JP2019513693A - Composition for amelioration of female menopausal symptoms comprising mandala mochi extract - Google Patents

Abstract

In the present specification, a composition for ameliorating female menopausal symptoms, or a composition for preventing or treating female menopausal diseases, which comprises a mandala extract as an active ingredient, the extract comprising water, a C1-C5 alcohol or It is an extract extracted using an aqueous solution of C1 to C5 alcohol, and the composition may be used as a food or a pharmaceutical composition, and the composition has an effect of improving physical heat balance of menopausal women, female menopausal symptoms It has the effect of alleviating or preventing or treating women's menopause. [Selected figure] Figure 1

Description

  The present specification relates to a composition for ameliorating feminine menopausal symptoms, or a composition for preventing or treating feminine menopausal diseases, which comprises a mandala extract as an active ingredient.

  Persimmon (Sasa borealis Makino) is the smallest bamboo among bamboos and grows naturally in the mountains of central and southern Korea. Acupuncture and moxibustion is the strongest drug in bamboo, and it is effective for intractable diseases such as diabetes, high blood pressure, gastritis, gastric ulcer, chronic hepatitis and cancer using only one acupuncture. In addition, it is known that acupuncture lowers heat and detoxifies it, thereby reducing sputum and facilitating urination, treating inflammation and suppressing cancer cells. Among the persimmons, Mandala Persimmon (Sasa quelpaertensis Nakai) is a regional endemic species that is limitedly distributed only in the area of Mt. Hanbong, and grows in large-scale communities within the distribution area, and it is an inland region It is distinguished from morphological features.

  However, with regard to epilepsy, in particular mandala, the direct effects on the amelioration of female menopausal symptoms and treatment and prevention of female menopausal diseases have not been examined.

Korean Patent No. 10-0720971 Korean Patent No. 10-0672842

  Focusing on the above-mentioned problems, the inventors of the present invention have been researching on the extract of Mandala japonicum to improve the menopausal symptoms of women, and to prevent and treat women's menopausal diseases. The inventors have found that it has an effect and an effect to improve the physical heat balance of menopausal women, resulting in the present invention.

  One aspect of the present invention is to provide a composition for ameliorating feminine menopausal symptoms, or a composition for preventing or treating feminine menopausal diseases, which comprises a mandala extract as an active ingredient.

  One aspect of the present invention is to provide a composition for improving the physical heat balance of menopausal women, which comprises the extract of Mandala as an active ingredient.

  One aspect of the present invention provides a composition for ameliorating female menopausal symptoms, or a composition for preventing or treating female menopausal diseases, which comprises a mandala extract as an active ingredient.

  In one aspect of the present invention, the composition is a composition further comprising a lotus root extract.

  In one aspect of the present invention, the composition comprises a cocoon extract, Japanese persimmon extract, Japanese touki extract, Sanshuyu extract, cinnamon extract, mulberry root extract, small mulberry persimmon extract, and licorice extract It is a composition which further contains any one or more selected from the group.

In one aspect of the present invention, the extract is a water extract, an C ₁ -C ₅ alcohol extract or C ₁ -C ₅ alcohol aqueous extract is a composition.

  In one aspect of the present invention, the extract of Mandala according to the present invention is a composition that is 0.001 to 90% by mass based on the total mass of the composition.

  In one aspect of the present invention, the composition for alleviating female menopausal symptoms is a composition characterized by improving physical heat balance of menopausal women.

  In one aspect of the present invention, the female menopausal symptoms include skin flushing, facial flushing, fever, sweating, numbness of the hands and feet, arthralgia, myalgia, skin elasticity loss, dry skin, fatigue, palpitations, insomnia, depression The composition is any one or more of: disorder, anxiety, headache, nervousness, vaginal discharge reduction, vaginal dryness, vaginal contraction, sexual pain, and sexual insensitivity.

  In one aspect of the present invention, the female menopausal disease is a composition wherein menopausal muscle disease, bone disease or heart disease.

  In one aspect of the present invention, whether the bone disease is menopausal rheumatoid arthritis, degenerative arthritis, osteoporosis, rickets, osteomalacia disease, or Paget's disease of bone; or the heart The disease may be menopause angina or arteriosclerosis.

  In one aspect of the invention, the composition may be a pharmaceutical composition.

  In one aspect of the present invention, the composition for alleviating female menopausal symptoms may be a health functional food composition.

  The composition according to one aspect of the present invention is effective in improving female menopausal symptoms or preventing or treating female menopausal symptoms.

  The composition according to one aspect of the present invention has an effect of improving vaginal dryness in menopausal women.

  The composition according to one aspect of the present invention has a rapid temperature change alleviation effect on menopausal women.

  The composition according to one aspect of the present invention has an effect of alleviating a rapid rise in body temperature of a menopausal woman or a sudden fall in body temperature.

  The composition according to one aspect of the present invention has a flush or skin flush relief effect for menopausal women.

  The composition according to one aspect of the present invention is effective in improving the inconvenient symptoms caused by the heat sensation in menopausal women.

  The composition according to one aspect of the present invention is effective in treating or preventing muscle disease, bone disease, heart disease, skin disease, neuropsychiatric disease or sexual function disease in menopausal women.

  The composition according to one aspect of the present invention is a skin flush, facial flush, heat sensation, sweating, numbness of hands and feet, arthralgia, myalgia, skin elasticity reduction, dry skin, fatigue, palpitations, insomnia, menopausal women. It has the effect of improving any one or more of depression, anxiety, headache, nervousness, vaginal discharge reduction, vaginal dryness, vaginal contraction, sexual pain and sexual insensitivity.

  The composition according to one aspect of the present invention is effective in improving the physical heat balance of menopausal women.

It is a Kupperman index (Kupperman Index) evaluation item which concerns on Experimental example 1 of this invention. It is a menopausal disorder rating scale (Menopause Rating Scale) evaluation item which concerns on Experimental example 1 of this invention. It is the photograph which measured the heat feeling alleviation effect in the upper half concerning experimental example 3 of the present invention. It is the photograph which measured the heat feeling alleviation effect in the upper half concerning experimental example 3 of the present invention. It is the photograph which measured the heat feeling alleviation effect in the face concerning experiment example 3 of the present invention. It is the photograph which measured the heat feeling alleviation effect in the face concerning experiment example 3 of the present invention. It is the photograph which measured the temperature fall alleviation effect in the site | part of the hand which concerns on Experimental example 3 of this invention. It is the photograph which measured the temperature fall alleviation effect in the site | part of the hand which concerns on Experimental example 3 of this invention. It is a vaginal symptom evaluation item which concerns on Experimental example 6 of this invention.

  Hereinafter, the present invention will be described in detail.

  One aspect of the present invention provides a composition for ameliorating female menopausal symptoms, or a composition for preventing or treating female menopausal diseases, which comprises a mandala extract as an active ingredient.

  One aspect of the present invention is a method for ameliorating female menopausal symptoms, or preventing or treating female menopausal diseases, said method comprising administering to a subject in need thereof an effective amount of Mandala extract. Providing a method comprising the step of administering.

  One aspect of the present invention provides use of the extract of Mandala in the manufacture of a composition for ameliorating female menopausal symptoms or preventing or treating female menopausal diseases.

  One aspect of the present invention provides a mandala extract for ameliorating female menopausal symptoms, or for preventing or treating female menopausal diseases.

  In the present specification, "Syran" is scientifically named Sasa quelpaertensis Nakai. Mandala (Sasa quelpaertensis Nakai) is an endemic species that is limitedly distributed only in the area of Mt. Hanbong, and grows in large-scale communities within the distribution area, and it is morphologically similar to that of inland areas. It is distinguished from the features. Mandala, which contains a lot of stored starch in resource botanical terms, has long been used as an important salvage plant during food starvation in the Jeju area, and it is a plant that can be used as a resource plant. It is.

  In the present specification, “extract” is any substance obtained by extracting the components therein from a natural product, regardless of the extraction method or the type of the components. For example, it is a broad concept including any of those obtained by extracting a component to be dissolved in a natural product from water and an organic solvent, and those obtained by extracting only a specific component of the natural product. In one embodiment of the present invention, the organic solvent is not particularly limited, and may be methanol, ethanol, isopropyl alcohol, n-propyl alcohol, C1-C5 lower alcohol such as n-butanol and isobutanol, glycerol, Polyhydric alcohols such as ethylene glycol, propylene glycol and 1,3-butylene glycol, hydrocarbon solvents such as methyl acetate, ethyl acetate, benzene, n-hexane, diethyl ether, dichloromethane, chloroform and the like, and petroleum ether, methyl acetate, It may be a nonpolar organic solvent such as benzene, hexane, chloroform, methylene chloride, dimethyl ether, ethyl acetate and the like.

In one embodiment, the extract may be an extract extracted with water. In another an embodiment, the extract may be a liquid extract was extracted with C ₁ -C ₅ alcohol. In yet another embodiment, the extract may be an extract extracted with ethanol, but is not limited thereto.

  In one aspect of the invention, the extract may be included in the composition in the form of a dried powder.

In one aspect of the present invention, the extract provides water, a C ₁ -C ₅ alcohol or C ₁ -C ₅ extract the aqueous alcohol was extracted with.

  In one aspect of the present invention, the composition is a composition further comprising a lotus root extract.

  In the present specification, “rens heart” is a seed of lotus flower, which is referred to as Nelumbinis Plumula in scientific name.

  In one aspect of the present invention, the composition comprises a cocoon extract, Japanese persimmon extract, Japanese touki extract, Sanshuyu extract, cinnamon extract, mulberry root extract, small mulberry persimmon extract, and licorice extract It is a composition for preventing or treating female menopausal symptoms, further comprising any one or more selected from the group. "Kinko" is known to be a seed of Hemeroccus edulis, and its scientific name is Cuscuta chinensis Lam. It is. "Follja" is known as fenugreek, and its scientific name is Trigonella foenum-graecum L. It is. "Nihon touki" is known as Korean angelica, and the scientific name is Angelica gigas N. It is. "Sanshuyu" is known as Sansai Yellow, Persimmon Tree, Stone Agate, Persimmon Persimmon, Cornus fruit or royal jelly, and the scientific name is Cornus officinalis Siebold et Zucc. It is. In the present invention, Sanshuyu may use Sanshuyu fruit. Cinnamon is also called meat katsura, and its scientific name is Cinnamomum aromaticum Nees. The roots of the kudzu are called sorrel (Puerariae Radix), and Pueraria lobata (Willd.) Ohwi or Pueraria thunbergii (Siebold & Zucc.) Benth. May be used. Fosiculi (Foeniculi Fructus) is from Foeniculum vulgare Mill. May be used. Glycyrrhiza glabra Linne may be used for licorice.

In one aspect of the present invention, the extract is a water extract, an C ₁ -C ₅ alcohol extract or C ₁ -C ₅ alcohol aqueous extract is a composition.

In one aspect of the present invention, the concentration of the C ₁ -C ₅ aqueous alcohol solution may be 40% to 90% (v / v). In one embodiment, the concentration of the C ₁ -C ₅ alcohol aqueous solution is 40% or more, 45% or more, 50% or more, 55% or more, 60% or more, 65% or more, 66% or more, 67% or more, 68 %, 69%, 70%, 71%, 72%, 73%, 74%, 75%, or 80% or more. The concentration of the C ₁ -C ₅ alcohol aqueous solution is 90% or less, 85% or less, 80% or less, 75% or less, 74% or less, 73% or less, 72% or less, 71% or less, 70% or less, 69% Below, 68% or less, 67% or less, 65% or less, or 60% or less may be sufficient. When the concentration of the C ₁ -C ₅ alcohol aqueous solution is within the above range, it is excellent in the improvement of female menopausal symptoms or in the treatment or prevention of female menopausal diseases.

In one aspect of the present invention, the C ₁ -C ₅ alcohol used is one or more selected from the group consisting of methanol, ethanol, isopropyl alcohol, n-propyl alcohol, n-butanol and isobutanol. Provide the composition.

  In one aspect of the present invention, the extract of Mandala according to the present invention is a composition that is 0.001 to 90% by mass based on the total mass of the composition. In one embodiment, the extract of Mandala can be contained in an amount of 0.1 to 60% by mass based on the total mass of the composition. In one embodiment, the extract of Mandala can be contained in an amount of 0.1 to 30% by mass based on the total mass of the composition. In still other embodiments, the extract of Mandala may be contained in an amount of 1 to 20% by mass based on the total mass of the composition. Specifically, the extract of Mandala spp. Is 0.001% by mass or more, 0.01% by mass or more, 0.1% by mass or more, 1% by mass or more, 2% by mass or more, based on the total mass of the composition. 2.5 mass% or more, 3 mass% or more, 5 mass% or more, 7 mass% or more, 8 mass% or more, 8.5 mass% or more, 10 mass% or more, 13 mass% or more, 15 mass% or more, 17 % By mass, 17.5% by mass or more, 20% by mass or more, or 25% by mass or more may be included. The extract of Mandala tuna is 90% by mass or less, 60% by mass or less, 50% by mass or less, 40% by mass or less, 30% by mass or less, 20% by mass or less, 19% by mass or less based on the total mass of the composition. 17 mass% or less, 15 mass% or less, 10 mass% or less, 9.5 mass% or less, 8 mass% or less, 5 mass% or less, or 3 mass% or less may be included. When the content of the mandala extract is within the above range, it is excellent in the improvement of female menopausal symptoms or in the treatment or prevention of female menopausal diseases.

  In one aspect of the present invention, the lotus root extract may be contained at 0.1 to 15% by mass based on the total mass of the composition. Specifically, the lotus root extract is 0.1 mass% or more, 1 mass% or more, 2 mass% or more, 2.5 mass% or more, 3 mass% or more, 5 mass% or more based on the total mass of the composition Above, 7 mass% or more, 8 mass% or more, or 8.5 mass% or more may be included. The lotus root extract may contain 15 mass% or less, 10 mass% or less, 9.5 mass% or less, 8 mass% or less, or 5 mass% or less based on the total mass of the composition. When the content of the lotus root extract is within the above range, it is excellent in the improvement of female menopausal symptoms or in the treatment or prevention of female menopausal diseases.

  In one aspect of the present invention, the cocoon extract, Japanese persimmon extract, Japanese touki extract or Sanshyu extract may be included at 0.1 to 5% by mass based on the total mass of the composition. In one aspect of the present invention, the extract of cinnamon or root extract of kudzu may be contained at 0.1 to 3% by mass based on the total mass of the composition. In one aspect of the present invention, the musk extract or licorice extract may be contained at 0.1 to 2% by mass based on the total mass of the composition. When the content of the spinach extract, fenugreek extract, Japanese touki extract, sanshuyu extract, cinnamon extract, mulberry root extract, small mustard incense extract or licorice extract is within the above range, female menopausal symptoms Excellent improvement or treatment or prevention of women's menopausal diseases.

  One aspect of the present invention provides a composition comprising, as active ingredients, 50 to 150 parts by mass of a mandala extract and 50 to 150 parts by mass of a lotus root extract.

  One aspect of the present invention is 50-150 parts by mass of Mandala extract, 50-150 parts by mass of lotus root extract, 60-120 parts by mass of cocoon extract, 60-120 parts by mass of Japanese fowl extract, Japanese touki extract 60 to 120 parts by mass, 60 to 120 parts by mass of Sanshuyu extract, 30 to 70 parts by mass of cinnamon extract, 30 to 70 parts by mass of root extract of kudzu A composition for ameliorating female menopausal symptoms or treating or preventing female menopausal diseases, comprising 20 parts by mass as an active ingredient.

  In one aspect of the present invention, the composition for alleviating female menopausal symptoms may be a composition characterized by improving the physical heat balance of menopausal women.

  In one aspect of the present invention, the female menopausal symptoms include skin flushing, facial flushing, fever, sweating, numbness of the hands and feet, arthralgia, myalgia, skin elasticity loss, dry skin, fatigue, palpitations, insomnia, depression It may be any one or more of illness, anxiety, headache, nervousness, vaginal discharge reduction, vaginal dryness, vaginal contraction, sexual pain and sexual insensitivity.

  In one aspect of the present invention, the female menopausal disease may be menopausal muscle disease, bone disease or heart disease. Specifically, whether the bone disease is rheumatoid arthritis due to menopause, degenerative arthritis, osteoporosis, rickets, osteomalacia disease, or Paget's disease of bone; or the heart disease is Menopause may be angina or arteriosclerosis.

  In one aspect of the invention, the composition may be a pharmaceutical composition.

  In one aspect of the present invention, the composition is in the form of powder, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, external preparations, suppositories, and sterile injectable solutions. Provided is a shaped composition.

  In one aspect of the present invention, the pharmaceutical composition may further include, in one aspect, suitable carriers, excipients and diluents commonly used for the production of pharmaceutical compositions. In one aspect, carriers, excipients, and diluents that may be included in the composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, Calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methyl hydroxybenzoate, propyl hydroxybenzoate, talc, magnesium stearate, mineral oil and the like can be mentioned.

  In addition, the pharmaceutical composition may be prepared by any conventional method such as powders, granules, tablets, capsules, suspensions, emulsions, oral forms such as syrups, aerosols, external preparations, suppositories, and sterile injection solutions. It may be used as a dosage form.

  When formulating, fillers, fillers, binders such as fillers, binders, wetting agents, disintegrants, surfactants and the like are usually used. Solid preparations for oral administration may include tablets, pills, powders, granules, capsules and the like. Such solid preparations may contain, in addition to the active ingredient, at least one or more excipients such as starch, calcium carbonate, sucrose or lactose, and gelatin. Besides simple excipients, lubricants such as magnesium stearate and talc may also be included. Liquid preparations for oral use include suspensions, internal solutions, emulsions, syrups and the like, which are commonly used as simple diluents such as water and liquid paraffin, and various excipients such as wetting agents, Sweetening agents, flavoring agents, preservatives and the like may be included. Formulations for parenteral administration may include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized formulations, suppositories. For non-aqueous solvents and suspensions, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate may be used. As bases for suppositories, witepsol, macrogol, tween 61, laurin fat, cacao butter, glycerogelatin etc. may be used.

  The dosage of the extract disclosed herein may vary depending on the condition of the patient, body weight, degree of disease, drug form, administration route and period, and may be selected within the range commonly used in the art. . In one aspect, the daily dose of the active ingredient may be 0.0001 to 0.5 g / kg based on dry weight, and in one aspect 0.001 to 0.1 g / kg administered. Good.

  In one aspect of the invention, the composition may be a food composition.

  In one aspect of the present invention, the composition for alleviating female menopausal symptoms may be a health functional food composition. For example, various foods, beverages, gums, tea, vitamin complex agents, health supplements and the like may be used in the form of powder, granules, tablets, capsules or beverages. The food composition of each dosage form may contain, in addition to the active ingredient, ingredients usually used in the relevant field, appropriately selected and blended without difficulty by those skilled in the art according to the dosage form or purpose of use, and other ingredients When applied in conjunction with, synergetic effects may occur.

  At this time, in the case of a general food composition, the amount of the active ingredient contained in the food or beverage may be in the range of 0.001 to 90% by mass of the total food mass, but is limited thereto It is not a thing. Moreover, in the case of a health food composition, although it may contain in 10-90 mass% of the whole foodstuff mass, it is not restrict | limited to this. In one aspect, the daily dose of the active ingredient upon ingestion as a food composition may be, but is not limited to, 0.0001 to 0.1 g / kg based on dry weight.

  In one embodiment, the composition may contain other components that can synergetically exert the main effects within the range that does not impair the main effects aimed by the present invention. For example, in order to improve physical properties, additives such as perfumes, dyes, bactericides, antioxidants, preservatives, moisturizers, thickeners, inorganic salts, emulsifiers, and synthetic polymers may be further included. In addition, auxiliary components such as water-soluble vitamins, fat-soluble vitamins, high molecular weight peptides, high molecular weight polysaccharides and seaweed extract may be further included. The above components may be suitably selected and blended without difficulty by those skilled in the art according to the dosage form or purpose of use, and the addition amount thereof may be selected within the range that does not impair the purpose and effect of the present invention. . For example, the addition amount of the component may be in the range of 0.01 to 5% by mass, more specifically 0.01 to 3% by mass, based on the total mass of the composition.

  The dosage form of the composition according to the present invention may be a solution, an emulsion, a viscous mixture, a tablet, a powder, a tablet, a capsule, a liquid, a granule, a pill, a flake, a paste, a syrup, a gel, a jelly, a bar or It may be in various forms such as edible films, and they may be administered in various ways such as simple drinking, injection, spray method or squeeze method.

  Hereinafter, the present invention will be described in more detail by way of examples. It is to be understood that these examples are merely for the purpose of illustrating the present invention, and that the scope of the present invention should not be construed as being limited by these examples. It will be obvious to the

[Examples 1 to 3]
After washing Mandala Persimmon purchased from Samyoung Food Materials Ind. Co., Ltd., leaves were separated from the Mandala Persimmon. The mass ratio of washed mandala leaf to purified water was set to a ratio of 1: 8, and then extracted at 95 ° C. ± 2 ° C. for 4 hours to obtain an extract. The extract was cooled to 75 ° C. ± 2 ° C. and filtered using a microfilter (5 μm). The filtrated extract was concentrated under reduced pressure at 35-40 Brix. The concentrate was dried on a spray drier to produce a powdered mandala extract.

  According to the same method as the method for producing the mandala extract, lotus root, spinach, Japanese perch, Japanese toki, sanshuyu, cinnamon, bark root, ginseng extract, and licorice extract were manufactured.

  The prepared extracts were used as components represented in Table 1 below to prepare Examples 1-3. In Table 1 below, the excipients include tapioca starch, glycerin, honey, microcrystalline cellulose, and sweeteners.

  The compositions of Examples 1 to 3 prepared above were prepared in the form of 3.75 g of a pill and allowed to be consumed by the test persons of the following experimental example once a day for 4 weeks, before intake The later results were measured.

<Experimental Example 1: Kupperman Index (Kupperman Index) and MRS (Menopause Rating Scale) Questionnaire Evaluation>
[Menopausal syndrome group questionnaire index]
Kupperman Index (Kupperman Index) and MRS (Menopause Rating Scale) are one of the representative indexes used in the Menopausal Tract Group Questionnaire, and in recent years, clinical trials using MRS tend to increase. In Japan, the Kupperman Index is used more frequently as a postmenopausal female health functional index. That is, both the Kupperman Index and the MRS are used as indicators by the KFDA in allowing menopausal women's health functionality. Therefore, Kupperman index or MRS evaluation against the experimenters can prove that the substance is effective for amelioration of female menopausal symptoms or for prevention or treatment of female menopausal diseases.

Menopausal women were selected according to the following criteria.
-Among women between the ages of 47 and 56, those who have irregular menstruation for at least 6 months or have an amenorrhea status for more than 2 months
-Healthy people without sudden and chronic physical disease including skin disease
-Those who do not have a fever (cold, flu)

  Women who meet the above criteria and who have received female hormone treatment or surgically menopausal within the last 3 months, who are taking medication for improvement of menopausal symptoms, or being treated with disease A total of 60 men were selected as menopausal women subjects except those taking certain drugs. The selected women's age range averaged 50.76 ± 2.52 years and went through a four week experimental period.

[Kupperman Index]
This is a questionnaire generally used as a scale to evaluate menopausal symptoms, which is scored with the degree of menopausal symptoms and consists of 12 questions, a four-point scale (0: none, 1: weak, 2: moderate , 3: Strong), the higher the score, the more menopausal symptoms are judged to be stronger. The Kupperman index evaluation items are shown in FIG.

  In Examples 1 to 3, the change in KI score and the change in itemized score before and after intake for the menopausal women were evaluated.

  As a result of the experiment, as shown in Table 2 below, it was confirmed that the improvement effect of menopausal symptoms appeared in the compound (Examples 1 to 3) containing Mandala extract and Mandala component. In the case of menopausal women, Kupfferman's index scores were measured lower when taking Examples 1 to 3 compared to before taking the intake, and in particular, in the case of Example 3, the effect was most excellent.

[MRS (Menopause Rating Scale)]
-A questionnaire generally used as a scale to evaluate menopausal symptoms, scored with the degree of menopausal symptoms and consisting of 11 questions, a five-point scale (0: none, 1: weak, 2: moderate Degree, 3: Strong, 4: Very strong), and the higher the score, the more menopausal symptoms are considered to be stronger. The MRS evaluation items are shown in FIG.

  Examples 1 to 3 evaluate the change in MRS score and the change in itemized scores before and after intake for the menopausal women.

  As a result of the experiment, as shown in Table 3 above, it was confirmed that the improvement effect of the menopausal symptoms appeared in the compound (Examples 1 to 3) containing Mandala extract and Mandala component. In the case of menopausal women, the intake of Examples 1 to 3 measures the MRS score lower than before intake, and in particular, in the case of Example 3, the effect is most excellent.

<Experimental example 2: Measurement of 24 h body temperature change>
In the case of menopausal women, they experience rapid temperature changes frequently in their daily lives, and this causes flushing and sleep disorder symptoms to appear, which is related to the compositions according to Examples 1 to 3 above. In order to confirm the improvement effect, the continuous temperature change of the 60 menopausal female test subjects was measured.

  In order to measure the temperature, subjects attach a temperature tracker patch (Temptraq®) to the center of their chest for 3 days (72H) each for 3 days before and after intake of the present composition, and from changes in body mean temperature and standard deviation The thermoregulatory effect was evaluated. Body temperature data were analyzed to determine the mean temperature and standard deviation for each study subject.

  As a result of the experiment, as shown in Table 4 below, it was confirmed that the body temperature deviation reducing improvement effect appeared in the compound (Examples 1 to 3) containing Mandala extract and Mandala component. Therefore, the composition according to the present invention is excellent in improving the physical heat balance of menopausal women, and in particular, Example 3 is the best.

<Experimental example 3: Measurement of body temperature-Confirmation of body heat balance and heat sensation alleviation effect>
Use the thermal imaging camera R300S (NEC, Japan) to check the upper body, face, and hand area to confirm the effect of alleviating the heat sensation and the heat balance improvement effect that occur on the upper body (chest, face, etc.) Photographs were taken and analyzed to make skin temperature assessments for each part. The infrared thermal imaging camera always kept a constant angle and distance when photographing the test site.

Upper body, face: Confirmation of the alleviating effect of hot feeling (representative inconvenient symptoms of menopausalism) relieving The heat relieving effect on the upper body and face was confirmed for the subjects who took Example 1 and Example 3 . The experimental results are shown in FIGS. 3a-3b and 4a-4b. FIGS. 3 a and 4 a show the subject who took Example 1 and FIGS. 3 b and 4 b show the subject who took Example 3.

  Referring to FIGS. 3-4, the original was a color drawing and gray scale was applied in the process of converting it to a monochrome drawing. The hue scale for each skin temperature is displayed in the temperature-based hue display located in the lower part of FIG. 3, the skin temperature is higher as it is located on the right (red series in the original), and the skin temperature is lower as it is located on the left (The original is blue series) Displayed.

  The hue scale for each skin temperature is displayed in the temperature-specific hue display located on the right side of FIG. 4; the skin temperature is higher as it goes up in the upper row (red series in the original) and the skin temperature is lower as it goes down in the lower (original Is displayed in blue series).

  Referring to FIGS. 3 to 4, the skin temperature of about 35 ° C. is displayed in red in the original and in bright colors in a monochrome drawing, and this part is a part where the skin temperature is high. Referring to FIGS. 3 to 4, it can be confirmed that the portion displayed in a bright color in the monochrome drawing, that is, the portion where the skin temperature is high has decreased after intake as compared to before intake.

  As a result of the experiment, as shown in Figs. 3 to 4, it is confirmed that there is a heat sensation alleviating effect on the upper body and face because the area of the high skin temperature area after intake is reduced compared to before intake. I was able to.

Hand: Confirmation of body temperature raising effect at hand site where heat transfer is not successful and temperature is low measured Temperature raising effect at hand site for subjects who ingested Example 1 and Example 3 confirmed. The experimental results are shown in Figures 5a-5b. FIG. 5 a shows the subject who took Example 1; FIG. 5 b shows the subject who took Example 3;

  Referring to FIG. 5, the original was a color drawing and gray scale was applied in the process of converting it to a monochrome drawing. The hue scale for each skin temperature is displayed in the temperature-specific hue display located on the right side of FIG. 5; the skin temperature is higher as it goes up in the upper row (red series in the original) and the skin temperature is lower as it goes down in the lower (original Is displayed in blue series).

  As a result of the experiment, as shown in FIG. 5, in the case of the hand site where the heat transfer was not successful and the temperature was measured low, when Example 1 and Example 3 were taken, the heat transfer to the end part of the body site was successful. It was confirmed that the temperature was rising.

  As described above, when a postmenopausal woman ingests Example 1 and Example 3 according to one aspect of the present invention, the temperature of the upper body with high temperature decreases and the temperature of the cold site increases, and the heat of the whole body We were able to confirm the effect of improved balance.

<Experimental example 4: Facial photography using Visia-CR and evaluation of skin hot flashes on cheeks>
In order to confirm the improvement effect of the phenomenon of defacement due to the heat rise (hot feeling) of the upper body, the color change of the facial region of the 60 menopausal female test subjects who ingested the composition of Examples 1 to 3 was measured did. The measurement was taken without flushing and sweating symptoms.

  Side profiles were taken using a high resolution digital camera [Visia-CR (Canfield Imaging System, USA)] for analysis of facial color change. A fixed angle was kept at the time of photographing using a jaw base and a forehead support, and the distance between the study subject and the camera was always kept constant.

  For the analysis of hot skin, after converting a face picture taken in cross-polarized mode to RBX Red, the buccal site is designated as the test site and S is measured using an image analysis program (Image-Pro Plus, USA) The average value of (Saturation) was determined. It means that skin warmth decreases as S value decreases.

  As a result of the experiment, as shown in Table 5, it was confirmed that the skin hot flashes (flashing) reducing effect appeared in the compound (Examples 1 to 3) containing Mandala extract and Mandala component.

<Experimental example 5: Measurement of skin moisturization at the cheek site using a Corneometer>
60 menopausal women who took the composition of Examples 1 to 3 in order to confirm the improvement effect of the skin dryness symptom (water loss) symptom due to the heat generated as the menopausal symptoms, especially the heat of the facial region Moisturization of the cheek area of the skin was measured.

  Skin moisturization at the buccal site was measured using Corneometer CM 825 (Courage and Khazaka, Germany). This is the principle of measuring the electrostatic loading capacity (capacitance) of the current conducted by the electrode gap adhering to the skin surface, and the moisturizing amount was measured three times and the average value was obtained and evaluated. The higher the skin's water content, the higher the figure.

  As a result of the experiment, as shown in Table 6 above, it was confirmed that the moisturizing of the facial region was improved with the compound (Examples 1 to 3) containing the extract of Mandala and Mandrel component.

<Experimental example 6: Questionnaire survey of vaginal symptoms>
Questionnaires were made on the representative symptoms that appear due to changes in the urogenital organs of menopausal women, and the symptoms were scored and scored. A questionnaire survey was conducted on the 60 menopausal female test subjects who took the compositions of Examples 1 to 3 according to changes in the urogenital area of menopausal women.

  The questionnaire consists of a total of 5 questions, using a 4-point scale (0: none, 1: weak, 2: moderate, 3: strong), and the higher the score, the more inconvenient symptoms of the vagina, which is a female organ, The evaluation items of the questionnaire are shown in FIG.

  As a result of the experiment, as shown in Table 7 above, it was confirmed that vaginal symptoms were improved by the compound (Examples 1 to 3) containing Mandala extract and Mandala component.

It is a Kupperman index (Kupperman Index) evaluation item which concerns on Experimental example 1 of this invention. It is a menopausal disorder rating scale (Menopause Rating Scale) evaluation item which concerns on Experimental example 1 of this invention. It is the photograph which measured the heat feeling alleviation effect ( subject which took in Example 1 ) in the upper body concerning experimental example 3 of the present invention. It is the photograph which measured the heat feeling alleviation effect ( subject who took in Example 3 ) in the upper body concerning experimental example 3 of the present invention. It is the photograph which measured the heat feeling alleviation effect (subject who took in Example 1 ) in the face concerning the example 3 of an application of this invention. It is the photograph which measured the heat feeling alleviation effect (subject who took in Example 3 ) in the face concerning the example 3 of an application of this invention. It is the photograph which measured the temperature fall alleviation effect ( subject who took in Example 1 ) in the site | part of the hand which concerns on Experimental example 3 of this invention. It is the photograph which measured the temperature fall alleviation effect ( subject who took in Example 3 ) in the site | part of the hand which concerns on Experimental example 3 of this invention. It is a vaginal symptom evaluation item which concerns on Experimental example 6 of this invention.

Claims (11)

  A composition for ameliorating female menopausal symptoms, or a composition for preventing or treating female menopausal diseases, which comprises a mandala extract as an active ingredient.   The composition according to claim 1, wherein the composition further comprises a lotus root extract.   The composition is any one selected from the group consisting of silkworm extract, Japanese persimmon extract, Japanese touki extract, Sanshuyu extract, cinnamon extract, kudzu root extract, small mustard incense extract, and licorice extract The composition of claim 2 further comprising one or more. The extract was water _extract, a C 1 -C ₅ alcohol extract or _C 1 -C ₅ alcohol aqueous extract composition of claim 1.   The composition according to claim 1, wherein the extract of Mandala versicolor is 0.001 to 90% by mass based on the total mass of the composition.   The composition according to claim 1, wherein the composition for ameliorating female menopausal symptoms improves physical heat balance of a menopausal woman.   The composition according to claim 1, wherein the composition for ameliorating female menopausal symptoms improves physical heat balance of a menopausal woman.   The composition according to claim 1, wherein the female menopausal disease is menopausal muscle disease, bone disease or heart disease. The bone disease is rheumatoid arthritis due to menopausal disease, degenerative arthritis, osteoporosis, rickets, osteomalacia disease, or Paget's disease of bone; or the heart disease is narrow due to menopausal disease The composition according to claim 8, which is a cardiovascular disease or arteriosclerosis.   10. The composition according to any one of the preceding claims, wherein said composition is a pharmaceutical composition.   The composition according to any one of claims 1 to 7, wherein the composition for alleviating female menopausal symptoms is a health functional food composition.