CN105920409A - Medicinal preparation for treating Alzheimer disease and application of medicinal preparation - Google Patents

Medicinal preparation for treating Alzheimer disease and application of medicinal preparation Download PDF

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CN105920409A
CN105920409A CN201610411425.0A CN201610411425A CN105920409A CN 105920409 A CN105920409 A CN 105920409A CN 201610411425 A CN201610411425 A CN 201610411425A CN 105920409 A CN105920409 A CN 105920409A
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parts
grams
pharmaceutical
radix
herba
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王传秀
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Qingdao Yuntian Biotechnology Co Ltd
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Qingdao Yuntian Biotechnology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/29Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296Epimedium
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/41Crassulaceae (Stonecrop family)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489Sophora, e.g. necklacepod or mamani
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535Perilla (beefsteak plant)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/54Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/69Polygalaceae (Milkwort family)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718Coptis (goldthread)
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/888Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention relates to a medicinal preparation for treating an Alzheimer disease and an application of the medicinal preparation. The medicinal preparation comprises coptis, perilla stems, epimedium, semen cuscutae, black soya beans, holly leaves, obcordateleaf raspberry fruits, burdock, wild rice shoots, orchis, liquorice, rhizoma acori graminei, polygala tenuifolia, rhodiola rosea, root of kudzu vine, eupatorium, piper cubeba, sophora flowers, Chuanxiong rhizome and borneol. The traditional Chinese medicine formula treats the Alzheimer disease by a qi regulating and blood circulation activating method. The medicinal preparation in the traditional Chinese medicine formula is low in therapeutic side effect and prepared from traditional Chinese medicines serving as raw materials through the scientific formula and repeated verification and preparation of clinical tests, conforms to the theory of traditional Chinese medicine, improves body immunity, has multiple action targets, is high in effective rate and suitable for clinical popularization and application, and has high development values.

Description

A kind of for pharmaceutical preparation treating Alzheimer and application thereof
Technical field
The present invention relates to, for medicine treating Alzheimer and application thereof, be used for treating alzheimer ' particularly to one Silent sick pharmaceutical preparation and purposes, belong to field of medicaments.
Background technology
Alzheimer (Alzheimer disease, AD), also referred to as senile dementia, is the common neurological of old people Property one of disease, be the lethal neurodegenerative diseases of a kind of Progressive symmetric erythrokeratodermia development, clinical manifestation be cognitive continuous with memory function Deteriorating, activity of daily living Progressive symmetric erythrokeratodermia goes down, with various neuropsychic symptoms and behavior disorder.AD prevalence in recent years With case fatality rate in gradually rising situation, according to statistics, ending the whole world in 2005 has 24,300,000 people to suffer from dementia, annual newly-increased dementia Case 4,600,000.The dull-witted number the nearlyest 8,000,000 of China, wherein AD nearly 6,000,000.In the age crowd more than 65 years old The sickness rate of AD accounts for the 50%-60% that age related is dull-witted.AD has been after cardiovascular disease, tumor and apoplexy The fourth-largest killer of the mankind, therefore, this will to family so that society causes increasingly white elephant, antidementia agent Research and development has caused the great attention of countries in the world the world of medicine.
In study medication achievement, the existing cholinester possessing evidence-based medical and accepted extensively by doctor and patient Enzyme inhibitor, glutamate receptor antagonists, calcium-ion channel antagonists;Be also possible to improve AD cognitive function of patients have The medicine of certain curative effect, and it has been applied to clinic, such as antioxidant, anti-inflammatory medicaments, improve brain metabolic drug etc., but mesh Front temporarily without abundant evidence-based medical support;Generally speaking, AD still lacks the medicine of satisfactory effect, unclear for the cause of disease, Multifactor relevant Complex Diseases, the feature of Chinese medicine Mutiple Targets, too many levels treatment may treat more advantage than Dan Badian.
The traditional Chinese medical science description of alzheimer disease can be sporadically appeared in " forgetful ", " forgetful ", " dementia ", " literary composition silly ", " dull-witted ", " melancholia ", In " insane disease " etc., to alzheimer disease in the understanding of etiology and pathogenesis than more consistent view it is: sick position is at brain, with internal organs merit Can imbalance relevant, to suffer from a deficiency of the kidney, relate to him dirty, turbid etc. as major pathogenetic factor with blood stasis, expectorant, characteristic of disease belongs to deficiency in origin and excess in superficiality, The deficiency and excesss that show as are interlocked more clinically.Chinese medicine is treating the differentiation of symptoms and signs for classification of syndrome of Alzheimer mainly to suffer from a deficiency of the kidney with phlegm syndrome the most Common, illustrate Alzheimer Chinese medical discrimination to suffer from a deficiency of the kidney, the most common expectorant is turbid blinds clear key, with prescription many employings the kidney invigorating, The medicine having one's ideas straightened out such as Rhizoma Acori Graminei, Radix Polygalae, Radix Polygoni Multiflori, Fructus Corni, Herba Epimedii etc., administering mode be traditional decoction oral to Medicine.Method that visible current clinical Chinese medicine Alzheimer is inheriting traditional and medicine.
Current Drug therapy, Western medicine is mainly based on Memantine hydrochloride tablet, but side effect is big, patient occur after taking addicted to Phenomenon, Chinese traditional treatment less effective, and the patient such as sleep, feel sick to be difficult to adhere to taking.
Summary of the invention
For the defect of prior art, the present invention be directed to the present situation treated at present, it is provided that one is used for treating Alzheimer Pharmaceutical preparation, have no side effect, effective.
Specifically, the concrete scheme of the present invention is achieved in that
First, inventor provides a kind of pharmaceutical preparation for treating Alzheimer, prescription according to drug matching experience In the Chinese medicine ingredients that contains be: Rhizoma Coptidis, Caulis Perillae, Herba Epimedii, Semen Cuscutae, Semen sojae atricolor, Folium Ilicis Cornutae, Fructus Rubi obcordati, Fructus Arctii, Caulis Zizaniae caduciflorae, Herba Orchidis Latifoliae, Radix Glycyrrhizae, Rhizoma Acori Graminei, Radix Polygalae, Radix Rhodiolae, Radix Puerariae, Herba Eupatorii, Fructus Litseae, Flos Sophorae, Rhizoma Chuanxiong, Borneolum Syntheticum.
Further, inventor provides a kind of pharmaceutical preparation for treating Alzheimer according to drug matching experience, place Each raw material dosage of side all has preferable curative effect, described formula and weight portion in the weight portion scope of the present invention: yellow Even 5-13 part, Caulis Perillae 6-14 part, Herba Epimedii 9-14 part, Semen Cuscutae 6-11 part, Semen sojae atricolor 5-10 part, Folium Ilicis Cornutae 10-18 Part, Fructus Rubi obcordati 5-16 part, Fructus Arctii 19-28 part, Caulis Zizaniae caduciflorae 7-14 part, Herba Orchidis Latifoliae 3-9 part, Radix Glycyrrhizae 8-16 part, Rhizoma Acori Graminei 15-29 part, Radix Polygalae 5-14 part, Radix Rhodiolae 8-17 part, Radix Puerariae 6-13 part, Herba Eupatorii 7-14 part, Fructus Litseae 3-11 part, Chinese scholartree Flower 10-30 part, Rhizoma Chuanxiong 5-14 part, Borneolum Syntheticum 6-10 part.
Further, carrying out preferably, reaching superior technique effect to the formula of above-mentioned weight portion, preferred formula is: Rhizoma Coptidis 9 parts, Caulis Perillae 10 parts, Herba Epimedii 11.5 parts, Semen Cuscutae 8.5 parts, 7.5 parts of Semen sojae atricolor, Folium Ilicis Cornutae 14 parts, Rubus pectinellus Really 10.5 parts, Fructus Arctii 24 parts, Caulis Zizaniae caduciflorae 10.5 parts, Herba Orchidis Latifoliae 6 parts, 12 parts of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 parts, Radix Polygalae 9.5 Part, Radix Rhodiolae 22.5 parts, Radix Puerariae 9.5 parts, Herba Eupatorii 10.5 parts, Fructus Litseae 7 parts, 20 parts of Flos Sophorae, Rhizoma Chuanxiong 9.5 parts, ice Sheet 8 parts.
Or:
Rhizoma Coptidis 9.5 parts, Caulis Perillae 10.5 parts, Herba Epimedii 12.5 parts, Semen Cuscutae 9 parts, 8.5 parts of Semen sojae atricolor, Folium Ilicis Cornutae 15 parts, Fructus Rubi obcordati 11.5 parts, Fructus Arctii 26 parts, Caulis Zizaniae caduciflorae 11.5 parts, Herba Orchidis Latifoliae 6 parts, 12.5 parts of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 parts, remote Will 10.5 parts, Radix Rhodiolae 23.5 parts, Radix Puerariae 9.5 parts, Herba Eupatorii 11.5 parts, Fructus Litseae 7.5 parts, 21 parts of Flos Sophorae, Rhizoma Chuanxiong 9.5 parts, Borneolum Syntheticum 8.5 parts.
In pharmaceutical preparation described above, the Chinese medicine used all uses its conventional medicinal part to be used as medicine, the dosage of drug used Rationally, after all medicines share, treatment Alzheimer is had to the effect of preferably treatment.
The function of each taste Chinese crude drug used in the pharmaceutical preparation of the treatment Alzheimer of the present invention is as follows:
Rhizoma Acori Graminei, acrid in the mouth, hardship, slightly warm in nature.
Gui Jing: GUIXIN, liver, spleen channel.
Function cures mainly: waking up the patient from unconsciousness by dissipating phlegm;Removing dampness circulation of qi promoting;Profit of dispeling the wind numbness;Reducing swelling and alleviating pain.Main calentura coma;Syncope due to accumulation of phlegm;Forgetful; Tinnitus;Deaf;Abdominal distention;Fasting dysentery;Rheumatic arthralgia;Traumatic injury;Carbuncle scabies.Neuroprotective, as pressed down The sinister and vicious property of excitement of NMDA processed and glutamate induction, suppresses monoamine oxidase A, when high dose, also has one to MA0B Fixed inhibitory action.
Radix Polygalae: bitter in the mouth, warm in nature.
Gui Jing: GUIXIN, kidney, lung meridian.
Function cures mainly: Fructus Alpiniae Oxyphyllae of calming the nerves, and eliminates the phlegm, detumescence.The insomnia and dreamful sleep caused for disarmony between the heart and kidney, forgetful palpitation with fear, mind Dimly, expectoration is not well, sore swollen toxin, breast swell and pain, god's Fructus Alpiniae Oxyphyllae, eliminates the phlegm, detumescence.The insomnia caused for disarmony between the heart and kidney Dreaminess, forgetful palpitation with fear, staring spells, expectoration is not well, sore swollen toxin.
Radix Rhodiolae: cold in nature, sweet in the mouth.
Gui Jing: lung meridian
Function cures mainly: QI invigorating lung heat clearing;Fructus Alpiniae Oxyphyllae is nourished heart;Hemostasis with astringents;Dissipating blood stasis for subsidence of swelling.Main deficiency of vital energy and physically weak;Fear of cold after being ill; Shortness of breath and fatigue;Cough due to lung-heat;Spitting of blood;Leucorrhea is suffered from diarrhoea;Traumatic injury;Burn and scald;Neurosis;Altitude sickness, yang invigorating expelling pathogenic factors from muscles, Rash antidiarrheal, relieving restlessness quenches the thirst, and Radix Puerariae total flavones and ethanol extract can improve cerebral cortex and Hippocampal Acetylcholine content, and reduce Hippocampal Acetylcholine transferase active, the Memory acquisition sexual disorders that antagonism east Liang alkali is imitated.
Borneolum Syntheticum: acrid in the mouth, hardship, cold in nature.
Gui Jing: GUIXIN, spleen, lung meridian.
Function cures mainly: refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Faint for calentura coma, convulsion, apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, attacked by pestiferous factors Stupor, conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.
Rhizoma Chuanxiong: acrid in the mouth, warm in nature.
Gui Jing: return liver, gallbladder, pericardium channel.
Function cures mainly: blood-activating and qi-promoting, wind-expelling pain-stopping.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen suffers from abdominal pain, breast side of body twinge, Tumbling and swelling, headache, rheumatic arthralgia.
Flos Sophorae: bitter in the mouth, cold in nature.
Gui Jing: return liver, large intestine channel.
Function cures mainly: cooling blood for hemostasis, purging liver-fire.For having blood in stool, hemorrhoidal bleeding, dysentery, metrorrhagia, spit blood, epistaxis, liver-heat Conjunctival congestion, dizziness of having a headache.
Fructus Litseae: acrid in the mouth, warm in nature.
Gui Jing: return spleen, stomach, kidney, bladder warp.
Effect: warming spleen and stomach for dispelling cold, promoting the circulation of QI to relieve pain, for cold syndrome of the stomach vomiting, coldness and pain in the epigastrium, colic of cold type suffers from abdominal pain, stagnancy of cold-damp, Turbid urine.
Herba Eupatorii: acrid in the mouth, property is put down.
Gui Jing: return spleen, stomach, lung meridian.
Function cures mainly: removing dampness by means of aromatics, appetizing of being amusing, and delivers expelling summer-heat.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass vomiting and nausea, sweet greasy in mouth, Halitosis, sialism, heat-damp in summer table disease, feeling of fullness in the head is uncomfortable in chest.
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: enter spleen, stomach, the heart, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain.
Herba Orchidis Latifoliae: sweet in the mouth, property is put down.
Function cures mainly: heart tonifying, and the kidney invigorating is promoted the production of body fluid, and quenches the thirst, strengthening the spleen and stomach.
Irritated thirsty, anorexia, menoxenia.Asthenia anemia, dizzy, dim eyesight.、
Caulis Zizaniae caduciflorae: sweet in the mouth, cold in nature
Gui Jing: liver;Spleen;Lung meridian.
Function cures mainly: relieving heat toxin;Relieving thirst and restlessness;Profit two is just.Main dysphoria with smothery sensation;Quench one's thirst;Constipation and anuresis;Jaundice;Dysentery;Pyretic stranguria; Conjunctival congestion;Breast antiperspirant not under;Skin infection.
Fructus Arctii: acrid in the mouth, cold in nature.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat.For anemopyretic cold, cough with copious phlegm, measles, rubella, Laryngopharynx swelling and pain, mumps erysipelas, carbuncle sore tumefacting virus.
Fructus Rubi obcordati: sour in the mouth, property is put down.
Function cures mainly: the kidney invigorating arresting seminal emission.Control neurasthenia, polyuria, seminal emission, premature ejaculation.
Folium Ilicis Cornutae: bitter in the mouth, cool in nature.
Gui Jing: return liver, kidney channel.
Function cures mainly: clearing away heat and nourishing YIN, suppressing the hyperactive liver, kidney tonifying.Spit blood for pulmonary tuberculosis, osteopyrexia and fever, have a dizzy spell;Hypertension.
Semen sojae atricolor: sweet in the mouth, property is put down
Gui Jing: spleen, kidney.
Function cures mainly: blood-enriching tranquillizing, improving eyesight spleen invigorating, the kidney invigorating tonifying YIN, removing toxic substances, edema due to deficiency of the spleen, beriberi edema, the people of body void And cold perspiration, old man's nephrasthenia deafness, children's's enuresis nocturna after infantile night sweat, spontaneous perspiration, especially calentura.
Semen Cuscutae: sweet in the mouth, warm in nature.
Gui Jing: return liver,kidney,spleen warp.
Function cures mainly: nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal, for impotence and seminal emission, dripping urination, loses Urinating frequently, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down.
Herba Epimedii: acrid in the mouth, warm in nature.
Gui Jing: return liver, kidney channel.
Function cures mainly: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, numb inflexible Contraction;Climacteric hypertension.
Caulis Perillae: acrid in the mouth, warm in nature.
Gui Jing: return lung, spleen channel.
Function cures mainly: regulating the flow of QI to ease the stomach, and pain relieving is antiabortive.Vexed for chest and diaphragm painful abdominal mass, gastralgia, belch vomiting, frequent fetal movement.
Rhizoma Coptidis: bitter in the mouth, cold in nature.
Gui Jing: GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.
Function cures mainly: heat clearing and damp drying, eliminating fire and detoxication.For damp and hot feeling of fullness, vomit acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, Hyperactivity of heart-fire, dysphoria and insomnia, heat in blood tells nosebleed, conjunctival congestion, and toothache is quenched one's thirst, carbuncle furuncle;External treatment eczema, eczema, auditory meatus Suppurate.It is burning hot that Rhizoma Coptidis (processed with wine) is apt to the clear part of the body cavity above the diaphragm housing the heart and lungs.For conjunctival congestion, aphtha.Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice clearing stomach stomach function regulating preventing or arresting vomiting.Tie mutually for cold and heat, wet Hankering resistance, feeling of fullness is vomitted.Cornel Rhizoma Coptidis soothing liver-QI stomach function regulating preventing or arresting vomiting.For incoordination between the liver and stomach, vomit acid regurgitation.
Above material medicine is extracted is prepared as pharmaceutically acceptable preparation.Pharmaceutical dosage form of the present invention selected from granule, In capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill One.More preferably granule or capsule or tablet.
The application in preparing Alzheimer disease drugs of the above preparation.The preparation method of its preparation is:
Traditional Chinese medicinal material raw materials is weighed up according to weight, with soak by water 3 times, each 40-60 minute, filters, merging filtrate, filter Liquid is evaporated to every 1 milliliter and is equivalent to raw medicinal herbs amount 1 weight portion, obtains decoction;Or sterilized, filling bottle, obtain oral Liquid;Or conventional method adds magnesium stearate, mixing, tabletting, coating, obtains tablet;Or addition conventional excipients, Load capsule, obtain capsule.
Wherein the preparation method of granule is:
(1) being weighed up according to weight by traditional Chinese medicinal material raw materials, add pure water and soak, the water surface is higher than powder 6-8cm, soaks 2.5 After hour, decoct 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merge decoction liquor, decompression Being concentrated into relative density is 1.06, standby;
(2) add the ethanol of 1.5 times 75% after the cooling of above-mentioned decocting liquid, fully mix, stand overnight so that it is precipitation, 24h Take its supernatant afterwards, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletizing, obtain granule, granule often wraps weight 10g.
Compared with prior art, the present invention has the advantage that with good effect and is:
The technical problem to be solved be to provide a kind of, few side effects better than existing curative effect of medication, can prolonged application in Control the Chinese medicinal formulae of Alzheimer cancer conditions of patients.This Chinese prescription is economic and practical, and from regulating the flow of vital energy, the method invigorated blood circulation is controlled Treating Alzheimer, the pharmaceutical preparation of Chinese prescription is low in treatment side effect, and the Chinese medicine using Chinese tradition is raw material, warp The prescription of science, and formulated by repeatedly verifying of clinical trial, meet the theory of Chinese medicine.Improve simultaneously The immunity of health, multiaction target spot, effective percentage is high, is suitable for clinical application, has higher Development volue.
Detailed description of the invention
The detailed description of the invention of the following stated, the only present invention, protection scope of the present invention is not limited thereto, any familiar Those skilled in the art in the technical scope that the invention discloses, the change that can readily occur in or replacement, all should contain Within protection scope of the present invention.
Embodiment 1: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 5 grams, Caulis Perillae 6 grams, Herba Epimedii 9 grams, Semen Cuscutae 6 grams, 5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 10 grams, Fructus Rubi obcordati 5 grams, Fructus Arctii 19 grams, Caulis Zizaniae caduciflorae 7 grams, Herba Orchidis Latifoliae 3 grams, 8 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 15 grams, Radix Polygalae 5 grams, Radix Rhodiolae 8 grams, Radix Puerariae 6 grams, Herba Eupatorii 7 grams, Fructus Litseae 3 grams, 10 grams of Flos Sophorae, Rhizoma Chuanxiong 5 grams, Borneolum Syntheticum 6 grams.
Above Chinese medicine composition is prepared as decoction, its concrete preparation method:
Being weighed up according to weight by traditional Chinese medicinal material raw materials, add pure water and soak, the water surface is higher than powder 3-5cm, after soaking 2 hours, Decocting 2 times, 1.5 hours for the first time, 1 hour for the second time, merge decoction liquor, medicinal liquid divides two grams, sooner or later respectively takes one gram.
Embodiment 2: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 13 grams, Caulis Perillae 14 grams, Herba Epimedii 14 grams, Semen Cuscutae 11 grams, 10 grams of Semen sojae atricolor, Folium Ilicis Cornutae 18 grams, Fructus Rubi obcordati 16 grams, Fructus Arctii 28 grams, Caulis Zizaniae caduciflorae 14 grams, Herba Orchidis Latifoliae 9 grams, 16 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 29 grams, Radix Polygalae 14 Gram, Radix Rhodiolae 17 grams, Radix Puerariae 13 grams, Herba Eupatorii 14 grams, Fructus Litseae 11 grams, 30 grams of Flos Sophorae, Rhizoma Chuanxiong 14 grams, Borneolum Syntheticum 10 grams.
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 3: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9 grams, Caulis Perillae 10 grams, Herba Epimedii 11.5 grams, Semen Cuscutae 8.5 grams, 7.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 14 grams, Fructus Rubi obcordati 10.5 grams, Fructus Arctii 24 grams, Caulis Zizaniae caduciflorae 10.5 grams, Herba Orchidis Latifoliae 6 grams, 12 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 grams, remote Will 9.5 grams, Radix Rhodiolae 22.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 10.5 grams, Fructus Litseae 7 grams, 20 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 Gram, Borneolum Syntheticum 8 grams.
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 4: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9.5 grams, Caulis Perillae 10.5 grams, Herba Epimedii 12.5 grams, Semen Cuscutae 9 grams, 8.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 15 grams, Fructus Rubi obcordati 11.5 grams, Fructus Arctii 26 grams, Caulis Zizaniae caduciflorae 11.5 grams, Herba Orchidis Latifoliae 6 grams, 12.5 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 grams, remote Will 10.5 grams, Radix Rhodiolae 23.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 11.5 grams, Fructus Litseae 7.5 grams, 21 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 grams, Borneolum Syntheticum 8.5 grams.
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 5: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 5 grams, Caulis Perillae 6 grams, Herba Epimedii 9 grams, Semen Cuscutae 6 grams, 5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 10 grams, Fructus Rubi obcordati 5 grams, Fructus Arctii 19 grams, Caulis Zizaniae caduciflorae 7 grams, Herba Orchidis Latifoliae 3 grams, 8 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 15 grams, Radix Polygalae 5 grams, Radix Rhodiolae 8 grams, Radix Puerariae 6 grams, Herba Eupatorii 7 grams, Fructus Litseae 3 grams, 10 grams of Flos Sophorae, Rhizoma Chuanxiong 5 grams, Borneolum Syntheticum 6 grams.
Above Chinese medicine composition is prepared as granule, its concrete preparation method:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add pure water soak, the water surface be higher than powder 4cm, soak 2.5 little Shi Hou, decocts 3 times, 1 hour for the first time, 0.5 hour for the second time, 0.5 hour for the third time, merges decoction liquor, reduce pressure dense Being reduced to relative density is 1.06, standby;
(2) add the ethanol of 1 times 75% after the cooling of above-mentioned decocting liquid, fully mix, stand overnight so that it is precipitation, 24h Take its supernatant afterwards, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.15 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletize, obtain granule.
Embodiment 6: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 13 grams, Caulis Perillae 14 grams, Herba Epimedii 14 grams, Semen Cuscutae 11 grams, 10 grams of Semen sojae atricolor, Folium Ilicis Cornutae 18 grams, Fructus Rubi obcordati 16 grams, Fructus Arctii 28 grams, Caulis Zizaniae caduciflorae 14 grams, Herba Orchidis Latifoliae 9 grams, 16 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 29 grams, Radix Polygalae 14 Gram, Radix Rhodiolae 17 grams, Radix Puerariae 13 grams, Herba Eupatorii 14 grams, Fructus Litseae 11 grams, 30 grams of Flos Sophorae, Rhizoma Chuanxiong 14 grams, Borneolum Syntheticum 10 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 7: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9 grams, Caulis Perillae 10 grams, Herba Epimedii 11.5 grams, Semen Cuscutae 8.5 grams, 7.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 14 grams, Fructus Rubi obcordati 10.5 grams, Fructus Arctii 24 grams, Caulis Zizaniae caduciflorae 10.5 grams, Herba Orchidis Latifoliae 6 grams, 12 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 grams, remote Will 9.5 grams, Radix Rhodiolae 22.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 10.5 grams, Fructus Litseae 7 grams, 20 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 Gram, Borneolum Syntheticum 8 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 8: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9.5 grams, Caulis Perillae 10.5 grams, Herba Epimedii 12.5 grams, Semen Cuscutae 9 grams, 8.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 15 grams, Fructus Rubi obcordati 11.5 grams, Fructus Arctii 26 grams, Caulis Zizaniae caduciflorae 11.5 grams, Herba Orchidis Latifoliae 6 grams, 12.5 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 grams, remote Will 10.5 grams, Radix Rhodiolae 23.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 11.5 grams, Fructus Litseae 7.5 grams, 21 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 grams, Borneolum Syntheticum 8.5 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 9: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 5 grams, Caulis Perillae 6 grams, Herba Epimedii 9 grams, Semen Cuscutae 6 grams, 5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 10 grams, Fructus Rubi obcordati 5 grams, Fructus Arctii 19 grams, Caulis Zizaniae caduciflorae 7 grams, Herba Orchidis Latifoliae 3 grams, 8 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 15 grams, Radix Polygalae 5 grams, Radix Rhodiolae 8 grams, Radix Puerariae 6 grams, Herba Eupatorii 7 grams, Fructus Litseae 3 grams, 10 grams of Flos Sophorae, Rhizoma Chuanxiong 5 grams, Borneolum Syntheticum 6 grams.
Above Chinese medicine composition is prepared as tablet, its concrete preparation method:
Traditional Chinese medicinal material raw materials is weighed up according to weight, after soak with ethanol 8-12 hour, with 20-25 times of weight 75-85% ethanol 2 times Backflow, refluxes 1-1.5 hour after each micro-boiling, filters, and recovery ethanol, to without alcohol taste, obtains extract;Low-temperature evaporation is to thick paste Shape, wet granulation, it is dried, adds appropriate median chain triglyceride oil and tween 80, mannitol, obtain tablet.
Embodiment 10: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 13 grams, Caulis Perillae 14 grams, Herba Epimedii 14 grams, Semen Cuscutae 11 grams, 10 grams of Semen sojae atricolor, Folium Ilicis Cornutae 18 grams, Fructus Rubi obcordati 16 grams, Fructus Arctii 28 grams, Caulis Zizaniae caduciflorae 14 grams, Herba Orchidis Latifoliae 9 grams, 16 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 29 grams, Radix Polygalae 14 Gram, Radix Rhodiolae 17 grams, Radix Puerariae 13 grams, Herba Eupatorii 14 grams, Fructus Litseae 11 grams, 30 grams of Flos Sophorae, Rhizoma Chuanxiong 14 grams, Borneolum Syntheticum 10 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 9.
Embodiment 11: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9 grams, Caulis Perillae 10 grams, Herba Epimedii 11.5 grams, Semen Cuscutae 8.5 grams, 7.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 14 grams, Fructus Rubi obcordati 10.5 grams, Fructus Arctii 24 grams, Caulis Zizaniae caduciflorae 10.5 grams, Herba Orchidis Latifoliae 6 grams, 12 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 grams, remote Will 9.5 grams, Radix Rhodiolae 22.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 10.5 grams, Fructus Litseae 7 grams, 20 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 Gram, Borneolum Syntheticum 8 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 9.
Embodiment 12: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9.5 grams, Caulis Perillae 10.5 grams, Herba Epimedii 12.5 grams, Semen Cuscutae 9 grams, 8.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 15 grams, Fructus Rubi obcordati 11.5 grams, Fructus Arctii 26 grams, Caulis Zizaniae caduciflorae 11.5 grams, Herba Orchidis Latifoliae 6 grams, 12.5 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 grams, remote Will 10.5 grams, Radix Rhodiolae 23.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 11.5 grams, Fructus Litseae 7.5 grams, 21 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 grams, Borneolum Syntheticum 8.5 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 9.
Embodiment 13: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 5 grams, Caulis Perillae 6 grams, Herba Epimedii 9 grams, Semen Cuscutae 6 grams, 5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 10 grams, Fructus Rubi obcordati 5 grams, Fructus Arctii 19 grams, Caulis Zizaniae caduciflorae 7 grams, Herba Orchidis Latifoliae 3 grams, 8 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 15 grams, Radix Polygalae 5 grams, Radix Rhodiolae 8 grams, Radix Puerariae 6 grams, Herba Eupatorii 7 grams, Fructus Litseae 3 grams, 10 grams of Flos Sophorae, Rhizoma Chuanxiong 5 grams, Borneolum Syntheticum 6 grams.
Above Chinese medicine composition is prepared as capsule, its concrete preparation method:
Traditional Chinese medicinal material raw materials is weighed up according to weight, after soak with ethanol 8-12 hour, with 20-25 times of weight 75-85% ethanol 2 times Backflow, refluxes 1-1.5 hour after each micro-boiling, filters, and recovery ethanol, to without alcohol taste, obtains extract;Low-temperature evaporation is to thick paste Shape, wet granulation, it is dried, adds appropriate powder-beta-dextrin and binding agent, mannitol, obtain capsule.
Embodiment 14: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 13 grams, Caulis Perillae 14 grams, Herba Epimedii 14 grams, Semen Cuscutae 11 grams, 10 grams of Semen sojae atricolor, Folium Ilicis Cornutae 18 grams, Fructus Rubi obcordati 16 grams, Fructus Arctii 28 grams, Caulis Zizaniae caduciflorae 14 grams, Herba Orchidis Latifoliae 9 grams, 16 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 29 grams, Radix Polygalae 14 Gram, Radix Rhodiolae 17 grams, Radix Puerariae 13 grams, Herba Eupatorii 14 grams, Fructus Litseae 11 grams, 30 grams of Flos Sophorae, Rhizoma Chuanxiong 14 grams, Borneolum Syntheticum 10 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 13.
Embodiment 15: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9 grams, Caulis Perillae 10 grams, Herba Epimedii 11.5 grams, Semen Cuscutae 8.5 grams, 7.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 14 grams, Fructus Rubi obcordati 10.5 grams, Fructus Arctii 24 grams, Caulis Zizaniae caduciflorae 10.5 grams, Herba Orchidis Latifoliae 6 grams, 12 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 grams, remote Will 9.5 grams, Radix Rhodiolae 22.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 10.5 grams, Fructus Litseae 7 grams, 20 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 Gram, Borneolum Syntheticum 8 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 13.
Embodiment 16: a kind of pharmaceutical preparation treating Alzheimer, includes than its composition according to weight fraction:
Rhizoma Coptidis 9.5 grams, Caulis Perillae 10.5 grams, Herba Epimedii 12.5 grams, Semen Cuscutae 9 grams, 8.5 grams of Semen sojae atricolor, Folium Ilicis Cornutae 15 grams, Fructus Rubi obcordati 11.5 grams, Fructus Arctii 26 grams, Caulis Zizaniae caduciflorae 11.5 grams, Herba Orchidis Latifoliae 6 grams, 12.5 grams of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 grams, remote Will 10.5 grams, Radix Rhodiolae 23.5 grams, Radix Puerariae 9.5 grams, Herba Eupatorii 11.5 grams, Fructus Litseae 7.5 grams, 21 grams of Flos Sophorae, Rhizoma Chuanxiong 9.5 grams, Borneolum Syntheticum 8.5 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 13.
Behavioristics's change of embodiment 17:Morris determined with Morris water Alzheimer mice
Memantine is mainly composed of chemical name: MEM amine hydrochlorate, is commonly used to clinically In being mainly used to treat, severe is to severe dementia of the Alzheimer type.The present invention selects it to test as positive control.
17.1, mice modeling and administration
The present invention selects 9 monthly age mices according to Richardson etc. at rats with bilateral Hippocampus CA 3 Region single injection state of aggregation A β 1-42 Method make AD model, it is divided into immediately model group, experiment A group, experiment B group, experiment C group, experiment D group, experiment E group, experiment F group and positive controls, often group 10, male and female half and half.Model group takes memantine 5mg/kg, tests A Group takes the pharmaceutical preparation (2.5g/kg) of embodiment 2, and experiment B group takes the pharmaceutical preparation (2.5g/kg) of embodiment 3, experiment C group clothes With the pharmaceutical preparation (2.5g/kg) of embodiment 7, experiment D group is taken the pharmaceutical preparation (2.5g/kg) of embodiment 11, is tested E group and take reality Executing the pharmaceutical preparation (2.5g/kg) of example 15, experiment F group is taken the pharmaceutical preparation (5g/kg) of embodiment 7, is separately taken 10 mices as right According to test, above-mentioned all mice medications are gastric infusion, once a day, and early 8:00.
17.2, test method
(Holland's Noldus company Ethovision XT monitoring is analyzed soft to utilize Morris water maze to carry out mice behavior analysis Part, Morris water maze system).Water maze test process is divided into the hiding platform of continuous 5d to obtain the space exploration of test and the 6th day Test two parts, every time by test packet and design dosed administration before test.Train every day 4 times, make mice in not same district every time Territory Xia Shui, water maze is divided into 1,2,3,4 regions, platform that is the 5th region by all directions, is positioned at the 4th region.Trip every time Swimming time 60s, every time training interval about 1h, mice does not find platform to calculate incubation period by 60s.Hide platform and obtain test Detection mice study capacitation;Space exploration testing inspection mice spatial memory capacity.
17.3. data statistics and processing method
Utilizing SPSS16.0 software statistics analysis, the escape latency hidden in platform acquisition test uses the variance of multiple measurement to divide Analysis study test is the most effective;The swimming time of all quadrants in space search test uses single factor test variance with passing through targeted number Analyze.Data acquisition mean ± standard deviation, the significance level of difference is set to bilateral P=0.05.
17.4. result of the test and discussion
The each treated animal of table 1 hides search platform incubation period (s) in platform test
Note
Compare with model group,#P < 0.05,##P < 0.01;
Compare with positive controls,P < 0.05,※※P < 0.01.
Table 2 each treated animal land regions time of staying and number of times
Note
Compare with model group,#P < 0.05,##P < 0.01;
Compare with positive controls,P < 0.05,※※P < 0.01.
As can be seen from Table 1 and Table 2, Chinese medicine preparation of the present invention can significantly improve animal learning memory impairment, significantly improves study and obtains Ability and spatial memory capacity, and its effect is significantly better than positive controls.This result shows, the pharmaceutical preparation in the present invention There is in terms of the treatment to Alzheimer syndrome huge Development volue.
17.5, acute toxicity test
Tested Chinese medicine preparation: the pharmaceutical preparation manufactured by embodiment of the present invention 1-16, makes solution, standby.
Experimental animal: regular grade kunming mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.
The solution of mouse stomach formulating medicinal preparations of the present invention, when given low reaches 735.5g crude drug/kg dosage, after administration, mice goes out Existing light activity reduces, and within about 1 hour, recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, Diet, take the photograph water, urine and body weight increase the most normal.
Result of the test shows: this medicine acute toxicity is extremely low, clinical drug safety.
17.6, long-term toxicity test for animals
Tested Chinese medicine preparation: the pharmaceutical preparation manufactured by embodiment of the present invention 1-16, makes solution, standby.
Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
4 kinds of pharmaceutical preparatioies: be divided into high, medium and low three dosage groups, per weight dosage be respectively patient's dose 180, 60,20 times;Experimental mouse is randomly divided into 49 groups, and wherein the pharmaceutical preparation of 48 groups of difference 3 kinds of three dosage of gavage, remains 1 group of filling Stomach normal saline (40 times of patient's dose);All 48 groups of gavages 180 days all continuously, observe animal general toxic reaction and serious Degree, place after death checks each position by rule of operation, and carries out hematology, ALT, BUN and the heart, liver, spleen, lung, kidney, The pathological examination of the main organs such as stomach;Through long-term feeding, all there is not toxic reaction in 13 groups of rats.Physically well develop.Naked eyes Outward appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group without pathologic change.Pathology report Accuse the most significant changes such as the heart, liver, spleen, lung, kidney, stomach, it is therefore contemplated that through proved by pathology, pharmaceutical preparation is to animal Show without chronic toxicity.
By two above toxicity test, it was demonstrated that the present invention is safe by the pharmaceutical preparation that embodiment 1-16 makes, nontoxic secondary work , can be taken by patient.
Embodiment 18: clinical experiment
18.1, physical data
Choose and in October, 2013~in February, 2016 enter group participation experiment the 100 example AD patients that my institute treats.Participant Meet the diagnostic criteria of " Chinese Spirit Obstacles classification and diagnostic criteria " the 3rd edition Alzheimer, get rid of vascular dementia And the mentally disturbed caused by other disease of brain.Women 52 example, male 48 example, age 65~91 years old, the mean age (65.8 ± 18.6) Year.The course of disease is the shortest 1 year, the longest 12 years, average 5.7 years.Monthly carry out before treatment and in treatment hematuria conventional, biochemical, The parallel electrocardiogram of lab testing, the EEG (electrocardiogram) examination such as blood ester, hepatic and renal function, check after terminating the course for the treatment of.
18.2, therapeutic scheme
Patient in this clinical trial is divided into 2 groups, respectively experimental group and matched group, and between two groups, patient profiles is consistent, without aobvious Write difference, be a course for the treatment of with 12 weeks.
Experimental group: 50 examples are the granule of the embodiment 7 of prescription of the present invention, wrap every day 2, the most once;20 days one The course for the treatment of, continuously 5 courses for the treatment of of treatment.
Matched group: 50 example maximal dose every day 20mg.Taking Memantine hydrochloride tablet, the dosage treated first week is 5mg every day (half, morning take), second week 10mg every day (each half, every day twice), the 3rd week every day 15mg (take one in the morning Sheet, takes half afternoon), take maintenance dose 20mg every day (the most a piece of, every day twice) of recommendation after the 4th week starts. 20 days courses for the treatment of, continuously 5 courses for the treatment of of treatment.
18.3, criterion of therapeutical effect
With reference to revision Webster adult's memory scale handbook.Before treatment, treat rear 5 course for the treatment of ends employing mini-mental state (MMSE), Webster adult's memory table (WMS) and vital function scale (ADL) are marked.According to MMSE score value Improvement situation evaluation AD curative effect:
Effective, improve >=4 points;
Effectively, 1~3 point is improved:
Invalid, substantially without changing before and after scoring.
Obvious effective rate=effective+effectively/total individual number.
18.4, therapeutic outcome
Before and after treatment, detection hematuria routine, biochemistry, blood ester, hepatic and renal function etc. all have no adverse effects.Matched group, 3 examples occur light Degree dizziness, 2 example stomach discomfort, it is not necessary to symptomatic treatment does not all affect Ureteral Calculus.Experimental group, 1 example is had a sleepless night once in a while, it is not necessary to right Disease treats the observation that do not affects the treatment, experimental group.It is shown in Table 3.
The therapeutic outcome of 3 liang of table group medicine
Group Effective Effectively Invalid Obvious effective rate
Matched group (50 example) 20 18 12 88%
Experimental group (50 example) 32 16 2 98%
From table 3 it can be seen that effective 20 examples of matched group, effective 18 examples, invalid 12 examples, total effective rate 88%;Experimental group Effective 32 examples, effective 16 examples, invalid 2 examples, total effective rate 98%, therapeutic effect is substantially better than prior art.
18.5, model case
Case 1: season, female, 68 years old, Shandong region people.Over 2013, my institute checks, family members accompany and tell, season exists Have a strong temperament at an early age, a pure female man, before 3 years, vagueness in memory occurred, the road gone home can not find, even more serious After being, household is not recognized, Drug therapy always after making a definite diagnosis before 3 years, but bad during state of an illness fashion, after carrying out outpatient clinic, warp Crossing guardian to agree to understand into group, check that hematuria routine, biochemistry, blood ester, hepatic and renal function etc. are all normal, Therapeutic Method is this The pharmaceutical preparation of inventive embodiment 7, allows its household assist dredging psychology simultaneously, keeps good daily life and psychology shape State, further consultation after 3 months, situation is clearly better, and life can be taken care of oneself, and also has the sensation of relatives to household, nothing in therapeutic process Uncomfortable or any untoward reaction, continues to take 3 months, the basic rehabilitation of patient, Effect of follow-up visit by telephone not recurrence in 1 year.
Case 2: Zhao, man, 77 years old, people from Handan, Hebei.In May, 2015, my institute checked, household accompanies and tells, 6 Year, the my old man of front Zhao was dead, lived by oneself always, depressed, bad during mental status fashion, and before 1 year, household finds to suffer from Person is the most forgetful, often forgets key, mobile phone etc., household accompanies him more, but after half a year, old man does not recognize and goes home Road, the ability oneself taken care of number one is substantially reduced, and when hospital of districts and cities is diagnosed as AD, agrees to understand into group, inspection through guardian Have a blood test routine urinalysis, biochemistry, blood ester, hepatic and renal functions etc. are all normal, and Therapeutic Method is the pharmaceutical preparation of embodiments of the invention 7, Further consultation after 3 months, situation is clearly better, and life can be taken care of oneself, and can also oneself go home after going out, without uncomfortable in therapeutic process Or any untoward reaction, continue to take 3 months, the basic rehabilitation of patient, Effect of follow-up visit by telephone not recurrence in 1 year.
Embodiment 19: human toxicity is tested
Randomly draw medical patients with Alzheimer disease 50 example, age 25~60 years old, average 41.5 years old, the maleest 25 examples, female 25 examples;The course of disease is the shortest 1 year, the longest 12 years, average 5.7 years.Carry out toxicity assessment.
19.1, toxicity assessment
Health check-up of each work after continuing one month with drug administration before medication, health check-up project:
(1) general health check-up project: temperature pulse respiration;
(2) blood, urine, stool routine examination inspection, before and after treatment, each work is once;
(3) liver function AST, ALT;Renal function BUN, CR and blood glucose;Cardiac function CPK, LDH, EKG;Coagulation function and Platelet.
19.2, to toxicity assessment classification, standard is as follows:
0 grade: avirulence Symptoms;
L level: mild toxicity Symptoms;
2 grades: moderate signs of toxicity shows;
3 grades: serious toxicity Symptoms;
4 grades: threat to life signs of toxicity shows;
Draw according to physical examination result analysis, in 50 example patients with Alzheimer disease, 0 grade of 49 people, 1 grade of 1 people, 3 grade of 0 people, 4 grade of 0 people.Only have 1 example laxativeness, occur that the probability of side reaction is little.
It can be seen that pharmaceutical preparation of the present invention can efficiently control the disease of patients with Alzheimer disease from curative effect and toxicity assessment Change process, and toxic and side effects is less.

Claims (8)

1. one kind for treating the pharmaceutical preparation of Alzheimer, it is characterised in that: described pharmaceutical preparation includes following Chinese crude drug: Rhizoma Coptidis, Caulis Perillae, Herba Epimedii, Semen Cuscutae, Semen sojae atricolor, Folium Ilicis Cornutae, Fructus Rubi obcordati, Fructus Arctii, Caulis Zizaniae caduciflorae, Herba Orchidis Latifoliae, Radix Glycyrrhizae, Rhizoma Acori Graminei, Radix Polygalae, Radix Rhodiolae, Radix Puerariae, Herba Eupatorii, Fructus Litseae, Flos Sophorae, Rhizoma Chuanxiong, Borneolum Syntheticum.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Rhizoma Coptidis 5-13 part, Caulis Perillae 6-14 part, Herba Epimedii 9-14 part, Semen Cuscutae 6-11 part, Semen sojae atricolor 5-10 part, Folium Ilicis Cornutae 10-18 Part, Fructus Rubi obcordati 5-16 part, Fructus Arctii 19-28 part, Caulis Zizaniae caduciflorae 7-14 part, Herba Orchidis Latifoliae 3-9 part, Radix Glycyrrhizae 8-16 part, stone Chang Pu 15-29 part, Radix Polygalae 5-14 part, Radix Rhodiolae 8-17 part, Radix Puerariae 6-13 part, Herba Eupatorii 7-14 part, Fructus Litseae 3-11 part, Flos Sophorae 10-30 part, Rhizoma Chuanxiong 5-14 part, Borneolum Syntheticum 6-10 part.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Rhizoma Coptidis 9 parts, Caulis Perillae 10 parts, Herba Epimedii 11.5 parts, Semen Cuscutae 8.5 parts, 7.5 parts of Semen sojae atricolor, Folium Ilicis Cornutae 14 parts, Huang Bubble fruit 10.5 parts, Fructus Arctii 24 parts, Caulis Zizaniae caduciflorae 10.5 parts, Herba Orchidis Latifoliae 6 parts, 12 parts of Radix Glycyrrhizae, Rhizoma Acori Graminei 25 parts, Radix Polygalae 9.5 parts, Radix Rhodiolae 22.5 parts, Radix Puerariae 9.5 parts, Herba Eupatorii 10.5 parts, Fructus Litseae 7 parts, 20 parts of Flos Sophorae, Rhizoma Chuanxiong 9.5 Part, Borneolum Syntheticum 8 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Rhizoma Coptidis 9.5 parts, Caulis Perillae 10.5 parts, Herba Epimedii 12.5 parts, Semen Cuscutae 9 parts, 8.5 parts of Semen sojae atricolor, Folium Ilicis Cornutae 15 parts, Fructus Rubi obcordati 11.5 parts, Fructus Arctii 26 parts, Caulis Zizaniae caduciflorae 11.5 parts, Herba Orchidis Latifoliae 6 parts, 12.5 parts of Radix Glycyrrhizae, Rhizoma Acori Graminei 26 parts, Radix Polygalae 10.5 parts, Radix Rhodiolae 23.5 parts, Radix Puerariae 9.5 parts, Herba Eupatorii 11.5 parts, Fructus Litseae 7.5 parts, 21 parts of Flos Sophorae, Rhizoma Chuanxiong 9.5 parts, Borneolum Syntheticum 8.5 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that: described pharmaceutical dosage form is selected from granule, capsule, sheet One in agent, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill.
Pharmaceutical preparation the most according to claim 5, it is characterised in that: described pharmaceutical dosage form is selected from preferably granule or capsule Or tablet is a kind of.
7. the preparation method of the granule described in claim 1-6, it is characterised in that concrete step is included as:
(1) being weighed up according to weight by traditional Chinese medicinal material raw materials, add pure water and soak, the water surface is higher than powder 6-8cm, soaks 2.5 After hour, decoct 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merge decoction liquor, decompression Being concentrated into relative density is 1.06, standby;
(2) add the ethanol of 1.5 times 75% after the decocting liquid cooling of step (1), fully mix, stand overnight so that it is be heavy Form sediment, after 24h, take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletizing, obtain granule, granule often wraps weight 10g.
Pharmaceutical preparation the most according to claim 1, it is characterised in that: the medicine of Alzheimer is being prepared in described pharmaceutical preparation Purposes in thing.
CN201610411425.0A 2016-06-09 2016-06-09 Medicinal preparation for treating Alzheimer disease and application of medicinal preparation Withdrawn CN105920409A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108295194A (en) * 2018-03-19 2018-07-20 齐齐哈尔医学院 It is a kind of to be used to treat Chinese medicine composition of Alzheimer disease and its preparation method and application

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104587345A (en) * 2015-02-10 2015-05-06 张宏斌 Traditional Chinese medicine preparation for treating alzheimer disease and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104587345A (en) * 2015-02-10 2015-05-06 张宏斌 Traditional Chinese medicine preparation for treating alzheimer disease and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108295194A (en) * 2018-03-19 2018-07-20 齐齐哈尔医学院 It is a kind of to be used to treat Chinese medicine composition of Alzheimer disease and its preparation method and application

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