WO2018190630A1 - Composition permettant la prévention, l'amélioration ou le traitement de maladies associées au syndrome des ovaires polykystiques comprenant un extrait d'ecklonia cava en tant que principe actif - Google Patents

Composition permettant la prévention, l'amélioration ou le traitement de maladies associées au syndrome des ovaires polykystiques comprenant un extrait d'ecklonia cava en tant que principe actif Download PDF

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Publication number
WO2018190630A1
WO2018190630A1 PCT/KR2018/004237 KR2018004237W WO2018190630A1 WO 2018190630 A1 WO2018190630 A1 WO 2018190630A1 KR 2018004237 W KR2018004237 W KR 2018004237W WO 2018190630 A1 WO2018190630 A1 WO 2018190630A1
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WIPO (PCT)
Prior art keywords
polycystic ovary
ovary syndrome
ecklonia cava
extract
related diseases
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PCT/KR2018/004237
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English (en)
Korean (ko)
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이혜원
고병섭
양현
편보정
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한국 한의학 연구원
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Publication of WO2018190630A1 publication Critical patent/WO2018190630A1/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
    • A61K36/02—Algae
    • A61K36/03—Phaeophycota or phaeophyta (brown algae), e.g. Fucus
    • 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
    • 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
    • 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
    • A23V2250/00—Food ingredients
    • A23V2250/20—Natural extracts
    • A23V2250/202—Algae extracts

Definitions

  • the present invention relates to a composition for the prevention, improvement or treatment of polycystic ovary syndrome-related diseases comprising the Ecklonia cava extract as an active ingredient.
  • Polycystic ovary syndrome is an endocrine metabolism that affects 4-12% of women of childbearing age.
  • the diagnostic criteria for polycystic ovary syndrome presented by the National Institutes of Health in 1990, require both chronic ovulation and clinical or biochemical devogenic hyperglycemia.
  • the diagnostic criteria of the European / US Reproductive Endocrinology Association, revised in 2003 consisted of three types of chronic ovulation, clinical or biochemical hyperandrogenemia, and ten small follicles with a bead-shaped beads along the edge of the enlarged ovary. When two or more of the criteria are satisfied, it is defined as polycystic ovary syndrome.
  • polycystic ovary syndrome The cause of polycystic ovary syndrome is not yet clear. As with other complications, the development of polycystic ovary syndrome is believed to have both genetic and environmental factors. As the technique developed, the focus of primary pathophysiology shifted from the ovary to the hypothalamus-pituitary axis, and then to the deficiency of insulin action. Although studies on the association between various genetic factors and polycystic ovary syndrome have been reported, there is no clinically applicable genetic test.
  • Symptoms of polycystic ovary syndrome include (1) oligomenorrhea or amenorrhea, (2) hyperandrogenism and / or hyperandrogenemia, and (3) morphological polycystic ovary morphology. )to be.
  • oligomenorrhea or amenorrhea oligomenorrhea or amenorrhea
  • hyperandrogenism and / or hyperandrogenemia oligomenorrhea or amenorrhea
  • hyperandrogenism and / or hyperandrogenemia morphological polycystic ovary morphology.
  • premature ovarian failure occurs when ovarian function does not function normally and is classified as ovulatory cycle insufficiency, luteal insufficiency, or ovulation cycle insufficiency. do.
  • Ovulation cycles are also physiological in puberty and menopause, but infertile in mature women.
  • Progesterone insufficiency causes degeneration of the corpus luteum function quickly, causing infertility and miscarriage.
  • Ovulation cycle negativity is thought to be due to an abnormality of the follicle length because it is more than just the length of the cycle.
  • ovarian insufficiency can basically appear as a menopausal symptom when the age comes to menopause, but abnormally under 40 years of age, such symptoms may cause difficulty in pregnancy. The worsening of symptoms in these conditions leads to premature menopause.
  • menopause begins with menopause and postmenopausal women are at risk for many diseases due to hormonal imbalances, calcium deficiency and increased oxidative stress in the body.
  • diseases such as coronary artery disease, osteoporosis, Alzheimer's disease increases rapidly due to estrogen change in menopause, and in particular, the decrease in estrogen after menopause causes rapid bone loss.
  • Ecklonia cava is a seaweed belonging to the seaweed family and lives in the southern coastal area including South Korea's East Sea and Jeju Island.
  • Ecklonia pollen contains a lot of phlorotannin called polyphenol.
  • the Ecklonia cava containing a large amount of a strong antioxidant active material such as phlorotannin is attracting attention as a new functional material.
  • Ecklonia pollen contains antioxidants such as alpha-tocopherol. Studies on the bioactive components of Ecklonia cava and their use are underway.
  • Kim Jin-ah and Lee Jong-mi describe the antioxidant activity and whitening effect of Ecklonia phlorotannin in a research paper (Kim et al., Food Sci. Biotechnol. 2004. Vol 13, pages 476-480). Journal of the Korean Home Economics Association, 2004. Vol. 42. No. 5, pages 193-203), has also been reported on the antioxidant effect by heat treatment or extraction method.
  • the present invention is derived by the above requirements, the present invention provides a composition for the prevention, improvement or treatment of polycystic ovary syndrome-related diseases comprising the Ecklonia cava extract as an active ingredient, Ecklonia cava extract is an active ingredient of the present invention It has a regulating activity of androgen DHEA (Dehydroepiandrosterone), decreases blood luteinizing hormone / follicle stimulating hormone ratio, increases blood follicular stimulating hormone, testosterone and ovarian follicle The present invention was completed by confirming that there was an effect of reducing the number of follicular cysts.
  • Ecklonia cava extract is an active ingredient of the present invention
  • the present invention is Ecklonia cava ) provides a pharmaceutical composition for the prevention or treatment of polycystic ovary syndrome-related diseases comprising the extract as an active ingredient.
  • the present invention is Ecklonia cava ) Provides a health functional food composition for preventing or improving diseases related to polycystic ovary syndrome (polycystic ovary syndrome) comprising the extract as an active ingredient.
  • the present invention relates to a composition for the prevention, improvement or treatment of polycystic ovary syndrome-related diseases comprising the Ecklonia cava extract as an active ingredient.
  • Ecklonia cava extract the active ingredient of the present invention, has a regulating activity of androgen DHEA (Dehydroepiandrosterone), reduces blood luteinizing hormone / follicle stimulating hormone ratio, increases blood follicular stimulating hormone, and testosterone in blood
  • related drugs such as cystic ovarian syndrome, amenorrhea, hypermenorrhea, dysfunctional uterine bleeding, early menopause, infertility, ovarian failure and endometriosis It can be widely used in the functional food industry.
  • Con is a control group, cells without any treatment
  • FOR is a cell group treated with 10 ⁇ M of Forskolin to induce excessive secretion of androgens
  • MET is a positive control cell treated with 1 mM metformin.
  • PIO is a positive control cell treated with 10 ⁇ M pioglitazone.
  • Figure 2 is the result of confirming the expression level of the protein involved in the production of androgen DHEA (Dehydroepiandrosterone) using the human adrenal cell line (H295R) of the Ecklonia cava extract of the present invention by Western blot.
  • androgen DHEA Dehydroepiandrosterone
  • H295R human adrenal cell line
  • Figure 3 is to administer the Ecklonia cava extract according to the present invention in a PCOS animal model, confirming the effect of reducing the luteinizing hormone / follicle stimulating hormone ratio in the blood.
  • CON is a negative control group
  • PCOS is a PCOS group that abnormally increased the luteinizing hormone / follicle stimulating hormone ratio by administering letrozole
  • PCOS + EC500 is a group receiving letrozole and Ecklonia cava extract PCOS + positive was administered with 1 mg / kg / BW letrozole and 0.1 mg / kg / BW sustained release formulation for 2 weeks in the first half of the total experimental period of 4 weeks, and letrozole for the second 2 weeks.
  • the natural recovery group is a positive control group.
  • * Indicates a statistically significant increase in blood luteinizing hormone / follicular stimulating hormone ratio in the group of letrozole compared to CON, p ⁇ 0.05; # Shows that the ratio of luteinizing hormone / follicle stimulating hormone in blood was significantly decreased in the group treated with letrozole and Ecklonia cava extract, or the natural recovery group after letrozole treatment. , # Is p ⁇ 0.05.
  • Figure 4 is administered to the PCOS animal model of the Ecklonia cava extract according to the present invention, confirming the increase of follicular stimulating hormone (follicular stimulating hormone).
  • CON is a negative control group, normal group
  • PCOS is a PCOS group that abnormally reduced follicular stimulating hormone by administering letrozole
  • PCOS + EC500 is a group of letrozole and Ecklonia cava extract
  • PCOS + positive was administered with 1 mg / kg / BW letrozole and 0.1 mg / kg / BW sustained release formulation for 2 weeks in the first half of the total experimental period of 4 weeks, and letrozole for the second 2 weeks.
  • the natural recovery group, except for the administration of) is a positive control group.
  • Figure 5 is to administer the Ecklonia cava extract according to the present invention in a PCOS animal model, confirming the testosterone (testosterone) reduction effect.
  • CON is the negative control group, normal group
  • PCOS is the PCOS group that abnormally increased testosterone by administering letrozole
  • PCOS + EC500 is the administration group of letrozole and Ecklonia cava extract
  • PCOS + positive was administered with 1 mg / kg / BW letrozole and 0.1 mg / kg / BW sustained release formulation for two weeks in the first two weeks of the total experimental period, and for the second two weeks of letrozole. It is a positive control group, except for the natural recovery group.
  • the present invention is Ecklonia cava ) relates to a pharmaceutical composition for the prevention or treatment of polycystic ovary syndrome-related diseases comprising the extract as an active ingredient.
  • the Ecklonia cava extract may be prepared by a method comprising the following steps, but is not limited thereto:
  • step (3) concentrating and drying the filtered extract of step (2) to produce an extract.
  • the extraction solvent in step (1) is preferably selected from water, C 1 ⁇ C 4 lower alcohol or a mixture thereof, more preferably water, but is not limited thereto.
  • the extraction method may use all conventional methods known in the art, such as filtration, hot water extraction, immersion extraction, reflux cooling extraction and ultrasonic extraction.
  • the extraction solvent is preferably extracted by adding 1 to 20 times the weight of the dried Ecklonia cava, more preferably 5 to 15 times, and even more preferably 10 times.
  • Extraction temperature is preferably 60 ⁇ 100 °C but is not limited thereto.
  • the extraction time is preferably 1 to 48 hours, more preferably 1 to 24 hours, most preferably 3 hours is not limited thereto.
  • the concentration in step (3) is preferably, but not limited to, using a vacuum rotary concentrator or a vacuum rotary evaporator.
  • drying is preferably carried out under reduced pressure drying, vacuum drying, boiling drying, spray drying or lyophilization, more preferably freeze drying but not limited thereto.
  • the polycystic ovary syndrome is characterized by ovarian failure, and the polycystic ovary syndrome-related disease is preferably at least one selected from fossadrogenemia, amenorrhea, hypermenorrhea, dysfunctional uterine bleeding, premature menopause, infertility and endometriosis. It is not.
  • Ecklonia cava extract may further include a pharmaceutically acceptable carrier, excipient or diluent.
  • the pharmaceutical composition of the present invention may be administered orally or parenterally, and when parenteral administration, it is preferable to select external or intraperitoneal, rectal, intravenous, intramuscular, subcutaneous, intrauterine dural or cerebrovascular injection methods. Preferably it is used for external skin.
  • compositions of the present invention may be formulated using diluents or excipients, such as fillers, extenders, binders, wetting agents, disintegrants, surfactants and the like.
  • Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, which may comprise at least one excipient such as starch, calcium carbonate, sucrose or lactose (at least one compound). lactose) and gelatin.
  • excipient such as starch, calcium carbonate, sucrose or lactose (at least one compound). lactose) and gelatin.
  • lubricants such as magnesium stearate, talc and the like are also used.
  • Liquid preparations for oral administration include suspensions, solutions, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. have.
  • Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories.
  • non-aqueous solvent and the suspension solvent propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like can be used.
  • As the base of the suppository witepsol, macrogol, tween 61, cacao butter, laurin butter, glycero gelatin and the like can be used.
  • composition according to the invention is administered in a pharmaceutically effective amount.
  • pharmaceutically effective amount means an amount sufficient to treat a disease at a reasonable benefit / risk ratio applicable to medical treatment, and an effective dose level means the type, severity, and activity of the patient's disease. , Sensitivity to the drug, time of administration, route of administration and rate of release, duration of treatment, factors including concurrent use of the drug, and other factors well known in the medical arts.
  • the compositions of the present invention may be administered as individual therapeutic agents or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be single or multiple doses. Taking all of the above factors into consideration, it is important to administer an amount that can achieve the maximum effect with a minimum amount without side effects, which can be readily determined by one skilled in the art.
  • the dosage of the composition of the present invention can be used in a variety of ranges depending on the weight, age, sex, health, diet, time of administration, administration method, excretion rate and severity of the patient.
  • the present invention is Ecklonia cava ) relates to a health functional food composition for the prevention or improvement of polycystic ovary syndrome-related diseases comprising the extract as an active ingredient.
  • the polycystic ovary syndrome is characterized by ovarian failure, and the polycystic ovary syndrome-related disease is preferably at least one selected from fossadrogenemia, amenorrhea, hypermenorrhea, dysfunctional uterine bleeding, premature menopause, infertility and endometriosis. It is not.
  • Health functional food composition for the prevention or improvement of ovarian dysfunction related diseases comprising the Ecklonia cava extract as an active ingredient is prepared by any one selected from powders, granules, pills, tablets, capsules, candy, syrups and beverages, or added as a component of food Can be prepared, and can be appropriately prepared according to a conventional method.
  • Examples of foods to which the Ecklonia cava extract of the present invention may be added include dairy products including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, ice cream, various soups, beverages, Tea, drink, alcoholic beverages and vitamin complexes may be any one of the forms selected, including all the health functional foods in the conventional sense.
  • the dietary supplement includes various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectic acid and salts thereof, alkonic acid and salts thereof, organic acids, protective colloidal thickeners. , pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks, and the like. Others may contain pulp for the production of natural fruit juices and vegetable drinks. These components can be used independently or in combination.
  • the dietary supplement composition of the present invention may contain various flavors or natural carbohydrates as additional ingredients.
  • the natural carbohydrates are glucose, monosaccharides such as fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, sugar alcohols such as xylitol, sorbitol and erythritol.
  • sweetening agent natural sweetening agents such as tautin and stevia extract, synthetic sweetening agents such as saccharin and aspartame, and the like can be used.
  • the Ecklonia cava used in one embodiment of the present invention was used to purchase the Ecklonia cava collected or distributed in Jeju.
  • H295R human adrenal cell line
  • Forskolin Forskolin
  • androgen DHEA Dehydroepiandrosterone
  • 50 ⁇ g / ml of Ecklonia cava extract was treated, and 1 mM metformin (MET) and 10 ⁇ M pioglitazone (PIO) were used as positive controls.
  • MET metformin
  • PIO pioglitazone
  • mice used as experimental animals were supplied from Orient Bio, Inc. The experimental animals were used after 7 days of adaptation at the joint animal laboratory breeding facility of Chungnam National University.
  • the experimental method was deliberated by the Animal Experimental Ethics Committee of Chungnam National University.
  • the breeding and maintenance of experimental animals was carried out according to the animal care and use regulations of Chungnam National University Animal Lab.
  • Two dogs were housed in an individually ventilated cage (IVC) in a nursery that was kept constant in light and dark cycles.
  • IVC individually ventilated cage
  • Ecklonia cava extract of the present invention is characterized by changes in blood luteinizing hormone / follicle stimulating hormone ratio (LH / FSH ratio), blood follicular stimulating hormone (blood follicular stimulating hormone), blood testosterone, and ovarian follicular cyst The effect was investigated.

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Abstract

La présente invention concerne une composition destinée à la prévention, à l'amélioration ou au traitement de maladies liées au syndrome des ovaires polykystiques comprenant un extrait d'Ecklonia cava en tant que principe actif. L'extrait d'Ecklonia cava, qui est un principe actif de la présente invention, a une activité de régulation de la production de l'androgène déhydroépiandrostérone (DHEA), une activité de régulation de la production de l'androgène DHEA, un effet de réduction du rapport hormone lutéinisante/hormone de stimulation folliculaire dans le sang, un effet d'augmentation du taux de l'hormone de stimulation folliculaire dans le sang, et un effet de réduction du taux de la testostérone dans le sang et du nombre de kystes folliculaires ovariens. Par conséquent, l'extrait d'Ecklonia cava peut être utilisé efficacement pour prévenir, améliorer ou traiter une ou plusieurs maladies choisies parmi l'hyperandrogénisme, l'aménorrhée, l'hypoménorrhée, le saignement utérin dysfonctionnel, la ménopause prématurée, l'infertilité, l'insuffisance ovarienne et l'endométriose, qui sont des maladies liées au syndrome des ovaires polykystiques.
PCT/KR2018/004237 2017-04-14 2018-04-11 Composition permettant la prévention, l'amélioration ou le traitement de maladies associées au syndrome des ovaires polykystiques comprenant un extrait d'ecklonia cava en tant que principe actif WO2018190630A1 (fr)

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KR10-2017-0048334 2017-04-14
KR1020170048334A KR101907849B1 (ko) 2017-04-14 2017-04-14 감태 추출물을 유효성분으로 포함하는 다낭성 난소 증후군 관련 질환의 예방, 개선 또는 치료용 조성물

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CN113827611A (zh) * 2021-11-16 2021-12-24 复旦大学附属妇产科医院 海藻提取物gv971在制备治疗多囊卵巢综合征药物中的应用

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KR102159128B1 (ko) 2018-12-07 2020-09-23 동신대학교산학협력단 감태와 피조개 혼합 추출물을 포함하는 조성물

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KR20160094830A (ko) * 2015-01-30 2016-08-10 안용석 감태 발효 추출물을 유효성분으로 함유하는 혈전증 예방 또는 치료용 약학적 조성물 및 건강 기능 식품

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113827611A (zh) * 2021-11-16 2021-12-24 复旦大学附属妇产科医院 海藻提取物gv971在制备治疗多囊卵巢综合征药物中的应用

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