KR100846100B1 - Manufacturing method and that creation water of the allergy treatment composition which uses the vitis amurensis ruprecht - Google Patents

Manufacturing method and that creation water of the allergy treatment composition which uses the vitis amurensis ruprecht Download PDF

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KR100846100B1
KR100846100B1 KR1020070044760A KR20070044760A KR100846100B1 KR 100846100 B1 KR100846100 B1 KR 100846100B1 KR 1020070044760 A KR1020070044760 A KR 1020070044760A KR 20070044760 A KR20070044760 A KR 20070044760A KR 100846100 B1 KR100846100 B1 KR 100846100B1
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allergy
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신태용
이태규
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우석대학교 산학협력단
주식회사 금화양조
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/87Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/17Preparation or pretreatment of starting material involving drying, e.g. sun-drying or wilting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

A method for preparing a composition for treating allergy is provided to obtain the composition from an extract of Vitis amurensis Ruprecht, which shows excellent prophylactic and therapeutic effect on systemic allergy reaction and topical skin allergy reaction by inhibiting generation of TNF-alpha, IL-6 and IL-8 in human cells with minimized side effects caused by long term medication. A method for preparing a composition for treating allergy comprises the steps of: (a) drying Vitis amurensis Ruprecht to have a moisture content of less than 15%; (b) after putting the dried Vitis amurensis Ruprecht in methanol in a weight ratio of 20-40:60-80, extracting it under reflux cooling; (c) concentrating the Vitis amurensis Ruprecht extract to recover the methanol; and (d) freeze-drying the concentrated Vitis amurensis Ruprecht to obtain a lyophilized Vitis amurensis Ruprecht extract. The method further comprises a step of mixing 1-90 wt.% of the lyophilized Vitis amurensis Ruprecht with 10-99 wt.% of a pharmaceutically acceptable carrier. Further, the composition for treating allergy is used in a form of oral, skin applying or injection medicine.

Description

머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법 및 그 조성물{Manufacturing method and that creation water of the allergy treatment composition which uses the Vitis amurensis Ruprecht}Manufacturing method and composition of allergy treatment using the extract of the wild grapes {Manufacturing method and that creation water of the allergy treatment composition which uses the Vitis amurensis Ruprecht}

본 발명은 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법 및 그 조성물에 관한 것으로서, 더욱 상세하게는 인체에 안전하고 독성이 적은 머루 추출물을 인용하여 인체의 경구 제제나 피부 도포의 제형으로 제조함으로써 세포내에서 TNF-α와 IL-6 및 IL-8의 생성을 감소시키는 작용기전을 통해 전신성 알레르기 반응과 국소 피부 알레르기반응의 예방 및 치료에 우수한 효과를 나타내는 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법 및 그 조성물에 관한 것이다.The present invention relates to a method for producing a composition for treating allergy using an extract of mule, and a composition thereof. More specifically, by citing an extract of mule extract that is safe and less toxic to the human body, the cell is prepared by oral preparation or formulation of skin coating. Method for the preparation of allergen compositions using the extract of Murus which shows excellent effects on the prevention and treatment of systemic allergic reactions and local skin allergic reactions through a mechanism of reducing the production of TNF-α, IL-6 and IL-8 in the And to the composition.

일반적으로 알레르기란 광범위하고 복잡한 병리적 현상의 총화로 면역반응에 근거한 생체의 전신적 또는 국소적인 장해이다. 인체에 나타나는 알레르기는 면역 기전에 따라 I, Ⅱ, Ⅲ 및 Ⅳ형으로 분류된다. 이중 즉시형 과민반응에 속하는 I형 알레르기가 임상에 있어서 중요한 부분을 차지하고 있으며 아토피성 피부염, 알레르기성 비염, 기관지 천식, 고초열 및 화분증 등이 여기에 속한다.Allergies are generally systemic or localized disorders of living organisms based on immune responses that are the summation of a wide variety of complex pathological phenomena. Allergies present in the human body are classified into I, II, III and IV types according to the immune mechanism. Type I allergy, which is a type of immediate hypersensitivity reaction, is an important part of clinical practice, including atopic dermatitis, allergic rhinitis, bronchial asthma, hay fever and hay fever.

전술한 바와 같은 알레르기 중 Ⅰ형 알레르기는 비만세포(Mast cell)의 활성화에 의해 일어나며 비만세포의 과립에 염증의 매개체인 히스타민(Histamine)이 다량 함유되어 있음이 알려진 것은 1953년경이다. 알레르기 반응이 일어날 때 비만세포에서 히스타민이 방출되는 현상이 발견된 후에 이 기전을 구명하던 중 Ishizaka의 IgE의 발견은 비만세포가 즉시형 알레르기 반응에 관여함을 밝히는 중요한 계기가 되었다.Type I allergy, as described above, is caused by activation of mast cells, and it is known in 1953 that granules of mast cells contain a large amount of histamine, a mediator of inflammation. Ishizaka's discovery of IgE during the discovery of histamine release from mast cells during an allergic reaction became an important opportunity to identify the mast cells involved in the immediate allergic reaction.

즉, 비만세포 표면에는 IgE 고친화성 수용체가 있으며 이 수용체에 IgE가 결합한 후 다시 항원이 결합하여 가교가 형성되면 탈과립반응이 유발되어 과립 내용물인 히스타민(Histamine), 세로토닌(Serotonin), 브라드키닌(Bradykinin) 등과 같은 합성되어 저장되어있던 매개물질(Preformed mediator), 프로테아제(Protease), 프로테오글리칸(Proteoglycan) 등이 동시에 방출된다(Ishizaka 등, Histamine release from rat mast cells by antibodies against rat basophilic leukemia cell membrane. J. Immunol., 1977, 119: 1589-1596).In other words, the surface of the mast cell has a high IgE affinity receptor, and when IgE binds to the receptor and then cross-links to form an antigen, degranulation reaction is induced, resulting in histamine (Histamine), serotonin (Serotonin), and Bradykinin ) this was synthesized stored mediators (Preformed mediator), protease (protease), proteoglycans (proteoglycan), etc., such as is emitted simultaneously (Ishizaka, etc., Histamine release from rat mast cells by antibodies against rat basophilic leukemia cell membrane. J. Immunol., 1977, 119: 1589-1596).

한편, 1970년대 이후 새로운 지질성의 염증 매개체에 대한 연구 결과가 보고되기 시작하였으며 이들은 세포의 활성화에 동반하여 세포막 인지질로부터 생산된 프로스타그란딘류(Prostaglandins), 류코트리엔류(Leukotriens), 트롬복산(Thromboxane), 글리세로포스포리피드(Glycerophospholipids) 유도체인 PAF(Platelet activating factor) 등으로 다양한 생리활성을 나타내는 newly generated mediator로서 Ⅰ형 알레르기 반응을 포함한 각종의 염증반응에 관여함이 밝혀졌다. 이러한 지질성 매개체는 IgE 수용체가 가교를 형성할 때 비만세포에서 탈과립반응과 병행해서 생산 방출된다.Since the 1970s, studies on new lipid-mediated inflammatory mediators have begun to be reported. These include prostaglandins, leukotriens, thromboxane, and glycerol produced from cell membrane phospholipids along with cell activation. As a newly generated mediator exhibiting various physiological activities, such as platelet activating factor (PAF), a derivative of glycosphospholipids, it has been found to be involved in various inflammatory reactions including type I allergic reactions. These lipid mediators are produced and released in parallel with degranulation in mast cells when IgE receptors form crosslinks.

또한, 비만세포의 활성화에 동반하여 면역반응의 조절인자로 잘 알려진 cytokine은 IL-3(비만세포 증식인자), IL-4, IL-5 등이 있다(Galli SJ 등, Cytokine production by mast cells and basophils. Curr. Opin. Immunol., 1991, 3:865-72, Bradding P 등, Immunolocalization of cytokines in the nasal mucosa of normal and perennial rhinitic subjects. The mast cell as a source of IL-4, IL-5, and IL-6 in human allergic mucosal inflammation. J. Immunol., 1993, 151:3853-3865).In addition, cytokines well known as regulators of immune responses accompanied by activation of mast cells include IL-3 (mastocyte proliferation factor), IL-4, IL-5 (Galli SJ et al., Cytokine production by mast cells and basophils.Curr. Opin.Imunmun ., 1991, 3: 865-72, Bradding P et al., Immunolocalization of cytokines in the nasal mucosa of normal and perennial rhinitic subjects.The mast cell as a source of IL-4, IL-5, and IL-6 in human allergic mucosal inflammation.J. Immunol., 1993, 151: 3853-3865).

그리고, 현재 임상에서 사용되고 있는 알레르기 치료약물은 작용기전에 따라 탈과립저해제, 화학전달물질 작용억제제, 화학전달물질 합성저해제 등으로 대별할 수 있다. 이들 약물들 중 화학전달물질 작용억제제와 화학전달물질 합성저해제의 경우 약물작용점이 비교적 확실하지만 탈과립저해제의 경우 그 작용기전이 불분명한 상태이다.Allergic drugs currently being used in the clinic can be roughly classified into degranulation inhibitors, chemical transporter inhibitors, and chemical transporter inhibitors depending on the mechanism of action. Among these drugs, chemical transport inhibitors and chemical transport inhibitors have a relatively certain drug action point, but degranulation inhibitors have an unclear mechanism of action.

또한, 이들 약물들은 장기간 투여에 의해 여러 가지 부작용을 초래할 수 있다. Ⅰ형 알레르기는 비만세포의 활성화에 의해 방출되는 과립내용물인 활성아민류와 프로테아제(Protease)류, 세포막 인지질에서 생성되는 지질성 매개체, 전사의 활성화에 의해 생산되는 사이토카인(Cytokine)류 등이 관련되어 일어나는 생체의 자연스러운 현상이라고 종합할 수 있다.In addition, these drugs can cause various side effects by prolonged administration. Type I allergies include active amines and proteases, granule contents released by activation of mast cells, lipid mediators produced by membrane phospholipids, and cytokines produced by activation of transcription. It can be summarized as a natural phenomenon of living organisms.

전술한 바와 같은 I형 알레르기의 치료를 위해서는 비만세포에서 이들 생리활성 물질의 생산 및 유리에 대한 작용기전을 밝히고 장기복용에 따른 부작용을 최 소화할 수 있는 물질의 개발이 대단히 중요하다고 할 수 있다. 따라서, 비만세포에서 작용기전이 확실한 생리활성 물질의 생산 및 유리를 조절하는 약물을 개발한다면 알레르기의 예방 및 치료제가 될 것이다.For the treatment of type I allergy as described above, it can be said that the development of substances capable of elucidating the mechanism of action and production of these bioactive substances in mast cells and minimizing the side effects of long-term use is very important. Therefore, development of drugs that modulate the production and release of bioactive substances with certain mechanisms of action in mast cells would be a preventive and therapeutic agent for allergies.

본 발명은 전술한 바와 같은 종래 기술의 문제점을 해결하기 위한 것으로, 인체의 세포내에서 TNF-α와 IL-6 및 IL-8의 생성을 감소시키는 작용기전을 하는 머루 추출물을 통해 전신성 알레르기 반응 및 국소 피부 알레르기 반응의 예방과 치료 효과가 탁월하면서도 장기복용에 따른 부작용이 최소화된 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법 및 그 조성물을 제공함에 그 목적이 있다.The present invention is to solve the problems of the prior art as described above, systemic allergic reactions and the systemic allergic reaction through the extract of the melon function mechanism to reduce the production of TNF-α and IL-6 and IL-8 in the human cells and It is an object of the present invention to provide a method for producing an allergy treatment composition and a composition for treating allergic skin using the extract of Maru which is excellent in preventing and treating local skin allergic reactions and minimizing side effects due to long-term use.

아울러, 본 발명에 따른 기술은 머루 추출물을 함유하는 경구, 피부 도포 및 주사제 제제의 제형으로 제조된 알레르기 치료제를 통해 전신성 알레르기 반응 및 국소 피부 알레르기 반응의 예방 및 치료 효과가 있도록 함은 물론, 머루 추출물을 다양한 식품류에도 이용될 수 있도록 함에 있다.In addition, the technique according to the present invention, as well as to prevent and treat systemic allergic reactions and local skin allergic reactions through allergic agents prepared by the formulation of oral, skin application and injection formulations containing the melon extract, as well as melon extract It can be used in various foods.

전술한 목적을 달성하기 위해 구성되는 본 발명은 다음과 같다. 즉, 본 발명에 따른 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법은 (a) 머루를 수분함량 15% 이하로 건조시키는 단계; (b) 단계 (a)의 과정을 통해 건조된 머루를 메탄올에 투입하되 건조된 머루와 메탄올의 비율은 20∼40 : 60∼80 중량%의 비율로 투입하여 메탄올 수욕상에서 환류냉각 추출하는 단계; (c) 단계 (b)의 과정을 통해 환류냉각 추출된 머루 추출물을 농축시켜 메탄올을 회수하는 단계; 및 (d) 단 계 (c)의 과정을 통해 농축된 머루 추출물을 동결건조시켜 동결건조 머루 추출물을 수득하는 단계를 포함한 구성으로 이루어진다.The present invention configured to achieve the above object is as follows. In other words, the method for producing a composition for treating allergy using the extract of the beet according to the present invention comprises the steps of: (a) drying the beech to less than 15% moisture content; (b) injecting dried muru through methanol in the process of step (a), wherein the ratio of dried muru to methanol is added at a ratio of 20 to 40:60 to 80 wt% to extract reflux with cooling in a methanol water bath; (c) recovering methanol by concentrating the reflux extract extracted from the reflux through the process of step (b); And (d) lyophilizing the concentrated muru extract through the process of step (c) to obtain a lyophilized muru extract.

본 발명에 따른 기술은 단계 (d)의 과정을 통해 얻은 동결건조 머루 추출물 1∼90 중량%와 약제학적으로 허용 가능한 담체 10∼99 중량%의 조성비로 혼합하여 경구, 피부 도포 및 주사제 제제 중 어느 하나의 제형으로 제조할 수 있다.The technique according to the present invention is a mixture of 1 to 90% by weight of the lyophilized beet extract obtained through the process of step (d) and 10 to 99% by weight of a pharmaceutically acceptable carrier, which can be used for oral, dermal application and injection preparations. It can be prepared in one formulation.

본 발명에 다른 기술의 구성에서 담체는 부형제, 결합제, 활택제, 붕괴제, 피복제, 유화제, 현탁제, 용제, 안정화제, 흡수조제, 주사용수 및 등장화제로 이루어진 군으로부터 선택된 1종 이상의 담체일 수 있다.In a construction of another technique in the present invention, the carrier is at least one carrier selected from the group consisting of excipients, binders, lubricants, disintegrants, coatings, emulsifiers, suspensions, solvents, stabilizers, absorption aids, water for injection and isotonic agents. Can be.

전술한 바와 같은 구성을 통해 제조된 알레르기 치료용 조성물의 투여량은 동결건조 머루 추출물의 중량을 기준으로 500~2,000 mg/일의 양을 사용함이 양호하다.The dosage of the composition for treating allergy prepared through the configuration as described above is preferably used in the amount of 500 ~ 2,000 mg / day based on the weight of the lyophilized extract.

한편, 전술한 경구 제제는 과립제, 정제 또는 캅셀제로 제조되며, 피부 도포 제제는 크림제 또는 로션제로 제조될 수 있다.On the other hand, the oral preparations described above may be prepared in granules, tablets or capsules, and the skin coating preparations may be prepared in creams or lotions.

본 발명에 따른 머루 추출물을 이용한 알레르기 치료용 조성물은 전술한 바와 같은 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법에 의해 제조된다.The composition for treating allergies using the extract of the melon according to the present invention is prepared by a method for preparing the composition for treating allergies using the extract of melon as described above.

이하에서는 본 발명의 바람직한 실시 예에 따른 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법 및 그 조성물에 대하여 상세하게 설명하기로 한다.Hereinafter will be described in detail with respect to a method for producing a composition for treating allergy using the extract of the roe according to a preferred embodiment of the present invention and its composition.

먼저, 본 출원인은 전신성 알레르기와 국소 피부 알레르기의 치료제를 개발하고자 연구한 결과 머루가 전신성 알레르기 반응과 국소 피부 알레르기 반응에 대 해서 우수한 억제효과를 나타낸다는 사실을 실험적으로 규명하여 본 발명에 따른 알레르기 치료용 조성물을 완성하게 되었다.First, the present inventors have studied to develop a therapeutic agent for systemic allergy and local skin allergy, and experimentally proved that muru exhibits an excellent inhibitory effect on systemic allergic reactions and local skin allergic reactions. The composition was completed.

본 발명에 따른 기술의 주요 구성요소인 머루는 오래전부터 약이나 먹거리로 사용되어 왔기 때문에 인체에 안전하고 독성이 적으며, 통상적으로 신경성 두통, 식욕부진, 피로회복 등에 사용한다고 알려져 있다. 또한, 이러한 머루는 TNF-α와 IL-6 및 IL-8의 생성을 감소시키는 작용기전을 가지고, 전신성 알레르기 반응과 국소 피부 알레르기 반응의 예방 및 치료에 우수한 효과를 나타낸다.Since the main component of the technology according to the present invention has been used as a medicine or food for a long time, it is known to be safe and less toxic to the human body, and is commonly used for neurological headache, anorexia, and fatigue recovery. In addition, such melon has a mechanism of action that reduces the production of TNF-α, IL-6 and IL-8, and has an excellent effect on the prevention and treatment of systemic allergic reactions and local skin allergic reactions.

본 발명의 기술을 살펴보면 본 발명의 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법은 머루를 수분함량 15% 이하로 건조하는 단계, 건조된 머루를 메탄올에 투입하여 메탄올 수욕상에서 환류냉각 추출하는 단계, 환류냉각 추출된 머루 추출물을 농축시켜 메탄올을 회수하는 단계 및 농축된 머루 추출물을 동결건조시켜 동결건조 머루 추출물을 수득하는 단계를 포함한 구성으로 이루어진다.Looking at the technology of the present invention, the method for producing a composition for treating allergy using the extract of the present invention comprises the steps of drying the dried fruit to 15% or less moisture, the step of refrigeration cooling extraction in methanol water bath by putting dried dried fruit into methanol, Reflux cooling The extracted extract is concentrated to recover methanol, and the concentrated extract is freeze-dried to obtain a lyophilized extract.

한편, 전술한 바와 같은 구성을 통해 제조된 동결건조 머루 추출물과 약제학적으로 허용 가능한 담체를 일정 조성비로 혼합하게 되면 경구, 피부 도포 및 주사제 제제 중 어느 하나의 제형으로 제조할 수가 있다.On the other hand, if the lyophilized buckwheat extract prepared by the above-described configuration and the pharmaceutically acceptable carrier is mixed at a predetermined composition ratio, it can be prepared in any one of oral, dermal application and injection formulation.

전술한 바와 같은 본 발명의 구성에서 건조된 머루를 메탄올에 투입시 건조된 머루와 메탄올의 비율은 20∼40 : 60∼80 중량%의 비율로 건조된 머루를 메탄올에 투입하고, 동결건조 머루 추출물과 약제학적으로 허용 가능한 담체의 혼합 조성비는 동결건조 머루 추출물 1∼90 중량%와 약제학적으로 허용 가능한 담체 10∼99 중량%의 조성비로 혼합된다.In the composition of the present invention as described above, when the dried muru is added to methanol, the ratio of dried muru and methanol is added to the dried muru at methanol in a ratio of 20 to 40:60 to 80% by weight, and the freeze-dried muru extract The composition ratio of the pharmaceutically acceptable carrier and the pharmaceutically acceptable carrier is 1 to 90% by weight of the lyophilized extract and 10 to 99% by weight of the pharmaceutically acceptable carrier.

본 발명에 따른 머루 추출물을 이용한 알레르기 치료용 조성물의 구성에서 동결건조 머루 추출물과 혼합 조성되는 약제학적으로 허용 가능한 담체로는 이에 제한되는 것은 아니지만 부형제, 결합제, 활택제, 붕괴제, 피복제, 유화제, 현탁제, 용제, 안정화제, 흡수조제, 주사용수 및 등장화제로 이루어진 군으로부터 선택된 적어도 하나의 담체를 예로 들 수 있다.Pharmaceutically acceptable carriers, which are mixed with the lyophilized beets extract in the composition of the composition for treating allergy using the extract of the present invention according to the present invention, but are not limited thereto, excipients, binders, lubricants, disintegrating agents, coating agents, emulsifiers And at least one carrier selected from the group consisting of suspending agents, solvents, stabilizers, absorption aids, water for injection and isotonic agents.

본 발명에 따른 알레르기 치료용 조성물은 경구, 피부 도포 및 주사제 제제로써 제형화될 수 있으며, 경구 제제의 제형과 피부 도포 제제의 제형이 보다 바람직하다. 이때, 경구 제제로는 과립제, 정제, 캡슐제 등을 예시할 수 있으며, 피부 도포 제제로는 크림제나 로션제 등을 예시할 수 있다.The composition for treating allergies according to the present invention may be formulated as oral, dermal and injectable preparations, with the formulation of oral formulations and the formulations of skin coatings more preferred. At this time, oral preparations may be exemplified as granules, tablets, capsules, and the like, and skin coating preparations may be exemplified as creams or lotions.

한편, 본 발명에 따른 알레르기 치료용 조성물의 투여량은 환자의 나이, 성별, 체중에 따라 달라질 수 있으나, 통상 500~2,000 mg/일이 바람직하다.On the other hand, the dosage of the composition for treating allergy according to the present invention may vary depending on the age, sex and weight of the patient, but usually 500 to 2,000 mg / day is preferred.

또한, 본 발명에 따른 알레르기 치료용 조성물은 다양한 식품류에도 이용될 수 있으며, 본 발명의 조성물이 첨가될 수 있는 식품으로는 예컨대, 차, 술, 음료, 화장품, 건강보조 식품류 등을 예로 들 수 있고, 개, 토끼, 고양이 등의 온혈동물 치료에도 사용이 가능하다. 즉, 본 발명에 따른 제조방법에 의해 제조된 동결건조 머루 추출물을 차, 술, 음료, 화장품, 건강보조 식품류 등에 일정비율로 혼합하게 되면 다양한 식품류에도 이용될 수가 있다.In addition, the composition for treating allergy according to the present invention may be used in various foods, and foods to which the composition of the present invention may be added include, for example, tea, alcohol, beverages, cosmetics, health supplements, and the like. Can be used to treat warm-blooded animals such as dogs, rabbits and cats. In other words, when the lyophilized extract extracted by the manufacturing method according to the present invention is mixed with tea, liquor, beverages, cosmetics, health supplement foods at a certain ratio, it can be used in various foods.

본 발명에 따른 제조방법을 통해 제조된 동결건조 머루 추출물을 약제학적으로 허용 가능한 담체와 일정 조성비로 혼합하여 알레르기 치료용 경구 제제의 제형으로 제조하는 경우 정제와 캡슐제 및 과립제로 제조할 수 있다. 이때, 알레르기 치료용 경구 제제의 제형으로써 정제를 제조하는 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 추출물의 중량에 대하여 유당 80∼85 중량부, 동결건조 머루 추출물의 중량에 대하여 탈크 0.5∼1.0 중량부 및 동결건조 머루 추출물의 중량에 대하여 마크네슘 스테아레이트 0.05∼0.2 중량부의 조성비로 이루어진다.When the lyophilized buckwheat extract prepared by the preparation method according to the present invention is mixed with a pharmaceutically acceptable carrier at a predetermined composition ratio to prepare a formulation of an oral preparation for allergy treatment, it may be prepared as a tablet, capsule, and granule. At this time, when preparing a tablet as a formulation of an oral preparation for allergy treatment, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, the lactose 80 to 85 parts by weight, and the lyophilized buckwheat extract 0.5 to 1.0 parts by weight of talc and 0.05 to 0.2 parts by weight of magnesium stearate relative to the weight of the lyophilized extract.

그리고, 알레르기 치료용 경구 제제의 제형으로써 캡슐제를 제조하는 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 머루 추출물의 중량에 대하여 전분 1∼2 중량부 및 동결건조 머루 추출물의 중량에 대하여 스테아르산마그네슘 10∼20 중량부의 조성비로 혼합한 후 젤라틴 캡슐에 충전하는 구성으로 이루어진다.And, when preparing a capsule as a formulation of oral preparations for the treatment of allergy, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, 1 to 2 parts by weight of starch and lyophilized based on the weight of the lyophilized buckwheat extract. It is composed of a composition that is filled in gelatin capsules after mixing in a composition ratio of 10 to 20 parts by weight of magnesium stearate with respect to the weight of the extract.

아울러, 알레르기 치료용 경구 제제의 제형으로써 과립제를 제조하는 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 머루 추출물의 중량에 대하여 유당 10∼20 중량부 및 동결건조 머루 추출물의 중량에 대하여 탈크 0.5∼1.0 중량부의 조성비로 이루어진다.In addition, in the preparation of granules as a formulation of oral preparations for the treatment of allergy, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, 10-20 parts by weight of lactose and the lyophilized buckwheat It consists of a composition ratio of 0.5-1.0 weight part of talc with respect to the weight of an extract.

또한, 본 발명에 따른 기술은 본 발명에 따른 제조방법을 통해 제조된 동결건조 머루 추출물을 약제학적으로 허용 가능한 담체와 일정 조성비로 혼합하여 알레르기 치료용 피부 도포 제제의 제형으로 제조하는 경우 크림제와 로션제로 제조할 수 있다. 이때, 알레르기 치료용 피부 도포 제제의 제형으로써 크림제를 제조하는 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 머루 추출물의 중량에 대하여 백색바셀린 450∼550 중량부, 동결건 조 머루 추출물의 중량에 대하여 스테아린알코올 350∼450 중량부, 동결건조 머루 추출물의 중량에 대하여 프로피렌그라이콜 200∼280 중량부, 동결건조 머루 추출물의 중량에 대하여 스테아린산모노글리세린 100∼140 중량부, 동결건조 머루 추출물의 중량에 대하여 피마자유 0.1∼0.2 중량부, 동결건조 머루 추출물의 중량에 대하여 메틸파라벤 0.1∼0.2 중량부 및 동결건조 머루 추출물의 중량에 대하여 정제수 600∼650 중량부의 조성비로 이루어진다.In addition, the technique according to the present invention is mixed with a pharmaceutically acceptable carrier and a predetermined composition ratio of the lyophilized extract extracted through the manufacturing method according to the invention in the case of preparing the formulation of the skin coating formulation for allergy treatment and cream and It may be prepared as a lotion agent. In this case, when preparing a cream as a formulation of a skin coating formulation for allergy treatment, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, 450-550 parts by weight of white petrolatum with respect to the weight of the lyophilized buckwheat extract, Stearin alcohol 350-450 parts by weight relative to the weight of the lyophilized extract, 200-280 parts by weight of propylene glycol relative to the weight of the lyophilized extract, and 100-140 weight of monoglycerol stearic acid based on the weight of the lyophilized extract. 0.1,0.2 parts by weight of castor oil, 0.1 to 0.2 parts by weight of methyl paraben, and 600 to 650 parts by weight of purified water, based on the weight of lyophilized extract, Is done.

한편, 알레르기 치료용 피부 도포 제제의 제형으로써 로션제를 제조하는 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 머루 추출물의 중량에 대하여 글리세린 150∼170 중량부, 동결건조 머루 추출물의 중량에 대하여 올레인산 30∼50 중량부, 동결건조 머루 추출물의 중량에 대하여 트리에탄올아민 5∼15 중량부 및 동결건조 머루 추출물의 중량에 대하여 정제수 1650∼1700 중량부의 조성비로 이루어진다.On the other hand, when the lotion is prepared as a formulation of the skin coating formulation for allergy treatment, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, and 150 to 170 parts by weight of glycerin with respect to the weight of the lyophilized buckwheat extract, 30 to 50 parts by weight of oleic acid, 5 to 15 parts by weight of triethanolamine, and 1650 to 1700 parts by weight of purified water, based on the weight of the lyophilized meringue extract, based on the weight of the dried meringue extract.

또한, 본 발명에 따른 제조방법을 통해 제조된 동결건조 머루 추출물은 약제학적으로 허용 가능한 담체와 일정 조성비로 혼합하여 알레르기 치료용 주사제의 제형으로 제조할 수 있다. 이때, 알레르기 치료용 주사제의 경우 동결건조 머루 추출물과 담체의 조성비는 동결건조 머루 추출물 100 중량부, 동결건조 머루 추출물의 중량에 대하여 산성아황산나트륨 1.0∼2.0 중량부, 동결건조 머루 추출물의 중량에 대하여 메틸파라벤 0.5∼1.5 중량부, 동결건조 머루 추출물의 중량에 대하여 푸로펜파라벤 0.3∼1.0 중량부, 동결건조 머루 추출물의 중량에 대하여 제일인산나트륨 1.5∼2.5 중량부, 동결건조 머루 추출물의 중량에 대하여 제이인산나트륨 1.0∼1.5 중량부, 동결건조 머루 추출물의 중량에 대하여 수산화나트륨 1.0∼2.0 중량부 및 동결건조 머루 추출물의 중량에 대하여 주사용수 1.0∼2.0 중량부의 조성비로 이루어진다.In addition, the lyophilized beet extract prepared by the manufacturing method according to the present invention can be prepared in the formulation of an injection for treating allergy by mixing with a pharmaceutically acceptable carrier in a certain composition ratio. At this time, in the case of injection for allergy treatment, the composition ratio of the lyophilized buckwheat extract and the carrier is 100 parts by weight of the lyophilized buckwheat extract, 1.0-2.0 parts by weight of sodium sulfite acid, and the weight of the lyophilized buckwheat extract 0.5-1.5 parts by weight of methyl paraben, 0.3-1.0 parts by weight of furopenparaben, and 1.5-2.5 parts by weight of sodium phosphate monobasic, and lyophilized extract of mercury extract 1.0 to 1.5 parts by weight of sodium diphosphate, 1.0 to 2.0 parts by weight of sodium hydroxide relative to the weight of the lyophilized meringue extract, and 1.0 to 2.0 parts by weight of water for injection relative to the weight of the lyophilized meringue extract.

이하에서는 본 발명의 실시 예 및 제조 예를 통하여 본 발명에 따른 기술을 더욱 상세하게 설명하기로 한다. 이때, 본 발명이 하기 실시예 및 제조예로 제한되는 것은 아니다.Hereinafter, the technology according to the present invention will be described in more detail with reference to Examples and Manufacturing Examples of the present invention. At this time, the present invention is not limited to the following examples and preparation examples.

[실시 예 1]Example 1

머루(산머루)의 메탄올 추출물 제조Preparation of Methanol Extract of Wild Fruits

머루를 한약 건조기에서 건조한 후 70 중량 %의 메탄올 수욕상에서 환류냉각관을 부착하여 환류 추출한 다음 농축하여 메탄올을 회수하고, 동결건조기로 건조하여 동결건조 머루 추출물을 제조하였다.After drying the medicinal herbs in a medicine drier, reflux extraction by attaching a reflux condenser in a methanol water bath of 70% by weight, concentrated to recover the methanol, and dried by a lyophilizer to prepare a freeze-dried maru extract.

[실시 예 2]Example 2

전신성 알레르기 반응에 대한 머루 추출물의 농도에 따른 효과Effect of Concentrated Extract of Murume on Systemic Allergic Reaction

머루가 생쥐의 전신성 알레르기 반응에 미치는 효과를 확인하기 위하여 치사율 실험을 하였다. 표 1 은 전신성 알레르기 반응에 대한 머루의 농도에 따른 효과를 나타내고 있다. 탈과립제인 compound 48/80을 생쥐의 복강에 투여하기 60분 전에 머루 건조물을 0.005∼0.1 mg/g의 용량으로 복강 내에 주사하였으며 치사율은 아나필락시를 유발시킨 후 1시간 동안 관찰하였다. 생리식염수 200μl를 투여한 대조군은 100% 치사율을 보였지만 머루 추출물을 0.01 mg/g 투여하였을 때는 치사율이 80%, 0.05 mg/g을 투여하였을 때는 20%, 0.1 mg/g의 농도로 투여하였을 때는 치사율이 0%로 농도 의존적으로 치사율이 억제됨을 알 수 있었다 .A mortality study was conducted to determine the effects of the buckwheat on systemic allergic reactions in mice. Table 1 shows the effect of the concentration of melon on systemic allergic reactions. 60 minutes before the degranulation of Compound 48/80 was injected into the abdominal cavity of mice, the dried muru was injected intraperitoneally at a dose of 0.005 to 0.1 mg / g and mortality was observed for 1 hour after inducing anaphylaxis. The control group treated with 200 μl of saline showed 100% mortality, but the mortality rate was 80% when 0.01 mg / g was administered and 20% and 0.05 mg / g when 0.05 mg / g was administered. The mortality was suppressed in concentration-dependent manner at 0%.

전신성 알레르기 반응에 대한 머루 추출물의 농도에 따른 효과를 나타낸 표Table showing the effect of the concentration of the extract on systemic allergic reactions 머루 (mg/g, BW)Maroon (mg / g, BW) compound 48/80 (0.008 mg/g BW)compound 48/80 (0.008 mg / g BW) mortality (%)mortality (%) none (saline)none (saline) ++ 100100 0.0050.005 ++ 100100 0.010.01 ++ 8080 0.050.05 ++ 2020 0.10.1 ++ 00 0.10.1 -- 00

[실시 예 3]Example 3

전신성 알레르기 반응에 대한 머루 추출물의 시간에 따른 효과Effects of Muru extracts over Time on Systemic Allergic Reactions

머루 추출물이 생쥐의 전신성 알레르기 반응에 미치는 효과를 확인하기 위하여 시간에 따른 치사율 실험을 하였다. 표 2 는 전신성 알레르기 반응에 대한 머루 추출물의 시간에 따른 효과를 나타내고 있다. 탈과립제인 compound 48/80을 생쥐의 복강에 투여한 후 동결건조 머루 추출물 0.1 mg/g을 5분, 10분, 15분 및 20분에 각각 복강 내에 주사하였으며, 치사율은 아나필락시를 유발시킨 후 1시간 동안 관찰하였다. 탈과립제인 compound 48/80을 생쥐의 복강에 투여한 5분 후에 머루를 투여하였을 때 치사율은 0 %, 10분 후에 투여하였을 때는 40 %, 15분 후에 투여하였을 때는 80 %로 치사율이 시간 의존적으로 증가함을 알 수 있었다.The mortality test was conducted over time to determine the effect of the extract of Murume on systemic allergic reactions in mice. Table 2 shows the effects over time of the extract of the wild grapes on the systemic allergic reaction. Degranulation compound 48/80 was administered to the abdominal cavity of mice, and 0.1 mg / g of lyophilized wild berry extract was injected intraperitoneally at 5 minutes, 10 minutes, 15 minutes, and 20 minutes, respectively. The lethality was 1 hour after inducing anaphylaxis. Was observed. Mortality increased by 0% when 5 minutes after degranulation of Compound 48/80 in mice intraperitoneally, 40% after 10 minutes, and 80% after 15 minutes. I could see.

전신성 알레르기 반응에 대한 머루 추출물의 시간에 따른 효과를 나타낸 표Table showing the effects of Murume extract over time on systemic allergic reactions 머루 (mg/g, BW)Maroon (mg / g, BW) time (min)time (min) compound 48/80 (0.008 mg/g BW)compound 48/80 (0.008 mg / g BW) mortality (%)mortality (%) none (saline)none (saline) 00 ++ 100100 0.10.1 55 ++ 00 1010 ++ 4040 1515 ++ 8080 2020 ++ 100100

[실시 예 4]Example 4

국소 피부 알레르기 반응에 대한 머루 추출물의 효과Effects of Extracts of Muru on Local Skin Allergic Reactions

알레르기 치료효과를 갖는 약물을 개발할 때 많이 사용되는 수동형 국소 피부 알레르기 반응 (Passive Cutaneous Anaphylaxis, PCA)을 이용하여 머루 추출물의 피부 알레르기에 대한 효과를 실험하였다. PCA는 면역 글로블린 E에 의해 매개되는 알레르기 반응으로 항체를 국소 피부에 피내 주사하고, 48시간 후 항원을 생쥐의 꼬리 정맥으로 투여하여 인위적으로 알레르기 반응을 일으키는 실험 방법이다. 표 3 은 국소 피부 알레르기 반응에 대한 머루 추출물의 효과를 나타내고 있다. 항원과 항체를 생쥐에 투여하면 항체 주입 부위에 국소적으로 발적이 일어나 그 부위에 존재하는 비만세포가 활성화되어 국소적으로 알레르기 반응이 나타난다. 여기에 머루 추출물을 전처리한 결과 머루는 농도 의존적으로 국소 피부 알레르기 반응을 억제함을 알 수 있었다.Passive cutaneous anaphylaxis (PCA), which is widely used in the development of drugs with allergic effects, was used to test the effects of extracts on skin allergy. PCA is an experimental method in which an allergic reaction mediated by immunoglobulin E is injected intravenously into topical skin, and then an antigen is injected into the tail vein of a mouse artificially to cause an allergic reaction 48 hours later. Table 3 shows the effect of the fern extract on the topical skin allergic reaction. When antigen and antibody are administered to mice, local redness occurs at the site of antibody injection, thereby activating mast cells present at the site, thereby causing an allergic reaction locally. As a result of pretreatment of the extract, it was found that the extract suppressed the local skin allergic reaction in a concentration-dependent manner.

국소 피부 알레르기 반응에 대한 머루 추출물의 효과를 나타낸 표Table showing the effect of the extract of the wild grape on the topical skin allergic reaction 머루(mg/g)Maroon (mg / g) Anti-DNP IgE plus DNP_HSAAnti-DNP IgE plus DNP_HSA Inhibition (%)Inhibition (%) none (saline)none (saline) ++ 0.0010.001 ++ 17.717.7 0.010.01 ++ 21.321.3 0.10.1 ++ 52.1* 52.1 * 1One ++ 58.8* 58.8 *

[실시 예 5]Example 5

염증 유발성 사이토카인의 분비에 대한 머루 추출물의 효과Effects of Extracts of Murano on Secretion of Inflammatory Cytokines

종양괴사인자-알파(TNF-α), 인터루킨-6(IL-6)와 같은 염증 유발성 사이토카인은 비만세포에서 유리되거나 새로 합성되어 분비됨으로서 염증성 알레르기를 유발하는 중요한 생리활성 물질이다. 표 4, 표 5 및 표 6은 염증 유발성 사이토카인의 분비에 대한 머루 추출물의 효과를 나타내고 있다.Inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) are important bioactive substances that cause inflammatory allergies by being released from the mast cells or newly synthesized. Table 4, Table 5 and Table 6 show the effect of Murume extract on the secretion of proinflammatory cytokines.

Protein kinase C 활성화 인자인 Phorbol 12-myristate 13-acetate(PMA)와 칼슘 채널 활성화 인자인 Calcium ionophore A23187(A23187)은 비만세포를 활성화 하여 염증 유발성 사이토카인의 분비를 촉진한다는 것이 널리 알려져 있으며, 이들을 인체 비만세포주 (Human mast cell lime, HMC-1 )인 세포에 투여한 결과 종양괴사인자-알파와 인터루킨-6 및 인터루킨-8의 분비량이 증가하였다. 여기에 머루 추출물을 농도별로 전처리한 결과 머루 추출물은 농도 의존적으로 PMA와 A23187에 의한 종양괴사인자-알파, 인터루킨-6 및 인터루킨-8 분비량을 감소시켰다.Phorbol 12-myristate 13-acetate (PMA), a protein kinase C activator, and Calcium ionophore A23187 (A23187), a calcium channel activator, are known to activate mast cells to promote secretion of inflammatory cytokines. Administration of cells to human mast cell lime (HMC-1) resulted in increased tumor necrosis factor-alpha, interleukin-6 and interleukin-8 secretion. In addition, as a result of pretreatment of the extracts by concentration, the extracts reduced tumor necrosis factor-alpha, interleukin-6 and interleukin-8 secretion by PMA and A23187.

염증 유발성 사이토카인(Cytokine) TNF-α의 분비에 대한 머루 추출물의 효과를 나타낸 표Table showing the effect of the extract of Murhu on the secretion of proinflammatory cytokine TNF-α TreatmentTreatment Concentration (mg/ml)Concentration (mg / ml) TNF-α content (ng/ml)TNF-α content (ng / ml) none (saline)none (saline) 0.639 ± 0.0410.639 ± 0.041 PMA + A23187 (control)PMA + A23187 (control) 2.334 ± 0.0882.334 ± 0.088 PMA + A23187 + 머루PMA + A23187 + Maroo 0.010.01 2.035 ± 0.0242.035 ± 0.024 PMA + A23187 + 머루PMA + A23187 + Maroo 0.10.1 1.434 ± 0.074* 1.434 ± 0.074 * PMA + A23187 + 머루PMA + A23187 + Maroo 1One 1.168 ± 0.035* 1.168 ± 0.035 *

염증 유발성 사이토카인(Cytokine) IL-6의 분비에 대한 머루 추출물의 효과를 나타낸 표Table showing the effect of the extract of Murhu on the secretion of proinflammatory cytokine IL-6 TreatmentTreatment Concentration (mg/ml)Concentration (mg / ml) IL-6 content (ng/ml)IL-6 content (ng / ml) none (saline)none (saline) 0.074 ± 0.0200.074 ± 0.020 PMA + A23187 (control)PMA + A23187 (control) 0.214 ± 0.0310.214 ± 0.031 PMA + A23187 + 머루PMA + A23187 + Maroo 0.010.01 0.197 ± 0.0430.197 ± 0.043 PMA + A23187 + 머루PMA + A23187 + Maroo 0.10.1 0.149 ± 0.031* 0.149 ± 0.031 * PMA + A23187 + 머루PMA + A23187 + Maroo 1One 0.131 ± 0.012* 0.131 ± 0.012 *

염증 유발성 사이토카인(Cytokine) IL-8의 분비에 대한 머루 추출물의 효과를 나타낸 표Table showing the effect of the extract of Murhu on the secretion of proinflammatory cytokine IL-8 TreatmentTreatment Concentration (mg/ml)Concentration (mg / ml) IL-8 content (ng/ml)IL-8 content (ng / ml) none (saline)none (saline) 0.213 ± 0.0410.213 ± 0.041 PMA + A23187 (control)PMA + A23187 (control) 2.726 ± 0.550 2.726 ± 0.550 PMA + A23187 + 머루PMA + A23187 + Maroo 0.010.01 2.420 ± 0.173 2.420 ± 0.173 PMA + A23187 + 머루PMA + A23187 + Maroo 0.10.1 2.364 ± 0.241 2.364 ± 0.241 PMA + A23187 + 머루PMA + A23187 + Maroo 1One 1.407 ± 0.151* 1.407 ± 0.151 *

이하, 본 발명에 따른 알레르기의 치료용 조성물을 다양한 제형으로 제제화한 제조예를 설명하기로 한다.Hereinafter, the preparation examples of the composition for treating allergy according to the present invention in various dosage forms will be described.

[제조 예 1] 정제[Production Example 1] Tablet

하기의 조성에 따라 통상의 정제 제조방법으로 정제를 제조하였다.According to the following composition to prepare a tablet by a conventional tablet manufacturing method.

정제 조성물Tablet composition

동결건조 머루 추출물 ------------------------ 600.0 mgLyophilized Maroon Extract ------------------------ 600.0 mg

유당 --------------------------------------- 500.0 mgLactose -------------------------------------- 500.0 mg

탈크 ----------------------------------------- 5.0 mgTalc ----------------------------------------- 5.0 mg

마그네슘 스테아레이트 ------------------------ 1.0 mgMagnesium Stearate ------------------------ 1.0 mg

[제조 예 2] 캡슐제[Production Example 2] Capsule

하기와 같은 조성을 통해 통상의 캡슐제 제조방법으로 캡슐제를 제조하였다. 이때, 동결건조 머루 추출물을 체질하여 부형제와 혼합한 후 젤라틴 캡슐 중에 충전하여 캡슐을 제조하였다.A capsule was prepared by a conventional capsule preparation method through the composition as follows. At this time, the lyophilized buckwheat extract was sieved, mixed with an excipient, and filled into gelatin capsules to prepare capsules.

캡슐제 조성물Capsule Composition

동결건조 머루 추출물 ------------------------ 600.0 mgLyophilized Maroon Extract ------------------------ 600.0 mg

전분 1500 ----------------------------------- 10.0 mgStarch 1500 ----------------------------------- 10.0 mg

스테아르산마그네슘 ------------------------- 100.0 mgMagnesium Stearate ------------------------- 100.0 mg

[제조 예 3] 과립제Production Example 3 Granules

하기와 같은 조성을 통해 통상의 과립제 제조방법으로 과립제를 제조하였다.A granule was prepared by a conventional granule preparation method through the composition as follows.

과립제 조성물Granule composition

동결건조 머루 추출물 ------------------------ 600.0 mgLyophilized Maroon Extract ------------------------ 600.0 mg

유당 --------------------------------------- 100.0 mgLactose -------------------------------------- 100.0 mg

탈크 ----------------------------------------- 5.0 mgTalc ----------------------------------------- 5.0 mg

[제조 예 4] 주사제Production Example 4 Injection

하기와 같은 조성을 통해 통상의 주사제의 제조방법으로 주사제를 제조하였다.Injectables were prepared by a conventional method for preparing injectables through the following composition.

주사제 조성물Injectable Composition

동결건조 머루 추출물 ------------------------ 600.0 mgLyophilized Maroon Extract ------------------------ 600.0 mg

산성아황산나트륨 ---------------------------- 10.0 mgSodium acid sulfite ---------------------------- 10.0 mg

메틸파라벤 ----------------------------------- 6.0 mgMethylparaben ----------------------------------- 6.0 mg

푸로펜파라벤 --------------------------------- 4.0 mgFufenparaben --------------------------------- 4.0 mg

제일인산나트륨 ------------------------------ 12.0 mgSodium monophosphate ------------------------------ 12.0 mg

제이인산나트륨 ------------------------------- 8.0 mgSodium Diphosphate ------------------------------- 8.0 mg

수산화나트륨 -------------------------------- 10.0 mgSodium Hydroxide -------------------------------- 10.0 mg

주사용수 ------------------------------------ 10.0 mlWater for Injection ------------------------------------ 10.0 ml

[제조 예 5] 크림제Production Example 5 Cream

하기의 성분을 통상의 크림제 제조방법으로 크림제를 제조하였다.The following components were used to prepare a cream by the usual cream preparation.

크림제 조성물Cream composition

동결건조 머루 추출물 ------------------------- 50.0 gLyophilized Maroon Extract ------------------------- 50.0 g

백색바셀린 --------------------------------- 250.0 gWhite Vaseline --------------------------------- 250.0 g

스테아린알코올 ----------------------------- 200.0 gStearin Alcohol ----------------------------- 200.0 g

프로피렌그라이콜 --------------------------- 120.0 gPropylene glycol --------------------------- 120.0 g

스테아린산모노글리세린 ---------------------- 60.0 gStearic Acid Monoglycerine ---------------------- 60.0 g

피마자유 ------------------------------------- 0.08 gCastor Oil ------------------------------------- 0.08 g

메틸파라벤 ----------------------------------- 0.06 gMethylparaben ----------------------------------- 0.06 g

정제수 ------------------------------------- 319.86 gPurified Water ------------------------------------- 319.86 g

[제조 예 6] 로션제[Manufacture example 6] lotion system

하기의 성분을 통상의 로션제 제조방법으로 로션제를 제조하였다.The following components were used to prepare the lotion by the usual method of preparing the lotion.

로션제 조성물Lotion composition

동결건조 머루 추출물 ------------------------- 50.0 gLyophilized Maroon Extract ------------------------- 50.0 g

글리세린 ------------------------------------- 80.0 gGlycerin ------------------------------------- 80.0 g

올레인산 ------------------------------------- 20.0 gOleic acid ------------------------------------- 20.0 g

트리에탄올아민 -------------------------------- 5.0 gTriethanolamine -------------------------------- 5.0 g

정제수 -------------------------------------- 845 gPurified water -------------------------------------- 845 g

이상에서와 같이 본 발명에 따른 기술은 머루 추출물을 함유하는 경구, 피부 도포 및 주사제 제제의 제형으로 제조된 알레르기 치료제를 통해 전신성 알레르기 반응 및 국소 피부 알레르기 반응의 예방 및 치료를 할 수 있다.As described above, the technique according to the present invention can prevent and treat systemic allergic reactions and local skin allergic reactions through allergic agents prepared by the formulation of oral, skin application and injection preparations containing the melon extract.

본 발명은 전술한 실시 예에 국한되지 않고 본 발명의 기술사상이 허용하는 범위 내에서 다양하게 변형하여 실시할 수가 있다.The present invention is not limited to the above embodiments, and various modifications can be made within the scope of the technical idea of the present invention.

이상에서와 같이 본 발명에 따르면 인체의 세포내에서 TNF-α와 IL-6 및 IL-8의 생성을 감소시키는 작용기전을 하는 머루 추출물을 통해 전신성 알레르기 반응 및 국소 피부 알레르기 반응의 예방과 치료 효과가 탁월하면서도 장기복용에 따른 부작용이 최소화된 경구, 피부 도포 및 주사제 제제의 제형으로 제조된 알레르기 치료제를 제공할 수 있는 효과가 발현된다.As described above, according to the present invention, the effect of preventing and treating systemic allergic reactions and local skin allergic reactions through the extract of melon which has a mechanism of action that reduces the production of TNF-α and IL-6 and IL-8 in human cells. The effect of providing an allergy therapeutic agent prepared in the formulation of oral, dermal application and injectable preparations is excellent while minimizing the side effects of long-term use.

아울러, 본 발명에 따른 기술은 머루 추출물을 함유하는 경구, 피부 도포 및 주사제 제제의 제형으로 제조된 알레르기 치료제를 통해 전신성 알레르기 반응 및 국소 피부 알레르기 반응의 예방 및 치료 효과가 있도록 함은 물론, 머루 추출물을 차, 술, 음료, 화장품, 건강보조 식품류 등의 다양한 식품류에도 이용할 수 있다.In addition, the technique according to the present invention, as well as to prevent and treat systemic allergic reactions and local skin allergic reactions through allergic agents prepared by the formulation of oral, skin application and injection formulations containing the melon extract, as well as melon extract It can also be used for a variety of foods, such as tea, alcohol, beverages, cosmetics, dietary supplements.

Claims (6)

(a) 머루를 수분함량 15% 이하로 건조시키는 단계;(a) drying the mulberry to 15% or less of moisture; (b) 단계 (a)의 과정을 통해 건조된 머루를 메탄올에 투입하되 건조된 머루와 메탄올의 비율은 20∼40 : 60∼80 중량%의 비율로 투입하여 메탄올 수욕상에서 환류냉각 추출하는 단계;(b) injecting dried muru through methanol in the process of step (a), wherein the ratio of dried muru to methanol is added at a ratio of 20 to 40:60 to 80 wt% to extract reflux with cooling in a methanol water bath; (c) 단계 (b)의 과정을 통해 환류냉각 추출된 머루 추출물을 농축시켜 메탄올을 회수하는 단계; 및(c) recovering methanol by concentrating the reflux extract extracted from the reflux through the process of step (b); And (d) 단계 (c)의 과정을 통해 농축된 머루 추출물을 동결건조시켜 동결건조 머루 추출물을 수득하는 단계를 포함한 구성으로 이루어진 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법.(D) a method for producing a composition for treating allergy using an extract of buckwheat, comprising a step of lyophilizing the concentrated buckwheat extract through the process of step (c) to obtain a lyophilized buckwheat extract. 제 1 항에 있어서, 상기 단계 (d)의 과정을 통해 얻은 동결건조 머루 추출물 1∼90 중량%와 약제학적으로 허용 가능한 담체 10∼99 중량%의 조성비로 혼합하여 경구, 피부 도포 및 주사제 제제 중 어느 하나의 제형으로 제조하는 것을 특징으로 하는 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법.According to claim 1, wherein the composition of the oral, dermal application and injection formulation by mixing in a composition ratio of 1 to 90% by weight of the lyophilized extract of the extract obtained through the step (d) and 10 to 99% by weight of a pharmaceutically acceptable carrier Method for producing a composition for treating allergy using the extract of the melon, characterized in that it is prepared in any one formulation. 제 2 항에 있어서, 상기 담체는 부형제, 결합제, 활택제, 붕괴제, 피복제, 유화제, 현탁제, 용제, 안정화제, 흡수조제, 주사용수 및 등장화제로 이루어진 군으로부터 선택된 1종 이상의 담체인 것을 특징으로 하는 머루 추출물을 이용한 알 레르기 치료용 조성물의 제조방법.3. The carrier according to claim 2, wherein the carrier is at least one carrier selected from the group consisting of excipients, binders, lubricants, disintegrants, coating agents, emulsifiers, suspensions, solvents, stabilizers, absorption aids, water for injection and isotonic agents. Method for producing a composition for the treatment of allergy using the extract of the melon, characterized in that. 제 2 항에 있어서, 상기 알레르기 치료용 조성물의 투여량은 상기 동결건조 머루 추출물의 중량을 기준으로 500~2,000 mg/일인 것을 특징으로 하는 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법.The method of claim 2, wherein the dosage of the composition for treating allergy is 500 to 2,000 mg / day based on the weight of the lyophilized extract of the extract. 제 2 항에 있어서, 상기 경구 제제는 과립제, 정제 또는 캅셀제로 제조되며, 상기 피부 도포 제제는 크림제 또는 로션제로 제조되는 것을 특징으로 하는 머루 추출물을 이용한 알레르기 치료용 조성물의 제조방법.The method of claim 2, wherein the oral preparation is made of granules, tablets or capsules, and the skin coating preparation is made of a cream or lotion. 제 1 항 내지 제 5 항 중 어느 한 항의 방법으로 제조된 것을 특징으로 하는 머루 추출물을 이용한 알레르기 치료용 조성물.Claims 1 to 5, wherein the composition for the treatment of allergies using the extract of any one of the preceding, characterized in that it is prepared.
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Publication number Priority date Publication date Assignee Title
KR101051076B1 (en) 2009-06-09 2011-07-21 이태규 Composition for the treatment of allergy comprising peach and manufacturing method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR19990078667A (en) * 1999-07-23 1999-11-05 하종심 Cream for Itching Symptoms Improvement and Manufacturing Method thereof
KR19990083931A (en) * 1999-09-01 1999-12-06 하종심 Soap for Itching Symptoms Improvement and Manufacturing Method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR19990078667A (en) * 1999-07-23 1999-11-05 하종심 Cream for Itching Symptoms Improvement and Manufacturing Method thereof
KR19990083931A (en) * 1999-09-01 1999-12-06 하종심 Soap for Itching Symptoms Improvement and Manufacturing Method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101051076B1 (en) 2009-06-09 2011-07-21 이태규 Composition for the treatment of allergy comprising peach and manufacturing method thereof

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