KR100579689B1 - Compositions for the prevention or treatment of hyperlipidemia - Google Patents

Compositions for the prevention or treatment of hyperlipidemia Download PDF

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KR100579689B1
KR100579689B1 KR1020030091899A KR20030091899A KR100579689B1 KR 100579689 B1 KR100579689 B1 KR 100579689B1 KR 1020030091899 A KR1020030091899 A KR 1020030091899A KR 20030091899 A KR20030091899 A KR 20030091899A KR 100579689 B1 KR100579689 B1 KR 100579689B1
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group
composition
negative control
present
hyperlipidemia
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KR20050060312A (en
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권두리
박진현
서부일
이인범
구덕모
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주식회사 푸드사이언스
주식회사 피앤아이
학교법인 포항공과대학교
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/60—Fish, e.g. seahorses; Fish eggs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/234—Cnidium (snowparsley)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Abstract

본 발명은 물 1L에 제독된 복어; 유근피; 천궁; 구기자; 및 지구자를 각각 500 내지 1,500g; 5 내지 100g; 5 내지 100g; 5 내지 100g; 및 5 내지 100g의 비율로 포함하는 혼합물을 증류하여 얻어지는 수추출물 및 약제학적으로 허용가능한 첨가제를 포함하는 고지혈증 예방 또는 치료용 조성물을 제공한다.The present invention is blowfish detoxicated in 1L water; Root skin; Celestial arches; Wolfberry; And 500-1500 g of earth; 5 to 100 g; 5 to 100 g; 5 to 100 g; And it provides a composition for preventing or treating hyperlipidemia comprising a water extract obtained by distilling the mixture comprising a ratio of 5 to 100g and a pharmaceutically acceptable additive.

복어, 유근피, 천궁, 구기자, 지구자Puffer fish, Yugeunpi, Cheongung, Wolfberry, Earth globe

Description

고지혈증 예방 또는 치료용 조성물{Compositions for the prevention or treatment of hyperlipidemia}Compositions for the prevention or treatment of hyperlipidemia {Compositions for the prevention or treatment of hyperlipidemia}

본 발명은 제독된 복어, 유근피, 천궁, 구기자, 및 지구자로부터 얻어진 추출물을 유효성분으로 함유하는 고지혈증 예방 및 치료용 조성물에 관한 것이다.The present invention relates to a composition for preventing and treating hyperlipidemia, which contains extracts obtained from detoxified puffer fish, root muscle, horoscope, goji berry, and earth globe as an active ingredient.

고지혈증이란 중성 지방과 콜레스테롤 등의 지방대사가 제대로 이루어지지 않아 혈액 중에 지방량이 많아진 상태를 말한다. 혈청지질은 콜레스테롤, 트리그리세라이드, 인지질, 유리지방산 등으로 구성되어 있다. 이들은 지단백질(lipoprotein)의 형태로 체내에서 이동하며, 지단백질은 카일로마이크론(chylomicron), 초저밀도지단백질 (VLDL), 저밀도지단백질(LDL), 고밀도지단백질 (HDL)의 4가지로 분류된다. 고지혈증 치료를 위해서는 콜레스테롤의 혈중 농도를 낮추고 고밀도지단백질 즉 HDL의 혈중농도를 높일 필요가 있다.Hyperlipidemia refers to a condition in which the amount of fat in the blood is increased due to poor metabolism of triglycerides and cholesterol. Serum lipids are composed of cholesterol, triglycerides, phospholipids and free fatty acids. They move in the body in the form of lipoproteins, and lipoproteins are classified into four types: chylomicron, ultra low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL). In order to treat hyperlipidemia, it is necessary to lower the blood concentration of cholesterol and increase the blood concentration of HDL.

복어는 저칼로리, 고단백질, 저지방과 각종 무기질 및 비타민이 들어 있는 다이어트 식품으로 유용하며, 복어추출물이 알콜 대사에 효과가 있는 것으로 밝혀지고 있다(김동훈, 김동수, 최종원. Alcohol 섭취 쥐에서 alcohol 대사 효소계에 미치는 복어 추출물의 효과. 한국영양식량학회지. 1994;23(2):181-186; 김석환, 이 경희, 신두임, 김동희, 최종원. 복어추출물이 alcohol성 고요산혈증에 미치는 영향. 한국영양식량학회지. 1996;25(1):46-52.). 또한, 대한민국 특허공개 제2002-91641호는 복어 알의 수성 추출액을 이용한 유방암, 위암, 폐암, 간암, 난소암 등의 암을 치료할 수 있는 약학 조성물을 개시한 바 있다.Blowfish is useful as a diet food containing low calorie, high protein, low fat and various minerals and vitamins, and the blowfish extract has been shown to be effective in alcohol metabolism (Kim Dong-hoon, Kim Dong-soo, Choi Won-won. The Effects of Extracted Puffer Fish Extracts Korean Journal of Nutrition and Nutrition 1994.23 (2): 181-186; Kim, Suk-Hwan, Kyung-Hee Lee, Doo-Im Shin, Dong-Hee Kim, and Won-Won Choi.The Effects of Pufferfish Extract on Alcoholic Hyperuricemia. 1996; 25 (1): 46-52.). In addition, the Republic of Korea Patent Publication No. 2002-91641 discloses a pharmaceutical composition that can treat cancer, such as breast cancer, stomach cancer, lung cancer, liver cancer, ovarian cancer using the aqueous extract of pufferfish eggs.

한편, 대한민국 특허공개 제1999-10316호는 테트로도톡신을 제거한 복어와 십전대보탕의 원료 한약제를 포함하는 복어 추출물의 제조방법을 개시하면서, 복어가 혈중 알콜농도의 저하, 지방의 분해로 콜레스테롤을 감소시킨다고 기재되어 있다. 그러나, 상기 선행기술은 콜레스테롤을 감소시키는지 여부에 대한 구체적인 약리효과 자료를 개시하고 있지 않을 뿐 아니라, 콜레스테롤 감소효과가 복어 추출물 자체의 효과인지 복어와 십전대보탕의 원료 한약제를 포함하는 추출물의 효과인지도 명백히 밝히고 있지 않다.Meanwhile, Korean Patent Laid-Open Publication No. 1999-10316 discloses a method of preparing a blowfish extract comprising a raw Chinese herbal medicine of pufferfish and tenjeondaebotang from which tetrodotoxin has been removed, and describes that blowfish reduces cholesterol by lowering blood alcohol concentration and decomposition of fat. It is. However, the prior art does not disclose specific pharmacological data on whether or not to reduce cholesterol, and whether the cholesterol-lowering effect is the effect of the blowfish extract itself, or whether the extract including the raw herbal medicine of pufferfish and Sipjeondaebotang is effective. It is not clear.

본 발명자들은 고지혈증의 예방 및 치료에 유용한 천연 추출물을 개발하고자 연구를 하던 중, 복어와 유근피, 천궁, 구기자, 및 지구자의 수추출물이 콜레스테롤의 혈중농도를 억제할 뿐 아니라 HDL의 혈중농도를 효과적으로 상승시킨다는 것을 발견하여, 본 발명을 완성하게 되었다.The inventors of the present invention while researching to develop a natural extract useful for the prevention and treatment of hyperlipidemia, while the extracts of pufferfish and yukeunpi, cheongung, wolfberry, and earth not only suppress the blood plasma concentration of cholesterol but also effectively raise the blood concentration of HDL The present invention has been completed to complete the present invention.

따라서, 본 발명은 고지혈증의 예방 및 치료에 유용한 추출물을 제공하는 것을 목적으로 한다.Accordingly, an object of the present invention is to provide an extract useful for the prevention and treatment of hyperlipidemia.

본 발명의 일 태양에 따라, 물 1L에 제독된 복어; 유근피; 천궁; 구기자; 및 지구자를 각각 500 내지 1,500g; 5 내지 100g; 5 내지 100g; 5 내지 100g; 및 5 내지 100g의 비율로 포함하는 혼합물을 증류하여 얻어지는 수추출물 및 약제학적으로 허용가능한 첨가제를 포함하는 고지혈증 예방 또는 치료용 조성물이 제공된다.According to one aspect of the invention, puffer fish detoxified in 1 liter of water; Root skin; Celestial arches; Wolfberry; And 500-1500 g of earth; 5 to 100 g; 5 to 100 g; 5 to 100 g; And it provides a composition for preventing or treating hyperlipidemia comprising a water extract obtained by distilling the mixture comprising a ratio of 5 to 100g and a pharmaceutically acceptable additive.

본 발명의 조성물은 바람직하게는 물 1L에 제독된 복어; 유근피; 천궁; 구기자; 및 지구자를 각각 800 내지 1,000g; 10 내지 50g; 10 내지 50g; 10 내지 50g; 및 10 내지 50g을 포함할 수 있다. 또한, 본 발명의 조성물은 고지혈증 예방 또는 치료 효과의 증진을 위하여 인진쑥 5 내지 100g, 더욱 바람직하게는 10 내지 50g을 더 포함할 수 있다.The composition of the present invention preferably is blowfish detoxified in 1 L of water; Root skin; Celestial arches; Wolfberry; And 800-1,000 g of earth, respectively; 10-50 g; 10-50 g; 10-50 g; And 10 to 50 g. In addition, the composition of the present invention may further comprise 5 to 100g, more preferably 10 to 50g of jinjin mugwort to enhance the effect of preventing or treating hyperlipidemia.

본 발명에서 사용되는 복어는 분류학적으로 알려진 모든 복어를 사용할 수 있으며, 예를 들어 참복과, 불뚝복과. 거북복과, 가시복과 등에 속하는 복어들을 모두 사용할 수 있다. 상기에서 참복과에 속한 복어로서, 우리나 수역에 서식하는 복어는 자지복, 검복, 까치복 등 18종과 가시복의 1종을 합쳐 19종으로 알려져 있다. 복어에는 독성이 특히 강한 검복고, 자지복, 까치복 등이 있다. The puffer fish used in the present invention may use any taxonomically known puffer fish, for example, bokbokdae, firefish. You can use all of the puffer fish belonging to the turtle suit, thorn suit and the like. As a blowfish belonging to the bokbok family, there are 19 species of pufferfish, which are inhabited by us or in the body of water, including 18 species such as cock, sword and magpie. Blowfish are particularly toxic, including black robes, cocks and magpies.

본 발명에서 "제독된 복어"라 함은 복어의 간장, 생식선, 소화관, 피부 등에 들어있는 테트라도톡신이라는 신경독이 제거된 복어를 말하며, 통상 복어의 지느러미, 아가미, 눈을 제거하고 개복을 통하여 내장, 복어알, 그리고 피를 제거하여 흐르는 물에 1시간 동안 씻어서 제독할 수 있다.In the present invention, "adventured blowfish" refers to a blowfish that has been removed a neurotoxin called tetradotoxin contained in the liver, gonad, digestive tract, skin, etc. of the blowfish, and usually removes the fins, gills, and eyes of the blowfish Remove pufferfish, puffer fish, and blood and wash in running water for 1 hour to detoxify.

유근피는 느릅나무 또는 뿌리의 껍질로 치습, 이뇨제, 소종독에 사용하는 약재이다. 천궁은 중국이 원산지로서 우리나라의 한랭한 산간지방에서 당귀와 더불어 재배하는 다년생 약초로 강한 방향을 가지고 있다. 땅속의 덩어리 모양의 줄기 뿌 리를 천궁이라 한다. 한방에서 뿌리를 음위, 보익, 간질, 치통, 대하, 진통, 강장, 진정, 부인혈증, 치풍, 역상 등에 약재로 쓴다. 지구자는 갈매나무과에 속하는 가엽활엽교목(잎이 크고 키가 큰 나무)의 열매로서, 호깨, 헛개, 호리께, 볼개 등의 다른 이름으로 불리우는 약용식물이다. 구기자는 구기자나무의 열매로 단백질·지방·당질·칼슘·인·철분·베타인·루틴·비타민(A·B1·B2·C) 등이 들어 있어 흡수가 빠르다. 한방에서는 강장제·해열제로 쓰고 간기능 보호 작용이 뛰어나 부작용이 별로 없다. 또한, 인진쑥은 인진쑥은 국화과에 속하는 다년생 쑥을 말하며, 황달 등 간질환을 고치는 데 예부터 이름이 높으며, 소화계나 항암효과도 기대할 수 있다고 알려져 있다.Root root skin is a bark of elm or root and is used for moisturizing, diuretic and small poison. Cheonggung is a perennial herb that is native to China and grows with donkeys in the cold mountainous regions of Korea. Clump-shaped stem roots in the ground are called cheonggung. Herbal roots in the stomach, bowel, epilepsy, toothache, lobster, analgesic, tonic, soothing, gynecological, hurricane, reversed medicine is used. The earth is the fruit of the broad-leaved broad-leaved arborescent (tree with large and tall leaves) belonging to the sea buckthorn family. Goji berries are fruits of goji berry, which contain protein, fat, sugar, calcium, phosphorus, iron, betaine, rutin, and vitamins (A, B1, B2, C). In oriental medicine, it is used as a tonic and antipyretic. Injin mugwort is a perennial mugwort belonging to the chrysanthemum family. Injin mugwort is known for its treatment of liver diseases such as jaundice, and is known for its digestive and anticancer effects.

본 발명의 조성물에 함유되는 수추출물은 물 1L에 제독된 복어; 유근피; 천궁; 구기자; 및 지구자를 각각 500 내지 1,500g; 5 내지 100g; 5 내지 100g; 5 내지 100g; 및 5 내지 100g의 비율로 포함하는 혼합물을 증류하여 얻어진다. 증류방법은 통상의 증류방법(예를 들어, 단순 증류)에 따라 수행할 수 있으며, 바람직하게는 회분식 증류탑에서 125 ℃ 내지 135 ℃의 온도, 압력 2.8 내지 3.2 kgF/cm2에서 5 내지 7시간 동안 증류함으로써, 효과적으로 유용성분을 추출할 수 있다. 또한, 본 발명의 조성물이 인진쑥을 포함할 경우, 증류시 함께 혼합하여 증류함으로써 간단히 얻을 수 있다.The water extract contained in the composition of the present invention is blowfish detoxicated in 1L of water; Root skin; Celestial arches; Wolfberry; And 500-1500 g of earth; 5 to 100 g; 5 to 100 g; 5 to 100 g; And it is obtained by distilling the mixture containing in the ratio of 5-100 g. The distillation method can be carried out according to a conventional distillation method (for example, simple distillation), preferably in a batch distillation column for 5 to 7 hours at a temperature of 125 ℃ to 135 ℃, pressure 2.8 to 3.2 kgF / cm 2 By distillation, useful components can be extracted effectively. In addition, when the composition of the present invention comprises phosphorus mugwort, it can be obtained simply by mixing together and distilling during distillation.

본 발명의 조성물에 함유되는 약제학적으로 허용가능한 첨가제로는 통상적인 부형제, 붕해제, 결합제, 활택제, 현탁화제 등 중에서 1종 또는 2종 이상을 선택적 으로 사용할 수 있다. 예를 들어, 본 발명의 조성물을 정제 또는 경질캅셀제 등의 고형제형으로 제조할 경우, 부형제로서 미결정 셀룰로오즈, 유당, 저치환도 히드록시셀룰로오즈 등이 사용될 수 있고, 붕해제로서 전분글리콜산 나트륨, 무수인산일수소 칼슘 등이 사용될 수 있다. 결합제로는 폴리비닐피롤리돈, 저치환도 히드록시프로필셀룰로오즈, 히드록시프로필셀룰로오즈 등이 사용될 수 있고, 활택제로서는 스테아린산 마그네슘, 이산화규소, 탈크 등으로부터 선택하여 사용할 수 있다. 또한, 현탁화제로는 약제학 분야에서 통상적으로 사용되는 계면활성제(예를 들어, 소르비탄 에스테르류, 또는 폴리소르베이트류 등)를 사용할 수 있다.As the pharmaceutically acceptable additive contained in the composition of the present invention, one or two or more of conventional excipients, disintegrants, binders, lubricants, suspending agents and the like may be selectively used. For example, when the composition of the present invention is prepared in a solid form such as tablets or hard capsules, microcrystalline cellulose, lactose, low-substituted hydroxycellulose and the like can be used as excipients, sodium starch glycolate, anhydrous as a disintegrant. Calcium monohydrogen phosphate may be used. As the binder, polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose and the like can be used. The lubricant can be selected from magnesium stearate, silicon dioxide, talc and the like. As the suspending agent, surfactants commonly used in the pharmaceutical field (eg, sorbitan esters, polysorbates, etc.) may be used.

본 발명의 조성물은 고형 및 액상 형태를 포함한 다양한 형태의 제형으로 제제화할 수 있으며, 이들 제형은 정제, 캅셀제(경질 또는 연질), 액제(solution), 현탁제, 유제, 및 시럽제 등을 포함한다. 바람직하게는 액제, 현탁제, 유제, 및 시럽제 등의 액체 제형을 가질 수 있으며, 기능성 식품으로 제조할 수도 있다.The compositions of the present invention can be formulated in a variety of forms, including solid and liquid forms, which include tablets, capsules (hard or soft), solutions, suspensions, emulsions, syrups and the like. It may preferably have liquid formulations such as liquids, suspensions, emulsions, and syrups, and may also be prepared as a functional food.

본 발명의 조성물은 경구 또는 비경구를 포함한 다양한 투여방법으로 투여될 수 있으며, 바람직하게는 경구로 투여될 수 있다. 본 발명의 조성물은 고지혈증 예방 또는 치료가 필요한 사람에게 1일 0.1 내지 1000 mg/kg의 범위로 투여될 수 있다. 그러나, 상기 투여량은 나이, 연령 및 성별과 같은 상태 및 질병의 경중 등에 따라 적당한 양으로 조정하여 투여될 수 있으며, 이러한 투여량은 임상적으로 환자의 치료 또는 예방에 종사하는 당업자라면 용이하게 조정할 수 있다.The composition of the present invention may be administered by various methods of administration, including oral or parenteral, and may be preferably administered orally. The composition of the present invention can be administered to a person in need of preventing or treating hyperlipidemia in the range of 0.1 to 1000 mg / kg per day. However, the dosage may be adjusted to an appropriate amount depending on the condition such as age, age and gender and the severity of the disease, such dosage can be easily adjusted by those skilled in the art clinically engaged in the treatment or prevention of patients. Can be.

이하 본 발명을 실시예를 통하여 보다 구체적으로 설명한다. 그러나, 이 실시예는 본 발명을 예시적으로 설명하기 위한 것으로 본 발명의 범위가 이 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail with reference to Examples. However, this embodiment is for illustrative purposes only and the scope of the present invention is not limited to this embodiment.

실시예 1. Example 1.

참복(검자주복: Fugu rubripes rubripes)의 지느러미, 아가미, 눈을 제거하고, 개복하여 내장, 복어알, 그리고 피를 제거하여 흐르는 물에 1시간 동안 씻어서 제독처리 하였다. 제독된 복어 920g을 유근피 20g, 천궁 20g, 지구자 20g, 구기자 20g과 함께 물 1L 중에 혼합하였다. 상기 혼합물을 원통형 회분식 증류탑(55L 용량)에 주입하였다. 다음으로, 온도 130 ℃, 압력 3 kgF/cm2의 조건에서 약 6시간 동안 증류하여 액상 추출물 1.3 L를 얻었다. The fins, gills and eyes of the abalone ( Fugu rubripes rubripes ) were removed, and the abdomen was removed. 920 g of the admiral puffer fish was mixed with 1 g of water together with 20 g of dried root skin, 20 g of celestial organs, 20 g of earth globe, and 20 g of wolfberry. The mixture was injected into a cylindrical batch distillation column (55 L capacity). Next, the mixture was distilled for about 6 hours under conditions of a temperature of 130 ° C. and a pressure of 3 kgF / cm 2 to obtain 1.3 L of a liquid extract.

실시예 2. Example 2.

인진쑥 20g을 추가로 물 1L 중에 혼합한 것을 제외하고는, 실시예 1과 동일한 방법으로 액상 추출물 1.3 L를 얻었다. 1.3 L of liquid extract was obtained in the same manner as in Example 1, except that 20 g of phosphorus mugwort was further mixed in 1 L of water.

실시예 3. Example 3.

대한실험동물에서 구입한 200∼250g의 건강한 스프라그-도울리(Sprague-Dawley)계 랫트를 고형사료(rat chow, 삼양사)로 사육하면서 물을 충분히 공급하고 약 2주일간 사육실 환경에 적응시켰다.200-250 g of healthy Sprague-Dawley rats purchased from Korean experimental animals were fed with rat chow (Samyangsa) and were supplied with sufficient water and adapted to the room environment for about two weeks.

랫트를 각 군당 6마리(n=6) 씩 3군(정상군, 음성대조군, 시험군)으로 나누었 다. 랫트의 고지혈증은 Liu 등의 방법(Liu, S.J., Ramsey, R.K. and Fallon, H.J. Effects of ethanol on hepatic microsomal drug-metabolizing enzymes in the rat. Biochem Pharmacol. 1975;24(3):369-78.)에 따라 알콜성 고지혈증을 유발시켰다. 즉, 정상군은 고형사료와 물을 임으로 섭취하게 하였으며, 음성대조군과 시험군은 고형사료와 25% 알콜용액을 물대신 임의로 섭취하게 하였다. 시험군은 실시예 1에서 제조한 추출물을 1cc/100g의 용량으로 매일 하루 한번씩 경구투여하였다.Rats were divided into three groups (normal group, negative control group, and test group) with 6 animals (n = 6) in each group. Hyperlipidemia in rats was determined by Liu et al. (Liu, SJ, Ramsey, RK and Fallon, HJ Effects of ethanol on hepatic microsomal drug-metabolizing enzymes in the rat.Biochem Pharmacol. 1975; 24 (3): 369-78.) Thus causing alcoholic hyperlipidemia. That is, the normal group was ingested solid food and water randomly, and the negative control group and test group were randomly ingested solid food and 25% alcohol solution instead of water. The test group orally administered the extract prepared in Example 1 once daily at a dose of 1cc / 100g.

상기 시험을 8 주간 동안 계속하였으며, 마지막 24시간 동안 절식 시킨 후, 펜토바비탈 소듐(pentobarbital sod.) 0.1cc/100g을 복강주사하여 마취한 후 복부 정중선을 따라 개복하고 복부 대동액에서 혈액을 체혈하여 원심분리기로 3,300rpm에서 10분간 원심분리하여 혈청을 분리하였다. 별도로 간을 적출하여 무게를 측정하였다.The test was continued for 8 weeks, and after fasting for the last 24 hours, anesthetized by intraperitoneal injection of 0.1 cc / 100 g of pentobarbital sod., Followed by abdominal midline and bleeding blood from the abdominal synapse. Serum was separated by centrifugation at 3,300 rpm for 10 minutes with a centrifuge. Separately, livers were extracted and weighed.

트리글리세리드(Triglyceride)는 Cleantech TG-S시액(아산제약)을 사용하여 효소법으로 SEQUOIA-TURNER model-340 spectrophtometer(U.S.A)기기로 파장 550nm로 분석하였으며, HDL(High-Density lipoprotein)은 HDL-CHOLESTASE(아산제약)을 사용하여 효소법(5분법)으로 SEQUOIA-TURNER model-340 spectrophtometer(U.S.A)기기로 파장 500nm로 분석하였다. ALP는 알칼리성포스파타제 측정용시액(아산제약)을 사용하여 King-King법으로 SEQUOIA-TURNER model-340 spectrophtometer(U.S.A)기기로 파장500 nm로 분석하였으며, GOT 및 GPT는 혈청 트랜스아미나제(Transaminase) 측정용 시액을 사용하여 Reitman-Frankel법으로 SEQUOIA-TURNER model-340 spectrophtometer(U.S.A)기기로 파장 505nm로 분석하였다. 통계 처리는 Student's t-test로 하였으며, 유의성(P<0.05수준)을 검증하였다. 그 결과는 다음과 같다.Triglyceride was analyzed using a Cleantech TG-S solution (Asan Pharmaceutical) with an enzyme method using a SEQUOIA-TURNER model-340 spectrophtometer (USA) instrument with a wavelength of 550 nm. Pharmaceutical) using an enzyme method (5-minute method) was analyzed at a wavelength of 500nm with the SEQUOIA-TURNER model-340 spectrophtometer (USA) instrument. ALP was analyzed at 500 nm wavelength by King-King method using alkaline phosphatase measurement solution (Asan Pharmaceuticals) using SEQUOIA-TURNER model-340 spectrophtometer (USA). GOT and GPT were measured for serum transaminase. The solution was analyzed using a Reitman-Frankel method with a wavelength of 505 nm using a SEQUOIA-TURNER model-340 spectrophtometer (USA) instrument. Statistical treatment was done using Student's t-test, and significance (P <0.05) was verified. the results are as follow.

(1) 혈청 중 트리글리세리드의 함량에 미치는 영향(1) Effect on the content of triglycerides in serum

하기 표1의 결과에서 확인할 수 있는 바와 같이, 정상군의 트리글리세리드 농도(평균 ± 표준편차)는 38.8594 ± 3.47115(㎎/㎗)인데 비하여, 음성대조군은 86.6048 ± 10.58768로 정상군에 비하여 유의성있게 증가하였다. 그러나, 본 발명의 조성물을 투여한 시험군은 53.3156 ± 3.55279로 음성대조군에 비하여 유의성있게 감소하였다.As can be seen from the results of Table 1, the triglyceride concentration (mean ± standard deviation) of the normal group was 38.8594 ± 3.47115 (mg / ㎗) compared to the negative control group was 86.6048 ± 10.58768 significantly increased compared to the normal group . However, the test group to which the composition of the present invention was administered was significantly reduced compared to the negative control group at 53.3156 ± 3.55279.

군group 트리글리세리드 (㎎/㎗)Triglycerides (mg / dl) 정상군Normal 38.8594 ± 3.4711538.8594 ± 3.47115 음성대조군Negative Control 86.6048 ± 10.58768** 86.6048 ± 10.58768 ** 시험군Test group 53.3156 ± 3.55279* 53.3156 ± 3.55279 *

**: 정상군에 비해 유의성이 있음(P<0.01)**: significant compared with normal group (P <0.01)

*: 음성대조군에 비해 유의성이 있음 (P<0.01)*: Significant compared with negative control (P <0.01)

(2) 혈청 중 HDL의 함량에 미치는 영향(2) Effect on the content of HDL in serum

하기 표2의 결과에서 확인할 수 있는 바와 같이, 정상군의 HDL 농도(평균 ± 표준편차)는 36.3095 ± 1.33187(㎎/㎗)인데 비하여, 음성대조군은 27.2728 ± 4.09568로 정상군에 비하여 감소하였으나 유의성은 인정되지 않았다. 그런데, 본 발명의 조성물을 투여한 시험군은 48.7013 ± 4.77394로 음성대조군에 비하여 유의성있게 증가하였다.As can be seen from the results in Table 2, the HDL concentration (mean ± standard deviation) of the normal group was 36.3095 ± 1.33187 (mg / d), while the negative control group was 27.2728 ± 4.09568, but the significance was reduced. Not recognized. By the way, the test group administered the composition of the present invention was significantly increased compared to the negative control group 48.7013 ± 4.77394.

군group HDL (㎎/㎗)HDL (mg / dl) 정상군Normal 36.3095 ± 1.3318736.3095 ± 1.33187 음성대조군Negative Control 27.2728 ± 4.0956827.2728 ± 4.09568 시험군Test group 48.7013 ± 4.77394** 48.7013 ± 4.77394 **

**: 음성대조군에 비해 유의성이 있음 (P<0.01)**: Significant compared to negative control (P <0.01)

(3) 혈청 중 ALP의 함량에 미치는 영향(3) Effect on the content of ALP in serum

하기 표3의 결과에서 확인할 수 있는 바와 같이, 정상군의 ALP 활성(평균 ± 표준편차)은 11.6475 ± 1.51311(IU/l)인데 비하여, 음성대조군은 19.5402 ± 1.05326로 정상군에 비하여 유의성있게 증가하였다. 그런데, 본 발명의 조성물을 투여한 시험군은 14.4349 ± 0.98927로 음성대조군에 비하여 유의성있게 감소하였다.As can be seen from the results in Table 3, the ALP activity (mean ± standard deviation) of the normal group was 11.6475 ± 1.51311 (IU / l), while the negative control group was significantly increased compared to the normal group with 19.5402 ± 1.05326. . However, the test group administered the composition of the present invention was 14.4349 ± 0.98927 significantly reduced compared to the negative control group.

군group ALP 활성(IU/l)ALP activity (IU / l) 정상군Normal 11.6475 ± 1.5131111.6475 ± 1.51311 음성대조군Negative Control 19.5402 ± 1.05326** 19.5402 ± 1.05326 ** 시험군Test group 14.4349 ± 0.98927* 14.4349 ± 0.98927 *

**: 정상군에 비해 유의성이 있음(P<0.01)**: significant compared with normal group (P <0.01)

*: 음성대조군에 비해 유의성이 있음 (P<0.001)*: Significant compared to negative control (P <0.001)

(4) 혈청 중 GOT의 함량에 미치는 영향(4) Effect on the content of GOT in serum

하기 표4의 결과에서 확인할 수 있는 바와 같이, 정상군의 GOT(평균 ± 표준편차)는 52.6667 ± 1.90904 (karmen 단위)인데 비하여, 음성대조군은 118.6667 ± 9.09820로 정상군에 비하여 유의성있게 증가하였다. 그런데, 본 발명의 조성물을 투여한 시험군은 78 ± 8.61007로 음성대조군에 비하여 유의성있게 감소하였다.As can be seen from the results of Table 4, the GOT (mean ± standard deviation) of the normal group was 52.6667 ± 1.90904 (karmen units), while the negative control group was significantly increased compared to the normal group to 118.6667 ± 9.09820. However, the test group administered the composition of the present invention was significantly reduced compared to the negative control group was 78 ± 8.61007.

군group GOT (karmen 단위)GOT (karmen unit) 정상군Normal 52.6667 ± 1.9090452.6667 ± 1.90904 음성대조군Negative Control 118.6667 ± 9.09820** 118.6667 ± 9.09820 ** 시험군Test group 78 ± 8.61007* 78 ± 8.61007 *

**: 정상군에 비해 유의성이 있음(P<0.001)**: significant compared with normal group (P <0.001)

*: 음성대조군에 비해 유의성이 있음 (P<0.001)*: Significant compared to negative control (P <0.001)

(5) 혈청 중 GPT의 함량에 미치는 영향(5) Effect on the content of GPT in serum

하기 표4의 결과에서 확인할 수 있는 바와 같이, 정상군의 GPT(평균 ± 표준편차)는 31 ± 1.94936 (karmen 단위)인데 비하여, 음성대조군은 52.5 ± 3.01938로 정상군에 비하여 유의성있게 증가하였다. 그런데, 본 발명의 조성물을 투여한 시험군은 34.6667 ± 1.08525로 음성대조군에 비하여 유의성있게 감소하였다.As can be seen from the results in Table 4, the GPT (mean ± standard deviation) of the normal group was 31 ± 1.94936 (karmen units), the negative control group was 52.5 ± 3.01938 significantly increased compared to the normal group. However, the test group administered the composition of the present invention was significantly reduced compared to the negative control group to 34.6667 ± 1.08525.

군group GPT (karmen 단위)GPT (karmen unit) 정상군Normal 31 ± 1.9493631 ± 1.94936 음성대조군Negative Control 52.5 ± 3.01938** 52.5 ± 3.01938 ** 시험군Test group 34.6667 ± 1.08525* 34.6667 ± 1.08525 *

**: 정상군에 비해 유의성이 있음(P<0.001)**: significant compared with normal group (P <0.001)

*: 음성대조군에 비해 유의성이 있음 (P<0.01)*: Significant compared with negative control (P <0.01)

(6) 체중의 변화에 미치는 영향(6) effect on weight change

체중의 변화는 하기 표6과 같다. 시험을 시작하기 직전의 체중은 정상군이 352.5 ± 4.97829(g), 음성대조군이 346.8333 ± 3.59088, 본 발명의 조성물 투여군은 354 ± 2.62043으로 각 군간의 체중의 변화는 별다른 차이가 없었다.Changes in body weight are shown in Table 6 below. Body weight immediately before the test was 352.5 ± 4.97829 (g) in the normal group, 346.8333 ± 3.59088 in the negative control group, 354 ± 2.62043 in the composition-administered group of the present invention was not significantly different.

실험시작후 4주의 체중측정에서는 정상군이 439.1667 ± 10.56856(g)이었으나, 음성대조군의 체중은 336.3333 ± 3.69384로 나타나 정상군에 비하여 유의성있게 감소되었다. 그런데, 본 발명의 조성물 투여군은 377.5 ± 14.12268로 나타나 음성대조군에 비하여 유의성있게 증가되었다. The weight of the control group was 439.1667 ± 10.56856 (g), but the weight of the negative control group was 336.3333 ± 3.69384, which was significantly decreased compared to the normal group. However, the composition-administered group of the present invention was found to be 377.5 ± 14.12268, which was significantly increased compared to the negative control group.

실험시작 후 8주의 체중측정에서는 정상군이 484.8333 ± 12.30559(g)이었으나, 음성대조군의 체중은 360.3333 ± 5.78889로 나타나 정상군에 비하여 유의성있게 감소되었다. 그런데, 본 발명의 조성물 투여군은 396.6667 ± 13.46023로 나타나 대조군에 비하여 유의성있게 증가되었다.The weight of the control group was 484.8333 ± 12.30559 (g), but the weight of the negative control group was 360.3333 ± 5.78889, which was significantly decreased compared to the normal group. However, the composition-administered group of the present invention was 396.6667 ± 13.46023, which was significantly increased compared to the control group.

군group 체중(g)Weight (g) 0 주0 weeks 4 주4 weeks 8 주8 Weeks 정상군Normal 352.5 ± 4.97829352.5 ± 4.97829 439.1667 ± 10.56856439.1667 ± 10.56856 484.8333 ± 12.30559484.8333 ± 12.30559 음성대조군Negative Control 346.8333 ± 3.59088346.8333 ± 3.59088 336.3333 ± 3.69384** 336.3333 ± 3.69384 ** 360.3333 ± 5.78889** 360.3333 ± 5.78889 ** 시험군Test group 354 ± 2.62043354 ± 2.62043 377.5 ± 14.12268* 377.5 ± 14.12268 * 96.6667 ± 13.46023* 96.6667 ± 13.46023 *

**: 정상군에 비해 유의성이 있음(P<0.001)**: significant compared with normal group (P <0.001)

*: 음성대조군에 비해 유의성이 있음 (P<0.05)*: Significant compared with negative control (P <0.05)

(7) 간의 무게 변화에 미치는 영향(7) Effect on weight change of liver

간 무게의 변화는 하기 표7과 같다. 정상군이 11.9113 ± 0.20663(g)인데 비하여, 대조군은 9.3128 ± 0.21436로 정상군에 비하여 유의성있게 감소하였다. 그런데, 본 발명의 조성물 투여군은 10.7832 ± 0.36489로 대조군에 비하여 유의성있게 증가하였다. Changes in liver weight are shown in Table 7 below. The control group showed a significant decrease of 9.3128 ± 0.21436 compared to the normal group, compared with 11.9113 ± 0.20663 (g). However, the composition administration group of the present invention was significantly increased compared to the control group to 10.7832 ± 0.36489.

군group 간 무게 (g)Liver weight (g) 정상군Normal 11.9113 ± 0.2066311.9113 ± 0.20663 음성대조군Negative Control 9.3128 ± 0.21436** 9.3128 ± 0.21436 ** 시험군Test group 10.7832 ± 0.36489* 10.7832 ± 0.36489 *

**: 정상군에 비해 유의성이 있음(P<0.001)**: significant compared with normal group (P <0.001)

*: 음성대조군에 비해 유의성이 있음 (P<0.01)*: Significant compared with negative control (P <0.01)

본 발명에 따른 조성물은 고지혈증, 특히 알콜성 고지혈증의 예방 또는 치료에 유용하게 사용될 수 있다. The composition according to the invention can be usefully used for the prevention or treatment of hyperlipidemia, especially alcoholic hyperlipidemia.

Claims (4)

물 1L에 제독된 복어; 유근피; 천궁; 구기자; 및 지구자를 각각 500 내지 1,500g; 5 내지 100g; 5 내지 100g; 5 내지 100g; 및 5 내지 100g의 비율로 포함하는 혼합물을 증류하여 얻어지는 수추출물 및 약제학적으로 허용가능한 첨가제를 포함하는 고지혈증 예방 또는 치료용 조성물.Puffer fish detoxified with 1 liter of water; Root skin; Celestial arches; Wolfberry; And 500-1500 g of earth; 5 to 100 g; 5 to 100 g; 5 to 100 g; And a water extract obtained by distilling the mixture comprising a ratio of 5 to 100 g and a pharmaceutically acceptable additive. 삭제delete 제1항에 있어서, 상기 증류가 회분식 증류탑에서 125 ℃ 내지 135 ℃의 온도, 압력 2.8 내지 3.2 kgF/cm2에서 5 내지 7시간 동안 증류하여 이루어진 것을 특징으로 하는 조성물.The composition of claim 1, wherein the distillation is carried out in a batch distillation column at a temperature of 125 ° C to 135 ° C and a pressure of 2.8 to 3.2 kgF / cm 2 for 5 to 7 hours. 제1항에 있어서, 액제, 현탁제, 유제, 및 시럽제로 이루어진 군으로부터 선택된 제형을 갖는 것을 특징으로 하는 조성물.The composition of claim 1 having a formulation selected from the group consisting of liquids, suspensions, emulsions, and syrups.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101314768B1 (en) * 2011-08-05 2013-10-08 임병용 Preparation method of swellfish extracts with elm root

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101314768B1 (en) * 2011-08-05 2013-10-08 임병용 Preparation method of swellfish extracts with elm root

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