KR20210122167A - 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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- KR20210122167A KR20210122167A KR1020210040266A KR20210040266A KR20210122167A KR 20210122167 A KR20210122167 A KR 20210122167A KR 1020210040266 A KR1020210040266 A KR 1020210040266A KR 20210040266 A KR20210040266 A KR 20210040266A KR 20210122167 A KR20210122167 A KR 20210122167A
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Abstract
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 glycolysis 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 hot flashes and vaginal dryness, and psychological symptoms such as sleep disturbance, depression, and anxiety, as well as an 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 genitourinary atrophy. Most women experience it within 1 to 2 years, and symptoms may persist for more than 10 years. 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 period when the secretion of estrogen stops, the osteoporosis phenomenon due to bone loss is 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. have. In addition, in the case of calcium preparations typically used, when more than necessary calcium is ingested, urolithiasis may occur due to an increase in calcium excretion, so caution is required if there is a history of urolithiasis. In addition, as a representative drug used as a bone resorption inhibitor, estrogen raises the risk of coronary artery and stroke and cardiovascular system. In the case of calcitonin, injection or nasal spray is required. There is a problem that a rest period of several months is necessary because vision tolerance can develop. In the case of bisphosphonate, which is a representative treatment, nausea, vomiting, and indigestion may occur as gastrointestinal symptoms, and in the case of amino-bisphosphonate, it may cause esophagitis. It is recommended not to lie down abnormally, and caution is required when taking it. In the case of strontium, which has recently been developed and widely used as a treatment, the most common side effects are diarrhea (6.1%) and, in some patients, creatine kinase levels that are more than twice the upper limit of normal are observed. Therefore, there is a need to present a management plan that can alleviate symptoms caused by the decrease or discontinuation of estrogen, which is an important factor that lowers women's quality of life, and prevent the occurrence of chronic diseases, and the side effects caused by such synthetic hormone treatment are required. The need for development of materials for improving disorders due to the reduction or discontinuation of estrogen derived from natural products that can be reduced is increasing.
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, which is mainly stored in the subcutaneous tissue, and visceral fat, which is stored between the internal organs inside the abdominal cavity. Abdominal fat is commonly referred to as visceral fat and subcutaneous fat. When body fat accumulates more than necessary, obesity leads to obesity, which has been proven as one of the representative risk factors for chronic diseases such as cardiovascular disease, non-insulin-dependent diabetes mellitus, hypertension, stroke, and cancer. Obesity caused by body fat accumulation is classified into simple obesity and symptomatic obesity. Simple obesity, which causes health disorders, 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 due to 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.On the other hand, glycolysis ( Rosa rugosa Thunberg ) is a deciduous shrub belonging to the Rosaceae family, and contains various components such as roaamultin, quercetin, citric acid, malic acid, lycopene, tormentic acid, euacaphic acid, and biaaborossol A, and flowers and fruits are used for ornamental and It is used as a raw material for perfume or medicinal.
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 present inventors have completed the present invention by conducting a study to discover natural products that are effective in preventing and treating diseases caused by reduction or discontinuation 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 preventing or treating female menopausal syndrome comprising an extract of glycolysis 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 glycolysis 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 glycolysis 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 glycolysis 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.As used herein, the term "Glycolyte ( Rosa rugosa Thunberg)" is a deciduous shrub of the Rosaceae family, and there is no known use of the glycosylated extract, particularly, the glycosylated flower extract for reducing estrogen levels and increasing fat due to hormonal changes.
본 발명에서 해당화는 상업적으로 판매되는 것을 구입하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있다. In the present invention, glycosylation may be purchased commercially sold, or harvested or grown 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 any 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 glycolysis may be a flower of glycolysis.
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. The glycosylated extract contains 1 (C 1 ) to 4 (C 4 ) lower alcohols, such as water, methanol, ethanol or butanol, in a volume of about 2 to 20 times, specifically, about 3 to 5 times the dry weight of the lower alcohol. A polar solvent or a mixed solvent having a mixing ratio of about 1:0.1 to 1:10 is used as the elution solvent, and the extraction temperature is 20 to 100° C., specifically at room temperature, and the extraction period is about 4-12 hours to 4- Extraction can be performed using extraction methods such as hot water extraction, cold extraction, reflux cooling extraction, or ultrasonic extraction for 7 days, but there is no limitation as long as it is a method of extracting substances that have therapeutic activity in reducing estrogen levels and increasing fat due to hormonal changes can be used Specifically, it is extracted 1 to 5 times continuously, filtered under reduced pressure, and the filtered extract is concentrated under reduced pressure at 20 to 100° C., more specifically at room temperature, with a vacuum rotary concentrator, so that glycolysis soluble in water, lower alcohol, or a mixed solvent thereof It may be the result obtained by obtaining the extract, but it is not limited thereto, as long as it can exhibit the therapeutic effect of reducing estrogen levels and increasing fat due to hormonal changes of the present invention, and extracts, dilutions or concentrates of extracts, and extracts obtained by drying the extract It may include both a dried product, or a crude product or a purified product thereof. The glycosylated extract may be extracted from natural, hybrid, or variegated plants, and may be used alone or in combination with other pharmaceutically active extracts, fractions or compounds, as well as in appropriate combinations.
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. As used herein, the term "prevention and improvement" refers to any action that suppresses or delays the onset of fat increase due to estrogen level reduction and hormonal change by administration of the composition, and "treatment" refers to any action by administration of the composition. It refers to all behaviors that improve or beneficially change symptoms caused by a decrease in estrogen levels and an increase in fat due to 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 menopause syndrome may be acute female hormone deficiency symptoms, symptoms due to atrophy of the genitourinary system, mental instability, changes in the skin joint system, and osteoporosis. Specifically, hot flashes, sweating, chest palpitations, dizziness, tinnitus, high blood pressure, obesity, hyperlipidemia, digestive disorders, headache; mental instability such as memory impairment, depression, fatigue, anxiety, irritability, sleep disturbance, decreased libido; Symptoms associated with atrophy of the genitourinary system include vaginal infection, vaginal atrophy, vaginal dryness, dyspareunia, vaginitis, cystitis, dysuria, urgency; Skin atrophy, dry skin, myalgia, arthralgia as changes in the cutaneous joint system; and osteoporosis. The pharmaceutical composition may be for preventing, alleviating, or treating symptoms of menopause 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 comprising the glycolysis 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, powders, granules, tablets, capsules, suspensions, emulsions, syrups, and oral dosage forms such as aerosols, external preparations, suppositories, and sterile injection solutions can be formulated and used. At this time, the content of the glycolysis extract included in the composition is not particularly limited thereto, but may be included in an amount of 0.0001 to 10% by weight, and 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, gum acacia, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl as carriers, excipients and diluents. cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. When formulating the composition, it can be prepared using a diluent or excipient such as a filler, extender, binder, wetting agent, disintegrant, surfactant, etc. commonly used. Solid preparations for oral administration may include tablets, pills, powders, granules, capsules, etc., and these solid preparations include one or more excipients including glycolysis extract, for example, starch, calcium carbonate, sucrose (sucrose) or lactose (lactose), it can be prepared by mixing gelatin. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid formulations for oral use may include suspensions, internal solutions, emulsions, syrups, etc. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances, and preservatives are used. may be included. Formulations for parenteral administration may include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized formulations, and suppositories. Non-aqueous solvents and suspending agents include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like can be used.
본 발명의 상기 조성물은 약학적으로 유효한 양으로 투여될 수 있다. The composition of the present invention may 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 at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is dependent on the subject's type and severity, age, sex, and disease. It can be determined according to the type, drug activity, drug sensitivity, administration time, administration route and excretion rate, treatment period, factors including concurrent drugs, 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 may be administered single or multiple. Taking all of the above factors into consideration, it is important to administer an amount that can obtain the maximum effect with a minimum amount without side effects, 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 weight of the patient, the degree of disease, the drug form, the route and period of administration, but for a desirable effect, the glycosylated extract of the present invention is 0.0001 to 100 mg/kg per day. , preferably 0.001 to 100 mg/kg may be administered, and more specifically, 0.001 to 500 mg/kg may be administered. 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 mode of administration includes without limitation as long as it is a conventional method in the art, for example, oral, rectal or intravenous, muscle, It can be administered by subcutaneous, intrauterine dural or intracerebrovascular injection. A suitable dosage of the pharmaceutical composition of the present invention may be variously determined by factors such as formulation method, administration mode, age, weight, sex, pathological condition, food, administration time, administration route, excretion rate, and response sensitivity of the patient. 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 formulating using a pharmaceutically acceptable carrier and/or excipient according to a method that can be easily carried out by a person of ordinary skill in the art to which the present invention pertains. or may be prepared by incorporation into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension, or emulsion in oil or an aqueous medium, or may be in the form of an extract, powder, granule, tablet or capsule, and may additionally include a dispersant 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 menopause 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, chest 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 an extract of glycolysis 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 may be formulated in the same manner as the pharmaceutical composition and used as a health functional food or 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 the food composition containing the glycolysis extract as an active ingredient is used as a food additive, the glycolysis 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 suitably determined according to the purpose of use (prophylactic, health or therapeutic treatment), and may further include a food pharmaceutically acceptable food supplement additive. 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 major limitation on the amount of mixing. In addition, the food composition of the present invention may include all foods 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.As used herein, the term "functional food" means a food manufactured and processed using raw materials or ingredients useful for the human body according to Act No. 6727 of the Health Functional Food Act. It refers to ingestion for the purpose of obtaining useful effects for health purposes such as regulating nutrients with respect to structure and function or physiological effects. In addition, "health functional food" refers to food manufactured and processed by methods such as extraction, concentration, purification, mixing, etc. of specific ingredients as raw materials or in food raw materials 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. 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 in which the composition of the present invention can be used may include all conventionally manufactured and marketed foods. In addition, the food composition comprising the glycolysis extract of the present invention as an active ingredient can be prepared by mixing known additives with other suitable auxiliary ingredients that may be contained in food according to the selection of those skilled in the art. Foods that may be added include, for example, meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcohol It includes beverages, vitamin complexes, etc., and may be prepared by adding juice, tea, jelly and juice 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 food, etc.), processed meat products, fish meat products, tofu, jelly, noodles (eg, ramen, noodles, etc.), health Supplements, seasonings (eg soy sauce, soybean paste, red pepper paste, mixed soy sauce, etc.), sauces, confectionery (eg snacks), dairy products (eg fermented milk, cheese, etc.), other processed foods, kimchi, pickled foods (various kimchi, Pickles, etc.), beverages (eg, fruit, vegetable beverages, 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 ingredients, as in a conventional beverage. In addition, the health functional food of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, coloring agents, pectic acid and its salts, alginic acid and its salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, Alcohol, a carbonation agent used in carbonated beverages, etc. may be contained, and pulp for the production of natural fruit juice, fruit juice beverage, and vegetable beverage may be contained.
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 glycolysis 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.As used herein, the term "quasi-drug" refers to fibers, rubber products or the like, which are used for the purpose of treating, alleviating, treating or preventing diseases of humans or animals, have weak action on the human body or do not directly act on the human body, or non-machines and similar products, which are products that are used for sterilization, insecticide, and similar purposes to prevent infection It refers to items that are not instruments, machines, or devices, and items used for the purpose of pharmacologically affecting the structure and function of humans or animals, other than those that are not instruments, machines, or devices. 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 adding the glycosylated extract of the present invention as an active ingredient to a quasi-drug composition for the purpose of reducing estrogen levels and preventing or improving fat increase due to hormonal changes, 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 appropriately determined according to 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. The external preparation for skin is not particularly limited thereto, but is preferably prepared and used in the form of an ointment, lotion, spray, patch, cream, powder, suspension, gel, or gel. Personal hygiene products are not particularly limited thereto, but are preferably soap, cosmetics, wet tissue, 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, gargrin, 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 of preventing, alleviating, or treating female menopausal syndrome comprising administering to a subject an effective amount of an extract of glycolysis.
상기 개체는 폐경기로 인한 증상 또는 질환을 얻었거나 얻을 가능성이 있는 환자일 수 있다. The subject may be a patient who has acquired or is likely to acquire symptoms or disease due to menopause.
상기 해당화 추출물, 투여, 및 폐경기 증후군에 대한 자세한 내용은 상술한 내용을 참고할 수 있다. For more information on the glycolysis extract, administration, and menopause syndrome, reference may be made 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 preventing, improving, or treating female menopause syndrome comprising the glycolysis extract as an active ingredient, it has the effect of improving estrogen level and suppressing body fat increase due to hormone reduction in an ovariectomized animal model. It can be usefully used to increase. In particular, the glycolysis extract is non-toxic, unlike extracts from other parts, and since it is derived from a natural product that has been used as food for a long time and does not show side effects, it can be usefully used for preventing, improving or treating female menopause 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-producing ability of a glycosylated flower water extract, glycosylated fruit ethanol or water extract in cells.
FIG. 2 is a graph showing the activity of an ethanol extract of glycosylated flowers or a water extract of glycolysis flowers to improve total body fat in an ovariectomized mouse model.
3 is a graph showing the activity of an ethanol extract of glycosylated flower or a water extract of glycolysis flower in reducing the body fat ratio to body weight in an ovariectomized mouse model.
4 is a graph showing the activity of ethanol extract of glycosylated flowers or water extract of glycolysis flowers to improve estrogen levels 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 for illustrative purposes of the present invention, 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 glycosylation
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 corresponding flower were washed thoroughly with water, dried in the shade, and then powdered with the Waring brand. 500 g of powdered hyacinth flowers were put into 5 liters of ethanol, and extracted at 70° C. for 5 to 10 hours through an extractor, and filtered under reduced pressure through a filter paper (Whatman, USA). Then, after removing the ethanol solvent from the filtered extract using a vacuum rotary concentrator at room temperature, an ethanol extract of glycosylated flower was obtained as the extracted residue. In addition, 500 g of powdered glycosylated flowers were placed in 5 liters of distilled water, extracted at 100° C. for 5 to 10 hours, and filtered under reduced pressure through a filter paper (Whatman, 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 glycolysis 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. Glycolyte fruits were washed thoroughly with water, dried in the shade, and then powdered with the Waring brand. 10 g of powdered glycosylated fruit was placed in 100 ml of ethanol, extracted at 70° C. for 5 to 10 hours through an extractor, and filtered under reduced pressure through a 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 glycosylated fruit was obtained as the extracted residue. In addition, 10 g of powdered glycosylated fruit was placed in 100 ml of distilled water and extracted at 100° C. for 5 to 10 hours, followed by filtration under reduced pressure through a filter paper (Whatman, USA). Thereafter, water was removed from the filtered extract using a vacuum rotary concentrator at room temperature, and then a water extract of glycosylated fruit was obtained as the extracted residue.
실시예 2. 해당화 꽃 또는 열매 추출물의 에스트로겐 생성 증가 효과 확인Example 2. Confirmation of the effect of increasing estrogen production of glycosylated flower or fruit extract
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 extracts obtained from glycosylated flowers or fruits. The stabilized cells were replaced with assay media before seeding, cultured in an incubator for 24 hours , seeded at 3×10 4 cells/well in a 96-well plate, and cultured overnight. Thereafter, 10, 30, or 60 μg/ml of the glycosylated flower or fruit extract prepared in Example 1 was treated, and incubated in an incubator for 24 hours again. Then, the supernatant was removed, lysed with 1X lysis buffer 60 μl/well for 30 minutes, and then treated with 25 μl of cell lysate in a 96-well plate, and detected with a luminescent microplate reader. Detection conditions were set to substrat 25 μl, duration 1 second, and counting
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 glycosylated flower water extract exhibited superior estrogen-producing ability than the glycosylated fruit ethanol and water extract (FIG. 1). Therefore, using an ovariectomized animal model, the estrogen reduction improvement effect and the fat increase inhibitory effect according to the hormonal change were confirmed for the glycosylated flower extract.
실시예 3. 난소적출 마우스모델에서, 해당화 꽃의 에탄올 또는 물 추출물의 체지방 증가 억제 효과 및 estradiol 증가 효과 확인Example 3. In the ovariectomized mouse model, the effect of ethanol or water extract of glycosylated flowers to inhibit increase in body fat and increase in estradiol was confirmed
3-1. 해당화 꽃의 에탄올 또는 물 추출물의 체지방 증가 억제 효과 확인3-1. Confirmation of the effect of inhibiting body fat increase of ethanol or water extract of Glycophyte flower
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. In order to evaluate the inhibitory effect of ethanol and water extracts on the increase in body fat of glycosylated flowers, an ovariectomized model using C57BL/6 mice was used. The ovariectomy model can induce an increase in body fat because there is no hormone secreted by the ovaries. After ovaries were removed from 6-week-old C57BL/6 mice, they had a recovery period for 1 week, and then induced a hormone-reduced state for 6 weeks. Glycolysis flower ethanol extract or water extract was orally administered to mice induced to decrease hormones at a dose of 300 mg/kg daily for 6 weeks. Then, 13 weeks after ovariectomy, mice were anesthetized by intraperitoneal administration of Avertin [2, 2, 2-tribromoethanol], and total body fat mass and body fat-to-body fat ratio (%) using DEXA (Dual-energy X-ray absorptiometry) , body fat mass/individual 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, it was confirmed that the total body fat mass and body fat ratio increased rapidly in the case of the mice with the ovaries removed compared to the mice without the ovaries ( FIGS. 2 and 3 ). On the other hand, it was confirmed that when mice from which the ovaries were treated with the ethanol extract or water extract of glycolysis flowers, the total body fat mass and body fat ratio were rapidly decreased compared to the mice that were not treated ( FIGS. 2 and 3 ). In particular, it was confirmed that the group treated with the water extract of Glycophylla flower showed excellent activity in rapidly decreasing the total body fat mass and body fat ratio compared to the ethanol treatment group.
3-2. 해당화 꽃의 에탄올 또는 물 추출물의 에스트라디올 증가 효과 확인3-2. Confirmation of estradiol-increasing effect of ethanol or water extract of Glycophyte flower
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. In Example 3-1, the blood from the anesthetized mouse was treated in a serum separate tube (SST), and then centrifuged at 5000 rpm for 5 minutes to obtain serum. The estradiol content in the 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, for measuring 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 the unbound antibody was removed. Thereafter, 100 μl of a serum sample and 50 μl of a solution of estradiol conjugated with horseradish peroxidase (HRP) were treated, and the resultant was allowed to bind to estradiol primary antibody for 2 hours. After removing the unbound serum sample and the HRP-bound estradiol solution, it 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, it was confirmed that the level of estradiol in the serum was decreased in the case of the mice with the ovaries removed compared to the mice without the ovaries ( FIG. 4 ). In the case where the ovary-extracted mice were treated with the ethanol extract and the water extract of the flowers of glycolysis, it was confirmed that the level of estradiol increased compared to the mice that were not treated ( FIG. 4 ). In particular, it was confirmed that the activity of increasing the level of estradiol was excellent in the water extract treatment group of glycosylated flowers compared with the ethanol treatment group ( 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 looked at focusing on the embodiments thereof. Those of ordinary skill in the art to which the present invention pertains will 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 are to be considered in an illustrative rather than a restrictive sense. The scope of the present invention is indicated by the claims rather than the foregoing description, and all differences within the scope equivalent thereto should be construed as being included in the present invention.
Claims (7)
A pharmaceutical composition for preventing or treating female menopause syndrome comprising an extract of glycolysis as an active ingredient.
According to claim 1, wherein the extract is water, alcohol having 1 to 4 carbon atoms, and a pharmaceutical composition for the prevention or treatment of female menopause syndrome is extracted with any one or more solvents selected from the group consisting of mixed solvents thereof.
According to claim 1, wherein the menopausal syndrome is a pharmaceutical composition for preventing or treating female menopause syndrome that is caused by a decrease in estrogen secretion.
The group of claim 1, wherein the menopausal syndrome is atherosclerotic cardiovascular disease, tachycardia, hot flashes, chest palpitations, sweating, osteoporosis, depression, incontinence, dysuria, urinary incontinence, recurrent urinary tract inflammation, obesity, and alopecia. A pharmaceutical composition for the prevention or treatment of female menopause syndrome that is selected from.
The pharmaceutical composition for the prevention or treatment of female menopausal syndrome according to claim 1, wherein the glycosylated flower is a glycosylated flower.
A food composition for preventing or improving female menopausal syndrome comprising an extract of glycolysis as an active ingredient.
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| WO2021201532A1 (en) | 2021-10-07 |
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