KR20090074295A - Composition for preventing and/or treating dermatitis or increasing immunity comprising natural plants extract - Google Patents
Composition for preventing and/or treating dermatitis or increasing immunity comprising natural plants extract Download PDFInfo
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- KR20090074295A KR20090074295A KR1020080000025A KR20080000025A KR20090074295A KR 20090074295 A KR20090074295 A KR 20090074295A KR 1020080000025 A KR1020080000025 A KR 1020080000025A KR 20080000025 A KR20080000025 A KR 20080000025A KR 20090074295 A KR20090074295 A KR 20090074295A
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- skin
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- skin diseases
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Abstract
Description
본 발명은 아토피성 피부질환을 포함하는 알레르기성 피부질환 및 건선, 습진 여드름을 포함하는 염증성 피부질환을 예방 및 치료하고, 면역력을 증강시키는 생약 조성물에 관한 것으로서, 보다 상세하게는 유효성분으로서 백출 및 지실을 포함하는 지출환 및 그 가감방을 함유하는, 아토피성 피부질환을 포함하는 알레르기성 피부질환 및 건선, 습진 여드름을 포함하는 염증성 피부질환의 예방 또는 치료용, 또는 면역증강용 약학적 조성물 및 건강기능식품, 및 그 제조방법에 관한 것이다. The present invention relates to a herbal composition which prevents and treats allergic skin diseases including atopic skin diseases and inflammatory skin diseases including psoriasis and eczema acne, and enhances immunity. A pharmaceutical composition for the prevention or treatment of allergic skin diseases including atopic dermatitis and psoriasis, eczema acne, or inflammatory skin diseases including esophageal acne, which contains vesicles containing the fruit and the sub-galo It relates to a health functional food, and a manufacturing method thereof.
인체의 피부는 물리적, 화학적으로 외계로부터 신체를 보호하는 동시에 전신의 대사에 필요한 생화학적 기능을 영위하는 생명유지에 필수 불가결한 기관이다. 비교적 흔한 피부질환에는 아토피 피부염, 접촉피부염, 지루성 피부염, 두드러기, 무좀, 완선, 건선, 단순포진/대상포진, 피부건조증, 주부습진, 여드름 등이 있다. The skin of the human body is an indispensable organ for the maintenance of life, which physically and chemically protects the body from extraterrestrial and performs the biochemical functions necessary for metabolism of the whole body. Relatively common skin diseases include atopic dermatitis, contact dermatitis, seborrheic dermatitis, urticaria, athlete's foot, psoriasis, psoriasis, herpes simplex / shingles, dry skin, housewives and acne.
현재 피부 트러블 및 피부질환을 가진 환자의 수가 계속적으로 증가하는 추세이다. 미국 등 선진국의 경우 전 인구의 10% 정도가 피부질환으로 고통받고 있고, 우리나라의 경우도 그와 비슷한 형편이다. Currently, the number of patients with skin problems and skin diseases continues to increase. In developed countries such as the United States, about 10% of the population suffers from skin diseases, and in Korea, the situation is similar.
이러한 피부질환의 외인으로는 외계로부터 직접 피부에 작용하는 마찰, 압박, 타박 등의 기계적 자극을 비롯하여, 동물성, 식물성 및 광물성의 독물, 그 밖에 약품, 방사선, 온열, 한랭, 또는 세균, 사상균, 원충, 바이러스 등의 미생물이나 피부기생동물 등을 들 수 있으며, 내인으로는 위장장애, 간장병, 신 장병, 물질대사장애, 혈액질환, 내장종양, 내분비장애 등을 들 수 있다. 또한, 유전성 피부질환 및 모반, 모반증 등은 그 원인이 유전자에 의한 것이므로 내인성 피부병에 포함된다.The external causes of such skin diseases include mechanical stimuli such as friction, compression, and bruise, which act directly on the skin from the outside world, as well as animal, vegetable and mineral poisons, other medicines, radiation, heat, cold, or bacteria, filamentous fungi, protozoa , Microorganisms such as viruses and skin parasitic animals, etc., and endogenous diseases include gastrointestinal disorders, liver disease, kidney disease, metabolic disorders, blood diseases, visceral tumors, endocrine disorders. In addition, hereditary skin diseases, birthmarks, birthmarks and the like are included in endogenous skin diseases because the cause is caused by a gene.
피부질환 중, 특히 아토피 피부염은 아토피 알레르기를 가진 사람에서 나타나는 대표적인 피부질환으로서, 흔히 태열이라 불리는 만성피부질환의 하나이며 심한 소양감을 동반하는 재발성 만성 피부염이다. 최근 수십년 동안 환경오염 등에 의한 공기 매개성 알레르기 유발물질(allergen)의 증가와 건조성 피부를 형성시키는 조건의 증가 등으로 인하여 아토피 피부염에 대한 유병율이 계속 상승하고 있으며, 세계 전 인구의 10 내지 20%가 이 피부염으로 고통받고 있는 것으로 알려져 있다. 주증상은 가려움증 및 피부건조증이고, 면역학적 특성을 보여 다른 알레르기 질환인 두드러기, 천식, 알레르기성 비염, 알레르기성 결막염 등을 동반하는 경우도 있다.Among skin diseases, in particular, atopic dermatitis is a representative skin disease that occurs in people with atopic allergies, and is one of chronic skin diseases commonly referred to as febrile fever and recurrent chronic dermatitis with severe pruritus. In recent decades, the prevalence of atopic dermatitis continues to increase due to the increase in airborne allergens due to environmental pollution and the increase in conditions for forming dry skin. It is known that% suffer from this dermatitis. The main symptoms are itching and dry skin, and the immunological characteristics may be accompanied by other allergic diseases such as urticaria, asthma, allergic rhinitis and allergic conjunctivitis.
아토피 피부염은 알레르기 반응으로 인한 질환으로 이러한 알레르기 반응은 초기의 특이적 면역반응과 후기의 염증반응으로 나뉜다. 전기 알레르기 반응은 거의 대부분 비만세포를 매개로 일어나며, 세포막에 존재하는 고친화성의 IgE 수용체(FcεRI)를 통해서 활성화된다. IgE 수용체에 결합되어 있는 IgE 항체가 항원에 의하여 가교(bridge)를 형성하면 포스포리파아제 C (phospholipase C), 단백질 인산화효소 C, 칼슘 이온의 작용을 거쳐서 과립에 저장되어 있던 히스타민(histamine), 콘드로이틴(chondroitin) 황산염, 헤파린(heparin), 단백질 분해효소 등이 유리되며, 이들이 반응 초기 단계를 매개한다. 히스타민을 포함하 는 전기 화학 전달물질들은 알레르기 반응의 초기에 볼 수 있는 여러 가지 임상증상을 유발하는 원인물질들이며, 가장 많은 양을 차지하는 것은 히스타민이다. 따라서, 알레르기 반응에서는 히스타민에 의한 작용이 주요하며, 그 증상으로는 혈관 확장, 부종 등이 있다. 프로스타글란딘 (prostaglandin), 혈소판 활성인자(platelet-activating factor) 등도 알레르기 반응에서 주목받고 있는 화학 전달물질들이며, 화학 전달물질의 작용으로 인하여 나타나는 증상으로는 담마진, 소양증, 피부발적 등의 피부증상이 있다. Atopic dermatitis is a disease caused by an allergic reaction. The allergic reaction is divided into early specific immune response and late inflammatory response. Almost allergic reactions occur through mast cells and are activated through high-affinity IgE receptors (FcεRI) on the cell membrane. When the IgE antibody bound to the IgE receptor forms a bridge by the antigen, histamine and chondroitin stored in the granules through the action of phospholipase C, protein kinase C and calcium ions (chondroitin) sulfate, heparin, protease, and the like are released, which mediate the early stages of the reaction. Electrochemical carriers, including histamine, are the causative agents of various clinical symptoms seen early in the allergic reaction, with the largest amount being histamine. Therefore, in the allergic reaction, the action by histamine is the main, and the symptoms include vasodilation and edema. Prostaglandin, platelet-activating factor, and the like are also known as chemical transporters in allergic reactions, and the symptoms that occur due to the action of chemical transporters include skin symptoms such as dimples, pruritus, and skin redness.
또한 세포의 노화는 생리적 자연현상으로 인해 피부를 구성하고 있는 기본 단위인 피부 세포의 분열이 정상적으로 이루어지지 않고 재생되는 기간이 점점 길어지게 되며, 그 결과 피부는 탄력을 잃고, 노화 각질이 쌓이고 건조해지면서 주름이 생기기 시작한다. 현재, 노화로 인한 피부를 회복시키기 위해 수술이나 연고 및 비타민 C 요법 등을 사용하고 있지만 우리의 오랜 숙원인 팽팽하고 탄력 있는 피부를 유지하기는 역부족이다. In addition, the aging of the cells due to physiological natural phenomena, the period of regeneration of the skin cells, which are the basic units constituting the skin, are not normal, and the regeneration period becomes longer, and as a result, the skin loses its elasticity, the aging keratin accumulates and dries. Wrinkles begin to form. Currently, surgery, ointment, and vitamin C therapy are used to restore the skin caused by aging, but it is not enough to maintain the long and tender skin.
몇 년 전부터 천연물을 이용한 피부 노화 방지 및 피부 개선제 등이 개발되고 있다. 하지만 그 가운데는 남성호르몬인 안드로겐(androgen) 억제작용 및 그에 따른 피지분비증가 억제작용에 대한 피부 개선제로서의 기능 등을 가진 경우도 있으나 피부 질환에 대한 치료제로서의 실질적인 효과를 제공하지는 못하고 있는 실정이다. 최근에는 메디칼 스킨 케어(medical skin care)라 해서, 의학적 치료와 스킨 케어가 접목된 피부 치료방법이 우리나라뿐만 아니라 미국, 유럽, 일본 등지에서도 피부 치료를 위해 개발되고 있으나, 알레르기 피부질환 등에 효과를 보 이기도 하지만 여드름이나 기미, 주근깨 등을 개선시킬 뿐 여전히 많은 피부질환은 극복되지 않은 채 삶의 질을 저하시키는 중요한 원인이 되고 있다. Since several years, anti-aging and skin improvement agents using natural products have been developed. However, some of them have a function as a skin improver against androgen (androgen) inhibitory effect and sebum secretion increase inhibitory effect, but does not provide a practical effect as a treatment for skin diseases. Recently, medical skin care (medical skin care) combined with medical treatment and skin care method has been developed for the skin treatment not only in Korea, but also in the United States, Europe, Japan, etc., but it is effective in allergic skin diseases. It also improves acne, blemishes, and freckles. Still, many skin diseases have not been overcome and are a major cause of deterioration in quality of life.
한편, 면역세포에서 분비되는 인터페론-감마는 단구와 대식세포에서 항원 특이적, 비특이적 면역반응을 통하여 면역조절능을 증가시키는 중요한 역할을 한다. 인터페론 감마 분비가 감소되면 IgE 생성의 증가 혹은 항원제거 능력의 감소로 아토피 증상이 심해진다. 또한 인터페론 감마는 T 림프구에 작용하여 이들의 분화 및 성숙을 증진시킨다. 또한 CD4 T 림프구에서 Th1 림프구의 분화를 촉진시키며, Th2 림프구의 증식을 억제한다. 이러한 효과는 IL-1를 분비하도록 단핵식균세포를 활성화시키고, T 림프구가 기능적인 IL-12 수용체를 발현하도록 활성화시킴으로써 매개된다. Meanwhile, interferon-gamma secreted by immune cells plays an important role in increasing immunomodulatory capacity through antigen-specific and nonspecific immune responses in monocytes and macrophages. Decreased interferon gamma secretion aggravates atopic symptoms due to increased IgE production or reduced antigenic ability. Interferon gamma also acts on T lymphocytes to enhance their differentiation and maturation. It also promotes the differentiation of Th1 lymphocytes in CD4 T lymphocytes and inhibits the proliferation of Th2 lymphocytes. This effect is mediated by activating monocytes to secrete IL-1 and activating T lymphocytes to express functional IL-12 receptors.
아토피 피부염, 염증성 피부염 등을 포함하는 피부질환의 치료에는 보통 스테로이드제가 널리 사용되고 있으나, 스테로이드제는 면역기능 저하, 피부의 박화나 위축, 홍조 등의 다양한 부작용을 발현할 수 있고, 장기 연용시에는 스테로이드성 여드름, 스테로이드성 피부(피부위축, 모세혈관 확장, 자반), 스테로이드성 주사, 입주위 피부염, 다모, 색소탈실, 선조, 수포성 피부염, 피부출혈 등이 나타날 수 있으며, 원인은 그대로 둔 채 투여된다는 점이 문제이고, 약물에 대한 의존성이 생길 수 있는 것으로 알려져 있다. Steroids are widely used in the treatment of skin diseases including atopic dermatitis and inflammatory dermatitis. However, steroids can cause various side effects such as decreased immune function, thinning or atrophy of the skin, and flushing. Sexual acne, steroid skin (skin atrophy, capillary expansion, purpura), steroid injections, perioral dermatitis, hair growth, pigment loss, ancestors, bullous dermatitis, skin bleeding, etc. This is a problem, and it is known that dependence on drugs may occur.
스테로이드제 이외에도 현재 항염증 또는 피부질환 치료효과 등이 알려진 생약들의 유효성분을 추출하여 피부질환 치료제로 개발된 예들이 알려져 있으나, 대부분 가려움증이나 염증 등을 경감시켜 줄 뿐이어서 그 치료효과가 미미한 문제점이 있어 실제로는 그 적용에 한계가 있는 실정이다.In addition to steroids, there are known examples of the development of anti-inflammatory or skin disease active ingredients, which are known to be used to treat skin diseases. However, most of them only reduce the itch and inflammation. In reality, there is a limit to its application.
이처럼, 아직까지 부작용이 적으면서도 우수한 효과를 발휘하는 예방 또는 치료목적의 한방제제는 개발되지 않아 심각한 부작용을 나타내는 스테로이드 제제가 대부분 사용되고 있다. 또한, 최근에는 면역억제제가 피부질환 치료제로 개발되어 사용되기도 하였는데, 이런 제제는 면역기능 저하, 피부위축, 어린이 성장방해, 모세혈관 확장, 여드름, 부신피질기능 억제 등의 부작용이 수반되기 때문에 임상적 사용에 매우 주의해야 하는 문제점이 있다. As such, herbal medicines for prevention or treatment purposes, which have yet to be used with low side effects and excellent effects, have not been developed, and most steroid preparations showing serious side effects have been used. In recent years, immunosuppressants have been developed and used as treatments for skin diseases. These preparations are clinically used due to side effects such as decreased immune function, skin atrophy, growth inhibition of children, capillary expansion, acne, and adrenal cortex. There is a problem that requires very careful use.
따라서 인체 내 인터페론 감마 생성에 의한 면역기능 향상에 의한 젊은 피부를 유지 할 수 있고, 히스타민 생성 조절에 의한 알레르기와 같은 피부질환을 근본적으로 개선시킬 수 있는 제품의 개발이 절실히 요구되고 있다.Therefore, there is an urgent need for the development of products that can maintain young skin by improving immune function by the production of interferon gamma in the human body and fundamentally improve skin diseases such as allergies by regulating histamine production.
이에 본 발명자는 종래의 피부질환 치료제가 갖는 면역기능 저하, 신기능 저하, 호르몬 분비 이상 등의 부작용을 최소화하면서, 알레르기성, 염증성 피부질환의 예방 및 치료효과를 갖고 면역증강효능이 있는 조성물 개발을 위하여 지속적인 연구를 수행하였으며, 그 결과, 비를 다스리고 음식을 소화하고, 위를 강하게 하는 효능이 있으며, 식상, 담체 등에 널리 쓰이는 한방 처방인 지출환이 아토피 피부염을 포함하는 알레르기성 피부질환 및 기타 염증성 피부질환 개선효과 및 면역증강 효과가 있음을 확인하고 본 발명을 완성하게 되었다.Therefore, the present inventors have the effects of preventing and treating allergic and inflammatory skin diseases while minimizing side effects such as decreased immune function, renal function, abnormal hormone secretion, etc., which have conventional skin disease treatment agents, and to develop a composition having an immune enhancing effect. Continuous research has been conducted, and as a result, it is effective in controlling rain, digesting food, and strengthening the stomach, and allergic skin diseases including atopic dermatitis, and other inflammatory skin diseases, which are widely used in diet, carrier, etc. It was confirmed that there is an improvement effect and an immune enhancing effect and completed the present invention.
본 발명은 단순한 피부개선이나 일시적 치료가 아닌 피부질환의 근본 원인을 치료하는 지출환 및 그 가감방의 신규한 용도를 제공하는 것을 목적으로 하며, 본 발명에 따른 조성물은 알레르기 반응의 억제, 염증의 완화 및 면역력 향상을 통해 알레르기성 및 염증성 피부질환의 예방 및 치료효과를 나타내고 또한 면역증강효능을 갖는다. The present invention aims to provide a novel use of Nasuhwan and its additives to treat the root cause of skin diseases, not just skin improvement or temporary treatment, and the composition according to the present invention suppresses allergic reactions and alleviates inflammation. And through the improvement of immunity, it shows the prevention and treatment effect of allergic and inflammatory skin diseases and also has an immune enhancing effect.
본 발명은 유효성분으로 백출과 지실을 주된 약효 물질로 하는 지출환과 그 가감방의 아토피성 피부질환을 포함하는 알레르기성 피부질환 및 염증성 피부질환의 예방 또는 치료용, 또는 면역증강용 약학적 조성물 및 건강기능식품, 그 제조방법에 관한 것이다. The present invention is for the prevention or treatment of allergic skin diseases and inflammatory skin diseases, including blouse and fruit juice as main active substance as an active ingredient and atopic dermatitis of gagabang, or for enhancing or reducing the pharmaceutical composition and health It relates to a nutraceutical and a manufacturing method thereof.
이와 같이, 본 발명의 조성물은 히스타민 분비 억제 효과, 수동적 피부 억제 반응 및 이개 부종 억제 반응 등 알레르기 반응 및 염증반응을 억제시킴으로써 아토피 피부염과 같은 알레르기 피부질환 및 염증성 피부질환에 대한 예방 및 치료효과를 갖는다.As such, the composition of the present invention has a prophylactic and therapeutic effect against allergic skin diseases such as atopic dermatitis and inflammatory skin diseases by inhibiting allergic reactions and inflammatory reactions, such as histamine secretion inhibitory effect, passive skin inhibitory reaction, and edema suppression reaction. .
또한, 인체 면역기능 조절에 중요한 인터페론 감마 생성을 증가시킴으로써 면역기능을 증강시켜, 면역기능 저하로 인한 피부노화, 건선, 피부 건조증, 피부가려움증, 만성 습진 및 여드름의 치료 보조제로서 사용될 수 있다. 이러한 효과는 하기 실험예 1 내지 4로부터 확인하였다. In addition, it enhances immune function by increasing the production of interferon gamma, which is important for the regulation of human immune function, and can be used as an adjuvant for treatment of skin aging, psoriasis, dry skin, itching, chronic eczema and acne due to reduced immune function. This effect was confirmed from Experimental Examples 1 to 4 below.
본 발명에 이용된 지출환의 원료생약으로 사용되는 백출은 한의학적으로 보 기건비, 조습이수하고 지실은 파기소적, 화담소비의 효능을 가진 것으로 알려져 있다. Baekchul, which is used as a raw herbal medicine of Nasuhwan, used in the present invention, is known to have the benefits of hygiene, hygienic maintenance, and destruction of waste and hwadam consumption.
본 발명에 따른 조성물에서, 각 생약들은 통상의 방법에 의해 그 유효성분들을 각각 추출하거나, 또는 생약들을 혼합한 후 한꺼번에 추출하고, 필요한 경우 이를 농축건조시켜 분말화한다.In the composition according to the present invention, each herbal medicine is extracted by the conventional method, respectively, or mixed together with the herbal medicines at once, and if necessary, concentrated to dry and powdered.
본 발명에 따른 조성물은 추출물 자체를 이용하거나 또는 약제학적으로 허용되는 담체를 포함할 수 있다. 본발명의 조성물에 사용할 수 있는 약학적으로 허용되는 담체는, 예를 들면 경구투여용 제제의 경우 결합제, 활택제, 붕해제, 부형제, 가용화제, 안정화제 등이 있고, 국소투여용 제제의 경우 기제, 부형제, 윤활제, 보존제 등이 있다.The composition according to the invention may utilize the extract itself or may comprise a pharmaceutically acceptable carrier. Pharmaceutically acceptable carriers that can be used in the compositions of the present invention include, for example, binders, lubricants, disintegrants, excipients, solubilizers, stabilizers, and the like in the case of oral administration. Bases, excipients, lubricants, preservatives and the like.
본 발명에 따른 조성물은 약제학적 분야에서 공지된 방법에 의해 제제화할 수 있고, 예를 들면 액제, 시럽제, 캡슐제, 과립제, 분말, 에멀젼, 현탁화제, 겔, 연고, 크림 등으로 제제화할 수 있으며, 사용시에 다른 제형으로 바꾸어 사용할 수도 있다. The composition according to the present invention can be formulated by methods known in the pharmaceutical art, for example, in liquids, syrups, capsules, granules, powders, emulsions, suspending agents, gels, ointments, creams and the like. In the case of use, it can also be changed into another dosage form.
이와 같은 본 발명을 더욱 상세히 설명하면 다음과 같다.Referring to the present invention in more detail as follows.
본 발명에 따른 조성물에서 백출, 지실은 상업적으로 구입할 수 있는 통상의 생약 원물을 사용할 수 있고, 생약들을 (i) 각각 추출하거나, (ii) 혼합한 후 추출물을 제조하여 사용하거나, (iii) 생약추출물을 농축건조시켜 분말화하여 사용할 수 있다.In the composition according to the present invention, baekrye, jisil can use commercially available commercial herbal medicine, and (i) extract each of the herbal medicines, (ii) mix and prepare the extract, or (iii) herbal medicines. The extract can be concentrated to dryness and powdered.
본 발명에 따른 조성물에서, 각 생약들은 바람직하게는 일정한 중량비로 혼 합한 후, 물로 추출하여 얻어진다. In the composition according to the invention, each herbal is preferably obtained by mixing with a constant weight ratio and then extracting with water.
본 발명에 따른 조성물은 바람직하게는 백출 및 지실이 2~4 : 1~2 중량비로 혼합된 것이다. The composition according to the present invention is preferably a mixture of white acid and fat in a weight ratio of 2 to 4: 1 to 2 by weight.
상기 언급한 생약들의 조성비는 기존 한의서에 수재된 비율을 기준으로 하고 반복된 실험결과를 토대로 얻어진 것이며 그 하한치보다 낮을 경우에는 그 성분의 생리활성효과가 감소하며 그 상한치보다 높을 경우에는 타성분의 생리활성효과가 감소될 수 있어 조성물의 상승작용 및 협동작용이 저하될 우려가 있다. The composition ratios of the above-mentioned herbal medicines are obtained based on the ratios of the existing herbal medicines and based on repeated experiments. When lower than the lower limit, the physiological activity effect of the component decreases, and when higher than the upper limit, the physiology of other components There is a fear that the active effect can be reduced so that the synergy and cooperative action of the composition is reduced.
아토피성 피부질환을 포함하는 알레르기성 피부질환 및 염증성 피부질환의 예방 또는 치료, 면역증강을 위한 용도로 사용될 수 있으며, 이러한 효과는 하기 실험예 1 내지 4로부터 확인된다. 또한, 본 발명에 따른 조성물은 면역 관련세포로부터 사이토카인 및 화학적 매개물질의 생성을 조절하여 피부보호 및 피부질환 개선효과를 증강하는 것으로 추정된다. It can be used for the prevention or treatment of allergic skin diseases and inflammatory skin diseases, including atopic dermatological diseases, and for the use of immune augmentation, such effects are confirmed from Experimental Examples 1 to 4 below. In addition, the composition according to the present invention is estimated to enhance the skin protection and skin disease improvement effect by controlling the production of cytokines and chemical mediators from immune-related cells.
본 발명의 조성물은 예를 들어 백출 8g, 지실 4g을 넣고 물 600 ㎖를 붓고 약 2시간 반 동안 달여 약 150 ㎖로 농축시켜 탕제로 만든다. The composition of the present invention is, for example, 8 g of Baekchul, 4 g of lychee, pour 600 ml of water, decoction for about two and a half hours, and concentrate to about 150 ml to form a hot water.
본 조성물의 통상적인 1회 투여용량은 지출환의 일회투여용량에 따르는 바 상기 탕제 기준 체중 1 kg 당 1.5~2.5 ㎖이며 이를 1 일 3 회 복용한다. 이 용량의 액제를 동결건조 분말로 할 경우 0.3~1g/1회에 달한다. 그러나, 본 발명의 조성물은 환자의 체중, 연령, 성별, 병증의 경중정도와 소화상태에 따라 복용량을 적의 증감할 수 있다. 기타 제제에 있어서도 상기 액제 복용량을 고려하여 산출된 적정량을 경구 투여한다. A typical single dose of the composition is 1.5-2.5 ml per kg of body weight based on the single dose of the nasal pill and is taken three times a day. When the liquid solution of this capacity is lyophilized powder, it is 0.3 ~ 1g / 1 times. However, the composition of the present invention can be appropriately increased or decreased the dose depending on the weight, age, sex, severity of the patient and the digestive state. In other formulations, the appropriate amount calculated in consideration of the liquid dosage is administered orally.
이하, 본 발명을 하기 실시예에 의하여 보다 구체적으로 설명하지만 이들에 의해 본발명의 범위가 어떤 식으로든 제한되는 것은 아니다. Hereinafter, the present invention will be described in more detail with reference to the following examples, which are not intended to limit the scope of the present invention in any way.
실시예 1: 액제의 제조 Example 1 Preparation of Liquid
백출 8g, 지실4g에 물600 ㎖를 붓고 약 2시간 반 동안 달여 약 150 ㎖로 농축시켜 탕제로 만들었다. 600 g of water was poured into 8 g of Baekchul and 4 g of fruit chamber, and it was poured for about 2 and a half hours, concentrated to about 150 ml, and it was made into a sugar.
실시예 2: 정제의 제조Example 2: Preparation of Tablets
실시예 1에 의하여 제조된 농축된 탕제를 동결건조시켜 분말화한 후, 상기 분말 500 mg, 유당 100 mg, 전분 150 mg을 혼합하고, 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조하였다. After lyophilizing and concentrated the concentrated solution prepared in Example 1, 500 mg of the powder, 100 mg of lactose, 150 mg of starch were mixed, and the tablets were prepared by tableting according to a conventional method for preparing tablets.
실시예 3: 기타 제제의 제조 Example 3: Preparation of Other Formulations
일반적으로 알려진 통상의 방법에 따라 상기의 추출물로 환제, 과립제, 캅셀제를 제조하였다. 또한 상기의 추출물을 동결건조 한 후 그 분말을 초콜렛과 혼합하여 식품으로 제조하였다. Pills, granules, capsules were prepared from the above extracts according to a conventionally known method. In addition, the extract was lyophilized and the powder was mixed with chocolate to prepare a food.
실험예 1: 본 발명에 의한 히스타민 방출 억제효과 Experimental Example 1: Histamine release inhibitory effect according to the present invention
한약 추출물에 의한 히스타민 방출 억제효과를 조사하였으며 실험은 다음과 같이 하였다.The inhibitory effect of histamine release by herbal extracts was investigated.
흰쥐 복강에 30㎖ 정도의 Tyrode 완충용액 B (137mM NaCl, 5.3mM 글루코스, 12mM NaHCO3, 2.7mM KCl, 0.3mM NaH2PO4)를 주입하고 복부를 90초 정도 마사지 한 후 복막을 조심스럽게 열어서 파스퇴르 파이펫으로 복강내 세포를 포함하고 있는 티로드(Tyrode) 완충용액 B를 수거하였다. 이어, 상기 세포함유 용액을 150 × g 로 10분 동안 원심분리하여 세포를 침전시키고 침전된 세포에 티로드완충용액 B를 가하여 파이펫팅한 후 22.5% 메트리자마이드 (metrizamide) 용액 위에 살짝 적층하고 400 × g에서 15분 동안 원심분리하여 침전된 세포만을 얻었다. 전기 침전된 세포에 α-MEM(minimum essential medium)/50% FBS(fetal bovine serum)를 가하고, 파이펫팅하여 톨루이딘 블루염색 방법을 통해 비만세포가 95% 이상이고, 트립판 블루염색에 의해 생존능력이 97% 이상임을 확인하고 실험에 사용하였다. Inject 30ml Tyrode Buffer B (137mM NaCl, 5.3mM Glucose, 12mM NaHCO3, 2.7mM KCl, 0.3mM NaH2PO4) into the rat abdominal cavity, massage the abdomen for 90 seconds, and carefully open the peritoneum with a Pasteur pipette. Tyrode buffer B containing intraperitoneal cells was harvested. Subsequently, the cell-containing solution was centrifuged at 150 × g for 10 minutes to precipitate the cells, pipetted with the addition of T-load buffer B to the precipitated cells, and then lightly laminated on 22.5% metrizamide solution and 400 Centrifugation at x g for 15 minutes gave only precipitated cells. Α-MEM (minimum essential medium) / 50% FBS (fetal bovine serum) was added to the electroprecipitated cells and pipetted to 95% or more mast cells by toluidine blue staining, and viability by trypan blue staining. This was confirmed to be more than 97% and used in the experiment.
전기 정제된 비만세포에 α-MEM/50% FBS를 가하고 조심스럽게 파이펫팅한 다음, 2 × 105개의 세포가 되도록 분주하였다. 세포를 안정화시키기 위하여 한약 추출물을 처리하기 전에 37℃에서 10분 동안 미리 배양하고, 실시예 1에서 제조된 한약 추출물 수용액을 각각 0.01, 0.1, 1.0 mg/㎖ (증류수 1㎖당 한약 추출물 0.01, 0.1, 1 mg을 녹인 것)가 되도록 가하고 37℃에서 30분 동안 처리한 다음, 곧바로 '화합물 48/80 (baltzly et al., 1949, A family of long acting depressors. Journal of American Chemical Society 71, 1301-1305)' 각각 5.0 ㎍/㎖ (부피당 시약의 양)을 10분 동안 처리하였다. 반응 종료 후 400 × g에서 원심분리하여 상층액과 세포를 분리하였다.Α-MEM / 50% FBS was added to the previously purified mast cells, pipetted carefully, and aliquoted to 2 × 10 5 cells. In order to stabilize the cells, the incubation was carried out at 37 ° C. for 10 minutes before treatment of the herbal extract, and 0.01, 0.1, and 1.0 mg / ml of the herbal extract aqueous solution prepared in Example 1, respectively, of the herbal extract 0.01 and 0.1 per distilled water. , 1 mg dissolved) and treated at 37 ° C. for 30 minutes and immediately added Compound 48/80 (baltzly et al., 1949, A family of long acting depressors.Journal of American Chemical Society 71, 1301-). 1305) 'each 5.0 μg / ml (amount of reagent per volume) was treated for 10 minutes. After completion of the reaction, the supernatant and the cells were separated by centrifugation at 400 × g.
히스타민 정량은 OPA(ο-phthaldialdehyde) 형광광도법(spectrofluorometry)으로 438 nm에서 측정하였으며, 히스타민 분비의 억제율은 다음과 같은 식을 사용해 계산 하였다. Histamine quantitation was measured at 438 nm by OPA (ο-phthaldialdehyde) spectrofluorometry, and the inhibition rate of histamine secretion was calculated using the following equation.
억제율 (%) = 〔(A - B) × 100〕 / A Inhibition Rate (%) = ((A-B) × 100] / A
A : 약물을 부가하지 않았을 때의 히스타민양 A: histamine when no drug is added
B : 약물을 부가하였을 때의 히스타민양 B: Histamine amount when drug is added
그 결과, '화합물 48/80'에 의하여 유도된 복강 비만세포로부터 히스타민의 분비가 지출환(탕) 추출물에 의해 농도 의존적으로 억제됨을 확인할 수 있었다. 최고 효과농도는 1 mg/㎖ 이었으며 9%까지 억제함을 볼 수 있었고, 각각의 농도에 대해 P<0.05로 유의한 결과를 나타내었다(도 1). As a result, it was confirmed that the secretion of histamine from the abdominal mast cells induced by the compound 48/80 was concentration-dependently suppressed by the extract of Nabisu (tang). The highest effective concentration was 1 mg / mL and suppressed up to 9%, showing a significant result of P <0.05 for each concentration (FIG. 1).
실험예 2: 지출환(탕) 추출물의 피부 알레르기 반응에 대한 효과 Experimental Example 2: Effect of Nasuhwan (tang) Extract on Skin Allergic Reaction
수동적 피부 알레르기 반응에 대한 한약추출물의 효과를 조사하였다. 먼저 다음과 같은 방식으로 인위적인 피부 알레르기(passive cutaneous anaphylaxis, PCA) 반응을 일으켰다.The effects of herbal extracts on passive skin allergic reactions were investigated. First, a passive cutaneous anaphylaxis (PCA) reaction was caused in the following manner.
실험동물로서 4-6 주령이고 몸무게가 25-35g인 ICR 품종의 흰쥐(mouse)를 실험 군별로 5마리씩 사용하여 반복 실험하였다. 먼저 충분히 섭식시킨 후 24시간 경과한 상기 흰쥐를 대상으로 하였다. 상기 흰쥐는 대한 동물센터로부터 입수하였다. As an experimental animal, 5 rats of ICR varieties of 4-6 weeks old and weighing 25-35g were repeatedly used in each experimental group. First, the rats were fed 24 hours after sufficient feeding. The rats were obtained from the Korean Animal Center.
항-DNP(anti-DNP, dinitrophenyl) IgE를 상기 흰쥐의 피내 주입하여 피부를 감작시킨 다음, 48 시간 후에 항원 DNP-HSA (dinitrophenyl-human serum albumin)를 꼬리에 정맥 주사하여 IgE 의존성 피부 반응을 유발하였다. 이때 DNP-HSA는 PBS(phosphate buffered saline)으로 희석하였다. 흰쥐의 등에 항-DNP IgE 100ng 주입하고 48 시간 경과 후 4% 에반스 블루(evans blue)와 DNP-HSA를 1:1로 혼합한 용액을 쥐의 꼬리정맥에 주사하였다. 항원(DNP-HSA)을 투여하기 1 시간 전에 실시예 1의 한약 추출물 1g(추출물)/kg(체중의 양)을 흰쥐에 구강 투여하였다.Skin sensitization by intradermal injection of anti-DNP (dinitrophenyl) IgE in the rats followed by intravenous injection of antigen DNP-HSA (dinitrophenyl-human serum albumin) into the tail 48 hours later to induce an IgE dependent skin reaction It was. At this time, DNP-HSA was diluted with PBS (phosphate buffered saline). 100 ng of anti-DNP IgE was injected into the rat's back, and 48 hours later, a mixture of 4% Evans blue and DNP-HSA 1: 1 was injected into the tail vein of the rat. One hour prior to administration of the antigen (DNP-HSA), 1 g of the herbal extract of Example 1 (extract) / kg (weight of body weight) was orally administered to the rat.
흰쥐를 치사시킨 후 반응이 일어난 부위를 절단하여 0.1N 수산화칼륨500㎕를 첨가한 다음, 아세톤과 인산(5:13, w:w) 혼합용액을 4.5㎖씩 가하여 색소를 추출하였다. 620nm에서 추출물의 흡광도를 측정하였으며, 에반스 블루 표준 곡선을 이용하여 색소량을 측정하였다.After killing the rats, the reaction site was cleaved and 500 µl of 0.1 N potassium hydroxide was added, followed by adding 4.5 ml of acetone and phosphoric acid (5:13, w: w), and extracting the pigment. The absorbance of the extract was measured at 620 nm, and the pigment amount was measured using the Evans Blue standard curve.
그 결과, 한약 추출물 1g/kg 농도에서 수동적 피부 알레르기 반응을 가장 많이 억제하였다. 이러한 결과는 한약 추출물의 경구투여를 통해 국소, 즉 피부 알레르기 반응을 현저하게 억제할 수 있음을 의미한다 (표1). As a result, the passive skin allergic reaction was most suppressed at the concentration of 1 g / kg herbal extract. These results indicate that oral administration of herbal extracts can significantly inhibit local, ie, skin allergic reactions (Table 1).
[표1] 수동적 피부 알레르기반응에 있어서 지출환(탕)의 효과 *P<0.05[Table 1] Effect of Nasuhwan (tang) on Passive Skin Allergic Reaction * P <0.05
실험예 3: 지출환(탕) 추출물의 이개 부종 반응에 대한 효과 Experimental Example 3: Effect of the Nasuhwan (tang) extract on the edema reaction
실험동물로서 4-6 주령이고 몸무게가 25-35g인 ICR계 생쥐(mouse)를 실험군별로 4마리씩 사용하여 반복 실험하였다. 먼저 충분히 섭식시킨 후 24시간 경과한 상기 흰쥐를 대상으로 하였다. 상기 흰쥐는 대한 동물센터로부터 입수하였 다. Experimental animals were repeated 4-6 weeks old and weighing 25-35g ICR mice (four mice) for each experimental group. First, the rats were fed 24 hours after sufficient feeding. The rats were obtained from the Korean Animal Center.
먼저 한약 추출물을 농도별로 경구 투여한 뒤 1시간동안 반응시켰다. 그런 다음 화합물 48/80 (20 g/L)을 미세 주사기를 사용하여 쥐 귀 피하 내부에 주입하고 40분 후에 이개 부종반응이 일어난 부위의 귀 두께를 측정하였다. 표 2에서 나타난 바와 같이 낮은 농도에서는 유의한 효과가 없음을 알 수 있었고 1 g/kg일 때 이개 부종반응을 가장 많이 억제함을 알 수 있었으며 P<0.05로 유의한 결과를 얻었다.First, the herbal extracts were orally administered by concentration, and then reacted for 1 hour. Compound 48/80 (20 g / L) was then injected subcutaneously inside the rat ear using a micro syringe and ear thickness at the site of the edema reaction occurred after 40 minutes. As shown in Table 2, it can be seen that there is no significant effect at low concentrations, it was found that the most suppressed the edema response at 1 g / kg, P <0.05 was obtained.
[표2] 화합물 48/80 유도성 이개부종 반응에 있어서 추출물의 효과TABLE 2 Effect of extracts on 48/80 induced edema reaction
실험예 4: 한약 추출물의 인터페론감마 생성 효과 Experimental Example 4: interferon gamma production effect of the herbal extract
한약 추출물이 면역증강 기능을 담당하고 있는 인터페론 감마 생성을 유도하는지 여부를 조사하였다. We investigated whether herbal extracts induce the production of interferon gamma, which is responsible for immune enhancing function.
배양액 RPMI 1640/FBS에 T 세포주 Molt-4를 5% CO2, 37℃에서 배양한 다음 3 × 105개의 세포가 되도록 분주하였다. 세포를 안정화시키기 위하여 한약 추출물로 처리하기 전에 37℃에서 10분 동안 미리 배양하고, 한약 추출물 수용액을 각각 0.01, 0.1, 1.0 mg/㎖ (증류수 1 ㎖당 한약 추출물 0.01, 0.1, 1 mg을 녹인 것)가 되도록 가한 다음 24시간동안 반응 시키고 배양하였다. 반응 종료 후 400 × g에서 원심 분리하여 상층액과 세포를 분리하였다. 분리된 상층액 중 인터페론 감마의 단백질 수준을 조사하기 위하여 ELISA (enzyme linked immunosorbent assay)를 실행하였다. T cell line Molt-4 was incubated at 5% CO 2, 37 ° C. in culture RPMI 1640 / FBS, and then aliquoted to 3 × 10 5 cells. In order to stabilize the cells, the cells were pre-incubated at 37 ° C. for 10 minutes prior to treatment with the herbal extracts, and 0.01, 0.1 and 1.0 mg / ml of the aqueous herbal extracts were dissolved in 0.01, 0.1 and 1 mg of distilled water, respectively. ) Was added and reacted for 24 hours and incubated. After completion of the reaction, the supernatant and the cells were separated by centrifugation at 400 × g. Enzyme linked immunosorbent assay (ELISA) was performed to investigate the protein level of interferon gamma in the isolated supernatant.
인터페론 감마에 대한 단일클론 항체인 항 휴먼 (anti-human) 인터페론 감마 (1㎍/㎖)를 PBS (pH 7.4)로 희석하여, 96-웰 플레이트에 100㎕씩 각각 코팅한 다음, 4℃에서 12시간 동안 방치하였다. 전기 플레이트를 0.05% 트윈(Tween)이 포함된 PBS로 세척한 다음, 1% BSA, 5% 수크로스, 0.05% NaN3를 함유한 PBS로 1 시간 동안 차단시켰다. 여러 차례 세척한 다음, 원심 분리하여 얻은 상층액과 표준 곡선으로 사용할 재조합 인터페론 감마를 첨가한 후 37℃에서 2 시간 동안 방치하였다. 이어, 각 웰을 다시 세척하고 2차 항체 바이오틴(biotin)이 결합된 인터페론 감마 (0.2㎍/㎖)를 첨가하여 다시 37℃에서 2시간 동안 방치하였다. 웰을 세척한 다음, 아비딘(avidine) 이 연결된 과산화효소를 첨가하고 37℃에서 20분 동안 방치하였다. 웰을 다시 세척한 다음, ABTS (2,2´-Azino-bis(3-ethylbenzthia-Anti-human interferon gamma (1 μg / ml), a monoclonal antibody to interferon gamma, was diluted with PBS (pH 7.4) and coated 100 μl each in a 96-well plate, followed by 12 at 4 ° C. It was left for hours. The electrical plates were washed with PBS containing 0.05% Tween and then blocked for 1 hour with PBS containing 1% BSA, 5% sucrose, 0.05% NaN 3. After washing several times, the supernatant obtained by centrifugation and the recombinant interferon gamma to be used as a standard curve were added and left at 37 ° C. for 2 hours. Subsequently, each well was washed again and added to the secondary antibody biotin-bound interferon gamma (0.2 μg / ml) and left for another 2 hours at 37 ° C. The wells were washed and then avidin-linked peroxidase was added and left at 37 ° C. for 20 minutes. The wells are washed again, followed by ABTS (2,2´-Azino-bis (3-ethylbenzthia-
zoline-6-sulfonic acid) 기질을 첨가하고, 발색반응을 ELISA 판독기를 사용하여 405 nm에서 측정하였다.zoline-6-sulfonic acid) substrate was added and color development was measured at 405 nm using an ELISA reader.
실험 결과, 도 2에서 볼 수 있듯이, 한약 추출물이 인터페론 감마생성을 농 도 의존적으로 증가시킴을 알 수 있었다 (*P<0.05). As a result, as shown in Figure 2, the herbal extract was found to increase interferon gamma production concentration-dependently (* P <0.05).
실험예 5: 한약추출물의 아토피성 피부염 개선효과 Experimental Example 5: Improvement of Atopic Dermatitis by Herbal Extracts
최근 아토피 질환 동물모델로서 사용되고 있는 NC/Nga mouse는 specific pathogen free (SPF) 사육환경에서는 아토피 증상을 일으키지 않지만 conventional condition에서 사육될 경우 8주령 이후부터 홍반(erythema), 부종과 혈종(edema and excoriation), 진무름과 상처(erosion and scar), 털빠짐과 건조피부(hair loss and skin dryness) 같은 아토피 증상을 일으킨다. 본 연구는 conventional condition에서 자연적으로 유발된 아토피 증상이 실시예 1의한약 추출물의 경구 투여에 의해 개선되는 정도를 관찰하였다. 아토피 증상이 일어난 29주령 NC/Nga mouse는 각각 water, 지출환 25 mg/kg, 250 mg/kg을 매일 경구 투여 받았다. 도 3 에서 보듯이 아토피 증상은 다음과 같이 개선되는 결과를 나타냈다. NC / Nga mice, which have recently been used as animal models of atopic diseases, do not cause atopic symptoms in specific pathogen free (SPF) breeding environments, but when grown under conventional conditions, erythema, edema and hematoma after 8 weeks of age May cause atopic symptoms such as erosion and scar, hair loss and skin dryness. In this study, we observed the extent to which atopic symptoms naturally induced under conventional conditions were improved by oral administration of the herbal extract of Example 1. The 29-week-old NC / Nga mice with atopic symptoms received oral water, 25 mg / kg and 250 mg / kg daily, respectively. As shown in FIG. 3, atopy symptoms showed improvement as follows.
피부 손상 정도는 일주일 후 water 처리군과 약물처리군의 피부손상정도 육안으로 측정했다. 피부손상정도는 홍반과 출혈(erythema and hemorrhage), 부종과 혈종(edema and excoriation), 진무름과 상처(erosion and scarring), 탈모와 피부건조(hair loss and skin dryness) 항목에 대하여 양호함 (0), 약함 (1), 심함(2), 아주 심함(3)으로 평가하였고 각 실험쥐에 대하여 그 평가 점수를 합산하고 평균값을 구하였다. 육안평가는 실험에 관여하지 않은 일반관찰자에 의해 진행되었다. After one week, the skin damage was visually measured in the water treatment group and the drug treatment group. Skin damage is good for erythema and hemorrhage, edema and excoriation, erosion and scarring, hair loss and skin dryness (0) , Weak (1), severe (2), and severe (3) were evaluated. The scores were summed and averaged for each rat. Visual evaluation was conducted by general observers who were not involved in the experiment.
[도 1]히스타민 억제 효과 (*P<0.05)1: Histamine inhibitory effect (* P <0.05)
[도 2]한약 추출물의 인터페론 감마 생성 조절 효과 2 is the effect of the interferon gamma production regulation of herbal extracts
[도 3]한약 추출물의 아토피성 피부염 개선 효과 3 is atopic dermatitis improvement effect of the herbal extract
도1은 실시예1의 한약 추출물의 히스타민 억제효과를 도시한 것이고,Figure 1 shows the histamine inhibitory effect of the herbal extract of Example 1,
도2는 실시예1의 한약 추출물의 인터페론 감마생성효과를 도시한 것이다. Figure 2 illustrates the interferon gamma production effect of the herbal extract of Example 1.
도3은 실시예1의 한약 추출물의 아토피성 피부염 개선효과를 도시한 것이다.Figure 3 illustrates the atopic dermatitis improvement effect of the herbal extract of Example 1.
Claims (7)
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Cited By (2)
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KR101285720B1 (en) * | 2012-03-02 | 2013-07-19 | 주식회사 유니크메디케어 | Composition for improving acne |
CN117562895A (en) * | 2024-01-17 | 2024-02-20 | 中国中医科学院中药研究所 | Application of atractylenolide I in preparation of medicine for preventing/treating allergic purpura |
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KR101285720B1 (en) * | 2012-03-02 | 2013-07-19 | 주식회사 유니크메디케어 | Composition for improving acne |
CN117562895A (en) * | 2024-01-17 | 2024-02-20 | 中国中医科学院中药研究所 | Application of atractylenolide I in preparation of medicine for preventing/treating allergic purpura |
CN117562895B (en) * | 2024-01-17 | 2024-04-02 | 中国中医科学院中药研究所 | Application of atractylenolide I in preparation of medicine for treating allergic purpura |
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