KR20190034180A - Composition for relieving menopausal symptom - Google Patents
Composition for relieving menopausal symptom Download PDFInfo
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- KR20190034180A KR20190034180A KR1020190033127A KR20190033127A KR20190034180A KR 20190034180 A KR20190034180 A KR 20190034180A KR 1020190033127 A KR1020190033127 A KR 1020190033127A KR 20190033127 A KR20190033127 A KR 20190033127A KR 20190034180 A KR20190034180 A KR 20190034180A
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- extract
- thomsonii
- pueraria
- composition
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Abstract
Description
본 발명은 여성의 갱년기 증상 예방, 개선 및/또는 치료용 조성물에 관한 것이며, 더욱 구체적으로, 여성의 갱년기 증상 중 특히 안면홍조, 및/또는 골다공증의 예방, 개선 및/또는 치료에 효과적인 조성물에 관한 것이다.The present invention relates to a composition for preventing, ameliorating and / or treating a menopausal symptom in women, and more particularly, to a composition for preventing, ameliorating and / or treating a menopausal symptom in women, especially facial flushing and / will be.
여성의 폐경(menopause)이란 태어난 후 약 50년에 이르는 유전적으로 이미 결정된 난소의 기능이 수명을 다 함으로써 나타나는 월경의 중단 현상으로, 생식능력의 소실을 의미하며 병적 현상이 아닌 생리적인 변화이다. 현재 우리나라 여성의 평균 수명은 81.2세(2011년:통계청)로 대한산부인과학회에서 규정한 한국 여성의 평균 폐경 연령을 50세로 가정한다면 여성 일생의 약 1/3 이상을 여성호르몬이 고갈된 상태로 산다는 것을 의미한다.(약학정보원, 김성철)Women's menopause is a disruption of menstruation that occurs when the function of the genetically determined ovary reaches its life span of about 50 years after birth. It is a loss of reproductive capacity, not a morbid phenomenon, but a physiological change. At present, the average life expectancy of Korean women is 81.2 years (2011: National Statistical Office), assuming that the average age of menopause of Korean women prescribed by the Korean Obstetrics and Gynocology Society is 50 years old. (Pharmacy Information Center, Sung Chul Kim)
여성은 폐경을 맞이하면서 여성 호르몬의 분비 불균형 및 감소로 인해 혈관계, 근골격계, 비뇨생식기계 및 뇌신경 등 신체 전반에 걸쳐 변화가 일어난다. 즉 혈관 운동성증상과 심리적 증상인 안면 홍조, 야간 발한, 수면 장애, 피로감, 우울증, 불안감, 집중력 장애, 그리고 기억 장애와 비뇨생식계 위축에 의한 성교통, 빈뇨, 교원질 감소에 의한 피부탄력의 소실, 유방의 처짐, 그리고 치매 등의 다양한 질환 등이 동반된다(비특허문헌 1). 갱년기 증상은 개인마다 차이가 있지만 갱년기 증상을 많이 경험할수록, 정도가 심할수록, 그리고 기간이 길어질수록 여성의 삶의 질이 저하되는 것으로 보고되었을 뿐만(비특허문헌 2) 아니라, 갱년기 증상은 신체적인 노화와 함께 만성 질환으로 진행될 가능성이 높다.As women become menopausal, the female hormone imbalance and decrease causes changes throughout the body including the vascular system, musculoskeletal system, genitourinary system and cranial nerve. In other words, vasomotor symptoms and psychological symptoms such as facial flushing, night sweating, sleeping disorder, fatigue, depression, anxiety, concentration disorder, and dysmotility due to memory disorders and urinary gonadal atrophy, loss of skin elasticity due to decreased urinary frequency, collagen, Sagging, and dementia (Non-Patent Document 1). Although menopausal symptoms vary from person to person, it has been reported that the more severe the symptoms of menopausal symptoms, the greater the severity, and the longer the duration, the lower the quality of life of women (Non-Patent Document 2) It is highly likely to develop chronic diseases with aging.
갱년기 증상의 치료에는 호르몬 요법, 약물 요법, 운동 요법, 식이요법이 적용될 수 있으나 의학적으로 많이 사용하는 여성 호르몬 치료는 유방암 등의 위험을 증가시킬 수 있으며, 장기간 사용시에는 자궁암, 혈전혈관질환, 담낭질환, 고혈압의 비율을 증가시킬 수 있다. 때문에 최근 들어서는 에스트로겐 요법과 기타 약물 요법 등의 대체를 위하여 에스트로겐과 유사한 기능을 하는 것으로 보고되고 있는 피토에스트로겐(phytoestrogen)에 대한 연구가 많이 이루어지고 있다(비특허문헌 3).Although hormone therapy, pharmacotherapy, exercise therapy, and diet therapy can be applied to the treatment of menopausal symptoms, female hormone therapy, which is often used medically, may increase the risk of breast cancer. In the long term use, uterine cancer, , The ratio of hypertension can be increased. Recently, phytoestrogens, which have been reported to have estrogen-like functions for replacement of estrogen therapy and other drug therapies, have been extensively studied (Non-Patent Document 3).
상기와 같은 문제점을 해결하기 위하여, 본 발명은 여성 갱년기 증상을 치료, 예방 또는 개선하기 위한 조성물을 제공하고자 한다. In order to solve the above problems, the present invention provides a composition for treating, preventing or ameliorating female menopausal symptoms.
본 발명은 특히 여성 갱년기 증상 중 발한, 안면홍조 및/또는 골다공증 예방, 개선 또는 치료에 탁월한 효과를 갖는 조성물을 제공하고자 한다. The present invention intends to provide a composition having an excellent effect for prevention, improvement or treatment of sweating, facial flushing and / or osteoporosis in women's menopausal symptoms.
본 발명은 푸에라리아 톰소니(Pueraria thomsonii) 추출물을 유효성분으로 포함하는 여성 갱년기 증상 예방 또는 개선용 조성물을 제공한다. The present invention relates to a method for the treatment of Pueraria thomsonii ) extract as an active ingredient.
더욱 구체적으로 본 발명은 푸에라리아 톰소니의 꽃 또는 꽃봉오리 추출물을 유효성분으로 포함하는 여성 갱년기 증상 예방 또는 개선용 조성물을 제공한다. More specifically, the present invention provides a composition for preventing or ameliorating female menopausal symptoms comprising an extract of Flower or Bud of Pueraria thomsonii as an active ingredient.
본 발명은 푸에라리아 톰소니의 꽃 또는 꽃봉오리 추출물이 다른 부위에 비해서 더욱 우수한 발한, 안면홍조 및 골다공증 예방 또는 개선 효과를 가질 수 있다. The present invention may have the effect of preventing or improving sweating, facial flushing and osteoporosis, which is superior to other parts of the flower or bud extract of Pueraria Tomsoni.
본 명세서에서 언급된 푸에라리아 톰소니는 특별한 언급이 없는 이상 푸에라리아 톰소니의 꽃 또는 꽃봉오리 추출물을 일컫는 것으로 이해될 수 있다.The Pueraria Tomsonis referred to herein may be understood to refer to a flower or bud extract of Pueraria Tomsoni unless otherwise noted.
본 발명의 다른 실시예는 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리 추출물을 유효성분으로 포함하는 발한, 안면홍조 치료, 예방 또는 개선용 조성물을 제공한다. Another embodiment of the present invention provides a composition for treating sweating, facial flushing, prevention or improvement comprising Pueraria thomsonii flower or bud extract as an active ingredient.
바람직하게 상기 푸에라리아 톰소니 추출물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리를 60~90% 에탄올로 추출하여 얻을 수 있다. Preferably, the Pueraria thomsonii extract is obtained by extracting Pueraria thomsonii flowers or buds with 60 to 90% ethanol.
본 발명의 다른 실시예는 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리 추출물을 유효성분으로 포함하는 골다공증 치료, 예방 또는 개선용 조성물을 제공한다. Another embodiment of the present invention provides a composition for treating, preventing or ameliorating osteoporosis comprising Pueraria thomsonii flower or bud extract as an active ingredient.
바람직하게 상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리를 60~90% 에탄올로 추출하여 얻을 수 있다.Preferably, the composition is obtained by extracting Pueraria thomsonii flowers or buds with 60 to 90% ethanol.
상기 푸에라리아 톰소니는 우리나라에서 칡으로 일컬어지는 식물의 일종으로, 다른 푸에라리아(Pueraria) 속 식물들에 비해 아직까지 연구가 활발하지 않다. The Pueraria thomsonis is a kind of plant called 칡 in Korea, and its research is not yet active compared to other Pueraria plants.
본 발명의 발명자들은 여성 갱년기 증상을 예방 또는 개선할 수 있는 방안에 대해 오랜기간 연구한 결과, 그동안 연구가 미진하였던 푸에라리아 톰소니 추출물이 우수한 갱년기 증상 완화 효과가 있음을 확인하고 본 발명을 완성하게 되었다. The inventors of the present invention have long studied a method for preventing or ameliorating female menopausal symptoms, and as a result, it has been confirmed that Pueraria thomsoni extract, which has not been studied in the past, has an excellent effect of alleviating menopausal symptoms, thus completing the present invention .
본 발명의 발명자들은 푸에라리아 톰소니 추출물이 다른 푸에라리아 속 식물들에 비해 우수한 갱년기 증상 완화 효과가 있음을 확인하게 되었다. The inventors of the present invention have found that Pueraria thomsonii extract has an excellent effect of alleviating menopausal symptoms compared to other plants of the genus Pueraria.
푸에라리아 톰소니의 꽃 또는 꽃봉오리 추출물에 포함된 성분들의 조합으로 뛰어난 갱년기 여성 질환 치료, 개선 또는 예방 효과를 얻을 수 있으며, 특히 발한, 안면홍조 치료, 개선 또는 예방에 탁월한 효과를 기대할 수 있다.The combination of the ingredients contained in the flower or bud extract of Pueraria Tomsoni can provide excellent treatment, improvement or prevention of climacteric female disease, and can be particularly effective in the treatment of sweating, facial flushing, improvement or prevention.
본 발명에서 '갱년기 증상'이란, 난소의 노화 등으로 인하여 에스트로겐의 분비가 감소됨에 따라 폐경을 전후로 여성에게서 나타나는 증상 및 질환을 총칭한다. '갱년기 증후군' 또는 '폐경기 증상' 이라고도 불린다. 갱년기 또는 폐경기 증상은 예를 들어, 안면홍조, 발한, 신경질, 우울증, 어지럼증, 피로감, 관절통, 근육통, 두통, 가슴 두근거림, 의주감, 수면 중 발한, 수면 장애, 피부 건조, 질 건조증, 질 위축, 하부 요도 위축, 성교 통, 질염, 방광염, 배뇨통, 급뇨, 집중 장애, 기억력 장애, 불안, 신경 과민, 기억력 감퇴, 피부건조, 관절통 또는 골다공증 등이 있으며 이에 한정되지 않는다. In the present invention, 'menopausal symptoms' refers to symptoms and diseases that occur in women before and after menopause as the secretion of estrogen is decreased due to aging of ovaries and the like. It is also called 'menopausal syndrome' or 'menopausal symptoms'. Menopausal or postmenopausal symptoms may include, for example, facial flushing, sweating, nervousness, depression, dizziness, fatigue, arthralgia, myalgia, headache, chest throbbing, dizziness, sweating during sleep, But are not limited to, lower urinary tract atrophy, sexual intercourse, vaginitis, cystitis, dysuria, diarrhea, concentration disorders, memory disorders, anxiety, nervousness, memory loss, dry skin, arthralgia or osteoporosis.
본 발명에서 '안면홍조' 란, 폐경 여성의 75%가 경험한다고 알려져 있는 혈관운동증상의 대표적인 증상으로, 얼굴 목 가슴 부위의 피부가 갑자기 붉게 변하면서 전신의 불쾌한 열감과 발한이 동반되는 것을 말한다. 갱년기의 호르몬 변화에 의해 시상하부에서 thermoneutral zone이 좁아짐으로써 갱년기 혈관운동 증상이 나타나며, 체온이 조금만 상승하더라도 열감을 느끼게 된다. In the present invention, 'facial flushing' is a typical symptom of vasomotor symptoms, which is known to be experienced by 75% of postmenopausal women. The skin of the face, neck and chest suddenly turns red, accompanied by uncomfortable warmth and sweating of the whole body. Menopausal hormone changes in the hypothalamus by narrowing the thermoneutral zone symptoms of menopausal vasomotor symptoms appear, even if the body temperature is slightly elevated, you feel a sense of warmth.
본 발명에서 '발한'이란, 피부의 땀샘에서 땀이 분비되는 현상으로, 급작스럽게 열이 오르면서 땀을 흘리는 증상을 의미한다. In the present invention, 'sweating' refers to a phenomenon in which sweat is secreted from the sweat glands of the skin, and sweating occurs due to sudden heat rise.
본 발명에서 '골다공증' 이란, 뼈의 강도가 약해져서 골절이 일어날 가능성이 높은 상태를 의미하는 것으로, 유전적 요인, 조기 폐경, 약제 또는 흡연 등이 원인이 된다. 따라서, 여성의 폐경 등에 의하여 호르몬 생산의 감소로 인해 나타나는 '갱년기 골다공증'일 수 있다. 갱년기 골다공증이란 폐경기 여성에게서 호르몬 생산의 감소로 인해 뼈 형성에 관여하는 조골세포와 조직의 파괴와 흡수에 관여하는 파골세포의 불균형에 의해 발생하는 골다공 증상을 의미한다. In the present invention, 'osteoporosis' means a condition in which the strength of bone is weak and fracture is likely to occur, and is caused by a genetic factor, premature menopause, drug or smoking. Therefore, it may be a 'menopausal osteoporosis' caused by a decrease in hormone production by the menopause of a woman. Menopausal Osteoporosis refers to osteoporosis caused by osteoclastic imbalance that is involved in the destruction and uptake of osteoblasts and tissues involved in bone formation due to a decrease in hormone production in postmenopausal women.
본 발명에서 '예방'이란 본 발명의 조성물을 투여하여 목적하는 증상을 억제 또는 지연시키는 모든 행위를 의미한다. In the present invention, " prevention " means all actions that inhibit or delay a desired symptom by administration of the composition of the present invention.
본 발명에서 '치료'란 본 발명의 조성물을 투여하여 목적하는 증상 또는 질병을 호전시키거나 사라지게 되는 모든 행위를 의미한다. &Quot; Treatment " in the present invention means all actions that improve or disappear the desired symptom or disease by administration of the composition of the present invention.
본 발명에서 '개선'이란 본 발명의 조성물을 투여하여 목적하는 증상을 투여 전 보다 증세가 호전 또는 이롭게 변경되는 모든 행위를 의미한다.&Quot; Improvement " in the present invention refers to all the actions of improving or improving symptoms before administering the desired symptoms by administering the composition of the present invention.
본 발명의 조성물에 포함되는 추출물의 함량은 유효량으로 포함될 수 있다. 상기 용어 '유효량'은 갱년기 증상, 특히 발한, 안면홍조 또는 골다공증을 억제 또는 지연시키거나, 이미 나타난 증상을 호전시킬 수 있는 추출물의 양을 의미한다.The amount of the extract contained in the composition of the present invention may be included in an effective amount. The term " effective amount " refers to an amount effective to treat menopausal symptoms, particularly sweating, Refers to the amount of the extract that can inhibit or delay osteoporosis or ameliorate the symptoms already present.
상기 조성물에 포함되는 상기 푸에라리아 톰소니 추출물의 함량은 특별히 제한되지 않으며, 갱년기 증상 또는 발한, 안면홍조 또는 골다공증을 예방, 개선 또는 치료할 수 있다면 다양한 중량%로 포함될 수 있다. 예를 들어, 전체 조성물에 대하여, 푸에라리아 톰소니 추출물은 0.001 내지 50 중량% 포함될 수 있다. The content of the Pueraria thomsonii extract contained in the composition is not particularly limited and may be included in various weight percentages if it can prevent, ameliorate, or treat osteoporosis, facial flushing, or sweating. For example, for the entire composition, the Pueraria thomsonii extract may be included in an amount of 0.001 to 50% by weight.
또한, 본 발명의 일 실시예에 따라, 상기 조성물은 상기 추출물을 조성물 1g에 대하여 1mg 내지 1000 mg으로 포함할 수 있고, 바람직하게는 5 mg 내지 500mg 으로 포함할 수 있다.In addition, according to one embodiment of the present invention, the composition may contain 1 mg to 1000 mg of the extract, preferably 5 mg to 500 mg, per 1 g of the composition.
본 명세서에서 사용된 용어 '꽃'은 속씨식물의 생식기관으로 암술, 수술, 꽃잎, 꽃받침으로 이루어져 있는 식물의 기관을 의미한다. 아직 꽃이 피지 않고 맺히어 있는 상태인 '꽃봉오리'도 본 발명의 꽃의 범위에 포함된다. As used herein, the term " flower " refers to the organ of the plant, which is the reproductive organs of the gentian plant and is composed of pistil, stamen, petal and calyx. The 'flower bud', which is still in a state of being blossomed, is included in the flower of the present invention.
본 발명에서 '추출물'은 식물체 등을 추출용매로 추출하거나 추출용매로 추출하여 제조한 추출물에 분획용매를 가하여 분획하여 제조할 수 있다. The 'extract' in the present invention can be prepared by extracting a plant or the like with an extraction solvent or extracting with an extraction solvent, followed by fractionation with a fraction solvent.
추출물 또는 분획물은, 상기 추출물의 희석이나 농축, 상기 추출물을 건조하여 얻어지는 건조물, 상기 추출물의 조정제물이나 정제물 또는 이들의 혼합물 등 추출물 자체와 추출물을 이용하여 형성 가능한 모든 제형의 추출물을 포함한다. 구체적으로 본 발명의 추출물은 추출 후 건조 분말 형태로 제조되어 사용될 수 있다. 또한, 추출 또는 분획과정을 수행한 이후, 감압 여과 과정을 수행하거나 추가로 농축 및/또는 동결건조를 수행하여 농축하거나 용매를 제거할 수 있다. 상기 수득한 추출물은 사용시까지 급속 냉동 냉장고(deep freezer)에 보관할 수 있다.The extract or fraction includes all the formulations which can be formed using the extract itself and the extract, such as a diluted or concentrated extract of the extract, a dried product obtained by drying the extract, a controlled preparation or purified product of the extract, or a mixture thereof. Specifically, the extract of the present invention may be prepared in the form of a dry powder after extraction. Further, after the extraction or fractionation process, the filtration may be performed under reduced pressure or may be further concentrated and / or lyophilized to concentrate or remove the solvent. The obtained extract can be stored in a deep freezer until use.
상기 추출용매의 종류는 특별히 제한되지 아니하며, 본 발명의 목적 효과를 갖는 추출물을 수득할 수 있는 한 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 구체적으로, 물 및 유기용매로 이루어진 군에서 선택된 1종 이상 일 수 있다. 상기 유기용매는 메탄올, 에탄올 등의 탄소수 1 내지 5의 알코올, 에틸아세테이트, 아세톤 및 클로로포름으로 이루어진 군으로부터 선택된 하나 이상의 용매를 사용할 수 있다. The type of the above-mentioned extraction solvent is not particularly limited, and any solvent known in the art can be used as long as an extract having the objective effect of the present invention can be obtained. Specifically, it may be at least one selected from the group consisting of water and an organic solvent. The organic solvent may be at least one solvent selected from the group consisting of alcohols having 1 to 5 carbon atoms such as methanol and ethanol, ethyl acetate, acetone, and chloroform.
바람직하게는 에탄올을 사용할 수 있다. 바람직하게 상기 에탄올은 35% ~ 95%에탄올을 이용할 수 있으며, 더 바람직하게 60~90% 에탄올을 이용할 수 있다. Ethanol may be preferably used. Preferably, the ethanol may use 35% to 95% ethanol, more preferably 60 to 90% ethanol.
구체적인 실시예에서, 85%에탄올을 사용하여 추출한 푸에라리아 톰소니 추출물을 이용하여 갱년기 증상 개선 정도를 확인한 결과, 상기 추출물로 처리된 세포에서 에스트로겐수용체 활성도가 향상 되었고, 인체적용시험에서 추출물을 섭취한 실험군의 갱년기 증상이 개선됨을 확인 하였다.In a specific example, the degree of improvement in menopausal symptoms was examined using Pueraria thomsoni extract extracted with 85% ethanol. As a result, estrogen receptor activity was improved in the cells treated with the extract, Of menopausal symptoms.
상기 분획용매는 물, 부탄올, 에틸아세테이트, 클로로포름, 헥산 또는 이들의 혼합물일 수 있다. 상기 분획물은 상기 추출법으로 제조한 추출물, 구체적으로 조추출액에 분획과정을 더욱 실시한 분획물일 수 있다. 상기 분획용매는 에틸아세테이트, 에테르, 클로로포름, 벤젠, 헥산, 메틸렌클로라이드 및 이들의 혼합용매로 이루어진 군에서 선택된 용매일 수 있으며, 바람직하게는 헥산일 수 있다. 상기 분획과정은 구체적으로 상기 조추출액에 헥산, 플로로포름, 에틸아세테이트, 부탄올 및 물을 순서로 가한 후에, 층 분리한 헥산 분획물, 클로로포름 분획물, 에틸아세테이트 분획물, 부탄올 분획물 및 물 분획물을 순차적으로 수득하는 방법으로 수행할 수 있다.The fraction solvent may be water, butanol, ethyl acetate, chloroform, hexane or a mixture thereof. The fraction may be an extract prepared by the above extraction method, specifically, a fraction obtained by further fractionating the crude extract. The fraction solvent may be a solvent selected from the group consisting of ethyl acetate, ether, chloroform, benzene, hexane, methylene chloride and a mixed solvent thereof, preferably hexane. Specifically, the fractionation step is performed by sequentially adding hexane, chloroform, ethyl acetate, butanol, and water to the crude extract in this order, then sequentially fractionating the hexane fraction, the chloroform fraction, the ethyl acetate fraction, the butanol fraction, . ≪ / RTI >
본 발명에서 추출물의 제조방법은 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 추출할 수 있다. 상기 추출 방법의 비제한적인 예로는 열수 추출법, 초음파 추출법, 여과법, 환류 추출법 등을 들 수 있고, 이들을 단독으로 수행하거나 2종 이상의 방법을 함께 수행할 수 있다. 또한, 고순도의 추출물을 얻기 위하여 추출액을 같은 방법으로 1회 이상씩 더 추출 할 수도 있다.The method for producing the extract in the present invention is not particularly limited, and may be extracted according to a method commonly used in the art. Examples of the extraction method include hydrothermal extraction, ultrasonic extraction, filtration, and reflux extraction, and these may be performed alone or in combination of two or more. In order to obtain a high purity extract, the extract may be further extracted one or more times by the same method.
본 발명은 푸에라리아 톰소니(Pueraria thomsonii) 추출물을 유효성분으로 포함하는, 여성 갱년기 증상 예방 또는 개선용 화장료 조성물, 약학 조성물, 또는 식품 조성물을 제공할 수 있다. The present invention is applicable toPueraria thomsonii) Extract as an active ingredient, a cosmetic composition, a pharmaceutical composition, or a food composition for preventing or ameliorating a female menopausal symptom.
상기 조성물은 화장품, 의약품, 식품 또는 의약외품의 형태로 제공될 수 있다. The composition may be provided in the form of a cosmetic, a medicament, a food or a quasi-drug.
본 발명에 따른 약학적 조성물은 약학적으로 유효한 양의 푸에라리아 톰소니 추출물을 단독으로 포함하거나 하나 이상의 약학적으로 허용가능한 담체, 부형제 또는 희석제를 추가로 포함할 수 있다. 상기 "약학적으로 허용가능한"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 composition according to the present invention may further comprise a pharmaceutically effective amount of Pueraria thomsonii extract alone or in combination with one or more pharmaceutically acceptable carriers, excipients or diluents. The term " pharmaceutically acceptable " means a non-toxic composition which is physiologically acceptable and which, when administered to a human, 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 또는 희석제의 예로는, 락토즈, 덱스트로즈, 수크로즈, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀루로즈, 메틸 셀룰로즈, 폴리비닐피롤리돈, 물, 메틸하이드록시벤조에이트, 프로필하이드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유 등이 포함될 수 있다. 또한 상기 약학적 조성물은 충진제, 항응집제, 윤활제, 습윤제, 향료, 유화제 또는 방부제 등을 추가로 포함할 수 있다.Examples of the carrier, excipient or 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, mineral oil, and the like. The pharmaceutical composition may further include a filler, an anti-coagulant, a lubricant, a wetting agent, a flavoring agent, an emulsifying agent or an antiseptic agent.
상기 "약학적으로 유효한 양"이란, 음성 대조군에 비해 그 이상의 반응을 나타내는 양을 말하며 바람직하게는 갱년기 장애의 예방, 개선 및/또는 치료의 효과를 나타내기에 충분한 양을 말한다.The " pharmaceutically effective amount " refers to an amount that exhibits a further reaction than the negative control, and preferably refers to an amount sufficient to exhibit the effect of preventing, ameliorating, and / or treating a menopausal disorder.
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 발명의 약학적 조성물의 투여 경로로는 이에 한정되는 것은 아니지만, 경구적 또는 비경구적으로 투여될 수 있다. 비경구적 투여 경로로는 예를 들어, 경피, 비강, 복강, 근육, 피하 또는 정맥 등의 여러 가지 경로가 포함될 수 있다.The route of administration of the pharmaceutical composition of the present invention includes, but is not limited to, oral administration or parenteral administration. Parenteral routes of administration may include, for example, various routes such as transdermal, nasal, peritoneal, muscular, subcutaneous or intravenous.
또한, 본 발명의 약학적 조성물은 갱년기 장애의 예방, 개선 및/또는 치료 효과를 가지는 공지의 화합물과 병행하여 투여할 수 있다.In addition, the pharmaceutical composition of the present invention can be administered in combination with a known compound having an effect of preventing, ameliorating and / or treating a menopausal disorder.
또 다른 양태로, 본 발명은 상기 조성물 중 어느 하나의 조성물을 포함하는 식품 조성물을 제공한다.In another aspect, the present invention provides a food composition comprising any one of the above compositions.
본 발명의 식품 조성물은 식품, 기능성 식품(functional food), 영양 보조제(nutritional supplement), 건강식품(health feed) 및 식품 첨가제(food additives) 등의 모든 천연 소재의 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 feed, 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 들어, 건강식품으로는 본 발명의 조성물 자체를 차, 주스 및 드링크의 형태로 제조하여 음용하도록 하거나, 과립화, 캡슐화 또는 분말화하여 섭취할 수 있다. 또한, 본 발명의 식품 조성물은 추가로 업계에서 식품 조성물에 일반적으로 포함될 수 있는 다른 약효 성분 및/또는 첨가제를 더 포함할 수 있다.For example, as a health food, the composition of the present invention itself can be prepared in the form of tea, juice, and drink and then consumed, granulated, encapsulated or powdered. In addition, the food composition of the present invention may further comprise other active ingredients and / or additives generally included in the food composition in the industry.
예를 들어, 본 발명에 따른 식품 조성물은 수용성 비타민으로서 티아민(비타민B1), 리보플라빈, 아스코르브산, 니아신, 및 비타민B6를 포함할 수 있고, 지방산으로서 미리스틴산, 팔미트산, 스테아린산, 올레인산, 리놀레인산 등을 포함할 수 있으며, 약산 성분으로서는 글리콜산 및 초산을 포함할 수 있고, 아미노산으로서 트레오닌, 발린, 메티오닌, 이소루신, 루신, 페닐알라닌, 트립토판, 및 리신의 필수아미노산 8종을 비롯하여, 아스파르트산, 세린, 글루탐산, 프롤린, 글리신, 알라닌, 시스테인, 티로신, 히스티딘, 알지닌 등을 포함할 수 있다.For example, the food composition according to the present invention may contain thiamine (vitamin B1), riboflavin, ascorbic acid, niacin, and vitamin B6 as water-soluble vitamins, and may contain myristic acid, palmitic acid, stearic acid, Linolenic acid and the like, and the weak acid component may include glycolic acid and acetic acid, and eight amino acids including essential amino acids such as threonine, valine, methionine, isoleucine, leucine, phenylalanine, tryptophan and lysine, Aspartic acid, serine, glutamic acid, proline, glycine, alanine, cysteine, tyrosine, histidine, arginine and the like.
또 다른 양태로, 본 발명은 상기 조성물 중 어느 하나의 조성물을 포함하는 화장료 조성물을 제공한다.In another aspect, the present invention provides a cosmetic composition comprising any one of the above compositions.
본 발명의 화장료 조성물에 포함되는 성분은 본 발명의 유효 성분외에 화장료 조성물에 통상적으로 이용되는 성분들을 포함하며, 예컨대, 항산화제, 안정화제, 용해화제, 비타민, 안료 및 향료와 같은 통상적인 보조제, 그리고 담체를 포함한다.The ingredients contained in the cosmetic composition of the present invention include, in addition to the active ingredient of the present invention, the ingredients conventionally used in cosmetic compositions and include conventional additives such as antioxidants, stabilizers, solubilizers, vitamins, And a carrier.
본 발명에 따른 화장료는 당업계에서 통상적으로 제조되는 어떠한 제형으로도 제조될 수 있다. 예를 들어, 용액, 현탁액, 유탁액, 페이스트, 젤, 크림, 로션, 파우더, 비누, 계면활성제-함유 클렌징, 오일, 분말 파운데이션, 유탁액 파운데이션, 왁스 파운데이션 및 스프레이 등으로 제형화될 수 있으나, 이에 한정되는 것은 아니다.The cosmetic composition according to the present invention can be prepared into any formulation conventionally produced in the art. For example, they may be formulated as solutions, suspensions, emulsions, pastes, gels, creams, lotions, powders, soaps, surfactant-containing cleansing, oils, powder foundations, emulsion foundations, wax foundations and sprays, But is not limited thereto.
보다 상세하게는, 유연 화장수, 영양 화장수, 영양 크림, 마사지 크림, 에센스, 아이 크림, 클렌징 크림, 클렌징 폼, 클렌징 워터, 팩, 스프레이 또는 파우더의 제형으로 제조될 수 있다.More specifically, it can be manufactured in the form of a soft lotion, a nutritional lotion, a nutritional cream, a massage cream, an essence, an eye cream, a cleansing cream, a cleansing foam, a cleansing water, a pack, a spray or a powder.
본 발명의 제형이 용액 또는 유탁액인 경우에는 담체 성분으로서 용매, 용해화제 또는 유탁화제가 이용되고, 예컨대 물, 에탄올, 이소프로판올, 에틸 카보네이트, 에틸 아세테이트, 벤질 알코올, 벤질 벤조에이트, 프로필렌글리콜, 1,3-부틸글리콜 오일, 글리세롤 지방족 에스테르, 폴리에틸렌 글리콜 또는 소르비탄의 지방산 에스테르가 있다.When the formulation of the present invention is a solution or an emulsion, a solvent, a dissolving agent or an emulsifying agent is used as a carrier component, and examples thereof include water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, , 3-butyl glycol oil, glycerol aliphatic ester, polyethylene glycol or sorbitan fatty acid esters.
본 발명의 제형이 현탁액인 경우에는 담체 성분으로서 물, 에탄올 또는 프로필렌 글리콜과 같은 액상의 희석제, 에톡실화 이소스테아릴 알코올, 폴리옥시에틸렌 소르비톨 에스테르 및 폴리옥시에틸렌 소르비탄 에스테르와 같은 현탁제, 미소결정성 셀룰로즈, 알루미늄 메타하이드록사이드, 벤토나이트, 아가 또는 트라칸트 등이 이용될 수 있다.In the case where the formulation of the present invention is a suspension, a carrier such as water, a liquid diluent such as ethanol or propylene glycol, a suspending agent such as ethoxylated isostearyl alcohol, polyoxyethylene sorbitol ester and polyoxyethylene sorbitan ester, Castellulose, aluminum metahydroxide, bentonite, agar or tracant, etc. may be used.
본 발명의 제형이 계면-활성제 함유 클렌징인 경우에는 담체 성분으로서 지방족 알코올 설페이트, 지방족 알코올 에테르 설페이트, 설포숙신산 모노에스테르, 이세티오네이트, 이미다졸리늄 유도체, 메틸타우레이트, 사르코시네이트, 지방산 아미드 에테르 설페이트, 알킬아미도베타인, 지방족 알코올, 지방산 글리세리드, 지방산 디에탄올아미드, 식물성 유, 라놀린 유도체 또는 에톡실화 글리세롤 지방산 에스테르 등이 이용될 수 있다.When the formulation of the present invention is an interfacial active agent-containing cleansing, the carrier component is selected from aliphatic alcohol sulfate, aliphatic alcohol ether sulfate, sulfosuccinic acid monoester, isethionate, imidazolinium derivative, methyltaurate, sarcosinate, fatty acid amide Ether sulfates, alkylamidobetaines, aliphatic alcohols, fatty acid glycerides, fatty acid diethanolamides, vegetable oils, lanolin derivatives or ethoxylated glycerol fatty acid esters.
본 발명의 제형이 파우더 또는 스프레이인 경우에는 담체 성분으로서 락토즈, 탈크, 실리카, 알루미늄 하이드록사이드, 칼슘 실리케이트, 또는 폴리아미드 파우더가 이용될 수 있고, 특히 스프레이인 경우에는 추가적으로 클로로 플루오로하이드로카본, 프로판/부탄 또는 디메틸 에테르와 같은 추진체를 포함할 수 있다.In the case where the formulation of the present invention is a powder or a spray, lactose, talc, silica, aluminum hydroxide, calcium silicate, or polyamide powder may be used as a carrier component, and in the case of a spray, additionally a chlorofluorohydrocarbon , Propane / butane or dimethyl ether.
본 발명의 제형이 페이스트, 크림 또는 젤인 경우에는 담체 성분으로서 동물성 유, 식물성 유, 왁스, 파라핀, 전분, 트라칸트, 셀룰로즈 유도체, 폴리에틸렌 글리콜, 실리콘, 벤토나이트, 실리카, 탈크 또는 산화아연 등이 이용될 수 있다.When the formulation of the present invention is a paste, cream or gel, an animal oil, vegetable oil, wax, paraffin, starch, tracant, cellulose derivative, polyethylene glycol, silicone, bentonite, silica, talc or zinc oxide may be used as the carrier component .
본 발명에 따른 조성물은 여성 갱년기 증상 및/또는 발한, 안면홍조, 골다공증의 예방 또는 개선에 신속한 효과가 있으므로, 종래 갱년기 증상의 예방 또는 개선에 사용되는 호르몬 대체 요법(Hormone replacement therapy; HRT)에 유용하게 이용될 수 있다.The composition according to the present invention has a rapid effect on prevention and improvement of women's menopausal symptoms and / or sweating, facial flushing and osteoporosis, and thus is useful for hormone replacement therapy (HRT) used for prevention or improvement of conventional menopausal symptoms Lt; / RTI >
또한, 본 발명에 따른 조성물은 여성 갱년기 증상이나 발한, 안면홍조, 골다공증에 대한 종래의 치료제와 달리 세포 독성도 없을 뿐만 아니라 식품으로 사용될 정도로 부작용이 적고, 안전하므로, 종래 여성 갱년기 증상 및/또는 발한, 안면홍조, 골다공증에 대한 치료제로 그 활용도가 높다. In addition, the composition according to the present invention is free from cytotoxicity unlike the conventional therapeutic agents for female menopausal symptoms, sweating, facial flushing and osteoporosis, and has low side effects and is safe enough to be used as food, , Facial flushing, and osteoporosis.
도 1은 본 발명의 일 실시예에 따른 P. thomsonii 추출물과 P. lobata 추출물의 에스트로겐 수용체에 대한 활성을 나타내는 그래프이다.
도 2는 본 발명의 일 실시예에 따른 P. thomsonii 추출물과 P. lobata 추출물의 혈관운동증상 개선 효과를 나타내는 그래프이다.
도 3은 본 발명의 일 실시예에 따른 P. thomsonii 추출물과 P. lobata 추출물의 골 흡수 개선효과를 나타내는 그래프이다.
도 4는 본 발명의 일 실시예에 따른 P. thomsonii 부위별 추출물의 혈관운동증상 개선 효과를 나타내는 그래프이다.
도 5는 본 발명의 일 실시예에 따른 P. thomsonii 부위별 추출물의 골 흡수 개선효과를 나타내는 그래프이다.1 is a graph showing the activity of P. thomsonii extract and P. lobata extract on estrogen receptor according to an embodiment of the present invention.
FIG. 2 is a graph showing the effect of improving the vasomotor symptoms of P. thomsonii extract and P. lobata extract according to an embodiment of the present invention.
3 is a graph showing the bone resorption improving effect of P. thomsonii extract and P. lobata extract according to an embodiment of the present invention.
FIG. 4 is a graph showing an effect of improving the vasomotor symptoms of P. thomsonii extract according to an embodiment of the present invention.
FIG. 5 is a graph showing the bone resorption improving effect of P. thomsonii extract according to an embodiment of the present invention.
이하, 본 발명을 구체적으로 설명하기 위해 실시예 및 실험예를 들어 상세하게 설명하기로 한다. 그러나, 본 발명에 따른 실시예 및 실험예는 여러 가지 다른 형태로 변형될 수 있으며, 본 발명의 범위가 아래에서 상술하는 실시예 및 실험예에 한정되는 것으로 해석 되어서는 안된다. 본 발명의 실시예 및 실험예는 당업계에서 평균적인 지식을 가진 자에게 본 발명을 보다 완전하게 설명하기 위해서 제공되는 것이다.Hereinafter, the present invention will be described in detail with reference to Examples and Experimental Examples. However, the embodiments and examples according to the present invention can be modified into various other forms, and the scope of the present invention should not be construed as being limited to the above-described embodiments and experiments. The embodiments and experimental examples of the present invention are provided to enable those skilled in the art to more fully understand the present invention.
<< PuerariaPueraria 속 식물의 종별 비교 분석>Comparative analysis of plant species>
실시예1Example 1 . . PuerariaPueraria thomsoniithomsonii 와 Wow PuerariaPueraria lobatalobata 추출물의 제조 Preparation of extract
하기 실시예에서 Pueraria thomsonii 과 Pueraria lobata를 사용하였고, 건조된 상기 푸에라리아속 식물에 85%에탄올을 용매로 하여 70℃에서 4시간 추출한 후 감압 농축하여 각각의 추출물을 제조하였다.In the following examples, Pueraria thomsonii and Pueraria lobata were used. The dried extracts of the plants of the genus Pueraria were extracted with 85% ethanol for 4 hours at 70 ° C and concentrated under reduced pressure to prepare respective extracts.
실시예2Example 2 . 정제의 제조. Manufacture of tablets
실시예1에 따라 제조된 P. thomsonii 추출물, P. lobata 추출물과 잔량의 부형제(덱스트린)를 이용하여 하기 표 1의 비율과 같이 300mg 정제를 제조하였다.Using the extracts of P. thomsonii , P. lobata and residual excipients (dextrin) prepared according to Example 1, 300 mg tablets were prepared as shown in the following Table 1.
실시예3Example 3 . . 푸에라리아속Pueraria (( PuerariaPueraria ) 별 에스트로겐수용체 활성 평가) Estrogen receptor activity evaluation
P. thomsonii 추출물과 P. lobata 추출물의 에스트로겐수용체에 대한 활성을 확인하기 위하여 ERE(estrogen response element) reporter assay를 수행하였다. An estrogen response element (ERE) reporter assay was performed to determine the estrogen receptor activity of P. thomsonii and P. lobata extracts.
293T 세포를 10% FBS가 첨가된 DMEM 배지를 사용하여 24 well plate에서 24시간 배양 후, well당 5% charcoal stripped FBS containing phenol red free medium 500㎕으로 배지를 교환해 주고, transfection을 수행하였다. well당 ERa 0.1ug, ERE 0.1ug, pRL-Tk 10ng의 DNA를 Lipofectamine® reagents(Thermo Fisher Scientific)를 사용하여 transfection 하였다. transfection 4시간 후, 상기 P. thomsonii 추출물과 P. lobata 추출물을 각각 10ppm(DMSO 0.5㎕)으로 첨가하였고, 양성대조군으로 17β-estradiol(E2)을 1ppb(DMSO 0.5㎕)로, 음성 대조군(control, ctrl)으로는 동량의 DMSO(0.5㎕)를 처리하였다. 시료처리 24시간 후, Dual-Luciferase® Reporter Assay System (Promega)를 사용하여 발광정도(luminescence)를 측정하였고, 음성 대조군의 측정값을 기준(1.0)으로 하여 실험결과를 도 1에 나타내었다. 해당 측정값은 firefly luciferase 수치를 renilla luciferase 수치로 보정해 주었다.293T cells were cultured in DMEM medium supplemented with 10% FBS for 24 hours in a 24-well plate, and then transfected with 500 μl of 5% charcoal stripped FBS containing phenol red free medium per well. 0.1 ug of ERa, 0.1 ug of ERE and 10 ng of pRL-Tk per well were transfected using Lipofectamine reagents (Thermo Fisher Scientific). After 4 hours of transfection, the P. thomsonii extract and P. lobata extract were added to each well at 10 ppm (DMSO 0.5 μl), and 17β-estradiol (E2) was added to 1 ppb (DMSO 0.5 μl) as a positive control, ctrl) was treated with the same amount of DMSO (0.5 μl). The luminescence was measured 24 hours after the sample treatment using the Dual-Luciferase® Reporter Assay System (Promega), and the results of the experiment were shown in FIG. 1 with the negative control value as the reference (1.0). The measurements corrected firefly luciferase levels to renilla luciferase levels.
도 1에 나타낸 바와 같이, P. thomsonii 추출물은 P. lobata 추출물에 비해 에스트로겐수용체 활성이 뛰어난 것을 확인하였다.As shown in Fig. 1, the P. thomsonii extract was found to be superior to the P. lobata extract in estrogen receptor activity.
실시예4Example 4 . 용매(. menstruum( 에탄올:물Ethanol: water ) ) 비율 별By rate P. P. thomsoniithomsonii 추출물의 활성 The activity of the extract
Pueraria thomsonii 를 건조하여 하기 표 2와 같은 용매(에탄올: 물)로 70에서 4시간 추출한 후 감압 농축하여 추출물을 제조하였고, 에스트로겐수용체에 대한 활성을 확인하기 위하여 ERE(estrogen response element) reporter assay를 수행하였다. 실험방법은 실시예 3과 동일하게 수행하였으며, 상기 추출물은 각각 10ppm으로 첨가하였다. 음성 대조군의 측정값을 기준(1.0)으로 하여 실험결과를 표 2에 나타내었다. Pueraria thomsonii was dried and extracted with a solvent (ethanol: water) as shown in Table 2 for 4 hours at 70 ° C. and concentrated under reduced pressure to prepare an extract. An estrogen response element (ERE) reporter assay was performed to confirm estrogen receptor activity . The experiment was carried out in the same manner as in Example 3, and each of the extracts was added at 10 ppm. The results of the test are shown in Table 2 with the reference value (1.0) as the negative control value.
표 2에 나타낸 바와 같이, 35% ~ 95%에탄올 용매에서 에스트로겐수용체 활성이 우수했으며, 60~90% 에탄올 용매에서 가장 뛰어난 활성을 보였다.As shown in Table 2, the estrogen receptor activity was excellent in 35% to 95% ethanol solvent, and showed the highest activity in 60 to 90% ethanol solvent.
비율Ethanol: water
ratio
실시예Example 5. 5. P. P. thomsoniithomsonii 추출물의 갱년기 증상 완화 효과 Effect of extracts on menopausal symptoms
갱년기 증상을 겪고 있는 40대 후반에서 50대의 여성 60명을 무작위로 나누어 제조예1~3에 따라 제작한 정제를 하루 3정씩 섭취하도록 하였다. 2주, 4주간 복용하도록 한 다음 갱년기 증상의 개선 정도를 평가하였다.60 women in their 50s in their late 40s who were suffering from menopausal symptoms were randomly divided into three tablets prepared according to Preparation Examples 1 to 3. 2 weeks, and 4 weeks, respectively.
섭취 2주, 4주 후의 갱년기 증상의 개선 정도는 쿠퍼만 지수(Kupperman index)로 측정하였으며, 섭취 전의 수치를 100으로 보았을 때, 섭취 후의 감소율(%)을 하기 표3에 나타내었다. The degree of improvement of the menopausal symptoms after 2 weeks and 4 weeks after ingestion was measured by the Kupperman index and the reduction rate (%) after ingestion is shown in Table 3 when the pre-intake value is 100.
본 발명에서 사용된 쿠퍼만 지수(KI)는 학계에서 사용되는 갱년기 지수로서 갱년기 여성에게서 나타나는 11가지 증상(안면홍조, 발한, 불면증, 신경질, 우울증, 어지럼증, 피로감, 관절통 및 근육통, 두통, 가슴 두근거림, 질 건조)을 점수화한 것으로 각 항목의 점수에 가중치를 곱해 점수를 내고 이를 모두 더한 점수가 갱년기 점수이다.The Kupferman index (KI) used in the present invention is a menopausal index used in academia, which is a menopausal index used in academia and includes 11 symptoms (facial flushing, sweating, insomnia, nervousness, depression, dizziness, fatigue, arthralgia and myalgia, And vaginal dryness), and each item's score is multiplied by a weight to give a score, and the sum of all these scores is a menopausal score.
감소율(%)Cooperman Index
Decrease (%)
상기 표3에 나타낸 바와 같이, P. thomsonii 추출물을 혼합한 제조예2의 조성물은 위약군인 제조예1과 P. lobata 추출물을 혼합한 제조예3의 조성물보다 갱년기 증상 완화 효과가 월등히 우수한 것을 확인하였다.As shown in Table 3, it was confirmed that the composition of Preparation Example 2 in which P. thomsonii extract was mixed had an excellent effect of alleviating menopausal symptoms than the composition of Preparation Example 1 in placebo group and Preparation Example 3 in which P. lomataii extract was mixed .
특히 갱년기 증상 중 '안면홍조' 감소율을 확인한 결과, 하기 표 4에서 확인할 수 있듯이 제조예 2에서 가장 감소율이 뛰어났다는 것을 알 수 있었다. Especially, as a result of confirming the reduction rate of 'facial flushing' in the menopausal symptom, it was found that the rate of reduction was the highest in Manufacturing Example 2 as shown in Table 4 below.
하기 표 4의 결과로부터 본 발명의 P. thomsonii 추출물은 우수한 안면홍조 증상 감소 및 치료 효과가 있다는 것을 알 수 있다.From the results shown in the following Table 4, it can be seen that the P. thomsonii extract of the present invention has excellent facial flushing symptom reduction and therapeutic effect.
실시예Example 6. 혈관운동 증상 개선 효과 6. Improvement of vascular exercise symptoms
혈관 운동 증상은 폐경 여성의 75%가 경험한다고 알려져 있으며, 안면홍조(hot flush)가 대표 증상으로, 얼굴, 목, 머리, 가슴 부위의 피부가 갑작스럽게 붉게 변하면서 불쾌한 열감이 동반되는 것을 말한다. 혈관운동 증상의 변화를 확인하기 위해 피부온도 변화를 지표로 평가할 수 있으며, 동물실험에서는 rat 꼬리의 피부표면온도를 측정할 수 있다. (건강기능식품 기능성 평가 가이드, ‘갱년기 여성건강에 도움을 줄 수 있음’편, 식품의약품안전평가원)It is known that 75% of menopausal women experience vasomotor symptoms. Hot flush is the most common symptom. The skin on the face, neck, head, and chest is suddenly reddish and accompanied by uncomfortable warmth. To determine changes in vasomotor symptoms, skin temperature changes can be assessed as an indicator. In animal experiments, the skin surface temperature of the rat tail can be measured. (Guideline for Functional Evaluation of Health Functional Foods, 'Can Help Menopausal Women's Health', Food and Drug Safety Assessment Service)
11~12주령 암컷 Sprague-Dawley rats을 이용하여 1군 10마리는 가장수술(sham operation), 2~5군 40마리(군당 n=10)는 난소절제술 (ovariectomy, OVX)를 실시하였다. 표 5과 같이 군을 나누어서 수술 일주일 후부터 각 rat에 몸무게 g당 0.01ml씩 매일, 4주간 약물을 경구 투여하였다. 양성대조군으로 17β-estradiol(E2)을 투여해 주었고, 시험군은 P. thomsonii 추출물 또는 P. lobata 추출물을 투여하였다. 투여 4주 후 적외선 체온측정기를 사용하여 꼬리의 시작부터 2 cm 지점에서 온도를 측정하였고, 측정결과를 도 2에 나타내었다.Ovariectomy (OVX) was performed on 10 to 12 week old female Sprague-Dawley rats, and the sham operation was performed in 10 rats in the first group and 40 rats (n = 10 per group) in 2 to 5 rats. As shown in Table 5, the rats were divided into groups, and 0.01 mg / g of body weight was orally administered to each rat every day for 4 weeks. 17β-estradiol (E2) was administered as a positive control, and P. thomsonii extract or P. lobata extract was administered to the test group. After 4 weeks of administration, the temperature was measured at 2 cm from the beginning of the tail using an infrared thermometer, and the measurement result is shown in FIG.
도 2에 나타낸 바와 같이, P. thomsonii 추출물을 투여한 군에서 에스트로겐 결핍에 의한 꼬리온도상승 작용이 억제되는 것을 확인 하였다.As shown in Fig. 2, it was confirmed that the increase in the temperature of the tail due to the estrogen deficiency was suppressed in the group administered P. thomsonii extract.
실시예Example 7. 7. 골흡수Bone resorption 개선 효과 Improvement effect
골흡수 관련 지표인 CTX (C-terminal telopeptide of type I collagen) 측정을 위해 실시예6과 동일한 rats에서 시료를 8주간 경구투여 후 혈청을 수집하였다. 혈청에서의 CTX 농도는 Rat C-telopeptide of type I collagen ELISA Kit(MyBioSource)를 사용하여 제조사에서 제공된 방법에 따라 측정하였고, 그 결과를 도 3에 나타내었다.For the measurement of CTX (C-terminal telopeptide of type I collagen), which is an index related to bone resorption, samples were orally administered in the same rats as in Example 6 for 8 weeks and then serum was collected. The concentration of CTX in the serum was measured using the Rat C-telopeptide of type I collagen ELISA kit (MyBioSource) according to the method provided by the manufacturer, and the results are shown in FIG.
도 3에 나타낸 바와 같이, P. thomsonii 추출물을 투여한 군의 경우 OVX군 대비 CTX농도가 유의적으로 낮아진 확인하였고, 뼈의 흡수가 줄어들었음을 유추할 수 있다.As shown in FIG. 3, in the group administered P. thomsonii extract, the CTX concentration was significantly lowered compared to the OVX group, and it can be deduced that the absorption of bone was reduced.
P. thomsonii 추출물의 에스트로겐 수용체 활성이 P. lobata 추출물의 에스트로겐 수용체 활성보다 훨씬 뛰어남을 확인하였다 (실시예3). It was found that the estrogen receptor activity of P. thomsonii extract was much better than the estrogen receptor activity of P. lobata extract (Example 3).
여성 갱년기 증상 완화 효과 또한 P. thomsonii 추출물이 우수한 것을 확인하였다 (실시예5, 실시예6, 실시예7).The effect of alleviating female menopausal symptoms was also confirmed to be excellent for P. thomsonii extract (Example 5, Example 6, Example 7).
따라서, 에스트로겐수용체 활성이 우수한 Pueraria thomsonii 추출물은 여성 갱년기 증상, 특히 안면홍조, 골다공증을 예방, 치료 또는 개선에 효과적으로 사용될 수 있다.Therefore, Pueraria with excellent estrogen receptor activity thomsonii extracts can be effectively used to prevent, treat or ameliorate female menopausal symptoms, especially facial flushing, osteoporosis.
<< PuerariaPueraria thomsoniithomsonii 부위별 비교 분석> Comparative analysis by site>
실시예Example 8. 8. PuerariaPueraria thomsoniithomsonii 부위별 추출물의 제조 Preparation of extracts by site
Pueraria thomsonii의 꽃봉오리, 뿌리, 잎을 각각 채집하여 건조 후 분쇄하여 사용하였고, 85%에탄올을 용매로 하여 70℃에서 4시간 추출한 후 감압 농축하여 각각의 추출물을 제조하였다. Pueraria thomsonii buds, roots and leaves were collected, dried and pulverized. Extracts were prepared by concentrating the extracts at 70 ° C for 4 hours using 85% ethanol as a solvent.
실시예Example 9. 정제의 제조 9. Preparation of tablets
P. thomsonii 부위별 추출물과 잔량의 부형제(덱스트린)를 이용하여 하기 표 6의 비율과 같이 300mg 정제를 제조하였다. Using the extract of P. thomsonii and the remaining excipient (dextrin), 300 mg tablets were prepared as shown in Table 6 below.
실시예Example 10. 10. P. P. thomsoniithomsonii 부위별 By region 추출물의 갱년기 증상 완화 효과 Effect of extracts on menopausal symptoms
갱년기 증상을 겪고 있는 40대 후반에서 50대의 여성 60명을 무작위로 나누어 제조예1~4에 따라 제작한 정제를 하루 3정씩 섭취하도록 하였다. 2주, 4주간 복용하도록 한 다음 갱년기 증상의 개선 정도를 평가하였다.60 women in their 50s in their late 40s suffering from menopausal symptoms were randomly divided into 3 tablets per day according to the preparation examples 1 to 4. 2 weeks, and 4 weeks, respectively.
섭취 2주, 4주 후의 갱년기 증상의 개선 정도는 쿠퍼만 지수(Kupperman index)로 측정하였으며, 섭취 전의 수치를 100으로 보았을 때, 섭취 후의 감소율(%)을 하기 표 7에 나타내었다. The degree of improvement of the menopausal symptoms after 2 weeks and 4 weeks after ingestion was measured by the Kupperman index and the reduction rate (%) after ingestion is shown in Table 7, when the value before ingestion is 100.
본 발명에서 사용된 쿠퍼만 지수(KI)는 학계에서 사용되는 갱년기 지수로서 갱년기 여성에게서 나타나는 11가지 증상(안면홍조, 발한, 불면증, 신경질, 우울증, 어지럼증, 피로감, 관절통 및 근육통, 두통, 가슴 두근거림, 질 건조)을 점수화한 것으로 각 항목의 점수에 가중치를 곱해 점수를 내고 이를 모두 더한 점수가 갱년기 점수이다.The Kupferman index (KI) used in the present invention is a menopausal index used in academia, which is a menopausal index used in academia and includes 11 symptoms (facial flushing, sweating, insomnia, nervousness, depression, dizziness, fatigue, arthralgia and myalgia, And vaginal dryness), and each item's score is multiplied by a weight to give a score, and the sum of all these scores is a menopausal score.
감소율(%)Cooperman Index
Decrease (%)
상기 표 7에 나타낸 바와 같이, 꽃봉오리 추출물을 혼합한 제조예 5의 조성물은 위약군인 제조예4와 뿌리 또는 잎 추출물을 혼합한 제조예 6, 제조예 7보다 갱년기 증상 완화 효과가 월등히 우수한 것을 확인하였다.As shown in Table 7, the composition of Preparation Example 5 in which a flower bud extract was mixed showed that the effect of alleviating menopausal symptoms was much better than that of Preparation Example 4, which was a placebo group, and that of Preparation Example 6 and Preparation Example 7, Respectively.
특히 갱년기 증상 중 '안면홍조' 감소율을 확인한 결과, 하기 표 8에서 확인할 수 있듯이 제조예 5에서 가장 감소율이 뛰어났다는 것을 알 수 있었다. As a result of confirming the decrease rate of 'facial flushing' in the menopausal symptom, it was found that the rate of reduction was the highest in Manufacturing Example 5 as shown in Table 8 below.
하기 표 8의 결과로부터 본 발명의 P. thomsonii 꽃봉오리 추출물은 우수한 안면홍조 증상 감소 및 치료 효과가 있다는 것을 알 수 있다.From the results shown in Table 8, it can be seen that the P. thomsonii bud extract of the present invention has excellent facial flushing symptom reduction and therapeutic effect.
실시예Example 11. 혈관운동 증상 개선 효과 11. Improvement of vasomotor symptoms
혈관 운동 증상은 폐경 여성의 75%가 경험한다고 알려져 있으며, 안면홍조(hot flush)가 대표 증상으로, 얼굴, 목, 머리, 가슴 부위의 피부가 갑작스럽게 붉게 변하면서 불쾌한 열감이 동반되는 것을 말한다. 혈관운동 증상의 변화를 확인하기 위해 피부온도 변화를 지표로 평가할 수 있으며, 동물실험에서는 rat 꼬리의 피부표면온도를 측정할 수 있다. (건강기능식품 기능성 평가 가이드, ‘갱년기 여성건강에 도움을 줄 수 있음’편, 식품의약품안전평가원)It is known that 75% of menopausal women experience vasomotor symptoms. Hot flush is the most common symptom. The skin on the face, neck, head, and chest is suddenly reddish and accompanied by uncomfortable warmth. To determine changes in vasomotor symptoms, skin temperature changes can be assessed as an indicator. In animal experiments, the skin surface temperature of the rat tail can be measured. (Guideline for Functional Evaluation of Health Functional Foods, 'Can Help Menopausal Women's Health', Food and Drug Safety Assessment Service)
11~12주령 암컷 Sprague-Dawley rats을 이용하여 1군 10마리는 가장수술(sham operation), 2~6군 50마리(군당 n=10)는 난소절제술 (ovariectomy, OVX)를 실시하였다. 표 5과 같이 군을 나누어서 수술 일주일 후부터 각 rat에 몸무게 g당 0.01ml씩 매일, 4주간 약물을 경구 투여하였다. 양성대조군으로 17β-estradiol(E2)을 투여해 주었고, 시험군은 P. thomsonii 부위별 추출물을 투여하였다. 투여 4주 후 적외선 체온측정기를 사용하여 꼬리의 시작부터 2 cm 지점에서 온도를 측정하였고, 측정결과를 도 4에 나타내었다.Ovariectomy (OVX) was performed in 10 to 12-week-old female Sprague-Dawley rats, with 10 sham operation in
도 4에 나타낸 바와 같이, P. thomsonii 꽃봉오리 추출물을 투여한 군에서 에스트로겐 결핍에 의한 꼬리온도상승 작용이 억제되는 것을 확인 하였다.As shown in FIG. 4, it was confirmed that the increase in the temperature of the tail due to the estrogen deficiency was suppressed in the group to which P. thomsonii bud extract was administered.
실시예Example 12. 12. 골흡수Bone resorption 개선 효과 Improvement effect
골흡수 관련 지표인 CTX (C-terminal telopeptide of type I collagen) 측정을 위해 실시예8과 동일한 rats에서 시료를 8주간 경구투여 후 혈청을 수집하였다. 혈청에서의 CTX 농도는 Rat C-telopeptide of type I collagen ELISA Kit(MyBioSource)를 사용하여 제조사에서 제공된 방법에 따라 측정하였고, 그 결과를 도 5에 나타내었다.For the measurement of CTX (C-terminal telopeptide of type I collagen), which is an index related to bone resorption, the samples were orally administered in the same rats as in Example 8 for 8 weeks, and then the serum was collected. The concentration of CTX in the serum was measured using a Rat C-telopeptide of type I collagen ELISA kit (MyBioSource) according to the method provided by the manufacturer, and the results are shown in FIG.
도 5에 나타낸 바와 같이, P. thomsonii 꽃봉오리 추출물을 투여한 군의 경우 OVX군 대비 CTX농도가 유의적으로 낮아진 확인하였고, 뼈의 흡수가 줄어들었음을 유추할 수 있다.As shown in FIG. 5, in the group administered P. thomsonii bud extract, it was confirmed that the CTX concentration of the OVX group was significantly lower than that of the OVX group, suggesting that the absorption of bone was reduced.
Claims (17)
상기 푸에라리아 톰소니(Pueraria thomsonii) 추출물은 푸에라리아 톰소니(Pueraria thomsonii)의 꽃 또는 꽃봉오리 추출물인 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
The Pueraria thomsonii ) extract is a flower or bud extract of Pueraria thomsonii .
상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리 에탄올 추출물을 유효성분으로 포함하는 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
The composition may be in the form of Pueraria ( Pueraria) thomsonii ) flower or a flower bud ethanol extract as an active ingredient.
상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리 60~90% 에탄올 추출물을 유효성분으로 포함하는 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method of claim 3,
The composition may be in the form of Pueraria ( Pueraria) thomsonii ) flower or a bud of 60 to 90% ethanol as an active ingredient.
상기 여성 갱년기 증상은 안면홍조인 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
Wherein the female menopausal symptom is facial flushing.
상기 여성 갱년기 증상은 골다공증인 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
Wherein the female menopausal symptoms are osteoporosis.
상기 여성 갱년기 증상은 발한인 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
Wherein the female menopausal symptoms are sweating.
상기 조성물은 화장료 조성물, 약학 조성물 또는 식품 조성물인 것을 특징으로 하는 여성 갱년기 증상 예방 또는 개선용 조성물.The method according to claim 1,
Wherein the composition is a cosmetic composition, a pharmaceutical composition or a food composition.
상기 푸에라리아 톰소니(Pueraria thomsonii) 추출물은 푸에라리아 톰소니(Pueraria thomsonii)의 꽃 또는 꽃봉오리 추출물인 것을 특징으로 하는 안면홍조 치료, 예방 또는 개선용 조성물.10. The method of claim 9,
The Pueraria thomsonii ) extract is a flower or bud extract of Pueraria thomsonii .
상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리를 60~90% 에탄올로 추출한 것을 특징으로 하는 안면홍조 치료, 예방 또는 개선용 조성물.10. The method of claim 9,
The composition may be in the form of Pueraria ( Pueraria) thomsonii ) flower or a bud is extracted with 60 to 90% ethanol.
상기 푸에라리아 톰소니(Pueraria thomsonii) 추출물은 푸에라리아 톰소니(Pueraria thomsonii)의 꽃 또는 꽃봉오리 추출물인 것을 특징으로 하는 골다공증 치료, 예방 또는 개선용 조성물.13. The method of claim 12,
The Pueraria thomsonii ) extract is a flower or bud extract of Pueraria thomsonii .
상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리를 60~90% 에탄올로 추출한 것을 특징으로 하는 골다공증 치료, 예방 또는 개선용 조성물.13. The method of claim 12,
The composition may be in the form of Pueraria ( Pueraria) thomsonii ) flower or bud is extracted with 60 to 90% ethanol.
상기 푸에라리아 톰소니(Pueraria thomsonii) 추출물은 푸에라리아 톰소니(Pueraria thomsonii)의 꽃 또는 꽃봉오리 추출물인 것을 특징으로 하는 발한 치료, 예방 또는 개선용 조성물.16. The method of claim 15,
The Pueraria thomsonii ) extract is a flower or bud extract of Pueraria thomsonii .
상기 조성물은 푸에라리아 톰소니(Pueraria thomsonii) 꽃 또는 꽃봉오리를 60~90% 에탄올로 추출한 것을 특징으로 하는 발한 치료, 예방 또는 개선용 조성물.16. The method of claim 15,
The composition may be in the form of Pueraria ( Pueraria) thomsonii ) flower or bud is extracted with 60 to 90% ethanol.
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KR1020170029014A Division KR101964841B1 (en) | 2017-03-07 | 2017-03-07 | Composition for relieving menopausal symptom |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102217801B1 (en) | 2019-08-16 | 2021-02-18 | 이지원 | Composition for improving bone health and female menopausal symptoms, including Cirsium japonicum var. maackii (Maxim.) Matsum extract and Thymus vulgaris extract |
-
2019
- 2019-03-22 KR KR1020190033127A patent/KR20190034180A/en not_active Application Discontinuation
Non-Patent Citations (3)
Title |
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1. J Korean Soc Menopause, 2012, 18: 94-99 |
2. Women health Noursing, Hyunmoonsa, 1997 |
3. J East Asian Soc Dietary Life, 2006, 16(5), 533~541 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102217801B1 (en) | 2019-08-16 | 2021-02-18 | 이지원 | Composition for improving bone health and female menopausal symptoms, including Cirsium japonicum var. maackii (Maxim.) Matsum extract and Thymus vulgaris extract |
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