KR102275492B1 - Composition for Prevention or Treatment of Gastritis and Gastric ulcer Comprising Steamed Ginger Extract or 1-Dehydro-6-gingerdione Isolated therefrom as an Active Ingredient - Google Patents
Composition for Prevention or Treatment of Gastritis and Gastric ulcer Comprising Steamed Ginger Extract or 1-Dehydro-6-gingerdione Isolated therefrom as an Active Ingredient Download PDFInfo
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- KR102275492B1 KR102275492B1 KR1020200109860A KR20200109860A KR102275492B1 KR 102275492 B1 KR102275492 B1 KR 102275492B1 KR 1020200109860 A KR1020200109860 A KR 1020200109860A KR 20200109860 A KR20200109860 A KR 20200109860A KR 102275492 B1 KR102275492 B1 KR 102275492B1
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- Prior art keywords
- gingerdione
- gastritis
- ginger extract
- gastric ulcer
- dehydro
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Abstract
Description
본 발명은 위염 및 위궤양의 치료 또는 예방용 조성물에 관한 것으로, 더욱 구체적으로 증숙 생강 추출물, 또는 이로부터 분리된 1-디하이드로-6-진저다이온 화합물을 유효성분으로 함유하는 위염 및 위궤양의 치료 또는 예방용 조성물에 관한 것이다.The present invention relates to a composition for the treatment or prevention of gastritis and gastric ulcer, and more particularly, to a composition for treating or preventing gastritis and gastric ulcer, containing a steamed ginger extract or 1-dihydro-6-gingerdione compound isolated therefrom as an active ingredient. Or it relates to a composition for prevention.
위염은 대한민국 국민 9명 중 1명이 앓고 있는 가장 흔한 소화기계 질환 중 하나이다. Gastritis is one of the most common digestive system diseases, affecting 1 in 9 Koreans.
위염(gastritis)이란 위 내벽의 염증이 발생한 상태를 일컫는다. 또한, 위궤양(peptic ulcer)이란 넓은 범위로는 소장(small intestine)의 기시부인 위와 소장의 일부인 십이지장(duodenum) 내벽에 미란(erosion)이 발생한 상태를 칭한다(Najm WI., Primary Care. 38, 383-394, 2011). Gastritis is a condition in which the lining of the stomach is inflamed. In addition, peptic ulcer refers to a condition in which erosion occurs in the inner wall of the stomach, which is the origin of the small intestine, and the duodenum, which is a part of the small intestine (Najm WI., Primary Care. 38, 383). -394, 2011).
위염 및 위궤양의 일반적인 증상은 유사하며 상복부 부위의 통증(abdominal pain)을 주요 증상으로 하며, 동통(aching)과 작열감(burning), 선통(gnawing)을 동반할 뿐만이 아니라, 구역(nausea), 구토(vomiting), 복부 팽만감(bloating), 식욕감퇴(loss of appetite) 및 원인불명의 체중감소와 같은 증상이 관찰된다. 만성 위궤양의 경우 위출혈(bleeding), 천공(perforation) 및 십이지장과 연결된 유문부 폐색(pylorus obstruction)과 같은 증상을 야기하는 것으로 보고되고 있다(Milosavljevic T., Kostic-Milosavljevic M., Jovanovic I., Krstic M., Dig. Dis. 29, 491-493, 2011). The general symptoms of gastritis and gastric ulcer are similar, with abdominal pain as the main symptom, accompanied by aching, burning, and gnawing, as well as nausea and vomiting ( vomiting), abdominal bloating, loss of appetite, and unexplained weight loss are observed. Chronic gastric ulcer is reported to cause symptoms such as gastric bleeding, perforation, and pylorus obstruction connected to the duodenum (Milosavljevic T., Kostic-Milosavljevic M., Jovanovic I., Krstic M.) ., Dig. Dis. 29, 491-493, 2011).
위염과 위궤양을 유발하는 원인은 헬리코박터 필로리(Helicobacter pylori)의 감염, 비스테로이드성 항염증제(non-steroidal anti-inflammatory drugs, NSAIDs)의 사용, 흡연, 자가면역성 질환(autoimmune disease), 알코올 섭취 등이 있다. Gastritis and gastric ulcer are caused by infection with Helicobacter pylori, use of non-steroidal anti-inflammatory drugs (NSAIDs), smoking, autoimmune disease, and alcohol consumption. have.
위염 및 위궤양은 상기한 다양한 원인에 의해 유발되나, 위염의 원인은 헬리코박터 유발성, 과도한 음주, 스트레스, 자가면역 반응, 의약물의 장기 복용 등으로 보고 있으며, 치료 시에는 크게 두 분류로 나누어 헬리코박터 균주에 의해 유발되었는지에 따라 처방 의약을 달리하고 있다.Gastritis and gastric ulcer are caused by the various causes described above, but the cause of gastritis is considered to be Helicobacter pylori-induced, excessive drinking, stress, autoimmune reaction, long-term use of medications, etc. Prescription medications are different depending on whether it is caused by
다양한 원인 중 헬리코박터 필로리와 NSAIDs에 의한 위염/위궤양은 위 점막조직 내 호중구(neutrophil) 침윤을 유발하며 이로 인한 다양한 염증성 사이토카인을 유발하게 된다(Takaishi O, Arakawa T, Kim S, et al., Dig. Dis. Sci. 2405-2411, 1999). 스트레스에 의한 위 점막손상 모델에서 tumor necrosis factor-α(TNF-α)와 인터루킨(interleukins)과 같은 염증성 사이토카인의 과발현(over-expression) 변화가 관찰된다(Hamaguchi M, Watanabe T, Higuchi K et al., Dig. Dis. Sci. 2708-2715, 2001). 알코올 섭취에 의한 위염/위궤양은 위점액의 감소와 미세혈관 손상으로부터 시작되어 혈관투과성(vascular permeability)의 증가, 부종(edema) 형성을 유발하며 TNF-α과 같은 염증성 사이토카인과 산화적 손상을 일으키는 것으로 보고된 바 있다(Szabo S, Vincze A, Sandor Z, et al., Dig. Dis. Sci. 40-45, 1998). 사이토카인은 점막 면역(mucosal immune)을 조절하는 주요 인자이며, IL-1β, IL-2, IL-6와 TNF-α는 위염 및 위궤양의 병인과 밀접한 관련성을 갖는 것으로 보고된 바 있다(Lindholm C, Quiding-JarbrinkM, Lonroth H, et al., Infect immune. 5964-5971, 1998). Among various causes, gastritis/gastric ulcer caused by Helicobacter pylori and NSAIDs induces neutrophil infiltration in gastric mucosal tissue, which in turn induces various inflammatory cytokines (Takaishi O, Arakawa T, Kim S, et al., Dig. Dis. Sci. 2405-2411, 1999). In a stress-induced gastric mucosal injury model, changes in over-expression of inflammatory cytokines such as tumor necrosis factor-α (TNF-α) and interleukins are observed (Hamaguchi M, Watanabe T, Higuchi K et al. ., Dig. Dis. Sci. 2708-2715, 2001). Gastritis/gastric ulcer caused by alcohol ingestion begins with a decrease in gastric mucus and microvascular damage, increases vascular permeability, causes edema formation, and causes inflammatory cytokines such as TNF-α and oxidative damage. (Szabo S, Vincze A, Sandor Z, et al., Dig. Dis. Sci. 40-45, 1998). Cytokines are major factors regulating mucosal immunity, and IL-1β, IL-2, IL-6 and TNF-α have been reported to have a close relationship with the etiology of gastritis and gastric ulcer (Lindholm C , Quiding-Jarbrink M, Lonroth H, et al., Infect immune. 5964-5971, 1998).
위염 및 위궤양의 치료를 위해서 우선 생활 습관의 변화가 필요한데, 잦은 알코올 섭취, 흡연 및 불규칙한 식습관의 변화를 개선함으로써 위염 및 위궤양의 개선을 나타낼 수 있다. 또한, 생활 습관의 변화와 함께 약물치료 방법을 주로 병행하게 되는데, 약물 치료제로는 위산을 중화시키는 제산제, 히스타민 2 수용체 길항제(H2 receptor antagonists; cimetidine, ranitidine, famotidine, nizatidine 등), 프로스타글란딘 유사체(prostaglandin analogue; misoprostol), 양성자 펌프 억제제(proton-pump inhibitors; omeprazole, lansoprazole, esomeprazole, rabeprazole) 등이 사용된다. 그러나, 히스타민 2 수용체 길항제의 경우 두통, 무력감, 여성형 유방(gynecomastia), 성욕감퇴 등의 부작용이 보고되고 있으며, 양성자펌프억제제의 경우 두통, 어지러움, 복통, 가려움증, 근병증(myopathies) 등의 다양한 부작용이 보고된 바 있다. 따라서, 종래 사용되던 약제를 대체하여 부작용이 적은 천연물 유래 제재의 개발에 관심이 최근 들어 증가하는 추세이다.For the treatment of gastritis and gastric ulcer, a change in lifestyle is required first, and improvement of gastritis and gastric ulcer by improving frequent alcohol intake, smoking, and changes in irregular eating habits can be shown. In addition, along with lifestyle changes, drug treatment methods are mainly used. Drug treatment methods include antacids that neutralize gastric acid, histamine 2 receptor antagonists (cimetidine, ranitidine, famotidine, nizatidine, etc.), and prostaglandin analogues (prostaglandin). Analogs; misoprostol) and proton-pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole) are used. However, in the case of histamine 2 receptor antagonists, side effects such as headache, weakness, gynecomastia, and decreased libido have been reported, and in the case of proton pump inhibitors, various side effects such as headache, dizziness, abdominal pain, itchiness, and myopathies have been reported. has been reported Therefore, interest in the development of natural products-derived preparations with fewer side effects by replacing conventionally used drugs is a trend that is increasing in recent years.
한편, 위염 및 위궤양의 치료를 위해서 단일 식물추출물 또는 복합 식물추출물을 사용하고자 하는 시도가 있었으나, 아직 산업 현장에서 활용되기에 충분할 만큼의 위염 및 위궤양의 치료 효과를 나타내는 천연추출물은 거의 없었으며, 그 성분과 관련된 연구 성과는 미미한 상태이다. On the other hand, there have been attempts to use single plant extracts or complex plant extracts for the treatment of gastritis and gastric ulcer, but there have been few natural extracts showing the therapeutic effect of gastritis and gastric ulcer sufficient to be used in industrial fields yet, and the Research achievements related to ingredients are insignificant.
이러한 배경 아래에서, 본 발명자들은 천연추출물을 이용하여 위염 및 위궤양의 치료 효과를 증대시키기 위해 예의 노력한 결과, 증숙 생강 추출물과 이로부터 분리된 1-디하이드로-6-진저다이온 화합물이 비감염성 위염 및 위궤양의 치료에 효과가 있어 위염 및 위궤양의 치료 및 예방 목적으로 유용하게 활용될 수 있음을 확인하고, 본 발명을 완성하게 되었다.Under this background, the present inventors made diligent efforts to increase the therapeutic effect of gastritis and gastric ulcer using natural extracts. As a result, the steamed ginger extract and 1-dihydro-6-gingerdione compound isolated therefrom are non-infectious gastritis. and gastric ulcer, it was confirmed that it can be usefully used for the purpose of treatment and prevention of gastritis and gastric ulcer, and the present invention was completed.
따라서, 본 발명의 주된 목적은 비감염성 위염 및 위궤양의 치료 및 예방에 뛰어난 효과가 있는 증숙 생강 추출물, 또는 이로부터 분리된 1-디하이드로-6-진저다이온 화합물을 유효성분으로 함유하는 조성물을 제공하는 데 있다.Therefore, the main object of the present invention is to prepare a composition containing as an active ingredient a steamed ginger extract, or 1-dihydro-6-gingerdione compound isolated therefrom, which has excellent effects in the treatment and prevention of non-infectious gastritis and gastric ulcer. is to provide
또한, 본 발명의 다른 목적은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 제조방법을 제공하는 데 있다. Another object of the present invention is to provide a method for preparing a steamed ginger extract having an increased content of 1-dihydro-6-gingerdione compound.
본 발명의 다른 목적 및 이점은 하기의 발명의 상세한 설명, 청구범위 및 도면에 의해 보다 명확하게 된다.Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.
본 발명의 한 양태에 따르면, 본 발명은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물을 유효성분으로 포함하는 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물을 제공한다.According to one aspect of the present invention, non-infectious gastritis and gastric ulcer comprising a steamed ginger extract having an increased content of 1-dehydro-6-gingerdione compound as an active ingredient It provides a pharmaceutical composition for the prevention and treatment of.
본 발명자들은 수십 종의 식물추출물들의 위염 및 위궤양 효과를 검색하여 우수한 위염 및 위궤양 치료 및 예방 효능이 갖는 물질을 탐색하였고, 그 중 생강 추출물의 위염 및 위궤양 치료 및 예방 효과를 더욱 증진시키기 위해 노력한 결과, 증숙 생강 추출물에 존재하는 1-디하이드로-6-진저다이온 화합물의 함량이 증가되면서 증숙 생강 추출물의 위염 및 위궤양 치료 및 예방 효과가 증대되는 현상을 발견하였다.The present inventors searched for gastritis and gastric ulcer effects of dozens of plant extracts and searched for substances with excellent gastritis and gastric ulcer treatment and prevention effects, and among them, the results of efforts to further enhance the gastritis and gastric ulcer treatment and prevention effects of ginger extract , It was found that as the content of 1-dihydro-6-gingerdione compound present in the steamed ginger extract increased, the effect of the steamed ginger extract for treating and preventing gastritis and gastric ulcer was increased.
본 발명의 "생강"은 생강과(Zingiberaceae)의 생강속(Zingiber)에 속하는 다년생 식물을 의미하며, 뿌리줄기를 사용한다. 본 발명의 생강은 상업적으로 판매되는 것을 구입하여 사용하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있으나, 이에 제한되지 않는다."Ginger" of the present invention means a perennial plant belonging to the genus Zingiber of the family Zingiberaceae, and uses a rhizome. The ginger of the present invention may be purchased and used commercially sold, or harvested or grown in nature, but is not limited thereto.
본 발명에서 상기 추출에 사용되는 용매의 종류는 특별히 제한되지 않으며, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 상기 추출 용매의 비제한적인 예로는 물, 알코올 또는 이들의 혼합 용매 등을 들 수 있고, 이들은 단독으로 사용되거나 2종 이상 혼합하여 사용될 수 있으며, 구체적으로 물이 사용될 수 있다. 알코올을 용매로 사용하는 경우에는 구체적으로 탄소수 1 내지 4의 알코올을 사용할 수 있다.In the present invention, the type of solvent used for the extraction is not particularly limited, and any solvent known in the art may be used. Non-limiting examples of the extraction solvent include water, alcohol, or a mixed solvent thereof, and these may be used alone or in mixture of two or more, and specifically water may be used. When alcohol is used as a solvent, an alcohol having 1 to 4 carbon atoms may be specifically used.
본 발명의 용어 “추출물”이란, 목적하는 물질을 다양한 용매에 침지한 다음, 상온 또는 가온 상태에서 일정 시간 동안 추출하여 수득한 액상 성분, 상기 액상 성분으로부터 용매를 제거하여 수득한 고형분 등의 결과물을 의미한다. 뿐만 아니라, 상기 결과물의 희석액, 이들의 농축액, 이들의 조정제물, 정제물 등을 모두 포함하는 것으로 포괄적으로 해석될 수 있다. 이에 따라, 본 발명에서 제공하는 증숙 생강 추출물은 생강 추출물을 증숙 처리하여 얻어지는 추출액, 상기 추출액을 효소 분해하여 얻어지는 정제물, 또는 이들의 혼합물 등, 추출액 자체 및 추출액을 이용하여 형성 가능한 모든 제형의 추출물을 포함하는 것으로 해석될 수 있다.As used herein, the term “extract” refers to a liquid component obtained by immersing a target substance in various solvents and then extracting it for a certain period of time at room temperature or in a heated state, and a solid obtained by removing the solvent from the liquid component. it means. In addition, it can be comprehensively interpreted as including all of the dilutions of the above products, their concentrates, their preparations, and their purified products. Accordingly, the steamed ginger extract provided in the present invention is an extract obtained by steaming the ginger extract, a purified product obtained by enzymatic decomposition of the extract, or a mixture thereof, etc. Extracts of all formulations that can be formed using the extract itself and the extract may be interpreted as including
본 발명의 용어 “위염”이란 위 내벽의 염증이 발생한 상태를 의미한다. 상기 “위궤양”이란 넓은 범위로는 소장의 기시부인 위와 소장의 일부인 십이지장 내벽의 미란이 발생한 상태를 의미한다. 또한 상복부 통증이나 동통, 구역, 구토를 포함하는 주관적인 위염 및 위궤양 증상은 이학적 검진을 통해 객관적인 방법으로 정량화될 수 있다.As used herein, the term “gastritis” refers to a condition in which the lining of the stomach is inflamed. The term “gastric ulcer” refers to a condition in which erosion of the stomach, which is the origin of the small intestine, and the lining of the duodenum, which is a part of the small intestine, has occurred in a wide range. In addition, subjective symptoms of gastritis and gastric ulcer, including epigastric pain, pain, nausea, and vomiting, can be quantified in an objective way through physical examination.
본 발명의 용어 “예방”이란, 상기 증숙 생강 추출물을 유효성분으로 포함하는 조성물을 이용하여 위염 또는 위궤양의 발병을 억제 또는 지연시키는 모든 행위를 말한다. 본 발명의 용어 “치료”란, 상기 증숙 생강 추출물을 유효성분으로 포함하는 조성물을 이용하여 위염 또는 위궤양의 증세가 호전되거나 이롭게 변경되는 모든 행위를 의미한다.As used herein, the term “prevention” refers to any action of suppressing or delaying the onset of gastritis or gastric ulcer by using a composition comprising the steamed ginger extract as an active ingredient. As used herein, the term “treatment” refers to any action in which the symptoms of gastritis or gastric ulcer are improved or beneficially changed by using the composition comprising the steamed ginger extract as an active ingredient.
본 발명에 있어서, 위염 및 위궤양은 급성 위염 및 위궤양과 만성 위염 및 위궤양을 모두 포함한다. 특히, 본 발명은 과도한 음주, NSAID 복용 등에 의해 발병하는 급성 위염 또는 위궤양에 대하여 위의 점막을 직접적으로 보호하여 출혈, 염증 세포 침투, 부종, 상피 세포 소실 등을 예방하고 치료함으로써 급성 위염 또는 위궤양에 대해 현저한 예방 및 치료 효과를 가진다. 즉, 일반적으로 위내 산도를 떨어뜨려 급성 위염 내지 위궤양 치료에 사용하는 H2 수용체 안타고니스트, 양성자 펌프 억제제는 알코올로 인한 위점막 손상에 치료 반응성이 낮은 것과 달리 본원 발명의 조성물은 만성 위염 및 위궤양뿐만 아니라 급성 위염 및 위궤양, 특히 알코올성 급성 위염 및 위궤양에도 현저한 예방 및 치료 효과를 보인다. In the present invention, gastritis and gastric ulcer include both acute gastritis and gastric ulcer, and chronic gastritis and gastric ulcer. In particular, the present invention is directed to acute gastritis or gastric ulcer by directly protecting the gastric mucosa against acute gastritis or gastric ulcer caused by excessive drinking or taking NSAIDs to prevent and treat bleeding, inflammatory cell infiltration, edema, epithelial cell loss, etc. It has a significant preventive and therapeutic effect on That is, unlike H2 receptor antagonists and proton pump inhibitors, which are generally used for the treatment of acute gastritis or gastric ulcer by lowering the acidity of the stomach, the composition of the present invention has a low therapeutic response to alcohol-induced gastric mucosal damage. It shows remarkable preventive and therapeutic effects on gastritis and gastric ulcer, especially alcoholic acute gastritis and gastric ulcer.
본 발명의 구체적인 실험예에서, 본 발명자들은 위염 및 위궤양 질환 동물모델에서 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 위염 및 위궤양 예방 및 치료 효과를 시험하였고, 위염 및 위궤양의 육안적 평가를 바탕으로 알코올 섭취로 유도된 위점막 손상에 있어서 증숙 생강 추출물 처리군의 위 병변 면적이 직접적으로 감소하는 효과를 확인하였다(도 2 참조). 또한, 증숙 생강 추출물이 알코올 섭취로 인해 발생하는 주요 조직병리학적 이상소견인 위 점막상피세포의 탈락 및 괴사, 점막상피층 내 출혈, 점막하조직의 부종 등을 감소시킴을 확인할 수 있었다. 결론적으로, 본 발명의 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물은 위 병변 면적이 직접적으로 감소시켜 위염 및 위궤양의 예방 및 치료용 약학적 조성물의 유효성분으로 유용하게 사용될 수 있다.In a specific experimental example of the present invention, the present inventors reported gastritis and gastric ulcer of steamed ginger extract with an increased content of 1-Dehydro-6-gingerdione compound in an animal model of gastritis and gastric ulcer disease. The preventive and therapeutic effects were tested, and based on the gross evaluation of gastritis and gastric ulcer, the effect of directly reducing the gastric lesion area of the steamed ginger extract-treated group was confirmed in alcohol ingestion-induced gastric mucosal damage (see FIG. 2). ). In addition, it was confirmed that the steamed ginger extract reduced the major histopathological abnormalities caused by alcohol ingestion, such as exfoliation and necrosis of gastric mucosal epithelial cells, bleeding in the mucosal epithelial layer, and edema of the submucosal tissue. In conclusion, the steamed ginger extract with an increased content of the 1-Dehydro-6-gingerdione compound of the present invention directly reduces the area of the gastric lesion, thereby preventing and treating gastritis and gastric ulcer. It can be usefully used as an active ingredient in a pharmaceutical composition.
본 발명에서 용어 “증숙”은, 상기 생강 추출물에 온도를 가하여 증기에 의해 찌는 것(steaming)을 말한다. 증숙에 사용되는 장치로는 일정한 온도 및 압력에 의하여 증숙을 수행할 수 있는 것이면 제한되지 않는다.In the present invention, the term "steaming" refers to steaming by applying a temperature to the ginger extract. The apparatus used for steaming is not limited as long as it can perform steaming by a constant temperature and pressure.
본 발명에서 상기 증숙은 40 내지 180℃, 구체적으로 50 내지 150℃, 보다 구체적으로 60 내지 120℃에서 수행될 수 있으나, 이에 제한되지 않는다. 또한, 본 발명에서 상기 증숙 단계는 20 내지 180분, 구체적으로 25 내지 150분, 보다 구체적으로 30 내지 120분일 수 있으나, 이에 제한되지 않는다.In the present invention, the steaming may be carried out at 40 to 180 ℃, specifically 50 to 150 ℃, more specifically 60 to 120 ℃, but is not limited thereto. In addition, in the present invention, the steaming step may be 20 to 180 minutes, specifically 25 to 150 minutes, more specifically 30 to 120 minutes, but is not limited thereto.
또한, 본 발명의 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물에서, 상기 증숙 생강 추출물은 1차 α-아밀라아제 및 2차 셀룰라아제 효소로 효소처리된 것을 특징으로 한다. 본 발명의 상기 증숙 생강 추출물은 효소 처리를 통해 증숙 생강 추출물 내에 함유된 구성성분이 분해되어 추출물에 존재하는 불용성 입자가 분해되어 침전량이 감소되게 되며, 상기 효소분해 단계는 1차 효소 분해와 2차 효소 분해 단계를 순차적으로 수행할 수 있으나, 이에 제한되지 않는다. 본 발명에서 사용 가능한 효소로는 아밀라아제(amylase), 말타아제(maltase), 락타아제(lactase), 수크라아제(sucrase), 글루카나아제(glucanase), 셀룰라아제(cellulase), 헤미셀룰라아제(hemicellulase), 자일라나아제(xylanase) 등이 있으나, 이에 제한되지 않는다. 구체적인 예로, 1차 효소 분해 단계는 α-아밀라아제를 효소로 사용할 수 있으며, 2차 효소 분해 단계는 셀룰라아제를 효소로 사용할 수 있다.In addition, in the pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer of the present invention, the steamed ginger extract is characterized in that it is enzymatically treated with primary α-amylase and secondary cellulase enzymes. In the steamed ginger extract of the present invention, the components contained in the steamed ginger extract are decomposed through enzymatic treatment, so that insoluble particles present in the extract are decomposed to reduce the amount of precipitation, and the enzymatic decomposition step includes the first enzymatic decomposition and the second The enzymatic digestion step may be performed sequentially, but is not limited thereto. The enzymes usable in the present invention include amylase, maltase, lactase, sucrase, glucanase, cellulase, hemicellulase, xylana. and xylanase, but is not limited thereto. As a specific example, the first enzymatic digestion step may use α-amylase as an enzyme, and the second enzymatic digestion step may use cellulase as an enzyme.
또한, 본 발명의 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물에서, 상기 증숙 생강 추출물은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 전체 추출물 중량 대비 0.004% 이상으로 포함될 수 있다. In addition, in the pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer of the present invention, the steamed ginger extract contains a 1-dihydro-6-gingerdione compound content of the total extract weight. It may be included in an amount of 0.004% or more.
본 발명의 다른 양태에 따르면, 본 발명은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물을 유효성분으로 포함하는 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물을 제공한다.According to another aspect of the present invention, the present invention provides a pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer comprising a 1-dihydro-6-gingerdione compound as an active ingredient. to provide.
본 발명의 용어 “1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione)”이란, 생강으로부터 분리된 C17H22O4의 분자식과 하기 화학식 1의 구조를 갖는 알칼로이드 화합물의 일종을 의미한다. As used herein, the term “1-dihydro-6-gingerdione” refers to a molecular formula of C 17 H 22 O 4 isolated from ginger and an alkaloid compound having the structure of Formula 1 below. means some kind
[화학식 1][Formula 1]
본 발명의 구체적인 실험예에서, 본 발명자들은 위염 및 위궤양 질환동물모델에서 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 위염 및 위궤양 예방 및 치료 효과를 시험하였고, 위염 및 위궤양의 육안적 평가를 바탕으로 알코올 섭취로 유도된 위점막 손상에 있어서 1-디하이드로-6-진저다이온의 위 병변 면적이 직접적으로 감소하는 효과를 확인하였다(도 3 참조). 또한, 1-디하이드로-6-진저다이온 화합물이 알코올 섭취로 인해 발생하는 주요 조직병리학적 이상소견인 위 점막상피세포의 탈락 및 괴사, 점막상피층 내 출혈, 점막하조직의 부종 등을 감소시킴을 확인할 수 있었다. 결론적으로, 본 발명의 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물은 위 병변 면적이 직접적으로 감소시켜 위염 및 위궤양의 예방 및 치료용 약학적 조성물의 유효성분으로 유용하게 사용될 수 있다.In a specific experimental example of the present invention, the present inventors tested the gastritis and gastric ulcer prevention and treatment effect of 1-dihydro-6-gingerdione compound in an animal model of gastritis and gastric ulcer disease, Based on the gross evaluation of gastritis and gastric ulcer, it was confirmed that 1-dihydro-6-gingerdione directly decreased the gastric lesion area in alcohol ingestion-induced gastric mucosal damage (see FIG. 3 ). In addition, it was found that 1-dihydro-6-gingerdione compound reduced the major histopathological abnormalities caused by alcohol ingestion, such as exfoliation and necrosis of gastric mucosal epithelial cells, bleeding in the mucosal epithelial layer, and submucosal edema. could check In conclusion, the 1-dihydro-6-gingerdione compound of the present invention directly reduces the area of the gastric lesion and is therefore an active ingredient in a pharmaceutical composition for the prevention and treatment of gastritis and gastric ulcer. It can be useful.
본 발명의 조성물이 약제학적 조성물로 제조되는 경우, 본 발명의 약제학적 조성물은 약제학적으로 허용되는 담체를 포함한다. 본 발명의 약제학적 조성물에 포함되는 약제학적으로 허용되는 담체는 제제시에 통상적으로 이용되는 것으로서, 락토스, 덱스트로스, 수크로스, 솔비톨, 만니톨, 전분, 아카시아 고무, 인산 칼슘, 알기네이트, 젤라틴, 규산 칼슘, 미세결정성 셀룰로스, 폴리비닐피롤리돈, 셀룰로스, 물, 시럽, 메틸 셀룰로스, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일 등을 포함하나, 이에 한정되는 것은 아니다. 본 발명의 약제학적 조성물은 상기 성분들 이외에 윤활제, 습윤제, 감미제, 향미제, 유화제, 현탁제, 보존제 등을 추가로 포함할 수 있다. 적합한 약제학적으로 허용되는 담체 및 제제는 Remington's Pharmaceutical Sciences(19th ed., 1995)에 상세히 기재되어 있다.When the composition of the present invention is prepared as a pharmaceutical composition, the pharmaceutical composition of the present invention includes a pharmaceutically acceptable carrier. Pharmaceutically acceptable carriers included in the pharmaceutical composition of the present invention are commonly used in formulation, and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia gum, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil, and the like. it's not going to be The pharmaceutical composition of the present invention may further include a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, and the like, in addition to the above components. Suitable pharmaceutically acceptable carriers and agents are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995).
본 발명의 약제학적 조성물은 경구 또는 비경구 투여할 수 있다. The pharmaceutical composition of the present invention may be administered orally or parenterally.
본 발명의 약제학적 조성물의 적합한 투여량은 제제화 방법, 투여 방식, 환자의 연령, 체중, 성, 병적 상태, 음식, 투여 시간, 투여 경로, 배설 속도 및 반응 감응성과 같은 요인들에 의해 다양하게 처방될 수 있다. 본 발명의 약제학적 조성물의 바람직한 투여량은 성인 기준으로 0.01-200㎎/kg 범위 내이다.A suitable dosage of the pharmaceutical composition of the present invention is variously prescribed depending on factors such as formulation method, administration method, age, weight, sex, pathological condition, food, administration time, administration route, excretion rate, and reaction sensitivity of the patient. can be A preferred dosage of the pharmaceutical composition of the present invention is within the range of 0.01-200 mg/kg based on an adult.
본 발명의 약제학적 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 약제학적으로 허용되는 담체 및/또는 부형제를 이용하여 제제화함으로써 단위 용량 형태로 제조되거나, 또는 다용량 용기에 내입하여 제조될 수 있다. 이때 제형은 오일 또는 수성 매질중의 용액, 현탁액, 시럽제 또는 유화액 형태이거나 엑스제, 산제, 분말제, 과립제, 정제 또는 캅셀제 형태일 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.The pharmaceutical composition of the present invention is prepared in unit dosage form by formulating using a pharmaceutically acceptable carrier and/or excipient according to a method that can be easily carried out by a person of ordinary skill in the art to which the present invention pertains. Or, it may be prepared by pouring into a multi-dose container. In this case, the formulation may be in the form of a solution, suspension, syrup, or emulsion in oil or aqueous medium, or may be in the form of an extract, powder, powder, granule, tablet or capsule, and may additionally include a dispersant or stabilizer.
본 발명의 다른 양태에 따르면, 본 발명은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 함량이 증가된 증숙 생강 추출물을 유효성분으로 포함하는 비감염성 위염 및 위궤양의 예방용 식품 조성물을 제공한다. 상기 “증숙 생강 추출물”과, “위염”, “위궤양”, 및 “예방”은 상기 약학적 조성물에서 설명한 바와 같다. According to another aspect of the present invention, the present invention provides the prevention of non-infectious gastritis and gastric ulcer, comprising as an active ingredient a steamed ginger extract having an increased 1-Dehydro-6-gingerdione content. It provides a food composition for use. The "steamed ginger extract", "gastritis", "gastric ulcer", and "prevention" are the same as described in the pharmaceutical composition.
또한, 본 발명의 다른 양태에 따르면, 본 발명은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione)을 유효성분으로 포함하는 비감염성 위염 및 위궤양의 예방용 식품 조성물을 제공한다.In addition, according to another aspect of the present invention, the present invention provides a food composition for preventing non-infectious gastritis and gastric ulcer comprising 1-dihydro-6-gingerdione as an active ingredient do.
상기 식품 조성물은 건강기능식품의 형태로 사용될 수 있으나, 이에 제한되는 것은 아니다. The food composition may be used in the form of health functional food, but is not limited thereto.
본 발명의 식품 조성물은 증숙 생강 추출물의 분획물 또는 이의 가공물의 형태로 포함될 수 있고, 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물만 분리되어 사용될 수 있다. 또한, 상기 조성물은 유효성분 이외에 식품학적으로 허용 가능한 식품보조첨가제를 포함할 수 있다.The food composition of the present invention may be included in the form of a fraction of steamed ginger extract or a processed product thereof, and only the 1-dihydro-6-gingerdione compound may be used separately. In addition, the composition may include a food pharmaceutically acceptable food supplement additive in addition to the active ingredient.
본 발명에 있어서, "식품보조첨가제"란 식품에 보조적으로 첨가될 수 있는 구성요소를 의미하며, 각 제형의 건강기능식품을 제조하는데 첨가되는 것으로서 당업자가 적절히 선택하여 사용할 수 있다. 식품보조첨가제의 예로는 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 충진제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등이 포함되지만, 상기 예들에 의해 본 발명의 식품보조첨가제의 종류가 제한되는 것은 아니다.In the present invention, "food supplementary additive" means a component that can be added to food as an auxiliary, added to the manufacture of health functional food of each formulation can be appropriately selected and used by those skilled in the art. Examples of food supplement additives include various nutrients, vitamins, minerals (electrolytes), synthetic flavoring agents and flavoring agents such as natural flavoring agents, coloring agents and fillers, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners , pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonation agents used in carbonated beverages, etc., but the above examples are not limited to the types of food supplement additives of the present invention.
본 발명의 식품 조성물에는 건강기능식품이 포함될 수 있다. 본 발명에 있어서, "건강기능식품"이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 정제, 캅셀, 분말, 과립, 액상 및 환 등의 형태로 제조 및 가공한 식품을 말한다. 여기서 "기능성"이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건 용도에 유용한 효과를 얻는 것을 의미하며, 본 발명에서는 비감염성 위염 및 위궤양의 예방 효과를 얻는 것을 의미한다. 본 발명의 건강기능식품은 당업계에서 통상적으로 사용되는 방법으로 제조 가능하며, 제조시에는 당업계에서 통상적으로 첨가하는 원료 및 성분을 첨가하여 제조할 수 있다. The food composition of the present invention may include a health functional food. In the present invention, "health functional food" refers to a food manufactured and processed in the form of tablets, capsules, powders, granules, liquids, pills, etc. using raw materials or ingredients useful for the human body. Here, "functional" means to obtain a useful effect for health purposes such as regulating nutrients or physiological action with respect to the structure and function of the human body, and in the present invention, it means obtaining an effect of preventing non-infectious gastritis and gastric ulcer . The health functional food of the present invention can be manufactured by a method commonly used in the art, and can be prepared by adding raw materials and components commonly added in the art during manufacturing.
또한, 상기 건강기능식품의 제형 또한 건강기능식품으로 인정되는 제형이면 제한 없이 제조될 수 있다. 본 발명의 식품 조성물은 다양한 형태의 제형으로 제조될 수 있으며, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용 등이 없는 장점이 있고, 휴대성이 뛰어나, 비감염성 위염 및 위궤양을 개선하는 효과를 증진시키기 위한 보조제로 섭취가 가능하다.In addition, the dosage form of the health functional food may also be manufactured without limitation as long as it is a dosage form recognized as a health functional food. The food composition of the present invention can be prepared in various forms, and unlike general drugs, it has the advantage of not having side effects that may occur during long-term administration of the drug using food as a raw material, and has excellent portability and non-infectious gastritis. And it can be ingested as an adjuvant to enhance the effect of improving gastric ulcer.
본 발명의 건강기능식품이 취할 수 있는 형태에는 제한이 없으며, 통상적인 의미의 식품을 모두 포함할 수 있고, 기능성 식품 등 당업계에 알려진 용어와 혼용이 가능하다. 아울러 본 발명의 건강기능식품은 당업자의 선택에 따라 식품에 포함될 수 있는 적절한 기타 보조 성분과 공지의 첨가제를 혼합하여 제조할 수 있다. 첨가할 수 있는 식품의 예로는 육류, 소세지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 등이 있으며, 본 발명에 따른 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 함량이 증가된 증숙 생강 추출물 또는 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물을 주성분으로 하여 제조한 즙, 차, 젤리 및 주스 등에 첨가하여 제조할 수 있다. 또한, 동물을 위한 사료로 이용되는 식품도 포함된다.There is no limitation on the form that the health functional food of the present invention can take, and it may include any food in a conventional sense, and may be used interchangeably with terms known in the art, such as functional food. In addition, the health functional food of the present invention can be prepared by mixing known additives with other suitable auxiliary ingredients that may be included in the food according to the selection of those skilled in the art. Examples of foods that can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages and There are vitamin complexes and the like, and the steamed ginger extract or 1-dihydro-6-gingerdione (1-dehydro-6-gingerdione) having an increased content of 1-dehydro-6-gingerdione according to the present invention. Dehydro-6-gingerdione) compound can be prepared by adding it to juice, tea, jelly, juice, etc. Also included are foods used as feed for animals.
본 발명의 다른 양태에 따르면, 본 발명은 (a) 생강을 추출하는 단계; (b) 상기 생강 추출물을 증숙하는 단계; (c) 상기 증숙 생강 추출물을 1차 효소 분해하는 단계; 및 (d) 상기 1차 효소 분해된 증숙 생강 추출물을 2차 효소 분해하는 단계를 포함하는 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 제조방법을 제공한다. According to another aspect of the present invention, the present invention comprises the steps of (a) extracting ginger; (b) steaming the ginger extract; (c) first enzymatic decomposition of the steamed ginger extract; And (d) 1-dihydro-6-gingerdione (1-Dehydro-6-gingerdione) comprising the step of secondary enzymatic decomposition of the steamed ginger extract decomposed by the first enzyme, steamed ginger with an increased content of the compound A method for preparing an extract is provided.
본 발명의 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 제조방법에서, 상기 (b) 증숙 단계는 60℃ 내지 100℃에서 30분 내지 120분 동안 수행될 수 있으나, 이에 제한되지 않는다.In the method for preparing a steamed ginger extract having an increased content of 1-dihydro-6-gingerdione compound of the present invention, the (b) steaming step is performed at 60° C. to 100° C. It may be carried out for minutes to 120 minutes, but is not limited thereto.
또한, 본 발명의 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 제조방법에서, 상기 (c) 1차 효소 분해 단계는 α-아밀라아제를 효소로 사용하고, 상기 (d) 2차 효소 분해 단계는 셀룰라아제를 효소로 사용할 수 있으나, 이에 제한되지 않는다.In addition, in the method for preparing a steamed ginger extract having an increased content of 1-dihydro-6-gingerdione compound of the present invention, the (c) first enzymatic decomposition step is α- Amylase is used as an enzyme, and the (d) secondary enzymatic digestion step may use cellulase as an enzyme, but is not limited thereto.
본 발명의 구체적인 일 실시예에서는, 다양한 온도 및 시간으로 생강 추출물을 증숙하여 증숙 생강 추출물의 1-디하이드로-6-진저다이온 화합물의 함량을 측정한 결과, 일반 생강 추출물에 비하여 생강 추출물을 증숙하였을 경우에 1-디하이드로-6-진저다이온 화합물의 함량이 증가함을 확인할 수 있었다(표 1 및 도 1). 특히, 80℃에서 60분간 증숙하는 조건에서 1-디하이드로-6-진저다이온 화합물의 함량이 전체 증숙 생강 추출물 중량대비 4.61m%로 함유되게 되어 그 성분 함량이 현저하게 증가한 것을 확인할 수 있었다. 상기 결과를 통해, 종래 추출방법으로 얻어진 생강 추출물에 비하여, 위염 및 위궤양의 치료 및 예방 효과가 우수한 1-디하이드로-6-진저다이온 화합물의 함량을 현저히 증가시킬 수 있는 최적의 증숙 조건을 확인하였다.In a specific embodiment of the present invention, as a result of measuring the content of 1-dihydro-6-gingerdione compound in the steamed ginger extract by steaming the ginger extract at various temperatures and times, the ginger extract is steamed compared to the general ginger extract. It was confirmed that the content of the 1-dihydro-6-gingerdione compound increased (Table 1 and FIG. 1). In particular, it was confirmed that the content of 1-dihydro-6-gingerdione compound was contained at 4.61 m% based on the total weight of the steamed ginger extract under the conditions of steaming at 80° C. for 60 minutes, so that the component content was significantly increased. Through the above results, compared to the ginger extract obtained by the conventional extraction method, it was confirmed that the optimal steaming conditions can significantly increase the content of 1-dihydro-6-gingerdione compound, which is excellent in the treatment and prevention of gastritis and gastric ulcer. did.
본 발명의 특징 및 이점을 요약하면 다음과 같다:The features and advantages of the present invention are summarized as follows:
(1) 본 발명은 1-디하이드로-6-진저다이온 화합물의 함량이 증가된 증숙 생강 추출물, 또는 1-디하이드로-6-진저다이온 화합물을 유효성분으로 포함하는 비감염성 위염 및 위궤양의 예방 및 치료용 조성물을 제공한다.(1) The present invention provides a method for treating non-infectious gastritis and gastric ulcer comprising a steamed ginger extract with an increased content of 1-dihydro-6-gingerdione compound, or 1-dihydro-6-gingerdione compound as an active ingredient. A composition for prevention and treatment is provided.
(2) 본 발명의 비감염성 위염 및 위궤양의 예방 및 치료용 조성물은 알코올 섭취로 유도된 위점막 손상에 있어서 위 병변 면적을 직접적으로 감소시키고, 조직병리학적 이상소견 발생을 감소시킴으로써, 비감염성 위염 및 위궤양을 개선하는 우수한 효능을 나타낸다. (2) The composition for the prevention and treatment of non-infectious gastritis and gastric ulcer of the present invention directly reduces the area of gastric lesion and reduces the occurrence of histopathological abnormalities in the gastric mucosal damage induced by alcohol ingestion, thereby reducing the occurrence of non-infectious gastritis. and excellent efficacy in improving gastric ulcer.
(3) 또한, 본 발명의 증숙 생강 추출물의 제조방법은 비감염성 위염 및 위궤양의 예방 및 치료에 우수한 효과가 있는 1-디하이드로-6-진저다이온 화합물의 생산 목적으로 유용하게 이용 가능하다.(3) In addition, the method for preparing the steamed ginger extract of the present invention can be usefully used for the purpose of producing a 1-dihydro-6-gingerdione compound having excellent effects in the prevention and treatment of non-infectious gastritis and gastric ulcer.
도 1은 생강 추출물을 증숙하는 온도 및 시간의 조건에 따른 1-디하이드로-6-진저다이온 화합물의 함량에 대한 반응표면분석 결과를 나타낸 그래프이다.
도 2는 알코올 유발 위염 동물 모델에서 증숙 생강 추출물의 처리에 따른 위 병변 면적을 비교하여 나타낸 사진과 그래프이다(NOR: 정상대조구, CON: 음성대조구, SGE: 증숙 생강 추출물, GE: 생강 추출물).
도 3은 알코올 유발 위염 동물 모델에서 1-디하이드로-6-진저다이온 화합물의 처리에 따른 위 병변 면적을 비교하여 나타낸 사진과 그래프이다(NOR: 정상대조구, CON: 음성대조구, GE: 생강 추출물, 6GD: 1-디하이드로-6-진저다이온).
도 4는 알코올 유발 위염 동물 모델에서 증숙 생강 추출물, 및 1-디하이드로-6-진저다이온 화합물의 처리에 따른 위 병변 면적을 비교하여 나타낸 사진과 그래프이다(NOR: 정상대조구, CON: 음성대조구, SGE: 증숙 생강 추출물, GE: 생강 추출물, 6GD: 1-디하이드로-6-진저다이온). 1 is a graph showing the reaction surface analysis results for the content of 1-dihydro-6-gingerdione compound according to the conditions of temperature and time for steaming ginger extract.
2 is a photograph and graph showing comparison of gastric lesion area according to the treatment of steamed ginger extract in an alcohol-induced gastritis animal model (NOR: normal control, CON: negative control, SGE: steamed ginger extract, GE: ginger extract).
3 is a photograph and graph showing comparison of gastric lesion area according to treatment with 1-dihydro-6-gingerdione compound in an alcohol-induced gastritis animal model (NOR: normal control, CON: negative control, GE: ginger extract , 6GD: 1-dihydro-6-gingerdione).
Figure 4 is a photograph and graph showing the comparison of gastric lesion area according to the treatment of steamed ginger extract and 1-dihydro-6-gingerdione compound in an alcohol-induced gastritis animal model (NOR: normal control, CON: negative control) , SGE: steamed ginger extract, GE: ginger extract, 6GD: 1-dihydro-6-gingerdione).
이하, 실시예를 통하여 본 발명을 더욱 상세히 설명하기로 한다. 이들 실시예는 단지 본 발명을 예시하기 위한 것이므로, 본 발명의 범위가 이들 실시예에 의해 제한되는 것으로 해석되지는 않는다.Hereinafter, the present invention will be described in more detail through examples. These examples are only for illustrating the present invention, and therefore, the scope of the present invention should not be construed as being limited by these examples.
실시예 1. 생강 및 증숙 생강 추출물의 제조Example 1. Preparation of ginger and steamed ginger extract
1-1. 생강 추출물의 제조1-1. Preparation of ginger extract
생강을 세척하고, 5mm 두께로 절단한 다음, 생강을 45℃에서 40시간 동안 건조하였다. 이어, 건조 생강의 15배 중량의 70% 에탄올을 가하여 70℃에서 5시간 동안 추출 및 여과하였고, 65 내지 68℃의 온도 조건 및 400 내지 500 torr 압력 조건에서 60 brix로 농축하여 생강 추출물(GE, 시험예 1)을 수득하였다.Ginger was washed and cut to a thickness of 5 mm, and then the ginger was dried at 45° C. for 40 hours. Then, 70% ethanol 15 times the weight of dried ginger was added, extracted and filtered at 70° C. for 5 hours, and concentrated to 60 brix under a temperature condition of 65 to 68° C. and a pressure of 400 to 500 torr, and the ginger extract (GE, Test Example 1) was obtained.
1-2. 증숙 생강 추출물의 제조1-2. Preparation of steamed ginger extract
상기 실시예 1-1에서 제조한 생강 추출물 10g을 밀폐용기에 넣고 증숙기를 이용해 60℃, 80℃, 100℃에서 각각 30분, 60분, 및 120분 동안 증숙하였다. 증숙 처리된 추출물을 1차 효소(α-amylase 90℃/90min) 분해 공정을 진행 후에, 2차 효소(cellulose 50℃ / 60min) 분해 공정을 진행하였다. 90℃로 온도를 상승하여 효소를 불활화 한 후, 냉각 처리하였고, 데칸타(30 mesh) 후 원심 분리하였다. 규조토 여과(필터 프레스) 후에 농축(Brix 20이상, TS 18.5 이상)하였고, 이물 검사를 완료하여 증숙 생강 추출물(SGE)을 수득하였다.10 g of the ginger extract prepared in Example 1-1 was placed in an airtight container and steamed at 60° C., 80° C., and 100° C. for 30 minutes, 60 minutes, and 120 minutes, respectively. The steam-treated extract was subjected to a primary enzyme (α-
HPLC를 통해 증숙 생강 추출물(SGE)이 함유한 1-Dehydro-6-gingerdione 화합물의 함량을 확인하였고, Design Expert 12 프로그램을 통해 생강 추출물을 증숙하는 온도 및 시간 조건에 따른 1-디하이드로-6-진저다이온의 함량에 대한 반응표면분석을 수행하였다.The content of 1-Dehydro-6-gingerdione compound contained in the steamed ginger extract (SGE) was confirmed through HPLC, and 1-dihydro-6- according to the temperature and time conditions for steaming the ginger extract through the Design Expert 12 program. Response surface analysis was performed for the content of ginger dione.
그 결과, 1-Dehydro-6-gingerdione 화합물의 함량을 증가시키는 최적의 온도와 시간으로 80℃, 및 60분의 증숙 조건을 확인하였으며(도 1), 상기 조건에서 1-Dehydro-6-gingerdione 의 함량은 생강 추출물(GE, 시험예 1)에 비하여 약 1.83배 증가한 것을 확인할 수 있었다.As a result, 80 ℃ and 60 minutes of steaming conditions were confirmed as the optimum temperature and time to increase the content of 1-Dehydro-6-gingerdione compound (FIG. 1), and in the above conditions, 1-Dehydro-6-gingerdione It was confirmed that the content was increased by about 1.83 times compared to the ginger extract (GE, Test Example 1).
[표 1][Table 1]
실시예 2. 증숙 생강 추출물의 항위염 효과 분석Example 2. Analysis of anti-gastritis effect of steamed ginger extract
증숙 생강 추출물의 항위염 효과를 분석하였다. The anti-gastritis effect of steamed ginger extract was analyzed.
항위염 효과를 나타내는 지표물질로 추정되는 1-Dehydro-6-gingerdione 화합물의 함량 분석 결과에 따라, 증숙 생강 추출물은 1-Dehydro-6-gingerdione 화합물의 함량이 가장 높은 시험예 6을 사용하였고, 생강 추출물 대비 항위염 효과를 분석하였다.According to the result of analysis of the content of 1-Dehydro-6-gingerdione compound, which is estimated to be an indicator substance showing anti-gastritis effect, Test Example 6 with the highest content of 1-Dehydro-6-gingerdione compound was used as the steamed ginger extract, and ginger The anti-gastritis effect compared to the extract was analyzed.
마우스를 24시간 절식시킨 후, 생강 추출물(GE, 시험예 1)과 1-Dehydro-6-gingerdione 함량이 증가된 증숙 생강 추출물(SGE, 시험예 6)을 100mg/kg 용량으로 경구투여하였고, 1시간 후에 0.3M 염산을 함유한 60% 에탄올을 마리당 1.5 mL씩 경구 투여하여 동물모델에 알코올 유발 위염을 유도하였다.After fasting the mice for 24 hours, ginger extract (GE, Test Example 1) and steamed ginger extract with an increased 1-Dehydro-6-gingerdione content (SGE, Test Example 6) were orally administered at a dose of 100 mg/kg, 1 After an hour, 1.5 mL of 60% ethanol containing 0.3 M hydrochloric acid was orally administered to each animal to induce alcohol-induced gastritis in the animal model.
항위염 효과를 확인하기 위하여 1시간 후에 상기 알코올 유발 위염이 유도된 동물모델의 위를 적출하여 4% 파라포름알데하이드 2mL를 위 내로 주입하고 1시간 이상 고정하였다. 고정된 위의 대만부를 따라 절개하여 펼친 후, 디지털카메라를 이용하여 사진을 찍은 후 Focus Lite를 이용하여 위 병변(gastric lesion, mm2) 면적을 측정하였다. 항위염 효과의 판정을 위하여 대조군과 비교하는 Student's t-test와 ANOVA test가 사용되었다.In order to confirm the anti-gastritis effect, the stomach of the alcohol-induced gastritis induced animal model was excised 1 hour later, and 2 mL of 4% paraformaldehyde was injected into the stomach and fixed for at least 1 hour. After the incision was made along the fixed upper portion of the stomach and unfolded, a picture was taken using a digital camera, and the area of the gastric lesion (mm 2 ) was measured using Focus Lite. In order to determine the anti-gastritis effect, Student's t-test and ANOVA test compared with the control group were used.
에탄올 유발 위염 동물모델에서 위 병변 면적을 측정한 결과, 시험예 1의 생강 추출물을 투여한 실험군(GE)에서 32.37mm2(n=6)의 위병변 면적이 측정되어 음성대조군의 위병변 면적 64.78mm2(n=4) 대비 49.97%(p<0.001) 수준으로 관찰되었다.As a result of measuring the gastric lesion area in the ethanol-induced gastritis animal model, the gastric lesion area of 32.37mm 2 (n=6) was measured in the experimental group (GE) administered with the ginger extract of Test Example 1, and the gastric lesion area of the negative control group was 64.78. mm 2 (n=4) compared to 49.97% (p<0.001) level was observed.
이와는 달리, 본 발명의 증숙 생강 추출물(시험예 6)을 투여한 실험군(SGE)에서는 위병변 면적이 6.89mm2(n=6)로 나타나 음성대조군의 64.78mm2 대비 89.36% 수준으로 위병변 면적이 감소한 것으로 나타났다. In contrast, in the experimental group (SGE) administered with the steamed ginger extract of the present invention (Test Example 6), the gastric lesion area was 6.89 mm 2 (n=6), which was 89.36% compared to 64.78 mm 2 of the negative control group. appeared to decrease.
증숙 생강 추출물과 생강 추출물 투여군들의 위병변 면적을 비교해보면, 증숙 생강 추출물과 생강 추출물 투여군들의 위병변 면적은 각각 6.89mm2 및 32.37mm2로 측정되어, 증숙 생강 추출물을 투여한 군이 생강 추출물 투여군에 비해 위병변 면적이 78.71% 감소한 것으로 나타났으며, 증숙처리하지 않은 생강 추출물에 비해 위 보호 효과가 현저하게 우수한 것을 확인할 수 있었다(도 2 참조).Comparing the area of the stomach lesion of the groups administered with the steamed ginger extract and the ginger extract, the area of the stomach lesion of the group administered with the steamed ginger extract and the ginger extract was 6.89 mm 2 and 32.37 mm 2 , respectively. It was found that the area of the gastric lesion was reduced by 78.71% compared to the above, and it was confirmed that the gastric protective effect was significantly superior to that of the ginger extract that was not steamed (see FIG. 2).
실시예 3. 1-Dehydro-6-gingerdione 화합물 항위염 효과 분석Example 3. Analysis of 1-Dehydro-6-gingerdione compound anti-gastritis effect
실시예 2의 실험 결과를 바탕으로, 항위염 효과를 나타내는 지표물질로 추정되는 1-Dehydro-6-gingerdione 화합물이 갖는 항위염 효과를 분석하였다. Based on the experimental results of Example 2, the anti-gastritis effect of the 1-Dehydro-6-gingerdione compound, which is estimated to be an indicator material showing the anti-gastritis effect, was analyzed.
마우스를 24시간 절식시킨 후, 1-Dehydro-6-gingerdione 화합물을 10mg/kg 용량으로 경구투여하고 1시간 후에 0.3M 염산을 함유한 60% 에탄올을 마리당 1.5 mL씩 경구 투여하였다.After fasting the mice for 24 hours, 1-Dehydro-6-gingerdione compound was orally administered at a dose of 10 mg/kg, and after 1 hour, 60% ethanol containing 0.3 M hydrochloric acid was orally administered by 1.5 mL per mouse.
1시간 후에 위를 적출하여 4% 파라포름알데하이드 2mL를 위 내로 주입하여 1시간 이상 고정하였다. 고정된 위의 대만부를 따라 절개하여 펼친 후, 디지털카메라를 이용하여 사진을 찍은 후 Focus Lite를 이용하여 위병변(gastric lesion, mm2) 면적을 측정하였다. After 1 hour, the stomach was removed, and 2 mL of 4% paraformaldehyde was injected into the stomach and fixed for more than 1 hour. After cutting and spreading along the fixed upper portion of the stomach, a picture was taken using a digital camera, and the area of the gastric lesion (mm 2 ) was measured using Focus Lite.
분석 결과, 1-Dehydro-6-gingerdione 화합물을 투여한 실험군(6GD)은 위병변 면적이 13.76mm2(n=6)로 측정되어 음성대조군의 위병변 면적 측정값 64.78mm2(n=4)의 21.2%(p<0.001) 수준으로 관찰되었으며, 음성대조군 대비 위병변 면적 수치가 78.76% 감소하여 우수한 위 보호 효과가 있음을 확인할 수 있었다(도 3 참조). As a result of the analysis, the experimental group (6GD) administered with 1-Dehydro-6-gingerdione compound had a gastric lesion area of 13.76 mm 2 (n=6), and the negative control group had a measured gastric lesion area of 64.78 mm 2 (n=4). was observed at the level of 21.2% (p<0.001) of the gastric lesion, and compared to the negative control group, the gastric lesion area was reduced by 78.76%, confirming that there was an excellent gastric protection effect (see FIG. 3 ).
상기 1-Dehydro-6-gingerdione 화합물 처리군의 위병변 면적 수치는 증숙처리하지 않은 시험예 1의 생강 추출물을 투여한 실험군에서 관찰된 위병변 면적 32.37mm2(n=6) 대비 42.51% 수준으로, 1-Dehydro-6-gingerdione 화합물은 생강 추출물과 비교하여 위염의 예방 및 치료에 매우 효과적임을 확인할 수 있었다(도 3 참조). The gastric lesion area value of the 1-Dehydro-6-gingerdione compound-treated group was 42.51% compared to the gastric lesion area 32.37mm 2 (n=6) observed in the experimental group administered with the ginger extract of Test Example 1 without steaming treatment. , It was confirmed that the 1-Dehydro-6-gingerdione compound was very effective in the prevention and treatment of gastritis compared to the ginger extract (see FIG. 3 ).
한편, 1-Dehydro-6-gingerdione 화합물(10mg/kg), 증숙 생강 추출물(100mg/kg), 및 생강 추출물(100mg/kg) 투여군 상호 간의 위병변 억제 효과를 비교하면, 투여 용량에 차이가 있으나 증숙 생강 추출물, 1-Dehydro-6-gingerdione 화합물 순으로 효과가 우수한 것으로 나타났다(도 4 참조). On the other hand, when comparing the gastric lesion inhibitory effect between the groups administered with 1-Dehydro-6-gingerdione compound (10mg/kg), steamed ginger extract (100mg/kg), and ginger extract (100mg/kg), there is a difference in the dose, but It was found that the effects were excellent in the order of steamed ginger extract and 1-Dehydro-6-gingerdione compound (see FIG. 4).
상기 실험 결과를 검토하여 볼 때, 1-Dehydro-6-gingerdione 화합물의 함량이 증가된 증숙 생강 추출물과, 이의 유효성분인 1-Dehydro-6-gingerdione 화합물은 위염 및 위궤양 예방 및 치료에 현저한 효과가 있으며, 특히 알코올 등에 의해 발병하는 급성 위염 내지 위궤양에 현저한 예방 및 치료 효과를 보이는 것으로 확인할 수 있었다. When reviewing the experimental results, the steamed ginger extract with an increased content of the 1-Dehydro-6-gingerdione compound and the 1-Dehydro-6-gingerdione compound as an active ingredient thereof have significant effects in the prevention and treatment of gastritis and gastric ulcer. In particular, it was confirmed that it showed a remarkable preventive and therapeutic effect on acute gastritis or gastric ulcer caused by alcohol.
제조예 1. 약제의 제조Preparation Example 1. Preparation of pharmaceuticals
1-1. 정제의 제조1-1. manufacture of tablets
증숙 생강 추출물 (또는 1-Dehydro-6-gingerdione) 200㎎ (20mg)Steamed Ginger Extract (or 1-Dehydro-6-gingerdione) 200mg (20mg)
유당 100㎎Lactose 100mg
전분 100㎎Starch 100mg
스테아린산 마그네슘 적량Adequate amount of magnesium stearate
통상의 정제 제조방법에 따라 상기의 성분을 혼합하고 타정하여 정제를 제조하였다.Tablets were prepared by mixing and tableting the above ingredients according to a conventional tablet manufacturing method.
1-2. 액제의 제조1-2. Preparation of liquids
증숙 생강 추출물 (또는 1-Dehydro-6-gingerdione) 1000㎎ (100mg)Steamed Ginger Extract (or 1-Dehydro-6-gingerdione) 1000mg (100mg)
CMC-Na 20gCMC-Na 20g
이성화당 20gIsomerized sugar 20g
레몬향 적량Lemon flavored amount
1-3. 캡슐제의 제조1-3. manufacture of capsules
증숙 생강 추출물 (또는 1-Dehydro-6-gingerdione) 300㎎ (30mg)Steamed Ginger Extract (or 1-Dehydro-6-gingerdione) 300mg (30mg)
결정성 셀룰로오스 3㎎3 mg of crystalline cellulose
락토오스 14.8㎎Lactose 14.8mg
마그네슘 스테아레이트 0.2㎎Magnesium stearate 0.2mg
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 캡슐제를 제조하였다.According to a conventional capsule preparation method, the above ingredients were mixed and filled in a gelatin capsule to prepare a capsule.
1-4. 주사제의 제조1-4. manufacture of injections
증숙 생강 추출물 (또는 1-Dehydro-6-gingerdione) 300㎎ (30mg)Steamed Ginger Extract (or 1-Dehydro-6-gingerdione) 300mg (30mg)
만니톨 180㎎Mannitol 180mg
주사용 멸균 증류수 2974㎎Sterile distilled water for injection 2974mg
Na2HPO412H2O 26㎎Na 2 HPO 4 12H 2 O 26mg
통상의 주사제의 제조방법에 따라 1 앰플당(2㎖) 상기의 성분 함량으로 제조하였다.According to a conventional injection preparation method, the content of the above ingredients per 1 ampoule (2 ml) was prepared.
이상으로 본 발명의 특정한 부분을 상세히 기술하였는 바, 당업계의 통상의 지식을 가진 자에게 있어서 이러한 구체적인 기술은 단지 바람직한 구현예일 뿐이며, 이에 본 발명의 범위가 제한되는 것이 아닌 점은 명백하다.As described above in detail a specific part of the present invention, for those of ordinary skill in the art, this specific description is only a preferred embodiment, and it is clear that the scope of the present invention is not limited thereto.
따라서, 본 발명의 실질적인 범위는 첨부된 청구항과 그의 등가물에 의하여 정의된다고 할 것이다.Accordingly, the substantial scope of the present invention will be defined by the appended claims and their equivalents.
Claims (10)
상기 증숙 생강 추출물은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 전체 추출물 중량 대비 0.004% 이상인 것을 특징으로 하는,
비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물.1-dihydro-6-gingerdione (1-Dehydro-6-gingerdione) containing a compound containing steamed ginger extract as an active ingredient,
The steamed ginger extract is characterized in that the content of 1-dehydro-6-gingerdione compound is 0.004% or more based on the total weight of the extract,
A pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer.
상기 증숙은 60℃ 내지 100℃에서 30분 내지 120분 동안 수행되는 것을 특징으로 하는 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물.According to claim 1,
The steaming is a pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer, characterized in that it is performed for 30 minutes to 120 minutes at 60 ℃ to 100 ℃.
상기 증숙 생강 추출물은 1차 α-아밀라아제 및 2차 셀룰라아제 효소로 효소처리된 것을 특징으로 하는 비감염성 위염 및 위궤양의 예방 및 치료용 약학 조성물.According to claim 1,
A pharmaceutical composition for the prevention and treatment of non-infectious gastritis and gastric ulcer, characterized in that the steamed ginger extract is enzymatically treated with primary α-amylase and secondary cellulase enzymes.
상기 증숙 생강 추출물은 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 전체 추출물 중량 대비 0.004% 이상인 것을 특징으로 하는,
비감염성 위염 및 위궤양의 예방용 식품 조성물.1-dihydro-6-gingerdione (1-Dehydro-6-gingerdione) containing a compound containing steamed ginger extract as an active ingredient,
The steamed ginger extract is characterized in that the content of 1-dehydro-6-gingerdione compound is 0.004% or more based on the total weight of the extract,
A food composition for the prevention of non-infectious gastritis and gastric ulcer.
(b) 상기 생강 추출물을 증숙하는 단계;
(c) 상기 증숙 생강 추출물을 1차 효소 분해하는 단계; 및
(d) 상기 1차 효소 분해된 증숙 생강 추출물을 2차 효소 분해하는 단계를 포함하는, 1-디하이드로-6-진저다이온(1-Dehydro-6-gingerdione) 화합물의 함량이 증가된 증숙 생강 추출물의 제조방법.(a) extracting ginger;
(b) steaming the ginger extract;
(c) first enzymatic decomposition of the steamed ginger extract; and
(d) steamed ginger with an increased content of 1-Dehydro-6-gingerdione compound, comprising the step of secondary enzymatic decomposition of the steamed ginger extract decomposed by the first enzyme Method for preparing the extract.
상기 (b) 증숙 단계는 60℃ 내지 100℃에서 30분 내지 120분 동안 수행되는 것을 특징으로 하는 증숙 생강 추출물의 제조방법.9. The method of claim 8,
The (b) steaming step is a method for producing a steamed ginger extract, characterized in that it is carried out at 60 ° C. to 100 ° C. for 30 minutes to 120 minutes.
상기 (c) 1차 효소 분해 단계는 α-아밀라아제를 효소로 사용하고, 상기 (d) 2차 효소 분해 단계는 셀룰라아제를 효소로 사용하는 것을 특징으로 하는 증숙 생강 추출물의 제조방법.9. The method of claim 8,
The method for producing a steamed ginger extract, characterized in that the (c) first enzymatic digestion step uses α-amylase as an enzyme, and the (d) second enzymatic digestion step uses cellulase as an enzyme.
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| JP2015198661A (en) * | 2009-12-29 | 2015-11-12 | ヒルズ・ペット・ニュートリシャン・インコーポレーテッド | Compositions including ginger, for amelioration or prevention of inflammatory conditions |
| KR20160137761A (en) * | 2015-05-21 | 2016-12-01 | (주) 건우에프피 | Method for manufacturing fermented black ginger extract containing high shogaol and fermented black ginger extract powder |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102488117B1 (en) | 2021-12-15 | 2023-01-13 | (주)에스디생명공학 | Composition for Prevention or Treatment of Infective Gastritis by Helicobacter pylori Infection Comprising Steamed Ginger Extract as an Active Ingredient |
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