KR101885202B1 - Composition for preventing, improving or treating prostate disease comprising extract of Calamagrostis arundinacea as effective component - Google Patents
Composition for preventing, improving or treating prostate disease comprising extract of Calamagrostis arundinacea as effective component Download PDFInfo
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- KR101885202B1 KR101885202B1 KR1020170061459A KR20170061459A KR101885202B1 KR 101885202 B1 KR101885202 B1 KR 101885202B1 KR 1020170061459 A KR1020170061459 A KR 1020170061459A KR 20170061459 A KR20170061459 A KR 20170061459A KR 101885202 B1 KR101885202 B1 KR 101885202B1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2200/00—Function of food ingredients
- A23V2200/30—Foods, ingredients or supplements having a functional effect on health
Abstract
Description
본 발명은 실새풀 추출물을 유효성분으로 함유하는 전립선 질환의 예방, 개선 또는 치료용 조성물에 관한 것이다.The present invention relates to a composition for preventing, ameliorating or treating a prostate disease, which contains an extract of Aspergillus as an active ingredient.
전립선은 요도가 건조해지지 않도록 여러 가지 분비물을 만들어 내는 장기로, 남성 호르몬인 안드로겐과 밀접한 관련이 있다. 분비가 증가함에 따라 점점 커지는데, 20~30대의 전립선이 50대까지 유지되다 그 이후부터 비대해진다. 이것을 양성 전립선 비대증이라고 하며, 호르몬 치료로 크기를 정상으로 돌려놓았다 하더라도 부작용의 위험이 높고, 호르몬 치료를 멈추면 곧 원상 복귀되기 때문에 완치하기 어렵다. Prostate is the organ that produces various secretions to keep the urethra from drying out. It is closely related to the male hormone, androgens. As the secretion increases, the size of the prostate increases in the 20s and 30s. This is called benign prostatic hyperplasia and it is difficult to cure it because the risk of side effects is high even if the size is returned to normal by the hormone treatment and soon after stopping the hormone treatment.
전립선에 발생하는 대표적인 질환은 전립선 비대증, 만성 전립선염 및 전립선암을 꼽을 수 있다. 전립선염은 다양한 원인이 있지만 주로 세균 감염, 원인 모를 염증, 만성통증의 일환으로 생기는 질환이고, 전립선암은 전립선 중 비교적 바깥쪽부분에 악성 종양이 생긴 것인데, 미국의 한 조사 결과에 따르면, 전립선암이 전체 남성 암 환자 중 약 35%를 차지하고 있으며, 매년 2~3%씩 증가하고 있다고 한다. 우리나라에서의 발생 빈도는 10만 명당 세 명으로 아직까지 걱정할 수위는 아니지만, 점차 서구적으로 변해가는 식생활이나 급격히 불어나는 노년층 인구로 그 비율이 점차 높아지고 있다.Representative diseases that occur in the prostate gland include enlarged prostate, chronic prostatitis, and prostate cancer. Prostate cancer is a disease caused by bacterial infections, inflammatory or chronic pain, and prostate cancer is a malignant tumor in the relatively outer part of the prostate gland. According to a US study, It accounts for about 35% of all male cancer patients and is said to increase by 2-3% every year. The incidence in Korea is three per 100,000 people, yet it is not worrisome yet, but it is gradually increasing with the western dietary life and the rapidly aging population.
한편, 전립선 비대증(Benign prostatic hyperplasia, BPH)은 노화와 성호르몬의 불균형의 영향으로 요도 주위 전립선 '샘조직'이 커져 요도를 압박하여 배뇨증상이 나타나는 질환으로, 남성의 50세 이후 발병이 급격히 일어나는 남성질환이다. 최근 우리나라에서 전립선 비대증 질환자의 증가율이 매년 20%를 상회할 정도로 가파른 증가 추세이며, 전립선이행대 부분의 평활근(smooth cell)과 상피세포(epithelial)의 과도한 증식으로 야기되고, 전립선 비대증은 하부요로증상을 동반하는데, 이는 비대해진 전립선에 의한 해부학적 폐색과 전립선 평활근을 수축시키는 α1-수용체에 의한 기능적 폐색에 기인하는 것으로 알려져 있다. 폐색에 의한 주요 증상으로는 소변줄기가 가늘고 약해지는 세뇨 또는 약뇨, 소변을 시작할 때 한참 기다려야 하는 지연뇨, 소변 중 의지와 관계없이 중단되는 배뇨중단, 소변 후 물방울처럼 떨어지는 배뇨 말기 적하, 및 잔뇨감 등이 대표적이다. 전립선 비대의 다양한 기전 중에서 대표적인 기전은 남성호르몬인 테스토스테론(testosterone,T)과 디하이드로테스토스테론(dihydrotestosterone, DHT)이 관련되어 있다고 알려져 있다.On the other hand, benign prostatic hyperplasia (BPH) is a disease in which the urethral prostate "ganglion" is enlarged due to aging and the imbalance of sex hormones, resulting in urinary symptoms due to the pressure of the urethra. It is a male disease. Recently, the rate of growth of patients with hyperplasia of the prostate in Korea has been steadily increasing to more than 20% every year. It is caused by excessive proliferation of smooth muscle and epithelial part of the prostate transplantation part, , Which is known to be due to anatomical occlusion by the enlarged prostate and functional occlusion by the? 1 -receptor which contracts the prostate smooth muscle. The main symptoms of occlusion include urinary tract weakness or weak urine stem or urine, delayed urination to wait for a long time to start urinating, discontinuation of urination to stop irrespective of urinary incontinence, terminal urination dropping like urine drops, This is representative. It is known that the testosterone (T) and the dihydrotestosterone (DHT) are involved in the typical mechanism of the various mechanisms of prostate hypertrophy.
한편, 실새풀(Calamagrostis arundinacea)은 우리나라 산지에서 흔하게 보이는 벼과 종 가운데 하나로, 종종 산지 풀밭에서도 관찰되지만, 주로 밝은 숲속이나 숲 가장자리에서 산다. 그러면서 서식처환경에 따라 식물체의 크기와 외부 형태의 변화가 심하기 때문에 현장에서 ‘이것은 실새풀이다’라고 분류하기에 망설여지는 종이다. 기본적으로 습한 환경조건보다는 비교적 건조한 환경에서 흔하다. 어떤 개체는 잎이 아주 왜소하지만 억세다. 심지어 중금속이 오염된 군(軍) 포사격장에서도 우점하며, 뿌리 속에 아연(亞鉛)을 축적하는 것으로 알려져 있고, 잎이 새와 닮았으나, 꽃차례(花序)는 모여 나면서 곧추서고, 작은꽃이삭(小穗)이 채 1cm가 되지 않아 아주 부드러운 느낌을 준다. 그런 꽃차례 분위기는 마치 겨이삭속과 흡사하다. 실새풀 속명 칼라마그로스티스(Calamagrostis)는 희랍어에서 유래하는 갈대(calamos)와 라틴어에서 유래하는 벼과의 겨이삭속(Agrostis)이 합성된 명칭이다. On the other hand, room saepul (Calamagrostis arundinacea is one of the most common species of paddy in Korea and is often found in mountainous meadows, but it lives mainly in bright forests and forest edges. In addition, since the size and external shape of the plant varies greatly depending on the habitat environment, it is a species that is hesitated to classify as 'this is a plant' in the field. Basically, it is more common in relatively dry environments than in wet environmental conditions. Some individuals are very dwarf, but they are strong. It is also known to accumulate zinc in the roots and the leaves resemble birds, but the inflorescence is gathered and straightened, and the small flower ears Small) is less than 1cm, gives a very soft feeling. The atmosphere of the inflorescence is similar to that of the root. The genus Calamagrostis is a compound of the calamos derived from Greek and the Agrostis derived from Latin.
전립선 질환의 예방, 개선 또는 치료용 조성물로 알려진 천연 추출물에는 한국등록특허 제1653492호에 염증 또는 전립선 비대증 치료용 조성물로, 구슬꽃나무 잎 추출물 또는 이의 분획물을 유효성분으로 포함하는 것이 알려져 있으며, 일본등록특허 제5191525호에는 오람, 황 우산풍, 천심 연꽃 중에서 선택된 하나 이상의 천연물이 테스토스테론 5α-환원효소 저해제 및 안드로겐 수용체 결합 저해제로 알려져 있으나, 본 발명의 실새풀 추출물을 유효성분으로 포함하는 전립선 질환의 예방, 개선 또는 치료용 조성물에 대해서는 개시된 바 없다. Korean Patent No. 1653492 discloses a composition for treating inflammation or enlargement of the prostate gland, which comprises a bee flower leaf extract or a fraction thereof as an active ingredient and is known as a composition for prevention, improvement or treatment of prostate disease, Patent No. 5191525 discloses that at least one natural product selected from olam, yellow umbrella, and lily of the valley is known as a testosterone 5α-reductase inhibitor and an androgen receptor binding inhibitor. However, in the prevention of prostate disease , Compositions for improvement or treatment have not been disclosed.
본 발명은 상기와 같은 요구에 의해 도출된 것으로서, 본 발명은 실새풀 추출물을 유효성분으로 포함하는 전립선 질환의 예방, 개선 또는 치료용 조성물을 제공하고, 본 발명의 유효성분인 실새풀 추출물이 전립선 비대(BPH)에 의해 비후화된 전립선의 무게를 감소시키며, 혈청 및 전립선 내 테스토스테론 및 DHT의 함량을 현저하게 감소시킬 수 있다는 것을 확인함으로써, 본 발명을 완성하였다.The present invention provides a composition for preventing, ameliorating or treating a prostate disease comprising an extract of Aspergillus odorus as an active ingredient, and the present invention provides a composition for preventing, improving or treating a prostate disease, The present invention has been accomplished by confirming that the weight of the enlarged prostate can be reduced by hypertrophy (BPH) and the content of testosterone and DHT in serum and prostate can be significantly reduced.
상기 목적을 달성하기 위하여, 본 발명은 실새풀(Calamagrostis arundinacea) 추출물을 유효성분으로 포함하는 전립선 질환의 예방 또는 치료용 약학 조성물을 제공한다.In order to accomplish the above object, the present invention provides a pharmaceutical composition for preventing or treating a prostate disease comprising an extract of Calamagrostis arundinacea as an active ingredient.
또한, 본 발명은 상기 약학 조성물을 유효성분으로 포함하는 전립선 비대증에 의한 배뇨장애 개선제를 제공한다.The present invention also provides an agent for improving dysuria caused by hypertrophy of the prostate, which comprises the above pharmaceutical composition as an active ingredient.
또한, 본 발명은 실새풀(Calamagrostis arundinacea) 추출물을 유효성분으로 포함하는 전립선 질환의 예방 또는 개선용 건강기능식품 조성물을 제공한다.The invention also saepul chamber (Calamagrostis The present invention provides a health functional food composition for preventing or ameliorating a prostate disease, which comprises an extract of Arundinacea as an active ingredient.
본 발명은 실새풀 추출물을 유효성분으로 포함하는 전립선 질환의 예방, 개선 또는 치료용 조성물에 관한 것으로, 본 발명의 유효성분인 실새풀 추출물은 전립선 비대(BPH)에 의해 비후화된 전립선의 무게를 감소시키며, 혈청 및 전립선 내 테스토스테론 및 DHT의 함량을 현저하게 감소시키므로, 전립선 비대증, 전립선염 또는 전립선암의 전립선 질환에 효과적으로 적용할 수 있다. The present invention relates to a composition for preventing, ameliorating or treating a prostate disease comprising an extract of Aspergillus oryzae as an active ingredient, wherein the extract of the effective ingredient of the present invention, which is an effective ingredient of the present invention, And significantly reduce the content of testosterone and DHT in serum and prostate, so that it can be effectively applied to prostate diseases such as benign prostatic hyperplasia, prostatitis or prostate cancer.
도 1은 본 발명의 실새풀 추출물의 투여에 따른 전립선의 무게변화를 확인한 결과이다. NC는 음성대조군; BPH는 전립선 비대증 유발군; BPH+CA는 전립선 비대증 유발 및 실새풀 추출물 처리군; BPH+F는 전립선 비대증 유발 및 양성대조군인 피나스테리드(Finasteride) 처리군이다.
도 2는 본 발명의 실새풀 추출물의 투여에 따른 혈청 내 DHT 함량 변화를 확인한 결과이다. NC는 음성대조군; BPH는 전립선 비대증 유발군; BPH+CA는 전립선 비대증 유발 및 실새풀 추출물 처리군; BPH+F는 전립선 비대증 유발 및 양성대조군인 피나스테리드(Finasteride) 처리군이다.
도 3은 본 발명의 실새풀 추출물의 투여에 따른 혈청 내 테스토스테론의 함량 변화를 확인한 결과이다. NC는 음성대조군; BPH는 전립선 비대증 유발군; BPH+CA는 전립선 비대증 유발 및 실새풀 추출물 처리군; BPH+F는 전립선 비대증 유발 및 양성대조군인 피나스테리드(Finasteride) 처리군이다.
도 4는 본 발명의 실새풀 추출물의 투여에 따른 전립선 조직의 H&E 염색결과이다. NC는 음성대조군; BPH는 전립선 비대증 유발군; BPH+CA는 전립선 비대증 유발 및 실새풀 추출물 처리군; BPH+F는 전립선 비대증 유발 및 양성대조군인 피나스테리드(Finasteride) 처리군이다.
도 5는 본 발명의 실새풀 추출물의 투여에 따른 간에서의 ALT 및 AST 함량 변화를 확인한 결과이다. NC는 음성대조군; BPH는 전립선 비대증 유발군; BPH+CA는 전립선 비대증 유발 및 실새풀 추출물 처리군; BPH+F는 전립선 비대증 유발 및 양성대조군인 피나스테리드(Finasteride) 처리군이다.Fig. 1 shows the result of checking the weight change of the prostate according to the administration of the extract of the present invention. NC is a negative control; BPH is the cause of benign prostatic hyperplasia; BPH + CA is an effective treatment for benign prostatic hyperplasia; BPH + F is a group of benign prostatic hyperplasia-induced and positive control, Finasteride.
FIG. 2 shows the results of confirming changes in the DHT content in serum according to the administration of the extract of the present invention. NC is a negative control; BPH is the cause of benign prostatic hyperplasia; BPH + CA is an effective treatment for benign prostatic hyperplasia; BPH + F is a group of benign prostatic hyperplasia-induced and positive control, Finasteride.
FIG. 3 shows the result of confirming the change in the content of testosterone in the serum according to the administration of the extract of the present invention. NC is a negative control; BPH is the cause of benign prostatic hyperplasia; BPH + CA is an effective treatment for benign prostatic hyperplasia; BPH + F is a group of benign prostatic hyperplasia-induced and positive control, Finasteride.
FIG. 4 shows H & E staining results of the prostate tissue according to the administration of the extract of the present invention. NC is a negative control; BPH is the cause of benign prostatic hyperplasia; BPH + CA is an effective treatment for benign prostatic hyperplasia; BPH + F is a group of benign prostatic hyperplasia-induced and positive control, Finasteride.
FIG. 5 shows the results of examining changes in ALT and AST contents in the liver upon administration of the extract of Seedlings of the present invention. NC is a negative control; BPH is the cause of benign prostatic hyperplasia; BPH + CA is an effective treatment for benign prostatic hyperplasia; BPH + F is a group of benign prostatic hyperplasia-induced and positive control, Finasteride.
본 발명은 실새풀(Calamagrostis arundinacea) 추출물을 유효성분으로 포함하는 전립선 질환의 예방 또는 치료용 약학 조성물에 관한 것이다.The invention saepul chamber (Calamagrostis The present invention relates to a pharmaceutical composition for preventing or treating prostate disease, which comprises an extract of arundinacea as an active ingredient.
상기 전립선 질환은 전립선 비대증, 전립선암 또는 전립선염인 것이 바람직하지만 이에 한정하지 않으며, 더 바람직하게는 전립선 비대증이고, 전립선 비대증에 의한 탈모 또는 배뇨장애를 포함할 수 있다. The prostate disease is preferably benign prostatic hyperplasia, prostate cancer or prostatitis, but it is not limited thereto, more preferably it is benign prostatic hyperplasia, and may include hair loss or urination disorder due to enlarged prostate.
상기 실새풀 추출물은 하기의 단계를 포함하는 방법에 의해 제조할 수 있으나, 이에 한정하지 않는다:The Seaweed extract can be produced by a method including, but not limited to, the following steps:
(1) 실새풀에 추출용매를 가하여 추출하는 단계;(1) extracting an extractant by adding an extraction solvent to the extract;
(2) 단계 (1)의 추출물을 여과하는 단계; 및 (2) filtering the extract of step (1); And
(3) 단계 (2)의 여과한 추출물을 감압 농축하고 건조하여 추출물을 제조하는 단계. (3) The step of extracting the filtered extract of step (2) by concentration under reduced pressure and drying.
상기 단계 (1)에서 추출용매는 물, C1~C4의 저급 알코올 또는 이들의 혼합물 중에서 선택하는 것이 바람직하며, 더 바람직하게는 C1~C4의 저급 알코올이고, 더욱더 바람직하게는 99%(v/v) 메탄올이지만 이에 한정하지 않는다.In the step (1), the extraction solvent is preferably selected from water, a C 1 -C 4 lower alcohol or a mixture thereof, more preferably a C 1 -C 4 lower alcohol, even more preferably 99% (v / v) methanol, but is not limited thereto.
상기 제조방법에 있어서, 추출방법은 여과법, 열수 추출, 침지 추출, 환류 냉각 추출 및 초음파 추출 등의 당 업계에 공지된 모든 통상적인 방법을 이용할 수 있다. 상기 추출용매는 건조된 실새풀 중량의 1~20배 첨가하여 추출하는 것이 바람직하며, 더 바람직하게는 5~15배 첨가하는 것이다. 추출온도는 4 내지 50℃인 것이 바람직하나 이에 한정하지 않는다. 또한, 추출시간은 0.5~10시간인 것이 바람직하며, 0.5~5시간이 더욱 바람직하나 이에 한정하지 않는다. 상기 방법에 있어서, 단계 (3)의 감압농축은 진공 감압 농축기 또는 진공회전증발기를 이용하는 것이 바람직하나 이에 한정하지 않는다. 또한, 건조는 감압건조, 진공건조, 비등건조, 분무 건조 또는 동결 건조하는 것이 바람직하나 이에 한정하지 않는다.In the above production method, any conventional method known in the art such as filtration, hot water extraction, immersion extraction, reflux cooling extraction, and ultrasonic extraction may be used. The extraction solvent is preferably added in an amount of 1 to 20 times, more preferably 5 to 15 times the weight of the dried seedling. The extraction temperature is preferably 4 to 50 DEG C, but is not limited thereto. The extraction time is preferably 0.5 to 10 hours, more preferably 0.5 to 5 hours, but not always limited thereto. In the above method, it is preferable to use a vacuum decompression concentrator or a vacuum rotary evaporator for the decompression concentration in the step (3), but it is not limited thereto. The drying is preferably performed under reduced pressure, vacuum drying, boiling, spray drying or freeze drying, but not always limited thereto.
상기 실새풀 추출물은 혈청 내 DHT(dihydrotestosterone) 또는 테스토스테론(testosterone)의 함량을 감소시킬 수 있다. The Sephadex extract may reduce the content of DHT (dihydrotestosterone) or testosterone in serum.
본 발명의 약학 조성물은 상기 실새풀 추출물 이외에 추가로 담체, 부형제 또는 희석제를 더 포함할 수 있다. The pharmaceutical composition of the present invention may further comprise a carrier, an excipient or a diluent in addition to the above-mentioned extract.
본 발명의 약학 조성물은 경구 또는 비경구로 투여될 수 있으며, 비경구 투여 시 피부 외용 또는 복강 내, 직장, 정맥, 근육, 피하, 자궁 내 경막 또는 뇌혈관 내 주사 방식을 선택하는 것이 바람직하다.The pharmaceutical composition of the present invention may be administered orally or parenterally, and it is preferable to use an intravenous or intraperitoneal, rectal, intravenous, intramuscular, subcutaneous, intrauterine, or intracerebral injection method during parenteral administration.
본 발명의 약학 조성물은 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제될 수 있다. 경구투여를 위한 고형 제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형 제제는 하나 이상의 화합물에 적어도 하나 이상의 부형제 예를 들면, 전분, 탄산칼슘, 수크로오스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한, 단순한 부형제 이외에 스테아린산 마그네슘, 탈크 등과 같은 윤활제들도 사용된다. 경구 투여를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성 용제, 현탁제, 유제, 동결건조제제, 좌제가 포함된다. 비수성 용제 및 현탁 용제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈tween) 61, 카카오지, 라우린지, 글리세로 젤라틴 등이 사용될 수 있다.The pharmaceutical composition of the present invention can be prepared using a diluent such as a filler, an extender, a binder, a wetting agent, a disintegrant, a surfactant, or an excipient. Solid formulations for oral administration include tablets, pills, powders, granules, capsules, and the like, which may contain one or more excipients such as starch, calcium carbonate, sucrose or lactose lactose, gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate, talc, and the like may also be used. Liquid preparations for oral administration include suspensions, solutions, emulsions, syrups and the like. Various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included in addition to water and liquid paraffin, which are simple diluents commonly used. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of non-aqueous solvents and suspensions include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate, and the like. Examples of suppositories include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like.
본 발명에 따른 조성물은 약제학적으로 유효한 양으로 투여한다. 본 발명에 있어서, "약제학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효용량 수준은 환자의 질환의 종류, 중증도, 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 있으며, 단일 또는 다중 투여될 수 있다. 상기한 요소들을 모두 고려하여 부작용없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 당업자에 의해 용이하게 결정될 수 있다.The composition according to the present invention is administered in a pharmaceutically effective amount. In the present invention, "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 will depend on the type of disease, severity, , Sensitivity to the drug, time of administration, route of administration and rate of release, duration of treatment, factors including co-administered drugs, and other factors well known in the medical arts. The composition of the present invention can be administered as an individual therapeutic agent or in combination with other therapeutic agents, and can be administered sequentially or simultaneously with conventional therapeutic agents, and can be administered singly or in multiple doses. It is important to take into account all of the above factors and to administer the amount in which the maximum effect can be obtained in a minimal amount without side effects, which can be easily determined by those skilled in the art.
본 발명의 조성물의 투여량은 환자의 체중, 연령, 성별, 건강상태, 식이, 투여시간, 투여방법, 배설률 및 질환의 중증도에 따라 그 범위가 다양하게 사용할 수 있다.The dosage of the composition of the present invention may be varied depending on the patient's body weight, age, sex, health condition, diet, administration time, administration method, excretion rate, and severity of disease.
또한, 본 발명은 상기 약학 조성물을 유효성분으로 포함하는 전립선 비대증에 의한 배뇨장애 개선제에 관한 것이다.The present invention also relates to an agent for improving dysuria caused by hypertrophy of the prostate, which comprises the above pharmaceutical composition as an active ingredient.
또한, 본 발명은 실새풀(Calamagrostis arundinacea) 추출물을 유효성분으로 포함하는 전립선 질환의 예방 또는 개선용 건강기능식품 조성물에 관한 것이다.The invention also saepul chamber (Calamagrostis The present invention relates to a health functional food composition for preventing or ameliorating a prostate disease containing an extract of arundinacea as an active ingredient.
상기 실새풀 추출물을 유효성분으로 포함하는 전립선 질환의 예방 또는 개선용 건강기능식품 조성물은 음료, 환, 정제(tablet), 캡슐제(capsule), 산제 중에서 선택된 어느 하나로 제조하거나, 식품의 성분으로 첨가하여 제조될 수 있으며, 통상적인 방법에 따라 적절하게 제조될 수 있다. The health functional food composition for preventing or ameliorating a prostate disease, which comprises the extract as an active ingredient, is prepared from any one selected from a beverage, a ring, a tablet, a capsule, and a powder, And can be suitably produced according to a conventional method.
본 발명의 실새풀 추출물을 첨가할 수 있는 식품의 일례로는 육류, 소시지, 빵, 초콜릿, 캔디류, 스넥류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 중에서 선택된 어느 하나의 형태일 수 있으며, 통상적인 의미에서의 건강기능식품을 모두 포함한다.Examples of foods to which the extract of the present invention can be added include meat products, sausages, bread, chocolate, candies, snacks, confectionery, pizza, ramen noodles, other noodles, dairy products including ice- , Tea, a drink, an alcoholic beverage, and a vitamin complex, and includes all the health functional foods in a conventional sense.
상기 건강기능식품은 여러 가지 영양제, 비타민, 광물(전해질), 합성 및 천연 풍미제, 착색제 및 증진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알킨산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그 밖에 천연 과일 주스 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. The health functional foods include various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (cheese, chocolate etc.), pectic acid and its salts, alkynic acid and its salts, , pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. It may also contain flesh for the production of natural fruit juices and vegetable drinks. These components may be used independently or in combination.
본 발명의 건강기능식품 조성물은 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상기 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드, 말토스, 슈크로스와 같은 디사카라이드, 및 덱스트린, 사이클로덱스트린과 같은 폴리사카라이드, 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 감미제로서는 타우마틴, 스테비아 추출물과 같은 천연 감미제나, 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다.
The health functional food composition of the present invention may contain various flavors or natural carbohydrates as an additional ingredient. The natural carbohydrates are sugar saccharides such as monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, xylitol, sorbitol and erythritol. Examples of sweeteners include natural sweeteners such as tau martin and stevia extract, synthetic sweeteners such as saccharin and aspartame, and the like.
이하, 실시예를 이용하여 본 발명을 더욱 상세하게 설명하고자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로 본 발명의 범위가 이들에 의해 제한되지 않는다는 것은 당해 기술분야에서 통상의 지식을 가진 자에게 있어 자명한 것이다.
Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are merely illustrative of the present invention and that the scope of the present invention is not limited thereto.
실시예Example 1. 실새풀( 1. Room 전초outpost , 037-065) 추출물의 제조, 037-065) Preparation of extract
한국식물추출물은행(Korea Plant Extract Bank)으로부터 99.9%(v/v)의 메탄올(HPLC grade)을 추출용매로 사용하여 6.0%의 추출 수율로 대량 추출한 7.37g의 실새풀 추출물을 분양받아, 동물 실험(in vivo)에 사용하였다.
7.37g of the extract was obtained from Korean Plant Extract Bank at an extraction yield of 6.0% using 99.9% (v / v) methanol grade (HPLC grade) as an extraction solvent. ( in vivo ).
실시예Example 2. 동물 모델의 제작 및 통계 분석 2. Production and statistical analysis of animal models
10주령의 수컷 Wister 랫트(중앙실험동물)를 1주일 동안 순화시킨 후, 전립선 비대 유발군(BPH)은 3mg/kg의 프로피온산테스토스테론(testosterone propionate; TP)를 피하에 4주 동안 주입하여 모델을 확립하였다. 실새풀 추출물 투여군은 4주 동안 TP 주입 한 시간 전에 100mg/kg의 실새풀 추출물을 경구 투여하였으며, 양성대조군은 전립선 비대증 치료제로 사용되고 있는 5α-환원 효소 억제제인 피나스테리드(Finasteride)를 10 mg/kg의 양으로 투여하였다.After 10-week-old male Wister rats (central laboratory animals) were purified for 1 week, the prostate hypertrophy group (BPH) was injected with 3 mg / kg of testosterone propionate (TP) Respectively. In the group treated with the extract, the oral administration of 100 mg / kg of Zygomycorr japonicum extract was administered orally for 4 weeks before TP injection. The positive control group was treated with 10 mg / kg of Finasteride, a 5α-reductase inhibitor used as a treatment for benign prostatic hyperplasia Lt; / RTI >
통계학적 분석은 ANOVA로 수행하였으며, #는 정상군(NC)과 비교 시 통계적으로 유의미한 차이가 있는 경우로, P<0.05임을 의미하며; *는 전립선 비대증 유발군(BPH)과 비교 시 통계적으로 유의미한 차이가 있는 경우이고, P<0.05임을 의미한다.
Statistical analysis was performed with ANOVA, with # being statistically significant when compared to normal ( P <0.05); * Indicates a statistically significant difference compared to the BPH group, and P <0.05.
실시예Example 3. 전립선 무게 측정 3. Prostate Weighing
흰쥐에 프로피온산테스토스테론(testosterone propionate; TP)를 피하로 4주동안 주사하여 전립선 비대증을 유발하고 실새풀 추출물과 전립선 비대증 치료제로 사용 중인 피나스테리드(Finasteride)를 4주 동안 함께 경구 투여하였다. 약물 투여 종료 후 희생시킨 쥐의 전립선을 채취하여 무게를 비교하였다.The rats were injected subcutaneously with testosterone propionate (TP) for 4 weeks to induce hypertrophy of the prostate gland, and oral administration of finasteride (Finasteride), which is used as a therapeutic agent for the growth of the prostate gland and enlargement of the prostate gland, for 4 weeks. After the administration of the drug, sacrificed rat prostate glands were sampled and weighed.
그 결과, 도 1에 개시한 바와 같이, 각 실험군(정상군: NC, 전립선 비대증 유발군: BPH, 전립선 비대증 유발군+실새풀 추출물 투여군: BPH+CA, 전립선 비대증 유발군+Finasteride 투여군: BPH+F)으로부터 측정한 전립선의 무게는 TP로 전립선 비대증을 유발한 군은 정상군에 비해 그 무게가 증가하였고, 전립선 비대증 유발군에 비해 실새풀 추출물을 투여한 군에서 전립선의 무게가 유의적으로 감소하였다는 것을 확인하였다.
As a result, as shown in Fig. 1, BPH + CA, prostatic hyperplasia + Finasteride group: BPH + prostate hyperplasia + F), the weight of the prostate gland in the group that caused the hyperplasia of the prostate gland increased compared with that of the normal group, and the weight of the prostate gland significantly decreased Respectively.
실시예Example 4. 전립선의 4. Prostate DHTDHT 변화 change
전립선 비대증 동물 모델에서 혈청 내 DHT(dihydrotestosterone)의 함량을 확인하기 위해 실험 종료 후, 분리한 혈액을 4,000rpm에서 20분 동안 원심분리한 후 상등액을 취해 혈청에서 ELISA 키트(ALPCO, Salem)를 이용하여 DHT(dihydrotestosterone)의 함량을 측정하였다. After the end of the experiment, the separated blood was centrifuged at 4,000 rpm for 20 minutes to check the content of DHT (dihydrotestosterone) in an enlarged prostate animal model. The supernatant was taken from the serum, and the serum was measured using an ELISA kit (ALPCO, Salem) The content of DHT (dihydrotestosterone) was measured.
그 결과, 도 2에 개시한 바와 같이, 실새풀 추출물을 투여한 군에서 혈청 내 DHT(dihydrotestosterone)의 함량이 통계적으로 유의미하게 감소한 것을 확인하였다.
As a result, as shown in FIG. 2, it was confirmed that the content of DHT (dihydrotestosterone) in serum was statistically significantly decreased in the group administered with the extract of Seedlings.
실시예Example 5. 혈청 내 5. Serum 테스토스테론(testosterone)의Testosterone 함량 변화 분석 Analysis of content change
전립선 비대증 동물 모델에서 테스토스테론(testosterone)의 함량 변화를 확인하기 위해 실험 종료 후 분리한 혈액을 4,000rpm에서 20분간 원심분리한 후 상등액을 취해 혈청에서 ELISA kit (Cayman, USA)을 이용하여 테스토스테론(testosterone)의 함량을 측정하였다. After the end of the experiment, the separated blood was centrifuged at 4,000 rpm for 20 minutes, and the supernatant was taken. The serum was analyzed by ELISA kit (Cayman, USA) for the testosterone (testosterone ) Were measured.
그 결과, 도 3에 개시한 바와 같이 실새풀 추출물을 투여한 군에서 혈청 내 테스토스테론(testosterone)의 함량이 통계적으로 유의미하게 감소하였다.
As a result, as shown in FIG. 3, the testosterone content in serum decreased statistically significantly in the group administered with the extract of Seedlings.
실시예Example 6. 전립선의 조직병리학적 변화 6. Histopathological changes of the prostate gland
실험 종료 후 적출한 전립선을 10%의 중성 완충 포르말린으로 24시간 동안 고정한 후 파라핀으로 포매(paraffin embedding)하였다. 포매한 조직은 4μm의 두께로 박절하여 절편을 제작한 후, H&E[헤마톡실린(hematoxylin, Sigma-Aldrich, USA)과 에오신 와이 (eosin Y, Sigma-Aldrich)]로 염색하고, 봉입액으로 봉입하여 광학현미경으로 검경하였다. After the end of the experiment, the extracted prostate gland was fixed with 10% neutral buffered formalin for 24 hours and paraffin embedding was performed. The embryoid tissue was cut to a thickness of 4 μm and cut into sections and stained with H & E (hematoxylin, Sigma-Aldrich, USA) and eosin Y (Sigma-Aldrich) And examined with an optical microscope.
그 결과, 도 4에 개시한 바와 같이, 전립선 비대증 유발군에서는 상피세포의 높이와 수가 과증식되었으나, 실새풀 추출물을 투여한 군에서는 이러한 상피세포의 과증식이 억제되었다는 것을 확인하였다.
As a result, as shown in FIG. 4, the height and number of epithelial cells were increased in the prostatic hyperplasia-induced group, but it was confirmed that the proliferation of the epithelial cells was inhibited in the group treated with the extract.
실시예Example 7. 혈중 ALT 및 7. Serum ALT and ASTAST 측정 Measure
전립선 비대증 동물 모델에서 실새풀 추출물의 독성 여부를 확인하기 위해 실험 종료 후 분리한 혈액을 4,000rpm에서 20분 동안 원심분리한 후, 상등액을 취해 혈청에서 ALT와 AST의 함량 변화를 확인하였다. In order to confirm the toxicity of Aspergillus oryzae extracts in an enlarged prostate animal model, the separated blood was centrifuged at 4,000 rpm for 20 minutes after the end of the experiment, and the contents of ALT and AST in the serum were determined by taking the supernatant.
그 결과, 도 5에 개시한 바와 같이, 일반적인 간 독성(손상) 지표로 사용되는 ALT 및 AST의 함량이 정상군과 비교하여 전립선 비대증 유발군 및 실새풀 추출물 투여군 모두에서 통계적으로 유의미한 변화는 관찰되지 않았다.As a result, as shown in FIG. 5, there was no statistically significant change in the contents of ALT and AST used as common liver toxicity index I did.
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KR101653492B1 (en) * | 2015-04-16 | 2016-09-02 | 중앙대학교 산학협력단 | The composition for treating inflammation and benign prostate hyperplasia comprising extracts from leaves of Adina rubella hance or compound isolated therefrom |
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KR101653492B1 (en) * | 2015-04-16 | 2016-09-02 | 중앙대학교 산학협력단 | The composition for treating inflammation and benign prostate hyperplasia comprising extracts from leaves of Adina rubella hance or compound isolated therefrom |
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KR102376521B1 (en) | 2020-07-02 | 2022-03-21 | 충남대학교산학협력단 | Composition for preventing, improving or treating prostate disease comprising extract of Ainsliaea acerifolia as effective component |
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