WO2014098295A1 - 산화적 뇌손상 및 뇌기능 장애의 예방 또는 치료용 조성물 및 이의 제조방법 - Google Patents
산화적 뇌손상 및 뇌기능 장애의 예방 또는 치료용 조성물 및 이의 제조방법 Download PDFInfo
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- WO2014098295A1 WO2014098295A1 PCT/KR2012/011532 KR2012011532W WO2014098295A1 WO 2014098295 A1 WO2014098295 A1 WO 2014098295A1 KR 2012011532 W KR2012011532 W KR 2012011532W WO 2014098295 A1 WO2014098295 A1 WO 2014098295A1
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- 239000008213 purified water Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- DOUMFZQKYFQNTF-MRXNPFEDSA-N rosemarinic acid Natural products C([C@H](C(=O)O)OC(=O)C=CC=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 DOUMFZQKYFQNTF-MRXNPFEDSA-N 0.000 description 1
- TVHVQJFBWRLYOD-UHFFFAOYSA-N rosmarinic acid Natural products OC(=O)C(Cc1ccc(O)c(O)c1)OC(=Cc2ccc(O)c(O)c2)C=O TVHVQJFBWRLYOD-UHFFFAOYSA-N 0.000 description 1
- 229930183842 salvianolic acid Natural products 0.000 description 1
- STECJAGHUSJQJN-FWXGHANASA-N scopolamine Chemical compound C1([C@@H](CO)C(=O)O[C@H]2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-FWXGHANASA-N 0.000 description 1
- 229960002646 scopolamine Drugs 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 235000020712 soy bean extract Nutrition 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 229910021653 sulphate ion Inorganic materials 0.000 description 1
- YLJREFDVOIBQDA-UHFFFAOYSA-N tacrine Chemical compound C1=CC=C2C(N)=C(CCCC3)C3=NC2=C1 YLJREFDVOIBQDA-UHFFFAOYSA-N 0.000 description 1
- 229960001685 tacrine Drugs 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
Classifications
-
- 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
- A61K36/481—Astragalus (milkvetch)
-
- 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
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
Definitions
- the present invention is a composition for the prevention or treatment of oxidative brain damage and brain dysfunction comprising extracts of Astragalus and Salvia Miltiorrhiza as an active ingredient, methods for preparing the same, and oxidative brain damage and brain dysfunction comprising the extract as an active ingredient. It relates to food compositions for improvement or prevention.
- the brain and various parts of the hippocampus kill the cells that make up the brain, especially the nerve pathways that lead to multiple brain dysfunctions (behavior and memory loss). In addition, it stimulates the release of stress hormones through excessive activation of the HPA axis (hypothalamus-pituitary-adrenal axis) caused by stress reactions.
- the antioxidant ' system glycolutathione system, superoxide dismutase, catalase
- the object of the present invention is to provide a composition for the prevention or treatment of oxidative brain injury and brain dysfunction.
- Another object of the present invention is to prevent or treat oxidative brain injury and brain dysfunction.
- Another object of the present invention is to provide a food composition for the prevention or improvement of oxidative brain damage and brain dysfunction.
- the present invention is to extract the extract of
- compositions for the prevention or treatment of oxidative brain damage and brain dysfunction comprising as an active ingredient.
- the present invention provides a mixture of Astragalus and Salvia Militiorrhiza.
- a method of preparing a composition for the prevention or treatment of oxidative brain injury and brain dysfunction comprising the step of extracting with 10-70% ethanol is provided.
- the present invention provides a food composition for the prevention or improvement of oxidative brain damage and brain dysfunction, including the extract of Astragalus and Salvia Militiorrhiza as an active ingredient, and a method of preparing the food composition. do.
- the present invention relates to a composition for the prevention or treatment of oxidative brain damage and brain dysfunction, which contains extracts of Astragalus and Salvia Militiorrhiza as active ingredients.
- Astragali Radix is a medicinal herb belonging to the legumes (Leguminosae). It is used for weakness and species as a relaxation, tonic, cold, diuretic, etc. and is known to have vasodilatation and hypotension.
- Salviae Radix Is a medicinal herb belonging to Lataetae and contains tanshinone as its main ingredient, and is known as a tonic, pain and gynecological medicine in menstruation, menstrual bleeding, uterine bleeding and abdominal pain.
- the extracts of Astragalus and Salviae Radix of the present invention are effective for the prevention or treatment of oxidative damage and brain dysfunction of the brain caused by stress.
- the composition according to the present invention was administered to the experimental group, the anti-oxidation system, blood hormone and brain tissues showed significant improvement on the improvement of the related hormone and memory impairment.
- composition for the prevention or treatment of oxidative brain damage and brain dysfunction comprising the extracts of Astragalus and Salviae Radix of the present invention as active ingredients,
- Astragalloside IV pomononetin, rosemary acid, salvianolic acid B.
- the oxidative brain injury and brain dysfunction may be any one selected from dementia, Alzheimer's syndrome, Parkinson's syndrome and Huntington's syndrome.
- each extract of Astragalus and Dansam Is not significantly different in terms of the effects of treatment or prevention against oxidative brain damage and brain dysfunction compared to the case where it is used alone, and the above ratio is best.
- the extract of the present invention is prepared by extracting with an extraction solvent or by extracting with an extraction solvent.
- the extractant may be prepared by adding a fractional solvent to the extract.
- the extractant may be one or more selected from the group consisting of water and an organic solvent.
- the organic solvent may be alcohol, ethyl acetate, or 1 to 5 carbon atoms of methanol, ethanol or the like.
- Polar solvents such as acetone and non-polar solvents of nucleic acid or dichloromethane or their
- fraction solvent is water, butanol, ethyl acetate,
- It may be chloroform, nucleic acid or a combination thereof.
- the extract is subjected to a reduced pressure filtration process after the extraction or fractionation process.
- the extract can be concentrated or removed by performing additional concentrations and / or freeze drying.
- the obtained extract can be stored in a deep freezer until use.
- composition for the prevention or treatment of oxidative brain injury and brain dysfunction of the present invention is 0.001 to 99.99% by weight of the sulfur and salvia extract, It may be included in an amount of 0.1 to 99 in an amount of 7 ° C.
- the composition may contain nutrients, vitamins, electrolytes, flavors, coloring agents, neutralizing agents, pectic acid and salts thereof.
- alginic acid and salts thereof organic acids, protective colloid thickeners, pH regulators, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. Or in combination.
- composition containing the above sulfur and salvia extract as an active ingredient is prepared in the preparation thereof.
- compositions of the present invention may be parenterally administered (e.g., intravenously, subcutaneously, intraperitoneally, or locally) or orally, depending on the method of purpose.
- Preferred dosages include conditions, weight, degree of illness, Depending on the drug form, route of administration, and duration, it may be appropriately selected by those of ordinary skill in the art to which the present invention pertains.
- the therapeutic composition of the present invention is based on the amounts of Astragalus and Salvia extracts. In order to be more effective, it is recommended to administer from 0.01 to 100 mg / kg per day. The dosage can be administered once a day or several times.
- the present invention is a step of extracting the sulfur and salvia complex with 10-70% ethanol;
- compositions for the prevention or treatment of oxidative brain injury and brain dysfunction including
- the sulfuric and soybean combinations of the sulfuric acid: sweet soybean are from 1: 9 to 9: 1.
- the ratio is preferable to mix the ratio into a ratio, more preferably at a mixing ratio of 1: 1.
- a mixing ratio of 1: 1. In the step of extracting the sulphate and the mixture with ethanol, preferably with 30% ethanol.
- the ratio is out of the range, there is no significant difference in the effect of treatment or prevention against oxidative brain damage and brain dysfunction when compared to the use of the individual extracts of Astragalus and Salvia Militiorrhiza. The effect is the best.
- a method for preparing a composition for the prevention or treatment of oxidative brain injury and brain dysfunction comprises extracting with 10-70% ethanol, and the extracts of Astragalus and Salvia Miltifolia contained in the composition of the present invention. It is possible to control the destruction of the active ingredient and obtain a high yield of active ingredient.
- the present invention provides a food composition for the prevention or improvement of oxidative brain damage and brain dysfunction, which contains the extract of Astragalus and Salvia Miltiorrhiza. Extracting step; Freezing and drying the extract; Provides a method for producing a food composition for preventing or improving oxidative brain damage and brain dysfunction.
- food means one or more nutrients.
- the extract of sulfur and soybean extract may be contained in 0.0001 to 10% by weight of the total food composition, the food formulation using the ingredients commonly used in drinks, caramels, chocolate, It can be formulated as a diet bar formulation or a food that is fruit.
- the food composition may contain food acceptable food additives, and may further include appropriate carriers, excipients and diluents commonly used in the manufacture of food.
- compositions containing the extract of the present invention of Astragalus and Salviae Radix as active ingredients are
- 1 is an invention that includes extracts extracted using distilled water and ethanol, respectively.
- Drug composition using the two composition contents of the composition and the indicator substance.
- FIG. 3 is a graph showing the composition of the present invention against oxidative damage in the serum of rats induced by acute stress.
- composition of the present invention is a graph showing the efficacy of the composition of the present invention on lipid peroxidation in acute stress-induced brain tissue (cerebral hippocampus).
- FIG. 5 is a photograph confirming the efficacy and drug mechanisms for inflammation-related factors in the rat brain tissue (cerebral hippocampus) induced by acute stress.
- FIG. 6 is a graph showing the improvement effect on the memory impairment of rats induced by acute stress.
- FIG. 7 is a graph showing the pharmacological action against the memory disorder of rats induced by the acute stress of the present composition and the effect against oxidative damage of brain tissue.
- FIG. 8 is a graph showing the improvement effect on the oxidative brain damage and the secretion of stress hormone and secretion in rats induced by chronic binding stress.
- FIG. 9 is a table showing the hematological changes and antioxidant improvement effects of oxidative brain damage in rats induced by chronic stress of the present invention.
- FIG. 10 shows the oxidation of reddish derivatives of the present invention induced by chronic binding stress.
- FIG. 11 is a graph showing an improvement effect on the cognitive impairment of the present composition.
- Figure 12 shows the stress of rats in which the composition of the present invention is induced with chronic cold stress.
- This graph shows the effect of improving hormone secretion.
- Figure 13 shows the brain tissue of rats of the present invention induced by chronic cold stress.
- This graph shows the improvement effect on oxidative damage.
- FIG. 14 is a graph showing an improvement effect on enzymes related to inflammatory reaction and hormone metabolism of brain tissue of rats induced by chronic stress of the present invention.
- Fig. 15 shows the lesion composition of the brain tissue induced by chronic stress.
- This photo shows histological improvement.
- composition of the present invention was used to create a drug fingerprint using HPLC (Fig. 1).
- each group was represented as normal group -Nommal, control group (distilled water) -Control, and the invention composition of three concentrations -Myp 50, MyplOO, Myp200, and vitamin C-VitC100.
- the composition may be termed Myelophil), followed by a 12-hour removal of the beard and eyebrows, exerting extreme mental stress, and then dissecting the brain tissue and blood at necropsy to relate the efficacy of the drug to serum.
- the hormonal and oxidative damage and inflammation levels of brain tissues were evaluated in relation to the inflammatory-related factors in the tissues. The results are shown in Figs.
- composition 50, 100, 200 mg / kg, PO
- tacrine 10 mgkg, PO
- scopolamine a chemical drug that causes brain damage with memory loss and oxidative mechanisms 7
- the above ingredients were mixed and layered in an airtight cloth to prepare a powder.
- the tablets were prepared by mixing the above ingredients and tableting according to the conventional method for preparing tablets.
- the upper part of the air is mixed by mixing the above components in accordance with the manufacture of a common injection solution, layering the solution on a transparent type 5 ampoules of I, and dissolving the glass. It was encapsulated under a grid, and sterilized by autoclaving at 120 ° C. for at least 15 minutes to prepare an injection solution.
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Abstract
본발명은황기와단삼의추출물을유효성분으로포함하는산화적뇌손상및뇌기능 장애의 예방또는치료용조성물에관한것으로，본발명에따른조성물은실제임상에서 발생하는급성및장기간의과도한스트레스로인한뇌조직의손상및뇌기능장애와 유사한동물모델에서예방또는치료에매우유효한효과가있어,이에대한치료제로서 유용하게활용될수있다.
Description
명세서
발명의 명칭:산화적뇌손상및뇌기능장애의 예방또는치료용 조성물및이의제조방법
기술분야
[1] 본발명은황기와단삼의추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의예방또는치료용조성물，이의제조방법및상기추출물을 유효성분으로포함하는산화적뇌손상및뇌기능장애개선또는예방용 식품조성물에관한것이다.
배경기술
[2] 최근현대사회가급격한산업화와고령화에직면하면서다양한질병의증가와 더불어특히뇌관련질환이주요이슈로자리하고있다.이러한뇌관련질환의 대표적인원인으로과도한스트레스를들수있다.현대사회의급격한산업화및 발전에따라과도한스트레스는피할수없는것으로，이는불면증，우울증， 집중력장애，기억력감퇴，산화적손상및노화와같은뇌기능장애의진행을 유발하고이에따라점진적으로알츠하이머，파킨슨병및헌팅턴병과기능성 뇌조직의장애에대한유병율이증가하고있으며,또한이로인한사회적비용의 지출역시꾸준하게상승하고있다.
[3] 일반적으로과도한스트레스로인한뇌조직의손상은일차적으로신체적
반웅을하여무기력감을호소하게할뿐만아니라，뇌와여러부분중특히 해마를구성하고있는세포를사멸시켜대뇌로이동하는신경전달경로를 차단하여여러뇌기능장애 (행동장애및기억력감퇴)등을유발시키고,또한 스트레스반웅으로인한 HPA축 (시상하부-뇌하수체-부신축)의과도한활성화를 통하여스트레스성호르몬의분비를촉진시킨다.이러한스트레스성호르몬의 분비는 2차적으로활성산소 (reactive oxygen species, ROS)의과도한발생과이를 제거하는방어기전인항산화 '시스템 (glutathione system, superoxide dismutase, catalase)의결핍을초래하며, H조직의복합적인기능장애로인한신체적인 활동의제약까지초래하게된다. .
[4] 과도한스트레스로유도된산화적뇌손상및뇌기능장애의다양한패턴과
병의진행과정에있어임상적으로환자의경과에가장중요한단계는해마의 손상을억제하고,혹은이미시작된경우라면간경병의진행을억제하는것이다. 따라서산화적뇌손상및뇌기능장애의치료를연구하는대부분의수많은 연구자들은이와같은질환의예방이나치료제개발에노력을기울여왔다. 그럼에도블구하고아직특별한치료법이나치료약물이없는실정이다.
[5] 이와같은문제돌을해결하고자동서양에서여러 약물 (Acetyl-L-Carnitine - HC1 및 MAO, PNMT및 COMP inhibitor)들을발전시키고이에대한과학적인근거를 확보하고자하는노력 덕분에스트레스호르몬의대사와염증과관련한일정
부분개선에는효능을보였지만,약물의안정성및정확한작용기전에 대한 근본적인해결책을제시하지못한상태로남아있다ᅳ
[6] 본발명자는뇌조직의산화적손상으로인한뇌조직의손상및뇌기능장애와 관련한동물모델을이용하여다양한조합의한약재조성물을연구하고실험한 결과，황기와단삼의추출물이뇌조직의손상및뇌기능장애의예방과치료에 효과가있음을발견하고본발명을완성하였다.
발명의상세한설명
기술적과제
[7] 본발명의목적은산화적뇌손상및뇌기능장애의예방또는치료용조성물을 제공하는것이다.
[8] 본발명의다른목적은산화적뇌손상및뇌기능장애의 예방또는치료용
조성물의제조방법을제공하는것이다.
[9] 본발명의또다른목적은산화적뇌손상및뇌기능장애의 예방또는개선용 식품조성물을제공하는것이다.
과제해결수단
[1이 상기의목적을해결하기위해서，본발명은황기및단삼의추출물을
유효성분으로포함하는산화적뇌손상및뇌기능장애의 예방또는치료용 조성물을제공한다.
[11] 또한상기의다른목적을해결하기위하여，본발명은황기및단삼의흔합물을
10-70 %에탄올로추출하는단계를포함하는산화적뇌손상및뇌기능장애의 예방또는치료용조성물의제조방법을제공한다.
[12] 또한상기또다른목적을해결하기위하여，본발명은황기및단삼의추출물을 유효성분으로포함하는산화적뇌손상및뇌기능장애의예방또는개선용식품 조성물및상기식품조성물의 제조방법을제공한다.
[13] 이하，본발명을보다상세하게설명한다.
[14] 본발명은황기와단삼의추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의예방또는치료용조성물에관한것이다.
[15] 황기 (Astragali Radix)는콩과 (Leguminosae)에속하는생약제로완화,강장, 지한，이뇨약등으로서허약,수종에사용되며혈관확장및혈압강하작용이 있는 것으로알려진식물이다.단삼 (Salviae Radix)은순형과 (Ladiatae)에속하는 생약제로,주성분으로탄시논 (Tanshinone)등을함유하며한방에서는강장，통경 및부인병약으로서월경블순，자궁출혈,복통등에사용하는약제로알려져 있다.
[16] 종래에황기와단삼을이용한뇌의산화적손상및뇌기능장애에관한
웅용연구는전무한실정이었으나，본발명에서황기와단삼의추출물이 뇌조직의산화적손상과뇌기능장애의발생과진행을억제하고치료하는데 우수한효능이있는것으로확인되었다.
[17] 본발명의황기 및단삼의추출물은스트레스로인한뇌의산화적손상및 뇌기능장애의예방또는치료에효과적이다.본발명의일실시예에 있어서, 급성및만성스트레스로인한뇌손상올받은실험군에본발명에따른조성물을 투여하였을때,혈액및뇌조직에서항산화시스템의개선,관련호르몬의장애및 기억장애에대해서상당한개선효과를보였다.
[18] 본발명의황기및단삼의추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의예방또는치료용조성물에 있어서，상기유효성분은
아스트라갈로시드 IV，포모노네틴，로즈마리산，살비아놀릭액시드 B일수있다.
[19] 또한상기산화적뇌손상및뇌기능장애는치매,알츠하이머증후군,파킨슨 증후군，헌팅턴증후군에서선택되는어느하나일수있다.
[20] 본발명의조성물에포함되는황기와단삼의추출물은추출전에황기와
단삼을혼합하여추출함으로써제조할수있다.
[21] 추출물을추출하기 전흔합되는황기와단삼의증량비와관련하여，
바람직하게는황기：단삼을 9： 1내지 1： 9로하여혼합할수있으며，더욱 바람직하게는 1： 1의중량비로흔합할수있다.상기흔합비율의범위를 벗어나는경우에，황기와단삼의각추출물을단독으로사용한경우와비교할때 산화적뇌손상및뇌기능장애에대한치료또는예방의효과면에서큰차이가 없으며，상기의흔합비율일때그효과가가장좋다.
[22] 본발명의추출물은추출용매로추출하거나，추출용매로추출하여제조한
추출물에분획용매를가하여분획하여제조할수있다.상기추출용매는물및 유기용매로이루어진군에서선택된 1종이상일수있다.상기유기용매는 메탄올，에탄올둥의탄소수 1내지 5의알코올，에틸아세테이트또는아세톤 등의극성용매와핵산또는디클로로메탄의비극성용매또는이들의
흔합용매일수있으며,상기분획용매는물，부탄올,에틸아세테이트，
클로로포름，핵산또는이들의흔합물일수있다.
[23] 본발명의조성물에서황기및단삼의추출물의추출용매로 10~70%에탄을로 추출하는것이바람직하며 ,더욱바람직하게는 30%에탄올로추출하는것이 효과적이다.추출용매인 10~70%에탄올로추출함에따라본발명에따른 조성물에포함되는추출물의유효성분파괴를제어하고,고수율의유효성분을 수득할수있다.본발명의일실시예에서 30%에탄올로추출한추출물과 증류수로추출한추출물을포함한조성물의항산화능력을비교한결과 30% 에탄올로추출한추출물의항산화능력이더욱높음을확인할수있었다.
[24] 상기추출물은추출또는분획과정을수행한이후,감압여과과정을
수행하거나추가로농축및 /또는동결건조를수행하여농축하거나용매를 제거할수있다.상기수득한추출물은사용시까지급속냉동냉장고 (deep freezer)에보관할수있다.
[25] 본발명의산화적뇌손상및뇌기능장애의예방또는치료용조성물은，조성물 총증량에대하여상기황기및단삼추출물을 0.001내지 99.99중량 %,
바람직하게는 0.1내지 99증량 7。로포함할수있다.상기조성물은황기및단삼 추출물외에영양제，비타민,전해질,풍미제，착색제，중진제,펙트산및그의염，
[26] 알긴산및그의염 유기산，보호성콜로이드증점제， pH조절제,안정화제， 방부제，글리세린,알코올，탄산음료에사용되는탄산화제등을추가로함유할 수있으며，상기조성물에상기성분들이독립적으로또는조합하여추가될수 있다.
[27] 상기황기및단삼추출물을유효성분으로포함하는조성물은그제조에
통상적으로사용하는적절한담체，부형제및회석제를더욱포함할수있다.
[28] 본발명의조성물은목적하 방법에따라비경구투여 (예를들어정맥내， 피하,복강내또는국소에적용)하거나경구투여할수있다.바람직한투여량은 상태및체중，질병의정도,약물형태,투여경로및기간에따라다르지만, 본원발명이속하는기술분야에서통상의지식을가진자에의해적절하게 선택될수있다.바람직하게는본발명의치료용조성물은황기및단삼 추출물의양을기준으로 1일 0.0001내지 1000mg/kg으로,보다효과적이기 위해서는 0.01내지 100mg/kg으로투여하는것이바람직하다.투여는하루에 한번투여할수도있고，수회나누어투여할수도있다.상기투여량과
투여횟수는어떠한면으로든본발명의범위를한정하는것은아니다.
[29] 본발명은황기및단삼흔합물을 10~70%에탄올로추출하는단계；
[30] 상기추출물을동결건조하는단계;
[31] 를포함하는산화적뇌손상및뇌기능장애의예방또는치료용조성물의
제조방법을제공한다.
[32] 상기제조방법에서황기및단삼흔합물은황기：단삼을 1： 9내지 9： 1의
비을로흔합하는것이바람직하며,더욱바람직하게는 1： 1의흔합비율일때 더욱효과적이다.또한상기황기및흔합물을에탄올로추출하는단계에서， 바람직하게는 30%에탄올로추출할수있다.상기흔합비율의범위를벗어나는 경우에,황기와단삼의각추출물을단독으로사용한경우와비교할때산화적 뇌손상및뇌기능장애에 대한치료또는예방의효과면에서큰차이가없으며， 상기의흔합비율일때그효과가가장좋다.
[33] 본발명에따른산화적뇌손상및뇌기능장애의예방또는치료용조성물의 제조방법은 10~70%에탄올로추출하는단계를포함함에따라본발명의 조성물에포함되는황기및단삼의추출물의유효성분의파괴를제어하고， 고수율의유효성분을수득할수있다.
[34] 본발명은황기및단삼추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의예방또는개선용식품조성물을제공한다.또한본발명은황기 및단삼흔합물을 10내지 70%에탄올로추출하는단계 ;상기추출물을동결 건조하는단계;를포함하는산화적뇌손상및뇌기능장애의예방또는개선용 식품조성물의제조방법을제공한다.
[35] 본명세서에서식품이란함은영양소를한가지또는그이상함유하고있는
천연물또는가공품을의미하며,바람직하게는어느정도의가공공정을거쳐 직접먹을수있는상태가된것을의미하며，통상적인의미로서 ,건강기능식품, 음료，식품첨가제및음료첨가제를모두포함하는의도이다.
[36] 본발명에따른식품조성물에서황기및단삼의추출물의함량은전체식품 조성물중 0.0001내지 10중량 %함유할수있으며,그식품제형으로는 통상적으로사용되는성분들을이용하여드링크제，캬라멜，초콜릿,다이어트바 제형또는과쟈류인식품으로제형화될수있다.
[37] 상기식품조성물에는식품학적으로허용가능한식품보조첨가제를포함할 수있으며，식품의제조에통상적으로사용되는적절한담체,부형제및 희석제를더욱포함할수있다.
발명의효과
[38] 본발명의황기와단삼의추출물을유효성분으로포함하는조성물은실제
임상에서발생하는급성및장기간의과도한스트레스로인한뇌조직의손상및 뇌기능장애와유사한동물모델에서예방또는치료에매우유효한효과가있어, 이에대한치료제로서유용하게사용될수있다.
도면의간단한설명
[39] 도 1은증류수및에탄올을사용하여각각추출한추출물을포함한발명
조성물의 2가지의조성내용물과지표물질을이용한약물지문을나타낸것이다.
[40] 도 2는증류수및에탄올추출물에대한각각의항산화효능을나타낸
그래프이다.
[41] 도 3은본발명의조성물이급성스트레스로유발된랫드의혈청내의산화적 손상에대한효능을나타내는그래프이다..
[42] 도 4는급성스트레스로유도된뇌조직 (대뇌.해마)에서의지질과산화에대한 본발명의조성물의효능을나타낸그래프이다.
[43] 도 5는급성스트레스로유도된랫드의뇌조직 (대뇌.해마)에서의염증관련 인자들에대한효능및약물기전을확인한사진이다.
[44] 도 6은급성스트레스로유도된랫드의기억장애에대한개선효능을나타낸 그래프이다.
[45] 도 7은본발명조성물의급성스트레스로유도된랫드의기억장애에대한약리 작용및뇌조직의산화적손상에대한효능을나타낸그래프이다.
[46] 도 8은본발명조성물이만성구속스트레스로유도된랫드의산화적뇌손상에 대한개선효능및스트레스성호르몬과분비에대한개선효과를나타낸 그래프이다.
[47] 도 9는본발명조성물이만성스트레스로유도된랫드의산화적뇌손상에대한 혈액학적인변화관찰및항산화개선효능을보여주는표이다.
[48] 도 10은본발명조성물이만성구속스트레스로유도된렛드의산화적
뇌손상에대한스트레스호르몬대사효소및염증성요소들에 대한유전자
발현의변화분석을나타낸그래프이다.
[49] 도 11은본발명조성물이인지장애에대한개선효과를나타내는그래프이다.
[50] 도 12는본발명조성물이만성콜드스트레스로유도된랫드의스트레스
호르몬분비의개선효과를나타내는그래프이다.
[51] 도 13은본발명조성물이만성콜드스트레스로유도된랫드의뇌조직의
산화적손상에대한개선효과를나타낸그래프이다.
[52] 도 14는본발명조성물이만성스트레스로유도된랫드의뇌조직의염증반웅 및호르몬대사에관련효소들에대한개선효과를나타내는그래프이다.
[53] 도 15는발명조성물이만성스트레스로유도된뇌조직의병변에대한
조직학적인개선을보여주는사진이다.
발명의실시를위한형태
[54] 이하，본발명을실시예를통하여상세히설명한다.그러나이들실시예는본 발명을예시하기위한것으로,본발명의권리범위가이들실시예에의해 제한되는것으로해석되지는않으며，본발명의사상과범위내에서여러가지 변형또는수정할수있음은당업자에게명백한것이다.
[55]
[56] [실시예 1]황기와단삼의추출물을함유한조성물제조및추출용매에따른 항산화능력평가
[57] 1ᅳ1.증류수및에타음음추출용매로이용하조성봄제조
[58] 황기 (Astragali Radix)와단삼 (Salvia Miltiorrhizae Radix)을각각 1중량부의
비율로섞어구성된것을증류수를이용한열탕추출및 30%에탄올로추출하여， 여과와원심분리를거친후에동결건조하였다.최종적으로전탕전의건조 조성물의무게대비약 20.5 %와 18.0 «¾의건조액스를각각회수했다.회수된 건조액스의성분에대한품질관리및각각의추출물에대한성분분석의차이를 확인하기위하여본발명의조성물을구성하는 2종의한약물과지표성분 (황기: astragaloside IV, formonoetin;단삼: rosmarinic acid, Salvianolic acid B)을이용하여 HPLC를이용하여약물지문을만들었다 (도 1).
[59] 1-2.추출용매에따론항산화능력효능평가
[60] 1-1에서제조된각조성물에 대하여각각본발명물의구성물중유효성분이라 판단되는화합물 (황기 -아스트라갈로시드 IV(Astragaloside IV),
포모노네틴 (Formononetin);단삼-로즈마리산 (Rosmarinic acid),살비아놀릭 액시드 B(SalvianolicacidB))의함량의분석을하기표 1에나타내었다.
[61] 표 1
[Table 1]
증류수및 30%에탄올추출물에대한유효성분함량분석
[62] 1-1에서제조된각조성물즉，증류수및 30%에탄올로추출한조성물간의 항산화능력과관련하여,총항산화능 (total antioxidant capacity),
과산화수소제거능및총페놀함량을통하여평가해본결과 30%에탄올로 추출한본발명조성물의항산화능력이물로추출한조성물보다더우수함을 확인할수있었다 (도 2).
[63] [실시예 2]뇌조직의산화적손상에대한예방및치료효능평가
[64] 2-1.스트레스로유도뒤뇌조직의산화적손상에대하효능검정
[65] 5주령의숫컷 랫드 (SDrat, 180-200g) 60마리를 6그룹 (그룹당 10마리)으로 나누어 정상군을제외한나머지다섯그룹에는스트레스유도전 3일간하루에 한번씩각각의그룹에증류수，세농도의발명조성물 (50， 100, 200 mgkg)및 비타민 C(100mg/kg)를각각경구투여하였다. (이하，각실험결과를나타내는 도면에서각그룹을각각정상군 -Nommal,대조군 (증류수) -Control,세농도의 발명조성물 -Myp 50， MyplOO, Myp200,비타민 C-VitC100으로표시하였다.또한 본발명조성물을 Myelophil (미엘로필)이라표기할수있다.)이후， 12시간동안 수염및눈썹을제거하여극심한정신적인스트레스를가한다음,부검시뇌조직 및혈액을분리하여약물의효능을혈청에서스트레스관련호르몬，뇌조직의 산화적손상및염증정도및놔조직에서염증성관련요인과관련하여 평가하였다.그결과는도 3내지도 5에나타내었다.
[66] 혈청에서스트레스호르몬을평가하였올시，스트레스와관련된호르몬의 수치가실험군에서유의적으로감소되었으며，산화적손상을평가하는
실험에서는발명조성물을먹인실험군들이 매우유의성 있게개선되었으며 (도
3)，뇌조직의산화적손상및염증정도를알아보는실험에서도발명조성물의 효과가입증되었다 (도 4).또한약물의작용기전을알아보는실험에서도 뇌조직에서염증성관련요인을각각해마와대뇌에서측정하였을시
실험군에서상당히개선시키는효능을보였다 (도 5)
[67] 2-2.뇌손상음유밤하는약물에대하뇌조직의산화적손상과뇌기능장애에 대하효능검정
[68] 10주령의슷¾ C57마우스 (C57/BL6,24-27g)48마리를 6그룹 (그룹당
8마리)으로나누어정상군을제외한 5그룹에는 1주간증류수와본
발명조성물 (50, 100, 200 mg/kg, P.O)및타크린 (10 mgkg, P.O)를기억력감퇴 및 산화적기전을가진뇌손상을유발하는화학약물인스코폴라민 (lmg/kg, I.P)투여 7일전에하루 1회씩투여후첫행동관찰및뇌조직의산화적손상과 뇌기능장애에대한뇌조직에대한약물의효능을평가하였다.그결과는도 6 및도 7에나타냈다.
[69] 행동관찰및기억력감뢰에관한실험에서본발명조성물을투여한
실험군에서상당한개선을보였으며 (도 6)，혈액및뇌조직에서의산화적손상및 또한뇌에서중요한기능을담당하는기억력감퇴와관련한효소의활성을본 발명조성물을투여한실험군쎄서상당히개선시켰다 (도 7).
[70] [실시예 3]만성스트레스로유도된뇌조직의산화적손상에대한예방및치료 .효능평가
[71] 3-1.만성스트레스 ί구속스트레스ᅵ로이하산화적뇌조직의손상및뇌기능의 장애에대한븐밝명조성묽의효능검정
[72] 8주령의수컷 C57마우스 (C57/BL6,22-26g)60마리를 6그룹 (그룹당
10마리)으로나누어정상군을제외한모든그룹은증류수와본발명조성물 (25，
50， 100 mg/kg, P.O)및비타민 C (100 mgkg, P.O)를 3주간하루 1회씩
투여하였고，뇌손상을유발하는정신적스트레스인구속 -스트레스를 3주간하루
1회 3시간씩유도후,뇌조직과혈청에서정신적스트레스로유도된산화적 뇌조직의손상뿐만아니라뇌기능의장애에대한본발명따른조성물의효능을 평가하였다.
[73] 스트레스성호르몬과분비 및산화적뇌손상에관한실험에서실험에서본 발명조성물을투여한실험군에서상당한개선을보였으며 (도 8),혈액및 뇌조직에서의항산화시스템의개선효능뿐만아니라 (도 9)유전자발현및 단백질수준에서의산화적손상및염증에관한요소들의개선및스트레스성 호르몬의대사장애에도개선시키는효능을보였다.또한，본발명조성물을 투여한실험군은인지기억장애에대한부분에서상당한개선효과를보였다 (도 10및도 11)
[74] 3-2.만성스트레스 (콜드스트레스ᅵ로？ᅵ하산화적뇌손상에대하효능검정
[75] 5주령의수컷엘비뇨마우스 (Balb/C, 18-20g) 60'마리를 6그룹 (그룹당
8마리)으로나누어정상군을제외한모든그룹은증류수와본발명조성물 (25， 50， 100 mg/kg, P.O)및비타민 C (50 mg/kg, P.O)를 2주간하루 1회씩투여하였고， 콜드스트레스를 2주간하루 1회 4시간씩유도후，뇌조직과혈청에서정신적 스트레스로유도된산화적뇌손상에대한효능을단백질및유전자수준에서 확인하였다.
[76] 스트'레스성호르몬과분비및산화적뇌손상에관한실험에서본발명
조성물을투여한실험군에서상당한개선을보였으며 (도 12및 13),혈액및 뇌조직에서유전자발현및단백질수준에서의산화적손상및염증에관한 요소들의개선을보였다 (도 14).특히해마부분에서관찰된세포의사멸을본 발명조성물을투여한실험군에서상당히개선시킨것을확인할수있었다 (도 15)
[77]
[78] 하기에본발명의조성물을위한제제예를예시한다.
[79] [제조예 1]황기및단삼의추출물을이용한제제
[80] 제조예 1.산제의 제조
[81] 황기및단삼추출물분말 20 mg
[82] 유당 100 mg
[83] 탈크 10mg
[84] 상기의성분들을혼합하고기밀포에층진하여산제를제조하였다.
[85] 제조예 2.정제의 제조
[86] 황기및단삼추출물분말 10 mg
[87] 옥수수전분 100 mg
[88] 유당 lOOmg
[89] 스테아린산마그네슘 2 mg
[90] 상기의성분들을흔합한후통상의정제의제조방법에따라서타정하여정제를 제조하였다.
[91] 제조예 3.캡슴제의제조
[92] 황기및단삼의추출물 10mg
[93] 결정성셀를로오스 3 mg ·
[94] 락토오스 14.8 mg
[95] 마그네슘스테아레이트 0.2mg
[96] 통상의캡슐제제조방법에따라상기의성분을혼합하고젤라틴캡슐에
층전하여캡슐제를제조하였다.
[97] 제조예 4.주사액제의 제조
[98] 황기및단삼의추출물 10 g/mi
[99] 묽은염산 BP pH3.5로될때까지
[100] 주사용염화나트륨 BP최대 lm£
[101] 통상의주사액제의제조에따라상기의성분을흔합하고，용액을투명우리로 된 5 타입 I앰플증에층전시키고,유리를용해시킴으로써공기의상부
격자하에 봉입시 키 고， 120°C에서 15 분이상 오토클레 이브시 켜 멸균하여 주사액제를 제조하였다.
[102] [제제 예 2] 드링크제의 제조
[103] 황기 및 단삼의 추출물 lOOmg
[104] 포도당 10mg
[105] 구연산 0.6g 및 액상 올라고당 25g을 흔합한 후 정 제수 300ml를 가하여 각 병 에 200ml 씩 되 게 층전하였다. 병 에 충진한 후 130°C 에서 4 내지 5초간 살균하여 음료를 제조하였다. '
Claims
[청구항 1] 황기와단삼의추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의 예방또는치료용조성물.
[청구항 2] 제 1항에 있어서，상기유효성분은아스트라갈로시드 IV，
포모노네틴，로즈마리산,살비아놀릭액시드 B인것을특징으로 하는조성물.
[청구항 3] 제 1항또는제 2항에 있어서,황기와단삼와추출물은 10~70% 에탄올로추출한것임을특징으로하는조성물.
[청구항 4] 제 1항또는제 2항에 있어서,황기와단삼의중량비가 9:1내지 1:9 인것을특징으로하는.조성물.
[청구항 5] 제 1항또는제 2항에 있어서，산화적뇌손상및뇌기능장애는 치매,알츠하이머증후군，파킨슨증후군,헌팅턴증후군으로 -이루어진군에서선택된어느하나인것을특징으로하는조성물.
[청구항 6] 황기및단삼흔합물을 10내지 70%에탄올로추출하는단계 ;
상기추출물을동결건조하는단계;
를포함하는산화적뇌손상및뇌기능장애의예빙^또는치료용 조성물의제조방법. .
[청구항 7] 제 6항에 있어서,상기황기및단삼혼합물에서황기와단삼은 .
중량비가 9:1내지 1:9인것을특징으로하는조성물의제조방법.
[청구항 8] 황기와단삼의추출물을유효성분으로포함하는산화적뇌손상및 뇌기능장애의 예방또는개선용식품조성물.
[청구항 9] 제 8항에있어서,상기유효성분은아스트라갈로시드 IV,
포모노네틴,로즈마리산,살비아놀릭 액시드 B인것을특징으로 하는식품조성물.
[청구항 10] 제 8항에 있어서，황기와단삼의추출물은 10-70%에탄올로
추출한것임을특징으로하는조성물.
[청구항 11] 황기및단삼흔합물을 20내지 40%에탄올로추출하는단계 ;
상기추출물을동결건조하는단계;
를포함하는산화적뇌손상및뇌기능장애의예방또는개선용 식품조성물의제조방법ᅳ
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US14/653,873 US10195240B2 (en) | 2012-12-20 | 2012-12-27 | Composition for preventing or treating oxidative brain damage and brain dysfunction, and production method for same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020120149926A KR20140080289A (ko) | 2012-12-20 | 2012-12-20 | 산화적 뇌손상 및 뇌기능 장애의 예방 또는 치료용 조성물 및 이의 제조방법 |
| KR10-2012-0149926 | 2012-12-20 |
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|---|---|
| WO2014098295A1 true WO2014098295A1 (ko) | 2014-06-26 |
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| Application Number | Title | Priority Date | Filing Date |
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| PCT/KR2012/011532 WO2014098295A1 (ko) | 2012-12-20 | 2012-12-27 | 산화적 뇌손상 및 뇌기능 장애의 예방 또는 치료용 조성물 및 이의 제조방법 |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US10195240B2 (ko) |
| KR (1) | KR20140080289A (ko) |
| WO (1) | WO2014098295A1 (ko) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104758604A (zh) * | 2015-04-11 | 2015-07-08 | 河南金鸿堂制药有限公司 | 一种偏瘫复原中药胶囊制剂 |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10456368B2 (en) | 2016-09-26 | 2019-10-29 | Garrett E. Wdowin | Compositions for mitigating brain trauma and methods thereof |
| KR102001338B1 (ko) * | 2018-02-08 | 2019-07-17 | 동국대학교 경주캠퍼스 산학협력단 | 혼합 생약 추출물을 유효성분으로 함유하는 파킨슨병의 예방 또는 치료용 약학적 조성물 |
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| CN1330363C (zh) * | 2005-09-26 | 2007-08-08 | 山东省千佛山医院 | 治疗血管性痴呆的药物及其制备方法 |
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- 2012-12-27 US US14/653,873 patent/US10195240B2/en active Active
- 2012-12-27 WO PCT/KR2012/011532 patent/WO2014098295A1/ko active Application Filing
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104758604A (zh) * | 2015-04-11 | 2015-07-08 | 河南金鸿堂制药有限公司 | 一种偏瘫复原中药胶囊制剂 |
Also Published As
| Publication number | Publication date |
|---|---|
| US10195240B2 (en) | 2019-02-05 |
| US20150328271A1 (en) | 2015-11-19 |
| KR20140080289A (ko) | 2014-06-30 |
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