CN105920237A - Pharmaceutical preparation for treating Alzheimer's disease and application of pharmaceutical preparation - Google Patents

Abstract

The invention relates to a pharmaceutical preparation for treating Alzheimer's disease and an application of the pharmaceutical preparation. The pharmaceutical preparation consists of the following materials in parts by weight: 15-25 parts of rhizoma acori graminei, 10-20 parts of polygala roots, 20-30 parts of herba rhodiolae, 20-30 parts of rhizoma ligustici wallichii, 10-20 parts of radix puerariae, 3-9 parts of liquorice roots, 10-20 parts of herba epimedii, 10-20 parts of herba taraxaci, 15-25 parts of fruits of Chinese magnoliavine, 20-30 parts of semen brassicae, 10-20 parts of semen raphani, 10-20 parts of fructus cnidii, 10-20 parts of fructus gardeniae, 20-30 parts of folium mori, 20-30 parts of fructus arctii, 10-20 parts of acanthopanax roots, 15-25 parts of fructus corni, 10-20 parts of radix rehmanniae and 10-20 parts of bitter gourd. The pharmaceutical preparation disclosed by the invention is scientific in prescription, obvious in curative effect and free from toxic and side effects; the pharmaceutical preparation also has a certain curative effect on Alzheimer's disease accompanied diabetics, hypertension and the like; the pharmaceutical preparation has a plurality of action targets, and the pharmaceutical preparation is high in efficiency; therefore, the pharmaceutical preparation is suitable for clinical popularization and application.

Description

A kind of pharmaceutical preparation treating Alzheimer and application thereof

Technical field

The invention belongs to the field of medicaments of degenerative neurological diseases, especially relate to a kind of medicine system treating Alzheimer Agent and application thereof.

Background technology

Alzheimer (Alzheimer disease, AD), also referred to as senile dementia, is the common nerve of old people One of degenerative disease, is the lethal neurodegenerative diseases of a kind of Progressive symmetric erythrokeratodermia development, and clinical manifestation is cognitive and memory merit Can constantly deteriorate, activity of daily living Progressive symmetric erythrokeratodermia goes down, with various neuropsychic symptoms and behavior disorder.AD suffers from recent years Sick rate and case fatality rate are in gradually rising situation, and according to statistics, ending the whole world in 2005 has 24,300,000 people to suffer from dementia, increases newly every year Dull-witted case 4,600,000.The dull-witted number the nearlyest 8,000,000 of China, wherein AD nearly 6,000,000.The people of 65 years old it is more than at the age In Qun, the sickness rate of AD accounts for the 50%-60% that age related is dull-witted.AD be continue cardiovascular disease, tumor and apoplexy it After the fourth-largest killer of the mankind, therefore, this will be to family so that society causes increasingly white elephant, antidementia agent Research and development 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；It is also possible to that raising AD cognitive function of patients is had one The medicine of constant current modulation effect, and it has been applied to clinic, such as antioxidant, anti-inflammatory medicaments, improve brain metabolic drug etc., but at present 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 description of alzheimer disease can be sporadically appeared in " forgetful ", " forgetful ", " dementia ", " literary composition silly ", " dull-witted ", " strongly fragrant by the traditional Chinese medical science Card ", in " insane disease " etc., to alzheimer disease in the understanding of etiology and pathogenesis than more consistent view be: sick position at brain, with Visceral dysfunction is relevant, to suffer from a deficiency of the kidney, relates to him dirty, and turbid etc. as major pathogenetic factor with blood stasis, expectorant, characteristic of disease belongs to this Empty mark is real, and the deficiency and excesss that show as are interlocked more clinically.Chinese medicine treatment Alzheimer differentiation of symptoms and signs for classification of syndrome mainly suffering from a deficiency of the kidney and Phlegm syndrome is 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, many with prescription The medicine such as Rhizoma Acori Graminei, Radix Polygalae, Radix Polygoni Multiflori, Fructus Corni, Herba Epimedii etc. use the kidney invigorating, having one's ideas straightened out, administering mode is traditional Decoction oral is administered.Method that visible current clinical Chinese medicine Alzheimer is inheriting traditional and medicine.

Summary of the invention

The present invention selects compatibility of drugs according to dialectical to Alzheimer of the traditional Chinese medical science, science, it is provided that one is effectively treated and subtracts The pharmaceutical preparation of the light Alzheimer order of severity.

Specifically, the technical scheme is that and be achieved in that:

A kind of pharmaceutical preparation treating Alzheimer, includes according to weight fraction ratio:

Rhizoma Acori Graminei 15-25 part, Radix Polygalae 10-20 part, Radix Rhodiolae 20-30 part, Rhizoma Chuanxiong 20-30 part, Radix Puerariae 10-20 part, Radix Glycyrrhizae 3-9 part, Herba Epimedii 10-20 part, Herba Taraxaci 10-20 part, Fructus Schisandrae Chinensis 15-25 part, Semen Sinapis Albae 20-30 part, Lay Fu 10-20 part, Fructus Cnidii 10-20 part, Fructus Gardeniae 10-20 part, Folium Mori 20-30 part, Fructus Arctii 20-30 part, sting five Add 10-20 part, Fructus Corni 15-25 part, Radix Rehmanniae 10-20 part, Fructus Momordicae charantiae 10-20 part.

In order to obtain preferable technique effect further, a kind of pharmaceutical preparation treating Alzheimer, above each composition is pressed According to weight ratio it is:

Rhizoma Acori Graminei 20 parts, Radix Polygalae 15 parts, Radix Rhodiolae 25 parts, Rhizoma Chuanxiong 25 parts, Radix Puerariae 15 parts, 6 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 15 parts, Herba Taraxaci 15 parts, Fructus Schisandrae Chinensis 20 parts, Semen Sinapis Albae 25 parts, Semen Raphani 15 parts, Fructus Cnidii 15 parts, Fructus Gardeniae 15 parts, 25 parts of Folium Mori, Fructus Arctii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Fructus Corni 20 parts, Radix Rehmanniae 15 parts, 15 parts of Fructus Momordicae charantiae.

In order to obtain preferable technique effect further, a kind of pharmaceutical preparation treating Alzheimer, above each composition is pressed According to weight ratio it is:

Rhizoma Acori Graminei 15 parts, Radix Polygalae 20 parts, Radix Rhodiolae 20 parts, Rhizoma Chuanxiong 30 parts, Radix Puerariae 10 parts, 9 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 10 parts, Herba Taraxaci 10 parts, Fructus Schisandrae Chinensis 25 parts, Semen Sinapis Albae 30 parts, Semen Raphani 10 parts, Fructus Cnidii 10 parts, Fructus Gardeniae 10 parts, 20 parts of Folium Mori, Fructus Arctii 20 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Fructus Corni 15 parts, Radix Rehmanniae 10 parts, 10 parts of Fructus Momordicae charantiae.

In order to obtain preferable technique effect further, a kind of pharmaceutical preparation treating Alzheimer, above each composition is pressed According to weight ratio it is:

Rhizoma Acori Graminei 18 parts, Radix Polygalae 18 parts, Radix Rhodiolae 22 parts, Rhizoma Chuanxiong 26 parts, Radix Puerariae 17 parts, 6 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 12 parts, Herba Taraxaci 12 parts, Fructus Schisandrae Chinensis 18 parts, Semen Sinapis Albae 22 parts, Semen Raphani 16 parts, Fructus Cnidii 16 parts, Fructus Gardeniae 16 parts, 22 parts of Folium Mori, Fructus Arctii 28 parts, Radix Et Caulis Acanthopanacis Senticosi 16 parts, Fructus Corni 18 parts, Radix Rehmanniae 12 parts, 12 parts of Fructus Momordicae charantiae.

A kind of pharmaceutical preparation treating Alzheimer, described pharmaceutical preparation is treating and preventing the medicine of Alzheimer Or the application in health product.

A kind of pharmaceutical preparation of the pharmaceutical preparation treating Alzheimer, described pharmaceutical preparation is prepared as granule, powder, Capsule, pill, tablet, slow releasing agent and the most acceptable dosage form.

The moulding process that the pharmaceutical preparation of the present invention can be prepared used by different dosage form is different with adjuvant, as effective ingredient is , therapeutic effect is the most identical or approximates.The adjuvant of granule can be multitudinous Icing Sugar, Carboxymethyl cellulose sodium, dextrin and correctives Select in Deng；Powder can select from starch, kaolin, calcium phosphate, precipitated calcium carbonate etc.；The adjuvant of capsule can From silicon dioxide, sucrose, HPC, microcrystalline Cellulose, pregelatinized Starch, lactose, Icing Sugar, carboxymethylstach sodium, carboxylic first fiber Element sodium, hypromellose etc. select；The adjuvant of pill can be from starch, microcrystalline Cellulose, pregelatinized Starch etc. Select；The adjuvant of tablet can be from starch, dextrin, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, lactose, sugar Powder, carboxymethylstach sodium etc. select.

The pharmacological action of Chinese medicine used in the present invention:

Rhizoma Acori Graminei, acrid in the mouth, hardship, slightly warm in nature；GUIXIN, liver, spleen channel.Waking up the patient from unconsciousness by dissipating phlegm；Removing dampness circulation of qi promoting；Profit of dispeling the wind numbness；Disappear Swollen pain relieving.Main calentura coma；Syncope due to accumulation of phlegm；Forgetful；Tinnitus；Deaf；Abdominal distention；Fasting dysentery；Rheumatic arthralgia；Traumatic injury damages Wound；Carbuncle scabies.Neuroprotective, such as suppression NMDA and the sinister and vicious property of excitement of glutamate induction, suppresses monoamine oxidase, MAO A, when high dose, also has certain inhibitory action to MA0B.

Radix Polygalae, god's Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.The insomnia and dreamful sleep caused for disarmony between the heart and kidney, forgetful palpitation with fear, staring spells, Expectoration is not well, sore swollen toxin.

Radix Rhodiolae, sweet, bitter, flat.Return lung, heart channel.Function with cure mainly, benefiting QI for activating blood circulation, promote blood circulation and relieving asthma.

Rhizoma Chuanxiong, pungent, temperature.Return liver, gallbladder, pericardium channel.There is blood-activating and qi-promoting, wind-expelling pain-stopping.Ligustrazine is to central nervous system That unites has good protection effect, can improve neuron synthesis and secretion acetylcholinesterase, improve the neuron that damage causes Function reduction, the death of the cholinergic neuron that antagonism glutamate toxicity causes.

Radix Puerariae, 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 Hippocampus Acetyl choline content, and reduce Hippocampal Acetylcholine transferase active, the Memory acquisition sexual disorders that antagonism east Liang alkali is imitated.

Radix Glycyrrhizae, one of composition is liquirtin, the antidepressant activity of liquirtin, and its mechanism of action may be by regulating monoamine Mediator antagonism realizes；Chronic stress depression model can be found, and sugar consumption amount increases and prologue test behavior expression substantially changes Kind.

Herba Epimedii, warm in nature；Acrid in the mouth, sweet；Return liver, kidney channel.Effect and effect: kidney invigorating and YANG supporting, expelling wind and removing dampness.Control sexual impotence Not lifting, dribbling urination, muscles and bones contraction is anxious, and hemiplegia, weakness of the waist and knees, rheumatic arthralgia, extremity are meciless.Excessive in Herba Epimedii Sheep icariin has protective effect for endotheliocyte, mainly by reducing content and the expression of suppression Caspase-3 of NO Realize；Reduce AChE activity in cerebral tissue, improve learning and memory obstacle；And icariin can significantly inhibit Mitochondrial swelling, minimizing MDA content, thus maintain mitochondrion stable

Herba Taraxaci, flat sweet and slightly bitter taste.Can heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.Enter liver and enter stomach, the key medicine of antipyretic removing heat from blood.Can heat-transformation Poison, Detoxicating food-poisoning, core of subsiding a swelling, treat the merit that furunculosis acute mastitis, all pathogenic fire purging are set up.

Fructus Schisandrae Chinensis, sweet in the mouth, acid, warm in nature.Energy supplementing QI for promoting the production of body fluid, the kidney invigorating is nourished heart, and restrains astringent or styptic treatment for spontaneous sweating.Hindering for deficiency of vital energy Tianjin, body is tired Hyperhidrosis, cardiopalmus of losing heart；Breathing with cough caused by insufficiency of lung-QI or deficiency of both the lung and kidney, or breath with cough with the passing of time, lung qi consumption wound；Insufficiency of heart-YIN, Severe palpitation, insomnia forgetfulness；Instability of kidney QI, seminal emission, frequent micturition, or asthenia of both the spleen and kidney, incessant chronic diarrhea.

Semen Sinapis Albae, acrid in the mouth, warm in nature.Effect: exempt from drinkization water, eliminating phlegm for diminishing swelling.Curing mainly cold-phlegm foam, phlegm retention is stopped up long-pending, fullness in the chest Hypochondriac pain, cough with dyspnea, and subcutaneous nodule, arthralgia, the disease such as crane knee joint carbuncle of yin nature.Semen Raphani, pungent, sweet, flat.Return Spleen, stomach, lung meridian.Effect, promoting digestion and removing stagnation, dyspepsia and intestinal stasis relieving；Lowering the adverse-rising QI to resolve phlegm.Cure mainly: stagnation of QI due to dyspepsia；Distension and fullness in the abdomen；Diarrhoea； Weight after dysentery；Cough ant phlegm；QI rising in reverse order dyspnea with fullness of the chest.Effective ingredient sinapic acid choline ester. in Semen Sinapis Albae and Semen Raphani, has significant acetyl Acetylcholine esterase (AChE) inhibitory activity, is better than the suppression to serum AChE activity to the inhibitory action of brain homogenates AChE.

Fructus Cnidii, mildly bitter flavor gas is pungent, warm in nature, and warming the kidney to activate YANG dispels the wind, dampness, parasite killing.Control impotence in male, scrotum pruritus due to damp pathogen, Woman's leukorrhagia pudendal pruritus, cold uterus is infertile, rheumatism, scabies eczema.Its effective component of osthole, can hypermnesis Power, improves cognitive function, treats senile dementia.

Fructus Gardeniae, property bitterness is cold, pathogenic fire purging relieving restlessness；Clearing away heat-damp and promoting diuresis；Removing pathogenic heat from blood and toxic substance from the body, calentura is vexed；Liver-fire conjunctival congestion；Headache；Wet The yellow infantile malnutrition of heat；Stranguria；Dysentery hematuria；Aphtha of the mouth and tongue；Sore swollen toxin；Sprain and swell and ache.

Folium Mori, dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving.For anemopyretic cold, lung-heat type cough, dizziness headache, conjunctival congestion Dim-sighted.

Fructus Arctii, pungent, bitter, cold.Attach to the lung and stomach meridians.Dispelling wind and heat pathogens, lung qi dispersing sore-throat relieving, rash of detoxifying, skin ulcer is treated in detumescence.Its Effective ingredient arctigenin has antitumor and neuroprotective, can improve Alzheimer mice and easily damage.

Radix Et Caulis Acanthopanacis Senticosi, warm in nature；Acrid in the mouth；Bitter；Micro-sweet；Return liver, kidney channel.Effect: wind-damp dispelling；Invigorating the liver and kidney；Bone and muscle strengthening；Live Blood vessels.Main anemofrigid-damp arthralgia；Lumbocrural pain；Muscles and bones flaccidity is soft；The decimal a little walking retardation in children；Body void is frail；Traumatic injury；Fracture； Edema；Tinea pedis；Uncontrolled urination is itched.

Fructus Corni, sour in the mouth, puckery, slightly warm in nature；Return liver, kidney channel.Liver and kidney tonifying, essence astringing and desertion stemming.For vertigo and tinnitus, waist Knee joint soreness, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating is collapsed.

Radix Rehmanniae, Radix Rehmanniae sweet in the mouth, hardship, cold in nature.GUIXIN, liver, lung meridian.There is clearing away heat and cooling blood effect enter for warming febrile disease Nutrient blood, high fever coma, xerostomia crimson tongue.Such as qingying decoction.10 parts of Fructus Momordicae charantiae.

Fructus Momordicae charantiae, has effect of clearing away heat and removing summer, nourishing blood and invigorating qi, kidney and spleen invigorating, nourishing liver for improving eyesight, swollen to treatment dysentery, skin ulcer, Heatstroke heating, too much, the conjunctivitis of miliaria etc. are sick certain effect.

The scientific formula of the present invention, clear curative effect, have no side effect, for the adjoint diabetes of senile dementia, hypertension Having certain curative effect, multiaction target spot Deng also, effective percentage is high, is suitable for clinical application.

Detailed description of the invention

It is obvious to a person skilled in the art that the details of invention one exemplary embodiment, and without departing substantially from this In the case of bright spirit or essential attributes, it is possible to realize the present invention in other specific forms.Which point therefore, no matter from come Seeing, all should regard embodiment as exemplary, and be nonrestrictive, the scope of the present invention is by claims not It is that described above limits, it is intended that all changes fallen in the implication of equivalency and scope of claim are included at this In invention.

Embodiment 1

A kind of pharmaceutical preparation treating Alzheimer, each composition according to weight ratio is:

Rhizoma Acori Graminei 20 parts, Radix Polygalae 15 parts, Radix Rhodiolae 25 parts, Rhizoma Chuanxiong 25 parts, Radix Puerariae 15 parts, 6 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 15 parts, Herba Taraxaci 15 parts, Fructus Schisandrae Chinensis 20 parts, Semen Sinapis Albae 25 parts, Semen Raphani 15 parts, Fructus Cnidii 15 parts, Fructus Gardeniae 15 parts, 25 parts of Folium Mori, Fructus Arctii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Fructus Corni 20 parts, Radix Rehmanniae 15 parts, 15 parts of Fructus Momordicae charantiae.

Above pharmaceutical preparation is prepared as capsule, and preparation method is as follows:

(1) by above-mentioned weight ratio weighting raw materials boiling twice, add 8 times amount water every time, decoct 1 hour for the 1st time, Second time decocts 40 minutes, and merging filtrate, after filtration, obtains medicine concentrated solution；(2) by celphere (with sugar and shallow lake The granule of the 30-40 mesh made by powder mixing), it is placed in coating granulator；(3) with carboxymethylstach sodium as wet adhesive, Granule-the starch solids dispersion of 100 mesh is added with certain speed so that it is be uniformly adhered in celphere surface；(4) It is dried, screens 20-40 mesh sieve piller, to obtain final product.

Embodiment 2

A kind of pharmaceutical preparation treating Alzheimer, each composition according to weight ratio is:

Rhizoma Acori Graminei 15 parts, Radix Polygalae 20 parts, Radix Rhodiolae 20 parts, Rhizoma Chuanxiong 30 parts, Radix Puerariae 10 parts, 9 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 10 parts, Herba Taraxaci 10 parts, Fructus Schisandrae Chinensis 25 parts, Semen Sinapis Albae 30 parts, Semen Raphani 10 parts, Fructus Cnidii 10 parts, Fructus Gardeniae 10 parts, 20 parts of Folium Mori, Fructus Arctii 20 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Fructus Corni 15 parts, Radix Rehmanniae 10 parts, 10 parts of Fructus Momordicae charantiae.

Above pharmaceutical preparation is prepared as pill, and preparation method is as follows:

(1) by above-mentioned weight ratio weighting raw materials boiling twice, add 8 times amount water every time, decoct 1 hour for the 1st time, the Secondary decocts 40 minutes, merging filtrate, after filtration, is dried to fine powder, crosses 100 mesh sieves；(2) by celphere (with sugar Divide and the granule of the 30-40 mesh made by starch mixing), it is placed in coating granulator；(3) with pregelatinized Starch ethanol it is Wet adhesive, adds the granule-starch solids dispersion of 100 mesh with certain speed so that it is be uniformly adhered in blank pill Wicking surface；(4) it is dried, screens 20-40 mesh sieve piller, to obtain final product.

Embodiment 3

A kind of pharmaceutical preparation treating Alzheimer, each composition according to weight ratio is:

Rhizoma Acori Graminei 18 parts, Radix Polygalae 18 parts, Radix Rhodiolae 22 parts, Rhizoma Chuanxiong 26 parts, Radix Puerariae 17 parts, 6 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 12 parts, Herba Taraxaci 12 parts, Fructus Schisandrae Chinensis 18 parts, Semen Sinapis Albae 22 parts, Semen Raphani 16 parts, Fructus Cnidii 16 parts, Fructus Gardeniae 16 parts, 22 parts of Folium Mori, Fructus Arctii 28 parts, Radix Et Caulis Acanthopanacis Senticosi 16 parts, Fructus Corni 18 parts, Radix Rehmanniae 12 parts, 12 parts of Fructus Momordicae charantiae.

Above pharmaceutical preparation is prepared as tablet, and preparation method is as follows:

(1) Chinese medicine taking above amount decocts according to the method in embodiment 1, decocts rear medicinal liquid and concentrates, and concentrates To finite concentration (proportion is about 1:1)；(2) 1.1 times of ethanol put of cold rear addition, fully mix, stand overnight, make Its precipitation, takes its supernatant (filtering if desired) next day, and precipitate is cleaned with a small amount of 52% ethanol, and washing liquid merges with filtrate, After decompression recycling ethanol, to be concentrated to finite concentration time add a certain amount of water；(3) mixing stands certain time, makes precipitation complete, Rate mistake, filtrate low-temperature evaporation is to paste；(4) powdered extract powder adds suitable dextrin, pregelatinized Starch, tristearin Acid magnesium, adjuvant, after mixing, add and be pressed into the most whole to satisfactory granularity, carry out tabletting, obtain tablet.

Embodiment 4

A kind of pharmaceutical preparation treating Alzheimer, includes according to weight fraction ratio:

Rhizoma Acori Graminei 22 parts, Radix Polygalae 12 parts, Radix Rhodiolae 22 parts, Rhizoma Chuanxiong 25 parts, Radix Puerariae 16 parts, 6 parts of Radix Glycyrrhizae, excessive sheep The leaves of pulse plants 12 parts, Herba Taraxaci 12 parts, Fructus Schisandrae Chinensis 18 parts, Semen Sinapis Albae 22 parts, Semen Raphani 16 parts, Fructus Cnidii 15 parts, Fructus Gardeniae 12 parts, 28 parts of Folium Mori, Fructus Arctii 22 parts, Radix Et Caulis Acanthopanacis Senticosi 18 parts, Fructus Corni 19 parts, Radix Rehmanniae 16 parts, 17 parts of Fructus Momordicae charantiae.

Above pharmaceutical preparation is prepared as powder, and preparation method is as follows:

(1) Chinese medicine taking above amount conventionally decocts, and decoct rear medicinal liquid carrying out being concentrated into proportion is 1:1.2 Concentration；(2) 1.5 times of ethanol put of cold rear addition, fully mix, stand overnight so that it is precipitation, take its supernatant next day Liquid, precipitate is clean with a small amount of 50% ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, to be concentrated to finite concentration Time shift is put cold place and is stood certain time, makes precipitation complete；(3) rate mistake, filtrate low-temperature evaporation is to paste；(4) it is dried Extractum powder adds suitable starch and calcium phosphate adjuvant, after mixing, crosses 200 mesh sieves, obtain powder.

Embodiment 5: animal pharmacodynamic experiment

Memantine belongs to excitatory amino acid receptor antagonists, and in treatment, severe is to severe dementia of the Alzheimer type, Having preferable therapeutic effect in clinic, therefore the present invention selects it to test as positive control.

5.1, APP/PS1 bi-transgenic mice is raised and animal packet

50 APP/PS1 bi-transgenic mice are randomly divided into 5 groups: saline group, memantine group and Chinese medicine of the present invention is low, Middle and high dosage group (25,50,75mg kg^-1·d^-1), often group 10.Within after purchase 2 weeks, raise in advance, the most single cage Feed in the isoperibol that illumination/dark is 12h/12h, freely ingest and drink water.

5.2, Spatial memory aptitude tests (Morris water maze)

With reference to Morris water maze laboratory method, measure study and memory ability.Water maze used is a diameter 180cm, The round pool of high 55cm, pool inner wall is painted as black, depth of water 30cm, places a high 29cm at pool wall 35cm, Diameter 10cm round platform, experiment lasts 6d, and experiment is in two stages.

5.2.1 orientation navigation test

Before experiment, 1d allows free swimming 2min, from the 1st day, every natural gift upper and lower noon 2 periods, trains 4 times for every section. Randomly choosing place of entry during training, will put in water towards pool wall, record is found and is climbed up platform required time and (i.e. escapes latent The volt phase), adjacent 2 training are spaced apart 60s.If not finding platform in 120s, platform must be caused, this Time incubation period be designated as 120s.

5.2.2 space exploration experiment

At the 6th day, for the last time training recession was except underwater platform, will put in water towards pool wall at same place of entry, survey its At original platform quadrant activity time and total time ratio and the number of times striding across original platform relevant position in 120s.

5.3, experimental result

Statistical procedures: using SPSS 17.0 software to carry out data statistic analysis, measurement data represents with mean ± standard deviation (x ± s), the multifactor analysis of variance of logging data application repeated measure between group, enumeration data uses non-parametric rank test, with P ＜ 0.05 represents that difference has statistical significance.

5.3.1 escape latency

Monitor each group of mice in Morris water maze test experiments, search out platform and climb up the escape latency of platform, knot Fruit is shown in Table 1.In 5 days of test, the escape latency of all mices all shows as shortening trend.Saline group and each group of Chinese medicine Group is compared, and saline group escape latency is obviously prolonged (P < 0.05), and result is pointed out, model mice study and impaired memory function. Each dosage Chinese drug-treated group escape latency average relatively saline group is decreased obviously, and substantially shortens (P < 0.05) compared with saline group group,

The escape latency (Mean soil SEM, n=10) that table 1. is respectively organized

Group	1st day	2nd day	3rd day	4th day	5th day
						Saline group	120.3±10.3	92.7±9.4	77.6±8.6	57.4±7.8	39.9±6.4
Memantine group	118.3±12.3*	86.7±8.2*	65.7±6.5*	37.4±7.1*	18.3±4.2*
						Chinese medicine low dose group	122.3±11.8	93.7±8.9	67.6±7.2	46.7±6.7	23.4±5.4
Dosage group in Chinese medicine	119.7±9.7*	78.5±7.5*	56.4±5.8*	32.8±6.2**	15.7±4.9*
						Chinese medicine high dose group	124.3±14.1**	83.7±9.2*	61.9±6.3*	31.6±5.4**	14.7±6.2**

Compare with saline group, * * p < 0.01, * p < 0.05

5.3.2 across platform number of times

Monitoring removes after platform that each group cross-platform number of times of mice and each group of mice are in the activity time of original platform quadrant, with each medicine Group is compared by mice, and saline group mice substantially reduces at quadrant residing for original platform search time, strides across Yuanping City in search capability test The number of times of platform position also substantially reduces, and each dosage Chinese drug-treated group mice and memantine group mice are searched at original platform place quadrant Time and cross-platform number of times the most relatively model group significantly raise and increase.Result shows: Chinese medicine middle and high dosage group can preferably change The learning and memory function damage of kind AD model mice.

Each group of number of times of collapsing of table 2 (Mean soil SEM, n=10)

Group	Cost time (s) at target quadrant	Spanning platform number of times (secondary)
			Saline group	75.8±7.5	6.7±2.5
Memantine group	90.5±6.7**	9.6±3.9*
			Chinese medicine low dose group	85.7±8.4	7.0±3.2
Dosage group in Chinese medicine	98.9±9.5*	9.9±3.4*
			Chinese medicine high dose group	104.6±7.8*	11.3±4.2**

Compare with saline group, * * p < 0.01, * p < 0.05

5.4, toxicity test

5.4.1, toxicity test

This product is because by liquor strength, gastric infusion volume is limited cannot record median lethal dose(LD 50) (LD50), therefore with maximum medicine Liquid concentration (0.82g/ml) and animal maximum administration volume (0.5ml/10g body weight) gastric infusion 3 times (being spaced 4 hours) in a day, In one day, maximum dosage is 123g/kg.For adult's clinical medicine dose (0.33g/kg/d) 372.7 times.Continuous Observation 14 days, under this dosage, all there is not toxic reaction in animal.After administration, all animals body weight gradually increases, in 14 days animal without One is dead, has not seen any toxic reaction, does not also find toxicity target organ.

6.4.2, long term toxicity test

Method: according to the rat pharmacodynamics effective dose of this product and clinical plan daily dose, three dosage groups of this EXPERIMENTAL DESIGN, one Individual matched group, for 66.6g/kg, 22.2g/kg and 7.4g/kg group, respectively the 180 of adult's clinical medicine dose, 60,20 times, Matched group gives the normal saline of 20 times, often 40 rats of group, male and female half and half, and every day, oral administration gavage was administered 3 times, was administered volume 2ml/100g body weight, Per-Hop behavior 6 days, successive administration 26 weeks.During test the outward appearance behavior to rat observe, to body weight, The indexs such as food ration detect, and terminate to calculate organ coefficient respectively at being administered 13 weekends, 26 ends and 4 week convalescent period, carry out blood The detection of liquid, blood biochemical analysis and histopathologic examination.

6.4.3, result: during test, be respectively administered treated animal behavioral activity and outward appearance body.Levy performance without exception；Each administration group is moved The growth of thing food ration, body weight has no significant effect, and compares with matched group without difference (P ＞ 0.05)；Each administration group does not finds The harmful effect relevant to drug toxicity to the index such as hematology and blood biochemical analysis, compares without difference (P with matched group ＞ 0.05)；Each administration treated animal organs and tissues mode of appearance, position and internal organs tangent plane no abnormality seen, be administered 13 weekends, 26 weeks End spleen and thymus organ coefficient are without significant difference (P ＞ 0.05 or P ＞ 0.01) compared with matched group, and other organ coefficient is without substantially Impact (comparing P ＞ 0.05 with matched group)；This product 66.6g/kg treated animal internal organs do not find the pathological change relevant to medicine.

Conclusion: by acute toxicity testing and long term toxicity test, result shows that Chinese medicine preparation of the present invention had not both had acute toxicity, There is no long term toxicity, also without retardance toxic reaction, Chinese medicine preparation clinical drug safety of the present invention is described yet.

Embodiment 6: clinical experiment

6.1, physical data

Choose and in January, 2013～in July, 2015 enter group participation experiment the 108 example AD patients that my institute treats.Participant accords with Close " Chinese Spirit Obstacles classification and diagnostic criteria " the 3rd edition Alzheimer diagnostic criteria, get rid of vascular dementia and Mentally disturbed caused by other disease of brain.Women 67 example, male 41 example, age 65～91 years old, the mean age (65.8 ± 18.2) year.The course of disease is the shortest 0.8 year, the longest 15 years, average 5.5 years.Monthly carry out before treatment and in treatment hematuria conventional, The parallel electrocardiogram of lab testing, the EEG (electrocardiogram) examination such as biochemistry, blood ester, hepatic and renal function, check after terminating the course for the treatment of.

6.2, 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, for the pharmaceutical preparation of prescription of the present invention, 54 examples；

Matched group, gives huperzine A 0.1mg, 3 times/d, changes 0.2mg into, be administered orally three times a day after 1 week, 54 examples.

6.3, criterion of therapeutical effect

With reference to revision Webster adult's memory scale handbook.In treatment before, treatment after 48 weekends use mini-mental state (MMSE), Webster adult's memory table (WMS) and vital function scale (ADL) are marked.Improvement situation according to MMSE score value is commented Determine 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.

6.4, therapeutic outcome

Before and after treatment, detection hematuria routine, biochemistry, blood ester, hepatic and renal function etc. all have no adverse effects.Matched group, 2 examples occur light Degree dizziness, 1 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 (54 example)	29	18	7	87.0%
Experimental group (54 example)	32	20	2	96.3%

6.5, model case

Case 1: aunt Wang, female, 76 years old, have a strong temperament at an early age, wilful eager to do well in everything, going out before 2 years buys vegetables did not recognized suddenly The road gone home, does not recognizes household afterwards, just forgets, gatism in a lot of thing short time, makes a definite diagnosis rear one before 2 years Straight Drug therapy, but bad during state of an illness fashion, and have serious trend, after carrying out outpatient clinic, through understanding into group, check hematuria Routine, biochemistry, blood ester, hepatic and renal function etc. are all normal, and Therapeutic Method is the pharmaceutical preparation of the present invention, allows its household auxiliary simultaneously Helping dredging psychology, keep good daily life and mental status, further consultation after 3 months, situation is clearly better, and life can be certainly Reason, also has the sensation of relatives, without uncomfortable or any untoward reaction in therapeutic process to household.

Case 2: Zheng Shu, man, 69 years old, before 6 years, boss was dead, lives by oneself always, but 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 household starts band patient to examination in hospital, is diagnosed as AD, agrees to into group, Checking that hematuria routine, biochemistry, blood ester, hepatic and renal function etc. are all normal, Therapeutic Method is the pharmaceutical preparation of the present invention, allows simultaneously Its household accompanies old man to live together, has people to look after its daily life specially, keeps good daily life and mental status, and 3 Further consultation after individual month, 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.

Claims (6)

1. the pharmaceutical preparation treating Alzheimer, it is characterised in that described pharmaceutical preparation includes according to weight fraction ratio: Rhizoma Acori Graminei 15-25 part, Radix Polygalae 10-20 part, Radix Rhodiolae 20-30 part, Rhizoma Chuanxiong 20-30 part, Radix Puerariae 10-20 part, Radix Glycyrrhizae 3-9 part, Herba Epimedii 10-20 part, Herba Taraxaci 10-20 part, Fructus Schisandrae Chinensis 15-25 part, Semen Sinapis Albae 20-30 part, Semen Raphani 10-20 part, Fructus Cnidii 10-20 part, Fructus Gardeniae 10-20 part, Folium Mori 20-30 part, Fructus Arctii 20-30 part, Radix Et Caulis Acanthopanacis Senticosi 10-20 Part, Fructus Corni 15-25 part, Radix Rehmanniae 10-20 part, Fructus Momordicae charantiae 10-20 part.

A kind of pharmaceutical preparation treating Alzheimer, it is characterised in that: described pharmaceutical preparation According to weight ratio it is: Rhizoma Acori Graminei 20 parts, Radix Polygalae 15 parts, Radix Rhodiolae 25 parts, Rhizoma Chuanxiong 25 parts, Radix Puerariae 15 parts, Radix Glycyrrhizae 6 Part, Herba Epimedii 15 parts, Herba Taraxaci 15 parts, Fructus Schisandrae Chinensis 20 parts, Semen Sinapis Albae 25 parts, Semen Raphani 15 parts, Fructus Cnidii 15 Part, Fructus Gardeniae 15 parts, 25 parts of Folium Mori, Fructus Arctii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Fructus Corni 20 parts, Radix Rehmanniae 15 parts, 15 parts of Fructus Momordicae charantiae.

A kind of pharmaceutical preparation treating Alzheimer, it is characterised in that: described pharmaceutical preparation According to weight ratio it is: Rhizoma Acori Graminei 15 parts, Radix Polygalae 20 parts, Radix Rhodiolae 20 parts, Rhizoma Chuanxiong 30 parts, Radix Puerariae 10 parts, Radix Glycyrrhizae 9 Part, Herba Epimedii 10 parts, Herba Taraxaci 10 parts, Fructus Schisandrae Chinensis 25 parts, Semen Sinapis Albae 30 parts, Semen Raphani 10 parts, Fructus Cnidii 10 Part, Fructus Gardeniae 10 parts, 20 parts of Folium Mori, Fructus Arctii 20 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Fructus Corni 15 parts, Radix Rehmanniae 10 parts, 10 parts of Fructus Momordicae charantiae.

A kind of pharmaceutical preparation treating Alzheimer, it is characterised in that: described pharmaceutical preparation According to weight ratio it is: Rhizoma Acori Graminei 18 parts, Radix Polygalae 18 parts, Radix Rhodiolae 22 parts, Rhizoma Chuanxiong 26 parts, Radix Puerariae 17 parts, Radix Glycyrrhizae 6 Part, Herba Epimedii 12 parts, Herba Taraxaci 12 parts, Fructus Schisandrae Chinensis 18 parts, Semen Sinapis Albae 22 parts, Semen Raphani 16 parts, Fructus Cnidii 16 Part, Fructus Gardeniae 16 parts, 22 parts of Folium Mori, Fructus Arctii 28 parts, Radix Et Caulis Acanthopanacis Senticosi 16 parts, Fructus Corni 18 parts, Radix Rehmanniae 12 parts, 12 parts of Fructus Momordicae charantiae.

5. according to the pharmaceutical preparation treating Alzheimer a kind of described in claim 1-4, it is characterised in that: described pharmaceutical preparation Application in the medicine treating and preventing Alzheimer or health product.

6. according to the pharmaceutical preparation treating Alzheimer a kind of described in claim 1-4, it is characterised in that: described pharmaceutical preparation It is prepared as granule, powder, capsule, pill, tablet and the most acceptable dosage form.