WO2021022466A1 - 一种治疗因真菌深部感染导致中风的药品 - Google Patents

一种治疗因真菌深部感染导致中风的药品 Download PDF

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WO2021022466A1
WO2021022466A1 PCT/CN2019/099352 CN2019099352W WO2021022466A1 WO 2021022466 A1 WO2021022466 A1 WO 2021022466A1 CN 2019099352 W CN2019099352 W CN 2019099352W WO 2021022466 A1 WO2021022466 A1 WO 2021022466A1
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alkaloids
volatile oil
grams
medicine
weight
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French (fr)
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肖鸣春
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肖鸣春
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Priority to PCT/CN2019/099352 priority Critical patent/WO2021022466A1/zh
Priority to US17/632,865 priority patent/US20220280588A1/en
Publication of WO2021022466A1 publication Critical patent/WO2021022466A1/zh

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/30—Animal feeding-stuffs from material of plant origin, e.g. roots, seeds or hay; from material of fungal origin, e.g. mushrooms
    • 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
    • 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
    • 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
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • 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
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • 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)
    • A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/264—Aristolochia (Dutchman's pipe)
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
    • 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
    • A61K36/484—Glycyrrhiza (licorice)
    • 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)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
    • 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
    • A61K36/714—Aconitum (monkshood)
    • 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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A61K36/8888—Pinellia
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • 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
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Definitions

  • the invention created by the invention belongs to the field of medical and health care, and relates to the new application of the addition and subtraction of "Banxia Baizhu Tianma Decoction" in the preparation of medicines or health products for the treatment of stroke caused by deep infection of fungi, and specifically relates to the plant raw material medicines Tianma, Pinellia, Atractylodes, Poria
  • Superficial mycosis refers to infection of skin keratin tissues (including stratum corneum, nail plate, hair, etc.). Deep mycosis is also called invasive mycosis (IFD), which refers to fungal infectious diseases caused by fungi invading human subcutaneous mucosal tissues, blood and internal organs.
  • IFD invasive mycosis
  • Candida and Aspergillus and others such as Cryptococcus, Mucor and Pneumocystis.
  • GFFI Global Fungal Infection Action Foundation
  • Cryptococcus neoformans is mainly inhaled through the respiratory tract.
  • the first part of infection may be the lungs. From the lungs, it can spread to other parts of the body, including the skin, bones, and heart. The most vulnerable is the central nervous system, causing chronic meningitis.
  • Stroke is a cerebrovascular disease, a group of diseases of vascular-derived brain damage, commonly known as stroke.
  • the world-renowned medical journal "The Lancet” published a large-scale paper on China's public health research on June 24, 2019, which analyzed the mortality rate of Chinese people from 1990 to 2017 and the mortality rate of specific diseases.
  • the study identified the top ten death causes of Chinese in 2017 among 282 causes of death, and stroke became the number one cause of death for Chinese.
  • the weekly magazine New England Journal of Medicine published a paper describing the risk of stroke and death in different regions of the world, using GBD data.
  • This research focuses on the first stroke, including ischemic, which is due to blocked blood vessels to the brain, and hemorrhagic, which is due to fragile blood vessel rupture.
  • cerebrovascular diseases can be divided into two categories, namely ischemic and hemorrhagic.
  • Ischemia includes: transient ischemic attack, cerebral infarction (cerebral thrombosis, cerebral embolism, lacunar cerebral infarction).
  • Hemorrhagic cerebral hemorrhage, subarachnoid hemorrhage.
  • some people classify mixed strokes (hemorrhage and ischemic lesions at the same time or successively) as a single category.
  • the pathogenesis of stroke is not clear in the medical community.
  • the microembolism of the small blood vessel caused by the microembolism of the cervical aortic wall atherosclerosis may be the most common cause.
  • the cerebrovascular does not contract, and the cerebral blood flow not only does not decrease but increases significantly.
  • This kind of overperfusion under the action of hypertension leads to increased capillary pressure and capillary destruction, which can cause severe cerebral edema and hemorrhage.
  • the application of any vasodilator at this time is obviously harmful and unhelpful.
  • the clinical manifestations of stroke show different symptoms due to different vascular lesions.
  • the main clinical manifestations of ischemic stroke are sudden fainting, hemiplegia (hemiplegia), partial numbness, crooked tongue, blindness in one eye on the same side, slurred speech, and limbs Ataxia, blurred vision in both eyes.
  • Cerebral thrombosis tends to occur in patients over 50 years of age with cerebral arteriosclerosis, usually accompanied by a history of hypertension, diabetes, and heart disease. Some patients develop it during sleep. Severe cerebral embolism may suddenly coma, high fever, increased intracranial pressure, edema, brain herniation and death.
  • the most common hemorrhagic stroke is hypertension with arteriosclerosis, arteriovenous malformations or aneurysm rupture, cerebral arterial inflammatory vessel wall necrosis, etc.
  • the clinical symptoms are related to the location and amount of bleeding. There are clinical symptoms such as headache, dizziness, limb weakness, hemiplegia, disturbance of consciousness, cerebral edema, and coma.
  • the Sanyin meridian of the hand is: the lung meridian of hand Taiyin, the pericardium meridian of hand Jueyin, and the heart meridian of hand Shaoyin.
  • the Three Yang Meridians of Hand are: Hand Yangming Large Intestine Meridian, Hand Shaoyang Sanjiao Meridian, Hand Sun Small Intestine Meridian.
  • the Three Yang Meridians of the Foot are: the Stomach Meridian of Foot Yangming, the Gallbladder Meridian of Foot Shaoyang, and the Bladder Meridian of Foot Sun.
  • the three-yin meridians of the foot are: the spleen meridian of the foot Taiyin, the liver meridian of the foot jueyin, and the kidney meridian of the foot shaoyin.
  • the walking direction of the twelve meridians and the rule of handover the three yin meridians of the hand move from the chest to the hand and the three yang meridians of the hand, the three yang meridians of the hand move from the hand to the head and the three yang meridians of the foot, and the three yang meridians of the foot move from the head to the foot and the feet
  • the Sanyin meridian, the Sanyin meridian of the foot moves from the foot to the abdomen, and the chest is crossed to the Sanyin meridian of the hand.
  • the yin meridian and yang meridian intersect at the extremities
  • the yang meridian and yang meridian intersect at the head
  • the yin meridian and yin meridian intersect at the chest.
  • the relationship between the exterior and interior is: Lung Meridian-Large Intestine Meridian, Spleen Meridian-Stomach Meridian, Heart Meridian-Small Intestine Meridian, Kidney Meridian-Bladder Meridian, Pericardium Meridian-Triple Jiao Meridian, Liver Meridian-Gallbladder Meridian.
  • Alkaloids are one of the important effective ingredients in botanicals. There are many known types of alkaloids, and their structures are relatively complex. Based on the biogenic relationship of alkaloids combined with chemical classification, alkaloids are divided into 25 categories, such as: pyrroles, Tropines, pyrrolizidine, piperidines, lycosine, indolizidine, quinolizidine, acridinones, amphetamines, tetrahydroisoquinolines, spitroot Alkaloids, quinolines, peptides, terpenoid alkaloids, etc.
  • Alkaloids are mostly alkaline, and most of the alkaloids are crystalline. Alkaloids are all nitrogen-containing organic compounds, most of which have complex ring structures. Nitrogen is mostly contained in the ring. The strength of alkalinity is related to the structure type of alkaloids. Many researchers have discovered that alkaloids have many pharmacological activities, including anti-tumor, anti-viral, anti-inflammatory, antibacterial, analgesic, liver protection, cardiovascular effects and many other aspects.
  • morphine obtained from opium has a strong analgesic effect
  • codeine has an antitussive effect
  • papaverine has a smooth muscle relaxation effect
  • ephedrine in ephedra has an anti-asthmatic effect
  • berberine in berberine and berberine has antibacterial effects Function
  • Hyoscyamine in Datura, Hyoscyamus, Belladonna has antispasmodic effects and so on.
  • the pharmacological mechanism of the anti-tumor, anti-viral, anti-inflammatory, anti-bacterial, analgesic, liver protection, and cardiovascular effects of alkaloids in the medical field has not been fully studied. There has also been no report in the literature that alkaloids have the effect of treating deep fungal infections or treating strokes caused by fungal infections.
  • the extraction method of alkaloids can be determined after extraction with organic solvents based on the characteristics of alkaloid salts that are soluble in water but insoluble in water. Alkaloids are mostly soluble in organic solvents such as methanol, ethanol, ether, and chloroform, but are generally insoluble or hardly soluble in water. Based on this characteristic, different solvents can be used to extract alkaloids from plants. Commonly used methods are cold soaking, percolation, ultrasonic, Soxhlet extraction, and hot reflux extraction.
  • the supercritical fluid extraction method has high extraction efficiency, high purity, mild conditions, no pollution, and can change the temperature and pressure.
  • Volatile oil is a class of ingredients with important pharmacological effects in Chinese medicine and plants. Volatile oil is a general term for a kind of oily liquid in plants that has an aromatic odor and can volatile at room temperature. It is widely distributed in the plant kingdom, especially Compositae, Rutaceae, Umbelliferae, Lamiaceae, Lauraceae, Magnoliaceae, Zingiberaceae and other plants. Volatile oil is mainly composed of terpenoids and aromatic compounds and their oxygen-containing derivatives such as alcohols, aldehydes, ketones, phenols, ethers, lactones, etc., in addition to nitrogen-containing and sulfur-containing compounds.
  • volatile oil has anti-inflammatory, anti-allergic, anti-microbial, anti-mutation and anti-cancer, anthelmintic effects, enzyme inhibitory effects, effects on the central nervous system, and effects on the respiratory system.
  • the understanding and research on the active mechanism or pharmacological mechanism of volatile oil is still very limited.
  • volatile oil has the effect of treating deep fungal infections or treating strokes caused by fungal infections.
  • the extraction method of volatile oil can choose different extraction methods, such as 1. Steam distillation method: the extraction using the volatile and water-immiscible nature of volatile oil. 2. Organic solvent extraction method: use petroleum ether, ether and other organic solvents to use continuous reflux extraction method or cold soak method for extraction. 3. Supercritical fluid extraction method uses carbon dioxide supercritical fluid to extract volatile oil. 4. The cold pressing method is suitable for the extraction of fresh plants with high oil content.
  • Banxia Baizhu Tianma Decoction is a common prescription for treating wind, phlegm, dizziness and headache.
  • Sun Liting used Banxia Baizhu Tianma Decoction plus Changpu and Yujin as basic prescriptions, and treated 40 cases of vertigo (9 cases of hypertension, 14 cases of cerebral arteriosclerosis, and 11 cases of vertebrobasilar arterial insufficiency) by the method of TCM syndrome differentiation plus water decoction , 3 cases of cervical spondylosis, 3 cases of Meniere's disease). Results: 19 cases were cured, 14 cases were markedly effective, 5 cases were effective, and 2 cases were ineffective. [Heilongjiang Traditional Chinese Medicine, 1998].
  • Pinellia is a "warm and cold phlegm medicine”. Efficacy: dry dampness and resolve phlegm, reduce adverse effects and relieve vomiting, eliminate pimple and dispel congestion, reduce swelling and pain for external use, treat wet phlegm and cold phlegm syndrome.
  • Pinellia contains volatile oil, alkaloids and a variety of chemical components. Its alkaloids have anti-tumor effects.
  • Pinellia alcohol extract has broad-spectrum antibacterial activity and has a certain effect on fungus inhibition.
  • pinellia alkaloids and volatile oil have the effect of treating stroke caused by deep fungal infection or having thrombolytic effect.
  • Atractylodes macrocephala is a qi-supplementing medicine. Modern research Atractylodes macrocephala contains volatile oil, which has a calming effect. However, there have been no reports about the use of Atractylodes macrocephala alkaloids and volatile oils for the treatment of stroke caused by deep fungal infections or thrombolytic effects.
  • Gastrodia elata is a medicine for treating headaches, numbness of limbs, rheumatism and arthralgia. Modern research has found that the volatile oil of Gastrodia elata has a significant inhibitory effect on Aspergillus oryzae and Aspergillus flavus. The volatile oil of Gastrodia elata has a significant antitussive effect. And good expectorant effect. However, there have been no reports about the use of Gastrodia alkaloids and volatile oils for the treatment of stroke caused by deep fungal infections or thrombolytic effects.
  • Poria cocos is a diuresis and anti-tumor medicine. Modern research Poria cocos decoction, alcohol extract, and ether extract have diuretic, sedative, anti-tumor, and hypoglycemic effects. However, there have been no reports about the use of tuckahoe alkaloids and volatile oils in the treatment of stroke caused by deep fungal infections or thrombolytic effects.
  • Fresh orange peel is a qi-regulating medicine. Modern researches on its volatile frying agent can expand the trachea, and its volatile oil has stimulating and expectorant effects. However, there have been no reports about the use of alkaloids and volatile oils from fresh orange peels to treat strokes caused by deep fungal infections or have thrombolytic effects.
  • Licorice is a qi-tonifying medicine, and modern researches contain chemical ingredients such as alkaloids and polysaccharides.
  • alkaloids and polysaccharides there have been no reports about the use of licorice alkaloids and volatile oils for the treatment of stroke caused by deep fungal infections or thrombolytic effects.
  • the purpose of the present invention is to provide a medicine for the treatment of stroke caused by deep fungal infection, specifically to provide the plant raw materials in "Banxia Baizhu Tianma Decoction" contained in Gastrodia, Pinellia, Atractylodes, Poria, Fresh Orange Peel, and Licorice
  • "Banxia Baizhu Tianma Decoction” contained in Gastrodia, Pinellia, Atractylodes, Poria, Fresh Orange Peel, and Licorice
  • the new use of chemical component alkaloids and (or) volatile oil in preparing medicines or health products for treating stroke caused by fungal deep infection.
  • the drug for treating stroke caused by deep fungal infection is characterized in that the raw material of the drug is alkaloids and (or) volatile oil extracted from Gastrodia elata, and alkaloids and (or) volatile oil extracted from Pinellia ternata , Alkaloids extracted from Atractylodes macrocephala and (or) volatile oil, alkaloids extracted from Poria cocos and (or) volatile oil, alkaloids extracted from fresh orange peel and (or) volatile oil, alkaloids extracted from licorice and (or) volatile oil.
  • the medicine preparation method 1 is: take gastrodia elata alkaloids, pinellia alkaloids, atractylodes alkaloids, poria cocos alkaloids, fresh orange peel alkaloids, and licorice alkaloids and mix them in a certain proportion, and add various routines required when preparing different dosage forms Excipients are prepared into pharmaceutically acceptable dosage forms.
  • the medicine preparation method 2 is: take the essential oil of Gastrodia elata, the essential oil of Pinellia ternata, the essential oil of Atractylodes macrocephala, the essential oil of Poria cocos, the essential oil of fresh orange peel, the essential oil of licorice are mixed in a certain proportion, add various conventional auxiliary materials required when preparing different dosage forms, and prepare into pharmacy. Acceptable dosage form.
  • the medicine preparation method 3 is: take gastrodia elata and volatile oil, pinellia alkaloid and volatile oil, atractylodes alkaloid and volatile oil, tuckahoe alkaloid and volatile oil, fresh orange peel alkaloid and volatile oil, licorice alkaloid and volatile oil and mix in a certain proportion , Adding various conventional auxiliary materials required when preparing different dosage forms to prepare pharmaceutically acceptable dosage forms.
  • the preparation method and the extraction method of alkaloids can be determined after extraction with organic solvents, and different solvents are used to extract alkaloids from the plants Gastrodia elata, Pinellia ternata, Atractylodes macrocephala, Poria cocos, fresh orange peel, and licorice.
  • the first choice is supercritical fluid extraction, followed by membrane separation or ultrasonic extraction or Soxhlet extraction.
  • the supercritical fluid extraction method is the first choice for the volatile oil of Gastrodia, Pinellia, Atractylodes, Poria, and Licorice, followed by the organic solvent extraction method: use petroleum ether, ether and other organic solvents to use continuous reflux extraction or cold soaking, or water vapor Distillation method; cold pressing method is preferred for fresh orange peel.
  • the medicine provided by the present invention is characterized in that the weight parts of the raw material drug alkaloids of the medicine are: 0.01-50 parts by weight of gastrodia alkaloids, 0.01-50 parts by weight of pinellia alkaloids, and 0.01-50 parts by weight of Atractylodes alkaloids Parts by weight, tuckahoe alkaloids 0.01-50 parts by weight, fresh orange peel alkaloids 0.01-50 parts by weight, and licorice alkaloids 0.01-50 parts by weight.
  • the medicine provided by the present invention is characterized in that the parts by weight of the volatile oil of the raw material of the medicine are: 0.01-50 parts by weight of the essential oil of Gastrodia, 0.01-50 parts by weight of the essential oil of Pinellia ternata, 0.01-50 parts by weight of the essential oil of Atractylodes macrocephala, and Poria cocos
  • the volatile oil is 0.01-50 parts by weight
  • the fresh orange peel volatile oil is 0.01-50 parts by weight
  • the licorice volatile oil is 0.01-50 parts by weight.
  • the medicine provided by the present invention is characterized in that the dosage of the medicine to be taken in a day is further preferably: taking the weight of the alkaloid and volatile oil contained in 50 grams of Gastrodia elata, and the weight of the alkaloid and volatile oil contained in 35 grams of Pinellia tuber Weight, the weight of alkaloids and volatile oil contained in 30 grams of Atractylodes macrocephala, the weight of alkaloids and volatile oil contained in 30 grams of Poria cocos, the weight of alkaloids and volatile oil contained in 40 grams of fresh orange peel, and the biological content contained in 25 grams of licorice The weight of alkali and essential oil.
  • Specific preparation method Take 500 grams of Gastrodia elata, 350 grams of Pinellia ternata, 300 grams of Atractylodes macrocephala, 300 grams of Poria cocos, 400 grams of fresh orange peel, and 250 grams of licorice in the amount taken for 10 days, and then extract the respective alkaloids and volatile oils.
  • the extracted various alkaloids are mixed, and various conventional auxiliary materials required for preparing different dosage forms are added to prepare a pharmaceutically acceptable dosage form; the various extracted volatile oils are mixed, and various conventional auxiliary materials required for preparing different dosage forms are added , Prepared into a pharmaceutically acceptable dosage form.
  • the medicine is characterized in that the medicine can selectively increase the alkaloids and/or volatile oil contained in the raw materials Uncaria, Chuanxiong, Chuanwu, Xungufeng and Qingfengteng according to clinical symptoms.
  • the medicine is characterized in that the preparation method of the medicine is: extracting alkaloids and/or volatile oil from various plant raw materials of Gastrodia, Pinellia, Atractylodes, Poria, fresh orange peel, and licorice to prepare the medicine,
  • the pharmaceutically acceptable dosage forms such as tablets, powder injections, soft capsules, granules or capsules are prepared by conventional chemical preparation methods.
  • the medicine is characterized in that the preparation method of the medicine is: from each plant raw material medicine Gastrodia, Pinellia, Atractylodes, Poria, fresh orange peel, licorice or Uncaria or Chuanxiong or Chuanwu or Xungufeng or Alkaloids and/or volatile oils are extracted from Caulis Caulis sinensis to prepare medicines, which are made into pharmaceutically acceptable dosage forms such as tablets, powder injections, soft capsules, granules or capsules by conventional chemical preparation methods.
  • the medicines or health products for treating stroke caused by deep fungal infections are suitable for applications in medical drugs, health foods, health supplies, animal medicines, and animal feeds.
  • the pharmacology of various raw materials of the medicine provided by the present invention is:
  • Atherosclerosis of the cervical aorta is mainly a chronic inflammatory reaction caused by fungi.
  • the fungus reproduces on the damaged arterial wall, and the shed hyphal masses form micro emboli to block the blood circulation of small veins or arterioles. Cerebral hemorrhage and stroke are prone to occur at night because the fungus that stays on the head multiplies in large numbers at night when the patient’s body temperature is relatively low and the blood flow rate is slow, which accelerates the corrosion of cerebral blood vessels and forms more mycelial clusters.
  • the obstruction of blood circulation in the head causes the body’s autoimmune reaction to cause high blood pressure.
  • High blood pressure is equivalent to the principle of a water pump. Pressure can make blood flow up to the brain. Intracranial high pressure causes emboli formed by fungi to block blood vessels or rupture. Blood vessels cause stroke. Therefore, the applicant believes that the main pathogenic factors of hypertension and stroke are caused by fungal infection of blood vessels in the brain. Therefore, the treatment principle of stroke is the treatment of anti-deep fungal infection.
  • Gastrodia is a medicine for dispelling wind and relieving spasm, and belongs to the liver meridian. Because fungi can cause disseminated blood infections, and because of the slow blood flow in the veins, there is no oxygen, the fungi are more likely to stay and multiply in the veins, and the shed spore clusters are more likely to block the small veins. The applicant believes that the liver meridian comes from the hepatic portal vein system, so the liver meridian is the vein most susceptible to fungal infection.
  • the circulation path of the liver meridian as: starting from the big toe, going up to the liver vein through the inner front edge of the calf, and then going up the throat into the nasopharynx, the upper link system, crossing the governor channel at the top of the head, and the branches of the liver meridian It separates from the liver and connects with the pulmonary veins. Therefore, the liver meridian is an important group of veins that go up from the foot to the top of the head.
  • the lower limbs of the liver meridian are similar to the small saphenous vein in modern medicine.
  • the brain is also a place where fungi tend to stay, and the blood circulation of the eye is equivalent to the end microcirculation of the brain, and the end of the liver meridian is in the eye. Therefore, the disease of the liver meridian is the first disease of the eye. Symptoms such as increased intraocular pressure, cataracts, and blindness. The main pathology of stroke is damage to the cerebral blood vessels. Due to the blood-brain barrier, many drugs cannot enter the brain. Gastrodia can pass through the blood-brain barrier. It is an antifungal drug targeted to treat the brain. Therefore, the alkaloids of Gastrodia And volatile oil can treat antifungal infections of the liver and veins, especially for the treatment of brain blood vessels and upper respiratory tract. It can kill fungi and decompose fungal spores, and has a thrombolytic effect. Among the medicines provided by the present invention, the alkaloids and volatile oils of Gastrodia are the master medicine.
  • Pinellia is a "warm and cold phlegm medicine”.
  • the medicine is pungent and warm, and it belongs to the spleen, stomach and lung meridians. Indications of damp phlegm and cold phlegm syndrome.
  • fungi can cause systemic disseminated infection through blood circulation
  • the spleen meridian and lung meridians are important veins
  • the stomach meridian is the artery that accompanies the spleen meridian, so the spleen, stomach, and lung meridians are also susceptible to fungal infections.
  • the applicant believes that the spleen meridian originates from the splenic portal vein.
  • the circulatory path of the spleen meridian as: starting from the inner end of the big toe, entering the abdominal spleen along the front edge of the inner thigh, and then ascending to the tongue.
  • the branches run from the stomach to the chest and connect to the heart veins.
  • the veins of the lower limbs of the spleen are similar to the great saphenous vein in modern medicine.
  • the circulation path of the stomach meridian is: starting from the nose, connecting upward to the bladder meridian, from the pupil directly to the mouth, in front of the ear, and in front of the forehead. To the groin, go down the outer end of the middle toe along the front of the lower limbs to connect the spleen meridian.
  • the lower limb segment of the stomach meridian is similar to the anterior tibial artery in modern medicine.
  • the circulation path of the lung meridian is: starting from the middle of the lungs, going up to the throat, passing through the upper part of the chest to the front edge of the upper limbs, and ending at the radial end of the thumb.
  • the lung meridian comes from the pulmonary vein system, and the upper limbs of the lung meridian are similar to the cephalic vein in modern medicine.
  • Clinical Symptoms of Stroke The crooked tongue corresponds to the tongue at the end of the spleen meridian and the throat of the lung meridian.
  • the clinical symptoms of stroke are hemiplegia and numbness of the limbs, which are caused by the obstruction of the blood circulation of the upper and lower limbs.
  • the blood circulation of the hands and feet corresponding to the twelve meridians is very rich in capillaries. There are many small veins and small arteries, especially The blood circulation of the lower limbs is most likely to block the microcirculation by emboli formed by the shed fungal spore clusters. Varicose veins of the lower limbs are also caused by the same reason.
  • the acupuncture points on the twelve meridians are the places where fungal spores tend to stay and multiply to form thrombi. I think that the shed fungal spore masses usually embolize small veins and then to small arteries.
  • the microcirculation has many collateral circulations, the clinical symptoms are not obvious, but when it embolizes large veins or large arteries, it appears obvious
  • myocardial infarction occurs when it travels to the heart with the blood circulation and blocks the large arteries or veins of the heart
  • pulmonary infarction occurs when it travels to the lungs and blocks the large veins or arteries of the lungs.
  • a cerebral infarction occurs when the brain blocks the large arteries of the brain. Especially when a large artery is embolized, it can cause life-threatening.
  • the alkaloids and volatile oil of Pinellia ternata can target the treatment of fungal infections in the blood of the lung, spleen, and stomach channels, kill fungi and decompose fungal spore clusters, and have a thrombolytic effect. Cooperate with Gastrodia targeted therapy for fungal infections in the liver meridian.
  • the alkaloids and volatile oil of Pinellia ternata and the alkaloids and volatile oil of gastrodia elata compose the master medicine.
  • Atractylodes macrocephala is a medicine for invigorating qi, which belongs to the spleen and stomach channels.
  • Traditional Chinese medicine believes that "spleen deficiency produces phlegm and dampness" means that the fungus invades the blood vessels of the liver and causes disseminated blood infection. After the lung infection, the lung inflammation is formed, and a large amount of sputum is irritating to block the respiratory tract, causing difficulty in the exchange of oxygen and carbon dioxide.
  • “Qi deficiency” means hypoxia.
  • the qi-tonifying medicine Baizhu and the qi-regulating medicine “fresh orange peel” can promote the exchange of oxygen and carbon dioxide in the blood.
  • Fresh orange peel belongs to the spleen meridian and lung meridian. Therefore, the alkaloids and volatile oils of Atractylodes macrocephala and fresh orange peel are minister medicines in the technical scheme provided by the present invention, which assists Pinellia ternata to dredge the blood circulation of the lung meridians, spleen meridians, and stomach meridians. The role of thrombolysis.
  • Poria is a diuresis and swelling medicine. It is the main medicine for strengthening the spleen and removing dampness.
  • the heart meridian is a vein, starting from the heart and ending at the outer end of the ring finger, that is, the heart meridian comes from the superior vena cava opening similar to modern medicine.
  • the upper limb veins are similar to expensive veins.
  • the kidney meridian comes from the renal portal vein system.
  • the kidney meridian starts from the little toe of the foot, enters the lungs, enters the chest, and is connected to the heart meridian.
  • the veins of the lower limbs are similar to the deep foot veins in modern medicine.
  • the fungus infects the brain, causing inflammation and edema.
  • Poria diuresis and swelling. Therefore, the alkaloids and volatile oil of Poria are targeted treatments for fungal infections in the heart, spleen, and kidney channels.
  • Assist Gastrodia, Pinellia and Atractylodes macrocephala to enhance the exchange of oxygen and carbon dioxide, dredge the blood circulation of the heart, spleen, and kidney channels, and have a thrombolytic effect.
  • Licorice and Atractylodes are both invigorating Qi medicine, and licorice returns to the heart, lung, spleen and stomach meridians. It has the effect of relieving cough and expectorating, and also has the effect of reconciling medicine.
  • the alkaloids and volatile oil of licorice can help Atractylodes macrocephala to enhance the exchange of oxygen and carbon dioxide in the blood, can dredge the blood circulation of the heart, lung, spleen, and stomach meridians, and has a thrombolytic effect.
  • Uncaria and Gastrodia are both anti-wind and antispasmodic drugs, which belong to the liver and pericardium channels.
  • the pericardium meridian starts in the chest and ends at the middle finger, which is equivalent to the median elbow vein. Therefore, the alkaloids and volatile oils of Uncaria can assist Gastrodia elata through blood circulation, lower blood pressure, and have thrombolytic effect.
  • Modern medicine proves that its alkaloid has the effect of lowering blood pressure, but there is no relevant report that its alkaloid has an antifungal effect.
  • Chuanxiong is a medicine for promoting blood circulation and removing stasis, which belongs to the liver, gallbladder and pericardium meridians.
  • the gallbladder meridian is an artery.
  • the gallbladder meridian originates from the eyes and ends at the big toe. It is an artery that accompanies the liver meridian. Therefore, the alkaloids and volatile oil of Ligusticum chuanxiong can relax the blood circulation of the liver, gallbladder, and pericardium, and have a thrombolytic effect. It can be optionally used in the medicines provided by the present invention to assist the gastrodialysis to improve blood circulation.
  • Chuanwu is a medicine for dispelling wind, cold and dampness, and has the meridians of the heart, liver, kidney and spleen.
  • Contains a variety of alkaloids has obvious anti-inflammatory and analgesic effects. It can be used selectively when there are symptoms of severe stroke. Its alkalinity is relatively strong, and too large a dose can easily cause toxic reactions.
  • the alkaloids and volatile oil of Radix Rhizoma Polygoni can assist the blood circulation of gastrodia elata, Pinellia Shutongxin, liver, kidney, and spleen. It can kill fungi and decompose fungal spores, and has a thrombolytic effect.
  • Xungufeng is also a medicine for dispelling wind, cold and dampness, and it belongs to the liver meridian.
  • the alkaloids contained in Xungufeng have a significant effect on reducing swelling in rats with arthritis.
  • the medicine provided by the present invention can selectively increase Xungufeng and Xungufeng's alkaloids when lower limb edema caused by varicose veins or embolism occurs. And volatile oil to help Gastrodia unblock the blood circulation of the liver through the lower extremities, with thrombolytic effect.
  • Qingfengteng is also a medicine for dispelling wind, cold and dampness. It returns to the liver and spleen meridians and has a strong meridian effect.
  • Sinomenine has anti-inflammatory, analgesic, sedative and antitussive effects, and has obvious and antagonistic effects on arrhythmia.
  • the total alkaloids of Sinomenium have a rapid and powerful antihypertensive effect.
  • the anti-inflammatory mechanism of Qingfengteng in the prior art is not fully understood.
  • the alkaloids and volatile oils of Bone-seeking Wind and Caulis Caulis can be selectively increased to assist the alkaloids and volatile oils of Gastrodia and Pinellia to dredge the liver and spleen Blood circulation through the lower extremities has a thrombolytic effect and eliminates inflammation and edema caused by fungi.
  • composition of the raw materials of the medicine for the treatment of stroke caused by deep fungal infections of this embodiment the alkaloids contained in 50 grams of gastrodia, the alkaloids contained in 35 grams of Pinellia tuber, the alkaloids contained in 30 grams of Atractylodes macrocephala, Poria cocos 30 Alkaloids contained in gram, 40 grams of fresh orange peel, and 25 grams of licorice.
  • composition of the raw material medicine of the medicine for the treatment of stroke caused by deep fungal infection of this embodiment volatile oil contained in 50 grams of Gastrodia, volatile oil contained in 35 grams of Pinellia ternata, volatile oil contained in 30 grams of Atractylodes macrocephala, and 30 grams of Poria cocos The volatile oil contained in 40 grams of fresh orange peel, and the volatile oil contained in 25 grams of licorice.
  • the selected raw materials use supercritical fluid extraction or organic solvent extraction to extract volatile oil from 50 grams of Gastrodia elata, 35 grams of Pinellia ternata, 30 grams of Atractylodes macrocephala, 30 grams of Poria cocos, 25 grams of licorice, and 40 grams of fresh orange peel.
  • the volatile oil is extracted by cold pressing, then the respective volatile oils are mixed, conventional auxiliary materials are added, and soft capsules or granules are made according to the conventional chemical preparation process.
  • the composition of the raw material medicine of the medicine used to treat stroke caused by deep fungal infection of this embodiment the alkaloid contained in 30 grams of Gastrodia, the alkaloid contained in 30 grams of Pinellia ternata, the alkaloid contained in 20 grams of Atractylodes macrocephala, Poria 20
  • the alkaloids contained in gram the alkaloids contained in 30g of fresh orange peel, the alkaloids contained in 15g of licorice, the alkaloids contained in 20g of Uncaria, and the alkaloids contained in 15g of Ligusticum chuanxiong.
  • the supercritical fluid extraction method or membrane separation method to separate from Gastrodia 30g, Pinellia 30g, Atractylodes 20g, Poria 20g, Fresh orange peel 30g, Licorice 15g, Uncaria 20g , Extract the alkaloids from 15 grams of Ligusticum chuanxiong, mix the respective alkaloids, add conventional auxiliary materials, and make tablets according to the conventional process of preparing chemicals.
  • composition of the raw material medicine of the medicine used to treat stroke caused by deep fungal infection of this embodiment volatile oil contained in 30 grams of Gastrodia, volatile oil contained in 30 grams of Pinellia ternata, volatile oil contained in 20 grams of Atractylodes macrocephala, and 20 grams of Poria cocos
  • the selected raw materials use supercritical fluid extraction or organic solvent extraction to extract 30 grams of Gastrodia, 30 grams of Pinellia, 20 grams of Atractylodes, 20 grams of Poria, 15 grams of licorice, 20 grams of Uncaria, and 15 grams of Ligusticum chuanxiong.
  • the volatile oil is extracted, and 30 grams of fresh orange peel is used to extract the volatile oil by cold pressing, then the respective volatile oils are mixed, and conventional auxiliary materials are added to make soft capsules or granules according to the conventional chemical preparation process.
  • the composition of the raw material medicine of the medicine for treating stroke caused by deep fungal infection of this embodiment the alkaloid contained in 25 grams of gastrodia, the alkaloid contained in 15 grams of Pinellia tuber, the alkaloid contained in 15 grams of Atractylodes macrocephala, Poria 15
  • the alkaloids contained in gram the alkaloids contained in 20 grams of fresh orange peel, the alkaloids contained in 10 grams of licorice, the alkaloids contained in 20 grams of Ligusticum chuanxiong, and the alkaloids contained in 10 grams of Sichuan aconite.
  • the selected raw materials use supercritical fluid extraction or membrane separation to extract 25 grams of Gastrodia elata, 15 grams of Pinellia ternata, 15 grams of Atractylodes, 15 grams of Poria, 20 grams of fresh orange peel, 10 grams of licorice, 20 grams of Ligusticum chuanxiong, respectively.
  • the alkaloids are extracted from 10 grams of Chuanwu, the respective alkaloids are mixed, conventional auxiliary materials are added, and tablets are made according to the conventional chemical preparation process.
  • composition of the raw material medicine of the medicine for the treatment of stroke caused by deep fungal infection of this embodiment volatile oil contained in 25 grams of Gastrodia, volatile oil contained in 15 grams of Pinellia ternata, volatile oil contained in 15 grams of Atractylodes macrocephala, and 15 grams of Poria cocos
  • the selected raw materials use supercritical fluid extraction or organic solvent extraction to extract 25 grams of Gastrodia elata, 15 grams of Pinellia ternata, 15 grams of Atractylodes rhizome, 15 grams of Poria cocos, 10 grams of licorice, 20 grams of Ligusticum chuanxiong, and 10 grams of Chuanwu.
  • the volatile oil is extracted, and 25 grams of fresh orange peel is used to extract the volatile oil by cold pressing, and then the respective volatile oils are mixed, and conventional auxiliary materials are added to make soft capsules or granules according to the conventional chemical preparation process.
  • the composition of the raw material medicine of the medicine for treating stroke caused by deep fungal infection of this embodiment the alkaloid contained in 20 grams of Gastrodia, the alkaloid contained in 15 grams of Pinellia ternata, the alkaloid contained in 15 grams of Atractylodes macrocephala, and Poria 10
  • the alkaloids contained in gram the alkaloids contained in 20 grams of fresh orange peel, the alkaloids contained in 10 grams of licorice, the alkaloids contained in 15 grams of Uncaria, the alkaloids contained in 15 grams of Ligusticum chuanxiong, and the alkaloids contained in 15 grams of Chuanwu
  • the selected raw materials use supercritical fluid extraction or membrane separation to extract 20 grams of Gastrodia, 15 grams of Pinellia, 15 grams of Atractylodes, 15 grams of Poria, 20 grams of fresh orange peel, 10 grams of licorice, and 15 grams of Uncaria.
  • the alkaloids are extracted from 15 grams of Ligusticum chuanxiong, 10 grams of Chuanwu, 15 grams of Xungufeng, and 15 grams of Qingfengteng.
  • the respective alkaloids are mixed, and conventional auxiliary materials are added to prepare tablets according to the conventional process of preparing chemicals.
  • composition of the raw material medicine of the medicine used to treat stroke caused by deep fungal infection of this embodiment volatile oil contained in 20 grams of Gastrodia, volatile oil contained in 15 grams of Pinellia ternata, volatile oil contained in 15 grams of Atractylodes macrocephala, and 15 grams of Poria cocos
  • volatile oil contained in 20 grams of fresh orange peel, the volatile oil contained in 10 grams of licorice, the volatile oil contained in 15 grams of Uncaria, the volatile oil contained in 15 grams of Ligusticum chuanxiong, the volatile oil contained in 10 grams of Chuanwu, Xungufeng The volatile oil contained in 15 grams, the volatile oil contained in 15 grams of Caulis Caulis.
  • the selected raw materials use supercritical fluid extraction or organic solvent extraction to extract 20 grams of Gastrodia, 15 grams of Pinellia, 15 grams of Atractylodes, 15 grams of Poria, 10 grams of licorice, 15 grams of Uncaria, 15 grams of Ligusticum chuanxiong, respectively.
  • the volatile oil is extracted from 10 grams of Chuanwu and 15 grams of Xungufeng, 20 grams of fresh orange peel and 15 grams of Qingfengteng are extracted by cold pressing, and then the respective volatile oils are mixed, and conventional auxiliary materials are added. The process is made into soft capsules or granules.
  • the composition of the raw material medicine of the medicine used to treat stroke caused by deep fungal infection of this embodiment the alkaloid contained in 15 grams of Gastrodia, the alkaloid contained in 15 grams of Pinellia ternata, the alkaloid contained in 10 grams of Atractylodes macrocephala, Poria 10
  • the alkaloids contained in gram the alkaloids contained in 15 grams of fresh orange peel, the alkaloids contained in 10 grams of licorice, the alkaloids contained in 12 grams of Ligusticum chuanxiong, the alkaloids contained in 12 grams of Xungufeng, Qingfengteng Alkaloids contained in 15 grams.
  • the selected raw materials use supercritical fluid extraction or membrane separation to extract from Gastrodia 15g, Pinellia 15g, Atractylodes 10g, Poria 10g, Fresh orange peel 15g, Liquorice 10g, Chuanxiong 12g, respectively.
  • the alkaloids are extracted from 12 grams of Xungufeng and 15 grams of Qingfengteng, the respective alkaloids are mixed, conventional auxiliary materials are added, and tablets are made according to the conventional chemical preparation process.
  • the composition of the raw material medicine of the medicine for the treatment of stroke caused by deep fungal infection of this embodiment volatile oil contained in 15 grams of Gastrodia, volatile oil contained in 15 grams of Pinellia ternata, volatile oil contained in 10 grams of Atractylodes macrocephala, and 10 grams of Poria cocos
  • volatile oil contained in 15 grams of fresh orange peel, the volatile oil contained in 10 grams of licorice, the volatile oil contained in 12 grams of Ligusticum chuanxiong, the volatile oil contained in 12 grams of Xungufeng, and the volatile oil contained in 15 grams of Qingfengteng volatile oil contained in 15 grams of Gastrodia, volatile oil contained in 15 grams of Pinellia ternata, volatile oil contained in 10 grams of Atractylodes macrocephala, and 10 grams of Poria cocos
  • the selected raw materials use supercritical fluid extraction or organic solvent extraction to extract 15 grams of Gastrodia elata, 15 grams of Pinellia ternata, 10 grams of Atractylodes macrocephala, 10 grams of Poria cocos, 10 grams of licorice, 12 grams of Ligusticum chuanxiong, and 12 grams of Xungufeng.
  • the volatile oil is extracted from the extract, 15 grams of fresh orange peel and 15 grams of Caulis sylvestris are extracted by cold pressing, then the respective volatile oils are mixed, and conventional auxiliary materials are added to make soft capsules or granules according to the conventional chemical preparation process.
  • the inventiveness and novelty of the medicines provided by the present invention are shown in: the medicines provided by the present invention are prepared into chemical compounds by extracting alkaloids and (or) volatile oil from the botanical medicines Gastrodia, Pinellia, Atractylodes, Poria, fresh orange peel, and licorice.
  • Medicines that is, the alkaloids of gastrodia elata, the alkaloids of Pinellia ternata, the alkaloids of Atractylodes macrocephala, the alkaloids of Poria cocos, the alkaloids of fresh orange peel, and the alkaloids of licorice are mixed in proportion, and conventional auxiliary materials are added to prepare chemical drugs according to the routine Process to make tablets.
  • the existing chemicals which are made from alkaloids from a single plant, it has a significant improvement. It can reduce the content of single alkaloids in medicines and reduce the toxicity of single alkaloids due to excessive dosage.
  • morphine obtained from opium has a strong analgesic effect, because it is a single alkaloid, and it is prone to toxic side effects if the dose is too large to achieve the curative effect.
  • the medicine provided by the invention can target different organs and blood vessel tissues more effectively because of the synergistic effect of multiple alkaloids.
  • Chinese medicine is not necessarily all herbs, but also animals and minerals.
  • the main feature of modern Chinese medicine is that it is impossible to know all the ingredients, but to know the main ingredients, that is, to know the chemical ingredients that can cure diseases.
  • the chemical components of the medicine provided by the present invention are only alkaloids and volatile oils.
  • the pharmacological mechanism of the medicine provided by the present invention is clear.
  • the pharmacological mechanism of the alkaloids and volatile oil contained in Gastrodia, Pinellia, Atractylodes, Poria, Fresh Orange Peel, Licorice, Uncaria, Chuanxiong, Chuanwu, Xungufeng, Qingfengteng is Anti-fungal drugs. I believe that stroke is caused by deep fungal infection. The embolus in the blood is the mycelium that fungi multiply and shed.
  • the alkaloids and volatile oils contained in radix, Chuanwu, Xungufeng and Qingfengteng can kill fungi and decompose mycelium, that is, it has the effect of thrombolysis. And they can treat fungi in different arteries and veins, and can dredge blood circulation in different arteries and veins.
  • the applicant uses the raw materials gastrodia elata, pinellia, atractylodes, poria, tangerine peel, and licorice as the basic formula, dialectically add and subtract Uncaria, Chuanxiong, Chuanwu, Xungufeng, Qingfengteng using traditional methods to treat strokes caused by deep fungal infections In 3 patients, the clinical symptoms of stroke improved significantly after taking the medicine for half a month.
  • the medicine provided by the present invention is an extract of raw materials based on the traditional prescription "Banxia Baizhu Tianma Decoction", and extracts the volatile oils and biological substances contained in the botanical medicines Banxia, Baizhu, Tianma, Poria, fresh orange peel, licorice, Alkali is prepared into medicines or health products for treating stroke caused by fungi. Because the chemical composition of the medicines or health products provided by the present invention is clear, its effectiveness is obvious compared with traditional pharmaceutical methods.

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Abstract

一种半夏白术天麻汤加减在制备治疗真菌深部感染导致中风的药品或保健品中的应用，属于医疗保健领域，具体涉及植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草中含有的化学成分生物碱和挥发油在制备治疗因真菌深部感染导致中风的药物或保健品中的用途。

Description

一种治疗因真菌深部感染导致中风的药品 技术领域
本发明创造属医疗保健领域，涉及《半夏白术天麻汤》加减在制备治疗由深部感染真菌导致中风的药品或保健品中的新应用，具体涉及植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草中含有的化学成分生物碱和挥发油在制备治疗因真菌深部感染导致中风的药物或保健品中的新用途。
背景技术
现代医学将真菌病分为浅部真菌病和深部真菌病两大类。浅部真菌病是指皮肤角蛋白组织(包括角质层、甲板、毛发等)感染。深部真菌病也叫侵袭性真菌病(IFD)，是指真菌侵犯人体皮下粘膜组织、血液和内脏器官等引起的真菌感染性疾病。最常见的真菌病原体是念珠菌和曲霉菌及其他如隐球菌、毛霉菌、肺孢子菌等。据全球真菌感染行动基金会(GAFFI)不完全统计，全球每年有3亿人患上严重的真菌感染疾病，超过2500万人有非常高的病死或失明风险。但目前对真菌感染脑部引发的疾病的研究非常有限，而且现在市面上用于治疗真菌深部感染的药物，往往副作用大，长期使用对身体器官造成伤害，而且疗效也不理想，同时产生许多不良反应。而申请人早先申请的专利《破解癌症的致病因素和中医治疗方法》(申请号：201310274489.7)以及国际专利《一种治疗癌症的药物组合物及其制备方法》(申请号：PCT/CN2013/080936、进入中国申请号：201380075486.9进入美国专利号：US9498508B2)和国际专利《一种治疗生 殖系统癌症的药物组合及其制备方法》(PCT/CN2013/084813、进入中国申请号：201380053736.9，进入美国专利号：US9744206B2)中涉及中医治疗霉菌深部感染的方法，其中《半夏白术天麻汤》是治疗真菌感染的基础方剂，所以本申请在此基础上继续申请。
近些年的医学研究也证明曲霉菌、隐球菌病、毛霉病等真菌主要传播途径为呼吸道和皮肤，可导致系统性隐球菌病，肺曲霉病、鼻脑毛霉病、肺毛霉病、胃肠毛霉病、播散性毛霉病等。
现代医学研究也证明曲霉病的感染途径主要为吸入空气中的孢子，曲霉孢子随呼吸进入鼻窦和肺，萌发产生菌丝进入细胞质变，曲霉嗜好侵入血管。《皮肤性病学》也已证实白色念珠菌可通过外源或内源途径引起皮肤、粘膜和内脏、骨骼、脑的感染。
新型隐球菌主要经呼吸道吸入，首先感染的部位可能是肺部，从肺可播撒至全身其它部位，包括皮肤、骨、心脏等，而最易侵犯的是中枢神经系统，引起慢性脑膜炎。
现代研究证明真菌的孢子以出芽方式繁殖，形成菌丝，菌丝交织成团，当芽生孢子长到一定大小即与母体脱离。
中风属脑血管疾病，是血管源性脑部病损的一组疾病，俗称中风(stroke)。世界著名的医学期刊《柳叶刀》于2019年6月24日，发表了一项关于中国公共卫生研究的大型论文，分析了中国人1990-2017年间的死亡率以及特定疾病的死亡率。其中，该研究在282类致死原因中鉴定出2017年中国人的前十大死因，中风成为中国人头号死因。美国《新英格兰医学杂志》周刊2018年12月时就刊载过一篇论文，描述全球不同地区中风患病和死亡风险，使用的也是GBD的数据。 这一研究重点是首次中风，包括缺血性的，即缘于通往大脑的血管被阻塞，和出血性的，缘于脆弱的血管破裂。而且这一研究首次将中风风险起始年龄降低至25岁，以前都是45岁。《柳叶刀》2017年8月发布的一项研究结果显示，中国1/3以上的成年人患有高血压，这份研究得出同样结论：在中国，中风是最大死因，每年有1/5的死亡病例是中风造成的，高血压失控是一个很大的风险因素。
根据病因病理可将脑血管病分为两大类，即缺血性和出血性。缺血性有：短暂性脑缺血发作，脑梗塞(脑血栓形成、脑栓塞、腔隙性脑梗塞)。出血性有：脑出血、蛛网膜下腔出血。目前有人把混合性中风(同时或先后有出血、缺血性病损)单列为一类。目前医学界对中风的发病机制尚不明确，目前认为，颈部大动脉管壁粥样硬化病损处脱落的微栓子，造成小血管的微栓塞可能是最常见的病因。高血压患者因脑血管自动调节功能较差，导致脑血管不收缩，脑血流量不仅不减少反而显著增加。这种在高血压作用下的过度灌注，导致毛细血管内压力增加和毛细血管破坏，可引起严重脑水肿和出血。此时应用任何血管扩张剂显然是有害无益的。
中风的临床表现因不同的血管病损表现出不同的症状，缺血性的中风主要临床表现为突然昏倒，偏瘫(半身不遂)、偏身麻木、口舌歪斜、同侧单眼失明，言语不清、肢体共济失调、双眼视物模糊。
脑血栓好发于50岁以上有脑动脉硬化病患者，多伴有高血压、糖尿病、心脏病的病史，部分患者于睡眠中发病。脑栓塞严重者可突然昏迷，高热，颅内压增高，水肿，可发生脑疝而死亡。
出血性的中风最常见的是高血压伴动脉硬化，也有动静脉畸形或动脉瘤破裂、脑动脉炎性管壁坏死等，其临床症状与出血部位和出血量有关。出现头痛、头昏、 肢体无力、偏瘫、意识障碍、脑水肿、昏迷等临床症状。
中医认为中风的病理机制也比较复杂，认为其根本在于肝肾阴虚，脏腑功能失调，阴阳失调。
阴阳和五行学说，是中国古代的自然观。中医学大约在春秋末期(公元前五世纪)开始采用阴阳的理论，到了战国后期(公元前三世纪)又采用了新产生的五行学说，形成中医基础理论的框架。中医学认为人是一个由阴阳构成的有机的整体，具体划分为三阴三阳六个部分，三阴三阳分别与手足十二经络，五脏六府相联系。手三阴经为：手太阴肺经，手厥阴心包经，手少阴心经。手三阳经为：手阳明大肠经，手少阳三焦经，手太阳小肠经。足三阳经为：足阳明胃经，足少阳胆经，足太阳膀胱经。足三阴经为：足太阴脾经，足厥阴肝经，足少阴肾经。
十二经络的循行走向及交接规律：手三阴经从胸走向手交于手三阳经，手三阳经从手走向头交于足三阳经，足三阳经从头走向足交于足三阴经，足三阴经从足走向腹、胸部交于手三阴经。其中阴经与阳经交于四肢末端，阳经与阳经交于头，阴经与阴经交与胸。其表里关系是：肺经-大肠经、脾经-胃经、心经-小肠经、肾经-膀胱经、心包经-三焦经、肝经-胆经。中医界对阴阳五行学说的解析理论众多，但均未能明确其医学原理及理论依据，也一直未见有阴经是静脉，阳经是动脉的相关文献报道。
天然药物治病防病的基础在于其所含的有效成分，任何一种天然药物的化学成分都是十分复杂的。生物碱是植物药中重要的有效成分之一，已知生物碱种类很多，它们结构比较复杂，根据生物碱的生源关系结合化学分类为主，把生物碱分为25类，如：吡咯类、托品烷类、吡咯里西丁类、哌啶类、石松碱类、吲哚里西丁类、奎诺里西丁类、吖啶酮类、苯丙胺类、四氢异喹啉类、吐根碱类、喹 啉类、肽类、萜类生物碱等。生物碱多数是具有碱性的，大多数生物碱的性状为结晶体。生物碱均为含氮的有机化合物，大多数有复杂的环状结构，氮素多包含在环内，碱性强弱与其生物碱的结构类型有关。众多学者研究发现生物碱的药理活性众多，包括抗肿瘤、抗病毒、抗炎、抗菌、镇痛、护肝、心血管作用等诸多方面。如从鸦片中分得的吗啡具有强烈的镇痛作用；可待因具有止咳作用，罂粟碱具有松驰平滑肌作用；麻黄中的麻黄碱具有平喘作用；黄连、黄柏中的小檗碱具有抗菌作用；曼陀罗、天仙子、颠茄中的莨菪碱具有解痉的作用等等。这几种是目前研究得最多的生物碱，其作用也各有不同。但目前医学界对生物碱的抗肿瘤、抗病毒、抗炎、抗菌、镇痛、护肝、心血管作用的药理机制却没有完全研究清楚。也一直未见生物碱具有治疗真菌深部感染或治疗由真菌感染引发中风的作用的相关文献报道。
生物碱的提取方法，根据生物碱盐类能溶于水而生物碱不溶于水的特性，可以采用有机溶剂提取后测定。生物碱大都能溶于甲醇、乙醇、乙醚、氯仿等有机溶剂，一般不溶或难溶于水。基于这种特性，可用不同的溶剂将生物碱从植物中提取。常用的有冷浸、渗漉、超声波、索氏提取、热回流提取等方法。生物碱的提取新技术，1、膜分离法，具有不需要添加化学试剂，分离效率高，条件温和等优点。2、超临界流体萃取法，具有提取效率高、纯度高、条件温和、无污染、可改变温度和压力。
挥发油是中药和植物中一类具有重要药理作用的成分。挥发油是植物中一类具有芳香气味、在常温下能挥发的油状液体的总称，在植物界分布很广，特别是菊科、芸香科、伞形科、唇形科、樟科、木兰科、姜科等植物中。挥发油主要是由萜类和芳香族化合物以及它们的含氧衍生物如醇、醛、酮、酚、醚、内脂等组 成，此外还包括含氮及含硫化合物。现代药理实验表明：挥发油具有抗炎、抗过敏、抗微生物、抗突变和抗癌、驱虫作用、酶抑制作用、对中枢神经系统的作用、对呼吸系统的作用等。但对挥发油的活性机理或药理机制的理解和研究还非常有限。也一直未见挥发油具有治疗真菌深部感染或治疗由真菌感染引发中风的作用的相关文献报道。
挥发油的提取方法可选择不同的方法提取，如1、水蒸气蒸馏法：利用挥发油的挥发性和水不相混溶的性质进行的提取。2、有机溶剂提取法：用石油醚、乙醚等有机溶剂采用连续回流提取法或冷浸法进行提取。3、超临界流体萃取法，用二氧化碳超临界流体萃取挥发油。4、冷压法，适用于含油量较高的新鲜植物的提取。
《半夏白术天麻汤》为治疗风痰眩晕、头痛的常用方。孙立亭以半夏白术天麻汤加菖蒲、郁金为基本方，以中医辨证加减用水煎剂的方法治疗眩晕40例(高血压病9例，脑动脉硬化14例，椎-基底动脉供血不足11例，颈椎病3例，梅尼埃病3例)。结果：痊愈19例，显效14例，有效5例，无效2例。[黑龙江中医药，1998]。但一直未见《半夏白术天麻汤》用于治疗因深部感染真菌导致中风的相关报道，也一直未见以《半夏白术天麻汤》的原料药半夏、百术、天麻、茯苓、橘皮、甘草中含有的化学成分生物碱和(或)挥发油为原料混合制成的药品用于治疗因真菌深部感染导致中风或具有溶栓作用的相关文献报道。
半夏为″温化寒痰药″。功效：燥湿化痰，降逆止呕，消痞散结，外用消肿止痛，主治湿痰、寒痰证。现代研究半夏含有挥发油和生物碱及多种化学成分，其生物碱具有抗肿瘤作用，半夏醇提取液具有广谱的抗菌活性，对真菌的抑制作用也有一定的效果。但一直未见半夏生物碱和挥发油具有治疗因真菌深部感染引发 中风或具有溶栓作用的相关报道。
白术为补气药，现代研究白术含挥发油，其挥发油有镇静作用。但一直未见白术生物碱和挥发油用于治疗因真菌深部感染引发中风或具有溶栓作用的相关报道。
天麻为《息风止痉药》是治疗头痛、肢体麻木、风湿痹痛等的药品，现代研究发现乌天麻挥发油对米曲霉、黄曲霉有较明显的抑制作用，乌天麻挥发油具有显著的镇咳和良好祛痰作用。但一直未见天麻生物碱和挥发油用于治疗因真菌深部感染引发中风或具有溶栓作用的相关报道。
茯苓为利水消肿药，现代研究茯苓煎剂、醇提取物、乙醚提取物分别具有利尿、镇静、抗肿瘤、降血糖的作用。但一直未见茯苓生物碱和挥发油用于治疗因真菌深部感染引发中风或具有溶栓作用的相关报道。
鲜橘皮为理气药，现代研究其挥发油煎剂有扩张气管的作用，其挥发油有刺激性祛痰作用。但一直未见鲜橘皮的生物碱和挥发油用于治疗因真菌深部感染引发中风或具有溶栓作用的相关报道。
甘草为补气药，现代研究其含有生物碱，多糖等化学成分。但一直未见甘草的生物碱和挥发油用于治疗因真菌深部感染引发中风或具有溶栓作用的相关报道。
发明内容
本发明的目的在于提供一种治疗因真菌深部感染导致中风的药品，具体在于提供《半夏白术天麻汤》中的植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草中含有的化学成分生物碱和(或)挥发油在制备治疗因真菌深部感染导致中风的药物或保健品中的新用途。
进一步的，本发明提供的治疗因真菌深部感染导致中风的药品，其特征在于，所述药品的原料药由天麻提取的生物碱和(或)挥发油、半夏提取的生物碱和(或)挥发油、白术提取的生物碱和(或)挥发油、茯苓提取的生物碱和(或)挥发油、鲜橘皮提取的生物碱和(或)挥发油、甘草提取的生物碱和(或)挥发油组成。
其药品制备方法1为：取天麻生物碱、半夏生物碱、白术生物碱、茯苓生物碱、鲜橘皮生物碱、甘草生物碱按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型。
其药品制备方法2为：取天麻挥发油、半夏挥发油、白术挥发油、茯苓挥发油、鲜橘皮挥发油、甘草挥发油按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型。
其药品制备方法3为：取天麻生物碱和挥发油、半夏生物碱和挥发油、白术生物碱和挥发油、茯苓生物碱和挥发油、鲜橘皮生物碱和挥发油、甘草生物碱和挥发油按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型。
进一步的，所述的制备方法，生物碱的提取方法，可以采用有机溶剂提取后测定，用不同的溶剂将生物碱从植物天麻、半夏、白术、茯苓、鲜橘皮、甘草中提取。首选超临界流体萃取法，其次选膜分离法或超声波提取方法或索氏提取等方法。
天麻、半夏、白术、茯苓、甘草挥发油的提取方法首选超临界流体萃取法，其次选择有机溶剂提取法：用石油醚、乙醚等有机溶剂采用连续回流提取法或冷浸法，或选水蒸气蒸馏法；鲜橘皮首选冷压法提取。
进一步的，本发明提供的药品其特征在于，所述药品的原料药生物碱的重 量份是：天麻生物碱0.01～50重量份、半夏生物碱0.01～50重量份、白术生物碱0.01～50重量份、茯苓生物碱0.01～50重量份、鲜橘皮生物碱0.01～50重量份、甘草生物碱0.01～50重量份。
进一步的，本发明提供的药品其特征在于，所述药品的原料药挥发油的重量份是：天麻挥发油0.01～50重量份、半夏挥发油0.01～50重量份、白术挥发油0.01～50重量份、茯苓挥发油0.01～50重量份、鲜橘皮挥发油0.01～50重量份、甘草挥发油0.01～50重量份。
进一步的，本发明提供的药品其特征在于，所述药品一天需要服用的剂量进一步优选为：取天麻50克中含有的生物碱和挥发油的重量、半夏35克中含有的生物碱和挥发油的重量、白术30克中含有的生物碱和挥发油的重量、茯苓30克中含有的生物碱和挥发油的重量、鲜橘皮40克中含有的生物碱和挥发油的重量、甘草25克中含有的生物碱和挥发油的重量。
具体制备方法：以服用10天的量分别取天麻500克、半夏350克、白术300克、茯苓300克、鲜橘皮400、甘草250克，分别提取出各自的生物碱和挥发油，再把提取的各种生物碱混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型；把提取的各种挥发油混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型。
进一步的，所述药品其特征在于，所述药品可根据临床症状选择性增加原料药钩藤、川芎、川乌、寻骨风、青风藤中含有的生物碱和(或)挥发油。
进一步的，所述药品其特征在于，所述药品的制备方法为：从各植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草中提取生物碱和(或)挥发油制备成药品，以常规的制备化学药品的方法制成片剂、粉针剂、软胶囊、颗粒剂或胶囊剂等药学上可接受的剂型。
进一步的，所述药品其特征在于，所述药品的制备方法为：从各植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草或钩藤或川芎或川乌或寻骨风或青风藤中提取生物碱和(或)挥发油制备成药品，以常规的制备化学药品的方法制成片剂、粉针剂、软胶囊、颗粒剂或胶囊剂等药学上可接受的剂型。
所述用于治疗因真菌深部感染导致中风的药品或保健品，其适应范围包括：在医疗药品、保健食品、保健用品、动物药品、动物饲料方面的应用。
本发明提供的药品的各种原料药的药理为：
本发明的创造思路是从金代名医张元素的《头痛案》的研究开始，从而破解了中国古代传统文化《阴阳五行学说》。对《阴阳五行学说》的破解内容具体见申请人的另一申请201410299118.9《一种广谱抗厌氧菌的药物组合物》中详细地介绍了《阴阳五行》与现代医学的关系。《阴阳五行学说》是古代中医理论的基础。因古人把生存在阴经里的病菌称为″阴邪″，″阴邪″又分为″湿邪″、″寒邪″或″风邪″等。申请人受破解《阴阳学》的启发认为：中医所说的″阴经″为静脉，阳经为动脉。阴经里的″湿邪″便是生存在静脉里的对缺氧有耐受力的各种病菌，比如真菌、厌氧菌、病毒、杆菌等，″寒邪″则为真菌(霉菌)，″风邪″则是可以通过空气传染的病菌。因此申请人认为中医的″风寒感冒″就是曲霉菌、念珠菌或隐球菌等真菌感染上呼吸道引起的。而脑部的血管非常丰富， 中医十二经脉理论的循行走向及交接规律指出：阳经与阳经交于头，即各条动脉在头部交集。因此真菌非常容易进入脑血管，而真菌具有很强的破坏性，损伤血管壁使血管失去弹性，导致粥样硬化或破裂出血。
现代研究证明真菌的孢子以出芽方式繁殖，形成菌丝，菌丝交织成团，当芽生孢子长到一定大小即与母体脱离。因此申请人认为脱离的真菌孢子团相当于在血液中形成可以自由流动的栓子，即″颈部大动脉管壁粥样硬化病损处脱落的微栓子，造成小血管的微栓塞，阻塞血液循环″。而颈部大动脉管壁粥样硬化病主要是真菌引起的慢性炎症反应，真菌在受损的动脉壁处繁殖，脱落的菌丝团，形成微栓子阻塞小静脉或小动脉的血液循环。脑出血、脑中风容易在晚上发作的原因就是因为滞留头部的真菌在晚上趁病人的体温比较低、血液流速慢而大量繁殖，加速腐蚀了脑部血管，形成更多的菌丝团，使头部的血液循环受阻导致人体产生的自身免疫反应引起高血压，高血压相当于水泵的原理，加压才能是血液上行到脑部，而颅内高压又使真菌形成的栓子阻塞血管或破裂血管导致中风。因此申请人认为高血压及中风的主要致病因素是真菌感染脑部血管导致的。因此中风的治疗原则是抗深部真菌感染的治疗。
本人受霉菌喜酸厌碱的特性启发，且真菌最适应PH4-6，即真菌在碱性环境下不适应生存，得出植物原料药中含有的生物碱是抗真菌的主要化学成分，又受中医″芳香化湿、辛以化湿、温以化寒″的启发，得出植物原料药中含有的挥发油也是抗真菌的化学成分。
天麻为息风止痉药，归肝经。因真菌可以引起播散性血液感染，而静脉因血液流动的速度慢，没有氧气，真菌更容易在静脉中滞留、繁殖，脱落的孢子团也更容易阻塞小静脉。申请人认为肝经出自肝门静脉系，因此肝经是最容易受到真 菌感染的静脉。中国古代医家定义肝经循环路径为：起于足大趾，经小腿内侧前缘上行至肝脏静脉，再沿喉咙上行进入鼻咽部，上连目系，交督脉于头顶部，肝经支脉从肝分出上行与肺静脉连接。因此肝经是一组从足上行至头顶部的重要静脉群，肝经的下肢段类似于现代医学的小隐静脉。因脑部血管丰富，脑部也是真菌容易滞留的部位，而眼睛的血液循环相当于脑部的末端微循环，而肝经的末端穴位在眼睛，因此肝经的病变最先是眼睛发生病变，出现眼内压增高、白内障、失明等症状。中风的主要病变就是脑血管受损，由于血-脑屏障的原因，许多药品无法进入脑部，而天麻可以通过血-脑屏障，是靶向治疗脑部的抗真菌药品，因此天麻的生物碱和挥发油是可以治疗肝经静脉群的抗真菌感染，尤其是治疗脑部血管及上呼吸道的抗真菌感染，可以杀死真菌并分解真菌孢子团，具有溶栓的作用。在本发明提供的药品中天麻的生物碱和挥发油为君药。
半夏为″温化寒痰药″。药性辛，温，归脾、胃、肺经。主治湿痰、寒痰证。因真菌通过血液循环可以引起全身播散性感染，脾经、肺经为重要的静脉，胃经是与脾经伴行的动脉，因此脾、胃、肺经也容易受到真菌感染。申请人认为脾经出自脾门静脉系。中国古代医家定义脾经的循环路径为：起于大趾内侧端，沿大腿内侧前缘进入腹腔脾脏，再上行至舌，支脉从胃至胸，连接心脏静脉。脾经下肢段的静脉类似于现代医学的大隐静脉。胃经的循环路径为：起于鼻翼旁，向上连接膀胱经，从瞳孔直下口腔、耳前、额前，支脉从大迎穴下行至大椎、锁骨上窝深入体腔至胃部、脾脏，再下行至腹股沟，沿下肢前方下行中足趾外侧端，连接脾经。胃经的下肢段类似于现代医学的胫前动脉。肺经的循环路径为：起于肺部的中府，向上至喉部，经胸上部至腋前沿上肢内侧前缘，止于大拇指桡侧端。肺经出自肺部静脉系，肺经的上肢段类似于现代医学的头静脉。中风的临床症状 口舌歪斜对应脾经的末端舌部和肺经的喉部。中风的临床症状半身不遂，肢体麻木，就是上、下肢体的血液循环受阻引起的，对应十二经络的手、足的末端血液循环，其毛细血管非常丰富，有许多小静脉和小动脉，尤其是下肢的血液循环最容易使脱落的真菌孢子团形成的栓子阻塞微循环。下肢静脉曲张也是同样的原因引起的，十二经络上的穴位就是真菌孢子团容易滞留、繁殖形成血栓的位置。本人认为脱落的真菌孢子团一般是先栓塞小静脉、再到小动脉，因微循环有许多侧支循环替代，所以临床症状不明显，但当它栓塞了大静脉或大动脉时，就出现了明显的临床症状，比如当它随血液循环运行到心脏，阻塞了心脏的大动脉或大静脉时就会出现心肌梗塞，当运行到肺部阻塞了肺部的大静脉或大动脉时就会出现肺梗塞，当运行到脑部阻塞了脑部的大动脉时就会出现脑梗塞。尤其是栓塞了大动脉时会引起生命危险。因此半夏的生物碱和挥发油是可以靶向治疗肺经、脾经、胃经血液里的真菌感染，可以杀死真菌并分解真菌孢子团，具有溶栓的作用。与天麻靶向治疗肝经里的真菌感染形成团队协同作用。在本发明提供的药品中半夏的生物碱和挥发油与天麻的生物碱和挥发油共同组成君药。
白术为补气药，归脾、胃经。中医认为″脾虚生痰湿″也就是说真菌侵犯肝脏血管引起播散性血液感染，肺部感染后形成肺部炎症反应，刺激性产生大量痰液阻塞呼吸道引起氧气与二氧化碳交换困难。″气虚″则为缺氧，补气药白术与理气药″鲜橘皮″同用可以促进血液中的氧气与二氧化碳的交换。鲜橘皮归脾经、肺经，因此白术和鲜橘皮的生物碱和挥发油在本发明提供的技术方案中共为臣药，辅助半夏疏通肺经、脾经、胃经的血液循环，具有溶栓的作用。
茯苓为利水消肿药，归心、脾、肾经，为健脾祛湿的要药，心经为静脉，起于心脏，止于无名指外侧端，即心经出自类似现代医学的上腔静脉口，其上肢段 静脉类似贵要静脉。肾经出自肾门静脉系。肾经起于足小趾，入肺，进入胸中，与心经相连，其下肢段静脉类似现代医学的足深静脉。因真菌感染脑部，引起炎症水肿，产生大量液体积聚在脑部引起脑水肿，茯苓利尿消肿，因此茯苓的生物碱和挥发油是靶向治疗心经、脾经、肾经里的真菌感染的药品，辅助天麻、半夏、白术增强氧气与二氧化碳的交换作用，疏通心、脾、肾经的血液循环，具有溶栓作用。
甘草与白术同为补气药，甘草归心、肺、脾、胃经。具有止咳祛痰的作用，还具有调和药性的作用。甘草的生物碱和挥发油协助白术增强血液中的氧气与二氧化碳的交换作用，可以疏通心、肺、脾、胃经的血液循环，具有溶栓作用。
钩藤与天麻同为息风止痉药，归肝、心包经。心包经起于胸中，止于中指端，相当于肘正中静脉。因此钩藤的生物碱和挥发油可以辅助天麻舒通血液循环、起降压的作用，具有溶栓作用。现代医学证明其生物碱具有降压的作用，但未见其生物碱具有抗真菌的作用的相关报道。
川芎为活血化淤药，归肝、胆、心包经。胆经为动脉。胆经起于眼睛，止于足大趾，是与肝经伴行的动脉。因此川芎的生物碱和挥发油可以舒通肝、胆、心包经的血液循环，具有溶栓作用。在本发明提供的药品中可选择使用，辅助天麻舒通血液循环的作用。
川乌为祛风寒湿药，归心、肝、肾、脾经。含多种生物碱，有明显的抗炎、镇痛作用。当出现重症中风症状时，可选择性使用。其碱性比较强，剂量过大易引起中毒反应。川乌的生物碱和挥发油可以辅助天麻、半夏舒通心、肝、肾、脾经血液循环的作用，可以杀死真菌并分解真菌孢子团，具有溶栓的作用。
寻骨风也为祛风寒湿药，归肝经。寻骨风所含生物碱对大鼠关节炎有明显消 肿作用，本发明提供的药品中当出现下肢静脉曲张或栓塞引发下肢水肿时，可选择性增加寻骨风，寻骨风的生物碱和挥发油以辅助天麻疏通肝经下肢端的血液循环，具有溶栓作用。
青风藤也为祛风寒湿药，归肝、脾经，有较强的通经络作用。青风藤碱有抗炎、镇痛、镇静、镇咳作用，对心律失常有明显及拮抗作用，青风藤总碱的降压作用迅速、强大。但现有技术对青风藤的抗炎机制却没有完全清楚。本发明提供的药品中当出现下肢静脉曲张或栓塞引发下肢水肿时，可选择性增加寻骨风，青风藤的生物碱和挥发油以辅助天麻和半夏的生物碱和挥发油疏通肝经、脾经下肢端的血液循环，具有溶栓作用，并消除真菌引发的炎症水肿。
具体实施方式
实施例1
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻50克中含有的生物碱、半夏35克中含有的生物碱、白术30克中含有的生物碱、茯苓30克中含有的生物碱、鲜橘皮40克中含有的生物碱、甘草25克中含有的生物碱。
按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻50克、半夏35克、白术30克、茯苓30克、鲜橘皮40克、甘草25克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
实施例2
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻50 克中含有的挥发油、半夏35克中含有的挥发油、白术30克中含有的挥发油、茯苓30克中含有的挥发油、鲜橘皮40克中含有的挥发油、甘草25克中含有的挥发油。
按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天麻50克、半夏35克、白术30克、茯苓30克、甘草25克中提取出挥发油，鲜橘皮40克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
实施例3
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻30克中含有的生物碱、半夏30克中含有的生物碱、白术20克中含有的生物碱、茯苓20克中含有的生物碱、鲜橘皮30克中含有的生物碱、甘草15克中含有的生物碱、钩藤20克中含有的生物碱、川芎15克中含有的生物碱。
按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻30克、半夏30克、白术20克、茯苓20克、鲜橘皮30克、甘草15克、钩藤20克、川芎15克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
实施例4
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻30克中含有的挥发油、半夏30克中含有的挥发油、白术20克中含有的挥发油、茯苓20克中含有的挥发油、鲜橘皮30克中含有的挥发油、甘草15克中含有的挥发油、钩藤20克中含有的挥发油、川芎15克中含有的挥发油。
按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天 麻30克、半夏30克、白术20克、茯苓20克、甘草15克、钩藤20克、川芎15克中提取出挥发油，鲜橘皮30克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
实施例5
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻25克中含有的生物碱、半夏15克中含有的生物碱、白术15克中含有的生物碱、茯苓15克中含有的生物碱、鲜橘皮20克中含有的生物碱、甘草10克中含有的生物碱、川芎20克中含有的生物碱、川乌10克中含有的生物碱。
按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻25克、半夏15克、白术15克、茯苓15克、鲜橘皮20克、甘草10克、川芎20克、川乌10克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
实施例6
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻25克中含有的挥发油、半夏15克中含有的挥发油、白术15克中含有的挥发油、茯苓15克中含有的挥发油、鲜橘皮25克中含有的挥发油、甘草10克中含有的挥发油、川芎20克中含有的挥发油、川乌10克中含有的挥发油。
按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天麻25克、半夏15克、白术15克、茯苓15克、甘草10克、川芎20克、川乌10克中提取出挥发油，鲜橘皮25克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
实施例7
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻20克中含有的生物碱、半夏15克中含有的生物碱、白术15克中含有的生物碱、茯苓10克中含有的生物碱、鲜橘皮20克中含有的生物碱、甘草10克中含有的生物碱、钩藤15克中含有的生物碱、川芎15克中含有的生物碱、川乌10克中含有的生物碱、寻骨风15克中含有的生物碱、青风藤15克中含有的生物碱。
按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻20克、半夏15克、白术15克、茯苓15克、鲜橘皮20克、甘草10克、钩藤15克、川芎15克、川乌10克、寻骨风15克、青风藤15克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
实施例8
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻20克中含有的挥发油、半夏15克中含有的挥发油、白术15克中含有的挥发油、茯苓15克中含有的挥发油、鲜橘皮20克中含有的挥发油、甘草10克中含有的挥发油、钩藤15克中含有的挥发油、川芎15克中含有的挥发油、川乌10克中含有的挥发油、寻骨风15克中含有的挥发油、青风藤15克中含有的挥发油。
按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天麻20克、半夏15克、白术15克、茯苓15克、甘草10克、钩藤15克、川芎15克、川乌10克、寻骨风15克中提取出挥发油，鲜橘皮20克、青风藤15克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
实施例9
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻15 克中含有的生物碱、半夏15克中含有的生物碱、白术10克中含有的生物碱、茯苓10克中含有的生物碱、鲜橘皮15克中含有的生物碱、甘草10克中含有的生物碱、川芎12克中含有的生物碱、寻骨风12克中含有的生物碱、青风藤15克中含有的生物碱。
按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻15克、半夏15克、白术10克、茯苓10克、鲜橘皮15克、甘草10克、川芎12克、寻骨风12克、青风藤15克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
实施例10
本实施例的用于治疗因真菌深部感染导致中风的药品的原料药组成：天麻15克中含有的挥发油、半夏15克中含有的挥发油、白术10克中含有的挥发油、茯苓10克中含有的挥发油、鲜橘皮15克中含有的挥发油、甘草10克中含有的挥发油、川芎12克中含有的挥发油、寻骨风12克中含有的挥发油、青风藤15克中含有的挥发油。
按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天麻15克、半夏15克、白术10克、茯苓10克、甘草10克、川芎12克、寻骨风12克中提取出挥发油，鲜橘皮15克、青风藤15克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
当然，上述实施例仅仅是为了清楚地说明所作的举例，而非对实施方式的限定，对于本领域的普通技术人员来说，在上述说明的基础上还可以做出其他不同形式的变化或变动。这里无需也无法对所有的实施例予以穷举，而由此所引申的 显而易见的变化或变动仍处于本发明的保护范围之内。
本发明的创造性和新颖性
所以本发明提供的药品的创造性和新颖性表现在：本发明提供的药品是分别从植物药天麻、半夏、白术、茯苓、鲜橘皮、甘草中提取生物碱和(或)挥发油制备成化学药品，即把天麻的生物碱、半夏的生物碱、白术的生物碱、茯苓的生物碱、鲜橘皮的生物碱、甘草的生物碱按比例混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。相比现有的化学药品是取单一植物的生物碱制成的药品，具有显著的进步。它可以减少单一生物碱在药品中的含量，减少单一生物碱因用量过大而产生的毒性反应。比如从鸦片中分得的吗啡具有强烈的镇痛作用，就是因为其为单一生物碱，为达到疗效使其剂量过大而容易出现毒副作用。而且本发明提供的药品因是多种生物碱的协同作用，能更有效的靶向作用于不同的器官、血管组织。
相比现代制药方法制成的中药片剂、胶囊、颗粒剂等，本发明提供的药品具有显著的进步。中药不一定全是草药，也有动物、矿石类，现代中药最主要的特点就是无法知道所有成分，只是知道主要成分，即就是知道能治病的化学成分。而本发明提供的药品化学成分只有生物碱和挥发油。
本发明提供的药品药理机制清楚，天麻、半夏、白术、茯苓、鲜橘皮、甘草、钩藤、川芎、川乌、寻骨风、青风藤中含有的生物碱和挥发油其药理机制是抗真菌的药品，本人认为中风是由于真菌深部感染导致的，血液中的栓子是真菌繁殖脱落的菌丝团，而天麻、半夏、白术、茯苓、鲜橘皮、甘草、钩藤、川芎、川乌、寻骨风、青风藤中含有的生物碱和挥发油具有杀死真菌，分解菌丝团的作 用，即具有溶栓的作用。而且它们可以治疗不同动脉和静脉里的真菌，可以疏通不同的动脉和静脉的血液循环。
技术效果
传统经方《半夏白术天麻汤》已被临床证明是安全有效的。孙立亭以半夏白术天麻汤加菖蒲、郁金为基本方，以中医辨证加减用水煎剂的方法治疗脑动脉硬化14例，椎-基底动脉供血不足11例，取得良好的效果。申请人用原料药天麻、半夏、白术、茯苓、陈皮、甘草为基础方，辩证加减钩藤、川芎、川乌、寻骨风、青风藤用传统方法治疗因真菌深部感染引发的中风病人3例，在服药半个月后，中风的临床症状明显改善。本发明提供的药品是在传统经方《半夏白术天麻汤》为基础的原料药的提取物，提取植物药半夏、白术、天麻、茯苓、鲜橘皮、甘草、中含有的挥发油和生物碱制备成治疗因真菌导致中风的药品或保健品，因本发明提供的药品或保健品的化学成分明确，相比传统的制药方法，其有效性是显而易见的。

Claims (10)

  1. 一种治疗因真菌深部感染导致中风的药品，其特征在于，所述药品的原料药由天麻提取的生物碱和(或)挥发油、半夏提取的生物碱和(或)挥发油、白术提取的生物碱和(或)挥发油、茯苓提取的生物碱和(或)挥发油、鲜橘皮提取的生物碱和(或)挥发油、甘草提取的生物碱和(或)挥发油组成，所述药品的制备方法为：取天麻生物碱、半夏生物碱、白术生物碱、茯苓生物碱、鲜橘皮生物碱、甘草生物碱按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型；取天麻挥发油、半夏挥发油、白术挥发油、茯苓挥发油、鲜橘皮挥发油、甘草挥发油按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型；取天麻生物碱和挥发油、半夏生物碱和挥发油、白术生物碱和挥发油、茯苓生物碱和挥发油、鲜橘皮生物碱和挥发油、甘草生物碱和挥发油按一定比例混合，加入制备不同剂型时所需的各种常规辅料，制备成药学上可接受的剂型。
  2. 如权利要求1所述的药品，其特征在于，所述药品的原料药生物碱的重量份是：天麻生物碱0.01～50重量份、半夏生物碱0.01～50重量份、白术生物碱0.01～50重量份、茯苓生物碱0.01～50重量份、鲜橘皮生物碱0.01～50重量份、甘草生物碱0.01～50重量份。
  3. 如权利要求1所述的药品，其特征在于，所述药品的原料药挥发油的重量份是：天麻挥发油0.01～50重量份、半夏挥发油0.01～50重量份、白术挥发油0.01～50重量份、茯苓挥发油0.01～50重量份、鲜橘皮挥发油0.01～50重量份、甘草挥发油0.01～50重量份。
  4. 如权利要求1或2或3所述的药品，其特征在于，所述药品一天需要服用的 剂量进一步优选为：取天麻50克中合有的生物碱和挥发油的重量、半夏35克中合有的生物碱和挥发油的重量、白术30克中合有的生物碱和挥发油的重量、茯苓30克中合有的生物碱和挥发油的重量、鲜橘皮40克中合有的生物碱和挥发油的重量、甘草25克中合有的生物碱和挥发油的重量。
  5. 如权利要求1或2或3或4所述的药品，其特征在于，所述药品的制备方法为：从各植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草中提取生物碱和(或)挥发油制备成药品；生物碱的提取方法，可以采用有机溶剂提取后测定，用不同的溶剂将生物碱从植物中提取。首选超临界流体萃取法，其次选膜分离法或超声波提取方法或索氏提取等方法；挥发油的提取方法首选超临界流体萃取法，其次选择有机溶剂提取法：用石油醚、乙醚等有机溶剂采用连续回流提取法或冷浸法，或选水蒸气蒸馏法或冷压法提取，以常规的制备化学药品的方法制成片剂、粉针剂、软胶囊、颗粒剂或胶囊剂等药学上可接受的剂型。
  6. 如权利要求1或2或4或5所述的药品，其特征在于，所述药品的制备方法为按照选定原材料的重量份使用超临界流体萃取法或膜分离法分别从天麻50克、半夏35克、白术30克、茯苓30克、鲜橘皮40克、甘草25克中提取出生物碱，把各自的生物碱混合，加入常规辅料，按照常规制备化学药品的工艺制成片剂。
  7. 如权利要求1或3或4或5所述的药品，其特征在于，所述药品的制备方法为按照选定原材料的重量份使用超临界流体萃取法或有机溶剂提取法分别从天麻50克、半夏35克、白术30克、茯苓30克、甘草25克中提取出挥发油，鲜橘皮40克使用冷压法提取挥发油，再把各自的挥发油混合，加入常规辅料，按照常规制备化学药品的工艺制成软胶囊或颗粒剂。
  8. 如权利要求1或2或3或4或5或6或7所述的药品，其特征在于，所述药品可根据临床症状选择性增加原料药钩藤、川芎、川乌、寻骨风、青风藤中合有的生物碱和(或)挥发油。
  9. 如权利要求1或2或3或4或5或6或7或8所述的药品，其特征在于，所述药品的制备方法为：从各植物原料药天麻、半夏、白术、茯苓、鲜橘皮、甘草或钩藤或川芎或川乌或寻骨风或青风藤中提取生物碱和(或)挥发油制备成药品，以常规的制备化学药品的方法制成片剂、粉针剂、软胶囊、颗粒剂或胶囊剂等药学上可接受的剂型。
  10. 如权利要求1或2或3或4或5或6或7或8或9所述的药品，其特征在于，所述药品的适应范围包括：在医疗药品、保健食品、保健用品、动物药品、动物饲料方面的应用。
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