TR2023006253A2 - A COMBINATION FOR THE TREATMENT OF HEPATITIS, FATTY LIVER AND CIRRHOSIS - Google Patents
A COMBINATION FOR THE TREATMENT OF HEPATITIS, FATTY LIVER AND CIRRHOSISInfo
- Publication number
- TR2023006253A2 TR2023006253A2 TR2023/006253 TR2023006253A2 TR 2023006253 A2 TR2023006253 A2 TR 2023006253A2 TR 2023/006253 TR2023/006253 TR 2023/006253 TR 2023006253 A2 TR2023006253 A2 TR 2023006253A2
- Authority
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- Turkey
- Prior art keywords
- pharmaceutical combination
- feature
- herbal pharmaceutical
- treatment
- extract
- Prior art date
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Abstract
Mevcut buluş, hepatit, karaciğer yağlanması ve siroz tedavisinde destekleyici ve takviye edici olarak kullanılmak üzere Silybum Marianum (deve dikeni), Cynara scolymus (enginar), Ganoderma Lucidum (reishi mantarı) ve Taraksakum officinale (karahindiba) bitkilerinin tanımlanmış kısımlarından elde edilen bitkisel farmasötik ürün ve bu ürünün formülasyonu ile ilgilidir.The present invention is a herbal pharmaceutical product obtained from defined parts of Silybum Marianum (milk thistle), Cynara scolymus (artichoke), Ganoderma Lucidum (reishi mushroom) and Taraksakum officinale (dandelion) plants to be used as a supplement and supplement in the treatment of hepatitis, fatty liver and cirrhosis. and this relates to the formulation of the product.
Description
Teknik Alan Mevcut bulus, hepatit, karaciger yaglanmasi ve siroz tedavisinde destekleyici ve takviye edici olarak kullanilmak üzere Silybum Marianum (deve dikeni), Cynara scolymus (enginar), Ganoderma Lucidum (reishi mantari) ve Taraksakum officinale (karahindiba) bitkilerinin tanimlanmis kisimlarindan elde edilen bitkisel farmasötik ürün ve bu ürünün formülasyonu ile Teknigin Bilinen Durumu Gelistirilen bulusta yer alan Botanikteki ismi Silybum Marianum olan deve dikeni en kurak iklimlerde dahi yetisebildigi ve oldukça uzun boylu bir bitki olmasindan dolayi bu adi almistir. Deve dikeni bitkisinin henüz fidan oldugu ve daha genç dönemlerinde yiyecek olarak tüketildigi bilinmektedir. Yapilan bilimsel arastirmalar sonucunda deve dikeni bitkisinin faydalari arasinda agriyi kesme, kolesterol düsürme, karaciger enzimlerini dengeleme, alkol ve diger zararli maddelerin toksik etkilerini azaltma, Alzheimer ve Parkinson hastaliklarinda destek olma, basurun yok edilmesi ve yaslanma etkilerini geciktirme gibi etkiler sayilabilmektedir. Kombinasyonda yer alan diger ürün olan Enginar (Cynara scolymus), papatyagiller familyasindan mavi-mor renkli çiçekler açan, 50-150 cm boyunda çok senelik otsu bir bitkidir. Bir orta büyüklükteki enginar vitamin ve mineral deposudur. Düsük yag, yüksek life sahip sebze vitamin, mineral ve antioksidan zenginidir. Yüksek folat, C ve K vitaminleri içeren enginar, magnezyum, fosfor, potasyum ve demir açisindan da iyi bir kaynaktir. Tüm sebzeler arasinda antioksidan bakimindan en zenginidir. Kolesterolü dengeler, içerdigi potasyum sayesinde tansiyonu düzenler. Karaciger karbonhidrat, protein, lipit ile vitamin-mineral metabolizmasi ve steroid metabolizmasinda rol oynayan vücudun en büyük ve metabolik açidan en kompleks organidir. Toplumun %10,unda karaciger hastaliklari görülmekte, karaciger yaglanmasinin ise en sik görülen karaciger hastaligi oldugu bildirilmistir. Enginar karaciger sagliginin devami için ve karaciger hastaliklarinin tedavisinde siklikla kullanilmaktadir. Hepatektomi sonrasi karaciger rejenerasyonunun hizlandirilmasina destek oldugu yapilan çalismalarda gözlenmistir. Enginar içeriginde bulunan polifenoller ve Ilavonoidler araciligiyla, lipit peroksidasyonuna yol açan malondialdehit olusumunu azaltmaktadir. Sinarin ve silimarin güçlü antioksidan özellikleri ile süperoksit dismutaz, glutatyon peroksidaz gibi enzim aktivitelerini arttirarak, hepatik hidroksiprolin ve malondialdehid düzeylerini azaltarak alkole bagli olmayan yagli karaciger hastaliginin ileri evrelerinde de görülebilen karaciger hasarini önlemektedir. Enginar koleretik ve kolagog etki göstermekte ve koleretik aktivitesine bagli olarak kolerezis ve safra bilesiklerinin olusumunu arttirmaktadir. Enginar bu etkisiyle dispepsi tedavisi için de önerilmektedir. Lif zengini enginar, bagirsak dostu bakterilerin artmasini saglayarak kolon kanseri riskini düsürmeye yardimci olabilir. Ayrica kabizlik ve ishal gibi sorunlari da engelleyerek sindirim sisteminin düzgün çalismasini destekler. Probiyotik görevi gören inülin lifi enginari güçlü kilar. Mide bulantisi, mide eksimesi ve siskinlik gibi sindirim problemlerinin giderilmesinde etkili olabilir. Huzursuz bagirsak sendromu olarak da bilinen irritabl bagirsak sendromu; karin agrisi, kramp, ishal, siskinlik, kabizlik gibi sorunlari ortaya çikaran bir sindirim sistemi hastaligidir. Arastirmalarda, özellikle enginar yapraginin bu semptomlarin azalmasina yardimci olabilecegi belirtiliyor. Özellikle enginarda bulunan bazi bilesiklerin BSade yasanan kas spazmlarini durdurmaya, bagirsak bakterilerini dengelemeye, inIlamasyonu azaltmaya yardimci olabildigi söyleniyor. Arastirmalar, enginar özünün alfa- glukosidaz aktivitesini azalttigi, bu sayede kan sekerini düsürdügü belirtiyor. Ancak daha çok arastirma yapilmasi gerekiyor., Havyanlar üzerindeki yapilan arastirmalara göre, enginardaki rutin, kuersetin, silymarin va galik asit gibi antioksidanlarin kanseri önlemede etkili oldugu belirtiliyor. Örnegin; silymarinin cilt kanserini önleme ve tedavisinde iyilestirici rolü bulunur. Bu sebzede bulunan folik asit, yenidoganlarda tüp defektlerinden korunmaya yardimci olabilir. Bu yüzden hamilelik öncesi ve sonrasinda tüketilmesi önerilir. Enginar, bagisiklik sistemini kuvvetlendirerek, vücudunuzdaki serbest radikallere karsi savasmasina yardimci Kombinasyonun diger ürünü olan Reishi mantari Latince adi Ganoderma Lucidum olan bir mantar türüdür. Kore, Çin ve Japonya yaygin olarak yer alir. Ölümsüzlük mantari olarak da bilinen Reishi mantari en yararli türlerden bir tanesidir. Sedef hastaligina iyi gelmektedir, Böbrek yetmezligi hastaligindan korunmaya veya rahatsizligi ilerlemesini önlemek için kullanilir. Yorgunluk ve halsizligi önler, solunum sistemini düzenler, soguk alginligi ve öksürüge iyi gelir. Antioksidan maddeler içerir. Bu özelligi ile bagisiklik sistemini kuvvetlendirerek hastaliklara karsi direnç saglar. Akciger kanseri gibi bagisiklik sisteminin baskilanmis oldugu immün sistem rahatsizliklarina karsi koruyarak, hastaligin yayilmasini önler. Reishi mantari, alkaloidler, triterpenler, steroller ve türlü polisakaritleri içeren organik bilesenleri içermektedir. Bulus konusu formülasyonda yer alan Latince adi Taraksakum officinale olan (karahindiba), dünyanin birçok yerinde yetisir. Taraxacum officinale içerdigi seskiterpen laktonlar, triterpen ve saponinler, flavonoitler, müsilaj, inülin, diüretik, koleretik, antiinflamatuvar, antioksidan, antikarsinojenik, analj ezik, antihiperglisemik, antikoagülant ve prebiyotik etkilere sahiptir. Besleyici degeri oldukça yüksek olan Karahindiba, % 5'e varan yüksek bir oranda potasyum içermesinden dolayi, en iyi dogal potasyum kaynaklarindan biridir. A vitamini, C vitamini ve nikotinik asit ile kalsiyum ve türlü mineraller yönünden de zengindir. Ayrica, torexacin, retinol, levulin, inulin gibi bilesikler içerir. Bu nedenle yapraklari salatalara katilip yenir. Kökü de, yasken dogranip salatalara katilir. Kurutulan kökü birçok ülkede ögütülüp aci hindiba kahvesi olarak içilir. Avrupa'nin bazi ülkelerinde ve Hindistan'da tarimi yapilan türleri vardir ve bunlarin çiçek büyüklüklerinin çapi yedi santimetreye kadar varir. Kök sakizi da denilen bitki, köklerinden çikan sivinin pihtilasip kurutulmasiyla kauçuk eldesinde de faydalanilir. CN105725192A numarali Çin Patent Basvurusunda kanser, kardiyovasküler ve serebtovasküler hastaliklarda kullanilmak için hazirlanmis ganoderma lucidum kapsülü anlatilmaktadir. ESZ367523T3 numarali spanyol patent basvurusunda, kabugu çikarilmamis Cynara cardunculus (Enginar) veya Silybum marianum (deve dikeni) tanelerinin yüksek basinçta karistirilmasi ve soguk sikistirilmasiyla saglanan yag üretimi anlatilmaktadir. ekstraktin radyodermatitin önlenmesi ve/veya tedavisine yönelik bir ilacin hazirlanmasi için kullanimi anlatilmaktadir. Bulusun Amaci Kombinasyonda yer alan Silybum Marianum (deve dikeni), Cynara scolymus (enginar), Ganoderma Lucidum (reishi mantari) ve Taraksakum officinale (karahindiba) bitkilerinin ayri ayri, tek basina hepatit, karaciger yaglanmasi ve siroz tedavisinde etkileri uzun yillardir bilinmektedir. Silybum Marianum, Cynara scolymus, Ganoderma Lucidum ve Taraksakum officinale bitkilerinin hepatit, karaciger yaglanmasi ve siroz tedavisindeki etkileri gelistirilen bu kombinasyon ile arttirilmaktadir. Bu bulus her bir bitkiyi ayri ayri alip daha az yararlanmak yerine dörtlü bitki ekstraktinin birlikte alinarak biyoyararlanimin arttirilmasini saglanmaktadir. Hastaya uygulanan tedavinin ya da ilacin hastanin en lehine olacak seviyesine terapötik doz denilmektedir. Tedavinin ya da tedavide kullanilan ilacin etki eden en az düzeyi ile yan etki göstermedigi en yüksek seviye arasinda kalan deger terapötik dozdur. Vücuda giren etken maddeler terapötik doza ulasamazlarsa etki gösteremezler. Bazen terapötik etkinin görülebilmesi için etken maddenin çok yüksek dozda kullanilmasi gerekebilir. Bu durum beraberinde ilacin kullanim zorlugu ve ilaç maliyetinin artmasi gibi olumsuzluklari getirebilir. Sinerjik Etki: ki farkli etken madde bir arada kullanildiginda, tek baslarina kullanildiklari zamankinden daha kuvvetli etkinin görülme halidir. Terapötik etkiye ulasmak için yüksek dozda etken maddenin kullanilmasi gerektigi durumlarda sinerj ik etki istenilen bir durumdur. Kombinasyonda yer alan Silybum Marianum, Cynara scolymus, Ganoderma Lucidum ve Taraksakum officinale bitkilerinin bir arada kullanilmasi ile sinerj ik etki saglanarak terapötik doza daha kolay ulasilabilmektedir. Hazirlanis Yöntemi: Oral yolla alinan kati ve sivi dozaj sekilleri için gelistirilen bu kompozisyonda M Marianum meyve ekstresi, Cynara scolymus yaprak ekstresi, Ganoderma Lucidum ekstresi ve Taraksakum officinale kök ekstresi degisik oranlarda alinir, magnezyum stearat ilave edilerek homojen oluncaya kadar karistirilir. Magnezyum stearat yerine diger kaydiricilarda kullanilabilir. Homoj en karisim sert j elatin kapsüllere doldurulur. Yumusak j elatin kapsül, tablet gibi kati ve sivi her türlü dozaj sekillerinde de üretilebilir. Karisim içine konulan ekstrelerin miktari içerdikleri saponine göre degisir. Bu yüzden her bir ekstre miktari kombinasyon içerisinde degisiklik gösterir. Kombinasyonda Silybum Marianum'un %60 Silimarin tasiyan meyve ekstresi 300 mg- 500 mg arasinda kullanilirken Cynara scolymus fenolik bilesenler tasiyan yaprak ekstresi 300 mg- 500 mg arasinda kullanilir. Kombinasyondaki ekstre oranlari degisebilir. Silybum Marianum meyve ekstresi, Cynara scolymus yaprak ekstresi, Ganoderma Lucidum ekstresi ve Taraksakum officinale kök ekstrelerinin karistirilmasi ile bulus konusu kombinasyon hazirlanmaktadir. Dörtlü kombinasyon içine ayni etkilere sahip baska bitki veya bitki ekstreleri ilave edilebilir. Bu bulusla gelistirilen ekstre kombinasyonu; hepatit, karaciger yaglanmasi ve siroz tedavisinde destekleyici ve takviye edici olarak kullanilir. TR TR Technical Field The present invention is a herbal product obtained from defined parts of the plants Silybum Marianum (milk thistle), Cynara scolymus (artichoke), Ganoderma Lucidum (reishi mushroom) and Taraksakum officinale (dandelion) to be used as a supplement and supplement in the treatment of hepatitis, fatty liver and cirrhosis. Pharmaceutical product and formulation of this product and the State of the Art The milk thistle, whose botanical name is Silybum Marianum, is included in the invention and is named this because it can grow even in the driest climates and is a very tall plant. It is known that the milk thistle plant is still a sapling and is consumed as food in its younger stages. As a result of scientific research, the benefits of milk thistle plant include reducing pain, lowering cholesterol, balancing liver enzymes, reducing the toxic effects of alcohol and other harmful substances, supporting Alzheimer's and Parkinson's diseases, eliminating hemorrhoids and delaying the effects of aging. Artichoke (Cynara scolymus), the other product in the combination, is a perennial herbaceous plant from the daisy family, blooming with blue-purple flowers, 50-150 cm tall. A medium-sized artichoke is a source of vitamins and minerals. Low-fat, high-fiber vegetables are rich in vitamins, minerals and antioxidants. Containing high folate, vitamins C and K, artichoke is also a good source of magnesium, phosphorus, potassium and iron. It is the richest in antioxidants among all vegetables. It balances cholesterol and regulates blood pressure thanks to the potassium it contains. The liver is the largest and most metabolically complex organ of the body, playing a role in carbohydrate, protein, lipid, vitamin-mineral metabolism and steroid metabolism. Liver diseases are seen in 10% of the population, and it has been reported that fatty liver is the most common liver disease. Artichoke is frequently used to maintain liver health and in the treatment of liver diseases. It has been observed in studies that it supports the acceleration of liver regeneration after hepatectomy. Artichoke reduces the formation of malondialdehyde, which causes lipid peroxidation, through the polyphenols and lavonoids it contains. With their strong antioxidant properties, synarin and silymar prevent liver damage that can be seen in the advanced stages of non-alcoholic fatty liver disease by increasing enzyme activities such as superoxide dismutase and glutathione peroxidase and reducing hepatic hydroxyproline and malondialdehyde levels. Artichoke has choleretic and cholagogue effects and increases the formation of choleresis and bile compounds due to its choleretic activity. With this effect, artichoke is also recommended for the treatment of dyspepsia. Fiber-rich artichoke may help reduce the risk of colon cancer by increasing intestinal-friendly bacteria. It also supports the proper functioning of the digestive system by preventing problems such as constipation and diarrhea. Inulin fiber, which acts as a probiotic, makes artichokes strong. It can be effective in relieving digestive problems such as nausea, heartburn and bloating. Irritable bowel syndrome, also known as irritable bowel syndrome; It is a digestive system disease that causes problems such as abdominal pain, cramps, diarrhea, bloating and constipation. Research indicates that artichoke leaves, in particular, can help reduce these symptoms. It is said that some compounds, especially found in artichokes, can help stop muscle spasms, balance intestinal bacteria, and reduce inflammation. Research indicates that artichoke extract reduces alpha-glucosidase activity, thus lowering blood sugar. However, more research needs to be done. According to research on animals, it is stated that antioxidants such as routine, quercetin, silymarin and gallic acid in artichokes are effective in preventing cancer. For example; silymarin has a healing role in the prevention and treatment of skin cancer. The folic acid found in this vegetable may help protect from tubal defects in newborns. Therefore, it is recommended to consume it before and after pregnancy. Artichoke strengthens the immune system and helps your body fight against free radicals. Reishi mushroom, the other product of the combination, is a type of mushroom whose Latin name is Ganoderma Lucidum. Korea, China and Japan are common. Reishi mushroom, also known as the mushroom of immortality, is one of the most useful species. It is good for psoriasis, and is used to protect against kidney failure or to prevent the disease from progressing. It prevents fatigue and weakness, regulates the respiratory system, and is good for colds and coughs. Contains antioxidant substances. With this feature, it strengthens the immune system and provides resistance against diseases. It prevents the spread of the disease by protecting against immune system disorders in which the immune system is suppressed, such as lung cancer. Reishi mushroom contains organic compounds including alkaloids, triterpenes, sterols and various polysaccharides. Dandelion, whose Latin name is Taraksakum officinale (dandelion), included in the formulation subject to the invention, grows in many parts of the world. Taraxacum officinale contains sesquiterpene lactones, triterpenes and saponins, flavonoids, mucilage, inulin, diuretic, choleretic, anti-inflammatory, antioxidant, anticarcinogenic, analgesic, antihyperglycemic, anticoagulant and prebiotic effects. Dandelion, which has a very high nutritional value, is one of the best natural sources of potassium, as it contains potassium at a high rate of up to 5%. It is also rich in vitamin A, vitamin C and nicotinic acid, as well as calcium and various minerals. It also contains compounds such as torexacin, retinol, levulin and inulin. For this reason, its leaves are added to salads and eaten. The root can also be chopped when fresh and added to salads. The dried root is ground and drunk as bitter chicory coffee in many countries. There are species cultivated in some European countries and India, and their flower sizes are up to seven centimeters in diameter. The plant, also called root gum, is also used to obtain rubber by coagulating and drying the liquid from its roots. Chinese Patent Application No. CN105725192A describes a ganoderma lucidum capsule prepared for use in cancer, cardiovascular and cerebtovascular diseases. In the Spanish patent application numbered ESZ367523T3, oil production by mixing and cold compressing unhulled Cynara cardunculus (Artichoke) or Silybum marianum (milk thistle) grains at high pressure is described. The use of the extract for the preparation of a medicament for the prevention and/or treatment of radiodermatitis is disclosed. Purpose of the Invention The effects of the plants Silybum Marianum (milk thistle), Cynara scolymus (artichoke), Ganoderma Lucidum (reishi mushroom) and Taraksakum officinale (dandelion) in combination, individually and alone, in the treatment of hepatitis, fatty liver and cirrhosis have been known for many years. The effects of Silybum Marianum, Cynara scolymus, Ganoderma Lucidum and Taraksakum officinale plants in the treatment of hepatitis, fatty liver and cirrhosis are increased with this developed combination. This invention ensures that the bioavailability is increased by taking the quadruple plant extract together, instead of taking each plant separately and benefiting less. The level of treatment or medication administered to the patient that will be most beneficial to the patient is called therapeutic dose. The therapeutic dose is the value between the minimum effective level of the treatment or the drug used in the treatment and the highest level at which it does not cause side effects. If the active ingredients entering the body cannot reach the therapeutic dose, they cannot have an effect. Sometimes it may be necessary to use very high doses of the active ingredient in order to see the therapeutic effect. This situation may bring about negative effects such as difficulty in using the drug and increased drug costs. Synergistic Effect: When two different active ingredients are used together, a stronger effect is observed than when used alone. Synergistic effect is a desired situation in cases where high doses of the active ingredient must be used to achieve the therapeutic effect. By using the plants Silybum Marianum, Cynara scolymus, Ganoderma Lucidum and Taraksakum officinale in the combination, the therapeutic dose can be reached more easily by providing a synergistic effect. Preparation Method: In this composition developed for oral solid and liquid dosage forms, M Marianum fruit extract, Cynara scolymus leaf extract, Ganoderma Lucidum extract and Taraksakum officinale root extract are taken in different proportions, magnesium stearate is added and mixed until homogeneous. Other lubricants can be used instead of magnesium stearate. The homogeneous mixture is filled into hard gelatin capsules. Soft gelatin can be produced in all kinds of solid and liquid dosage forms such as capsules and tablets. The amount of extracts added to the mixture varies depending on the saponin they contain. Therefore, the amount of each extract varies within the combination. In combination, the fruit extract of Silybum Marianum containing 60% Silymarin is used between 300 mg and 500 mg, while the leaf extract of Cynara scolymus carrying phenolic compounds is used between 300 mg and 500 mg. Extract ratios in the combination may vary. The combination of the invention is prepared by mixing Silybum Marianum fruit extract, Cynara scolymus leaf extract, Ganoderma Lucidum extract and Taraksakum officinale root extracts. Other plants or plant extracts with the same effects can be added to the quadruple combination. The extract combination developed with this invention; It is used as a supporter and supplement in the treatment of hepatitis, fatty liver and cirrhosis. TR TR
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TR2023006253A2 true TR2023006253A2 (en) | 2023-06-21 |
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