KR101346244B1 - Composition for preventing or relieving alcohol-induced hangover comprising medicinal herbs - Google Patents
Composition for preventing or relieving alcohol-induced hangover comprising medicinal herbs Download PDFInfo
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- KR101346244B1 KR101346244B1 KR1020110064928A KR20110064928A KR101346244B1 KR 101346244 B1 KR101346244 B1 KR 101346244B1 KR 1020110064928 A KR1020110064928 A KR 1020110064928A KR 20110064928 A KR20110064928 A KR 20110064928A KR 101346244 B1 KR101346244 B1 KR 101346244B1
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Abstract
본 발명은 혼합 생약 제제를 유효성분으로 포함하는 숙취 해소용 조성물 및 알코올성 지방간 치료용 조성물에 관한 것이다. 구체적으로, 본 발명의 조성물은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 후박, 감초, 생강, 대추 및 헛깨를 유효성분으로 함유하여, 알코올 섭취 전 또는 후에 투여하는 경우 생체 내 알코올 대사를 촉진하여 혈중 알코올 농도를 신속하게 저하시킴으로써 숙취 해소 효과 또는 알코올성 간질환의 예방 또는 치료 효과를 나타낼 수 있다. The present invention relates to a hangover relief composition and alcoholic fatty liver treatment composition comprising a mixed herbal preparation as an active ingredient. Specifically, the composition of the present invention contains black shaft, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, sine, creation, thick, licorice, ginger, jujube and flatulose as an active ingredient, administered before or after alcohol intake In this case, by promoting alcohol metabolism in vivo, the blood alcohol concentration can be rapidly lowered, thereby reducing hangover or preventing or treating alcoholic liver disease.
Description
본 발명은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 유효성분으로 포함하는 숙취 예방 또는 해소용 조성물, 알코올성 간질환의 예방 또는 치료용 조성물, 및 그의 제조 방법에 관한 것이다. The present invention is a composition for preventing or eliminating hangovers, including prevention of alcoholic liver disease, including black shaft, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, autograph, creation, ginger, jujube, flatulence, black pepper, and licorice as an active ingredient. Or a therapeutic composition, and a method for producing the same.
현대인들은 그 정도가 지나쳐 소화할 수 없을 정도의 과량의 알코올을 섭취하여, 그로 인한 부작용인 갈증, 전신 권태, 피로감, 기억 상실, 복부 팽만감, 소화 불량, 구토, 설사, 비타민 결핍 현상 등의 숙취 현상으로 고생하는 경우가 많고, 알코올에 기인한 만성적 질환의 발병률도 증가하고 있다. 예를 들면, 알코올성 간질환 (간경변, 지방간, 간암 등)을 일으키거나, 락테이트 축적에 의한 피로 축적, 고혈당증 (hyperglycemia), 알코올성 간염 (alcoholic hepatitis), 기억력 감퇴, 집중력 감소, 감수성 저하 등의 여러 가지 병변 현상을 유발한다.Modern people consume excessive amounts of alcohol that can't be digested, resulting in hangover symptoms such as thirst, systemic boredom, fatigue, memory loss, abdominal bloating, indigestion, vomiting, diarrhea and vitamin deficiency. In many cases, the incidence of chronic diseases due to alcohol is also increasing. For example, alcoholic liver disease (liver cirrhosis, fatty liver, liver cancer, etc.), fatigue accumulation due to lactate accumulation, hyperglycemia, alcoholic hepatitis, memory loss, decreased concentration, decreased sensitivity, etc. Causes eggplant lesions.
숙취는 술을 마신 후에 나타나는 두통, 설사, 식욕부진, 오심, 구토, 오한, 식은땀을 뜻하며, 객관적인 증상으로는 인식, 운동능력 저하, 혈액학적 변화 및 호르몬의 변화를 일컫는다. 숙취의 원인은 탈수, 알코올 및 알코올 대사물(아세트알데히드, 포름알데히드, 아세톤 등)의 독성, 흡수 장애에 의한 영양소 결핍(혈당, 비타민, 무기질 결핍)으로 알려져 있다. 음주 후 나타나는 숙취는 알코올 자체에 기인한 독성뿐만 아니라 알코올이 체내에서 대사 과정 중 인체에 해로운 물질로 전환되고 뇌와 간을 포함한 소화기관에 유해한 물질로 작용함으로 나타나는 증상이다. 숙취 정도는 유전에 따른 개인의 편차, 일반 상태(영양 상태, 운동 상태, 탈수 정도, 건강 상태)에 따라 정도의 차이가 매우 심하다. Hangover refers to headache, diarrhea, anorexia, nausea, vomiting, chills, and cold sweating that occur after drinking alcohol. Objective symptoms include cognition, decreased exercise capacity, hematological changes, and changes in hormones. The cause of hangover is known as dehydration, toxicity of alcohol and alcohol metabolites (acetaldehyde, formaldehyde, acetone, etc.), and nutrient deficiency (blood sugar, vitamin, mineral deficiency) Hangover after drinking alcohol is not only toxicity caused by alcohol itself, but alcohol is transformed into harmful substance in human body during metabolic process and acts as harmful substance to digestive organs including brain and liver. The degree of hangover is very different according to the variation of individuals due to heredity, general condition (nutrition, exercise, dehydration, health).
음주 후 알코올은 식도 및 구강점막에서 소량 흡수되다가 약 10%는 위장에서 90%는 소장에서 흡수된다. 알코올은 3가지 경로를 통해 대사되는데, 에탄올의 농도가 낮을 때는 위장관 또는 간에 존재하는 알코올탈수소효소(alcohol dehydrogenase)와 아세트알데히드탈수소효소(acetaldehyde dehydrogenase)의 작용에 의해, 에탄올의 농도가 높을 때는 소포체에 존재하는 마이크로좀 에탄올 산화체계(MEOS: Microsomal ethanol oxidizing system)에 의해 아세트알데히드와 아세트산으로 대사되며, 이후 퍼옥시좀(peroxisome)에 존재하는 카탈라제(catalase)의 작용 등을 거쳐 이산화탄소(CO2)와 물(H2O)로 최종 분해된다. 적당량의 알코올이 유입되면 상기 기술한 대사 체계가 원활하게 작용하여 알코올 때문에 일어나는 제반 증상이 일어나지 않지만, 다량의 알코올 유입시 대사 체계의 균형이 파괴되어 생체 항상성을 유지하지 못하게 된다. 이러한 상황 하에서 가장 영향을 많이 받는 기관은 간인데, 장기적으로 지방간, 간경변증 등 여러 가지 간 기능 장애가 발생하고, 단기적으로는 두통 또는 두중감, 집중력 감퇴, 속 쓰림 및 소화 불량과 같은 숙취 증상이 초래된다. After drinking alcohol is absorbed in small amounts in the esophagus and oral mucosa, about 10% in the stomach 90% in the small intestine. Alcohol is metabolized through three pathways. When the concentration of ethanol is low, alcohol dehydrogenase and acetaldehyde dehydrogenase, which are present in the gastrointestinal tract or liver, acts on the endoplasmic reticulum. It is metabolized to acetaldehyde and acetic acid by the existing microsomal ethanol oxidizing system (MEOS), and then through the action of catalase present in the peroxisome, carbon dioxide (CO 2 ) and Final decomposition into water (H 2 O). When the proper amount of alcohol is introduced, the metabolic system described above works smoothly and does not cause any symptoms caused by alcohol. However, when a large amount of alcohol is introduced, the balance of the metabolic system is destroyed, and thus the homeostasis cannot be maintained. Under these circumstances, the most affected organs are the liver, which in the long term leads to various liver dysfunctions, including fatty liver and cirrhosis, and in the short term results in hangover symptoms such as headache or headache, loss of concentration, heartburn and indigestion. .
숙취에 대한 연구는 우리나라에서는 대부분 동물 실험을 통해 이루어지고, 국외는 인체 시험 위주로 실질적인 연구가 많이 진행되고 있다. 일본은 숙취 해소의 소재 개발을 중심으로, 미국과 유럽은 에탄올(메탄올)의 중독 증상, 독성 원인 물질 및 독성 기전 연구를 중심으로 활발히 행해지고 있다. 특히, 에탄올의 체내 대사 결과 생성된 테트라하이드로이소퀴놀린(tetrahydroisoquinoline)이나 테트라하이드로-베타-카볼린(tetrahydro-β-carbolines)의 구조가 모르핀(morphine)과 유사하여 금단증상이 나타나므로 에탄올 의존증을 유도한다. 최근 들어서는 알코올(에탄올)에 소량 들어있는 메탄올의 대사 및 포름알데히드가 숙취의 원인으로 지적된 바 있으며, 알코올에 의한 숙취는 알코올대사체인 아세트알데히드, 아세톤 등에 의한다는 것이 다수 보고되면서 새로운 연구 단계로 접어들고 있다 (Moser J, Bagchi D, Akubue PI, Stohs SJ.. Alcohol Alcohol. 28:287-295, 1993). 섭취한 알코올의 대부분은 산화되어 대사되므로, 대사되지 않고 배설되는 양은 섭취하는 양의 2%, 대량 섭취하는 경우라도 10% 미만에 불과하다. 따라서, 알코올에 의한 급성 독성은 에틸알코올, 아세트알데히드, 아세톤 및 기타 알코올 대사 산물의 변형 생성 물질에 기인하므로, 음주 후 혈중 알코올 농도를 낮추는 것은 급성 중독 상태에 머무는 시간을 단축시킬 수 있다는 점에서 실질적인 중요성을 갖는다고 볼 수 있다. Studies on hangover are mostly conducted through animal experiments in Korea, and substantial research is being conducted mainly on human trials abroad. In Japan and the United States, Europe and the United States are actively engaged in the study of toxic substances, toxic agents, and poisoning symptoms of ethanol (methanol). Particularly, since the structure of tetrahydroisoquinoline or tetrahydro-β-carbolines produced as a result of in-vivo metabolism of ethanol is similar to that of morphine, withdrawal symptoms are induced, do. Recently, the metabolism of methanol and formaldehyde in small amount of alcohol (ethanol) has been pointed out as a cause of hangover, and the hangover by alcohol is reported to be due to alcohol metabolism, acetaldehyde, acetone, etc. (Moser J, Bagchi D, Akubue PI, Stohs SJ. Alcohol Alcohol. 28: 287-295, 1993). Most of the alcohol consumed is oxidized and metabolized, so the amount that is not metabolized and excreted is only 2% of the intake amount, and even if the large amount is consumed, it is less than 10%. Therefore, since the acute toxicity by alcohol is attributed to the modification products of ethyl alcohol, acetaldehyde, acetone and other alcohol metabolites, lowering the blood alcohol concentration after drinking may shorten the stay time in the acute poisoning state, It can be said that it has importance.
숙취 제거와 관련하여, 천연 식품 또는 한약 재료로부터 추출한 성분을 함유한, 숙취해소에 유용한 효과가 있다고 알려져 있는 각종 제제 형태의 의약품 및 건강보조식품들이 개발되었다. 사용 원료로는 실크피브로인(대한민국 등록특허 제0528740호), 오가피, 노근, 모과, 앵두, 저두강(등록특허 제0528388호), 약쑥, 구기자, 건강, 진피, 연근, 지구자, 상심자, 오미자(등록특허 제0512912호), 아스타잔틴, 아스파라긴산(등록특허 제0520985호), 감잎, 감(등록특허 제0504351호), 진피, 백복령, 인진, 갈화, 갈근(등록특허 제0500373호), 아스파라거스, 녹차, 양파, 매실(등록특허 제0496524호), 두릅(등록특허 제0462329호), 콩, 콩나물, 포도씨(등록특허 제455075호), 지구자 열매의 활성 성분 호베노둘리놀(등록특허 제0452128호), 무, 사철쑥, 칡, 감잎, 삼백초(등록특허 제0451013호), 데커시놀(등록특허 제 0448680호), 지구자, 지구목, 헛개나무 혼합물, 갈근, 백하수오, 산약, 작약(등록특허 제0446061호), 백모근, 오디, 토사자, 갈화, 창출, 복분자, 뱀딸기, 방가지풀, 길핵(등록특허 제0442771호), 솔잎(등록특허 제0412425호), 갈화, 큰엉겅퀴종자, 타우린, 울금(등록특허 제0392876호), 나린진, 나린게닌(등록특허 제0375047호), 오리나무, 마가목(등록특허 제0181168호) 등이 있다. 기타 출원된 특허에 사용된 원료로는 말굽버섯, 녹차카테킨, 오가피, 손바닥선인장(백련초), 천마, 노루궁댕이버섯, 초두구, 프로폴리스, 자화육각수, 매생이, 오수유 등이 있다. 그러나 현재까지 상기 소재들을 사용하여 숙취해소용 음료, 식품, 껌 등이 개발되어 있긴 하지만, 그 효과가 눈에 띄게 탁월한 것은 거의 없는 실정이다. 또한, 일부 생약제를 함유하는 드링크제는 전신 권태, 복부 팽만감, 구토 또는 복통 등을 유발하는 경우가 있고, 고가의 생약제를 사용함으로써 고가로 판매되는 등의 문제점이 있다.In connection with the removal of hangover, various formulations of medicaments and health supplements containing compounds extracted from natural or herbal ingredients have been developed which are known to have a beneficial effect in relieving hangovers. The raw materials used are silk fibroin (Korean Patent No. 0528740), Ogapi, Root Root, Chinese Quince, Cherry, Low Head Steel (Registration No. 0528388), Mugwort, Wolfberry, Health, Dermis, Lotus Root, Earth, Worm and Omija (Registration No. 0512912), Astaxanthin, Aspartic Acid (Registration No. 0520985), Persimmon Leaf, Persimmon (Registration No. 0505435), Dermis, Paekbokyeong, Injin, Browning, Brown root (Patent No. 0500373), Asparagus , Green tea, onion, plum (registered patent No. 0496524), ulm (registered patent No. 0462329), soybeans, bean sprouts, grape seed (registered patent No. 455075), active ingredient Hobenodolinol (earthed fruit) 0452128), radish, cedar mugwort, 칡, persimmon leaf, three hundred seconds (registered patent No. 0451013), deckersinol (registered patent No. 0448680), earth, earth tree, hut mixture, reeds, baekshaosoh, cod, peony (Patent No. 0446061), Baek hairy root, Audi, earthenware, brown flower, creation, bokbunja, snakeberry, twig grass, gill core (registration) Huh No. 042771), pine needles (registered patent No. 0412425), brown flower, large thistle seed, taurine, turmeric (registered patent No. 0392876), naringin, naringenin (registered patent No. 0375047), alder, rowan (registered Patent number 081168). The raw materials used in the other patents include horseradish, mushroom, green tea catechin, ogapi, palm cactus (Paekyukcho), Chunma, Rootstock mushroom, Chopstick, Propolis, However, until now, the hangover, food, chewing gum and the like have been developed using the above materials, but the effect is almost outstanding. In addition, a drink containing some herbal medicines may cause systemic boredom, abdominal bloating, vomiting or abdominal pain, etc., and there are problems such as selling at high prices by using expensive herbal medicines.
간은 인간의 신체 장기 중 생체 내 대사가 가장 활발하게 일어나는 장기로서, 지방 성분이 포함된 음식 또는 알코올의 과다 섭취, 바이러스의 감염, 각종 약품과 같은 유해물질 등 다양한 원인에 의해 급성 또는 만성의 장애가 일어나며, 지방간, 간염, 황달, 간경화, 간암 등이 야기될 수 있다. 특히 음식을 통한 과다한 지방 또는 알코올 섭취는 간 조직에 지질이 쌓이는 지방간을 유발하며, 이때 혈청 속의 GOT(glutamate-oxaloacetate transaminase), GPT (glutamate-pyruvate transaminase), γ-GTP(γ-glutamyl transferase) 등이 증가하게 된다. 만성적인 에탄올 섭취가 고지혈증 및 지방간을 유발하는 기전과 관련하여, 알코올탈수소효소 (ADH)와 알데히드탈수소효소(ALDH)에 의한 에탄올의 대사 결과 간과 세포내 NADH/NAD+ 비율을 증가시키게 되고, 이와 같은 변화는 간세포 내에서 지방산의 산화와 TCA 사이클 활성을 증가시켜, 지방간을 초래하게 된다는 이론이 있다 (Murray R.K. 등, Haper's Biochemistry, Appleton & Lange, Connechcut, USA. 3rd ed, p260 (1993)). The liver is one of the most active organs in the human body. The liver is acute or chronic due to various causes such as excessive intake of foods or alcohol containing fat components, infection of viruses, harmful substances such as various medicines, etc. Fatty liver, hepatitis, jaundice, cirrhosis, liver cancer, and the like. In particular, excessive fat or alcohol intake through food causes fatty liver, which accumulates lipids in liver tissue, wherein GOT (glutamate-oxaloacetate transaminase), GPT (glutamate-pyruvate transaminase), and γ-GTP (γ-glutamyl transferase) Will increase. In relation to the mechanism by which chronic ethanol intake causes hyperlipidemia and fatty liver, the metabolism of ethanol by alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) increases the liver and intracellular NADH / NAD + ratios. Theorem has been shown to increase fatty acid oxidation and TCA cycle activity in hepatocytes, resulting in fatty liver (Murray RK et al., Haper's Biochemistry, Appleton & Lange, Connechcut, USA. 3rd ed, p260 (1993)).
알코올성 간 질환은 알코올성 지방간, 알코올성 간염 및 간경변증으로 나뉜다. 이중 지방간이 가장 흔한 편이나 때때로 이들 세 가지 질환은 서로 겹쳐 있을 수도 있으며 그 심한 정도는 주로 음주 소비량과 관계가 깊다. 과다한 알코올 섭취는 간 조직에 지질이 쌓이는 지방간을 유발하며, 이때 혈청 속의 GOT(glutamate-oxaloacetate transaminase), GPT (glutamate-pyruvate transaminase), γ-GTP(γ-glutamyl transferase) 등이 증가하게 된다. 이러한 간 내 지방 축적은 간에서 중성지방의 합성이 증가하고, 지단백 합성 후 혈중 분비 과정에 장애가 유발되고, 말초 지방 조직으로부터 유리된 지방의 간 유입은 증가하는 반면 지방산 산화 과정은 오히려 저하되기 때문에 유발되는 것으로 알려져 있다. 알코올성 간염은 흔히 지방 세포의 침윤과 더불어 간 조직의 염증 반응과 섬유화가 일어난 상태를 말하며, 나아가 간 세포가 괴사하고 교원질의 침착 정도가 증가하여 결절이 형성되면 알코올성 간경변증으로 진행한다. 술에 의한 간장 질환은 음주량이 많으면 많을수록, 그리고 그 기간이 길면 길수록 발생 위험률이 높아진다는 것은 누구나 쉽게 이해할 수 있으며 실제 여러 조사 결과들이 이를 뒷받침해주고 있다. Alcoholic liver disease is divided into alcoholic fatty liver, alcoholic hepatitis and cirrhosis. Fatty liver is the most common, but sometimes these three diseases may overlap each other, and the severity is mainly related to drinking consumption. Excessive alcohol intake causes fatty liver to accumulate lipids in liver tissue, which increases GOT (glutamate-oxaloacetate transaminase), GPT (glutamate-pyruvate transaminase), and γ-GTP (γ-glutamyl transferase). This accumulation of fat in the liver is caused by increased synthesis of triglycerides in the liver, impaired blood secretion after lipoprotein synthesis, increased liver inflow of free fat from peripheral adipose tissue, but rather a decrease in fatty acid oxidation It is known to become. Alcoholic hepatitis often refers to a condition in which inflammatory reactions and fibrosis of liver tissues occur along with infiltration of fat cells. Further, alcoholic liver cirrhosis progresses when nodules are formed due to necrosis of liver cells and increased degree of collagen deposition. It is easy for anyone to understand that hepatic disease caused by alcohol increases the higher the alcohol consumption and the longer the period, the more the results of the investigation.
이에, 본 발명자들은 인체에 부작용이 없으면서 음주로 인한 숙취 증상 및 만성적 알코올성 간질환에 대해서 우수한 효능을 갖는 새로운 조성물을 개발하기 위하여 연구를 거듭하던 중, 흑축 외 13종의 생약재가 혼합된 조성물이 독성 및 부작용 없이 혈중 알코올 농도를 신속하게 감소시키는 효과를 나타낸다는 것을 확인하여 본 발명을 완성하였다. Thus, the inventors of the present invention, while continuing to research a new composition having excellent effects on the hangover symptoms and chronic alcoholic liver disease caused by drinking without side effects on the human body, the composition mixed with 13 kinds of herbal medicines other than black shaft is toxic And it was confirmed that the effect of rapidly reducing the blood alcohol concentration without side effects to complete the present invention.
본 발명은, 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 유효 성분으로 포함하는 숙취 예방 또는 해소용 조성물을 제공한다.The present invention provides a composition for preventing or eliminating hangover, which comprises black shaft, brown root, dermis, hawthorn, chondura, bokyeong, Yanggang, coriander, creation, ginger, jujube, flatulence, black pepper, and licorice as active ingredients.
본 발명은 또한, 상기 조성물의 유효량을 함유하는 숙취 예방 또는 해소용 단위 투여 제형을 제공한다.The present invention also provides a unit dosage form for preventing or eliminating hangovers containing an effective amount of the composition.
또한, 본 발명은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 유효 성분으로 포함하는 알코올성 지방간의 예방 또는 치료용 약학적 조성물을 제공한다.In addition, the present invention is a pharmaceutical composition for the prevention or treatment of alcoholic fatty liver, including black axis, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, autograph, creation, ginger, jujube, flatul, pak, and licorice as active ingredients To provide.
본 발명은 또한, 상기 조성물을 포함하는 건강기능식품 및 건강기능음료를 제공한다.The present invention also provides a health functional food and health functional beverage comprising the composition.
또한, 본 발명은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 건조시킨 후 절단하는 단계; 상기 원료들을 칭량하여 혼합하는 단계; 혼합물을 분쇄하는 단계; 및 밀가루 풀을 먹인 후 환 형태로 제조하는 단계를 포함하는, 상기 조성물의 제조 방법을 제공한다.In addition, the present invention comprises the steps of drying and cutting black shaft, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, cod, creation, ginger, jujube, flatul, bakbak, and licorice; Weighing and mixing the raw materials; Grinding the mixture; And it provides a method for producing the composition, comprising the step of preparing a flour form after feeding the flour paste.
이하, 본 발명에서 사용되는 용어를 정의한다.Hereinafter, terms used in the present invention are defined.
본 발명에서 사용되는 용어 "숙취(alcohol-induced hangover)"는 알코올 섭취 후에 나타나는 부작용, 예를 들면 피로감, 전신권태, 복부팽만감, 구토, 속쓰림, 인지기능의 감소와 같은, 알코올 및 그의 대사산물인 알데히드에 의해 유도되는 복합적인 임상적 증상을 의미한다. The term "alcohol-induced hangover" as used herein refers to alcohol and its metabolites, such as side effects that occur after alcohol consumption, such as fatigue, general boredom, bloating, vomiting, heartburn, and decreased cognitive function. It refers to a combination of clinical symptoms induced by aldehydes.
본 발명에서 사용되는 용어 "알코올성 지방간(alcohol-induced fatty liver)"은 장기간의 알코올 섭취에 기인한 간 내 지질 대사의 이상으로, 정상 간에 비해 많은 양의 지방이 축적된 상태 또는 질환을 의미한다. As used herein, the term "alcohol-induced fatty liver" refers to a condition or disease in which a large amount of fat is accumulated compared to normal liver due to abnormalities in lipid metabolism in the liver due to prolonged alcohol intake.
본 발명에서 사용되는 용어 "예방"은 본 발명의 조성물의 투여로 알코올 섭취 후에 숙취의 발생을 억제시키거나 진행을 지연시키는 모든 행위를 의미한다. As used herein, the term "prevention" means any action that inhibits the development or delays the progression of a hangover after ingestion of alcohol by administration of a composition of the present invention.
본 발명에서 사용되는 용어 "해소" 및 "완화"는 본 발명의 조성물의 투여로 숙취에 기인한 임상적 증상 또는 상태를 제거하거나, 유의하게 완화 또는 호전시키는 모든 행위를 의미한다.As used herein, the terms "resolve" and "mitigate" refer to any action that eliminates, significantly alleviates, or ameliorates a clinical symptom or condition resulting from a hangover by administration of a composition of the present invention.
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 발명에서 사용되는 용어 "개체"는 본 발명의 조성물을 투여하여 숙취 증상이 호전될 수 있는 인간, 원숭이, 말, 소, 돼지, 염소, 토끼 또는 쥐와 같은 포유류를 포함한 모든 동물을 의미한다. 바람직한 실시 양태에서, 상기 개체는 인간이다. As used herein, the term "individual" refers to any animal, including mammals such as humans, monkeys, horses, cattle, pigs, goats, rabbits, or rats, by which the composition of the present invention can improve hangover symptoms. In a preferred embodiment, the subject is a human.
본 발명에서 사용되는 용어 "유효량"은 개체의 생물학적 또는 의학적 반응의 유발, 증상의 완화, 질환의 예방, 질환 진행의 둔화 또는 지연 등을 유도하기에 충분한 조성물의 양을 지칭한다. 이는 개체의 질환의 종류, 중증도, 투여물질의 활성, 투여물질에 대한 민감도, 투여 시간, 투여 경로 및 배출비율, 치료기간, 병용 약물을 포함한 다양한 인자에 따라 결정될 수 있다. As used herein, the term “effective amount” refers to an amount of a composition sufficient to induce a biological or medical response of an individual, alleviate symptoms, prevent disease, slow or delay disease progression, and the like. This may depend on a variety of factors including the type of disease, severity, activity of the administered substance, sensitivity to the administered substance, time of administration, route and rate of administration, duration of treatment, concomitant medications.
이하, 본 발명을 상세히 설명한다.Hereinafter, the present invention will be described in detail.
본 발명의 일 양태는, 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 유효 성분으로 포함하는 숙취 예방 또는 해소용 조성물에 관한 것이다.One aspect of the present invention relates to a composition for preventing or eliminating hangover, which comprises black shaft, black root, dermis, hawthorn, chodogu, bokyeong, Yanggang, coriander, creation, ginger, jujube, flatulence, black pepper, and licorice as active ingredients. will be.
본 발명의 또다른 양태는, 상기 생약재들을 유효 성분으로 함유하는 알코올성 지방간의 예방 또는 치료용 약학적 조성물에 관한 것이다.Another aspect of the present invention relates to a pharmaceutical composition for preventing or treating alcoholic fatty liver containing the herbal medicines as an active ingredient.
본 발명의 조성물에 사용되는 흑축(Pharbitis seed, 견우자)은 메꽃과 (Convolvulaceae)의 나팔꽃 (Pharbitis nil Choisy)의 흑색 종자로, 성분으로는 지방유 약 11%와 수지성 배당체인 파르비틴(pharbitin)을 약 2% 함유하고 있고, 장관 연동운동 촉진에 의한 사하 작용, 이뇨 작용 및 살충 효과가 알려져 있다 (대한약전 V 제2부 pp651). 한의학에서는 부종, 만성신우신염, 간경화로 인한 복수 등에 사용되어 왔다. Pharbitis seed (Purbitis seed) used in the composition of the present invention is a morning glory ( Pharbitis ) of Convolvulaceae nil It is a black seed of Choisy ), which contains about 11% fatty oil and about 2% pharbitin, a resinous glycoside, and it is known to have hypothalamic, diuretic and insecticidal effects by promoting intestinal peristalsis ( KP V Part 2 pp651). In oriental medicine, it has been used for edema, chronic pyelonephritis, ascites due to cirrhosis of the liver.
본 발명의 조성물에 사용되는 갈근(Pueraria lobata Ohwi)은 콩과에 속하는 낙엽 활엽 만목으로 주피를 제거한 뿌리(Puerariae Radix)를 지칭한다. 주성분으로 다이드제인(daidzein), 다이드진(daidzin), 퓨에라린(puerarin) 등을 함유한다. 또한 트리테르페노이드 화합물인 소야사포제놀(soyasapogenol) A와 쿠주사포제놀(Kuzusapogenol) B 등을 함유하며 이러한 성분은 진정 작용, 하열 작용 및 혈관의 이완 작용을 하는 것으로 알려져 있다. 갈근은 알코올로 인한 지방간을 억제하는 약제로서 (Kwon HJ et al., World J. Gastroenterol. 11(35):5512-5516, 2005), 갈근의 수추출물은 알코올 투여로 인한 지방 대사와 항산화 효소의 장애를 제거하는 역할을 한다 (Lee JS. et al., Clin. Chim. Acta. 347(1-2):121-128, 2004). The root root ( Pueraria lobata Ohwi ) used in the composition of the present invention refers to the root (Puerariae Radix) from which the bark is removed by deciduous broad-leaf tree belonging to the legume. Its main ingredient contains daidzein, daidzin, puerarin and the like. In addition, it contains a triterpenoid compound soyasapogenol A and Kuzusapogenol B, etc. These ingredients are known to have a sedation, hypothermia and vascular relaxation. Brown root is a drug that inhibits fatty liver caused by alcohol (Kwon HJ et al., World J. Gastroenterol. 11 (35): 5512-5516, 2005). Serves to eliminate the disorder (Lee JS. Et al., Clin. Chim. Acta. 347 (1-2): 121-128, 2004).
상기 조성물에 사용되는 진피는 운향과의 귤(Citrus unshiu Markovich) 또는 동속 근연식물(산초나무과 Rutaceae)의 성숙한 과피이다. 진피에는 D-limonene, linalol, linalylacetate 등이 함유되어 있고, 플라보노이드인 헤스페리딘, 나린진(naringin), 포르시린(porcirin) 및 노빌레틴(nobiletin)이 함유되어 있다. 진피는 항알레르기 활성, 진정 효과, 항바이러스 활성, 세로토닌 작용도 향상, 간손상 억제 효과를 나타내는 것으로 보고된 바 있다. The dermis used in the composition is citrus unshiu Markovich ) or mature rind of the same plant (Rhusaceae). The dermis contains D-limonene, linalol, linalylacetate, and the flavonoids hesperidin, naringin, porcirin and nobiletin. The dermis has been reported to show antiallergic activity, sedative effect, antiviral activity, serotonin activity and inhibitory effect on liver damage.
산사는 장미과(Rosaceae)에 속하는 산사나무(Crataegus pinnatifida Bunge for. Pinnatifida)의 열매를 건조시킨 것이다. 구형 또는 도란형이고 산사자라고도 지칭되며, 약리 성분으로는 히페로시드(hyperoside), 퀘르세틴(quercetin), 올레아놀(oleanol)이 있다. 약효는 건위, 소화, 강장, 고혈압, 월경통 등에 사용한다.Sansa is Hawthorn (Crataegus belongs to the rose family (Rosaceae) pinnatifida Bunge for. Pinnatifida ) is dried fruit. Spherical or obovate, also called hawthorn, pharmacological components include hyperoside, quercetin, and oleanol. The drug is used in stomach, digestion, tonic, high blood pressure, dysmenorrhea, etc.
초두구(Alpinia katsumadai)는 중국 남부, 인도, 베트남, 말레시아 등 열대 지방 원산의 여러해살이풀로서, 특히 열매를 초두구로 지칭한다. 초두구 추출물의 활성으로 항염, 항소양 작용(Jung rat al. J. Dermatol. Sci. 53:81-84, 2008), 항산화작용(Lee et al. Phytother. Res. 17:1041-1047, 2003), 콜레스테롤에스테라제 저해 효과(Kim et al. Kor. J. Fopod Sci. Technol. 32:200-205, 200) 등이 알려져 있으며, 유효성분으로는 신경세포 보호작용을 갖는 플라보노이드 화합물(Jeong et al. Nat. Prod. Sci. 13:268-271, 2007), 항구토 작용을 갖는 디아릴헵타노이드(diarylheptanoid) 등이 보고되어 있다. Alpinia katsumadai is a perennial plant native to tropical regions such as southern China, India, Vietnam, and Malaysia. Anti-inflammatory, anti-pruritic activity with the activity of the extract of Curdula (Jung rat al. J. Dermatol. Sci. 53: 81-84, 2008), antioxidant activity (Lee et al. Phytother. Res. 17: 1041-1047, 2003) , Cholesterol esterase inhibitory effect (Kim et al. Kor. J. Fopod Sci. Technol. 32: 200-205, 200) and the like, as an active ingredient flavonoid compound having a neuronal protective action (Jeong et al. Nat. Prod. Sci. 13: 268-271, 2007), diarylheptanoids with anti-earth action have been reported.
복령(Poria cocos ( Schw .) Wolf)은 소나무 뿌리에 기생하여 혹처럼 크게 자란 균핵으로, 직경 약 20∼50 cm의 덩어리로서 지하 20 내지 50 cm 깊이에 달린다. 백색인 것을 백복령, 적색인 것을 적복령이라 한다. 포도당이 사슬모양으로 결합된 물질인 다당류 파기민이 약 93%을 차지하며, 그 외에 파기민산, 에브리코산. 폴리포텐산 A, C 트리테르페노이드, 엘고스테롤, 레시틴, 아데닌, 콜린 등을 함유한다. 한약재로 강장, 이뇨, 진정 등의 효능이 있어 신장병, 방광염, 및 요도염에 사용되어 왔다. Poria cocos ( Schw .) Wolf is a fungal species that grows on the roots of pines and grows like a hump. White is called Baekbokyeong, and red is called red. Polysaccharide pagamine, a substance in which glucose is linked in a chain, accounts for about 93%, and pagiminic acid and ebricolic acid. Polypotenic acid A, C triterpenoids, elgosterol, lecithin, adenine, choline and the like. It is an herbal medicine that has been used for kidney disease, cystitis, and urethritis due to its tonic, diuretic, and soothing effects.
양강(Alpinia officinarum)은 생강과에 속하는 다년생 초본으로, 늦여름부터 초가을에 4-6년생을 채취하여 특히 근경을 세절하여 햇볕에 말린 것을 지칭한다. 0.5~1.5%의 정유가 함유되어 있고 그 주요 활성 성분으로 1,8-시네올, 신나민산(cinnamic acid)의 메틸에스테르, 피넨(pinene), 카디넨(cadinene) 등이 있다. 그 외에 가란진(galangin), 켐페리드(kaempferid), 알피닌(alpinin) 등의 플라보노이드가 분리 및 동정되었다. 항염증 및 항산화 활성, 췌장 리파아제 억제 활성 (Shin JE 등, 2004), 지방산 합성 억제 (Li BH, 등, 2003), 5-알파 리덕타아제 억제 (Kim YU 등, 2003) Jan;69(1):72-4.) 등의 효능이 보고되었다.Yangjiang ( Alpinia officinarum ) is a perennial herb belonging to the family Ginger, which refers to harvesting 4-6 years from late summer to early autumn, especially cutting the roots and drying them in the sun. It contains 0.5 ~ 1.5% of essential oil and its main active ingredients are 1,8-cineol, methyl ester of cinnamic acid, pinene, and cardinene. In addition, flavonoids such as galangin, kaempferid, and alpinin were isolated and identified. Anti-inflammatory and antioxidant activity, pancreatic lipase inhibitory activity (Shin JE et al., 2004), fatty acid synthesis inhibition (Li BH, et al., 2003), 5-alpha reductase inhibitory (Kim YU et al., 2003) Jan; 69 (1) : 72-4.) And the like have been reported.
사인(Ammomum xanthioides Wallich)은 생강과(Zingiberaceae)에 속하는 다년생 초본으로서, 약재로 사용하는 씨는 타원형 또는 난원형을 이루며 둔한 세 개의 모서리가 있고, 길이 15-20 mm, 지름 10-15 mm이다. 알려진 성분으로는 정유성분이 있으며, 그 주성분은 보르네올 (Borneol), 보르닐-아세테이트 (Bornyl-acetate), 리날로올 (Linalool), 네롤리돌 (Nerolidol) 등이 있다 (이충섭 외, 사인의 기원과 형태에 관한 문헌적 고찰, 대한본초학회지, p 96-105, 1986 ). Autograph ( Ammomum xanthioides Wallich ) is a perennial herb belonging to the Zingiberaceae family. Seeds used as medicinal herb are oval or oval in shape with three dull corners, 15-20 mm long and 10-15 mm in diameter. Known ingredients include essential oils, the main components of which are Borneol, Bornyl-acetate, Linalool, and Nerolidol. Literature Review on the Form and Form, Korean Journal of Herbology, pp. 96-105, 1986).
창출은 국화과(Compositae)에 속하는 모창출(Atractylodes lancea De Candolle) 또는 북창출(Atractylodes chinensis Koidzumi)의 근경으로, 주로 건위 소화제나 지사 정장약 등으로 이용되어 왔다. 창출의 주요 성분은 아트라세티논(atractylone), 아트라세티레노이드(atractylenolide) I, II, III, 테트라하이드로아란톨시톨(tetrahydroalantolcton), 아부테노리드(abutenolide) B, b-에데스몰(b-eudesmol), 히네솔(hinesol) 등이다. 창출은 수분대사를 촉진시켜 이뇨 및 발한을 촉진시키고, 정장에도 효과적이므로 그러므로 음주 후 알코올의 배설을 촉진시켜 숙취에 도움이 될 수 있을 것으로 사료된다.Creation is Atractylodes belonging to Compositae lancea De Candolle or Atractylodes chinensis Koidzumi ) 's roots have been used mainly as a fire extinguishing agent or a branch medicine. The main components of the production are atractylone, atractylenolide I, II, III, tetrahydroalantocitol, abutenolide B, b-edesmol eudesmol), hinesol and the like. The creation promotes diuresis and sweating by stimulating water metabolism, and is effective in suits. Therefore, it may be helpful for hangover by promoting the excretion of alcohol after drinking.
생강(Zingiber cassumunar Roxb .)은 생강과(Zingiberaceae) 식물에 속하는 진지버(Zingiber) 속 식물로서, 열대 아시아 원산으로 우리 나라에서는 주로 남부에서 재배된다. 생강의 뿌리는 전통의학에서 소화기계, 중추신경계, 골관절계 질환의 치료에 약초로 이용되어 왔으며, 그 외에도 혈중 지질 및 당 수치를 낮추고, 항산화 (Masuda et al., Chem. Lett., 1993), 항염증 (Jeenapongsa et al., J. Ethnopharmacol., 87, 2003), 및 살충 작용 (Nugroho et al., Phytochemistry, 41, pp129-132, 1996)이 보고되었다. 생강은 진기베롤(zingiberol), α-진기베렌(α-zingiberene)과 같은 정유성분, 진저론(zingerone), 쇼가올(shogaol), 6-진저롤(6-gingerol)과 같은 신미성분을 함유하고, 미량의 신미성 물질은 8-진저롤(8-gingerol), 10-진저롤(10-gingerol), 디하이드로진저론(dehydrozingerone)의 다양한 생리활성 물질들을 높게 함유한다. Ginger ( Zingiber cassumunar Roxb . ) Is a genus of Zingiber belonging to the Zingiberaceae plant. Native to tropical Asia, it is grown mainly in the south of our country. Ginger roots have been used in traditional medicine for the treatment of diseases of the digestive system, central nervous system and osteoarthritis, in addition to lowering blood lipids and sugar levels, antioxidants (Masuda et al., Chem. Lett., 1993), Anti-inflammatory (Jeenapongsa et al., J. Ethnopharmacol., 87, 2003), and pesticidal action (Nugroho et al., Phytochemistry, 41, pp129-132, 1996). Ginger contains essential oils such as zingiberol, α-zingiberene, and sour ingredients such as zingerone, shogaol and 6-gingerol. Trace amounts of microtic substances are high in various bioactive substances, such as 8-gingerol, 10-gingerol, and dehydrozingerone.
대추(Zizyphus jujuba MILL)는 갈매나무과(Rhamnaceae)의 낙엽 활엽교목으로, 열매인 대추는 식용하거나 약용하고, 특히 멧대추씨는 산조인이라 부르며 이를 수면장애, 불면증, 심장불안, 초조, 심화 등에 대표적인 약재로 이용된다. 그 외에, 대추는 항알레르기 성분이 있어서 기관지천식을 비롯한 내분비질환에 효과적이며, 추출물은 이뇨작용 및 혈압 강하 효과가 있다. 열매의 주성분은 당류(프럭토오스, 글루코오스, 람노오스)이고, 그 외에 유기산(싱아산, 사과산, 포도주산, 호박산, 글리콜산)과 단백질, 비타민 A, B2 및 C, 칼슘, 인 등을 함유한다.Jujube ( Zizyphus jujuba MILL ) is a deciduous broad-leaved arboreous tree of Rhamnaceae. The fruit jujube is edible or medicinal. Especially, the jujube seed is called Sanjoin and is used as a representative medicine for sleep disorder, insomnia, heart anxiety, anxiety, deepening. In addition, the jujube is effective in endocrine diseases, including bronchial asthma, because the anti-allergic component, the extract has a diuretic effect and blood pressure lowering effect. The main components of the fruit are sugars (fructose, glucose, rhamnose), and other organic acids (single acid, malic acid, wine acid, succinic acid, glycolic acid), proteins, vitamins A, B 2 and C, calcium, phosphorus, etc. It contains.
헛깨나무(Hovenia dulis Thunb)는 갈매나무과(Rhamnaceae)로 열매를 포함한 열매자루에 활성 성분인 다당류가 다량 함유된 것으로 밝혀졌다. 본 발명의 조성물에 사용되는 헛깨나무 열매(지구자)는 사염화탄소로 유도한 간 손상을 억제하는 효과를 가지며(Hase K et al., Biol. Pharm. Bull. 20(4):381-385, 1997), 그로부터 분리한 디하이드로플라보놀(dihydroflavonols), 호베니틴(hovenitins) I, Ⅱ 및 Ⅲ는 알코올로 인한 간 손상의 억제 활성을 갖는 것으로 밝혀졌다 (Yoshikawa M et al., Yakugaku Zasshi 117(2):108-118, 1997). 또한, 헛개나무 열매에서 분리한 석탄산 화합물에는 글루타메이트로 유도한 뇌손상을 억제하는 효과가 있음이 보고되었다 (Li G et al., Arch. Pharm. Res. 28(7):804-809, 2005).The Hovenia dulis Thunb is a Rhamnaceae that has been found to contain a large amount of active polysaccharides in fruit pods . Hawthorn fruit (earth) used in the composition of the present invention has the effect of inhibiting carbon tetrachloride-induced liver damage (Hase K et al., Biol. Pharm. Bull. 20 (4): 381-385, 1997 ), Dihydroflavonols, hovenitins I, II and III isolated therefrom have been shown to have inhibitory activity against liver damage caused by alcohol (Yoshikawa M et al., Yakugaku Zasshi 117 (2). ): 108-118, 1997). In addition, it has been reported that the phenolic compounds isolated from the bark fruit have an effect of inhibiting glutamate-induced brain damage (Li G et al., Arch. Pharm. Res. 28 (7): 804-809, 2005). .
후박나무(Magnolia officinalis Rehd . et Wils .)은 목련과(Magnoliaceae)에 속하는 다년생 초본으로, 본 발명에서 사용하는 후박은 4월 내지 6월 사이에 후박나무로부터 겉피를 벗기고 그늘에서 말린 뿌리 껍질, 줄기 껍질 및 가지 껍질을 지칭한다. 후박은 천식과 위장병 치료에 사용되어 왔으며, β-유데스몰(β-eudesmol), 마그놀(magnolol), 호노키올(honokiol), 마치올(machiol), 마그노쿠라린(magnocurarine), 탄닌과 같은 성분이 함유되어 있다. 이 중 호노키올은 폴리페놀(polyphenol)에 속하는 물질로 항우울, 혈전응고 저해, 신경 안정, 항균 효능을 나타내는 유용한 물질로 이용되고 있다. Magnolia officinalis Rehd . meat Wils . ) Is a perennial herb belonging to the Magnoliaceae, and the peppermint used in the present invention refers to the root bark, stem bark and branch bark peeled from the bark and dried in the shade between April and June. Thick peppers have been used to treat asthma and gastrointestinal disorders, such as β-eudesmol, magnolol, honokiol, machiol, magnocurarine, and tannins. Contains ingredients. Honokiol is a substance belonging to polyphenol (polyphenol) is used as a useful material that exhibits antidepressant, antithrombotic inhibition, nerve stability, antibacterial effect.
감초(Glycyrrhiza Radix)는 장미목 콩과(Leguminosae)의 여러해살이 풀로, 본원발명에서 사용하는 뿌리는 단맛을 나타내어 감미료로도 사용된다. 또한, 한의약, 티벳, 인도 등지에서 폐질환 및 염증 질환에 대한 약재, 또는 다른 생약재의 독성을 완화 및 중화시키는 약재로 사용되어 왔다. 트리테르페노이드계 사포닌인 글리시리진(glycyrrhizin) 및 글리시르헥틴산(glycyrrhetinic acid)을 함유하며 플라보노이드인 리퀴리티게닌(liquiritigenin), 이소리퀴리티게닌(isoliquiritigenin), 리퀴리틴(liquiritin), 네오리퀴리틴(neoliquiritin) 등, 및 이소플라보노이드인 글리세스트론(glycestrone), 글리시롤(glycyrol), 이소글리시롤(isoglycyrol), 리코리딘(licoridin) 등이 함유되어 있다. 알려진 약리학적 활성으로는 항염, 항궤양 효과, 소염, 해열진통 효과 및 에스트로겐 활성이 있다. Licorice ( Glycyrrhiza Radix ) is a perennial herb of Legumes soybean (Leguminosae), and the root used in the present invention has a sweet taste and is also used as a sweetener. In addition, herbal medicine, Tibet, India, etc. have been used as a medicine for mitigating and neutralizing the toxicity of medicinal herbs or other herbal medicines for lung diseases and inflammatory diseases. Containing triterpenoid-based saponins, glycyrrhizin and glycyrrhetinic acid, flavonoids liquiritigenin, isoliquiritigenin, liquiritin, and neori Neoliquiritin and the like, as well as isoflavonoids such as glycycestrone, glycyrol, isoglycyrol, licoridin, and the like. Known pharmacological activities include anti-inflammatory, anti-ulcer effect, anti-inflammatory, antipyretic analgesic effect and estrogen activity.
본 발명의 조성물에 사용되는 상기 생약재들의 혼합 조성비는 건조 중량 기준으로, 흑축 15 내지 30 중량부, 갈근 10 내지 20 중량부, 진피 5 내지 15 중량부, 산사 5 내지 10 중량부, 초두구 5 내지 10 중량부, 복령 5 내지 10 중량부, 양강 3 내지 6 중량부, 사인 3 내지 6 중량부, 창출 1 내지 5 중량부, 생강 3 내지 6 중량부, 대추 3 내지 6 중량부, 지구자 3 내지 6 중량부, 후박 1 내지 5 중량부, 및 감초 1 내지 5 중량부인 것이 바람직하다. 보다 바람직하게는, 상기 조성비는 건조 중량 기준으로, 흑축 20 내지 25 중량부, 갈근 12 내지 15 중량부, 진피 8 내지 12 중량부, 산사 6 내지 8 중량부, 초두구 6 내지 8 중량부, 복령 6 내지 8 중량부, 양강 4 내지 5 중량부, 사인 4 내지 5 중량부, 창출 3 내지 4 중량부, 생강 3 내지 4 중량부, 대추 4 내지 5 중량부, 지구자 4 내지 5 중량부, 후박 3 내지 4 중량부, 및 감초 3 내지 4 중량부이나, 이에 한정되는 것은 아니다.The mixed composition ratio of the herbal medicines used in the composition of the present invention is based on dry weight, 15 to 30 parts by weight of black shaft, 10 to 20 parts by weight, dermis 5 to 15 parts by weight, hawthorn 5 to 10 parts by weight, grass crab 5 to 10 parts by weight, 5 to 10 parts by weight of Fuling, 3 to 6 parts by weight of Yanggang, 3 to 6 parts by weight, 1 to 5 parts by weight, 1 to 5 parts by weight of ginger, 3 to 6 parts by weight of ginger, 3 to 6 parts by weight of jujube, 3 to 4 weight parts It is preferable that they are 6 weight part, 1-5 weight part of thick foils, and 1-5 weight part of licorice. More preferably, the composition ratio is 20 to 25 parts by weight, black root 12 to 15 parts by weight, dermis 8 to 12 parts by weight, hawthorn 6 to 8 parts by weight, 6 to 8 parts by weight of head bean sprouts, Fuling, on a dry weight basis. 6 to 8 parts by weight, mild steel 4 to 5 parts by weight, sine 4 to 5 parts by weight, creation 3 to 4 parts by weight, ginger 3 to 4 parts by weight, jujube 4 to 5 parts by weight, earth 4 to 5 parts by weight, thick foil 3 to 4 parts by weight, and licorice 3 to 4 parts by weight, but is not limited thereto.
본 발명의 조성물을 구성하는 생약재들은, 원료 자체 또는 그의 분쇄물에 한정되지 않으며, 동물에게 투여할 수 있도록 제형화(예컨대, 분말화)한 가공물, 원료의 추출물 또는 착즙을 포함하는, 다양한 형태로 존재할 수 있다. The herbal medicines constituting the composition of the present invention are not limited to the raw material itself or its pulverized product, but in various forms, including processed products (eg, powdered), formulated for administration to animals, extracts or juices of the raw materials. May exist.
일 구체예에서, 본 발명의 조성물을 구성하는 생약재들은, 각각의 원료를 건조시킨 뒤 분쇄하여 제조된 분말 형태일 수 있다. 본 구체예에서, 상기 분말 형태의 조성물은 원료인 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 지구자, 후박, 및 감초를 건조시킨 후 적절한 크기로 절단하고; 상기 원료들을 칭량하여 혼합하고; 혼합물을 분쇄함으로서 제조될 수 있다. 또다른 구체예에서, 본 발명의 조성물은 상기와 같이 제조된 분말 혼합물에 밀가루 풀을 첨가하여 환 형태로 제조될 수 있다.In one embodiment, the herbal medicines constituting the composition of the present invention may be in the form of a powder prepared by drying and then grinding each raw material. In the present embodiment, the composition in the form of powder is a suitable size after drying the raw materials such as black shaft, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, sign, creation, ginger, jujube, earth, bakbak, and licorice Cutting; Weighing and mixing the raw materials; It can be prepared by grinding the mixture. In another embodiment, the composition of the present invention can be prepared in a cyclic form by adding flour paste to the powder mixture prepared as above.
본 발명의 다른 구체예에서, 본 발명의 조성물을 구성하는 상기 생약재들 중 하나 이상은 원료에 추출 용매를 처리하여 얻은 추출물 또는 착즙 형태일 수 있다. 상기 추출물은 당업계에서 조 추출물(crude extract)로 통용되는 의미를 갖지만, 광의적으로는 추출물을 추가적으로 분획(fractionation)한 분획물도 포함한다. 뿐만 아니라, 상기 조 추출물 또는 분획물에 정제 과정을 추가적으로 적용하여 얻은 것도 포함한다. 예를 들면, 상기 추출물을 일정한 분자량 컷-오프 값을 갖는 한외 여과막을 통과시켜 얻은 분획물, 다양한 크로마토그래피 (크기, 전하, 소수성 또는 친화성에 따른 분리를 위해 제작된 것)에 의해 분리한 분획물 등, 다양한 정제 방법을 통해 얻어진 분획물을 포함한다. 또한, 본 명세서에서 사용되는 용어 "추출물" 및 "분획물"은 상기 추출액 및 분획의 희석액 또는 농축액, 추출액 및 분획을 건조하여 수득되는 건조물, 또는 추출액 및 분획의 조 정제물 또는 정제물을 포함하는 광의적 의미로 사용된다.In another embodiment of the present invention, one or more of the herbal medicines constituting the composition of the present invention may be in the form of extract or juice obtained by treating the raw material with an extraction solvent. The extract has a meaning commonly used as a crude extract in the art, but broadly includes a fraction additionally fractionating the extract. As well as those obtained by additionally applying a purification process to the crude extracts or fractions. For example, a fraction obtained by passing the extract through an ultrafiltration membrane having a constant molecular weight cut-off value, a fraction separated by various chromatography (manufactured for separation according to size, charge, hydrophobicity or affinity), and the like, Fractions obtained through various purification methods. As used herein, the terms "extract" and "fraction" are used broadly to include dilutions or concentrates of the extracts and fractions, dried products obtained by drying the extracts and fractions, or crude purified or purified products of the extracts and fractions. It is used in an absolute sense.
추가적인 양태에서, 본 발명은 상기 기술된 숙취 해소용 조성물의 제조 방법을 제공한다. In a further aspect, the present invention provides a method for preparing the hangover composition described above.
본 발명의 조성물은 ICR 마우스를 사용한 동물 실험에서, 40% 에탄올 투여 30분 전에 미리 투여한 경우, 알코올 투여 4시간 후 혈중 에탄올 농도를 음성대조군 대비 약 43% 감소시키는 것으로 나타나 (실시예 3-1, 도 1), 급성 알코올 투여시 알코올의 체내 대사를 촉진하는 효능이 있음을 확인하였다. 또한, 3주간에 걸쳐 1일 1회 상기 조성물 및 20% 에탄올 투여를 반복한 후 혈중 에탄올 농도를 측정한 결과, 음성대조군에 비해 혈중 에탄올 농도가 통계적으로 유의하게 감소하여 장기적인 알코올 섭취에 대해서도 효과를 나타낸다는 것을 확인하였다 (실시예 3-2, 도 1). 알코올에 의한 급성 독성은 에틸알코올, 아세트알데히드 및 기타 알코올 대사 산물의 변형 생성 물질 등에 기인한다고 보고되어 있으므로, 알코올 섭취 후 혈중 알코올 농도를 낮추는 것은 음주에 의한 급성 중독 상태에 머무는 시간을 단축시킬 수 있다. 이에 근거하여, 본 발명의 조성물은 알코올 및 알코올 대사 산물에 기인한 숙취 증상을 해소시킬 수 있다. 또한, 본 발명의 조성물은 혈중 알코올의 신속한 대사 및 제거를 야기하여, 과량 및 장기간의 알코올 섭취로 인한 알코올성 간질환, 예를 들면, 지방간, 간염, 간경변 등의 질환의 예방, 완화, 또는 치료에 기여할 수 있다. The composition of the present invention was found to reduce blood ethanol concentration by about 43% compared to the negative control group after 4 hours of alcohol administration in an animal experiment using ICR mice 30 minutes before 40% ethanol administration (Example 3-1 1, it was confirmed that the acute alcohol administration has the effect of promoting the metabolism of alcohol. In addition, after repeating the composition and 20% ethanol administration once a day for three weeks, blood ethanol concentration was measured. As a result, the blood ethanol concentration was statistically significantly reduced compared to the negative control group. It confirmed that it shows (Example 3-2, FIG. 1). Acute toxicity by alcohol is reported to be due to modified products of ethyl alcohol, acetaldehyde and other alcohol metabolites, so lowering blood alcohol levels after alcohol intake can shorten the time spent in acute poisoning by drinking. . Based on this, the composition of the present invention can relieve hangover symptoms due to alcohol and alcohol metabolites. In addition, the compositions of the present invention may cause rapid metabolism and elimination of alcohol in the blood, contributing to the prevention, alleviation, or treatment of alcoholic liver diseases such as fatty liver, hepatitis, cirrhosis, etc. due to excessive and prolonged alcohol intake. Can be.
또한, 상기 급성 및 만성 알코올 분해능 측정 시험에 사용된 마우스의 체중 변화를 측정한 결과, 시험기간 동안 음성대조군 대비 시험물질 투여군의 체중은 차이가 없었다 (실시예 2, 표 3). 생존기간 동안 본 발명의 조성물에 의한 일반 증상의 변화, 중독 증상, 전신 운동성 및 행동 패턴 등을 관찰한 결과 유의한 변화가 나타나지 않았으며, 채혈 후 부검 결과에서도 주요 장기에 있어 이상 소견이 발견되지 않았다. 상기 실시예에서, 본 발명의 조성물은 상용량의 5배로 투여되었으므로, 포유동물에 투여시 과량 범위에서도 안전하고 무독성일 것으로 예상된다. In addition, as a result of measuring the weight change of the mice used in the acute and chronic alcohol resolution test, the weight of the test substance administration group compared to the negative control group during the test period was no difference (Example 2, Table 3). Observational changes of general symptoms, symptoms of intoxication, systemic motility and behavioral patterns during the survival period did not show significant changes, and no autopsy findings were found in the major organs after blood collection. . In this embodiment, the composition of the present invention was administered at five times the normal dose, so it is expected that it will be safe and nontoxic even in the excessive range when administered to a mammal.
본 발명의 조성물에는 상기 주요성분 이외에도 보조성분으로 비타민 B, C, E나 베타카로틴, Ca, Mg, Zn 등의 미네랄 함유 화합물, 레시틴 등의 인지질, 또는 말톨, 올리고당, 아미노산 등의 화합물을 사용할 수 있다. 특히, 비타민 C, E, 베타카로틴, 말톨 중 2 내지 3 가지의 성분을 혼합하여 사용하는 경우 생체 활성을 보강할 수 있으므로 더욱 바람직하다. 또한, 상기 성분 이외에도 공지의 첨가제로서 미각을 돋구기 위하여 매실, 레몬향, 파인애플향 또는 허브향과 같은 천연향료 또는 천연과즙, 클로르필린(Chlorophyllin), 플라보노이드(Flovonoid) 등의 천연색소 또는 감미 성분인 과당, 벌꿀, 당알코올, 설탕 등과 구연산, 구연산나트륨 같은 산미제를 혼합하여 사용할 수 있다.In addition to the above-mentioned main components, the composition of the present invention may be used as auxiliary ingredients, mineral-containing compounds such as vitamins B, C, E, beta-carotene, Ca, Mg, and Zn, phospholipids such as lecithin, or compounds such as maltol, oligosaccharides, and amino acids. have. In particular, when used by mixing two to three components of vitamin C, E, beta carotene, maltol is more preferable because it can enhance the biological activity. In addition to the above ingredients, in order to enhance the taste as a known additive, natural flavors such as plum, lemon, pineapple or herb, or natural fruit juice, natural pigments such as chlorophyllin, flavonoids, or fructose, sweet sugar Can be mixed with honey, sugar alcohol, sugar and acidulants such as citric acid and sodium citrate.
본 발명의 또다른 양태에서, 본 발명은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 지구자, 후박, 및 감초를 포함하는 숙취 해소용 조성물의 유효량을 함유하는 단위 투여 제형(unit dose form)을 제공한다.In another aspect of the present invention, the present invention is an effective amount of a hangover-relieving composition comprising black axis, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, sine, creation, ginger, jujube, earthlings, pepper, and licorice It provides a unit dose form containing (unit dose form).
본 발명의 조성물은 본 발명이 속하는 기술분야에 공지되어 있는 통상적인 약제학적 투여 제형으로 제제화될 수 있다. 상기 제형은 경구투여제제, 주사용 제제, 좌제, 경피투여제제, 및 경비투여제제를 포함하며 이에 한정되지 않는 임의의 제형으로 제제화되어 투여될 수 있다. 일 구체예에서, 본 발명의 단위 투여 제형은 정제, 환제, 캡슐제, 사셰(sachet), 산제, 과립제, 용액, 현탁제, 에멀젼, 시럽제, 엘릭서제(elixir), 엑스제 또는 에어로졸(aerosol)과 같은 경구 투여용 제형이다. Compositions of the present invention may be formulated in conventional pharmaceutical dosage forms known in the art. The formulations may be formulated and administered in any formulation including, but not limited to, oral, injectable, suppository, transdermal, and non-administered agents. In one embodiment, the unit dosage form of the present invention is a tablet, pill, capsule, sachet, powder, granule, solution, suspension, emulsion, syrup, elixir, extract or aerosol It is a formulation for oral administration such as.
또한 상기 단위 투여 제형은 제형에 따라 통상적으로 사용되는 약제학적 또는 생리학적으로 허용가능한 담체를 추가적으로 포함할 수 있다. 상기 담체는 부형제, 희석제, 충진제, 증량제, 결합제, 활택제, 습윤제, 붕해제, 안정화제, 방부제,계면활성제로부터 선택되는 1종 이상일 수 있다. 상기 담체는 예를 들면 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 포함하나, 이에 제한되지 않는다. In addition, the unit dosage form may further include a pharmaceutically or physiologically acceptable carrier commonly used according to the dosage form. The carrier may be at least one selected from excipients, diluents, fillers, extenders, binders, lubricants, wetting agents, disintegrants, stabilizers, preservatives, surfactants. The carrier is, for example, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, Polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.
일 구체예에서, 본 발명의 조성물은 경구 투여를 위한 고체 제형로서, 정제, 환제, 산제, 과립제, 캡슐제, 사셰 등의 형태일 수 있다. 이러한 고체 제형은 본 발명의 조성물과 함께, 하나 이상의 약제학적 또는 생리학적으로 허용 가능한 부형제, 예를 들면, 희석제, 활택제, 결합제, 붕해제, 감미제, 안정제, 또는 방부제를 포함할 수 있다. 구체적으로, 희석제로는 유당, 옥수수 전분, 젤라틴, 칼슘카보네이트, 대두유, 미정질 셀룰로오스, 또는 만니톨, 활택제로는 마그네슘 스테아레이트 또는 탈크, 결합제로는 폴리비닐피롤리돈 또는 히드록시프로필셀룰로오스가 사용될 수 있다. 또한, 붕해제로는 카르복시메틸셀룰로오스 칼슘, 전분글리콜산나트륨, 폴라크릴린칼륨, 또는 크로스포비돈, 감미제로는 백당, 과당, 솔비톨, 또는 아스파탐, 안정제로는 카르복시메틸셀룰로오스나트륨, 베타-사이클로덱스트린, 백납, 또는 잔탄검, 방부제로는 파라옥시안식향산메틸, 파라옥시안식향산프로필, 또는 솔빈산칼륨이 사용될 수 있다. In one embodiment, the composition of the present invention is a solid dosage form for oral administration and may be in the form of tablets, pills, powders, granules, capsules, sachets and the like. Such solid dosage forms may comprise one or more pharmaceutically or physiologically acceptable excipients, such as diluents, glidants, binders, disintegrants, sweeteners, stabilizers, or preservatives, with the compositions of the present invention. Specifically, lactose, corn starch, gelatin, calcium carbonate, soybean oil, microcrystalline cellulose, or mannitol, magnesium stearate or talc as a lubricant, and polyvinylpyrrolidone or hydroxypropyl cellulose as a binder may be used. have. In addition, as a disintegrant, carboxymethyl cellulose calcium, sodium starch glycolate, potassium polyacrylic acid, or crospovidone, sweetener as white sugar, fructose, sorbitol, or aspartame, stabilizer as carboxymethyl cellulose sodium, beta-cyclodextrin, As lead, or xanthan gum, and preservatives, methyl paraoxybenzoate, propyl paraoxybenzoate, or potassium sorbate may be used.
다른 구체예에서, 본 발명의 조성물은 경구용 액상 제형으로서, 현탁제, 내용 액제, 에멀젼, 시럽제, 엘릭서제 등의 형태일 수 있다. 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 또한, 상기 성분 이외에도 공지의 첨가제로서 미각을 돋구기 위하여, 매실향, 레몬향, 파인애플향, 허브향 등의 천연향료, 천연과즙, 클로로필린, 플라보노이드 등의 천연색소, 과당, 벌꿀, 당알코올, 설탕과 같은 감미성분, 또는 구연산, 구연산 나트륨과 같은 산미제를 혼합하여 사용할 수도 있다. In another embodiment, the compositions of the present invention are oral liquid formulations, which may be in the form of suspensions, intraocular solutions, emulsions, syrups, elixirs, and the like. In addition to the commonly used simple diluents, water and liquid paraffin, various excipients may be included, for example wetting agents, sweetening agents, fragrances, preservatives and the like. In addition to the above components, natural additives such as natural flavors such as plum flavor, lemon flavor, pineapple flavor and herb flavor, natural fruit juice, natural coloring matters such as chlorophyllin and flavonoid, fructose, honey, sugar alcohol, sugar Or acidic agents such as citric acid and sodium citrate may be mixed and used.
또다른 구체예에서, 본 발명의 조성물은 비경구 투여용 제형으로 제제화될 수 있으며, 멸균된 수용액, 비수성 용제, 현탁제, 유제, 동결건조 제제, 좌제 등이 포함된다. 주사제의 경우는 이에 한정되는 것은 아니나, 한크액(Hank's solution), 링거액(Ringer's solution), 생리 식염 완충액과 같은 생리학적으로 적합한 완충액을 사용하여 제조할 수 있다. 또한 비수성 용제, 현탁제로는 프로필렌글리콜, 폴리에틸렌글리콜, 올리브오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있으며, 그 외에 안정제, 분산제 등을 추가적으로 포함할 수 있다. 또한 본 발명의 조성물은 분말 형태로 제조되어, 사용 전에 멸균수와 같은 적당한 담체에 의해 재구성되어 사용될 수 있다. 좌제로 제제화되는 경우, 기제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로젤라틴 등이 사용될 수 있으나, 이에 한정되지 않는다.In another embodiment, the compositions of the present invention may be formulated for parenteral administration and include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories, and the like. Injectables may be prepared using a physiologically suitable buffer such as, but not limited to, Hank's solution, Ringer's solution, and physiological saline buffer. In addition, non-aqueous solvents and suspending agents may be used propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate, and the like, and may further include stabilizers, dispersants, and the like. In addition, the compositions of the present invention may be prepared in powder form and reconstituted with a suitable carrier such as sterile water before use. When formulated as a suppository, bases may include, but are not limited to, witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like.
본 발명의 조성물을 포함하는 단위 투여 제형은 인간, 원숭이, 말, 소, 돼지, 염소, 토끼 또는 쥐와 같은 포유동물에 다양한 경로로 투여될 수 있다. 투여의 모든 방식이 예상될 수 있으며, 예를 들면, 경구, 관절 내, 정맥, 근육, 피하, 경피, 직장, 비강, 자궁내경막 또는 뇌혈관내(intracerebroventricular) 투여 등이 가능하다. 상기 조성물은 또한 당해 기술 분야에 공지되어 있는 다른 방법 (예를 들어 Remington's Pharmaceutical Science 최신판에 기재된 방법들)을 이용할 수도 있다. 가장 바람직한 구체예에서, 상기 조성물은 경구 투여 목적의 단위 투여 제형으로 제제화될 수 있다. Unit dosage forms comprising a composition of the present invention can be administered to a mammal, such as human, monkey, horse, cow, pig, goat, rabbit or rat, by various routes. All modes of administration can be envisaged, for example oral, intraarticular, intravenous, intramuscular, subcutaneous, transdermal, rectal, nasal, endometrial or intracerebroventricular. The composition may also use other methods known in the art, such as those described in the latest edition of Remington's Pharmaceutical Science. In the most preferred embodiment, the composition may be formulated in unit dosage form for oral administration.
본 발명에 따른 조성물의 1회 인체 투여량은 3 g 내지 20 g인 것이 바람직하나 이에 한정되지 않는다. 실제 투여량은 개체의 연령, 체중, 증상의 경중, 알코올 섭취량, 빈도, 대사 속도, 반응감응성과 같은 환자측 요인, 및 투여 제형, 투여 경로, 투약 기간과 같은 약물측 요인에 따라 가변적일 수 있으며, 당업자에 의해 적절하게 선택될 수 있다. 바람직한 구체예에서, 본 발명의 조성물의 1일 투여량은 성인 기준으로 3 g 내지 20 g, 바람직하게는 5 g 내지 15 g, 더욱 바람직하게는 약 10 g이 되도록, 임의로 수회 나누어서 투여할 수 있다.The single human dose of the composition according to the present invention is preferably 3 g to 20 g, but is not limited thereto. Actual dosages may vary depending on the subject's age, weight, severity of symptoms, patient side factors such as alcohol intake, frequency, metabolic rate, responsiveness, and drug side factors such as dosage form, route of administration, duration of administration, It may be appropriately selected by those skilled in the art. In a preferred embodiment, the daily dose of the composition of the present invention may be administered in several divided doses, such that it is 3 g to 20 g, preferably 5 g to 15 g, more preferably about 10 g on an adult basis. .
또한 추가적인 양태에서, 본 발명은 상기 숙취 해소용 조성물 및 식품학적으로 허용가능한 식품보조 첨가제를 포함하는, 건강기능성 식품 또는 건강기능성 음료를 제공한다. 본 발명의 숙취 해소용 조성물은 자체로서 건강기능성 식품 또는 음료로 제제화되거나, 또는 각종 식품 및 음료에 첨가되어 사용될 수 있다. In a further aspect, the present invention provides a health functional food or health functional beverage comprising the hangover composition and a food acceptable additive. The hangover composition of the present invention may be formulated as a health functional food or a beverage or added to various foods and beverages.
본 명세서에서에 사용되는 용어 "건강기능성 식품(음료)"은 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조 및 가공한 식품(음료)을 의미하며, "기능성"은 인체의 구조 및 기능에 대해 생체 방어, 생체 리듬의 조절, 질병의 예방, 개선 및 회복 등 유용한 생리학적 효과를 발휘하도록 설계된 것을 의미한다. 본 발명의 건강기능성 식품 또는 음료는, 급성 및 만성적 알코올 섭취에 수반되는 숙취 증상, 예를 들면, 피로감, 전신권태, 복부팽만감, 구토, 속쓰림, 및 인지기능의 감소, 및 기타 알코올 섭취에 기인한 병변, 예를 들면, 알코올성 간질환, 고혈당증, 기억력 감퇴, 집중력 감소, 감수성 저하 등의 예방, 개선 또는 회복과 관련된 기능을 수행할 수 있다. As used herein, the term "health functional food (beverage)" refers to a food (beverage) manufactured and processed using raw materials or ingredients having a useful functionality to the human body, "functional" means a structure and function of the human body. It is designed to exert useful physiological effects such as biological defense, regulation of biological rhythm, prevention of disease, improvement and recovery. The health functional food or beverage of the present invention is caused by hangover symptoms associated with acute and chronic alcohol intake, such as fatigue, general boredom, bloating, vomiting, heartburn, and decreased cognitive function, and other alcohol intakes. Function to prevent, ameliorate, or recover lesions, such as alcoholic liver disease, hyperglycemia, memory loss, decreased concentration, decreased sensitivity, and the like.
일 구체예에서, 본 발명의 조성물은 당해 기술분야에 공지되어 있는 기능성 식품(functional food), 영양 보조제(nutritional supplement), 건강식품(health food) 및 식품 첨가제(food additive) 등을 포함하는, 통상적인 건강기능성 식품의 종류로 제제화될 수 있다. 또한, 상기 건강기능성 식품은 의약의 단위 투여 제형과 동일한 방식으로, 예를 들면 정제, 환제, 산제, 과립제, 캡슐제, 사셰(sachet), 엘릭서제(elixir), 현탁액, 에멀젼, 용액, 시럽 또는 에어로졸(aerosol)와 같은 제형으로 제조될 수 있다. 상기 식품학적으로 허용 가능한 보조첨가제로는 제조하고자 하는 제형의 제조에 당해 기술분야에서 사용 가능한 것으로 공지되어 있는 임의의 담체 또는 첨가제가 이용될 수 있다. In one embodiment, the compositions of the present invention are conventional, including functional foods, nutritional supplements, health foods, food additives, and the like, known in the art. It can be formulated into a kind of dietary supplement. The dietary supplement may also be used in the same manner as the unit dosage form of a medicament, for example tablets, pills, powders, granules, capsules, sachets, elixirs, suspensions, emulsions, solutions, syrups or It may be prepared in a formulation such as aerosol. As the food acceptable acceptable additive, any carrier or additive known to be usable in the art may be used to prepare a formulation to be prepared.
또다른 구체예에서, 본 발명은 상기 숙취 해소용 조성물을 함유하는 건강기능성 음료를 제공한다. 이러한 음료 또는 드링크제는 음주 후에는 단독으로, 또한 음주 전에는 고알콜 함량의 주류에 첨가하여 음용될 수 있다.In another embodiment, the present invention provides a health functional beverage containing the composition for relieving hangovers. Such beverages or drinks may be consumed alone after drinking or in addition to alcohol having a high alcohol content before drinking.
본 발명의 건강기능성 음료는 통상의 음료와 같이 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상기 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드, 말토오스, 수크로오스와 같은 디사카라이드, 및 덱스트린, 시클로덱스트린과 같은 폴리사카라이드, 자일리톨, 소르비톨, 에리트리톨 등의 당알코올을 포함한다. 향미제로는 타우마틴, 스테비아 추출물과 같은 천연 감미제, 또는 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있으나 이에 제한되지 않는다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ㎖ 당 일반적으로 0.01 내지 0.04 g, 바람직하게는 약 0.02 내지 0.03 g이다. 그 외에 본 발명의 건강기능성 음료는 다양한 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 증진제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있다. 이러한 성분들은 독립적으로 또는 조합하여 사용할 수 있으며, 첨가제의 비율은 본 발명의 조성물 0 내지 약 20 중량% 범위에서 선택되는 것이 일반적이다.The health functional beverage of the present invention may contain a flavoring agent or a natural carbohydrate or the like as an additional component, as in a conventional beverage. The natural carbohydrates include glucose, monosaccharides such as fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, sugar alcohols such as xylitol, sorbitol and erythritol. Flavoring agents may include, but are not limited to, natural sweeteners such as taumartin, stevia extract, or synthetic sweeteners such as saccharin and aspartame. The proportion of said natural carbohydrates is generally from 0.01 to 0.04 g, preferably from about 0.02 to 0.03 g per 100 ml of the composition of the present invention. In addition, the health functional beverage of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, colorants and enhancers, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective properties Colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. These components may be used independently or in combination, and the proportion of the additive is generally selected from the range of 0 to about 20% by weight of the composition of the present invention.
이때, 식품 또는 음료 중의 조성물의 양은, 그의 사용 목적(예방, 건강, 또는 치료적 처치 등)에 따라 적절하게 결정될 수 있다. 일반적으로 건강기능성 식품 조성물의 경우 전체 식품 중량의 0.01 내지 15 중량%, 바람직하게는 1 내지 5 중량%로 첨가될 수 있으며, 건강기능성 음료 조성물의 경우 100 ㎖를 기준으로 0.02 내지 10 g, 바람직하게는 0.3 내지 1 g의 비율로 첨가될 수 있다. 그러나 건강 조절을 목적으로 하는 장기간의 섭취의 경우에는, 상기 양은 제시된 범위 이하일 수 있다. At this time, the amount of the composition in the food or beverage can be appropriately determined according to the purpose of its use (prevention, health, or therapeutic treatment, etc.). In general, the functional food composition may be added in an amount of 0.01 to 15% by weight, preferably 1 to 5% by weight of the total food weight, 0.02 to 10 g, preferably based on 100 ml for the functional food composition May be added in a ratio of 0.3 to 1 g. However, for long term intakes for health control purposes, the amount may be below the indicated range.
본 발명에서 사용되는 모든 기술 용어는 달리 정의되지 않는 이상, 본 발명의 관련 분야에서 통상의 당업자가 일반적으로 이해하는 바와 같은 의미로 사용된다. 또한 본 명세서에는 바람직한 방법이나 시료가 기재되나, 이들의 유사체 및 균등물들도 본 발명의 범주에 포함된다. 본 명세서에 참고문헌으로 기재되는 모든 간행물의 내용은 본 발명에 도입된다.All technical terms used in the present invention are used in the meaning as commonly understood by those skilled in the art in the related field of the present invention, unless otherwise defined. Also described herein are preferred methods or samples, but analogs and equivalents thereof are included within the scope of the present invention. The contents of all publications referred to herein are incorporated herein by reference.
본 발명에 따른 조성물은 흑축, 갈근, 진피, 산사, 초두구, 복령, 양강, 사인, 창출, 생강, 대추, 헛깨, 후박, 및 감초를 유효성분으로 포함하여, 우수한 혈중 알코올 대사 촉진 효능을 나타낸다. 본원발명의 조성물은 알코올 섭취 전에 투여된 경우 신속하게 혈중 알코올 농도를 감소시켜 효율적인 숙취 예방 및 제거 효과를 나타내고, 만성적 알코올 섭취로 인한 간질환의 예방 및 치료에 기여하며, 상용량을 초과하는 농도에서 부작용 및 독성을 나타내지 않아 알코올에 기인한 숙취 또는 간질환의 예방 또는 개선용 음료 및 건강식품으로 유용하게 사용할 수 있다. The composition according to the present invention, including black shaft, brown root, dermis, hawthorn, chodugu, bokyeong, Yanggang, sign, creation, ginger, jujube, flatul, bakbak, and licorice as an active ingredient, exhibits excellent blood alcohol metabolism promoting effect . The composition of the present invention rapidly reduces blood alcohol concentration when administered prior to alcohol intake, exhibits an effective hangover prevention and elimination effect, contributes to the prevention and treatment of liver disease due to chronic alcohol intake, side effects at concentrations above the normal dose And it does not exhibit toxicity can be usefully used as a beverage and health food for the prevention or improvement of hangover or liver disease caused by alcohol.
도 1은 본 발명의 조성물을 ICR 마우스에 투여한 경우 단회 또는 반복적 에탄올 투여시 에탄올의 혈중 농도 변화에 미치는 영향을 도시한 그래프이다 (SA: 단회투여-음성대조군, 1시간 후 채혈, SB: 단회투여-시험물질 투여군, 1시간 후 채혈, SC: 단회투여-음성대조군, 4시간 후 채혈, SD: 단회투여-시험물질 투여군, 4시간 후 채혈, RA: 반복투여-음성대조군, RB: 반복투어-시험물질 투여군, †: SC군 대비 p<0.01, *: RA군 대비 p<0.05). 1 is a graph showing the effect on the blood concentration change of ethanol when a single or repeated ethanol administration of the composition of the present invention to ICR mice (SA: single dose-negative control, blood collection after 1 hour, SB: single) Dosage-Test Substance-treated group, 1 hour after collection, SC: Single-dose-negative control, 4 hours after-dose, SD: Single-dose-Test Substance administered, 4 hours after blood collection, RA: Repeated-negative control, RB: Repeated tour -Test substance administration group, †: p <0.01 compared to SC group, *: p <0.05 compared to RA group).
이하, 본 발명을 하기 실시예 및 제제예에 의해 더욱 구체적으로 설명한다. 그러나 이들 실시예는 본 발명에 대한 이해를 돕기 위한 예시일 뿐, 어떤 의미로든 본 발명의 범위가 이들에 의해 제한되는 것은 아니다.Hereinafter, the present invention will be described in more detail with reference to the following Examples and Formulation Examples. However, these examples are only illustrative to aid the understanding of the present invention, and the scope of the present invention in any sense is not limited thereto.
실시예Example 1: 숙취 해소용 조성물의 제조 1: Preparation of Hangover Relief Composition
표 1에 기재된 약재를 건조 상태로 준비하고, 이를 칭량에 적절한 크기로 잘게 절단하였다. 각각의 약재를 표시된 중량이 되도록 칭량하여 혼합한 후, 혼합물을 통상의 방법으로 분쇄하였다. 분말 상태의 혼합물에 밀가루로 제조된 풀을 먹이고, 약 3 g 내지 20 g의 환으로 제조하였다. The medicines listed in Table 1 were prepared in a dry state, which was chopped to a size suitable for weighing. After weighing and mixing each medicine to the indicated weight, the mixture was ground in a conventional manner. The powdered mixture was fed with a paste made of wheat flour and prepared into a ring of about 3 g to 20 g.
상기 재료들 중, 감초는 중국산을, 후박은 울릉도산을 사용하였으며, 나머지 재료는 국내산으로서 시중에서 구입하여 사용하였다.Of the above materials, licorice was produced in China, and Hubak was used in Mt. Ulleungdo, and the rest of the materials were domestically purchased and used.
참고예Reference Example 1: 시험동물의 사육 및 처리 1: Breeding and processing test animals
6주령의 CrljOri:CD1 ICR(Institute of Cancer Research) 마우스 수컷 50마리를 7일 동안, 온도 22±3 ℃, 상대습도 50±20 %, 조도 150-300 Lux 조건의 실험실에 적응시킨 후 시험에 사용하였다. 적응기간 동안, 음용수로는 R/O system을 이용한 역삼투압 초순수를, 사료로는 방사선 멸균 사료(Purina)를 자유섭취시켰으며, 시험 개시 시 시험동물들 간의 체중 편차 범위가 평균 ± 20 % 이내가 되도록 하였다. 50 male 6-week-old CrljOri: CD1 Institute of Cancer Research (ICR) mice were acclimated to a laboratory at a temperature of 22 ± 3 ° C, 50 ± 20% relative humidity, and 150-300 Lux roughness for 7 days. It was. During the acclimation period, drinking water was freely ingested with reverse osmosis ultrapure water using the R / O system, and feed with radiation sterilized feed (Purina). It was made.
상기 시험동물들은 투여 당일 무작위법으로 각 군의 평균 체중이 가능한 한 균등하게 배분되도록 하기 표 2와 같이 7마리(급성 알코올 분해능 시험) 또는 11마리(만성 알코올 분해능 시험)씩 6개의 군을 구성하였다. 시험 중 개체 식별을 위해서는 미부 표시법을 사용하였다.The test animals consisted of six groups of seven (acute alcohol resolution test) or 11 (chronic alcohol resolution test) as shown in Table 2 below so that the average weight of each group was distributed as evenly as possible by random method on the day of administration. . The tail notation was used to identify individuals during the test.
단회투여
시험
Single dose
exam
시험Repeated administration
참고예Reference Example 2: 시험물질의 조제 2: Preparation of Test Substance
시험물질로는 실시예 1에서 제조된 환(흑색) 형태의 조성물을 사용하였으며, 대조물질로는 동물 사육시 음수로 공급되는 역삼투압 초순수를 사용하였다. 시험물질은 임상예정 투여농도(0.1 g/kg)의 5배인 0.5 g/kg을 투여 농도로 설정하고, 대조물질인 역삼투압 초순수에 대한 용해도 테스트 결과에 따라 적절한 농도가 되도록 상기 조성물을 역삼투압 초순수에 용해시켜 조제하였다.As a test material, the composition of the ring (black) form prepared in Example 1 was used, and as a control material, reverse osmosis ultrapure water supplied as a negative water for animal breeding was used. The test substance was set at 0.5 g / kg, which is five times the expected clinical administration concentration (0.1 g / kg), and the composition was adjusted to an appropriate concentration according to the solubility test result for the reverse osmosis ultra pure water. It was prepared by dissolving in.
에탄올(Merck 사)을 대조물질인 역삼투압 초순수에 용해시켜 40% (4g/kg, 5 mL/kg; 급성 알코올 분해능 시험) 또는 20% (2 g/kg, 2.5 mL/kg: 만성 알코올 분해능 시험) 에탄올 용액을 조제하였다. 투여 직전 조제되므로 안정성, 순도 등 별도의 분석을 실시하지 않았다. Ethanol (Merck) was dissolved in the control reverse osmosis ultrapure water, 40% (4g / kg, 5 mL / kg; acute alcohol resolution test) or 20% (2 g / kg, 2.5 mL / kg: chronic alcohol resolution test ) Ethanol solution was prepared. Since it was prepared immediately before administration, no separate analysis such as stability and purity was performed.
참고예Reference Example 3: 통계처리 및 분석 3: Statistical Processing
체중 및 혈청 분석(에탄올, 아세트알데히드) 결과의 통계적 유의성은 대조값으로부터의 변동을 스튜던트 t-검정(student's t-test)에 의해 분석하였으며, p 값이 0.05 미만인 경우 통계적으로 유의한 것으로 판정하였다. 구체적으로, p 값이 0.05 미만인 경우 *, 0.01 미만인 경우 †로 표시하여 유의성의 차이를 판단하였다.The statistical significance of the results of body weight and serum analysis (ethanol, acetaldehyde) were analyzed by Student's t-test, and the change from the control value was determined to be statistically significant when the p value was less than 0.05. Specifically, when the p value is less than 0.05, * and less than 0.01, † was indicated to determine the difference in significance.
실시예Example 2: 경구 독성 시험 2: oral toxicity test
실시예 1에 따라 제조된 본 발명의 조성물을 임상 예정 투여농도(0.1 g/kg)의 5배 양으로 마우스에 경구투여한 경우 음성대조군 대비 임상 증상 및 체중 변화를 관찰하여 독성 및 부작용 존부를 판단하였다. When the composition of the present invention prepared according to Example 1 was orally administered to mice at a 5-fold amount of the clinically planned administration concentration (0.1 g / kg), the clinical symptoms and the weight change compared to the negative control were observed to determine the presence of toxicity and side effects. It was.
방법Way
각 군의 시험동물에 대하여, 본 발명의 조성물을 포함하는 시험물질 및 에탄올 투여 30분 후에 나타나는 임상 증상을 관찰하였으며, 반복투여군(만성 알코올 분해능 시험)의 경우, 3주 동안 매일 1회씩 지속적인 관찰을 실시하였다. 약물에 의한 일반상태의 변화, 중독 증상 및 폐사 여부를 관찰하였으며, 관찰시 피부와 털, 눈과 점막의 변화, 그 밖의 호흡기계, 순환기계, 자율신경 및 중추신경계, 전신운동성 및 행동 패턴을 포함시켰다. 진전, 경련, 유연, 설사, 졸림, 수면 및 혼수에 대해서도 특별히 주의하여 관찰하였다. For the test animals in each group, the clinical symptoms appearing 30 minutes after administration of the test substance and ethanol containing the composition of the present invention were observed, and in the repeated dose group (chronic alcohol resolution test), continuous observation was performed once daily for 3 weeks. Was carried out. Changes in general condition by drugs, symptoms of intoxication, and death were observed, including changes in skin and hair, eyes and mucous membranes, other respiratory and circulatory systems, autonomic and central nervous systems, systemic motility and behavioral patterns. I was. Particular attention was also paid to tremor, convulsions, softening, diarrhea, drowsiness, sleep and lethargy.
반복투여군에 대해서는, 시험 개시후 주 2회 체중을 측정하였으며 그 변화 추이를 하기 표 3에 나타내었다.For the repeated dose group, the body weight was measured twice a week after the start of the test and the change is shown in Table 3 below.
장기에 대한 독성 여부를 확인하기 위해, 각 군당 채혈시간에 따라 마취제(Zoletil:Rompun의 5:1 혼합물을 1/7로 희석하여 6 mg/kg으로 복강주사함)를 사용하여 마취한 후, 개복하여 각 주요 장기별 이상유무를 육안으로 관찰하였다. To determine the toxicity to organs, anesthesia was performed using an anesthetic (diluted 1/7 with a 5: 1 mixture of Zotilil: Rompun intraperitoneally injected at 6 mg / kg) according to the blood collection time for each group, followed by anesthesia. Therefore, each major organ was observed visually.
결과result
반복투여-음성대조군(RA) 11마리의 개체 중 1마리가 마지막 투여일에 사망하였고, 그외의 모든 군의 개체는 생존하였다. 하기 표 3에 나타난 바와 같이, 반복투여기간 동안 음성대조군과 실험군의 체중을 스튜던트 t-검정에 의해 분석한 결과, 통계적으로 유의한 체중 변화는 없었으며, 상기 1마리를 제외한 모든 마우스는 체중 증가를 보이면서 건강하게 생존하였다.One of 11 subjects with repeated-negative control (RA) died on the last day of administration, and all other groups survived. As shown in Table 3 below, the weight of the negative control group and the experimental group was analyzed by Student's t-test during the repeated administration period, and there was no statistically significant weight change. Visible and healthy.
경과일Elapsed Days
임상 증상 관찰 결과, 모든 군의 개체들은 에탄올 투여 후 30분 동안 졸림 및 비틀거림이 관찰되었으나, 그 이후부터는 특이한 임상 증상은 관찰되지 않았다. 또한, 시험물질 투여와 관련된 독성 반응 및 기타 임상 증상은 관찰되지 않았으며, 각 관찰 항목에 있어서 실험군 및 대조군의 차이는 유의하지 않았다.As a result of clinical symptom observation, all groups of subjects showed drowsiness and staggering for 30 minutes after ethanol administration, but thereafter, no specific clinical symptoms were observed. In addition, no toxic response and other clinical symptoms related to administration of the test substance were observed, and the difference between the experimental group and the control group was not significant in each observation item.
채혈 후 모든 개체를 부검하여 주요 장기(심장, 간, 폐, 비장, 신장, 대장)들을 육안으로 관찰한 결과, 이상 소견이 발견되지 않았다. 시험기간 중 사망한 반복투여-음성대조군(RA) 1마리의 경우 간과 소화기간이 일부 손상되어 있음을 확인하였으나, 동일 군의 다른 개체들은 이상이 발견되지 않았으므로 본 시험결과와 무관한 사망 개체만의 개별 임상증상으로 판단된다. After the blood collection, all the subjects were autopsied and the major organs (heart, liver, lung, spleen, kidney, colon) were visually observed. No abnormalities were found. One repeat dose-negative control group that died during the study was found to have some damage to the liver and digestive system.However, no other abnormalities were found in the same group. Is considered to be an individual clinical symptom.
실시예Example 3: 혈중 알코올 농도 측정 시험 3: blood alcohol concentration test
본 실시예에서는 에탄올 투여 전 본 발명의 조성물을 실험동물에 단회 또는 반복 투여하였을 때 혈중 에탄올 및 아세트알데히드 농도 변화를 측정하여, 에탄올의 분해능을 평가하였다. In this example, the ethanol and acetaldehyde concentrations were measured by measuring changes in blood ethanol and acetaldehyde when the composition of the present invention was administered to the experimental animals once or repeatedly before ethanol administration.
3-1. 급성 알코올 분해능 시험3-1. Acute Alcohol Resolution Test
방법Way
7일 동안 적응시킨 마우스를 표 2에 기재된 바와 같이 군당 7마리씩 SA, SB, SC 및 SD군으로 분배하고, 식이에 의한 알코올 흡수 및 분해의 차이를 제거하기 위해 시험물질 투여 18시간 전부터 금식시켰다. 알코올 투여 전에 실시예 1의 조성물 또는 대조물질(역삼투압 초순수)을 경구로 섭취시켜 혈중 알코올 농도의 변화에 미치는 효과를 측정하였다.Mice adapted for 7 days were distributed into SA, SB, SC and SD groups, 7 per group, as described in Table 2, and fasted 18 hours prior to administration of test substance to eliminate differences in alcohol uptake and degradation by diet. Prior to the administration of alcohol, the composition or the control material (reverse osmosis ultrapure water) of Example 1 was ingested orally to determine the effect on the change in blood alcohol concentration.
마우스를 한 손으로 보정하고 실험군인 SB 및 SD 군에 참고예 3에서 제조된 시험물질(0.5 g/kg, 7 mL/kg)을 존데(sonde)를 이용한 경구투여방법으로 위 내에 주입하였다. 동일한 방법으로, 음성대조군인 SA 및 SC 군에 시험물질과 동량(7 mL/kg)의 역삼투압 초순수를 경구 투여하였다. 상기 투여 30분 후에, 알코올 대사 유도를 위해 40% 에탄올 (4g/kg, 5 mL/kg)을 1회 투여하였다.The mouse was calibrated with one hand and the test material (0.5 g / kg, 7 mL / kg) prepared in Reference Example 3 was injected into the stomach by oral administration using sonde to the experimental group SB and SD. In the same manner, the negative control group SA and SC group was orally administered the same amount (7 mL / kg) reverse osmosis ultrapure water with the test material. 30 minutes after the administration, 40% ethanol (4 g / kg, 5 mL / kg) was administered once to induce alcohol metabolism.
시험물질 투여 후 30분 후부터 자유 급식하여 시간별로 희생시켰다. 즉, 군당 채혈시간에 따라(투여 1시간 또는 4시간 후) 마취제(Zoletil:Rompun의 5:1 혼합물을 1/7로 희석하여 6 mg/kg으로 복강주사함)를 사용하여 마취한 후 개복하여 심장 채혈을 실시하였다. 얻어진 전혈을 원심분리시켜 (4 ℃, 4000 rpm, 15분) 혈청을 분리하고 -80 ℃에 보관하였다. After 30 minutes after administration of the test substance, free feeding was performed and sacrificed hourly. That is, according to the blood collection time per group (after 1 hour or 4 hours), anesthesia (diluted 5: 1 mixture of Zotilil: Rompun in 1/7 and intraperitoneally injected at 6 mg / kg) was then anesthetized. Heart blood collection was performed. The obtained whole blood was centrifuged (4 ° C., 4000 rpm, 15 minutes) to separate serum and stored at −80 ° C.
에탄올 측정 kit (R-Biopharm, 독일)를 사용하여 에탄올 농도 분석을 실시하였다. 구체적으로, 반응 혼합물(포타슘 디포스페이트 완충액과 NAD의 혼합물) 3 mL와 혈청 0.1 mL를 혼합하여 3분 동안 반응시킨 후, 340 nm에서 흡광도를 측정하였다. 이 반응물에 알코올 디하이드로제나아제(alcohol dehydrogenase) 0.05 mL를 첨가하여 17분간 반응시킨 후, 340 nm에서 흡광도를 측정하였다. 상기 흡광도의 차이값(△A)을 이용하여 하기 식에 따라 에탄올의 최종 농도(C)를 구하였다. Ethanol concentration analysis was performed using an ethanol measurement kit (R-Biopharm, Germany). Specifically, 3 mL of the reaction mixture (a mixture of potassium diphosphate buffer and NAD) and 0.1 mL of serum were mixed and reacted for 3 minutes, and then absorbance was measured at 340 nm. 0.05 mL of alcohol dehydrogenase was added to the reaction, followed by reaction for 17 minutes, and the absorbance was measured at 340 nm. Using the difference value (ΔA) of the absorbance, the final concentration (C) of ethanol was obtained according to the following equation.
C = △A × (V × MG ) / (ε×d × v × 2 × 1000) [g/L]
C = ΔA × (V × MG ) / (ε × d × v × 2 × 1000) [g / L]
V = 최종 부피 [mL]V = final volume [mL]
c = 샘플 부피 [mL]c = sample volume [mL]
MW = 분석 물질의 분자량 [g/mol]MW = molecular weight of the analyte [g / mol]
d = 광로 길이(light path) [cm]d = light path [cm]
ε = NADH의 흡광 계수 [1×mmol-1×cm-1]ε = absorbance coefficient of NADH [1 × mmol -1 × cm -1 ]
(340 nm의 경우: 6.3) (At 340 nm: 6.3)
아세트알데히드 측정 kit (R-Biopharm, 독일)를 사용하여 상기와 유사한 방식으로 혈중 아세트알데히드 농도 분석을 실시하였다. 측정된 농도를 평균 ± 표준편차 또는 평균값으로 나타내었다 (표 4, 도 1).Blood acetaldehyde concentration analysis was performed in a similar manner to the above using the acetaldehyde measurement kit (R-Biopharm, Germany). Measured concentrations are expressed as mean ± standard deviation or mean value (Table 4, FIG. 1).
결과result
에탄올 투여 1시간 후에 채혈한 경우, 음성대조군(SA) 대비 시험물질 투여군(SB)의 혈청 내 에탄올 농도는 통계적으로 유의한 차이가 없었던 반면, 에탄올 투여 4시간 후에 채혈했을 때, 시험물질 투여군(SD)의 혈청 중 농도는 음성대조군(SC)의 농도보다 약 57%로 현저하게 감소하여, 통계적으로 유의한 차이를 보였다 (p<0.01). 따라서, 본 발명의 조성물은 에탄올 섭취시 체내 에탄올 대사 속도를 향상시키는 것을 확인하였다.When blood was collected 1 hour after ethanol administration, the serum ethanol concentration of test substance administration group (SB) was not statistically significant compared to the negative control group (SA). ) Serum concentration was significantly decreased to about 57% than that of the negative control group (SC), showing a statistically significant difference (p <0.01). Therefore, the composition of the present invention was confirmed to improve the rate of ethanol metabolism in the body upon ethanol intake.
혈청 내 아세트알데히드 농도는 모든 군에서 측정되지 않았으며, 따라서 본 시험에서 사용한 아세트알데히드 측정 키트에서 아세트알데히드의 최소 측정값인 0.05 g/L 미만일 것으로 사료된다.Acetaldehyde concentrations in serum were not measured in all groups and therefore are believed to be less than 0.05 g / L, the minimum measurement of acetaldehyde in the acetaldehyde measurement kit used in this test.
3-2. 만성 알코올 분해능 시험3-2. Chronic Alcohol Resolution Test
방법Way
7일 동안 적응시킨 마우스를 표 2에 기재된 바와 같이 11마리씩 RA 및 RB군으로 분배하고, 최초 투여 18시간 전부터 절식시켰다. 실시예 1의 조성물 (0.5 g/kg, 7 mL/kg) 또는 대조물질(역삼투압 초순수)(7 mL/kg)을 경구로 섭취시킨 후에, 30분 뒤 알코올 대사 유도를 위해 20% 에탄올 (2 g/kg, 2.5 mL/kg)을 투여하였다. 2일차 부터는 절식 없이 시험물질 및 에탄올을 투여하고, 투여 후 30분간 절식한 후부터는 자유 급식하였으며, 이 과정을 3주 동안 매일 반복시행하였다.Mice adapted for 7 days were divided into 11 RA and RB groups as described in Table 2 and fasted 18 hours before the first dose. After oral ingestion of the composition of Example 1 (0.5 g / kg, 7 mL / kg) or control (reverse osmosis ultrapure water) (7 mL / kg), 30 minutes later, 20% ethanol (2 g / kg, 2.5 mL / kg). From day 2, the test substance and ethanol were administered without fasting, and after 30 minutes of fasting, free feeding was performed, and this process was repeated every day for 3 weeks.
3주 경과 후에, 마취제(Zoletil:Rompun의 5:1 혼합물을 1/7로 희석하여 6 mg/kg으로 복강주사함)를 사용하여 마취한 후 개복하여 심장 채혈을 실시하였다. 상기 실시예 3-1에 기재된 것과 동일한 방법으로, 혈청을 분리하고 에탄올 측정 kit 및 알세트알데히드 측정 kit(R-Biopharm, 독일)를 사용하여 혈중 에탄올 및 아세트알데히드 농도를 분석하였다 (표 5 및 도 1). After 3 weeks, anesthesia (diluted 5: 1 mixture of Zotiltil: Rompun to 1/7 and intraperitoneally injected at 6 mg / kg) was anesthetized, followed by laparotomy and blood collection. In the same manner as described in Example 3-1, serum was isolated and blood ethanol and acetaldehyde concentrations were analyzed using an ethanol measurement kit and an aldehyde measurement kit (R-Biopharm, Germany) (Table 5 and FIG. One).
결과result
상기 표 5에 나타난 바와 같이, 음성대조군(RA) 대비 시험물질 투여군(RB)의 혈중 에탄올 농도는 약 72%로 감소하여, 통계적으로 유의한 감소를 나타냈다 (p<0.05). 이에 따라, 본 발명의 조성물은 만성적으로 투여되는 에탄올에 대해서도 대사 촉진 효능이 있는 것으로 확인되었다. As shown in Table 5, the blood ethanol concentration of the test substance-administered group (RB) compared to the negative control group (RA) decreased to about 72%, showing a statistically significant decrease (p <0.05). Accordingly, the composition of the present invention was confirmed to have metabolic promoting effects against chronically administered ethanol.
혈청 내 아세트알데히드 농도는 모든 군에서 측정되지 않았으며, 따라서 본 시험에서 사용한 아세트알데히드 측정 키트에서 아세트알데히드의 최소 측정값인 0.05 g/L 미만일 것으로 사료된다.Acetaldehyde concentrations in serum were not measured in all groups and therefore are believed to be less than 0.05 g / L, the minimum measurement of acetaldehyde in the acetaldehyde measurement kit used in this test.
이하 본 발명의 조성물을 포함하는 의약, 식품 및 음료의 일부 제제예가 제시되나 본 발명이 이에 제한되는 것은 아니다. 본 발명의 조성물은 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸, 좌제 및 멸균 주사 용액 등의 형태로, 가능한 가장 우수한 약학적 제제, 건강기능성 식품 및 음료를 얻기 위하여 당해 기술분야에 알려진 모든 방식으로 제조될 수 있다.Hereinafter, some formulation examples of medicines, foods and beverages including the composition of the present invention are presented, but the present invention is not limited thereto. The compositions of the present invention are in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, suppositories, and sterile injectable solutions, for example in order to obtain the best possible pharmaceutical preparations, health foods and beverages. It can be prepared in any manner known to the.
제제예Formulation example 1: 약학적 제제의 제조 1: Preparation of pharmaceutical preparations
1-1. 1-1. 산제의Sanje 제조 Produce
실시예 1의 조성물 ........... 10 gComposition of Example 1 ....... 10 g
유당 ......................... 1 gLactose ......................... 1 g
탈크 ....................... 10 mgTalc ....................... 10 mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다.
The above components are mixed and filled in airtight bags to prepare powders.
1-2. 캡슐제의 제조1-2. Preparation of capsules
실시예 1의 조성물 ............. 500 ㎎Composition of Example 1 ............ 500 mg
유당 .......................... 250 ㎎Lactose ............... 250 mg
옥수수 전분 ................... 250 ㎎Corn starch ..... 250 mg
탈크 ..........................., 6 ㎎ Talc ..........................., 6 mg
스테아린산 마그네슘 ............. 5 mgMagnesium Stearate ............. 5 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.
제제예Formulation example 2: 식품의 제조 2: manufacture of food
2-1. 건강기능성 식품의 제조2-1. Preparation of health functional food
실시예 1의 조성물 ...................... 1000 mgComposition of Example 1 ... 1000 mg
산화아연 ................................ 1.5 ㎎Zinc Oxide ......................... 1.5 mg
산화마그네슘 ............................. 12 ㎎Magnesium Oxide ......................................... 12 mg
스테아린산 마그네슘 ..................... 1.5 ㎎Magnesium Stearate ............... 1.5 mg
피에이취칼라 I ............................ 9 ㎎PA Color ............................................ 9 mg
히드록시프로필메틸셀룰로오스 ............ 6.8 ㎎Hydroxypropylmethylcellulose ............ 6.8 mg
글리세린지방산에스테르 ..................0.35 ㎎Glycerin Fatty Acid Ester ...... 0.35 mg
비타민 B ................................. 30 ㎎Vitamin B ....................... 30 mg
비타민 C ................................. 12 ㎎Vitamin C ................................. 12 mg
비타민 E ..................................23 ㎎Vitamin E .................................. 23 mg
통상의 건강식품 제조방법에 따라 상기의 성분을 혼합한 다음, 과립을 제조하고, 통상의 방법에 따라 건강식품 조성물 제조에 사용할 수 있다.After mixing the above components according to a conventional health food production method, granules may be prepared and used to prepare a health food composition according to a conventional method.
2-2. 2-2. 선식의Solar 제조 Produce
현미, 보리, 찹쌀, 율무를 공지의 발법으로 알파화시켜 건조시킨 것을 배전한 후 분쇄기로 입도 60 메쉬의 분말로 제조하였다. 검은콩, 검은깨, 들깨도 공지의 방법으로 쪄서 건조시킨 것을 배전한 후 분쇄기로 입도 60 메쉬의 분말로 제조하였다. 실시예 1에 따라 제조된 조성물을 열풍 건조기로 건조시키고, 분쇄기로 입도 60 메쉬로 분쇄하여 건조 분말을 얻었다.Brown rice, barley, glutinous rice, and yulmu were alphalated by a known method and dried to be roasted, and then ground to a powder having a particle size of 60 mesh. Black beans, black sesame, and perilla were steamed and dried by a known method, and then they were made into a powder having a particle size of 60 mesh by a grinder. The composition prepared according to Example 1 was dried with a hot air dryer and pulverized to a particle size of 60 mesh with a grinder to obtain a dry powder.
상기에서 제조한 곡물류, 종실류, 및 본 발명의 조성물의 건조 분말을 다음과 같은 비율로 배합하여 제조하였다:The grains, seeds, and dry powders of the compositions of the present invention prepared above were formulated in the following proportions:
곡물류 (현미 30 중량부, 율무 15 중량부, 보리 20 중량부),Cereals (30 parts by weight brown rice, 15 parts by weight brittle, 20 parts by weight of barley),
종실류 (들깨 7 중량부, 검은콩 8 중량부, 검은깨 7 중량부),Seeds (7 parts by weight perilla, 8 parts by weight of black beans, 7 parts by weight of black sesame seeds),
본 발명의 조성물의 건조분말 (15 중량부).Dry powder (15 parts by weight) of the composition of the present invention.
제제예Formulation example 3: 음료의 제조 3: Manufacturing of beverages
3-1. 숙취 해소용 기능성 음료의 제조3-1. Preparation of functional drink for hangover
실시예 1의 조성물 15 중량부에, 비타민 C 0.1 중량부, 과당 5.8 중량부, 백설탕 3.8 중량부, 구연산 0.12 중량부, 사과산 0.03 중량부, 구연산나타륨 0.04 중량부 및 치자청색소 0.02 중량부를 배합하여 계량된 물에 완전히 용해시켰다. 약 1시간 동안 85 ℃에서 교반 가열한 후, 제조된 용액을 여과하여 멸균된 용기에 취득하여 밀봉 멸균한 뒤 냉장 보관하였다. To 15 parts by weight of the composition of Example 1, 0.1 parts by weight of vitamin C, 5.8 parts by weight of fructose, 3.8 parts by weight of white sugar, 0.12 parts by weight of citric acid, 0.03 parts by weight of malic acid, 0.04 parts by weight of sodium citrate, and 0.02 parts by weight of gardenia blue pigment And completely dissolved in the metered water. After stirring and heating at 85 ° C. for about 1 hour, the prepared solution was collected by filtration into a sterilized container, sealed and sterilized, and stored in a refrigerator.
3-2. 건강 음료의 제조3-2. Manufacture of healthy drinks
실시예 1의 조성물 15 중량부, 액상 과당 0.5 중량부, 올리고당 2 중량부, 설탕 2 중량부, 식염 0.5 중량부, 및 물 75 중량부를 균질하게 배합하여 순간 살균을 한 후 이를 유리병, 패트병 등 소포장 용기에 포장하여 건강 음료를 제조하였다.15 parts by weight of the composition of Example 1, 0.5 parts by weight of liquid fructose, 2 parts by weight of oligosaccharides, 2 parts by weight of sugar, 0.5 parts by weight of salt, and 75 parts by weight of water were homogeneously blended for instantaneous sterilization, followed by a glass bottle, a plastic bottle, etc. Healthy drinks were prepared by packaging in small packaging containers.
3-3. 탄산음료의 제조3-3. Manufacture of carbonated drinks
실시예 1의 조성물 15 중량부, 설탕 5 ~ 10 중량부, 구연산 0.05 ~ 0.3 중량부, 카라멜 0.005 ~ 0.02 중량부, 및 비타민 C 0.1 ~ 1 중량부를 혼합하고 여기에 79 ~ 94 중량부의 정제수를 섞어서 시럽을 만들고, 상기 시럽을 95 ~ 98℃에서 20 내지 180초간 살균하여 냉각수와 1:4의 비율로 혼합한 다음 탄산가스를 0.5 내지 0.82 중량부로 주입하여 탄산음료를 제조하였다.15 parts by weight of the composition of Example 1, 5 to 10 parts by weight of sugar, 0.05 to 0.3 parts by weight of citric acid, 0.005 to 0.02 parts by weight of caramel, and 0.1 to 1 parts by weight of vitamin C and mixed with 79 to 94 parts by weight of purified water A syrup was made, and the syrup was sterilized at 95 to 98 ° C. for 20 to 180 seconds, mixed with cooling water at a ratio of 1: 4, and then carbonated gas was injected at 0.5 to 0.82 parts by weight to prepare a carbonated beverage.
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CN104399056A (en) * | 2014-12-23 | 2015-03-11 | 陈晨 | Multipurpose medicine for dispelling effects of alcohol |
KR101953441B1 (en) * | 2016-11-07 | 2019-02-28 | 김대호 | Composition for hangover annul material based on oriental medicine material, manufacturing method for pill type hangover annul material using the same, and pill type hangover annul material manufactured by the same |
WO2019140479A1 (en) * | 2018-01-19 | 2019-07-25 | Clever Health Pty Ltd | Compositions and methods for the prophylaxis or treatment of a condition associated with alcohol consumption |
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KR102269936B1 (en) * | 2020-05-29 | 2021-06-28 | 유한회사 한풍제약 | A beverage composition for relieving hangover and preparing method the same |
CN113559152B (en) * | 2021-09-27 | 2021-12-14 | 北京本草源生物科技有限公司 | Liver-protecting traditional Chinese medicine composition and beverage as well as preparation method and application thereof |
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