KR101103393B1 - Composition containing a herbal extract for preventing and treating respiratory organ disease - Google Patents
Composition containing a herbal extract for preventing and treating respiratory organ disease Download PDFInfo
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- KR101103393B1 KR101103393B1 KR1020080113929A KR20080113929A KR101103393B1 KR 101103393 B1 KR101103393 B1 KR 101103393B1 KR 1020080113929 A KR1020080113929 A KR 1020080113929A KR 20080113929 A KR20080113929 A KR 20080113929A KR 101103393 B1 KR101103393 B1 KR 101103393B1
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- KR
- South Korea
- Prior art keywords
- extract
- expectorant
- antitussive
- pharmaceutical composition
- activity
- Prior art date
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Abstract
본 발명은 진해, 거담 활성을 나타내는 호흡기 질환의 예방 및 치료용 조성물에 관한 것으로, 상세하게는 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 생약 추출물과 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하고, 거담 활성, 진해 활성 및 항히스타민 활성 효과를 나타냄을 확인함으로써, 호흡기 질환의 예방 및 치료에 유용한 약학조성물 및 건강기능식품으로 이용될 수 있다. The present invention relates to a composition for the prophylaxis and treatment of respiratory diseases exhibiting antitussive and expectorant activity, and specifically, selected from the group consisting of one or more herbal extracts selected from the group consisting of baekbaek, chylopodium and ducts; It can be used as a pharmaceutical composition and health functional food useful for the prevention and treatment of respiratory diseases by containing two or more mixed herbal extracts as an active ingredient and confirming that it exhibits expectorant activity, antitussive activity and antihistamine activity.
황백, 희첨, 연교, 호흡기, 거담, 진해, 항히스타민 Yellowish white, comedy, fellowship, respiratory organs, expectorant, Jinhae, antihistamine
Description
본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 추출물을 유효성분으로 함유하는 진해 또는 거담용 조성물로서 호흡기 질환의 예방 및 치료에 유용한 조성물에 관한 것이다. The present invention relates to a composition useful for the prevention and treatment of respiratory diseases as an antitussive or expectorant composition containing as an active ingredient at least one extract selected from the group consisting of yellowish white, rare and yeongyo.
또한, 본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 추출물을 유효성분으로 함유하는 진해 또는 거담용 조성물로서 호흡기 질환의 예방 및 치료에 유용한 조성물에 관한 것이다. In addition, the present invention relates to a composition for the prevention and treatment of respiratory diseases as an antitussive or expectorant composition containing as an active ingredient two or more mixed extracts selected from the group consisting of yellowish white, rare and ducts.
우리 몸의 호흡기는 물리·화학적인 자극에 대해 끊임없이 방어하고 있는 기관 중 하나로 자극물질이 호흡기로 유입되면 대부분의 자극물질은 코털에 걸려 호흡기로 들어오지 못하나 이를 통과한 미세한 자극물질은 점액으로 둘러싸여지고, 기도 벽에 위치한 미세한 섬모의 운동에 의해 위로 혹은 밖으로 내보내지게 되는데, 바로 이것이 기침의 기본 작용원리이다. 기침은 기 언급한 바와 같이 기도 점막 자극에 의해 반사적으로 일어나는 방어기전이고 지나친 자극에 의한 지속적인 기침이 유발될 경우, 환자의 삶의 질을 경감시키고 악화시키게 된다. 기침과 같은 원리로 외부에서 먼지나 자극물질 등이 유입되면 우리 몸의 기관지에서는 타액과 함께 근육운동을 해서 외부로 밀어내게 되는데 이것이 객담형성의 원인이며 폐 등 기관지의 염증에 의해서 짙은 화농성 객담이 생기게 되는 것이다. The respiratory system of our body is one of the organs that constantly defends against physical and chemical stimuli. When the stimulant enters the respiratory tract, most of the stimulant gets caught in the nose and does not enter the respiratory tract, but the fine stimulant passed through it is surrounded by mucus, The tiny cilia located on the airway wall send them out or up, which is the basic principle of coughing. Cough, as mentioned earlier, is a reflexive defense mechanism caused by airway mucosal stimulation, and when a persistent cough is caused by excessive stimulation, it reduces and worsens the quality of life of the patient. In the same principle as coughing, when dust or irritants are introduced from the outside, the body's bronchus moves muscles with saliva and pushes them to the outside. This is the cause of sputum formation, which causes dark purulent sputum due to inflammation of the bronchus and lungs. Will be.
결과적으로 찬공기, 병원성 미생물을 포함한 외부 이물질, 대기 오염 물질, 알레르기 유발 물질 등과 같은 물리ㆍ화학적 요인등에 의해 기침 및 가래가 발생되며 이를 크게 세가지로 나눌 수 있다. As a result, cough and sputum are caused by physical and chemical factors such as cold air, external foreign substances, including pathogenic microorganisms, air pollutants, and allergens, which can be divided into three categories.
첫째, 물리ㆍ화학적 요인으로 인해 후두, 기관, 기관지, 인두, 부비동, 횡격막 등의 기침 수용체를 자극하면 뇌의 연수 부위의 기침 중추에 자극이 전달되고 기침 반사가 일어난다. 이러한 자극성 기침반사와 밀접히 관련있는 진해제의 기전은, 중추성과 말초성으로 대별되며, 중추성 진해제의 기전은 연수의 해소 중추를 억제하여 기침을 조절하는 약물로서 코데인(codeine), 덱스트로메토르판(dextromethorphan), 노스캡핀(noscapine), 에페드린(ephedrine), 지페프롤(zipeprol) 등이 있는데 이러한 성분들은 종종 심혈관계 혈전반응이나 심근경색, 호흡억제, 진정작용, 위장장애 등등의 부작용을 유발하는 경우가 있다. 말초성 진해제는 말초에 있는 신장 수용체 (stretch receptor)에 작용하여 기침을 조절하는 것으로 상대적으로 중추성 진해제의 단점을 보완하여 안전하고, 최근에 이러한 진해제의 개발이 많이 시도되고 있으며 대표적인 약물로는 레보프로피진(levopropizine), 벤조나테이트(benzonatate), 벤조자인(benzozaine), 벤질알콜(benzyl alchol) 등이 사용되고 있다. First, stimulation of cough receptors in the larynx, trachea, bronchus, pharynx, sinuses, diaphragm due to physical and chemical factors, the stimulus is transmitted to the cough center of the soft zone of the brain and cough reflex occurs. The mechanisms of antitussives, which are closely related to these irritant cough reflexes, are classified into central and peripheral, and the mechanisms of central antitussives are drugs that control cough by inhibiting the relieving center of soft water, such as codeine and dextromethorphan ( dextromethorphan, noscapine, ephedrine, zipeprol, etc. These components often cause side effects such as cardiovascular thrombosis, myocardial infarction, respiratory depression, sedation, and gastrointestinal disorders. There is. Peripheral antitussives act on the kidney's kidney receptor (stretch receptor) to control cough, which is relatively safe to compensate for the disadvantages of central antitussives, and the development of such antitussives has recently been tried a number of representative drugs Levopropizine, benzonatate, benzozaine, benzyl alcohol, and the like are used.
둘째, 물리ㆍ화학적 요인으로 인해 부교감 신경계가 활성화되면 기관지 평활근이 수축되고 따라서 기관지 경련이나 기관지 수축과 같은 증상이 나타날 수 있다. 이때 베타 2 아고니스트(β2-adrenergic receptor agonist)는 베타 2 수용체를 자극하여 평활근을 이완시키고, 잔틴(xanthine) 유도체는 포스포디에스테라제(phosphodiesterase)의 억제에 의한 cAMP를 증가시키거나 기관지 평활근을 직접 이완시키는 역할을 하여 점액분비를 증대시키면서 점액을 용해시키며 섬모운동을 촉진시켜 진해, 거담 활성을 나타낸다. 이러한 작용을 나타내는 약물로는, 베타 2 아고니스트로써 클렌부테롤(clenbuterol), 밤부테롤(bambuterol), 포르모테롤(formoterol) 등이 있으며, 잔틴(xanthine) 유도체로써, 테오필린(theophylline), 아미노필린(aminophylline), 아세피필린(acepifylline), 바미필린(bamifylline)등이 있다. Second, when the parasympathetic nervous system is activated due to physico-chemical factors, bronchial smooth muscle contracts and thus symptoms such as bronchial spasms and bronchial contractions may occur. At this time, the beta 2 agonist stimulates the beta 2 receptor to relax the smooth muscle, and the xanthine derivative increases cAMP or inhibits bronchial smooth muscle by inhibition of phosphodiesterase. It acts as a direct relaxation, increasing mucus secretion while dissolving mucus and promoting ciliary movement. Drugs exhibiting this action include beta 2 agonists such as clenbuterol, bambuterol and formoterol, and xanthine derivatives such as theophylline and aminophylline. aminophylline), acepiphylline (acepifylline), bamifylline and the like.
이외에 생성된 점액을 용해시켜 점도를 감소시키고 기관지의 섬모 운동을 촉진함으로써 객담 배출을 촉진시키는 점액 용해제 혹은 거담제 등이 있다. 기도 점액은 기도에서 여러 가지 중요한 기능을 가진다. 즉, 외부에서 기도로 들어온 입자로부터 기도를 보호하고, 흡입공기의 습도를 유지하며, 흡입된 화학물질이나 가스 등을 점액의 단백질과 결합, 섬모 작용으로 제거하는 역할을 가진다. 또한 점액은 이뮤노글로블린 A(IgA), 라이소자임(lysozyme), 락토페린(lactoferrin) 등과 같은 면역 기능에 중요한 역할을 하는 물질을 가지고 있다. 대부분의 거담제는 식물 등을 이용하여 수천 년 동안 민간약 또는 경험처방으로 사용하여 왔고 화합물로는 카르보시스테인(carbocysteine), N-아세틸시스테인(N-acetylcysteine), 시스테인 에 틸에스테르 염산염 등과 같은 시스테인 유도체가 거담제로 사용되고 있다. 전술한 시스테인 유도체들이 거담제로 사용될 때 완전히 만족할 만한 것은 아니며 특히, N-아세틸 시스테인 및 시스테인 에틸에스테르 염산염은 모두 독성이 강하고 화학적으로 불안정한 문제점을 갖고 있다. 그러므로 물리, 화학적 안정성은 좋으면서 보다 적은 부작용과 독성, 우수한 거담효과를 갖는 거담제의 개발이 요구되어 왔다. In addition, there is a mucus solubilizer or expectorant that dissolves the produced mucus to reduce viscosity and promote bronchial cilia, thereby promoting sputum discharge. Airway mucus has several important functions in prayer. That is, it protects the airway from particles entering the airway from the outside, maintains the humidity of the intake air, and serves to remove the inhaled chemicals and gases by binding to the mucus protein, cilia. Mucus also has substances that play an important role in immune function, such as immunoglobulin A (IgA), lysozyme, lactoferrin, and the like. Most expectorants have been used as folk medicines or experience prescriptions for thousands of years using plants, etc. Compounds include cysteine derivatives such as carbocysteine, N-acetylcysteine, and cysteine ethyl ester hydrochloride. It is used as an expectorant. The above-mentioned cysteine derivatives are not completely satisfactory when used as an expectorant, and in particular, N-acetyl cysteine and cysteine ethyl ester hydrochloride have both high toxicity and chemical instability. Therefore, the development of expectorants with good physical and chemical stability and less side effects, toxicity and good expectorant effects has been required.
이러한 필요성에 의해서 최근에는 천연물 유래의 진해거담제 연구가 활발히 진행되고 있으며, 이와 관련한 대표적인 연구로는 기도의 미주신경을 자극하여 점막의 분비를 촉진시켜 거담작용을 발현함과 동시에 진해작용의 보조적 역할을 하는 사포닌(saponin), 알칼로이드(alkaloid)등을 함유하는 식물 (김숙영외, Kor. J. Pharmacogn.19(2):133-140, 1998)에 관한 보고가 있기도 하다.Recently, researches on antitussive expectorants derived from natural products have been actively conducted. In this regard, representative studies related to airway stimulate the vagus nerve of the airway to promote the secretion of mucous membranes to express expectoration and at the same time play an auxiliary role of antitussive action. There are also reports on plants containing saponins, alkaloids, etc. (Sook Young Kim et al . , Kor. J. Pharmacogn . 19 (2): 133-140, 1998).
셋째, 물리ㆍ화학적 요인으로 인해 비만세포에서 염증매개물질 등이 방출하게 된다. 비만세포는 히스타민(histamine)이나 사이토카인(cytokine)등과 같은 염증 매개물질을 함유하는 작은 사이토플라스믹 그라뉼(cytoplasmic granule)을 포함하고 있다. 알러지 유발인자(Allergen)에 노출되면 체내에서는 IgE라는 항체가 B 세포에서 생성되는데, 이것이 비만세포 표면에 부착된다. 이후 다시 알러지 유발인자에 노출되면 IgE가 부착된 비만세포에서는 강력한 염증 매개체인 히스타민을 비롯한 화학물질들이 방출되어 이에 의해 기도 내 분비물, 염증에 의한 삼출액, 흡입 이물, 세균 등이 증가하게 되며 이는 객담 형성으로 이어진다. 진해제로 널리 쓰이는 codeine 등의 기존 약물들은 호흡 및 기침에 대한 진정 작용이 뛰어나지만 비만세포의 탈과립을 유발하여 히스타민을 유리시키는 부작용을 가지고 있다. Third, inflammatory mediators are released from mast cells due to physical and chemical factors. Mast cells contain small cytoplasmic granules containing inflammatory mediators such as histamine and cytokines. When exposed to an allergen, the body produces an antibody called IgE in B cells, which attaches to the surface of mast cells. Subsequent exposure to allergens causes the release of allergens, including histamine, a potent inflammatory mediator, from IgE-attached mast cells, resulting in increased secretions in the airways, effusions from inflammation, inhaled foreign bodies, and bacteria. Leads to. Existing drugs such as codeine, widely used as antitussives, have excellent sedative effects on breathing and coughing, but have side effects that release histamine by causing degranulation of mast cells.
또한 상기와 같은 설명을 바탕으로 진해거담과 밀접한 관련이 있는 기작 및 기능으로 감염 원인균 제거 및 2차 감염예방을 할 수 있도록 하는 항균작용과, 염증매개체의 합성을 억제하는 항염작용, 비만세포로부터 히스타민 분비 억제를 하는 항히스타민작용, 염증 및 조직손상을 방지하는 항산화작용, 면역세포로부터 염증매개체를 방출하는 엘라스타제(elastase) 활성억제작용, 혈관투과성 염증반응에 관여하는 히알루로니다제(hyaluronidase) 활성 저해작용 등이 필요한 기능이라 할 수 있을 것이다. In addition, based on the above description, the mechanism and function closely related to antitussive expectoration, antibacterial action to enable the removal of the causative agent and prevention of secondary infection, anti-inflammatory action to inhibit the synthesis of inflammatory mediators, histamine from mast cells Antihistamine activity that inhibits secretion, antioxidant activity that prevents inflammation and tissue damage, elastase activity release that releases inflammatory mediators from immune cells, hyaluronidase activity involved in vascular permeable inflammatory reactions Inhibition, etc. will be a function that requires.
이에 본 발명자들은 거담 또는 진해용 조성물을 개발하기 위하여 연구한 결과, 황백, 희첨 또는 연교의 단독 생약 추출물과 상기 단독 생약 추출물의 혼합물이 거담 활성, 진해 활성 및 항히스타민 활성 효과를 나타냄을 확인함으로써 본 발명을 완성하였다. Therefore, the present inventors have studied to develop an expectorant or antitussive composition, the present invention by confirming that the mixture of the sole herbal extract of baekbaek, rare or yeongyo and the extract of the sole herbal extract shows expectorant activity, antitussive activity and antihistamine activity effect Was completed.
상기 목적을 수행하기 위하여, 본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 추출물을 유효성분으로 함유하는 거담 또는 진해용 조성물을 제공한다. In order to accomplish the above object, the present invention provides an expectorant or antitussive composition containing one or more extracts selected from the group consisting of yellowish white, rare and yeonkyo as an active ingredient.
또한, 본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하고, 상기 혼합 생약 추출물은 황백 추출물, 희첨 추출물 및/또는 연교 추출물의 혼합물인, 거담 또는 진해용 조성물을 제공한다. In addition, the present invention contains two or more mixed herbal extracts selected from the group consisting of yellowish white, rare and yeongyo as an active ingredient, the mixed herbal extract is a mixture of yellowish white extract, raree extract and / or ductile extract, expectorant or Jinhae It provides a composition for.
본 발명에서 사용하는 생약인 황백(Phellodendri cortex)은 산초나무과(Rutaceae)에 속하는 다년생 초본이다. 황벽나무 및 동속 근연식물의 수피를 황백이라 하며 바깥쪽은 회황갈색~회갈색이고 안쪽면은 황색~어두운 황갈색이다. 황백은 항균작용, 혈당 강하 작용, 항염 및 항암 작용 등의 약리 효과가 있는 것으로 알려져 있으며, 한방에서는 건위제, 이뇨제, 소염제, 피하출혈흡수촉진제 등으로 사용되고 있다. 주요 약리 성분으로서 알칼로이드(alkaloid)인 베르베 린(berebrine), 팔마틴(palmatine), 콥티신(coptisine), 자트로리진(jatrorrhizine), 펠로덴드린(phellodendrine), 마그노플로린(magnoflorine) 등을 함유하고 있는 것으로 알려져 있다 (정보섭, 신민교, 도해 향약(생약)대사전, 790-791, 1990). Herbal medicine (Phellodendri cortex) used in the present invention is a perennial herb belonging to the family Rutaceae. The bark of yellow wall and related plants is called yellow white. The outside is grayish brown to gray brown and the inside is yellow to dark yellowish brown. It is known that baekbaek has pharmacological effects such as antibacterial action, hypoglycemic action, anti-inflammatory and anti-cancer action, and is used in herbal medicine as a gastric agent, diuretic agent, anti-inflammatory agent, and subcutaneous bleeding absorption accelerator. Main pharmacological ingredients include alkaloids such as berebrine, palmatine, copmatine, coptisine, jatrorrhizine, phellodendrine, magnoflorine, etc. It is known to have been (Jung Ji-sup, Shin Min-kyo, Doha Herbal Dictionary), 790-791, 1990.
본 발명에서 사용하는 생약인 희첨(Siegesbeckiae Herba)은 국화과(Compositae)에 속하는 일년생 초본으로 털진득찰(Siegebeckia pubescens Makino), 진득찰(Siegebeckia glabrescens Makino) 및 동속 근연식물의 지상부이다. 높이는 보통 50~100cm이며, 줄기는 직립하고 보통 자색을 띤다. 희첨은 항염증작용, 혈압강하작용, 항염 및 항암 작용 등의 약리 효과가 있는 것으로 알려져 있으며, 한방에서는 예로부터 사지마비, 관절통과 근육통, 학질, 급성 간염, 고혈압, 외상출혈 등을 치료하는 목적으로 사용되어 왔다. 지금까지 알려진 주요 성분으로는 다루틴(darutin)과 같은 알칼로이드(alkaloid), 키레놀, 17-하이드록시-16알파(-)-카우란-19-카르복실릭 산과 같은 에스터 류, 16-아세틸-키레놀, 다루티제놀, 다루토사이드, 이소프로필리데네키레놀, 키레놀, 네오다루토사이드, 시에제스벡키올, 시에제스벡키오사이드 등의 디테르펜 류가 알려져 있다 (1. 정보섭, 신민교, 도해 향약(생약)대사전, 1070-1071, 1990., 2. 중약대사전, 도서출판 정담, 6660-6666, 1998).Herbal medicine (Siegesbeckiae Herba), which is used in the present invention, is an annual herb belonging to the genus Compositae and is the ground part of Siegebeckia pubescens Makino, Siegebeckia glabrescens Makino, and the related plant. The height is usually 50-100cm, the stem is upright, and usually purple. Rhubarb is known to have pharmacological effects such as anti-inflammatory action, hypotensive action, anti-inflammatory and anti-cancer action, and in traditional medicine, for the purpose of treating limb paralysis, arthralgia and myalgia, malaria, acute hepatitis, hypertension and traumatic bleeding. Has been used. The main ingredients so far known are alkaloids such as darutin, chilenol, esters such as 17-hydroxy-16alpha (-)-kauran-19-carboxylic acid, 16-acetyl- Diterpenes such as chilenol, darutizenol, darutoside, isopropylidenechilenol, chilenol, neodarutoside, sisesvecchiol and siesesvecchioside are known (1. , Shin Mingyo, Dohae Hyangje (Medicinal Medicine), 1070-1071, 1990., 2. Chinese Medicinal Dictionary, Book Publishing Jungdam, 6660-6666, 1998).
본 발명에서 사용하는 생약인 연교(Forsythiae Fructus)는 물푸레나무과(Oleaceae)에 속하며 개나리 및 동속근연식물의 과실이다. 낙엽관목으로 높이 3m 내외에 달하고 가지가 옆으로 뻗어 나거나 길게 뻗어서 덩굴처럼 밑으로 처진다. 연교는 항균작용, 항바이러스작용, 강심작용 및 이뇨작용 등의 약리효과가 있는 것으로 알려져 있으며, 한방에서는 예로부터 종창, 임질, 통경, 치질, 이뇨, 결핵, 해독 등의 치료제로 사용되고 있다. 지금까지 알려진 주요성분으로는 포시톨(Forsythol), 스테롤 화합물, 사포닌, 플라보놀 배당체, 올레아노릭 산 및 알칼로이드가 함유되어 있는 것으로 알려져 있다(1. 정보섭, 신민교, 도해 향약(생약)대사전, 974-975, 1990., 2. Kim TJ. Korean Resources Plants, 262, Seoul National University Pub. 1991). Herbal medicine (Forsythiae Fructus), which is used in the present invention, belongs to Oleaceae and is a fruit of forsythia and related plant. It is a deciduous shrub reaching about 3m in height, with branches extending sideways or extending long and sagging like vines. Yeongyo is known to have pharmacological effects such as antibacterial action, antiviral action, cardiovascular action and diuretic effect, and has been used in Chinese medicine for treatment of swelling, gonorrhea, pain, hemorrhoids, diuresis, tuberculosis, and detoxification. The major ingredients known to date are known to contain Forsythol, sterol compounds, saponins, flavonol glycosides, oleanolic acid and alkaloids (1. -975, 1990., 2.Kim TJ.Korean Resources Plants, 262, Seoul National University Pub. 1991).
황백, 희첨 및 연교추출물 각각에 대하여 호흡기 질환 관련한 연구결과 조사를 해 본 결과, 이들 생약 중 희첨의 경우 호흡기질환 관련, 더욱 상세하게는 기도 수축 억제 활성, 기도염증 억제 작용, 5-리폭시게나제 억제 활성, 포스포다이에스터라제 4 억제 작용, 루코트리엔 D4 길항작용, 항히스타민 활성 등 천식관련 질환에 대한 특허출원(한국공개특허 10-2005-0121094)이 되어 있으나, 거담활성 및 진해활성에 관련하여서는 아직까지 연구된 바 없다. Investigation of the results of respiratory diseases for each of the white and yellow extracts and the extracts showed that respiratory diseases were related to respiratory diseases, more specifically airway contraction inhibitory activity, airway inflammation inhibitory effect, and 5-lipoxygenase inhibition. Patent application for asthma-related diseases such as activity, phosphodiesterase 4 inhibitory activity, leukotriene D4 antagonism, antihistamine activity, but related to expectorant and antitussive activity It has not been studied yet.
따라서, 본 발명의 거담 및 진해 활성과 기존의 천식과의 차이점을 하기와 같이 설명한다. Therefore, the difference between the expectorant and antitussive activity of the present invention and conventional asthma is explained as follows.
천식이란, 기관지가 여러 자극에 대하여 민감하게 반응하는 만성적 비전염성의 폐쇄성 기도질환을 의미한다. 기도가 염증반응과 점막부종 등의 광범위한 자극을 받으면 기도 평활근이 과잉 수축하게 되고, 최종적으로 기도폐색을 주 증상으로 하는 천식 발작이 일어난다. 천식의 발병기전은 외부로부터 유입된 항원이 체내로 들어오면 TH2 세포가 활성화되어 인터루킨-4와 인터루킨-5와 같은 사이토카인을 분 비하게 되며 이러한 사이토카인은 B세포를 형질세포로 분화시켜 IgE 항체 생산 및 비만세포 증식을 촉진시킨다. 생성된 IgE는 비만세포의 IgE 수용체에 결합하고 있다가, 2차적으로 항원이 체내에 들어오면 항원-항체 반응이 일어나 히스타민과 같은 염증 매개물질 등을 분비하여 기관지 수축을 일으키는 것이다. 천식을 치료하는 약물의 치료 기전은 기관지 염증을 저하시키는 것을 목적으로 하는 항염증제, 비만세포가 탈과립되는 것을 억제하는 약물, 알레르기나 염증을 일으키는 원인인 류코트리엔 경로 조절 약물, 기관지확장작용이 있는 약물 등으로 구분할 수 있다. 상기 한국공개특허문헌에 사용된 희첨의 경우 상기와 같은 약리학적 근거 및 작용기전에 연관된 기도수축 억제 실험, 기도 염증 억제 실험 등의 증상 완화 활성과 5-리폭시게나제 억제작용, 포스포다이에스터라제 4 억제작용, 루코트리엔 D4 길항작용 및 항히스타민 작용 등에 대한 기전별 억제 활성을 근거로 항천식 활성에 대한 용도가 기재되어 있다. Asthma is a chronic noncommunicable obstructive airway disease in which the bronchus responds to various stimuli. When the airways are subjected to extensive irritation such as inflammatory reactions and mucosal edema, the airway smooth muscles contract excessively, and asthma attacks, which are mainly caused by airway obstruction, occur. The pathogenesis of asthma is when TH2 cells are activated when antigen from the outside enters the body to secrete cytokines such as interleukin-4 and interleukin-5, and these cytokines differentiate B cells into plasma cells to produce IgE antibodies. Promotes production and mast cell proliferation. The produced IgE binds to the mast cell's IgE receptor, and when the antigen enters the body secondly, an antigen-antibody reaction occurs to secrete an inflammatory mediator such as histamine, causing bronchial contraction. Mechanisms for treating asthma include anti-inflammatory drugs aimed at reducing bronchial inflammation, drugs that inhibit degranulation of mast cells, leukotriene pathway-controlling drugs that cause allergies or inflammation, and drugs that have bronchodilator effects. Can be distinguished. In the case of Rareul used in the Korean Patent Laid-Open Publications, symptomatic activity and 5-lipoxygenase inhibitory activity, phosphodiesterase 4, such as airway contraction suppression experiments and airway inflammation suppression experiments associated with the above pharmacological basis and mechanism of action The use for anti-asthma activity is described on the basis of mechanism-specific inhibitory activity against inhibitory activity, leukotriene D4 antagonism and antihistamine action.
한편, 본 발명에 따른 진해 거담 활성의 작용기전 및 증상은 천식과는 구별이 된다. 즉, 기침은 기침 반사를 통해 일어나는데, 기침 수용체가 물리적 자극이나 각종 화학물질에 의한 화학적 자극에 노출되면, 미주신경, 삼차신경 등의 구심성 통로를 거쳐 이러한 자극이 뇌의 연수에 존재하는 기침중추에 전달된다. 전달된 자극은 기침중추에서 통합 및 변형 과정을 거친 후 다시 미주신경, 횡격막 신경, 척추운동신경 등의 원심성 통로를 통해 전달되고 이 때 기침 반응이 일어난다. On the other hand, the mechanism of action and symptoms of antitussive expectorant activity according to the present invention is distinguished from asthma. That is, cough occurs through cough reflexes. When the cough receptors are exposed to physical stimuli or chemical stimuli by various chemicals, they are passed through afferent channels such as the vagus nerve and the trigeminal nerve. Is passed on. The delivered stimulus is processed through the process of integration and transformation at the cough center and then through the centrifugal channels such as the vagus nerve, the diaphragm nerve, and the spinal motor nerve.
또한, 이러한 다양한 기침 자극 물질은 기도의 다양한 수용체들을 활성화 시켜서 기침을 발생시킨다. 기침 수용체는 인체 내의 여러 부위에 분포되어 있는데 주로 후두나 기관지에 분포되어 있고, 주로 미주신경을 통해 자극이 유발된다. 기침의 감각 신경 말단은 C-fibers, Aδ-fibers, rapidly adapting receptors (RARs), slowly adapting stretch receptors (SARs) 등의 다양한 수용체로 구성되며, 자극성 물질들이 이러한 신경 말단의 수용체를 자극함으로써 기침을 유발 시키는 것으로 알려져 있다 (Drug Discovery Today: Disease Models vol. 1, No. 3, 2004, p. 297-302). In addition, these various cough irritants activate coughs by activating various receptors in the airways. Cough receptors are distributed in various parts of the human body, mainly in the larynx or bronchus, and are mainly stimulated through the vagus nerve. Sensory nerve endings in cough consist of a variety of receptors such as C-fibers, Aδ-fibers, rapidly adapting receptors (RARs), and slowly adapting stretch receptors (SARs). (Drug Discovery Today: Disease Models vol. 1, No. 3, 2004, p. 297-302).
그러므로, 기침의 조절을 위해서는 기침 중추와 기침 감각 신경을 억제하는 중추성 진해제와 말초성 진해제가 주로 사용된다. 중추성 진해제는 뇌의 연수 부위의 기침 중추에 직접 작용하여 기침 반사를 억제하며 말초성 진해제는 기침을 일으키는 미주신경의 수용체들을 차단하거나 활성을 억제함으로써 기침을 조절하는 것으로 알려져 있다 (Pulmonary Pharmacology (1996) 9, 357-364). Therefore, central cough and peripheral cough suppressants that suppress cough central and cough sensory nerves are mainly used to control cough. Central cough suppresses cough reflexes by directly acting on the cough centers of the softened areas of the brain. Peripheral antitussives are known to control cough by blocking or inhibiting the activity of cilia that cause cough (Pulmonary Pharmacology (1996) 9, 357-364).
거담활성은 먼지나 자극 물질 등의 유입으로 인해 기관지에서 객담이 생성되는 것을 억제하거나 또는 기 생성된 객담의 배출을 촉진시키는 역할을 하며 약물에 따라 그 기전은 다양하다. 직접 점막선에 작용하여 객담 분비를 촉진시키거나 미주신경을 통해 반사적으로 분비를 촉진함으로써 하부 기관지에서 인두로 자극성 물질이 쉽게 제거되도록 하기도 하며, 또한 객담 속의 점성 단백질 분자의 결합을 바꾸거나 분해하여 객담의 점도를 묽게 하기도 하고, 계면활성물질의 생성을 촉진시켜 기관지 분비물을 용해시킴으로써 점액 분비 작용을 촉진하기도 하며, 기관지 섬모 운동을 촉진함으로써 용해된 객담의 배출 속도를 증가시키기도 한다 (최신약리학 개정3판, 은종영 외, 현문사, 2005, p. 334-336). The expectorant activity inhibits the production of sputum in the bronchi due to the inflow of dust or irritants, or promotes the release of sputum, and the mechanism varies depending on the drug. It acts directly on mucous membranes to stimulate sputum secretion or reflexively through the vagus nerve to facilitate removal of irritants from the lower bronchus into the pharynx, and also to alter or break down the binding of viscous protein molecules in sputum. It may also be used to dilute the viscosity of viscosities, to promote the production of surfactants, to dissolve bronchial secretions, to promote mucus secretion, and to promote bronchial cilia, thereby increasing the rate of discharge of dissolved sputum. , Eun Jong-eun et al., Hyeonmunsa, 2005, p. 334-336).
본 발명에서는 가장 널리 이용되고 있는 동물모델을 활용한 기침 증상과 객담 증상을 억제 해주는 활성을 검증하는 실험을 통하여, 본 발명에 사용된 조성물이 진해 및 거담 활성을 나타냄을 확인하였다. 본 발명에서 수행한 기침 억제능 실험 모델은 진해제 평가에 대한 실험으로 가장 널리 사용되고 있는 방법이며, 실험에 사용된 기니아 피그 역시 기침 연구에 가장 적합한 동물 모델로 유용하게 사용되고 있다. 또한 본 발명에서 사용된 시트르산에 대한 기니아 피그에서의 반응이 인간에서의 반응과 유사하기 때문에 기니아 피그는 인간의 기침 반사를 연구하는 데에도 좋은 모델이 되고 있다 (Drug Discovery Today: Disease Models, Vol. 3, No. 3, 2006, p. 237-241). In the present invention, through the experiment to verify the activity to suppress the cough symptoms and sputum symptoms using the most widely used animal model, it was confirmed that the composition used in the present invention exhibits antitussive and expectorant activity. The experimental model for cough suppression ability performed in the present invention is the most widely used method for the evaluation of antitussives, and the guinea pigs used in the experiment are also usefully used as the most suitable animal model for cough research. In addition, since the reaction in the guinea pigs to citric acid used in the present invention is similar to that in humans, guinea pigs are also a good model for studying human cough reflexes (Drug Discovery Today: Disease Models, Vol. 3, No. 3, 2006, p. 237-241).
본 발명에서 수행한 페놀레드 배출 실험법 역시 기관지 점액 분비물 배출능을 검정하기 위한 방법으로 고안되었으며, 실제로 효과적인 거담제로 널리 알려진 많은 약물들을 이 방법을 활용하여 검증해 본 결과, 거담 활성을 검증하기에 우수한 동물 모델임이 알려져 있다 (Journal of Pharmacological Methods 11, 1984, p. 151-157). The phenol red excretion test performed in the present invention was also designed as a method for assaying bronchial mucus secretion ability, and in fact, many drugs widely known as effective expectorants were verified using this method, and thus excellent in verifying expectoration activity. It is known to be an animal model (Journal of Pharmacological Methods 11, 1984, p. 151-157).
따라서, 본 발명의 기침은 천식에서 나타나는 알레르기성 기침과는 구별되는 신경 자극성 기침을 설명하는 것으로, 앞서 설명한 바와 같이, 본 발명의 진해, 거담 활성은 그 발병 기전이 천식과 본질적으로 완연히 다르며, 본 발명은 진해 거담 치료에 유용한 조성물에 관한 것으로서 본 발명에 사용된 희첨은 과학적으로 적합한 평가 방법에 의해 진해 및 거담 활성이 우수함을 입증하여 본 발명을 완성하였다. Therefore, the cough of the present invention describes a neurostimulating cough that is distinguished from an allergic cough appearing in asthma. As described above, the antitussive and expectorant activity of the present invention is completely different from the asthma in its pathogenesis. The present invention relates to a composition useful for the treatment of antitussive expectoration, which completes the present invention by demonstrating that antitussive and expectorant activity is excellent by a scientifically suitable evaluation method.
본 발명에 있어서, ‘황백, 희첨 및/또는 연교의 혼합 추출물’이라는 용어는 황백, 희첨 및 연교를 각각 추출하여 얻어진 황백 추출물, 희첨 추출물 및/또는 연교 추출물과의 혼합물, 및 황백, 희첨 및/또는 연교의 혼합물을 추출하여 얻어진 추출물을 모두 의미하기 위한 것으로 사용된다. 또한 상기 ‘추출물’은 조추출물 또는 특정 용매 가용 추출물 (분획)을 의미하는 것으로, 용액, 농축물 또는 분말 상태일 수 있다. In the present invention, the term 'mixed extract of yellow white, rare and / or duct bridges' refers to a mixture of yellow white extract, rare extract and / or duct extract, which is obtained by extracting yellow white, rare and duct bridges respectively, and yellow white, rare and / or duct extract. Or it is used to mean all the extracts obtained by extracting a mixture of duct bridge. In addition, the 'extract' refers to a crude extract or a specific solvent soluble extract (fraction), and may be in a solution, concentrate or powder state.
본원에서 정의되는 ‘추출물’은 상기 생약의 조추출물 또는 상기 조추출물의 극성용매 가용 추출물임을 특징으로 한다. "Extract" as defined herein is characterized in that the crude extract of the crude drug or a polar solvent soluble extract of the crude extract.
본원에서 정의되는 조추출물은 정제수를 포함한 물, 탄소수 1 내지 6개의 직쇄 또는 분지형 알코올 또는 이들의 혼합용매로부터 선택된 용매, 바람직하게는 물, 10 내지 70%(v/v)의 에탄올 수용액 또는 수포화 부틸 알코올임을 특징으로 한다. The crude extract as defined herein is a solvent selected from water, including purified water, straight-chain or branched alcohols having 1 to 6 carbon atoms or mixed solvents thereof, preferably water, 10-70% (v / v) aqueous ethanol solution or water. It is characterized by a saturated butyl alcohol.
본원에서 정의되는 극성용매 가용 추출물은 탄소수 1 내지 6개의 직쇄 또는 분지형 알코올, 바람직하게는 수포화 부틸 알코올임을 특징으로 한다. The polar solvent soluble extract as defined herein is characterized by being a straight or branched alcohol having 1 to 6 carbon atoms, preferably saturated butyl alcohol.
이하, 본 발명의 조추출물 및 조추출물의 극성용매 가용 추출물을 수득하는 방법을 상세히 설명한다. Hereinafter, the crude extract of the present invention and the method for obtaining the polar solvent soluble extract of the crude extract will be described in detail.
본 발명의 황백, 희첨 및 연교 조추출물은, 건조된 각각의 생약을 세절하여 무게(g)의 약 3배 내지 20배, 바람직하게는 약 5배 내지 15배의 물, C1 내지 C6의 직쇄 또는 분지형 알콜 또는 이들의 혼합용매, 바람직하게는 물, 10 내지 70%(v/v)의 에탄올 수용액 또는 수포화 부틸 알코올로, 40℃ 내지 110℃, 바람직하게는 55 ℃ 내지 90℃의 추출온도에서 약 0.5 내지 20시간, 바람직하게는 약 1 내지 10시간 동안 냉침, 열수추출, 초음파 추출, 환류 냉각 추출방법을 이용하여 수득한 추출액을 여과, 감압농축 또는 건조하여 본 발명의 조추출물을 수득할 수 있다. The yellowish white, rare and softened crude extracts of the present invention are cut into each dried herbal medicine by about 3 to 20 times the weight (g), preferably about 5 to 15 times the water, C1 to C6 straight chain or Branched alcohols or mixed solvents thereof, preferably water, 10 to 70% (v / v) aqueous ethanol solution or saturated butyl alcohol, extraction temperature of 40 ° C to 110 ° C, preferably 55 ° C to 90 ° C The crude extract of the present invention may be obtained by filtration, concentration under reduced pressure, or drying the extract obtained by using a cold, hot water extraction, ultrasonic extraction, reflux cooling extraction method for about 0.5 to 20 hours, preferably about 1 to 10 hours. Can be.
상기 조추출물을 여과하여 여액을 모으고, 다시 잔사에 생약 원료 중량의 4 내지 7배의 물, 알코올 수용액 또는 수포화 부틸 알코올을 가하여 가온 후 2~5시간 재 추출하고 여과하여 이전의 여액과 혼합함으로써 추출효율을 높인다. 여기서 용매의 양이 너무 적으면 교반이 어렵게 되고 추출물의 용해도가 낮아져 추출효율이 떨어지게 되고, 지나치게 많은 경우는 다음 정제단계에서 사용되는 저급 알코올의 사용량이 많아져 경제적이지 못하여 취급상 문제가 발생할 수 있다. 본 발명에서는 1차 추출 후 다시 재 추출하는 방법을 채택하였는데, 생약추출물을 대량 생산하는 경우 효과적으로 여과를 한다 하더라도 생약 자체의 수분 함량이 높기 때문에 손실이 발생하게 되어 1차 추출만으로는 추출효율이 떨어지므로 이를 방지하기 위함이다. 또한, 각 단계별 추출효율을 검증한 결과 2차 추출에 의해 전체 추출량의 80 내지 90% 정도가 추출되는 것으로 밝혀졌고, 3차 이상의 다단계 추출은 경제성이 없는 것으로 판단된다. The crude extract was filtered to collect the filtrate, and then 4 to 7 times the weight of the crude raw material, water or alcoholic solution or saturated butyl alcohol was added to the residue, followed by heating and re-extracting for 2 to 5 hours, followed by filtration and mixing with the previous filtrate. Increase the extraction efficiency If the amount of solvent is too small, the stirring becomes difficult and the solubility of the extract is low, the extraction efficiency is lowered. If the amount is too large, the amount of lower alcohol used in the next purification step is increased, which is not economical and may cause handling problems. . In the present invention, after the first extraction, the method of re-extraction is adopted again. However, even if the medicinal herb extract is mass-produced, even though the filtration is effective, the loss occurs because the water content of the herb itself is high. This is to prevent this. In addition, as a result of verifying the extraction efficiency of each step, it was found that about 80 to 90% of the total extraction amount is extracted by the second extraction, and the third or more multistage extraction is not economical.
또한 본 발명의 극성 용매 가용 추출물은 상기 조추출물을 약 2 내지 10배, 바람직하게는 약 3 내지 7배 부피의 물로 현탁시킨 후, 수포화 부틸 알코올과 같은 극성 용매를 현탁액의 0.5 내지 3배, 바람직하게는 동량 내지 2배 가하여 1회 내지 5회, 더욱 바람직하게는 2회 내지 3회 동안 극성용매 가용 층을 추출한 후 감압 농축하여 제조한다. In addition, the polar solvent soluble extract of the present invention is suspended in the crude extract of about 2 to 10 times, preferably about 3 to 7 times the volume of water, the polar solvent such as saturated butyl alcohol 0.5 to 3 times of the suspension, It is preferably prepared by adding the same amount to 2 times, extracting the polar solvent soluble layer for 1 to 5 times, more preferably 2 to 3 times, and then concentrating under reduced pressure.
층 분리 후 얻어진 저급 알코올 분획을 50~60℃로 감압 농축하여 시료 중에 잔존하는 용매를 제거한다. 이렇게 얻어진 농축물은 농축물 총량의 25~50배의 물로 2~3회 공비 농축하고 재차 동량의 물을 가하여 균질하게 현탁시킨다. 이와 같이 농축 건조 시 물로 공비 농축하는 이유는 얻어진 생약 추출액을 의약품 원료로 사용하기 위해 잔존하는 저급 알코올의 함량을 효과적으로 조절하고자 함이다. The lower alcohol fraction obtained after layer separation is concentrated under reduced pressure at 50-60 ° C. to remove the solvent remaining in the sample. The concentrate thus obtained is azeotropically concentrated two to three times with water of 25 to 50 times the total amount of the concentrate, followed by the addition of the same amount of water and suspended homogeneously. The reason for azeotropic concentration with water at the time of concentrated drying is to effectively control the content of the remaining lower alcohol in order to use the obtained herbal extract as a raw material for pharmaceuticals.
상기와 같이 1, 2차에 걸쳐 물, C1 내지 C6의 직쇄 또는 분지형 알코올 또는 이들의 혼합용매로 추출하여 얻은 추출액은 여과 및 농축한 다음, 여액 중에 함유된 불필요한 단백질, 다당류 및 지방산 등의 불순물을 정제하는데, 본 발명에서는 여액과 동량의 저급 알코올로 2 내지 4회 분리를 실시하여 용매 분획을 얻음으로써 불순물을 정제한다. 이때 저급 알코올로는 탄소수 1 내지 6의 알코올로서, 바람직하게는 부틸알코올, 프로필알코올 또는 이소프로필알코올을 사용하며, 저급 알코올 사용량이 여액에 비하여 적을 경우에는 지방산 등의 불필요한 성분들에 의한 미립자가 형성되어 층 분리가 원활하지 못할 뿐만 아니라 유효활성성분의 추출 함량이 낮아지게 되므로 효율적이지 못하다. As described above, the extract obtained by extraction with water, C1 to C6 straight chain or branched alcohol, or a mixed solvent thereof is filtered and concentrated, and then impurities such as unnecessary proteins, polysaccharides and fatty acids contained in the filtrate. In the present invention, in the present invention, impurities are purified by performing two to four separations with a filtrate and the same amount of lower alcohol to obtain a solvent fraction. In this case, as the lower alcohol, alcohol having 1 to 6 carbon atoms, preferably butyl alcohol, propyl alcohol or isopropyl alcohol, and when the amount of lower alcohol is less than that of the filtrate, fine particles are formed by unnecessary components such as fatty acids. Therefore, the separation of the layers is not smooth and the extraction content of the active ingredient is lowered, which is not efficient.
상기 혼합 추출물 내의 함량비는 하기의 조성으로 나타낼 수 있다.The content ratio in the mixed extract may be represented by the following composition.
황백 추출물과 희첨 추출물의 중량비는 고형분 중량 기준으로 10 : 1 내지 1 : 1 (황백 추출물 중량 : 희첨 추출물 중량)이고, 황백 추출물과 연교 추출물의 중량비는 고형분 중량 기준으로 15 : 1 내지 1 : 1 (황백 추출물 중량 : 연교 추출물 중량)이며, 희첨 추출물과 연교 추출물의 중량비는 고형분 중량 기준으로 20 : 1 내지 1 : 1 (희첨 추출물 중량 : 연교 추출물 중량)이고, 황백 추출물, 희첨 추 출물 및 연교 추출물의 중량비는 고형분 중량 기준으로 20 : 1 : 1 내지 1 : 1 : 1 (황백 추출물 중량 : 희첨 추출물 중량 : 연교 추출물)인 것이 좋다. 상기 ‘고형분’은 추출물 제조에 사용된 용매를 제거한 상태를 의미하며, 이하 동일하다. The weight ratio of the white and yellow extracts is 10: 1 to 1: 1 based on the solids weight (the weight of the white and yellow extracts), and the weight ratio of the white and yellow extracts is 15: 1 to 1: 1 based on the solids weight. Yellow baek extract weight: duct bridge extract weight), the weight ratio of the rare extract and duct bridge extract is 20: 1 to 1: 1 (rare extract weight: duct extract weight) based on the solid content weight, The weight ratio is preferably 20: 1: 1 to 1: 1: 1 (yellow white extract weight: rare extract weight: duct bridge extract) based on the solid content weight. The term 'solid content' means a state in which the solvent used to prepare the extract is removed, and is the same below.
또한, 본 발명의 한 구체예에 따른 혼합 극성 용매 가용 추출물에 있어서, 각 추출물의 함량비는 다음과 같이 할 수 있다. In addition, in the mixed polar solvent soluble extract according to one embodiment of the present invention, the content ratio of each extract may be as follows.
황백 추출물과 희첨 추출물의 중량비는 고형분 중량 기준으로 7 : 1 내지 1 : 1 (황백 추출물 중량 : 희첨 추출물 중량)이고, 황백 추출물과 연교 추출물의 중량비는 고형분 중량 기준으로 10 : 1 내지 1 : 1 (황백 추출물 중량 : 연교 추출물 중량)이며, 희첨 추출물과 연교 추출물의 중량비는 고형분 중량 기준으로 10 : 1 내지 1 : 1 (희첨 추출물 중량 : 연교 추출물 중량)이고, 황백 추출물, 희첨 추출물 및 연교 추출물의 중량비는 고형분 중량 기준으로 10 : 1 : 1 내지 1 : 1 : 1 (황백 추출물 중량 : 희첨 추출물 중량 : 연교 추출물)일 수 있다. 상기한 바와 같이, ‘고형분’은 추출물 제조에 사용된 용매를 제거한 상태를 의미한다. The weight ratio of the white and yellow extracts is 7: 1 to 1: 1 (the weight of the white and yellow extracts) based on the solids weight, and the weight ratio of the white and yellow extracts is 10: 1 to 1: 1 (based on the weight of the solids) Yellow white extract weight: weight of duct bridge extract), the weight ratio of rare extract and duct bridge extract is 10: 1 to 1 (weight of rare extract: weight of duct extract) based on the weight of solids, and weight ratio of baekbaek extract, rare extract and duct bridge extract May be 10: 1: 1 to 1: 1: 1 (yellow white extract weight: rare extract weight: duct bridge extract) based on the solid content weight. As described above, 'solid content' means a state in which the solvent used to prepare the extract is removed.
본 발명은 상기 제조방법으로 얻어지는 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 생약 추출물을 유효성분으로 함유하는 호흡기 질환의 예방 또는 치료용 조성물을 제공한다. The present invention provides a composition for the prevention or treatment of respiratory diseases, containing as an active ingredient one or more herbal extracts selected from the group consisting of yellowish white, rare and yeongyo obtained by the above method.
또한, 본 발명은 상기 제조방법으로 얻어지는 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하는 호흡기 질환의 예방 또는 치료용 조성물을 제공한다. In another aspect, the present invention provides a composition for the prevention or treatment of respiratory diseases comprising two or more mixed herbal extracts selected from the group consisting of yellowish white, rare and duct bridge obtained by the production method as an active ingredient.
본원에서 정의되는 호흡기 질환은 기침 또는 가래를 동반하는 폐기종, 만성기 관지염, 기관지선종, 고립성폐결절, 폐결핵, 농흉, 폐농양, 감기, 독감 또는 폐의 조직구 증식증, 바람직하게는 폐기종, 폐렴, 감기, 독감을 포함한다. Respiratory diseases defined herein include emphysema, chronic bronchitis, bronchial adenoma, isolated pulmonary nodules, pulmonary tuberculosis, empyema, lung abscess, cold, flu or histiocytosis of the lungs, preferably emphysema, pneumonia, cold Contains the flu.
본 발명의 호흡기 질환의 예방 및 치료용 조성물은, 조성물 총 중량에 대하여 상기 화합물을 0.001 내지 99% 중량, 바람직하게는 0.1 내지 50% 중량으로 포함한다. The composition for preventing and treating a respiratory disease of the present invention comprises 0.001 to 99% by weight, preferably 0.1 to 50% by weight of the compound, based on the total weight of the composition.
그러나 상기와 같은 조성은 반드시 이에 한정되는 것은 아니고, 환자의 상태 및 질환의 종류 및 진행 정도에 따라 변할 수 있다. However, the composition is not limited thereto, and may vary depending on the condition of the patient, the type of disease, and the progress of the disease.
본 발명의 추출물을 포함하는 조성물은 약학적 조성물의 제조에 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함할 수 있다. The composition comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the manufacture of pharmaceutical compositions.
본 발명에 따른 추출물을 포함하는 조성물은, 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용제의 형태로 제형화하여 사용될 수 있으며, 추출물을 포함하는 조성물에 포함될 수 있는 담체, 부형제 및 희석제로서는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로스, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 들 수 있다. 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 추출물 에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이트 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제제, 좌제가 포함된다. 비수성용제, 현탁제로는 프로필렌글리콜 (propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔 (witepsol), 마크로골, 트윈 (tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다. Compositions comprising extracts according to the invention are formulated in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral preparations, suppositories and sterile injectables, respectively, according to conventional methods. The carriers, excipients and diluents which may be used in the composition comprising the extract, and lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, Calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. When formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, and surfactants are usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and the solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose in the extract. ) Or lactose, gelatin and the like are mixed. In addition to simple excipients, lubricants such as magnesium styrate talc are also used. Examples of the liquid preparation for oral use include suspensions, solutions, emulsions, and syrups. In addition to water and liquid paraffin, simple diluents commonly used, various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included . Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like can be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.
본 발명의 추출물의 바람직한 투여량은 환자의 상태 및 체중, 질병의 정도, 약물형태, 투여경로 및 시간에 따라 다르지만, 당업자에 의해 적절하게 선택될 수 있다. 그러나 바람직한 효과를 위해서, 본 발명의 추출물은 1일 1mg/kg 내지 1000mg/kg, 바람직하게는 50mg/kg 내지 500mg/kg, 보다 바람직하게는 150mg/kg 내지 300mg/kg으로 투여하는 것이 좋다. 투여는 하루에 한번 투여할 수도 있고, 수회 나누어 투여할 수 있다. 따라서, 상기 투여량은 어떠한 면으로든 본 발명의 범위를 한정하는 것은 아니다. Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the time of administration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 1 mg / kg to 1000 mg / kg, preferably 50 mg / kg to 500 mg / kg, more preferably 150 mg / kg to 300 mg / kg per day. The administration may be carried out once a day or divided into several doses. Thus, the dosage amounts are not intended to limit the scope of the invention in any manner.
본 발명의 조성물은 쥐, 생쥐, 가축, 인간 등의 포유동물에 다양한 경로로 투여될 수 있다. 투여의 모든 방식은 예상될 수 있는데, 예를 들면, 경구, 직장 또 는 정맥, 근육, 피하, 자궁내 경막 또는 뇌혈관내 (intracerebroventricular) 주사에 의해 투여될 수 있다. The composition of the present invention may be administered to mammals such as rats, mice, livestock, humans, and the like in various routes. All modes of administration can be expected, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.
본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 생약 추출물을 유효성분으로 함유하는 호흡기 질환의 예방 또는 개선용 건강기능식품을 제공한다. The present invention provides a health functional food for the prevention or improvement of respiratory diseases containing at least one herbal extract selected from the group consisting of yellowish white, rare and yeonkyo as an active ingredient.
또한, 본 발명은 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하는 호흡기 질환의 예방 또는 개선용 건강기능식품을 제공한다. In another aspect, the present invention provides a health functional food for the prevention or improvement of respiratory diseases containing two or more mixed herbal extracts selected from the group consisting of yellow white, rare and yeongyo as an active ingredient.
본 발명의 추출물을 포함하는 조성물은 호흡기 질환의 예방 및 개선을 위한 약제, 식품 및 음료 등에 다양하게 이용될 수 있다. 본 발명의 추출물을 첨가할 수 있는 식품으로는, 예를 들어, 각종 식품류, 음료, 껌, 차, 비타민 복합제, 건강보조 식품류 등이 있고, 분말, 과립, 정제, 캡슐 또는 음료인 형태로 사용할 수 있다. The composition containing the extract of the present invention can be used in various ways, such as drugs, foods and drinks for the prevention and improvement of respiratory diseases. Examples of the foods to which the extract of the present invention can be added include various foods, beverages, gums, tea, vitamin complexes, health supplements and the like, and they can be used as powders, granules, tablets, capsules or beverages have.
본 발명의 추출물 자체는 독성 및 부작용은 거의 없으므로 예방 목적으로 장기간 복용 시에도 안심하고 사용할 수 있는 약제이다. Since the extract itself of the present invention has little toxicity and side effects, it is a drug that can be used safely even when taken for long periods of time.
본 발명의 상기 추출물은 호흡기 질환의 예방 및 개선을 목적으로 식품 또는 음료에 첨가될 수 있다. 이때, 식품 또는 음료 중의 상기 추출물의 양은 일반적으로 본 발명의 건강식품 조성물로서 전체 식품 중량의 0.01 내지 15 중량%로 가할 수 있으며, 건강 음료 조성물로서 100ml을 기준으로 0.02 내지 10g, 바람직하게는 0.3 내지 1g의 비율로 가할 수 있다. The extract of the present invention may be added to food or beverage for the purpose of preventing and improving respiratory diseases. At this time, the amount of the extract in the food or beverage can be generally added to 0.01 to 15% by weight of the total food weight as a health food composition of the present invention, 0.02 to 10g, preferably 0.3 to about 100ml as a health beverage composition It can be added at a rate of 1 g.
본 발명의 건강 음료 조성물은 지시된 비율로 필수 성분으로서 상기 추출물을 함유하는 것 외에 액체성분에는 특별한 제한점은 없으며 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예는 포도당, 과당 등의 모노사카라이드, 말토스, 슈크로스 등의 디사카라이드 및 덱스트린, 시클로덱스트린 등의 폴리사카라이드 등과 같은 통상적인 당 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 상술한 것 이외의 향미제로서 천연 향미제(타우마틴, 스테비아 추출물, 레바우디오시드 A, 글리시르히진 등) 및 합성 향미제(사카린, 아스파르탐 등)를 유리하게 사용될 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ml 당 일반적으로 약 1 내지 20g, 바람직하게는 약 5 내지 12g이다. In addition to containing the extract as an essential ingredient in the indicated ratio, the health beverage composition of the present invention is not particularly limited in the liquid component and may contain various flavors or natural carbohydrates as additional ingredients, as in general beverages. Examples of the above-mentioned natural carbohydrates include conventional sugars such as monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and polysaccharides such as dextrin and cyclodextrin, and xylitol, sorbitol, erythritol and the like. It is a sugar alcohol. As flavoring agents other than those described above, natural flavoring agents (tauumatin, stevia extract, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of said natural carbohydrates is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.
상기 외에 본 발명의 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 중진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있다. 그밖에 본 발명의 조성물들은 천연 과일 쥬스 및 과일 쥬스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 그렇게 중요하진 않지만 본 발명의 조성물 100 중량부 당 0 내지 약 20 중량부의 범위에서 선택되는 것이 일반적이다. In addition to the above, the composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. The compositions of the present invention may also contain pulp for the production of natural fruit juices and fruit juice beverages and vegetable beverages. These components can be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.
본 발명의 진해, 거담 활성을 나타내는 호흡기 질환의 예방 및 치료용 조성 물은 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 생약 추출물과 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하고, 거담 활성, 진해 활성 및 항히스타민 활성 효과를 나타냄을 확인함으로써, 호흡기 질환의 예방 및 치료에 유용한 약학조성물 및 건강기능식품으로 유용하게 이용될 수 있다. The composition for the prevention and treatment of the antitussive and expectorant respiratory disease of the present invention is one or more herbal extracts selected from the group consisting of yellowish white, rare and ducts and two or more mixed herbs selected from the group consisting of yellowish white, rare and ducts By containing the extract as an active ingredient, confirming the expectorant activity, antitussive activity and antihistamine activity, it can be usefully used as a pharmaceutical composition and health functional food useful for the prevention and treatment of respiratory diseases.
본 발명의 진해, 거담 활성을 나타내는 호흡기 질환의 예방 및 치료용 조성물은 황백, 희첨 및 연교로 이루어진 군에서 선택된 1종 이상의 생약 추출물과 황백, 희첨 및 연교로 이루어진 군에서 선택된 2종 이상의 혼합 생약 추출물을 유효성분으로 함유하고, 거담 활성, 진해 활성 및 항히스타민 활성 효과를 나타냄을 확인함으로써, 호흡기 질환의 예방 및 치료에 유용한 약학조성물 및 건강기능식품으로 유용하게 이용될 수 있다. The composition for the prevention and treatment of respiratory disorders showing antitussive and expectorant activity of the present invention is one or more herbal extracts selected from the group consisting of yellowish white, rare and ducts, and two or more mixed herbal extracts selected from the group consisting of yellowish white, rare and ducts It can be usefully used as a pharmaceutical composition and health functional food useful for the prevention and treatment of respiratory diseases by containing as an active ingredient, confirming that the expectorant activity, antitussive activity and antihistamine activity.
이하, 본 발명을 실시예 및 실험예에 의해 상세히 설명한다. Hereinafter, the present invention will be described in detail with reference to Examples and Experimental Examples.
단, 하기 실시예 및 실험예는 본 발명에 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예 및 실험예에 한정되는 것은 아니다. However, the following Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited to the following Examples and Experimental Examples.
실시예 1 : 단독 생약 조추출물의 제조 (A)Example 1 Preparation of Single Herbal Crude Extract (A)
1-1. 황백 추출물 (PC-GA)1-1. Yellow White Extract (PC-GA)
경동시장에서 구입한 황백을 물로 세척하여 협잡물을 제거한 후, 건조된 황백 250 g을 2.0 ℓ의 물, 50% 에탄올 수용액 및 수포화부탄올로, 80℃에서 3시간씩 2회 열수 추출한 뒤, 추출액을 여과 후 감압 농축하여 각각 추출물 52.5 g (원생약 대비 21.0% 수율), 45.0 g (원생약 대비 18.0% 수율) 및 25.5 g (원생약 대비 10.2% 수율)을 얻었고, 이를 이하, PC-GA-1, PC-GA-2, PC-GA-3이라 명명하여 실험예로 사용하였으며, 이 중 PC-GA-1 및 PC-GA-2는 하기 실시예 2-1의 시료로 사용하였다. After washing the sulfur white purchased from Gyeongdong market with water to remove contaminants, 250 g of the dried sulfur white was extracted with 2.0 L of water, 50% ethanol aqueous solution and saturated butanol twice at 80 ° C. for 3 hours and then extracted with hot water. After filtration and concentration under reduced pressure, 52.5 g (21.0% yield of the original drug), 45.0 g (18.0% yield) and 25.5 g (10.2% yield of the original drug) of the extract were obtained. , PC-GA-2 and PC-GA-3 were used as experimental examples, and PC-GA-1 and PC-GA-2 were used as samples in Example 2-1.
1-2. 희첨 추출물 (SH-GA)1-2. Rare Extract (SH-GA)
경동시장에서 구입한 희첨을 물로 세척하여 협잡물을 제거한 후, 건조된 희첨 250 g을 2.0 ℓ의 물, 50% 에탄올 수용액 및 수포화부탄올로, 80℃에서 3시간씩 2회 열수 추출한 뒤, 추출액을 여과 후 감압 농축하여 각각 추출물 49.0 g (원생약 대비 19.6% 수율), 42.0 g (원생약 대비 16.8% 수율) 및 21.0 g (원생약 대비 8.4% 수율)을 얻었고, 이를 이하, SH-GA-1, SH-GA-2, SH-GA-3이라 명명하여 실험예로 사용하였으며, 이 중 SH-GA-1 및 SH-GA-2는 하기 실시예 2-2의 시료로 사용하였다. After removing rare substances by washing with rare water purchased from Gyeongdong market, 250 g of dried rare water was extracted with 2.0 L of water, 50% ethanol aqueous solution and saturated butanol twice at 80 ° C. for 3 hours, and then extracted with extract. After filtration and concentration under reduced pressure, extracts 49.0 g (19.6% yield) and 42.0 g (16.8% yield) and 21.0 g (8.4% yield) were obtained. , SH-GA-2 and SH-GA-3 were used as experimental examples, of which SH-GA-1 and SH-GA-2 were used as samples in Example 2-2.
1-3. 연교 추출물 (FS-GA)1-3. Yeongyo Extract (FS-GA)
경동시장에서 구입한 연교를 물로 세척하여 협잡물을 제거한 후, 건조된 연 교 250 g을 2.0 ℓ의 물, 50% 에탄올 수용액 및 수포화부탄올로, 80℃에서 3시간씩 2회 열수 추출한 뒤, 추출액을 여과 후 감압 농축하여 각각 추출물 52.5 g (원생약 대비 21.0% 수율), 46.7 g (원생약 대비 18.7% 수율) 및 18.4 g (원생약 대비 7.4% 수율)을 얻었고, 이를 이하, FS-GA-1, FS-GA-2, FS-GA-3이라 명명하여 실험예로 사용하였으며, 이 중 FS-GA-1 및 FS-GA-2는 하기 실시예 2-3의 시료로 사용하였다. After removing the contaminants by washing the bridges purchased at Gyeongdong Market with water, 250 g of the dried bridges were extracted with 2.0 L of water, 50% ethanol solution and saturated butanol, and extracted twice with hot water at 80 ° C. for 3 hours. After filtration and concentration under reduced pressure, 52.5 g (21.0% yield of the original drug), 46.7 g (18.7% yield of the original drug) and 18.4 g (7.4% yield of the original drug) were obtained, respectively, FS-GA- 1, FS-GA-2, named FS-GA-3 was used as an experimental example, of which FS-GA-1 and FS-GA-2 was used as a sample of Example 2-3 below.
실시예 2 : 단독 생약 조추출물의 극성용매 가용추출물의 제조 (B)Example 2 Preparation of Polar Solvent Soluble Extract of Single Herb Crude Extract (B)
2-1. 황백 극성용매 가용 추출물 (PC-GB)2-1. Yellow White Polar Solvent Soluble Extract (PC-GB)
상기 실시예 1-1에서 얻은 PC-GA-1, PC-GA-2 52.5 g, 45.0g에 0.3 L의 물을 가해 현탁시키고, 여기에 수포화 부틸 알코올 0.6 L를 가하여, 2회 층 분리한 후, 수포화 부틸 알코올 분획만을 모아 건조될 때까지 감압 농축하였다. 대부분의 부틸 알코올과 물이 증발된 상태에서 0.2 L의 물을 가해 공비 농축한 후, 다시 2회 반복하고, 최종적으로 0.1 L의 증류수를 가하여 현탁 시킨 후, 동결건조하여 분말 상태의 황백 추출물 12.7 g (원생약 대비 5.1% 수율) 및 21.5 g (원생약 대비 8.6% 수율) 을 얻었으며, 이를 이하, PC-GB-1 및 PC-GB-2라 명명하였고, 하기 실험예의 시료로 사용하였다. To 52.5 g and 45.0 g of PC-GA-1 and PC-GA-2 obtained in Example 1-1, 0.3 L of water was added and suspended, 0.6 L of saturated butyl alcohol was added thereto, and the layers were separated twice. Thereafter, only the saturated butyl alcohol fractions were collected and concentrated under reduced pressure until drying. After most of the butyl alcohol and water were evaporated, 0.2 L of water was added to azeotropically concentrated, and then repeated twice. Finally, 0.1 L of distilled water was added and suspended, followed by lyophilization. (5.1% yield compared to the original drug) and 21.5 g (8.6% yield compared to the original drug) were obtained, which were hereinafter referred to as PC-GB-1 and PC-GB-2, and used as a sample of the following experimental example.
2-2. 희첨 극성용매 가용 추출물 (SH-GB)2-2. Rare Polar Solvent Soluble Extract (SH-GB)
상기 실시예 1-2에서 얻은 SH-GA-1, SH-GA-2 49.0 g, 42.0g에 0.3 L의 물을 가해 현탁시키고, 여기에 수포화 부틸 알코올 0.6 L를 가하여, 2회 층 분리한 후, 수포화 부틸 알코올 분획만을 모아 건조될 때까지 감압 농축하였다. 대부분의 부틸 알코올과 물이 증발된 상태에서 0.2 L의 물을 가해 공비 농축한 후, 다시 2회 반복하고, 최종적으로 0.1 L의 증류수를 가하여 현탁 시킨 후, 동결건조하여 분말 상태의 희첨 추출물 9.3 g (원생약 대비 3.7% 수율) 및 15.0 g (원생약 대비 6.0% 수율) 을 얻었으며, 이를 이하, SH-GB-1 및 SH-GB-2라 명명하였고, 하기 실험예의 시료로 사용하였다. 0.3 L of water was added to 49.0 g of SH-GA-1 and 42.0 g of SH-GA-1 and SH-GA-2 obtained in Example 1-2, and 0.6 L of saturated butyl alcohol was added thereto to separate the layers twice. Thereafter, only the saturated butyl alcohol fractions were collected and concentrated under reduced pressure until drying. Most of the butyl alcohol and water were evaporated and azeotropically concentrated by adding 0.2 L of water, and then repeated twice. Finally, 0.1 L of distilled water was added and suspended, followed by lyophilization and 9.3 g of powdered rare extract. (3.7% yield relative to the crude drug) and 15.0 g (6.0% yield relative to the crude drug) were obtained, which were named SH-GB-1 and SH-GB-2 below, and used as a sample of the following experimental example.
2-3. 연교 극성용매 가용 추출물 (FS-GB)2-3. Soft-bridge Polar Solvent Soluble Extract (FS-GB)
상기 실시예 1-2에서 얻은 FS-GA-1, FS-GA-2 52.5 g, 46.7g에 0.3 L의 물을 가해 현탁시키고, 여기에 수포화 부틸 알코올 0.6 L를 가하여, 2회 층 분리한 후, 수포화 부틸 알코올 분획만을 모아 건조될 때까지 감압 농축하였다. 대부분의 부틸 알코올과 물이 증발된 상태에서 0.2 L의 물을 가해 공비 농축한 후, 다시 2회 반복하고, 최종적으로 0.1 L의 증류수를 가하여 현탁 시킨 후, 동결건조하여 분말 상태의 연교 추출물 13.2 g (원생약 대비 5.3% 수율) 및 21.0 g (원생약 대비 8.4% 수율) 을 얻었으며, 이를 이하, FS-GB-1 및 FS-GB-2라 명명하였고, 하기 실험예의 시료로 사용하였다. 0.3 L of water was added and suspended in 52.5 g and 46.7 g of FS-GA-1 and FS-GA-2 obtained in Example 1-2, and 0.6 L of saturated butyl alcohol was added thereto to separate the layers twice. Thereafter, only the saturated butyl alcohol fractions were collected and concentrated under reduced pressure until drying. Most of the butyl alcohol and water was evaporated, 0.2 L of water was added, the azeotropic concentration was repeated, and then repeated twice. Finally, 0.1 L of distilled water was added and suspended, followed by freeze-drying. (5.3% yield compared to the original drug) and 21.0 g (8.4% yield compared to the original drug) were obtained, hereinafter referred to as FS-GB-1 and FS-GB-2, and used as a sample of the following experimental example.
실시예 3 : 생약추출물의 혼합물 제조Example 3: Preparation of a mixture of herbal extracts
상기 실시예 1 및 실시예 2의 각각의 추출물에 대한 거담 활성, 진해 활성 및 항히스타민 활성을 측정한 결과, 하기 실험예 1 내지 실험예 6에 나타난 바와 같이, 50% 에탄올 수용액 및 그에 기인한 극성 용매 가용추출물의 활성이 우수하였으며 이를 토대로 각각의 조합으로 혼합물을 제조하였다. The expectorant activity, antitussive activity, and antihistamine activity of the extracts of Examples 1 and 2 were measured, and as shown in Experimental Examples 1 to 6 below, 50% aqueous ethanol solution and the polar solvent resulting therefrom The activity of the soluble extract was excellent and based on this, a mixture was prepared in each combination.
제조예 1 : 황백 및 희첨 생약추출물의 혼합물 제조Preparation Example 1 Preparation of Mixture of Yellowish White and Rare Herb Extract
상기 실시예 1-1의 황백 추출물 (PC-GA-2) 및 실시예 1-2의 희첨 추출물 (SH-GA-2)의 혼합 비율을 중량 기준으로 10 : 1 내지 1 : 1로 혼합하였다. 균질한 혼합이 되도록 하기 위하여 혼합 추출물에 2 내지 3 중량배 가량의 물을 첨가한 후, 50 내지 60℃의 온도하에서 감압농축을 하고, 얻어진 농축물에 다시 동량의 물을 가하여 균질하게 현탁시킨 후, 동결건조시킴으로써 분말상태의 혼합물을 제조하였다. The mixing ratio of the yellowish white extract (PC-GA-2) of Example 1-1 and the rare extract (SH-GA-2) of Example 1-2 was mixed in a weight ratio of 10: 1 to 1: 1. In order to achieve a homogeneous mixture, 2-3 weight times of water was added to the mixed extract, concentrated under reduced pressure at a temperature of 50 to 60 ° C., and the same amount of water was added to the obtained concentrate, and then suspended. The powder mixture was prepared by lyophilization.
제조예 2 : 황백 및 연교 생약추출물의 혼합물 제조Preparation Example 2 Preparation of Mixture of Yellowish White and Yeonkyo Herbal Medicine Extract
상기 실시예 1-1의 황백 추출물 (PC-GA-2) 및 실시예 1-3의 연교 추출물 (FS-GA-2)의 혼합 비율을 중량 기준으로 15 : 1 내지 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing the mixing ratio of the sulfur white extract (PC-GA-2) of Example 1-1 and the duct extract (FS-GA-2) of Example 1-3 to 15: 1 to 1: 1 by weight Except that, a mixture was prepared in the same manner as in Preparation Example 1.
제조예 3 : 희첨 및 연교 생약추출물의 혼합물 제조Preparation Example 3 Preparation of Mixture of Rare and Yeonkyo Herbal Medicine Extracts
상기 실시예 1-2의 희첨 추출물 (SH-GA-2) 및 실시예 1-3의 연교 추출물 (FS-GA-2)의 혼합 비율을 중량 기준으로 20 : 1 내지 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing the mixing ratio of the rare extract (SH-GA-2) of Example 1-2 and the duct extract (FS-GA-2) of Example 1-3 in 20: 1 to 1: 1 by weight Except that, a mixture was prepared in the same manner as in Preparation Example 1.
제조예 4 : 황백, 희첨 및 연교 생약추출물의 혼합물 제조Preparation Example 4 Preparation of Mixture of Yellowish White, Rare and Fructus Herbal Extracts
상기 실시예 1-1의 황백 추출물 (PC-GA-2), 실시예 1-2의 희첨 추출물 (SH-GA-2) 및 실시예 1-3의 연교 추출물 (FS-GA-2)의 혼합 비율을 중량 기준으로 20 : 1 : 1 내지 1 : 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing of the sulfur white extract (PC-GA-2) of Example 1-1, the rare extract (SH-GA-2) of Example 1-2 and the duct extract (FS-GA-2) of Example 1-3 A mixture was prepared in the same manner as in Preparation Example 1, except that the ratio was mixed from 20: 1: 1 to 1: 1: 1 by weight.
제조예 5 : 황백 및 희첨 극성 용매 가용추출물의 혼합물 제조Preparation Example 5 Preparation of Mixture of Soluble White and Rare Polar Solvent Soluble Extracts
상기 실시예 2-1의 황백 추출물 (PC-GB-2) 및 실시예 2-2의 희첨 추출물 (SH-GB-2)의 혼합 비율을 중량 기준으로 7 : 1 내지 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing the mixing ratio of the sulfur white extract (PC-GB-2) of Example 2-1 and the rare extract (SH-GB-2) of Example 2-2 by 7: 1 to 1: 1 by weight Except that, a mixture was prepared in the same manner as in Preparation Example 1.
제조예 6 : 황백 및 연교 극성 용매 가용추출물의 혼합물 제조Preparation Example 6 Preparation of a Mixture of Soluble Extracts of Yellow and Soft Polar Solvents
상기 실시예 2-1의 황백 추출물 (PC-GB-2) 및 실시예 2-3의 연교 추출물 (FS-GB-2)의 혼합 비율을 중량 기준으로 10 : 1 내지 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing the mixing ratio of the sulfur white extract (PC-GB-2) of Example 2-1 and the duct extract (FS-GB-2) of Example 2-3 in 10: 1 to 1: 1 by weight Except that, a mixture was prepared in the same manner as in Preparation Example 1.
제조예 7 : 희첨 및 연교 극성 용매 가용추출물의 혼합물 제조Preparation Example 7 Preparation of Mixture of Soluble Extracts of Lean and Ductile Polar Solvents
상기 실시예 2-2의 희첨 추출물 (SH-GB-2) 및 실시예 2-3의 연교 추출물 (FS-GB-2)의 혼합 비율을 중량 기준으로 10 : 1 내지 1 : 1로 혼합하는 것을 제외 하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing the mixing ratio of the rare extract (SH-GB-2) of Example 2-2 and the duct extract (FS-GB-2) of Example 2-3 in 10: 1 to 1: 1 by weight Except that, a mixture was prepared in the same manner as in Preparation Example 1.
제조예 8 : 황백, 희첨 및 연교 극성 용매 가용추출물의 혼합물 제조Preparation Example 8 Preparation of Mixture of Soluble Extract of Yellow White, Rare, and Soft Bridge Polar Solvent
상기 실시예 2-1의 황백 추출물 (PC-GB-2), 실시예 2-2의 희첨 추출물 (SH-GB-2) 및 실시예 2-3의 연교 추출물 (FS-GB-2)의 혼합 비율을 중량 기준으로 10 : 1 : 1 내지 1 : 1 : 1로 혼합하는 것을 제외하고, 상기 제조예 1과 동일한 방법으로 혼합물을 제조하였다. Mixing of the sulfur white extract of Example 2-1 (PC-GB-2), the rare extract of Example 2-2 (SH-GB-2) and the duct extract of Example 2-3 (FS-GB-2) A mixture was prepared in the same manner as in Preparation Example 1, except that the ratio was mixed from 10: 1: 1 to 1: 1: 1 by weight.
실험예 1 : 단독 생약 추출물의 거담 활성 측정Experimental Example 1: Measurement of expectorant activity of single herbal extract
상기 실시예 1 및 실시예 2의 황백, 희첨 및 연교 조추출물과 극성 용매 가용추출물에 대한 거담 활성을 측정하기 위해, Engler 등의 방법을 이용하여 (Engler H, Szelenyi I, J.Pharmacol. Moth. 11, 151~157, 1984., ; Bao-quin Lin et., Pulmonary Pharmacology & Therapeutics 21, 259~263, 2008.), 하기와 같은 공정으로 실험을 수행하였다. In order to measure the expectorant activity of the yellowish white, rare and duct crude crude extracts and the polar solvent soluble extracts of Examples 1 and 2, Engler et al. (Engler H, Szelenyi I, J. Pharmacol. Moth. 11, 151-157, 1984., Bao-quin Lin et., Pulmonary Pharmacology & Therapeutics 21, 259-263, 2008.), experiments were carried out by the following process.
양성대조약물 (ambroxol, Sigma) 및 시험약물(실시예 1 내지 실시예 2의 조추출물 및 극성 용매 가용추출물)을 경구 투여하고 30분 후, 페놀레드를 복강 주사하였다 (500 mg/kg 용량으로 투여하며, 페놀레드는 생리 식염수에 녹인다). 30분 후, 디에틸이더(diethyl ether)를 이용해 마취시키고 복부 대동맥을 절단하여 방혈시킨 후, 기관 (trachea) 전체를 절제하였다. 분리된 기관을 1 ml의 생리 식염수에 넣어 30분 동안 세척하였고, 10,000 rpm으로 5분간 상온에서 원심 분리하여 상등액 에 1 N 가성소다 (NaOH)를 첨가 (상등액 1 ml당 1N NaOH 0.1 ml 첨가)한 후에 546 nm에서 흡광도를 측정하여 페놀레드의 농도로서 거담활성을 측정하였으며, 결과는 하기 표 1에 나타내었다. 30 minutes after oral administration of a positive control drug (ambroxol, Sigma) and a test drug (crude extract of Examples 1 to 2 and a polar solvent soluble extract), phenol red was intraperitoneally injected (500 mg / kg dose) Phenol red is dissolved in saline solution). After 30 minutes, anesthetized with diethyl ether, the abdominal aorta was cut and bled, and then the entire trachea was excised. The separated organs were placed in 1 ml of physiological saline, washed for 30 minutes, centrifuged at 10,000 rpm for 5 minutes at room temperature, and 1N caustic soda (NaOH) was added to the supernatant (0.1 ml of 1N NaOH per 1 ml of supernatant). After measuring the absorbance at 546 nm was measured the expectorant activity as a concentration of phenol red, the results are shown in Table 1 below.
실험결과, 상기 표 1에서 나타나는 바와 같이, 전반적으로 활성이 우수함을 알 수 있었으며, 특히, 실시예 2의 PC-GB-2의 객담 배출능이 가장 우수한 활성을 나타냄을 확인할 수 있었다.As a result, as shown in Table 1, it was found that the overall activity is excellent, in particular, it was confirmed that the sputum discharge capacity of the PC-GB-2 of Example 2 shows the most excellent activity.
실험예 2. 단독 생약 추출물의 혼합물에 대한 거담활성 측정Experimental Example 2. Determination of expectorant activity on a mixture of single herbal extracts
실시예 1 및 실시예 2의 각각의 추출물에 대한 거담 활성을 측정한 결과, 50% 에탄올 수용액(PC-GA-2, SH-GA-2, FS-GA-2) 및 그에 기인한 극성 용매 가용추출물(PC-GB-2, SH-GB-2, FS-GB-2)의 활성이 우수하였으며 이를 토대로 상기 실시예 3과 같이 혼합물을 제조(제조예 1~8)하였고, 상기 실험예 1의 방법으로 거담 활성을 측정하였으며 결과는 하기 표 2에 나타내었다. The expectorant activity of each of the extracts of Examples 1 and 2 was measured to find that 50% aqueous ethanol solution (PC-GA-2, SH-GA-2, FS-GA-2) and the resulting polar solvent soluble The activity of the extracts (PC-GB-2, SH-GB-2, FS-GB-2) was excellent and based on this, a mixture was prepared as in Example 3 (Preparation Examples 1 to 8), and The expectorant activity was measured by the method and the results are shown in Table 2 below.
실험결과, 상기 표 2에서 나타나는 바와 같이, 혼합물을 제조하였을 경우, 단독 추출물일때보다 효과가 증대되는 것을 확인하였으며, 특히, 세가지 생약을 혼합할 경우에 객담배출능이 가장 우수한 활성을 나타냄을 확인할 수 있었다. As a result of the experiment, as shown in Table 2, when the mixture was prepared, it was confirmed that the effect is increased than when the extract alone, in particular, it was confirmed that the sputum discharge ability showed the most excellent activity when mixing three herbal drugs .
실험예 3. 단독 생약 추출물의 진해 활성 측정Experimental Example 3. Determination of antitussive activity of single herbal extract
상기 실시예 1 내지 실시예 2의 황백, 희첨 및 연교 조추출물과 극성 용매 가용추출물의 진해 활성을 측정하기 위해, Tanaka 등의 방법을 이용하여(Motomu Tanaka and Kei Maruyama., J. Pharmacol. Sci. 93, 465~470, 2003., Daoui, Cognon, Naline et.,Am. J. Respir. Crit. Care. Med. 158, 42~48, 1998.), 하기와 같은 공정으로 실험을 수행하였다. In order to measure the antitussive activity of the yellowish white, rare and duct crude crude extracts and the polar solvent soluble extracts of Examples 1 to 2, using Tanaka et al. (Motomu Tanaka and Kei Maruyama., J. Pharmacol. Sci. 93, 465-470, 2003., Daoui, Cognon, Naline et., Am. J. Respir. Crit.Care.Med. 158, 42-48, 1998.), experiments were carried out as follows.
수컷 기니피그 (6주령, 샘타코 바이오 코리아)에 시험약물을 경구 투여하고 1시간 후 기니피그를 플레티시스모그래프 챔버 (Buxco, U.S.A.)에 넣은 후, 기침 유발제인 시트르산(Citric acid, Sigma)을 분무하여 기침을 유발시켰다. 양성대조군으로는 진해제로 사용되고 있는 테오브로민(Theobromine, Sigma)을 사용하였으며, 2 M의 시트르산에 기니피그를 10분간 노출시키고 이때 발생하는 기침수를 15분간 측정하였고, 결과는 하기 표 3에 나타내었다. After 1 hour of oral administration of test drug to male guinea pigs (6 weeks old, Samtaco Bio Korea), the guinea pigs were placed in a plastismograph chamber (Buxco, USA), and then sprayed with citrate-citing citric acid (Sigma). Causing a cough. As a positive control, theobromine (Sigma), which is used as an antitussive agent, was used. The guinea pig was exposed to 2 M citric acid for 10 minutes, and the cough water generated at this time was measured for 15 minutes, and the results are shown in Table 3 below.
실험예 4. 단독 생약 추출물의 혼합물에 대한 진해 활성 측정Experimental Example 4. Determination of antitussive activity against a mixture of single herbal extracts
실시예 1 및 실시예 2의 각각의 추출물에 대한 진해 활성을 측정한 결과, 50% 에탄올 수용액(PC-GA-2, SH-GA-2, FS-GA-2) 및 그에 기인한 극성 용매 가용추출물(PC-GB-2, SH-GB-2, FS-GB-2)의 활성이 우수하였으며 이를 토대로 실시예 3과 같이 혼합물을 제조(제조예 1~8)하여 상기 실험예 3의 방법으로 진해 활성을 측정하였으며 결과는 하기 표 4에 나타내었다. The antitussive activity of each of the extracts of Examples 1 and 2 was measured to find that 50% aqueous ethanol solution (PC-GA-2, SH-GA-2, FS-GA-2) and the resulting polar solvent soluble The activity of the extracts (PC-GB-2, SH-GB-2, FS-GB-2) was excellent and based on this, a mixture was prepared as in Example 3 (Preparation Examples 1 to 8) to the method of Experimental Example 3 Antitussive activity was measured and the results are shown in Table 4 below.
실험결과, 상기 표 4에서 나타나는 바와 같이, 혼합물을 제조하였을 경우, 단독 추출물일때보다 효과가 증대되는 것을 확인하였으며, 특히, 세가지 생약을 혼합할 경우에 기침억제능이 가장 우수한 활성을 나타냄을 확인할 수 있었다.As a result of the experiment, as shown in Table 4, when the mixture was prepared, it was confirmed that the effect is increased than when the extract alone, in particular, it was confirmed that the cough inhibitory activity showed the most excellent activity when mixing three herbal drugs .
실험예 5. 단독 생약 추출물의 항히스타민 활성 측정Experimental Example 5. Determination of antihistamine activity of single herbal extract
상기 실시예 1 내지 실시예 2의 황백 및 연교 조추출물과 극성 용매 가용추출물의 항히스타민 활성을 측정하기 위해, Honuchi 등의 방법을 이용하여(Masako Honuchi and Yoshiyuki Seyama, J. Health Sci., 52(6), 711~717, 2006., Naoki Inagaki et. Biol. Pharm. Bull. 24(7), 829~834, 2001.), 하기와 같은 공정으로 실험을 수행하였다. In order to measure the antihistamine activity of the yellowish white and ductile crude extract and the polar solvent soluble extract of Examples 1 to 2, using a method such as Honuchi (Masako Honuchi and Yoshiyuki Seyama, J. Health Sci., 52 (6 ), 711-717, 2006., Naoki Inagaki et. Biol. Pharm. Bull. 24 (7), 829-834, 2001.
난백알부민으로 감작시킨 수컷 랫드 (7주령, 샘타코 바이오 코리아)의 복강세포를 이용하여 항히스타민 효과를 측정하였다. 양성 대조군으로는 케토티펜(Ketotifen, Sigma)을 사용하였다. 난백알부민으로 감작시킨 랫드에게 시험약물을 경구 투여하고 약물을 사흘간 경구 투여한 후, 복강 비만세포를 분리하였다. 분리된 복강 비만세포 (2 x 105cells/ml)에 다시 약물을 처리하였다. 마지막으로, 비면역학적인 방법으로 비만세포의 탈과립을 유도하여 히스타민을 분비시키는 물질인 컴파운드48/80 (compound 48/80, Sigma)을 10 μg/ml의 농도로 동일하게 처리하고, 이때 비만세포로부터 유리된 히스타민의 양을 정량하여 시험 물질들이 비만세포로부터 히스타민 유리를 억제시키는가를 알아보았다. 아무 약물도 투여하지 않은 랫드의 비만세포로부터 유리된 히스타민의 양에 대한 상대적인 양을 측정하였으며, 결과는 하기 표 5에 나타내었다. Antihistamine effects were measured using celiac cells of male rats (7 weeks old, Samtaco Bio Korea) sensitized with egg white albumin. Ketotyfen (Ketotifen, Sigma) was used as a positive control. Rats sensitized with egg white albumin were orally administered with the test drug and orally with the drug for three days, and then the peritoneal mast cells were isolated. Isolated celiac mast cells (2 × 10 5 cells / ml) were again treated with the drug. Finally, compound 48/80 (compound 48/80, Sigma), a substance that induces degranulation of mast cells to secrete histamine by the non-immunological method, is treated in the same concentration at a concentration of 10 μg / ml. The amount of free histamine was quantified to determine whether the test substances inhibited histamine release from mast cells. Relative amounts relative to the amount of histamine released from mast cells in rats that were not administered any drug were measured, and the results are shown in Table 5 below.
Example 2
200
(Ketotifen)Positive control group
(Ketotifen)
5
실험예 6. 단독 생약 추출물의 혼합물에 대한 항히스타민 활성 측정Experimental Example 6. Determination of antihistamine activity on a mixture of single herbal extracts
실시예 1 및 실시예 2의 각각의 추출물에 대한 항히스타민 활성을 측정한 결과, 50% 에탄올 수용액(PC-GA-2, FS-GA-2) 및 그에 기인한 극성 용매 가용추출물(PC-GB-2, FS-GB-2)의 활성이 우수하였으며 이를 토대로 실시예 3과 같이 혼합물을 제조(제조예 1~8)하여 상기 실험예 5의 방법으로 진해 활성을 측정하였으며 결과는 하기 표 6에 나타내었다. As a result of measuring the antihistamine activity of each extract of Example 1 and Example 2, 50% aqueous ethanol solution (PC-GA-2, FS-GA-2) and the resulting polar solvent soluble extract (PC-GB- 2, FS-GB-2) was excellent and based on this, the mixture was prepared as in Example 3 (Preparation Examples 1 to 8) to measure the antitussive activity by the method of Experimental Example 5 and the results are shown in Table 6 below. It was.
200
(Ketotifen)Positive control group
(Ketotifen)
5
실험결과, 상기 표 6에서 나타나는 바와 같이, 혼합물을 제조하였을 경우, 단독 추출물일때보다 효과가 증대되는 것을 확인하였으며, 특히, 세가지 생약을 혼합할 경우에 가장 우수한 항히스타민 활성을 나타냄을 확인할 수 있었다.As a result of the experiment, as shown in Table 6, when the mixture was prepared, it was confirmed that the effect is increased than when the extract alone, in particular, it was confirmed that the most excellent antihistamine activity when mixing the three herbs.
하기에 본 발명의 추출물을 포함하는 조성물의 제제예를 설명하나, 본 발명은 이를 한정하고자 함이 아닌 단지 구체적으로 설명하고자 함이다. Hereinafter, the preparation examples of the composition including the extract of the present invention, but the present invention is not intended to limit it, but is intended to explain in detail only.
제제예 1. 산제의 제조Formulation Example 1 Preparation of Powder
실시예 1 내지 3의 추출물 80 mg80 mg of extracts of Examples 1-3
유당 100 mg Lactose 100 mg
탈크 10 mg Talc 10 mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다. The above ingredients are mixed and filled in an airtight cloth to prepare a powder.
제제예 2. 정제의 제조Formulation Example 2 Preparation of Tablet
실시예 1 내지 3의 추출물 100 mg100 mg of extract of Examples 1 to 3
옥수수전분 100 mg Corn starch 100 mg
유당 100 mg Lactose 100 mg
스테아린산 마그네슘 2 mg 2 mg magnesium stearate
상기의 성분들을 혼합한 후 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다. After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.
제제예 3. 캅셀제의 제조 Formulation Example 3 Preparation of Capsule
실시예 1 내지 3의 추출물 100 mg100 mg of extract of Examples 1 to 3
결정성 셀룰로오스 3 mg 3 mg of crystalline cellulose
락토오스 14.8 mg Lactose 14.8 mg
마그네슘 스테아레이트 0.2 mg Magnesium Stearate 0.2 mg
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 캡슐제를 제조한다. According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.
제제예 4. 주사제의 제조Formulation Example 4 Preparation of Injection
실시예 1 내지 3의 추출물 10 mg10 mg extract of Examples 1 to 3
만니톨 180 mg Mannitol 180 mg
주사용 멸균 증류수 2974 mg Sterile distilled water for injection 2974 mg
Na2HPO4,12H2O 26 mg Na2HPO4,12H2O 26 mg
통상의 주사제의 제조방법에 따라 1 앰플당(2㎖) 상기의 성분 함량으로 제조한다. According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule (2 ml).
제제예 5. 액제의 제조Formulation Example 5 Preparation of Liquid
실시예 1 내지 3의 추출물 20 mg 20 mg of extracts of Examples 1 to 3
이성화당 10 g 10 g of isomerized sugar
만니톨 5 g 5 g of mannitol
정제수 적량 Purified water quantity
통상의 액제의 제조방법에 따라 정제수에 각각의 성분을 가하여 용해시키고 레몬향을 적량 가한 다음 상기의 성분을 혼합한 다음 정제수를 가하여 전체를 정제수를 가하여 전체 100㎖로 조절한 후 갈색병에 충진하여 멸균시켜 액제를 제조한다. After dissolving each component in purified water according to the usual method of preparing a liquid solution, adding lemon flavor appropriately, mixing the above components, adding purified water, adjusting the whole to 100 ml by adding purified water, and then filling into a brown bottle. The solution is prepared by sterilization.
제제예 6. 건강 식품의 제조Formulation Example 6 Preparation of Healthy Food
실시예 1 내지 3의 추출물 1000mg1000 mg of extract of Examples 1-3
비타민 A 아세테이트 70 ㎍ 70 μg of Vitamin A Acetate
비타민 E 1.0 ㎎ Vitamin E 1.0 mg
비타민 B1 0.13 ㎎ Vitamin B1 0.13 mg
비타민 B2 0.15 ㎎ Vitamin B2 0.15 mg
비타민 B6 0.5 ㎎ Vitamin B6 0.5 mg
비타민 B12 0.2 ㎍ 0.2 μg of vitamin B12
비타민 C 10 ㎎ Vitamin C 10 mg
비오틴 10 ㎍ 10 μg biotin
니코틴산아미드 1.7 ㎎ Nicotinic Acid 1.7 mg
엽산 50 ㎍ 50 μg folic acid
판토텐산 칼슘 0.5 ㎎ Calcium Pantothenate 0.5mg
무기질 혼합물 적량 Mineral mixture
황산제1철 1.75 ㎎ Ferrous Sulfate 1.75 mg
산화아연 0.82 ㎎ Zinc Oxide 0.82 mg
탄산마그네슘 25.3 ㎎ Magnesium carbonate 25.3 mg
제1인산칼륨 15 ㎎ Potassium monophosphate 15 mg
제2인산칼슘 55 ㎎ Dibasic calcium phosphate 55 mg
구연산칼륨 90 ㎎ Potassium Citrate 90 mg
탄산칼슘 100 ㎎ Calcium Carbonate 100 mg
염화마그네슘 24.8 ㎎ Magnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 건강식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 건강식품 제조방법에 따라 상기의 성분을 혼합한 다음, 과립을 제조하고, 통상의 방법에 따라 건강식품 조성물 제조에 사용할 수 있다. Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.
제제예 7. 건강 음료의 제조Formulation Example 7 Preparation of Healthy Drink
실시예 1 내지 3의 추출물 1000 mg1000 mg of extract of Examples 1 to 3
구연산 1000 ㎎ Citric acid 1000 mg
올리고당 100 g 100 g oligosaccharides
매실농축액 2 g Plum concentrate 2 g
타우린 1 g 1 g of taurine
정제수를 가하여 전체 900 ㎖ Add 900 ml of purified water
통상의 건강음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1시간동안 85℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2ℓ 용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 건강음료 조성물 제조에 사용한다. The above components were mixed according to a conventional health drink manufacturing method, and the mixture was heated at 85 DEG C for about 1 hour with stirring, and the solution thus prepared was filtered to obtain a sterilized 2-liter container, which was sealed and sterilized, ≪ / RTI >
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 수요계층, 수요국가, 사용용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다. Although the composition ratio is a mixture of the components suitable for the preferred beverage as a preferred embodiment, the blending ratio may be arbitrarily varied according to the regional and national preferences such as the demand level, the demanding country, and the intended use.
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CN103948853A (en) * | 2014-05-04 | 2014-07-30 | 苏玉琴 | Method of treating cough and cough medicine prepared by method |
CN104225406A (en) * | 2014-10-09 | 2014-12-24 | 杨丽丽 | Chinese medicine for treating lung abscess |
CN104367819A (en) * | 2014-10-27 | 2015-02-25 | 青岛祥翔生物医药科技有限公司 | Traditional Chinese medicine for treating convalescent pulmonary abscess |
CN104940813A (en) * | 2015-06-10 | 2015-09-30 | 吴光付 | Traditional Chinese medicine composition for treating cholelithiasis and cholecystitis, and preparation method thereof |
CN105106790A (en) * | 2015-09-01 | 2015-12-02 | 江淑芬 | Traditional Chinese medicine composition for treating bronchial asthma and preparation method thereof |
US11129861B2 (en) | 2017-02-01 | 2021-09-28 | Okchundang Co., Ltd. | Methods for treating inflammatory diseases |
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CN115969892B (en) * | 2021-10-15 | 2023-10-20 | 北京中医药大学东直门医院 | Application of herba siegesbeckiae aqueous extract in preparation of medicines for improving myocardial reperfusion injury |
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