DE102004054133A1 - Silymarin-based food supplement for improving diet and reducing the risk of diseases of civilization, e.g. diabetes, contains a standardized flavonolignan fraction from Marian thistle and a dried Yacon root preparation - Google Patents
Silymarin-based food supplement for improving diet and reducing the risk of diseases of civilization, e.g. diabetes, contains a standardized flavonolignan fraction from Marian thistle and a dried Yacon root preparation Download PDFInfo
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- DE102004054133A1 DE102004054133A1 DE102004054133A DE102004054133A DE102004054133A1 DE 102004054133 A1 DE102004054133 A1 DE 102004054133A1 DE 102004054133 A DE102004054133 A DE 102004054133A DE 102004054133 A DE102004054133 A DE 102004054133A DE 102004054133 A1 DE102004054133 A1 DE 102004054133A1
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- SEBFKMXJBCUCAI-UHFFFAOYSA-N NSC 227190 Natural products C1=C(O)C(OC)=CC(C2C(OC3=CC=C(C=C3O2)C2C(C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-UHFFFAOYSA-N 0.000 title claims abstract description 35
- SEBFKMXJBCUCAI-HKTJVKLFSA-N silibinin Chemical compound C1=C(O)C(OC)=CC([C@@H]2[C@H](OC3=CC=C(C=C3O2)[C@@H]2[C@H](C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-HKTJVKLFSA-N 0.000 title claims abstract description 32
- 235000017700 silymarin Nutrition 0.000 title claims abstract description 31
- 229960004245 silymarin Drugs 0.000 title claims abstract description 31
- 244000134540 Polymnia sonchifolia Species 0.000 title claims abstract description 28
- 235000003406 Polymnia sonchifolia Nutrition 0.000 title claims abstract description 28
- 235000015872 dietary supplement Nutrition 0.000 title claims abstract description 19
- 235000010841 Silybum marianum Nutrition 0.000 title claims abstract description 8
- 201000010099 disease Diseases 0.000 title claims abstract description 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims abstract description 8
- 244000272459 Silybum marianum Species 0.000 title abstract description 9
- 235000005911 diet Nutrition 0.000 title description 10
- 230000037213 diet Effects 0.000 title description 10
- 238000002360 preparation method Methods 0.000 title description 5
- 206010012601 diabetes mellitus Diseases 0.000 title description 3
- 239000000284 extract Substances 0.000 claims abstract description 14
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
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- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- LRCFXGAMWKDGLA-UHFFFAOYSA-N dioxosilane;hydrate Chemical compound O.O=[Si]=O LRCFXGAMWKDGLA-UHFFFAOYSA-N 0.000 claims description 2
- 235000019426 modified starch Nutrition 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 229920001592 potato starch Polymers 0.000 claims description 2
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- 235000012762 dietary quality Nutrition 0.000 claims 1
- 235000021409 diet quality Nutrition 0.000 abstract description 3
- 239000004480 active ingredient Substances 0.000 abstract description 2
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- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 10
- 230000003078 antioxidant effect Effects 0.000 description 6
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- SEBFKMXJBCUCAI-WAABAYLZSA-N (2r,3r)-3,5,7-trihydroxy-2-[(2s,3s)-3-(4-hydroxy-3-methoxyphenyl)-2-(hydroxymethyl)-2,3-dihydro-1,4-benzodioxin-6-yl]-2,3-dihydrochromen-4-one Chemical compound C1=C(O)C(OC)=CC([C@H]2[C@@H](OC3=CC=C(C=C3O2)[C@@H]2[C@H](C(=O)C3=C(O)C=C(O)C=C3O2)O)CO)=C1 SEBFKMXJBCUCAI-WAABAYLZSA-N 0.000 description 4
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 241000208838 Asteraceae Species 0.000 description 1
- 241001233914 Chelidonium majus Species 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 208000004930 Fatty Liver Diseases 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- 244000044980 Fumaria officinalis Species 0.000 description 1
- 235000006961 Fumaria officinalis Nutrition 0.000 description 1
- 239000009095 Hepatofalk Substances 0.000 description 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 description 1
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- 108010007622 LDL Lipoproteins Proteins 0.000 description 1
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- 241000801963 Lebeda Species 0.000 description 1
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- 235000001537 Ribes X gardonianum Nutrition 0.000 description 1
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- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 108010069201 VLDL Cholesterol Proteins 0.000 description 1
- 108010062497 VLDL Lipoproteins Proteins 0.000 description 1
- 238000000540 analysis of variance Methods 0.000 description 1
- 230000003178 anti-diabetic effect Effects 0.000 description 1
- 239000003472 antidiabetic agent Substances 0.000 description 1
- 229940094199 black currant oil Drugs 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 230000001989 choleretic effect Effects 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
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- 230000002443 hepatoprotective effect Effects 0.000 description 1
- 231100000334 hepatotoxic Toxicity 0.000 description 1
- 230000000055 hyoplipidemic effect Effects 0.000 description 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 description 1
- 201000008980 hyperinsulinism Diseases 0.000 description 1
- 208000006575 hypertriglyceridemia Diseases 0.000 description 1
- 230000000999 hypotriglyceridemic effect Effects 0.000 description 1
- 230000003308 immunostimulating effect Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
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- 150000002500 ions Chemical class 0.000 description 1
- 230000037356 lipid metabolism Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 229940096421 milk thistle extract Drugs 0.000 description 1
- 235000020727 milk thistle extract Nutrition 0.000 description 1
- 235000021281 monounsaturated fatty acids Nutrition 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000020824 obesity Nutrition 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
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- 230000008621 organismal health Effects 0.000 description 1
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- 229920006395 saturated elastomer Polymers 0.000 description 1
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- 238000007619 statistical method Methods 0.000 description 1
- 238000009120 supportive therapy Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
- 229940046001 vitamin b complex Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Nutrition Science (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Emergency Medicine (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Medicines Containing Plant Substances (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
Description
Erfindungsbereichinvention range
Die Erfindung betrifft die Zusammensetzung eines Nahrungsergänzungsmittels auf der Basis von Silymarin, d.h. einer standardisierten Fraktion von Flavonolignanen aus dem Samenextrakt der Mariendistel (Silybum marianum), die zu einer Erhöhung der Diätqualität mit positiver Wirksamkeit auf die Verminderung des Risikos einer Zivilisationserkrankung, wie Diabetes mellitus und Hyperlipidämie, beiträgt und ggfs. den gesamten Gesundheitszustand des Organismus von Risikogruppen der Bevölkerung günstig beeinflusst.The The invention relates to the composition of a dietary supplement based on silymarin, i. a standardized faction of flavonolignans from the seed extract of the milk thistle (Silybum marianum) leading to an increase the diet quality with positive Effectiveness on reducing the risk of civilization disease, such as diabetes mellitus and hyperlipidemia, and possibly contributes to the overall health of the organism is favorably influenced by risk groups of the population.
Die „Silybum marianum (L) Gaertner" (Mariendistel, Asteraceae) findet in der europäischen Traditionsmedizin wegen ihrer hepatoprotektiven Wirkung seit Jahrhunderten Verwendung. Deren Wurzeln, Blätter und Samen wurden als Nahrung zubereitet (Morazzoni und Bombardelli, 1995). Die Bezeichnung Silymarin wird für den Extrakt aus dem Samen der „S. marianum (Cardui mariae extractum siccum)" verwendet, der 70–80% des Silymarinkomplexes, d.h. eines Gemischs aus auf Silibinin standardisierten Flavonolignanen und 30–20% einer chemisch nicht definierten Fraktion, enthält.The "Silybum marianum (L) Gaertner "(milk thistle, Asteraceae) takes place in the European Traditional medicine because of its hepatoprotective effect for centuries Use. Their roots, leaves and seeds were prepared as food (Morazzoni and Bombardelli, 1995). The term silymarin is used for the extract of the seed the "S. marianum (Cardui mariae extractum siccum) "containing 70-80% of the silymarin complex, i.e. a mixture of silibinin standardized flavonolignans and 30-20% one chemically defined fraction contains.
Der „S.-marianum"-Extrakt und Silibinin schützen die Leber vor der Wirkung hepatoxischer Stoffe (s. DE-A-19 23 082 und DE-A 35 37 656).The "S. marianum" extract and silibinin protect the liver against the action of hepatoxic substances (see DE-A-19 23 082 and DE-A 35 37 656).
Der „S.-marianum"-Extrakt und Silibinin verhindern die von kupferhaltigen Ionen induzierte Oxidation der menschlichen LDL-Lipoproteine in vitro (s. Škottová et al., 1999).The "S. marianum" extract and silibinin prevent the copper - containing ions induced oxidation of the human LDL lipoproteins in vitro (see Škottová et al., 1999).
Der Extrakt und die Flavonolignane der „S. Marinanum", insbesondere das Bilibinin bishemisukcinat sind als unterstützende Therapie bei der Behandlung mit Zitostatika (s. Lentzen at al., 1998) gut wirksam.Of the Extract and the flavonolignans of "S. Marinanum ", especially that Bilibinin bishemisukcinat are considered as a supportive therapy in the treatment with cestostatics (see Lentzen et al., 1998).
In der Tschechischen Republik bildet der „S.-marianum"-Extrakt einen aktiven Bestandteil von Medikamenten, die als Hepatoprotektiva klassifiziert sind, z.B. FLAVOBION®, SILYGAL®, LAGOSA® oder LEGALON® (der Extraktgehalt in einer Tablette ist 100–204mg, d.h. 70–150mg Silymarinkomplex), das Phytopräparat SIMEPAR® enthält den „S.-marianum"-Extrakt in der Kombination mit dem Vitamin B-Komplex, das HEPABEN® mit dem „Fumaria-officinalis"-Extrakt und das HEPATOFALK® PLANTA mit dem „Chelidonium-majus"-Extrakt. Die Indikation dieser Präparate ist um die cholekinetische und choleretische Wirkung erweitert. Bei den Nahrungsergänzungsmitteln beträgt die Extraktmenge in einer Tablette 15–100mg., d.h. 10–70mg Silymarinkomplex.In the Czech Republic the "S. marianum" extract is an active ingredient of medicaments, which are classified as Hepatoprotektiva such Flavobion ®, SILYGAL ®, ® or Lagosa LEGALON ® (the extract content in one tablet is 100-204mg, ie contains 70-150mg Silymarinkomplex) which Phytopräparat SIMEPAR ® the "S. marianum" extract in combination with the vitamin B-complex, the HEPABEN ® with the "Fumaria officinalis" extract and the HEPATOFALK ® PLANTA with the " Chelidonium-majus "extract. The indication of these preparations is extended by the cholekinetic and choleretic effects. In the case of dietary supplements, the amount of extract in one tablet is 15-100 mg, ie 10-70 mg of silymarin complex.
Beschrieben ist ebenfalls ein Nahrungsergänzungsmittel mit Wirkung auf Plasmalipide und die Antioxidationskapazität des Bluts gemäß der CZ PV 2000-4404, die als Wirkungskomponenten ein Gemisch des Mariendistelextrakts und mindestens eines n-3- und n-6- polyungesättigte Fettsäuren enthaltendes Pflanzenöls enthält. Dieses Präparat hat eine positive Wirkung auf die Cholesterinparameter, die Lebersteatose und den Antioxidationszustand des Organismus, besitzt jedoch keine präbiotische Wirkung.described is also a dietary supplement with effect on plasma lipids and the antioxidant capacity of the blood according to the CZ PV 2000-4404, which as active components a mixture of the milk thistle extract and at least one n-3- and n-6 polyunsaturated fatty acids containing vegetable oil contains. This preparation has a positive effect on the cholesterol parameters, the liver steatosis and the antioxidant state of the organism, but has none prebiotic Effect.
Im Zusammenhang mit der Suche nach neuen Naturquellen mit antidiabetischen, Nährwert-, immunostimulierenden und anderen Eigenschaften wurde experimentell festgestellt, dass verarbeitete Knollen des Yacon (Smallanthus sonchifolius) eine präbiotische Wirkung aufweisen, was z.B. in den Artikeln von Romin Pedreschi et al.: „Andean Yacon Root (Smallanthus sonchifolius Poepp. EndI) Fructooligosacharides as a Potential Novel Source of Prebiotics", Journal of Agricultural and Food Chemistry, 2003, oder Aleš Lebeda et al.: "Biologická a chemická variabilita maky a jakonu", Chem. Listy 97, Seiten 548–556, 2003, beschrieben ist.in the Related to the search for new natural sources with antidiabetic, nutrition, immunostimulating and other properties became experimental found that processed tubers of the Yacon (Smallanthus sonchifolius) a prebiotic Have effect, which is e.g. in the articles by Romin Pedreschi et al .: "Andean Yacon Root (Smallanthus sonchifolius Poepp. EndI) Fructooligosacharides as a Potential Novel Source of Prebiotics, Journal of Agricultural and Food Chemistry, 2003, or Aleš Lebeda et al .: "Biologická a chemická variabilita maky a jakonu ", Chem. Listy 97, pages 548-556, 2003, is described.
Das Bestreben der vorliegenden Erfindung ist daher, ein Nahrungsergänzungsmittel zu schaffen, das die bekannte Wirkung des Silymarin mit der neuentdeckten Wirkung des Yacon in sich vereint.The Endeavor of the present invention is therefore, a dietary supplement to create the well-known effect of silymarin with the newly discovered Effect of the Yacon united in itself.
Zusammenfassung der ErfindungSummary the invention
Eine neue Wirksamkeit gegenüber dem bisherigen Stand weist das Nahrungsergänzungsmittel auf der Basis von Silymarin auf, das zu einer Erhöhung der Diätqualität mit positiver Wirksamkeit auf die Verminderung des Risikos einer Zivilisationserkrankung beiträgt, wobei die Erfindung darin besteht, dass das Nahrungsergänzungsmittel als Wirkungskomponenten ein Gemisch aus 10 bis 90 Gewichts-% der standardisierten Flavonolignanenfraktion aus dem Extrakt der Mariendistel (Cardui mariae extractum siccum) und 90 bis 10 Gewichts-% der galenisch zubereiteten, getrockneten Yaconknolle (Smallanthus sonchifolius) enthält.A new efficacy over the prior art has been the dietary supplement based on silymarin, which contributes to an increase of the diet quality with positive effect on the reduction of the risk of civilization disease, the invention being that the food containing as active components a mixture of 10 to 90% by weight of the standardized Flavonolignanenfraktion from the extract of the milk thistle (Cardui mariae extractum siccum) and 90 to 10% by weight of the galenically prepared, dried yacon tuber (Smallanthus sonchifolius).
Ein weitere Ausbildung der Erfindung besteht darin, dass die Wirkungskomponenten des Nahrungsergänzungsmittels ggf. mit einer bis zu 20-fachen Gewichtsmenge eines physiologisch unschädlichen Vehikels vermischt sind, das in einer vorteilhaften Zusammensetzung 0,1 bis 80 Gewichts-% an inertem Füllstoff und 0,05 bis 10 Gewichts-% an Schmierstoffen enthält.One Another embodiment of the invention is that the effect components of the nutritional supplement optionally with up to 20 times the weight of a physiological harmless Vehicles are mixed, in an advantageous composition 0.1 to 80% by weight of inert filler and 0.05 to 10% by weight contains lubricants.
Gemäß einer weiteren Ausbildung der Erfindung ist der inerte Füllstoff aus einer Stoffgruppe ausgewählt, die mikrokristalline Zellulose und/oder Siliziumoxid und/oder Kartoffelstärke und/oder Maisstärke und/oder modifizierte Stärke enthält, und sind die Schmierstoffe aus einer Stoffgruppe ausgewählt, die Talkum und/oder hydratisiertes Siliziumoxid und/oder Stearinsäure und/oder Kalziumstearat enthält.According to one Another embodiment of the invention is the inert filler selected from a group of substances, the microcrystalline cellulose and / or silica and / or potato starch and / or Corn starch and / or modified starch contains and the lubricants are selected from a group of substances that Talc and / or hydrated silica and / or stearic acid and / or Contains calcium stearate.
Die Wirksamkeit des Nahrungsergänzungsmittels der genannten Zusammensetzung äußert sich darin, dass sich die Kombination des Sylimarins mit Yacon als Vorbeugung gegen chronische Zivilisationserkrankungen, die durch ein atherogenes Lipoproteinprofil, die Leberstearose und einen verschlechterten Antioxidationszustand des Organismus gekennzeichnet sind, positiv auswirkt. Das Nahrungsergänzungsmittel zeichnet sich ferner durch eine nachweisbar präbiotische Wirksamkeit aus, da Yacon Zucker enthält, der die nichtpatogene Darmflora unterstützt, welche die Tätigkeit des Verdauungssystems günstig beeinflusst.The Effectiveness of the dietary supplement The composition mentioned above is expressed in that the combination of Sylimarin with Yacon as a prevention against chronic civilization diseases caused by an atherogenic Lipoprotein profile, liver stasis and a worsening Antioxidant state of the organism are marked, positive effect. The dietary supplement is also characterized by a demonstrable prebiotic efficacy, because Yacon contains sugar, which supports non-patogenic intestinal flora causing activity the digestive system favorable affected.
Ausführungsbeispiele der Erfindungembodiments the invention
Die Möglichkeiten einer konkreten Anwendung der Erfindung sind aus den folgenden Beispielen ersichtlich:The options a concrete application of the invention are from the following examples seen:
Beispiel 1example 1
Die Wirksamkeit der ausgewählten Zusammensetzung des Nahrungsergänzungsmittels, d.h. des Nutrazeutikums, wurde an einer Gruppe von 44 Freiwilligen, sog. Probanden, der metabolischen Beratungsstelle eines der Krankenhäuser der Olmützer Region getestet, wobei das Kriterium für deren Eingliederung in die Studie der Befund des metabolischen Syndroms, d.h. der nachweisbaren Hyperinsulinämie, Hypertinie, Hypertriglyzeridämie und Fettleibigkeit waren. Ihr Einverständnis zur Studiendurchführung gab die ethische Kommission des entsprechenden Krankenhauses. Die Probanden wurden in drei Gruppen eingeteilt:
- 1) PLACEBO: 15 Probanden, d.h. Patienten, dieser Gruppe wurde mikrokristalline Zellulose P als Placebo in einer Tagesdosis von 3,2g gereicht, wobei eine Kapsel 200mg Zellulose P enthielt.
- 2) SILYMARIN: 14 Probanden wurde Silymarin in einer Tagesdosis von 0,8g gereicht, wobei eine Kapsel 134mg Silymarin enthielt.
- 3) SILYMARIN-YACON: 15 Probanden dieser Gruppe wurde ein kombiniertes Präparat in einer Tagesdosis von 0,8g Silymarin und 2,4g Yacon gereicht, wobei 1 Kapsel 50mg Silymarin und 150mg der galenisch zubereiteten Yaconknolle enthielt.
- 1) PLACEBO: 15 subjects, ie patients, of this group were given microcrystalline cellulose P as a placebo in a daily dose of 3.2g, with one capsule containing 200mg of cellulose P.
- 2) SILYMARIN: 14 subjects were given silymarin in a daily dose of 0.8g, with one capsule containing 134mg of silymarin.
- 3) SILYMARIN-YACON: 15 subjects of this group received a combined preparation in a daily dose of 0.8g silymarin and 2.4g yacon, with 1 capsule containing 50mg silymarin and 150mg of the galenically prepared yacon tuber.
Die klinische Studie wurde im Verlauf des Jahres 2002 durchgeführt, wobei die Präparate den Probanden während einer Dauer von 90 Tagen gereicht wurden. Anschließend wurden die Ergebnisse der Studie mittels des statistischen Verfahrens der Streuungsanalyse, der sog. ANOVA, eingeschätzt. Die Eingangsergebnisse zu Beginn des 1. Monats des Studienverlaufs und die Endergebnisse am Ende des 3. Monats des Studienverlaufs sowie deren Differenz wurden statistisch ausgewertet und mit den Werten der Placebos verglichen. Die Ergebnisse sind aus der Tabelle 1 ersichtlich.The clinical study was conducted during the course of 2002, with the preparations the subjects during 90 days. Subsequently were the results of the study using the statistical method of Scattering analysis, the so-called ANOVA, estimated. The input results at the beginning of the first month of the study and the final results at the end of the third month of the study course as well as their difference were statistically evaluated and compared with the placebo values. The results are shown in Table 1.
Die resultierende Wirkung des nur Silymarin enthaltenden Nutrazeutikums äußerte sich in einer statistisch bedeutenden Verminderung des Spiegels der Triglyzeride. Bei der Kombination von Yacon und Silymarin konnte eine statistisch bedeutende Verminderung des Spiegels der Triglyzeride und der Glukose im Blut der Patienten festgestellt werden. Es konnten dabei keinerlei statistisch bedeutende, negative Einflüsse beider gereichter Nutrazeutika auf die Parameter des Sicherheitslabors festgestellt werden.The the resulting effect of the nutraceutical containing only silymarin was expressed in a statistically significant decrease in the level of triglycerides. In the combination of yacon and silymarin could be a statistical significant reduction in the level of triglycerides and glucose be detected in the blood of the patients. There could be no statistically significant, negative influences of both handed out nutraceuticals to the parameters of the safety laboratory.
Tabelle 1 Der Einfluss des Silymarin (SIL) + Yacon (YAC) auf die Triglyzeride (TAG), das Cholesterol und die Glukose bei Probanden mit einem metabolischen Syndrom (Durchschnitt ± S.D. *p < 0,05). Table 1 Influence of silymarin (SIL) + yacon (YAC) on triglycerides (TAG), cholesterol and glucose in subjects with metabolic syndrome (mean ± SD * p <0.05).
Beispiel 2Example 2
Die hypolipidemischen und Antioxidationseffekte des Yacons, des Silymarins und der Kombination dieser Drogen wurden an Ratten an zwei Experimentalmodellen der diätinduzierten Veränderungen im Lipidmetabolismus und dem Antioxidationszustand der Ratten studiert. Beide Diäten enthielten 1% Cholesterin und 10% qualitativ unterschiedliches Fett. Zum Hervorrufen der Lebersteatose mit Fibrose und proatherogenen Änderungen im Lipoproteinprofil wurde Schweinefett verwendet, das reich an gesättigten und monoungesättigten Fettsäuren ist (lard fat diet = LFD), und zur Sensibilisierung des Oxidationszustands der Ratten wurde Johannisbeeröl verwendet, das reich an polyungesättigten Fettsäuren ist (black currant oil diet = BCOD). Yacon und Silymarin wurden 3 Wochen lang als Bestandteil dieser Diäten in einer Konzentration von 0,1, 0,5 und 1,0% gereicht. Bei der Drogenkombination wurden Diätkonzentrationen von 1% Yacon (mikronisierter Staub aus getrockneten Knollen) und 0,33% Silymarin gewählt.The hypolipidemic and antioxidant effects of yacon, silymarin and the combination of these drugs were administered to rats on two experimental models the diet-induced changes in the lipid metabolism and the antioxidant state of the rats. Both diets contained 1% cholesterol and 10% qualitatively different fat. To induce hepatic steatosis with fibrosis and proatherogenic changes In the lipoprotein profile, pork fat rich in saturated and monounsaturated fatty acids (Lard fat diet = LFD), and to sensitize the oxidation state the rats became currant oil used, which is rich in polyunsaturated fatty acids (black currant oil diet = BCOD). Yacon and Silymarin were given 3 weeks long as part of these diets in a concentration of 0.1, 0.5 and 1.0%. In the drug combination were diet concentrations of 1% yacon (micronized dried tubers dust) and 0.33% silymarin was chosen.
Die
Kombination von 1% Yacon und 0,33% Sifymarin (
Figur 1 Wirkung eines Gemisches von Yacon + Silymarin auf das Profil der Lipoproteide und der Leberlipide bei Ratten (Durchschnitt ± S.E., n = 6, *p < 0,05). FIG. 1 Effect of a mixture of yacon + silymarin on the profile of lipoproteins and liver lipids in rats (mean ± SE, n = 6, * p <0.05).
Beispiel 3Example 3
Als
optimale, den Anforderungen an die Stabilität und Homogenität nachkommende
Medikamentenform wurde nach klinischer Erprobung eine 300mg-Gelatinekapsel mit
folgender, beispielhafter Zusammensetzung gewählt:
Industrielle Verwendbarkeitindustrial usability
Das Nahrungsergänzungsmittel auf der Basis von Silymarin kann zur Vorbeugung von Zivilisationserkrankungen, wie z.B. Diabetes mellitus und Hyperlipidämie, ggfs. als präventives Nahrungsergänzungsmittel, das den Gesamtzustand des menschlichen Organismus günstig beeinflusst, verwendet werden.The Dietary supplements based on silymarin can be used to prevent civilization diseases, such as. Diabetes mellitus and hyperlipidemia, if necessary as preventive Dietary supplement, the the general state of the human organism is favorably influenced become.
Claims (5)
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DE202004021241U DE202004021241U1 (en) | 2003-11-10 | 2004-11-08 | Silymarin-based food supplement for improving diet and reducing the risk of diseases of civilization, e.g. diabetes, contains a standardized flavonolignan fraction from Marian thistle and a dried Yacon root preparation |
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CZPV2003-3042 | 2003-11-10 |
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Cited By (3)
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WO2009103788A1 (en) | 2008-02-22 | 2009-08-27 | Cm & D Pharma Limited | Compositions comprising phytoestrogens selective for estrogen beta receptor and dietary fibres |
EP2266619A1 (en) * | 2008-03-04 | 2010-12-29 | Dikovskiy, Aleksander Vladimirovich | Pharmaceutical composition based on hepatoprotector and prebiotic, the production and use thereof |
ITMI20130425A1 (en) * | 2013-03-20 | 2014-09-21 | Istituto Biochimico Italiano | COMPOSITION FOR THE TREATMENT OF THE METABOLIC SYNDROME AND THE METABOLIC-OXIDATIVE ALTERATIONS IN PATIENTS WITH NON-ALCOHOLIC STEATOEPATITIS (NASH) |
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2003
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2009103788A1 (en) | 2008-02-22 | 2009-08-27 | Cm & D Pharma Limited | Compositions comprising phytoestrogens selective for estrogen beta receptor and dietary fibres |
US20110027230A1 (en) * | 2008-02-22 | 2011-02-03 | Alfredo Di Leo | Compositions comprising phytoestrogenes selective for estrogen beta receptor and dietary fibres |
EA020095B1 (en) * | 2008-02-22 | 2014-08-29 | См Энд Д Фарма Лимитед | Compositions comprising phytoestrogens selective for estrogen beta receptor and dietary fibres |
EP2266619A1 (en) * | 2008-03-04 | 2010-12-29 | Dikovskiy, Aleksander Vladimirovich | Pharmaceutical composition based on hepatoprotector and prebiotic, the production and use thereof |
EP2266619A4 (en) * | 2008-03-04 | 2011-07-20 | Dikovskiy Aleksander Vladimirovich | Pharmaceutical composition based on hepatoprotector and prebiotic, the production and use thereof |
ITMI20130425A1 (en) * | 2013-03-20 | 2014-09-21 | Istituto Biochimico Italiano | COMPOSITION FOR THE TREATMENT OF THE METABOLIC SYNDROME AND THE METABOLIC-OXIDATIVE ALTERATIONS IN PATIENTS WITH NON-ALCOHOLIC STEATOEPATITIS (NASH) |
WO2014147119A1 (en) * | 2013-03-20 | 2014-09-25 | Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. | Silybin for the treatment of metabolic oxidative alterations in patients with non-alcoholic steatohepatitis (nash) |
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SK5336Y1 (en) | 2010-01-07 |
PL205939B1 (en) | 2010-06-30 |
CZ20033042A3 (en) | 2005-06-15 |
SK322004A3 (en) | 2005-06-02 |
PL370897A1 (en) | 2005-05-16 |
CZ295149B6 (en) | 2005-06-15 |
SK500272009U1 (en) | 2009-07-06 |
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