leaves and/or stems of the raw hwangchil tree, but the leaves and/or stems of the hwangchil tree may be used in the form of dried dried herbal medicines.
  • the solvent of the tree of hwangchil and leaf extract of hwangchil may be a mixed solvent in which water and ethanol are mixed. More specifically, the mixed solvent may be a mixture of water and ethanol in a weight ratio of 6:4 to 8:2, preferably a mixture of 7:3.
  • the pharmaceutical composition according to the present invention can be formulated based on the formulation standards for conventional pharmaceutical preparations of the Food and Drug Administration (KFDA).
  • Hwangchil extract or fermented hwangchil liquid metabolite is preferably mixed with a pharmaceutically acceptable carrier according to a conventional method, administration method, dosage form, and therapeutic purpose, diluted or encapsulated in a container-shaped carrier.
  • the pharmaceutical composition may be formulated and administered in any dosage form including, but not limited to, oral administration preparations, injections, suppositories, transdermal preparations, and nasal administration preparations, preferably solutions, suspensions, powders, It may be formulated as a dosage form for oral administration such as granules, tablets, capsules, pills, or extracts.
  • each of the formulations When formulating into each of the formulations, it can be prepared by adding a pharmaceutically acceptable carrier or additive necessary for the production of each formulation.
  • a pharmaceutically acceptable carrier or additive necessary for the production of each formulation.
  • one or more of a diluent, a lubricant, a binder, a disintegrant, a sweetener, a stabilizer, and a preservative may be selected and used as the carrier, and as an additive, a fragrance, vitamins, and antioxidants
  • a fragrance e.g., a stearicant, a binder, a disintegrant, a sweetener, a stabilizer, and a preservative
  • the carrier and additive can be any pharmaceutically acceptable, specifically, lactose, corn starch, soybean oil, microcrystalline cellulose, or mannitol as a diluent, magnesium stearate or talc as a lubricant, and polyvinylpyrrolidone as a binder. Or hydroxypropyl cellulose is preferable.
  • the disintegrating agent is carboxymethylcellulose calcium, sodium starch glycolate, polar acrylic acid potassium, or crospovidone
  • the sweetener is sucrose, fructose, sorbitol, or aspartame
  • the stabilizer is sodium carboxymethylcellulose, beta-cyclodextrin, White lead or xanthan gum, as the preservative, methyl paraoxybenzoate, propyl paraoxybenzoate, or potassium sorbate is preferable.
  • the pharmaceutical composition is divided into several times arbitrarily so that the total daily dose is 1 to 100 g/kg as hwangchil extract and 0.01 to 50 g/kg as hwangchil tree crude drug as an active ingredient, based on adults, in order to obtain a hyperuricemia improvement effect.
  • the dosage may be appropriately increased or decreased depending on the type of disease to be treated or prevented, the degree of disease progression, administration route, sex, age, weight, and the like.
  • functional food means a food manufactured and processed using raw materials or ingredients useful for the human body according to the Health Functional Food Act.
  • functional health food can be formulated in the formulation of conventional functional food known in the art using a pharmaceutically acceptable carrier.
  • the functional food may be prepared as, for example, powders, granules, tablets, capsules, suspensions, emulsions, syrups, liquids, aerosols, extracts, and the like.
  • any carrier or additive known to be usable in the art for the preparation of the formulation to be prepared may be used.
  • the xanthine oxidase enzyme inhibitory activity test of Hwangchil extract and active ingredient was performed according to the method of Stirpe and Corte Della. 0.2 mL of 2 mM xanthine substrate solution was added to 0.1 mL of extracts with different concentrations (0.5-8.0 mg/mL) and 0.6 mL of 0.1 M potassium phosphate buffer (pH 7.5), and 0.1 mL of xanthine oxidase (0.2 uint/mL) was added.
  • FIG. 1 The results of examining the XO inhibitory activity of Hwangchil tree extract and active ingredients are shown in FIG. 1 .
  • the Hwangchil hot water extract and the alcohol extract by concentration it was confirmed that the higher the concentration of alcohol, the higher the XO inhibitory activity.
  • the extract using Hwangchil within 3 months after collection (New) has about twice the XO inhibitory activity than the extract using Hwangchil that has been collected for more than 1 year (Old). It was confirmed that there was a difference in activity depending on the storage period.
  • the reducing power (antioxidant power) of a substance is the degree to which the DPPH radical is reduced by reaction with a certain amount of sample solution using 2,2-Diphenyl-1-picryl hydrazyl (DPPH), a stable free radical as a model of the unsaturated fatty acid radical. is measured with a spectrophotometer to indirectly measure the antioxidant capacity of the sample. That is, 2,2-Diphenyl-1-picrylhydrazyl (DPPH) is a chemically stabilized water-soluble free radical, a purple compound that exhibits characteristic light absorption at 517 nm.
  • DPPH 2,2-Diphenyl-1-picrylhydrazyl
  • the radical (DPPH) is extinguished while giving away electrons, and the color changes from the initial purple color to yellow, which has the advantage that the oxidation activity can be easily observed with the naked eye.
  • well-known vitamin C ascorbic acid
  • the sample and DPPH were dissolved in DMSO and then diluted in methanol, and 90 ⁇ l of DPPH (100 ⁇ M) and 10 ⁇ l of the sample were placed in a 96 well culture plate 37 After reacting at °C for 10 minutes, absorbance was measured at 517 nm.
  • the DPPH radical scavenging activity was expressed as an IC 50 value.
  • the DCFH-DA measurement method is a method used to measure the amount of reactive oxygen species (ROS) in the cell or the ROS scavenging ability of a specific substance in the cell. diacetate (DCFH-DA) is used. DCFH-DA diffuses into the cell and is converted to 2'7' (DCFH) by intracellular esterase, and this substance is rapidly converted to 2'7' (DCF) with fluorescence by ROS. It was used during the experiment.
  • ROS reactive oxygen species
  • the cell line used in the experiment is the doxorubicin-resistant cell line AML-2/DX100 of AML-2, a leukemia cell that expresses relatively little catalase activity.
  • AML-2/DX100 doxorubicin-resistant cell line AML-2/DX100 of AML-2
  • DCFH-DA DCFH-DA radical scavenging ability
  • DPPH radical scavenging abilityIC 50 ( ⁇ g/ml) DCFH-DA radical scavenging ability (%) 100 ⁇ g/ml 50 ⁇ g/ml Hwangchil DW 110 ⁇ 3.17 83 ⁇ 1.0 62 ⁇ 7.5 Hwangchil 30% EtOH 145 ⁇ 10.58 88 ⁇ 1.9 72 ⁇ 3.0 Hwangchil 50% EtOH 52 ⁇ 0.678 88 ⁇ 1.8 70 ⁇ 2.2 Hwangchil 70% EtOH 50 ⁇ 2.08 67 ⁇ 1.8 60 ⁇ 0.6 New 30% EtOH 45 ⁇ 3.51 82 ⁇ 1.5 64 ⁇ 1.9 Old 30% EtOH 98 ⁇ 6.48 78 ⁇ 3.2 58 ⁇ 0.9 Vit-C 5.3 ⁇ 0.26 84 ⁇ 1.6 66 ⁇ 0.5
  • Test substance I Hwangchil tree (leaf, stem) 30% ethanol extract
  • Test substance II Hwangchil tree (leaf, stem) hot water extract
  • An individual identification card that distinguishes capacity by color is attached to the breeding box, and a unique number is assigned to the breeding box.
  • test identification record was attached at the entrance to the breeding room.
  • the breeding box and water bottle were exchanged at least once a week.
  • G2-G8 hyperuricemia induced group
  • the dose of the test substance was set based on the information provided by the sponsor.
  • the dosing profile is as follows.
  • Administration route and reason for selection Oral administration and the planned clinical route were applied. Frequency and duration of administration It is administered once/day, for 7 days, and on the day on which the inducer is administered, administration was carried out 1 hour after the administration of the inducer. Calculation of dosage It was calculated as 10 mL/kg based on the recently measured body weight.
  • Administration method The animal's cervical region was fixed and administered directly into the stomach using a syringe equipped with a sonde.
  • the liver was harvested by perfusion with Saline.
  • Xanthine oxidase inhibitory activity was measured using a kit (Sigma-Aldrich, MAK078) with liver tissue and serum extracted at the time of autopsy.
  • the excipient control group (G2) is a uric acid increase statistically significant compared to the control group (G1) has been observed (P ⁇ 0.01).
  • Hwangchil tree (leaf, stem) 30% ethanol extract 50, 100, and 200 mg/kg administration group (G5-G7) showed 15.30%, 17.68%, and 21.71% reductions in serum uric acid, respectively, compared to the excipient control group (G2).
  • G8 hot water extract
  • a statistically significant 26.92% decrease in serum uric acid was observed compared to the excipient control group (G2) ( P ⁇ 0.05).
  • the probenecid 50 mg/kg administration group (G3) showed no change in serum uric acid compared to the excipient control group (G2), but the allopurinol 50 mg/kg administration group (G4) showed a statistically significant decrease in serum uric acid ( P ⁇ 0.01).
  • Urinary uric acid measurement the excipient control group (G2) is not significantly reduced urinary uric acid statistically significant compared to the control group (G1) has been observed (P ⁇ 0.05).
  • all groups (G5-G8) administered with 30% ethanol extract of Hwangchil tree (leaf, stem) and hot water extract of Hwangchil tree (leaf, stem) no statistically significant change was observed compared to the excipient control group (G2), but urine uric acid showed a decreasing trend.
  • the probenecid 50 mg/kg group (G3) showed no statistically significant difference in urine uric acid, but showed a decreasing trend, and the allopurinol 50 mg/kg group (G4) showed a statistically significant difference. urinary uric acid by a decrease was observed (P ⁇ 0.05).
  • the measurement results are shown in FIG. 2 .
  • the probenecid 50 mg/kg group (G3) showed no statistically significant change in urine uric acid compared to the excipient control group (G2), but the allopurinol 50 mg/kg group (G4) showed a statistically significant intrahepatic xanthine oxidase activity decrease was observed (P ⁇ 0.01).
  • the measurement results are shown in FIG. 3 .
  • GROUPS XANTHINE OXIDASE ACTIVITIES MALE
  • MALE GROUPS XANTHINE OXIDASE ACTIVITIES
  • G1 1.04 ⁇ 0.03 0.048 ⁇ 0.003
  • G2 0.96 ⁇ 0.02 0.046 ⁇ 0.002
  • G3 0.94 ⁇ 0.02 0.046 ⁇ 0.002
  • G4 0.35 ⁇ 0.00 ** 0.023 ⁇ 0.001 ** G5 0.99 ⁇ 0.02 0.043 ⁇ 0.001
  • G6 0.93 ⁇ 0.02 0.042 ⁇ 0.002

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Abstract

La présente invention concerne une composition comprenant un extrait de Dendropanax morbifera Lev. en tant que principe actif et, plus particulièrement, une composition médicale ou une composition alimentaire fonctionnelle ayant pour effet de prévenir, de soulager et/ou de traiter l'hyperuricémie. Selon la présente invention, une technologie pour soulager l'hyperuricémie à l'aide d'une nouvelle substance naturelle, qui surmonte les limitations des produits existants et a à la fois une activité inhibitrice de la xanthine oxydase et un effet d'excrétion d'acide urique, peut être obtenue. De plus, par conduite systématique d'une recherche scientifique moderne telle que des études sur l'efficacité pharmacologique, la séparation et la purification d'ingrédients actifs, la sécurité et la toxicité de ressources natives à la Corée, une fondation pour le développement de ressources biologiques natives de Corée en tant que marques internationales célèbres peut être établie comme dans le cas du ginseng. En outre, des applications à divers domaines industriels, tels que des matières médicinales naturelles utilisant un extrait de Dendropanax morbifera Lev. et leur utilisation en tant qu'aliment fonctionnel pour la santé peuvent être développées.
PCT/KR2020/012420 2020-02-26 2020-09-15 Composition pour soulager l'hyperuricémie comprenant un extrait de dendropanax morbifera lev. WO2021172678A1 (fr)

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