KR100496019B1 - γ-oryzanol with reducing effect on blood glucose level - Google Patents
γ-oryzanol with reducing effect on blood glucose level Download PDFInfo
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- KR100496019B1 KR100496019B1 KR10-2002-0042544A KR20020042544A KR100496019B1 KR 100496019 B1 KR100496019 B1 KR 100496019B1 KR 20020042544 A KR20020042544 A KR 20020042544A KR 100496019 B1 KR100496019 B1 KR 100496019B1
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- oryzanol
- blood sugar
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- 231100000344 non-irritating Toxicity 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 239000000312 peanut oil Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 235000020183 skimmed milk Nutrition 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 235000011069 sorbitan monooleate Nutrition 0.000 description 1
- 239000001593 sorbitan monooleate Substances 0.000 description 1
- 229940035049 sorbitan monooleate Drugs 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229940083466 soybean lecithin Drugs 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
-
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
-
- 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
- A23V2200/328—Foods, ingredients or supplements having a functional effect on health having effect on glycaemic control and diabetes
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Botany (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Public Health (AREA)
- Nutrition Science (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Medicines Containing Plant Substances (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Steroid Compounds (AREA)
Abstract
본 발명은 버려지는 쌀겨로부터 추출한 감마 오리자놀이 혈당 저하 효과를 가지는 것을 밝혀내고 이를 우리나라에서 유병율과 사망률의 증가로 인해 사회·경제적 차원에서 문제가 되고 있는 당뇨병 환자의 혈당을 저하시키는데 적용하는 것이다.The present invention finds that gamma oryzanole extracted from discarded rice bran has a hypoglycemic effect and applies it to lowering blood sugar of diabetic patients, which is a problem in the socio-economic dimension due to an increase in prevalence and mortality in Korea.
또한 본 발명은 감마 오리자놀을 당뇨병 환자의 혈당을 감소시키는 유효성분으로 사용하는 약학적 제제 및 건강보조식품에 관한 것이다.The present invention also relates to pharmaceutical preparations and dietary supplements using gamma oryzanol as an active ingredient to reduce blood sugar levels in diabetic patients.
Description
본 발명은 감마 오리자놀이 혈당저하 효과가 있음을 발견하고, 상기 감마 오리자놀을 혈당을 저하시키는 유효성분으로 함유하는 약학적 제제에 관한 것이다.The present invention finds that gamma oryzanole has a hypoglycemic effect, and relates to a pharmaceutical formulation containing the gamma oryzanol as an active ingredient for lowering blood sugar.
우리나라에서 당뇨병 유병율 및 사망률의 증가는 잘 알려진 사실로 당뇨병은 암 및 순환기계 질환과 더불어 3대 질병의 하나로 지목되고 있으며, 혈당조절이 잘 되지 않은 환자에서는 동맥경화 등의 합병증도 동반하므로 당뇨병에 관련된 문제는 개인뿐 아니라 사회·경제적 차원에서 미치는 영향이 심각하다.The increase in diabetes prevalence and mortality rate is well known in Korea. Diabetes is one of the three major diseases in addition to cancer and circulatory disease. In addition, patients with poor blood sugar control have complications such as arteriosclerosis. The problem is that the impact on the socio-economic level as well as the individual is serious.
당뇨병 관리의 목적은 정상 혈당 유지와 합병증을 예방하는데 있으며, 각종 혈당강하제와 인슐린 등의 약제가 많이 이용되고 있으나 각종 부작용과 당뇨병 환자들에게 거부감이 보고되고 있고 최근에는 췌장을 이식하는 수술 등이 개발되었으나 일반화되기에는 상당한 시간이 소요될 것으로 보고 있다.The purpose of diabetes management is to maintain normal blood sugar and prevent complications. Various drugs such as hypoglycemic agents and insulins are used, but various side effects and rejection have been reported for diabetics. Recently, surgery for transplanting the pancreas has been developed. However, it is expected to take considerable time to generalize.
당뇨병 제형은 현재 주로 주사형태로 제조되어서 환자가 직접 투여할 수 없어 병원으로 직접 가야하는 문제점이 있었다. 최근에는 개인이 집에서 주사 가능하기는 하나 주사후 혈당이 급격히 낮아질 수 있고, 시간, 주사용량을 확인하여야 하며, 주사 위치를 바꾸는 등 번거로운 점이 많아 스트레스가 되고 있다.Diabetic formulations are currently produced mainly in the form of injections, so there is a problem in that patients cannot directly administer to the hospital. Recently, the individual can be injected at home, but blood sugar can be drastically lowered after the injection, time, and dosage should be checked, and the cumbersome points such as changing the injection location are becoming stressful.
일반적으로 감마 오리자놀은 쌀겨에 많이 함유되어 있으며, 항산화력이 높아 식품의 안정성을 높이기 위해 사용되었다. 또한 감마 오리자놀은 주로 폐경과 콜레스테롤 수치 상승, 다양한 위장관 질병들의 치료제로만 사용되어 왔을 뿐 혈당강하 작용에 대해서는 지금까지 알려진 바가 없었고, 당뇨병 치료제로는 사용되지 않고 있었다.In general, gamma-orizanol is high in rice bran and its high antioxidant power has been used to enhance food stability. In addition, gamma-orizanol has been used mainly for the treatment of menopause, elevated cholesterol levels, and various gastrointestinal diseases, but it has not been known about the hypoglycemic effect, and it has not been used for the treatment of diabetes.
이에 본 발명자들은 부작용이 적고 환자들에게 거부감을 주지 않으면서 혈당을 감소시키는 성분들을 연구하던 중, 버려지는 쌀겨에서 추출한 감마 오리자놀이 혈당 저하 효과를 가짐을 발견하고, 감마 오리자놀을 혈당을 감소시키는 유효성분으로 사용함으로써 본 발명을 완성하게 되었다.Accordingly, the inventors of the present invention, while studying the components that reduce the blood sugar without side effects and without objection to the patient, found that gamma oryzanole extracted from discarded rice bran has a hypoglycemic effect, and gamma oryzanol is effective in reducing blood glucose. By using it as a component, this invention was completed.
따라서 본 발명에서는 감마 오리자놀을 혈당을 감소시키는 유효성분으로 함유하는 당뇨병 치료제 및 건강보조식품을 제공하고자 한다.Therefore, the present invention is to provide a diabetic therapeutic agent and dietary supplement containing gamma oryzanol as an active ingredient for reducing blood sugar.
본 발명은 당뇨병 치료 및 관리를 목적으로 이용되고 있는 각종 약제나 수술에서 나타날 수 있는 문제점을 보완하기 위하여 안출한 것으로, 안전성이 이미 검토된 천연물질 중에서 혈당 저하 효과가 있을 것으로 추정되는 물질을 탐색하였고, 당뇨병 모델에서 혈당 관련 요인인 공복 및 비공복 혈당, 장기적인 혈당 상태 지표인 당화혈색소 그리고 인슐린 수준에 영향을 줄 수 있음을 확인한 후 혈당저하 효과를 가지는 기능성 식품을 제공하고자 하는 것이다. The present invention was devised to supplement the problems that may occur in various drugs or surgery that are used for the treatment and management of diabetes mellitus, and searched for substances suspected of having a hypoglycemic effect among natural substances whose safety has already been examined. In the diabetes model, it is intended to provide functional foods having hypoglycemic effects after confirming that blood glucose-related factors such as fasting and non-fasting blood sugars, glycated hemoglobin as long-term glycemic state indicators, and insulin levels may be affected.
특히, 경구형으로 투여가능하며, 아울러 식품 등에도 첨가가 가능한 당뇨병 치료제를 제공하고자 한다. In particular, the present invention is to provide a therapeutic agent for diabetes that can be administered orally and can be added to foods.
본 발명은 감마 오리자놀을 유효성분으로 함유하는 당뇨병 치료용 약제 및 식품 조성물을 제공한다. 본 발명에 있어서 상기 감마 오리자놀은 버려지는 쌀겨에서 추출하여 이용할 수 있는데, 이 경우, 부산물의 부가가치를 향상시킬 수 있다.The present invention provides a pharmaceutical and food composition for treating diabetes containing gamma-orizanol as an active ingredient. In the present invention, the gamma oryzanol can be extracted and used in the discarded rice bran, in which case, it is possible to improve the added value of the by-products.
본 발명에서는 약학적 제제 조성물 총 중량에 대하여 감마 오리자놀을 1∼50 중량%로 함유하는 것을 특징으로 한다.The present invention is characterized by containing 1 to 50% by weight of gamma-orizanol relative to the total weight of the pharmaceutical formulation composition.
본 발명에서 사용한 감마 오리자놀은 일본 Wako pure chemical industries사에서 제조한 γ-오리자놀을 사용하였다.The gamma oryzanol used in the present invention used γ-orizanol manufactured by Wako pure chemical industries in Japan.
또한 본 발명에 따른 약학적 제제의 제형에는 특별히 한정되지 않으나, 경구투여용으로 구강용 또는 주사약제가 가능하며, 식품 첨가물로도 사용할 수 있다.In addition, the formulation of the pharmaceutical preparations according to the present invention is not particularly limited, oral or injectable pharmaceuticals may be used for oral administration, and may also be used as food additives.
본 발명의 조성물은 오일 또는 수성매질에서 용액, 현탁액 또는 유화액의 형태가 되거나, 사용하기 전에 무균, 발열물질이 제거된 물로 녹여 사용하는 건조분말의 형태가 되어 경구용 제형, 피하주사, 정맥주사, 근육주사 등의 비경구형 제형으로 제형화할 수 있다.The composition of the present invention may be in the form of a solution, suspension or emulsion in oil or an aqueous medium, or in the form of a dry powder which is dissolved in sterile, pyrogen-free water before use, oral formulation, subcutaneous injection, intravenous injection, It may be formulated into parenteral formulations such as intramuscular injection.
경구용 제형의 경우, 본 발명의 조성물은 약제학적으로 허용 가능한 담체와 부형제를 이용하여 공지의 방법으로, 예를 들면, 정제, 트로키제, 함당정제, 수성 또는 유성 현탁액, 분산가능 가루 혹은 입자, 유화액, 연질 혹은 경질 캡슐, 시럽, 일릭서와 같은 형태로 제제화되며, 이는 단위 투여량 형태 및 다용량 용기에 담아서 완성품을 제조할 수 있다. In the case of oral formulations, the compositions of the present invention may be prepared by known methods using pharmaceutically acceptable carriers and excipients, for example tablets, troches, sugar-containing tablets, aqueous or oily suspensions, dispersible flours or particles. , Emulsions, soft or hard capsules, syrups, elixirs, and the like, which can be prepared in unit dosage form and in multi-dose containers to produce the finished product.
경구용 제형 중, 정제는 탄산칼슘, 탄산나트륨, 락토스, 인산칼슘, 인산나트륨 등의 불활성 희석제; 옥수수, 녹말, 알긴산 등의 입자화제; 붕해제; 녹말, 젤라틴, 아카시아 등의 결합제; 스테아르산마그네슘(magnesium stearate), 스테아르산, 탈크 등의 윤활제와 같이, 정제의 제조에 사용 가능한 부형제와 섞여진 상태로 제조될 수 있다. 정제는 코팅되지 않은 상태로 사용하거나, 위장관내의 흡수와 정제의 분해를 저해하기 위해 코팅하여 사용될 수 있다. 예를 들어, 글리세릴모노스테아레이트와 글리세릴디스테아레이트 등의 시간 저해 물질을 적용해도 좋다. 경질캅셀은 본 발명의 화합물을 탄산칼슘, 인산칼슘, 카올린 등의 불활성 고체 희석제에 섞은 것이고, 연질캅셀은 물이나 혼합이 가능한 폴리프로필렌글리콜(polypropylene glycol), PEGs(polyethylene glycol), 에탄올 등의 용매와 땅콩기름, 액상 파라핀, 올리브 오일등의 기름 용매에 활성성분을 섞은 것이다. In oral formulations, tablets may be inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate, sodium phosphate; Granulating agents such as corn, starch and alginic acid; Disintegrants; Binders such as starch, gelatin and acacia; It may be prepared in admixture with excipients usable for the manufacture of tablets, such as lubricants such as magnesium stearate, stearic acid, talc and the like. Tablets can be used uncoated or coated to inhibit absorption and degradation of the tablets in the gastrointestinal tract. For example, you may apply time inhibiting substances, such as glyceryl monostearate and glyceryl distearate. Hard capsule is a compound of the present invention is mixed with an inert solid diluent such as calcium carbonate, calcium phosphate, kaolin, etc., soft capsule is a solvent such as polypropylene glycol, PEGs (polyethylene glycol), ethanol, etc. that can be mixed with water And the active ingredients in oil solvents such as peanut oil, liquid paraffin and olive oil.
수용성 현탁제는 수용성 현탁제 제조에 적당한 부형제와 활성 성분을 함께 혼합한 것으로, 부형제로는, 예를 들면, 나트륨카르복시메틸셀룰로오스, 메틸셀룰로오스, 히드록시-프로필메틸셀룰로오스, 알긴산나트륨, 폴리비닐-피롤리돈, 트래거캔스검(gum tragacanth), 아카시아검(gum acacia) 등의 현탁화제; 폴리옥시에틸렌스테아레이트와 같은 지방산과 알킬렌 옥사이드를 축합한 화합물들; 헵타데카에틸렌옥시세탄올(heptadecaethyleneoxycetanol)과 같이 긴 지방산에 알킬렌 옥사이드를 축합한 화합물들; 폴리옥시에틸렌소르비톨모노올레이트와 같이 무수헥시톨(hexitol anhydride)과 지방산에서 유래한 부분 에스테르를 에틸렌 옥사이드와 축합한 화합물들; 습윤제; 또는 분산화제 등이 있다. 수용성 현탁제는 방부제, 착색제, 향신료, 감미료 등을 함유한다.The water-soluble suspending agent is a mixture of excipients and active ingredients suitable for the preparation of water-soluble suspending agents. Excipients include, for example, sodium carboxymethyl cellulose, methyl cellulose, hydroxy-propyl methyl cellulose, sodium alginate, polyvinyl-pi Suspending agents such as ralidone, gum tragacanth, gum acacia and the like; Compounds condensing fatty acids such as polyoxyethylene stearate and alkylene oxides; Compounds in which alkylene oxides are condensed with long fatty acids such as heptadecaethyleneoxycetanol; Compounds which condensate partial esters derived from anhydrous hexitol anhydride and fatty acids, such as polyoxyethylene sorbitol monooleate, with ethylene oxide; Wetting agents; Or dispersing agents. Water-soluble suspensions contain preservatives, colorants, spices, sweeteners and the like.
유성 현탁제는 올리브유, 세사미유(sesami oil) 등의 식물성 오일 또는 액상 파라핀 같은 광물성 오일에 활성 성분을 현탁시킨 것으로, 예를 들어 비즈왁스, 경화 파라핀, 세틸 알코올 등의 농후제(thickening agent)를 함유한다. 또한, 방부제, 착색제, 향신료, 감미료 등을 함유하는데, 이러한 조성은 비타민 C 같은 항산화제를 가하여 보존할 수 있다.The oily suspension is a suspension of an active ingredient in a vegetable oil such as olive oil, sesami oil, or a mineral oil such as liquid paraffin. For example, a thickening agent such as beeswax, hardened paraffin, cetyl alcohol, etc. may be used. It contains. It also contains preservatives, colorants, spices, sweeteners and the like, which can be preserved by adding antioxidants such as vitamin C.
분산성의 파우더와 입자는 분산화제, 습윤제, 현탁화제, 보존제 등을 넣어 함께 혼합한 상태로 활성 성분을 가지고 있다. 적절한 분산화제, 습윤제나 현탁화제는 앞서 이미 언급한 것을 예로 들 수 있다. 부가적인 부형제는, 예를 들어, 감미료, 향신료, 착색제 등이 있다.Dispersible powders and particles have an active ingredient in a state in which a dispersing agent, a wetting agent, a suspending agent, a preservative and the like are mixed together. Suitable dispersing, wetting or suspending agents can be mentioned by way of example already mentioned above. Additional excipients are, for example, sweeteners, spices, colorants and the like.
유중수형 유화액은 올리브유 같은 식물성 기름 또는 액상 파라핀 같은 광물성 오일을 유상으로 하고, 대두레시틴(soy bean lecithin) 등의 자연산 인지질, 소르비탄모노올레이트와 같은 무수헤시톨이나 지방산의 에스테르에서 유래된 것, 리옥시에틸렌소르비톨모노올레이트와 같이 무수헥시톨(hexitol anhydride)과 지방산에서 유래한 부분 에스테르를 에틸렌 옥사이드와 축합한 화합물들을 유화제로하여 활성성분을 유화시킨 것 등이 있다. Water-in-oil emulsions are derived from vegetable oils such as olive oil or mineral oils such as liquid paraffin, and are derived from natural phospholipids such as soy bean lecithin, and esters of anhydrous hecitol or fatty acids such as sorbitan monooleate. And compounds obtained by condensation of ethylene oxide with partial esters derived from anhydrous hexitol anhydride and fatty acids, such as lyoxyethylene sorbitol monooleate, as emulsifiers.
시럽과 일릭서는 글리세롤, 프로필렌글리콜, 소르비톨, 슈크로스 등의 감미료와 함께 활성성분을 혼합하여 제조될 수 있다. Syrups and elixirs can be prepared by mixing the active ingredient with sweeteners such as glycerol, propylene glycol, sorbitol, sucrose and the like.
비경구형 제형은 멸균된 주사 가능 용액 혹은 무독성의 사용가능한 희석제나 용매, 예를들어 1,3-부탄디올 등의 용매에 활성성분을 현탁시킨 현탁액으로 제제화하여 주사할 수 있다. 사용 가능한 부형제나 용매중에는 물, 링거액 그리고 등장성 식염수 용액이 있다. 또한, 에탄올, 폴리에틸렌글리콜, 폴리프로필렌글리콜 같은 공용매를 사용할 수 있다. 또한, 멸균된 비휘발성 오일을 관습적으로 용매 혹은 현탁 용매로 사용할 수 있다. 이런 목적으로 섞는 무자극, 비휘발성 오일(bland fixed oil)은 합성 모노-, 디-글리세라이드를 포함하여 사용한다. 또한, 올레인산과 같은 지방산을 주사제 마련에 사용할 수 있다. 좌제 형태는 약물을 상온에서는 고체였다가 직장내의 온도에서는 액체가 되어 직장내에서 녹아 약물을 방출하게 하는 적절한 무자극성 부형제, 예를 들면, 코코아버터, 폴리에틸렌글리콜과 혼합하여, 제제화한 후, 직장에 투여할 수 있다. Parenteral formulations may be injected by injection into a sterile injectable solution or a suspension in which the active ingredient is suspended in a non-toxic usable diluent or solvent such as 1,3-butanediol. Among the excipients or solvents available are water, Ringer's solution and isotonic saline solution. Cosolvents such as ethanol, polyethylene glycol, and polypropylene glycol can also be used. In addition, sterile, nonvolatile oils can be customarily used as solvents or suspending solvents. Mixed, non-stimulating, bland fixed oils for this purpose include synthetic mono- and diglycerides. In addition, fatty acids such as oleic acid can be used for the preparation of injectables. The suppository form is formulated by mixing the drug with a suitable non-irritating excipient, e.g. cocoa butter, polyethylene glycol, which is solid at room temperature but liquid at the rectal temperature and will melt in the rectum to release the drug. May be administered.
식품 첨가물로는 음료수, 제빵, 드링크, 유지류, 아이스크림, 과자, 떡, 스넥류, 이유식, 주류, 조미료류, 레토르트, 통조림 등 각종 조리가공식품류를 포함한다.Food additives include beverages, baking, drinks, oils, ice cream, sweets, rice cakes, snacks, baby foods, alcoholic beverages, seasonings, retorts, canned foods.
이하 실시예를 들어 본 발명을 상세히 설명하지만, 본 발명이 이들 실시예로만 한정되는 것은 아니다.Hereinafter, the present invention will be described in detail with reference to Examples, but the present invention is not limited to these Examples.
[제조예 1] 빵의 제조Production Example 1 Production of Bread
감마 오리자놀 5.0 중량%, 밀가루 65.0 중량%, 설탕 4.2 중량%, 소금 0.6 중량% 및 이스트 1.5 중량%를 첨가하여 물 23.7 중량%와 함께 반죽을 만들었다. 상기 반죽을 37℃에서 4시간동안 발효한 후 180℃에서 40분동안 가열하여 빵을 제조하였다.A dough was prepared with 23.7 wt% water by adding 5.0 wt% gamma oryzanol, 65.0 wt% flour, 4.2 wt% sugar, 0.6 wt% salt and 1.5 wt% yeast. The dough was fermented at 37 ° C. for 4 hours and then heated at 180 ° C. for 40 minutes to prepare bread.
[제조예 2] 아이스크림의 제조Preparation Example 2 Preparation of Ice Cream
감마 오리자놀 0.5 중량%, 생크림(35%) 18 중량%, 혼합탈지분유 11 중량%, 아이스당 6 중량%, 유화안정제(구아검 22.5 중량%, 로커스트빈검 19.5 중량%, 카라기난 4.5 중량%, 타마린드검 3.5 중량%, 글리세린 지방산 에스테르 50 중량%) 0.2 중량%, 정백당 10 중량%, 정제수 54.3 중량%를 넣고 통상적인 아이스크림 제조 공정에 따라 감마 오리자놀을 함유한 아이스크림을 제조하였다.Gamma Orizanol 0.5 wt%, fresh cream (35%) 18 wt%, mixed skim milk powder 11 wt%, ice sugar 6 wt%, emulsifying stabilizer (guar gum 22.5 wt%, locust bean gum 19.5 wt%, carrageenan 4.5 wt%, tamarind 3.5% by weight of gum, 50% by weight of glycerin fatty acid ester) 0.2% by weight, 10% by weight per pure water, 54.3% by weight of purified water was prepared according to the conventional ice cream manufacturing process ice cream containing gamma oryzanol.
[제조예 3] 시리얼 우유의 제조Production Example 3 Production of Cereal Milk
감마 오리자놀 2.5 중량%, 산마 0.12 중량%, 찹쌀현미 0.2 중량% 및 율뮤 0.12 중량%에 우유 92.56 중량%를 섞어 혼합하고, 여기에 과당 2.4 중량%, 설탕 2.0 중량% 및 죽염 0.1 중량%를 첨가하여 교반하면서 혼합하였다. 혼합이 완료된 후, 균질기를 통과시켜 균질을 하고, 130℃에서 3초간 살균한 후 냉각하여 감마 오리자놀을 함유하는 우유를 제조하였다.2.5% by weight of gamma oryzanol, 0.12% by weight of wild yam, 0.2% by weight of brown rice and 0.12% by weight of yulmu were mixed with 92.56% by weight of milk, 2.4% by weight of fructose, 2.0% by weight of sugar and 0.1% by weight of bamboo salt Mix with stirring. After mixing was completed, the mixture was passed through a homogenizer, homogenized, sterilized at 130 ° C. for 3 seconds, and cooled to prepare a milk containing gamma-orizanol.
[시험예 1][Test Example 1]
본 실험에서는 생후 3개월된 100 마리의 수컷 KK 마우스에 대두유 20%로 배합한 고지방식이를 2주간 급여하여 당뇨를 발현시켰고, 비공복 혈당이 200㎎/dl 이상인 당뇨 마우스 40마리를 혈당 및 체중을 고려하여 20마리씩 완전 임의배치하여 2군으로 나누어 사용하였다. 두 개의 실험군 중 한 군에는 감마 오리자놀 무첨가식이를 그리고 다른 한 군에는 0.2%의 감마 오리자놀 첨가식이를 8주간 급여하면서 식이 및 물 섭취량을 주 2∼3회 조사하였고, 공복 및 비공복 혈당과 체중은 주 1회 일정한 시간에 측정하였으며, 감마 오리자놀 급여 8주째에 내당능을 조사하였다. 혈당은 미정맥에서 측정하였고, 내당능 시험은 14시간 절식시킨 실험동물의 복강에 포도당(30g/100㎖)을 0.3g/100g 수준이 되도록 500㎕ 이하 수준에서 투여전, 투여한 후 30분과 120분의 혈당을 미정맥에서 blood glucose sensor(Medisense, USA)로 측정하였으며 혈당면적(glucose area)은 내당능 검사시 측정된 혈당 반응 곡선에서 곡선 아래 면적으로 계산하였다. 일반적인 안전성 항목으로 당뇨 마우스의 간, 심장 및 신장 무게를 조사하였고, 혈액 일부는 EDTA 처리된 시험관에 담아 4℃에서 냉장보관하였다가 1주일 이내에 당화혈색소 분석용으로 사용하였으며, 나머지는 3000rpm에서 20분간 원심분리한 후 혈청 인슐린 농도 분석에 사용하였다. 장기간의 혈당상태 지표로서 당화혈색소 농도는 MicromatTM Ⅱ hemoglobin A1C Test Catridge로 분석하였고, 혈청 인슐린 수준은 rat insulin specific radioimmunoassay(RIA) kit(Linco, USA)를 가지고 γ-counter(Cobra, USA)로 측정하였다. 분석자료는 SAS 프로그램을 이용하여 분석한 후 평균과 표준오차로 제시하였으며, 그 결과를 표 1에 나타내었다.In this experiment, 100-year-old male KK mice were fed high-fat diet containing 20% soybean oil for 2 weeks to express diabetes. 40 diabetic mice with non-fasting blood glucose of 200 mg / dl or more were fed with blood sugar and body weight. In consideration of this, 20 animals were completely randomized and used in two groups. Dietary and water intakes were examined two to three times per week for eight weeks with one diet containing no gamma oryzanol-free diet and the other group with a 0.2% gamma oryzanol diet. Measured once a week at a fixed time, glucose tolerance was examined at the 8th week of gamma-orizanol supplementation. Blood glucose was measured in the vein, and the glucose tolerance test was performed for 30 hours and 120 minutes before and after administration at the level of 500 μl or less so that glucose (30g / 100mL) was 0.3g / 100g level in the abdominal cavity of the animals fasted for 14 hours. Blood glucose was measured by the blood glucose sensor (Medisense, USA) in the vein and the glucose area was calculated by the area under the curve from the blood glucose response curve measured during the glucose tolerance test. As a general safety item, liver, heart and kidney weights of diabetic mice were examined, and some blood was stored in EDTA-treated test tubes and refrigerated at 4 ° C for analysis of glycated hemoglobin within one week, and the rest was used for 20 minutes at 3000 rpm. After centrifugation it was used for serum insulin concentration analysis. The glycated hemoglobin concentration was analyzed by Micromat TM Ⅱ hemoglobin A 1C Test Catridge as an indicator of long-term blood glucose levels. Measured. The analytical data were analyzed using SAS program and presented as mean and standard error. The results are shown in Table 1.
* 식이효율 = 체중증가량/식이섭취량* Dietary efficiency = weight gain / dietary intake
상기 표 1에서 보여주는 바와 같이 쌀겨에서 추출한 감마 오리자놀을 당뇨병 마우스에게 급여하였을 때, 식이 및 물 섭취량과 체중증가량 그리고 식이 섭취량과 체중증가량으로부터 계산한 식이 효율은 대조군과 큰 차이를 보이지 않았다. 그리고 표 2에서와 같이 간, 심장 및 신장의 무게도 감마 오리자놀 첨가군에서 큰 차이가 없어 감마 오리자놀은 식이섭취량이나 조직의 무게를 비롯한 동물의 일반적인 성장 및 안전성 항목에 영향을 미치지 않는 것으로 보인다.As shown in Table 1, when gamma oryzanol extracted from rice bran was fed to diabetic mice, the dietary efficiency calculated from the dietary and water intake and weight gain, and the dietary intake and weight gain did not show a significant difference from the control group. As shown in Table 2, the weights of liver, heart and kidney were also not significantly different in the gamma-orizanol-added group, so gamma-orizanol did not appear to affect the general growth and safety items of animals, including dietary intake or tissue weight.
표 3은 감마 오리자놀의 혈당 저하 효과를 보여주는 것으로 당뇨 마우스에게 감마 오리자놀을 실험식이의 0.2% 수준에서 8주간 급여하였을 때, 공복 혈당이 31%, 비공복 혈당이 15%, 장기간의 혈당농도 지표인 당화혈색소의 수준이 7% 낮아졌고, 내당능이 개선되어 혈당면적이 26% 감소하였으며 혈청 인슐린 수준은 86% 증가한 것으로 나타났다.Table 3 shows the hypoglycemic effects of gamma-orizanol. When diabetic mice were fed gamma-orizanol for 8 weeks at the 0.2% level of the experimental diet, fasting blood sugar levels were 31%, non-fasting blood sugar levels were 15%, and long-term blood glucose concentration indexes. The glycated hemoglobin level was reduced by 7%, glucose tolerance improved by 26%, and serum insulin level was increased by 86%.
최근 천연 건강보조 및 기능성 식품에 대한 선호도가 높아짐에 따라 천연 식물성 원료가 함유하는 기능 성분의 분리 및 확인 연구가 활발히 이루어지고 있으나 우리가 매일 섭취하는 쌀의 도정과정에서 생산되는 쌀겨로부터 혈당 관련 인자를 찾으려는 노력은 거의 없었다. 그러나 시험결과 감마 오리자놀은 혈당 저하 효과가 있는 것으로 나타나 각종 건강보조 및 기능성 식품에 이용되어 당뇨병 환자의 혈당 조절에 기여하고 부산물의 부가가치 향상에도 도움이 될 것으로 보인다.Recently, as the preference for natural health supplements and functional foods has increased, studies on the separation and identification of functional ingredients contained in natural plant raw materials have been actively conducted.However, blood sugar-related factors from rice bran produced during the milling process There was little effort to find. However, as a result of the test, gamma-orizanol has a hypoglycemic effect, which may be used in various health supplements and functional foods to contribute to glycemic control of diabetics and to improve the added value of by-products.
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