KR20220105361A - Composition for preventing, improving or treating female climacteric symptoms comprising vitexin as an active ingredient - Google Patents
Composition for preventing, improving or treating female climacteric symptoms comprising vitexin as an active ingredient Download PDFInfo
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- KR20220105361A KR20220105361A KR1020210007955A KR20210007955A KR20220105361A KR 20220105361 A KR20220105361 A KR 20220105361A KR 1020210007955 A KR1020210007955 A KR 1020210007955A KR 20210007955 A KR20210007955 A KR 20210007955A KR 20220105361 A KR20220105361 A KR 20220105361A
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- preventing
- menopausal symptoms
- active ingredient
- improving
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- 239000000843 powder Substances 0.000 description 1
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- 239000000186 progesterone Substances 0.000 description 1
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- 230000028327 secretion Effects 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
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- 239000002562 thickening agent Substances 0.000 description 1
- 201000008297 typhoid fever Diseases 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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- 229940088594 vitamin Drugs 0.000 description 1
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- 150000003722 vitamin derivatives Chemical class 0.000 description 1
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- DGVVWUTYPXICAM-UHFFFAOYSA-N β‐Mercaptoethanol Chemical compound OCCS DGVVWUTYPXICAM-UHFFFAOYSA-N 0.000 description 1
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- A23V2200/302—Foods, ingredients or supplements having a functional effect on health having a modulating effect on age
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- A23V2250/00—Food ingredients
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Abstract
Description
본 발명은 여성 갱년기 증상의 예방, 개선 또는 치료용 조성물에 관한 것으로, 구체적으로는 바이텍신을 유효성분으로 포함하는 여성 갱년기 증상의 예방, 개선 또는 치료용 약학적 조성물 또는 여성 갱년기 증상의 예방 또는 개선용 식품 조성물에 관한 것이다. The present invention relates to a composition for preventing, ameliorating or treating female menopausal symptoms, and specifically, to a pharmaceutical composition for preventing, improving or treating female menopausal symptoms comprising vitexin as an active ingredient, or for preventing or improving female menopausal symptoms It relates to a food composition.
여성의 갱년기는 40~50 대에 나타나며, 난소의 노화로 인한 에스트로겐 즉, 여성 호르몬의 분비 감소에 기인하며, 폐경을 전후로 약 2~10 년에 걸쳐 나타난다. 여성의 갱년기에 의한 증상은 크게는 다섯 가지 분류로 구분되며, 구체적으로 첫째 혈관성 변화에 의한 증상으로 안면홍조, 빈맥, 발한, 두통이 있고, 둘째 근골격계 변화에 의한 증상으로 근육통, 관절통, 요통이 있으며, 셋째 비뇨생식기 변화에 의한 증상으로 빈뇨, 뇨실금이 있고, 넷째 뇌신경계 변화에 의한 증상으로 기억력 감퇴, 우울증, 집중력 감퇴, 현기증이 있으며, 다섯째 일반적 변화에 의한 증상으로 시력 감퇴, 피부 및 모발의 변화가 있다. 여성 갱년기 증상들은 정도의 차이는 있으나, 폐경 전·후 여성의 약 80%가 경험하고 있다. 무엇보다도 주목할 만한 사실은 갱년기를 거치면서 여성의 생명에 영향을 미치는 중요한 변화가 장기간에 걸쳐 발생하는데 그것은 골다공증과 심혈관계 질환의 발생 위험성 증가이다. 이러한 여성 갱년기 증상들을 고려해 볼 때 갱년기 증후군이 중년 여성들의 신체적, 정신적 건강 및 삶의 질적인 면에서 지대한 영향을 미침을 알 수 있다. 따라서, 이를 치료할 수 있는 방법이 절대적으로 필요하다. Menopause appears in women in their 40s and 50s, and it is caused by a decrease in the secretion of estrogen, that is, female hormones due to ovarian aging, and appears over about 2 to 10 years before and after menopause. Symptoms due to menopause in women are divided into five categories. Specifically, the first symptoms due to vascular changes include hot flashes, tachycardia, sweating, and headache, and second symptoms due to changes in the musculoskeletal system include muscle pain, joint pain, and back pain. , third symptoms due to urogenital changes include frequent urination and incontinence, fourth symptoms due to changes in the cranial nervous system include memory loss, depression, loss of concentration, and dizziness. There is a change. Although the symptoms of women's menopause vary in degree, about 80% of women before and after menopause experience it. Above all, it is noteworthy that important changes that affect a woman's life occur over a long period of time during menopause, which is an increased risk of osteoporosis and cardiovascular disease. Considering these women's menopausal symptoms, it can be seen that menopausal syndrome has a profound effect on the physical and mental health and quality of life of middle-aged women. Therefore, there is an absolute need for a method capable of treating it.
종래에는 여성의 갱년기 증상을 치료하기 위하여, 호르몬 대체요법, 비스테로이드계 제제 및 골다공증 치료를 위한 약물 치료법 등이 개발되었고, 이중에서 지금까지 가장 효과적으로 알려진 방법은 호르몬 대체요법이다. 호르몬 대체요법은 폐경 여성에서 여성 호르몬의 결핍으로 인하여 나타나는 증상을 경감시키기 위하여 여성 호르몬을 투여하는 치료법을 의미한다. 여성 호르몬을 단독으로 투여하는 경우 자궁내막 증식이 발생할 수 있어 보통 황체호르몬을 병합 투여한다. 그러나, 호르몬 대체요법의 경우, 5~10 년 이상 장기적으로 시행 시 암 발병 가능성에 대한 논쟁이 있고, 두통, 체중 증가 또는 심혈관 질환 발생 등의 부작용이 있으며, 인위적인 호르몬 투여에 대한 반감 및 월경 재개 가능성 등으로 인하여 많은 국내 여성들이 호르몬 요법에 대해 거부감을 가지고 있다. 일반 갱년기 여성들을 대상으로 안전하고 복용이 편리한 여성 갱년기 증상을 개선할 수 있는 치료용 성분의 개발이 절실히 요구되고 있다.Conventionally, in order to treat menopausal symptoms in women, hormone replacement therapy, nonsteroidal agents, and drug therapy for the treatment of osteoporosis have been developed, and the most effective method known so far is hormone replacement therapy. Hormone replacement therapy refers to a treatment in which female hormones are administered to relieve symptoms caused by a deficiency of female hormones in postmenopausal women. If female hormones are administered alone, endometrial hyperplasia may occur, so progesterone is usually administered in combination. However, in the case of hormone replacement therapy, there is a debate about the possibility of cancer when implemented for more than 5-10 years, there are side effects such as headache, weight gain, or cardiovascular disease, antipathy to artificial hormone administration, and the possibility of menstruation resumption Because of this, many Korean women have objection to hormone therapy. There is an urgent need to develop therapeutic ingredients that can improve women's menopausal symptoms that are safe and convenient for general menopausal women.
한편 바이텍신(Vitexin)은 Apigenin-8-C-D glucopyranoside, apigenin flavone glucoside로도 알려져 있으며 포도상구균, 티푸스균, 대장균 등에 대해 항균 효과가 있는 것으로 알려져 있다. 또한 플라본류 화학물질 때문에 강한 항산화 특성을 갖고 있으며, 염증과 산화 스트레스 억제 및 탄수화물 대사를 증진하는 효과를 나타내는 것으로 알려져 있다. 그러나 바이텍신의 여성 갱년기 증상의 예방 또는 개선 효과는 알려져 있지 않았는바, 본 발명자는 바이텍신의 여성 갱년기 증상의 예방, 개선 효과를 확인함으로써 본 발명을 완성하게 되었다.On the other hand, Vitexin is also known as Apigenin-8-C-D glucopyranoside and apigenin flavone glucoside, and is known to have antibacterial effects against Staphylococcus aureus, Typhoid bacillus, Escherichia coli, and the like. In addition, it has strong antioxidant properties due to flavone chemicals, and is known to exhibit the effect of inhibiting inflammation and oxidative stress and promoting carbohydrate metabolism. However, the preventive or ameliorating effect of vitexin for female menopausal symptoms was not known, and the present inventors have completed the present invention by confirming the preventive and ameliorating effects of vitaxin for female menopausal symptoms.
상기와 같은 문제점을 해결하기 위해 본 발명은 바이텍신을 유효성분으로 포함하는 여성 갱년기 증상의 예방, 개선 또는 치료용 조성물을 제공하고자 한다.In order to solve the above problems, the present invention is to provide a composition for preventing, improving or treating female menopausal symptoms comprising vitexin as an active ingredient.
또한, 바이텍신을 유효성분으로 포함하는 여성 갱년기 증상의 예방, 개선 또는 치료용 조성물의 제조방법을 제공하고자 한다.In addition, an object of the present invention is to provide a method for preparing a composition for preventing, improving, or treating female menopausal symptoms comprising vitexin as an active ingredient.
상기와 같은 목적을 달성하기 위해 본 발명은 바이텍신을 유효성분으로 포함하는 여성 갱년기 증상의 예방, 개선 또는 치료용 조성물을 제공한다.In order to achieve the above object, the present invention provides a composition for preventing, improving or treating female menopausal symptoms comprising vitexin as an active ingredient.
또한, 바이텍신을 유효성분으로 포함하는 여성 갱년기 증상의 예방, 개선 또는 치료용 조성물의 제조방법을 제공한다.In addition, there is provided a method for preparing a composition for preventing, improving or treating female menopausal symptoms comprising vitexin as an active ingredient.
본 발명에 있어서, 상기 바이텍신(Vitexin)은 조성물 전체 중량 대비 0.5 내지 10 중량%, 바람직하게는 1 내지 8 중량%, 더욱 바람직하게는 5~6중량% 포함된다. 상기 범위 미만이면 여성 갱년기 질환의 예방 또는 개선효과가 미미하고, 상기 범위를 초과하면 독성이 나타날 우려가 있다.In the present invention, the Vitexin (Vitexin) is included in 0.5 to 10% by weight, preferably 1 to 8% by weight, more preferably 5 to 6% by weight relative to the total weight of the composition. If it is less than the above range, the effect of preventing or improving female menopausal disease is insignificant, and if it exceeds the above range, there is a risk of toxicity.
상기 조성물은 유효성분으로 아그너사이드(Agnuside) 또는 아네톨(Anethole) 중 어느 하나 이상을 추가적으로 더 포함할 수 있다. 이때 상기 아그너사이드는 조성물 전체 중량 대비 1 내지 5중량%, 바람직하게는 2~3중량% 포함될 수 있다. 상기 범위 미만이면 여성 갱년기 질환의 예방 또는 개선효과가 미미하고, 상기 범위를 초과하면 독성이 나타날 우려가 있다.The composition may further include any one or more of agnuside and anethole as an active ingredient. In this case, the agnerside may be included in an amount of 1 to 5% by weight, preferably 2 to 3% by weight, based on the total weight of the composition. If it is less than the above range, the effect of preventing or improving female menopausal disease is insignificant, and if it exceeds the above range, there is a risk of toxicity.
상기 아네톨은 조성물 전체 중량 대비 0.5 내지 10 중량%, 바람직하게는 1 내지 7 중량%, 더욱 바람직하게는 3~4중량%로 포함될 수 있다. 상기 범위 미만이면 여성 갱년기 질환의 예방 또는 개선효과가 미미하고, 상기 범위를 초과하면 독성이 나타날 우려가 있다. The anetol may be included in an amount of 0.5 to 10% by weight, preferably 1 to 7% by weight, and more preferably 3 to 4% by weight based on the total weight of the composition. If it is less than the above range, the effect of preventing or improving female menopausal disease is insignificant, and if it exceeds the above range, there is a risk of toxicity.
상기 유효성분은 제한되는 것은 아니지만 바람직하게는 순결나무의 열매, 잎, 꽃, 씨앗, 뿌리, 줄기, 가지 또는 껍질에서 추출된 것일 수 있으며, 더욱 바람직하게는 순결나무의 열매에서 추출된 것일 수 있다.The active ingredient is not limited, but preferably may be extracted from the fruit, leaf, flower, seed, root, stem, branch or bark of the chastity tree, more preferably, it may be extracted from the fruit of the chastity tree .
상기 순결나무 추출물의 추출 용매는 제한되는 것은 아니지만, 바람직하게는 30 내지 70%(v/v) 에탄올, 더욱 바람직하게는 50%(v/v) 에탄올로 추출한 것일 수 있다. 상기 용매로 추출할 경우 경제적이면서도 추출되는 유효성분의 극대화시킬 수 있는 장점이 있다.The extraction solvent of the chrysanthemum extract is not limited, but preferably 30 to 70% (v/v) ethanol, more preferably 50% (v/v) ethanol. When extracting with the solvent, it is economical and has the advantage of maximizing the extracted active ingredient.
상기 갱년기 증상은 혈중 지질 장애, 빈맥, 발한, 두통, 체지방 증가, 복부 비만, 안면홍조, 피부건조, 질건조증, 질위축, 질내 pH 불균형, 하부 요도 위축, 질염, 방광염, 배뇨통, 빈뇨, 요실금, 급뇨, 집중장애, 단기 기억장애, 불안, 신경과민, 우울증, 기억력 감퇴, 근육통, 관절통, 골다공증, 골밀도 감소 중 선택되는 어느 하나 이상일 수 있으나, 이에 제한되는 것은 아니다.The menopausal symptoms include blood lipid disorders, tachycardia, sweating, headache, increased body fat, abdominal obesity, hot flushes, dry skin, vaginal dryness, vaginal atrophy, vaginal pH imbalance, lower urethral atrophy, vaginitis, cystitis, dysuria, frequent urination, incontinence, Urgency, concentration disorder, short-term memory disorder, anxiety, irritability, depression, memory loss, muscle pain, arthralgia, osteoporosis, may be any one or more selected from a decrease in bone density, but is not limited thereto.
본 발명에 따른 갱년기 증상의 예방 또는 개선용 조성물은 식품 조성물 또는 약학적 조성물이며, 상기 식품 조성물은 건강기능 식품 조성물을 포함하는 의미이다.The composition for preventing or improving menopausal symptoms according to the present invention is a food composition or a pharmaceutical composition, and the food composition is meant to include a health functional food composition.
본 발명에 따른 갱년기 증상의 예방, 개선 또는 치료용 조성물은 상기 유효성분 외에 약학적으로 허용되는 담체, 결합제, 활탁제, 붕해제, 부형제, 가용화제, 분산제, 안정화제, 현탁화제 등을 추가적으로 더 포함할 수 있고, 예를 들면 락토즈, 덱스트로즈, 수크로즈, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말디톨, 전분, 알지네이트, 칼슘 포스페이트, 칼슘 실리케이트, 말토덱스트린, 이산화규소, 셀룰로오스, 메틸 셀룰로오스, 미정질 셀룰로오스, 폴리비닐피롤리돈, 메틸하이드록시벤조에이트, 프로필하이드록시벤조에이트, 탈크, 마그네슘 스테아레이트 등일 수 있으나 이에 제한되는 것은 아니다.The composition for preventing, improving or treating menopausal symptoms according to the present invention further contains a pharmaceutically acceptable carrier, binder, lubricant, disintegrant, excipient, solubilizer, dispersing agent, stabilizing agent, suspending agent, etc. in addition to the active ingredient. may include, for example, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, malditol, starch, alginate, calcium phosphate, calcium silicate, maltodextrin, silicon dioxide, cellulose, methyl cellulose, It may be microcrystalline cellulose, polyvinylpyrrolidone, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and the like, but is not limited thereto.
또한, 상기 약학 조성물은 당 업계에서 제제화에 통상적으로 사용되는 방법으로 정제, 캡슐, 서방형 제제, 엘릭서, 서스펜션, 시럽, 웨이퍼, 단위 투약 주사제 앰플, 현탁액 등의 제형으로 제조될 수 있다.In addition, the pharmaceutical composition may be prepared in the form of tablets, capsules, sustained-release preparations, elixirs, suspensions, syrups, wafers, unit dose injection ampoules, suspensions, etc. by methods commonly used for formulation in the art.
상기 약학 조성물의 투여 방식은 경구 투여, 정맥내 투여, 근육내 투여, 동맥내 투여, 골수내 투여, 경막내 투여, 심장내 투여, 경피 투여, 피하 투여, 복강내 투여, 비강내 투여, 장관 투여, 구강 및 설하는 포함하는 국소 투여, 직장 투여, 국소 투여, 진피 투여, 점막 투여, 척추내 투여 등의 방법으로 투여될 수 있고, 바람직하게는 경구 투여일 수 있으나, 이에 제한되는 것은 아니다. 또한, 상기 투여 시 각 투여 방식에 절절한 제형으로 제제화되어 투여될 수 있으며, 제제화는 당 업계에서 널리 알려져 있는 방법으로 제제화될 수 있다.The administration method of the pharmaceutical composition is oral administration, intravenous administration, intramuscular administration, intraarterial administration, intramedullary administration, intrathecal administration, intracardiac administration, transdermal administration, subcutaneous administration, intraperitoneal administration, intranasal administration, enteral administration It may be administered by methods such as topical administration, rectal administration, topical administration, dermal administration, mucosal administration, intravertebral administration, etc., including oral and sublingual administration, and preferably oral administration, but is not limited thereto. In addition, at the time of administration, it may be formulated and administered in a formulation appropriate for each administration method, and the formulation may be formulated by a method well known in the art.
상기 약학 조성물은 투여 대상의 연령, 체중, 건강 상태, 성별, 투여시간, 투여 경로, 배출율, 유효성분의 함량, 예방 또는 치료될 특정 질환의 중증도 등에 따라 적절하게 선택될 수 있고, 투여 횟수는 1일 1회 또는 2회, 격일마다, 격주마다, 격월 등의 방식으로 투여할 수 있다.The pharmaceutical composition may be appropriately selected according to the age, weight, health status, sex, administration time, administration route, excretion rate, content of active ingredient, severity of a specific disease to be prevented or treated, etc. of the subject to be administered, and the number of administration is 1 Administration may be performed once or twice a day, every other day, every other week, every other month, or the like.
또한, 상기 식품 조성물은 당 업계에서 식품을 제조하기 위해 통상적으로 사용하는 향미제, 풍미제, 안정화제, 증점제, 방부제 등을 추가적으로 더 포함할 수 있고, 예를 들면 락토즈, 덱스트로즈, 수크로즈, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말디톨, 전분, 알지네이트, 칼슘 포스페이트, 칼슘 실리케이트, 말토덱스트린, 이산화규소, 셀룰로오스, 메틸 셀룰로오스, 미정질 셀룰로오스, 폴리비닐피롤리돈, 메틸하이드록시벤조에이트, 프로필하이드록시벤조에이트, 탈크, 마그네슘 스테아레이트 등일 수 있으나 이에 제한되는 것은 아니다.In addition, the food composition may further include flavoring agents, flavoring agents, stabilizers, thickeners, preservatives, etc. commonly used in the art for preparing food, for example, lactose, dextrose, water Crose, sorbitol, mannitol, xylitol, erythritol, malditol, starch, alginate, calcium phosphate, calcium silicate, maltodextrin, silicon dioxide, cellulose, methyl cellulose, microcrystalline cellulose, polyvinylpyrrolidone, methylhydroxybenzoate, It may be propylhydroxybenzoate, talc, magnesium stearate, etc., but is not limited thereto.
상기 식품 조성물은 음료, 껌, 차, 비타민 복합제, 분말, 과립, 정제, 캡슐,과자, 등의 형태로 제조될 수 있다. The food composition may be prepared in the form of beverages, gums, tea, vitamin complexes, powders, granules, tablets, capsules, confectionery, and the like.
상기 식품 조성물은 섭취 대상의 연령, 체중, 건강 상태, 성별, 투여시간, 유효성분의 함량, 질환의 중증도 등에 따라 적절하게 선택될 수 있고, 섭취 횟수는 1일 1회 또는 2회, 격일마다, 격주마다, 격월 등의 방식으로 섭취할 수 있다.The food composition may be appropriately selected according to the age, weight, health condition, sex, administration time, content of active ingredient, severity of disease, etc. of the ingestion target, and the number of intakes is once or twice a day, every other day, It can be taken every other week, every other month, etc.
본 발명에 따른 여성 갱년기 증상의 예방 또는 개선용 조성물의 유효성분은 시판되는 것을 사용할 수도 있으나, 순결나무로부터 추출하는 경우 하기의 단계를 포함하는 방법에 의해 제조될 수 있다;The active ingredient of the composition for preventing or improving female menopausal symptoms according to the present invention may be commercially available, but may be prepared by a method comprising the following steps when extracted from chastity trees;
(a) 추출 단계;(a) extraction step;
(b) 여과 및 농축 단계;.(b) filtration and concentration steps;
상기 (a) 추출 단계는 순결나무의 열매, 잎, 꽃, 씨앗, 뿌리, 줄기, 가지 또는 껍질을 원료로 하여 유효 성분을 추출하는 단계이다. The (a) extraction step is a step of extracting the active ingredient from the fruit, leaf, flower, seed, root, stem, branch or bark of the chastity tree as a raw material.
상기 원료 중량 대비 2 내지 4배, 바람직하게는 3배의 추출 용매를 넣어 추출할 수 있고, 추출 온도는 85 내지 95℃, 바람직하게는 90℃, 추출 시간은 1 내지 4시간, 바람직하게는 2~3시간, 추출 스팀압은 1kg/cm2 이하, 바람직하게는 0.5kg/cm2 이하에서 추출할 수 있다. 상기 조건 범위 미만으로 추출 시 유효성분이 잘 추출되지 않을 수 있고, 상기 조건 범위를 초과하여 추출할 경우 유효성분이 파괴되거나 불순물이 함께 추출될 수 있다.2 to 4 times, preferably 3 times the weight of the raw material can be extracted by adding an extraction solvent, and the extraction temperature is 85 to 95°C, preferably 90°C, and the extraction time is 1 to 4 hours, preferably 2 ~3 hours, the extraction steam pressure is 1 kg/cm 2 or less, preferably 0.5 kg/cm 2 or less can be extracted. When the extraction is less than the condition range, the active ingredient may not be well extracted, and when the extraction exceeds the condition range, the active ingredient may be destroyed or the impurities may be extracted together.
상기 (b) 여과 및 농축 단계에서 여과는 제한되는 것은 아니지만 바람직하게는 카트리지 필터를 사용할 수 있고, 필터 규격은 
상기 농축은 제한되는 것은 아니지만 바람직하게는 감압농축일 수 있다. 상기 농축 온도는 85 내지 95℃, 바람직하게는 90℃, 압력은 500 ± 30mmHg에서 농축할 수 있다. 상기 조건을 벗어나는 경우 농축이 제대로 되지 않거나 과농축될 수 있다. The concentration is not limited, but preferably concentration under reduced pressure. The concentration temperature is 85 to 95 ℃, preferably 90 ℃, the pressure can be concentrated at 500 ± 30mmHg. If the above conditions are exceeded, the concentration may not be properly performed or the concentration may be over-concentrated.
상기 단계를 통해 수득한 유효성분을 이용하여 여성 갱년기 증상의 예방 또는 개선용 약학적 조성물 또는 식품 조성물을 제조하는 경우, 하기의 단계를 추가적으로 더 포함할 수 있다;In the case of preparing a pharmaceutical composition or a food composition for preventing or improving female menopausal symptoms using the active ingredient obtained through the above step, the following steps may be further included;
(c) 부형제 혼합 단계; (c) mixing an excipient;
(d) 건조 단계.(d) drying step.
상기 (c) 부형제 혼합 단계는 준비된 유효성분에 부형제(담체, 결합제, 활탁제, 붕해제, 가용화제, 분산제, 안정화제, 현탁화제 등 포함)를 혼합하는 단계이다.The (c) excipient mixing step is a step of mixing excipients (including carriers, binders, lubricants, disintegrants, solubilizers, dispersants, stabilizers, suspending agents, etc.) with the prepared active ingredient.
상기 (d) 건조 단계는 상기 (c) 단계에 의해 제조된 혼합물을 건조시키는 단계로, 건조 방식은 제한되는 것은 아니지만 바람직하게는 동결건조 방식일 수 있고, 동결 온도는 -18℃ 이하일 수 있다.The (d) drying step is a step of drying the mixture prepared by the step (c), and the drying method is not limited, but may preferably be a freeze-drying method, and the freezing temperature may be -18°C or less.
상기 단계를 통해 제조된 조성물은 추출물 건조 수득물 : 덱스트린이 1: 0.5~3, 바람직하게는 1:1의 중량비로 혼합된 것이다.The composition prepared through the above step is a mixture of dry extract: dextrin in a weight ratio of 1: 0.5 to 3, preferably 1:1.
본 발명은 혈중 지질 장애, 빈맥, 발한, 두통, 체지방 증가, 복부 비만, 안면홍조, 피부건조, 질건조증, 질위축, 하부 요도 위축, 질염, 방광염, 배뇨통, 빈뇨, 요실금, 급뇨, 집중장애, 단기 기억장애, 불안, 신경과민, 우울증, 기억력 감퇴, 근육통, 관절통, 골다공증, 골밀도 감소와 같은 여성 갱년기 증상을 예방, 개선하는데 효과적인 약학 조성물, 식품 조성물을 제공할 수 있고, 상기 조성물은 일반적으로 시판되는 여성 갱년기용 건강기능식품, 의약품과 달리 식물성 에스트로겐에 의한 부작용이 발생되지 않는 장점이 있다.The present invention relates to blood lipid disorders, tachycardia, sweating, headache, increased body fat, abdominal obesity, hot flashes, dry skin, vaginal dryness, vaginal atrophy, lower urethral atrophy, vaginitis, cystitis, dysuria, frequent urination, incontinence, urgency, difficulty concentrating, Short-term memory disorders, anxiety, irritability, depression, memory loss, muscle pain, arthralgia, osteoporosis, it is possible to provide a pharmaceutical composition and a food composition effective for preventing and ameliorating female menopausal symptoms such as decreased bone density, and the composition is generally commercially available Unlike health functional foods and pharmaceuticals for menopausal women, it has the advantage that side effects caused by phytoestrogens do not occur.
이하, 본 발명을 실시예 및 실험예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail by way of Examples and Experimental Examples.
단, 하기 실시예 및 실험예는 본 발명을 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예 및 실험예에 한정되는 것은 아니다.However, the following Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited to the following Examples and Experimental Examples.
<바이텍신의 제조><Production of Vitexin>
순결나무의 열매를 원료로 하여 바이텍신을 추출하였다. 구체적인 방법은 다음과 같이 진행하였다;Vitaxin was extracted from the fruit of the chastity tree as a raw material. The specific method proceeded as follows;
순결나무 열매를 준비하여 순결나무 열매의 중량 대비 3배의 에탄올 50%(v/v)를 용매로 하여 추출하였다. 추출 온도는 90℃, 추출 시간은 2~3시간 동안 1kg/cm2 이하 스팀압 하에서 추출하였다. 이후 
<실시예 1 내지 5><Examples 1 to 5>
상기와 같이 수득한 바이텍신을 각각 0.1, 1, 3, 5, 10 중량%로 포함되도록 제조하였다.The vitaxin obtained as described above was prepared to contain 0.1, 1, 3, 5, and 10 wt%, respectively.
<실험예1> 이스트를 이용한 에스트로겐-유사 활성 유도능 실험<Experimental Example 1> Estrogen-like activity inducing ability experiment using yeast
본 발명에 따른 바이텍신을 포함하는 조성물의 에스트로겐-유사 활성을 확인하기 위해 다음과 같은 실험을 수행하였다.The following experiment was performed to confirm the estrogen-like activity of the composition containing the vitaxin according to the present invention.
시료로는 상기 실시예 1 내지 5를 사용하였고, 비교예는 위하여 갱년기 개선용 한약재로 상용화되어 있는 백수오와 에스트로겐 유사체인 β-에스트라디올(β-estradiol)을 사용하였다. 실험대상으로는 인간 에스트로겐 수용체의 유전자를 가지고 있는 재조합 이스트(yeast) 균주를 사용하였으며, 재조합 이스트 균주를 이용하여 글리세올린 화합물에 대한 에스트로겐-유사 활성을 측정하였다. 인간 에스트로겐 수용체를 가지고 있는 재조합 이스트 균주인 사카로마이세스 세레비지애 ER+LYS8127(Saccharomyces cerevisiae ER+LYS 8127) 균주를 30℃ 온도가 유지되는 배양기에서 300rpm으로 교반하면서 배양하였다. 이때 배지로는 YNB(yeast nitrogen base 6.74g/ℓ, 덱스트로스(dextrose) 20g/ℓ, L-라이신(L-lysine) 36mg/ℓ 및 L-히스티딘(L-histidine) 24mg/ℓ로 구성된 배지를 사용하였다. 2일 동안 배양한 후 이스트 균주들의 OD600nm에서 흡광도가 1.0~2.0에 도달하도록 하였다. 그 다음 상기 이스트로부터 에스트로겐 수용체를 생산하기 위하여 50μM의 CuSO4가 첨가된 배지를 OD600nm에서 흡광도가 0.03이 되도록 희석하였다. 50㎖ 코니칼 튜브에 상기 희석된 이스트 5㎖ 및 각 시료를 첨가하였다. 각 시료를 첨가한 후 30℃ 온도가 유지되는 배양기에서 300rpm으로 교반하면서 배양하고, 각 시료를 첨가하고 교반하여 배양한 이스트를 OD600nm에서 흡광도가 0.25가 되도록 희석하여 96-웰 플레이트에 100㎕씩 첨가하였다.Examples 1 to 5 were used as samples, and for comparative examples, white sorghum and estrogen analog β-estradiol, which are commercialized as herbal medicines for improving menopause, were used. As a test subject, a recombinant yeast strain having a human estrogen receptor gene was used, and the estrogen-like activity to the glycerolin compound was measured using the recombinant yeast strain. A recombinant yeast strain having a human estrogen receptor, Saccharomyces cerevisiae ER+LYS8127 (Saccharomyces cerevisiae ER+LYS 8127), was cultured while stirring at 300rpm in an incubator maintained at a temperature of 30°C. At this time, a medium composed of YNB (yeast nitrogen base 6.74 g/ℓ, dextrose 20 g/ℓ, L-lysine 36 mg/ℓ and L-histidine 24 mg/ℓ) was used as the medium. After culturing for 2 days, the absorbance at OD600nm of yeast strains reached 1.0 to 2.0. Then, in order to produce estrogen receptors from the yeast, a medium supplemented with 50 μM CuSO4 was used so that the absorbance at OD600nm was 0.03. 5 ml of the diluted yeast and each sample were added to a 50 ml conical tube. After each sample was added, incubated with stirring at 300 rpm in an incubator maintained at a temperature of 30 ° C., and each sample was added and stirred. The cultured yeast was diluted to an absorbance of 0.25 at OD600nm and added to a 96-well plate by 100 μl.
첨가 후 각각의 배지 색깔을 측정하기 위해 OD590nm에서 흡광도를 측정하였으며, β-갈락토시다제(βGalactosidase)의 활성은 2mg/㎖의 O-니트로페닐-β-D-갈락토피라노시드(ONPG), 0.1% SDS(sodium dodecyl sulfate), 50mM β-머캅토에탄올 및 25U/㎖의 자이몰라제(zymolyase)가 첨가된 버퍼(60mM Na2HPO4, 40mM NaH2PO4, 10mM KCl, 1mM MgSO4, pH 7.0)를 첨가하여 유도하였다. 유도 후 20분간 상온에서 배양한 다음 OD420nm 에서 흡광도를 측정하였고, OD420nm-OD590nm 값을 산출하여 음성대조군으로 나머지 값을 나누었다. 그 결과, 실시예 1 내지 3은 비교예인 백수오 추출물 대비 약 2배 이상의 활성을 나타내었고, β-에스트라디올과 유사한 활성을 나타내었다. After addition, absorbance was measured at OD590nm to measure the color of each medium, and the activity of β-galactosidase was 2 mg/ml of O-nitrophenyl-β-D-galactopyranoside (ONPG). , 0.1% SDS (sodium dodecyl sulfate), 50mM β-mercaptoethanol, and 25U/ml zymolyase-added buffer (60mM Na2HPO4, 40mM NaH2PO4, 10mM KCl, 1mM MgSO4, pH 7.0) was added. induced. After incubation at room temperature for 20 minutes after induction, absorbance was measured at OD420nm, OD420nm-OD590nm values were calculated, and the remaining values were divided into negative controls. As a result, Examples 1 to 3 exhibited about twice or more activity compared to the Baeksoo extract, which is a comparative example, and exhibited similar activity to β-estradiol.
<실험예2> 난소절제 동물 모델에서의 여성갱년기증상 개선 효능 평가<Experimental Example 2> Evaluation of the efficacy of improving female menopausal symptoms in an ovariectomized animal model
실험은 생후 7주령의 SD 암컷 랫트를 구입하여 일정한 온도(23±1℃)와 습도 (50%±5)하에서 1주간 적응시킨 후 인체 폐경을 모방한 갱년기 증상 유발 모델을 만들기 위해 마취 하에서 양쪽 난소절제수술(OVX)을 실시하였다. 대조군(sham)에는 난소는 그대로 둔 채 모의수술만 실시한 후 7일간의 회복기를 두었다. 난소절제군은 모의수술군(Sham), 난소절제군(OVX)), β-에스트라디올 투여군), 실시예 1 내지 5 투여군, 백수오 추출물군으로 나누어 구성하고, 각 추출물은 랫트 체중 kg당 200mg의 농도로 4주간 경구 투여하였다. 시험기간 동안 고형사료와 물은 자유로이 섭취하게 하고, 사육환경은 온도 23±0.5℃, 상대습도 50±5%, 12시간 간격으로 명-암(light-dark) 사이클로 자동 유지시켰다. 실험기간 종료 후 12시간 절식시키고, 희생 전 체중을 측정하고, 실험동물의 마취는 럼푼과 졸레틴을 2:3의 비율로 혼합한 마취제를 사용하였다. 실험동물로부터 혈액을 채취한 후 원심분리(1,000g, 15min, 4℃)하고, 분석 전까지 -80℃의 초저온냉동고에서 보관하였다. 오스테오칼신(osteocalcin: bone turnover 지표) 및 에스트로겐의 혈중 함량분석은 진단 kit(로슈)를 사용하여 electrochemilumino immunoassay 법으로 측정하였다. 본 발명에 따른 실시예 1 내지 5를 섭취 후 여성갱년기 대표증상인 안면홍조의 지표로서 랫트의 꼬리피부온도를 측정하였다. 랫트를 고정대에 고정하고 안정시킨 후 적외선 온도측정기(Pioneer electronic ＆ research)를 이용하여 총 3회 측정하여 그 평균값으로 꼬리피부온도를 측정하였다. The experiment was conducted by purchasing 7-week-old SD female rats and acclimatizing them for 1 week under constant temperature (23±1℃) and humidity (50%±5). Resection surgery (OVX) was performed. In the control group (sham), the ovaries were left as they were and only a simulated operation was performed, followed by a 7-day recovery period. The ovariectomy group consists of a simulated surgery group (Sham), ovariectomy group (OVX)), β-estradiol administration group), Examples 1 to 5 administration group, and Baeksuo extract group, and each extract is 200mg per kg of rat body weight. was orally administered at a concentration of 4 weeks. During the test period, solid feed and water were freely ingested, and the breeding environment was automatically maintained in a light-dark cycle with a temperature of 23±0.5° C., a relative humidity of 50±5%, and an interval of 12 hours. After the end of the experiment period, they were fasted for 12 hours, their body weight was measured before sacrifice, and an anesthetic mixed with rumpun and zoletine in a ratio of 2:3 was used for anesthesia of the experimental animals. After collecting blood from the experimental animals, it was centrifuged (1,000g, 15min, 4℃) and stored in a cryogenic freezer at -80℃ until analysis. Blood content analysis of osteocalcin (bone turnover index) and estrogen was measured by electrochemilumino immunoassay using a diagnostic kit (Roche). After ingestion of Examples 1 to 5 according to the present invention, the tail skin temperature of rats was measured as an indicator of hot flashes, which is a representative symptom of female menopause. After fixing and stabilizing the rat on a fixture, it was measured a total of three times using an infrared thermometer (Pioneer electronic & research), and the tail skin temperature was measured as the average value.
모의수술군(Sham), 난소절제군(OVX)), β-에스트라디올 투여군, 실시예1 내지 5 투여군을 비교한 결과, 본 발명에 따른 실시예 투여군에서는 난소절제 후 야기되는 체중증가를 저해하고, 혈중 에스트로겐 농도 수준을 증가시키며, 골지표인 오스테오칼신의 혈중농도를 감소시키는 효과를 나타내었다. 특히 실시예 1 내지 3이 우수한 결과를 나타내었다. 또한, 안면홍조의 지표인 꼬리피부온도에서도, 본 발명에 따른 실시예 투여군에서 정상수준의 체온으로 유지시키는 역할을 하는 것으로 나타났다.As a result of comparing the simulated surgery group (Sham), ovariectomy group (OVX)), β-estradiol administration group, and Examples 1 to 5 administration group, the Example administration group according to the present invention inhibited weight gain caused after ovariectomy and , increased the level of estrogen in the blood, and showed the effect of decreasing the blood concentration of osteocalcin, a Gol indicator. In particular, Examples 1 to 3 showed excellent results. In addition, in the tail skin temperature, which is an indicator of hot flashes, it was found that it plays a role in maintaining the body temperature at a normal level in the administration group according to the present invention.
반면 시판 여성갱년기증상 개선용 한약재 추출물인 백수오 투여군과 β-에스트라디올(β-estradiol) 투여군은 체온을 제외한 평가항목들에서 뚜렷한 개선효과를 나타내지 않았다.On the other hand, the group administered with baeksuo, a commercially available herbal extract for improving women's menopausal symptoms, and the group administered with β-estradiol did not show significant improvement in all evaluation items except body temperature.
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| KR20200136721A (en) | 2019-05-28 | 2020-12-08 | 동아제약 주식회사 | Composition for preventing or treating woman menopause symptoms comprising Cordyceps militaris Concentrate as an active ingredient |
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| KR20200136721A (en) | 2019-05-28 | 2020-12-08 | 동아제약 주식회사 | Composition for preventing or treating woman menopause symptoms comprising Cordyceps militaris Concentrate as an active ingredient |
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