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WO2020122373A1 - Composition comprenant un extrait de glycyrrhiza uralensis en tant que principe actif pour la prévention, l'atténuation ou le traitement du syndrome d'hypogonadisme d'apparition tardive - Google Patents

Composition comprenant un extrait de glycyrrhiza uralensis en tant que principe actif pour la prévention, l'atténuation ou le traitement du syndrome d'hypogonadisme d'apparition tardive Download PDF

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Publication number
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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Prior art keywords
extract
sam
active ingredient
prevention
composition
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Ceased
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PCT/KR2019/012112
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English (en)
Korean (ko)
Inventor
고병섭
정동호
양현
김혜진
황주태
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Korea Institute of Oriental Medicine KIOM
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Korea Institute of Oriental Medicine KIOM
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Publication of WO2020122373A1 publication Critical patent/WO2020122373A1/fr
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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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • 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

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Abstract

La présente invention concerne une composition comprenant un extrait de Glycyrrhiza uralensis en tant que principe actif pour la prévention, l'atténuation ou le traitement du syndrome d'hypogonadisme d'apparition tardive L'extrait de Glycyrrhiza uralensis qui est un principe actif de la présente invention peut augmenter le taux de testostérone et la force musculaire et améliorer le nombre de spermatozoïdes et la motilité des spermatozoïdes. Par conséquent, la composition selon la présente invention peut être utilisée en tant qu'aliment fonctionnel ou produit médicinal pour la santé pour prévenir, atténuer ou traiter un syndrome d'hypogonadisme d'apparition tardive.
PCT/KR2019/012112 2018-12-14 2019-09-19 Composition comprenant un extrait de glycyrrhiza uralensis en tant que principe actif pour la prévention, l'atténuation ou le traitement du syndrome d'hypogonadisme d'apparition tardive Ceased WO2020122373A1 (fr)

Applications Claiming Priority (2)

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KR1020180162111A KR102122408B1 (ko) 2018-12-14 2018-12-14 자감초 추출물을 유효성분으로 포함하는 남성갱년기 증후군의 예방, 개선 또는 치료용 조성물
KR10-2018-0162111 2018-12-14

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KR102762131B1 (ko) 2021-03-09 2025-02-04 주식회사 바이오케어 녹용 발효물을 유효성분으로 포함하는 남성 갱년기 증후군 예방, 개선 또는 치료용 조성물

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WO2017079463A1 (fr) * 2015-11-04 2017-05-11 Prescient Pharma Llc Compositions anti-vieillissement et leurs procédés d'utilisation
KR101776277B1 (ko) * 2016-06-22 2017-09-11 주식회사 케이바이오스 동물사료첨가제 조성물 및 동물사료용 조성물
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KR101797720B1 (ko) * 2015-10-19 2017-11-20 유한회사 농업회사법인 베네허브 울금 및 감초 추출물의 혼합물을 유효성분으로 함유하는 갱년기 증상 예방 및 치료용 약학적 조성물

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20100120751A (ko) * 2009-05-07 2010-11-17 원광대학교산학협력단 근력약화, 근위축, 구음장애, 연하장애의 증상을 개선·지연시키기 위한 조성물
WO2017079463A1 (fr) * 2015-11-04 2017-05-11 Prescient Pharma Llc Compositions anti-vieillissement et leurs procédés d'utilisation
KR20170143147A (ko) * 2016-06-21 2017-12-29 주식회사 성균바이오텍 환경호르몬에 의한 남성의 생식기능 저하를 개선하는 식물추출 조성물
KR101776277B1 (ko) * 2016-06-22 2017-09-11 주식회사 케이바이오스 동물사료첨가제 조성물 및 동물사료용 조성물
CN105944062A (zh) * 2016-06-24 2016-09-21 孙喜范 一种治疗男性更年期综合症中药组合物

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