KR102275268B1 - Composition for relieving menopausal symptom or osteoporosis - Google Patents

Abstract

The present invention relates to a composition for preventing or improving women's menopausal symptoms and/or osteoporosis, and since the composition of the present invention has a rapid effect on preventing or improving women's menopausal symptoms, a hormone used for preventing or improving conventional menopausal symptoms It can be usefully used for Hormone replacement therapy (HRT).
In addition, the composition of the present invention has no cytotoxicity, unlike conventional therapeutic agents for female menopausal symptoms, has few side effects enough to be used as food, and is safe, so it can be effectively used compared to conventional therapeutic agents for female menopausal symptoms.

Description

Composition for improving menopausal symptoms or osteoporosis {COMPOSITION FOR RELIEVING MENOPAUSAL SYMPTOM OR OSTEOPOROSIS}

The present invention relates to a composition for preventing, improving, or treating women's menopausal symptoms and/or osteoporosis, comprising the extract of the ginseng root mixture.

Menopause in women refers to the cessation of menstruation that occurs when the genetically determined ovarian function reaches the end of its life span for about 50 years after birth. It means loss of fertility and is a physiological change rather than a pathological phenomenon. Currently, the average lifespan of Korean women is 81.2 years (2011: Statistics Korea), and if the average age of menopause prescribed by the Korean Society of Obstetrics and Gynecology is 50, it is estimated that more than one third of a woman's life is spent in a state of depletion of female hormones. (Pharmaceutical Information Service, Kim Seong-cheol).

As women approach menopause, changes occur throughout the body, including the vascular system, musculoskeletal system, genitourinary system, and cranial nerve, due to imbalance and decrease in female hormone secretion. In other words, vasomotor symptoms and psychological symptoms such as hot flashes, night sweats, sleep disturbance, fatigue, depression, anxiety, difficulty concentrating, dyspareunia due to memory disturbance and urogenital atrophy, frequent urination, loss of skin elasticity due to collagen decrease, and breast It is accompanied by various diseases such as sagging, cardiovascular and musculoskeletal symptoms, dementia, and the like (Non-Patent Document 1). Although menopausal symptoms differ from person to person, it has been reported that the more experienced, the more severe, and the longer the duration of menopause symptoms, the lower the quality of life for women (Non-Patent Document 2). It is more likely to progress to chronic diseases with aging.

Hormone therapy, drug therapy, exercise therapy, and diet can be applied to the treatment of menopausal symptoms, but female hormone therapy, which is widely used medically, may increase the risk of breast cancer, etc. , may increase the rate of hypertension. Therefore, in recent years, many studies have been conducted on phytoestrogen, which is reported to have a function similar to estrogen, in order to replace estrogen therapy and other drug therapies (Non-Patent Document 3).

Prior studies related to the improvement of menopausal symptoms include angelica, cheongung, baekchul, baekbongryeong, red ginseng and soybean extract as main ingredients, and functional foods that can improve menopausal symptoms (Patent Document 1), and astragalus, kaleidoscope, arrowroot, As a food containing soybean extract as a main component, there is a food (Patent Document 2) having an excellent improvement effect on women's menopausal symptoms.

89% of women who experience spontaneous menopause experience at least one of the symptoms of menopause, and menopausal symptoms are also reported to be common. Accordingly, the present inventors have developed a natural material that can effectively alleviate menopausal symptoms and effectively improve osteoporosis due to menopause, and have completed a composition for preventing or improving female menopausal symptoms comprising a mixture of extracts of ginseng root and crustaceans.

1. Republic of Korea Patent Publication 10-2003-0048109 2. Republic of Korea Patent Publication 10-2006-0031203

1. J Korean Soc Menopause, 2012, 18: 94-99 2. Women health Noursing, Hyunmoonsa, 1997 3. J East Asian Soc Dietary Life, 2006, 16(5), 533~541

An object of the present invention is to provide a composition effective for preventing, ameliorating or treating the general symptoms of female menopause and/or osteoporosis.

The present invention provides a composition for the prevention, treatment or improvement of menopausal symptoms and/or osteoporosis, comprising the extract of rhubarb root and crustaceans.

The composition may be a food composition, a pharmaceutical composition or a cosmetic composition.

In addition, the present invention provides a health functional food containing the extract.

In addition, the present invention provides a cosmetic, pharmaceutical and/or quasi-drug comprising the composition.

Since the composition according to the present invention has a rapid effect on the prevention or improvement of female menopausal symptoms and/or osteoporosis, it can be usefully used for hormone replacement therapy (HRT) used for the prevention or improvement of conventional menopausal symptoms. .

In addition, the composition according to the present invention does not have cytotoxicity unlike conventional therapeutic agents for female menopausal symptoms or osteoporosis, and has few side effects and is safe enough to be used as food, so it is used as a therapeutic agent for conventional female menopausal symptoms and/or osteoporosis. The usability is high.

1 is a graph showing the cell activity of a mixed extract according to an embodiment of the present invention against an estrogen receptor-positive human breast cancer cell line.
2 is a graph showing the proliferation promoting effect on osteoblasts of the mixed extract of the present invention according to an embodiment of the present invention;
3 is a graph showing the differentiation promoting effect on osteoblasts of the mixed extract according to an embodiment of the present invention.
4 is a graph showing the proliferation inhibitory effect on osteoclasts of the mixed extract according to an embodiment of the present invention.

The present invention relates to a composition for preventing, ameliorating or treating menopausal symptoms, comprising the extract of ginseng root and crustacean extract.

In addition, the present invention relates to a composition for preventing, improving, or treating osteoporosis, comprising the extract of rhubarb root and crustaceans.

Hereinafter, the composition according to the present invention will be described in more detail.

In one embodiment of the present invention, the cell activity is improved by treating the mixed extract of the extract of the ginseng extract and the crustacean extract in a breast cancer cell line (MCF-7 cell line), and the extract of the present invention is directly taken using the Kupperman index. As a result, it was confirmed experimentally that the menopausal symptoms were improved (Experimental Examples 1 and 5). In addition, when the mixed extract of the present invention was treated with osteoblast-like cells (MG-63 cells), the proliferation of osteoblasts was promoted, and on the contrary, it was experimentally confirmed that the proliferation was inhibited in osteoclasts (Experimental Examples 2 to 4) ).

Therefore, since the mixed extract of the present invention can treat or improve menopausal symptoms and osteoporosis at the same time, the composition of the present invention may be a composition for preventing, treating or improving menopausal symptoms and osteoporosis, including the extract of the ginseng root and the crustaceans.

As described above, the composition for preventing or improving menopausal symptoms and/or osteoporosis according to the present invention includes a mixed extract. The mixed extract includes extracts of garlic root and crustaceans. More specifically, the mixed extract is a mixed extract of ground root and crust

The mixed extract may contain 1 to 100 parts by weight of the crust extract based on 10 parts by weight of the extract of the ginseng root. Preferably, the crust extract may be included in an amount of 5 to 50 parts by weight, more preferably 8 to 20 parts by weight, based on 10 parts by weight of brown root. In an embodiment of the present invention, it was confirmed that the mixed extract containing the extracts of brown root and crustaceans in a 1:1 ratio was superior to the single extract in improving or preventing the symptoms of female menopause and osteoporosis.

In addition, the brown root and crust mixed extract may further include 1 to 100 parts by weight of the crust extract based on 10 parts by weight of the brown root extract, preferably 5 to 50 parts by weight, more preferably 8 to 20 parts by weight. can

In the present invention, ' Puerariae Radix ' is a perennial creeping herb belonging to Leguminosae, arrowroot ( Pueraria). lobata ), it is a herbal medicine widely used in oriental medicine clinical practice due to its effects of regurgitation, saengjin (生津), tussine (透疹) and elevating branch (升阳止瀉). Garlic contains various compounds belonging to isoflavones.

In the present invention, 'Citri Furctus' refers to the fruit of Citrus aurantum, Citrus natsudaidai, or its cultivars (Rutaceae) belonging to the rutaceae family. Various compounds belonging to flavones and flavonoids as main components have been isolated, and it is reported that they are effective in antioxidant and anti-inflammatory properties. A specific example of crust, Aurantium acre , Aurantium bigarella , Aurantium corniculatum , Aurantium corniculatum , Aurantium coronatum , Aurantium distortum , Aurantium humile , Aurantium myrtifolium , Aurantium orientale , Aurantium Silvestre , Aurantium sinense , Aurantium variegatum , Aurantium vulgare, Citrus bigaradia, Citrus humilis, Citrus amara, Citrus aurata, Citrus benikoji, Citrus bigaradia, Citrus calot, Citrus canaliculata, Citrus changshan - huyou, Citrus communis, Citrus dulcimedulla, Citrus dulcis, Citrus florida, Citrus funadoko, Citrus fusca, Citrus glaberrima, Citrus humilis, Citrus intermedia, Citrus iwaikan, Citrus iyo, Citrus karna, Citrus keraji, Citrus kotokan, Citrus medioglobosa, Citrus mitsuharu, Citrus myrtifolia , Citrus natsudaidai, Citrus omikanto, Citrus pseudogulgul, Citrus reshni, Citrus rokugatsu, Citrus rumphii, Citrus sinograndis, Citrus subcompressa, Citrus sulcata, Citrus taiwanica, Citrus tangelo, Citrus tengu, Citrus tosa -asahi, Citrus truncate , Citrus vulgaris , Citrus yatsushiro , and Citrus yuge - hyokan , but are not limited to the above examples. The crust includes all those purchased commercially sold, or grown or harvested in nature.

In the present invention, the 'extract' can be prepared by extracting a plant body with an extraction solvent or by adding a fractionation solvent to an extract prepared by extracting it with an extraction solvent.

The extract or fraction includes extracts of all formulations that can be formed using the extract itself and the extract, such as dilution or concentration of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof. . Specifically, the extract of the present invention may be prepared and used in the form of a dry powder after extraction. In addition, after performing the extraction or fractionation process, a reduced pressure filtration process or additional concentration and/or freeze-drying may be performed to concentrate or remove the solvent. The obtained extract may be stored in a deep freezer until use.

The plants used in the extract of the present invention include both natural, hybrid or mutated plants of plants and cultures and cultures of plant tissues.

The type of the extraction solvent is not particularly limited, and any solvent known in the art may be used as long as an extract having the desired effect of the present invention can be obtained. Specifically, it may be at least one selected from the group consisting of water and an organic solvent. As the organic solvent, one or more solvents selected from the group consisting of alcohols having 1 to 5 carbon atoms such as methanol and ethanol, ethyl acetate, acetone, and chloroform may be used.

Preferably, water can be used. In a specific example, as a result of checking the degree of improvement in menopausal symptoms using a mixed extract of brown root and crust extracted using purified water, the viability, osteoblast differentiation and proliferation ability of cells treated with the mixed extract were improved, and the mixed extract It was confirmed that the menopausal symptoms of the ingested experimental group were improved.

The fractionation solvent may be water, butanol, ethyl acetate, chloroform, hexane, or a mixture thereof. The fraction may be an extract prepared by the above extraction method, specifically, a fraction obtained by further subjecting the crude extract to a fractionation process. The fractionation solvent may be a solvent selected from the group consisting of ethyl acetate, ether, chloroform, benzene, hexane, methylene chloride, and a mixed solvent thereof, preferably hexane. In the fractionation process, hexane, fluoroform, ethyl acetate, butanol and water were sequentially added to the crude extract, followed by layer-separated hexane fraction, chloroform fraction, ethyl acetate fraction, butanol fraction and water fraction were sequentially obtained can be done in this way.

The method for preparing the extract in the present invention is not particularly limited, and it may be extracted according to a method commonly used in the art. Non-limiting examples of the extraction method include a hot water extraction method, an ultrasonic extraction method, a filtration method, a reflux extraction method, and the like, and these may be performed alone or two or more methods may be performed together. In addition, in order to obtain a high-purity extract, the extract may be further extracted one or more times in a seasoned method.

In the present invention, 'menopausal symptoms' refers to symptoms and diseases that appear in women before and after menopause due to decreased estrogen secretion due to ovarian aging. It is also called 'menopausal syndrome' or 'menopausal symptoms'. Menopause or menopause symptoms include, for example, hot flashes, sweating, nervousness, depression, dizziness, fatigue, joint pain, muscle pain, headache, light palpitations, feeling of tightness, sweating during sleep, sleep disturbance, dry skin, vaginal dryness, vaginal atrophy , lower urethral atrophy, dyspareunia, vaginitis, cystitis, dysuria, urgency, difficulty concentrating, memory impairment, anxiety, nervousness, memory loss, dry skin, joint pain, or osteoporosis, and the like. It may also be a cardiovascular disorder such as heart disease, high blood pressure, or stroke.

In the present invention, 'osteoporosis' refers to a condition in which bone strength is weakened and fractures are highly likely, and is caused by genetic factors, early menopause, drugs or smoking. Therefore, it may be 'menopausal osteoporosis' caused by a decrease in hormone production due to menopause in women. Menopausal osteoporosis refers to osteoporosis symptoms caused by an imbalance between osteoblasts involved in bone formation and osteoclasts involved in tissue destruction and resorption in postmenopausal women due to a decrease in hormone production.

In the present invention, 'prevention' means any action that suppresses or delays a desired symptom by administering the composition of the present invention.

In the present invention, 'treatment' refers to any action that improves or disappears a desired symptom or disease by administering the composition of the present invention.

In the present invention, 'improvement' refers to any action in which the symptoms are improved or changed advantageously compared to before administration of the desired symptoms by administering the composition of the present invention.

The content of the extract included in the composition of the present invention may be included in an effective amount. The term 'effective amount' refers to the amount of the extract that can suppress or delay menopausal symptoms or osteoporosis, improve the symptoms already appeared, or promote the differentiation and proliferation of osteoblasts.

The content of the mixed extract included in the composition may be included in various weight % if it can prevent, improve or treat menopausal symptoms or osteoporosis. Specifically, with respect to the entire composition, the extract of the ginseng root may contain 0.001 to 30% by weight, and the crust extract may include 0.001 to 30% by weight. If each active ingredient is included below the lower limit, the efficacy of preventing, treating, or improving female menopausal symptoms or osteoporosis may not be exhibited. can affect

In addition, according to an embodiment of the present invention, the composition may include 1 mg to 1000 mg of the mixed extract with respect to 1 kg of the composition, preferably 5 mg to 500 mg, more preferably 5 mg to 100 mg may include

The composition according to the present invention may be a food composition for preventing or improving menopausal symptoms or osteoporosis, including a mixed extract.

In addition, the present invention provides a food for preventing or improving menopausal symptoms or osteoporosis comprising the composition.

Since the brown root and crust contained in the food composition of the present invention have been used as natural substances for a long time and have proven their stability, they can be prepared and consumed in the form of foods that can be consumed on a daily basis, so they have a high effect in preventing or improving menopausal symptoms and osteoporosis. can be expected

The 'food' means a natural product or processed product containing one or more nutrients, and preferably means a state that can be eaten directly through a certain amount of processing, and as a general meaning, a health functional food, It is meant to include all functional foods, beverages, food additives and beverage additives.

The food includes all foods in a conventional sense, and may be, for example, various foods, beverages, gum, tea, vitamin complexes, health functional foods, and the like. In addition, in the present invention, foods include special nutritional foods (eg, formula milk, young, baby food, etc.), processed meat products, fish meat products, tofu, jelly, noodles (eg, ramen, noodles, etc.), health supplements, seasoned foods ( Ex, soy sauce, soybean paste, red pepper paste, mixed soy sauce, etc.), sauces, sweets (eg snacks), dairy products (eg fermented milk, cheese, etc.), other processed foods, kimchi, pickled foods (various kimchi, pickles, etc.), beverages ( Examples include, but are not limited to, fruit and vegetable beverages, soy milk, fermented beverages, etc.) and natural seasonings (eg, ramen soup, etc.).

The food, functional food, health functional food, beverage, food additive and beverage additive may be prepared by a conventional manufacturing method.

The functional food is the same term as food for special health use (FoSHU), and refers to a food with high medical and medical effects processed to efficiently exhibit bioregulatory functions in addition to nutrition supply. . Herein, the term "functionality" refers to obtaining useful effects for health purposes, such as regulating nutrients or physiological actions with respect to the structure and function of the human body. The functional food of the present invention can be prepared by a method commonly used in the art, and at the time of manufacture, it can be prepared by adding raw materials and components commonly added in the art. In addition, the formulation of the functional food may be prepared without limitation as long as it is a formulation recognized as a functional food. The composition for food of the present invention can be prepared in various forms, and unlike general drugs, it has the advantage that there are no side effects that may occur during long-term administration of the drug using food as a raw material, and has excellent portability, and the present invention Functional food of can be consumed as a supplement to enhance the effect of preventing or improving menopausal symptoms or osteoporosis.

In the present invention, health functional food is a food group or food composition that has added value to act and express the function of the food for a specific purpose using physical, biochemical, and bioengineering methods, etc. It refers to food that is designed and processed to sufficiently express body control functions related to recovery, etc. It has an active health maintenance or promotion effect compared to general food, and health supplement food means food for the purpose of health supplementation. In some cases, the terms functional food, health food, and dietary supplement are used interchangeably.

Specifically, the health functional food is a food prepared by adding the extract of the present invention or a fraction thereof to food materials such as beverages, teas, spices, gums, and confectionery, or encapsulating, powdering, suspension, etc., when ingested. It means that it has a specific effect on health, but unlike general drugs, it has the advantage of not having side effects that may occur when taking a drug for a long period of time using food as a raw material.

The health functional food of the present invention may include the composition in an amount of 1 to 70% by weight, preferably 1 to 15% by weight, based on the total weight% of the health functional food.

The food may include a food additive that is pharmaceutically acceptable, and may further include suitable carriers, excipients and diluents commonly used in the manufacture of health functional foods.

The composition may include additional ingredients that are commonly used in food compositions to improve odor, taste, vision, and the like. For example, vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, pantothenic acid, and the like may be included. Also, it may include minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu), and chromium (Cr). In addition, it may include amino acids such as lysine, tryptophan, cysteine, and valine.

The composition comprises a preservative (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetate, etc.), a disinfectant (bleaching powder and high bleaching powder, sodium hypochlorite, etc.), an antioxidant (butylhydroxyanisole (BHA), butylhydroxytoluene, etc.) (BHT), etc.), coloring agents (tar pigments, etc.), coloring agents (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasonings (MSG sodium glutamate, etc.), sweeteners (dulcin, cyclimate, saccharin, sodium, etc.) ), flavorings (vanillin, lactones, etc.), swelling agents (alum, D-potassium hydrogen tartrate, etc.), strengthening agents, emulsifiers, thickeners (foams), film agents, gum base agents, foam inhibitors, solvents, food additives such as improving agents additives). The additive may be selected according to the type of food and used in an appropriate amount.

When the extract or a fraction thereof of the present invention is used as a food additive, the extract or a fraction thereof may be added as it is or used together with other foods or food ingredients, and may be appropriately used according to a conventional method. The mixed amount of the active ingredient may be suitably determined according to the purpose of its use (prevention, health or therapeutic treatment). In general, in the production of food or beverage, the food composition of the present invention is added in an amount of 15 parts by weight or less, preferably 10 parts by weight or less, based on the raw material. However, when ingested for a long period of time for health and hygiene purposes, it may contain an amount below the above range, and since there is no problem in terms of safety, the active ingredient may be used in an amount above the above range.

The present invention may be used as an example of a food composition as a health drink composition.

In the present invention, beverage means a generic term for drinking to quench thirst or enjoy taste, and includes health functional beverages.

The beverage is not particularly limited in other ingredients other than containing the extract as an active ingredient as an essential ingredient in the indicated ratio, and may contain various flavoring agents or natural carbohydrates as additional ingredients like a conventional beverage.

Examples of the natural carbohydrate include monosaccharides such as glucose or fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, or sugar alcohols such as xylitol, sorbitol, erythritol, etc. . The flavoring agent may be a natural flavoring agent such as stevia extract such as thaumatin or rebaudioside A or glycyrrhizin, or a synthetic flavoring agent such as saccharin or aspartame.

The amount of the natural carbohydrate added may be generally about 1 g to 20 g, preferably 5 g to 12 g per 100 ml of the food composition of the present invention. In addition, the composition of the present invention may further contain pulp for the production of natural fruit juice, fruit juice beverage, and vegetable beverage.

In addition to the above, the food composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavoring agents such as synthetic and natural flavoring agents, coloring agents and thickeners (cheese, chocolate, etc.), pectic acid and its salts, alginic acid and It may contain additives such as salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. The proportion of these additives is not very important, but is generally selected in the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the composition of the present invention.

The health functional beverage is a beverage group or beverage composition that has added value to act and express the function of the beverage for a specific purpose using physical, biochemical, and bioengineering methods, etc., to control biological defense rhythm, prevent disease and recover. It refers to a beverage designed and processed to sufficiently express the body control functions related to the living body.

The health functional beverage is not particularly limited in other ingredients except for containing the extract of the present invention as an essential ingredient in the indicated ratio, and may contain various flavoring agents or natural carbohydrates as additional ingredients like a conventional beverage.

The above food may additionally contain food additives, and, unless otherwise specified, whether it is suitable as a food additive according to the general rules and general test methods of the Food Additives Code approved by the Ministry of Food and Drug Safety and standards and standards for the item judged by

In addition, the composition according to the present invention may be a pharmaceutical composition for preventing or treating menopausal symptoms or osteoporosis including a mixed extract.

In addition, the present invention relates to a pharmaceutical or quasi-drug comprising the pharmaceutical composition.

According to one embodiment, it was confirmed that the viability of cells was improved by treating the mixed extract of the present invention on a breast cancer cell line (MCF-7 cell line), and as a result of directly taking the extract of the present invention using the Kupperman index, It was confirmed experimentally that the menopausal symptoms were improved (Experimental Example 1 and Experimental Example 5). In addition, it was experimentally confirmed that when the mixed extract of the present invention was treated with osteoblast-like cells (MG-63 cells), the proliferation of osteoblasts was promoted and, conversely, the proliferation of osteoclasts was inhibited (Experimental Examples 2 to 4). ).

The 'pharmaceutical composition' refers to a composition used for the purpose of diagnosing, treating, alleviating, treating or preventing diseases of animals including humans.

The content of the mixed extract included in the composition may be included in various weight % if it can prevent, improve or treat menopausal symptoms or osteoporosis. Specifically, with respect to the entire composition, the extract of the ginseng root may contain 0.001 to 30% by weight, and the crust extract may include 0.001 to 30% by weight. When each active ingredient is included below the lower limit, the efficacy of preventing or treating female menopausal symptoms may not be exhibited, and when included above the upper limit, the physical properties, color, and unique flavor of the active ingredient itself may affect the product. .

In addition, the pharmaceutical composition of the present invention may be used alone or in combination with other active pharmaceutically active compounds exhibiting a preventive or therapeutic effect on menopausal symptoms and/or osteoporosis, or in an appropriate group.

The composition of the present invention is administered in a pharmaceutically effective amount. The pharmaceutically effective amount means an amount sufficient to treat a disease with a reasonable benefit/risk ratio applicable to medical treatment and not to cause side effects, and the effective dose level is determined by the patient's health condition, disease type, severity, The activity of the drug, sensitivity to the drug, administration method, administration time, administration route and excretion rate, treatment period, factors including drugs used in combination or concurrently, and other factors well known in the medical field may be determined according to factors. Specifically, it is generally 0.01 mg to 5000 mg per day per 1 kg of the body weight of the administered subject, and may be administered in divided doses once or several times a day at regular time intervals according to the judgment of a doctor or pharmacist, but is not limited thereto.

The composition may be administered to mammals such as rats, mice, livestock, and humans by various routes such as parenteral and oral administration, and all modes of administration can be expected, for example, oral, rectal or intravenous, intramuscular , by subcutaneous, intrauterine intrathecal or intracerebroventricular injection.

The pharmaceutical composition of the present invention may include the above extract as an active ingredient alone, and may further include a pharmaceutically acceptable carrier, excipient, diluent and/or sub-component according to the formulation, method of use, and purpose of use. have.

More specifically, in addition to the above active ingredients, nutrients, vitamins, electrolytes, flavoring agents, coloring agents, thickeners, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, It may further contain glycerin, alcohol, a carbonation agent used in carbonated beverages, and the like.

The 'pharmaceutically acceptable' means that when it is physiologically acceptable and administered to an animal, preferably a human, it does not usually cause an allergic reaction such as gastrointestinal disorder, dizziness, or a reaction similar thereto. The pharmaceutically effective amount may be appropriately changed depending on the disease and its severity, the age, weight, health status, sex, administration route, and treatment period of the patient.

Examples of the pharmaceutically acceptable carrier, excipient or diluent include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, Cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil, propylhydroxybenzoate, talc, magnesium stearate and mineral oil , dextrin, calcium carbonate, dextrin, calcium carbonate, propylene glycol, liquid paraffin and at least one selected from the group consisting of physiological saline, but is not limited thereto, and all common carriers, excipients or diluents can be used.

The ingredients may be added independently or in combination to the active ingredient, the extract.

The formulation of the pharmaceutical composition may vary depending on the method of use, and may be formulated using a method well known in the art to provide rapid, sustained or delayed release of the active ingredient after administration to a mammal. can Examples of the formulation include ointments, creams, tablets, pills, powders, granules, capsules, suspensions, internal solutions, emulsions, syrups, aqueous solutions, non-aqueous solutions, suspensions and emulsions. It may be a formulation selected from the group consisting of .

For the formulation, excipients, for example, conventional fillers, extenders, binders, disintegrants, surfactants, anti-aggregants, lubricants, wetting agents, fragrances, emulsifiers, preservatives, sweeteners, fragrances or preservatives may be further included.

In general, solid preparations for oral administration include tablets (TABLETS), pills, soft or hard capsules (CAPSULES), pills (PILLS), powders (POWDERS), and granules (GRANULES), and such preparations include one or more An excipient, for example, may be prepared by mixing starch, calcium carbonate, sucrose or lactose, gelatin, and the like. In addition to simple excipients, lubricants such as magnesium stearate and talc may also be used.

In addition, liquid formulations for oral administration include suspensions (SUSTESIONS), internal solutions, emulsions (EMULSIONS), and syrups (SYRUPS). In addition to water or liquid paraffin, which are commonly used simple diluents, various excipients, for example, Wetting agents, sweetening agents, flavoring agents, preservatives, and the like may be included.

Examples that may be mentioned for dermal administration include dusting powders, emulsions, suspensions, oils, sprays, ointments, greasy ointments, cream pastes, gels, foams, or suitable for producing solutions, Transdermal therapeutic system (TTS) ) suitable carriers and/or excipients. The topical pharmaceutical preparation of the present invention may be in a semi-solid dosage form, and in particular, there are ointments (solution ointments, suspension ointments), creams, gels or pastes. Mainly used in the oil phase are fatty alcohols such as lauryl alcohol, cetyl alcohol, stearyl alcohol, fatty acids such as palmitic or stearic acid, liquid or solid paraffin or ozokerite, liquid to solid waxes, such as for example isopropyl myristate, natural fats or some synthetic fats such as coconut fatty acid triglycerides, hydrogenated oils such as hydrogenated peanut or castor oil, or fatty acid partial esters of glycerol such as glycerol monostearate or glycerol Distearate is present. Suitable emulsifiers include surfactants, for example nonionic surfactants, for example fatty acid esters of polyalcohols or ethylene oxide adducts thereof, such as polyglycerol fatty acid esters or polyoxyethylene sorbitan fatty acid esters, sorbitan fatty acid esters, such as sorbitan oleate and/or sorbitan isostearate and the like, isostearates, sterols, or polyoxyethylene fatty alcohol ethers or fatty acid esters such as anionic surfactants such as alkali metal salts of fatty alcohol sulfonates, Examples include sodium lauryl sulfate, sodium cetyl sulfate or sodium stearyl sulfate, which are commonly used in the presence of the fatty alcohol, for example cetyl alcohol or stearyl alcohol. Among these, it is possible to add to the aqueous phase an agent, for example, a polyalcohol, such as glycerol, sorbitol, propylene glycol and/or polyethylene glycol, which in particular prevents drying of the cream, or a preservative, a flavoring agent, etc., to the aqueous phase.

The pharmaceutical preparation of the present invention may be an anhydrous ointment, suitable for topical use and containing paraffin, particularly low-viscosity paraffin, which is liquid at body temperature, or the natural or partially synthetic fat, for example, coconut fatty acid triglyceride. Cerides, hydrogenated oils such as hydrogenated peanut or castor oil, fatty acid partial esters of glycerol such as glycerol monostearate and distearate, silicones such as polymethylsiloxanes such as hexamethyldisiloxane or octamethyltri It may contain siloxanes, for example fatty alcohols associated with water-based creams and increasing the water absorption capacity, and sterols, wool waxes, other emulsifiers and/or other additives.

In the present invention, when the pharmaceutical composition is formulated as a pharmaceutical, reference may be made to the contents disclosed in Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA, and the documents are incorporated as a part of this specification.

The pharmaceutical composition may be a quasi-drug composition.

As used herein, the term "quasi-drug" refers to fibers, rubber products, or the like, which are used for the purpose of treating, alleviating, treating or preventing diseases of humans or animals, have weak action on the human body or do not directly act on the human body, Non-machines and similar products, which are products that are used for sterilization, insecticide and similar purposes to prevent infection, and are used for the purpose of diagnosing, treating, alleviating, treating or preventing diseases of humans or animals. Items that are not instruments, machines, or devices, and items used for the purpose of pharmacologically affecting the structure and function of humans or animals, other than those that are not instruments, machines, or devices, specifically, external preparations for skin or individuals It may be a hygiene product, but is not limited thereto.

When the mixed extract or fraction of the present invention is added to a quasi-drug composition for the purpose of preventing or treating menopausal symptoms or osteoporosis, the extract or fraction may be added as it is or used together with other quasi-drug components, and appropriately according to a conventional method Can be used. The mixing amount of the active ingredient can be appropriately determined according to the purpose of use.

The external preparation for skin is not particularly limited thereto, but may be prepared and used in the form of, for example, ointment, lotion, spray, patch, cream, powder, suspension, gel, or gel. The personal care products are not particularly limited thereto, but specifically, soap, cosmetics, wet wipes, toilet paper, shampoo, skin cream, face cream, toothpaste, lipstick, perfume, makeup, foundation, ball touch, mascara, eye shadow, sunscreen It may be a lotion, a hair care product, an air freshener gel or a cleansing gel. In addition, another example of the quasi-drug composition of the present invention is a disinfectant cleaner, shower foam, wet tissue, detergent soap, hand wash, mask or ointment.

In addition, the pharmaceutical composition of the present invention may be used alone or in combination with methods using surgery, hormone therapy, drug therapy, and biological response modifiers for improvement, alleviation, treatment or prevention.

The present invention provides a method for preventing or treating menopausal symptoms or osteoporosis, comprising administering the composition for preventing or treating menopausal symptoms or osteoporosis to an individual

As used herein, the terms 'menopausal symptoms', 'menopausal osteoporosis', 'prevention', 'treatment' and 'administration' are the same as described above.

The dosage, administration frequency, and administration route for the administration are the same as described above.

As used herein, the term 'individual' refers to a monkey, cow, horse, sheep, pig, chicken, turkey, quail, cat, dog, mouse, rat, rabbit or It means all animals, including guinea pigs, and can effectively prevent or treat the disease by administering the composition of the present invention to an individual.

In addition, the composition according to the present invention may be a cosmetic composition.

The cosmetic composition may be for preventing or improving menopausal symptoms or osteoporosis. Specifically, it may be for improving or preventing symptoms such as dry skin or hot flushes caused by menopause.

The 'menopausal symptoms', 'menopausal osteoporosis', 'improvement' and 'prevention' of the present invention are as described above.

The effective amount of the extract included in the composition of the present invention may vary depending on the form in which the composition is commercialized, how the extract is applied to the skin, and the time it stays on the skin.

For example, when the composition is commercialized as a pharmaceutical for dermatological treatment, the extract may be included at a higher concentration than when commercialized as a cosmetic that is applied to the skin on a daily basis. Even when commercialized as cosmetics, in the case of wash-off type cosmetics, such as makeup removers and detergents, in which active ingredients stay on the skin within a short period of time, a relatively high concentration of extract may be included. On the other hand, in the case of leave-on type cosmetics, such as lotions, emulsions, creams, and essences, in which active ingredients stay on the skin for a long time, it may be okay to include a lower concentration of extracts compared to wash-off type cosmetics. .

In addition, the composition may be used as an external preparation for skin.

The composition can be used in any formulation that can be applied to the skin. Specific examples include solutions, suspensions, emulsions, pastes, gels, creams, lotions, powders, soaps, surfactant-containing cleansing, oils, foundations, lotions, cosmetic ointments, sprays, packs, sunscreens, makeup bases, powders, makeup It may have a formulation selected from the group consisting of a remover and a cleaning agent, but is not limited to the above examples.

The cosmetic composition containing the extract according to the present invention is a cosmetically acceptable carrier, diluent, adjuvant, colorant, stabilizer, flavoring agent, surfactant, oil, humectant, alcohol, thickener, antioxidant for easy use and handling. , pH adjuster, sunscreen, and the like, and when used as an external composition for skin, any formulation that can be applied to the skin, such as liquid, oil, cream, ointment, stick, pack, pasta, powder, etc. Available. In addition, these may be included alone or two or more types.

When the cosmetic composition is formulated as a cosmetic, it may contain a known dermatologically acceptable excipient acting as a carrier for the active ingredient, specifically, International cosmetic ingredient dictionary, 6th ed., The cosmetic, Toiletry and Fragrance Association , Inc., Washington, 1995 may be referred to. These documents are incorporated as part of this specification.

In addition, the present invention relates to a cosmetic comprising a mixed extract as an active ingredient.

The cosmetics may have any one formulation selected from the group consisting of lotions, essences, skins, lotions, creams, and packs.

The cosmetics include, for example, skin, skin softener, skin toner, astringent, lotion, milk lotion, moisture lotion, nourishing lotion, massage cream, nourishing cream, moisturizing cream, hand cream, foundation, essence, nourishing essence, pack, cleansing foam, There are cleansing lotions, cleansing creams, body lotions and body cleansers, but is not limited thereto.

Numerical values described in the above specification should be interpreted as including equivalent ranges unless otherwise specified.

Hereinafter, examples and the like will be described in detail to help the understanding of the present invention. However, the embodiments according to the present invention may be modified in various other forms, and the scope of the present invention should not be construed as being limited to the following examples. The embodiments of the present invention are provided to more completely explain the present invention to those of ordinary skill in the art.

[ Example ]

manufacturing example One. in vitro Preparation of extracts upon evaluation

The extract used in the following examples was an ethanol extract, which was purchased from OBM Lab Co., Ltd. and used. The extract is a raw material input process of mixing raw materials and 100% alcohol, extraction process at room temperature, filtration process to remove impurities, solid content It was prepared through a process of concentration to 85%, and used for in vitro cell experiments.

manufacturing example 2. Cooperman's index Manufacturing of soft capsules for clinical evaluation

The manufacturing process of soft capsules for clinical evaluation was largely divided into the process of making the main raw material (menopausal material) and the process of making the soft capsule.

First, as the main raw material, 10 times the amount of purified water was added to the dry powder sample of brown root, and then extracted at 80° C. for 6 hours using an extraction device. The extract was filtered using a filter paper having a diameter of 160 mm, and the filtered extract was concentrated under reduced pressure, followed by freeze-drying to prepare a powdery extract. The crust was prepared in the same way as the extract.

After that, the main raw material for menopause and excipients such as soybean oil, beeswax, and soybean lecithin d-alpha tocopherol are mixed and stirred to remove air bubbles to prepare the contents of the soft capsule, and purified water, color, glycerin, modified starch, and carrageenan are stirred to make the capsules. After preparing the base, the contents of the capsule base were filled and molded according to the weight, and then dried to prepare a soft capsule. Specific content ratios of the contents of the soft capsules are as shown in Table 1 below.

Raw material name Comparative Example 1 Comparative Example 2 Comparative Example 3 Example 1 Root Extract - 20 - 10 crust extract - - 20 10 soybean oil 92.95 72.95 72.95 72.95 beeswax 5 5 5 5 Soy Lecithin 2 2 2 2 D-α-tocopherol 0.05 0.05 0.05 0.05

Experimental example One. MCF -7 Cell Viability Measurement for Cells

Cell viability of the extract against the estrogen receptor-positive human breast cancer cell line, the MCF-7 cell line, was measured. CCK-8 analysis using MCF-7 cells is an experimental method that can confirm the effect that naturally-derived female hormones in a sample can have on women.

MCF-7 cells were cultured in 96 well plate using DMEM medium supplemented with 10% FBS. After culturing for 24 hours, it was divided into a negative control group (untreated group, control) and a positive control group (Estradiol treatment group, E2). Afterwards, using CCK-8, cell viability was measured. 10 μl of CCK-8 reagent per 100 μl of medium was treated, and absorbance was measured at 450 nm after 1 hour. The results are shown in FIG. 1 .

As shown in FIG. 1 , the cell activity was higher than that of the untreated group when each extract was treated with each extract, but the cell viability (Cell Viability) when the extracts were mixed with each extract was higher than that of each extract alone. ) was significantly improved compared to other treatment groups.

Experimental example 2. Osteoblast proliferation promoting effect

CCK-8 assay was performed on human osteoblast-like MG-63 cells to confirm the osteoblast proliferation promoting effect.

Experiments were conducted with a negative control group (untreated group, control) and a positive control group (Estradiol treatment group, E2), each individual extract treatment group (P. was performed

First, a uniform number of MG-63 cells were cultured in a 96-well plate using EMEM medium supplemented with 10% FBS. After culturing for 24 hours, the medium was replaced with EMEM medium without FBS, and the negative control group (untreated group, control), the positive control group (Estradiol treatment, E2), the brown root extract and the crust extract were treated individually, respectively, and the brown root and crust were 1: 1, and each of the mixed extracts was treated. After 48 hours of treatment, cell viability was measured using CCK-8. 10 μl of CCK-8 reagent per 100 μl of medium was treated, and absorbance was measured at 450 nm after 1 hour. The results are shown in FIG. 2 .

As shown in FIG. 2 , when the mixed extract of brown root and crustaceans was treated, it was confirmed that the osteoblast proliferation effect was better than that of the single extract treatment group, and compared with the positive control group (E2 treatment group) when the mixed extract was treated It was also confirmed that the osteoblast proliferation effect was more excellent.

Experimental example 3. Osteoblast differentiation promoting effect

In order to confirm the osteoblast differentiation promoting effect of each extract, ALP activity was measured in human osteoblast-like MG-63 cells. First, a uniform number of MG-63 cells were cultured in a 24-well plate using DMEM medium supplemented with 10% FBS. After culturing for 24 hours, the medium was changed to 10% charcoal stripped FBS containing phenol red free medium (medium), and the negative control group (untreated group, control) and positive control group (Estradiol, E2), brown root extract, and crust extract were treated alone. , was treated with a mixed extract at 1:1 ratio of ginseng root + crust. After culturing for 3 days, it was treated once again with the same concentration of extract in the same medium and then cultured for 3 more days. After a total of 6 days of culture, assays were performed with SensoLyte® pNPP Alkaline Phosphatase Assay Kit (ANASPEC AS-72146) to measure ALP activity. Cells are washed twice with assay buffer, 200 μl of assay buffer containing Triton X-100 is added, and the plate is placed on ice for 10 minutes shaking incubation. did. After transferring the cell suspension to a microcentrifuge tube, centrifuged at 2500 X g at 4°C for 10 minutes, and 50 μl of the supernatant and 50 μl of pNPP substrate were placed in a 96 well plate for 30 minutes. After the reaction, absorbance was measured at 405 nm. The results are shown in FIG. 3 .

As shown in FIG. 3 , it was confirmed that the cells treated with the mixed extract exhibited the efficacy of promoting osteoblast differentiation much more than the single treatment group.

Experimental example 4. Inhibitory effect on osteoclast proliferation

To confirm the osteoclast proliferation inhibitory effect of each extract, osteoclasts were cultured with B-bridge® Rat Primary Precursor Osteoclasts Culture Kit, and then CCK-8 assay was performed. First, a uniform number of cells were seeded in a 96-well plate using the culture medium included in the kit, and then a negative control group (untreated group, control) and a positive control group (Estradiol-treated group, E2) , Gargeun and Crustaceae alone extracts and Crustacea + Crustaceae mixed extracts were treated with different concentrations (10, 50, 100ppm). After 72 hours of sample treatment, cell viability was measured using CCK-8. 10 μl of CCK-8 reagent per 100 μl of medium was treated, and absorbance was measured at 450 nm after 1 hour. The results are shown in FIG. 4 .

As shown in FIG. 4 , it was confirmed that the cells treated with the mixed extract exhibited the efficacy of inhibiting osteoclast proliferation much more effectively compared to the single extract treatment group. In particular, it was confirmed that the effect of inhibiting osteoclast proliferation significantly increased as the treatment concentration increased.

Experimental example 5. Evaluation of the effect of alleviating menopausal symptoms

60 women in their late 40s to 50s suffering from menopausal symptoms were randomly divided and the soft capsules of Comparative Examples 1 to 4 and Example 1 were taken 3 capsules a day for 8 weeks, and then the degree of improvement in menopausal symptoms was evaluated did.

Comparative Example 1 refers to a group that did not take the extract, Comparative Example 2 refers to a group that took the extract alone, Comparative Example 3 refers to a group that took the extract alone, and Example 1 refers to the group that took the mixed extract of Garlic Root and Crustaceae.

The degree of improvement in menopausal symptoms after 8 weeks of ingestion was measured by the Kupperman index, and when the value before ingestion was taken as 100, the relative values after ingestion are shown in Table 2 below.

The Kupperman index (KI) used in the present invention is a menopausal index used in academia, and has 11 symptoms (hot flush, sweating, insomnia, nervousness, depression, dizziness, fatigue, joint and muscle pain, headache, and chest palpitations) that appear in menopausal women. distance, vaginal dryness) is scored, and the score of each item is multiplied by a weight to give a score, and the sum of these scores is the menopause score.

Comparative Example 1 Comparative Example 2 Comparative Example 3 Example 1 93.3 86.4 89.3 78.8 * The lower the total Kupperman index, the better the symptoms.

From Table 2, it was confirmed that the composition of Example 1, in which the black root and crust was mixed, was much more effective in relieving menopausal symptoms than when each extract was treated alone.

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Claims (23)

A food composition for preventing or improving menopausal symptoms, comprising the extracts of ginseng root and crustaceans as active ingredients. The method of claim 1,
With respect to 10 parts by weight of the extract,
A food composition for preventing or improving menopausal symptoms comprising 1 to 100 parts by weight of a crust extract. 3. The method according to claim 1 or 2,
The extract is an extract of one or more extraction solvents selected from the group consisting of water, alcohol having 1 to 5 carbon atoms, ethyl acetate, acetone, and chloroform. 3. The method according to claim 1 or 2,
A composition further comprising one or more components selected from the group consisting of soybean oil, beeswax, lecithin and tocopherol. A health functional food for preventing or improving menopausal symptoms, which contains extracts of garlic root and crustaceans as active ingredients. 6. The method of claim 5,
With respect to 10 parts by weight of the extract,
A health functional food for preventing or improving menopausal symptoms comprising 1 to 100 parts by weight of a crust extract. 7. The method according to claim 5 or 6,
The extract is an extract of one or more extraction solvents selected from the group consisting of water, alcohol having 1 to 5 carbon atoms, ethyl acetate, acetone and chloroform, food. A pharmaceutical composition for the prevention or treatment of menopausal symptoms, comprising the extracts of ginseng root and crustaceans as active ingredients. 9. The method of claim 8,
With respect to 10 parts by weight of the extract,
A pharmaceutical composition for preventing or treating menopausal symptoms comprising 1 to 100 parts by weight of a crust extract. 10. The method according to claim 8 or 9,
The extract is an extract of one or more extraction solvents selected from the group consisting of water, alcohol having 1 to 5 carbon atoms, ethyl acetate, acetone, and chloroform. A cosmetic composition for preventing or improving menopausal symptoms, comprising extracts of garlic root and crustaceans as active ingredients. A cosmetic comprising the composition according to claim 11 . 10. A pharmaceutical product comprising the composition according to claim 8 or 9. A quasi-drug comprising a composition for the prevention or improvement of menopausal symptoms, comprising the extracts of garlic root and crustaceans as active ingredients. delete delete delete delete delete delete delete delete delete

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