KR102511361B1 - Composition for Preventing, Improving or Treating Postmenopausal Syndrome Comprising Rosa rugosa Thunberg Extract - Google Patents
Composition for Preventing, Improving or Treating Postmenopausal Syndrome Comprising Rosa rugosa Thunberg Extract Download PDFInfo
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Abstract
본 발명은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방, 개선 또는 치료용 조성물에 관한 것으로, 난소적출 동물모델에서 에스트로겐 수치 개선효과 및 호르몬 감소에 의한 체지방증가 억제 효과가 있어 에스트로겐 수치 감소 및 호르몬 감소에 의한 체지방증가에 있어 유용하게 활용될 수 있다.The present invention relates to a composition for the prevention, improvement, or treatment of female menopausal syndrome containing an extract of Glycosa as an active ingredient, which has an effect of improving estrogen levels in an ovariectomized animal model and suppressing increase in body fat by reducing hormones, thereby reducing estrogen levels and reducing hormones. It can be usefully used in increasing body fat by reducing.
Description
본 발명은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방, 개선 또는 치료용 조성물에 관한 것이다.The present invention relates to a composition for preventing, improving or treating female menopausal syndrome, comprising an extract of Glycosa as an active ingredient.
여성의 경우 난소의 기능저하로 인해 에스트로겐 수준이 감소하게 되면, 체내 에스트로겐 수치 감소와 함께 다양한 증상이 나타난다. 대표적인 증상으로 안면 홍조, 질 건조증이 있고, 수면 장애, 우울, 불안 등의 심리적 증상, 심혈관질환 및 골다공증 등의 만성질환 위험이 증가된다. 에스트로겐 수치가 감소하는 시기의 여성 50% 이상에서는 비뇨생식기 위축으로 인한 질 건조증, 가려움증 등의 증상을 경험하는 것으로 알려져 있으며, 에스트로겐 분비가 중단되는 시기의 여성 75%에서는 혈관운동 증상 중 특히 안면홍조를 대부분의 여성이 1 내지 2년 내외로 경험하며, 10년 이상 증상이 지속되기도 한다. 또한, 점차 월경주기가 불규칙해지거나 출혈 양에도 변화가 오기 시작하며, 여러 가지 부정적인 신체적 변화를 경험하게 되고 에스트로겐의 분비가 중단되는 시기 이후부터는 골소실로 인한 골다공증 현상이 두드러지게 나타난다. In women, when estrogen levels decrease due to ovarian dysfunction, various symptoms appear along with a decrease in estrogen levels in the body. Representative symptoms include facial flushing and vaginal dryness, sleep disorders, psychological symptoms such as depression and anxiety, and increased risk of chronic diseases such as cardiovascular disease and osteoporosis. It is known that more than 50% of women during the period when estrogen levels decrease experience symptoms such as vaginal dryness and itching due to urogenital atrophy, and 75% of women during the period when estrogen secretion ceases experience hot flushes among vasomotor symptoms. Most women experience it for 1 to 2 years, and symptoms may last for 10 years or more. In addition, the menstrual cycle gradually becomes irregular or the amount of bleeding begins to change, various negative physical changes are experienced, and after the time when estrogen secretion is stopped, osteoporosis due to bone loss becomes prominent.
이러한 에스트로겐의 분비가 중단 이후 문제를 감소시키기 위하여 합성 에스트로겐을 포함한 호르몬 대체요법이 사용되고 있으나, 장기간의 추적연구에서 유방암, 정맥혈전색전증 뿐만 아니라 관상동맥질환, 뇌졸중 등의 질환이 오히려 증가되는 것으로 보고되고 있다. 또한, 대표적으로 사용되는 칼슘제제의 경우 필요 이상의 칼슘의 섭취 시, 칼슘 배설의 증가로 인하여 요로결석이 발생할 수 있으므로 요로결석의 병력이 있는 경우 주의를 요한다. 또한, 골 흡수 억제제로 사용하고 있는 대표적인 약물로 에스트로겐의 경우 관상동맥과 뇌졸중 등의 위험과 심혈관계에 대한 위험이 제기되고 있으며, 칼시토닌(calcitonin)의 경우 주사 혹은 비강분무를 하여야 한다는 점과 장기간 사용 시 내성이 생길 수 있으므로 몇 개월씩 휴식기간이 필요하다는 문제가 있다. 대표적인 치료제인 비스포스포네이트(bisphosphonate)의 경우 위장관 증상으로 오심, 구토, 소화불량 등이 발생할 수 있고 아미노－비스포스포네이트의 경우 식도염을 유발할 수 있어서 큰 컵으로 한 컵 이상의 맹물과 함께 복용하고 적어도 30분에서 1시간 이상 눕지 않도록 하는 것을 권장하는 등 복용에 주의를 요한다. 최근 개발되어 치료제로 널리 쓰이고 있는 스트론튬(strontium)의 경우 가장 흔한 부작용으로는 설사(6.1%)와 또한 일부 환자에서 정상 상한치의 2배가 넘는 크레아틴 키나아제(creatinine kinase) 수치가 관찰되고 있다. 따라서 여성의 삶의 질을 저하시키는 중요한 요인이 되는 에스트로겐의 감소 또는 중단으로 인한 증상을 완화시키고 만성질환의 발생을 예방할 수 있도록 하는 관리 방안의 제시가 요구되고 있으며, 이러한 합성호르몬 치료에 의한 부작용을 줄일 수 있는 천연물 유래의 에스트로겐의 감소 또는 중단으로 인한 장애 개선용 소재에 대한 개발 필요성이 증대되고 있다.Hormone replacement therapy including synthetic estrogen is used to reduce the problem after the secretion of estrogen is stopped, but in long-term follow-up studies, diseases such as breast cancer and venous thromboembolism as well as coronary artery disease and stroke have been reported to increase. there is. In addition, in the case of calcium preparations that are typically used, when calcium is consumed more than necessary, urinary stones may occur due to increased calcium excretion, so caution is required if there is a history of urinary stones. In addition, as a representative drug used as a bone resorption inhibitor, estrogen raises the risk of coronary artery and stroke, as well as the cardiovascular system. There is a problem that a break period of several months is necessary because time tolerance may develop. In the case of bisphosphonate, a representative treatment, gastrointestinal symptoms such as nausea, vomiting, and indigestion may occur, and amino-bisphosphonate may cause esophagitis. It is recommended not to lie down for too long, so caution is required when taking it. In the case of strontium, which has recently been developed and is widely used as a treatment, the most common side effect is diarrhea (6.1%), and in some patients, creatinine kinase levels that are more than twice the upper limit of normal are observed. Therefore, it is required to suggest a management plan that can alleviate the symptoms caused by the reduction or cessation of estrogen, which is an important factor in reducing the quality of life of women, and prevent the occurrence of chronic diseases. There is an increasing need to develop materials for improving disorders due to the reduction or cessation of estrogen derived from natural products that can be reduced.
체지방은 주로 피하조직에 저장되어 있는 피하지방과 복강 안쪽의 내장 사이에 저장되어 있는 내장지방으로 구분할 수 있다. 흔히 말하는 복부지방은 이러한 내장지방과 피하지방을 총칭하는 것이다. 체지방이 필요 이상으로 축적되면 비만이 되고 이로 인해 심혈관계 질환, 인슐린 비의존성 당뇨, 고혈압, 중풍 및 암 등의 만성질환의 대표적인 위험인자의 하나로 입증되고 있다. 체지방 축적에 의한 비만은 단순성 비만과 증후성 비만으로 분류되는데 건강상의 장해를 유발하는 원인이 되는 단순성 비만은 과식, 운동부족, 기초대사 저하 등을 들 수 있다. 또한 증후성 비만은 임의의 기초질환이 원인이 되어 발생하는 것으로 약제에 기인한 비만, 내분비성 비만, 시상하부성 비만, 유전성 비만에 기인한 비만 등을 들 수 있다. Body fat can be divided into subcutaneous fat stored mainly in the subcutaneous tissue and visceral fat stored between the intestines inside the abdominal cavity. Abdominal fat, commonly referred to as abdominal fat, is a general term for these visceral and subcutaneous fat. When body fat is accumulated more than necessary, obesity becomes, and this has been proven as one of the representative risk factors for chronic diseases such as cardiovascular disease, non-insulin dependent diabetes, hypertension, stroke, and cancer. Obesity caused by body fat accumulation is classified into simple obesity and symptomatic obesity. Simple obesity, which causes health problems, includes overeating, lack of exercise, and low basal metabolism. In addition, symptomatic obesity is caused by any underlying disease, and includes drug-induced obesity, endocrine obesity, hypothalamic obesity, and obesity caused by hereditary obesity.
한편, 해당화(Rosa rugosa Thunberg)는 장미과에 속하는 낙엽관목으로, roaamultin, quercetin, citric acid, malic acid, lycopene, tormentic acid, euacaphic acid, biaaborossol A 등의 다양한 성분을 함유하고, 꽃과 열매는 관상용 및 향수의 원료나 약용으로 쓰인다.Meanwhile, Rosa rugosa Thunberg is a deciduous shrub belonging to the Rosaceae family, and contains various components such as roaamilin, quercetin, citric acid, malic acid, lycopene, tormentic acid, euacaphic acid, and biaaborossol A, and its flowers and fruits are used for ornamental and It is used as a raw material for perfume or for medicinal purposes.
이에, 본 발명자들은 에스트로겐의 수치 감소 또는 중단으로 인한 질환의 예방 및 치료 효과가 있는 천연물을 발굴하기 위한 연구를 수행하여 본 발명을 완성하였다. Accordingly, the inventors of the present invention completed the present invention by conducting research to discover natural products that are effective in preventing and treating diseases caused by a decrease or cessation of estrogen levels.
본 발명의 하나의 목적은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 치료용 약학적 조성물을 제공하는 것이다.One object of the present invention is to provide a pharmaceutical composition for the prevention or treatment of female menopausal syndrome comprising an extract of Glycosa as an active ingredient.
본 발명의 다른 목적은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 개선용 식품 조성물을 제공하는 것이다.Another object of the present invention is to provide a food composition for preventing or improving female menopausal syndrome, comprising an extract of glycosylation as an active ingredient.
본 발명의 또 다른 목적은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 개선용 의약외품 조성물을 제공하는 것이다.Another object of the present invention is to provide a quasi-drug composition for preventing or improving female menopausal syndrome, comprising an extract of Glycosa as an active ingredient.
본 발명의 일 양상은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 치료용 약학적 조성물을 제공한다.One aspect of the present invention provides a pharmaceutical composition for preventing or treating female menopausal syndrome, comprising an extract of Glycosa as an active ingredient.
본 발명에서 용어, "해당화(Rosa rugosa Thunberg)"는 장미과 낙엽관목으로, 해당화 추출물, 특히, 해당화 꽃 추출물이 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가의 치료 용도에 대해서는 알려진 바가 없다.In the present invention, the term " Rosa rugosa Thunberg" is a deciduous shrub in the family Rosaceae, and nothing is known about the use of an extract of a deciduous flower, in particular, an extract of a flower of a saccharaceae, in the treatment of fat increase caused by estrogen level reduction and hormonal change.
본 발명에서 해당화는 상업적으로 판매되는 것을 구입하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있다. In the present invention, glycosylation can be purchased commercially, or collected or cultivated in nature.
본 발명의 일 구체예에 따르면, 상기 추출물은 물, 탄소수 1 내지 4의 알코올 및 이들의 혼합 용매로 이루어진 군에서 선택된 어느 하나 이상의 용매로 추출되는 것일 수 있다.According to one embodiment of the present invention, the extract may be extracted with one or more solvents selected from the group consisting of water, alcohols having 1 to 4 carbon atoms, and mixed solvents thereof.
본 발명의 일 구체예에 따르면, 상기 해당화는 해당화 꽃일 수 있다.According to one embodiment of the present invention, the glycosylation may be a glycosylation flower.
해당화 추출물은 건조 중량의 약 2 내지 20배, 구체적으로는, 약 3 내지 5배에 달하는 부피의 물, 메탄올, 에탄올 또는 부탄올 등과 같은 탄소수 1(C1) 내지 4(C4)의 저급 알코올의 극성 용매 또는 이들의 약 1:0.1 내지 1:10의 혼합비를 갖는 혼합용매를 용출 용매로써 사용하고, 추출 온도는 20 내지 100℃, 구체적으로 실온에서, 추출 기간은 약 4-12시간 내지 4-7일 동안 열수 추출, 냉침 추출, 환류 냉각 추출 또는 초음파 추출 등의 추출방법을 사용하여 추출할 수 있으나, 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가의 치료 활성이 있는 물질을 추출하는 방법이라면 제한없이 이용될 수 있다. 구체적으로는, 1회 내지 5회 연속 추출하여 감압여과하고 그 여과추출물을 진공회전농축기로 20 내지 100℃, 더 구체적으로는 실온에서 감압 농축하여 물, 저급 알코올 또는 이들의 혼합용매에 가용한 해당화 추출물을 수득한 결과물이 될 수 있으나, 본 발명의 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가의 치료 효과를 나타낼 수 있는 한, 이에 한정되지 않고, 추출액, 추출액의 희석액 또는 농축액, 추출액을 건조하여 얻어지는 건조물, 또는 이들의 조정제물 또는 정제물을 모두 포함할 수 있다. 해당화 추출물은 천연, 잡종, 변종식물로부터 추출될 수 있으며, 단독으로 또는 타 약학적 활성 추출물, 분획물 또는 화합물과의 결합뿐만 아니라 적당한 집합으로 사용될 수 있다.Glycosa extract is about 2 to 20 times the dry weight, specifically, about 3 to 5 times the volume of water, methanol, ethanol or butanol, such as carbon atoms 1 (C 1 ) to 4 (C 4 ) lower alcohol A polar solvent or a mixed solvent having a mixing ratio of about 1:0.1 to 1:10 is used as an elution solvent, the extraction temperature is 20 to 100 ° C, specifically at room temperature, and the extraction period is about 4-12 hours to 4- It can be extracted using an extraction method such as hot water extraction, cold needle extraction, reflux cooling extraction, or ultrasonic extraction for 7 days, but there is no limitation as long as it is a method of extracting a substance that is active in treating fat increase due to estrogen level reduction and hormonal change. can be used Specifically, it is extracted continuously 1 to 5 times and filtered under reduced pressure, and the filtered extract is concentrated under reduced pressure at 20 to 100 ° C., more specifically at room temperature, using a vacuum rotary concentrator, so that it is soluble in water, lower alcohol or a mixed solvent thereof. It may be the result of obtaining the extract, but is not limited thereto, as long as it can exhibit the therapeutic effect of fat increase due to estrogen level reduction and hormonal change of the present invention, extract, dilution or concentrate of the extract, obtained by drying the extract Dried products, or any of these refined or purified products may be included. Glycosa extracts can be extracted from natural, hybrid, and mutant plants, and can be used alone or in combination with other pharmacologically active extracts, fractions, or compounds, as well as in a suitable set.
본 발명에서 용어, "예방 및 개선"은 상기 조성물의 투여에 의해 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가를 억제하거나 발병을 지연시키는 모든 행위를 의미하며, "치료"는 상기 조성물의 투여에 의해 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가에 의한 증세가 호전되거나 이롭게 변경되는 모든 행위를 의미한다. In the present invention, the term "prevention and improvement" refers to all actions that suppress or delay the onset of fat increase due to estrogen level reduction and hormonal change by administration of the composition, and "treatment" by administration of the composition It refers to all activities that improve or beneficially change symptoms due to the decrease in estrogen levels and the increase in fat caused by hormonal changes.
상기 폐경기 증후군은 에스트로겐의 감소 또는 결핍으로 인한 증상을 일으키는 증후군을 의미한다. 폐경기 증후군의 주요 증상으로는 급성 여성호르몬 결핍 증상, 비뇨생식기계의 위축에 따른 증상, 정신적 불안정, 피부 관절계 변화, 및 골다공증일 수 있으며, 구체적으로는 급성 여성호르몬 결핍 증상으로서 안면 홍조, 발한, 가슴 두근거림, 현기증, 이명, 고혈압, 비만, 고지혈증, 소화기 장애, 두통; 정신적 불안정으로서 기억력 장애, 우울증, 피로감, 불안감, 신경과민, 수면 장애, 성욕 감퇴; 비뇨생식기계의 위축에 따른 증상으로서, 질 감염, 질 위축, 질 건조증, 성교통, 질염, 방광염, 배뇨통, 급뇨; 피부관절계 변화로서 피부 위축, 피부 건조, 근육통, 관절통; 및 골다공증일 수 있다. 상기 약학적 조성물은 폐경기 증후군의 증상을 예방, 완화, 또는 치료하는 것일 수 있다. The menopausal syndrome refers to a syndrome that causes symptoms due to a decrease or deficiency of estrogen. The main symptoms of menopausal syndrome include acute female hormone deficiency symptoms, symptoms due to atrophy of the urogenital system, mental instability, skin joint system changes, and osteoporosis. Specifically, acute female hormone deficiency symptoms include hot flashes, sweating, and chest. palpitations, dizziness, tinnitus, hypertension, obesity, hyperlipidemia, digestive disorders, headache; Mental instability, memory impairment, depression, fatigue, anxiety, nervousness, sleep disturbance, decreased libido; Symptoms accompanying atrophy of the genitourinary system include vaginal infection, vaginal atrophy, vaginal dryness, dyspareunia, vaginitis, cystitis, dysuria, and urgency; Skin atrophy, skin dryness, myalgia, arthralgia as changes in the cutaneous articular system; and osteoporosis. The pharmaceutical composition may prevent, alleviate, or treat symptoms of menopausal syndrome.
본 발명의 해당화 추출물을 유효성분으로 포함하는 약학적 조성물은 약학적 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다. 구체적으로, 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. 이때, 상기 조성물에 포함되는 해당화 추출물의 함량은 특별히 이에 제한되지 않으나, 조성물 총 중량에 대하여 0.0001 내지 10 중량%로 포함될 수 있으며, 보다 구체적으로는, 0.001 내지 1 중량% 포함될 수 있다. The pharmaceutical composition containing the glycosylation extract of the present invention as an active ingredient may further include suitable carriers, excipients and diluents commonly used in the preparation of pharmaceutical compositions. Specifically, it may be formulated and used in the form of oral formulations such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, external preparations, suppositories and sterile injection solutions. At this time, the content of the glycosylation extract included in the composition is not particularly limited thereto, but may be included in 0.0001 to 10% by weight, more specifically, 0.001 to 1% by weight based on the total weight of the composition.
상기 약학적 조성물은 담체, 부형제 및 희석제로는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 포함할 수 있다. 상기 조성물을 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제될 수 있다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함될 수 있으며, 이러한 고형제제는 해당화 추출물을 포함하여 한가지 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제될 수 있다. 또한 단순한 부형제 이외에 마그네슘 스티레이트, 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당될 수 있는데, 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조 제제, 좌제가 포함될 수 있다. 비수성용제, 현탁제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다.The pharmaceutical composition includes lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. When formulating the composition, it may be prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants. Solid preparations for oral administration may include tablets, pills, powders, granules, capsules, and the like, and these solid preparations may contain one or more excipients, such as starch, calcium carbonate, sucrose, etc. It may be prepared by mixing sucrose or lactose, gelatin, and the like. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid preparations for oral use may include suspensions, solutions for internal use, emulsions, and syrups. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, aromatics, and preservatives are used. can be included Formulations for parenteral administration may include sterilized aqueous solutions, non-aqueous solvents, suspensions, emulsions, freeze-dried formulations, and suppositories. Propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate may be used as non-aqueous solvents and suspending agents. As a base for the suppository, witepsol, macrogol, tween 61, cacao butter, laurin paper, glycerogeratin and the like may be used.
본 발명의 상기 조성물은 약학적으로 유효한 양으로 투여될 수 있다. The composition of the present invention can be administered in a pharmaceutically effective amount.
본 발명에서 용어, "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효 용량 수준은 개체 종류 및 중증도, 연령, 성별, 질환의 종류, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출 비율, 치료기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있다. 그리고 단일 또는 다중 투여될 수 있다. 상기 요소를 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 당업자에 의해 용이하게 결정될 수 있다. 본 발명의 조성물의 바람직한 투여량은 환자의 상태 및 체중, 질병의 정도, 약물 형태, 투여경로 및 기간에 따라 다르지만, 바람직한 효과를 위해서, 본 발명의 해당화 추출물은 1일 0.0001 내지 100 mg/kg으로, 바람직하게는 0.001 내지 100 mg/kg으로 투여될 수 있고, 보다 구체적으로는, 0.001 내지 500 mg/kg이 투여될 수 있다. 투여는 하루에 한번 투여할 수도 있고, 수회 나누어 투여할 수도 있다. 상기 조성물은 쥐, 가축, 인간 등의 다양한 포유동물에 다양한 경로로 투여할 수 있으며, 투여의 방식은 당업계의 통상적인 방법이라면 제한없이 포함하며, 예를 들어, 경구, 직장 또는 정맥, 근육, 피하, 자궁내 경막 또는 뇌혈관 내 주사에 의해 투여될 수 있다. 본 발명의 약학적 조성물의 적합한 투여량은 제제화 방법, 투여 방식, 환자의 연령, 체중, 성, 병적 상태, 음식, 투여 시간, 투여 경로, 배설 속도 및 반응 감응성과 같은 요인들에 의해 다양하게 결정될 수 있다.As used herein, the term "pharmaceutically effective amount" means an amount sufficient to treat a disease with a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is dependent on the type and severity of the subject, age, sex, and disease. It may be determined according to factors including type, activity of drug, sensitivity to drug, administration time, route of administration and excretion rate, duration of treatment, drugs used concurrently, and other factors well known in the medical field. The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. And it can be single or multiple administrations. It is important to administer the amount that can obtain the maximum effect with the minimum amount without side effects in consideration of all the above factors, and can be easily determined by those skilled in the art. The preferred dosage of the composition of the present invention varies depending on the condition and body weight of the patient, the severity of the disease, the type of drug, the route of administration and the period of administration. , preferably 0.001 to 100 mg/kg, and more specifically, 0.001 to 500 mg/kg. Administration may be administered once a day, or may be administered in several divided doses. The composition can be administered to various mammals such as rats, livestock, and humans by various routes, and the method of administration includes without limitation as long as it is a conventional method in the art, for example, oral, rectal or intravenous, intramuscular, It may be administered by subcutaneous, intrauterine, or intracerebrovascular injection. A suitable dosage of the pharmaceutical composition of the present invention will be variously determined by factors such as formulation method, administration method, patient's age, weight, sex, medical condition, food, administration time, administration route, excretion rate and reaction sensitivity. can
본 발명의 약학적 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 약학적으로 허용되는 담체 및/또는 부형제를 이용하여 제제화 함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기 내에 내입시켜 제조될 수 있다. 이때 제형은 오일 또는 수성 매질중의 용액, 현탁액 또는 유화액 형태이거나 엑스제, 분말제, 과립제, 정제 또는 캅셀제 형태일 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.The pharmaceutical composition of the present invention is prepared in unit dosage form by formulation using a pharmaceutically acceptable carrier and/or excipient according to a method that can be easily performed by those skilled in the art. or it may be prepared by incorporating into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension or emulsion in an oil or aqueous medium, or may be in the form of an extract, powder, granule, tablet or capsule, and may additionally contain a dispersing agent or stabilizer.
본 발명의 일 구체예에 따르면, 상기 폐경기 증후군은 에스트로겐 분비 감소에 의해 유발되는 것일 수 있다.According to one embodiment of the present invention, the menopausal syndrome may be caused by a decrease in estrogen secretion.
본 발명의 일 구체예에 따르면, 상기 폐경기 증후군은 동맥경화성 심혈관병, 빈맥, 안면홍조, 가슴 두근거림, 발한, 골다공증, 우울증, 요실금, 배뇨곤란, 오줌 소태, 재발성 비뇨기계 염증, 비만 및 탈모증으로 이루어진 군에서 선택되는 것일 수 있다.According to one embodiment of the present invention, the menopausal syndrome is atherosclerotic cardiovascular disease, tachycardia, hot flashes, palpitations, sweating, osteoporosis, depression, urinary incontinence, dysuria, urinary retention, recurrent urinary tract inflammation, obesity and alopecia It may be selected from the group consisting of.
본 발명의 다른 양상은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 개선용 식품 조성물을 제공한다.Another aspect of the present invention provides a food composition for preventing or improving female menopausal syndrome, comprising a glycosylation extract as an active ingredient.
구체적으로, 본 발명에 따른 식품 조성물은 상기 약학적 조성물과 동일한 방식으로 제제화되어 건강기능식품으로 이용되거나, 각종 식품에 첨가될 수 있다. Specifically, the food composition according to the present invention is formulated in the same way as the pharmaceutical composition and used as a health functional food, or may be added to various foods.
해당화 추출물을 유효성분 포함하는 식품 조성물이 식품 첨가물로 사용될 경우, 해당화 추출물이 그대로 첨가되거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상의 방법에 따라 적절하게 사용할 수 있다. 유효 성분의 혼합량은 사용 목적(예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있으며, 식품학적으로 허용가능한 식품 보조 첨가제를 추가로 포함할 수 있다. 본 발명의 조성물은 천연물로부터 유래한 추출물을 유효성분으로 포함하므로 안정성 면에서 문제가 없기 때문에 혼합량에 큰 제한은 없다. 또한, 본 발명의 식품 조성물은 통상적인 의미의 식품을 모두 포함할 수 있으며, 기능성 식품, 건강기능식품 등 당업계에 알려진 용어와 혼용 가능하다.When a food composition containing an active ingredient of a glycosylation extract is used as a food additive, the glycosylation extract may be added as it is or used together with other foods or food ingredients, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be appropriately determined according to the purpose of use (prevention, health, or therapeutic treatment), and may further include food additives acceptable in food science. Since the composition of the present invention contains an extract derived from a natural product as an active ingredient, there is no problem in terms of stability, so there is no great limitation on the mixing amount. In addition, the food composition of the present invention may include all food in a conventional sense, and may be used interchangeably with terms known in the art, such as functional food and health functional food.
본 발명의 용어, "기능성 식품"은 건강기능식품에 관한 법률 제6727호에 따른 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조 및 가공한 식품을 의미하며, "기능성"이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건 용도에 유용한 효과를 얻을 목적으로 섭취하는 것을 의미한다. 또한, "건강기능식품"은 건강보조의 목적으로 특정성분을 원료로 하거나 식품 원료에 들어있는 특정성분을 추출, 농축, 정제, 혼합 등의 방법으로 제조, 가공한 식품을 말하며, 상기 성분에 의해 생체방어, 생체리듬의 조절, 질병의 방지와 회복 등 생체조절기능을 생체에 대하여 충분히 발휘할 수 있도록 설계되고 가공된 식품을 말하는 것으로서, 상기 건강식품용 조성물은 질병의 예방 및 질병의 회복 등과 관련된 기능을 수행할 수 있다.The term of the present invention, "functional food" refers to food manufactured and processed using raw materials or ingredients having useful functionalities for the human body according to the Act on Health Functional Foods No. 6727, and "functional" means It refers to intake for the purpose of obtaining useful effects for health purposes, such as regulating nutrients with respect to structure and function or physiological action. In addition, "health functional food" refers to a food manufactured and processed by using a specific ingredient as a raw material or by extracting, concentrating, refining, mixing, etc. a specific ingredient contained in a food raw material for the purpose of health supplementation. It refers to food designed and processed to sufficiently exert biological control functions such as biological defense, regulation of biological rhythm, prevention and recovery of disease, etc., and the health food composition has functions related to disease prevention and recovery from disease. can be performed.
본 발명의 조성물이 사용될 수 있는 식품에는 통상적으로 제조 및 판매되고 있는 식품이 모두 포함될 수 있다. 또한, 본 발명의 해당화 추출물을 유효성분으로 포함하는 식품 조성물은 당업자의 선택에 따라 식품에 함유될 수 있는 적절한 기타 보조 성분과 공지의 첨가제를 혼합하여 제조될 수 있다. 첨가될 수 있는 식품은 예를 들어, 육류, 소세지, 빵, 쵸코렛, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림 류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알콜 음료 및 비타민 복합제 등을 포함하며, 본 발명에 따른 추출물을 주성분으로 하여 제조된 즙, 차, 젤리 및 주스 등을 첨가하여 제조될 수 있다.Foods to which the composition of the present invention can be used may include all conventionally manufactured and sold foods. In addition, the food composition containing the glycosylation extract of the present invention as an active ingredient may be prepared by mixing appropriate auxiliary ingredients and known additives that may be contained in food according to the selection of those skilled in the art. Foods that can be added include, for example, meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, chewing gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcohol It includes beverages and vitamin complexes, and can be prepared by adding juice, tea, jelly, juice, etc. prepared using the extract according to the present invention as a main component.
또한, 본 발명에 적용될 수 있는 식품에는 예를 들어, 특수영양식품(예: 조제유류, 영,유아식 등), 식육가공품, 어육제품, 두부류, 묵류, 면류(예: 라면류, 국수류 등), 건강보조식품, 조미식품(예: 간장, 된장, 고추장, 혼합장 등), 소스류, 과자류(예:스낵류), 유가공품(예: 발효유, 치즈 등), 기타 가공식품, 김치, 절임식품(각종 김치류, 장아찌 등), 음료(예: 과실, 채소류 음료, 두유류, 발효음료류 등), 천연조미료(예, 라면스프 등) 등의 식품이 포함될 수 있다.In addition, foods that can be applied to the present invention include, for example, special nutritional foods (eg, formula milk, infant, baby food, etc.), processed meat products, fish meat products, tofu, jelly, noodles (eg, ramen, noodles, etc.), health Supplemental foods, seasonings (e.g. soy sauce, soybean paste, gochujang, mixed paste, etc.), sauces, confectionery (e.g. snacks), dairy products (e.g. fermented milk, cheese, etc.), other processed foods, kimchi, pickled foods (various types of kimchi, Pickles, etc.), beverages (eg, fruit, vegetable drinks, soy milk, fermented beverages, etc.), and natural seasonings (eg, ramen soup, etc.) may be included.
본 발명의 건강기능식품 조성물이 음료의 형태로 사용될 경우, 통상의 음료와 같이 여러 가지 감미제, 향미제 또는 천연 탄수화물 등이 추가 성분으로 함유될 수 있다. 그 밖에 본 발명의 건강기능식품은 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등이 함유될 수 있으며, 천연 과일쥬스, 과일쥬스 음료 및 야채 음료의 제조를 위한 과육이 함유될 수 있다.When the health functional food composition of the present invention is used in the form of a beverage, various sweeteners, flavoring agents, or natural carbohydrates may be contained as additional components, as in conventional beverages. In addition, the health functional food of the present invention includes various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, It may contain alcohol, a carbonating agent used in carbonated beverages, and the like, and may contain fruit flesh for the production of natural fruit juice, fruit juice beverages, and vegetable beverages.
본 발명의 또 다른 양상은 해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방 또는 개선용 의약외품 조성물을 제공한다.Another aspect of the present invention provides a quasi-drug composition for preventing or improving female menopausal syndrome, comprising an extract of Glycosa as an active ingredient.
본 발명에서 용어, "의약외품"은 사람이나 동물의 질병을 치료, 경감, 처치 또는 예방할 목적으로 사용되는 섬유, 고무제품 또는 이와 유사한 것, 인체에 대한 작용이 약하거나 인체에 직접 작용하지 아니며, 기구 또는 기계가 아닌 것과 이와 유사한 것, 감염 예방을 위하여 살균, 살충 및 이와 유사한 용도로 사용되는 제제 중 하나에 해당하는 물품으로서, 사람이나 동물의 질병을 진단, 치료, 경감, 처치 또는 예방할 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것 및 사람이나 동물의 구조와 기능에 약리학적 영향을 줄 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것을 제외한 물품을 의미하며, 피부 외용제 및 개인위생용품도 포함한다.In the present invention, the term "quasi-drugs" refers to textiles, rubber products or similar products used for the purpose of treating, mitigating, treating or preventing human or animal diseases, weakly acting on the human body or not directly acting on the human body, and devices or non-machines and similar items, products falling under one of the categories of agents used for sterilization, insecticidal, and similar purposes to prevent infection, which are used for the purpose of diagnosing, treating, mitigating, treating, or preventing human or animal diseases It refers to items that are not instruments, machines, or devices, and items other than instruments, machines, or devices that are used for the purpose of pharmacologically affecting the structure and function of humans or animals. Also includes supplies.
본 발명의 해당화 추출물을 유효성분으로 포함하는, 에스트로겐 수치 감소와 호르몬 변화에 의한 지방 증가의 예방 또는 개선을 목적으로 의약외품 조성물에 첨가할 경우, 상기 추출물을 그대로 첨가하거나 다른 분획물이나 다른 의약외품 성분과 함께 사용할 수 있고, 통상적인 방법에 따라 적절하게 사용할 수 있다. 유효 성분의 혼합량은 사용 목적에 따라 적합하게 결정할 수 있다.When added to a quasi-drug composition for the purpose of preventing or improving fat increase due to estrogen level reduction and hormonal change, containing the glycosylation extract of the present invention as an active ingredient, the extract is added as it is or together with other fractions or other quasi-drug ingredients It can be used, and it can be used suitably according to a conventional method. The mixing amount of the active ingredient can be suitably determined depending on the purpose of use.
피부 외용제는 특별히 이에 제한되지 않으나, 바람직하게는 연고제, 로션제, 스프레이제, 패취제, 크림제, 산제, 현탁제, 겔제 또는 젤의 형태로 제조되어 사용될 수 있다. 개인위생용품에는 특별히 이에 제한되지 않으나, 바람직하게는 비누, 화장품, 물티슈, 휴지, 샴푸, 피부 크림, 얼굴 크림, 치약, 립스틱, 향수, 메이크업, 파운데이션, 볼터치, 마스카라, 아이섀도우, 선스크린 로션, 모발 손질 제품, 에어프레쉬너 겔 또는 세정 겔이 포함될 수 있다. 또한, 본 발명의 의약외품 조성물은 소독청결제, 샤워폼, 가그린, 물티슈, 세제비누, 핸드워시, 가습기 충진제, 마스크, 연고제 또는 필터충진제와 같은 제품에 적용될 수 있다. External skin preparations are not particularly limited thereto, but are preferably prepared and used in the form of ointments, lotions, sprays, patches, creams, powders, suspensions, gels or gels. Personal hygiene products are not particularly limited thereto, but are preferably soap, cosmetics, wet wipes, tissue paper, shampoo, skin cream, face cream, toothpaste, lipstick, perfume, makeup, foundation, cheek touch, mascara, eye shadow, sunscreen lotion , hair care products, air freshener gels or cleansing gels. In addition, the quasi-drug composition of the present invention can be applied to products such as disinfectant cleaner, shower foam, gargreen, wet tissue, detergent soap, hand wash, humidifier filler, mask, ointment or filter filler.
또 다른 양상은 개체에 해당화 추출물을 유효량만큼 투여하는 단계를 포함하는 여성 폐경기 증후군을 예방, 경감, 또는 치료하는 방법을 제공한다. Another aspect provides a method for preventing, alleviating, or treating female menopausal syndrome comprising administering an effective amount of a glycosylation extract to a subject.
상기 개체는 폐경기로 인한 증상 또는 질환을 얻었거나 얻을 가능성이 있는 환자일 수 있다. The subject may be a patient who has or is likely to have a symptom or disease due to menopause.
상기 해당화 추출물, 투여, 및 폐경기 증후군에 대한 자세한 내용은 상술한 내용을 참고할 수 있다. For details on the glycolytic extract, administration, and menopausal syndrome, refer to the above description.
해당화 추출물을 유효성분으로 포함하는 여성 폐경기 증후군 예방, 개선 또는 치료용 조성물에 따르면, 난소적출 동물모델에서 에스트로겐 수치 개선효과 및 호르몬 감소에 의한 체지방증가 억제 효과가 있어 에스트로겐 수치 감소 및 호르몬 감소에 의한 체지방증가에 있어 유용하게 활용될 수 있다. 특히, 해당화 추출물은 다른 부위의 추출물과 달리 독성이 없고, 오랫동안 식품으로 사용되어온 천연물에서 유래되어 부작용을 나타내지 않으므로, 여성 폐경기 증후군 예방, 개선 또는 치료에 유용하게 활용될 수 있다.According to the composition for the prevention, improvement, or treatment of female menopausal syndrome, which contains an extract of Glycosa as an active ingredient, it has the effect of improving estrogen levels and inhibiting the increase in body fat by reducing hormones in an ovariectomized animal model, thereby reducing body fat by reducing estrogen levels and hormones. It can be useful for increasing. In particular, unlike extracts from other parts of the body, glycocalyx extract is non-toxic and does not show side effects because it is derived from natural products that have been used as food for a long time, so it can be usefully used for preventing, improving, or treating female menopausal syndrome.
도 1은 세포에서 해당화 꽃 물 추출물, 해당화 열매 에탄올 또는 물 추출물의 에스토로겐 생성능을 측정한 그래프이다.
도 2는 난소적출 마우스모델에서 해당화 꽃 에탄올 추출물 또는 해당화 꽃 물 추출물이 총 체지방량을 개선시킨 활성에 관한 그래프이다.
도 3는 난소적출 마우스모델에서 해당화 꽃 에탄올 추출물 또는 해당화 꽃 물 추출물이 체중대비 체지방비율을 감소시킨 활성에 관한 그래프이다.
도 4은 난소적출 마우스모델에서 해당화 꽃 에탄올 추출물 또는 해당화 꽃 물 추출물이 에스트로겐 수치를 개선시킨 활성에 관한 그래프이다. 1 is a graph measuring the estrogen-generating ability of a water extract of Glycosa flower and an ethanol or water extract of Glycosa fruit in cells.
2 is a graph showing the activity of improving the total body fat mass of an ethanol extract of Glycosa flower or a water extract of Glycosa flower in an ovariectomized mouse model.
Figure 3 is a graph showing the activity of reducing the body fat ratio to body weight of the ethanol extract of Glycosa flower or the water extract of Glycosa flower in an ovariectomized mouse model.
FIG. 4 is a graph showing the activity of improving estrogen levels by an ethanol extract of Glycosa flower or a water extract of Glycosa flower in an ovariectomized mouse model.
이하 본 발명을 하나 이상의 실시예를 통하여 보다 상세하게 설명한다. 그러나, 이들 실시예는 본 발명을 예시적으로 설명하기 위한 것으로 본 발명의 범위가 이들 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through one or more embodiments. However, these examples are intended to illustrate the present invention by way of example, and the scope of the present invention is not limited to these examples.
실시예 1. 해당화 꽃 또는 열매 추출물 제조Example 1. Preparation of Flower or Fruit Extract of Glycosa
해당화의 꽃을 물로 깨끗이 세척하여 그늘에서 건조한 후, 와링 브랜드로 분말화하였다. 분말화된 해당화 꽃 500g을 에탄올 5ℓ에 넣고 추출기를 통해 5 내지 10시간 동안 70℃로 추출하고, 여지(와트만사, 미국)로 감압 여과하였다. 그 후, 실온에서 진공회전농축기를 사용하여 여과 추출물로부터 에탄올 용매를 제거한 후, 추출된 잔사로써 해당화 꽃 에탄올 추출물을 수득하였다. 또한, 분말화된 해당화 꽃 500g을 증류수 5ℓ에 넣고 100℃에서 5 내지 10시간 동안 추출하고, 여지(와트만사, 미국)로 감압 여과하였다. 그 후, 실온에서 진공회전농축기를 사용하여 여과 추출물로부터 물을 제거한 후, 추출된 잔사로써 해당화 꽃의 물 추출물을 수득하였다. The flowers of the flower were washed thoroughly with water, dried in the shade, and powdered with Waring brand. 500 g of powdered sugar flower was put in 5 L of ethanol, extracted at 70 ° C for 5 to 10 hours through an extractor, and filtered under reduced pressure with filter paper (Whatman, USA). Thereafter, the ethanol solvent was removed from the filtered extract using a vacuum rotary concentrator at room temperature, and an ethanol extract of the flower of Glycosa was obtained as the extracted residue. In addition, 500 g of powdered sugarflower flowers were put in 5 liters of distilled water, extracted at 100 ° C. for 5 to 10 hours, and filtered under reduced pressure with filter paper (Whatman Co., USA). Thereafter, water was removed from the filtered extract using a vacuum rotary concentrator at room temperature, and then a water extract of the flower of the flower was obtained as the extracted residue.
해당화 열매는 물로 깨끗이 세척하여 그늘에서 건조한 후, 와링 브랜드로 분말화하였다. 분말화된 해당화 열매 10g을 에탄올 100㎖에 넣고 추출기를 통해 5 내지 10시간 동안 70℃로 추출한 후, 여지(와트만사, 미국)로 감압 여과하였다. 그 후, 실온에서 진공회전농축기를 사용하여 여과 추출물로부터 에탄올 용매를 제거한 후, 추출된 잔사로써 해당화 열매의 에탄올 추출물을 수득하였다. 또한, 분말화된 해당화 열매 10g을 증류수 100㎖에 넣고 100℃에서 5 내지 10시간 동안 추출한 후, 여지(와트만사, 미국)로 감압 여과하였다. 그 후, 실온에서 진공회전농축기를 사용하여 여과 추출물로부터 물을 제거한 후, 추출된 잔사로서 해당화 열매의 물 추출물을 수득하였다. The fruit of the honeysuckle was washed thoroughly with water, dried in the shade, and then powdered into a Waring brand. 10 g of powdered sugarcane fruit was put in 100 ml of ethanol, extracted at 70° C. for 5 to 10 hours through an extractor, and filtered under reduced pressure with filter paper (Whatman, USA). Thereafter, the ethanol solvent was removed from the filtered extract using a vacuum rotary concentrator at room temperature, and then an ethanol extract of the fruit of Glycosa was obtained as the extracted residue. In addition, 10 g of the powdered sugarcane fruit was put in 100 ml of distilled water, extracted at 100 ° C. for 5 to 10 hours, and filtered under reduced pressure with filter paper (Whatman, USA). Thereafter, water was removed from the filtered extract using a vacuum rotary condenser at room temperature, and then a water extract of the fruit of the sugarcane was obtained as an extracted residue.
실시예 2. 해당화 꽃 또는 열매 추출물의 에스트로겐 생성 증가 효과 확인Example 2. Confirmation of the estrogen production increasing effect of the flower or fruit extract of Glycosa
해당화 꽃 또는 열매로부터 얻은 추출물의 에스트로겐 활성 평가를 위해 T47D-KBluc 세포주를 이용하였다. 안정화 시킨 세포는 seeding 전 assay media로 교체 후 24시간 인큐베이터에서 배양하고 96 웰 플레이트에 3×104 cells/well로 seeding하여 밤새 배양하였다. 이후, 실시예 1에서 준비한 해당화 꽃 또는 열매 추출물을 10, 30, 또는 60㎍/㎖ 처리하고, 다시 24시간 인큐베이터에서 배양하였다. 그 다음, 상등액을 제거하고, 1X lysis buffer 60㎕/well로 30분 lysis 시킨 후, 96 웰 플레이트에 cell lysate 25㎕ 처리하고, luminescent microplate reader로 검출하였다. 검출 조건은 substrat 25㎕, duration 1초 및 counting time은 2초로 설정하였다.The T47D-KBluc cell line was used to evaluate the estrogenic activity of the extracts obtained from the flower or fruit of Glycaceae. The stabilized cells were cultured in an incubator for 24 hours after replacement with assay media before seeding, seeded in a 96-well plate at 3×10 4 cells/well, and cultured overnight. Thereafter, the flower or fruit extract prepared in Example 1 was treated with 10, 30, or 60 μg/ml, and then cultured in an incubator for 24 hours. Then, the supernatant was removed, lysed with 60 μl/well of 1X lysis buffer for 30 minutes, and 25 μl of cell lysate was treated in a 96-well plate and detected with a luminescent microplate reader. Detection conditions were set to 25 μl of substrat, 1 second duration, and 2 seconds counting time.
그 결과, 해당화 꽃 물 추출물이 해당화 열매 에탄올 및 물 추출물보다 우수한 에스트로겐 생성능을 나타내는 것으로 확인되었다(도 1). 이에, 난소적출 동물모델을 이용하여, 해당화 꽃 추출물에 대한 에스트로겐 감소 개선 효과 및 호르몬 변화에 따른 지방 증가 억제 효과를 확인하였다.As a result, it was confirmed that the water extract of the flower of Glycosa was superior to the ethanol and water extracts of the Hacaceae fruit to produce estrogen (FIG. 1). Therefore, using an ovariectomized animal model, the estrogen-reduction improvement effect and the fat increase-inhibiting effect due to hormonal changes of the flower extract of Glycosa were confirmed.
실시예 3. 난소적출 마우스모델에서, 해당화 꽃의 에탄올 또는 물 추출물의 체지방 증가 억제 효과 및 estradiol 증가 효과 확인Example 3. In an ovariectomized mouse model, the effect of ethanol or water extracts of Glycopsis flowers on the inhibition of body fat increase and the effect of increasing estradiol was confirmed
3-1. 해당화 꽃의 에탄올 또는 물 추출물의 체지방 증가 억제 효과 확인3-1. Confirmation of the inhibitory effect of body fat increase of ethanol or water extracts
해당화 꽃 에탄올 및 물 추출물의 체지방 증가 억제 효과를 평가하기 위해서 C57BL/6 마우스를 이용한 난소 적출 모델을 사용하였다. 난소 적출 모델은 난소에서 분비되는 호르몬이 없기 때문에 체지방의 증가를 유도할 수 있다. 6주령의 C57BL/6 마우스에서 난소를 적출한 후, 1주 동안 회복기를 가지고, 그 후, 6주 동안 호르몬 감소 상태를 유도하였다. 호르몬 감소가 유도된 마우스에 6주 동안 해당화 꽃 에탄올 추출물 또는 물 추출물을 매일 300㎎/㎏의 용량으로 구강투여하였다. 그 후, 난소 적출 후 13주 후 마우스에 Avertin[2, 2, 2-tribromoethanol]을 복강 투여하여 마취하고, DEXA(Dual-energy X-ray absorptiometry)를 이용하여 총 체지방량과 체중 대비 체지방 비율(%, 체지방량/개체무게×100)을 측정하였다. An ovariectomy model using C57BL/6 mice was used to evaluate the inhibitory effect of the ethanol and water extracts from Glycosa flower on body fat increase. The ovariectomy model can induce an increase in body fat because there is no hormone secreted by the ovaries. Ovaries were removed from 6-week-old C57BL/6 mice, followed by a recovery period for 1 week, and then a hormone reduction state was induced for 6 weeks. To the mice whose hormone reduction was induced, ethanol extract or water extract of glycolysis flower was orally administered at a dose of 300 mg/kg every day for 6 weeks. Then, 13 weeks after ovariectomy, Avertin [2, 2, 2-tribromoethanol] was intraperitoneally administered to the mouse to anesthetize it, and DEXA (Dual-energy X-ray absorptiometry) was used to measure the total body fat mass and body fat ratio (%) , body fat mass/body weight × 100) were measured.
그 결과, 난소를 적출한 마우스의 경우 난소를 적출하지 않은 마우스와 비교하여 총 체지방량 및 체지방 비율이 급격히 증가하는 것으로 확인되었다(도 2 및 도 3). 한편, 난소를 적출한 마우스에 해당화 꽃의 에탄올 추출물 또는 물 추출물을 처리한 경우 처리하지 않은 마우스와 비교하여 총 체지방량 및 체지방비율이 급격히 감소하는 것으로 확인되었다(도 2 및 도 3). 특히, 해당화 꽃의 물 추출물 처리군이 에탄올 처리군과 비교하여 총 체지방량 및 체지방비율이 급격히 감소하는 활성이 우수한 것으로 확인되었다.As a result, in the case of the ovariectomized mouse, it was confirmed that the total body fat amount and body fat ratio increased rapidly compared to the non-ovariectomized mouse (FIG. 2 and FIG. 3). On the other hand, when the ovariectomized mice were treated with the ethanol extract or water extract of the flowers of the flower, it was confirmed that the total body fat amount and body fat percentage decreased rapidly compared to the untreated mice (FIG. 2 and FIG. 3). In particular, it was confirmed that the group treated with the water extract of the flower of the flower showed excellent activity in reducing the total body fat mass and body fat percentage rapidly compared to the ethanol treatment group.
3-2. 해당화 꽃의 에탄올 또는 물 추출물의 에스트라디올 증가 효과 확인3-2. Confirmation of estradiol-increasing effects of ethanol or water extracts from Glycodon flowers
실시예 3-1에서 마취한 마우스로부터 심장채혈을 한 혈액을 SST(serum separate tube)에 처리한 후, 5000rpm으로 5분간 원심 분리하여 혈청을 얻었다. 혈청 내의 에스트라디올(estradiol) 함량은 면역측정법을 이용하여 측정하였다. Serum was obtained by processing the blood collected from the heart from the mouse anesthetized in Example 3-1 in a serum separate tube (SST), and then centrifuged at 5000 rpm for 5 minutes. The estradiol content in serum was measured using an immunoassay method.
구체적으로, 에스트라디올 함량 측정은 Goat anti-mouse IgG가 코팅된 96 웰 플레이트에 에스트라디올 일차 항체를 1시간 동안 결합시킨 후, 결합하지 않은 항체를 제거하였다. 그 후, 혈청시료 100㎕ 및 HRP(horseradish peroxidase)와 결합된 에스트라디올 용액 50㎕를 처리한 후, 2시간 동안 에스트라디올 일차 항체에 결합시켰다. 결합하지 않은 혈청 시료 및 HRP와 결합된 에스트라디올 용액을 제거한 후, HRP 기질과 30분 동안 반응시켰다. 그 후, 반응을 정지시키기 위해 2N 황산용액을 100㎕ 처리하고, 450 nm에서 흡광도를 측정하였다.Specifically, to measure the estradiol content, the primary estradiol antibody was bound to a 96-well plate coated with Goat anti-mouse IgG for 1 hour, and then unbound antibodies were removed. Thereafter, 100 μl of the serum sample and 50 μl of an estradiol solution combined with HRP (horseradish peroxidase) were treated, and then bound to the estradiol primary antibody for 2 hours. After removing the unbound serum sample and the HRP-bound estradiol solution, the mixture was reacted with the HRP substrate for 30 minutes. Thereafter, 100 μl of 2N sulfuric acid solution was treated to stop the reaction, and absorbance was measured at 450 nm.
그 결과, 난소를 적출한 마우스의 경우 난소를 적출하지 않은 마우스와 비교하여 혈청 내 에스트라디올의 수치가 감소하는 것을 확인하였다(도 4). 이렇게 난소를 적출한 마우스에 해당화 꽃의 에탄올 추출물 및 물 추출물을 처리한 경우 처리하지 않은 마우스와 비교하여 에스트라디올의 수치가 증가하는 것을 확인하였다(도 4). 특히 해당화 꽃의 물 추출물 처리군이 에탄올 처리군과 비교하여 에스트라디올의 수치를 증가하는 활성이 우수한 것을 확인하였다(도 4).As a result, in the case of ovariectomized mice, it was confirmed that the level of estradiol in serum was decreased compared to the non-ovariectomized mice (FIG. 4). It was confirmed that when the ovariectomized mice were treated with the ethanol extract and the water extract of the flower of Glycaceae, the level of estradiol increased compared to the untreated mice (FIG. 4). In particular, it was confirmed that the group treated with the water extract of the flower of Glycosa was superior in the activity of increasing the level of estradiol compared to the group treated with ethanol (FIG. 4).
이제까지 본 발명에 대하여 그 실시예들을 중심으로 살펴보았다. 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자는 본 발명이 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 변형된 형태로 구현될 수 있음을 이해할 수 있을 것이다. 그러므로 개시된 실시예들은 한정적인 관점이 아니라 설명적인 관점에서 고려되어야 한다. 본 발명의 범위는 전술한 설명이 아니라 청구범위에 나타나 있으며, 그와 동등한 범위 내에 있는 모든 차이점은 본 발명에 포함된 것으로 해석되어야 할 것이다.So far, the present invention has been examined focusing on the embodiments. Those skilled in the art to which the present invention pertains will be able to understand that the present invention can be implemented in a modified form without departing from the essential characteristics of the present invention. Therefore, the disclosed embodiments should be considered from an illustrative rather than a limiting point of view. The scope of the present invention is shown in the claims rather than the foregoing description, and all differences within the equivalent range should be construed as being included in the present invention.
Claims (7)
상기 여성 폐경기 증후군은 에스트로겐 분비 감소로 인한 체지방의 증가인 것인, 약학적 조성물.
A pharmaceutical composition for preventing or treating female menopausal syndrome, comprising a water extract of a flower of Glycosa as an active ingredient and increasing estrogen production,
The female menopausal syndrome is an increase in body fat due to a decrease in estrogen secretion, the pharmaceutical composition.
상기 여성 폐경기 증후군은 에스트로겐 분비 감소로 인한 체지방의 증가인 것인, 식품 조성물.
A food composition for preventing or improving female menopausal syndrome, comprising a water extract of a flower of Glycosa as an active ingredient and increasing estrogen production,
The female menopausal syndrome is an increase in body fat due to a decrease in estrogen secretion, a food composition.
상기 여성 폐경기 증후군은 에스트로겐 분비 감소로 인한 체지방의 증가인 것인, 의약외품 조성물.A quasi-drug composition for preventing or improving female menopausal syndrome, comprising a water extract of the flower of Glycosa as an active ingredient and increasing estrogen production,
The female menopausal syndrome is an increase in body fat due to a decrease in estrogen secretion, quasi-drug composition.
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