WO2018099216A1 - 一种治疗动脉粥样硬化高血压病的中药组合物及其应用 - Google Patents

一种治疗动脉粥样硬化高血压病的中药组合物及其应用 Download PDF

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WO2018099216A1
WO2018099216A1 PCT/CN2017/107740 CN2017107740W WO2018099216A1 WO 2018099216 A1 WO2018099216 A1 WO 2018099216A1 CN 2017107740 W CN2017107740 W CN 2017107740W WO 2018099216 A1 WO2018099216 A1 WO 2018099216A1
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traditional chinese
chinese medicine
medicine composition
eucommia ulmoides
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French (fr)
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万光瑞
荆云
潘国聘
朱茉莉
万佳
李鹏
牛慧芳
薛金涛
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新乡医学院
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Priority to RU2019102150A priority Critical patent/RU2736357C2/ru
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • 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)
    • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • 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)
    • A61K36/74—Rubiaceae (Madder 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/898—Orchidaceae (Orchid family)
    • A61K36/8988—Gastrodia
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment

Definitions

  • the invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating atherosclerosis hypertension and an application thereof.
  • the blood circulation is the red life transport line of the human body. It mainly transports the nutrients absorbed and absorbed and the oxygen inhaled into the whole body tissue cells, and transports the metabolites of the tissue cells to maintain the normal metabolism of the whole body tissues and cells. , exchange is not limited.
  • the heart is the driving force of the blood circulation. The heart contracts to inject blood into the artery. The artery gradually branches into a fine blood vessel network, allowing the blood to exchange substances with the tissue cells. The nutrients and oxygen in the blood enter the tissue cells, and the metabolic waste of the tissue cells enters the blood. The heart is concentrated by the vein, and then the heart delivers the metabolic waste in the blood to the lungs, kidneys, liver, etc., thereby circulating, and the internal environment of the body is relatively stable.
  • Blood pressure is the side pressure of blood flow to the vessel wall. Including arterial blood pressure and venous blood pressure, the blood pressure is usually measured by the blood pressure of the radial artery.
  • the systolic blood pressure is the side pressure of the blood contracting blood to the blood vessel wall.
  • the diastolic blood pressure is the side pressure of the blood on the blood vessel wall when the heart is diastolic, and the normal systolic blood pressure. ⁇ 130 mmHg, diastolic blood pressure ⁇ 85 mmHg, and higher than 140 mmHg/90 mmHg is hypertension.
  • Atherosclerosis atherosclerosis
  • Hypertensive lesions are characterized by vascular wall remodeling, plaque hyperplasia, luminal stenosis, reduced tissue blood supply, accumulation of metabolites, enhanced work of reflexive heart, resulting in elevated blood pressure to ensure tissue blood supply, and no clinical symptoms in the early stage.
  • the blood pressure is high and low, called the compensation period.
  • AS continues to increase, the patient's blood pressure remains high, and there is still a clinical symptom of insufficient blood supply, called decompensation, which is primary hypertension.
  • Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases and is an important public health problem.
  • AS atherosclerosis
  • the object of the present invention is to overcome the defects in the prior art, and to provide a traditional Chinese medicine composition for treating atherosclerotic hypertension capable of realizing multi-channel, multi-level and multi-target comprehensive blood reduction, the following raw materials are divided into parts by weight.
  • the number is prepared: 60-300 parts of Salvia miltiorrhiza, 50-280 parts of Eucommia ulmoides, 50-260 parts of Uncaria, 10-100 parts of Rhizoma Coptidis, 50-240 parts of Apocynum venetum, 50-200 parts of Gastrodia, 50-200 of Dilong Parts, red to 6 to 20 parts, car front 20 to 300.
  • the traditional Chinese medicine composition is prepared according to the following parts by weight: 280 parts of Salvia miltiorrhiza, 246 parts of Eucommia ulmoides, 230 parts of Uncaria, 80 parts of Rhizoma Coptidis, 240 parts of Apocynum venetum, 180 parts of Gastrodia elata, 190 parts of Dijon, Red 8 pieces of music and 200 pieces of car front.
  • the traditional Chinese medicine composition is prepared according to the following parts by weight: 80 parts of Salvia miltiorrhiza, 100 parts of Eucommia ulmoides, 60 parts of Uncaria, 10 parts of Rhizoma Coptidis, 60 parts of Apocynum venetum, 60 parts of Gastrodia elata, 60 parts of Dijon, Red 12 copies and 50 pieces of psyllium.
  • the traditional Chinese medicine composition is prepared according to the following parts by weight: 240 parts of Salvia miltiorrhiza, 220 parts of Eucommia ulmoides, 220 parts of Uncaria, 50 parts of Rhizoma Coptidis, 100 parts of Apocynum venetum L., 160 parts of Gastrodia elata, 160 parts of Dijon, Red 15 songs and 150 copies of the psyllium.
  • the traditional Chinese medicine composition is prepared according to the following parts by weight: 180 parts of Salvia miltiorrhiza, 150 parts of Eucommia ulmoides, 80 parts of Uncaria, 60 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum, 80 parts of Gastrodia elata, 80 parts of Dijon, Red 8 songs and 60 copies of the psyllium.
  • the traditional Chinese medicine composition is prepared according to the following parts by weight: 220 parts of Salvia miltiorrhiza, 200 parts of Eucommia ulmoides, 260 parts of Uncaria, 50 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum, 80 parts of Gastrodia elata, 100 parts of Dijon, Red 10 songs and 120 baskets.
  • the invention contains 9 kinds of traditional Chinese medicines, and the functions played by Junchen Zuozhi are as follows:
  • Salvia miltiorrhiza is a medicinal herb, its traits are: bitter and bitter, slightly cold, heart, liver;
  • Pharmacological action: 1 has significant preventive and anti-atherosclerotic cardio-cerebral ischemic injury, which is the ultimate goal of the present invention, so Salvia miltiorrhiza is used as a drug, Salvia miltiorrhiza can significantly improve heart and brain blood supply, improve the body's tolerance Oxygen capacity, significantly inhibiting lactic acid Dehydrogenase (LDH), creatine kinase (CK) release, improve heart and brain ischemia, infarction and heart and brain function;
  • LDH lactic acid Dehydrogenase
  • CK creatine kinase
  • anticoagulant promote fibrinolysis, inhibit platelet aggregation, inhibit thrombosis; reduce blood lipids;
  • Eucommia is a drug, its traits are: sweet, warm;
  • Eucommia extract significantly reduces acute and chronic hypertension
  • Eucommia contains 4 types of antihypertensive components: lignans, such as rosin diglucoside (PDG), phenylpropanoids (chlorogenic acid, caffeic acid), Iridoids (gentipin, genipin, aucubin) and flavonoids (quercetin, rutin).
  • lignans such as rosin diglucoside (PDG), phenylpropanoids (chlorogenic acid, caffeic acid), Iridoids (gentipin, genipin, aucubin) and flavonoids (quercetin, rutin).
  • the various antihypertensive components in Eucommia ulmoides have the most significant effect on the relaxation of blood vessels by geniposide and geniposide; a lignin may increase the concentration of cAMP in vascular smooth muscle by inhibiting phosphodiesterase.
  • b-propanoid caffeic acid By inducing nitric oxide synthase in endothelial cells, it promotes the synthesis of NO and dilates blood vessels; geniposide and genipin in c-alkenyl ethers may increase cAMP concentration to relax blood vessels and lower blood pressure; In the flavonoids, quercetin reduces the intracellular free calcium level, relaxes blood vessels and lowers blood pressure through dual inhibition of voltage-dependent calcium channels and receptor-operated calcium channels in vascular smooth muscle cells.
  • the combined effect is to promote the release of NO, inhibit Ca2+ influx, angiotensin (Ang II) production, phosphodiesterase activity, and direct relaxation of blood vessels to produce antihypertensive effects.
  • the antihypertensive effect of fried Eucommia leaves is greater than that of Eucommia ulmoides leaves, and the effect of decoction is stronger than that of tincture.
  • the vasodilating effect of rosin diglucoside (PDG) and quercetin was the best when the ratio was 1:1, the maximum relaxation effect of quercetin was 74.2%, the maximum relaxation effect of PDG was 98%, and the maximum relaxation of Eucommia ulmoides extract. The effect was 95.6%, and the maximum relaxation effect of PDG and quercetin was 192.5%.
  • the depressor of Eucommia ulmoides leaves has three mechanisms: central inhibition, acting on peripheral nerves, and directly acting on vascular smooth muscle;
  • Eucommia ulmoides leaf and leaf decoction have significant sedative and hypnotic effects on the central nervous system, which can significantly prolong the sleep time of mice.
  • the analgesic effect is equivalent to that of aspirin, which can improve symptoms such as dizziness and insomnia in clinical practice;
  • Uncaria Uncaria is a drug, its traits are: sweet and bitter, slightly cold, the main liver;
  • Uncaria sinensis contains 4 components, its antihypertensive and negative heart rate effects on rhynchophylline (average arterial pressure decreased by 42.0%) > rhynchophylline (32.1%) > Uncaria total alkaloid (21.3%) > Non-alkaloids (12.4%), mechanism: a can directly or reflexively inhibit vascular motor center, block sympathetic nerves, enhance acetylcholine effect, inhibit L-type calcium channel, promote potassium channel opening, relax peripheral blood vessels, reduce Peripheral resistance, longer lasting significant blood pressure lowering, long-term use of no drug resistance; b significantly inhibited heart rate and atrioventricular conduction, slowed heart rate, reduced cardiac output, lower blood pressure; c against angiotensin II induced pressor; d inhibits angiotensin II-induced proliferation of vascular smooth muscle cells, inhibits arterial collagen deposition, and resists arteriosclerosis;
  • Antioxidant Uncaria petroleum ether extract (PE), chloroform extract (CE), ethyl acetate extract (AE) and ethanol extract (EE), the order of antioxidant activity is: E>Vc>AE>CE >Alk>PE;
  • Rhy rhyncholine
  • b isorubicin dose-dependently inhibits the production of proinflammatory cytokines tumor necrosis factor and NO induced by lipopolysaccharide in glial cells.
  • c hook vine decoction significantly increased the pain threshold of mice, reduced capillary permeability, inhibited the inflammation caused by xylene, and significantly reduced the swelling of the auricle of mice;
  • berberine is a drug, its traits are: bitter, cold;
  • berberine BBR, Ber
  • berberine BBR
  • Ber the name of berberine.
  • Ber has a competitive blocking effect on a receptor.
  • Ber has a strong affinity for the a1 receptor, and the effect of Ber blocking the a1 receptor is 2 to 3 times that of blocking the a2 receptor. It has been reported to be 7.1 to 10 times.
  • bBer is an M receptor agonist, which inhibits horse serum cholinesterase activity, accumulates Ach, acts on M receptors on the vascular endothelium, dilates blood vessels to lower blood pressure, and c releases NOBer to produce arterial relaxation through intact endothelial synthesis and NO release. effect.
  • d Activate the K+ channel.
  • the high concentration of Ber activates the K+ channel, hyperpolarizing the membrane potential of vascular smooth muscle cells, producing an endothelium-independent vasodilation and reducing blood pressure; e inhibits intracellular Ca2+ release. Ber can inhibit the release of Ca2+ in the intracellular reservoir, reduce the contraction of blood vessels, and exert a hypotensive effect;
  • BBR low-density lipoprotein receptor mRNA
  • ERK extracellular regulated kinase
  • LDLR lipid synthesis in hepatocytes
  • AMPK Activated protein kinase
  • JNK JNK pathway
  • h.BBR enhances the expression of PPAR (peroxisome proliferator-activated receptor), enhances glycolipid metabolism, controls the differentiation of 3T3.L1 adipocytes and human omental cells, and inhibits macrophage inflammation by enhancing PPARct and PPARB. Expression of factors, reducing inflammation and stabilizing plaques;
  • PPAR peroxisome proliferator-activated receptor
  • BBR can improve hyperinsulinemia, regulate blood lipids and blood sugar, redistribute body fat, reduce body weight, is a safe and effective drug for the treatment of insulin resistance, early type 2 diabetes and hyperlipidemia.
  • Mechanism of action activation of AMP-activated protein kinase (AMPK, "energy regulator") pathway: a. inhibit mitochondrial aerobic oxidation, promote glucose glycolysis, increase AMP/ATP ratio, activate AMPK; b. BBR activate AMPK After promoting glycolysis, it strengthens glucose metabolism, enhances the expression of glucose transporter 4 (GLUT-4); c. promotes glucose transport.
  • AMPK AMP-activated protein kinase
  • BBR inhibits the activity of glucose transport a-glucosidase in intestinal epithelium like acarbose, and effectively inhibits the absorption of glucose
  • GLP-1 secretion in diabetic rats stimulates insulin secretion and improves islet function
  • g. Activates PPART pathway, enhances endothelial eNOS expression, improves myocardial blood supply, inhibits hyperglycemia-induced cardiac hypertrophy
  • PPART is a new drug for the treatment of type II diabetes.
  • the target of ketones (TZDs) can increase body mass.
  • BBR has the opposite effect on PPAR1, which can reduce body mass, inhibit lipid aggregation, improve insulin resistance, and have stronger weight-loss effect.
  • CCP berberine polysaccharide
  • the CCP with different charge levels had a scavenging effect on hydroxyl radicals, superoxide anion radicals and DPPH free radicals, and CCP-II had a strong scavenging rate of hydroxyl radicals.
  • Hydroxyl radicals are produced during metabolism and are highly toxic to organisms. They can cause oxidative damage and destruction of cell membranes, leading to cell necrosis or mutation, aging, tumors and other diseases.
  • Superoxide anion radicals have strong activity and can cause cells.
  • DNA damage is also a precursor of many active radicals; DPPH is a relatively stable free radical with unpaired electrons with a free electron on its N atom.
  • the antioxidant activity of CCP increases with increasing charge.
  • berberine II can improve the body's ability to scavenge oxygen free radicals, significantly reduce carbon tetrachloride (Ccl), D-galactose (D-Gal-N), liver caused by acetaminophen (AP) Cell damage, protect the normal structure of mitochondria, adjust energy metabolism disorder, its effect is stronger than the positive control drug biphenyl diester; at the same time reduce malondialdehyde content, enhance superoxide dismutase activity, anti-oxidation induced by cerebral ischemia-reperfusion Sexual injury, inhibition of apoptosis;
  • Apocynum venetum leaves Apocynum venetum leaves for the drug, its traits are: sweet and bitter, cool, return to the liver;
  • Pinggan soothe the nerves, clearing heat and water. For liver yang dizziness, palpitations, insomnia, edema and oliguria; hypertension, neurasthenia, nephritis edema. Modern research Apocynum venetum contains chemical components such as total flavonoids, organic acids, amino acids and trace elements;
  • Gastrodia Gastrodia elata is an adjuvant, its traits are: sweet and flat, return to the liver, non-toxic;
  • Gastrodia elata polysaccharide can significantly reduce serum nitric oxide (NO) content, plasma endothelin (ET) content, angiotensin II (Ang II) content in the dose range
  • NO serum nitric oxide
  • ET plasma endothelin
  • Ang II angiotensin II
  • the dose-dependent reduction of systolic and diastolic blood pressure had no significant effect on heart rate and urine volume in rats;
  • Gastrodia elata extract and gastrodin could reduce coronary and cerebrovascular resistance, have mild and long-lasting blood pressure lowering effect, and can improve Bioavailability and blood pressure lowering effect of rhynchophylline;
  • Gastrodia elata polysaccharide can significantly increase superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH- in serum, liver, brain and heart tissue of model mice) P x) activity, significantly inhibiting malondialdehyde (MDA) content.
  • Gastrodia Polysaccharide can reduce the content of MDA by eliminating excess free radicals, improve the learning and memory ability of aging mice, promote the recovery of cranial nerves, and delay cell senescence;
  • Anti-diabetic gastrodin can increase the expression of cystathionine synthetase (CBS) in the insulin resistance model, regulate the transcription and translation level of CBS, and reduce the content of homocysteine by exerting anti-oxidation effect.
  • Dilong Dilong is an adjuvant, its traits are: cold, taste;
  • Dilong extract can increase the activity of antioxidant enzymes in the body and remove the peroxidation products inside the body.
  • Another sedative, antiasthmatic, diuretic, anti-cancer, enhance immunity, etc., the above effects are designated as the second adjuvant of the invention, in combination with the above drugs to reverse and reduce atherosclerosis hypertension;
  • red yeast red yeast is an adjuvant, its traits are: sweet, warm, return to the liver, spleen, large intestine;
  • Red yeast rice contains natural monacolin or lovastatin, which has high inhibitory effect on the rate-limiting enzyme of cholesterol synthesis in the body, and can effectively block cholesterol synthesis (70% of human body cholesterol is synthesized by the body), which is significantly reduced.
  • Serum triglyceride (TG), cholesterol (TC), low-density lipoprotein (LDL-C), elevated high-density lipoprotein (HDL-C) is recognized as a hypolipidemic drug, mainly due to atherosclerosis It is caused by multiple factors of lipid peroxidation. For the treatment of hypertension, it is necessary to lower blood fat and anti-oxidation, and to terminate and reduce atherosclerosis in order to gradually cure hypertension, so it is necessary to increase red yeast rice;
  • Red yeast has the effect of preventing and treating AS and better blood pressure lowering, can protect vascular endothelial cells, inhibit lipid deposition in liver, reduce platelet aggregation and whole blood viscosity.
  • the above effects, especially hypolipidemic effect, are designated as the third adjuvant of the invention. Medicine to assist in the prevention of the continued development of atherosclerosis;
  • psyllium for the drug, its traits are: sweet and salty, slightly cold, non-toxic. Into the bladder, spleen, kidney three;
  • Pre-flowering water extract alcohol solution can inhibit Na+K+ATPase activity, promote the excretion of water, sodium chloride, urea and uric acid, and significantly increase urine output.
  • Psyllium polysaccharide contains many hydrophilic groups, which can be swelled to several tens of times, so that the feces are soft and easy to discharge, preventing acute complications caused by constipation;
  • Pseudosciaena sinensis polysaccharide can stabilize endothelial cell membrane structure and reduce free radical damage and lipid peroxidation products.
  • MDA can increase the activity of SOD in cells
  • PSP can enhance the proliferation activity of cells and inhibit the activity of OX.LDL
  • balance the release of NO and NOS expression in endothelial cells and increase the expression of ICAM.1 against OX.LDL-induced endothelial cell injury.
  • Eucommia ulmoides can be replaced by Eucommia leaves, and the substitution ratio is 2:3 of Eucommia ulmoides than Eucommia leaves.
  • the Chinese medicine composition can also be added with a promoting absorbent, a sustained release agent and a flavoring agent.
  • Salvia miltiorrhiza as a medicinal herb
  • Eucommia ulmoides Oliv. Uncaria sinensis
  • Rhizoma Coptidis Apocynum venetum L.
  • Tianma, Dilong, and Red koji as adjuvants
  • psyllium as a drug
  • medicinal Danshen for prevention and treatment of cardio-cerebral ischemic injury
  • the medicinal herbs Eucommia ulmoides, Rhizoma Coptidis, Uncaria, and Apocynum venetum are used to exert blood vessels to lower blood pressure, and can also be used to prevent and treat atherosclerosis
  • the adjuvants Tianma, Dilong, and Red Yeast are used to prevent and treat atherosclerosis, and can also be used for Assist in lowering blood pressure
  • use medicinal sap to prevent blood stasis and diuresis, and prevent acute complications caused by constipation.
  • the traditional Chinese medicine composition can be used for treating atherosclerotic hypertension, multi-channel, multi-level, multi-target synergistic prevention and treatment of atherosclerotic hypertension, achieving comprehensive blood pressure lowering, anti-lipid peroxidation, lowering blood fat, Regulate blood sugar, anticoagulation, anti-inflammatory, and reversal to reduce the role of atherosclerosis.
  • the invention has the advantages of:
  • the formula of the invention does not contain toxic Chinese medicine, and is suitable for long-term use of atherosclerotic hypertension patients.
  • the invention relates to a traditional Chinese medicine composition for treating atherosclerosis hypertension and the use thereof, the Chinese medicine composition comprising the following raw materials prepared in parts by weight: 60-300 parts of Salvia miltiorrhiza, 50-280 parts of Eucommia leaves, hook 50 to 260 parts of vine, 10 to 100 parts of berberine, 50 to 240 parts of apocynum venetum, 50 to 200 parts of gastrodia, 50 to 200 parts of earthworm, 6 to 20 parts of red yeast rice, and 20 to 300 parts of psyllium.
  • the traditional Chinese medicine composition can be prepared by the following raw materials in parts by weight: 280 parts of Salvia miltiorrhiza, 246 parts of Eucommia ulmoides, 230 parts of Uncaria, 80 parts of Rhizoma Coptidis, 240 parts of Apocynum venetum, 180 parts of Gastrodia elata, 190 parts of Dijon, 8 red koji and 200 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 80 parts of Salvia miltiorrhiza, 100 parts of Eucommia ulmoides, 60 parts of Uncaria, 10 parts of Rhizoma Coptidis, 60 parts of Apocynum venetum, 60 parts of Gastrodia, 60 parts of Gastrodia, 60 parts of Dilong, 12 red koji and 50 psyllium.
  • the traditional Chinese medicine composition can be prepared by using the following raw materials in parts by weight: 240 parts of Salvia miltiorrhiza, 220 parts of Eucommia ulmoides, 220 parts of Uncaria, 50 parts of Rhizoma Coptidis, 100 parts of Apocynum venetum, 160 parts of Gastrodia, 160 parts of Dijon, 15 red koji and 150 psyllium.
  • the traditional Chinese medicine composition can be prepared by using the following raw materials in parts by weight: 180 parts of Salvia miltiorrhiza, 150 parts of Eucommia ulmoides, 80 parts of Uncaria, 60 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum, 80 parts of Gastrodia elata, 80 parts of Dijon, 8 red koji and 60 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 220 parts of Salvia miltiorrhiza, 200 parts of Eucommia ulmoides, 260 parts of Uncaria, 50 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum L., 80 parts of Gastrodia elata, 100 parts of Dijon, 10 red koji and 120 psyllium.
  • the traditional Chinese medicine composition can be prepared by using the following raw materials in parts by weight: 60 parts of Salvia miltiorrhiza, 50 parts of Eucommia ulmoides, 50 parts of Uncaria, 10 parts of Rhizoma Coptidis, 50 parts of Apocynum venetum, 50 parts of Gastrodia elata, 50 parts of Dijon, 6 red koji and 20 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 300 parts of Salvia miltiorrhiza, 280 parts of Eucommia ulmoides, 260 parts of Uncaria, 100 parts of Rhizoma Coptidis, 240 parts of Apocynum venetum, 200 parts of Gastrodia elata, 200 parts of Dijon, 20 red koji and 300 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 180 parts of Salvia miltiorrhiza, 165 parts of Eucommia ulmoides, 145 parts of Uncaria, 55 parts of Rhizoma Coptidis, 145 parts of Apocynum venetum, 125 parts of Gastrodia elata, 125 parts of Dijon, 13 red songs, psyllium 160 copies.
  • the traditional Chinese medicine composition can be prepared by the following raw materials in parts by weight: 280 parts of Salvia miltiorrhiza, 246 parts of Eucommia ulmoides, 230 parts of Uncaria, 80 parts of Rhizoma Coptidis, 240 parts of Apocynum venetum, 180 parts of Gastrodia elata, 190 parts of Dijon, 8 red koji and 200 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 80 parts of Salvia miltiorrhiza, 100 parts of Eucommia ulmoides, 60 parts of Uncaria, 10 parts of Rhizoma Coptidis, 60 parts of Apocynum venetum, 60 parts of Gastrodia, 60 parts of Gastrodia, 60 parts of Dilong, 12 red koji and 50 psyllium.
  • the traditional Chinese medicine composition can be prepared by using the following raw materials in parts by weight: 240 parts of Salvia miltiorrhiza, 220 parts of Eucommia ulmoides, 220 parts of Uncaria, 50 parts of Rhizoma Coptidis, 100 parts of Apocynum venetum, 160 parts of Gastrodia, 160 parts of Dijon, 15 red koji and 150 psyllium.
  • the traditional Chinese medicine composition can be prepared by using the following raw materials in parts by weight: 180 parts of Salvia miltiorrhiza, 150 parts of Eucommia ulmoides, 80 parts of Uncaria, 60 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum, 80 parts of Gastrodia elata, 80 parts of Dijon, 8 red koji and 60 psyllium.
  • the traditional Chinese medicine composition can be prepared according to the following parts by weight: 220 parts of Salvia miltiorrhiza, 200 parts of Eucommia ulmoides, 240 parts of Uncaria, 50 parts of Rhizoma Coptidis, 80 parts of Apocynum venetum L., 80 parts of Gastrodia elata, 100 parts of Dijon, 10 red koji and 120 psyllium.
  • SHR model group 24 Beijing Weitong SHR (spontaneously hypertensive rats) were randomly divided into four groups: SHR model group, service group, nifedipine group, and Huoxue Qianyang granule group.
  • the arterial blood pressure tester dynamically detects the systolic blood pressure of SHR at 1 week, 2 weeks, and 4 weeks after administration.
  • the results showed that the group of the present invention had a significant reduction in SHR systolic and diastolic blood pressure, and its antihypertensive effect was slightly less than that of SHR in the nifedipine group, which was significantly better than that of the Huoxue Qianyang granule group, and the three groups were compared with the SHR model group. , p ⁇ 0.05.
  • the experimental results suggest that there are significant differences between the Tongxinluo group and the model group compared with the model group. Among them, the experimental results of the maximum relaxation rate of the Ach vessels in the isolated vascular ring of the rats in the present invention are the best.
  • Tips (1) The present invention has a good blood pressure lowering effect, and its effect is close to the western medicine nifedipine, but no side effects of nifedipine; (2) the invention combined with nifedipine can improve the therapeutic effect, long-term treatment can Reduce the dose of nifedipine and reduce the side effects of nifedipine.
  • Case 1 Jinmou, male, 44 years old, with hypertension for 6 years, long-term treatment with western medicine, higher blood pressure, headache, head Halo, affecting work, panic, began taking the capsule preparation of the present invention in August 2016, 4 capsules per day, three times a day, three days later, the blood pressure gradually stabilized and decreased, headache, dizziness disappeared, did not affect the work, still Keep taking it and feel a lot easier on the head and body.
  • Case 2 Lu Moumou, male, 65 years old, with hypertension for more than 10 years, from December 2015 to May 2016, he was hospitalized for cerebral vasospasm three times. He could not control blood pressure with depressive blood pressure, etc. The fainting, head swelling, and psychological burden are very heavy.
  • the capsule preparation of the present invention was added. Each time 4 capsules, three times a day, two or three days, the mind was relaxed, and the signs of hemiplegia were also improved.
  • Case 3 The original, female, 76 years old, has a history of hypertension for nearly 30 years, long-term use of blood pressure lowering drugs, so that blood pressure is basically maintained. In April 2016, he felt dizziness, dizziness, and blood pressure rose to 176mmHg/110mmHg. He began to take the capsule preparation of the present invention, 4 capsules each time, three times a day, to stabilize blood pressure, slightly higher than normal, and the patient felt relaxed and relaxed. , in good mental condition, still continue to take it.
  • Case 4 Zhao, male, 39 years old, height 173cm, weight 97kg, suffering from hypertension for 2 years, diabetes for 1 year, no obvious symptoms, no treatment, sudden dizziness, headache, tinnitus in late September 2016 Measuring blood pressure 172mmHg/94mmHg, starting to take the capsule preparation of the invention, 4 capsules each time, three times a day, blood pressure slowly decreased, now slightly higher than normal, blood sugar has also improved, no obvious symptoms, continue to take the invention, and control diet .

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Abstract

本发明属于中医药技术领域，具体涉及一种治疗动脉粥样硬化高血压病的中药组合物及其应用，其组分包括丹参60～300份、杜仲叶50～280份、钩藤50～260份、黄连10～100份、罗布麻叶50～240份、天麻50～200份、地龙50～200份、红曲6～20份、车前子20～300份。本发明多途径、多层次、多靶点协同防治动脉粥样硬化高血压病，另外本发明配方不含有毒中药，适合动脉粥样硬化高血压患者长期服用。

Description

一种治疗动脉粥样硬化高血压病的中药组合物及其应用 [技术领域]
本发明属于中医药技术领域，具体涉及一种治疗动脉粥样硬化高血压病的中药组合物及其应用。
[背景技术]
血液循环是人体的红色生命运输线，主要将消化吸收的营养物质和呼吸吸入的氧气输送到全身的组织细胞，并将组织细胞的代谢产物运走，维持全身组织细胞的正常新陈代谢，生命不息，交换不止。心脏是血液循环的动力，心脏收缩将血液射入动脉，动脉逐渐分支成细微血管网，让血液与组织细胞进行物质交换，血液中营养物质和氧进入组织细胞，组织细胞的代谢废物进入血液，由静脉逐级汇聚心脏，然后心脏将血液中代谢废物输送到肺、肾、肝等排出体外，由此循环不息，维持机体的内环境相对稳定。
血压是血流对血管壁的侧压力。包括动脉血压和静脉血压，通常谈的血压是测肱动脉的血压，其收缩压是心脏收缩射出血液对血管壁的侧压力，舒张压是心脏舒张时血液对血管壁的侧压力，正常收缩压＜130mmHg，舒张压＜85mmHg，而高于140mmHg/90mmHg为高血压。
原发性高血压是动脉粥样硬化(AS)引起的高血压病。高血压病病变特征是血管管壁重构，斑块增生，管腔狭窄，组织供血减少，代谢产物堆积，反射性心脏做功增强，引起血压升高，以保障组织供血，早期多无临床症状，血压忽高忽低，称为代偿期。随着时间推移，AS持续加重，病人血压保持高水平状态，仍出现供血不足性临床症状，称为失代偿期，即原发性高血压病。高血压病是心脑血管病最主要的危险因素，是重要的公共卫生问题。据《中国居民营养与慢性病状况报告(2015)》显示，在我国现有2亿高血压患者，全国每年因高血压过早死亡人数高达200万，直接医疗费用每年达366亿元，稳居我国居民死因之首。
动脉粥样硬化(AS)的发病机理：申请人认为是脂质过氧化多因协助所致。即脂质过氧化引发巨噬细胞无限度吞噬死沉积血管壁所致，有关高血脂、高血糖、高血粘、吸烟、高血压等则是AS形成和发展的重要帮凶。
目前，高血压病的防治，西医对高血压病治疗目标是：把血压降至理想状态，防止并发症，降低病残率及死亡率，提高生活质量。因此，西医在治疗原则上就不治本，中医药可以 逆转或减轻AS(治本)，但市场上现有的中药制剂多含有毒中药，或疗效尚需提高。
[发明内容]
本发明的目的在于克服现有技术中的缺陷，而提供一种能够实现多途径、多层次、多靶点综合降血的治疗动脉粥样硬化高血压病的中药组合物，下列原料按照重量份数配制而成：丹参60～300份、杜仲叶50～280份、钩藤50～260份、黄连10～100份、罗布麻叶50～240份、天麻50～200份、地龙50～200份、红曲6～20份、车前子20～300份。
所述中药组合物采用下列原料按照重量份数配制而成：丹参280份、杜仲叶246份、钩藤230份、黄连80份、罗布麻叶240份、天麻180份、地龙190份、红曲8份、车前子200份。
所述中药组合物采用下列原料按照重量份数配制而成：丹参80份、杜仲叶100份、钩藤60份、黄连10份、罗布麻叶60份、天麻60份、地龙60份、红曲12份、车前子50份。
所述中药组合物采用下列原料按照重量份数配制而成：丹参240份、杜仲叶220份、钩藤220份、黄连50份、罗布麻叶100份、天麻160份、地龙160份、红曲15份、车前子150份。
所述中药组合物采用下列原料按照重量份数配制而成：丹参180份、杜仲叶150份、钩藤80份、黄连60份、罗布麻叶80份、天麻80份、地龙80份、红曲8份、车前子60份。
所述中药组合物采用下列原料按照重量份数配制而成：丹参220份、杜仲叶200份、钩藤260份、黄连50份、罗布麻叶80份、天麻80份、地龙100份、红曲10份、车前子120份。
本发明含9味中药，按照君臣佐使所发挥的作用如下：
1、丹参：丹参为君药，其性状为：味苦微辛，性微寒，归心、肝经；
功能：活血祛瘀，通经止痛，清心除烦。是治疗心脑血管疾病的常用中药；
药理作用：①有显著预防和抗动脉粥样硬化心脑缺血性损伤作用，这正是本发明的最终目的，故以丹参为君药，丹参能显著改善心脑供血，提高机体的耐缺氧能力，显著抑制乳酸 脱氢酶(LDH)、肌酸激酶(CK)的释放，改善心脑缺血、梗死和心脑功能；
②有抗凝、促进纤溶、抑制血小板聚集，抑制血栓形成；降血脂作用；
③丹参在细胞和基因水平调控ET(血管内皮细胞分泌的一种活性多肽)的合成与释放，降低在缺血再灌注时内皮素(ET)异常升高，阻断ET引起的血管强烈收缩等一系列不良影响；
④有较温和的通过卵巢起作用的雌激素活性，降低血糖、增强免疫、抗纤维化等作用；
2、杜仲：杜仲为臣药，其性状为：味甘，性温；
功能：补益肝肾、强筋壮骨、固经安胎的功效；
药理作用：①杜仲提取物显著降低急慢性高血压，杜仲含4类降压成分：木脂素类，如松脂醇二葡糖苷(PDG)、苯丙素类(绿原酸、咖啡酸)、环烯醚萜类(京尼平苷酸、京尼平苷、桃叶珊瑚苷)和黄酮类(槲皮素、芦丁)。杜仲中各种降压成分以京尼平苷和京尼平苷酸对血管的舒张作用最为显著；a木质素类可能通过对磷酸二酯酶的抑制作用，使血管平滑肌中cAMP的浓度升高，从而激活蛋白激酶A，抑制钙离子的内流，也可能通过影响K+通道活性，使动脉平滑肌细胞膜电位去极化或超极化，发挥舒血管降血压作用；b苯丙素类的咖啡酸能通过诱导内皮细胞中一氧化氮合酶，促使NO的合成增加，舒张血管；c环烯醚萜类中的京尼平苷酸、京尼平可能升高cAMP浓度来舒张血管，降低血压；d黄酮类中槲皮素通过对血管平滑肌细胞电压依赖性钙通道和受体操纵性钙通道的双重抑制作用，降低细胞内游离钙水平，舒张血管，降低血压。综合作用是通过促进NO释放，抑制Ca2+内流、血管紧张素(Ang II)的生成、磷酸二酯酶的活性，和直接舒张血管等途径产生降压作用。炒杜仲叶的降压作用大于生杜仲叶，水煎剂的作用强于酊剂。松脂醇二葡糖苷(PDG)和槲皮素在比例为1∶1组合时血管舒张效果最好，槲皮素最大舒张效果为74.2％，PDG最大舒张效果为98％，杜仲叶浸膏最大舒张效果为95.6％，PDG和槲皮素组合后最大舒张效果可达192.5％。杜仲叶的降压有3种机制：中枢抑制、作用于外周神经、直接作用于血管平滑肌；
②杜仲叶皮、叶煎剂对中枢神经具有显著的镇静催眠作用，能明显延长小鼠的睡眠时间，其镇痛作用与阿司匹林的功效相当，在临床上能改善头晕失眠等症状；
③较强的降血脂，调节血糖，抗氧化，抗炎，保护心脑血管，恢复血管弹性，利尿清热等药理作用，其突出的降血压及相关作用被定为本发明的第一臣药，引领臣药降血压，协同 君药保障心脑供血；
3、钩藤：钩藤为臣药，其性状为：味甘苦，微寒，主入肝经；
功能：熄风止痉，清热平肝；肝经热盛、肝风内动；
药理作用：①钩藤中含4种成分，其降压及负性心率作用异钩藤碱(平均动脉压降低42.0％)＞钩藤碱(32.1％)＞钩藤总碱(21.3％)＞钩藤非生物碱(12.4％)，机理：a能直接或反射性抑制血管运动中枢、阻滞交感神经、增强乙酰胆碱效应，抑制L-型钙通道，促进钾离子通道开放，舒张外周血管、降低外周阻力、较持久显著的降血压，长期用无耐药现象；b明显抑制心率和房室传导，减慢心率，减少心输出量，降低血压；c对抗血管紧张素II所致升压作用；d抑制血管紧张素II诱导的血管平滑肌细胞增殖，抑制动脉胶原沉积，抗动脉硬化；
②抗氧化：钩藤石油醚提取物(PE)、氯仿提取物(CE)、乙酸乙酯提取物(AE)和乙醇提取物(EE)，抗氧化活性顺序为：E＞Vc＞AE＞CE＞Alk＞PE；
③抗炎：a钩藤碱(Rhy)有效地抑制炎性细胞因子释放的脂多糖，浓度依赖性地抑制LPS诱导的炎症细胞因子的产生；
b异钩藤碱剂量依赖性地抑制神经胶质细胞由脂多糖诱导产生的致炎细胞因子肿瘤坏死因子、NO的产生。c钩藤煎液显著地提高小鼠痛阈值，降低毛细血管通透性，抑制由二甲苯所致的炎症反应，显著地减轻小鼠耳廓的肿胀；
④镇惊安神、抗心律失常、抗凝、降血脂、调节血糖、降低血清胰岛素水平、增加心脑血流量，抗心脑缺血损伤，保护心脏和大脑。其突出的降血压及相关作用被定为本发明的第二臣药，协同发挥抗动脉粥样硬化降血压作用；
4、黄连：黄连为臣药，其性状为：味苦，寒；
功能：清热燥湿，泻火解毒。用于湿热痞满，高热神昏，心火亢盛，心烦不寐。现代研究黄连含小檗碱(黄连素，BBR)，分子式与相对分子量为C2OH18NO4，易溶于沸水；
药理作用：①对循环系统的作用：①降血压：a小檗碱(berberine，BBR，Ber)，义名黄连素。Ber对a受体有竞争性阻断作用。Ber对a1受体有较强的亲和力，Ber阻断a1受体产生的效应是阻断a2受体所产生效应的2倍～3倍.有报道为7.1倍～10倍。bBer是M受体激动剂，能抑制马血清胆碱酯酶活性，使Ach堆积，作用血管内皮上的M受体，扩张血管降血压；c释放NOBer是通过完整内皮合成和释放NO产生动脉松弛作用。d活化K+通道。Ber高浓度可活化K+通道，使血管平滑肌细胞膜电位超极化，产生不依赖内皮的血管扩张而降压；e抑制细胞内Ca2+释放。Ber可抑制细胞内贮库Ca2+释放，降低血管的收缩了，发挥降压作用；
②降血脂：小檗碱不同于他汀类抑制脂合成而降脂，BBR是：a.通过细胞外调节激酶(ERK)信号通路的活化促进低密度脂蛋白受体mRNA(LDLRmRNA)转录增加，上调LDLR蛋白的表达，加速LDL利用和降解，显著降低TC、TG、LDL-C，分别为21.41％、26.4％、28.22％，改善肝功，升高HDL-C不明显；b.通过磷酸腺苷活化蛋白激酶(AMPK)途径和JNK途径，上调LDLR，抑制肝细胞内脂质的合成；c.抑制LDL-C的氧化修饰及OX-LDL造成的内皮功能紊乱；d.显著降低血清Lp-PLA2、MMP-9、OxLDI及MCP-1水平，升高血清TIMP-1水平，作用效果与辛伐他汀相似；e.BBR与胆固醇抑制吸收剂依折麦布有类似的作用，抑制肠道胆固醇的吸收；f.BBR通过PPARct发挥良好的降低甘油三酯的作用，PPARct也是降甘油三酯药物非诺贝药的靶点；g.BBR可以改善肠道菌群来改善高脂饮食大鼠的代谢紊乱。h.BBR通过增强PPARct、PPARB，降低PPAR(过氧化物酶体增殖物激活受体)的表达，改善糖脂代谢，控制3T3.L1脂肪细胞和人大网膜细胞的分化，抑制巨噬细胞炎症因子的表达，减轻炎症反应，稳定斑块；
③降血糖，BBR能改善高胰岛素血症，调节血脂血糖，使体脂重新分布，减轻体重，是治疗胰岛素抵抗、早期2型糖尿病与高血脂安全有效的药物。作用机制：激活AMP激活的蛋白激酶(AMPK，“能量调节器”)途径：a.抑制线粒体有氧氧化，促进葡萄糖的酵解，使AMP/ATP比值升高，激活AMPK；b.BBR激活AMPK后促进糖酵解而加强糖代谢，增强葡萄糖转运蛋白4(GLUT-4)的表达；c.促进葡萄糖转运。是二甲双胍和罗格列酮治疗2型糖尿病、肥胖的重要靶点；e.BBR像阿卡波糖等一样抑制肠上皮葡萄糖转运a-糖苷酶的活性，有效抑制葡萄糖的吸收；f.促进肠道糖尿病鼠GLP-1的分泌，刺激胰岛素分泌，改善胰岛功能；g.激活PPART途径，增强内皮eNOS表达，改善心肌供血，抑制高血糖诱导的心肌肥大，PPART是治疗II型糖尿病新药噻唑烷二酮类(TZDs)作用的靶点，能增加体质量，BBR对PPARl的作用与之相反，能减轻体质量，抑制脂质聚集，改善胰岛素抵抗，有更强的减肥作用；
④抗氧化，4种黄连多糖(CCP)有较好的降糖活性和清除自由基的作用。a.4组带电量不同的CCP对羟自由基、超氧阴离子自由基、DPPH自由基均有清除作用，其中CCP-II对羟自由基清除率较强。羟自由基在新陈代谢过程中产生，对生物体毒性强、危害大，能引起细胞膜氧化性损伤和破坏，导致细胞坏死或突变，衰老、肿瘤等疾病；超氧阴离子自由基活性强，可以导致细胞内DNA损伤，也是很多活性游离基的前体；DPPH是一种带有不配对电子的比较稳定的自由基，其N原子上有一个游离电子。CCP的抗氧化活性随着带电量增多而增强。b.胡黄连苷II能提高机体清除氧自由基能力，明显减轻四氯化碳(Ccl)、D-氨基半乳糖(D-Gal-N)、对乙酞氨基酚(AP)所致的肝细胞损伤，保护线粒体正常结构，调整能量代谢紊乱，其作用强于阳性对照药联苯双酯；同时减少丙二醛含量，增强超氧化物歧化酶活性，抗脑缺血再灌注所致的氧化性损伤，抑制细胞凋亡；
⑤扩血管，强心，减慢心率，护脑，抗炎，抗凝，抗AS等作用。其突出的降血压及相关作用被定为本发明的第三臣药，协同发挥抗动脉粥样硬化降血压作用；
5、罗布麻叶：罗布麻叶为臣药，其性状为：味甘苦，性凉，归肝经；
功能：平肝安神，清热利水。用于肝阳眩晕，心悸失眠，浮肿尿少；高血压，神经衰弱，肾炎浮肿。现代研究罗布麻含有总黄酮类、有机酸类、氨基酸类和微量元素等化学成分；
药理作用：①降血压：高血压被称为“不死的癌症”。西药降压效果虽好，长期服用副作用大，因不治本，越治越重。罗布麻叶降压效果渐进稳固，是理想的降压中草药。所含金丝桃苷和异槲皮素能刺激动脉血管产生一氧化氮，引起血管舒张，也可有效降低自主神经紊乱 性血压升高。其降压作用10min开始，最大降压时间是给药量30～40min，出现平缓降压曲线，大剂量则降压作用增加，含有松驰血管的物质，对心率无影响；
②强心利尿。能使心脏收缩幅度增大，心率变慢，有强心甙样作用，可使动脉粥样硬化家兔的心电图变化恢复正常，显著扩张冠脉，增加心脏糖元再合成。小量能增加肾血流，利尿作用较强，但大量则减少尿量；
③降血脂，抗氧化，软化血管，抗动脉粥样硬化，抗心肌纤维化，抗抑郁，抗心脑缺血损伤，保护心脑，延缓衰老，降解烟毒，解酒保肝，润肠通便，安神助眠，提高免疫力等作用，其良好的降血压和强心利尿作用被定为本发明的第四臣药，协同发挥抗动脉粥样硬化降血压作用；
6、天麻：天麻为佐药，其性状为：味甘性平，归肝经，无毒；
功能：息风定惊。治眩晕眼黑，头风头痛，肢体麻木，半身不遂，语言蹇涩。现代研究，天麻富含天麻素(Gas)，天麻甙元、天麻多糖等；
药理作用：①降血压：天麻多糖能明显降低高血压模型大鼠血清一氧化氮(NO)含量、血浆内皮素(ET)含量下降，血管紧张素II(Ang II)的含量，在剂量范围内呈剂量依赖性降低收缩压和舒张压，对大鼠心率及尿量没有明显作用；天麻提取液和天麻苷能降低冠脉和脑血管阻力，有轻度而持久的降血压作用，并能提升钩藤碱的生物利用度和降血压效果；
②抗氧化：天麻多糖可显著提高模型小鼠血清、肝、脑、心组织中的超氧化岐化酶(SOD)、过氧化氢酶(CAT)、谷胱甘肽过氧化物酶(GSH-P x)活性，明显抑制丙二醛(MDA)含量。天麻多糖通过消除过量的自由基，降低MDA的含量，改善衰老小鼠的学习记忆能力，促进脑神经的恢复，延缓细胞衰老；
③抗糖尿病天麻素能增加胰岛素抵抗模型中胱硫醚合成酶(CBS)表达，调控CBS的转录和翻译水平，通过发挥抗氧化作用来降低同型半胱氨酸的含量。天麻素对STZ诱导痛性糖尿病神经病变(PDN)的实验动物模型，能呈剂量依赖性地扭转糖尿病所致的瞬态钠电流(INaT)增强和钾电流减弱，尤其缓慢失活钾电流(IAS)，阻止外周慢性疼痛；
④保护脑，抗抑郁，防治阿尔茨海默病，改善睡眠，增强免疫，抗炎，抗凝血，抗血栓，治疗心肌炎、心肌肥厚、心肌纤维化等，上述作用被定为本发明的第一佐药，协同上述诸药 降低高血压，减轻高血压患者的症状；
7、地龙：地龙为佐药，其性状为：性寒，味成；
功能：清热定惊，通络、平喘，利尿；用于高热神昏，半身不遂，尿少水肿，高血压症；
药理作用：①新型溶栓剂，地龙提取物可激活纤维蛋白和纤溶酶原活性，直接溶解血栓，对健康的人群有明显降纤、溶栓、抗凝血等作用，毒副作用低，可口服给药；
②降血压，地龙多肽以及类血小板活化因子，能够缓慢持久有效的降低血压；
③地龙提取液可以提高机体抗氧化酶的活性，清除机体内部的过氧化产物。另有镇静、平喘、利尿、抗癌、增强免疫等作用，上述作用被定为本发明的第二佐药，协同上述诸药逆转和减轻动脉粥样硬化高血压病；
8、红曲：红曲为佐药，其性状为：味甘、温，归肝、脾、大肠经；
功能：活血化瘀，健脾消食；
药理作用：①红曲含天然莫那柯林类或洛伐他汀类物质，对体内胆固醇合成限速酶有高效抑制作用，能有效阻断胆固醇合成(人体70％胆固醇由体内合成)，显著降低血清甘油三酯(TG)、胆固醇(TC)、低密度脂蛋白(LDL-C)，升高高密度脂蛋白(HDL-C)，是公认的降血脂药，因动脉粥样硬化高血压主要是由脂质过氧化多因协助引起，为此高血压病的治疗必须降血脂和抗氧化，终止和减轻动脉粥样硬化才能逐渐根治高血压，所以增加红曲是必要的；
②红曲有防治AS和较好的降血压作用，能保护血管内皮细胞，抑制脂质在肝脏沉积，降低血小板聚集和全血黏度，上述作用尤其降血脂作用被定为本发明的第三佐药，协助上述诸药预防动脉粥样硬化的继续发展；
9、车前子：车前子为使药，其性状为：味甘咸，气微寒，无毒。入膀胱、脾、肾三经；
功能：利水通便，清热明目。治疗湿痹，目赤障翳，大小便不通；
药理作用：①降压、利尿、通便。车前草水提醇沉液能抑制Na+K+ATP酶活性，促进水、氯化钠、尿素与尿酸的排泄，显著增加尿量。车前子多糖含有很多亲水基团，能吸水膨胀至几十倍，使粪便松软易排，预防因便秘诱发的急性并发症；
②抗氧化、抗衰老，车前黄酮对羟自由基有清除作用，其抗氧化能力与维生素c相似；车前子多糖(PSP)能稳定内皮细胞膜结构，减少自由基损害和脂质过氧化产物MDA的生成，提高细胞SOD的活力；PSP能增强细胞的增殖活性，抑制OX.LDL的活性；平衡内皮细胞NO的释放和NOS表达，对抗OX.LDL致内皮细胞损伤时ICAM.1表达的增多；下调OX.LDL诱导的内皮细胞损伤凋亡相关基因c-myc、P53的mRNA水平；
③降脂、降糖、减肥等作用。
杜仲可用杜仲叶替代，替代比例是杜仲比杜仲叶2∶3。
所述中药组合物还能添加促进吸收剂、缓释剂和调味剂。
丹参作为君药，杜仲、钩藤、黄连、罗布麻叶作为臣药，天麻、地龙、红曲作为佐药，车前子作为使药，君药丹参用于防治心脑缺血性损伤；臣药杜仲、黄连、钩藤、罗布麻用于发挥扩血管降血压，还可用于防治动脉粥样硬化；佐药天麻、地龙、红曲用于防治动脉粥样硬化的作用，还可用于协助降血压；使药车前子用于降压利尿通便的作用，预防因便秘诱发的急性并发症。
所述中药组合物能用于治疗动脉粥样硬化高血压病，多途径、多层次、多靶点协同防治动脉粥样硬化高血压病，实现综合降血压、抗脂质过氧化、降血脂、调血糖、抗凝、抗炎、逆转减轻动脉粥样硬化的作用。
本发明同现有技术相比，其优点在于：
1、多途径、多层次、多靶点协同防治动脉粥样硬化高血压病；
2、可实现综合降血压、抗脂质过氧化、降血脂、调血糖、抗凝、抗炎、逆转减轻动脉粥样硬化的作用
3、依据药典本发明配方不含有毒中药，适合动脉粥样硬化高血压患者长期服用。
[附图说明] [具体实施方式]
下面对本发明作进一步说明，应当理解，此处所描述的具体实施例仅仅用以解释本发明， 并不用于限定本发明。
本发明为一种治疗动脉粥样硬化高血压病的中药组合物及其应用，该中药组合物包含下列原料按照重量份数配制而成：丹参60～300份、杜仲叶50～280份、钩藤50～260份、黄连10～100份、罗布麻叶50～240份、天麻50～200份、地龙50～200份、红曲6～20份、车前子20～300份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参280份、杜仲叶246份、钩藤230份、黄连80份、罗布麻叶240份、天麻180份、地龙190份、红曲8份、车前子200份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参80份、杜仲叶100份、钩藤60份、黄连10份、罗布麻叶60份、天麻60份、地龙60份、红曲12份、车前子50份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参240份、杜仲叶220份、钩藤220份、黄连50份、罗布麻叶100份、天麻160份、地龙160份、红曲15份、车前子150份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参180份、杜仲叶150份、钩藤80份、黄连60份、罗布麻叶80份、天麻80份、地龙80份、红曲8份、车前子60份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参220份、杜仲叶200份、钩藤260份、黄连50份、罗布麻叶80份、天麻80份、地龙100份、红曲10份、车前子120份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参60份、杜仲叶50份、钩藤50份、黄连10份、罗布麻叶50份、天麻50份、地龙50份、红曲6份、车前子20份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参300份、杜仲叶280份、钩藤260份、黄连100份、罗布麻叶240份、天麻200份、地龙200份、红曲20份、车前子300份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参180份、杜仲叶165份、钩藤145份、黄连55份、罗布麻叶145份、天麻125份、地龙125份、红曲13份、车前子 160份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参280份、杜仲叶246份、钩藤230份、黄连80份、罗布麻叶240份、天麻180份、地龙190份、红曲8份、车前子200份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参80份、杜仲叶100份、钩藤60份、黄连10份、罗布麻叶60份、天麻60份、地龙60份、红曲12份、车前子50份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参240份、杜仲叶220份、钩藤220份、黄连50份、罗布麻叶100份、天麻160份、地龙160份、红曲15份、车前子150份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参180份、杜仲叶150份、钩藤80份、黄连60份、罗布麻叶80份、天麻80份、地龙80份、红曲8份、车前子60份。
所述中药组合物可采用下列原料按照重量份数配制而成：丹参220份、杜仲叶200份、钩藤240份、黄连50份、罗布麻叶80份、天麻80份、地龙100份、红曲10份、车前子120份。
以下结合具体实施例对本发明中的施工技术方案进行进一步说明。
实验例一：大鼠降血压实验
采用北京维通SHR(自发性高血压大鼠)24只，随机分为四组，分别为SHR模型组、服本发明组、服硝苯地平组、服活血潜阳颗粒组，用上海无创尾动脉血压检测仪动态检测服药后1周、2周、4周SHR的收缩压。结果显示：服本发明组对SHR收缩压和舒张压有显著性降低作用，其降压作用略小于SHR服硝苯地平组，明显优于服活血潜阳颗粒组，三组与SHR模型组比较，p＜0.05。
实验例二：大鼠离体血管环Ach血管最大舒张率实验(见表1)
表1：大鼠离体血管环Ach血管最大舒张率实验
序号 分组 n AChEmax(％) AChEC50(μM)
1 空白对照组 8 95.43±12.61# 0.28±0.04#
2 模型组 8 52.32±14.63* 2.48±0.15*
3 通心络组 8 71.34±17.65*# 1.89±0.24*#
4 本发明组 8 74.49±16.09*# 1.46±0.22*#
注：*与空白对照组比较，P＜0.05；#模型组比较，P＜0.05。
实验结果提示：通心络组、本发明组与模型组相比均有显著性差异，其中以本发明组大鼠离体血管环Ach血管最大舒张率实验效果最佳。
实验例三
人体试验：临床降血压试验：8月份选取高血压病人29例，对照组服硝苯地平缓释片每次5～10mg，每天2次；本发明组服本发明胶囊制剂，每次3～4粒，每天3次；试验组是对照组加服本发明胶囊制剂。用药前和8周后检测血压，结果本发明组有显著的降血压效果，接近对照组——硝苯地平缓释片组；本发明胶囊制剂与硝苯地平缓释片联合应用，又明显优于对照组和单纯应用本发明胶囊制剂组(详见表2)。
表2 三组高血压患者治疗效果对对比(
Figure PCTCN2017107740-appb-000001
mmHg)
Figure PCTCN2017107740-appb-000002
注：各组治疗前收缩压和舒张压之间无显著性差异；*是治疗8周后与治疗前对比，p＜0.05；#是试验组分别与对照组、本发明组对比，p＜0.05。
提示：(1)本发明有较好的降血压作用，其作用接近西药硝苯地平，但无硝苯地平的副作用；(2)本发明与硝苯地平联用可提升治疗效果，长期治疗可以减小硝苯地平的剂量，减少硝苯地平的副作用。
病例1：金某，男，44岁，高血压病6年，长期用西药治疗，血压越治越高，头疼、头 晕，影响工作，感到恐慌，于2016年8月开始服用本发明胶囊制剂，每次4粒，每天三次，三天后血压逐渐趋于稳定和下降，头疼、头晕症状消失，不影响工作，至今仍坚持服用，感觉头部和全身轻松很多。
病例2：吕某某，男，65岁，高血压10余年，2015年12月～2016年5月三次发生脑血管痉挛住院治疗，用代文等降压都不能很地控制血压，病人经常头昏、头胀，心理负担很重，2016年6月开始加服本发明胶囊制剂，每次4粒，每天三次，两三天就感到头脑轻松，偏瘫体征也也有所改善，现仍继续服用。
病例3：原某某，女，76岁，有近30年高血压病史，长期服用降血压药物，使血压基本维持正常。2016年4月突感头晕、头昏，血压升高到176mmHg/110mmHg，开始加服本发明胶囊制剂，每次4粒，每天三次，使血压稳定，略高于正常，患者感到头脑和全身轻松，精神状态良好，至今仍继续服用。
病例4：赵某，男，39岁，身高173cm，体重97kg，患高血压2年，糖尿病1年，因无明显不适症状，未进行治疗，2016年9月下旬突然出现头晕、头疼、耳鸣，测量血压172mmHg/94mmHg，开始服本发明胶囊制剂，每次4粒，每天三次，血压缓慢下降，现略高于正常，血糖也有所好转，无明显不适症状，仍继续服用本发明，并控制饮食。

Claims (10)

  1. 一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于包含下列原料按照重量份数配制而成：丹参60～300份、杜仲叶50～280份、钩藤50～260份、黄连10～100份、罗布麻叶50～240份、天麻50～200份、地龙50～200份、红曲6～20份、车前子20～300份。
  2. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述组合物采用下列原料按照重量份数配制而成：丹参280份、杜仲叶246份、钩藤230份、黄连80份、罗布麻叶240份、天麻180份、地龙190份、红曲8份、车前子200份。
  3. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述组合物采用下列原料按照重量份数配制而成：丹参80份、杜仲叶100份、钩藤60份、黄连10份、罗布麻叶60份、天麻60份、地龙60份、红曲12份、车前子50份。
  4. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述组合物采用下列原料按照重量份数配制而成：丹参240份、杜仲叶220份、钩藤220份、黄连50份、罗布麻叶100份、天麻160份、地龙160份、红曲15份、车前子150份。
  5. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述组合物采用下列原料按照重量份数配制而成：丹参180份、杜仲叶150份、钩藤80份、黄连60份、罗布麻叶80份、天麻80份、地龙80份、红曲8份、车前子60份。
  6. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述组合物采用下列原料按照重量份数配制而成：丹参220份、杜仲叶200份、钩藤260份、黄连50份、罗布麻叶80份、天麻80份、地龙100份、红曲10份、车前子120份。
  7. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于杜仲能用杜仲叶替代，替代比例是杜仲比杜仲叶2∶3。
  8. 如权利要求1所述的一种治疗动脉粥样硬化高血压病的中药组合物，其特征在于所述中药组合物还能添加促进吸收剂、缓释剂和调味剂。
  9. 如权利要求1所述的治疗动脉粥样硬化高血压病的中药组合物，其特征在于丹参作为君药，杜仲、钩藤、黄连、罗布麻叶作为臣药，天麻、地龙、红曲作为佐药，车前子作为 使药，君药丹参用于防治心脑缺血性损伤；臣药杜仲、黄连、钩藤、罗布麻用于发挥扩血管降血压，还可用于防治动脉粥样硬化；佐药天麻、地龙、红曲用于防治动脉粥样硬化的作用，还可用于协助降血压；使药车前子用于降压利尿通便的作用，预防因便秘诱发的急性并发症。
  10. 一种采用如权利要求1-6任一所述的中药组合物的应用，其特征在于所述中药组合物能用于治疗动脉粥样硬化高血压病，多途径、多层次、多靶点协同防治动脉粥样硬化高血压病，实现综合降血压、抗脂质过氧化、降血脂、调血糖、抗凝、抗炎、逆转减轻动脉粥样硬化的作用。
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