KR101596728B1 - Composition comprising zinc/red ginseng, octacosanol and vitamin for preventing and ameliorating andropause symptoms - Google Patents

Abstract

The present invention relates to a food composition and a pharmaceutical composition comprising a mixture of zinc and red ginseng, an octacosanol mixture, and a mixture of vitamins for preventing and ameliorating andropause symptoms. In addition, the present invention relates to a kit comprising a mixture of zinc and red ginseng, an octacosanol mixture, and a mixture of vitamins for preventing and ameliorating andropause symptoms.

Description

TECHNICAL FIELD The present invention relates to a composition for preventing and ameliorating male menopausal symptoms, which includes zinc / red ginseng, octacosanol, and vitamins.

The present invention relates to a composition for preventing and improving male menopausal symptoms, comprising zinc / red ginseng, octacosanol and vitamins.

In recent years, due to the development of medical science and economic development, many problems have been raised for an aging society. It is not simply a disease-free condition, but a daily life that includes the quality of life would be a truly healthy life.

Physical inequality leads to an increase in various chronic diseases, but it is not easy to have enough exercise and leisure time due to busy daily life.

The aging process is accompanied by a gradual decline in body function, which includes not only major organs such as heart, lung, kidney, liver, brain, but also endocrine system. Symptoms of aging include decreased overall wellbeing, labor force, muscle mass and strength, reproductive capacity and masculinity, sexual desire, sexual function, increased central body fat, and osteoporosis, urinary incontinence, arteriosclerosis, Cognitive impairment, memory impairment, emotional disturbances, and sleep disturbances (Behre HM, Bauss S, Kliesch S, Keck C, Simoni M, Nieschlag E. Potential of testosterone buciclate for male contraception, endocrine differences between responders and nonresponders. Clin Endocrinol Metab 1995; 80: 2394-403).

Men, like women, do not experience a sudden decline in gonadal function around the age of 50, but as they get older, they feel a decrease in male and reproductive capacity due to a gradual decline in serum hormone levels produced by the testes or adrenals. Men are reported to have a reduction of 0.4% of total testosterone levels and 1.2% of free testosterone levels each year. This reduction in male hormone levels is associated with changes in sexual function, bone metabolism, muscle and fat distribution, mood and cognitive abilities J Clin Endocrinol Metab 1991; 73: 1016- 25, Gooren. (2002). The results of the study were as follows: LJ. The benefits and risks of androgen therapy in the aging male: prostate disease, lipids and vascular factors. The function of testosterone increases male genitalia, male secondary growth, sexual desire development, skeletal muscle and muscle development. It is common that testosterone binds to receptors of 5α-reductase to form DHT (Dehydrotestosterone) and DHT is reported to cause hair loss (Lee YJ and Lee JY, Clinical Analysis and Treatments for androgenetic Alopecia of Men, J. Kor. Cosm. 13, No. 2 (2007) p. 799-810).

Changes in male hormones can cause dizziness, including fatigue, digestive problems, anorexia, etc., due to systemic symptoms, and they are not as severe as in women, but they are accompanied by facial flushing, fever, palpitation, arthralgia, and elevated blood pressure. Neurologic symptoms also include nervousness, memory loss, depression, loss of mental focus, insomnia, obsession, headache, lower back pain, back pain, and tinnitus.

In addition, men have a tendency to decrease the amount and intensity of muscles, regardless of physical activity, as a result of age, which is also due to a decrease in serum hormone levels. Decreased male hormone levels increase the blood lipid levels, affect the onset of coronary heart disease in the heart, and can also cause abdominal obesity. Although there are differences in the symptoms of menopause according to individuals, all men undergo the process of aging, and at the same time, the function of the human body falls. In fact, health problems and menopause after middle age can be attributed mainly to a decrease in hormones, and hormone production in men declines by 1% each year, peaking at age 30. It can be seen that the production of male hormone is decreased below normal in 7% of men 40 ~ 60 years old, 21% of men 60 ~ 80 years old and 35% of men 80 years old and over, Symptoms appear.

Accordingly, the present inventors have conducted studies on a material having the ability to prevent, alleviate, ameliorate and treat male menopausal symptoms. When using certain mixtures together, male menopausal symptoms are significantly improved. In particular, The inventors confirmed that the ability to ameliorate such menopausal symptoms significantly increased upon ingestion, and completed the present invention.

It is an object of the present invention to provide a composition for preventing and ameliorating male menopausal symptoms.

In order to achieve the above object, the present invention provides a food composition for prevention and improvement of male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture, and a vitamin mixture.

The present invention also provides a pharmaceutical composition for preventing and treating male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture, and a vitamin mixture.

The present invention also provides a kit for preventing and ameliorating male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture, and a vitamin mixture.

The food composition and the pharmaceutical composition of the present invention have the effect of alleviating, improving and treating male menopausal symptoms.

Figure 1 shows changes in plasma testosterone levels in SD rats to which samples were administered.
Figure 2 shows blood SHBG levels in SD rats to which the sample was administered.
FIG. 3 shows the nitric oxide level (A) and the nitric oxide synthase activity (B) of the SD rats to which the sample was administered.
4 shows the lipid peroxide content (A) and glutathione content (B) in the penile corpus cavernosum tissues of the SD rats to which the sample was administered in the SD rats to which the sample was administered.
FIG. 5 shows changes in swimming time of SD rats to which a sample was administered.
Fig. 6 shows changes in sperm counts in SD rats to which the sample was administered.

The present invention

A zinc / red ginseng mixture, and a pharmaceutical composition for preventing and treating male menopausal symptoms.

Also,

A zinc / red ginseng mixture and a mixture of octacosanol; and a pharmaceutical composition for preventing and treating male menopausal symptoms.

Also,

A zinc / red ginseng mixture and a vitamin mixture; and a pharmaceutical composition for preventing and treating male menopausal symptoms.

Also,

A zinc / red ginseng mixture, a mixture of octacosanol and a vitamin, and a pharmaceutical composition for preventing and treating male menopausal symptoms.

The present invention also relates to a kit for the prevention / amelioration / prevention / treatment of male menopausal symptoms comprising a zinc / red ginseng mixture, a mixture of octacosanol and a vitamin.

Hereinafter, the present invention will be described in detail.

Zinc / red ginseng mixture

The zinc / red ginseng mixture of the present invention is a mixture of zinc and red ginseng. The zinc is preferably zinc oxide. The red ginseng is preferably fermented red ginseng. The red ginseng fermented product is preferably prepared by inoculating lactic acid bacteria into red ginseng or red ginseng powder and fermenting the same. The type of lactic acid bacteria is preferably lactobacillus, and may be, for example, lactobacillus brevis, but is not particularly limited. Preferably, the zinc / red ginseng mixture is prepared by mixing zinc and red ginseng at a weight ratio of 1:10 to 1:25, more preferably 1:15 to 1:20 by weight.

Octacosanol  mixture

The octacosanol mixture of the present invention includes octacosanol and maca extract. Preferably, the octacosanol mixture of the present invention comprises octacosanol, maca extract and plant extract. At this time, the octacosanol mixture is preferably mixed with a plant extract: octacosanol: maca extract in a weight ratio of 1: 3 to 10: 1.3 to 3, but is not particularly limited. The extraction is solvent extraction using a lower alcohol or water having 5 or less carbon atoms, preferably solvent extraction using ethanol or water. The maca uses the outpost of maca, preferably the root of maca. The plant is at least one, preferably two or more, more preferably three or more, still more preferably four or more, selected from the group consisting of omija, gugija, bokbunja, casualties, and soil. Most preferably, the plant extract is an extract of Omija, Gujia, Bokbunja, Casualties and Tumor. At this time, it is preferable to use the fruit of Omija, Kjigae, Bokbunja, Casualties and the people.

Vitamin mixture

The vitamin mixture of the present invention includes one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D and vitamin E. Preferably, the vitamin mixture of the present invention is one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D and vitamin E, niacin, pantothenic acid, folic acid, Iron, zinc, selenium and chromium.

Male menopausal symptoms

The food compositions, pharmaceutical compositions and kits of the present invention have the effect of preventing, ameliorating, treating and alleviating male menopausal symptoms. In addition, the food composition, the pharmaceutical composition and the kit of the present invention have the ability to testosterone, inhibit sexual dysfunction, promote fatigue recovery, or improve exercise performance.

The male menopausal symptoms of the present invention are useful for the treatment of menopausal symptoms such as fatigue, digestive disorders, anorexia, dizziness, facial flushing, fever, palpitations, arthralgia, elevated blood pressure, neuropsychiatric, memory loss, depression, loss of mental concentration, insomnia, obsession, Low back pain, tinnitus, decreased testosterone, decreased sexual function, and decreased ability to perform.

Food composition

The present invention relates to a food composition for preventing and improving male menopausal symptoms comprising at least one selected from the group consisting of zinc / red ginseng mixture, octacosanol mixture and vitamin mixture. Preferably, the present invention relates to a food composition for preventing and improving male menopausal symptoms comprising two or more selected from the group consisting of zinc / red ginseng mixture, octacosanol mixture and vitamin mixture. Most preferably, the present invention relates to a food composition for preventing and ameliorating male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture and a vitamin mixture.

The food of the present invention may be, but is not limited to, a health supplement food, a health functional food, a functional food, and the like. The composition for prevention and improvement of male menopausal symptoms of the present invention is added to natural foods, processed foods, .

The food composition of the present invention can be used as it is as an active ingredient as it is, or can be used in combination with other food or food composition, and can be suitably used according to a conventional method, as a composition for prevention and improvement of male menopausal symptoms of the present invention. The amount of the active ingredient to be mixed can be suitably determined according to its intended use (prevention, improvement, or therapeutic treatment). In general, the food composition for preventing and ameliorating male menopausal symptoms of the present invention is added in an amount of 0.1 to 70 parts by weight, preferably 2 to 50 parts by weight, per 100 parts by weight of the raw material of food or beverage . The effective dose of the food composition for preventing and ameliorating male menopausal symptoms can be used in accordance with the effective dose of the pharmaceutical composition. However, in the case of long-term intake for the purpose of health and hygiene or health control, And the active ingredient may be used in an amount in the above-mentioned range because there is no problem in terms of safety.

There is no particular limitation on the kind of the food. The food composition may be used in the form of tablets, hard or soft capsules, liquids, suspensions, and the like, which may contain conventional excipients, such as excipients in the case of oral preparations, Binders, disintegrators, lubricants, solubilizers, suspending agents, preservatives or extenders.

Examples of the food to which the food composition for preventing or ameliorating menopausal symptoms of the male can be added include dairy products including meat, sausage, bread, chocolate, candy, snack, confectionery, pizza, ramen, other noodles, gums, ice cream, Various soups, beverages, tea, drinks, alcoholic beverages and vitamin complexes, and other nutrients, but the present invention is not limited to these kinds of foods.

Pharmaceutical composition

The present invention relates to a pharmaceutical composition for preventing and treating male menopausal symptoms comprising at least one selected from the group consisting of zinc / red ginseng mixture, octacosanol mixture and vitamin mixture. Preferably, the present invention relates to a pharmaceutical composition for the prevention and treatment of male menopausal symptoms comprising two or more selected from the group consisting of zinc / red ginseng mixture, octacosanol mixture and vitamin mixture. Most preferably, the invention relates to a pharmaceutical composition for the prevention and treatment of male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture and a vitamin mixture.

The pharmaceutical composition of the present invention may contain 0.01 to 99 parts by weight, preferably 0.02 to 60 parts by weight, of a pharmaceutical composition for the prevention and treatment of menopausal symptoms of the present invention, based on 100 parts by weight of the total pharmaceutical composition , And more preferably 0.02 to 30 parts by weight. However, this can be increased or decreased according to the needs of the patient, and can be appropriately increased or decreased depending on the condition such as the degree of menopausal symptoms.

The pharmaceutical composition of the present invention can be administered orally or parenterally. The pharmaceutical composition of the present invention can be prepared using a conventional pharmaceutically acceptable carrier. For example, in the case of a preparation for oral administration, it can be prepared using excipients, binders, disintegrants, lubricants, solubilizers, suspending agents, preservatives or extenders.

The dosage of the pharmaceutical composition of the present invention may be determined by a specialist depending on various factors such as the patient's symptoms, age, etc., but is generally administered in a dose of 0.01 μg to 200 μg, preferably 0.01 μg to 50 μg . Also, the daily dosage of the pharmaceutical composition or a half, 1/3 or 1/4 dose thereof is contained, and it can be administered 1 to 6 times a day. However, in the case of long-term administration for the purpose of skin health maintenance and hygiene, the amount may be less than the above range, and since the active ingredient has no problem in terms of safety, it may be used in an amount exceeding the above range.

Kit

The present invention relates to a kit for preventing, ameliorating, alleviating or treating male menopausal symptoms comprising a zinc / red ginseng mixture, an octacosanol mixture and a vitamin mixture.

The zinc / red ginseng mixture, octacosanol mixture and vitamin mixture are each contained separately in the kit. Preferably, the kit contains a zinc / red ginseng mixture, an octacosanol mixture and a vitamin mixture separately in a daily dosage amount. More preferably, the kit is divided into three zones, each containing zinc / red ginseng mixture, octacosanol mixture and vitamin mixture. The kit of the present invention is such that the above-mentioned mixtures are separately contained so as to be programmed into the mixtures and taken at predetermined time intervals.

Advantages and features of the present invention and methods of achieving them will become apparent with reference to the embodiments described in detail below. It should be understood, however, that the invention is not limited to the disclosed embodiments, but is capable of many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, To fully disclose the scope of the invention to those skilled in the art, and the invention is only defined by the scope of the claims.

≪ Materials and methods >

material

The zinc / red ginseng mixture was prepared by mixing red ginseng fermentation powder and zinc oxide at a weight ratio of 17: 1. The red ginseng fermented powder was prepared by pulverizing 6-year-old ginseng red ginseng and inoculating the red ginseng powder with Lactobacillus brevis KCTC 11390BP for 3 days. Commercially available zinc oxide was purchased and used.

The octacosanol mixture was prepared by mixing octacosanol, maca extract powder and plant mixture in a weight ratio of 5.8: 2: 1. Commercially available octacosanol was purchased and used. The above-mentioned maca extract powder was prepared by using commercially available roots of peroxylic acid maca, which were extracted with hot water and powdered to prepare powder. The plant mixture was prepared by mixing the hot-water extract powders of the fruits of Omija, Gujia, Bokbunja, Casualties and Tumors with the same ratio.

The vitamin mixture is a mixture of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, niacin, pantothenic acid, folic acid, iron, zinc, selenium and chromium in a ratio of 0.2: 0.2: 9: 0.2: 1.3: 1.3: 0.5: 0.1: 2.3: 0.8: 3.8: 1.6.

Breeding of experimental animals

In this study, Sprague-Dawley male rats, 12 weeks old, were purchased from BioLink. Sixteen rats were randomly housed in the experimental group for 6 weeks. Experimental animals were divided into two groups of cages in a temperature of 22 ± 2 ° C, 55 ± 5% relative humidity and 12 hours of darkness. In addition to the normal group, which was orally administered with saline, 500 mg of each sample was orally administered to the experimental group, and the dietary intake and body weight were measured every 3 days during the experimental period.

Blood collection and serum collection

Before the experiments, approximately 400-500 μl of blood was drawn from the tail vein after CO2 anesthesia, similarly, the animals were anaesthetized with CO2 every week between 16:00 and 18:00, 500 μl of blood was collected and blood was collected from the heart at the end of the experiment. The collected blood was put into ice and centrifuged at 13,000 rpm for 10 minutes at 4 ° C.

Enzyme source  pharmacy

The lower abdomen of the animal was lightly anesthetized using CO2 as an inhalation anesthetic. Blood was collected from the abdominal aorta and the corpus cavernosum was excised. The extracted penile corpus cavernosum was cleaned with physiological saline, and the remaining foreign matter and blood were removed with a filter paper. Four times the amount of 0.1 M potassium phosphate buffer (pH 7.4) solution per 1 g of corpus cavernosum tissue was added and ground with Ultra-Turrax T25 (lKA-Lab, Germany) to make a homogenate. The supernatant was centrifuged at 600 xg for 10 minutes using a refrigerated centrifuge (Hanil Supra 22K), and the supernatant was used as a source of lipid peroxide, glutathione and nitrite. The supernatant was again centrifuged at 10,000 xg for 30 minutes The supernatant obtained after centrifugation was used as an enzyme source for measuring NOS activity.

Nitric oxide synthase  Active measurement

NOS activity was measured by a colorimetric assay using the NADPH diaphorase activity assay (Schmidt, HW, Smith, RM, Nakzne, M., Murad, F. Ca2 + / Calmodulin-dependent NO synthase Type-1: Abiopteroflavoprotein with Ca2 + / Calmodulin-independent diaphorase and reductase activities. Biochem. 31: 3243-3249, 1992.). The specific measurement method is as follows. L-arginine, NADPH, EDTA, CaCl2, dithiothreεitol, calmodulin and NBT were added to 50 mM Hepes (pH 7.4) solution and incubated at 37 ℃ for 5 min. Respectively. The activity of the enzyme was calculated by dividing the amount of protein used in the absorbance value measured at a wavelength of 585 nm.

Nitrite  Content measurement

The amount of nitrite (N02-) in the tissues was measured colorimetrically according to the Griess reaction (Tracey, WR, Linden, J., Michael, JP, Roger, AJ Comparative spectrophotometric and biological assay for nitric oxide and endothelium- ) Griess solution was prepared by mixing 1% sulfanilamide, 0.1% naphtylethylene diamine and 2.5% phosphoric acid, and the enzyme source 200 μl of the same amount of Griess TS was reacted at room temperature for 10 minutes and the change of absorbance at 550 nm was measured. The amount of nitrite was calculated by using a standard curve using sodium nitrite, and the amount of nitrite per gram of the rat tissue was expressed in μmole.

Determination of lipid peroxide content

The lipid peroxide content was determined by the method of Ohkawa et al. (Ohkawa, H., N. Ohishi and K. Yaki, 1979. Assay for lipid peroxide in animal tissues by thiobarbituric acid reaction, Anal. Biochem 95 (2): 351-358.) . The concrete method is as follows. First, a solution of 8.1% SDS, 20% acetate buffer (pH 3.5) and 0.8% thiobarbituric acid (TBA) was added to the milled homogenate for 1 hour at room temperature. Then, the resulting red colored TBA reactive substance was transferred to a n-butanol: pyridine (15: 1) mixed solution, and the absorbance at 532 nm was measured and quantified. The amount of lipid peroxide is expressed in nmoles in the amount of MDA per gram of tissue.

Glutathione  Content measurement

Glutathione content was determined according to Ellman's method (Ellman GL, 1959. Tissue sulfhydryl group, Arch Biochem Biophy 82: 70-72). The concrete method is as follows. 4% sulfosalicylic acid was added to the tissue lysis solution to obtain a supernatant. To the supernatant was added a constant amount of 0.1 M sodium phosphate buffer (pH 8.0) containing 0.1 mM 5,5'-dithiobis (2-nitrobenzoic acid), and the absorbance of the resulting p-nitrothiophenol was measured at a wavelength of 412 nm Respectively. The GSH content is expressed in nmoles in the amount of GSH contained per 1 g of tissue.

Blood testosterone measurement

Serum testosterone content was measured as follows. Plasma samples and standard solutions were added to a pre-coated microplate using a testosterone EIA kit (Enzo Life Sciences, Plymouth Meeting, PA, USA). Testosterone specific antibodies were incubated in an orbital shaker at 300 RPM for 1 hour, solution, and react at 300 RPM and RT for 1 hour in an orbital shaker. Wash it three times with wash buffer, a detergent containing saline. Subsequently, pNpp substrate was added and reacted for 1 hour at 37 ° C without light. After adding stop solution containing trisodium phosphate, the absorbance was measured at 405 nm immediately.

Blood SHBG  Measure

Serum SHBG content was measured as follows. Plasma samples and standard solutions are added to a pre-coated microplate using the SHBG EIA Kit (Cloud-clone Corp., Houston, Tex., USA) and incubated at 37 ° C for 2 hours. After removing the solution, add the detection reagent A, seal it, react at 37 ° C for 1 hour, and wash it three times with wash buffer. The solution is then removed and incubated at 37 ° C for 30 min with detection reagent B. Wash them five times. Then, the solution is removed, and TMB substrate is added, and the reaction is stopped after light is blocked for 20 minutes at 37 ° C. Finally, stop solution is added and absorbance is measured immediately at 450 nm.

Forced swimming

The forced swimming movement was performed as follows. A plastic water tank (50 W × 40 D × 60 H (cm)) for forced swimming was filled with sterilized water to a height of about 40 cm and maintained at a water temperature of 25 ± 2 ° C using an underwater heater (Aquarium Heater, EIEIM GmbH & Co. KG. . Exhaustive swimming measurements of rats were performed with 8 animals per test group by performing a forced swimming exercise until the nose of the mouse fell below the water surface for more than 5 seconds (exhaustion) .

Plasma lipid analysis

The content of triglyceride in blood was measured as follows. First, the absorbance was measured by an enzymatic method using a kit for measuring plasma triglyceride (ASAN pharmaceutical co Ltd. Korea). The serum total cholesterol content was measured by an enzymatic method using a kit for measuring total cholesterol (ASAN pharmaceutical co Ltd. Ltd. Korea) and the absorbance at 500 nm was measured. The high-density lipoprotein (HDL) ASAN pharmaceutical co Ltd. Korea) and the absorbance is measured.

AST  And ALT  Measure

The contents of serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase) were measured as follows. Plasma AST and ALT assay kit (ASAN pharmaceutical co Ltd. Korea) is analyzed using the Reitman-Frankel method and the absorbance is measured at a wavelength of 505 nm.

Statistical processing

The results of the present invention were statistically analyzed using a statistical package for social science, version 12.0, Raleigh, NC, USA. All results were expressed as mean ± SD and statistical significance was tested using one-way analysis of variance followed by Tukey's test at p <0.05. And

&Lt; Example 1 >

500 mg of zinc / red ginseng mixture was orally administered to SD rats daily. Dietary intake and body weight were measured every 3 days during the experiment.

&Lt; Example 2 >

500 mg of octacosanol mixture was orally administered to SD rats daily, and the dietary intake and body weight were measured at intervals of 3 days during the experiment.

&Lt; Example 3 >

Vitamin mixture 500 mg was orally administered to SD rats daily. Dietary intake and body weight were measured at 3-day intervals during the experiment.

<Example 4>

Zinc / red ginseng mixture and octacosanol mixture were mixed in an equal amount to prepare a complex, and 500 mg of the complex was orally administered to SD rats daily. Dietary intake and body weight were measured at 3-day intervals during the experiment.

&Lt; Example 5 >

The zinc / red ginseng mixture and the vitamin mixture were mixed in an equal amount to prepare a composite, and 500 mg of the complex was orally administered to the SD rats daily. Dietary intake and body weight were measured at 3-day intervals during the experiment.

&Lt; Example 6 >

The complex was prepared by mixing the zinc / red ginseng mixture, the octacosanol mixture, and the vitamin mixture in the same amounts, respectively (i.e., a weight ratio of 1: 1: 1), and then 500 mg of the complex was orally administered to the SD rats daily. Dietary intake and body weight were measured at 3-day intervals during the experiment.

<Control group>

500 mg of physiological saline was orally administered to SD rats daily. Dietary intake and body weight were measured at 3-day intervals during the experiment.

Experimental Example 1 Weight gain, dietary intake and long-term weight:

During the experimental period, weight gain and dietary intake of experimental animals were measured.

As a result, the body weight gain was 3.4 to 4.5 g / day, and there was no significant difference in each group. Dietary intake was also in the range of 15.9 to 17.5 g / day, with no significant difference. No changes in body weight gain and dietary intake were observed during the experimental period (Examples 1 to 6) (Table 1).

FER: Weight gain / Dietary intake

 <Experimental Example 2> Change of blood testosterone

Testosterone, a male hormone, is mainly produced in the testes and is present in the free form or in combination with serum proteins, albumin and sex hormone binding globulins (Isidori AM, Giannetta E, Gianfrilli D, Greco EA, Bonifacio V, Aversa A Testosterone has been shown to induce male sexual differentiation, masculinization, and sexual functioning in men. In addition, It is important to maintain sexual function and has various functions throughout the body including muscle, bone, kidney, skin, bone marrow, liver, alveoli, central nervous system, etc. [Derby CA, Zilber S, Brambilla D, Morales KH, McKinlay JB. Men Clinical Endocrinol (Oxf) 65: 125-131 (2006)]. Changes in the endocrine system in men were defined as menopausal period, and sexual desire and sexual intercourse Erectile dysfunction, Men's menopausal symptoms, such as decreased muscle mass, increased body fat, decreased memory, reduced bone volume, and depression, are associated with lowering of male hormones (Morales A, Schulman CC, Tostain J, CW Wu F. Testosterone deficiency syndrome to be named appropriately: the importance of accurate terminology. J Eur Urol 50: 407-409 (2006)].

The changes of testosterone were measured after oral administration of each sample for 4 weeks to SD rats.

As a result, in the control group, Example 2 and Example 3, blood testosterone levels were 12.7 and 32.6, respectively. 12.4 pg / ml, whereas in Example 1 and Examples 4 and 6 containing red ginseng and zinc, blood testosterone levels were increased by 23, 4, 32, 4, 20.2, and 38.6 pg / ml, respectively. The increase of testosterone was observed in the oral administration group of the zinc / red ginseng-containing masticatory group, especially in the case of Example 6, the increase was more pronounced than in the other groups. This result shows that administration of a 4 week zinc / red ginseng mixture and a sample thereof increased testosterone secretion in vivo and could help alleviate symptoms of male menopause caused by testosterone reduction (Fig. 1).

<Experimental Example 3> Changes in serum SHBG

SHBG is a sex hormone-binding globulin that binds to testosterone and regulates the actual action of testosterone [Shea JL, Wongt PY, Chen Y. Free testosterone: clinical utility and important analytical aspects of measurement. J. Adv Clin Chem 63: 59-84 (2014)]. When SHBG binds to testosterone, it loses its hormone activity, and when separated it becomes a hormone that actually works. 40-80% of testosterone is biologically inactivated in association with SHBG, and in the Massachusetts Male Aging Study, 1,156 men aged 40-70 years were examined and their SHBG increased by 1.3% per year [Hammond GL . Diverse roles for sex hormone-binding globulin in reproduction. J Biol Reprod. 85: 431-441 (2011)).

To investigate the effect of the sample of the present invention on the level of SHBG, serum SHBG levels were measured at 4 weeks after administration.

As a result, the groups of Examples 1, 4, 5 and 6, which are the groups of administration of the zinc / gums mixture or the samples containing the same, showed 167.8, 180.4, 182.3 and 161.3 ng / ml, respectively, while the groups of Example 2, Example 3, Example 4 and Example 5 showed no significant difference from the control group. The SHBG in Example 6 was significantly different from the control group. The exact mechanism of this outcome has not yet been studied, but the combination of zinc / red ginseng mixture, octacosanol mixture and vitamin mixture may reduce SHBG, which may indicate increased levels of activated testosterone (Fig. 2) .

<Experimental Example 4> Changes in nitrite and nitric oxide synthase

In order for the penis to become erect, the penis cavernosal artery and the penis smooth muscle must be completely relaxed and the blood must be accumulated in the sinusoidal space in the cavernous cavernous fissure [Chirist, GJ The penis as a vascular organ. Urol Clin North Am. 22 (4): 727-745, 1995.]. The endothelium-dependent relaxant secreted from the cavernosal endothelial cells relaxes the corpus cavernosum causing penile erection and is known to be an endogenous substance that acts like NO [Palmer, RMJ, Ferrige, AG, Moncada, S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 327: 524-526, 1987. Azadzoi, KM, Kim, N., Browne, ML, Goldstein, I., Cohen, RA, Saenz de Tezada, I. Modified corpus cavernosum smooth muscle tone of endothelium-derived nitric oxide and cyclooxygenase products. J Urol. 147: 220-225, 1992).

In addition, as the penile erection phenomenon due to cavernosal nerve stimulation is inhibited by the NO biosynthesis enzyme NOS inhibitor, NO has become a powerful neurotransmitter involved in penile erection [Knispel, HH, Goessl, C., Beckmann, R. Nitric oxide mediates relaxation in rabbit and human corpus cavernosum smooth muscle. Urol Res. 20: 253-257, 1992.]. NO activates guanylate cyclase in the body and promotes the biosynthesis of c-GMP [Kimura, H., Mittal, CK and Murad, F. Activation of guanylate cyclase from rat liver and other tissues by sodium azide. J Biol Chem. 250 (20): 8016-8022). It is known that c-GMP, which is generated at this time, promotes relaxation of vascular smooth muscle, which is the most important factor causing penile erection by intensifying the blood flow into the corpus cavernosum [Kimura, H., Mittal, CK and Murad, F. Activation of guanylate cyclase from rat liver and other tissue by sodium azide. J Biol Chem. 250 (20): 8016-8022.].

The effects of the samples of the present invention on nitrite content and nitric oxide synthase activity in corpus cavernosum tissue were evaluated.

As a result, the nitrite content in the corpus cavernosum tissues of the control group was 0.40 μmoles / g, but in Example 1 and Examples 4 and 6, the nitrite content in the corpus cavernosum tissues was 0.49, 0.47, 0.43, and 0.54 μmoles / . In particular, the NO contents in Examples 1 and 6 were significantly increased compared with the control (Fig. 3A).

The nitric oxide synthase activity of the control group was 1.40 [Delta] OD / mg, but it was 1.61, 1.64 and 1.69 [Delta] OD / mg in Example 1, Example 4, Example 5 and Example 6, respectively. In particular, the NO synthase activities of Examples 1, 4, and 6 were significantly increased compared to the control (FIG. 3B). Therefore, the increase in NO in the treated group of zinc / red ginseng mixture or a sample containing it appeared to be due to an increase in the activity of NO synthase involved in NO synthesis.

<Experimental Example 5> Changes in lipid peroxidation and glutathione contents

The penile palsy function can be deteriorated by the underlying damage of penile cells. One of the important factors causing cellular damage is the peroxidic lipid, a toxic factor that causes cell death by destroying the cell membrane [Hornsby, PJ , Crivello, JF The role of lipid peroxidation and biological antioxidants in the function of the adrenal cortex. Part 2. Mol Cell Endocrinol. 30: 123-147, 1983; McCord, JM Oxygen-derived free radicals in postischemic tissue injury. N Engl J Med. 312 (3): 159-163, 1985). Therefore, the amount of lipid peroxidation in the penis tissue and the amount of glutathione that can remove it are important.

The effect of the sample of the present invention on the lipid peroxide content and glutathione content in the corpus cavernosum tissue was evaluated.

As a result, in the case of the lipid peroxide content in the corpus cavernosum tissues, the vitamin mixture (Example 3) and the sample administration group containing them (Examples 5 and 6) were 5.23, 5.34 and 5.36 nmole / ) (Fig. 4A).

On the other hand, the content of glutathione, which plays an important role in the removal of lipid peroxide, was not significantly different between the control and the experimental groups. The above results show that less lipid peroxides were produced in the compound administration groups (Examples 5 and 6) containing the vitamin mixture (Example 3) or the vitamin mixture than the other experimental groups (FIG. 4B).

Therefore, the samples contain a component that inhibits the lipid peroxidation reaction, thereby reducing the production of lipid peroxidase and inhibiting damage to the penile tissue cells, thereby blocking the sexual function to some extent.

&Lt; Experimental Example 6 >

And evaluated whether the exercise performance of the present invention was improved by administering the sample. For this purpose, for Examples 1 to 6, the forced swimming ability to swim until the draining after the samples were administered for 4 weeks was measured.

As a result, the swimming time was 113.5 seconds for the control group, and the swimming time was 145.3 to 173.4 seconds for the samples not containing the vitamin mixture. In particular, the experimental groups of Example 4, Example 5 and Example 6 showed significantly increased swimming time compared to the control group (FIG. 5).

These results show that the sample of the present invention has helped to improve the athletic performance of the experimental animals. This is consistent with previous studies that steroid hormones such as male hormones have been implicated in improving muscle mass, muscle strength and motor performance [Schroeder, ET, Terk, M. and Sattler, FR improves muscle mass and strength but not muscle quality: results from two studies. Am. J. Physiol. J Endocrinol. Metab. 16: 285 (2003); Schroeder, ET, Vallejo, AF, Zheng, L., Stewart, Y., Flores, C., Nakao, S., Martinez, C. and Sattler, FR Six-week improvements in muscle mass and strength during androgen therapy in older men. J. Gerontol. A. Biol. Sci. Med. Sci. 60: 1586 (2005)). It was thought that increased testosterone by the samples of the present invention had an effect on the improvement of exercise performance.

<Experimental Example 7> Changes in sperm count

Testosterone has important effects on spermatogenesis and motility [Moss JL, Crosnoe LE, Kim ED. Effect of rejuvenation hormones on spermatogenesis. J Fertil Steril. 99: 1814-1820 (2013)]. It was confirmed in Experimental Example 2 that administration of the sample of the present invention increased testosterone. Based on this, the total number of spermatozoa of the experimental animals of Examples 1 to 6 was measured in order to measure the effect of the administration of the present invention on the number of spermatozoa.

As a result, in the total sperm count, the control group had a sperm count of 5.54 × 10 ⁷ , but 6.10 × 10 ⁷ in Example 1, and 6.01 × 10 ⁷ and 5.94 × 10 ^{7 in} Example 4, Example 5, 10 ⁷ , and 6.88 × 10 ⁷ , respectively. Among them, the number of spermatozoa in Example 6 including the zinc / red ginseng mixture, the octacosanol mixture, and the vitamin mixture was the highest (Fig. 6). These results show that administration of a combination of zinc / red ginseng mixture, octacosanol mixture, and vitamin mixture maximally increases total sperm count. This was judged to be an effect of increased testosterone secretion and SHBG reduction.

<Conclusion>

According to the results of Experimental Examples 1 to 7, the composite of zinc / red ginseng mixture (Example 1), zinc / red ginseng mixture and octacosanol mixture (Example 4), zinc / red ginseng mixture + vitamin mixture (Example 5) Administration of a complex containing zinc / red ginseng mixture + octacosanol mixture + vitamin mixture (Example 6), rather than administration, showed excellent menopausal relaxation effect. This was thought to be due to an increase in testosterone, a male hormone, an increase in NO content, which is related to penile erection, and a decrease in lipid peroxidation, which may impair penile tissue.

Claims (11)

A mixture of zinc oxide and red ginseng fermentation product;
Octacosanol mixture; and
Vitamin mixtures
The red ginseng fermented product is prepared by inoculating Lactobacillus brevis into red ginseng or red ginseng powder and fermenting the same,
Wherein the octacosanol mixture comprises octacosanol, macaques root extract and plant extract in a weight ratio of 1: 3 to 10: 1.3 to 3,
The plant extract is an extract of fruit of Schizandra chinensis,
Fatigue, decrease in testosterone, and decrease in exercise performance.
delete delete delete delete The method according to claim 1,
Wherein said vitamin mixture comprises one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D and vitamin E. Food composition for improvement.
The method according to claim 1,
Wherein the vitamin mixture is selected from the group consisting of one or more vitamins selected from the group consisting of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D and vitamin E, niacin, pantothenic acid, folic acid, iron, And chromium. &Lt; RTI ID = 0.0 &gt; 8. &lt; / RTI &gt;
The method according to claim 1,
The food composition according to claim 1, wherein the food composition has the ability to testosterone, inhibit sexual function lowering, promote fatigue recovery, or improve exercise performance.
A mixture of zinc oxide and red ginseng fermentation product;
Octacosanol mixture; and
Vitamin mixtures,
The red ginseng fermented product is prepared by inoculating Lactobacillus into red ginseng or red ginseng powder and fermenting it,
Wherein the octacosanol mixture comprises octacosanol, macaques root extract and plant extract in a weight ratio of 1: 3 to 10: 1.3 to 3,
The plant extract is an extract of fruit of Schizandra chinensis,
Depression, fatigue, decreased testosterone, and impaired exercise performance.
A mixture of zinc oxide and red ginseng fermentation product;
Octacosanol mixture; and
Vitamin mixtures,
The red ginseng fermented product is prepared by inoculating Lactobacillus into red ginseng or red ginseng powder and fermenting it,
Wherein the octacosanol mixture comprises octacosanol, macaques root extract and plant extract in a weight ratio of 1: 3 to 10: 1.3 to 3,
The plant extract is an extract of fruit of Schizandra chinensis,
A testosterone reduction, and a decrease in exercise performance. &Lt; RTI ID = 0.0 &gt; 15. &lt; / RTI &gt;
11. The method of claim 10,
Wherein the mixture of zinc oxide and red ginseng fermented product, the mixture of octacosanol and the vitamin is separately contained in the kit.

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