WO2016124080A1 - 20(r)-ginsenoside rg3 destiné à la préparation d'un médicament pour la prévention et/ou le traitement de l'obésité ou ses applications et médicament associé - Google Patents

20(r)-ginsenoside rg3 destiné à la préparation d'un médicament pour la prévention et/ou le traitement de l'obésité ou ses applications et médicament associé Download PDF

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Publication number
WO2016124080A1
WO2016124080A1 PCT/CN2016/071569 CN2016071569W WO2016124080A1 WO 2016124080 A1 WO2016124080 A1 WO 2016124080A1 CN 2016071569 W CN2016071569 W CN 2016071569W WO 2016124080 A1 WO2016124080 A1 WO 2016124080A1
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Prior art keywords
extract
ginsenoside
drug
obesity
preventing
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English (en)
Chinese (zh)
Inventor
富力
惠敏
王凯乾
刘正贤
鲁明明
盖鑫
柳洋
鲁岐
刘国友
王硕
樊宏宇
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • 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)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708—Rheum (rhubarb)

Definitions

  • the invention belongs to the field of medicine, relates to a medicine for treating obesity or health food, and particularly relates to the application of a traditional Chinese medicine ginseng extract component in preventing or/and treating obesity medicine or health food.
  • Obesity is commonly known as rich disease. As people's living standards continue to improve, obesity has become more and more concerned. It can be predicted that obesity will become one of the main reasons for affecting physical health in the 21st century. Obesity is the result of a combination of genetic and environmental factors that cause excessive accumulation and/or abnormal distribution of body fat and weight gain.
  • the World Health Organization believes that obesity is an epidemic in most developed and developing countries. At present, there are 1 billion people in the world who are overweight. Nearly 15% of adults in China are overweight and obese. It is roughly estimated that there are at least 200-300 million overweight people in the country, and at least 30-40 million people with obesity. The data shows that it is 70 million people.
  • Obesity not only affects posture and activity, but also causes a series of changes in physiological functions. At the same time, obesity also increases the incidence of some diseases, such as coronary artery disease, cardiac arrest, arterial hypertension, peripheral vascular disease, hyperlipidemia, diabetes, gout, pulmonary insufficiency, sleep and respiratory arrest, Osteoarthritis, cholecystitis and low-resistance infection, cholelithiasis, chronic venous stasis ulcer, gastroesophageal reflux, sexual dysfunction caused by dysmenorrhea, hirsutism, infertility and urgency, frequent urination.
  • diseases such as coronary artery disease, cardiac arrest, arterial hypertension, peripheral vascular disease, hyperlipidemia, diabetes, gout, pulmonary insufficiency, sleep and respiratory arrest, Osteoarthritis, cholecystitis and low-resistance infection, cholelithiasis, chronic venous stasis ulcer, gastroes
  • Obesity patients have excessive accumulation of liver fat, increased fatty acid synthesis in the liver, oxidative disorders, reduced decomposition, and reduced output, all of which can cause accumulation of various forms of fatty acids, mainly triglycerides in the liver.
  • the oxidation products of these fatty acids and fatty acids can destroy the hepatocyte biofilm, resulting in cytotoxicity.
  • BMI Body mass index
  • Excessive BMI is a major risk factor for the onset of type 2 diabetes. As the BMI increases, the likelihood of developing diabetes increases exponentially. Excluding age, the risk of diabetes in women with BMI greater than 35 increased by 93-fold and 42-fold, respectively, compared with those of the same sex with a BMI of less than 21. In addition, it is worth noting that the distribution of adipose tissue is also an important risk factor for the onset of diabetes. Even if the BMI is controlled within the normal range, if the waist circumference is greater than 102 cm, the risk of diabetes will increase by 3.5 times.
  • the general obesity has no obvious clinical manifestations, and for a few extremely obese people can cause ventilatory function disorders, which can Decreased arterial oxygen saturation and increased carbon dioxide saturation, as well as apnea, etc., eventually lead to persistent hypoxia and hypercapnia.
  • obesity can also cause a series of psychological and social adaptation problems, such as inferiority, forgetfulness, mental retardation, and decreased social adaptability.
  • the treatment of obesity mainly includes diet behavior therapy, exercise therapy, drug therapy and surgery.
  • diet behavior therapy For most obese patients, reducing heat intake and increasing physical activity is not enough. It is often stopped after losing weight, and the weight rises rapidly, even exceeding the weight before weight loss.
  • Select surgery usually vertical ligature stomach
  • Angioplasty and gastric bypass surgery are also considered too risky to accept.
  • Early application of drug treatment can prevent the occurrence of complications and enhance patient confidence.
  • individual treatment options should be selected according to different situations, and at the same time, weight-loss drugs must be adhered to on the basis of controlling diet and exercise.
  • fenfluramine Fenfluramine
  • sibutramine fenfluramine
  • the drug has been banned by the FDA in 1997.
  • Sibutramine is also very limited in its application due to adverse reactions such as dry mouth, headache, palpitations, and elevated blood pressure.
  • lipid absorption inhibitors such as Orlistat
  • Orlistat reduce the absorption of lipids in the intestine by inhibiting the intestinal lipase.
  • Long-term use can cause the lack of fat-soluble vitamins in the body, and Colon cancer is dangerous, and American consumer organizations are asking Orlistat to withdraw from the market.
  • ginseng saponin As a main active ingredient of ginseng, ginseng saponin is widely used and used as ginseng. Among them, 20(R)-ginsenoside Rg3 is the most attractive ingredient. It is the main active ingredient of ginseng and has good safety.
  • the anti-tumor oral preparation is prepared for clinical use and is intensively studied as an injection.
  • the inventors used advanced separation and purification technology to extract 20(R)-ginsenoside Rg3, an active ingredient for treating obesity, from ginseng herbs, and can provide a highly effective and low-toxic drug for obesity patients.
  • the primary object of the present invention is to provide a new application of 20(R)-ginsenoside Rg3 for preventing or/and treating obesity diseases, and to provide 20(R)-ginsenoside Rg3, in view of the technical problems existing in the treatment and treatment of obesity.
  • Therapeutic properties and efficacy of obesity a new application in the treatment, conditioning and alleviation of obesity disorders or health foods.
  • an aspect of the present invention provides an application of 20(R)-ginsenoside Rg3 in the preparation of a medicament or a health care product for preventing or/and treating obesity.
  • the drug consists of 20(R)-ginsenoside Rg3 and a pharmaceutically acceptable carrier.
  • the 20(R)-ginsenoside Rg3 content is ⁇ 1%, preferably ⁇ 30%, further preferably ⁇ 60%, still more preferably ⁇ 80%, still more preferably ⁇ 98%.
  • the 20(R)-ginsenoside Rg3 content is from 1% to 98%; preferably from 30% to 80%, more preferably 60%.
  • pharmaceutically acceptable carriers are generally approved by health care professionals for this purpose and as inactive ingredients of the agent.
  • a compilation of pharmaceutically acceptable carriers can be found in the Handbook of Pharmaceutical excipients, 2nd edition, edited by A. Wade and P. J. Weller. Edited by the American Pharmaceutical Association, Washington and The Pharmaceutical Press, London, 1994).
  • the carrier comprises an excipient such as starch, water or the like; a lubricant such as magnesium stearate or the like; a disintegrating agent such as microcrystalline cellulose; a filler such as lactose; and a binder, Such as pregelatinized starch, dextrin, etc.; sweeteners; antioxidants; preservatives, flavoring agents, spices, etc.;
  • the medicament is in the form of a tablet, a capsule, a pill, a powder, a granule, a syrup, a solution, an emulsion, an injection, a spray, an aerosol, a gel, a cream, a cataplasm, a rubber plaster. Or in the form of a plaster.
  • the 20(R)-ginsenoside Rg3 content is ⁇ 1%, preferably ⁇ 30%, further preferably ⁇ 60%, still more preferably ⁇ 80%, still more preferably ⁇ 98%.
  • Another aspect of the present invention provides a medicament or health care product comprising 20(R)-ginsenoside Rg3 for preventing or/and treating an obesity disease.
  • the 20(R)-ginsenoside Rg3 content is ⁇ 1%, preferably ⁇ 30%, further preferably ⁇ 60%, still more preferably ⁇ 80%, still more preferably ⁇ 98%.
  • the 20(R)-ginsenoside Rg3 content is ⁇ 1%, preferably 1% to 98%; preferably 30% to 80%, and still more preferably 60%.
  • the ratio of the weight of the 20(R)-ginsenoside Rg3 to the total weight of the drug or health care product is from 0.01 to 10:100, preferably from 0.1 to 10:100, further preferably from 1 to 10:100. .
  • the medicine or health care product further includes raw rhubarb extract, glutinous rice extract, Polygonum cuspidatum extract, Atractylodes lancea extract, Alisma orientalis extract, Cassia extract, Senna leaf extract, Coix seed extract One or more of the substance, the raw hawthorn extract, the Ligustrum lucidum extract, the hawthorn extract, the hazelnut extract, the chrysanthemum extract soy protein powder, and the soybean phospholipid.
  • the medicament can be prepared into various dosage forms by methods well known in the art, such as tablets, capsules, pills, powders, granules, syrups, solutions, emulsions, injections, sprays, aerosols, gels. , cream, cataplasm, rubber plaster or plaster.
  • the present invention also provides a method of treating an obesity disease comprising administering to a subject a therapeutically effective amount of a pharmaceutical composition of 20(R)-ginsenoside Rg3, the therapeutically effective amount of which is 0.06 to 12 mg/kg.d, It is preferably 1 to 6 mg/kg.d, and more preferably 1.5 to 3 mg/kg.d.
  • terapéuticaally effective amount as used herein, unless otherwise indicated, is intended to mean a medicament which is required to produce an effective effect. "Therapeutically effective amount” is adjustable and variable, and is ultimately determined by the medical staff. The factors considered include the route of administration and the nature of the formulation, the recipient's weight, age, etc., and the nature of the disease being treated and severity.
  • the present invention has the following distinct advantages:
  • the present invention excavates a new medicinal value for the known compound 20(R)-ginsenoside Rg3, which is used for alleviating and treating obesity, and can be prepared into a medicament for preventing or/and treating obesity or Health foods have opened up a new field for the application of ginseng herbs.
  • the 20(R)-ginsenoside Rg3 of the invention has strong pharmacological action, has remarkable effects for preventing, regulating and treating obesity, has quick effect, small toxic and side effects, good safety, can be taken for a long time, and has good medicinal use. prospect.
  • the raw materials of the invention have rich sources, low cost, safe clinical use, simple preparation process, can be made into various dosage forms, and have small dosage and convenient use, so it is easy to promote.
  • the present invention can prepare a medicament for preventing and treating obesity by using a single component of 20(R)-ginsenoside Rg3 active ingredient, and can also use 20(R)-ginsenoside Rg3 and other active ingredients (for example, Rhubarb extract, glutinous rice extract, Polygonum cuspidatum extract, Atractylodes lancea extract, Alisma orientalis extract, Cassia extract, Senna leaf extract, Coix seed extract, Raw hawthorn extract, Ligustrum lucidum extract,
  • a compound medicine for treating obesity is prepared by co-preparing a combination of hawthorn extract, hazelnut extract, chrysanthemum extract soy protein powder, and soybean phospholipid.
  • Rg3 tablets were prepared according to the following ratios:
  • ginsenoside Rg3 and starch were uniformly mixed, granules were prepared, and talc powder and magnesium stearate were added and uniformly mixed, and then pressed into 10,000 tablets.
  • Rg3 granules were prepared according to the following ratio:
  • Ginsenoside Rg3 (content 63%) 200g
  • the ginsenoside Rg3 and the microcrystalline cellulose were uniformly mixed, and then granulated into bags to prepare 10,000 bags.
  • Rg3 capsules were prepared according to the following ratios:
  • Ginsenoside Rg3 (content 98%) 10g
  • the ginsenoside Rg3 and the starch were uniformly mixed and then encapsulated to prepare 10,000 tablets.
  • Rg3 tablets were prepared according to the following ratios:
  • the ginsenoside Rg3, the rhubarb extract, the raw hawthorn extract and the starch were uniformly mixed and granulated, and talc powder and magnesium stearate were added and mixed, and then pressed into 10,000 tablets.
  • Rg3 capsules were prepared according to the following ratios:
  • Ginsenoside Rg3 (content 63%) 30g
  • the ginsenoside Rg3, the Atractylodes macrocephala extract and the starch were uniformly mixed and then encapsulated to prepare 10,000 tablets.
  • Rg3 granules were prepared according to the following ratio:
  • the ginsenoside Rg3, the hazelnut extract, the scorpion scorpion extract, the soybean phospholipid and the soy protein powder were mixed and granulated, and then bagged to prepare 10,000 bags.
  • Ginsenoside Rg3 (content >98%), Dalian Fusheng Natural Medicine Development Co., Ltd., batch number: 20120303; ginsenoside Rg3 standard provided by China National Institute for the Control of Pharmaceutical and Biological Products, and HPLC calibration, the content is 98.2%;
  • Wistar rats weighing 200 ⁇ 20g, both male and female, were purchased from the Experimental Animal Center of Dalian Medical University, and the quality certificate number was SCXK(13)2002-0002.
  • the common feed was purchased from the Experimental Animal Center of Dalian Medical University. The common feeds were as follows: flour 19% corn flour 23% sorghum flour 6% bran 10% soybean meal 15% vegetable oil 2% cod liver oil 1% fish meal 10% bone meal 1% beer yeast 1% salt 1% starch 6.6% glycine 3.4% methionine 0.5% calcium carbonate 0.5%.
  • High-fat and high-salt feed such as: ordinary feed 100g, cooked lard 10g, whole milk powder 10g, 1 egg, 10 drops of cod liver oil, fresh soybean sprouts 250g, salt 2.5%.
  • the fresh soybean sprouts are dried, crushed and mixed with the common feed in proportion.
  • the mixed feed is weighed daily and added to the eggs, milk powder, cod liver oil, salt and water to mix and knead the strips for use.
  • the rats were weighed and randomly divided into 6 groups, 10 in each group, which were blank control group, model control group, positive drug control group, ginsenoside Rg3 high, medium and low dose groups.
  • the blank control group was given pure water by intragastric administration at 0.lml/10g after the start of the experiment; the model control group was given the same volume of purified water by intragastric administration of 0.1 ml/g; the positive drug control group was given orlistat 10 mg/kg by gavage.
  • Ginsenoside Rg3 was administered intragastrically at a high, medium and low dose group of ginsenoside Rg3 at 6 mg/kg, 3 mg/kg, 1.5 mg/kg, once a day.
  • Table 1 shows the effect of 20(R)-ginsenoside Rg3 on the growth state of rats. The results of measuring body weight, body length and Lee index of rats are shown in Table 1.
  • the Lee index of the rats in the dose group and the Lee index in the model group were different (P ⁇ 0.05), suggesting that the high, medium and low doses of 20(R)-ginsenoside Rg3 can significantly reduce the body weight of the rats, reduce the Lee index, and have weight loss.
  • Role because there is no difference in body length of each group, suggesting that 20(R)-ginsenoside Rg3 does not affect the growth of animals.

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

Abstract

L'invention concerne un 20(R)-ginsenoside Rg3 destiné à la préparation d'un médicament pour la prévention et/ou le traitement de l'obésité ou ses applications et un médicament associé. Selon les études menées, le 20(R)-ginsenoside Rg3 s'est avéré efficace dans le traitement de l'obésité avec peu d'effets secondaires, un seul principe actif ou la combinaison de plusieurs principes actifs pouvant servir à sa préparation.
PCT/CN2016/071569 2015-02-06 2016-01-21 20(r)-ginsenoside rg3 destiné à la préparation d'un médicament pour la prévention et/ou le traitement de l'obésité ou ses applications et médicament associé Ceased WO2016124080A1 (fr)

Applications Claiming Priority (2)

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CN201510065281.3A CN105982905A (zh) 2015-02-06 2015-02-06 20(R)-人参皂苷Rg3在制备预防或/和治疗肥胖症药物中的应用及药物
CN201510065281.3 2015-02-06

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WO2016124080A1 true WO2016124080A1 (fr) 2016-08-11

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CN108704060A (zh) * 2018-09-03 2018-10-26 杭州市红十字会医院 一种通便消脂的中药组合物及其制备方法
CN111840351A (zh) * 2019-04-29 2020-10-30 成都中医药大学 一种治疗慢性萎缩性胃炎的药物及其制备方法
CN112023000A (zh) * 2020-09-25 2020-12-04 陕西中医药大学 一种轻身丸

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