KR101660291B1 - Composition for Preventing, Treating or Improving Sex Hormone-related Diseases or Symptoms comprising Extract from Cudrania tricuspidata or Mixture of Extract from Cudrania tricuspidata and Extract from Lepidium meyenii - Google Patents

Abstract

(A) Cudrania tricuspidata extract; Or (b) a composition for preventing, treating or ameliorating a sex hormone-related disease or symptom comprising a mixture of extract and maca extract as an active ingredient. The composition of the present invention increases male and female sex hormone precursors and bioactive sex hormones and significantly improves male and female hormone deficiency symptoms such as menopausal symptoms.

Description

TECHNICAL FIELD The present invention relates to a composition for preventing, treating or ameliorating a sex hormone-related disease or symptom, which comprises a mixture of a mushroom extract, a mushroom extract or a mixture of a mushroom extract and a mushroom extract. Extract from Cudrania tricuspidata and Extract from Lepidium meyenii}

The present invention relates to a composition for preventing, treating or ameliorating a sex hormone-related disease or symptom, which comprises a mixture of an extract or a coconut extract and a maca extract.

Menopause is a term used to describe women's menopause classically, which means that the function of the gonads (ovaries) has deteriorated due to aging. However, the concept of male menopausal syndrome due to the gradual reduction of male hormones is emerging in males, even if not visible changes such as women's menopause, and the official term is the International Society for the Study of Aging associated testosterone deciency syndrome (TDS) 'along with' late-onset hypogonadism (LOH) 'as determined at the Aging Male meeting. Men's Menopausal Syndrome is a clinical and biochemical syndrome associated with typical symptoms and serum testosterone deficiency experienced in men with increasing age, which can impair quality of life and negatively affect the function of various organs . In Korea, Park et al. (Park MG et al . Hypogonadism: A survey of males in their 40s and above. Korean J Androl 2007; 25: 26-31 ) reported the proportion of men over 40, mainly appealing to the decrease in libido and balgiryeok survey using a Korean translation of Androgen Deciency in Aging Male (ADAM) questionnaire to 64.6% , More than half of Korean middle-aged men have menopausal symptoms.

Women's menopause is a kind of endocrine syndrome that is a transition period in which the overall and gradual decrease of ovarian function occurs and physiological function and sexual function are reduced or lost. It is a process of menopause, which is a permanent stoppage of menstruation It comes. Postmenopausal women may develop acute chronic symptoms due to changes in hormones, such as decreased estrogen production, elevated follicle stimulating hormone and luteinizing hormone. In other words, psychological symptoms such as vasomotor symptoms such as hot flushing, night sweating, anxiety, loss of concentration and depression may appear as initial symptoms, and urinary and epidermal symptoms appearing within several years of menopause may be followed by osteoporosis, And cerebrovascular diseases.

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.

The present inventors have sought to develop natural products excellent in the prevention, treatment or amelioration of diseases or symptoms related to male sex hormone. As a result, the present invention has been completed by confirming that the extract of Cucumis japonica has an effect of increasing male sex hormone precursor and increasing active sex hormone, and that the effect is increased when it is mixed with maca extract.

Accordingly, an object of the present invention is to provide a composition for preventing, treating or ameliorating a sex hormone-related disease or symptom.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.

According to one aspect of the present invention there is provided a composition comprising: (a) Cudrania tricuspidata extract; Or (b) a composition for preventing, treating or ameliorating a sex hormone-related disease or condition comprising a mixture of extract and maca extract as an active ingredient.

The present inventors have sought to develop natural products excellent in the prevention, treatment or amelioration of diseases or symptoms related to male sex hormone. As a result, it was confirmed that the extracts of Cucumis japonica have an effect of increasing sex hormone precursor and active sex hormone, and that the effect is enhanced when they are mixed with maca extract.

The extract of Cajunprima and / or Maca which is used in the composition of the present invention may be used in various extraction solvents when it is obtained by treating the extractant or the extractant in Macaca fasciculata. According to one embodiment of the present invention, a polar solvent or a non-polar solvent can be used. Suitable polar solvents are (i) water, (ii) alcohols (preferably methanol, ethanol, propanol, butanol, n-propanol, iso-propanol, n-butanol, 1-pentanol, Or ethylene glycol), (iii) acetic acid, (iv) dimethyl-formamide (DMFO) and (v) dimethyl sulfoxide (DMSO). Suitable nonpolar solvents are acetone, acetonitrile, ethyl acetate, methyl acetate, fluoroalkane, pentane, hexane, 2,2,4-trimethylpentane, decane, cyclohexane, cyclopentane, diisobutylene, 1- But are not limited to, pentane, 1-chlorobutane, 1-chloropentane, o -xylene, diisopropyl ether, 2- chloropropane, toluene, 1- chloropropane, chlorobenzene, benzene, diethyl ether, diethylsulfide, Methane, 1,2-dichloroethane, aniline, diethylamine, ether, carbon tetrachloride, and THF.

According to another embodiment of the present invention, the extraction solvent used in the present invention may be selected from the group consisting of (a) water, (b) an anhydrous or hydric alcohol having 1 to 4 carbon atoms (methanol, ethanol, propanol, butanol, (E) ethyl acetate, (f) chloroform, (g) butyl acetate, (h) 1,3-butylene glycol, (i) hexane, and (j) Diethyl ether. According to certain embodiments of the present invention, the extract of the present invention is obtained by treatment with water, ethanol or a combination thereof.

As used herein, the term " extract " means that it is used in the art as a crude extract as described above, but broadly includes fractions obtained by further fractionating the extract. That is, the extract of Curcuma longa or Maca can be obtained not only by using the above-mentioned extraction solvent but also by additionally applying a purification process thereto. For example, a fraction obtained by passing the above extract through an ultrafiltration membrane having a constant molecular weight cut-off value, and a separation by various chromatography (manufactured for separation according to size, charge, hydrophobicity or affinity) The fraction obtained by the purification method is also included in the extract of Curcumin or Maca of the present invention.

The Cucurbit's extract and / or Maca extract used in the present invention may be prepared in powder form by an additional process such as vacuum distillation and freeze-drying or spray drying.

As used herein, the term " comprising as an active ingredient " is meant to include an amount sufficient to achieve the efficacy or activity of the following coconut extract and / or maca extract. Since the present invention is a composition extracted from maca, which is a natural plant material, there is no adverse effect on the human body even when it is administered in an excessive amount. Thus, the quantitative upper limit of the composition of the present invention can be selected by a person skilled in the art have.

According to certain embodiments of the present invention, the mixture of Curcuma longa extract and Maca extract of the present invention has a blending ratio of 10: 1 to 1:10, and the mixing ratio of 9: 1 to 8: 2, According to the example, it has a mixing ratio of 7: 3 to 6: 4.

The present invention relates to the use of DHEA (Dehydroepiandrosterone) family (DHEA and DHEA-s), testosterone (total testosterone (TT), free testosterone (FT) and physiologically active testosterone (BT)), estradiol Diol (TE), free estradiol (FE) and physiologically active estradiol (BE)] and SHBG (Sex Hormone Binding Globulin) have different physiological activities. Through the stable regulation of the sex hormone of the present invention, a natural product having an effect of improving sex hormone related diseases and symptoms has been developed.

According to an embodiment of the present invention, the sex hormone related disease is selected from the group consisting of male menopausal syndrome, female menopausal syndrome, genital dysplasia, androgen resistance syndrome, gonadal dysfunction syndrome, Kallmann syndrome, Klinefelter syndrome, Turner syndrome, menopause, testicular decline, puberty delay, premature ejaculation, menstrual disorders, reproductive disorders, amenorrhea or polycystic ovary syndrome.

According to another embodiment of the present invention, the sex hormone related symptom is infertility, hair loss, weight gain, depression, anxiety, panic attack, insomnia, prostate problem, sexual pleasure problem, irregular menstrual cycle or sex drive.

According to a particular embodiment of the invention, the male menopausal syndrome is selected from the group consisting of joint or muscular pain, osteoporosis, hyperhidrosis, sleep disorder, excitement, nervousness, emotional disturbance, lethargy, fatigue, muscle weakness, depression, The female menopausal syndrome is characterized by a decrease in erectile function, aging or genitourinary function, and the female menopausal syndrome includes facial flushing, sweating, heart discomfort, sleeping problems, depression, irritability, anxiety, physical fatigue, mental fatigue, sexual problems, Discomfort or muscle discomfort.

According to one embodiment of the present invention, a mixture of extracts or extracts of Curcuma longa and Cucurbitaceae and maca extracts increases serum DHEA, DHEA-s and SHBG concentrations and decreases SHBG concentrations. In addition, a mixture of extracts of CJ, CJ, and MKA increases the concentrations of serum testosterone and bioactive testosterone, and blood estradiol and bioactive estradiol.

According to another embodiment of the present invention, a mixture of extracts of Cibumporin or Cibumpora extract and maca extract may reduce the Aging Males' Symptom (ADS) and ADR (Male Reproductive Dysfunction) in male menopause and aging, And decreases the MRS (Menopause rating scale) value indicating aging.

The compositions of the present invention may be prepared with pharmaceutical compositions.

According to a preferred embodiment of the present invention, the composition of the present invention comprises: (a) a pharmaceutically effective amount of the above-mentioned extract of Curcuma longa and / or Maca extract of the present invention; And (b) a pharmaceutically acceptable carrier. As used herein, the term " pharmaceutically effective amount " means an amount sufficient to achieve the efficacy or activity of the above-described coconut extract and / or maca extract.

When the composition of the present invention is manufactured from a pharmaceutical composition, the pharmaceutical composition of the present invention includes a pharmaceutically acceptable carrier. The pharmaceutically acceptable carriers to be contained in the pharmaceutical composition of the present invention are those conventionally used in the present invention and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, But are not limited to, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrups, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. It is not. The pharmaceutical composition of the present invention may further contain a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, etc. in addition to the above components. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington ' s Pharmaceutical Sciences (19th ed., 1995).

The pharmaceutical composition of the present invention can be administered orally or parenterally, and is preferably administered orally.

The appropriate dosage of the pharmaceutical composition of the present invention may vary depending on factors such as the formulation method, administration method, age, body weight, sex, pathological condition, food, administration time, administration route, excretion rate, . Typical dosages of the pharmaceutical compositions of the present invention are in the range of 0.001-1000 mg / kg on an adult basis.

The pharmaceutical composition of the present invention may be formulated into a unit dose form by formulating it using a pharmaceutically acceptable carrier and / or excipient according to a method which can be easily carried out by a person having ordinary skill in the art to which the present invention belongs. Or by intrusion into a multi-dose container. The formulations may be in the form of solutions, suspensions, syrups or emulsions in oils or aqueous media, or in the form of excipients, powders, powders, granules, tablets or capsules, and may additionally contain dispersing or stabilizing agents.

The composition of the present invention can be provided as a food composition. (A) the extract of Curcuma longa; Or (b) a composition for preventing, ameliorating or treating a sex hormone-related disease or symptom comprising an active ingredient of a mixture of extract and maca extract, is prepared from a food composition, And includes, for example, proteins, carbohydrates, fats, nutrients, flavoring agents, and flavoring agents. Examples of the above-mentioned carbohydrates are monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, oligosaccharides and the like; And polysaccharides such as dextrin, cyclodextrin and the like, and sugar alcohols such as xylitol, sorbitol and erythritol. Natural flavorings such as tau martin and stevia extract (e.g., rebaudioside A and glycyrrhizin) and synthetic flavorings (saccharine, aspartame, etc.) can be used as flavorings. For example, when the food composition of the present invention is prepared as a drink, it may further contain citric acid, liquid fructose, sugar, glucose, acetic acid, malic acid, juice, mulberry extract, jujube extract, licorice extract, have.

(A) the extract of Curcuma longa; Or (b) a food composition for preventing or ameliorating a sex hormone-related disease or symptom comprising a mixture of extract and maca extract as an active ingredient. When the composition of the present invention is prepared with a functional food composition, it includes components that are conventionally added in food production, and includes, for example, proteins, carbohydrates, fats, nutrients, and seasonings. For example, when it is made of a drink, a flavoring agent or a natural carbohydrate may be added as an additional ingredient in addition to the maca extract as an active ingredient. For example, natural carbohydrates include monosaccharides (e.g., glucose, fructose, etc.); Disaccharides (e.g., maltose, sucrose, etc.); oligosaccharide; Polysaccharides (e.g., dextrin, cyclodextrin and the like); And sugar alcohols (e.g., xylitol, sorbitol, erythritol, etc.). Natural flavoring agents (e.g., tau marin, stevia extract, etc.) and synthetic flavoring agents (e.g., saccharin, aspartame, etc.) may be used as flavorings.

The features and advantages of the present invention are summarized as follows:

(a) The present invention relates to a process for the preparation of Cudrania a composition for preventing, treating or ameliorating a sex hormone-related disease or symptom comprising, as an active ingredient, a mixture of a tricuspidata extract or a mixture of Cucurbitaceae extract and maca extract.

(b) The composition of the present invention increases the sex hormone precursor and bioactive sex hormone.

(c) The composition of the present invention significantly improves male and female hormone deficiency symptoms, such as menopausal symptoms.

FIGS. 1A and 1B show the results of measuring the effects of the extracts of Cheddar Extract, Maca Extract or Cheddar Extract and Maca extract on the secretion of mouse DHEA (FIG. 1A) and DHEA-S (FIG. 1B). 'CTL' refers to the control, 'C' refers to the extract of Cucumisan, 'M' refers to the extract of Maka, and 'C + M' refers to the mixture of extract and maca extract.
FIG. 2 shows the results of measurement of the effect of a mixture of CJ, CJ, or CJ extracts on the secretion of SHBG (Sex Hormone-Binding Globulin) in mouse blood. 'CTL' refers to the control, 'C' refers to the extract of Cucumisan, 'M' refers to the extract of Maka, and 'C + M' refers to the mixture of extract and maca extract.
FIGS. 3A and 3B show the results of measurement of the effect of a mixture of CJ, CJ, or CJ and Maca extracts on the secretion of male mouse blood testosterone (FIG. 3A) and active testosterone (FIG. 3B). 'CTL' refers to the control, 'C' refers to the extract of Cucumisan, 'M' refers to the extract of Maka, and 'C + M' refers to the mixture of extract and maca extract.
4A and 4B are graphs showing the results of measurement of the effect of the extracts of CJ, CJ, or CJ and MacA extract on the secretion of estradiol (Fig. 4A) and active estradiol (Fig. 4B) . 'CTL' refers to the control, 'C' refers to the extract of Cucumisan, 'M' refers to the extract of Maka, and 'C + M' refers to the mixture of extract and maca extract.
FIG. 5 shows the results of the testosterone increase rate after ingesting a mixture of 60 extracts of CJP or CJP extract and MKA extract of 40 years old and over. 'CTL' refers to a control, 'C' refers to a mixture of extracts, and 'C + M' refers to a mixture of extracts and maca extracts.
FIG. 6 shows the results of the growth rate of estradiol after ingestion of a mixture of 60 extracts of Chengzipong or Cjimipon and Maca extract of middle aged women over 40 years of age. 'CTL' refers to a control, 'C' refers to a mixture of extracts, and 'C + M' refers to a mixture of extracts and maca extracts.
FIG. 7 shows the results of evaluating and quantifying male menopausal symptoms improved by AMS (Aging Male's Symptom), which is improved by a mixture of extracts of CJ, CJ, and MAKA extract. 'C' means cucumber extract, 'C + M' means mixture of extract and maca extract, and 'Placebo' means control.
FIG. 8 shows the results of evaluating and quantifying female menopausal symptoms improved by a mixture of extracts of CJ, CJ, or MAKA extract with MRO (Menopause Rating Scale). 'C' means cucumber extract, 'C + M' means mixture of extract and maca extract, and 'Placebo' means control.

Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

Example 1: Preparation of extract or maca extract and preparation of mixture

Preparation of Cudrania tricuspidata Extract

After the pulp is crushed, the purified water with a volume (w / v) of about 6 times the weight of the pulverized water is extracted by the hot water extraction method for about 5 hours using the solvent, and then the second extraction is performed by adding 5 times of purified water. The extract was immediately filtered and concentrated in vacuo, mixed with dextrin in a ratio of 1: 1, and spray-dried or lyophilized to obtain an extract.

Manufacture of maca extract (Lepidium meyenii)

The maca is pulverized and then subjected to hot water extraction for 4 hours or more with purified water having a volume (w / v%) of about 6 times the weight of the pulverized material as a solvent, followed by secondary extraction with 4 times of purified water. The extract was filtered with a filter paper, and the filtrate was concentrated in vacuo. The extract and dextrin were mixed at a ratio of 5: 7 and spray-dried or lyophilized to obtain a powdery extract.

Manufacture of a mixture of Cajrippum extract and Maca extract

The extract of Cajonpolma obtained from the above example and the maca extract were mixed at a ratio of 10: 1 to 1:10, preferably 9: 1 to 8: 2, more preferably 7: 3 to 6: 4, A mixture of maca extract is prepared.

Test Example  1: Increase in male hormone and sperm function

Increased sex hormone precursors DHEA, DHEA-s, sex hormone testosterone and estradiol and inhibiting sex hormone bioactivity Reduction of globulin SHBG

The composition of the present invention is useful for the determination of blood levels of the sex hormone precursor DHEA (Dehydroepiandrosterone), DHEA-s, sex hormone testosterone, estradiol, and sex hormone-binding globulin (SHBG) And confirmed the effect on the prevention or treatment of diseases and symptoms related to male sex hormone regulation.

Increase in sex hormones in rats

Sprague-Dawley rats (Samtako, Korea) weighing 250 g were divided into control group, cucumber extract, maca extract and mixture of cucumber extract and maca extract. The rats were divided into 10 rats Magnetic 5 and male 5 were used for the experiment. During the breeding period, rats were fed free of solid feed and distilled water. At the same time of day, a mixture of cucumber extract or cucumber extract and maca extract (mixture ratio of 6: 4) dissolved in physiological saline was added at a concentration of 5 mg / kg The control group was orally administered the same amount of physiological saline for 1 month. After the last oral administration, the mice were fasted for 8 hours and then anesthetized with ether. Blood was collected from the abdominal vein, transferred to a heparinized tube, and centrifuged at 2,500 rpm (4 ° C) for 15 minutes. Plasma was isolated. Serum hormone levels were measured according to the manufacturer's manual using DHEA, DHEA-s, SHBG, testosterone and estradiol ELISA kit (ADI-901-093, 065, 174; Enzo Life Sciences, Respectively.

Results were expressed as means and standard deviations. For statistical significance, Student's t-test was used and p <0.05 was considered significant. The results are shown in Fig. 1 to Fig.

As shown in Fig. 1, DHEA levels of about 1.38 nmol / L and 0.2 nmol / L, respectively, were significantly lower in control group (CTL) than control group (C) And DHEA-s levels were increased by about 7.6 nmol / L and 0.81 nmol / L, respectively. DHEA and DHEA-s levels were significantly increased by 2.1 nmol / L and 15.01 nmol / L, respectively, when the mixture (C + M) was consumed.

In addition, in the results of Fig. 2, when the extracts C and M were separately consumed, the levels of SHBG decreased by about 2.0 nmol / L and 0.2 nmol / L, respectively, compared with the control (CTL) M), the SHBG level was significantly reduced to about 2.8 nmol / L compared with the control group.

In the results shown in FIG. 3, when the extracts of Cajunpong (C) and Maca (M) were consumed separately, the levels of testosterone in blood increased by 31% and -1%, respectively, Were increased by about 42% and 5%, respectively. When the mixture (C + M) was consumed, serum testosterone and physiologically active testosterone levels were increased by 59% and 61%, respectively.

As shown in FIG. 4, in the female rats, the levels of estradiol in the blood were increased by 29% and 2%, respectively, compared to the control (CTL) Diol levels increased by about 38% and 10%, respectively. When the mixture (C + M) was consumed, the values of estradiol and physiologically active estradiol in blood were 51% and 55%, respectively.

Test Example  2: Human test  Regulation of Serum Sex Hormone Through

The composition of the present invention was ingested in male and female adults, and the sex hormone regulating effect of the inventive composition was confirmed by confirming the change in blood concentration of sex hormone precursor and male sex hormone and the decrease of sexual hormone physiological activity inhibitory globulin before and after ingestion.

Subject and Period

Sixty middle-aged men over 40 years of age who agreed to this test were divided into two groups: a placebo, which consumed placebo, and an experimental group, which consumed a mixture of CJP or CJP and maca extract (C + M; . Each group was randomly assigned to receive 500 mg / day of placebo or experimental drug for 4 weeks. Also, 60 middle - aged women over 40 years old were randomly classified in the same manner and the same experiment was conducted. Before and after the ingestion, the concentration of sex hormones in the blood was measured by the method of Experimental Example 1 to evaluate the sex hormone regulation by the ingestion of the composition.

Sex hormone increase effect in adult men and women

Blood was collected at 2:00 pm, which is the same time before and after the ingestion, in the control and experimental male and female arm veins, transferred to a heparinized tube, centrifuged at 2,500 rpm (4 ° C) for 15 minutes, . Serum sex hormone levels were measured according to the manufacturer's manual using testosterone and estradiol ELISA kit (ADI-901-065, 174; Enzo Life Sciences, USA) for isolated plasma.

Results were expressed as means and standard deviations. For statistical significance, Student's t-test was used for statistical significance and p <0.05 was considered significant. The results are shown in Fig. 5 and Fig.

As shown in FIG. 5, the testosterone level of the testee increased by about 15.1% in the test group (C + M) compared to the control group (CTL) Testosterone levels were increased by 23.4% compared to the control group.

In addition, in the results of FIG. 6, the estradiol levels in the blood were increased by about 17.7%, respectively, in the case of the women taking the extract of Cucumis japonica (C), and when the mixture (C + M) Diol levels increased by 26.7% compared to the control group.

Test Example  3: Clinical trial to prevent male menopause

Men were administered the composition of the present invention, and male menopausal symptoms due to male hormone control abnormality were confirmed through male menopausal evaluation questionnaire before and after consumption.

Subject and Period

Sixty middle-aged men over 40 years of age who agreed to this test were divided into two groups: a placebo (control group) ingesting placebo and a mixture of CJP (C) and composition (C + M; Each group was randomly assigned to receive 500 mg / day of placebo or experimental drug for 4 weeks. Before and after ingestion, the menstrual assessment of the men due to ingestion of the composition was conducted by answering the test sheets of Table 1.

Korean version AMS ( Aging Males' Symptom ) Rating

The AMS rating developed in this German language is based on the age of the aging process, which is characterized by aging (eg, aging, depression, anxiety and depression). In 1999, Heinemann et al. (Heinemann LAJ, Zimmermann T, Vermeulen A, (Daig I, Heinemann LA, Kim S, Kwon S, Lee JH, Kim JH, Kim JH, Kim JH, Leungwattanaki S, Badia X, Myon E, et al. Aging Males' Symptoms (AMS) scale: review of its methodological characteristics. All items consist of 17 items. All items are quantified as no symptoms (1 point), lightness (2 points), moderate (3 points), severe (4 points), and very severe (5 points). A score of 27 points or more was judged as positive. According to the degree of symptoms, 17-26 points were no (no), 27-36 points were little, 37-49 points were moderate, 50 points were severe (severe). AMS 17 questions are categorized into three sub-components: mental, physical, and sexual. Items 6-8, 11 and 13 are mental elements, 1-5, 9 and 10 are physical factors, 12, 14-17 are sexual (Table 1).

The AMS results of the experimental group and the control group of the present invention are shown in Table 2 and FIG. 7, and the results are shown as mean and standard deviation. Statistical processing was performed using the Student t -test and considered to be significant at p <0.05 Respectively.

As a result of the test, the AMS score of the control group was not significantly different before and after the ingestion, whereas the intake of the extract of Cjimipung (C) of the present invention was decreased by about 11 points compared with that of the ingestion, and the improvement rate of male menopausal symptoms was about 24% (C + M) group showed a decrease in AMS score by about 21 points compared with that before intake, indicating a 49% improvement in male menopausal symptoms. As a result, it was confirmed that the composition of the present invention alleviated menopausal symptoms caused by aging of men such as vitality improvement, libido, vigor, improvement of erection, improvement of sleep, and emotional stability, which are AMS test items.

- AMS score before ingestion AMS score after embedding Improved symptoms of menopausal symptoms
(%) The control group (placebo) 44.33 + - 5.59 45.95 ± 7.76 97 The experimental group (C) 44.12 + - 4.75 32.63 + - 4.31 * 124 Experimental group (C + M), which consumed a mixture of CJP extract and maca extract, 42.53 + - 5.50 21.37 ± 3.85 * 149 *

Test Example  4: Human test  Prevention of female menopause through

The present invention provides a method for preventing and treating female menopausal symptoms due to female hormone control abnormalities through a female menopausal evaluation questionnaire before and after consumption of the composition of the present invention.

Subject and Period

Sixty middle-aged women over 40 years of age who agreed to this test were randomly assigned to a placebo supplemented with placebo and a mixture of CJP extract (C), CJP extract and maca extract (C + M; 6: 4 mixture) Each experimental group was randomly divided into 20 groups. Each group was given 500 ㎎ of placebo or experimental drug for 8 weeks. Before and after ingestion, the menstrual assessment of women due to ingestion of the composition was conducted by answering the test sheets of Table 3.

Korean version MRS ( Menopause Rating Scale )

The Kupperman index, published by Kupperman et al. In 1953, is the most commonly used self-report questionnaire to be used as a symptom evaluation scale in studies related to women's menopausal symptoms. MRS is the MENOPOL (menopause-specific quality of life questionnaire) which was supplemented by Hildich in 1992. MRS is a measurement method that was newly supplemented in 1996. MRS has been credited and credited to many studies around the world. Physical symptoms, mental symptoms, and genitourinary symptoms. It has the advantage that it has fewer questions and is convenient and convenient. The following questionnaires are used in actual research (Table 3).

A total score of 0-4 points to a good menopausal state and a good menopause, and 5-8 points to a mild menopausal state. 9-15 points are menopausal symptoms of severe menopausal status and require specialist diagnosis because there are menopausal disorders. A score of 16 or higher is a severe menopausal state, indicating that long-term planning and treatment is highly needed.

As a result of the test, the MRS score of the control group was not significantly different before and after the ingestion, whereas the MRS score of the cough extract group of the present invention was reduced by about 4.3 points before the ingestion, showing a 37% improvement in female menopausal symptoms. In addition, the MRS score of the composition of the present invention was lowered by about 8.1 points to about 64% of the women in the menstrual cycle group. Thus, it was confirmed that the composition of the present invention alleviates female menopausal symptoms caused by aging of women such as vitality improvement, sexual desire, sleeping problem, nervous stability, urinary problems, joint problems, depression, irritability and vaginal health.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the same is by way of illustration and example only and is not to be construed as limiting the scope of the present invention. It is therefore intended that the scope of the invention be defined by the claims appended hereto and their equivalents.

Claims (9)

A pharmaceutical composition for the prevention, treatment or amelioration of male menopausal syndrome which comprises a mixture of extracts of Cajripp and Maca extract as an active ingredient.
delete delete The method of claim 1, wherein the male menopausal syndrome is selected from the group consisting of joint or muscular pain, osteoporosis, hyperhidrosis, sleeping disorder, excitement, nervousness, emotional instability, lethargy, fatigue, muscle weakness, depression, Aging, or genitourinary dysfunction.
delete 5. The composition of claim 1 or 4, wherein the mixture of Cirgipolate extract and Maca extract is in a weight ratio of 10: 1 to 1:10.
delete A food composition for preventing or ameliorating male menopausal syndrome, which comprises a mixture of an extract of Cajonpol and a maca extract as an active ingredient.
A functional food composition for preventing or ameliorating male menopausal syndrome, which comprises a mixture of extracts of Cajonpol and Maca extract as an active ingredient.

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