KR102140329B1 - Composition for preventing, ameliorating or treating allergic disease comprising Veronica persica extract as effective component - Google Patents
Composition for preventing, ameliorating or treating allergic disease comprising Veronica persica extract as effective component Download PDFInfo
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- KR102140329B1 KR102140329B1 KR1020180097198A KR20180097198A KR102140329B1 KR 102140329 B1 KR102140329 B1 KR 102140329B1 KR 1020180097198 A KR1020180097198 A KR 1020180097198A KR 20180097198 A KR20180097198 A KR 20180097198A KR 102140329 B1 KR102140329 B1 KR 102140329B1
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- South Korea
- Prior art keywords
- extract
- atopic dermatitis
- composition
- algae extract
- allergic
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Abstract
본 발명은 큰개불알풀 추출물을 유효성분으로 함유하는 알러지성 질환의 예방, 개선 또는 치료용 조성물에 관한 것으로, 본 발명의 큰개불알풀 추출물은 집먼지 진드기 유발 알러지성 아토피 피부염 질환 마우스에 도포 시 아토피 피부염 점수의 감소; 귀 부종 감소; 귀와 등에서의 가려움이 줄어 긁는 횟수 감소; 표피 두께, 염증 세포 수 및 비만세포 수가 감소하는 효과가 있다. 따라서 본 발명의 큰개불알풀 추출물은 알러지성 질환, 특히 아토피 피부염의 예방, 개선 또는 치료에 대한 의약품, 의약외품 또는 건강기능식품에 사용할 수 있다.The present invention relates to a composition for the prevention, improvement or treatment of allergic diseases, which contains the extract of algae extract, as an active ingredient, the extract of algae extract of the present invention is atopic dermatitis when applied to a house dust mite-induced allergic atopic dermatitis disease mouse Reduction of scores; Reduced ear edema; Reduced itching in the ears and back, reducing the number of scratches; It has the effect of reducing epidermal thickness, number of inflammatory cells and mast cells. Therefore, the large algae extract of the present invention can be used in pharmaceuticals, quasi-drugs or health functional foods for preventing, improving or treating allergic diseases, especially atopic dermatitis.
Description
본 발명은 큰개불알풀 추출물을 유효성분으로 함유하는 알러지성 질환의 예방, 개선 또는 치료용 조성물에 관한 것이다.The present invention relates to a composition for the prevention, improvement or treatment of allergic diseases, which contains a large extract of algae extract as an active ingredient.
알러지(allergy)는 면역 시스템의 오작동으로 보통 사람에게는 별 영향이 없는 물질이 어떤 사람에게는 두드러기, 가려움, 콧물 또는 기침 등의 이상 과민 반을 일으키는 것을 말하며, WHO에서는 이미 알러지 질환을 21세기에 가장 문제가 되는 제 7대 질병으로 포함하였다. 주요한 알러지 질환으로는 아토피 피부염, 천식, 비염 등이 있다. 알러지는 현재까지 뚜렷한 치료제가 없을 정도로 현대의학의 난치병에 가까운 질환이다. 현재 알러지 질환 치료에 있어서 근본적인 치료제가 아닌 항히스타민제, 효과는 우수하나 부작용이 많은 스테로이드의 사용으로 질환은 더욱 악화되고 환자의 경제적 부담은 계속 증가하고 있다. Allergy is a malfunction of the immune system, which means that substances that have little effect on the average person cause abnormal hypersensitivity reactions such as hives, itchiness, runny nose or cough in some people, and WHO is already the most problematic in the 21st century. Was included as the seventh disease. The main allergic diseases include atopic dermatitis, asthma, and rhinitis. Allergy is a disease close to incurable disease in modern medicine so far that there is no clear treatment. Antihistamines, which are not fundamental therapeutic agents in the treatment of allergic diseases, have excellent effects but use of steroids with many side effects make the disease worse and the economic burden of patients continues to increase.
대체로, 아토피 증상이나 알러지 질환은 산업의 발달, 식생활의 서구화 및 인스턴트화, 심각한 환경오염 발생, 새집증후군과 같은 신종 질병 등과 함께 동반되면서, 21세기에 접어들어 더욱 꾸준히 증가하고 있는 추세이다. 알러지 질환의 발병 추세는 국내뿐 아니라 서구 사회나, 심지어 개발이 진행되고 있는 여러 후진국에서 조차도 심각하게 발생하고 있으므로, 이들 질환 치료제는 범세계적인 시장수요를 창출할 것으로 예상된다. In general, atopic symptoms and allergic diseases have been increasing steadily in the 21st century, accompanied by industrial development, westernization and instantiation of eating habits, serious environmental pollution, and new diseases such as sick house syndrome. The trend of developing allergic diseases is not only in Korea, but also in western societies, and even in many developing countries, where development is taking place, so these treatments are expected to create global market demand.
아토피성 피부염(atopic dermatitis)은 심한 소양감(가려움증), 습진성 피부질환 및 피부 건조증 등을 동반하는 만성의 재발성 염증 피부질환으로서 1930년대 Wise & Sulzberger에 의해 처음 알려졌다. 아토피성 피부염은 대부분 유아기나 소아 때 발생하여 호전과 악화를 반복하다가 보통은 성장하면서 자연스럽게 사라지는 것이 보통이나 간혹 성인기까지 병변이 지속되기도 한다. 현재 국내 아토피성 피부염 환자는 어린이에게서 10~30%의 유병률을 보이고 있으며 성인에게서는 1~3%의 유병률을 보이고 있다. 아토피성 피부염은 환경적인 요소와 유전적인 소인이 모두 관여하는 복합적인 질환으로 알려져 있는데, 최근 아토피성 피부염의 발생률의 증가에 미치는 요인으로는 대기오염, 핵가족화, 모유 수유의 감소, 가계 수입과 교육 수준의 증가, 항생제 사용의 증가로 인한 항원에 대한 노출의 증가, 주거환경 변화, 공업 발달로 인한 새로운 항원 물질의 등장 등 여러 요인들이 복합적으로 관여하는 것으로 여겨진다. Atopic dermatitis is a chronic recurrent inflammatory skin disease that accompanies severe pruritus (itching), eczema, and dry skin, and was first known by Wise & Sulzberger in the 1930s. Atopic dermatitis usually occurs in infancy or childhood, and after repeated improvement and exacerbation, it usually disappears naturally as it grows, but sometimes lesions persist until adulthood. Currently, patients with atopic dermatitis in Korea have a prevalence of 10~30% in children and 1~3% in adults. Atopic dermatitis is known as a complex disease involving both environmental factors and genetic predisposition. Recently, factors affecting the incidence of atopic dermatitis have increased air pollution, nuclear family, reduced breastfeeding, household income and education. A number of factors are believed to be involved, including increased levels, increased exposure to antigens due to increased use of antibiotics, changes in the living environment, and the emergence of new antigenic substances due to industrial development.
큰개불알풀(Veronica persica)은 해넘이한해살이로 보통 가을에 발아하고, 밑부분에서 가지가 갈라져서 사방으로 비스듬히 자라며, 부드러운 털이 있다. 잎은 밑부분에서는 마주나고, 잎자루가 있으며, 윗부분에서는 어긋나고, 잎자루가 없으며, 부드러운 털이 있다. 꽃은 1~6월에 잎겨드랑이에서 긴 꽃자루를 내면서 청백색으로 피고 짙은 색 줄무늬가 있다. 큰개불알풀은 개불알풀 종류 가운데 가장 흔하다. 개불알풀 종류는 키가 20cm를 넘지 않는데 큰개불알풀이 그 가운데 식물체 크기가 가장 크다. 이름에 '큰' 자가 더해진 까닭인데, 일본명에서 번역된 한글명칭이다. 큰개불알풀은 서남아시아가 원산으로, 유럽에는 1800년대 초에 귀화한 것으로 알려져 있다. 종소명 페르시카(persica)는 서아시아의 페르시아를 의미한다. Veronica persica germinates in the fall as a year-old nymph, and the branches are split at the bottom to grow obliquely and have soft hairs. Leaves are opposite at the bottom, with petioles, misaligned at the top, without petioles, and with soft hairs. Flowers bloom from January to June with long peduncles on the axilla, blooming in blue-white, with dark stripes. Large firefly is the most common type of firefly. The type of dogfly is not more than 20cm tall, and the large dogfly is the largest plant size among them. This is because the'big' character is added to the name, which is the Korean name translated from the Japanese name. It is known that the large algae bloom originated from South-West Asia and naturalized in Europe in the early 1800s. The term pesca (persica) means Persia in West Asia.
큰개불알풀 관련 선행기술로는 한국공개특허 제2006-0125489호에 항염, 항알레르기 및 항천식 활성을 갖는 꼬리풀속 식물추출물을 함유하는 약학조성물이 개시되어 있고, 한국공개특허 제2011-0085657호에 베로니카 론기폴리아(Veronica longifolila L) 추출물을 유효성분으로 함유하는 피부 미백용 조성물이 개시되어 있으나, 본 발명의 큰개불알풀 추출물을 유효성분으로 함유하는 알러지성 질환의 예방, 개선 또는 치료용 조성물에 관한 것은 개시되어 있지 않다.As a prior art related to large bulging grass, Korean Patent Publication No. 2006-0125489 discloses a pharmaceutical composition containing a plant extract from the tailweed having anti-inflammatory, anti-allergic and anti-asthmatic activities, and Korean Patent Publication No. 2011-0085657. A composition for skin whitening containing Veronica longifolila L extract as an active ingredient is disclosed, but a composition for preventing, improving or treating an allergic disease containing the large algae extract of the present invention as an active ingredient Things are not disclosed.
본 발명은 상기와 같은 요구에 의해 도출된 것으로서, 본 발명은 큰개불알풀 추출물을 유효성분으로 함유하는 알러지성 질환의 예방, 개선 또는 치료용 조성물을 제공하고, 본 발명의 큰개불알풀 추출물은 집먼지 진드기 유발 알러지성 아토피 피부염 질환 마우스에 도포 시 아토피 피부염 점수의 감소; 귀 부종 감소; 귀와 등에서의 가려움이 줄어 긁는 횟수 감소; 표피 두께, 염증 세포 수 및 비만세포 수가 감소하는 효과가 있다는 것을 확인함으로써, 본 발명을 완성하였다.The present invention has been derived by the above-described needs, the present invention provides a composition for preventing, improving or treating allergic diseases containing the extract of algae extract as an active ingredient, the extract of algae extract of the present invention is house dust Decrease in atopic dermatitis score when applied to mite-induced allergic atopic dermatitis disease mice; Reduced ear edema; Reduced itching in the ears and back, reducing the number of scratches; The present invention was completed by confirming that there was an effect of reducing the epidermal thickness, the number of inflammatory cells and the number of mast cells.
상기 목적을 달성하기 위하여, 본 발명은 큰개불알풀(Veronica persica) 추출물을 유효성분으로 함유하는 알러지성 질환의 예방 또는 치료용 약학 조성물을 제공한다.In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention or treatment of allergic diseases, which contains the extract of Verona persica (Veronica persica) as an active ingredient.
또한, 본 발명은 큰개불알풀 추출물을 유효성분으로 포함하는 알러지성 질환의 예방 또는 개선용 의약외품을 제공한다.In addition, the present invention provides a quasi-drug for the prevention or improvement of allergic diseases comprising the extract of large algae extract.
또한, 본 발명은 큰개불알풀 추출물을 유효성분으로 포함하는 알러지성 질환의 예방 또는 개선용 건강기능식품 조성물을 제공한다.In addition, the present invention provides a health functional food composition for the prevention or improvement of allergic diseases comprising a large extract of algae extract as an active ingredient.
본 발명의 큰개불알풀 추출물은 집먼지 진드기 유발 알러지성 아토피 피부염 질환 마우스에 도포 시 아토피 피부염 점수의 감소; 귀 부종 감소; 귀와 등에서의 가려움이 줄어 긁는 횟수 감소; 표피 두께, 염증 세포 수 및 비만세포 수가 감소하는 효과가 있다. 따라서 본 발명의 큰개불알풀 추출물은 알러지성 질환, 특히 아토피 피부염의 예방, 개선 또는 치료에 유용하게 사용될 수 있다. A large extract of algae extract of the present invention includes a reduction in atopic dermatitis score when applied to a house dust mite-induced allergic atopic dermatitis disease mouse; Reduced ear edema; Reduced itching in the ears and back, reducing the number of scratches; It has the effect of reducing epidermal thickness, number of inflammatory cells and mast cells. Therefore, the large algae extract of the present invention can be useful for the prevention, improvement or treatment of allergic diseases, especially atopic dermatitis.
도 1은 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 피부 변화를 확인한 사진이다.
도 2는 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 일자별 아토피 피부염 점수의 변화를 확인한 결과이다. ###은 정상군(Normal)에 비해 대조군(Control)이 통계적으로 유의미하게 일자별 아토피 피부염 점수가 증가했다는 것으로, p<0.001임을 의미하고, ***은 대조군(Control)에 비해 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)이 통계적으로 유의미하게 일자별 아토피 피부염 점수가 감소했다는 것으로, p<0.001임을 의미한다.
도 3은 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 일자별 귀 두께(귀 부종)의 변화를 확인한 결과이다. ###은 정상군(Normal)에 비해 대조군(Control)이 통계적으로 유의미하게 일자별 귀 두께가 증가했다는 것으로, p<0.001임을 의미하고, *, ***은 대조군(Control)에 비해 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)이 통계적으로 유의미하게 일자별 귀 두께가 감소했다는 것으로, *는 p<0.05임을 의미하며, ***은 p<0.001임을 의미한다.
도 4는 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 일자별 긁는 횟수의 변화를 확인한 결과이다. ###은 정상군(Normal)에 비해 대조군(Control)이 통계적으로 유의미하게 일자별 긁는 횟수가 증가했다는 것으로, p<0.001임을 의미하고, **, ***은 대조군(Control)에 비해 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)이 통계적으로 유의미하게 일자별 긁는 횟수가 감소했다는 것으로, **는 p<0.01임을 의미하며, ***은 p<0.001임을 의미한다.
도 5는 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 귀(a, b) 및 등(b, d) 피부에서 표피 두께(a, c) 및 염증세포 수(b, d)를 H&E 염색으로 확인한 결과이다. ###은 정상군(Normal)에 비해 대조군(Control)이 통계적으로 유의미하게 표피 두께 또는 염증세포 수가 증가했다는 것으로, p<0.001임을 의미하고, $, $$, $$$는 대조군(Control)에 비해 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)이 통계적으로 유의미하게 표피 두께 또는 염증세포 수가 감소했다는 것으로, $는 p<0.05임을 의미하고, $$는 p<0.01임을 의미하며, $$$는 p<0.001임을 의미한다.
도 6은 알러지성 아토피 피부염 질환 동물모델에서 정상군(Normal), 대조군(Control), 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)의 귀(a) 및 등(b) 피부에서 비만세포 수를 확인한 결과이다. ###은 정상군(Normal)에 비해 대조군(Control)이 통계적으로 유의미하게 비만세포 수가 증가했다는 것으로, p<0.001임을 의미하고, $$, $$$는 대조군(Control)에 비해 큰개불알풀 추출물 투여군(VPE 1%(w/v), VPE 3%(w/v)) 및 양성대조군(Tacrolimus)이 통계적으로 유의미하게 비만세포 수가 감소했다는 것으로, $$는 p<0.01임을 의미하며, $$$는 p<0.001임을 의미한다.1 is a normal group (Normal), a control group (Control), a large algae extract group (
Figure 2 is a normal group (Normal), a control group (Control), large algae extract group (
FIG. 3 shows a normal group, a control group, a large algae extract group (
FIG. 4 is a normal group (Normal), a control group (Control), a large algae extract group (
Figure 5 in the allergic atopic dermatitis disease animal model normal group (Normal), control group (Control), large algae extract group (
FIG. 6 shows a normal group, a control group, a large algae extract administration group (
본 발명은 큰개불알풀(Veronica persica) 추출물을 유효성분으로 함유하는 알러지성 질환의 예방 또는 치료용 약학 조성물에 관한 것이다.The present invention relates to a pharmaceutical composition for the prevention or treatment of allergic diseases, which contains the extract of Veronica persica as an active ingredient.
본 발명에서 용어, '예방'은 상기 조성물의 투여에 의해 알러지성 질환을 억제하거나 발병을 지연시키는 모든 행위를 의미하며, '치료'는 상기 조성물의 투여에 의해 알러지성 질환의 증세가 호전되거나 이롭게 변경하는 모든 행위를 의미한다.In the present invention, the term'prevention' refers to all actions that inhibit or delay the onset of allergic diseases by administration of the composition, and'treatment' improves or beneficially improves the symptoms of allergic disease by administration of the composition. It means any action that changes.
상기 알러지성 질환은 아토피성 피부염(atopic dermatitis), 알러지성 피부염(allergic dermatitis), 접촉성 피부염, 두드러기, 가려움증, 곤충 알러지, 식품 알러지, 약품 알러지, 부종, 과민증(anaphylaxis), 알러지성 비염(allergic rhinitis), 천식(asthma) 및 알러지성 결막염(allergic conjunctivitis) 중에서 선택된 어느 하나인 것이 바람직하지만 이에 한정하지 않는다. The allergic diseases include atopic dermatitis, allergic dermatitis, contact dermatitis, hives, itching, insect allergies, food allergy, drug allergies, edema, anaphylaxis, allergic rhinitis rhinitis, asthma, and allergic conjunctivitis are preferably any one selected from, but are not limited to.
상기 큰개불알풀 추출물은 하기의 단계를 포함하는 방법에 의해 제조할 수 있으나, 이에 한정하지 않는다:The algae extract can be prepared by a method comprising the following steps, but is not limited to this:
(1) 큰개불알풀에 추출용매를 가하여 추출하는 단계;(1) extracting by adding an extraction solvent to the large algae extract;
(2) 단계 (1)의 추출물을 여과하는 단계; 및 (2) filtering the extract of step (1); And
(3) 단계 (2)의 여과한 추출물을 농축하고 건조하여 추출물을 제조하는 단계. (3) Concentrating and drying the filtered extract of step (2) to prepare an extract.
상기 단계 (1)에서 추출용매는 물, C1~C4의 저급 알코올 또는 이들의 혼합물 중에서 선택하는 것이 바람직하며, 더 바람직하게는 에탄올이지만 이에 한정하지 않는다. 상기 제조방법에 있어서, 추출방법은 여과법, 열수 추출, 침지 추출, 환류 냉각 추출 및 초음파 추출 등의 당 업계에 공지된 모든 통상적인 방법을 이용할 수 있다. 상기 추출용매는 큰개불알풀 중량의 1~20배 첨가하여 추출하는 것이 바람직하며, 더 바람직하게는 5~15배 첨가하는 것이고, 더욱더 바람직하게는 10배 첨가하는 것이다. 추출온도는 60~100℃인 것이 바람직하나 이에 한정하지 않는다. 또한, 추출시간은 1~48시간인 것이 바람직하며, 1~24시간이 더욱 바람직하고, 3시간이 가장 바람직하나 이에 한정하지 않는다. 상기 방법에 있어서, 단계 (3)의 농축은 진공 회전 농축기 또는 진공회전증발기를 이용하는 것이 바람직하나 이에 한정하지 않는다. 또한, 건조는 감압건조, 진공건조, 비등건조, 분무 건조 또는 동결건조하는 것이 바람직하며, 더 바람직하게는 동결건조이나 이에 한정하지 않는다.In the step (1), the extraction solvent is preferably selected from water, a lower alcohol of C 1 to C 4 or a mixture thereof, more preferably ethanol, but is not limited thereto. In the above manufacturing method, any conventional methods known in the art, such as filtration, hot water extraction, immersion extraction, reflux cooling extraction, and ultrasonic extraction, may be used as the extraction method. The extraction solvent is preferably extracted by adding 1 to 20 times the weight of large algae, more preferably 5 to 15 times, and even more preferably 10 times. The extraction temperature is preferably 60 to 100°C, but is not limited thereto. Also, the extraction time is preferably 1 to 48 hours, more preferably 1 to 24 hours, and most preferably 3 hours, but is not limited thereto. In the above method, the concentration of step (3) is preferably, but not limited to, a vacuum rotary concentrator or a vacuum rotary evaporator. In addition, drying is preferably dried under reduced pressure, vacuum drying, boiling drying, spray drying or freeze drying, and more preferably freeze drying or not.
본 발명의 약학 조성물은 약학적으로 허용 가능한 담체, 부형제 또는 희석제를 추가로 포함할 수 있다. 본 발명의 약학 조성물에 포함되는 약학적으로 허용되는 담체는 제제 시에 통상적으로 이용되는 것으로서, 식염수, 멸균수, 링거액, 완충 식염수, 덱스트로즈 용액, 말토덱스트린 용액, 글리세롤, 에탄올, 락토스, 덱스트로스, 수크로스, 솔비톨, 만니톨, 전분, 아카시아 고무, 인산 칼슘, 알기네이트, 젤라틴, 규산 칼슘, 미세결정성 셀룰로스, 폴리비닐피롤리돈, 셀룰로스, 시럽, 메틸 셀룰로스, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일 등을 포함하나, 이에 한정되는 것은 아니다. 또한, 상기 성분들 이외에 항산화제, 완충액, 정균제, 희석제, 계면활성제, 결합제, 윤활제, 습윤제, 감미제, 향미제, 유화제, 현탁제 또는 보존제 등을 추가로 포함할 수 있다. 본 발명의 약학 조성물은 경구 또는 비경구 투여할 수 있으며, 비경구 투여는 주사 또는 피부에 도포하는 방법으로 투여할 수 있는 것이다. 상기 피부에 도포하는 경우는 연고제, 첩부제 또는 분무제의 제형으로 제조된 것을 이용하는 것이 바람직하다. 본 발명의 약학 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. The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient or diluent. The pharmaceutically acceptable carrier included in the pharmaceutical composition of the present invention is commonly used in the preparation, saline, sterile water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, ethanol, lactose, and deck Strath, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, syrup, methyl cellulose, methylhydroxybenzoate, propyl Hydroxybenzoates, talc, magnesium stearate and mineral oil, but is not limited thereto. In addition, antioxidants, buffers, bacteriostatic agents, diluents, surfactants, binders, lubricants, wetting agents, sweeteners, flavoring agents, emulsifiers, suspending agents or preservatives may be further included in addition to the above components. The pharmaceutical composition of the present invention may be administered orally or parenterally, and parenteral administration may be administered by injection or application to the skin. When applied to the skin, it is preferable to use those prepared in the form of ointments, patches or sprays. Suitable dosages of the pharmaceutical compositions of the invention may be variously prescribed by factors such as formulation method, mode of administration, patient's age, weight, sex, morbidity, food, time of administration, route of administration, rate of excretion and response sensitivity. Can.
또한, 본 발명은 큰개불알풀 추출물을 유효성분으로 포함하는 알러지성 질환의 예방 또는 개선용 의약외품에 관한 것이다.In addition, the present invention relates to a quasi-drug for the prevention or improvement of allergic diseases comprising the extract of algae extract.
본 발명에서 용어, '의약외품'은 사람이나 동물의 질병을 치료, 경감, 처치 또는 예방할 목적을 사용되는 섬유, 고무제품 또는 이와 유사한 것, 인체에 대한 작용이 약하거나 인체에 직접 작용하지 아니하며, 기구 또는 기계가 아닌 것과 이와 유사한 것, 감염형 예방을 위하여 살균, 살충 및 이와 유사한 용도로 사용되는 제제 중 하나에 해당하는 물품으로서, 사람이나 동물의 질병을 진단, 치료, 경감, 처치 또는 예방할 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것 및 사람이나 동물의 구조와 기능에 약리학적 영향을 줄 목적으로 사용하는 물품 중 기구, 기계 또는 장치가 아닌 것을 제외한 물품을 의미한다. 또한 상기 의약외품은 피부외용제 및 개인 위생용품을 포함한다.In the present invention, the term 'quasi-drug' refers to a fiber, rubber product or the like used for the purpose of treating, reducing, treating or preventing a disease of a person or animal, has a weak effect on the human body or does not act directly on the human body, Or non-mechanical and similar products, one of the agents used for sterilization, pesticide and similar purposes for the prevention of infection, for the purpose of diagnosing, treating, reducing, treating or preventing human or animal diseases Means of items that are not used as devices, machines or devices, and those used for purposes of pharmacologically affecting the structure and function of a person or animal, except those that are not devices, machinery or devices. In addition, the quasi-drug includes external skin preparations and personal hygiene products.
본 발명의 큰개불알풀 추출물을 의약외품 첨가물로 사용할 경우, 상기 추출물을 그대로 첨가하거나 다른 의약외품 또는 의약외품 성분과 함께 사용할 수 있고, 통상적인 방법에 따라 적절하게 사용할 수 있다. 유효성분의 혼합량은 사용 목적에 따라 적합하게 결정될 수 있다. 상기 피부외용제는 특별히 이에 제한되지 않으나, 바람직하게는 연고제, 로션제, 스프레이제, 패취제, 크림제, 산제, 현탁제, 겔제 또는 젤의 형태로 제조되어 사용될 수 있다. 상기 개인위생용품에는 특별히 이에 제한되지 않으나, 바람직하게는 비누, 화장품, 물티슈, 휴지, 샴푸, 피부 크림, 얼굴 크림, 치약, 립스틱, 향수, 메이크업, 파운데이션, 볼터치, 마스카라, 아이섀도우, 선스크린 로션, 모발 손질 제품, 에어프레쉬너 겔 또는 세정겔일 수 있다. 또한, 본 발명의 의약외품 조성물의 또 다른 예로 소독청결제, 샤워폼, 가그린, 물티슈, 세제비누, 핸드워시, 가습기 충진제, 마스크, 연고제 또는 필터 충진제가 있다.When the extract of large algae extract of the present invention is used as a quasi-drug additive, the extract may be added as it is or used with other quasi-drug or quasi-drug components, and may be suitably used according to a conventional method. The mixing amount of the active ingredient can be appropriately determined according to the purpose of use. The external preparation for skin is not particularly limited thereto, but may be preferably used in the form of an ointment, lotion, spray, patch, cream, powder, suspension, gel, or gel. The personal hygiene products are not particularly limited, but preferably soap, cosmetics, wipes, tissues, shampoo, skin cream, face cream, toothpaste, lipstick, perfume, makeup, foundation, ball touch, mascara, eye shadow, sunscreen It can be a lotion, a hair care product, an air freshener gel or a cleaning gel. In addition, another example of the quasi-drug composition of the present invention is a disinfectant cleaner, shower foam, gagreen, wipes, detergent soap, hand wash, humidifier filler, mask, ointment or filter filler.
또한, 본 발명은 큰개불알풀 추출물을 유효성분으로 포함하는 알러지성 질환의 예방 또는 개선용 건강기능식품 조성물에 관한 것이다.In addition, the present invention relates to a health functional food composition for the prevention or improvement of allergic diseases comprising a large extract of algae extract as an active ingredient.
상기 조성물은 분말, 과립, 환, 정제, 캡슐, 캔디, 시럽 및 음료 중에서 선택된 어느 하나의 제형으로 제조되는 것이 바람직하지만, 이에 한정하지 않는다.The composition is preferably prepared in any one formulation selected from powders, granules, pills, tablets, capsules, candy, syrups and beverages, but is not limited thereto.
본 발명의 건강기능식품 조성물은 큰개불알풀 추출물을 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 혼합하여 제조될 수 있고, 통상적인 방법에 따라 적절하게 제조될 수 있다. 상기 큰개불알풀 추출물을 첨가할 수 있는 식품의 예로는 카라멜, 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 수프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 중에서 선택된 어느 하나의 형태일 수 있으며, 통상적인 의미에서의 건강기능식품을 모두 포함한다. 즉, 상기 식품의 종류에는 특별한 제한은 없다. 상기 건강기능식품 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 및 천연 풍미제, 착색제 및 증진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 또한, 천연 과일 주스 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 상기의 성분은 독립적으로 또는 조합하여 사용할 수 있다. 또한, 본 발명의 건강기능식품 조성물은 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있으며, 상기 천연 탄수화물은 포도당, 과당과 같은 단당류, 말토스, 슈크로스와 같은 이당류, 덱스트린, 사이클로덱스트린과 같은 다당류, 자일리톨, 소르비톨, 에리트리톨 등의 당알코올이다. 상기 천연 탄수화물의 비율은 크게 중요하지 않지만, 본 발명의 조성물 100g에 대하여, 0.01~0.04g인 것이 바람직하고, 더욱 바람직하게는 0.02~0.03g을 포함하는 것이지만 이에 한정하지 않는다. 감미제로서는 타우마틴, 스테비아 추출물과 같은 천연 감미제나, 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다.
The health functional food composition of the present invention may be prepared by adding the extract of algae extract as it is or mixing it with other foods or food ingredients, and may be appropriately prepared according to a conventional method. Examples of foods that can be added to the extract of algae extract include caramel, meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages , Tea, drink, alcoholic beverages and vitamin complexes, and may be in any one form, and includes all of the health functional foods in the ordinary sense. That is, there is no particular limitation on the type of food. The dietary supplement composition includes various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners , pH adjusting agents, stabilizers, preservatives, glycerin, alcohol, carbonic acid used in carbonated beverages, and the like. It may also contain flesh for the production of natural fruit juices and vegetable drinks. The above components can be used independently or in combination. In addition, the health functional food composition of the present invention may contain various flavors or natural carbohydrates as additional ingredients, and the natural carbohydrates include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, dextrin, and cyclo Polysaccharides such as dextrin, sugar alcohols such as xylitol, sorbitol, and erythritol. The ratio of the natural carbohydrate is not critical, but for 100 g of the composition of the present invention, it is preferably 0.01 to 0.04 g, and more preferably 0.02 to 0.03 g, but is not limited thereto. As the sweetener, natural sweeteners such as taumatin and stevia extract, synthetic sweeteners such as saccharin and aspartame can be used.
이하, 실시예를 이용하여 본 발명을 더욱 상세하게 설명하고자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로 본 발명의 범위가 이들에 의해 제한되지 않는다는 것은 당해 기술분야에서 통상의 지식을 가진 자에게 있어 자명한 것이다.
Hereinafter, the present invention will be described in more detail using examples. It is obvious to those skilled in the art that these examples are only intended to illustrate the present invention in more detail and that the scope of the present invention is not limited by them.
실시예Example 1. One. 큰개불알풀Big dog 추출물의 제조 Preparation of extract
큰개불알풀 건조 중량의 10배에 해당하는 70%(v/v) 에탄올 수용액에 큰개불알풀을 침지하여 잘 교반한 다음, 열을 가해 2시간 동안 2회 환류 추출하고 여과지를 이용하여 여과하였다. 상기 추출액을 50~55℃에서 농축기를 사용하여 감압 농축한 후, 동결 건조시켜 큰개불알풀 추출물을 수득하였다.
After immersing the large algae in a 70% (v/v) ethanol aqueous solution corresponding to 10 times the dry mass of the large algae, the mixture was stirred well, then heated to reflux twice for 2 hours and filtered using filter paper. The extract was concentrated under reduced pressure using a concentrator at 50-55° C., and then freeze-dried to obtain a large algae extract.
실시예 2. 알러지성 아토피 피부염 유발 동물모델을 이용한 아토피 피부염의 효과 확인 실험Example 2. Experiment for confirming the effect of atopic dermatitis using an animal model causing allergic atopic dermatitis
(1) 알러지성 아토피 피부염 동물모델(1) Animal model of allergic atopic dermatitis
알러지성 아토피 피부염은 8주령 NC/Nga 마우스의 피부에 알러지성 아토피 유발 항원인 천연 집먼지 진드기 유래 성분 연고(AD Biostir, 일본) 100mg을 21일 동안 3~4일 간격으로 6회 도포하여 유발하였다. 실험시작일에 4% SDS 150㎕를 도포하고 1시간 방치한 후 집먼지 진드기 항원 100mg을 등과 양쪽 귀에 각각 적용하였다.
Allergic atopic dermatitis was caused by applying 100 mg of a natural house dust mite-derived component ointment (AD Biostir, Japan), which is an allergic atopy-inducing antigen, to the skin of an 8-week-old NC/Nga mouse 6 times at 3-4 day intervals for 21 days. On the day of the experiment, 150 μl of 4% SDS was applied and left for 1 hour, and then 100 mg of house dust mite antigen was applied to the back and ears, respectively.
(2) (2) 알러지성Allergic 아토피 피부염 동물에서 피부염 억제 측정 Measurement of dermatitis inhibition in atopic dermatitis animals
알러지성 피부염 마우스에서 피부손상 정도를 주 2회 평가하였다. 홍반/출혈(erythema/hemorrhage), 부종(edema), 찰과상/미란(excoriation/erosion), 반흔/건조(scarring/dryness)의 항목으로 나누어 총 3단계(0;none, 1;mild, 2;moderate, 3;severe)[종합적 피부염 점수(0-12점)]로 공지의 방법으로 평가하였다.The degree of skin damage was evaluated twice a week in allergic dermatitis mice. Erythema/hemorrhage, edema, excoriation/erosion, scarring/dryness, and total 3 steps (0;none, 1;mild, 2;moderate) , 3;severe) (total dermatitis score (0-12 points)).
그 결과, 도 1에 개시한 바와 같이 알러지성 피부염이 유발된 마우스의 피부 상태가 본 발명의 큰개불알풀 추출물을 처리한 경우 매우 호전된 것을 확인하였고, 본 발명의 큰개불알풀 추출물 처리군은 상기 항목에 따른 아토피 피부염 점수가 시간이 지날수록 낮아지는 것을 확인하였다(도 2).
As a result, as shown in FIG. 1, it was confirmed that the skin condition of the mouse inducing allergic dermatitis was greatly improved when the large algae extract of the present invention was treated, and the large algae extract treatment group of the present invention was It was confirmed that the atopic dermatitis score according to the item was lowered with time (FIG. 2).
(3) (3) 알러지성Allergic 아토피 피부염 동물에서 Atopic dermatitis in animals 귀부종Edema 변화 측정 Change measurement
알러지 피부염 마우스에서 각 귀의 두께를 Digital caliper(DC150-2, CAS Disital caliper)로 주 2회 측정하여 알러지성 귀 부종 변화를 평가하였다. In allergic dermatitis mice, the thickness of each ear was measured twice a week with a digital caliper (DC150-2, CAS Disital caliper) to evaluate changes in allergic ear edema.
모든 측정 결과는 평균(mean)과 표준편차(standard deviation; SD)로 나타내었으며, 실험군 간의 차이는 Student's t-test를 사용하여 통계학적 분석을 수행하였으며, p < 0.05 값인 경우에 통계적으로 유의성이 있는 것으로 판정하였다. 도 3에 개시한 바와 같이, 아토피 피부염의 유발에 따른 귀부종이 증가하였으나, 본 발명의 큰개불알풀 추출물 투여군은 통계적으로 유의미하게 귀부종이 가라앉은 것을 확인하였다.
All measurement results were expressed as mean and standard deviation (SD). The difference between the experimental groups was statistically analyzed using Student's t-test and statistically significant when p <0.05. It was judged to be. As disclosed in FIG. 3, ear edema increased due to the induction of atopic dermatitis, but the group administered with the extract of algae extract of the present invention statistically significantly confirmed that the ear edema subsided.
(4) (4) 알러지성Allergic 아토피 피부염 동물에서 가려움 횟수 측정 Measuring the number of itching in animals with atopic dermatitis
알러지 피부염 마우스에서 20분 동안 주 2회 측정하여 귀와 등의 가려움 횟수를 평가하였다. 모든 측정 결과는 평균(mean)과 표준편차(standard deviation; SD)로 나타내었으며, 실험군 간의 차이는 Student's t-test를 사용하여 통계학적 분석을 수행하였으며, p < 0.05 값인 경우에 통계적으로 유의성이 있는 것으로 판정하였다.It was measured twice a week for 20 minutes in allergic dermatitis mice to evaluate the number of itching of the ears and back. All measurement results were expressed as mean and standard deviation (SD). The difference between the experimental groups was statistically analyzed using Student's t-test and statistically significant when p <0.05. It was judged to be.
본 발명의 큰개불알풀 추출물 투여군은 통계적으로 유의미하게 긁는 횟수가 대조군에 비해 감소하였다(도 4).
In the group administered with the extract of algae extract of the present invention, the number of scratches was statistically significantly reduced compared to the control group (FIG. 4 ).
(5) (5) 알러지성Allergic 아토피 피부염 동물에서 염증세포 침윤 및 피부장벽 손상 측정 Measurement of inflammatory cell infiltration and skin barrier damage in atopic dermatitis animals
알러지 피부염 마우스의 귀와 등 피부 조직을 적출하여 H&E(hematoxylin and eosin) 염색 후, 이미지측정프로그램(iSolution FL ver 9.1)을 이용하여 염증세포 침윤 정도 및 표피 두께 변화를 측정하였다. 모든 측정 결과는 평균(mean)과 표준편차(standard deviation; SD)로 나타내었으며, 실험군 간의 차이는 one-way ANOVA를 사용하여 통계학적 분석을 수행하였으며, p < 0.05 값인 경우에 통계적으로 유의성이 있는 것으로 판정하였다. After allergic dermatitis mouse ear and back skin tissues were extracted and stained with H&E (hematoxylin and eosin), the degree of inflammatory cell infiltration and epidermal thickness change were measured using an image measurement program ( i Solution FL ver 9.1). All measurement results were expressed as mean and standard deviation (SD), and the difference between the experimental groups was statistically analyzed using one-way ANOVA and statistically significant when p <0.05. It was judged to be.
그 결과, 도 5에 개시한 바와 같이, 아토피 피부염의 유발에 따라 귀 및 등의 표피 두께가 증가하였고, 염증세포 수가 증가하였으나, 본 발명의 큰개불알풀 추출물 투여군은 통계적으로 유의미하게 귀 및 등의 표피 두께가 감소하였고, 염증세포 수가 감소한 것을 확인하였다.
As a result, as shown in Figure 5, the epidermal thickness of the ear and back increased with the induction of atopic dermatitis, and the number of inflammatory cells increased, but the group administered with the extract of the large antler extract of the present invention was statistically significant in the ears and back It was confirmed that the epidermal thickness decreased and the number of inflammatory cells decreased.
(6) (6) 알러지성Allergic 아토피 피부염 동물에서 비만세포(mast cell)의 개수 확인 Confirmation of the number of mast cells in atopic dermatitis animals
알러지 피부염 마우스의 귀와 등 피부 조직을 적출하여 TB(Toluidine Blue) 염색 후, 이미지측정프로그램(iSolution FL ver 9.1)을 이용하여 비만 세포 수의 변화를 측정하였다. 모든 측정 결과는 평균(mean)과 표준편차(standard deviation; SD)로 나타내었으며, 실험군 간의 차이는 one-way ANOVA를 사용하여 통계학적 분석을 수행하였으며, p < 0.05 값인 경우에 통계적으로 유의성이 있는 것으로 판정하였다. After allergic dermatitis mouse ear and back skin tissues were extracted and stained with TB (Toluidine Blue), the change in mast cell number was measured using an image measurement program ( i Solution FL ver 9.1). All measurement results were expressed as mean and standard deviation (SD), and the difference between the experimental groups was statistically analyzed using one-way ANOVA and statistically significant when p <0.05. It was judged to be.
그 결과, 도 6에 개시한 바와 같이, 아토피 피부염의 유발에 의해 비만세포 수가 증가하였으나, 본 발명의 큰개불알풀 추출물 투여군은 통계적으로 유의미하게 비만세포 수가 감소한 것을 확인하였다.As a result, as shown in FIG. 6, the number of mast cells increased due to the induction of atopic dermatitis, but it was confirmed that the number of mast cells statistically significantly decreased in the administration group of the large algae extract of the present invention.
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