KR101793531B1 - A composition and functional food comprising an combination extract of Atractylodes macrocephala KOIDZ, Morus alba L., Lycium chinensis, Euphoria lingan STEUD, Achyranthus japonica NAKAI, Eucommia ulmoides OLIV and Asparagus cochinchinensis MERR for preventing or treating postmenopause syndrome - Google Patents

Abstract

The present invention relates to a composition comprising a combination herb medicine extract of Atractylodes macrocephala koidz, Morus alba, Lycium chinense, Dimocarpus longan, Achyranthes aspera, Eucommia ulmoides and Asparagus cochinchinensis for preventing or treating menopausal syndrome as active ingredients. Based on measurement of an effect on reducing recessive flush by using the skin temperature of the tail of menopausal mice, and experiments for evaluating the endurance athletic performance using mice, it was confirmed that an endurance athletic time is increased in an extract administration group compared to a control group, and an increase in the skin temperature of the tail is inhibited, so that it was confirmed that the extract has effects of reducing and treating menopausal syndrome, and can be utilized as a raw material for manufacturing medicines, health functional foods and health supplements.

Description

TECHNICAL FIELD The present invention relates to a composition for the treatment and prevention of a menopausal syndrome containing an extract of a herbal medicine as an active ingredient, a combination of Atractylodes macrocephala KOIDZ, Morus alba L., Lycium chinensis, Euphoria lingan STEUD, Achyranthus japonica NAKAI, Eucommia ulmoides OLIV and Asparagus cochinchinensis MERR for preventing or treating postmenopause syndrome}

The composition containing the herbal extracts of the present invention as an active ingredient in combination with the herbal extracts of the present invention has the ability to measure the global athletic ability and the skin temperature of the tail using the menopausal mice, Increased exercise time, and increased skin temperature. Therefore, the composition of the present invention is useful for prevention and improvement of menopausal syndrome related to change in female hormone levels and female hormone action before and after menopause or disease.

[Patent Document 1] Korea Patent No. 10-1400913

[Patent Document 2] Korean Patent No. 10-0419121

[Literature 3] Ipseub et al. 1, Daeheejaejang, Daeheejang, Yeonglim, pp545-548, 1998

[Literature 4] Ipseub et al. 1, Daehae Encyclopedia, Young Lim, pp. 826-828, 1998

[Literature 5] I, I, and others 1

[Patent Literature 6] Paech K, Webb P, Kuiper G, Differential ligand activation of estrogen receptors ER-alpha and ER-beta at AP1 site. Science , 1997,277 ; 1508-1510

[7] Na-Ra Han, Na-Rae Kim, Hyung-Min Kim Hyun-Ja Jeong, Cysteine prevent menopausal syndromes in ovariectomized mouse, Reproductive Sci , 2016, 23 , 670

[Document 8] Minghua Li, Chunmei Li, Wade S. Parkhouse, Age-related differences in the des IGF-I-mediated activation of Akt-1 and p70 S6K in mouse skeletal muscle, Mechanisms of Ageing and Development, 2003, 124: 771

The present invention relates to a composition for treating and preventing menopausal syndrome, which comprises, as an active ingredient, a herbal medicine extract of a combination of Pyrrhiza edulis, Liliaceae, Pyralidae, Pyralidae, Liliaceae,

Menopause is an inevitable phenomenon in all women, but the resulting deficiency of female hormones is an important factor that causes physical and mental diseases over a long period of time. The so-called " postmenopausal syndrome " includes various symptoms and diseases, which can be classified into early acute symptoms, mid-term symptoms, and long-term sequelae of the terminal period. The early symptoms of menopause include vasomotor symptoms such as hot flushes and night sweats, and mental and psychological symptoms, which show limited characteristics that disappear with the passage of menopause. Mid-term symptoms include symptoms of atrophy of the urogenital system and symptoms caused by collagen loss from the connective tissue of each part of the body. This mid-term symptom, as opposed to acute initial symptoms with limited characteristics, is exacerbated as the menopausal period elapses.

The long-term after effects of the late menopausal period, such as osteoporosis, cardiovascular disease and cerebrovascular disease, are the major diseases and senile dementia. (Hwang, Hyung-moo) Menopausal Symptoms and Female Hormone Therapy Korean Medical Journal, Vol. 49, No. 1, 11-29,

According to the results of a study on postmenopausal symptoms performed in Korea since the 1980s, the prevalence rate of menopausal symptoms in postmenopausal women in Korea has ranged from 57% to 90%. The range of symptoms experienced is neurosis, musculoskeletal symptoms, fatigue and general weakness, Frequency and intensity. In menopausal symptoms, facial flushing and sweating were reported to be more symptomatic in the late 1990s than in the 1980s. In the 2000s, 89% of women who experienced natural menopause experienced at least one of menopausal symptoms, and facial flushing was reported to be the most common (61%). (Behavioral Patterns of Menopausal Symptoms and Survey on the Actual Conditions of Women's Health) No. 2012-E63013-00.

Hormone therapy is typically used to treat such diseases or conditions related to female hormone regulation. However, hormone therapy has been shown to cause side effects such as breast cancer, stroke, heart attack, venous thrombosis, and cardiovascular disease. (Korean Patent No. 10-1400913)

In order to overcome the problems caused by the hormone therapy, development of an agent for improving female menopausal symptoms based on natural herbal medicine has been attempted.

Atopy is a perennial herbaceous plant belonging to the family Asteraceae (Compositae), which refers to the root of atractylodes macrocephala KOIDZ and related plants. It contains essential oils, Atractylone and Atractylol. , Arthritis, each donation, urine discomfort, etc. (Information and communication, Daehae Encyclopedia, Yeonglim Corp, pp1026, 1998).

It is known that Morus alba L. is a seed of Morus alba L. and a relative plant belonging to the Moraceae family. It contains sugar, tannic acid, linolic acid, stearinic acid, It is known to have been used for the treatment of painful joints, joint disadvantages, and the like.

Gugija refers to mature fruit of Lycium chinensis, Lycium barbarum L., a vine shrub belonging to Solanaceae, and contains substances such as carotene, nicotinic acid and the like , And has been known to have hypoglycemic and cholesterol lowering effects, blood pressure lowering effects, and the like (Information Sourcing, Illustrated Diary, and Young Lim, pp. 826-828, 1998).

Ryeonggak refers to the epidermis of Euphoria lingan STEUD, an evergreen tree belonging to the Sapinaceae family. It contains substances such as glucose, seoddang and tartaric acid, and has been used for the treatment of insomnia and forgetfulness. (Information Sourcing, Dictionary of Contemplation of Diagrams, Yeonglim Publishing House, pp 371-373, 1998).

It is called the root of Achyranthus japonica NAKAI or Acyranthes bidentata Blume belonging to the Amaranthaceae. It is composed of triterpeoid saponin, ecdysterone, (inokosterone), and has been used in the treatment of uterine contraction, hypotension, and analgesia.

It refers to the bark of Eucommia ulmoides OLIV, a benthic tree belonging to the Eucommiaceae, and is composed of gutta-percha, alkaloid, pectin, ketose, And linoleic acid (linoleic aicd), and blood pressure lowering action, diuretic action, etc. are known (Information Information, Illustrated Dictionary of Dietary Encouragement, Younglim Corp, pp605-606, 1998).

Chunmunmdong refers to a tuber of a multi-annual vine herb, Asparagus cochinchinensis MERR, belonging to the Liliaceae and contains substances such as asparagine, mucus, sitosterol and smilagenin , Antimicrobial action, insecticidal action, and anti-ulcer action are known.

Ginger refers to the root of a ginger (Zingiber officinale ROSC), a multi-annual herb ginger (Zingiberaceae) belonging to the genus Zingiberaceae, and is a zingiberol, zingiberone, phellandrene, gingerol, (Shogaol), etc., and antimicrobial and antiparasitic activities are known. (Information, Outline, Illustrated Dictionary of Containing Medicine, Young Lim, pp. 260-262, 1998).

Jujube refers to the fruit of the jujube (Zizyphus jujuba MILL), a broad-leaved tree belonging to the Rhamnaceae family. It contains substances such as protein, organic acid, etc., and it is known to strengthen muscles, protect the liver and increase weight Information and Communication, Daehee Medicinal Dictionary, Yeonglim Publishing House, pp296-297, 1998).

However, none of the above-mentioned documents discloses or suggests prevention, suppression, improvement, or treatment of menopausal syndrome or similar symptoms containing an effective ingredient of a combination herbal medicine comprising extracts of Bacillus thuringiensis, Bacillus thuringiensis, Bacillus thuringiensis, There is no bar.

Accordingly, the present inventors have searched for natural substances superior to the improvement of the menopausal syndrome and confirmed that the combination extract of the present invention exhibits an excellent menopausal syndrome improvement effect in a menopausal animal experiment and a simple clinical experiment, thereby completing the present invention.

In order to solve the above-mentioned problems, the present invention provides a pharmaceutical composition for the treatment and prevention of a menopausal syndrome which comprises as an active ingredient, a combination herbal medicine extract consisting of Baekjoo, Bokseongjae, Gujija,

The present invention also provides a health functional food for preventing and ameliorating a menopausal syndrome which comprises an extract of a combination herbal medicine consisting of a herbal extract, a herbal extract, a gojira, a yanglani,

Combination herbal extracts as defined herein include extracts that are soluble in water, including purified water, C1 to C4 lower alcohols or mixed solvents thereof, preferably water or a mixed solvent of water and alcohol.

Combination herbal extracts as defined herein further comprise one or more herbal extracts consisting of ginger and jujube; One or more vitamins selected from the group consisting of vitamin A, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, biotin, nicotinamide, folic acid, and calcium pantothenate; And / or at least one inorganic substance selected from the group consisting of ferrous sulfate, zinc oxide, magnesium carbonate, potassium monophosphate, calcium diphosphate, potassium citrate, calcium carbonate, and magnesium chloride.

The preferred combination weight of the crude herbal medicine extracts as defined herein is (1) a combination of a herbal extract, a herbarium, a mackerel, a yogurt, a yogurt, (W / w), more preferably 1 to 5 parts by weight, more preferably 1 to 5 parts by weight, from 1 to 10 parts by weight, from 1 to 10 parts by weight, from 1 to 10 parts by weight, from 1 to 10 parts by weight, from 1 part by weight to 10 parts by weight, (W / w), more preferably 1 to 3 parts by weight, 1 to 5 parts by weight, 1 to 5 parts by weight, 1 to 5 parts by weight, 1 to 5 parts by weight and 1 to 5 parts by weight, (W / w) of Pigment 1 to 3, Wassle 1 to 3, Piglets 1 to 3, and Pigment 1 to 3; (b) In the case of a combination of red pepper, red pepper, red pepper, yongcheng, mulberry, mulberry, astringent gong, ginger and jujube, (W / w), more preferably from 1 to 5, from 1 to 5, from 1 to 5, from 1 to 5, from 1 to 10, from 2 to 10, from 1 to 10 from ginger, from 1 to 10 from ginger, (W / w), more preferably 1 to 3 times, 3 to 5 times, 1 to 5 times, 5 to 10 times, 1 to 5 times, 1 to 5 times, 1 to 5 times, 1 to 5 times, (W / w) blended with 1 to 3 parts by weight of ginger 1 to 3, ginger 1 to 3, puppet gum 1 to 3, worm 1 to 3, gum 1 to 3, gum 1 to 3, ginger 1 to 2 and jujube 1 to 2 And combinations thereof.

The term "menopausal syndrome" as defined herein is preferably selected from the group consisting of premenopausal or postmenopausal or menopausal syndromes due to a disease, more preferably, fatigue, hot flashes, vasomotor symptoms, depression, anxiety, dizziness, headache , Arthralgia, myalgia, osteoporosis, insomnia, dryness of vagina, and the like.

Hereinafter, the present invention will be described in detail.

Combination herbal extracts of the present invention can be obtained as follows.

The combination herbal medicine extract of the present invention is prepared by mixing herbal medicine ingredients such as white tea, liquorice liquor, gugija, yongcheng, liquor, mugwort and mugwort, if necessary, ginger and jujube, at a certain mixing ratio, After shrimp treatment, the mixture is crushed to a volume of about 1 to 20 times, preferably about 2 to 10 times the weight of the herbal material, a C1 to C4 lower alcohol or a mixture thereof, Extraction such as hot water extraction, cold extraction, reflux cooling extraction, ultrasonic extraction or supercritical extraction for about 1 hour to 1 day, preferably for 2 hours to 8 hours at a temperature of 120 to 120 ° C, preferably 20 to 100 ° C Method, preferably a hot water extraction method, the extract is filtered after cooling, and the filtrate is lyophilized to obtain a crude herbal medicine extract of the present invention.

In addition, the present invention provides a health functional food for improving and preventing menopausal syndrome, which comprises an extract of a combination herbal medicine consisting of a herbal extract, a herbarium, a lily of the valley, a yanglani, a lily of the valley,

The extract as defined herein is a polar solvent selected from water, alcohol, lower alcohols having 1 to 4 carbon atoms or a mixed solvent thereof, preferably water or water and a mixed solvent, more preferably water or 20 to 90% water And an extract that is soluble in the alcohol mixture.

The present invention also provides a pharmaceutical composition and a health functional food for the treatment and prevention of menopausal syndrome which comprises the combined herbal medicine extract prepared by the above production method and the above-mentioned manufacturing method as an active ingredient.

The combined herbal medicine extracts prepared above were measured in terms of global athletic ability and tail skin temperature using an in vivo on-menopausal mouse, and the experimental group administered with the extracts of Examples 1 to 3 was compared with the negative control group It is confirmed that the time is increased, the increase of skin temperature of tail is suppressed, and the effect of improving the menopausal symptom is excellent in a simple clinical example. Thus, a health supplement food and a health functional food such as a drug for prevention and treatment of menopausal syndrome, a menopausal nutritional supplement, Found that the combination extract could be used as a raw material for the prevention and prevention of menopausal syndrome.

Accordingly, the present invention provides an agent for improving menopausal syndrome, which comprises, as an active ingredient, a combination herbal medicine extract consisting of dried or syrupy, dried syrup, gugija,

The composition of the present invention contains the herbal extract in an amount of 0.01 to 99% by weight based on the total weight of the composition.

However, the composition is not limited thereto, and may vary depending on the condition of the patient, the type of disease, and the progress of the disease.

Compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions.

The composition containing the extract according to the present invention may be formulated in the form of powders, granules, tablets, capsules, oral preparations such as suspensions, emulsions, syrups and aerosols, external preparations, suppositories and sterilized injection solutions, Examples of carriers, excipients and diluents that can be included in the composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium Silicates, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, magnesium stearate and mineral oil. In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrant, or a surfactant is usually used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, which may contain at least one excipient, such as starch, calcium carbonate, sucrose, Or lactose, gelatin, and the like. In addition to simple excipients, lubricants such as magnesium stearate talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. As a suppository base, witepsol, macrogol, tween 61, cacao paper, laurin, glycerol gelatin and the like can be used.

The preferred dosage of the extract of the present invention varies depending on the condition and the weight of the patient, the degree of disease, the type of drug, the administration route and the period of time, but can be appropriately selected by those skilled in the art. However, for the desired effect, the extract is preferably administered at a dose of 0.01 mg / kg to 10 g / kg per day, preferably 1 mg / kg to 1 g / kg per day. The administration may be carried out once a day or divided into several doses. Therefore, the dose is not intended to limit the scope of the present invention in any aspect.

The composition of the present invention may be administered to mammals such as rats, mice, livestock, humans, and the like in various routes. All modes of administration may be expected, including, for example, oral and rectal or intravenous administration.

The present invention also provides a health functional food for the improvement and prevention of menopausal syndrome, which comprises an extract of a combination herbal medicine consisting of Baekjoo, Suksikjae, Gugija, Yongsan, Yusu, Jumung,

 Further, the present invention provides a menopausal nutritional supplement containing, as an active ingredient, a combination herbal medicine extract consisting of Baekjong, Sukjima, Gugija, Yonggaku, Wusu, Jugong,

The health functional food containing the extract of the present invention can be used variously for medicines, foods and drinks for the improvement and prevention of the menopausal syndrome. Examples of the foods to which the extract of the present invention can be added include various foods, beverages, gums, tea, vitamin complex, leach tea, health supplement foods and the like, and they are in the form of powder, granule, tablet, capsule or beverage Can be used.

Accordingly, the present invention also provides a food additive for improving and preventing fatigue syndrome and menopausal syndrome, which comprises as an active ingredient an extract of a combination of a herbal extract, a herbal extract,

The food forms to which the extract of the present invention can be added include various foods of candy, beverages, gums, tea, a vitamin complex, or foods that are health supplement foods.

The health beverage composition of the present invention may contain various flavors or natural carbohydrates as an additional ingredient, such as ordinary beverages, in addition to containing a mixture of the above extract as an essential ingredient in the indicated ratios, have. Examples of the above-mentioned natural carbohydrates include monosaccharides such as disaccharides such as glucose and fructose such as maltose, sucrose and the like and polysaccharides such as dextrin, cyclodextrin and the like Sugar, and sugar alcohols such as xylitol, sorbitol, and erythritol. As natural flavors other than those described above, natural flavors (such as tau martin, stevia extract (e.g., rebaudioside A, glycyrrhizin)) and synthetic flavors (saccharin, aspartame, etc.) have. The ratio of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention.

In addition to the above-mentioned composition, the composition of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors, coloring agents and intermediates (cheese, chocolate etc.), pectic acid and its salts, Salts, organic acids, protective colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated beverages and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components may be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

Experimental evaluation of global athletic performance using mice in vivo on herbal extracts of the present invention and measurement of tail skin temperature showed that the experimental group had an increase in global exercise time and a rise in tail skin temperature . It has been confirmed that the combination extract can be used as a raw material for producing a health functional food or a health supplement such as a medicament for the treatment of menopausal symptoms or a menopausal nutritional supplement by confirming that it exhibits an excellent effect for improving menopausal symptoms in a liver clinical sample Bar, and menopausal syndrome, or a health functional food useful for prevention, treatment, prevention and improvement.

Hereinafter, the present invention will be described in detail with reference to the following Reference Examples and Experimental Examples.

However, the following Reference Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following Reference Examples and Experimental Examples.

Example 1. Preparation of Preparation Example 1 (CB1)

The dry form of herbal medicines purchased from Omni Herb were mixed at a weight ratio of 20 (1.5 parts by weight, 1.5 parts by weight, 1.5 parts by weight, 1.5 parts by weight, 2 parts by weight, 1 part by weight, 1 part by weight, 1 part by weight, 1 part by weight ginger, 0.5 part by weight) After addition of a volume of water, the mixture was refluxed with an extractor (COSMOS 660, Kyesho Machinery Industries) at 100 ° C for 5 hours, filtered through a filtration tank equipped with a 100 mesh screen, and then the supernatant was vacuum- The herbal extract was obtained and the other components were added in combination with a certain weight ratio {calcium (KMK 0.3), vitamin B1 (German DSM) 0.003, and vitamin B2 0.001 (BASF Korea) (CB1) was obtained and used as a sample in the following experiment.

Example 2. Preparation of Preparation Example 2 (CB2)

The dry form of herbal medicines purchased from Omni Herb were mixed at a ratio of 20 times the weight of the blend formulated with a certain weight ratio (1.5, 1.2, 1.5, 2.0, 2, 2, 2, 0.5, 0.5) 70% ethanol of the volume was added and the mixture was refluxed with an extractor (COSMOS 660, Kyorseo Machinery Industry) at 100 ° C for 5 hours. The filtrate was filtered through a filter equipped with a filter mesh of 100 mesh. The supernatant was decompressed and concentrated, (CB2) of the present invention was used as a sample for the following experiment.

Example 3. Preparation of Preparation Example 3 (CB3)

20 times as much water as the weight of the blend formulated with the dry ingredients of the omni herb was mixed with a certain weight ratio (1.5: 1.5, 1.2: 1, 1.5: 1, 2: 1, 1: 1, 2: 1, (COSMOS 660, Kyorseo Machinery Industry) at 100 ° C for 5 hours. The filtrate was then filtered through a filter equipped with a 100-mesh screen. The supernatant was then reduced in pressure and concentrated and freeze- ) Was obtained and used as a sample for the following experiment.

Experimental Example  1. Climacteric Animal Experiment

In order to confirm the effect of improving the menopausal syndrome of the above-mentioned samples, an experiment was carried out as follows in a menopausal animal model in which ovariectomy was performed as described in the literature.

1-1. Experimental animal

Seven weeks old ICR mouse (28 ~ 30g) was supplied from Orient Bio Korea and used for 5 days in an animal laboratory. Water and feed were freely taken, temperature (23 ± 2 ℃) Humidity (50 ± 10%) and darkness (12 hours) were automatically adjusted.

1-2. Experimental Method

1-2-1. Mouse ovariectomy

An 8-week-old ICR mouse was anesthetized with the use of Park et al. (J Korean Neurosurg Soc. 2010, 48; p309), and the dorsal area was cut with scissors. The ovary was excised, the back was closed with a suture, disinfected, antibiotics were administered, and the body temperature was maintained until waking on a heating pad, to produce a menopausal model mouse. After two weeks of recovery, they were used for the experiment.

1-2-2. Tail skin temperature measurement

Samples of the present invention were orally administered in one dose group after 2 weeks of ovariectomy. The control (Sham) and negative control (OVX + saline) were orally administered with physiological saline. The mouse was weighed 2 weeks after the administration and the mouse was placed in a restrainer for 5 minutes to measure the tail skin temperature before starting the exercise. The 1 cm portion from the base of the tail was measured at intervals of 1 minute The temperature of the tail was measured using a rotary camera (FLIR T600, USA) (Basal temperature, T _B ), and the treadmill (Exer-3/6, Columbus instruments, USA) After exercise, the animals were moved back to the fixator and the tail temperature (Forced Exercise Temperature, T _E ) was measured using an infrared camera three times at intervals of one minute (Hideki et al., J Pharmacol Sci, 2005,98: 323). The temperature before the exercise was calculated as the average of three times (T _B ), and the total skin temperature of the tail skin after exercise was calculated by the following formula (1).

In order to test hot flush, one of the symptoms of menopausal syndrome, ovariectomy of mice was performed and the extracts of Examples 1 to 3 were orally administered for 2 weeks and then the skin temperature of the tail was measured using a thermal camera .

As shown in Table 1, when the TST was significantly increased in the negative control (OVX + saline), it was judged that the ovariectomy was successful. It was confirmed that TST, which is an indicator of hot flushes, was significantly reduced in the experimental groups administered with the extracts of Examples 1 to 3, respectively, as compared with the negative control group.

1-2-3. Treadmill  Used Anti-fatigue  Experiment

The effects of the extracts of Examples 1 to 3 on the menopausal fatigue were evaluated by a treadmill exercise test using menopausal mice. Minghua et al. (2003, 124: 771) modified the treadmill angle to 10 degrees and started to travel at a speed of 15 m / min. The speed was increased to a maximum of 30 m / min, and the time (maximum driving time) until the mouse became inoperable was measured.

As a result of measuring the maximum running time using a treadmill after administering the extracts of Examples 1 to 3 for 2 weeks, the control group showed a significant decrease of 26.2 ± 1.4 minutes and 13.7 ± 1.0 minutes in the negative control group, Were significantly increased compared to the negative control samples The maximum travel time was shown (Table 2).

1-3. Statistical processing

Statistical analysis was performed using ANOVA (ANOVA). Statistical significance was tested using the Student-Newman-Keuls test when p <0.05 was considered significant.

In conclusion The samples of the present invention exhibited excellent hot flush reduction effect in the tail skin temperature test of menopausal mice and showed excellent maximum running time in the menopausal anti-fatigue test, It is considered to improve or cure menopausal hot flushes and menopausal fatigue.

Experimental Example 2. Simplified Clinical Experiment

Fifty women with an average age of 50 years, who had symptoms of menopausal symptoms before and after menopause, were randomly divided into five groups, and the comparison group in which the capsule and the sample of the above example were not added was administered twice, twice a day, twice a day for 4 weeks And the average value of the Kupperman index (Table 3), which is a menopausal evaluation index, was obtained. The results are shown in Table 4.

Kupperman Index Symptom none slightly usually Severe One Flushing, fever, burning 0 4 8 12 2 Sweating (sweat) 0 2 4 6 3 insomnia 0 2 4 6 4 nervousness 0 One 2 3 5 depression 0 One 2 3 6 whirl 0 One 2 3 7 Fatigue 0 One 2 3 8 Joint pain, muscle pain 0 One 2 3 9 headache 0 One 2 3 10 Heart beating 0 One 2 3 11 Vaginal dry 0 One 2 3

From Table 4 above, it can be seen that the samples of the present invention show a marked improvement, and the samples of the present invention are excellent in the improvement of the menopausal syndrome, while there is no significant change in the control group in which the sample is not added.

Clinical Effect on Menopausal Syndrome (Kupperman Index Change) sample Score before taking Score after taking 2 weeks Menopausal control group 28.8 24.3 Menopausal Example 1 29.9 10.9 Menopausal Example 2 28.5 9.8 Menopausal Example 3 30.2 10.3

Hereinafter, formulation examples of the composition containing the extract of the present invention will be described, but the present invention is not intended to be limited thereto but is specifically explained.

Preparation Example 1. Preparation of powder

CB1 ----------------------------------------------- 200 mg

Lactose ---------------------------------------------- 100 mg

Talc ----------------------------------------------- 10 mg

The above components are mixed and filled in airtight bags to prepare powders.

Formulation Example 2. Preparation of tablets

CB2 ----------------------------------------------- 200 mg

Corn starch ---------------------------------------- 100 mg

Lactose ---------------------------------------------- 100 mg

Magnesium stearate --------------------------------- 2 mg

After mixing the above components, tablets are prepared by tableting according to the usual preparation method of tablets.

Formulation Example 3. Preparation of capsules

CB3 ----------------------------------------------- 200 mg

Crystalline cellulose - 3 mg

Lactose ----------------------------------------- 14.8 mg

Magnesium stearate 0.2 mg &lt; RTI ID = 0.0 &gt;

The above components are mixed in accordance with a conventional method for producing a capsule, and filled in a gelatin capsule to prepare a capsule.

Formulation Example 4. Preparation of injection

CB1 ----------------------------------------------- 200 mg

Mannitol -------------------------------------------- 180 mg

Sterile sterilized distilled water for injection ------------------------------- 2974 mg

Na ₂ HPO _{4 ,} 12H ₂ O ---------------------------------------- 26 mg

(2 ml) per ampoule in accordance with the usual injection method.

Formulation Example 5. Preparation of a liquid preparation

CB2 ----------------------------------------------- 200 mg

Ising Party -------------------------------------------- 10 g

Mannitol ----------------------------------------------- 5 g

Purified water -----------------------------------------------

Each component was added and dissolved in purified water according to the usual liquid preparation method, and the lemon flavor was added in an appropriate amount. Then, the above components were mixed, and purified water was added thereto. The whole was added with purified water to adjust the total volume to 100 ml, And sterilized to prepare a liquid preparation.

Preparation Example 6. Preparation of health food (nutritional supplement)

CB3 --------------------------------------------- 1000 mg

Vitamin mixture --------------------------------------

Vitamin A Acetate ------------------------------- 70 μg

Vitamin E ----------------------------------------- 1.0 mg

Vitamin B1 --------------------------------------- 0.13 mg

Vitamin B2 --------------------------------------- 0.15 mg

Vitamin B6 ---------------------------------------- 0.5 mg

Vitamin B12 --------------------------------------- 0.2 g

Vitamin C ------------------------------------------ 10 mg

Biotin -------------------------------------------- 10 μg

Nicotinic acid amide 1.7 mg

Folic acid ---------------------------------------------- 50 g

Calcium pantothenate ------------------------------------ 0.5 mg

Mineral Mixture --------------------------------------

Ferrous sulfate 1.75 mg &lt; RTI ID = 0.0 &gt;

Zinc oxide - 0.82 mg

Magnesium carbonate ------------------------------------ 25.3 mg

Potassium phosphate monohydrate 15 mg

Secondary calcium phosphate --------------------------------------- 55 mg

Potassium citrate ---------------------------------------- 90 mg

Calcium carbonate ----------------------------------------- 100 mg

Magnesium chloride ------------------------------------ 24.8 mg

Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.

Formulation Example 7. Preparation of health drink

CB1 -------------------------------------------- 1000 mg

Citric acid ----------------------------------------- 1000 mg

Oligosaccharides ----------------------------------------- 100 g

Taurine --------------------------------------------- 1 g

Add purified water - 900 ml total

The above components were mixed according to a conventional health drink manufacturing method, and the mixture was stirred and heated at 85 ° C for about 1 hour. The resulting solution was filtered to obtain a sterilized 2-liter container, which was sealed and sterilized, It is used in the production of the health beverage composition of the invention.

Although the composition ratio is a mixture of the components suitable for the preferred beverage as a preferred embodiment, the compounding ratio may be arbitrarily varied depending on the regional and national preferences such as the demand level, the demanding country, and the intended use.

Claims (14)

(a) extracts containing a combination herbal medicine extract consisting of a lotus, a loner, a lily of the valley, a dragonfly, a lily of the valley, A pharmaceutical composition for the treatment and prevention of a menopausal syndrome associated with a change in sex hormones selected from fatigue, hot flashes, depression, anxiety, dizziness, headache, joint pain, muscle pain, osteoporosis, insomnia and vaginal dryness. delete The method according to claim 1,
The combination weight of the combination herbal medicine extract is 1 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10, wax 1 to 10, manganese 1 to 10, and manganese 1 to 10 parts by weight (w / w); (b) In the case of a combination of red pepper, red pepper, red pepper, yongcheng, mulberry, mulberry, astringent gong, ginger and jujube, (W / w) of 10 to 10, 2 to 10, 1 to 10, ginger 1 to 10 and 1 to 10 of jujubes. The method according to claim 1,
Wherein the combined herbal medicine extract is an extract which is soluble in water containing purified water, lower alcohol of C1 to C4 or a mixed solvent thereof. delete (a) extracts containing a combination herbal medicine extract consisting of a lotus, a sickle, a gojira, a yangyu, a wuss, a mugwort and a mugwort or (b) a mugwort, A health functional food for the improvement and prevention of menopausal syndrome selected from fatigue, hot flushes, depression, anxiety, dizziness, headache, joint pain, muscle pain, osteoporosis, insomnia and vaginal dryness associated with a change in sex hormones. delete The method according to claim 6,
The combination weight of the combination herbal medicine extract is 1 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10, wax 1 to 10, manganese 1 to 10, and manganese 1 to 10 parts by weight (w / w); (b) In the case of a combination of red pepper, red pepper, red pepper, yongcheng, mulberry, mulberry, astringent gong, ginger and jujube, (W / w) of 10 to 10, 2 to 10, 1 to 10, ginger 1 to 10 and 1 to 10 of jujubes. (a) extracts containing a combination herbal medicine extract consisting of a lotus, a loner, a lily of the valley, a dragonfly, a lily of the valley, A dietary supplement for improving and preventing menopausal syndromes selected from fatigue, hot flashes, depression, anxiety, dizziness, headache, joint pain, muscle pain, osteoporosis, insomnia and vaginal dryness associated with a change in sex hormones. delete 10. The method of claim 9,
The combination weight of the combination herbal medicine extract is 1 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10, wax 1 to 10, manganese 1 to 10, and manganese 1 to 10 parts by weight (w / w); (b) In the case of a combination of red pepper, red pepper, red pepper, yongcheng, mulberry, mulberry, astringent gong, ginger and jujube, (W / w) of 1 to 10, 2 to 10, 1 to 10, ginger 1 to 10 and 1 to 10 of jujubes. (a) extracts containing a combination herbal medicine extract consisting of a lotus, a sickle, a gojira, a yangyu, a wuss, a mugwort and a mugwort or (b) a mugwort, Menopause nutritional supplements. delete 13. The method of claim 12,
The combination weight of the combination herbal medicine extract is 1 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10 to 10, 10, wax 1 to 10, manganese 1 to 10, and manganese 1 to 10 parts by weight (w / w); (b) In the case of a combination of red pepper, red pepper, red pepper, yongcheng, mulberry, mulberry, astringent gong, ginger and jujube, (W / w) of 1 to 10, 2 to 10, 1 to 10, ginger 1 to 10 and 1 to 10 of jujube.