KR101794929B1 - Composition comprising Galla Rhois extract for preventing or treating constipation - Google Patents
Composition comprising Galla Rhois extract for preventing or treating constipation Download PDFInfo
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- KR101794929B1 KR101794929B1 KR1020160099684A KR20160099684A KR101794929B1 KR 101794929 B1 KR101794929 B1 KR 101794929B1 KR 1020160099684 A KR1020160099684 A KR 1020160099684A KR 20160099684 A KR20160099684 A KR 20160099684A KR 101794929 B1 KR101794929 B1 KR 101794929B1
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- extract
- constipation
- preventing
- composition
- present
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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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/22—Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
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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
-
- 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
- A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
Abstract
Description
본 발명은 오배자(Galla Rhois) 추출물을 유효성분으로 포함하는 변비의 예방 또는 치료용 조성물에 관한 것이다. The present invention relates to a composition for preventing or treating constipation comprising an extract of Galla Rhois as an active ingredient.
근래 식생활의 서구화로 육류와 인스턴트 식품의 섭취 증가로 인한 식이섬유 부족, 산업화로 인한 스트레스 등의 다양한 요인으로 변비를 호소하는 사람들이 점차 늘어나고 있다. 변비(Constipation)는 의학적으로 일주일에 3회 이하의 배변이거나, 하루 배변량이 30 g이하일 때 변비라고 정의한다. 정상적인 상태에서는 음식물을 섭취한 후 24시간이면 대변이 되어 배설되나, 변비가 있는 사람은 며칠에 한 번 변을 보거나 매일 보더라도 그 양이 적어 결과적으로 섭취한 음식물의 장내 체류시간이 길어지는 것이다. 변비의 원인으로는 아침식사를 거름으로 인한 대장연동운동의 저하, 식생활의 서구화로 인한 식이섬유의 부족, 운동부족으로 인한 기초체력 및 복근력 저하, 다이어트, 과다한 약물 복용으로 인한 약물 중독 등 여러 가지가 있다.Recently, people are complaining of constipation due to diverse factors such as lack of dietary fiber and industrialization stress due to increase of intake of meat and instant food due to westernization of dietary habits. Constipation is defined as constipation when it is medically less than 3 bowel movements a week or when the bowel movement is 30g or less per day. Under normal conditions, it is excreted in the stool 24 hours after ingestion of food. However, people with constipation see the stools every few days or even if they see it every day, resulting in a longer stay in the intestinal tract of the resulting food. The causes of constipation include a decrease in the intestinal motility caused by eating breakfast, a lack of dietary fiber due to westernization of dietary life, a decrease in basic physical strength and abdominal strength due to lack of exercise, dieting, drug addiction due to excessive use of drugs, have.
예로부터 만병의 근원으로까지 일컬어지고 있는 변비는 식욕이 없고 늘 복부가 팽만한 상태에 있을 뿐 아니라 배설되지 못한 변의 독소가 장을 통하여 혈액에 흡수됨으로써 피부노화를 촉진시키고 두통이나 여드름, 피부 발진 등이 나타나며, 변비가 심하면 배변시 치열의 파손과 치액의 탈출 등 치질의 원인이 되고, 변속에 있는 독소에 의해 대장암까지 발생된다. 또한 변비가 지속되면 체외로 배출되어야 할 콜레스테롤이나 지방이 몸 속에 남아있어서 동맥 경화 또는 담석증을 유발할 수 있으며, 더 나아가서는 고혈압과 심장비대를 일으켜 심장병으로 악화될 수 있다. 이 외에도 뇌졸중, 면역결핍, 시력장애, 정신질환(우울증) 등 다양하고 심각한 2차 질환의 원인이 되므로 변비는 적극적인 예방과 치료가 필요한 중요한 질환이라 할 수 있다.Constipation, which is said to be the source of all diseases from ancient times, has no appetite and is not only in a state where the abdomen is always bloated, but also toxins of the unexcited side are absorbed into the blood through the intestines, thereby promoting aging of the skin and causing headache, acne, skin rash And when constipation is severe, it breaks the dentition and escapes the dentition when it is defecated, and it causes the hemorrhoids by the toxin in the shift. If constipation persists, cholesterol or fat that should be excreted outside the body may remain in the body, which may lead to arteriosclerosis or gallstone disease. Furthermore, hypertension and cardiac hypertrophy may be exacerbated by heart disease. In addition, stroke, immunodeficiency, vision disorders, and mental illness (depression), such as a variety of serious secondary causes of the disease, so constipation is an important disease can be an active prevention and treatment.
이에 현재까지 변비 치료 및 개선을 위한 다양한 의약품과 기능성식품이 판매되고 있으나 의약품의 경우 대부분 센나, 대황 등의 안트라퀴논 유도체 성분이 함유된 자극성 약제를 사용함으로써 복통, 설사 등의 부작용과 함께 임신 중 복용이나 지속적인 복용에 문제가 있으며, 기능성 식품의 경우도 과학적으로 그 효과가 충분히 입증되지 못한 것이 대부분이어서 변비 개선의 근본문제를 해결하지 못하고 있어 제품의 신뢰성이 떨어지고 있는 실정이다.To date, various medicines and functional foods for constipation treatment and improvement have been marketed. However, most of the medicines use stimulant medicines containing anthraquinone derivatives such as Senna and Rhubarb to treat side effects such as abdominal pain and diarrhea, And functional foods are not scientifically proved to be effective enough to solve the fundamental problem of constipation improvement, and thus the reliability of the product is deteriorating.
한편, 오배자(Galla Rhois)는 오배자면충이 옻나무과의 붉나무(Rhus javanica L.)의 잎에 기생하여 만든 벌레집으로 문합(文蛤), 백충창(白蟲倉)이라고도 하며, 전체의 50~70%가 갈로탄닌류로 갈릭에시드(gallic acid), 펜타갈로일 글루코오즈(pentagalloyl glucose) 등이 주요성분으로 밝혀지고 있다.On the other hand, Galla Rhois is an insect house which is made by insect parasitic on the leaves of rhus javanica L. (Rhus javanica L.) and it is also called as anchovy and white chestnut. 50 to 70% Galactanines such as gallic acid, pentagalloyl glucose and the like have been found to be major components.
벌레집은 생성과정은 하기와 같다. 9월 하순 벌레집에 구멍을 뚫고 나온 날개 있는 암벌레가 중간숙주인 선태류(Minum versicatum, M. trichomane)에 새끼벌레를 낳고, 새끼벌레는 선태류의 즙을 빨아 먹고 자라서 흰 납으로 벌레집을 만들고 겨울을 난다. 다음해 봄에 번데기가 되고 4월 하순 번데기에 서 나와 날개 있는 암벌레가 된다. 암벌레는 교미 후 붉나무의 가지에 날개 없는 암수컷의 새끼벌레를 낳고 죽는다. 날개 없는 암벌레는 어린잎에 옮겨 기생하며 벌레집이 자란다. 이때 그 크기가 본래의 5 배나 되기 때문에 오배자라는 이름이 붙었다고 한다. 이른 가을 벌레가 나가기 전에 벌레집을 따서 증기에 쪄서 벌레를 죽인 후 말린다. The process of generating the insect house is as follows. Late September A female insect winged with a hole in the insect house gave birth to a midwife (Minum versicatum, M. trichomane) with a chimpanzee. The chimpanzee sucked the juice of the cetacean, . It becomes a pupa in the spring of the following year, and comes out in the pupa of late April and becomes a female worm with a wing. The female worms give birth to female wingless female wingless worms on the branches of the rhusi after mating and die. Wingless worms are transferred to young leaves and parasitized, and the house of insects grows. At that time, the size is five times the original size, so it is said that it is called obi. Before the early autumn bug leaves, it picks up the insect house, steam it in the steam, kills the insect, and dries.
오배자의 약효로는 수렴, 지사, 지혈제로 설사, 가래, 당뇨, 하혈, 빈혈뿐만 아니라, 궤양성 결장염, 방사성 직장염, 유정, 폐결핵으로 인한 도한, 각혈, 이질, 자한, 당뇨병, 식도암, 치질, 화상, 조루, 야제(夜啼), 가을철에 유행하는 장염 등에 치료효과가 있는 것으로 알려진바 있으나, 변비 개선 효과에 대해서는 전혀 개시된 바가 없다.The pharmacological effects of diarrhea include diarrhea, diarrhea, hemorrhage, hemorrhage, diarrhea due to ulcerative colitis, radioactive rectalitis, oil well, pulmonary tuberculosis, , Premature ejaculation, oozing (啼.), And seasonal influenza in autumn, but the effect of improving constipation has not been disclosed at all.
본 발명자들은 변비 개선 효과를 갖는 물질에 대해 연구하던 중, 오배자 추출물이 변의 배변개수 및 중량을 증가시키고, 변 내 수분함량을 증가시켜 배변을 부드럽게 하며, 점막 및 근육의 두께를 증가시키고 점액 분비를 증가시켜 장 기능을 향상시킴으로써 변비를 개선하는 효과가 우수함을 확인하고 본 발명을 완성하였다. The inventors of the present invention have been studying a substance having a constipation-improving effect, and found that the extract of the rhizomes increases the number and weight of the stool, increases the water content in the stomach to soften the bowel, increases the mucous membrane and muscle thickness, To improve the intestinal function, thereby improving the constipation. Thus, the present invention has been completed.
본 발명의 목적은 오배자 추출물을 유효성분으로 포함하는 변비의 예방 또는 치료용 조성물을 제공하는 것이다.It is an object of the present invention to provide a composition for the prevention or treatment of constipation comprising an extract of Opuntia as an active ingredient.
상기 목적을 위하여, 본 발명은 오배자 추출물을 유효성분으로 포함하는 변비의 예방 또는 치료용 약학적 조성물을 제공한다.For this purpose, the present invention provides a pharmaceutical composition for the prevention or treatment of constipation, comprising an opioid extract as an active ingredient.
또한, 본 발명은 오배자 추출물을 유효성분으로 포함하는 변비의 예방 또는 개선용 식품 조성물을 제공한다.In addition, the present invention provides a food composition for preventing or ameliorating constipation, comprising an opioid extract as an active ingredient.
본 발명에 따른 오배자 추출물은 변의 배변개수 및 중량을 증가시키고, 변 내 수분함량을 증가시켜 배변을 부드럽게 하며, 점막 및 근육의 두께를 증가시키고 점액 분비를 증가시켜 장 기능을 향상시킴으로써 변비를 개선하는 효과가 우수하므로, 변비의 예방 또는 치료에 유용하게 사용될 수 있다.The rhizome extract according to the present invention improves constipation by increasing the number and weight of stools of the stomach, increasing the water content in the stomach to soften the stool, increasing the mucous membrane and muscle thickness, increasing mucus secretion, It can be effectively used for preventing or treating constipation.
도 1은 본 발명의 오배자 추출물의 성분 분석을 위해 흡광도, DPPH 라디칼 억제 활성 및 NMR 분석을 수행한 결과를 나타낸 도이다.
도 2는 본 발명의 오배자 추출물을 처리한 동물 모델의 대장을 적출한 후 H&E 및 Alcian blue로 염색하고, 이를 광학현미경으로 관찰한 결과를 나타낸 도이다.
도 3은 본 발명의 오배자 추출물을 처리한 동물 모델의 대장을 적출한 후 mAChR M2 및 M3의 발현량을 측정한 결과를 나타낸 도이다.
도 4는 본 발명의 오배자 추출물을 처리한 동물 모델의 대장을 적출한 후 pPKC 및 pPI3K의 발현량을 측정한 결과를 나타낸 도이다.
도 5는 본 발명의 오배자 추출물을 처리한 동물 모델의 대장을 적출한 후 Gα 및 IP3의 발현량을 측정한 결과를 나타낸 도이다.FIG. 1 is a graph showing the results of performing absorbance, DPPH radical suppressing activity, and NMR analysis for analyzing components of the extract of Opuntia ficus-indica according to the present invention.
FIG. 2 is a graph showing the results of staining of H & E and Alcian blue, followed by observation with an optical microscope, of an animal model treated with the extract of Opuntia ficus-indica according to the present invention.
FIG. 3 is a graph showing the results of measuring the expression levels of mAChR M2 and M3 after extracting the large intestine of an animal model treated with the extract of Opuntia ficus-indica according to the present invention.
FIG. 4 is a graph showing the results of measuring the expression levels of pPKC and pPI3K after extracting the large intestine of an animal model treated with the extract of Opuntia ficus-indica according to the present invention.
FIG. 5 is a graph showing the results of measuring the expression levels of Gα and IP3 after extracting the large intestine from an animal model treated with the extract of Opuntia ficus-indica according to the present invention.
본 발명은 오배자(Galla Rhois) 추출물을 유효성분으로 함유하는, 변비의 예방 또는 치료용 조성물을 제공한다.The present invention provides a composition for preventing or treating constipation, which comprises an extract of Galla Rhois as an active ingredient.
본 발명의 조성물은 약학적 조성물, 식품 조성물을 포함한다.The compositions of the present invention include pharmaceutical compositions, food compositions.
이하 본 발명을 상세히 설명한다. Hereinafter, the present invention will be described in detail.
본 발명의 유효성분인 오배자 추출물은 당업계에 공지된 추출 및 분리하는 방법을 사용하여 천연으로부터 추출 및 분리하여 수득한 것을 사용할 수 있으며, 본 발명에서 정의된 '추출물'은 적절한 용매를 이용하여 추출된 조추출물, 극성용매 가용 추출물 또는 비극성용매 가용 추출물을 모두 포함한다. The crude extract of the present invention, which is an active ingredient of the present invention, can be obtained by extracting and isolating from nature using an extraction and separation method known in the art, and the 'extract' defined in the present invention can be extracted Crude extract, polar solvent-soluble extract, or non-polar solvent-soluble extract.
상기 오배자로부터 추출물을 추출하기 위한 적절한 용매로는 물 또는 약학적으로 허용되는 유기용매로서 어느 것을 사용해도 무방하다. 예를 들어, 상기 용매로는 정제수, 메탄올(methanol), 에탄올(ethanol), 프로판올(propanol), 이소프로판올(isopropanol) 및 부탄올(butanol) 등의 탄소수 1 내지 4의 알코올, 아세톤(acetone), 에테르(ether), 벤젠(benzene), 클로로포름(chloroform), 에틸아세테이트(ethyl acetate), 메틸렌클로라이드(methylene chloride), 헥산(hexane), 시클로헥산(cyclohexane) 등의 각종 용매를 단독으로 또는 2종 이상 혼합하여 사용할 수 있으며, 바람직하게는 물 또는 탄소수 1 내지 4의 알코올일 수 있으며, 더욱 바람직하게는 물이다. As a suitable solvent for extracting the extract from the dwarf, any of water or a pharmaceutically acceptable organic solvent may be used. Examples of the solvent include alcohols having 1 to 4 carbon atoms such as purified water, methanol, ethanol, propanol, isopropanol, and butanol, acetone, ether various solvents such as ether, benzene, chloroform, ethyl acetate, methylene chloride, hexane and cyclohexane may be used alone or as a mixture of two or more thereof. And preferably water or an alcohol having 1 to 4 carbon atoms, and more preferably water.
추출 방법으로는 열수추출법, 냉침추출법, 환류냉각추출법, 용매추출법, 수증기증류법, 초음파추출법, 용출법, 압착법 등의 방법이 사용될 수 있으며, 바람직하게는 열수추출법을 통해 추출될 수 있다. 또한 목적하는 추출물은 추가로 통상의 분획 공정을 수행할 수도 있으며, 통상의 정제 방법을 이용하여 정제될 수도 있다. Examples of the extraction method include hot water extraction, cold extraction, reflux cooling, solvent extraction, steam distillation, ultrasonic extraction, elution, and compression. The desired extract may further be subjected to a conventional fractionation process or may be purified using a conventional purification method.
예를 들어, 본 발명의 조성물의 유효성분인 오배자 추출물은 상기 열수추출법으로 추출된 1차 추출물을, 감압 증류 및 동결 건조 또는 분무 건조 등과 같은 추가적인 과정에 의해 분말 상태로 제조할 수 있다. 또한 상기 1차 추출물을 실리카겔 컬럼 크로마토그래피(silica gel column chromatography), 박층크로마토그래피(thin layer chromatography), 고성능 액체 크로마토그래피(high performance liquid chromatography) 등과 같은 다양한 크로마토그래피를 이용하여 추가로 정제된 분획으로도 얻을 수 있다.For example, the crude extract, which is an active ingredient of the composition of the present invention, can be prepared into a powdery state by an additional process such as vacuum distillation, freeze-drying, or spray drying. In addition, the primary extract can be further purified into a further purified fraction using various chromatographies such as silica gel column chromatography, thin layer chromatography, high performance liquid chromatography and the like Can be obtained.
따라서 본 발명에서 사용되는 오배자 추출물은 추출, 분획 또는 정제의 각 단계에서 얻어지는 모든 추출액, 분획 및 정제물, 그들의 희석액, 농축액 또는 건조물을 모두 포함하는 개념이다.Therefore, the opiate extract used in the present invention is a concept including all the extracts, fractions and tablets obtained in each step of extraction, fractionation or purification, their diluted solution, concentrate or dried product.
상기와 같은 오배자 추출물은 변의 배변개수 및 중량을 증가시키고, 변 내 수분함량을 증가시켜 배변을 부드럽게 한다. The above-mentioned obtusa extract increases the number of bowel movements and weight of the bowel, increases moisture content in the bowel, and softens bowel movements.
또한, 상기 오배자 추출물은 점막 및 근육의 두께를 증가시키고 점액 분비를 증가시켜 장 기능을 향상시켜 변비의 예방, 개선 또는 치료를 위한 약학적 조성물이나 식품 조성물로 사용될 수 있다.In addition, the extract may be used as a pharmaceutical composition or food composition for preventing, ameliorating or treating constipation by increasing the thickness of mucous membrane and muscle and increasing mucus secretion to improve intestinal function.
본 발명의 변비는 다양한 원인으로 유발되는 변비를 포함할 수 있다. 구체적으로, 과식 또는 스트레스 등이 주요한 원인인 일과성 변비, 운동부족이나 과로로 인해 복근력이 저하되어 발생하는 이완성 변비 또는 결장성 변비, 대장의 운동 기능 및 배변욕 저하로 인해 발생하는 상습성 또는 직장성 변비 및 대장의 운동이 너무 강하여 변의 통과를 방해하여 발생하는 경련성 변비일 수 있다.The constipation of the present invention may include constipation caused by various causes. Concretely, transient constipation, which is a major cause of overeating or stress, diastolic or rectal constipation caused by lack of exercise or abdominal discomfort due to overwork, constipation due to exercise, And constrictive constipation that occurs because movement of the large intestine is too strong to interfere with passage of the sides.
또한, 본 발명의 변비는 약물에 의한 변비를 포함할 수 있다. 변비를 유발할 수 있는 약제로는 칼슘 통로 차단제, 항콜린성 약제, 진통제, 항우울제, 항히스타민제, 진경제, 항경련제, 알루미늄 함유 제산제, 철분 제제 등일 수 있으며, 구체적으로는 신경질환 또는 암과 같은 약물의 부작용으로 인한 변비일 수 있다.In addition, the constipation of the present invention may include constipation by the drug. Examples of the medicaments which can cause constipation include calcium channel blockers, anticholinergic drugs, analgesics, antidepressants, antihistamines, antispasmodics, anticonvulsants, aluminum-containing antacids, iron preparations and the like. Lt; / RTI > constipation.
본 발명의 일 실시예에서는 설사를 억제하는 약물인 로페라미드(loperamide)를 투여하여 변비를 유발한 동물모델을 이용하여 실험하였다.In one embodiment of the present invention, loperamide (loperamide), an anti-diarrhea drug, was administered to an animal model that caused constipation.
본 발명의 조성물은 상기 오배자 추출물와 함께 변비 개선 효과를 갖는 공지의 유효성분을 1종 이상 더 함유할 수 있다.The composition of the present invention may further contain at least one known active ingredient having an effect of improving constipation, together with the above extract of Opium hygroscopy.
본 발명의 조성물은 약학적 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다. 또한 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. 당해 기술 분야에 알려진 적합한 제제는 문헌 (Remington's Pharmaceutical Science, 최근, Mack Publishing Company, Easton PA)에 개시되어 있는 것을 사용하는 것이 바람직하다. 포함될 수 있는 담체, 부형제 및 희석제로는 락토오스, 덱스트로오스, 수크로오스, 소르비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로오스, 메틸 셀룰로오스, 미정질 셀룰로오스, 폴리비닐 피롤리돈, 물, 메틸히드록시 벤조에이트, 프로필히드록시 벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유 등이 있다. 상기 조성물을 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 조성물에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로오스, 락토오스, 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스테아레이트, 탈크 같은 윤활제들도 사용된다. 경구를 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, 비수성용제, 현탁제, 유제, 동결건조 제제, 좌제가 포함된다. 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 compositions of the present invention may further comprise suitable carriers, excipients and diluents conventionally used in the manufacture of pharmaceutical compositions. In addition, it can be formulated in the form of powders, granules, tablets, capsules, suspensions, emulsions, oral preparations such as syrups and aerosols, external preparations, suppositories and sterilized injection solutions according to a conventional method. Suitable formulations known in the art are preferably those as disclosed in Remington ' s Pharmaceutical Science, recently, Mack Publishing Company, Easton PA. Examples of carriers, excipients and diluents which may be included include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, Cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. When the composition is formulated, it is prepared using a diluent such as a filler, an extender, a binder, a wetting agent, a disintegrant, a surfactant, or an excipient usually used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, which may contain at least one excipient such as starch, calcium carbonate, sucrose, lactose, Gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Examples of the suppository base include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like.
본 발명에서 사용되는 용어 "투여"는 임의의 적절한 방법으로 개체에게 소정의 본 발명의 조성물을 제공하는 것을 의미한다.The term "administering" as used herein is meant to provide any desired composition of the invention to a subject in any suitable manner.
본 발명의 약학적 조성물의 바람직한 투여량은 환자의 상태 및 체중, 질병의 정도, 약물형태, 투여경로 및 기간에 따라 다르지만, 당업자에 의해 적절하게 선택될 수 있다. 바람직한 효과를 위해서, 본 발명의 오배자 추출물의 일일 투여량은 1일 250 mg/kg 이상의 양으로 투여할 수 있으며, 하루에 한번 투여할 수도 있고, 수 회 나누어 투여할 수도 있다.The preferred dosage of the pharmaceutical composition of the present invention varies depending on the condition and the weight of the patient, the degree of disease, the type of drug, the route of administration and the period of time, but can be appropriately selected by those skilled in the art. For a desired effect, the daily dose of the extract of the present invention may be administered in an amount of 250 mg / kg or more per day, or may be administered once a day or divided into several times.
본 발명의 약학적 조성물은 개체에게 다양한 경로로 투여될 수 있다. 투여의 모든 방식은 예상될 수 있는데, 예를 들면, 경구, 직장 또는 정맥, 근육, 피하, 자궁 내 경막 또는 뇌혈관 내 주사에 의해 투여될 수 있다.The pharmaceutical composition of the present invention may be administered to a subject in various routes. All modes of administration may be expected, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intra-uterine dural or intracerebral injection.
본 발명의 조성물은 변비 개선 효과를 위하여 단독으로, 또는 수술, 방사선 치료, 호르몬 치료, 화학 치료 및 생물학적 반응 조절제를 사용하는 방법들과 병용하여 사용할 수 있다.The composition of the present invention can be used alone or in combination with methods using surgery, radiation therapy, hormone therapy, chemotherapy, and biological response modifiers for the purpose of improving constipation.
본 발명에서, "식품"이란, 질병의 예방 및 개선, 생체방어, 면역, 병후의 회복, 노화 억제 등 생체조절 기능을 가지는 식품을 말하는 것으로, 장기적으로 복용하였을 때 인체에 무해해야 한다. In the present invention, the term "food" refers to a food having a biological control function such as prevention and improvement of disease, bio-defense, immunity, recovery after disease, suppression of aging and the like.
본 발명의 식품 조성물은 변비의 예방 또는 개선을 목적으로 건강기능식품에 첨가될 수 있다. 본 발명의 오배자 추출물을 식품 첨가물로 사용할 경우, 상기 오배자 추출물을 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다. 유효성분의 혼합양은 사용 목적(예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있다. 일반적으로, 식품 또는 음료의 제조 시에 본 발명의 오배자 추출물은 원료에 대하여 15중량% 이하, 바람직하게는 10 중량% 이하의 양으로 첨가된다. 그러나, 건강 및 위생을 목적으로 하거나 또는 건강 조절을 목적으로 하는 장기간의 섭취의 경우에는 상기 범위 이하일 수 있으며, 안전성 면에서 아무런 문제가 없기 때문에 유효성분은 상기 범위 이상의 양으로도 사용될 수 있다.The food composition of the present invention can be added to a health functional food for the purpose of preventing or improving constipation. When the extract according to the present invention is used as a food additive, the extract can be directly added or used together with other food or food ingredients, and can be suitably used according to a conventional method. The amount of the active ingredient to be mixed can be suitably determined according to the intended use (prevention, health or therapeutic treatment). Generally, in the production of a food or beverage, the rhizome extract of the present invention is added in an amount of 15% by weight or less, preferably 10% by weight or less, based on the raw material. However, in the case of long-term intake for the purpose of health and hygiene or for the purpose of controlling health, the amount may be less than the above range, and since there is no problem in terms of safety, the active ingredient may be used in an amount exceeding the above range.
상기 식품의 종류에는 특별한 제한은 없다. 상기 물질을 첨가할 수 있는 식품의 예로는 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 수프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 건강식품을 모두 포함한다.There is no particular limitation on the kind of the food. Examples of the foods to which the above substances can be added include dairy products including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen noodles, gums, ice cream, various soups, drinks, tea, Alcoholic beverages, and vitamin complexes, all of which include health foods in a conventional sense.
본 발명의 건강음료 조성물은 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 포함할 수 있다. 상술한 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드, 말토오스, 수크로오스와 같은 디사카라이드, 및 덱스트린, 사이클로덱스트린과 같은 천연 감미제나, 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ml 당 일반적으로 약 0.01 내지 10 g, 바람직하게는 약 0.01 내지 0.1 g 이다.The health beverage composition of the present invention may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. The natural carbohydrates may be monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, natural sweeteners such as dextrin and cyclodextrin, synthetic sweeteners such as saccharine and aspartame, and the like. The ratio of the natural carbohydrate is generally about 0.01 to 10 g, preferably about 0.01 to 0.1 g per 100 ml of the composition of the present invention.
상기 외에 본 발명의 조성물은 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, 탄산 음료에 사용되는 탄산화제 등을 포함할 수 있다. 그 밖에 본 발명의 조성물은 천연 과일주스, 과일주스 음료 및 야채 음료의 제조를 위한 과육을 포함할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 크게 중요하진 않지만 본 발명의 조성물 100 중량부 당 0.01 내지 0.1 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, the composition of the present invention may further contain various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, A carbonating agent used in a carbonated beverage, and the like. In addition, the composition of the present invention may comprise flesh for the production of natural fruit juices, fruit juice drinks and vegetable drinks. These components may be used independently or in combination. Although the ratio of such additives is not critical, it is generally selected in the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the composition of the present invention.
또한, 본 발명은 오배자 추출물을 유효성분으로 함유하는, 장 기능 개선용 조성물을 제공한다.Further, the present invention provides a composition for improving intestinal function, comprising a rhizome extract as an active ingredient.
본 발명의 일실시예에 있어서, 상기 조성물은 장 기능을 개선시켜 변비를 경감하거나 예방할 수 있다.In one embodiment of the present invention, the composition can ameliorate or prevent constipation by improving bowel function.
이하 본 발명의 이해를 돕기 위하여 바람직한 실시예 및 제제예를 제시한다. 그러나 하기 실시예 및 제제예는 본 발명을 보다 쉽게 이해하기 위하여 제공되는 것일 뿐, 실시예 및 제제예에 의해 본 발명의 내용이 한정되는 것은 아니다.Hereinafter, preferred embodiments and examples of the present invention will be described in order to facilitate understanding of the present invention. However, the following examples and preparative examples are provided only for the purpose of easier understanding of the present invention, and the present invention is not limited by the examples and preparation examples.
실시예Example 1. 오배자 추출물의 준비 1. Preparation of horseradish extract
오배자(Galla Rhois)는 2013년 10월 동안 홍천지역에서 수확된 것을 선별하여 수세 및 60℃에서 건조하였다. 상기 건조된 오배자 시료를 균일하게 분쇄한 후 10배의 증류수를 가하고 순환추출장치를 이용하여 90℃에서 9시간 동안 추출하였다. 그 후 상기 추출액을 0.4 μm로 여과한 후, 진공 증발 및 동결건조하여 오배자 추출물 시료를 준비하였다. Galla Rhois harvested from the Hongcheon area during October 2013, washed and dried at 60 ° C. The dried dumbbell sample was uniformly pulverized, and then 10 times of distilled water was added thereto, followed by extraction at 90 ° C for 9 hours using a circulation extractor. Thereafter, the extract was filtered at 0.4 μm, and then vacuum evaporation and freeze-drying were performed to prepare a sample of Avalanche Extract.
실시예Example 2. 오배자 추출물의 성분 분석 2. Analysis of Composition of Rhizoma Extract
오배자 추출물의 그 유효성분을 확인하기 위하여, 상기 실시예 1에서 수득한 오배자 추출물에 대하여 흡광도를 측정하였으며, 그 결과를 도 1a에 나타내었다.In order to confirm the active ingredient of the extract, the absorbance of the extract obtained in Example 1 was measured, and the results are shown in FIG. 1A.
도 1a에 나타낸 바와 같이, 오배자 추출물의 유효성분인 오배자 추출물의 유효성분으로서 갈산(gallic acid), 갈로타닌(gallotannin) 및 메틸 갈레이트(methyl gallate)을 확인하였고, 갈산, 갈로타닌 및 메틸 갈레이트는 각각 212/257 nm, 213/278 nm, 214/268 nm에서 최대 흡수파장을 나타내었다. As shown in FIG. 1A, gallic acid, gallotannin and methyl gallate were identified as effective components of the extract of Opuntia ficus-indica extract, which is an active ingredient of Opuntia ficus-indica extract, and galactan, galantanine and methyl gallate Showed maximum absorption wavelengths at 212/257 nm, 213/278 nm and 214/268 nm, respectively.
또한, 오배자 추출물의 HPLC 분석을 수행하였다. 구체적으로, HPLC 분석을 위하여 Korea Bio-IT Foundry Busan Center의 PDA UV-vis 검출기와 Summit Dual-Gradient HPLC System(Dionex, USA)을 사용하였고, 분리는 40℃가 유지되는 YMC-Triart C18 column (S-5 mm/12 nm, 150 mm × 4.6 mm I.D.)에서 수행하였다. 이동상 용매는 용매 A(물 내 0.4% 포름산)와 용매 B(아세토니트릴)로 구성하였고 이동상 구배 조건은 다음과 같다: 0-5분, 10% B; 5-6분, 10-15% B; 6-40분, 15% B; 40-41분, 15-30% B; 41-50분, 30% B; 50-55분, 30-10% B; 55-60분, 10% B. 이때, 주입 부피는 전체 루프 주입의 5 ml이고, 유속은 0.8 ml/분, 검출은 280 nm에서 수행하였으며, 그 결과를 도 1b에 나타내었다. In addition, HPLC analysis of the rhizome extract was performed. For the HPLC analysis, PDA UV-vis detector and Summit Dual-Gradient HPLC System (Dionex, USA) from Korea Bio-IT Foundry Busan Center were used. The separation was performed on YMC-Triart C18 column -5 mm / 12 nm, 150 mm x 4.6 mm ID). The mobile phase solvent consisted of solvent A (0.4% formic acid in water) and solvent B (acetonitrile) and the mobile phase gradient conditions were: 0-5 min, 10% B; 5-6 minutes, 10-15% B; 6-40 minutes, 15% B; 40-41 min, 15-30% B; 41-50 min, 30% B; 50-55 min, 30-10% B; 55-60 min, 10% B. At this time, the injection volume was 5 ml of the whole loop injection, the flow rate was 0.8 ml / min, and the detection was performed at 280 nm, and the results are shown in FIG.
도 1b에 나타낸 바와 같이, 오배자 추출물의 유효성분인 오배자 추출물의 유효성분으로서 갈산, 갈로타닌 및 메틸 갈레이트의 존재를 확인하였다.As shown in Fig. 1B, the presence of gallic acid, galactanine and methyl gallate was confirmed as an effective ingredient of the extract of Opuntia ficus-indica, an effective ingredient of the Opuntia ficus-indica extract.
또한, 오배자 추출물의 DPPH 라디칼 억제 활성 분석을 수행하였다. 구체적으로, 13가지 다른 농도의 오배자 추출물 및 95 %의 EtOH 용액 100 μL 또는 95 %의 EtOH 용액의 0.1 mM DPPH 100 μL을 혼합하여 50 % 에탄올 용액에 용해시키고, 실온에서 30분 동안 배양한 후, Versa-max plate reader (Molecular Devices, Sunnyvale, CA, USA)를 사용하여 517 nm에서 흡광도를 측정하였으며, 그 결과를 도 1c에 나타내었다.In addition, DPPH radical scavenging activity analysis of the rhizome extract was carried out. Specifically, a mixture of 100 μL of 95% EtOH solution or 100 μL of 0.1 mM DPPH in 95% EtOH solution was dissolved in 50% ethanol solution and incubated at room temperature for 30 minutes. Then, Absorbance was measured at 517 nm using a Versa-max plate reader (Molecular Devices, Sunnyvale, Calif., USA) and the results are shown in FIG.
도 1c에 나타낸 바와 같이, 오배자 추출물의 DPPH 라디칼 소거능이 매우 높게 나타나 높은 항산화 활성을 나타냄을 확인하였다.As shown in Fig. 1 (c), DPPH radical scavenging activity of the extract of Opuntia mushroom was very high, indicating that it exhibited a high antioxidative activity.
실시예Example 3. 실험동물 사육 및 실험식이 3. Experimental animal breeding and empirical formula
실험동물은 SD (Sprague Dawley) 랫트 7주령 수컷을 구입하여 사용하였으며, 온도 23±2℃, 습도 50±10%, 12시간 명암조건에서 사육하였다. 실험동물은 구입 후 1주일 동안 순화한 다음, 각 군당 6마리씩을 배치하여 총 7군으로 실험군을 분류하였다. 실험군은 정상대조군(NO), 오배자 추출물 투여군(GEGR)(1000 ㎎/㎏), 로페라미드(loperamide) 투여군(Vehicle)(4 ㎎/㎏), 로페라미드+저농도 오배자 추출물 투여군(250 mg/kg)(LoGEGR), 로페라미드+중농도 오배자 추출물 투여군(500 ㎎/㎏)(MiGEGR), 로페라미드+고농도 오배자 추출물 투여군(1000 ㎎/㎏)(HiGEGR) 및 양성대조군(BS)으로 나누었다. 양성대조군으로는 변비치료제로 알려진 비코그린(Kolon Pharmaceuticals Inc., Gyenggido, Korea)을 이용하였다. 정상군을 제외한 모든 군에 대하여 4 ㎎/㎏의 용량의 로페라미드(Sigma, St. Louis, MO, USA)를 3일 동안 오전 9시와 오후 6시에 피하투여하여 변비를 유발하였고, 4일째 오전 9시에 각 시료를 경구투여하고 5일째 오전 9시에 안락사하여 실험을 실시하였다.Seven weeks old male Sprague Dawley (SD) rats were purchased and used for breeding at a temperature of 23 ± 2 ° C and a humidity of 50 ± 10% for 12 hours. The experimental animals were purified for 1 week after purchase, and then 6 animals were placed per group, and the experimental groups were classified into 7 groups. The experimental group was divided into two groups: normal control (NO), gigantoprine (GEGR) (1000 ㎎ / ㎏), loperamide (Vehicle) (4 ㎎ / ㎏), rofemide + (HiGEGR) and a positive control group (BS), respectively, compared with the control group (LoGEGR), rofemide + medium concentration group (500 ㎎ / ㎏) (MiGEGR) . As a positive control, Vikogreen (Kolon Pharmaceuticals Inc., Gyenggido, Korea), which is known as a constipation treatment agent, was used. Lipelamide (Sigma, St. Louis, Mo., USA) was administered subcutaneously at 9 o'clock and 6 o'clock for 3 days to all patients except for the normal group. Each sample was orally administered at 9:00 am on the first day and euthanized at 9:00 am on the fifth day.
실험예Experimental Example 1. 체중, 사료 섭취량 및 1. Weight, feed intake and 음수량Quantity of water 측정 Measure
상기 실시예 3의 각 실험군에 대하여 로페라미드를 처리하여 매일 오전 10시에 체중, 사료섭취량 및 음수량을 측정하였으며, 그 결과를 하기 표 1에 나타내었다.Each of the experimental groups of Example 3 was treated with looperamide, and the body weight, feed intake and the amount of insulin were measured daily at 10 am. The results are shown in Table 1 below.
표 1에 나타낸 바와 같이, 실험기간 동안의 사료 섭취량과 음수량은 로페라미드로 변비를 유발시킨 군(Vehicle)이 오배자 추출물 투여군(GEGR)보다 사료섭취량이 다소 감소하는 경향을 보였으나, 사료섭취량과, 음수량 및 몸무게는 통계적으로 각 군별로 유의적인 큰 차이는 없었다As shown in Table 1, the feed intake and the amount of insulin during the experimental period showed a tendency that the feed intake of the vehicle causing the constipation to rofeamid was slightly lower than that of the GEGR administered group, , And there was no statistically significant difference between the groups in terms of volume and weight
실험예Experimental Example 2. 변의 개수 및 변 중량 측정 2. Number of sides and variable weight measurement
상기 실시예 3의 각 실험군에 대하여 로페라미드 투여시작 후 3일째에 케이지 안의 깔집과 변을 깨끗하게 갈아준 후에 24시간 후에 변을 수거하였으며, 변의 개수 및 변의 중량을 측정하였으며, 그 결과를 하기 표 2에 나타내었다. For each of the experimental groups of Example 3, after 3 days from the start of administration of ropelamide, the bedding and sides of the cage were cleanly cleaned. After 24 hours, the sides were collected and the number of sides and the weight of the sides were measured. Respectively.
(a, P<0.05, b, P<0.05, 정상대조군과 비교, 이하 동일)(a, P < 0.05, b, P < 0.05,
변의 개수는 정상대조군(NO)이 40.3±1.5개에서 로페라미드 단독 투여 군(Vehicle)이 29.7±1.7개로 감소하여 로페라미드에 대한 변비유발이 확인되었고, 양성대조군(BS)에서는 50.8±2.3개로 로페라미드에 의한 변비유발이 억제된 것을 확인하였다. 또한 오배자 추출물의 농도의존적으로 변의 개수가 증가하는 경향을 보였고, 로페라미드+고농도 오배자 추출물 투여군(HiGEGR)은 BS군보다 더 많은 변의 개수가 관찰되어, 로페라미드 투여에 의해 감소된 변의 개수를 오배자 추출물이 완화시킨다는 것을 확인하였다. The number of stools was decreased from 40.3 ± 1.5 in the normal control group to 29.7 ± 1.7 in the vehicle alone group and was found to be 50.8 ± 2.3 in the positive control group And it was confirmed that the induction of constipation by the pyramid was suppressed by the open circuit. In addition, the number of stools tended to increase depending on the concentration of Rhus verniciflua extract, and the number of stools treated with ropheramide + high concentration of Rhus verniciflua extract (HiGEGR) was higher than that of BS, It was confirmed that Rhus verniciflua extract relaxes.
변의 중량 또한 오배자 추출물 투여군(LoGEGR, MiGEGR, HiGEGR)에서 농도의존적으로 증가되는 것을 확인하였다. (LoGEGR, MiGEGR, HiGEGR) in the control group.
실험예Experimental Example 3. 3. 대장관내Intestine 점액질의 분비효과 측정 Measuring secretion effect of mucus
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관을 10% 포름알데히드로 고정하여 조직처리 과정을 거치고 파라핀으로 embedding 하여 4 ㎛ 두께로 절편을 제작하였다. 그 후 H&E 및 Alcian blue(pH 2.5)로 염색하여 광학현미경으로 관찰하였으며, 그 결과를 도 2에 나타내었다.For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. The extracted large intestine was fixed with 10% formaldehyde, subjected to a tissue treatment process, and embedded in paraffin to prepare a slice with a thickness of 4 μm. Thereafter, the cells were stained with H & E and Alcian blue (pH 2.5) and observed with an optical microscope. The results are shown in FIG.
도 2에 나타낸 바와 같이, 정상대조군에 비하여 로페라미드 투여군에서 점액질이 감소되는 경향을 보였다. 반면에 양성대조군은 염색되는 점액질이 증가되는 것을 확인할 수 있었고, 오배자 추출물을 투여한 군에서는 농도별로 점액질이 증가되는 것을 확인하였다.As shown in FIG. 2, mucus tended to decrease in the roferamide-treated group compared to the normal control group. On the other hand, positive control group was found to increase the amount of mucin to be stained, and that of mucus extract group was increased by concentration.
실험예Experimental Example 4. 점막, 근육 및 평평한 내강 표면의 두께 측정 4. Measurement of thickness of mucosa, muscle and flat luminal surface
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관을 10% 포름알데히드로 고정하여 조직처리 과정을 거치고 파라핀으로 embedding 하여 4 ㎛ 두께로 절편을 제작하였다. 그 후 점막, 근육 및 평평한 내강 표면의 두께를 측정하였으며, 그 결과를 하기 표 3에 나타내었다.For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. The extracted large intestine was fixed with 10% formaldehyde, subjected to a tissue treatment process, and embedded in paraffin to prepare a slice with a thickness of 4 μm. The thickness of the mucosa, muscle and flat luminal surface was then measured and the results are shown in Table 3 below.
표 3에 나타낸 바와 같이, 점막, 근육 및 평평한 내강 표면의 두께는 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 감소하는 경향을 보였으며 양성대조군(BS)에서는 다시 회복되었다. 또한 오배자 추출물의 농도의존적으로 점막, 근육 및 평평한 내강 표면의 두께가 유의적으로 증가하는 것을 확인하였다.As shown in Table 3, the thickness of mucous membrane, muscle and flat luminal surface showed a tendency to decrease in rofemide alone group (vehicle) compared to normal control group (NO), and regained in positive control group (BS). In addition, it was confirmed that the thickness of mucous membrane, muscle and flat luminal surface was significantly increased depending on the concentration of Rhus verniciflua extract.
실험예Experimental Example 5. 배상세포 및 crypt의 수의 측정 5. Measurement of number of goblet cells and crypt
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관을 10% 포름알데히드로 고정하여 조직처리 과정을 거치고 파라핀으로 embedding 하여 4 ㎛ 두께로 절편을 제작하였다. 그 후 상기 절편에서 점액 준비세포인 배상세포(goblet cells)와 장선(crypt of lieberkuhn)의 수를 측정하였으며, 그 결과를 하기 표 4에 나타내었다. For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. The extracted large intestine was fixed with 10% formaldehyde, subjected to a tissue treatment process, and embedded in paraffin to prepare a slice with a thickness of 4 μm. Then, the number of goblet cells and crypts of lieberkhns, which are mucous preparation cells, was measured in the above section, and the results are shown in Table 4 below.
18.3a 271.7 ±
18.3 a
표 4에 나타낸 바와 같이, 배상세포 및 장선(crypt)의 수는 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 감소하는 경향을 보였으며 양성대조군(BS)에서는 다시 회복되었다. 또한 오배자 추출물의 농도의존적으로 배상세포 및 장선(crypt)의 수가 유의적으로 증가하는 것을 확인하였다.As shown in Table 4, the number of reperfusion cells and crypts tended to decrease in the rofemide alone group compared to the normal control group (NO), and recovered again in the positive control group (BS). In addition, it was confirmed that the number of goblet cells and crypts was significantly increased in a dose dependent manner.
실험예Experimental Example 6. 6. mAChRmAChR (( 무스카린성Muskarine Castle 아세틸콜린 수용체)의 발현량 측정 Acetylcholine receptor)
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관에서 mAChR(무스카린성 아세틸콜린 수용체)의 발현량을 측정하기 위하여 RNA를 추출하여 RT-PCR을 수행하였으며, 그 결과를 도 3에 나타내었다.For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. RNA was extracted and RT-PCR was performed to measure the expression level of mAChR (muscarinic acetylcholine receptor) in the extracted large bowel, and the results are shown in FIG.
도 3에 나타낸 바와 같이, mAChR의 발현은 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 감소하는 경향을 보였으며 양성대조군(BS)에서는 다시 회복되었다. 또한 오배자 추출물의 농도의존적으로 유의적으로 증가하는 것을 확인하였다.As shown in FIG. 3, the expression of mAChR tended to decrease in the rofemide alone group (vehicle) compared to the normal control group (NO), and regained in the positive control group (BS). In addition, it was confirmed that the concentration of Rhus verniciflua extract was significantly increased depending on the concentration.
실험예Experimental Example 7. 7. PKCPKC 및 And PI3KPI3K 의 발현량 측정Of expression level
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관에서 pPKC 및 pPI3K의 발현량을 측정하기 위하여 단백질을 추출하여 웨스턴 블롯을 수행하였으며, 그 결과를 도 4에 나타내었다.For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. In order to measure the expression levels of pPKC and pPI3K in the extracted large intestine, proteins were extracted and subjected to Western blotting. The results are shown in FIG.
도 4에 나타낸 바와 같이, pPKC의 발현은 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 감소하는 경향을 보였으며 양성대조군(BS)에서는 다시 회복되었다. 또한 오배자 추출물의 농도의존적으로 유의적으로 증가하는 것을 확인하였다.As shown in Fig. 4, the expression of pPKC tended to decrease in the rofemide alone group (vehicle) compared to the normal control group (NO), and regained in the positive control group (BS). In addition, it was confirmed that the concentration of Rhus verniciflua extract was significantly increased depending on the concentration.
반면, pPI3K의 발현은 로페라미드 단독 투여 군(Vehicle)과 양성대조군(BS)에서 높게 나타났으며, 오배자 추출물 투여군에서는 매우 낮은 것을 확인하였다.On the other hand, the expression of pPI3K was high in rofemide alone group and in positive control group (BS).
실험예Experimental Example 8. Gα 및 8. Ga and IP3IP3 발현량 측정 Measurement of expression level
상기 실시예 3의 각 실험군에 대하여 대장은 맹장 이후 부분부터 직장까지 부위의 양쪽을 적출하였다. 적출한 대장관에서 Gα의 발현량을 측정하기 위하여 단백질을 추출하여 웨스턴 블롯을 수행하였고, IP3의 발현량을 측정하기 위하여 IP3 분석 키트를 사용하여 흡광도를 측정하였으며, 그 결과를 도 5에 나타내었다.For each experimental group of Example 3, both sides of the colon from the posterior cecum to the rectum were excised. Proteins were extracted and Western blot was performed to measure the expression level of Gα in the extracted large intestine. Absorbance was measured using an IP3 assay kit to measure the expression level of IP3. The results are shown in FIG. 5 .
도 5에 나타낸 바와 같이, Gα의 발현은 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 증가하였으며, 양성대조군(BS) 및 오배자 추출물 투여군에서 다소 감소하는 경향을 확인하였다.As shown in FIG. 5, the expression of Gα was increased in rofemide alone group (vehicle) compared to the normal control group (NO), and a slight decrease was observed in the group administered with the positive control (BS)
반면, IP3의 발현은 정상대조군(NO)에 비하여 로페라미드 단독 투여 군(Vehicle)에서 감소하였으며 양성대조군(BS)에서는 다시 회복되었다. 또한 오배자 추출물의 농도의존적으로 유의적으로 증가하는 것을 확인하였다.On the other hand, the expression of IP3 decreased in the rofemide alone group (vehicle) compared to the normal control group (NO) and regained in the positive control group (BS). In addition, it was confirmed that the concentration of Rhus verniciflua extract was significantly increased depending on the concentration.
상기와 같이, 본 발명의 오배자 추출물은 변의 배변개수 및 중량을 증가시키고, 변 내 수분함량을 증가시켜 배변을 부드럽게 하며, 점막 및 근육의 두께를 증가시키고 점액 분비를 증가시켜 장 기능을 향상시킴으로써 변비를 개선하는 효과가 우수함을 실험을 통해 확인하였다.As described above, the rhizome extract of the present invention increases the number of bowel movements and weight, improves the bowel function by increasing moisture content in the bowel, enhances mucous membrane and muscle thickness, and increases mucous secretion, The results of this study are as follows.
이하 본 발명의 오배자 추출물을 함유하는 변비의 예방 또는 치료용 약학적 조성물 및 식품 조성물의 제제예를 설명하나, 본 발명을 한정하고자 함이 아닌 단지 구체적으로 설명하고자 함이다.Hereinafter, a pharmaceutical composition and a pharmaceutical composition for preventing or treating constipation containing the extract of Opuntia ficus, according to the present invention, will be described, but the present invention is not limited thereto but specifically described.
제제예 1. 약학적 제제의 제조Formulation Example 1. Preparation of pharmaceutical preparations
1-1. 1-1. 산제의Sanje 제조 Produce
오배자 추출물 20 mgLucie extract 20 mg
유당 100 mg
탈크 10 mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다.The above components are mixed and filled in airtight bags to prepare powders.
1-2. 정제의 제조1-2. Manufacture of tablets
오배자 추출물 10 mgOpuntia extract 10 mg
옥수수전분 100 mg
유당 100 mg
스테아린산 마그네슘 2 mg
상기의 성분들을 혼합한 후 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다.After mixing the above components, tablets are prepared by tableting according to the usual preparation method of tablets.
1-3. 캡슐제의 제조1-3. Preparation of capsules
오배자 추출물 10 mgOpuntia extract 10 mg
결정성 셀룰로오스 3 mgCrystalline cellulose 3 mg
락토오스 14.8 mgLactose 14.8 mg
마그네슘 스테아레이트 0.2 mgMagnesium stearate 0.2 mg
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 캡슐제를 제조한다.The above components are mixed according to a conventional capsule preparation method and filled in gelatin capsules to prepare capsules.
1-4. 주사제의 제조1-4. Injection preparation
오배자 추출물 10 mgOpuntia extract 10 mg
만니톨 180 mg180 mg mannitol
주사용 멸균 증류수 2974 mgSterile sterilized water for injection 2974 mg
Na2HPO4·2H2O 26 mgNa 2 HPO 4 .2H 2 O 26 mg
통상의 주사제의 제조방법에 따라 1 앰플당 (2 ml) 상기의 성분 함량으로 제조한다.(2 ml) per 1 ampoule in accordance with the usual injection preparation method.
1-5. 1-5. 액제의Liquid 제조 Produce
오배자 추출물 20 mgLucie extract 20 mg
이성화당 10 g10 g per isomer
만니톨 5 g5 g mannitol
정제수 적량Purified water quantity
통상의 액제의 제조방법에 따라 정제수에 각각의 성분을 가하여 용해시키고 레몬향을 적량 가한 다음 상기의 성분을 혼합한 다음 정제수를 가하여 전체를 100 ml로 조절한 후 갈색병에 충진하여 멸균시켜 액제를 제조한다.Each component was added and dissolved in purified water according to the usual liquid preparation method, the lemon flavor was added in an appropriate amount, the above components were mixed, and purified water was added to adjust the whole volume to 100 ml. Then, the solution was filled in a brown bottle and sterilized, .
제제예Formulation example 2. 식품 제제의 제조 2. Manufacture of food preparation
1-1. 건강식품의 제조1-1. Manufacture of health food
오배자 추출물 100 mgOpuntia extract 100 mg
비타민 혼합물 적량Vitamin mixture quantity
비타민 A 아세테이트 70 g 70 g of vitamin A acetate
비타민 E 1.0 mgVitamin E 1.0 mg
비타민 B1 0.13 mgVitamin B1 0.13 mg
비타민 B2 0.15 mg0.15 mg of vitamin B2
비타민 B6 0.5 mgVitamin B6 0.5 mg
비타민 B12 0.2 g 0.2 g of vitamin B12
비타민 C 10 mg
비오틴 10 g Biotin 10 g
니코틴산아미드 1.7 mgNicotinic acid amide 1.7 mg
엽산 50 g Folate 50 g
판토텐산 칼슘 0.5 mgCalcium pantothenate 0.5 mg
무기질 혼합물 적량Mineral mixture quantity
황산제1철 1.75 mg1.75 mg of ferrous sulfate
산화아연 0.82 mg0.82 mg of zinc oxide
탄산마그네슘 25.3 mgMagnesium carbonate 25.3 mg
제1인산칼륨 15 mgPotassium monophosphate 15 mg
제2인산칼슘 55 mgSecondary calcium phosphate 55 mg
구연산칼륨 90 mgPotassium citrate 90 mg
탄산칼슘 100 mg
염화마그네슘 24.8 mgMagnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 건강식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 건강식품 제조방법에 따라 상기의 성분을 혼합한 다음, 과립을 제조하고, 통상의 방법에 따라 건강식품 조성물 제조에 사용할 수 있다.Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.
2-2. 2-2. 건강음료의Health drink 제조 Produce
오배자 추출물 100 mgOpuntia extract 100 mg
비타민 C 15 gVitamin C 15 g
비타민 E(분말) 100 gVitamin E (powder) 100 g
젖산철 19.75 g19.75 g of ferrous lactate
산화아연 3.5 g3.5 g of zinc oxide
니코틴산아미드 3.5 gNicotinic acid amide 3.5 g
비타민 A 0.2 gVitamin A 0.2 g
비타민 B1 0.25 gVitamin B1 0.25 g
비타민 B2 0.3gVitamin B2 0.3g
물 정량Water quantification
통상의 건강음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1시간 동안 85℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2 l 용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 건강음료 조성물 제조에 사용한다.The above components were mixed according to a conventional health drink manufacturing method, and the mixture was stirred and heated at 85 DEG C for about 1 hour. The solution thus prepared was filtered and sterilized in a sterilized 2 liter container, It is used in the production of the health beverage composition of the invention.
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만 수요계층이나, 수요국가, 사용용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다.Although the compositional ratio is relatively mixed with a component suitable for a favorite drink, it is also possible to arbitrarily modify the compounding ratio according to the regional or national preference such as the demand class, the demanding country, and the use purpose.
Claims (9)
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