WO2020122373A1 - Composition comprising glycyrrhiza uralensis extract as active ingredient for prevention, alleviation, or treatment of late-onset hypogonadism syndrome - Google Patents

Composition comprising glycyrrhiza uralensis extract as active ingredient for prevention, alleviation, or treatment of late-onset hypogonadism syndrome Download PDF

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WO2020122373A1
WO2020122373A1 PCT/KR2019/012112 KR2019012112W WO2020122373A1 WO 2020122373 A1 WO2020122373 A1 WO 2020122373A1 KR 2019012112 W KR2019012112 W KR 2019012112W WO 2020122373 A1 WO2020122373 A1 WO 2020122373A1
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extract
sam
active ingredient
prevention
composition
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PCT/KR2019/012112
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French (fr)
Korean (ko)
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고병섭
정동호
양현
김혜진
황주태
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한국 한의학 연구원
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • 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
    • A23V2200/302—Foods, ingredients or supplements having a functional effect on health having a modulating effect on age
    • 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
    • A23V2250/21—Plant extracts
    • 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
    • A23V2300/00—Processes
    • A23V2300/14—Extraction

Definitions

  • the present invention is Glycyrrhiza uralensis ) It relates to a composition for the prevention, improvement or treatment of menopausal syndrome, comprising an extract as an active ingredient.
  • menopause Normally, the term menopause was used only for women, but the concept of male menopausal syndrome has emerged due to changes in endocrine due to the gradual decrease in testosterone production in men.
  • Menopausal menopause decreases muscle mass and muscle strength, decreases body mass index, decreases hair loss and changes skin, intellectual activity, spatial perception ability, tiredness, decreases sexual desire and erections, especially mood changes accompanied by decreased erection during sleep, deterioration and instability , Bone density, visceral fat increase, etc.
  • Korean Patent Publication No. 2017-0045548 discloses a pharmaceutical composition for preventing and treating menopausal symptoms containing a mixture of turmeric and licorice extract as an active ingredient, and in Chinese Patent Publication No. 107050391.
  • the pharmaceutical composition of the menopausal syndrome is disclosed, the composition for preventing, improving or treating menopausal syndrome comprising the extract of the apricot extract of the present invention as an active ingredient has not been disclosed.
  • the present invention has been derived by the above-described needs, the present invention provides a composition for the prevention, improvement or treatment of menopausal syndrome, which includes the extract of the self-primerium as an active ingredient, and the extract of the self-cleaning liquor is the content of testosterone , Not only can increase muscle strength, increase sperm count and sperm motility, but also decrease the aromatase activity of the aromatase activity statistically significantly compared to the licorice extract, testosterone/SHBG (sex hormone) The present invention was completed by confirming that the binding globulin) binding rate was also statistically significantly reduced.
  • the present invention provides a health functional food composition for the prevention or improvement of menopausal syndrome, which contains the extract of the licorice root as an active ingredient.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of menopausal syndrome, which contains the extract of narcissus as an active ingredient.
  • the present invention relates to a composition for the prevention, amelioration, or treatment of menopausal syndrome, comprising the extract of Jagamcho as an active ingredient.
  • Jagamcho extract an active ingredient of the present invention, increases the content of testosterone, increases muscle strength, improves sperm count and sperm motility, reduces aromatase activity, and testosterone/SHBG (sex hormone binding globulin) It has the effect of reducing the binding rate. Therefore, the composition of the present invention can be used as a health functional food or medicine for prevention, improvement or treatment of menopausal syndrome.
  • SAM-R1-Young is a 6-week-old young SAM mouse
  • SAM-R1-Vehicle is a 4-month-old SAM mouse that has undergone natural aging
  • SAM-P8-Negative is a 4-month-old SAM mouse that promotes aging
  • SAM- P8-Testostrone is a positive control and is a 4 month old SAM mouse that is orally administered testosterone propionate for 2 months to a 4 month old SAM mouse whose aging is accelerated
  • SAM-P8-JGC 150mg/kg
  • SAM-P8-JGC 400mg/kg is a 400-month-old SAM mouse that promotes aging. This is a 4-month-old SAM mouse that was orally administered with the extract of /kg Jagamcho for 2 months .
  • SAM-P8-JGC 400mg/kg
  • SAM-P8-JGC 400mg/kg
  • SAM-P8-JGC 400mg/kg
  • SAM-P8-JGC 400mg/kg
  • Figure 2 is a result confirming the motility (muscle) of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered.
  • a is SAM-R1-Young compared to SAM-R1-Vehicle, SAM-P8-Negative, SAM-P8-Testostrone, SAM-P8-JGC(150mg/kg), SAM-P8-JGC(400mg/kg)
  • the time required to fall into the state was statistically significantly reduced, p ⁇ 0.05
  • b is compared to SAM-P8-Negative, SAM-P8-Testostrone, SAM-P8-JGC (150mg/kg), SAM-P8- JGC (400mg/kg) was found to have a statistically significant increase in the time taken to fall into the motility guidelines, p ⁇ 0.05.
  • Figure 3 is a result of confirming the sperm count of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered. ** is a statistically significant decrease in the number of sperm of SAM-P8-Negative compared to SAM-R1-Vehicle, p ⁇ 0.01, and #, ### are SAM-P8-Testostrone compared to SAM-P8-Negative The number of sperm of SAM-P8-JGC (400mg/kg) was statistically significantly increased. # is p ⁇ 0.05 and ### is p ⁇ 0.001.
  • Figure 4 is a result confirming the motility sperm ratio of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered.
  • *** is a statistically significant decrease in sperm motility of SAM-P8-Negative compared to SAM-R1-Vehicle, p ⁇ 0.001, and #, ### are SAM-P8- compared to SAM-P8-Negative Sperm motility of Testostrone, SAM-P8-JGC (150mg/kg) or SAM-P8-JGC (400mg/kg) was statistically significantly increased, # is p ⁇ 0.05, ### is p ⁇ 0.001 to be.
  • GC(H) is a licorice water extract treatment group
  • GC(E) is a licorice 70% ethanol extract treatment group
  • JGC(H) is a liquorice water extract treatment group
  • JGC( E) is a group treated with 70% ethanol extract of Jagamcho *** is a statistically significant decrease in the aromatase activity of the licorice or self-dried licorice extract treated group compared to the control group, p ⁇ 0.001, and ### is the licorice extract treated group of the present invention compared to the licorice extract treated group This statistically significant decrease in aromatase activity was statistically significant, p ⁇ 0.001.
  • T-SHBG Sex hormone binding globulin binding rate (%) of the licorice extract and the extract of the licorice extract of the present invention.
  • Con is a control group not treated with anything
  • GC(H) is a licorice water extract treatment group
  • GC(E) is a licorice 70% ethanol extract treatment group
  • JGC(H) is a liquorice water extract treatment group
  • JGC( E) is a group treated with 70% ethanol extract of Jagamcho **
  • *** is that the T-SHBG was statistically significantly reduced in the group treated with the extract of the licorice extract of the present invention compared to the licorice extract-treated group
  • ** is p ⁇ 0.01
  • *** is p ⁇ 0.001.
  • the present invention relates to a health functional food composition for the prevention or improvement of menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
  • the menopausal syndrome is preferably, but not limited to, a decrease in testosterone hormone, a decrease in muscle strength or a decrease in sperm count and motility.
  • the extract of the liquorice can be prepared by a method including the following steps, but is not limited to this:
  • step (3) Concentrating and drying the filtered extract of step (2) to prepare an extract.
  • the licorice is roasted with licorice, preferably, the licorice is picked and cut into thin slices, then sprayed with water and baked on the fire until the liquorice becomes a yellowish violet when the surface is sufficiently wet with water.
  • the liquorice becomes a yellowish violet when the surface is sufficiently wet with water.
  • the extraction solvent is preferably selected from water, a lower alcohol of C 1 to C 4 or a mixture thereof, more preferably ethanol, even more preferably 70% (v/v) ethanol, It is not limited to this.
  • any conventional methods known in the art such as filtration, hot water extraction, immersion extraction, reflux cooling extraction, and ultrasonic extraction, may be used as the extraction method.
  • the extraction solvent is preferably extracted by adding 1 to 20 times the weight of dried citrus, more preferably 5 to 15 times, and even more preferably 10 times.
  • the extraction temperature is preferably 20 to 80°C, but is not limited thereto.
  • the extraction time is preferably 10 to 100 hours, but is not limited thereto.
  • the concentration of step (3) is preferably, but not limited to, a vacuum rotary concentrator or a vacuum rotary evaporator.
  • the drying is preferably dried under reduced pressure, vacuum drying, boiling drying, spray drying or freeze drying, and more preferably freeze drying or not.
  • the health functional food composition for preventing or improving menopausal syndrome comprising the extract of the extract of citrus as an active ingredient, is one selected from pills, tablets, capsules, powders, powders, granules, candy, syrup and beverages. It can be prepared by adding it as an ingredient of food, or it can be appropriately prepared according to a conventional method.
  • Examples of foods to which the extract of persimmon vinegar of the present invention can be added are meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other dairy products including noodle, gum, ice cream, various soups, beverages , Tea, drink, alcoholic beverages and vitamin complexes, and may include any form of health functional food in the usual 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, alginic acid and salts thereof, organic acids, protective colloidal thickeners, It may contain a pH adjusting agent, stabilizer, preservative, glycerin, alcohol, carbonic acid used in carbonated beverages, and the like. In addition, it may contain flesh for the preparation of natural fruit juices and vegetable drinks. These ingredients can be used independently or in combination.
  • the health functional food composition of the present invention may contain various flavoring agents or natural carbohydrates as additional components.
  • the natural carbohydrates are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol and erythritol.
  • sweetener natural sweeteners such as taumatin and stevia extract, and synthetic sweeteners such as saccharin and aspartame can be used.
  • the present invention relates to a pharmaceutical composition for the prevention or treatment of menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
  • the extract of the liquorice 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 parenterally administered, it is preferable to select an injection method for external use of the skin or intraperitoneal, rectal, intravenous, intramuscular, subcutaneous, intrauterine epidural or cerebrovascular.
  • the pharmaceutical composition of the present invention may be prepared using diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, and the like.
  • Solid preparations for oral administration include tablets, pills, powders, granules, capsules, etc.These solid preparations contain at least one excipient in one or more compounds, such as starch, calcium carbonate, sucrose or lactose ( lactose) and gelatin.
  • lubricants such as magnesium stearate, talc and the like are used in addition to simple excipients.
  • Liquid preparations for oral administration include suspending agents, intravenous solutions, emulsions, syrups, etc.
  • Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories.
  • non-aqueous solvents and suspension solvents propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate may be used.
  • injectable esters such as ethyl oleate
  • a base for suppositories witepsol, macrogol, Tween 61, cacao butter, laurin, glycero gelatin, etc. may be used.
  • composition according to the invention is administered in a pharmaceutically effective amount.
  • a pharmaceutically effective amount means an amount sufficient to treat the disease at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is the type of patient's disease, severity, and activity of the drug , Sensitivity to drug, time of administration, route of administration and rate of excretion, duration of treatment, factors including co-drugs and other factors well known in the medical field.
  • the composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with a conventional therapeutic agent, and may be administered single or multiple. Considering all of the above factors, it is important to administer an amount that can achieve the maximum effect in a minimal amount without side effects, which can be easily determined by those skilled in the art.
  • the dosage of the composition of the present invention can be used in a variety of ranges depending on the patient's weight, age, sex, health status, diet, administration time, administration method, excretion rate and disease severity.
  • Licorice was purchased from the Gyeongdong market, cut evenly, and then sprinkled with water to bake it over the fire until it turned yellow to purple, then powdered.
  • mice used as experimental animals were supplied from Central Laboratory Animal Co., Ltd. and used.
  • the experimental animals were used after being acclimatized for 7 days in the breeding facility of the Korean Institute of Oriental Medicine.
  • the experimental method was deliberated by the Animal Experimental Ethics Committee of the Korean Institute of Oriental Medicine, and the breeding and maintenance of the experimental animal was based on the animal management and use regulations of the Joint Animal Laboratory of the Korean Institute of Oriental Medicine, temperature 23 ⁇ 1°C, humidity 50 ⁇ 10%, In a breeding room kept constant at a 12-hour light and dark cycle, 4 animals were housed in individually ventilated cages (IVCs).
  • the SAM-R1 strain mouse was used as a strain control for SAM-P8, which has the property of promoting aging.
  • mice in the rest of the groups performed adaptive training for treadmill exercise for 15 minutes for 2 weeks twice a week, followed by this exercise after rest. After 2 weeks, the final measurement was increased at a speed of 10 m/min, 15 m/min, and 20 m/min at 5 minute intervals to run until exhausted. The exercise ability of each individual was evaluated by comparing the exhaustion time. The time when the guideline occurred was defined as the first time that lagging could not be followed three times, and one run was set to run more than 5 minutes continuously without falling behind in speed. This test was measured three times a week after the end of administration.
  • the control group and the experimental group were bred under each appropriate condition, anesthetized with avertin, and then the testicles of the blood-extracted test rats were extracted to the outside, and then the entire and posterior parts of the epididymis were ligated and extracted with hemostatic forceps, and then cut. Did.sperm was collected and placed on a 12-well plate containing M16+10% FBS, sperm count was counted using a Makler Counting Chamber, and motility of viable sperm was observed at 10-minute intervals for 1 hour.
  • the aromatase activity inhibition measurement was evaluated by measuring the fluorescence intensity of fluorescein, a hydrolysis product of DBF (dibenzylfluorescein) by aromatase.
  • 90 ⁇ l NADPH-regeneration buffer solution (2.6 mM NADP+, 7.6 mM glucose-6-phosphate, 0.8 unit/ml glucose-6-phosphate dehydrogenase) with 10 ⁇ L perilla and licorice water or 70% (v/v) ethanol extract
  • 100 ⁇ l enzyme and substrate mixture (DBF 2 ⁇ M, 40 pmol/ml aromatase
  • the mixture was mixed with 50 mM potassium phosphate (pH 7.4) containing 4 mg/ml albumin and reacted at 37°C for an additional 30 minutes.
  • 150 ⁇ l of 2N NaOH was added, and after react
  • Example 7 Licorice extract and of the present invention Jagamcho Extract Testosterone (T)/ SHBG (Sex hormone binding globulin) Bonding rate (%) compare
  • a 10-well plate coated with 10 ⁇ g/ml SHBG protein was treated with 10 ⁇ M testosterone and 100 ⁇ g/ml of water or 70% (v/v) ethanol extract of persimmon and licorice, respectively, and reacted for 4 hours, followed by PBS. Washed 3 times to treat 10 ⁇ g/ml testosterone-HRP bound antibody. After antibody treatment, reacted for 3 hours, and then washed 3 times with PBS to treat a 100 ⁇ l TMB (3, 3'5, 5'-Tetramethylbenzidine) solution, and after standing for 30 minutes, absorbance was measured at 450 nm. Then, the binding rate of SHBG-testosterone was calculated.
  • TMB 3, 3'5, 5'-Tetramethylbenzidine

Abstract

The present invention relates to a composition comprising a Glycyrrhiza uralensis extract as an active ingredient for prevention, alleviation, or treatment of late-onset hypogonadism syndrome. The Glycyrrhiza uralensis extract that is an active ingredient in the present invention can increase testosterone level and muscular strength and improve sperm count and sperm motility. Therefore, the composition of the present invention can be used as a health functional food or medicinal product for preventing, alleviating, or treating late-onset hypogonadism syndrome.

Description

자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물Composition for the prevention, improvement or treatment of menopausal syndrome, comprising the extract of Jagamchocho as an active ingredient
본 발명은 자감초( Glycyrrhiza uralensis) 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물에 관한 것이다.The present invention is Glycyrrhiza uralensis ) It relates to a composition for the prevention, improvement or treatment of menopausal syndrome, comprising an extract as an active ingredient.
통상 갱년기란 용어는 여성에 한정되어 사용되었으나, 남성에서도 노화에 따라 남성 호르몬 생산의 점진적 감소로 인한 내분비 변화로 남성 갱년기 증후군의 개념이 대두되고 있다.Normally, the term menopause was used only for women, but the concept of male menopausal syndrome has emerged due to changes in endocrine due to the gradual decrease in testosterone production in men.
50대 이후의 남성들에게서 갱년기 여성과 유사한 예민함, 우울감, 기억력 장애, 집중력 저하, 피로함, 불면, 안면 홍조, 근육량 및 골밀도 저하, 주기적 발한과 성적 활력의 저하 등과 같은 복합적 증상이 나타나는 것을 남성갱년기라 정의하고 있으며, 국제 남성갱년기학회 International Society for the Study of the Aging Male(ISSAM) 및 국제남성과학회 International Society of Andrology(ISA)가 공동으로 2004년 제4차 ISSAM congress에서 이들 명칭을 후기발현남성성선기능저하증(Late-onset hypogonadism, LOH)으로 통일하였다. 현재에는 LOH가 가장 광범위하게 사용되고 있지만, andropause, androgen deficiency for aging male(ADAM), partial androgen deficiency for aging male(PADAM), male climateric 등과 같은 다양한 이름으로 불리고 있다. 남성갱년기는 근육량 및 근력의 저하와 체질량 지수 감소, 체모 감소와 피부 변화, 지적 활동, 공간 지각 능력, 피곤, 성적 욕구의 감소와 발기, 특히 수면 중 발기 감소, 기분저하 및 불안정성을 동반하는 기분 변화, 골밀도 저하, 내장 지방의 증가 등과 같은 복합증후군을 나타낸다.Men who are in their 50s or older have multiple symptoms similar to menopausal women, such as hypersensitivity, depression, memory impairment, decreased concentration, fatigue, insomnia, hot flashes, decreased muscle mass and bone density, periodic sweating and decreased sexual vitality. In the 4th ISSAM congress of 2004, the International Society for the Study of the Aging Male (ISSAM) and the International Society of Andrology (ISA) jointly express these names as the late-expressing male sexual function. Unified with late-onset hypogonadism (LOH). LOH is the most widely used nowadays, but it is called by various names such as andropause, androgen deficiency for aging male (ADAM), partial androgen deficiency for aging male (PADAM), and male climateric. Menopausal menopause decreases muscle mass and muscle strength, decreases body mass index, decreases hair loss and changes skin, intellectual activity, spatial perception ability, tiredness, decreases sexual desire and erections, especially mood changes accompanied by decreased erection during sleep, deterioration and instability , Bone density, visceral fat increase, etc.
치료를 위해서는 폐경기 여성에 에스트로겐 대체 요법을 사용하는 것과 유사한 방식으로 남성 호르몬 대체 요법의 사용 가능성이 주장되고 있다. 한 연구에 따르면, 남성 갱년기 환자들을 테스토스테론 운데카노에이트를 사용하여 치료하는 경우, 상당한 개선 효과가 얻어지는 것으로 보고된 바 있다. 그러나, 남성 호르몬의 투여는 간, 지질 상태, 심혈관 및 전립선 질환 등에 역효과를 미칠 수 있다는 위험성 또한 보고되어 있다. 따라서 최근에는 이러한 약물의 치료요법에 의한 문제점을 극복하기 위하여 천연 생약을 주성분으로 하는 남성갱년기 증후군 개선제의 개발이 시도되고 있다. 하지만 아직까지는 생약재를 주성분으로 하는 종래기술은 남성갱년기 증후군의 단편적 증상인 성기능에 한정되는 경우가 많아, 성기능 개선과 더불어 근력 증가 등의 개선 효과 등 복합적 효과를 나타내는 제제에 관한 기술은 미흡한 실정이다.For treatment, the possibility of using testosterone replacement therapy in a manner similar to the use of estrogen replacement therapy in postmenopausal women is claimed. According to one study, it has been reported that treatment of male menopausal patients with testosterone undecanoate results in significant improvement. However, it has also been reported that the administration of testosterone may adversely affect liver, lipid status, cardiovascular and prostate diseases. Therefore, in recent years, in order to overcome the problems caused by the treatment of these drugs, the development of male menopausal syndrome improvement agents based on natural herbal drugs has been attempted. However, until now, the prior art based on herbal medicines is often limited to sexual function, which is a fragmentary symptom of menopausal syndrome, and there is insufficient technology for formulations that exhibit complex effects such as improvement in sexual function and improvement in muscle strength.
한편, 갱년기 관련 종래 기술로는 한국공개특허 제2017-0045548호에 울금 및 감초 추출물의 혼합물을 유효성분으로 함유하는 갱년기 증상 예방 및 치료용 약학적 조성물이 개시되어 있고, 중국공개특허 제107050391호에 남성 갱년기 증후군의 약학 조성물이 개시되어 있으나, 본 발명의 자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물에 대해서는 개시된 바 없다.On the other hand, in the prior art related to menopause, Korean Patent Publication No. 2017-0045548 discloses a pharmaceutical composition for preventing and treating menopausal symptoms containing a mixture of turmeric and licorice extract as an active ingredient, and in Chinese Patent Publication No. 107050391. Although the pharmaceutical composition of the menopausal syndrome is disclosed, the composition for preventing, improving or treating menopausal syndrome comprising the extract of the apricot extract of the present invention as an active ingredient has not been disclosed.
본 발명은 상기와 같은 요구에 의해 도출된 것으로서, 본 발명은 자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물을 제공하고, 자감초 추출물은 테스토스테론(Testosterone)의 함량을 증가시키고, 근력을 증가시키며, 정자수 및 정자의 운동성을 증진시킬 수 있을 뿐만 아니라, 감초 추출물에 비해 자감초 추출물이 아로마타아제 활성을 통계적으로 유의미하게 더 감소시키며, 테스토스테론/SHBG(sex hormone binding globulin) 결합율도 통계적으로 유의미하게 감소시키는 효과가 있다는 것을 확인함으로써, 본 발명을 완성하였다.The present invention has been derived by the above-described needs, the present invention provides a composition for the prevention, improvement or treatment of menopausal syndrome, which includes the extract of the self-primerium as an active ingredient, and the extract of the self-cleaning liquor is the content of testosterone , Not only can increase muscle strength, increase sperm count and sperm motility, but also decrease the aromatase activity of the aromatase activity statistically significantly compared to the licorice extract, testosterone/SHBG (sex hormone) The present invention was completed by confirming that the binding globulin) binding rate was also statistically significantly reduced.
상기 목적을 달성하기 위하여, 본 발명은 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물을 제공한다.In order to achieve the above object, the present invention provides a health functional food composition for the prevention or improvement of menopausal syndrome, which contains the extract of the licorice root as an active ingredient.
또한, 본 발명은 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 치료용 약학 조성물을 제공한다.In addition, the present invention provides a pharmaceutical composition for the prevention or treatment of menopausal syndrome, which contains the extract of narcissus as an active ingredient.
본 발명은 자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물에 관한 것이다. 본 발명의 유효성분인 자감초 추출물은 테스토스테론(Testosterone)의 함량을 증가시키고, 근력을 증가시키며, 정자수 및 정자의 운동성을 증진시킬 수 있을 뿐만 아니라, 아로마타아제 활성을 감소시키며, 테스토스테론/SHBG(sex hormone binding globulin) 결합율을 감소시키는 효과가 있는 것이다. 따라서 본 발명의 조성물은 남성갱년기 증후군의 예방, 개선 또는 치료용 건강기능식품 또는 의약품으로 사용할 수 있다.The present invention relates to a composition for the prevention, amelioration, or treatment of menopausal syndrome, comprising the extract of Jagamcho as an active ingredient. Jagamcho extract, an active ingredient of the present invention, increases the content of testosterone, increases muscle strength, improves sperm count and sperm motility, reduces aromatase activity, and testosterone/SHBG (sex hormone binding globulin) It has the effect of reducing the binding rate. Therefore, the composition of the present invention can be used as a health functional food or medicine for prevention, improvement or treatment of menopausal syndrome.
도 1은 본 발명의 자감초 추출물을 투여한 SAM(senescence-accelerated mouse) 동물 모델에서의 혈청 내 테스토스테론의 함량 변화를 확인한 결과이다. SAM-R1-Young은 6주령의 어린 SAM 마우스이고, SAM-R1-Vehicle은 자연 노화가 진행된 4개월령의 SAM 마우스이며, SAM-P8-Negative는 노화가 촉진되는 4개월령의 SAM 마우스이고, SAM-P8-Testostrone은 양성대조군으로 노화가 촉진되는 4개월령의 SAM 마우스에 테스토스테론(testosterone propionate)을 2개월 동안 경구 투여한 4개월령의 SAM 마우스이며, SAM-P8-JGC(150mg/kg)는 노화가 촉진되는 4개월령의 SAM 마우스에 150mg/kg의 자감초 추출물을 2개월 동안 경구 투여한 4개월령의 SAM 마우스이고, SAM-P8-JGC(400mg/kg)는 노화가 촉진되는 4개월령의 SAM 마우스에 400mg/kg의 자감초 추출물을 2개월 동안 경구 투여한 4개월령의 SAM 마우스이다 . *은 SAM-R1-Vehicle 대비 SAM-P8-Negative가 통계적으로 유의미하게 테스토스테론의 함량이 감소하였다는 것으로, p<0.05이고, ##, ###은 SAM-P8-Negative 대비 SAM-P8-테스토스테론 또는 SAM-P8-JGC(400mg/kg)가 통계적으로 유의미하게 테스토스테론의 함량이 증가하였다는 것으로, ##는 p<0.01이고, ###는 p<0.001이다.1 is a result confirming a change in the content of testosterone in serum in a SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered. SAM-R1-Young is a 6-week-old young SAM mouse, SAM-R1-Vehicle is a 4-month-old SAM mouse that has undergone natural aging, and SAM-P8-Negative is a 4-month-old SAM mouse that promotes aging, and SAM- P8-Testostrone is a positive control and is a 4 month old SAM mouse that is orally administered testosterone propionate for 2 months to a 4 month old SAM mouse whose aging is accelerated, and SAM-P8-JGC (150mg/kg) promotes aging. SAM-P8-JGC (400mg/kg) is a 400-month-old SAM mouse that promotes aging. This is a 4-month-old SAM mouse that was orally administered with the extract of /kg Jagamcho for 2 months . * Indicates that SAM-P8-Negative compared to SAM-R1-Vehicle statistically significantly reduced testosterone content, and p<0.05, and ##, ### are SAM-P8-Negative compared to SAM-P8-Negative Alternatively, SAM-P8-JGC (400mg/kg) showed a statistically significant increase in the content of testosterone, ## is p<0.01, and ### is p<0.001.
도 2는 본 발명의 자감초 추출물을 투여한 SAM(senescence-accelerated mouse) 동물 모델의 운동성(근력)을 확인한 결과이다. a는 SAM-R1-Young 대비 SAM-R1-Vehicle, SAM-P8-Negative, SAM-P8-Testostrone, SAM-P8-JGC(150mg/kg), SAM-P8-JGC(400mg/kg)의 운동성 지침상태에 빠지는데 걸리는 시간이 통계적으로 유의미하게 감소하였다는 것으로, p<0.05이고, b는 SAM-P8-Negative 대비, SAM-P8-Testostrone, SAM-P8-JGC(150mg/kg), SAM-P8-JGC(400mg/kg)의 운동성 지침상태에 빠지는데 걸리는 시간이 통계적으로 유의미하게 증가하였다는 것으로, p<0.05이다.Figure 2 is a result confirming the motility (muscle) of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered. a is SAM-R1-Young compared to SAM-R1-Vehicle, SAM-P8-Negative, SAM-P8-Testostrone, SAM-P8-JGC(150mg/kg), SAM-P8-JGC(400mg/kg) The time required to fall into the state was statistically significantly reduced, p<0.05, and b is compared to SAM-P8-Negative, SAM-P8-Testostrone, SAM-P8-JGC (150mg/kg), SAM-P8- JGC (400mg/kg) was found to have a statistically significant increase in the time taken to fall into the motility guidelines, p<0.05.
도 3은 본 발명의 자감초 추출물을 투여한 SAM(senescence-accelerated mouse) 동물 모델의 정자수를 확인한 결과이다. **는 SAM-R1-Vehicle 대비, SAM-P8-Negative의 정자수가 통계적으로 유의미하게 감소하였다는 것으로, p<0.01이고, #, ###은 SAM-P8-Negative 대비 SAM-P8-Testostrone 또는 SAM-P8-JGC(400mg/kg)의 정자수가 통계적으로 유의미하게 증가하였다는 것으로, #은 p<0.05이고, ###은 p<0.001이다. Figure 3 is a result of confirming the sperm count of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered. ** is a statistically significant decrease in the number of sperm of SAM-P8-Negative compared to SAM-R1-Vehicle, p<0.01, and #, ### are SAM-P8-Testostrone compared to SAM-P8-Negative The number of sperm of SAM-P8-JGC (400mg/kg) was statistically significantly increased. # is p<0.05 and ### is p<0.001.
도 4는 본 발명의 자감초 추출물을 투여한 SAM(senescence-accelerated mouse) 동물 모델의 운동성 정자 비율을 확인한 결과이다. ***는 SAM-R1-Vehicle 대비, SAM-P8-Negative의 정자 운동성이 통계적으로 유의미하게 감소하였다는 것으로, p<0.001이고, #, ###은 SAM-P8-Negative 대비 SAM-P8-Testostrone, SAM-P8-JGC(150mg/kg) 또는 SAM-P8-JGC(400mg/kg)의 정자 운동성이 통계적으로 유의미하게 증가하였다는 것으로, #은 p<0.05이고, ###은 p<0.001이다.Figure 4 is a result confirming the motility sperm ratio of the SAM (senescence-accelerated mouse) animal model to which the extract of the licorice root of the present invention is administered. *** is a statistically significant decrease in sperm motility of SAM-P8-Negative compared to SAM-R1-Vehicle, p<0.001, and #, ### are SAM-P8- compared to SAM-P8-Negative Sperm motility of Testostrone, SAM-P8-JGC (150mg/kg) or SAM-P8-JGC (400mg/kg) was statistically significantly increased, # is p<0.05, ### is p<0.001 to be.
도 5는 감초 추출물 및 본 발명의 자감초 추출물의 아로마타아제 저해 활성을 비교한 결과이다. Con은 아무것도 처리하지 않은 대조군이고, GC(H)는 감초 물 추출물 처리군이고, GC(E)는 감초 70% 에탄올 추출물 처리군이며, JGC(H)는 자감초 물 추출물 처리군이고, JGC(E)는 자감초 70% 에탄올 추출물 처리군이다. ***는 대조군 대비 감초 또는 자감초 추출물 처리군의 아로마타아제 활성이 통계적으로 유의미하게 감소하였다는 것으로, p<0.001이고, ###는 감초 추출물 처리군 대비 본 발명의 자감초 추출물 처리군이 통계적으로 유의미하게 아로마타아제 활성이 통계적으로 유의미하게 감소하였다는 것으로, p<0.001이다.5 is a result of comparing the aromatase inhibitory activity of the licorice extract and the extract of the licorice extract of the present invention. Con is a control group not treated with anything, GC(H) is a licorice water extract treatment group, GC(E) is a licorice 70% ethanol extract treatment group, JGC(H) is a liquorice water extract treatment group, JGC( E) is a group treated with 70% ethanol extract of Jagamcho *** is a statistically significant decrease in the aromatase activity of the licorice or self-dried licorice extract treated group compared to the control group, p<0.001, and ### is the licorice extract treated group of the present invention compared to the licorice extract treated group This statistically significant decrease in aromatase activity was statistically significant, p<0.001.
도 6은 감초 추출물 및 본 발명의 자감초 추출물의 테스토스테론(T)/SHBG(Sex hormone binding globulin) 결합율(%)을 비교한 결과이다. Con은 아무것도 처리하지 않은 대조군이고, GC(H)는 감초 물 추출물 처리군이고, GC(E)는 감초 70% 에탄올 추출물 처리군이며, JGC(H)는 자감초 물 추출물 처리군이고, JGC(E)는 자감초 70% 에탄올 추출물 처리군이다. **, ***는 감초 추출물 처리군 대비 본 발명의 자감초 추출물 처리군이 통계적으로 유의미하게 T/SHBG가 통계적으로 유의미하게 감소하였다는 것으로, **는 p<0.01이고, ***는 p<0.001이다.6 is a result of comparing the testosterone (T) / SHBG (Sex hormone binding globulin) binding rate (%) of the licorice extract and the extract of the licorice extract of the present invention. Con is a control group not treated with anything, GC(H) is a licorice water extract treatment group, GC(E) is a licorice 70% ethanol extract treatment group, JGC(H) is a liquorice water extract treatment group, JGC( E) is a group treated with 70% ethanol extract of Jagamcho **, *** is that the T-SHBG was statistically significantly reduced in the group treated with the extract of the licorice extract of the present invention compared to the licorice extract-treated group, ** is p<0.01, and *** is p<0.001.
본 발명은 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물에 관한 것이다.The present invention relates to a health functional food composition for the prevention or improvement of menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
상기 남성갱년기 증후군은 테스토스테론 호르몬의 감소, 근력저하 또는 정자 수 및 운동성의 감소를 수반하는 것이 바람직하지만 이에 한정하지 않는다. The menopausal syndrome is preferably, but not limited to, a decrease in testosterone hormone, a decrease in muscle strength or a decrease in sperm count and motility.
상기 자감초 추출물은 하기의 단계를 포함하는 방법에 의해 제조할 수 있으나, 이에 한정하지 않는다:The extract of the liquorice can be prepared by a method including the following steps, but is not limited to this:
(1) 자감초 분말에 추출용매를 가하여 추출하는 단계;(1) extracting an extract solvent by adding an extracting solvent;
(2) 단계 (1)의 추출물을 여과하는 단계; 및 (2) filtering the extract of step (1); And
(3) 단계 (2)의 여과한 추출물을 농축하고 건조하여 추출물을 제조하는 단계. (3) Concentrating and drying the filtered extract of step (2) to prepare an extract.
상기 단계 (1)의 자감초는 감초를 불에 구운 것으로, 바람직하게는 감초를 고르고 얇게 절단한 후, 물을 뿌려 표면이 물기로 충분히 젖으면 감초가 누런 보라빛이 될 때까지 불 위에서 구워 제조한 것이지만 이에 한정하지 않는다.In the step (1), the licorice is roasted with licorice, preferably, the licorice is picked and cut into thin slices, then sprayed with water and baked on the fire until the liquorice becomes a yellowish violet when the surface is sufficiently wet with water. One thing, but not limited to this.
상기 단계 (1)에서 추출용매는 물, C 1~C 4의 저급 알코올 또는 이들의 혼합물 중에서 선택하는 것이 바람직하며, 더 바람직하게는 에탄올이고, 더욱더 바람직하게는 70%(v/v) 에탄올이지만 이에 한정하지 않는다.In step (1), the extraction solvent is preferably selected from water, a lower alcohol of C 1 to C 4 or a mixture thereof, more preferably ethanol, even more preferably 70% (v/v) ethanol, It is not limited to this.
상기 제조방법에 있어서, 추출방법은 여과법, 열수 추출, 침지 추출, 환류 냉각 추출 및 초음파 추출 등의 당 업계에 공지된 모든 통상적인 방법을 이용할 수 있다. 상기 추출용매는 건조된 자감초 중량의 1~20배 첨가하여 추출하는 것이 바람직하며, 더 바람직하게는 5~15배 첨가하는 것이고, 더욱더 바람직하게는 10배 첨가하는 것이다. 추출온도는 20~80℃인 것이 바람직하나 이에 한정하지 않는다. 또한, 추출시간은 10~100시간인 것이 바람직하나, 이에 한정하지 않는다. 상기 방법에 있어서, 단계 (3)의 농축은 진공 회전 농축기 또는 진공회전증발기를 이용하는 것이 바람직하나 이에 한정하지 않는다. 또한, 건조는 감압건조, 진공건조, 비등건조, 분무 건조 또는 동결건조하는 것이 바람직하며, 더 바람직하게는 동결건조이나 이에 한정하지 않는다.In the above manufacturing method, any conventional methods known in the art, such as filtration, hot water extraction, immersion extraction, reflux cooling extraction, and ultrasonic extraction, may be used as the extraction method. The extraction solvent is preferably extracted by adding 1 to 20 times the weight of dried citrus, more preferably 5 to 15 times, and even more preferably 10 times. The extraction temperature is preferably 20 to 80°C, but is not limited thereto. In addition, the extraction time is preferably 10 to 100 hours, but is not limited thereto. In the above method, the concentration of step (3) is preferably, but not limited to, a vacuum rotary concentrator or a vacuum rotary evaporator. In addition, the drying is preferably dried under reduced pressure, vacuum drying, boiling drying, spray drying or freeze drying, and more preferably freeze drying or not.
상기 자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물은 환, 정제(tablet), 캡슐(capsule), 산제, 분말, 과립, 캔디, 시럽 및 음료 중에서 선택된 어느 하나로 제조하거나, 식품의 성분으로 첨가하여 제조될 수 있으며, 통상적인 방법에 따라 적절하게 제조될 수 있다. The health functional food composition for preventing or improving menopausal syndrome, comprising the extract of the extract of citrus as an active ingredient, is one selected from pills, tablets, capsules, powders, powders, granules, candy, syrup and beverages. It can be prepared by adding it as an ingredient of food, or it can be appropriately prepared according to a conventional method.
본 발명의 자감초 추출물을 첨가할 수 있는 식품의 일례로는 육류, 소시지, 빵, 초콜릿, 캔디류, 스넥류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 중에서 선택된 어느 하나의 형태일 수 있으며, 통상적인 의미에서의 건강기능식품을 모두 포함한다.Examples of foods to which the extract of persimmon vinegar of the present invention can be added are meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other dairy products including noodle, gum, ice cream, various soups, beverages , Tea, drink, alcoholic beverages and vitamin complexes, and may include any form of health functional food in the usual sense.
상기 건강기능식품은 여러 가지 영양제, 비타민, 광물(전해질), 합성 및 천연 풍미제, 착색제 및 증진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그 밖에 천연 과일 주스 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. The dietary supplement includes various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, It may contain a pH adjusting agent, stabilizer, preservative, glycerin, alcohol, carbonic acid used in carbonated beverages, and the like. In addition, it may contain flesh for the preparation of natural fruit juices and vegetable drinks. These ingredients can be used independently or in combination.
본 발명의 건강기능식품 조성물은 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상기 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드, 말토스, 슈크로스와 같은 디사카라이드, 및 덱스트린, 사이클로덱스트린과 같은 폴리사카라이드, 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 감미제로서는 타우마틴, 스테비아 추출물과 같은 천연 감미제나, 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다.The health functional food composition of the present invention may contain various flavoring agents or natural carbohydrates as additional components. The natural carbohydrates are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol and erythritol. As the sweetener, natural sweeteners such as taumatin and stevia extract, and synthetic sweeteners such as saccharin and aspartame can be used.
또한 본 발명은 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 치료용 약학 조성물에 관한 것이다.In addition, the present invention relates to a pharmaceutical composition for the prevention or treatment of menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
상기 자감초 추출물 이외에 추가로 약제학적으로 허용가능한 담체, 부형제 또는 희석제를 더 포함할 수 있다. 본 발명의 약학 조성물은 경구 또는 비경구로 투여될 수 있으며, 비경구 투여 시 피부 외용 또는 복강 내, 직장, 정맥, 근육, 피하, 자궁 내 경막 또는 뇌혈관 내 주사 방식을 선택하는 것이 바람직하다.In addition to the extract of the liquorice, it 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 parenterally administered, it is preferable to select an injection method for external use of the skin or intraperitoneal, rectal, intravenous, intramuscular, subcutaneous, intrauterine epidural or cerebrovascular.
본 발명의 약학 조성물은 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제될 수 있다. 경구투여를 위한 고형 제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형 제제는 하나 이상의 화합물에 적어도 하나 이상의 부형제 예를 들면, 전분, 탄산칼슘, 수크로오스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한, 단순한 부형제 이외에 스테아린산 마그네슘, 탈크 등과 같은 윤활제들도 사용된다. 경구 투여를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성 용제, 현탁제, 유제, 동결건조제제, 좌제가 포함된다. 비수성 용제 및 현탁 용제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈 61, 카카오지, 라우린지, 글리세로 젤라틴 등이 사용될 수 있다.The pharmaceutical composition of the present invention may be prepared using diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, and the like. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, etc.These solid preparations contain at least one excipient in one or more compounds, such as starch, calcium carbonate, sucrose or lactose ( lactose) and gelatin. In addition, lubricants such as magnesium stearate, talc and the like are used in addition to simple excipients. Liquid preparations for oral administration include suspending agents, intravenous solutions, emulsions, syrups, etc. In addition to water and liquid paraffin, which are commonly used as diluents, various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, can be included. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories. As non-aqueous solvents and suspension solvents, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate may be used. As a base for suppositories, witepsol, macrogol, Tween 61, cacao butter, laurin, glycero gelatin, etc. may be used.
본 발명에 따른 조성물은 약제학적으로 유효한 양으로 투여한다. 본 발명에 있어서, "약제학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효용량 수준은 환자의 질환의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출 비율, 치료기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있으며, 단일 또는 다중 투여될 수 있다. 상기한 요소들을 모두 고려하여 부작용없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 당업자에 의해 용이하게 결정될 수 있다.The composition according to the invention is administered in a pharmaceutically effective amount. In the present invention, "a pharmaceutically effective amount" means an amount sufficient to treat the disease at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is the type of patient's disease, severity, and activity of the drug , Sensitivity to drug, time of administration, route of administration and rate of excretion, duration of treatment, factors including co-drugs and other factors well known in the medical field. The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with a conventional therapeutic agent, and may be administered single or multiple. Considering all of the above factors, it is important to administer an amount that can achieve the maximum effect in a minimal amount without side effects, which can be easily determined by those skilled in the art.
본 발명의 조성물의 투여량은 환자의 체중, 연령, 성별, 건강상태, 식이, 투여시간, 투여방법, 배설률 및 질환의 중증도에 따라 그 범위가 다양하게 사용할 수 있다.The dosage of the composition of the present invention can be used in a variety of ranges depending on the patient's weight, age, sex, health status, diet, administration time, administration method, excretion rate and disease severity.
이하, 실시예를 이용하여 본 발명을 더욱 상세하게 설명하고자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로 본 발명의 범위가 이들에 의해 제한되지 않는다는 것은 당해 기술분야에서 통상의 지식을 가진 자에게 있어 자명한 것이다. Hereinafter, the present invention will be described in more detail using examples. It is obvious to those skilled in the art that these examples are only intended to illustrate the present invention more specifically and that the scope of the present invention is not limited by them.
실시예Example 1. One. 자감초Jagamcho 추출물의 제조 Preparation of extract
감초를 경동시장에서 구입하여 고르고 얇게 절단한 후, 물을 뿌려 표면이 물기로 충분히 젖으면 감초가 누런 보라빛이 될 때까지 불 위에서 구워 자감초로 만든 후, 분말화 하였다.Licorice was purchased from the Gyeongdong market, cut evenly, and then sprinkled with water to bake it over the fire until it turned yellow to purple, then powdered.
이후, 상기 제조한 자감초 분말에 10배의 부피가 되도록 물 또는 에탄올을 첨가한 후, 70℃에서 12시간 동안 추출하였다. 추출물은 0.4㎛ 필터로 여과한 후 진공회전농축기로 농축하고, 동결건조하여 자감초 추출물을 제조하였다.Thereafter, water or ethanol was added to the prepared citrus vinegar powder to have a volume of 10 times, followed by extraction at 70°C for 12 hours. The extract was filtered through a 0.4 µm filter, concentrated with a vacuum rotary concentrator, and freeze-dried to prepare an extract of Jagamcho.
실시예Example 2. 실험동물 사육 및 처치 2. Experimental animal breeding and treatment
실험동물로 사용된 수컷 SAM-R1 및 SAM-P8 마우스는 ㈜중앙실험동물에서 공급받아 사용하였다. 실험동물은 한국한의학연구원의 공동동물실험실 사육시설에서 7일 동안 적응시킨 후 사용하였다. 실험방법은 한국한의학연구원 동물실험윤리위원회의 심의를 거쳤으며, 실험 동물 사육 및 유지는 한국한의학연구원 공동동물실험실의 동물 관리 및 사용 규정에 입각하여 온도 23±1℃, 습도 50±10% 내외, 12시간 명암주기로 일정하게 유지된 사육실에서 IVC(individually ventilated cage)에 4마리씩 넣어 사육하였다. SAM-R1계통의 마우스는 노화가 촉진되는 특성을 가지는 SAM-P8의 계통 대조군으로 사용하였다.Male SAM-R1 and SAM-P8 mice used as experimental animals were supplied from Central Laboratory Animal Co., Ltd. and used. The experimental animals were used after being acclimatized for 7 days in the breeding facility of the Korean Institute of Oriental Medicine. The experimental method was deliberated by the Animal Experimental Ethics Committee of the Korean Institute of Oriental Medicine, and the breeding and maintenance of the experimental animal was based on the animal management and use regulations of the Joint Animal Laboratory of the Korean Institute of Oriental Medicine, temperature 23±1℃, humidity 50±10%, In a breeding room kept constant at a 12-hour light and dark cycle, 4 animals were housed in individually ventilated cages (IVCs). The SAM-R1 strain mouse was used as a strain control for SAM-P8, which has the property of promoting aging.
실시예Example 3. 혈중 테스토스테론의 함량 분석 3. Analysis of the content of testosterone in the blood
혈중 테스토스테론의 함량 분석을 위하여, 모델 동물을 아버틴(Avertin)으로 마취하여 복대동맥에서 전혈을 채혈하였다. 채혈한 전혈은 SST tube에 옮긴 후 충분히 섬유소에 의한 혈액응고가 진행되면 4,000rpm에서 10분 동안 원심분리한 후 적혈구의 용혈 등에 주의하여 상층액인 혈청을 취하여 혈중 테스토스테론 함량 분석에 사용하였으며, 본 실시예 2에서 사용하고 남은 혈청의 경우 초저온냉동고에 보관하였다. 혈중 테스토스테론 함량 분석은 ELISA(enzyme-linked immunosorbent assay) 분석을 통해 실시하였다.To analyze the content of testosterone in the blood, model animals were anesthetized with avertin, and whole blood was collected from the abdominal aorta. After the whole blood collected was transferred to the SST tube and sufficiently coagulated by fibrin, it was centrifuged at 4,000 rpm for 10 minutes, and then, taking care of hemolysis of red blood cells, and taking the serum, which is the supernatant, was used for the analysis of testosterone content in the blood. The remaining serum used in Example 2 was stored in a cryogenic freezer. Blood testosterone content analysis was carried out through an ELISA (enzyme-linked immunosorbent assay) analysis.
그 결과, 도 1에 개시한 바와 같이 노화에 의해 혈청 내 테스토스테론의 함량이 현저하게 감소하였으나, 본 발명의 자감초 추출물을 투여한 군에서는 통계적으로 유의미하게 혈청 내 테스토스테론 함량이 증가한 것을 확인하였다.As a result, as shown in Figure 1, the content of testosterone in the serum was significantly reduced by aging, but it was confirmed that the testosterone content in the serum was statistically significantly increased in the group to which the extract of the narcissus extract of the present invention was administered.
실시예Example 4. 노화마우스 모델을 이용한 4. Using the aging mouse model 트레드밀을Treadmill 이용한 운동성(근력) 분석 Mobility (muscle) analysis
대조군을 제외한 나머지 그룹의 실험동물들은 주 2회 2주 동안 15분 동안 트레드밀 운동에 대한 적응 훈련을 실시하고 휴식 후 본 운동을 실시하였다. 2주 후 최종 측정에서 5분 간격으로, 10m/min, 15m/min, 20m/min의 속력으로 증속하여 지칠 때까지 달리게 하였다. 지칠 때까지 걸리는 시간(exhaustion time)을 비교하여 각 개체의 운동능력을 평가하였다. 지침이 발생한 시각은 3회 연속으로 따라가지 못하고 뒤처짐이 발생하는 첫 시간으로 정의하였으며, 1회의 달림은 속도에 뒤처지지 않고 5분 이상을 연속으로 달리는 것으로 설정하였다. 이 시험은 투여가 끝난 1주 경에 3회에 걸쳐 측정하였다.Experimental animals in the rest of the groups, except the control group, performed adaptive training for treadmill exercise for 15 minutes for 2 weeks twice a week, followed by this exercise after rest. After 2 weeks, the final measurement was increased at a speed of 10 m/min, 15 m/min, and 20 m/min at 5 minute intervals to run until exhausted. The exercise ability of each individual was evaluated by comparing the exhaustion time. The time when the guideline occurred was defined as the first time that lagging could not be followed three times, and one run was set to run more than 5 minutes continuously without falling behind in speed. This test was measured three times a week after the end of administration.
그 결과, 도 2에 개시한 바와 같이, 노화가 촉진된 동물 모델에서는 운동능력이 빠르게 감소하여 지침이 발생하는 시간이 빠르게 나타났으나, 본 발명의 자감초 추출물을 투여받은 노화촉진 동물모델에서는 지치는데 걸리는 시간이 지연됨을 확인하였다.As a result, as shown in FIG. 2, in the animal model in which aging was promoted, the motor ability rapidly decreased and the time when the guidance occurred was rapidly appeared. It was confirmed that the time taken to delay was delayed.
실시예Example 5. 5. MaklerMakler counting chamber를 이용한 정자의 개수 및 운동성 분석 Analysis of sperm count and motility using counting chamber
대조군 및 실험군을 각 해당 조건으로 사육하여 아버틴(Avertin)으로 마취한 후, 혈액 채취가 끝난 실험쥐의 고환을 외부로 적출한 다음 부고환의 전부와 후부를 지혈 겸자로 결찰 및 적출한 다음, 세절하였다. 정자를 회수하여 M16+10% FBS가 포함된 12웰 플레이트에 올려놓고 Makler Counting Chamber를 이용하여 정자수를 카운팅하였으며, 생존 정자의 운동성을 1시간 동안 10분 간격으로 관찰하였다.The control group and the experimental group were bred under each appropriate condition, anesthetized with avertin, and then the testicles of the blood-extracted test rats were extracted to the outside, and then the entire and posterior parts of the epididymis were ligated and extracted with hemostatic forceps, and then cut. Did. Sperm was collected and placed on a 12-well plate containing M16+10% FBS, sperm count was counted using a Makler Counting Chamber, and motility of viable sperm was observed at 10-minute intervals for 1 hour.
그 결과, 도 3 및 도 4에 개시한 바와 같이, 노화가 촉진된 모델에서는 정자 수 및 정자의 운동성이 모두 감소하였으나, 본 발명의 자감초 추출물을 투여한 실험군에서는 정자 수 및 정자의 운동성이 회복되는 것을 확인할 수 있었다. As a result, as shown in FIGS. 3 and 4, in the model in which aging was promoted, both sperm count and sperm motility were reduced, but in the experimental group to which the extract of Jagamja extract of the present invention was administered, sperm count and sperm motility were recovered. I was able to confirm it.
실시예Example 6. 감초 추출물 및 본 발명의 6. Licorice extract and of the present invention 자감초Jagamcho 추출물의 아로마타아제 저해 활성 비교 Comparison of aromatase inhibitory activity of extract
아로마타아제 활성 억제 측정은 아로마타아제에 의한 DBF(dibenzylfluorescein)의 가수분해 생성물인 플루오르세인(fluorescein)의 형광 강도를 측정함으로써 평가하였다. 10㎕ 자감초 및 감초의 물 또는 70%(v/v) 에탄올 추출물을 90㎕ NADPH-regeneration 완충용액(2.6mM NADP+, 7.6mM glucose-6-phosphate, 0.8unit/㎖ glucose-6-phosphate dehydrogenase, 13.9mM MgCl 2, 1mg/㎖ 알부민이 포함된 50mM 포타슘 포스페이트(pH 7.4))과 혼합하여 37℃에서 30분 동안 반응시킨 후, 100㎕ 효소 및 기질 혼합물 (DBF 2μM, 40pmol/㎖ 아로마타아제, 4 mg/㎖ 알부민이 포함된 50mM 포타슘 포스페이트(pH 7.4))과 혼합하여 37℃에서 추가로 30분 동안 반응시켰다. 반응 후 2N NaOH 150㎕를 첨가하여 37℃에서 2시간 동안 반응 후, 반응 용매의 형광값을 흡광(excitation):485nm/발광(emission):535nm에서 측정하였다.The aromatase activity inhibition measurement was evaluated by measuring the fluorescence intensity of fluorescein, a hydrolysis product of DBF (dibenzylfluorescein) by aromatase. 90 µl NADPH-regeneration buffer solution (2.6 mM NADP+, 7.6 mM glucose-6-phosphate, 0.8 unit/ml glucose-6-phosphate dehydrogenase) with 10 µL perilla and licorice water or 70% (v/v) ethanol extract After mixing with 13.9 mM MgCl 2 and 50 mg potassium phosphate (pH 7.4) containing 1 mg/ml albumin for 30 minutes at 37° C., 100 μl enzyme and substrate mixture (DBF 2 μM, 40 pmol/ml aromatase, The mixture was mixed with 50 mM potassium phosphate (pH 7.4) containing 4 mg/ml albumin and reacted at 37°C for an additional 30 minutes. After the reaction, 150 µl of 2N NaOH was added, and after reacting at 37° C. for 2 hours, the fluorescence value of the reaction solvent was measured at excitation:485nm/emission:535nm.
그 결과, 도 5에 개시한 바와 같이, 감초 추출물 및 본 발명의 자감초 추출물을 처리하는 경우, 대조군에 비해 남성호르몬의 감소 원인인 아로마타아제의 활성이 감소한다는 것을 확인하였으며, 본 발명의 자감초 추출물은 감초 추출물에 비해 통계적으로 유의미하게 아로마타아제 활성을 더 감소시키는 것으로 나타났다. As a result, as shown in Figure 5, when processing the licorice extract and the extract of the licorice extract of the present invention, it was confirmed that the activity of aromatase, which is a cause of the decrease in male hormone, is reduced compared to the control group. Licorice extract was found to statistically significantly decrease aromatase activity compared to licorice extract.
실시예Example 7. 감초 추출물 및 본 발명의 7. Licorice extract and of the present invention 자감초Jagamcho 추출물의 테스토스테론(T)/ Extract Testosterone (T)/ SHBGSHBG (Sex hormone binding globulin) (Sex hormone binding globulin) 결합율Bonding rate (%) 비교(%) compare
10㎍/㎖ SHBG 단백질이 코팅된 96웰 플레이트에 10μM 테스토스테론과 자감초 및 감초의 물 또는 70%(v/v) 에탄올 추출물 100㎍/㎖을 각각 처리하여, 4시간 동안 반응시킨 후, PBS로 3회 세척하여 10㎍/㎖의 테스토스테론-HRP 결합된 항체를 처리하였다. 항체 처리 후, 3시간 동안 반응시킨 다음, 다시 PBS로 3회 세척하여 100㎕ TMB(3, 3' 5, 5'-Tetramethylbenzidine) 용액을 처리하였고, 30분 동안 방치한 후, 흡광도를 450nm에서 측정하여 SHBG-테스토스테론의 결합율을 계산하였다.A 10-well plate coated with 10 μg/ml SHBG protein was treated with 10 μM testosterone and 100 μg/ml of water or 70% (v/v) ethanol extract of persimmon and licorice, respectively, and reacted for 4 hours, followed by PBS. Washed 3 times to treat 10 μg/ml testosterone-HRP bound antibody. After antibody treatment, reacted for 3 hours, and then washed 3 times with PBS to treat a 100 μl TMB (3, 3'5, 5'-Tetramethylbenzidine) solution, and after standing for 30 minutes, absorbance was measured at 450 nm. Then, the binding rate of SHBG-testosterone was calculated.
그 결과, 도 6에 개시한 바와 같이, 감초 추출물 처리군 대비 본 발명의 자감초 추출물 처리군의 테스토스테론(T)/SHBG 결합율이 통계적으로 유의미하게 감소하였다는 것을 확인하였다.As a result, as shown in FIG. 6, it was confirmed that the testosterone (T)/SHBG binding rate of the licorice extract treated group of the present invention was statistically significantly reduced compared to the licorice extract treated group.

Claims (6)

  1. 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물.A health functional food composition for preventing or improving menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
  2. 제1항에 있어서, 상기 남성갱년기 증후군은 테스토스테론 호르몬의 감소, 근력저하 또는 정자 수 및 운동성의 감소를 수반하는 것을 특징으로 하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물.The method of claim 1, wherein the menopausal syndrome is a health functional food composition for the prevention or improvement of menopausal syndrome, characterized in that accompanied by a decrease in testosterone hormone, decreased muscle strength or sperm count and motility.
  3. 제1항에 있어서, 상기 자감초 추출물의 추출용매는 물, C 1~C 4의 저급 알코올 또는 이들의 혼합물인 것을 특징으로 하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물.The method of claim 1, wherein the extract solvent of the extract of gamjachoe water, C 1 ~ C 4 lower alcohol or a mixture thereof, characterized in that for preventing or improving menopausal syndrome health functional food composition.
  4. 제1항에 있어서, 상기 자감초 추출물은 환, 정제(tablet), 캡슐(capsule), 산제, 분말, 과립, 캔디, 시럽 및 음료 중에서 선택된 어느 하나의 제형으로 제조되는 것을 특징으로 하는 남성갱년기 증후군의 예방 또는 개선용 건강기능식품 조성물.The menopausal syndrome according to claim 1, wherein the extract is made of any one selected from pills, tablets, capsules, powder, granules, candy, syrup and beverages. Health functional food composition for prevention or improvement of.
  5. 자감초 추출물을 유효성분으로 함유하는 남성갱년기 증후군의 예방 또는 치료용 약학 조성물.Pharmaceutical composition for the prevention or treatment of menopausal syndrome, which contains the extract of Jagamchocho as an active ingredient.
  6. 제5항에 있어서, 상기 자감초 추출물 이외에 추가로 담체, 부형제 또는 희석제를 더 포함하는 것을 특징으로 하는 남성갱년기 증후군의 예방 또는 치료용 약학 조성물.[6] The pharmaceutical composition for preventing or treating menopausal syndrome according to claim 5, further comprising a carrier, an excipient, or a diluent in addition to the extract of the licorice root.
PCT/KR2019/012112 2018-12-14 2019-09-19 Composition comprising glycyrrhiza uralensis extract as active ingredient for prevention, alleviation, or treatment of late-onset hypogonadism syndrome WO2020122373A1 (en)

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