WO2017193817A1 - 一种含绞股蓝的防三高及痛风的保健药物组合物 - Google Patents

一种含绞股蓝的防三高及痛风的保健药物组合物 Download PDF

Info

Publication number
WO2017193817A1
WO2017193817A1 PCT/CN2017/082122 CN2017082122W WO2017193817A1 WO 2017193817 A1 WO2017193817 A1 WO 2017193817A1 CN 2017082122 W CN2017082122 W CN 2017082122W WO 2017193817 A1 WO2017193817 A1 WO 2017193817A1
Authority
WO
WIPO (PCT)
Prior art keywords
gynostemma pentaphyllum
pharmaceutical composition
leaves
gout
gynostemma
Prior art date
Application number
PCT/CN2017/082122
Other languages
English (en)
French (fr)
Inventor
谢其润
张钊
王少可
窦平
Original Assignee
谢其润
张钊
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 谢其润, 张钊 filed Critical 谢其润
Priority to AU2017262874A priority Critical patent/AU2017262874A1/en
Publication of WO2017193817A1 publication Critical patent/WO2017193817A1/zh
Priority to US16/184,286 priority patent/US20190070240A1/en

Links

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)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A61K36/424—Gynostemma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488—Pueraria (kudzu)
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
    • 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)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • 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
    • A61K36/739—Sanguisorba (burnet)
    • 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)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods

Definitions

  • the invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a health care pharmaceutical composition containing Gynostemma pentaphyllum and three gout and gout.
  • hyperuricemia The most important biochemical basis for gout is hyperuricemia.
  • the "four high disease” medicines which are becoming more and more popular, refer to hyperlipidemia, hypertension, hyperglycemia, and hyperuricemia.
  • the Ministry of Health the prevalence of hypertension in adults in China is 18.8%, the prevalence of diabetes in adults is 2.6%, and the prevalence of dyslipidemia in adults is 18.6%.
  • the survey data in the next 20 years, China will face a large-scale epidemic of hyperlipidemia, hypertension, hyperglycemia and hyperuricemia.
  • the medical profession is mainly based on western medicine for the prevention and treatment of "four highs". These drugs need to be taken for a long time or even for life, which is not only expensive but also has certain side effects.
  • the ideal means of prevention and treatment of "four highs” should be early prevention and early intervention, based on the comprehensive formula of health plants, and Good living habits. This is not only safe and effective, it has no side effects, and it can make people healthier through these beneficial plants.
  • the present invention provides a health-care pharmaceutical composition containing Gynostemma pentaphyllum-resistant three-high and gout, which removes dirt, garbage and toxins from the inner wall of blood, so that blood can be unblocked in the blood vessels, so that the heart, brain, kidney, The blood vessels of the liver and various organs are softened, so that the aging cells are cleared from the human body, and the self-regulation of the human body is restored to normal.
  • Gynostemma Pentaphyllum is a perennial grass vine of the genus Gynostemma. There are 16 kinds of 3 subspecies in the world, 11 species and 1 subspecies in China, and 6 subspecies in Pingli (short stalk, long stalk, scutellaria, white hair, light leaf, sweet taste, hazelnut). Gynostemma pentaphyllum is mainly distributed in the south of the Qinling Mountains and in the Yangtze River Basin. Xishuang wet, scattered light, humus, the bottom of the rock between 200-1500 meters, the edge of the ditch, the environment under the forest.
  • Gynostemma pentaphyllum The main components of Gynostemma pentaphyllum are saponins, polyphenols, flavonoids, polysaccharides and trace elements such as zinc, selenium, iron, calcium and magnesium, vitamins A and B. It has the functions of regulating human body physiology, enhancing human immunity, counteracting glucocorticoid side effects, anti-oxidation and blood fat reduction.
  • Gynostemma pentaphyllum originally domesticated from wild species
  • ploidy bodies (2X, 4X, 6X)
  • the difference between different places of origin is also very large, especially saponins, polyphenols, flavonoids and trace element selenium, etc., there are great differences.
  • the different active components of Gynostemma pentaphyllum produced in different regions of China and the world are not only very different, but also No single Gynostemma pentaphylla is the best of all major active ingredients.
  • the diploid Gynostemma pentaphyllum in Pingli County, Shaanxi Province analyzed the highest levels of polyphenols and flavonoids, while the tetraploid Gynostemma saponins and selenium content were the highest among all tested samples. Ok, its total saponin content averages 8.5%.
  • the active ingredients of the leaves of the plants are most desirable.
  • the reasonable Gynostemma formula (2X+4X) is rich in bioactive substances such as polyphenols, flavonoids (especially rutin and quercetin), saponins and selenium, which can effectively regulate the normal metabolism of the human body and promote human health. Function, lowering cholesterol to achieve lipid-lowering, softening blood vessels, promoting cardiovascular function, thereby regulating blood pressure, and its effective active ingredients can also play a role in regulating blood sugar.
  • the invention is based on years of analysis and research, and cooperates with the University of Maryland in the United States to systematically and meticulously analyze, detect and study various Gynostemma pentaphyllum. It has completely changed the formula that has been dominated by single Gynostemma for many years, and the idea of focusing only on Gynostemma.
  • the novel combination of the invention starts from fully comprehensively synthesizing saponins, polyphenolic compounds, flavonoids, minerals (especially selenium) and polysaccharide bioactive substances of Gynostemma pentaphyllum. Proportionate combination of specific varieties of Gynostemma pentaphyllum and tetraploid material into a new Gynostemma pentaphyllum formula.
  • the invention is based on the detected bioactive components and is compatible with the selenium-enriched health medicinal materials, so that the overall effect on the three high levels of conditioning is further strengthened. If it can be taken frequently, it can not only regulate the three highs, but also promote the health of the internal organs, and There are no side effects yet.
  • Eucommia ulmoides and Eucommia bark have been strong and visceral since ancient times.
  • Eucalyptus leaves are rich in various flavonoids and various phenolic acids, which can effectively promote cardiovascular health and coronary blood flow.
  • Amount, and a variety of (about 27 species) lignan compounds have been detected, particularly rosinol diglucoside, which has a good blood pressure regulating function.
  • Alkaloids and mulberry leaf polysaccharides from mulberry leaves can promote the activity of insulin ⁇ cells, especially the DNJ (I-deoxynojirimycin), which is unique in mulberry leaves, is a potent inhibitor of glucose metabolism enzymes, which can effectively improve insulin resistance. And a variety of flavonoids in the mulberry leaves also have the effect of regulating the three high.
  • DNJ I-deoxynojirimycin
  • Pueraria lobata has been grown in selenium-enriched soil for many years. It is rich in selenium and rich in isoflavones. It has been used for yin deficiency and thirst, spleen diarrhea, yang diarrhea, liver and stomach, and good regulation of vascular system since ancient times. Function, in the expansion of coronary artery, lipid-lowering, blood pressure, blood sugar regulation and other aspects have efficacy.
  • Psyllium is rich in a variety of organic acids, choline, glycosides and polyphenols, and has a good diuretic effect, while light bamboo leaves have a variety of flavonoids and bioactive polysaccharides and other phenolic acids, etc. Very good diuretic effect.
  • Aromatic geranium (pelargonium graveolens), also known as geranium geranium, is native to southern Africa. It is now widely cultivated around the world as a coriander, spice and medicinal crop, and is also an ornamental horticultural plant. Aromatic geranium has a fragrant aroma and is widely used as a health care plant. It has a long history of use all over the world. This medicine can help liver and kidney detoxification, promote lymphatic function and diuresis, and help relieve stress. Therefore, it is an ideal companion medicine to prevent gout.
  • Sanguisorba minor also known as the garden cellar. Because its beautiful pinnate leaves are similar to eucalyptus, the small mantle is native to North Africa. Europe and Central and Western Asia, because of its rich in vitamins and fresh taste, is widely used in Europe and America for food and drink, such as salad dressing, folder Sandwiches, juice, but because of its good nourishing effect and diuretic effect, it is also used as an auxiliary health care product for preventing gout. It is more effective in combination with other materials in this formulation.
  • the combination can promote the normal metabolism of the human body, regulate the vitality and immunity of the human body cells, and strengthen the function of the internal organs, thereby achieving the health care effect of effectively preventing and treating "three highs" and hyperuricemia, and enhancing human health and longevity.
  • a health care pharmaceutical composition containing Gynostemma pentaphyllum and a gout characterized in that the pharmaceutical composition is Gynostemma pentaphyllum, Eucommia ulmoides, frost mulberry leaves, psyllium, light bamboo leaves, Pueraria lobata, aromatic geranium, small
  • the mantle is made by mixing raw materials, in terms of parts by mass: 40-70% of Gynostemma pentaphyllum, 5-20% of Eucommia ulmoides leaves, 5-20% of frost mulberry leaves, 5-10% of Psyllium chinensis, 2-10% of light bamboo leaves 2,10% of Pueraria lobata powder, 2 to 8% of aromatic geranium, and 2 to 8% of small mantle.
  • the pharmaceutical composition is prepared by mixing the following raw materials in parts by mass: 50 to 70% of Gynostemma pentaphyllum, 6 to 12% of Eucommia ulmoides, 6 to 12% of mulberry leaves, 6 to 12% of Psyllium chinensis, and light bamboo leaves. 6 to 8%, 6 to 8% of Pueraria lobata, 2 to 5% of aromatic geranium, and 2 to 5% of small mantle.
  • the raw materials in the pharmaceutical composition are: by mass fraction: 60% of Gynostemma pentaphyllum, 10% of Eucommia ulmoides, 10% of mulberry leaves, 4% of Psyllium chinensis, 4% of P. sylvestris, 4% of Pueraria lobata, 4%, Aromatic geranium 4%, small mantle 4%.
  • Gynostemma pentaphyllum is a mixture of diploid Gynostemma pentaphyllum leaves and tetraploid Gynostemma peninsula leaves.
  • the pharmaceutical composition can be formulated into tablets, pills, granules, granules, powders and the like.
  • the invention is compatible with traditional Chinese medicines such as frosted mulberry leaves, eucommia leaves and pueraria powder, and removes dirt, garbage and toxins from the inner wall of the blood, so that the blood can pass through the blood vessels, and the heart, brain, kidney, liver and organs are The blood vessels are softened, so that the aging cells are cleared from the human body, and the self-regulation of the human body is restored to normal.
  • the reasonable Gynostemma formula (2X+4X) can effectively lower cholesterol, thereby lowering blood fat, softening blood vessels, promoting cardiovascular function, thereby regulating blood pressure, and its effective active ingredients can also regulate blood sugar.
  • the invention adopts diploid and tetraploid Gynostemma pentaphyllum and the combination of frost mulberry leaves, Eucommia ulmoides, Psyllium chinensis, Phyllostachys pubescens L., Gegenfang and geranium, and small mantle, etc., which can effectively promote human health self. Regulate the function, so as to clear the blood, vomit, new, strong and dirty, reduce the "four high.”
  • the formula is all made up of botanicals with health benefits. Compared with western medicines, it is not only low cost, no side effects, but also provides many healthy saponins, polyphenols, flavonoids, polysaccharides and Nutrients such as minerals make the human body healthier.
  • This compatibility also takes into account the traditional Chinese herbal medicine theory of Chinese herbal medicines as a reference for compatibility, combining the analysis of effective active ingredients of the materials used, and different kinds of active ingredients (such as saponins, polyphenols, flavonoids).
  • Classes, flavonoids, isoflavones, Alkaloids, polysaccharides, organic acids, minerals, vitamins, etc. are rationally combined, taking into account the characteristics and characteristics of different materials, combining the research results of many years at home and abroad, so as to formulate this side, compared with conventional drugs, this
  • the invention is unique in that it starts from the source of “four highs” and promotes the metabolism and self-regulation of human cells through the reasonable compatibility of different proportions of various herbs.
  • Gout is a category of "cracking disease", and it is also known as the festival wind, white tiger wind, white tiger calendar and so on. Modern medicine believes that gout is a group of heterogeneous chronic metabolic diseases caused by metabolic disorders. Can It is divided into asymptomatic hyperuricemia, acute gouty arthritis, intermittent and chronic phase.
  • Main symptoms the affected joints of acute onset are burning, redness, pain, joint flexion and extension.
  • Tongue vein red tongue, yellow greasy moss, pulse or slippery slippery or slippery.
  • the compound preparation of the present invention was administered, 3 g/time, three times a day. 10 days for a course of treatment, 2 courses for continuous treatment
  • BUN Blood urea nitrogen
  • Cr serum creatinine
  • ALT alanine aminotransferase
  • AST aspartate aminotransferase
  • Clinical efficacy evaluation including the judgment of TCM syndrome efficacy and clinical comprehensive efficacy judgment.
  • the criteria for determining the efficacy of TCM syndromes are set by reference to the National Traditional Chinese Medicine Administration's “Diagnostic and Efficacy Standards for TCM Syndrome”; the criteria for clinical comprehensive efficacy are formulated in accordance with the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine.

Landscapes

  • 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)
  • Botany (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (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

本发明公布了一种含绞股蓝的防三高及痛风的保健药物组合物，所述药物组合物以绞股蓝、杜仲叶、霜桑叶、车前子、淡竹叶、野葛根粉为原料混合制成，按质量份数计为：绞股蓝40～70％、杜仲叶5～20％、霜桑叶5～20％、车前子5～10％、淡竹叶2～10％、野葛根粉2～10％、芳香天竺葵2～8％、小地榆2～8％。所述绞股蓝为二倍体绞股蓝叶片和四倍体绞股蓝叶片按比例混合而成。本发明主要针对"四高"人群，用于防治高血脂、高血压、高血糖、高尿酸血症。

Description

一种含绞股蓝的防三高及痛风的保健药物组合物 技术领域
本发明属于中药技术领域，具体涉及一种含绞股蓝的防三高及痛风的保健药物组合物。
背景技术
高血脂、高血压、高血糖，俗称“三高”，是目前我国影响到人类健康的大问题，全国已有这类问题的人群达数亿之多，而且还在逐年增长。国际上许多发达国家也普遍存在着这一大问题，也是医学界的一个难题。“三高”是人类许多疾病和亚健康的源头，随着“三高”的发展和恶化，会引发一系列的病症和并发症，严重地影响到人类的健康乃至寿命。
痛风最重要的生化基础是高尿酸血症。近年来越来越流行的“四高症”医学上指高血脂、高血压、高血糖、高尿酸血症。研究表明，20年内我国将大规模流行“四高症”，根据卫生部公布的我国成人高血压患病率为18.8％，成人糖尿病患病率为2.6％，成人血脂异常患病率为18.6％等调查数据，在未来20年内，我国将面临高血脂、高血压、高血糖、高尿酸血症的较大规模流行。
目前医学界对“四高”的防治以西药为主，这些药物需要长期乃至终身服用，不仅花费大，而且都有一定的副作用。理想的防治“四高”手段应该是早预防、早干预，以保健植物的综合配方为主，并配 之以良好的生活习惯。这样不仅安全有效，无副作用，还能通过这些补益的植物让人们更健康。
发明内容
为解决上述问题，本发明提供了一种含绞股蓝的防三高及痛风的保健药物组合物，清除血液内壁的污垢、垃圾与毒素，使血液在血管内畅通无阻，使心，脑、肾、肝及各脏器的血管得到软化，使衰老的细胞从人体内清除出去，使人体的自我调节恢复正常。
所述绞股蓝(Gynostemma Pentaphyllum)为葫芦科绞股蓝属多年生草质藤本植物。全世界已发现有16种3亚种，我国有11种1亚种，平利有6种亚种(短梗、长梗、七叶胆、白毛、光叶、甜味、喙果)，绞股蓝主要分布于秦岭以南，长江流域诸省区。喜阴湿、散射光、腐殖土、海拔200—1500米之间的岩底、沟边、林下的环境。绞股蓝的主要成分为皂甙类、多酚类、黄酮类、多糖类和锌、硒、铁、钙、镁等微量元素、维生素A、B等。具有调节人体生理机能，增强人体免疫力，抵消糖皮激素副作用、抗氧化、降血脂等功能。
绞股蓝有许多不同的种和杂交种(最初是从野生种驯化过来的)，自然界也有不同的倍性体(2X、4X、6X……)。不同种之间，不同倍性体之间，其生物活性功能和有效成分差异很大。而不同产地之间其差异也很大，尤其是皂苷、多酚类、黄酮类以及微量元素硒等，都有很大的差异。根据我们在美国实验室进行的分析来看，中国和世界上不同地区生产的不同的绞股蓝，其有效成分不仅差异很大，而且并 没有一种单一的绞股蓝在所有主要有效成分上是最好的。在所有分析样品中，陕西平利县绞股蓝研究所的二倍体绞股蓝分析到的多酚类和黄酮类含量最高，而该所的四倍体绞股蓝的皂苷和硒的含量也是所有检测样品中最好的，其总皂甙含量平均达到8.5％。而且植株不同部位中，无论二倍体或四倍体，均以植株叶片的有效成分最为理想。合理的绞股蓝配方(2X+4X)含有丰富的生物活性物质多酚类、黄酮类(尤其是芦丁和槲皮素)、皂甙以及硒等物质，能有效地调节人体正常新陈代谢，促进人体健康的功能，降低胆固醇从而达到降脂、软化血管、促进心血管功能，从而达到调节血压的作用，而其有效活性成分对血糖也能起到一定的调节作用。
本发明是基于多年的分析和研究，与美国马里兰大学的合作研究，对各地各种绞股蓝进行了系统和细致的分析，检测和研究。彻底改变了过去多年来一直以单一绞股蓝为主体的配方，以及仅仅关注绞股蓝皂甙的思路。本发明新的组合方是从全方位充分综合绞股蓝的皂甙、多酚类化合物、黄酮类化合物、矿物质(尤其是硒)、多糖类生物活性物质入手。按比例把特定产地特定品种的绞股蓝二倍体和四倍体材料组合成一个崭新的绞股蓝新种配方。
本发明根据检测到的生物活性成分，配伍富硒的保健药材，使其总体对调理三高的作用进一步加强了，如能经常服用，不仅能调控三高，也能促进五脏六腑的健康，而且还没有副作用。
杜仲叶功同杜仲树皮，自古以来就是强健脏腑的良药，杜仲叶丰富的多种黄酮类物质和多种酚酸能有效促进心血管健康和冠脉血流 量，而且已检测到多种(约27种)木脂类化合物，特别是松脂醇二葡萄糖苷这一化合物有很好的调节血压功能。
霜桑叶中的生物碱和桑叶多糖能促进胰岛素β细胞的活性，尤其是桑叶中特有的DNJ(I-脱氧野尻霉素)是强效的糖代谢酶抑制剂，能有效改善胰岛素抵抗，而霜桑叶中的多种黄酮类物质也有调节三高的功效。
野葛根在富硒土壤生长多年，硒含量丰富且富含异黄酮，自古以来就用于阴虚消渴、脾虚泄泻、升阳止泻、护肝养胃，对血管系统也有很好的调节作用，在扩张冠状动脉、降脂、降压、调节血糖等方面都有功效。
车前子富含多种有机酸、胆碱、苷类和多酚类物质，有良好的利尿作用，而淡竹叶中有多种黄酮类物质和生物活性多糖及其他酚酸类等化合物，也有很好的利尿通淋作用。
芳香天竺葵(pelargonium graveolens)又名香叶天竺葵，原产非洲南部。现作为香菜、香料和药用作物在世界各地普遍栽培，也是极具观赏性的园艺植物。芳香天竺葵气味芳香，作为保健植物用途很广，在世界各地也有很长的使用历史。该药材可以帮助肝、肾排毒，促进淋巴系统功能并利尿，还能帮助缓解压力。因此是一种理想的配伍药材来防治痛风。
小地榆(sanguisorba minor)，又名庭院地榆。由于其美丽的羽状叶与榆树相似而得名，小地榆原产北非。欧洲和中西亚，由于其富含维生素而且口感清新，在欧美广泛用来食用和饮用，如拌色拉、夹 三明治、打汁饮用，但由于其很好的滋补作用和利尿作用，在当地也被用作防痛风的辅助保健品。在本配方中与其他材料配伍更能增效。
综上所述，以2种绞股蓝(2X、4X)，配伍上述药材，就形成我们的产品的配方，本方君臣互补，具有调节机体自身代谢的功效，也加速了高尿酸从体内排出，在防治传统“三高”的同时，也能有效防治高尿酸血症，治疗痛风。该组合方能促进人体的正常新陈代谢，调节人体细胞自身活力和免疫力，强健五脏六腑功能，从而达到有效防治“三高”及高尿酸血症，增强人体健康长寿的保健效果。
为达到上述目的，本发明采用的技术方案为：
一种含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述药物组合物以绞股蓝、杜仲叶、霜桑叶、车前子、淡竹叶、野葛根粉、芳香天竺葵、小地榆为原料混合制成，按质量份数计为：绞股蓝40～70％、杜仲叶5～20％、霜桑叶5～20％、车前子5～10％、淡竹叶2～10％、野葛根粉2～10％、芳香天竺葵2～8％、小地榆2～8％。
进一步地，所述药物组合物由以下原料按质量份数配合制成：绞股蓝50～70％、杜仲叶6～12％、霜桑叶6～12％、车前子6～12％、淡竹叶6～8％、野葛根粉6～8％、芳香天竺葵2～5％、小地榆2～5％。
进一步地，所述药物组合物中各原料按质量份数计为：绞股蓝60％、杜仲叶10％、霜桑叶10％、车前子4％、淡竹叶4％、野葛根粉4％、芳香天竺葵4％、小地榆4％。
进一步地，所述绞股蓝为二倍体绞股蓝叶片和四倍体绞股蓝叶片混合而成。
进一步地，按质量份数计所述二倍体绞股蓝叶片：四倍体绞股蓝叶片＝2：5～5：2。优选地，所述二倍体绞股蓝叶片：四倍体绞股蓝叶片＝1：1。
进一步地，所述药物组合物可制成片剂、丸剂、冲剂、颗粒剂、粉剂等。
本发明通过绞股蓝与霜桑叶、杜仲叶、葛根粉等传统中药配伍，清除血液内壁的污垢、垃圾与毒素，使血液在血管内通无阻，使心，脑、肾、肝及各脏器的血管得到软化，使衰老的细胞从人体内清除出去，使人体的自我调节恢复正常。合理的绞股蓝配方(2X+4X)能有效地降低胆固醇从而达到降脂、软化血管、促进心血管功能，从而达到调节血压的作用，而其有效活性成分对血糖也能起到一定的调节作用。
本发明采用二倍体及四倍体的绞股蓝与霜桑叶、杜仲叶、车前子、淡竹叶、葛根芳和香天竺葵、小地榆等国内外保健药材配伍，能有效地促进人体健康的自我调节功能，从而达到疏通血脉、吐故纳新、强健脏腑、降低“四高”。该配方全部由有健康补益作用的植物药材配伍而成，与西药相比，不仅成本低、无副作用，而且还能为人体提供许多有益健康的皂苷、多酚类、黄酮类、多糖类和矿物元素等营养物质，使人体更健康。
此配伍也综合考虑到了中药材的四性五味及归经等传统中药材理论作为配伍的参考，结合所用材料有效活性成分的分析，把不同种类的活性成分(如皂甙类、多酚类、黄酮类、类黄酮类、异黄酮类、 生物碱、多糖、有机酸、矿物质、维生素等)加以合理的组合，并兼顾了不同材料的特性和特点，结合了国内外多年的科研成果，从而制定本方，和常规药物相比，本发明的独特之处在于：从“四高”源头入手，通过多种药材不同比例的合理配伍，以促进人体细胞的新陈代谢和自我调节功能，降血脂，通血脉，强五脏，促平衡，改善血管系统的生物活性，软化血管，消除隐患，增加通透，利尿通淋，抑制“四高”。从根本上逐步解决“四高”问题，最终达到康复和健康的目的。
具体实施方式
下面结合实施例对本发明进一步的说明，实施例中的百分比均为重量百分比，但本发明并不局限于此。
实施例1
二倍体绞股蓝30％、四倍体绞股蓝30％、杜仲叶10％、霜桑叶10％、车前子4％、淡竹叶4％、野葛根粉4％、芳香天竺葵4％、小地榆4％
实施例2
二倍体绞股蓝20％、四倍体绞股蓝50％、杜仲5％、霜桑叶5％、车前子10％、淡竹叶2％、野葛根粉2％、芳香天竺葵2％、小地榆4％
实施例3
二倍体绞股蓝50％、四倍体绞股蓝20％、杜仲6％、霜桑叶5％、车前子6％、淡竹叶6％、野葛根粉3％、芳香天竺葵2％、小地榆2％
实施例4
二倍体绞股蓝25％、四倍体绞股蓝25％、杜仲叶12％、霜桑叶12％、车前子5％、淡竹叶6％、野葛根粉5％、芳香天竺葵5％、小地榆5％
实施例5
二倍体绞股蓝20％、四倍体绞股蓝20％、杜仲叶15％、霜桑叶15％、车前子10％、淡竹叶8％、野葛根粉5％、芳香天竺葵5％、小地榆2％
实施例6
二倍体绞股蓝15％、四倍体绞股蓝30％、杜仲叶18％、霜桑叶15％、车前子6％、淡竹叶6％、野葛根粉3％、芳香天竺葵2％、小地榆5％
实施例7
二倍体绞股蓝30％、四倍体绞股蓝15％、杜仲叶15％、霜桑叶15％、车前子8％、淡竹叶8％、野葛根粉5％、芳香天竺葵2％、小地榆2％
实施例8
二倍体绞股蓝20％、四倍体绞股蓝20％、杜仲叶15％、霜桑叶10％、车前子9％、淡竹叶5％、野葛根粉5％、芳香天竺葵8％、小地榆8％
实施例9本发明复方制剂治疗痛风性关节炎临床实施例
痛风属“痹病”范畴，又名历节风，白虎风，白虎历节等。现代医学认为痛风是嘌呤代谢障碍所致的一组异质性慢性代谢性疾病。可 分为无症状高尿酸血症期、痛风性关节炎急性发作期、间歇期及慢性期。
近年来随着中医药的蓬勃发展，在继承传统疗法基础上，痛风的中医治疗研究与现代医学实验相结合，有内治、外治及内外合治等多种治疗方法。
9.1资料与方法
选取60例临床诊断的湿热蕴结型急性痛风性关节炎患者作为研究对象，其中男36例，女24例，年龄51至72岁，平均年龄(62±1.2)岁。
参照国家中医药管理局的《中药新药临床研究指导原则》及《中医内科病证诊断疗效标准》”，临床表现为痛风的湿热蕴结证型者：
主症：急性起病的受累关节灼热、红肿、疼痛、关节屈伸不利。
次症：发热，身困倦怠、口粘或口苦，便溏不爽或大便不畅、小便短黄。
舌脉：舌红，苔黄腻，脉濡或脉滑或滑数。
给予低热能、低蛋白、低曙呤饮食，严格戒酒，尤其是啤酒，少饮含果糖类饮料及酸奶，保持每天饮水量在以上；多休息，关节尽量制动，抬高患肢，避免负重，穿鞋要舒适以防关节损伤；避免过度疲劳、受凉受潮及精神紧张等；慎用影响尿酸排泄的药物。服用本发明复方制剂，3克/次，一日三次。10天为一个疗程，连续治疗2个疗程
9.2观测指标
治疗前后血尿素氮(BUN)、血肌酐(Cr)、谷丙转氨酶(ALT)、谷草转氨酶(AST)等肝肾功能。
9.3疗效评定
临床疗效评定，包括中医证候疗效判定及临床综合疗效判定。中医证候疗效判定标准参考国家中医药管理局《中医病证诊断疗效标准》而设；临床综合疗效判定标准参照《中药新药临床研究指导原则》拟定。
临床控制：临床症状、体征消失或基本消失，证候积分减少
显效：临床症状、体征明显改善，证候积分减少
有效：临床症状、体征均有好转，证候积分减少
无效：临床症状、体征无明显改善，甚或加重，证候积分减少不足。
9.4治疗结果
表1-患者本次发作病程
Figure PCTCN2017082122-appb-000001
表-2患者治疗前后炎症指标比较(
Figure PCTCN2017082122-appb-000002
)
Figure PCTCN2017082122-appb-000003
9.5不良反应情况及处理：
(1)对肝肾功能的影响：予以本研究治疗方案后，治疗组与对照组在BUN、Cr、ALT、AST等肝肾功能检测方面均无明显异常改变。
(2)对消化道功能影响：予以本研究治疗方案后，治疗组中有例出现大便次数增多，便质偏稀，但均可耐受。
实施例10
将本发明实施例1～8中的产品按照国家富硒食品标准《GB28050-2011》进行检测，检测结果显示本发明硒元素含量在0.20～5.00mg/kg，符合富硒食品产品标准。用高效液相色谱(HPLC)为基础的改进新技术检测其产品中含有：皂苷108.4～188.2mg/g；多酚23.5～37.5mg/g；总黄酮22.5～36.5mg/g。
虽然本发明已参照如上所述的具体实施例来描述，但本技术领域的普通技术人员应当认识到，以上实施例仅是用以说明本发明而不是限制本发明，只要在本发明的实质精神范围内对上述实施例的变化、变型都应落入本申请的权利要求书请求保护的范围内。

Claims (8)

  1. 一种含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述药物组合物以绞股蓝、杜仲叶、霜桑叶、车前子、淡竹叶、野葛根粉、芳香天竺葵、小地榆为原料混合制成，按质量份数计为：绞股蓝40～70％、杜仲叶5～20％、霜桑叶5～20％、车前子5～10％、淡竹叶2～10％、野葛根粉2～10％、芳香天竺葵2～8％、小地榆2～8％。
  2. 根据权利要求1所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述药物组合物由以下原料按质量份数配合制成：绞股蓝50～70％、杜仲叶6～12％、霜桑叶6～12％、车前子6～12％、淡竹叶6～8％、野葛根粉6～8％、芳香天竺葵2～5％、小地榆2～5％。
  3. 根据权利要求2所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述药物组合物中各原料按质量份数计为：绞股蓝60％、杜仲叶10％、霜桑叶10％、车前子4％、淡竹叶4％、野葛根粉4％、芳香天竺葵4％、小地榆4％。
  4. 根据权利要求1～3中任一项所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述绞股蓝为二倍体绞股蓝叶片和四倍体绞股蓝叶片混合而成。
  5. 根据权利要求4所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，按质量份数计所述二倍体绞股蓝叶片：四倍体绞股蓝叶片＝2：5～5：2。
  6. 根据权利要求5所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，按质量份数计所述二倍体绞股蓝叶片：四倍体绞股蓝叶片＝1：1。
  7. 根据权利要求1～3中任一项所述的含绞股蓝的防三高及痛风的保健药物组合物，其特征在于，所述药物组合物制成片剂、丸剂、冲剂、颗粒剂、粉剂。
  8. 如权利要求1所述的含绞股蓝的防三高及痛风的保健药物组合物的用途，其特征在于：将所述药物组合物用于防治高血脂、高血压、高血糖及高尿酸血症。
PCT/CN2017/082122 2016-05-09 2017-04-27 一种含绞股蓝的防三高及痛风的保健药物组合物 WO2017193817A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2017262874A AU2017262874A1 (en) 2016-05-09 2017-04-27 Gynostemma pentaphyllum containing health care pharmaceutical composition for preventing hyperlipidemia, hypertension, hyperglycemia, and gout
US16/184,286 US20190070240A1 (en) 2016-05-09 2018-11-08 Gynostemma pentaphyllum-containing health care pharmaceutical composition for preventing hyperlipidemia, hypertension, hyperglycemia and gout

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610300713.9A CN105998762A (zh) 2016-05-09 2016-05-09 一种含绞股蓝的防三高及痛风的保健药物组合物
CN2016103007139 2016-05-09

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/184,286 Continuation US20190070240A1 (en) 2016-05-09 2018-11-08 Gynostemma pentaphyllum-containing health care pharmaceutical composition for preventing hyperlipidemia, hypertension, hyperglycemia and gout

Publications (1)

Publication Number Publication Date
WO2017193817A1 true WO2017193817A1 (zh) 2017-11-16

Family

ID=57098786

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2017/082122 WO2017193817A1 (zh) 2016-05-09 2017-04-27 一种含绞股蓝的防三高及痛风的保健药物组合物

Country Status (4)

Country Link
US (1) US20190070240A1 (zh)
CN (1) CN105998762A (zh)
AU (2) AU2017262874A1 (zh)
WO (1) WO2017193817A1 (zh)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105663245A (zh) * 2016-02-29 2016-06-15 张钊 一种含绞股蓝的复方中药组合物及其制备方法
CN108617821A (zh) * 2017-03-22 2018-10-09 平利县绞股蓝研究所 一种含绞股蓝的防三高保健茶饮料及其制备方法
US10639343B2 (en) * 2018-01-04 2020-05-05 Btc Corporation Preparation method of Gynostemma pentaphyllum leaves extract and Gynostemma pentaphyllum extract prepared by the method thereof
CN112273503A (zh) * 2019-07-26 2021-01-29 蒋鹤 一种茶包及其制备方法与应用方法
CN110559417A (zh) * 2019-09-27 2019-12-13 贵州布依阿妈电子商务有限公司 一种舒缓痛风的艾药灸条及其制备方法
CN115119917A (zh) * 2021-03-26 2022-09-30 陕西罗麻丹医药有限公司 一种能溶解血栓净化血液的固体饮料及其制备方法
CN114832063B (zh) * 2022-06-07 2023-09-22 廖志航 一种具有调节血糖、血脂和/或尿酸作用的组合物

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104027529A (zh) * 2014-06-24 2014-09-10 贵州遵义华源医药保健品有限公司 一种调节血脂、血压、血糖的中药组合物及其制备方法
CN105853507A (zh) * 2016-05-09 2016-08-17 张钊 含绞股蓝的具有防治三高及护肝功效的保健药物组合物

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104435567A (zh) * 2014-11-07 2015-03-25 成都华熹科技有限公司 一种含绞股蓝的治疗痛风的中药组合物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104027529A (zh) * 2014-06-24 2014-09-10 贵州遵义华源医药保健品有限公司 一种调节血脂、血压、血糖的中药组合物及其制备方法
CN105853507A (zh) * 2016-05-09 2016-08-17 张钊 含绞股蓝的具有防治三高及护肝功效的保健药物组合物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ZHANG, ZHAO ET AL.: "The Summarize of Gynostemma pentaphyllum (Thunb) Makino", FOOD RESEARCH AND DEVELOPMENT, vol. 32, no. 11, 30 November 2011 (2011-11-30), pages 193 - 196 *

Also Published As

Publication number Publication date
US20190070240A1 (en) 2019-03-07
CN105998762A (zh) 2016-10-12
AU2017262874A1 (en) 2018-11-29
AU2017101878A4 (en) 2020-06-18

Similar Documents

Publication Publication Date Title
WO2017193817A1 (zh) 一种含绞股蓝的防三高及痛风的保健药物组合物
Sweeney et al. Evidence-based systematic review of dandelion (Taraxacum officinale) by natural standard research collaboration
CN102919836B (zh) 一种降糖、降压、降脂、通便养颜、减肥、抗疲劳保健品及其生产工艺
CN109007808A (zh) 一种解酒护肝组合物及包含其的解酒护肝制剂
WO2017148183A1 (zh) 一种含绞股蓝的复方中药组合物及其制备方法
CN102907604A (zh) 一种降糖、降压、减肥、通便养颜、抗疲劳保健品及其生产工艺
CN102125127B (zh) 一种功能青稞红曲茶及其制备方法
CN101695327B (zh) 一种保健肾茶
CN103355619B (zh) 一种滇橄榄葛根保健食品
KR100947278B1 (ko) 하엽 추출물을 주성분으로 하는 탄수화물 및 지방 흡수억제 활성을 가지는 생약 조성물과 이의 제조 방법
CN105853507A (zh) 含绞股蓝的具有防治三高及护肝功效的保健药物组合物
CN106176953A (zh) 一种包含青钱柳叶、罗汉果和桑叶的降血糖保健组合物
CN101972025B (zh) 一种竹醋保健饮料及其制备方法
CN103920140B (zh) 一种人用降糖减肥降脂复方制剂
CN105853506A (zh) 一种含绞股蓝的降压保健药物组合物
CN103977390B (zh) 一种生姜洋葱药酒组合物的制备方法及其用途
CN106962910B (zh) 一种降血压的保健组合物
CN1128586C (zh) 芦苇保健饮料
CN101491668B (zh) 一种具有降血糖功能的组合物及其制备方法
CN105998196A (zh) 一种含绞股蓝的降血糖保健药物组合物
CN103932176B (zh) 一种具有辅助降血脂功能的保健食品组合物及其制备方法和用途
CN105853505A (zh) 一种含绞股蓝的益气补肺保健药物组合物
CN104886252A (zh) 一种复合中药解酒酸奶及其制备工艺
KR20110101916A (ko) 혼합 생약재 추출물을 유효성분으로 함유하는 피로회복용 조성물
CN107029092A (zh) 一种马奶降糖中药组合物及其制备方法和应用

Legal Events

Date Code Title Description
NENP Non-entry into the national phase

Ref country code: DE

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17795435

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2017262874

Country of ref document: AU

Date of ref document: 20170427

Kind code of ref document: A

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 08/03/2019)

122 Ep: pct application non-entry in european phase

Ref document number: 17795435

Country of ref document: EP

Kind code of ref document: A1