KR101460126B1 - Composition for preventing and improving sex hormone-related disease and symptoms comprising dandelion extract or dandelion containing multiple extract as an active ingredient - Google Patents
Composition for preventing and improving sex hormone-related disease and symptoms comprising dandelion extract or dandelion containing multiple extract as an active ingredient Download PDFInfo
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- KR101460126B1 KR101460126B1 KR1020130014407A KR20130014407A KR101460126B1 KR 101460126 B1 KR101460126 B1 KR 101460126B1 KR 1020130014407 A KR1020130014407 A KR 1020130014407A KR 20130014407 A KR20130014407 A KR 20130014407A KR 101460126 B1 KR101460126 B1 KR 101460126B1
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- extract
- dandelion
- composition
- rooibos
- menopausal
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2200/00—Function of food ingredients
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Abstract
본 발명은 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 새로운 용도에 관한 것으로, 더욱 상세하게는 민들레 및 루이보스 복합 추출물 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 및 증상의 예방 및 개선용 식품 조성물 및 약학적 조성물에 관한 것이다. 본 발명의 조성물은 혈중 성호르몬 전구체와 남녀 성호르몬 수준을 증가시키며, 생체 성호르몬 활성억제글로블린의 농도를 감소시켜 생체 활성을 갖는 남성 및 여성의 성호르몬수치를 향상시킴으로서 남성 및 여성의 갱년기 또는 갱년기 관련 질환 및 증상의 개선과 예방에 효과적이다.The present invention relates to a novel use of a dandelion extract or a dandelion and a rooibos combination extract and more particularly to a food composition and a pharmaceutical composition for preventing and ameliorating menopausal or menopausal related diseases and symptoms, . The composition of the present invention increases serum sex hormone precursor and male sex hormone level and decreases the concentration of bioactive hormone activity inhibitory globulin to improve sex hormone levels of male and female having bioactivity, It is effective for the improvement and prevention of related diseases and symptoms.
Description
본 발명은 민들레 추출물 및 루이보스 추출물의 새로운 용도에 관한 것으로, 더욱 상세하게는 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 예방 및 개선용 식품 조성물 및 약학적 조성물에 관한 것이다.
The present invention relates to a novel use of a dandelion extract and a rooibos extract, and more particularly to a food composition and a pharmaceutical composition for preventing and improving menopausal symptoms, which comprise an extract of dandelion or a compound extract of dandelion and rooibos as an active ingredient.
민들레는 국화과 다년초 식물로 그 전초를 건조한 것을 포공영이라 하여 한방에서 약제로 사용하고 있다. 민들레는 민간이나 한방에서 소염, 강장, 해열, 이뇨, 건위, 거담, 해독제 등에 이용되어 왔고, 서양에서도 담즙분비 촉진, 항류마티스, 이뇨 등의 작용으로 약제로 사용되어 왔다. 또한, 본초정의(本草定議)에는 민들레가 그 성질이 청량하여 열독, 홍종, 창정, 옹양의 치료에 효과가 있으며, 내복과 외용이 모두 가능하다고 기재되어 있다. 그러나 민들레의 남성 갱년기 예방 또는 개선에 관하여는 연구된 바가 없다.Dandelion is a plant of Asteraceae and perennial plant, and its dried outpowder is called as Pongyong. Dandelion has been used in the private sector and in oriental medicine for anti-inflammation, tonic, fever, diuretic, dryness, genomes, antidote and has been used as a medicine in Western countries for the promotion of bile secretion, antirheumatics and diuretic. In addition, it is said that the dandelion is effective in the treatment of the dandelion, the dandelion, the dandelion, the dandelion, and the dandelion, and both the underwear and the external use are possible. However, there has been no research on the prevention or improvement of menopause in male dandelion.
루이보스는 남아프리카 희망봉의 고원 지대에서만 서식하는 침엽수로 각종 피부질환 개선, 알레르기 증상 (아토피성 피부염 등의 치료)의 치료, 혈압의 정상화 작용, 당뇨병 개선, 변비 해소와 정장 작용, 노화 억제, 정신안정, 이뇨 작용, 간기능의 개선, 항균, 살균 작용 등이 알려져 있다. 그러나 루이보스의 남성 갱년기 예방 또는 개선에 관하여는 연구된 바가 없다.
Rooibos is a conifer that lives only in the highlands of the Cape of the South Africa. It treats various skin diseases, treats allergic symptoms (such as atopic dermatitis), improves blood pressure, improves diabetes, resolves constipation, Diuretic action, improvement of liver function, antibacterial action, sterilization action, etc. are known. However, there has been no research on the prevention or improvement of male clopidogy of rooibos.
여성 갱년기란 여성의 월경이 끝나는 시기 전후에 나타나는 과도기적인 기간을 의미하며, 이때 건강에 따라 에스트로겐 분비가 자연스럽게 지방세포에서 발생되지 않아 에스트로겐 부족 현상을 겪게 된다. 체내에 에스트로겐이 감소함에 따라 뇌하수체는 난소를 자극하기 위해 더 많은 난포자극호르몬을 생산하게 되는데, 여성 갱년기의 대부분의 증상들은 에스트로겐 감소와 난포자극 호르몬의 증가에 따른 결과이다. 여성 갱년기 증상으로는 우울감, 수면장애, 뼈 및 근육 통증, 심계향진, 발한, 안면홍조, 건망증 등이 있다.Women's menopause is a transitional period that occurs before and after the end of menstruation, and estrogen secretion naturally does not occur in adipocytes, resulting in estrogen deficiency. As estrogen decreases in the body, the pituitary gland produces more follicle stimulating hormone to stimulate the ovaries. Most symptoms of female menopause are the result of estrogen deprivation and increased follicle stimulating hormone. Female menopausal symptoms include depression, sleeping disorders, bone and muscle pain, heart palpitations, sweating, facial flushing, and forgetfulness.
이러한 여성 갱년기를 치료하기 위한 방법으로는 호르몬 요법, 에스트로겐 크림, 약물 제제 등이 있으나 호르몬 요법이 가장 대표적이라고 할 수 있다. 그러나 호르몬 요법은 유방암, 뇌졸중, 심장마비, 정맥 혈전증, 심혈관계질환 등을 증가시키는 것으로 나타났다.Hormone therapy, estrogen cream, and drug preparations are among the methods to treat women's menopause, but hormone therapy is the most representative. However, hormone therapy has been shown to increase breast cancer, stroke, heart attack, venous thrombosis, and cardiovascular disease.
남성 갱년기란 신체의 노화현상에 따라 남성이 전반적인 신체적, 정신적 측면의 쇠퇴 현상을 겪게 되는 과정이라 할 수 있다. 남성에서 신경과민, 정서불안, 우울증, 현기증, 안면홍조, 발한, 수면장애, 활력저하, 기억력저하, 업무능력감소, 성욕감퇴 등의 증상이 나타남을 남성 갱년기라 명명하였다(Werner AA. The male climateric. J Am Med Assoc 1939;112:1441-1443). 남성 갱년기란 남성호르몬의 저하로 인한 영향으로 남성적 특징, 전반적인 생활 활력이나 기분이 서서히 저하되는 것을 의미한다. 여성과 마찬가지로 남성에게도 50대 전후부터 갱년기가 발생하기 시작하여 나이가 들수록 발생 빈도가 늘어가며, 나이가 들면서 부신분비의 기능, 정자의, 생식력, Leydig 세포 기능이 감퇴하고, 혈청 테스토스테론이 감소하면서 남성 갱년기 증세가 나타나게 된다. ISSAM(International society for the study of the aging male)에 의하면, 남성호르몬 저하에 따라 성적욕구감소, 발기능력의 저하, 우울함과 짜증을 수반하는 기분의 저하, 기억력 감소, 제지방량의 감소, 체모의 감소와 피부노화, 골밀도 감소, 내장지방 증가 등이 나타난다고 한다(대한 성학회. 제 1회 의사를 위한 성치료 교육과정 2003. 11.). 이러한 남성 갱년기의 원인은 기타 환경적 요인 외에도 주원인이 남성 호르몬을 주축으로 한 내분비계의 쇠태에 있어 그동안은 남성 호르몬의 보충치료가 주된 치료요법으로 알려져 왔다. 남성 호르몬 보충요법은 먹는 약이나 바르는 제제, 붙이는 패치형 제제, 주사요법 등이 있다. Men's menopause is a process in which men experience a general decline in physical and mental aspects as a result of aging of the body. Men were referred to as menopausal for symptoms such as nervousness, emotional distress, depression, dizziness, facial flushing, sweating, sleeping disturbances, diminished vitality, decreased memory, decreased work capacity, and loss of libido (Werner AA. J Am Med Assoc 1939; 112: 1441-1443). Men's menopause means that men's characteristics, overall vitality and mood are gradually deteriorated due to the deterioration of male hormones. As with women, men also begin to develop menopausal symptoms from around the age of 50. As the age increases, the incidence of adrenal gland function, sperm, fertility, Leydig cell function declines and serum testosterone decreases with age Menopausal symptoms will appear. According to ISSAM (International Society for the Study of the Aging Male), depression of male hormone leads to a decrease in sexual desire, a decrease in erectile function, a decrease in mood accompanied by depression and irritation, a decrease in memory, And skin aging, decreased bone density, and increased visceral fat (The Korean Academy of Sexual Surgery. In addition to other environmental factors, male hormone replacement therapy has been known as the main therapy for the menopausal decline of male hormones. Male hormone replacement therapy includes eating or applying drugs, sticking patches, and injecting therapy.
그러나, 남성 호르몬 요법을 통한 남성 갱년기 질환의 치료는 전립선의 크기를 증가시켜 이미 발생한 전립선암 크기를 증가시키거나 수면 중 무호흡증의 악화, 여성형 유방 발생, 적혈구증가증 발생, 심혈관질환 위험도 증가 등의 부작용이 따를 수 있다. However, the treatment of male menopausal disease through male hormone therapy increases the size of the prostate gland to increase the size of the prostate cancer that has already occurred, or the side effects such as worsening of sleep apnea, gynecomastia, erythropoiesis, and increased risk of cardiovascular disease You can follow.
또한, 이러한 호르몬 치료요법은 갱년기 질환의 근본적인 발병 원인을 치료하지는 못하며, 누구나 나이가 들면서 갱년기 증세를 겪게 되므로 그 예방이 무엇보다 중요하다. In addition, this hormone therapy does not cure the underlying cause of menopausal disease, and everybody is suffering from menopausal symptoms as they get older, so prevention is of utmost importance.
따라서 갱년기를 예방 및 개선하며, 부작용이 적은 천연물 유래 갱년기 예방 및 개선용 조성물의 개발이 시급하다.
Therefore, it is urgent to develop a composition for prevention and improvement of menopausal period, and for prevention and improvement of climacteric symptoms derived from natural products with few side effects.
이에 본 발명자들은 갱년기 예방 및 개선 효능이 뛰어난 새로운 천연성분에 관하여 연구하던 중, 민들레 추출물이 성호르몬을 증가시켜 갱년기 개선 및 치료하는데 효과가 있으며, 민들레 추출물과 루이보스 추출물을 함께 적용하는 경우 그 효과가 더욱 우수해지는 것을 발견하여 본 발명을 완성하였다.
Accordingly, the inventors of the present invention have found that when a new natural ingredient having excellent preventive and / or ameliorating effects on menopausal symptoms is studied, the effect of the dandelion extract and rooibos extract is enhanced when the dandelion extract is added to the sex hormone And thus the present invention has been completed.
따라서 본 발명의 목적은 민들레 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공하는 것이다.
Accordingly, an object of the present invention is to provide a food composition for preventing and ameliorating a menopausal or menopausal-related disease or symptom comprising a dandelion extract as an active ingredient.
본 발명의 다른 목적은 민들레 추출물을 유효성분으로 포함하는 남성 갱년기 또는 남성 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공하는 것이다.
Another object of the present invention is to provide a pharmaceutical composition for the prevention and treatment of male menopausal or menopausal symptoms or symptoms related to dandelion extract as an active ingredient.
본 발명의 다른 목적은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공하는 것이다.
Another object of the present invention is to provide a food composition for preventing and ameliorating a menopausal or menopausal-related disease or symptom comprising an extract of dandelion and rooibos as an active ingredient.
본 발명의 다른 목적은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공하는 것이다.
Another object of the present invention is to provide a pharmaceutical composition for the prevention and treatment of a menopausal or menopausal-related disease or symptom comprising an extract of dandelion and rooibos as an active ingredient.
상기의 목적을 달성하기 위하여, 본 발명은 민들레 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공한다.In order to accomplish the above object, the present invention provides a food composition for preventing or ameliorating a disease or symptom related to menopausal or menopausal period which comprises a dandelion extract as an active ingredient.
본 발명의 다른 목적을 달성하기 위하여, 본 발명은 민들레 추출물을 유효성분으로 포함하는 남성 갱년기 또는 남성 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공한다.In order to accomplish another object of the present invention, the present invention provides a pharmaceutical composition for preventing and treating a menopausal or menopausal menopausal disease or symptom comprising a dandelion extract as an active ingredient.
본 발명의 다른 목적을 달성하기 위하여, 본 발명은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공한다.In order to accomplish another object of the present invention, the present invention provides a food composition for preventing or ameliorating menopausal or menopausal symptoms or symptoms comprising an extract of dandelion and rooibos as an active ingredient.
본 발명의 다른 목적을 달성하기 위하여, 본 발명은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공한다.
In order to accomplish another object of the present invention, the present invention provides a pharmaceutical composition for preventing and treating a menopausal or menopausal period-related disease or symptom comprising an extract of dandelion and rooibos as an active ingredient.
이하 본 발명을 상세히 설명한다.
Hereinafter, the present invention will be described in detail.
본 발명의 조성물은 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하며, 갱년기 또는 갱년기 관련 질환 또는 증상의 예방, 개선 및 치료 목적으로 사용될 수 있다.
The composition of the present invention contains dandelion extract or dandelion and rooibos combination extract as active ingredients and can be used for the purpose of preventing, ameliorating and treating a menopausal or menopausal related disease or condition.
본 발명의 민들레(Taraxacum platycarpum Dahlst.)는 속씨식물문 쌍자엽강에 속하는 국화과의 여러해살이식물로 한국, 중국, 일본 등에 분포한다. The dandelion ( Taraxacum platycarpum Dahlst.) Of the present invention is a perennial plant of Asteraceae belonging to the dicotyledonous root of the gentian plant, and is distributed in Korea, China, Japan and the like.
여름에 꽃대가 나오고 그 끝에는 노란 꽃이 핀다. 우리나라에서는 어리고 연한 잎을 나물로 먹고, 유럽에서는 서양민들레의 잎을 샐러드로 사용하며 뉴질랜드에서는 커피 대용으로 뿌리를 사용하기도 한다. 민들레 잎에는 비타민 A, 비타민 E, 비타민 C 등이 풍부하며, 칼륨, 칼슘, 철 등의 무기질성분이 풍부하다. 한방에서는 꽃피기 전의 식물체를 포공영(蒲公英)이라는 약재로 쓰는데, 열로 인한 종창, 유방염, 인후염, 맹장염, 복막염, 급성간염, 황달에 효과가 있으며, 열로 인해 소변을 못 보는 증세에도 사용된다. 민들레의 주사액은 황색포도구균의 내성균주, 용혈성연쇄구균에 대하여 비교적 강한 살균작용이 있고 쥐에게 경구투여하면 흡수가 양호하고 항균 작용을 보인다(동양의학대사전, 경희대학교 출판국, p514~515, 1999).
In summer, a peduncle comes out and a yellow flower blooms at the end. In Korea, young and light leaves are used as herbs. In Europe, leaves of Western dandelion are used as salads. In New Zealand, roots are used as substitutes for coffee. Dandelion leaves are rich in vitamin A, vitamin E, and vitamin C, and are rich in minerals such as potassium, calcium, and iron. In one room, the plant before flowering is used as a medicine called 公 公英. It is effective for fever, mastitis, sore throat, appendicitis, peritonitis, acute hepatitis and jaundice caused by heat. The injection of dandelion has relatively strong antimicrobial activity against resistant Staphylococcus aureus and hemolytic streptococci of Staphylococcus aureus and shows good absorption and antimicrobial action when administered orally to rats (Oriental Medicine Dictionary, Kyunghee University Press, p514 ~ 515, 1999) .
루이보스(Aspalathus linearis (Burm.f.) R.Dahlgren.)는 콩과 식물에 속하는 침엽수로 남아프리카공화국 케이프타운 북쪽에 있는 세더버그 산맥 일대에만 자생한다. 식물 루이보스는 가운데가 부드러운 껍질로 된 본 줄기를 가진 관목처럼 생겼으며, 토양의 표면 가까운 곳에서부터 여러 갈래로 딱딱한 가지가 자라나고, 또 그 주변으로 가늘고 얇은 잔가지와 함께 얇고 날카로우면서도 부드럽고 바늘처럼 생긴 잎에 대략 10mm 정도에 하나씩 혹은 다발을 이루어 달려있다. 자연상태에서 자라난 이 식물의 키는 1m에서 1.5m에 이르기까지 다양하며, 재배되어 수확상태에 이르렀을 때의 키는 기후 또는 토양조건에 따라 0.5m 내지 1.5m 정도 된다. 루이보스에는 단백질, 각종미네랄, 철분, 망간, 칼슘, 비타민C 등이 균형 있게 포함되어 있으며, 항산화물질로 플라보노이드계의 켈세친 롤리페놀이 풍부하게 함유되어 있어 항산화효과가 있는 것으로 알려져 있다. 알려진 효능으로는 피부질환 개선, 알레르기 증상의 치료, 이뇨 작용, 간기능 개선, 변비 해소, 항암, 항바이러스, 당뇨병 개선, 항스트레스 효과 등이 보고되어 있다.
Rooibos ( Aspalathus linearis (Burm.f.) R.Dahlgren.) is a coniferous plant belonging to leguminous plants native to the Sedbergh Mountains, north of Cape Town, South Africa. The plant rooibos is like a shrub with a trunk with a soft shell in the middle. It grows from several places near the surface of the soil, with hard branches, thin and sharp, with a thin, thin twig around it, About 10 mm in width or in a bundle. The height of this plant, which grows in its natural state, varies from 1m to 1.5m, and when it is harvested it grows from 0.5m to 1.5m depending on climate or soil conditions. Rooibos contains protein, various minerals, iron, manganese, calcium and vitamin C in a balanced manner. It is antioxidant, and is known to have antioxidant effect because it is rich in flavonoid-based kelecetinolol phenol. Known efficacies include improvement of skin diseases, treatment of allergic symptoms, diuretic action, improvement of liver function, relieving constipation, anticancer, antiviral, diabetic improvement, antistress effect.
본 발명의 민들레 추출물 또는 루이보스 추출물은 공지의 천연물 추출방법에 의하여 추출될 수 있으며, 바람직하게는 물, 탄소수 1 내지 6개의 유기용매 및 아임계 또는 초임계 유체로 이루어진 군에서 선택된 하나 이상의 용매로 추출될 수 있으며, 상기 탄소수 1 내지 6개의 유기용매는 탄소수 1 내지 6개의 알코올(alcohol), 아세톤(acetone), 에테르(ether), 벤젠(benzene), 클로로포름(chloroform), 에틸아세테이트(ethyl acetate), 메틸렌클로라이드(methylene chloride), 헥산(hexane), 시클로헥산(cyclohexane) 및 석유에테르(petroleum ether)로 이루어진 군 중에서 선택된 것일 수 있다.The dandelion extract or rooibos extract of the present invention can be extracted by a known natural substance extraction method and is preferably extracted with water, at least one organic solvent having 1 to 6 carbon atoms, and at least one solvent selected from the group consisting of subcritical or supercritical fluids And the organic solvent having 1 to 6 carbon atoms may be selected from the group consisting of alcohol having 1 to 6 carbon atoms, acetone, ether, benzene, chloroform, ethyl acetate, And may be selected from the group consisting of methylene chloride, hexane, cyclohexane, and petroleum ether.
본 발명의 추출물 제조에 사용되는 용매는 더욱 바람직하게는 물, 탄소수 1 내지 6개의 알코올 또는 이들의 혼합용매일 수 있으며, 상기 탄소수 1 내지 6개의 알코올은 에탄올 일 수 있다. 상기 용매의 양은 추출하는 민들레 또는 루이보스의 양에 다라 달라질 수 있으며, 바람직하게는 민들레 또는 루이보스 중량의 1 배 내지 20배의 부피, 더욱 바람직하게는 3배 내지 10배의 부피량일 수 있다.The solvent used in the preparation of the extract of the present invention is more preferably water, an alcohol having 1 to 6 carbon atoms or a mixture thereof, and the alcohol having 1 to 6 carbon atoms may be ethanol. The amount of the solvent may vary depending on the amount of dandelion or rooibus to be extracted, and may be preferably 1 to 20 times the volume of the dandelion or rooibose, more preferably 3 to 10 times the volume.
본 발명의 추출물 추출온도는 특별히 제한되지 아니하며, 예를 들어 0℃ 내지 120℃일 수 있으며, 바람직하게는 50℃ 내지 100℃일 수 있다. 본 발명의 추출물 추출시간은 특별히 제한되지 아니하며, 예를 들어 1시간 내지 10일일 수 있으며, 바람직하게는 2시간 내지 6시간 일 수 있다.The extraction temperature of the extract of the present invention is not particularly limited and may be, for example, from 0 캜 to 120 캜, preferably from 50 캜 to 100 캜. The extraction time of the extract of the present invention is not particularly limited, and may be, for example, 1 hour to 10 days, preferably 2 hours to 6 hours.
본 발명 추출물은 공지의 천연물 추출법으로 추출될 수 있다. 예를 들어 냉침추출, 열수추출, 초음파 추출, 환류냉각 추출, 가열 추출법으로 추출할 수 있으며, 바람직하게는 열수추출 또는 환류 냉각 추출법으로 추출할 수 있으며, 1회 내지 10회, 바람직하게는 2회 내지 7회 반복 추출할 수 있다.The extract of the present invention can be extracted by a known natural substance extraction method. For example, it can be extracted by cold extraction, hot water extraction, ultrasonic extraction, reflux cooling extraction, or heat extraction, preferably by hot water extraction or reflux cooling extraction. The extraction can be performed once to 10 times, preferably twice To 7 times.
본 발명의 추출물은 여과하여 액상으로 사용할 수 있으며, 바람직하게는 분무건조 또는 동결건조의 건조 공정을 통하여 고형화하여 사용할 수 있다. 더욱 바람직하게는 분무건조 또는 동결건조 전 덱스트린을 혼합하여 건조할 수 있다.
The extract of the present invention can be used as a liquid phase by filtration, and can be solidified through a drying process such as spray drying or lyophilization. More preferably, the dextrin can be mixed and dried before spray drying or freeze-drying.
본 발명의 민들레 추출물은 상기 건조 공정 전 발효 공정을 추가로 거칠 수 있다. 본 발명의 발효 공정을 통하여 본 발명의 민들레 추출물의 남성 갱년기에 대한 효과는 더욱 증가될 수 있다. 본 발명의 민들레 추출물의 발효 공정은 공지의 발효방법에 의할 수 있으며, 발효 균주는 특별히 제한되지 아니하나, 유산균일 수 있으며, 바람직하게는 Bifidobacterium longum 또는 Lactobacillus acidophilus, Lactobacillus bulgaricus 또는 Sterptococcus thermophilus 또는 Bifidobacterium infantis 또는 Lactobacillus casei 또는 Lactobacillus Plantarum 또는 이들 유산균의 혼합균주일 수 있다. 발효 조건은 사용되는 균주의 종류에 따라 달라질 수 있으며, 예를 들어 24 내지 72시간 동안, 바람직하게는 36 내지 48시간 동안 20℃ 내지 48℃에서 발효한 후, 살균, 여과, 농축하여 상기 건조공정을 통하여 고형화 할 수 있다.
The dandelion extract of the present invention may further be subjected to a fermentation process before the drying process. Through the fermentation process of the present invention, the effect of the dandelion extract of the present invention on male menopausal period can be further increased. The fermentation process of the dandelion extract of the present invention can be carried out by a known fermentation method. The fermentation strain is not particularly limited, but it may be lactic acid bacteria, preferably Bifidobacterium longum or Lactobacillus acidophilus , Lactobacillus bulgaricus or Sterptococcus thermophilus or Bifidobacterium infantis or Lactobacillus casei or Lactobacillus Plantarum or a mixed strain of these lactic acid bacteria. The fermentation conditions may be varied depending on the type of the strain used. For example, fermentation may be performed at 20 ° C to 48 ° C for 24 to 72 hours, preferably 36 to 48 hours, followed by sterilization, filtration, Lt; / RTI >
본 발명의 민들레 및 루이보스 복합 추출물을 포함하는 조성물은 민들레 및 루이보스 복합 추출물을 모두 포함하는 것을 특징으로 하며, 포함되는 민들레 추출물과 루이보스 추출물의 비율은 특별히 제한되지 아니하나, 바람직하게는 10 : 1 내지 1 : 10일 수 있으며, 더욱 바람직하게는 9 : 1 내지 6 : 4일 수 있으며, 가장 바람직하게는 9 : 1 내지 8 : 2 일 수 있다.
The composition comprising the dandelion and the rooibos combination extract of the present invention is characterized in that it contains both the dandelion and the rooibos combination extract. The ratio of the dandelion extract to the rooibos extract is not particularly limited, but is preferably 10: 1: 10, more preferably from 9: 1 to 6: 4, and most preferably from 9: 1 to 8: 2.
본 발명의 민들레 추출물 또는 민들레 및 루이보스 복합 추출물은 남성 및 여성의 성호르몬을 증가시키는데 효능이 있다.The dandelion extract or dandelion and rooibos combination extract of the present invention is effective in increasing sex hormones in males and females.
본 발명은 남성 및 여성의 성호르몬은 바람직하게는 DHEA family (DHEA, DHEA-s), Testosterone (total testosterone-TT, free testosterone-FT, bioavailable testosterone-BF), Estradiol (total estradiol-TE, free estradiol-FE, bioavailable estradiol-BE), SHBG (sex hormone binding globulin)일 수 있다.The sex hormones of male and female are preferably DHEA family (DHEA, DHEA-s), testosterone (total testosterone-TT, free testosterone-FT, bioavailable testosterone-BF), estradiol -FE, bioavailable estradiol-BE), sex hormone binding globulin (SHBG).
본 발명의 일실험예에서는 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 2개월간 섭취한 암수 랫트의 혈중 DHEA, DHEA-sulfate(DHEA-s), SHBG 농도를 측정하였다. 그 결과 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 섭취한 랫트는 대조군에 비하여 혈중 DHEA 수치가 각각 1.14, 1.58 nmol/L 가량 증가한 것을 확인하였고, DHEA-s의 수치는 각각 9.58, 15.01 nmol/L 가량 증가하였다. 또한 SHBG의 경우는 각각 1.6, 2.4 nmol/L 가량 감소하였다.DHEA, DHEA-s and SHBG levels in blood of male and female rats fed with dandelion extract or dandelion and rooibos combination extracts for 2 months were measured. As a result, in rats fed with dandelion extract or dandelion and rooibos combination extract, the levels of DHEA in the blood were increased by 1.14 and 1.58 nmol / L, respectively, compared to the control group. DHEA-s levels were increased by 9.58 and 15.01 nmol / L Respectively. And SHBG decreased by 1.6 and 2.4 nmol / L, respectively.
또한, 2개월간 추출 혼합물을 섭취한 수컷 랫트의 혈중 테스토스테론과 암컷에서 랫트의 혈중 에스트라디올의 농도를 각각 측정한 결과, 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 섭취한 수컷 랫트는 혈중 테스토스테론의 수치가 각각 42%, 62% 가량 증가되었고 테스토스테론의 생체 활성화 형태인 bioavailable-testosterone (BT) 수치는 각각 53%, 72% 가량 향상되었다. 또한 암컷 랫트의 혈중 에스트라디올의 측정결과에서 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 섭취한 암컷 랫트는 혈중 에스트라디올의 수치가 각각 31%, 47% 가량 증가되었고 에스트라디올의 생체 활성화 형태인 bioavailable-estradiol (BE) 수치는 각각 43%, 61% 가량 향상 되었다. In addition, the concentrations of estradiol in the blood of test rats and male rats fed the extract mixture for 2 months were measured. As a result, male rats receiving the dandelion extract or the dandelion and rooibos combination extracts showed levels of blood testosterone 42% and 62%, respectively, and bioavailable-testosterone (BT) values of testosterone bioactivity were increased by 53% and 72%, respectively. In addition, in the measurement of estradiol in blood of female rats, female rats fed with dandelion extract or dandelion and rooibos combination extract increased the levels of estradiol in blood by 31% and 47%, respectively, and bioavailable-estradiol (BE) values were improved by 43% and 61%, respectively.
본 발명의 다른 일실험예에서는 40세 이상의 중년 남녀에게 민들레 및 루이보스 복합 추출물을 섭취하게 하고, 남성의 혈중 테스토스테론과 여성의 에스트라디올 농도의 개선율을 측정하였다. 그 결과 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 혼합물을 섭취한 중년 남성의 경우 혈중 테스토스테론이 각각 8.42%, 18.32% 가량 향상되었다. 또한 중년 여성의 혈중 에스트라디올 수치가 각각 11.65%, 24.65% 가량 향상되었다.
In another experimental example of the present invention, a mixture of dandelion and rooibos extracts was administered to middle-aged men and women over 40 years old, and blood testosterone levels of male and female were measured for improvement of estradiol concentration. As a result, blood testosterone was improved by 8.42% and 18.32% in middle-aged men taking a mixture of dandelion extract or a mixture of dandelion and rooibos combination extracts. Also, the blood estradiol levels of middle-aged women were improved by 11.65% and 24.65%, respectively.
한편 본 발명의 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 혼합물은 남성 및 여성의 갱년기 관련 질환 또는 증상을 예방, 개선 및 치료하는 데 탁월한 효능이 있다.Meanwhile, the dandelion extract of the present invention or a mixture of dandelion and rooibos combination extract has excellent efficacy in preventing, ameliorating and treating male and female menopausal symptoms or symptoms.
본 발명의 갱년기 또는 갱년기 관련 질환 또는 증상은 남성 및 여성의 성호르몬 저하에 의한 모든 질환 또는 증상일 수 있으며, 바람직하게는 테스토스테론 저하증, 에스트로겐 저하증, 성호르몬 전구체(DHEA) 저하증, 성호르몬결합글로불린(sex hormone binding globulin) 증가 질환, 신경과민, 정서불안, 우울증, 현기증, 안면홍조, 발한, 수면장애, 활력저하, 기억력저하, 업무능력 감소, 성욕감퇴, 발기부전, 정자 운동성 감소, 정력 감소, 체력 저하, 운동능력 감소, 체모감소, 피부노화, 골밀도 감소 및 내장지방증가로 이루어진 군에서 선택된 하나 이상의 질환 또는 증상일 수 있으며, 더욱 바람직하게는 테스토스테론 저하증, 에스트로겐 저하증, 성호르몬 전구체(DHEA) 저하증, 성호르몬결합글로불린(sex hormone binding globulin) 증가 질환으로 이루어진 군에서 선택된 하나 이상의 질환 또는 증상 일 수 있다.The menopausal or menopausal related disease or symptom of the present invention may be any disease or symptom caused by sex hormone depression in males and females, and is preferably selected from the group consisting of hypothyroidism, estrogen hypothesis, hypoglycemic precursor (DHEA) hypoglycemia, sex hormone binding globulin Sex hormone binding globulin Increased disease, nervousness, emotional disturbance, depression, dizziness, facial flushing, sweating, sleeping disorders, decreased vitality, decreased memory capacity, reduced work capacity, decreased sexual desire, decreased erectile dysfunction, reduced sperm motility, And more preferably at least one disease or condition selected from the group consisting of hypogonadism, hypogonadism, hypogonadism (DHEA) hypogonadism, hypogonadism, hypogonadism, Sex hormone binding globulin (GH) -binding globulin May be one or more diseases or conditions.
본 발명의 일실험예에서는 남성 갱년기와 노화를 나타내는 AMS(Aging Males' Symptom) 및 ADAM(Androgen Deficiency in Aging Males) 관련 설문조사를 실시하였다. 그 결과 민들레 및 루이보스 복합 추출물의 혼합물을 섭취한 군의 경우 AMS 조사에서 31%의 남성 갱년기 증상 개선을 확인하였으며, ADAM조사에서 28%의 남성 갱년기 유병율 감소를 확인하였다.In one experimental example of the present invention, AMS (Aging Males' Symptom) and ADAM (Androgens Deficiency in Aging Males) questionnaire regarding male menopause and aging were conducted. As a result, AMS investigated 31% of male menopausal symptom improvement in a group of dandelion and rooibos combination extracts, and 28% of male menopausal decline in ADAM.
상기 AMS(Aging Males' Symptom) 설문조사는 1999년 Heinemann 등(Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New 'Aging Male's Symptom'(AMS) Scale. The Aging Male 1992, 2:105-114.)이 독일어로 개발한 AMS scale은 노화가 남성의 삶의 질에 및은 영향을 객관적으로 평가하기 위해 고안된, 타당도와 신뢰도가 입증된 도구로, 한국판은 2003년 김세현의 번역판이 타당도와 신뢰도가 입증되었다(Daig I, Heinemann LA, Kim S et al. The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics. Health Qual Life Outcomes (2003) 1:77.; 이길형 등, Korean J Fam Med. (2010) 31:613-621).The AMS (Aging Males' Symptom) survey was conducted in 1999 by Heinemann et al. (Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New Aging Male Symptom (AMS) Scale. The Aging Male 1992, 2: 105-114 The AMS scale developed in German is a validated and reliable instrument designed to objectively assess the effects of aging on the quality of life and the quality of life in men. (AMS) scale: review of its methodological characteristics, Health Qual Life Outcomes (2003) 1:77 .; Lee, Gil-Hyung et al., Korean J Fam Med. (2010) 31: 613-621).
상기 ADAM(Androgen Deficiency in Aging Males) 설문조사는 2000년 Morley 등(Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D, et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000, 49:1239-1242.)이 자신들의 임상경험을 근거로 대표적인 10가지 증상들을 확인하여 남성호르몬 결핍을 평가하기 위해 개발한 검사지로서 40세 이상의 남성에서 남성호르몬 결핍 상태를 선별할 수 있는 진단검사로서 타당성이 입증되었다. 문항수가 그리 많지 않고, 진단의 민감도가 높아 남성호르몬 결핍 선별검사로 흔히 이용된다. 한글판 ADAM 검사지는 김수웅 등(김수웅, 오승준, 백재승, 김세철. Androgen Deficiency in Aging Males(ADAM) 설문지의 한국어 번역본 개발. 대한비뇨기과학회지 2004, 45(7):674-679.)이 남성 갱년기 환자들을 선별하고 이를 임상연구에 활용할 수 있도록 영어판을 한글판으로 번역한 검사지이다. The ADAM (Androgen Deficiency in Aging Males) survey was conducted in 2000 by Morley et al. (Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D, et al., Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000, 49: 1239-1242), which was developed to evaluate male hormone deficiency by identifying 10 representative symptoms based on their clinical experience, which can be used to screen male hormone deficiency status in men over 40 years of age It has proved to be valid as a diagnostic test. The number of questions is low and the sensitivity of diagnosis is high, so it is often used as a test for sex hormone deficiency. The Korean Journal of Urology 2004, 45 (7): 674-679.) The male ADAM screening group was selected for the male climacteric patients (Kim, Soo-Woong, Oh Seungjoon, Baek Jae- And translated it into Korean version so that it can be used for clinical research.
또한 본 발명의 다른 일실험예에서는 여성 갱년기와 노화를 나타내는 MRS (Menopause rating scale) 설문 조사를 실시하였다. 그 결과 민들레 및 루이보스 복합 추출물을 섭취한 군의 경우 MRS 조사에서 섭취전과 비교하여 4.47 점이 개선되었다. In another experimental example of the present invention, a menopause rating scale (MRS) questionnaire was conducted to show female menopause and aging. As a result, the intake of dandelion and rooibos combination extracts was improved by 4.47 points compared to that before ingestion by MRS.
상기 MRS (Menopause rating scale) 설문 조사는 1953년 Kupperman등이 발표한 Kupperman index는 현재까지 여성 갱년기 증상과 관련한 연구에서 증상 평가 척도로서 가장 많이 사용되고 있는 자가 설문 검사 방식이다. 이 방식을 보완하여 1992년 Hildich 등이 보완하여 만든 것이 MENQOL(The menopause-specific quality of life questionnaire)이며 이것을 다시 1996년에 새롭게 보완하여 만든 측정법이 MRS이다. MRS는 전세계적으로 많은 연구들에 인용되면서 신뢰도와 타당성이 인정되고 있다. 신체증상, 정신증상, 비뇨생식기증상 등 총 11개 문항으로 구성되어 있으며 문항수가 적고 간편하여 편리하다는 장점을 가지고 있다.The Mup (Menopause rating scale) questionnaire was published in 1953 by Kupperman et al., And the Kupperman index is the most frequently used questionnaire survey method for symptom evaluation in 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.
따라서 본 발명은 민들레 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공한다.Accordingly, the present invention provides a food composition for preventing and ameliorating a menopausal or menopausal-related disease or symptom comprising a dandelion extract as an active ingredient.
또한 본 발명은 민들레 추출물을 유효성분으로 포함하는 남성 갱년기 또는 남성 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공한다.The present invention also provides a pharmaceutical composition for the prevention and treatment of male menopausal or menopausal-related diseases or symptoms comprising an extract of dandelion as an active ingredient.
또한 본 발명은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 개선용 식품 조성물을 제공한다.The present invention also provides a food composition for preventing and ameliorating menopausal or menopausal symptoms or symptoms comprising an extract of dandelion and rooibos as an active ingredient.
또한 본 발명은 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 치료용 약학적 조성물을 제공한다.The present invention also provides a pharmaceutical composition for the prevention and treatment of a menopausal or menopausal-related disease or symptom comprising an extract of dandelion and rooibos as an active ingredient.
본 발명의 식품조성물은 식품, 기능성 식품(functional food), 영양 보조제(nutritional supplement), 건강식품(health food) 및 식품 첨가제(food additives) 등의 모든 천연소재의 가공 형태를 포함한다. 상기 유형의 식품 조성물은 당 업계에 공지된 통상적인 방법에 따라 다양한 형태로 제조할 수 있다.The food composition of the present invention includes all natural forms of processing such as food, functional food, nutritional supplement, health food, and food additives. Food compositions of this type may be prepared in a variety of forms according to conventional methods known in the art.
예를 들면, 건강식품으로는 민들레 추출물 또는 민들레 추출물 및 루이보스 추출물 자체를 차, 주스 및 드링크의 형태로 제조하여 음용하도록 하거나, 과립화, 캡슐화 및 분말화하여 섭취할 수 있다. 또한, 본 발명의 민들레 추출물 또는 민들레 추출물 및 루이보스 추출물과 갱년기에 의해 유발되는 질환 또는 증상의 예방 또는 개선의 효과가 있다고 알려진 공지의 활성 성분과 함께 혼합하여 조성물의 형태로 제조할 수 있다.For example, as a health food, a dandelion extract or a dandelion extract and a rooibos extract itself may be prepared in the form of tea, juice, and drink and then ingested, granulated, encapsulated and powdered. In addition, the composition of the present invention can be prepared by mixing the dandelion extract of the present invention or the dandelion extract and the rooibos extract together with a known active ingredient known to be effective for preventing or ameliorating a disease or symptom caused by menopause.
또한, 식품으로는 음료(알콜성 음료 포함), 과실 및 그의 가공식품(예: 과일통조림, 병조림, 잼, 마아말레이드 등), 어류, 육류 및 그 가공식품(예: 햄, 소시지 콘비이프 등), 빵류 및 면류(예: 우동, 메밀국수, 라면, 스파게티, 마카로니 등), 과즙, 각종 드링크, 쿠키, 엿, 유제품(예: 버터, 치즈 등), 식용식물유지, 마아가린, 식물성 단백질, 레토르트 식품, 냉동식품, 각종 조미료(예: 된장, 간장, 소스 등) 등에 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 첨가하여 제조할 수 있다. 또한, 본 발명의 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 식품 첨가제의 형태로 사용하기 위해서는 분말 또는 농축액 형태로 제조하여 사용할 수 있다.
Foods also include beverages (including alcoholic beverages), fruits and processed foods (such as canned fruits, bottles, jams, maal malaysia, etc.), fish, meat and processed foods such as ham, sausage, ), Breads and noodles (eg udon, buckwheat noodles, ramen noodles, spaghetti, macaroni, etc.), juice, various drinks, cookies, sugar, dairy products such as butter, cheese, edible vegetable oil, margarine, vegetable protein, Can be prepared by adding a dandelion extract or a dandelion and rooibos combination extract to foods, frozen foods, various kinds of seasonings (eg soybean paste, soy sauce, sauce, etc.). In addition, in order to use the dandelion extract or the combined extract of dandelion and rooibus of the present invention in the form of a food additive, it may be prepared in the form of powder or concentrate.
본 발명의 식품 조성물 중 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 바람직한 함량은 식품 조성물 총 중량에 대하여 0.001 내지 50 중량%일 수 있으며, 바람직하게는 0.1 내지 30 중량% 범위로 함유될 수 있다.
The preferred content of the dandelion extract or the dandelion and rooibos combination extract in the food composition of the present invention may be 0.001 to 50 wt%, preferably 0.1 to 30 wt%, based on the total weight of the food composition.
본 발명에 따른 약학적 조성물은 약학적으로 유효한 양의 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 혼합물을 단독으로 포함하거나 하나 이상의 약학적으로 허용되는 담체, 부형제 또는 희석제를 추가로 포함할 수 있다. 상기에서 "약학적으로 허용되는" 이란 생리학적으로 허용되고 인간에게 투여될 때, 활성성분의 작용을 저해하지 않으며 통상적으로 위장 장애, 현기증과 같은 알레르기 반응 또는 이와 유사한 반응을 일으키지 않는 비독성의 조성물을 말한다. The pharmaceutical compositions according to the present invention may further comprise a pharmaceutically effective amount of a dandelion extract or a mixture of dandelion and rooibos combination extracts alone or in combination with one or more pharmaceutically acceptable carriers, excipients or diluents. The term "pharmaceutically acceptable" as used herein means a non-toxic composition which is physiologically acceptable and which, when administered to humans, does not inhibit the action of the active ingredient and does not normally cause an allergic reaction such as gastrointestinal disorder, dizziness, .
상기 담체, 부형제 및 희석제의 예로는, 락토즈, 덱스트로즈, 수크로즈, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 폴리비닐피롤리돈, 물, 메틸하이드록시벤조에이트, 프로필하이드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 들 수 있다. 또한 상기 약학 조성물은 충진제, 항응집제, 윤활제, 습윤제, 향료, 유화제 및 방부제 등을 추가로 포함할 수 있다. Examples of the carrier, excipient and diluent include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, Polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. The pharmaceutical composition may further include a filler, an anti-coagulant, a lubricant, a wetting agent, a flavoring agent, an emulsifier, and an antiseptic agent.
상기에서 "약학적으로 유효한 양"이란 음성 대조군에 비해 그 이상의 반응을 나타내는 양을 말하며 바람직하게는 갱년기에 의해 유발되는 질환 또는 증상 예방 및 치료의 효과를 나타내기에 충분한 양을 말한다. 본 발명에 따른 민들레 추출물 또는 민들레 및 루이보스 복합 추출물의 약학적으로 유효한 양으로는 0.01 내지 100 mg/day/kg 체중이다. 그러나 상기 약학적으로 유효한 양은 질환의 종류 및 이의 중증정도, 환자의 연령, 체중, 건강상태, 성별, 투여 경로 및 치료기간 등과 같은 여러 인자에 따라 적절히 변화될 수 있다.
The term "pharmaceutically effective amount " as used herein refers to an amount that exhibits a higher level of response than the negative control, and preferably refers to an amount sufficient to exhibit the effect of preventing or treating a disease or symptom caused by menopause. The pharmaceutically effective amount of the dandelion extract or dandelion and rooibos combination extract according to the present invention is 0.01 to 100 mg / day / kg body weight. However, the pharmaceutically effective amount may be appropriately changed depending on various factors such as the type and severity of the disease, the age, body weight, health condition, sex, administration route and treatment period of the patient.
또한, 본 발명의 약학적 조성물은 포유동물에 투여된 후 활성 성분의 신속, 지속 또는 지연된 방출을 제공할 수 있도록 당업계에 공지된 방법을 사용하여 제형화될 수 있다. 제형은 분말, 과립, 정제, 에멀젼, 시럽, 에어로졸, 연질 또는 경질 젤라틴 캡슐, 멸균 주사용액, 멸균 분말의 형태일 수 있다.In addition, the pharmaceutical composition of the present invention may be formulated using methods known in the art so as to provide rapid, sustained or delayed release of the active ingredient after administration to the mammal. The formulations may be in the form of powders, granules, tablets, emulsions, syrups, aerosols, soft or hard gelatine capsules, sterile injectable solutions, sterile powders.
본 발명 조성물의 투여 경로로는 이에 한정되지는 않으나 경구적 또는 비경구적으로 투여 될 수 있다. 비경구적 투여 경로로는 예를 들면, 경피, 비강, 복강, 근육, 피하 또는 정맥 등의 여러 경로가 포함된다.The administration route of the composition of the present invention is not limited thereto, but it can be administered orally or parenterally. Parenteral routes of administration include, for example, various routes such as transdermal, nasal, peritoneal, muscular, subcutaneous or intravenous.
본 발명의 약학적 조성물은 갱년기 또는 갱년기 관련 질환 또는 증상의 예방 및 치료의 효과를 가지는 공지의 화합물과 병행하여 투여할 수 있다.
The pharmaceutical composition of the present invention may be administered in combination with a known compound having an effect of preventing or treating a disease or symptom related to menopausal or menopausal period.
이와 같이 본 발명의 민들레 추출물 또는 민들레 및 루이보스 복합 추출물은 남녀 모두에서 갱년기 또는 갱년기 관련 질환 또는 증상의 예방, 개선 및 치료를 위한 식품 및 의약품 등에 유용하게 적용될 수 있다.
As described above, the dandelion extract of the present invention or the combined extract of dandelion and rooibos can be applied to foods and medicines for the prevention, improvement and treatment of menopausal or menopausal diseases or symptoms.
이상 살펴본 바와 같이, 본 발명은 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방, 개선 및 치료용 식품 조성물 및 약학적 조성물을 제공한다. 본 발명의 조성물은 혈중 남녀 총 성호르몬 수준을 증가시키며, SHBG의 감소를 통해 활성화형태의 성호르몬을 증가시켜, 남성 및 여성의 갱년기 또는 갱년기 관련 질환 및 증상의 예방 및 치료에 효과적이다.
INDUSTRIAL APPLICABILITY As described above, the present invention provides a food composition and a pharmaceutical composition for preventing, ameliorating, and treating a menopausal or menopausal-related disease or symptom, which comprises a dandelion extract or a combined extract of dandelion and rooibos as an active ingredient. The composition of the present invention increases the sex hormone level of male and female in blood and increases sex hormone of activated form through reduction of SHBG, and is effective for prevention and treatment of male and female menopausal or menopausal related diseases and symptoms.
도 1은 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가한 쥐의 DHEA의 분비량을 정량적으로 측정한 결과이다(CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 2는 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가한 쥐의 DHEA-s의 분비량을 정량적으로 측정한 결과이다(CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 3은 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 감소된 쥐의 SHBG의 혈액내 농도를 측정한 결과이다. (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 4는 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가된 수컷 쥐의 추출물 섭취전 대비 증가한 혈중 전체 테스토스테론 (TT, total testosterone)의 증가량의 증가량 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 5는 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가된 수컷 쥐의 추출물 섭취전 대비 증가한 생체 활성화 형태의 테스토스테론(BT, bioavailable testosterone)의 증가량 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 6은 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가된 암컷 쥐의 추출물 섭취 전 대비 증가한 혈중 전체 에스트라디올 (TE, total estradiol)의 증가량 과 생체 활성화 형태의 에스트라디올의 증가량 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 7은 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가된 암컷 쥐의 추출물 섭취 전 대비 증가한 생체 활성화 형태의 에스트라디올 (BE, bioavailable estradiol)의 증가량 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 8은 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의하여 증가된 40대 이상 남성의 성호르몬 테스토스테론의 농도를 나타낸 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 9는 민들레 추출물과 민들레 및 루이보스 복합 추출물에 의해 증가된 40대 이상 여성의 성호르몬 에스트라디올의 농도를 나타낸 결과이다 (CTL: 대조군, D: 민들레 추출물, R: 루이보스 추출물, M+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 10은 민들레 및 루이보스 복합 추출물에 의하여 개선된 남성 갱년기 증상을 AMS를 통해 평가하여 정량화한 결과이다(placebo: 위약군(대조군), D+R: 민들레 추출물과 루이보스 추출물의 혼합조성물).
도 11은 민들레 및 루이보스 복합 추출물에 의하여 개선된 여성 갱년기 증상 수치를 MRS를 통해서 평가하여 정량화한 결과이다(placebo: 위약군(대조군), D+R: 민들레 추출물과 루이보스 추출물의 혼합조성물). FIG. 1 is a result of quantitative measurement of the amount of DHEA secreted from dandelion extract and dandelion and rooibos combination extract (CTL: control, D: dandelion extract, R: rooibos extract, M + R: dandelion extract and rooibos extract .
FIG. 2 is a result of quantitative measurement of the amount of DHEA-s secreted by the dandelion extract and the combined extract of dandelion and rooibose (CTL: control, D: dandelion extract, R: rooibos extract, M + R: dandelion extract Mixed composition of rooibos extract).
FIG. 3 is a result of measurement of blood concentration of SHBG in a rat reduced by dandelion extract and dandelion and rooibos combination extract. (CTL: control group, D: dandelion extract, R: rooibos extract, M + R: mixed composition of dandelion extract and rooibos extract).
FIG. 4 is a graph showing an increase in the increase in total testosterone (TT) of the male rats by the addition of dandelion extract and dandelion and rooibos combination extract (CTL: control, D: dandelion extract, R: Roots extract, M + R: a mixture of dandelion extract and rooibos extract).
FIG. 5 is a graph showing an increase in the amount of testosterone (BT, bioavailable testosterone) increased by the addition of the extract of dandelion and the extract of dandelion and rooibos to the extract of male rats (CTL: control, D: dandelion extract, R: Roots extract, M + R: a mixture of dandelion extract and rooibos extract).
FIG. 6 is a graph showing an increase in total estradiol (TE) and an increase in estradiol in the form of bioactivation, which were increased by the addition of dandelion extract and dandelion and rooibos combination extracts (CTL: control , D: dandelion extract, R: rooibos extract, M + R: mixed composition of dandelion extract and rooibos extract).
FIG. 7 shows the results of increasing amounts of bioavailable estradiol (BE, bioactivation form), which was increased by the addition of dandelion extract and dandelion and rooibos combination extract (CTL: control, D: dandelion extract, R : Rooibos extract, M + R: mixed composition of dandelion extract and rooibos extract).
FIG. 8 shows the results of sex hormone testosterone concentration in male subjects over 40 years old, which was increased by the combination of dandelion extract and dandelion and rooibos combination extract (CTL: control group, D: dandelion extract, R: rooibos extract, M + And rooibos extract).
FIG. 9 is a graph showing the concentration of sex hormone estradiol in women aged 40 and over, which was increased by dandelion extract and a combination of dandelion and rooibos combination (CTL: control group, D: dandelion extract, R: rooibos extract, M + A mixed composition of an extract and a rooibos extract).
FIG. 10 is a result of evaluating and quantifying male menopausal symptoms improved by the combination of dandelion and rooibos combination with AMS (placebo: placebo group (control), D + R: mixed composition of dandelion extract and rooibos extract).
FIG. 11 is a result of evaluating and quantifying female menopausal symptom levels improved by the combined extract of dandelion and rooibos through MRS (placebo: placebo group (control), D + R: mixed composition of dandelion extract and rooibos extract).
이하, 본 발명을 실시예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail with reference to examples.
단, 하기 실시예는 본 발명을 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예에 한정되는 것은 아니다.
However, the following examples are illustrative of the present invention, and the present invention is not limited to the following examples.
<실시예 1> ≪ Example 1 >
민들레 추출물, 루이보스 추출물 및 민들레 및 루이보스 복합 추출물의 제조Manufacture of dandelion extract, rooibos extract and dandelion and rooibos combination extract
<1-1> 민들레 추출물의 제조<1-1> Preparation of Dandelion Extract
민들레를 선별하여 분쇄한 뒤, 분쇄물 중량의 약 7배의 부피량(w/v)의 정제수를 용매로 하여 약 4시간 동안 열수추출방법으로 추출하고, 4배의 정제수를 가하여 2차 추출한다. 본 추출물을 바로 여과하여 진공농축한 후 덱스트린과 1:1로 혼합하여 분무건조하거나 동결건조하여 민들레 추출물을 얻었다.
The dandelion was screened and pulverized, and purified water of about 7 times the weight of the pulverized water (w / v) was extracted with a hot water extraction method using a solvent for about 4 hours, followed by a second extraction with 4 times of purified water . The extract was immediately filtered and concentrated in vacuo, mixed with dextrin 1: 1, spray dried or lyophilized to obtain a dandelion extract.
<1-2> 루이보스 추출물의 제조<1-2> Preparation of rooibos extract
루이보스를 선별하여 분쇄한 뒤, 분쇄물 중량의 약 8배의 부피량(w/v%)의 정제수를 용매로 하여 2시간 이상 열수추출하고, 4배의 정제수를 가하여 2차 추출한다. 추출물을 여과포로 여과하고, 여액을 진공 농축한 후, 추출물과 덱스트린을 3:7로 혼합하여 분무건조하거나 동결건조하여 분말 추출물을 획득하였다.
After the roots are pulverized, the roots are subjected to hot water extraction for 2 hours or more with purified water having a volume (w / v%) of about 8 times the weight of the pulverized material as a solvent, followed by secondary extraction with four times of purified water. The extract was filtered with a filter, the filtrate was concentrated in vacuo, and the extract and dextrin were mixed in a ratio of 3: 7 and spray-dried or lyophilized to obtain a powdery extract.
<1-3> 민들레 및 루이보스 복합 추출물 제조<1-3> Manufacture of Dandelion and Rooibos combination extract
상기 실시예에서 얻은 각각의 민들레 분말 추출물과 루이보스 분말 추출물을 9:1 또는 8:2의 비율로 혼합하여 민들레 및 루이보스 복합 추출물을 제조하였다.
Each of the dandelion powder extracts and the rooibos powder extracts obtained in the above examples were mixed at a ratio of 9: 1 or 8: 2 to prepare a dandelion and roubobus combination extract.
<시험예 1> ≪ Test Example 1 >
성호르몬 전구체 DHEA, DHEA-s, 성호르몬 테스토스테론, 에스트라디올의 증가 및 성호르몬 생체 활성억제 글로블린 SHBG 의 감소Sex hormone precursors DHEA, DHEA-s, sex hormone testosterone, increase of estradiol and inhibition of sex hormone bioactivity Reduction of globulin SHBG
본 발명의 조성물이 혈중 남녀 성호르몬 전구체 DHEA와 DHEA-s 및 성호르몬 테스토스테론과 에스트라디올 그리고 성호르몬 생체 활성 억제 글로블린 SHBG 혈 중 농도에 영향을 확인하여 남녀 성호르몬 증가에 효과가 있는지를 확인하였다.
It was confirmed that the composition of the present invention has an effect on the increase of male sex hormone by examining the blood levels of male and female sex hormone precursors DHEA, DHEA-s, sex hormone testosterone, estradiol and sex hormone bioactivity-inhibiting globulin SHBG blood concentrations.
<1-1> 본 발명의 조성물 섭취로 인한 쥐에서의 성호르몬 증가 효과≪ 1-1 > Effect of the composition of the present invention on the increase of sex hormone in rats
체중 250g 내외의 스프라그-다우리(Sparague-Dawley) 계통의 랫트(Samtako, Korea)를 아무것도 섭취하지 않은 대조군, 본 발명의 조성물(실시예 1-1 내지 1-3의 조성물)을 섭취한 실험군으로 나누어 각각 6구씩 암컷3마리와 수컷3마리를 실험에 이용하였다. 사육기간 중에는 쥐 고형 사료와 증류수를 자유롭게 섭취하도록 하였고, 매일 오전 같은 시간에 생리식염수에 녹인 민들레 추출물(실시예 1-1) 또는 민들레 및 루이보스 복합 추출물 (실시예 1-3; 8:2의 혼합비)을 10mg/kg의 농도로, 대조군은 동일량의 생리식염수를 2개월간 경구투여 하였다. 마지막 경구 투여 후 8시간 동안 절식시킨 후 에테르 마취 후 개복하여 복대정맥으로 혈액을 채취한 후, heparin 처리된 튜브로 옮겨 담고 2,500rpm(4℃)에서 15분간 원심분리하여 혈장을 분리하였다. 분리된 혈장을 대상으로 DHEA, DHEA-s, SHBG, Testosterone, Estradiol ELISA kit (ADI-901-093, 065, 174; Enzo Life Sciences, U.S.A.)을 이용하여 제조사의 매뉴얼에 따라 혈중 성호르몬 함량을 측정하였다.
(Sprague-Dawley rats (Samtako, Korea) at a weight of about 250 g, a control group not consuming anything, an experimental group ingesting the composition of the present invention (compositions of Examples 1-1 to 1-3) And 3 males and 3 males were used for the experiment. During the breeding period, mice were allowed to ingest solid feed and distilled water freely, and the dandelion extract (Example 1-1) dissolved in physiological saline at the same time of day every morning or the mixed extract of dandelion and rooibos (Example 1-3; mixing ratio of 8: 2 ) At a concentration of 10 mg / kg, and the control group was orally administered the same amount of physiological saline for 2 months. After the last oral administration, the mice were fasted for 8 hours. After ether anesthesia, the blood was collected from the abdominal vein, transferred to a heparinized tube, and centrifuged at 2,500 rpm (4 ° C) for 15 minutes to separate the plasma. Serum sex hormone levels were measured according to the manufacturer's manual using DHEA, DHEA-s, SHBG, Testosterone, Estradiol ELISA kit (ADI-901-093, 065, 174; Enzo Life Sciences, USA) Respectively.
결과는 평균과 표준편차로 나타내었으며 유의성 검증을 위해 통계처리는 Student's t-test를 이용하였으며, p<0.05 시에 유의한 것으로 간주하여 표시하였다, 그 결과는 [도 1] 내지[도 7]에 나타내었다.
Results were expressed as mean and standard deviation. For statistical significance, Student's t-test was used for statistical significance. P <0.05 was considered to be significant. The results are shown in FIGS. 1 to 7 Respectively.
측정 결과, [도 1]에서 보듯이 민들레 추출물(D)과 루이보스 추출물(R)을 각각 섭취한 경우, 대조군(CTL)에 비해 각각 약 1.2 nmol/L, 0.2 nmol/L 의 혈중 DHEA 수치가 증가하였다As shown in FIG. 1, when the dandelion extract (D) and the rooibos extract (R) were separately consumed, the serum DHEA levels of about 1.2 nmol / L and 0.2 nmol / L were increased And
또한 [도 2]의 결과에서 DHEA-s의 수치는 각각 약 9 nmol/L, 5 nmol/L 가량 증가하였다. 그리고 [도 1]과 [도 2]에서 혼합물(D+R)을 섭취한 경우, DHEA와 sulfated DHEA의 수치가 대조군에 비해 각각 1.6 nmol/L. 15 nmol/L 가까이 증가하였다.Also, in the results of [Fig. 2], the values of DHEA-s were increased by about 9 nmol / L and 5 nmol / L, respectively. When the mixture (D + R) was consumed in [Fig. 1] and [Fig. 2], the values of DHEA and sulfated DHEA were 1.6 nmol / L. 15 nmol / L.
또한 [도 3]의 결과에서 민들레 추출물(D)과 루이보스(R)을 각각 섭취한 경우, 대조군(CTL)에 비해 각각 약 1.6 nmol/L, 0.7 nmol/L 가량 혈중 SHBG 농도가 감소하였고 혼합물(D+R)을 섭취한 경우, SHBG의 수치가 대조군에 비해서 약 2.4 nmol/L 가까이 의미있게 감소하였다.In addition, when the dandelion extract (D) and rooibose (R) were separately consumed in the result of [Fig. 3], the SHBG concentration in the blood was decreased by about 1.6 nmol / L and 0.7 nmol / L, respectively, D + R), the SHBG level was significantly reduced by about 2.4 nmol / L compared to the control group.
또한 [도 4]의 결과에서 민들레 추출물(D)과 루이보스(R)를 각각 섭취한 경우, 수컷 랫트에서 대조군(CTL)에 비해서 혈중 총 테스토스테론 (TT)의 수치는 각각 38%, 2% 가량 증가하였다. In addition, when the dandelion extract (D) and rooibose (R) were separately taken from the results of [Figure 4], the total testosterone (TT) level in the male rats was 38% and 2% higher than that of the control (CTL) Respectively.
또한 [도 5]에서 민들레 추출물(D)과 루이보스(R)를 각각 섭취한 경우, 혈중 생리활성형 테스토스테론 (BT) 의 수치는 각각 약 45%, 4% 증가하였다. 그리고 [도 4]와 [도 5]에서 혼합물(D+R)을 섭취한 경우 혈중 총 테스토스테론(TT)과 생리활성형 테스토스테론 (BT)의 수치는 각각 58%, 64% 가까이 의미있는 증가를 보였다.In addition, when the dandelion extract (D) and rooibose (R) were separately taken in [Fig. 5], the levels of physiologically active testosterone (BT) in the blood were increased by about 45% and 4%, respectively. The total testosterone (TT) and physiologically active testosterone (BT) levels were significantly increased by 58% and 64% when the mixture (D + R) was consumed in both FIG. 4 and FIG. 5 .
또한 [도6] 결과에서 민들레 추출물(D)과 루이보스(R)를 각각 섭취한 경우, 암컷 랫트에서 대조군(CTL)에 비해서 혈중 총 에스트라디올(TE)의 수치는 각각 33%, 6% 가량 증가하였다 In addition, when the dandelion extract (D) and rooibose (R) were separately taken from the results of [Figure 6], the total estradiol (TE) level in the blood of the female rats was 33% and 6% higher than that of the control (CTL) And
또한 [도 7]의 결과에서 민들레 추출물(D)과 루이보스(R)를 각각 섭취한 경우, 혈중 생리 활성형 에스트라디올 (BE)의 수치는 각각 약 40%, 5% 증가하였다. 그리고 혼합물(D+R)을 섭취한 경우 혈중 총 에스트라디올 (BT)과 생리활성형 에스트라디올 (BE)의 수치는 각각 49%, 58% 가까이 의미있는 증가를 보였다.
In addition, when the dandelion extract (D) and rooibose (R) were separately taken from the results of [Figure 7], the levels of physiologically active estradiol (BE) in the blood were increased by about 40% and 5%, respectively. Total dietary estradiol (BT) and physiologically active estradiol (BE) levels were significantly increased by 49% and 58%, respectively, when the mixture (D + R) was consumed.
<< 실험예Experimental Example 2> 2>
인체시험을Human test 통한 혈중 성호르몬 증가 효과 Increased Serum Sex Hormone Through
남녀 성인에서 본 발명의 조성물을 섭취하게 하여 섭취 전후 성호르몬 전구체 및 남녀 성호르몬의 혈중 농도 변화와 성호르몬 생리활성 억제 글로불린의 감소를 확인하여 발명 조성물의 성호르몬 증가 효과를 확인하였다.
The composition of the present invention was ingested in male and female adults, and the sex hormone proliferative effect of the inventive composition was confirmed by confirming the change of blood concentration of sex hormone precursor and male sex hormone and the decrease of sexual hormone physiological activity inhibitory globulin before and after ingestion.
<2-1> 연구 대상 및 기간<2-1> Subjects and Periods
본 검사에 동의한 만 40세 이상 중년 남성 40명을 위약을 섭취한 대조군(placebo)과 본 발명의 민들레 추출물 또는 민들레 추출물과 루이보스 추출물의 혼합물(D+R; 1:9 혼합비)을 섭취한 실험군으로 각 10명씩 임의로 분류하여 4주간 위약 또는 실험약을 일일 400 mg 씩 섭취하도록 하였다. 또한 만 40세 이상 중년 여성 40명을 위와 같은 방식으로 임의로 분류하여 같은 방식으로 실험을 진행하였다. 섭취 전과 후에 <시험예 2-2>의 방법으로 혈액내 성호르몬의 농도를 조사하여 본 조성물의 섭취로 인한 남녀 성호르몬 증가 평가를 실시하였다.
40 middle-aged and over 40 year old men who agreed to this test were randomly assigned to a placebo with a placebo and a mixture of dandelion extract or dandelion extract and rooibos extract (D + R; 1: 9 mixture ratio) Were randomly divided into 10 groups, and 400 mg / day of placebo or experimental drug was administered for 4 weeks. In addition, 40 middle - aged women over 40 years old were randomly classified in the same manner and the same experiment was conducted. The concentration of sex hormones in the blood was measured by the method of <Test Example 2-2> before and after the ingestion to evaluate the increase of sex hormone by the ingestion of the composition.
<2-1> 본 조성물 섭취로 인한 성인 남녀에서의 성호르몬 증가 효과<2-1> Increase of sex hormone in adult men and women due to ingestion of this composition
혈액은 섭취 전과 후에 동일한 시각인 오후 2시에 실험군 남녀의 혈액을 팔 정맥으로 채취한 후, heparin 처리된 튜브로 옮겨 담고 2,500rpm(4℃)에서 15분간 원심분리하여 혈장을 분리하였다. 분리된 혈장을 대상으로 Testosterone, Estradiol ELISA kit (ADI-901-065, 174; Enzo Life Sciences, U.S.A.)을 이용하여 제조사의 매뉴얼에 따라 혈중 성호르몬 함량을 측정하였다.Blood was sampled at 2:00 pm, which is the same time before and after the ingestion, in the arm vein of the experimental group, and transferred to a heparinized tube. The plasma was separated by centrifugation at 2,500 rpm (4 ° C) for 15 minutes. Serum sex hormone levels were measured according to the manufacturer's manual using the Testosterone and Estradiol ELISA kit (ADI-901-065, 174; Enzo Life Sciences, U.S.A.).
결과는 평균과 표준편차로 나타내었으며 유의성 검증을 위해 통계처리는 Student's t-test를 이용하였으며, p<0.05 시에 유의한 것으로 간주하여 표시하였다, 그 결과는 [도 8] 및[도 9]에 나타내었다.
Results were expressed as mean and standard deviation. For statistical significance, Student's t-test was used for statistical significance, and it was regarded as significant at p <0.05. The results are shown in FIG. 8 and FIG. 9 Respectively.
측정 결과, [도 8]에서 보듯이 민들레 추출물(D)을 섭취한 남성의 경우, 대조군(CTL)에 비해 약 8.4%의 혈중 총 테스토스테론 수치 (TT)가 증가하였고, 혼합물(D+R)을 섭취한 경우, 혈중 총 테스토스테론 (TT)의 수치가 대조군에 비해 18% 가까이 증가하였다.As shown in FIG. 8, the total testosterone level (TT) of the male patient who consumed the dandelion extract (D) was increased by 8.4% compared to the control (CTL) When ingested, total blood testosterone (TT) levels increased by 18% compared to the control.
또한 [도 9]의 결과에서 민들레 추출물(D)을 섭취한 여성의 경우, 대조군(CTL)에 비해 각각 약 11.6%의 혈중 총 에스트라디올 (TE) 수치가 증가하였고, 혼합물(D+R)을 섭취한 경우, 혈중 총 에스트라디올 (BE)의 수치가 대조군에 비해 24.7% 가까이 증가하였다.
In addition, the results of [Figure 9] show that the total dietary estradiol (TE) level of the women who took the dandelion extract (D) increased by about 11.6% and the mixture (D + R) When ingested, total oestradiol (BE) levels in blood increased by 24.7% compared to the control.
<< 실험예Experimental Example 3> 3>
인체시험을Human test 통한 남성 갱년기 예방 효과 Menopause Prevention Through
남성에게 본 발명의 조성물을 섭취하게 하여 섭취 전후 남성 갱년기 평가 설문지를 통해 남성 갱년기 예방 및 치료 효과를 확인하였다.
Men were administered the composition of the present invention, and men's menopause prevention and treatment effects were confirmed through a menopausal evaluation questionnaire before and after consumption.
<3-1> 연구 대상 및 기간<3-1> Subjects and Period
본 검사에 동의한 만 40세 이상 중년 남성 50명을 위약을 섭취한 대조군(placebo)과 본 발명의 조성물의 혼합물(D+R; 1:9 혼합비)을 섭취한 실험군으로 각 25명씩 임의로 분류하여 4주간 위약 또는 실험약을 일일 400 mg 씩 섭취하도록 하였다. 섭취 전과 후에 <시험예 3-2>와 <시험예 3-3>의 검사지에 답하도록 하여 본 조성물의 섭취로 인한 남성 갱년기 평가를 실시하였다.
Fifty men aged 40 years and older who agreed to this test were randomly assigned to a placebo group (placebo) and a mixture of the composition of the present invention (D + R; 1: 9 mixture ratio) 400 mg / day of placebo or experimental drug for 4 weeks. Men's menopausal evaluation was performed by ingesting the composition in answering the test papers of <Test Example 3-2> and <Test Example 3-3> before and after the ingestion.
<3-2> 한글판 <3-2> Localization AMSAMS (( AgingAging Males'Males' SymptomSymptom ) ) ScaleScale
1999년 Heinemann 등(Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New 'Aging Male's Symptom'(AMS) Scale. The Aging Male 1992, 2:105-114.)이 독일어로 개발한 AMS scale은 노화가 남성의 삶의 질에 및은 영향을 객관적으로 평가하기 위해 고안된, 타당도와 신뢰도가 입증된 도구로, 한국판은 2003년 김세현의 번역판이 타당도와 신뢰도가 입증되었다(Daig I, Heinemann LA, Kim S et al. The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics. Health Qual Life Outcomes (2003) 1:77.; 이길형 등, Korean J Fam Med. (2010) 31:613-621). 본 발명의 조성물 섭취군과 위약군의 AMS 결과는 [표 1]과 [도 10]에 나타내었으며, 결과값은 평균과 표준편차로 기입하였고, 통계처리는 Student's t-test를 이용하였으며, p<0.05 시에 유의한 것으로 간주하여 표시하였다.
The AMS scale, developed in German, was used to assess the effects of aging on the aging process, including aging (Aging Male's Symptom) (AMS) Scale. The Aging Male 1992, 2: 105-114. Heinemann et al., 1999; Heinemann LAJ, Zimmermann T, Vermeulen A, , The validity and reliability of the Korean version of the Korean version were verified in 2003 by Dae I, Heinemann LA, Kim S et al. The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics, Health Qual Life Outcomes (2003) 1:77. The AMS results of the composition of the present invention and the placebo group are shown in [Table 1] and [Figure 10], and the results were expressed as mean and standard deviation. Statistical analysis was performed using Student's t-test, p <0.05 Were considered to be significant.
시험 결과, [표 1]과 [도 10]의 결과에서 대조군의 AMS 점수가 섭취 전후 크게 차이가 없는 반면, 본 조성물 섭취군은 섭취 전에 비해 AMS 점수가 약 13점 감소하여 약 31% 의 남성 갱년기 증상 개선율을 보였다. 이로써 본 발명의 조성물이 AMS 검사항목인 활력개선, 성욕, 정력, 발기개선, 수면개선, 정서안정 등 남성 노화로 인해 나타나는 갱년기 증상을 완화시킴을 확인하였다.
As a result of the test, the AMS score of the control group was not significantly different before and after the ingestion in the results of [Table 1] and [Figure 10], whereas the AMS score of the composition intake group was decreased by about 13 points before the ingestion, Symptom improvement rate. 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.
(% of before)Improved symptoms of menopausal symptoms
(% of before)
<3-3><3-3> 한글판 Korean version ADAMADAM ( ( AndrogenAndrogen DeficiencyDeficiency inin AgingAging MalesMales ) )
2000년 Morley 등(Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D, et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000, 49:1239-1242.)이 자신들의 임상경험을 근거로 대표적인 10가지 증상들을 확인하여 남성호르몬 결핍을 평가하기 위해 개발한 검사지로서 40세 이상의 남성에서 남성호르몬 결핍 상태를 선별할 수 있는 진단검사로서 타당성이 입증되었다. 문항수가 그리 많지 않고, 진단의 민감도가 높아 남성호르몬 결핍 선별검사로 흔히 이용된다. 한글판 ADAM 검사지는 김수웅 등(김수웅, 오승준, 백재승, 김세철. Androgen Deficiency in Aging Males(ADAM) 설문지의 한국어 번역본 개발. 대한비뇨기과학회지 2004, 45(7):674-679.)이 남성 갱년기 환자들을 선별하고 이를 임상연구에 활용할 수 있도록 영어판을 한글판으로 번역한 검사지이다. ADAM의 10개 문항은 각각의 증세에 대해 예 또는 아니오로 대답할 수 있게 되어있으며, 성기능의 저하 또는 그 밖의 증상 유무를 평가함으로써 남성호르몬 결핍 여부를 평가할 수 있는 검사이다. 검사항목 중 문항 1 또는 7에서 예라고 답하거나, 1번과 7번 문항을 제외한 항목에서 3개 이상 예라고 답한 경우 남성호르몬 결핍 증세가 있어 남성갱년기 증세가 있다고 볼 수 있다. In 2000, Morley et al. (Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D, et al, Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000, 49: 1239-1242) , Which was developed to evaluate male hormone deficiency by examining 10 representative symptoms based on clinical experience of men and women over 40 years of age. The number of questions is low and the sensitivity of diagnosis is high, so it is often used as a test for sex hormone deficiency. The Korean Journal of Urology 2004, 45 (7): 674-679.) The male ADAM screening group was selected for the male climacteric patients (Kim, Soo-Woong, Oh Seungjoon, Baek Jae- And translated it into Korean version so that it can be used for clinical research. The ADAM's 10 questions are available to answer yes or no to each symptom and can be assessed for male hormone deficiency by assessing sexual dysfunction or other symptoms. If you answered yes to question 1 or 7 of the test items, or if you answered yes to three or more questions in items other than
본 발명의 조성물 섭취군(실험군)과 위약군(대조군)의 ADAM 결과는 [표 2]와 같이 ADAM 검사지에 의한 남성갱년기 유병률(%, 각 군의 전체 피험자 중 남성호르몬 결핍 증세를 호소하는 사람의 비율)로 나타내었다.
The ADAM results of the composition of the present invention (experimental group) and the placebo group (control group) are shown in Table 2, and the menopausal prevalence rate (%, by the ADAM test paper) ).
시험 결과 [표 2]에서 보는 바와 같이, 대조군에서는 위약 섭취 전후 ADAM 검사지로 평가한 남성갱년기 유병률에 큰 변화가 없는 반면, 본 조성물 섭취군은 섭취 후 ADAM 검사지로 평가한 남성갱년기 유병률이 약 28% 감소하였다. 이로써 본 발명의 조성물이 ADAM 검사항목인 성욕감퇴, 발기저하개선, 기력, 체력, 운동능력 개선, 삶의 질, 우울감개선, 업무능력향상 등에 효과적으로 나타나 남성 갱년기 증상을 호전시킴을 확인하였다.
As shown in Table 2, the control group had no significant change in male menopausal prevalence as assessed by the ADAM before and after the placebo intake, whereas the menstrual group of the present composition had a male premenopausal prevalence of about 28% Respectively. Thus, it was confirmed that the composition of the present invention is effective for ADAM test items such as loss of sexual desire, improvement of erectile deterioration, improvement in energy, physical strength, athletic ability, quality of life, improvement of depression and work ability.
<< 실험예Experimental Example 4> 4>
인체시험을Human test 통한 여성 갱년기 예방 효과 Prevention of female menopause through
여성에게 본 발명의 조성물을 섭취하게 하여 섭취 전후 여성 갱년기 평가 설문지를 통해 여성호르몬 조절 이상에 의한 여성 갱년기 예방 및 치료 효과를 확인하였다.
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.
<4-1> 연구 대상 및 기간<4-1> Subjects and Periods
본 검사에 동의한 만 40세 이상 중년 여성 40명을 위약을 섭취한 대조군(placebo)과 본 발명의 조성물의 혼합물(D+R; 1:9 혼합비)을 섭취한 실험군으로 각 20명씩 임의로 분류하여 4주간 위약 또는 실험약을 일일 500 mg 씩 섭취하도록 하였다. 섭취 전과 후에 <시험예 4-1>의 검사지에 답하도록 하여 본 조성물의 섭취로 인한 여성 갱년기 평가를 실시하였다.
40 middle-aged and over 40 year old women who agreed to this test were randomly divided into 20 experimental groups that received placebo and a mixture (D + R; 1: 9 mixture ratio) of the composition of the present invention For 4 weeks, 500 mg of placebo or experimental drug was given daily. Before and after ingestion, the menstrual period was evaluated by the administration of the composition by answering the <Test Example 4-1>.
<4-1> 한글판 MRS(<4-1> Korean version MRS MenopauseMenopause RatingRating ScaleScale ))
1953년 Kupperman등이 발표한 Kupperman index는 현재까지 여성 갱년기 증상과 관련한 연구에서 증상 평가 척도로서 가장 많이 사용되고 있는 자가 설문 검사 방식이다. 이 방식을 보완하여 1992년 Hildich 등이 보완하여 만든 것이 MENQOL(The menopause-specific quality of life questionnaire)이며 이것을 다시 1996년에 새롭게 보완하여 만든 측정법이 MRS이다. MRS는 전세계적으로 많은 연구들에 인용되면서 신뢰도와 타당성이 인정되고 있다. 신체증상, 정신증상, 비뇨생식기증상 등 총 11개 문항으로 구성되어 있으며 문항수가 적고 간편하여 편리하다는 장점을 가지고 있다. 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.
총점을 계산하여 0~4점은 양호한 갱년기 상태로서 원만한 갱년기를 이야기하며 5~8점은 경미한 갱년기 상태로서 관리가 필요함을 보여준다. 9~15점은 중증도 갱년기 상태로서 갱년기 장애가 있으므로 전문가의 진단가 치료가 필요하다. 16점 이상은 심한 갱년기 상태로서 장기적인 계획과 치료가 매우 필요함을 나타내는 수치이다. A total score of 0 to 4 indicates a good menopausal state as a good menopause, and a score of 5 to 8 indicates a mild menopausal state requiring management. 9 to 15 points are menopausal menopausal status, which is a serious menopause, so specialist diagnosis is needed. A score of 16 or higher is a severe menopausal state, indicating that long-term planning and treatment is highly needed.
시험 결과, [도 12]의 결과에서 대조군의 MRS 점수가 섭취 전후 크게 차이가 없는 반면, 본 조성물 섭취군은 섭취 전에 비해 MRS 점수가 약 4.4점 감소하여 약 45% 의 여성 갱년기 증상 개선율을 보였다. 이로써 본 발명의 조성물이 MRS 검사항목인 활력개선, 성욕, 수면문제, 신경안정, 비뇨기 문제, 관절문제, 우울감, 과민성 등 여성 노화로 인해 나타나는 여성 갱년기 증상을 완화시킴을 확인하였다.
In the results of [Fig. 12], the MRS score of the control group was not significantly different before and after the ingestion, whereas the MRS score of the intake group of the composition was decreased by about 4.4 points and the improvement rate of the female menopausal symptom was about 45%. Thus, it was confirmed that the composition of the present invention alleviated the symptoms of female menopausal symptoms caused by aging of women such as vitality improvement, sexual desire, sleeping problem, nervous stability, urinary problems, joint problems, depression, and irritability.
본 발명은 민들레 추출물 또는 민들레 및 루이보스 복합 추출물을 유효성분으로 포함하는 갱년기 또는 갱년기 관련 질환 또는 증상의 예방, 개선 및 치료용 식품 조성물 및 약학적 조성물을 제공한다. 본 발명의 조성물은 혈중 남녀 총 성호르몬 수준을 증가시키며, SHBG의 감소를 통해 활성화형태의 성호르몬을 증가시켜, 남녀 갱년기 또는 갱년기 관련 질환 및 증상의 예방 및 치료에 효과적이므로 산업상 이용 가능성이 높다.The present invention provides a food composition and a pharmaceutical composition for preventing, ameliorating and treating a menopausal or menopausal related disease or symptom comprising a dandelion extract or a combined extract of dandelion and rooibos as an active ingredient. The composition of the present invention increases the sex hormone levels of male and female in blood, increases sex hormone of activated form through reduction of SHBG, and is effective for prevention and treatment of male and female menopausal or menopausal diseases and symptoms, .
Claims (9)
A composition for preventing or ameliorating male menopausal symptoms comprising a dandelion extract as an active ingredient, wherein the dandelion extract is an extract using water, an alcohol having 1 to 6 carbon atoms, or a supercritical fluid as a solvent.
A pharmaceutical composition for preventing or treating male menopausal symptoms comprising an extract of dandelion as an active ingredient, wherein the dandelion extract is an extract using water, an alcohol having 1 to 6 carbon atoms, or a supercritical fluid as a solvent.
The composition according to claim 1, wherein the composition further comprises a rooibos extract as an active ingredient, wherein the rooibos extract is an extract using water, an alcohol having 1 to 6 carbon atoms, or a supercritical fluid as a solvent.
[3] The composition according to claim 2, wherein the composition further comprises a rooibos extract as an active ingredient, wherein the rooibos extract is an extract using water, an alcohol having 1-6 carbon atoms, or a supercritical fluid as a solvent.
The composition according to claim 3 or 4, wherein the weight ratio of the dandelion extract and the rooibos extract is 10: 1 to 1:10.
3. The method according to claim 1 or 2, wherein the male menopausal symptoms are selected from the group consisting of hypogonadism, hypoglycemic precursor (DHEA) hypothermia, nervousness, emotional disturbance, depression, facial flushing, sweating, Wherein the composition is at least one selected from the group consisting of depression, erectile dysfunction, decreased sperm motility, decreased tack, decreased physical strength, decreased exercise capacity, decreased body hair, and decreased bone density.
5. The composition according to any one of claims 1 to 4, wherein the composition increases blood levels of male hormone testosterone.
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| US14/819,441 US10245292B2 (en) | 2013-02-08 | 2015-08-06 | Composition for enhancing male sex hormone and men's health |
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| CN107802681A (en) * | 2017-11-06 | 2018-03-16 | 庄光天 | A kind of medicine for treating AIDS |
| KR20230002103A (en) | 2021-06-29 | 2023-01-05 | (주)세준에프앤비 | A composition comprising a kudzu of extracts for preventing or alleviating climacteric syndrome, health fuctional food, and methode for producing the same |
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| KR101525948B1 (en) * | 2014-12-10 | 2015-06-05 | 주식회사 엔에스웰니스 | Composition comprising carob extract for preventing, improving menopause of man |
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| JPH06211682A (en) * | 1993-01-21 | 1994-08-02 | Fuji Kuginuki | Enhancer for endocrine system |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107802681A (en) * | 2017-11-06 | 2018-03-16 | 庄光天 | A kind of medicine for treating AIDS |
| KR20230002103A (en) | 2021-06-29 | 2023-01-05 | (주)세준에프앤비 | A composition comprising a kudzu of extracts for preventing or alleviating climacteric syndrome, health fuctional food, and methode for producing the same |
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