KR100857896B1 - Composition for improving allergy containing clematidis radix extract - Google Patents
Composition for improving allergy containing clematidis radix extract Download PDFInfo
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- KR100857896B1 KR100857896B1 KR1020070023052A KR20070023052A KR100857896B1 KR 100857896 B1 KR100857896 B1 KR 100857896B1 KR 1020070023052 A KR1020070023052 A KR 1020070023052A KR 20070023052 A KR20070023052 A KR 20070023052A KR 100857896 B1 KR100857896 B1 KR 100857896B1
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- South Korea
- Prior art keywords
- extract
- allergy
- gastric
- saponin
- composition
- Prior art date
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2200/00—Function of food ingredients
- A23V2200/30—Foods, ingredients or supplements having a functional effect on health
- A23V2200/304—Foods, ingredients or supplements having a functional effect on health having a modulation effect on allergy and risk of allergy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
Abstract
Description
도 1은 위령선 사포닌 풍부 분획의 알러지 증상 개선 효과를 평가한 사진이다.1 is a photograph evaluating the effect of allergic symptoms of gastric saponin-rich fractions.
본 발명은 식물 추출물을 함유하는 것을 특징으로 하는 아토피성 피부염, 천식 등의 알러지 개선용 조성물, 및 알러지 개선에 유용한 식물 추출물을 제조하는 방법에 관한 것이다.The present invention relates to a composition for improving allergy, such as atopic dermatitis, asthma, and a method for producing a plant extract useful for allergy improvement, characterized by containing a plant extract.
아토피(atopy)란 그리스어인 ‘a-topos'가 어원으로 특이한, 이상한, 비정상적인 반응, 기묘한, 뜻을 알 수 없는 등의 의미가 있다. 말 그대로 아토피란 다양한 원인이 복잡하게 뒤엉켜 발생하며 완화와 재발을 반복한다. 원인이 복잡하고 다양하다는 것은 그만큼 치료가 어렵다는 것을 의미한다. 알러지(allergy)를 우리말로 풀이해도 아토피(atopy)와 동일하게 해석되는데, 아토피가 알러지보다 좀 더 복잡한 의미를 가진다. 1923년 미국의 쿠크(Cooke)와 코카(Coca)가 유전적 소인이 있는 알러지 질환을 다른 알러지 질환과 구분하기 위해 아토피성 질환이라고 부르고 이들 질환에 이환되는 유전적 경향을 아토피라고 부르기 시작하였다. 즉, 아토피는 알러지 질환의 일종인데, 일반적인 알러지 증상들과 달리 유전적인 경향을 나타낸다는 것이다. 다시 말해서 아토피는 아토피 소인이 있는 개인에서 피부, 호흡기 점막, 안점막, 장점막 등에 나타나는 일련의 알러지 증상이라고 정의된다. 아토피 질환에는 천식, 결막염, 피부염 등이 있으며 이들 질환은 단독 또는 여러 질환이 동시에 나타날 수 있는데, 일반적으로 아토피 피부염이 그 대표적인 예라고 할 수 있다(김정희, 아토피 피부염의 최신지견 , 소아알레르기 및 호흡기, 14, 12-23, 2004).Atopy is a Greek word for "a-topos," meaning unusual, unusual, unusual reactions, strange, unknown meanings, etc. Literally, atopy is a complex entanglement of a variety of causes, repeated remission and relapse. Complex and diverse causes mean that treatment is difficult. Allergy in Korean is interpreted the same as atopy, which has a more complex meaning than allergy. In 1923, Cooke and Coca of the United States began to call atopic diseases to distinguish allergic diseases with genetic predispositions from other allergic diseases, and to call atopy for the genetic tendency of these diseases. In other words, atopy is a type of allergic disease that, unlike the common allergic symptoms, tends to be genetic. In other words, atopy is defined as a series of allergic symptoms that occur in the skin, respiratory mucosa, eye mucosa, and intestinal mucosa in individuals with atopic predisposition. Atopic disease, and asthma, conjunctivitis, dermatitis, etc. These diseases are alone or there several diseases can appear simultaneously generally have atopic dermatitis can be said that a representative example (Kim Jung Hee, the latest findings of atopic dermatitis, Pediatric Allergy and Respiratory Diseases, 14, 12-23, 2004 ).
아토피성 피부염의 원인은 아직까지 확실하게 규명되지 못하고 있으며 임상증상도 건조피부, 습진 등으로 다양하게 표현되기 때문에 발병 기전도 어느 한가지로만 설명될 수 없으므로 '원인과 특징이 불분명하다'는 것이 특징이다. 일반적으로 천식, 비염, 두드러기 등의 각종 알러지 증상을 동반하는 경우가 흔하며, 가족력을 갖는 경우 발생 빈도가 높아 유전성 소인을 갖는다고 추정되고 있으나, 생활 환경과 정서 상태 등 개인별로 천차만별의 다인자적 악화요인이 있다. 아토피성 피부염의 주증상은 가려움인데, 가려워서 긁게 되면 습진성 병변으로 발전하고 이러한 병변이 진행되면서 다시 더 심한 소양증이 유발되는 일련의 악순환이 반복되게 된다. 따라서 이들 환자에서 가장 중요한 치료는 어떤 방식으로든 가려움증을 없애주는 것이 관건이다.The cause of atopic dermatitis has not yet been reliably identified, and since the clinical symptoms are variously expressed in dry skin, eczema, etc., the pathogenesis can not be explained by any one of them. . Generally allergic symptoms such as asthma, rhinitis, urticaria, etc. are often accompanied, and family history has a high incidence of genetic predisposition, but it is estimated to have multifactorial deterioration factors by individual such as living environment and emotional state. There is this. The main symptom of atopic dermatitis is itching, and when itchy and scratched, it develops into eczematous lesions, and as the lesion progresses, a series of vicious cycles occur, causing further pruritus. Therefore, the most important treatment in these patients is to get rid of itching in some way.
한편, 인체에는 외부로부터 세균이나 바이러스 등의 이물질이 침입할 때, 이들에 맞서 신체를 지키기 위한 생체 방어 기구인 면역시스템이 갖추어져 있으며, 알러지 질환은 이 면역시스템이 지나치게 작용하기 때문에 일어나는 것이다. 이러한 알러지 질환은 근래 대기오염, 식생활의 변화, 육체적 또는 정신적인 스트레스의 증가, 거주환경 변화에 따른 실내오염 등의 환경 변화 또는 인간 체질 변화 등에 의하여 발생하기도 하지만 그 원인은 매우 다양하며 명확하지 않다.On the other hand, when foreign substances such as bacteria or viruses invade from the outside, the human body is equipped with an immune system that is a biological defense mechanism to protect the body against them, and allergic diseases occur because this immune system is excessively acting. These allergic diseases are caused by recent air pollution, changes in diet, physical or mental stress, environmental changes such as indoor pollution due to changes in living environment, or changes in human constitution, but the causes are very diverse and unclear.
이러한 알러지 질환으로는 천식, 아토피성 피부염, 알러지성 결막염, 화분증과 같은 알러지성 비염, 음식물 알러지 등이 있다. 특히 아토피성 피부염은 유아기 시에는 그 가려움 때문에 환자뿐만 아니라 그 부모도 괴롭히는 것이며, 대부분은 성인이 되기 전에 낫지만 성인기까지 계속되면 얼굴이나 가슴, 팔꿈치나 무릎 안 쪽 등의 피부가 두껍게 되어 심한 가려움이 일어나 사춘기의 남녀를 괴롭힌다. 이 아토피성 피부염의 치료법으로는 외용 요법이 주된 방법으로서 증상에 따라서 부신피질 호르몬제, 항히스타민제, 지방산 보충제, 기타 항염증제 등을 이용한다. 그러나 이들 요법은 대증요법으로서 알러지 질환을 완치시키는 것이 아니고, 또한 약재를 이용함에 따른 부작용들도 심각한 것으로 알려져 있다.Such allergic diseases include asthma, atopic dermatitis, allergic conjunctivitis, allergic rhinitis such as hay fever, and food allergies. In particular, atopic dermatitis is annoying not only to patients but also to parents because of the itching during infancy. Most of the time, it is better before adulthood, but if it continues until adulthood, the skin of the face, chest, elbow or the inside of the knee becomes thick and itchy. Get up and tease adolescents. For the treatment of atopic dermatitis, external therapy is the main method, and depending on the symptoms, corticosteroids, antihistamines, fatty acid supplements, and other anti-inflammatory agents are used. However, these therapies do not cure allergic diseases as symptomatic therapy, and the side effects of using the medicine are also known to be serious.
케모카인은 알러지성, 염증성 및 자가면역성 장애 및 질환, 예컨대 천식, 죽상경화증, 사구체신염, 췌장염, 재협착, 류마티스성 관절염, 당뇨병성 신병증, 폐섬유증 및 이식 거부반응의 중요한 매개자로서 포함되었다. 따라서 케모카인 기능의 길항 물질의 사용은 상기 장애 및 질환의 진행을 되돌리거나 또는 방해하는 것을 도울 수 있다. 특히 MCP-1(Monocyte Chemotactic Protein-1)의 상승된 발현은 다수의 만성 염증성 질환에서 관찰되었으며[Proost 등, Int . J. Clin . Lab . Res ., 26:211-223(1996); Taub D.D., Cytokine Growth Factor Rev., 7:355-376(1996)], 상기 질환에 포함되는 류마티스성 관절염에서도 관찰되었고[Robinson 등. Clin Exp Immunol , 101:398-407(1995); Hosaka 등, ibid . 97:451-457(1994); Koch 등, J. Clin . Invest ., 90:772-779(1992); Villiger 등, J. Immunol ., 149:722-727(1992)], 천식에서도 관찰되었으며[Hsieh 등, J. Allergy Clin . Immunol., 98:580-587(1996); Alam 등, Am . J. Respir . Crit . Care Med ., 153:1398-1404(1996); Kurashima 등, J. Leukocyte Biol ., 59:313-316(1996); Sugiyama 등, Eur . Respir . J., 8:1084-1090(1995)], 건선에서도 관찰되었고[Gillitzer R 등, J. Invest . Dermatol ., 101-127(1993)], 지연형 과민반응에 대해서도 항-MCP-1 항체는 생쥐 동물 모델에서 억제 효과 및 치료 효과를 보이는 것이 관찰되었다[Rand ML 등, Am. J. Pathol., 148:855(1996)]. 또한 MCP-1은 마크로파지, 평활근 세포, 섬유아세포 및 혈관 내피 세포에 의해 만들어지는 케모카인이며, 호염기성 세포에 의한 히스타민 방출 조절뿐만 아니라 단핵세포, 기억 T 세포 및 자연 킬러 세포의 세포 이동과 세포 결합을 일으키는 것으로도 보고되었다[Rollins BJ 등, Proc. Natl . Acad . Sci ., 85:3738-3742(1988); Matsushima K 등, J. Exp . Med., 169:1485-1490(1989); Jiang Y 등, Am . J. Physiol ., 267: C1112 -C1118(1994); Allavena P 등, Eur . J. Immunol ., 24:3233-3236(1994)]. MCP-1은 또한 알러지 반응에 중요한 역할을 하는 면역 글로불린 IgE 및 IgG4 생산을 증가시키므로 이에 대한 길항제는 알러지 증상의 개선 및 알러지 치료에 중요한 역할을 할 수 있다는 보고도 있다[Kaplan AP 등, Exp . Dermatol ., 4(4):260-265(1995); Kimata H 등, J. Exp . Med ., 183:2397(1996); Giampiero G 등, Curr . Opinion Immunol ., 13(6):733- 737(2001); Romagnani S 등, Mol . Immunol ., 38(12-13):881-885(2002); Pierre - Olivier F 등, J. Allergy & Clin . Immunol ., 118(2):536-538(2006); Martin S 등, J. Allergy & Clin. Immunol ., 118(1):190-197(2006)]. 따라서 알러지 증상의 대표적인 예인 아토피성 피부염이나 천식 등의 효과적인 치료를 위하여 적절한 MCP-1 길항제 또는 MCP-1 억제제를 사용하는 것은 매우 효과적인 방법임이 명확하다.Chemokines have been included as important mediators of allergic, inflammatory and autoimmune disorders and diseases such as asthma, atherosclerosis, glomerulonephritis, pancreatitis, restenosis, rheumatoid arthritis, diabetic nephropathy, pulmonary fibrosis and transplant rejection. Thus, the use of antagonists of chemokine function may help reverse or hinder the progression of the disorder and disease. In particular, elevated expression of MCP-1 (Monocyte Chemotactic Protein-1) has been observed in many chronic inflammatory diseases [ Proost et al . , Int . J. Clin . Lab . Res ., 26: 211-223 (1996); Taub DD, Cytokine Growth Factor Rev., 7: 355-376 (1996) ], and was also observed in rheumatoid arthritis included in the disease [ Robinson et al. Clin Exp Immunol , 101: 398-407 (1995); Hosaka et al . , Ibid . 97: 451-457 (1994); Koch et al . , J. Clin . Invest ., 90: 772-779 (1992); Villiger et al . , J. Immunol ., 149: 722-727 (1992) ] and have also been observed in asthma [ Hsieh et al., J. Allergy Clin . Immunol., 98: 580-587 (1996); Alam et al . , Am . J. Respir . Crit . Care Med ., 153: 1398-1404 (1996); Kurashima et al., J. Leukocyte Biol ., 59: 313-316 (1996); Sugiyama et al . , Eur . Respir . J., 8: 1084-1090 (1995) ] and also observed in psoriasis [ Gillitzer R et al., J. Invest . Dermatol ., 101-127 (1993) ], and anti-MCP-1 antibodies were also shown to have inhibitory and therapeutic effects in mouse animal models [Rand ML et al., Am. J. Pathol., 148: 855 (1996). MCP-1 is also a chemokine made by macrophages, smooth muscle cells, fibroblasts and vascular endothelial cells, and regulates histamine release by basophils as well as cell migration and cell binding of monocytes, memory T cells, and natural killer cells. It has also been reported to cause [ Rollins BJ et al., Proc. Natl . Acad . Sci ., 85: 3738-3742 (1988); Matsushima K et al . , J. Exp . Med., 169: 1485-1490 (1989); Jiang Y et al . , Am . J. Physiol ., 267: C1112- C1118 (1994); Allavena P et al . , Eur . J. Immunol ., 24: 3233-3236 (1994) . MCP-1 also increases the IgE and IgG4 immunoglobulin production plays an important role in the allergic response thereto for antagonists has been reported that it can play an important role in the improvement and treatment of allergic symptoms, allergic [Kaplan AP et al . , Exp . Dermatol ., 4 (4): 260-265 (1995); Kimata H et al . , J. Exp . Med ., 183: 2397 (1996); Giampiero G et al . , Curr . Opinion Immunol ., 13 (6): 733- 737 (2001); Romagnani S et al . , Mol . Immunol ., 38 (12-13): 881-885 (2002); Pierre - Olivier F et al . , J. Allergy & Clin . Immunol ., 118 (2): 536-538 (2006); Martin S et al. , J. Allergy & Clin. Immunol ., 118 (1): 190-197 (2006) ]. Therefore, it is clear that a suitable MCP-1 antagonist or MCP-1 inhibitor is a very effective method for the effective treatment of allergic symptoms such as atopic dermatitis and asthma.
최근 들어 천연물을 소재로하여 알러지 증상을 개선하고자 하는 많은 연구들이 발표되고 있다. 대한민국 특허출원 제10-2003-0077911호에서는 항알러지 및 항염증 활성을 갖는 다래 추출물을 함유하는 식품첨가제, 동물사료첨가제 또는 화장료 조성물에 대하여 개시되어 있으며, 대한민국 특허출원 제10-2004-0000781호에서는 특정 식물추출물로서 백년초 등으로부터 얻은 식물추출물을 배합한 피부용 화장료 조성물의 아토피 피부 질환 치유 효과가 우수함을 개시하고 있으며, 특허출원 제10-2004-0011984호에서는 자초의 추출물을 사용하여 아토피 피부염 또는 건조증을 치료하는 용도로 사용하는 조성물을 개시하고 있기도 하다. Recently, many studies have been published to improve allergy symptoms using natural materials. Korean Patent Application No. 10-2003-0077911 discloses a food additive, an animal feed additive or a cosmetic composition containing a worm extract having anti-allergic and anti-inflammatory activity, and in Korea Patent Application No. 10-2004-0000781 It is disclosed that the atopic skin disease healing effect of the skin cosmetic composition containing plant extracts obtained from baeknyeoncho, etc. as a specific plant extract is excellent. Patent application No. 10-2004-0011984 discloses atopic dermatitis or dryness using the extract of There is also disclosed a composition for use in therapy.
이와 같이 각종 천연식물자원으로부터 알러지 증상을 개선하기 위한 치료제를 개발하고자 하는 시도가 많이 있으나, 대부분 물 또는 에탄올을 추출 용매로 사용하여 추출한 조추출물을 사용하는 경우가 많아서 효과가 기대하는 것보다 미약하거나 혹은 조추출물을 사용함으로써 불필요한 성분들이 많이 함유되게 되어 예상하지 못한 부작용이 발생하는 경우도 많이 있는 것으로 알려져 있다.As described above, there have been many attempts to develop a therapeutic agent for improving allergic symptoms from various natural plant resources, but most of them use crude extract extracted using water or ethanol as an extraction solvent, and the effect is weaker than expected. Or it is known that there are many cases of unexpected side effects due to the use of crude extract to contain a lot of unnecessary components.
따라서 본 발명이 이루고자 하는 기술적 과제는 부작용이 적어 안전하면서도 알러지 개선 효과가 뛰어난 조성물, 및 이를 함유하는 의약품, 기능성 식품 또는 화장품을 제공하는 것이다.Therefore, the technical problem to be achieved by the present invention is to provide a composition having fewer side effects and safe allergy improvement effect, and pharmaceuticals, functional foods or cosmetics containing the same.
본 발명이 이루고자 하는 다른 기술적 과제는 안전하면서도 알러지 개선 효과가 뛰어난 위령선 추출물의 제조방법을 제공하는 것이다.Another technical problem to be achieved by the present invention is to provide a method for preparing a gastric extract of a safe yet excellent allergic effect.
상기 기술적 과제를 달성하기 위하여, 본 발명은 위령선 추출물을 유효성분으로 함유하는 것을 특징으로 하는 알러지 개선용 조성물을 제공하며, 보다 바람직하게는 상기 위령선 추출물이 위령선 추출물의 사포닌 풍부 분획 또는 위령선 저급 알코올 추출물의 n-부탄올 분획인 것을 특징으로 하는 알러지 개선용 조성물을 제공한다.In order to achieve the above technical problem, the present invention provides a composition for improving allergy, characterized in that it contains the gastric extract as an active ingredient, more preferably, the gastric extract is saponin-rich fraction or gastric gland lower alcohol extract of the gastric extract The n-butanol fraction provides an allergy improving composition.
본 발명은 또한 (S1) 위령선 또는 분쇄된 위령선을 준비하는 단계; (S2) 상기 위령선을 저급 알코올로 추출하여 위령선 조추출물을 얻는 단계; (S3) 상기 위령선 조추출물을 n-부탄올로 분배추출하는 단계를 포함하는 것을 특징으로 하는 안전하고 알러지 개선 효능이 뛰어난 위령선 추출물의 제조방법을 제공한다.The present invention also comprises the steps of (S1) preparing a gasoline or crushed gasoline; (S2) extracting the gastric gland with lower alcohol to obtain a gastric gland extract; (S3) provides a method for producing a safe and allergic effect of the above-mentioned gastric gland extract, characterized in that it comprises the step of extracting the gastric gland extract as n-butanol.
이하, 본 발명의 위령선 추출물 함유 조성물 및 안전하고 알러지 개선 효능이 뛰어난 위령선 추출물의 제조방법에 대해 보다 구체적으로 설명한다.Hereinafter, the method for preparing a gastric extract of the present invention and a method for preparing a gastric extract excellent in safety and allergy improvement will be described in more detail.
위령선(威靈仙, Radix Clematidis)은 미나리아재비과(Ranunculaceae)에 속하는 다년생 낙엽성 식물인 으아리(Clematis mandshurica MAXIM., Clematis mandshurica RUPR.), 외대으아리(고칫대꽃)(Clematis brachyura MAXIM.), 참으아리(Clematis paniculate THUNB.), 철선련(Clematis florida THUNB.), 큰꽃으아 리(Clematis patens MORREN.) 및 동속 근연식물의 뿌리 및 뿌리 줄기를 건조한 것으로, 중국에서는 위령선(Clematis chinensis OSBECK.)와 좁은입사위질빵(Clematis hexapetala PALL.)을 함께 기원으로 한다. 이러한 위령선은 진통작용, 항말라리아작용, 항균작용, 유산작용, 담즙분비촉진작용, 평활근 이완작용, 항이뇨작용, 강심 및 혈압강하작용 등이 있다고 알려져 있다[Chinese Materia Medica , Chemistry, Pharmacology and Applications , You - Ping Zhu , 1998].Radix Clematidis is a perennial deciduous plant belonging to the Ranunculaceae family, Clematis mandshurica MAXIM., Clematis mandshurica RUPR., Clematis brachyura MAXIM. (Clematis paniculate THUNB.), Clematis florida THUNB., Clematis patens MORREN. And dried roots and rhizomes of related plants. In China, the clematis chinensis OSBECK. Originated with Clematis hexapetala PALL. These wiryeongseon is known to be, such as analgesic action, anti-malarial action, antibacterial action, action heritage, bile secretion promoting action, smooth muscle relaxing action, an anti-diuretic, cardiac and blood pressure lowering action [Chinese Materia Medica , Chemistry, Pharmacology and Applications , You - Ping Zhu , 1998 ].
본 발명의 알러지 개선용 조성물은 유효성분으로 위령선 추출물, 바람직하게는 안전하고 알러지 개선 효과가 향상된 위령선 추출물의 사포닌 풍부 분획 또는 위령선 저급 알코올 추출물의 n-부탄올 분획을 포함한다.The composition for allergy improvement of the present invention includes a saponin-rich fraction or an n-butanol fraction of a gastric liquor lower alcohol extract of a gastric extract, preferably a safe and allergic effect, as an active ingredient.
미국의 California Poison Control System(www.calpoison.org)에서는 독성을 유발하는 식물들 중에서 위령선이 섭취시에 구토나 설사와 같은 독성을 유발할 수 있거나, 피부에 접촉시 발적과 자극을 유발할 수 있으며, 발적은 매우 심하고 통증을 일으킬 수도 있는 식물이라고 분류되어 있으며, 미국 식품의약청에서도 위령선 속의 식물들은 독성 식물로 분류되어 사용시 주의할 필요가 있는 식물로 지정되어 있다. 따라서 이러한 위령선으로부터 안전한 추출물을 얻는 연구는 필수적이며, 통상적인 추출물의 경우 위장관 독성 또는 피부독성이 생길 위험성이 존재한다.In the California Poison Control System (www.calpoison.org) of the United States, among the poisonous plants, the gastrointestinal tract may cause toxicity, such as vomiting or diarrhea when ingested, or may cause redness and irritation upon skin contact. Is classified as a very severe and painful plant, and the U.S. Food and Drug Administration is classified as a toxic plant and designated as a plant that needs attention when used. Therefore, the study of obtaining a safe extract from these gastric vessels is essential, there is a risk of gastrointestinal toxicity or skin toxicity in the case of conventional extracts.
본 발명은 위령선 추출물 중에서도 사포닌이 풍부한 분획이 통상적인 추출물보다 부작용이 없으며 알러지 개선 효과가 월등히 향상된다는 놀라운 사실에 기초하며, 위령선 조추출물의 n-부탄올 분획이 사포닌이 풍부하고 부작용이 적으며 알러지 개선 효과가 뛰어나다는 놀라운 사실에 기초한다. 따라서 본 발명 알러지 개 선용 조성물은 유효성분으로 위령선 추출물 중 사포닌 풍부 분획을 함유하는 것이 더욱 바람직하다.The present invention is based on the surprising fact that the saponin-rich fractions among the gastric extracts have no side effects than the conventional extracts, and the allergic improvement effect is significantly improved, and the n-butanol fraction of the crude gastric extracts is rich in saponins and has fewer side effects and allergy improvement. It's based on the amazing fact that it works. Therefore, the allergy improvement composition of the present invention more preferably contains a saponin-rich fraction in the gastric extract of the stomach as an active ingredient.
위령선 추출물의 사포닌 풍부 분획은 (S1) 위령선 또는 분쇄된 위령선을 준비하는 단계; (S2) 상기 위령선을 저급 알코올로 추출하여 위령선 조추출물을 얻는 단계; (S3) 상기 위령선 조추출물을 n-부탄올로 분배추출하는 단계를 포함하는 제조방법에 의해 제조될 수 있다.Saponin-rich fraction of the gastric gland extract is prepared by (S1) gastric gland or crushed gastric gland; (S2) extracting the gastric gland with lower alcohol to obtain a gastric gland extract; (S3) it can be prepared by a manufacturing method comprising the step of extracting the extract of the gastric gland to n-butanol.
그러나 본 발명의 사포닌 풍부 분획은 상기 제조방법으로 얻어진 것에 한정되는 것은 아니며, 위령선으로부터 용매추출과정을 반복하여 사포닌류 성분들을 풍부하게 함유하도록 제조한 것이면 어느 것이나 사용될 수 있다.However, the saponin-rich fraction of the present invention is not limited to that obtained by the above production method, and any solvent may be used as long as the saponin-rich fraction is prepared to contain abundant saponin components by repeating the solvent extraction process.
위령선 추출물은 통상적인 용매추출방법으로 물, 에탄올, 메탄올, 부탄올, 클로로포름, 디클로로메탄, 헥산, 에틸아세테이트 등의 사용가능한 용매를 이용하여 추출하거나, 초임계 이산화탄소 추출법을 통해서도 얻을 수 있으며, 또한 추출하여 얻어진 것을 다시 정제함으로써 더욱 고순도로 정제할 수도 있다.Maeseran extract can be extracted using a common solvent extraction method using available solvents such as water, ethanol, methanol, butanol, chloroform, dichloromethane, hexane, ethyl acetate, or also obtained by supercritical carbon dioxide extraction method. It can also refine | purify with higher purity by refine | purifying the obtained thing again.
본 발명의 알러지 개선용 조성물은 의약품, 기능성 식품 및 화장품의 형태로 제조될 수 있다. 이러한 의약품, 기능성 식품 및 화장품은 약제학적으로 허용되는 부형제 또는 첨가제를 포함할 수 있다. 본 발명의 알러지 개선용 조성물은 단독으로 혹은 어떤 편리한 운반체, 부형제 등과 함께 혼합하여 투여될 수 있고, 그러한 투여 제형은 단회투여 또는 반복투여 제형일 수 있다. The allergy improving composition of the present invention can be prepared in the form of pharmaceuticals, functional foods and cosmetics. Such pharmaceuticals, nutraceuticals and cosmetics may comprise pharmaceutically acceptable excipients or additives. The allergy improving composition of the present invention may be administered alone or in admixture with any convenient carrier, excipient, etc., and such dosage forms may be single or repeated dose formulations.
본 발명의 알러지 개선용 조성물을 포함하는 의약품, 기능성 식품 또는 화장품은 고형 제제, 반고형제제 또는 액상 제제일 수 있다. 고형 제제는 산제, 과립 제, 정제, 캅셀제, 좌제 등이 있으나, 이에 한정되는 것은 아니다. 고형 제제에는 부형제, 착향제, 결합제, 방부제, 붕해제, 활택제, 충진제 등이 포함될 수 있으나 이에 한정되는 것은 아니다. 반고형 제제로는 크림제, 로션제, 유화제, 리니멘트제 등이 있으나, 이에 한정되는 것은 아니며, 적당한 착색제, 착향제, 안정화제, 점성화제, 계면활성제 등을 첨가하여 제조할 수 있다. 액상 제제로는 물, 알코올, 프로필렌 글리콜 용액 같은 용액제, 현탁액제, 유제 등이 있으나, 이에 한정되는 것은 아니며, 적당한 착색제, 착향제, 안정화제, 점성화제 등을 첨가하여 제조할 수 있다.Medicines, functional foods or cosmetics containing the allergy improving composition of the present invention may be a solid preparation, a semisolid preparation or a liquid preparation. Solid preparations include, but are not limited to, powders, granules, tablets, capsules, suppositories, and the like. Solid form preparations may include, but are not limited to, excipients, flavors, binders, preservatives, disintegrants, lubricants, fillers and the like. Semi-solid preparations include, but are not limited to, creams, lotions, emulsifiers, lining agents, and the like, and may be prepared by adding suitable colorants, flavoring agents, stabilizers, viscosity agents, surfactants, and the like. Liquid formulations include, but are not limited to, solutions such as water, alcohols, propylene glycol solutions, suspensions, emulsions, and the like, and may be prepared by adding suitable colorants, flavors, stabilizers, viscosity agents, and the like.
본 발명의 알러지 증상 개선용 조성물은 치료해야할 질환 및 개체의 상태에 따라 경구제, 주사제(예를 들어, 근육주사, 복강주사, 정맥주사, 주입(infusion), 피하주사, 임플란트), 흡입제, 비강투여제, 질제, 직장투여제, 설하제, 경피적용제, 토피칼제 등으로 투여될 수 있으나, 이에 한정되는 것은 아니다. 투여경로에 따라 통상적으로 사용되고 비독성인, 약제학적으로 허용되는 운반체, 첨가제, 비히클을 포함하는 적당한 투여 유닛 제형으로 제제화될 수 있다. 일정 시간 동안 약물을 지속적으로 방출할 수 있는 데포(depot) 제형 또한 본 발명의 범위에 포함된다.The allergy symptom improving composition of the present invention may be administered orally, by injection (eg, intramuscular injection, intraperitoneal injection, intravenous injection, infusion, subcutaneous injection, implant), inhalant, nasal cavity, depending on the condition to be treated and the condition of the individual. Administration, vaginal, rectal, sublingual, transdermal, topical, etc. may be administered, but is not limited thereto. It may be formulated into a suitable dosage unit dosage form comprising a pharmaceutically acceptable carrier, excipient, vehicle, conventionally used and nontoxic, depending on the route of administration. Depot formulations capable of continually releasing the drug for a period of time are also within the scope of the present invention.
알러지 증상 개선이라는 본 발명의 목적을 달성하기 위하여 본 발명의 위령선 사포닌 풍부 분획은 매일 약 0.01 mg/kg 내지 약 10 g/kg이 투여될 수 있으며, 약 0.1 mg/kg 내지 약 1 g/kg의 1일 투여 용량이 바람직하다. 그러나 상기 투여량은 투여 경로 및 제형, 환자의 상태(연령, 성별, 체중 등), 치료하고 있는 상태의 심각성, 추출방법에 따른 위령선의 사포닌-풍부 분획의 함량 등에 따라 다양할 수 있다. 필요에 따라 편리성을 위하여 1일 총 투여량이 나누어지고 하루 동안 여러 번 나누어 투여될 수 있다.Gastric saponin-rich fraction of the present invention may be administered daily from about 0.01 mg / kg to about 10 g / kg to achieve the purpose of improving the allergy symptom, and from about 0.1 mg / kg to about 1 g / kg Daily doses are preferred. However, the dosage may vary depending on the route and formulation of administration, the condition of the patient (age, sex, weight, etc.), the severity of the condition being treated, the content of the saponin-rich fraction of the gastric gland according to the extraction method, and the like. If desired, the total daily dose may be divided for convenience and divided several times throughout the day.
본 발명의 위령선 추출물이 사용될 수 있는 알러지 질환으로는 아토피성 피부염, 천식, 결막염, 비염, 두드러기, 음식물 알러지 등이 있다.Allergic diseases in which the gastric gland extract of the present invention can be used include atopic dermatitis, asthma, conjunctivitis, rhinitis, urticaria, food allergies and the like.
이하, 본 발명을 보다 구체적으로 설명하기 위하여 하기 실시예 등을 들어 설명한다. 그러나 본 발명에 따른 실시예들은 여러 가지 다른 형태로 변형될 수 있으며 본 발명의 범위가 아래에서 상술하는 실시예들에 한정되는 것으로 해석돼서는 안 된다. 본 발명의 실시예들은 본 발명의 구체적 이해를 돕기 위해 예시적으로 제공되는 것이다.Hereinafter, the following examples and the like will be described in order to describe the present invention in more detail. However, embodiments according to the present invention may be modified in many different forms and the scope of the present invention should not be construed as being limited to the embodiments described below. Embodiments of the present invention are provided by way of example in order to facilitate a specific understanding of the present invention.
<실시예 1> 위령선 조추출물의 제조<Example 1> Preparation of crude gasoline extract
위령선 뿌리를 구입하여 분쇄한 다음 1Kg 중량당 약 3L의 70% 메탄올을 가하고 실온에서 3일 동안 추출하는 과정을 3회 반복하였으며, 이것을 여과한 여액을 가지고 회전감압농축기로 45℃에서 감압농축하는 단계를 거쳐서 위령선 조추출물을 얻었다. 이때 고형분은 8.58%이었다.Purchasing and crushing the gastric roots of the stomach, and adding about 3L of 70% methanol per 1Kg weight and extracted three times at room temperature for 3 days, and the filtrate was concentrated under reduced pressure at 45 ℃ with a rotary pressure reducer The crude extract was obtained by passing through. Solid content was 8.58% at this time.
<실시예 2> 위령선의 사포닌-풍부 분획 제조Example 2 Preparation of Saponin-Rich Fraction of Gastric Gland
실시예 1에서 얻어진 위령선 조추출물을 물(1L)과 에틸 아세테이트(1L)로 3회 분배 추출하였으며, 물층은 다시 n-부탄올(1L)로 3회 분배 추출하였다. 각 층을 감압농축하여 에틸 아세테이트 분획, n-부탄올 분획 그리고 물 분획을 얻었다. 이 중 n-부탄올 분획을 TLC를 이용하여 성분을 확인하였다. n-부탄올 분획에 대한 TLC전개용매로는 CHCl3:MeOH:H2O=65:35:10을 사용하였고, 준비된 용매가 들어있는 TLC 챔버 안에 시료를 흡착시킨 TLC를 넣어 전개시킨 뒤 건조하여 10% H2SO4수용액에 담근 후 건조시키고 가열하여 발색되는 양상과 Rf 값을 확인하여 n-부탄올 분획에는 사포닌류의 성분들이 다량 함유되어 있는 사포닌-풍부 분획임을 확인하였다. 이때 수득률은 2.14%이었다.The gastric extract obtained in Example 1 was extracted three times with water (1 L) and ethyl acetate (1 L), and the water layer was extracted three times with n -butanol (1 L). Each layer was concentrated under reduced pressure to obtain an ethyl acetate fraction, n -butanol fraction and water fraction. Among them, n -butanol fractions were identified using TLC. CHCl 3 : MeOH: H 2 O = 65: 35: 10 was used as the TLC developing solvent for the n -butanol fraction, and the sample was adsorbed into a TLC chamber containing a prepared solvent, developed, and dried. It was confirmed that the n -butanol fraction was saponin-rich fraction containing a large amount of saponins in the n -butanol fraction by dipping in an aqueous solution of% H 2 SO 4 and drying and heating. At this time, the yield was 2.14%.
<처방예 1> 크림(Cream)제제의 제조<Prescription Example 1> Preparation of Cream
이렇게 제조된 위령선의 사포닌-풍부 분획은 경구 또는 경피를 포함한 모든 투여 경로를 통하여 적용될 수 있으나 본 발명에서는 알러지 증상의 개선 효과를 평가하기 위하여 하기 표 1 처방예 1의 크림제제를 제조하여 평가하였으나, 본 발명이 아래 예시에 한정되는 것은 아니며, 로션, 비누, 팩, 화장수, 연고, 현탁액제, 유화제 등의 외용제제나 또는 정제, 액제, 캡슐제, 과립제, 산제, 주사제, 현탁액제, 유화제 등의 경구용 제제가 모두 포함될 수 있다.The saponin-rich fraction of the gastric gland prepared in this way can be applied through all routes of administration including oral or transdermal, but in the present invention, in order to evaluate the improvement effect of allergy symptoms, the cream formulation of Table 1 was prepared and evaluated. The present invention is not limited to the examples below, and oral preparations such as lotions, soaps, packs, lotions, ointments, suspensions, emulsifiers, or tablets, liquids, capsules, granules, powders, injections, suspensions, emulsifiers, and the like. All formulations may be included.
<실시예 3> 위령선 조추출물 및 사포닌-풍부 분획의 알러지 증상 관련 사이토카인 억제 활성Example 3 Cytokine Inhibitory Activity Related to Allergy Symptoms of Gastric Gland Extract and Saponin-Rich Fraction
(1) IL-1beta와 TNF-alpha 생성 억제(1) Inhibition of IL-1beta and TNF-alpha Production
인간 활액(synovial) 세포를 실험 3일 전에 2차 배양(1×105 cells/ml)하여 12 웰 플레이트에 2×106개 세포를 각 웰에 분주한 후, 우태아혈청결핍 RPMI-1640 배양액으로 12시간 배양시켰다. 위령선 조추출물(10mcg/ml)과 사포닌-풍부 분획 (10 또는 1mcg/ml)을 처리하고, 1시간 후 rhIL-1beta(100U/ml)와 rhTNF-alpha(100ng/ml)를 각각의 웰에 첨가하였다. 6시간 후 RPMI-1640 배양액으로 각 웰을 세척한 후 새로운 배양액과 위령선 조추출물 및 사포닌-풍부 분획으로 처리하고 48시간 동안 CO2 배양기에서 배양하였다. 배양 종료 후 전체 배양액을 2000rpm에서 5분간 원심분리하여 상층액을 회수하여, ELISA 키트로 생산량을 측정하였다. 그 결과 하기 표 2에 나타내었다. 하기 표 2에 나타나는 바와 같이, 위령선 사포닌-풍부 분획은 위령선 조추출물에 비하여 IL-1beta와 TNF-alpha 분비량을 농도의존적으로 더욱 강력하게 억제함이 확인되었다.Human synovial cells were secondary cultured (1 × 10 5 cells / ml) 3 days before the experiment, and 2 × 10 6 cells were dispensed into each well in a 12 well plate, followed by fetal bovine serum deficient RPMI-1640 medium. Incubated for 12 hours. Treated gastric crude extract (10mcg / ml) and saponin-rich fractions (10 or 1mcg / ml) and after 1 hour rhIL-1beta (100U / ml) and rhTNF-alpha (100ng / ml) were added to each well It was. After 6 hours, each well was washed with RPMI-1640 culture solution, treated with fresh culture medium, gastric crude extract, and saponin-rich fractions, and incubated in a CO 2 incubator for 48 hours. After the completion of the culture, the whole culture solution was centrifuged at 2000 rpm for 5 minutes to recover the supernatant, and the yield was measured using an ELISA kit. The results are shown in Table 2 below. As shown in Table 2, it was confirmed that gastric saponin-rich fractions inhibit IL-1beta and TNF-alpha secretion more strongly than crude gastric extract.
상기 표 2에서, *는 p<0.05에서 유의성 있는 차이가 있음을 의미한다.In Table 2, * means that there is a significant difference at p <0.05.
(2) MCP-1 생성억제(2) Inhibition of MCP-1 Production
샌드위치 ELISA법을 이용하여 MCP-1과 그 수용체 CCR2의 결합 저해 활성을 확인하였다. 이것은 세포와 MCP-1을 반응시킨 후 결합하지 않은 MCP-1의 양을 측정함으로써 간접적인 결합 저해 활성을 확인하는 방법이다. 96-웰 ELISA 플레이트에 MCP-1의 포획 항체(capture antibody, anti-hMCP-1 antibody, PBS로 1:250 희석)를 100ul를 첨가하여 4℃에서 24시간 코팅시켰다. 100ul의 블로킹 용액(1% BSA, 5% sucrose, 0.05% NaN3의 PBS)을 첨가하여 37℃에서 1시간 블로킹시킨 후, 세척 용액(0.05% Tween-20의 PBS)로 3회 세척하였다. THP-1 세포를 HEPES 완충액(50mM HEPES, 1mM CaCl2, 5mM MgCl2, 150mM NaCl, 0.5% BSA, pH7.2)로 현탁시킨 후, rhMCP-1(1nM)과 위령선 조추출물(5ul) 및 위령선의 사포닌-풍부 분획(5ul)을 넣고 37℃에서 1시간 반응시켰다. 반응 후 상등액 100ul를 포획 항체로 코팅된 96-웰 ELISA 플레이트에 첨가하였다. 2시간 동안 실온에서 배양한 후 플레이트를 세척하고, 바이오틴이 부착된 anti-hMCP-1 항체(1:5000 희석, 1ng/웰)를 처리하여 실온에서 다시 2시간 반응시킨 후 다시 플레이트를 세척하고 스트렙타비딘(streptavidin)-HRP(1:1000 희석, 1ug/ml)을 첨가하여 실온에서 20분간 배양하였다. 플레이트를 세척한 후 퍼옥시다제 기질 시약(100ul/웰)를 첨가하여 실온에서 30분 배양시켰다. 50ul의 중단 용액(3M H2SO4)을 첨가하여 반응을 중지시킨 후 마이크로플레이트 리더로 450nm에서 MCP-1을 측정하였다. 위령선 조추출물 및 사포닌-풍부 분획의 최종 농도를 25ug/ml로 하여 MCP-1 활성 저해 효과를 측정한 결과, 위령선 추출물을 처리하지 않은 대조군에서는 약 4.3%의 활성 저해 효과를 나타낸 반면, 위령선 조추출물을 처리한 군에서는 42.4%의 활성 저해 효과를, 위령선의 사포닌-풍부 분획을 처리한 군에서는 81.7%로서 위령선 조추출물에 비하여 약 2배 정도 강력한 활성 저해 효과를 나타내었다.The sandwich ELISA method was used to confirm the binding inhibitory activity of MCP-1 and its receptor CCR2. This is a method of confirming indirect binding inhibitory activity by measuring the amount of MCP-1 that is not bound after reacting MCP-1 with cells. MCP-1 capture antibody (capture antibody, anti-hMCP-1 antibody, diluted 1: 250 with PBS) was added to a 96-well ELISA plate and coated at 4 ° C. for 24 hours. 100 ul of blocking solution (1% BSA, 5% sucrose, 0.05% NaN 3 PBS) was added and blocked at 37 ° C. for 1 hour, followed by three washes with wash solution (PBS with 0.05% Tween-20). THP-1 cells were suspended in HEPES buffer (50 mM HEPES, 1 mM CaCl 2 , 5 mM MgCl 2 , 150 mM NaCl, 0.5% BSA, pH7.2), followed by rhMCP-1 (1 nM), gastric crude extract (5ul) and gastric gland Saponin-rich fractions (5ul) were added and reacted at 37 ° C for 1 hour. After reaction, 100 ul of supernatant was added to 96-well ELISA plates coated with capture antibody. After incubation for 2 hours at room temperature, the plate was washed, treated with biotin-attached anti-hMCP-1 antibody (1: 5000 dilution, 1 ng / well), reacted for another 2 hours at room temperature, and the plate was washed again and strep Tavidine (streptavidin) -HRP (1: 1000 dilution, 1ug / ml) was added and incubated for 20 minutes at room temperature. The plates were washed and then incubated for 30 minutes at room temperature with the addition of peroxidase substrate reagent (100ul / well). The reaction was stopped by the addition of 50ul of stop solution (3M H 2 SO 4 ) and the MCP-1 was measured at 450nm with a microplate reader. As a result of measuring the inhibitory effect of MCP-1 activity with a final concentration of 25 g / ml of gasoline crude extract and saponin-rich fractions, the control group not treated with the gastric extract showed about 4.3% of the inhibitory activity. In the group treated with 42.4% of the activity inhibitory effect, the saponin-rich fraction of the gastric liquor was 81.7%, which was about twice as strong as the crude extract.
이와 같이 위령선의 사포닌-풍부 분획은 알러지 증상의 유발과 관계가 깊은 것으로 알려진 사이토카인인 IL-1beta, TNF-alpha 및 MCP-1을 위령선의 알코올 조추출물에 비하여 더욱 강력하게 유의성 있게 억제함으로써 알러지 증상의 개선에 유용하게 사용할 수 있음이 확인되었다.As such, saponin-rich fractions of gastric glands allergic symptoms by inhibiting the cytokines IL-1beta, TNF-alpha and MCP-1, which are known to be associated with the allergic symptoms, are more strongly than alcoholic extracts of the gastric glands. It was found that it can be usefully used for improvement.
<실시예 4> 아토피성 피부염에 대한 유효성 평가-1Example 4 Evaluation of Effectiveness on Atopic Dermatitis-1
(1) 아토피성 피부염의 유전적 소인이 있는 아토피성 피부염 환자 24인을 대상으로 하여, 상기 처방예에서 제조한 크림제를 1개월 동안 통상의 화장품과 동일한 용법 용량으로 도포하도록 하였다.(1) For 24 patients with atopic dermatitis with a genetic predisposition to atopic dermatitis, the cream preparation prepared in the above-mentioned prescription example was applied for 1 month at the same dosage as a conventional cosmetic.
그 결과 24인 중 11인은 아토피성 피부염 증상이 상당히 완화되었으며, 6인은 어느 정도 완화되었고, 4인은 효과가 미미한 정도였으며, 3인은 거의 변화가 없었다. 여기에서 증상이 완화되었다는 것은 가려움증이 진정되고 피부 발적이 가라앉은 것을 의미한다. 또한 어느 경우에도 화장료에 의한 과민반응이나 부작용은 나타나지 않았다.As a result, 11 out of 24 patients had ameliorated symptoms of atopic dermatitis, 6 had some relief, 4 had minimal effect, and 3 had little change. The relief of the symptoms here means that the itching has subsided and the skin redness has subsided. In neither case, there was no hypersensitivity or side effects caused by cosmetics.
(2) 아토피성 피부염의 유전적 소인이 없는 아토피성 피부염 환자 20인을 대상으로 하여, 상기 처방예에서 제조한 크림제를 1개월 동안 통상의 화장품과 동일한 용법 용량으로 도포하도록 하였다.(2) In 20 patients with atopic dermatitis without genetic predisposition of atopic dermatitis, the cream preparation prepared in the above-mentioned prescription example was applied for 1 month at the same dosage as a conventional cosmetic.
그 결과 20인 중 11인은 아토피성 피부염이 거의 원상회복 되었으며, 6인은 상당히 완화되었고, 3인은 어느 정도 완화되었다. 여기에서 증상이 완화되었다는 것은 가려움증이 진정되고 피부 발적이 가라앉은 것을 의미한다. 또한 위와 마찬가지로 어느 경우에도 화장료에 의한 과민반응이나 부작용은 나타나지 않았다.As a result, 11 out of 20 had almost recovered from atopic dermatitis, 6 were alleviated considerably, and 3 were alleviated to some extent. The relief of the symptoms here means that the itching has subsided and the skin redness has subsided. In addition, as in the above case, there was no hypersensitivity reaction or side effects caused by cosmetics.
상기 피험자들 중 일 인의 결과를 도 1에 나타내었다. 도 1은 위령선의 사포닌-풍부 분획의 알러지 증상 개선 효과를 평가한 사진이다.The results of one of the subjects are shown in FIG. 1. 1 is a photograph evaluating the allergic symptoms improvement effect of the saponin-rich fraction of the gastrointestinal tract.
<실시예 5> 아토피성 피부염에 대한 유효성 평가-2Example 5 Evaluation of Effectiveness on Atopic Dermatitis-2
상기 처방예 1에 제시된 아토피 증상 개선용 화장료 조성물의 아토피 피부에 대한 개선 효과를 임상적으로 측정하기 위하여 본 발명의 위령선의 사포닌-풍부 분획 함유 화장료 조성물(처방예 1)과 종래 처방의 화장료 조성물(위령선 사포닌-풍부 분획을 함유하지 않은 대조용 처방)을 가지고 임상시험을 실시하였다. 즉, 6세-50세 연령 분포의 단순 아토피 피부를 가진 사람 25명과 아토피 피부 염증을 가진 사람 15명이 남녀 비율 29:11로 구성된 피험자를 대상으로 매일 2-3회, 15일간 사용하면서 가려움증 해소, 각질층 보습 및 보호막 형성(장벽회복), 표피층 신진대사 정상화, 염증 치유 등의 아토피 개선 상태를 육안으로 관찰하여 그 효과를 판정하여 하기 표 3과 같은 결과를 얻었다.In order to clinically measure the improvement effect on the atopic skin of the cosmetic composition for improving atopic symptoms presented in Formulation Example 1, the saponin-rich fraction-containing cosmetic composition (prescription example 1) of the gastric gland of the present invention and the cosmetic composition of a conventional prescription ( A clinical trial was conducted with a control regimen containing no gastric saponin-rich fractions. That is, 25 people with simple atopic skin with age distribution of 6 to 50 years old and 15 people with atopic dermatitis irritate itching 2-3 times daily for 15 days. Atopic improvements such as stratum corneum hydration and protective film formation (repair of the barrier), normalization of epidermal metabolism, healing of inflammation, etc. were visually observed and the effects thereof were determined.
이와 같이 본 발명에 의한 위령선 사포닌-풍부 분획 함유 조성물은 아토피 증상 개선 효과가 매우 우수한 것으로 판명되었다. 이러한 결과를 통해 볼 때, 본 발명의 위령선 사포닌-풍부 분획 함유 알러지 증상 개선용 조성물은 종래 처방의 화장료에 비하여 아토피 피부에 대하여 우수한 개선 효과를 가지는 것을 확인하였다.As described above, the gastric gland saponin-rich fraction-containing composition according to the present invention was found to have a very good effect of improving atopic symptoms. From these results, it was confirmed that the gastric saponin-rich fraction-containing allergy symptom improving composition of the present invention has an excellent improvement effect on atopic skin compared to the cosmetics of the conventional prescription.
<실시예 6> 천식에 대한 유효성 평가Example 6 Evaluation of Effectiveness on Asthma
7세 및 65세의 천식이 있는 남성 피험자들에게 하루에 2회, 아침과 저녁에 각각 5mg과 30mg의 본 발명의 위령선 사포닌-풍부 분획 함유 알러지 질환 개선용 조성물을 물에 고르게 분산시킨 다음 경구로 복용시킨바, 1개월 정도 복용 후에 천식으로 인한 기침 발생 횟수가 복용 전에 비하여 70% 이상 감소하는 효과를 확인하였다.Male subjects 7 and 65 years old with asthma twice daily, morning and evening, 5 mg and 30 mg of the gastrointestinal saponin-rich fraction containing allergic disease of the present invention evenly dispersed in water and then orally After taking about one month, the number of coughs caused by asthma decreased by more than 70% compared to before taking.
<실시예 7> 피부자극시험Example 7 Skin Stimulation Test
(1) 피험자 20명의 등(Back)에 처방예 1의 조성물 일정량(0.1g)을 핀 챔버(Finn chamber)와 스캔포어 테이프(Scanpore tape)을 이용하여 24시간 폐쇄첩포한 다음 제거하고 90분 후에 자극도를 전문가 2명이 ICDRG(International Contact Dermatitis Research Group) 스케일에 따라 판정하였다. 판정기준을 아래와 같으며, 결과는 다음의 표 4와 같다.(1) After a certain amount (0.1 g) of the composition of Formulation Example 1 (0.1 g) was closed on the back of 20 subjects using a Finn chamber and Scanpore tape for 24 hours, and then removed, 90 minutes after Stimulation was determined by two experts according to the International Contact Dermatitis Research Group (ICDRG) scale. Judgment criteria are as follows, and the results are shown in Table 4 below.
[판정기준][Criteria]
(-) : 자극이 전혀 없음(0점)(-): No stimulus at all (0 points)
(±) : 매우 약한 발적(1점)(±): Very weak redness (1 point)
(+) : 약한 발적(2점)(+): Mild redness (2 points)
(++) : 강한 발적(3점)(++) Strong redness (3 points)
(+++) : 매우 강한 발적 또는 부종 있음(4점)(+++): Very strong redness or edema (4 points)
상기의 결과를 살펴보면, 처방예 1과 대조용 처방의 조성물은 피부자극도에 있어서 거의 차이가 나타나지 않음으로써 본 발명의 위령선 사포닌-풍부 분획에 의한 피부자극은 거의 없는 안전한 소재임을 확인하였다.Looking at the results, it was confirmed that the composition of Formulation Example 1 and the control formulation is almost no difference in the skin irritation degree, so that the skin irritation by the saponin-rich fraction of the present invention is almost a safe material.
(2) 반복 적용시 피부 자극 정도를 알아보기 위해, ROAT(Repeated Open Application Test)를 병행하였다. 피험자 35명의 팔하부 안쪽(Forearm)에 처방예 및 대조용 조성물 일정량(0.1g)을 팔 양쪽에 각각 1개씩, 주 5회, 1일 2회씩 2주간 도포하였다. 그리고 평가 마지막날 시험 부위의 피부 자극 여부를 육안으로 판정하여 자극을 보이는 수를 계수하였다. 그 결과는 표 5와 같다.(2) To determine the degree of skin irritation during repeated application, ROAT (Repeated Open Application Test) was performed in parallel. Forearm of 35 subjects was applied with a prescribed amount (0.1 g) of prescription and control composition on each side of the arm, 5 times a week and 2 times a day for 2 weeks. And on the last day of evaluation, the skin irritation of the test site was visually determined and the number of stimuli was counted. The results are shown in Table 5.
상기 표 5의 결과를 보면 장기간 사용시에도 본 발명의 위령선 사포닌-풍부 분획 함유 조성물은 대조용 조성물에 비하여 거의 피부자극이 없는 안전한 소재임을 확인하였다.The results of Table 5 confirm that the gastric gland saponin-rich fraction-containing composition of the present invention is a safe material having almost no skin irritation compared to the control composition even after long-term use.
이와 같이, 본 발명은 아토피성 피부염, 천식 등과 같은 알러지 반응에 의하여 유발되는 다양한 병증에 대한 개선 효과가 뛰어난 조성물 및 이를 포함하는 알러지 증상 개선용 의약품, 기능성 식품 또는 화장품을 제공한다. 본 발명은 또한 부작용이 적으며, 알러지 개선 효과가 뛰어난 위령선 추출물의 제조방법을 제공한다.As such, the present invention provides a composition excellent in improving effects on various conditions caused by an allergic reaction such as atopic dermatitis, asthma and the like, and a medicine, functional food or cosmetics for improving allergic symptoms comprising the same. The present invention also provides a method for preparing a gastric extract, which has fewer side effects and is excellent in allergic effect.
Claims (6)
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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KR101397961B1 (en) * | 2012-05-22 | 2014-05-27 | 대전대학교 산학협력단 | Composition comprising the extract of complex herb an active ingredient for preventing and alleviating allergic or non-allergic skin disease and the use thereof |
KR101503588B1 (en) | 2013-03-26 | 2015-03-18 | 바이오스펙트럼 주식회사 | Composition for Improving Skin Conditions Comprising Clematis mandshurica Ruprecht Extract |
CN115671123A (en) * | 2021-07-21 | 2023-02-03 | 苏州凯祥生物科技有限公司 | Application of clematis root saponin in preparation of purine-lowering medicine |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR101397961B1 (en) * | 2012-05-22 | 2014-05-27 | 대전대학교 산학협력단 | Composition comprising the extract of complex herb an active ingredient for preventing and alleviating allergic or non-allergic skin disease and the use thereof |
KR101503588B1 (en) | 2013-03-26 | 2015-03-18 | 바이오스펙트럼 주식회사 | Composition for Improving Skin Conditions Comprising Clematis mandshurica Ruprecht Extract |
CN115671123A (en) * | 2021-07-21 | 2023-02-03 | 苏州凯祥生物科技有限公司 | Application of clematis root saponin in preparation of purine-lowering medicine |
CN115671123B (en) * | 2021-07-21 | 2024-03-22 | 苏州凯祥生物科技有限公司 | Application of clematis root saponin in preparation of purine-reducing medicament |
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