KR20230111433A - A medicine for treating fatty liver - Google Patents
A medicine for treating fatty liver Download PDFInfo
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- KR20230111433A KR20230111433A KR1020220007271A KR20220007271A KR20230111433A KR 20230111433 A KR20230111433 A KR 20230111433A KR 1020220007271 A KR1020220007271 A KR 1020220007271A KR 20220007271 A KR20220007271 A KR 20220007271A KR 20230111433 A KR20230111433 A KR 20230111433A
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- South Korea
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- fatty liver
- medicine
- present
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- 208000010706 fatty liver disease Diseases 0.000 title claims abstract description 35
- 208000004930 Fatty Liver Diseases 0.000 title claims abstract description 33
- 206010019708 Hepatic steatosis Diseases 0.000 title claims abstract description 33
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Classifications
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
-
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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- A—HUMAN NECESSITIES
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- 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)
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- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8888—Pinellia
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Biotechnology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Alternative & Traditional Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
Description
본 발명은 지방간 치료제에 관한 것이다. 상기 치료제는 한약재로 약학분야에 속한다.The present invention relates to a therapeutic agent for fatty liver. The therapeutic agent belongs to the pharmaceutical field as a herbal medicine.
지금까지 서양의학에서는 지방간을 예방하고 치료하는 효과적인 약물이 없었다. 한의학은 경험이 풍부한 한의사가 추천할 수 있다. 일반적으로 B-초음파가 효과를 테스트하는 기준이 되는 1~3개월 이내에 치료될 수 있다. 서양 의약품은 비타민 B, C, E, 레시틴, 우르소데옥시콜산, 실리마린, 이노신, 코엔자임 A, 환원 글루타티온, 타우린, 카르니틴 오로테이트, 글루코노락톤, 미 몇몇 지리 저하제(간지청((肝旨淸)) 등은 항산화제, 간 세포, 지방 제거제를 보호하는 데 자주 사용된다. 위에서 언급한 많은 약물이 있지만 대부분은 여전히 그 효능과 안전성에 대해 추가 검증이 필요하다.Until now, there has been no effective drug to prevent and treat fatty liver in Western medicine. Oriental medicine can be recommended by an experienced oriental doctor. In general, it can be cured within 1 to 3 months, when B-ultrasound is the criterion for testing its effectiveness. Western medicines are frequently used to protect antioxidants, liver cells, and fat-removing agents, such as vitamins B, C, E, lecithin, ursodeoxycholic acid, silymarin, inosine, coenzyme A, reduced glutathione, taurine, carnitine orotate, gluconolactone, and some lipid-lowering drugs in the United States. There are many drugs mentioned above, but most of them still need further validation for their efficacy and safety. do
한의학에서는 지방간이 주로 과식, 비만, 과음, 습열독(濕熱病)을 느끼거나 정서장애, 만성질환과 허약함, 음식물의 축적, 기의 정체, 기의 유행등으로 인해 발생한다고 보고 있다. 병변이 간에 있는 질병은 간, 담낭, 비장, 위, 신장 및 기타 내부 장기와 밀접한 관련이 있다. 많은 학자들은 이 질병의 발병기전이 간부전, 비장부전, 습열 내부 축적, 가래 혼탁 및 정체, 혈저, 그리고 결국 습, 가래 및 혈정의 형성으로 보고, 이는 간을 차단하게 되며, 그리고 지방간을 형성한다. 가래, 습, 정체라는 병리학적 산물 외에도 신체의 기와 혈액 결핍, 간 조절 장애 및 신장 정수 손실, 목(木)을 함유하지 않는 수(水)와과 관련이 있다고 생각하는 사람들이 있다. 한의학에서는 주로 가래를 제거하고 습을 제거하고 혈액 순환을 촉진하고 혈액 정체를 제거하며 간을 진정시키고 우울증을 완화하며 비장을 강화하고 습을 제거하여 지방간을 치료한다. 또한 상태에 따라 열을 내리게 하고 해독하고, 담즙을 축적, 신을 원하게 하고 간에 영양을 공급하여 보충할 수 있다.In oriental medicine, it is believed that fatty liver is mainly caused by overeating, obesity, excessive drinking, damp heat poisoning, emotional disorders, chronic diseases and weakness, accumulation of food, stagnation of qi, and prevalence of qi. Diseases involving the liver are closely related to the liver, gallbladder, spleen, stomach, kidneys and other internal organs. Many scholars view the pathogenesis of this disease as liver failure, spleen failure, internal accumulation of moist heat, sputum opacity and stagnation, hemorrhage, and eventually the formation of damp, sputum and blood clots, which block the liver, and form fatty liver. In addition to the pathological products of phlegm, dampness, and stagnation, there are people who think that it is related to the body's Qi and blood deficiency, liver dysregulation and loss of kidney water, and water that does not contain wood. In oriental medicine, it is mainly used to remove phlegm, remove dampness, promote blood circulation, remove blood stasis, soothe the liver, relieve depression, strengthen the spleen, and remove dampness to treat fatty liver. In addition, depending on the condition, it can lower heat, detoxify, accumulate bile, seduce the kidneys, and supply nutrients to the liver to replenish it.
본 발명자는 수년간의 연구 및 실행 요약을 통해 중국 전통 의학 이론에 기초하여 지방간 치료를 위한 독창적인 약을 개선하고 지방간 치료를 위한 새로운 약을 개발했다.Through years of research and practice summary, the present inventors have improved the original medicine for fatty liver treatment based on the traditional Chinese medicine theory and developed a new medicine for fatty liver treatment.
본 발명의 목적은 한약 조성물인 지방간 치료제를 제공하는 것이다.An object of the present invention is to provide a therapeutic agent for fatty liver, which is a herbal composition.
본 발명의 다른 목적은 상술한 지방간 치료제의 제조방법을 제공하는 것이다. 이 방법은 생약을 원료로 사용하고 현대 제약 기술로 수행된다.Another object of the present invention is to provide a method for preparing the above-mentioned fatty liver treatment agent. This method uses herbal medicine as raw material and is performed with modern pharmaceutical technology.
본 발명의 또 다른 목적은 지방간 치료에 있어서 상기 언급된 의약의 용도를 제공하는 것이다.Another object of the present invention is to provide the use of the above-mentioned medicament in the treatment of fatty liver.
본 발명은 반하(rhizoma pinelliae)(淸半夏)을 주약으로 하여 튀긴 치자(fried gardenia)(梔子), 산사(hawthorn)(山査), 강황(turmeric)(郁金), 대황(rhubarb)(大黃), 민들레(dandelion)(蒲公英), 감초(licorice)(甘草) 등을 사용하여 제조한다. 상기 원료의 조성비는 강황 20~60중량부, 산사 20~60중량부, 민들레 6~26중량부, 튀긴 치자 60~100중량부, 대황 4~44중량부, 감초 20~60중량부, 반하 44~84중량부이다; 바람직하게는 상기 원료의 조성비는 강황 40중량부, 산사 40중량부, 민들레 16중량부, 튀긴 치자 80중량부, 대황 24중량부, 감초 40중량부, 반하 64중량부이다.In the present invention, fried gardenia, hawthorn, turmeric, rhubarb, dandelion, licorice, etc. are prepared using rhizoma pinelliae as a main ingredient. manufactured using The composition ratio of the raw material is turmeric 20-60 parts by weight, hawthorn 20-60 parts by weight, dandelion 6-26 parts by weight, fried gardenia 60-100 parts by weight, rhubarb 4-44 parts by weight, licorice 20-60 parts by weight, Banha 44-84 parts by weight; Preferably, the composition ratio of the raw material is turmeric 40 parts by weight, hawthorn 40 parts by weight, dandelion 16 parts by weight, fried gardenia 80 parts by weight, rhubarb 24 parts by weight, licorice 40 parts by weight, banha 64 parts by weight.
또한, 본 발명의 목적에 따르면, 본 발명은 원료약품을 비율로 혼합하여 투명한 연고제를 제조하고 과립화하는 단계를 포함하는 지방간 치료제의 제조방법을 제공한다. In addition, according to the object of the present invention, the present invention provides a method for preparing a fatty liver treatment comprising the step of preparing a transparent ointment by mixing the raw materials in a ratio and granulating.
특정 구체예에서, 상기 언급된 약의 제조 방법은 각각의 원료를 물에 첨가하고 달인후, 바람직하게는 3회 달인이고 그 결과물들을 합하고, 여과하고, 여과액을 농축하여 맑은 연고를 얻고, 이를 다른 약용 부형제와 잘 혼합하여 경구 제제를 제조하는 단계를 포함한다. In a specific embodiment, the method for preparing the above-mentioned drug includes adding each raw material to water and decocting, preferably 3 times, combining the results, filtering, and concentrating the filtrate to obtain a clear ointment, and mixing it well with other medicinal excipients to prepare an oral preparation.
보다 구체적으로, 약의 제조 방법은 다음과 같다: 각 원료를 물에 1차 3시간으로 3회 달이고, 2차, 3차 2시간씩 달인 후, 그 결과물을 합하여 여과하고 여과액을 농축하여 각각 생약 3g, 상대밀도 1.20으로 하여 맑은 연고로 하고 적당량의 약용 부형제를 취하여 혼합하고 과립화하여 건조시킨다.More specifically, the preparation method of the drug is as follows: each raw material is decocted in water three times for 3 hours, the second and third times for 2 hours, then the results are combined and filtered, and the filtrate is concentrated to make a clear ointment with 3 g of herbal medicine and a relative density of 1.20, and an appropriate amount of medicinal excipients are taken, mixed, granulated, and dried.
본 발명의 또 다른 목적은 지방간 치료에 있어서 상기 언급된 의약의 용도를 제공하는 것이다.Another object of the present invention is to provide the use of the above-mentioned medicament in the treatment of fatty liver.
본 발명의 지방간 치료제가 치료할 수 있는 지방간은 비만 지방간, 알코올성 지방간, 영양실조 지방간, 당뇨병성 지방간, 임신 지방간, 약물 유발 지방간 및 기타 질환에 의한 지방간을 포함한다. Fatty liver that can be treated by the fatty liver treatment agent of the present invention includes obesity fatty liver, alcoholic fatty liver, malnutrition fatty liver, diabetic fatty liver, pregnancy fatty liver, drug-induced fatty liver, and fatty liver caused by other diseases.
장기간의 임상 의약 수행 후, 우리는 본 발명의 약제 원료를 선택하여 약제를 형성할 때, 특히 각 원료가 그 중량부로서 강황 40, 산사 40중량부, 민들레 16중량부, 튀긴 치자 80중량부, 대황 24중량부, 감초 40중량부, 반하 64중량일 때 예상치 못한 치료 효과가 발생하함을 확인하였다.After conducting clinical medicine for a long time, we confirmed that when the pharmaceutical raw materials of the present invention are selected to form a drug, in particular, unexpected therapeutic effects occur when each raw material contains 40 parts by weight of turmeric, 40 parts by weight of hawthorn, 16 parts by weight of dandelion, 80 parts by weight of fried gardenia, 24 parts by weight of rhubarb, 40 parts by weight of licorice, and 64 parts by weight of Banha.
한의학의 이론에 따르면, 본 발명의 의약은 증후군 분화에 따른 치료를 제공하고 우수한 치료 효과를 달성하였다.According to the theory of oriental medicine, the medicament of the present invention provides treatment according to syndrome differentiation and achieves excellent therapeutic effect.
요약하자면, 선행기술에 지방간 치료를 위한 양방약이 개시되어 있지만, 지금까지 본 발명의 약의 구체적인 원료 비율에 대한 보고가 없고, 본 발명의 원료비를 선택하여 제조한 약제의 지방간 치료에 대한 임상적 치료 효과를 공개한 사람도 없다. In summary, western medicine for the treatment of fatty liver has been disclosed in the prior art, but so far there has been no report on the specific raw material ratio of the drug of the present invention, and the clinical therapeutic effect on the treatment of fatty liver of the drug prepared by selecting the raw material ratio of the present invention No one has disclosed.
실시 예embodiment
실시예 1: 과립Example 1: Granules
강황 40g, 산사 40g, 민들레 16g, 튀긴 치자 80g, 대황 24g, 감초 40g, 청반하 64g을 칭량하였다. 이들을 각각 3, 2, 2시간 동안 3번 물에 달였다. 달인 결과물들을 합하여 여과하였다. 여과액을 각각 원료 3g당 1g으로 그리고 1.20의 상대밀도로 농축하여 투명한 연고를 만들었다. 투명한 연고에 백설탕과 시클로덱스트린을 2:1:1로 첨가하였다. 혼합물을 충분히 균일하게 저어준 후 분무과립법에 따라 과립화한 후 건조시킨 후 배열하고 포장하여 과립을 제조하였다.40 g of turmeric, 40 g of hawthorn, 16 g of dandelion, 80 g of fried gardenia, 24 g of rhubarb, 40 g of licorice, and 64 g of Cheongbanha were weighed. They were decocted in water three times for 3, 2, and 2 hours, respectively. The decoction products were combined and filtered. The filtrate was concentrated to 1 g per 3 g of each raw material and to a relative density of 1.20 to make a clear ointment. White sugar and cyclodextrin were added in a 2:1:1 ratio to the clear ointment. The mixture was sufficiently and uniformly stirred, granulated according to the spray granulation method, dried, arranged, and packed to prepare granules.
실시예 2: 정제Example 2: Tablets
상기 실시 예의 방법으로 제조된 건조 분말을 통상적인 방법에 따라 압착하여 정제를 제조하였다.Tablets were prepared by compressing the dry powder prepared by the method of the above example according to a conventional method.
실시예 3: 캡슐Example 3: Capsule
상기 실시예의 방법으로 제조된 과립을 젤라틴 캡슐에 포장하여 캡슐을 제조하였다.The granules prepared by the method of the above example were packaged in gelatin capsules to prepare capsules.
실험 1: 품질 표준 연구(과립)Experiment 1: Quality standard study (granules)
[성상] 이 제품은 담황색 과립이다.[Appearance] This product is pale yellow granules.
튀긴 치자: 이 원료 10g을 취하여 물 15ml를 넣어 녹이고 초산에틸로 3회 추출하고 매회 15ml씩 취하고 초산에틸용액과 합하여 2ml로 농축하여 시험용액으로 하였다. 따로 튀긴 치자 대조 원료 1g을 취하여 물 15ml를 넣어 30분간 초음파추출하고 여과하고 여과액을 초산에틸로 3회 추출하고, 매회 15ml씩 취하여 초산에틸용액을 합하여 2ml로 농축하여 대조용액으로 하였다. 박층크로마토그래피법에 따라 위의 두 용액을 각각 10㎕씩 취하여 동일한 실리카겔 G 박층판에 반점한다. 현상제로 에틸아세테이트-클로로포름-포름산(6:4:2)을 사용하여 현상하여 꺼내어 건조하였다. 5% 바닐린황산시험용액을 분무하고 105℃에서 약 5분간 가열하였다. 시험용액의 크로마토그램에서 같은 색의 반점이 대조용액의 크로마토그램의 해당 위치에 나타났다Fried Gardenia: 10 g of this raw material was dissolved in 15 ml of water, extracted three times with ethyl acetate, 15 ml each time was taken, combined with ethyl acetate solution, concentrated to 2 ml, and used as a test solution. Separately, take 1 g of the fried gardenia control material, add 15 ml of water, ultrasonically extract for 30 minutes, filter, and extract the filtrate three times with ethyl acetate, take 15 ml each time, combine the ethyl acetate solution, and concentrate to 2 ml to obtain a control solution. According to the thin layer chromatography method, take 10 μl of each of the above two solutions and spot them on the same silica gel G thin layer plate. It was developed using ethyl acetate-chloroform-formic acid (6:4:2) as a developer, and then taken out and dried. A 5% vanillin sulfate test solution was sprayed and heated at 105° C. for about 5 minutes. In the chromatogram of the test solution, a spot of the same color appeared at the corresponding position in the chromatogram of the control solution.
감초: 이 원료를 10g 취하여 물 15ml를 넣어 녹이고 석유에테르로 2회 추출하되 매회 10ml씩 추출하고 초산에틸용액을 합하여 농축하여 2ml를 시험용액으로 하였다. 대조용으로 감초 원료 0.5g을 따로 취하여 물 10ml를 넣고 30분간 초음파추출하여 여과하고 여과액을 석유에테르로 2회, 매회 10ml씩 추출하고 초산에틸용액을 합하여 2ml로 하여 대조용액으로 하였다. 박층크로마토그래피법에 따라 위의 두 용액을 각각 5㎕씩 취하여 같은 실리카겔 G 박층판에 반점하였다. 현상제로 클로로포름-메탄올-물(6:4:2)을 사용하여 현상하고 꺼내어 건조하였다. 5% 바닐린황산시험용액을 분무하고 105℃에서 약 5분간 가열하였다. 시험용액의 크로마토그램에서, 같은 색의 반점이 대조용액의 크로마토그램의 해당 위치에 나타났다.Licorice: 10 g of this raw material was dissolved in 15 ml of water, extracted twice with petroleum ether, 10 ml each time, and ethyl acetate solution was combined and concentrated to make 2 ml of the test solution. For control, 0.5 g of licorice raw material was separately added to 10 ml of water, ultrasonically extracted for 30 minutes, filtered, and the filtrate was extracted twice with petroleum ether, 10 ml each time, and ethyl acetate solution was combined to make 2 ml and used as a control solution. According to the thin layer chromatography method, 5 μl of each of the above two solutions was taken and spotted on the same silica gel G thin layer plate. It was developed using chloroform-methanol-water (6:4:2) as a developer, taken out and dried. A 5% vanillin sulfate test solution was sprayed and heated at 105° C. for about 5 minutes. In the chromatogram of the test solution, a spot of the same color appeared at the corresponding position of the chromatogram of the control solution.
실험 2: 급성 독성 실험(과립)Experiment 2: Acute toxicity test (granules)
실험 방법: 절반은 수컷, 절반은 암컷으로 구성된 30마리의 Kunming 마우스를 가져와 케이지당 5마리의 마우스를 사육하였다. 주위 온도는 18±2℃이고 상대 습도는 70±5%였다. 쥐에게 과립을 먹이고 음수는 자유롭게 마시도록 놔두었다. 예비실험 결과에 따르면 시험약은 16시간 공복(물 섭취 없이)후 위관영양으로 1회 1.2g/체중 20g, 6시간에 1회, 2회 연속 총용량은 60g/kg으로 투여되었다. 투여 후 음식물 및 음수는 자유롭게 하도록 하였다. 투여 당일 동물의 반응을 면밀히 관찰하고 기록하고, 7일 동안 아침과 오후에 1일 1회 연속적으로 관찰하였다.Experiment method: 30 Kunming mice, half male and half female, were bred at 5 mice per cage. The ambient temperature was 18±2° C. and the relative humidity was 70±5%. The mice were fed the granules and allowed to drink the drinking water ad libitum. According to the results of the preliminary experiment, the test drug was administered by gavage after 16 hours of fasting (without water intake) at a dose of 1.2g/20g of body weight once, once every 6 hours, and a total dose of 60g/kg twice consecutively. After administration, food and drink were allowed freely. On the day of administration, the animal's response was closely observed and recorded, and observed continuously once a day in the morning and afternoon for 7 days.
실험 결과: 투여 후 7일 동안 관찰한 결과 독성 반응은 발생하지 않았다.Test results: As a result of observation for 7 days after administration, no toxic reaction occurred.
결론: 위관영양법에 의한 Kunming 마우스에 대한 이 과립의 최대 허용 용량은 60g/kg 이었다. 사람이 소비하는 양의 100배에 해당한다.CONCLUSIONS: The maximum tolerated dose of this granule for Kunming mice by gavage was 60 g/kg. It is equivalent to 100 times the amount consumed by humans.
실험 3: 지방간 치료 관찰(과립)Experiment 3: Observation of fatty liver treatment (granules)
2003년부터 2007년까지 상기 과립제를 이용하여 지방간 및 고지혈증 환자 200명의 예를 관찰하였다. 효과는 상당했다. 메커니즘은 처방과 관련되어 기를 촉진하고 혈액 순환을 촉진하며 열을 제거하고 습을 촉진할 수 있다. 이 과립제와 일부 보조제를 기본 처방으로 하여 B-초음파로 진단된 지방간 환자 100명을 치료하였고, 90은 완화되었고 10명은 효과가 없었다. 고지혈증과 죽상동맥경화증 환자의 유효율은 각각 91.3%와 85.2%였다. 관해 사례 중 85건이 1~2년 동안 추적 관찰되었다. 5명의 지방간에서만 관해가 더디고 나머지는 유의하게 개선되었다. 고지혈증 환자 60명 중 50명에서 1년 복용 후 총 콜레스테롤이 16%, 중성지방이 30% 감소했다.From 2003 to 2007, 200 patients with fatty liver and hyperlipidemia were observed using the granules. The effect was significant. The mechanism involved in the prescription can promote qi, promote blood circulation, remove heat and promote moisture. With this granule and some supplements as a basic prescription, 100 patients with fatty liver diagnosed by B-ultrasound were treated, 90 were alleviated and 10 were ineffective. The effective rates of hyperlipidemia and atherosclerosis patients were 91.3% and 85.2%, respectively. Eighty-five of the remission cases were followed up for 1 to 2 years. Remission was slow in only 5 patients with fatty liver, and the rest showed significant improvement. In 50 out of 60 patients with hyperlipidemia, total cholesterol decreased by 16% and triglyceride by 30% after taking it for one year.
위의 과립제는 지방간에 상당한 치료 효과가 있으며 심장, 뇌, 간, 신장 및 혈액의 정상적인 기능에는 뚜렷한 영향이 없다. 그들은 심전도 및 대뇌 혈류 그래프에서 개선 경향이 있다. 따라서 새로운 지방간 및 혈액 지질 강하제로서 일정한 임상적 이점을 보인다.The above granules have a significant therapeutic effect on fatty liver and have no apparent effect on the normal functions of the heart, brain, liver, kidney and blood. They tend to improve on electrocardiograms and cerebral blood flow graphs. Therefore, it shows certain clinical advantages as a new fatty liver and blood lipid lowering agent.
Claims (5)
강황 20~60중량부, 산사 20~60중량부, 민들레 6~26중량부, 튀긴 치자 60~100중량부, 대황 4~44중량부, 감초 20~60중량부, 반하 44~84중량부.A treatment for fatty liver characterized in that it is prepared by extracting active ingredients from the following raw materials:
Turmeric 20-60 parts by weight, hawthorn 20-60 parts by weight, dandelion 6-26 parts by weight, fried gardenia 60-100 parts by weight, rhubarb 4-44 parts by weight, licorice 20-60 parts by weight, banha 44-84 parts by weight.
하기 원료로부터 유효성분을 추출하여 제조한 것을 특징으로 하는 지방간 치료제:
강황 40 중량부, 산사 40중량부, 민들레 16중량부, 튀긴 치자 80중량부, 대황 24중량부, 감초 40중량부, 반하 64중량부.According to claim 1,
A treatment for fatty liver characterized in that it is prepared by extracting active ingredients from the following raw materials:
Turmeric 40 parts by weight, hawthorn 40 parts by weight, dandelion 16 parts by weight, fried gardenia 80 parts by weight, rhubarb 24 parts by weight, licorice 40 parts by weight, banha 64 parts by weight.
상기 원료들을 비율로 혼합하여 맑은 연고를 제조하고 과립화하는 것을 포함하는 지방간 치료제의 제조 방법.According to any one of claims 1 to 2,
A method for producing a therapeutic agent for fatty liver comprising mixing the raw materials in a ratio to prepare a clear ointment and granulating.
각 원료를 물에 넣어 달인 다음, 여과하고, 여과액을 농축하여 맑은 연고를 얻고, 다른 약용 부형제와 잘 혼합하여 경구용 제제를 제조하는 것을 특징으로 하는 제조 방법.According to claim 3,
A manufacturing method characterized in that each raw material is decocted in water, filtered, and the filtrate is concentrated to obtain a clear ointment, and mixed well with other pharmaceutical excipients to prepare an oral preparation.
상기 원료들을 물로 3회 달이는 것을 특징으로 하는 제조 방법.
According to claim 4,
A manufacturing method characterized in that the raw materials are decocted three times with water.
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