CN104027428A - Preparation method of traditional Chinese medicine compound and application in prevention and treatment of Alzheimer disease - Google Patents

Abstract

The invention discloses a preparation method of a traditional Chinese medicine compound and application in prevention and treatment of Alzheimer disease. The traditional Chinese medicine compound is composed of 180 parts of Ginkgo leaf, 180 parts of Radix Polygonum Multiflorum Preparata, 90 parts of glossy privet fruit, 90 parts of Salvia miltiorrhiza, 90 parts of in Eucommia ulmoides, 90 parts of Cyathula officinalis, and 60 parts of Uncaria tomentosa. The traditional Chinese medicine compound is prepared by the method of: subjecting the Ginkgo leaf, glossy privet fruit, Salvia miltiorrhiza and Uncaria tomentosa to heating reflux extraction by 30-95% ethanol 1-4 times, recovering ethanol from the extracted solution and conducting concentration to obtain an extract A; adding water into the Radix Polygonum Multiflorum Preparata, Eucommia ulmoides, and Cyathula officinalis to conduct decoction and extraction 1-4 times, concentrating the decocted solution and then performing alcohol precipitation, recovering ethanol from the alcohol precipitated solution and conducting concentration, thus obtaining an extract B; and drying the extract A and the extract B, taking the dry extracts, and adding appropriate auxiliary materials to prepare hard capsules, soft capsules, tablets and granules. The traditional Chinese medicine compound prepared by the method provided by the invention can significantly improve the treatment effect on various diseases caused by cerebral arteriosclerosis, and has preventive and therapeutic effects on Alzheimer disease.

Description

A kind of preparation method of Chinese medicine compound and the application in senile dementia prevention and cure

Technical field

The invention belongs to technical field of traditional Chinese medicine pharmacy, more specifically relate to a kind of preparation method of Chinese medicine compound and the application in senile dementia prevention and cure.

Background technology

The present invention is at " a kind of Chinese medicine for the treatment of cerebral arteriosclerosis " (number of patent application: 200410045091.7, publication number: CN1596960A) on the prescription basis of Patent Application Publication, according to the different qualities of the contained active substance of each crude drug in prescription, a kind of new Technology (abbreviation new technology) that adopts different extractions and formulation method to found, the prepared medicine of adopting new technology, compared with preparation method (being called for short former technique) the gained basic substance of its material base and former Patent Application Publication, there is substantial difference, the medicine of preparation of adopting new technology not only can significantly improve the curative effect of this compound recipe for various diseases due to cerebral arteriosclerosis, and expand its application in senile dementia prevention and cure.

Former technique is: 70% ethanol heating extraction three times for Folium Ginkgo by prescription in proportioning, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae, add for the first time 1500ml, extract 2 hours, add for the second time 1200ml, extract 1.5 hours, add for the third time 1200ml, extract 1 hour, merge extractive liquid,, filters, decompression filtrate recycling ethanol is to without alcohol taste, concentrated for subsequent use.Medicinal residues after alcohol extraction and the Radix Polygoni Multiflori Preparata of writing out a prescription in proportioning, the Cortex Eucommiae, Radix Cyathulae, four tastes such as Ramulus Uncariae Cum Uncis, decoct with water twice, 2400ml for the first time adds water, 1800ml for the second time adds water, each 2 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (60～65 DEG C), clear paste adds ethanol to be made to reach 60% containing alcohol amount, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol is extremely without ethanol taste, with Folium Ginkgo, Fructus Ligustri Lucidi, tanshinol is carried concentrated solution and is merged, above-mentioned extractum adopts conventional method to make oral liquid, or make tablet after being dried to dry extract, capsule, granule.The purposes of original application patent " a kind of Chinese medicine for the treatment of cerebral arteriosclerosis " is to be used for the treatment of the diseases such as dizziness headache due to middle-aged and elderly people cerebral arteriosclerosis, Hiccough and deaf, blurred vision, hypomnesis, insomnia, soreness of the waist and knees, numb limbs and tense tendons.

New technology of the present invention has overcome some drawbacks of former technique.New technology and former technique comparison, its main feature is: 1. Ramulus Uncariae Cum Uncis is jointly used together with Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae to ethanol extraction, make full use of the total alkaloids in Ramulus Uncariae Cum Uncis raw material, avoid the conversion of Ramulus Uncariae cum Uncis alkali simultaneously, to strengthen the curative effect of this compound treatment cardiovascular and cerebrovascular disease; 2. no longer water extraction together with other raw medicinal material of the medicinal residues after Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae alcohol extraction, not only save extract, the concentrated and alcohol deposit fluid energy consumption while reclaiming ethanol, and the consumption of ethanol while having greatly reduced precipitate with ethanol; 3. be studied adjustment, effective component extracting to greatest extent to extracting solvent consumption; 4. this product is made to the solid preparations such as hard capsule, soft capsule, tablet or granule, solve indissoluble or insoluble precipitated the separating out of composition in aqueous solution such as uncaria total alkaloids, bilobalide, oleanolic acid, TANSHINONES, cryptotanshinone, and the technological deficiency that is degraded of the water soluble ingredient such as danshensu, salvianolic acid, thereby improve drug quality and curative effect in aqueous solution.

Inventor confirms that through experimentation former technique exists following drawback: 1. raw material Ramulus Uncariae Cum Uncis medicinal material extract method is not suitable for: Ramulus Uncariae Cum Uncis and Radix Polygoni Multiflori, the Cortex Eucommiae, Radix Cyathulae four Chinese medicine material are adopted water extraction 2 times by former technique, leaching filtrate, after filtrate is concentrated, add ethanol precipitate with ethanol, process results not only directly causes the effective ingredient Ramulus Uncariae cum Uncis alkali in raw material Ramulus Uncariae Cum Uncis to transform, and will make uncaria total alkaloids all lose.Scientist's studies confirm that for many years both at home and abroad, the main effective ingredient of Ramulus Uncariae Cum Uncis is uncaria total alkaloids, it has calcium antagonism, nitricoxide synthase (NOS) suppresses, regulate norepinephrine, dopamine, 5～hydroxytryptamine neuron system, antiplatelet aggregation and antithrombotic, the effects such as blood pressure lowering, wherein topmost composition is Ramulus Uncariae cum Uncis alkali (rhynchophylline) and isorhynchophylline (isorhynchophylline), account for respectively the more than 28.9% and 14.7% of uncaria total alkaloids, its all with this compound recipe cure mainly function and indication is corresponding, but Ramulus Uncariae Cum Uncis alkaloid is water insoluble, the extraction rate of transform that decocting boils is below 20%, and can only suspendible or be deposited in water extract, if concentrated after again extracting solution being filtered, Ramulus Uncariae Cum Uncis alkaloid will be lost idle most by filtering, secondly, while decocting Ramulus Uncariae Cum Uncis, motherland's traditional medicine is all by its " under rear ", and to prevent the conversion of Ramulus Uncariae cum Uncis alkali, modern medicine and pharmacology also confirms: Ramulus Uncariae cum Uncis alkali long period in aqueous solution heats the in the situation that of decoction, will be converted into isorhynchophylline.Therefore, Ramulus Uncariae Cum Uncis must be advisable with ethanol extraction, and former technique is carried out long-time extraction and had technology drawback taking water as solvent.2. former technique has increased unnecessary processing step, material, energy loss is very big: Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae is after 70% ethanol extraction 3 times, and its active ingredient is as Folium Ginkgo flavone, bilobalide, oleanolic acid, danshensu, red phenol total acid, TANSHINONES, all substantially carried to the greatest extent no matter cryptotanshinone etc. are water solublity or fat-soluble active component, in its medicinal residues, a residual fraction macromolecular components is as starch, Fructus Ligustri Lucidi polysaccharide, the materials such as glycoprotein, wherein only have polysaccharide component to there is certain physiologically active, by its medicinal residues water extraction together with the flavour of a drug such as Radix Polygoni Multiflori Preparata again, although can Extraction parts Fructus Ligustri Lucidi polysaccharide composition, but by water extraction liquid after concentrated again through 60% ethanol precipitate with ethanol, this part polysaccharide precipitated removing again, by medicinal residues again with other raw materials merging extracting in waters, the consumption of ethanol while not only greatly increasing precipitate with ethanol, and greatly increased extraction, organic solvent reclaims, energy consumption when concentrated, has also improved drug administration amount, and of no avail to improving drug quality and curative effect.3. former technique is extracted solvent amount wretched insufficiency, the active component rate of transform is low: when Folium Ginkgo, Fructus Ligustri Lucidi, three alcohol extractions of Radix Salviae Miltiorrhizae, ethanol consumption is respectively 4.2 times, 3.3 times, 3.3 times of medical material weight, when twice water extraction of the flavour of a drug such as medicinal residues and Radix Polygoni Multiflori, amount of water is respectively 3.0 times, 2.3 times of medical material weight, solvent amount drowning medical material face completely in leaching process, extraction benefit is low, the effective ingredient rate of transform is extremely low, and each batch puts that to reveal the medical material on solvent surface inconsistent when extracting, cause every batch of drug quality unbalanced, have a strong impact on drug quality and curative effect.4. former technique mainly adopts oral liquid formulation, dosage form selection is improper: Ginkgolides in Ginkgo biloba L. Leaves, Oleanolic Acid in Herbal Ligustrum lucidum, uncaria total alkaloids in Ramulus Uncariae Cum Uncis, TANSHINONES in Radix Salviae Miltiorrhizae, the main effective ingredient such as cryptotanshinone is all insoluble in water or water insoluble, if make aqueous solution preparation, mentioned component is except most by loss in technical process, residual very little a part of composition also can be in storage process precipitated separating out, heavy knot not only has a strong impact on presentation quality at the bottom of bottle, and have a strong impact on pharmaceutical effectiveness, both having made to add solubilizing agent in aqueous solution can not effectively address the above problem, therefore this compound recipe should not be made aqueous solution preparation.The present invention, by technological improvement, has overcome the various drawbacks that former its preparation process aspect exists, and makes its technique more rational, and production practices are had to practicality, operability.

Another feature of compound recipe medicine of the present invention is the control that can be used for senile dementia.The treatment that the disclosed purposes of publication number CN1596960A patent application " a kind of Chinese medicine for the treatment of cerebral arteriosclerosis " is cerebral arteriosclerosis, be used for the treatment of dizziness headache, Hiccough and deaf, blurred vision, hypomnesis, insomnia due to middle-aged and elderly people cerebral arteriosclerosis, soreness of the waist and knees, the diseases such as numb limbs and tense tendons.Above-mentioned curing mainly in indication, the symptom of the Patients ' Cognitive respond aspects such as hypomnesis and senile vascular dementia have certain dependency, but above-mentioned all cure mainly indication all with senile dementia onrelevant.The disclosed preparation method comparison of the preparation method of a kind of compound recipe of the present invention and CN1596960A patent application, the feature of maximum of the present invention is to extract and has retained and can, through fat-soluble active ingredients such as the Ramulus Uncariae cum Uncis alkali of blood brain barrier, isorhynchophylline, bilobalide, stilbene glucoside, TANSHINONES, cryptotanshinones, test and show that it can be applicable to the control of senile dementia.

Senile dementia (claims again Alzheimer, A1zheimer disease, be called for short AD) and vascular dementia (Vascular dementia, be called for short VD) be two kinds of different diseases, senile dementia (AD) is the senile disturbance of intelligence syndrome that causes disordered brain function to cause due to tangle and senile plaque, and vascular dementia (VD) is the another type dementia that directly causes the brain atrophy due to pathological changes and the vasculogenic factor of large brain cognitive function to cause due to vascular factor pathological changes, both are at epidemiology, pathogenesis, pathological manifestations, clinical manifestation, imaging examination, lab testing, all there is substantial differences in diagnostic criteria and treatment aspect, its main difference point is:

Epidemiology: in American-European countries, more than 60 years old in old people, 6%～12% generation is dull-witted, within 85 years old, above old man has 20%～40% dementia occurs, and wherein more than half is AD; In China, by being taken the lead by BJ Union Hospital, the epidemiological investigation that 42890 old men are carried out of being participated in by 109 doctors at 6 cities 10Ge center, the whole nation shows, the northern area of China over-65s resident prevalence of dementia is 6.9%, wherein AD is that 4.2%, VD is 1.9%; South China area over-65s resident prevalence of dementia is 3.9%, and wherein AD is that 2.8%, VD is 0.9%; In China's old dementia patients, AD sickness rate is about 3 times of VD.

Pathogenesis: AD can be divided into familial and sporadic, the AD of familial is autosomal dominant inheritance, No. 21 chromosomal app genes, No. 14 chromosomal PS1 and No. 1 chromosomal PS2 gene are undergone mutation, for the cause of disease of familial AD, the morbidity of sporadic AD is now sure on gene level an APOE gene.Comparatively popular the having of morbidity hypothesis of AD at present: amyloid-beta hypothesis, Tau albumen hypothesis, neural blood vessel hypothesis, oxidative stress theory etc.And VD, because the various vasculogenic factor pathological changes such as cerebral ischemia, cerebral hemorrhage, low perfusion, cerebral embolism directly cause the corresponding cognitive function of brain region, pathological changes occurs, be that vasculogenic factor causes due to toxic substance injured brain tissue.

It is neural inflammatory speckle (NP) and tangle (NFT) that the main pathology of pathology aspect: AD is changed into two kinds, in AD patient's cerebral cortex part, in hippocampus and various nucleus and thalamus, there is a large amount of NP, think that the formation of NP is mainly due to A amyloid beta deposition; NFT's is mainly to form in neuronic cyton, and research shows that the neuronal cell that contains NFT has become retrograde pathological changes mostly, and the main component of tangle is mainly P-tau albumen.And the pathological change of VD is varied, more common pathological change is that multiple lacuna sexually transmitted disease (STD) becomes and large-area infarction pathological changes and atherosclerosis, usually the pathological change with ventricles of the brain expansion with brain atrophy; Cerebral infarction can be sent out as multiple focuses or multiple focus, is absorbed by normal cerebral tissue, thereby has formed space, visible glial cells hyperplasia under mirror after slough liquefaction; The deep small vessel disease change that most scholar tends to white matter and grey matter is the main pathology reason that forms VD.

Clinical manifestation: AD and VD are both with cognitive dysfunction, wherein AD is taking dysmnesia as main, development has obvious stage, and become master with the degenerative disease of temporal lobe, top, the early stage decline of action skill, prosopagnosia, the reading comprehension ability mostly showing as due to dysmnesia, language understanding obstacle, top apraxia declines, degradation under the ability of visual space, along with pathological changes further develops, executive capability due to appearance prefrontal lobe is impaired declines, its onset is generally more hidden, patient's age of onset is all bigger than normal, and the progress of the state of an illness is slower; And the symptom going out because the different causes of disease and different focus are expressed that shows clinically of VD is not quite similar, memory dysfunction is not essential clinically, and general VD is acute or subacute onset, and the age of patient's morbidity is also relatively less than normal compared with AD.

The MRI of imaging examination: AD shows the cortex diffuse atrophy that mostly is Hippocampus and temporal lobe, top, and CT examination can show ventricles of the brain expansion and brain atrophy; The necrosis of the corresponding cerebral tissue that the main change on the MRI of VD is arranged for different lesion vesselses, thereby be shown as long T1 and the T2 of corresponding site, brain CT can return show the infarct of different parts and white matter loose, show as the low-density shadow of corresponding site.

Lab testing: when AD patient falls ill in early days, significantly raising appears in the A β 1-42 in its cerebrospinal fluid in Tau albumen and venous blood; And VD patient is while falling ill in early days, the A β 1-42 in Tau and venous blood in cerebrospinal fluid changes not obvious.

The current Main Basis clinical manifestation of diagnosis and the certain auxiliary examination of diagnosis aspect: AD, diagnostic criteria has " Americanism obstacle diagnosis statistic handbook " and two kinds of diagnostic criterias of NINCDS-ADRDA, in the development of AD diagnostic criteria, all emphasize the importance of objective evidence, as Molecular biology, iconography change and the detection of gene level accordingly.The diagnostic criterias such as the diagnostic criteria of VD is various, the DSM-IV of the ADDTC that mainly contains NINDS-AIREN, California, USA adopting clinically, the ICD-10 of WHO classification of diseases, Americanism morbidity statistics and diagnosis handbook.

Therefore, senile dementia (AD) is diverse two concepts with vascular dementia (VD), is two kinds of diverse diseases, and former patent application does not relate to the preventive and therapeutic effect of this compound recipe to senile dementia (AD).

For AD pathogeny, the medicine for the treatment of in the market senile dementia mainly contains and suppresses medicine and the large class of cholinesterase inhibitor two that A β forms and deposits, secondly be glutamate receptor antagonists, calcium ion antagonist, remove free radical agent and non-oxidizability medicine, the auxiliary therapy medicines such as estrogen, said medicine all can only partial rcsponse symptom, there is treatment limitation, can not treat on the whole disease, and there is certain toxic and side effects, resisting for many years senile dementia research and development all recognizes domestic and international research worker with clinical use experience, need to accomplish early diagnosis and the treatment of many targets to the treatment of AD, the traditional Chinese medicine of China is owing to having many target spots, multipath effect feature and day by day cause the concern of research worker.

This compound recipe is just possessing These characteristics.In this compound recipe Ramulus Uncariae Cum Uncis, in Rhomotoxine, Ginkgolides in Ginkgo biloba L. Leaves, Radix Polygoni Multiflori, in stilbene glucoside, tanshinone in salvia miltiorrhiza bunge and cryptotanshinone, the Cortex Eucommiae, geniposide is all proved AD is had to good prevention effect.Find as researchs such as Le Bars P, take Folium Ginkgo extract after 6 months, symptom light to AD, moderate patient has alleviation, and without obvious adverse reaction, Chu Jin, Ye Cuifei etc. study discovery, stilbene glucoside can reduce beta amyloid peptide and cause Model of Dementia mouse brain cortex Content of IL-6, the activity of rising Hippocampus and cortex choline acetyltransterase and acetylcholinesterase, increase the expression that D-galactose causes brain aging CA 1 Zone of Hippocampus in Mouse nerve growth factor and neurotrophic factor-3, alleviate the degree that neuron degeneration changes, thereby reach the effect of control Alzheimer's disease, the neurotoxicity of cryptotanshinone reversible by glutamate induction found in the research such as Zhang, increase the release of lactic acid dehydrogenase and the gathering of neural DNA, and change the expression of Bcl-2 family protein and play neuroprotective, its inhibitor LY294002 that can block PI3K makes PI3K/Akt Pathway Activation and protects cerebral cortex nerve, Yu X Y research thinks that patient's AD brain inner tissue generally all there will be ammonia concentration level to raise abnormally, thereby and cryptotanshinone can reduce ammonia concentration in cerebral tissue for the many neurodegenerative diseases including AD by blood brain barrier, Matsumi etc. studies confirm that the Hippocampal Neuron Cells of In vitro culture, the genipin of 20umol/L and 40umol/L all can obviously suppress the cell-cytotoxic reaction that A β causes, and be dose-effect dependency, thereby protection permissive cell, because genipin can transmission target cell membrane, directly protection hippocampal neuron avoids the harm of A β, genipin also can antagonism wound and the memory deficits in mice that causes of scopolamine, the genipin of 5mg/L can be induced the growth of PC12h cell axon, its neurotrophic effect mechanism to PC12h cell may be by improving neuron pattern NO synthase activity, thereby being generated, NO increases the generation that excites mitogen protein kinase (MAPK) cascade reaction, recently research shows, thereby genipin may make extracellular signal-regulated kinase phosphorylation excite MAPR cascade reaction to work by the conduction of NO-cGMP-PKG signal path, yellow thick ability etc. by research Ramulus Uncariae Cum Uncis loose on alzheimer disease mouse model free radical, antioxidase due to Chronic aluminum poisoning impact and mechanism of action, proof Ramulus Uncariae Cum Uncis is loose can improve mouse brain index, reduce mortality rate, keep body weight in normal condition, strengthen oxidation resistance, suppress MAO-B activity, strengthen removing the effect of lipid peroxide and metabolic waste thereof, reduce spilling of LDH, maintain NO in normal level, thereby Cell protection, opposing is dull-witted.Mentioned component is the main effective ingredient in this compound recipe just, and every kind of composition has the approach and the target spot that are not quite similar to the effect of senile dementia, many target spots of multicomponent senile dementia prevention and cure feature of this compound recipe just, the medicine that is developed to senile dementia prevention and cure has realistic meaning.

Summary of the invention:

The object of the present invention is to provide a kind of Chinese patent medicine for senile dementia prevention and cure.

Another object of the present invention be to provide a kind of for senile dementia prevention and cure, and can improve the preparation method of the Chinese patent medicine of cerebral arteriosclerosis therapeutic effect.

The object of the invention is to be achieved through the following technical solutions:

The preparation method of Chinese medicine compound and the application in senile dementia prevention and cure, is characterized in that its prescription medical material is by weight: 180 parts of Folium Ginkgos, 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, 60 parts of Ramulus Uncariae Cum Uncis.

A preparation method for Chinese medicine compound, is characterized in that it comprises the following steps:

(1) Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae, the Ramulus Uncariae Cum Uncis got in prescription weight proportion add 30～96% alcohol heating reflux extraction 1～4 time, add amount of alcohol and be 3～18 times of medical material weight, each return time is 0.5～5 hour, and extracting solution reclaims ethanol concentrated, obtains extractum A;

(2) getting the heating that adds water of Radix Polygoni Multiflori Preparata, the Cortex Eucommiae, the Radix Cyathulae of prescription in weight proportion decocts and extracts 1～4 time, amount of water is 3～20 times of medical material weight, each decocting time is 0.5～4 hour, after decoction liquor is concentrated, add ethanol to reaching 30～90% containing alcohol amount, room temperature or cold preservation are placed and within 6～56 hours, are made precipitation, leaching supernatant decompression recycling ethanol is also concentrated, obtains extractum B;

(3) extractum A and extractum B merge dry or are dried separately respectively, obtain dry extract, and dry extract is pulverized, and obtain dry extract;

(4) (3) gained dry extract is added acceptable adjuvant and conventional formulation method on pharmaceutics make hard capsule, soft capsule, tablet, granule.

(5) Folium Ginkgo in crude drug also can be directly with the Folium Ginkgo extract sold on market for preparation, the weight portion of Folium Ginkgo extract is 0.5%～20% of Folium Ginkgo weight portion.

(6) concentrating under reduced pressure of simmer down to described in preparation method, thin film concentration or the vacuum film one in concentrated; Described extract dry is the one in the dry or airpillow-dry of constant pressure and dry, drying under reduced pressure, spraying.

The medicine (abbreviation new technology) that below adopts the embodiment of the present invention 1 to prepare, and the medicine (being called for short former technique) of preparing with the disclosed preparation technology of publication number CN1596960A patent application, studies confirm that beneficial effect of the present invention by comparison and the pharmacodynamic experiment of two kinds of active constituents of medicine content.

1, the comparison of two kinds of active constituents of medicine

Divide and get Folium Ginkgo 180g, Radix Polygoni Multiflori Preparata 180g, Fructus Ligustri Lucidi 90g, Radix Salviae Miltiorrhizae 90g, Cortex Eucommiae 90g, Radix Cyathulae 90g, Ramulus Uncariae Cum Uncis 60g, two parts, extract and check with proper method by former technique and new technology respectively:

(1) former technique: get Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae three tastes 70% ethanol heating extraction three times, add for the first time 1500ml, extract 2 hours, add for the second time 1200ml, extract 1.5 hours, add for the third time 1200ml, extract 1 hour, merge extractive liquid,, filters, decompression filtrate recycling ethanol is to without alcohol taste, concentrated for subsequent use.The medicinal residues of three taste medical materials and Radix Polygoni Multiflori Preparata after alcohol extraction, the Cortex Eucommiae, Radix Cyathulae, four tastes such as Ramulus Uncariae Cum Uncis, decoct with water twice, 2400ml for the first time adds water, 1800ml for the second time adds water, each 2 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (60～65 DEG C), clear paste adds ethanol to be made to reach 60% containing alcohol amount, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol is extremely without ethanol taste, with Folium Ginkgo, Fructus Ligustri Lucidi, tanshinol is carried concentrated solution and is merged, continue to be concentrated into relative density 1.30 (60～65 DEG C), vacuum drying, pulverize, obtain dry extract 127.3g.

(2) new technology: get Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae, Ramulus Uncariae Cum Uncis four tastes and add 70% ethanol 3360ml heating and refluxing extraction 2 times, each 1.5 hours, extracting solution filters, and filtrate recycling ethanol is also concentrated into relative density 1.30 (60～65 DEG C), obtains extractum A; The add water 2880ml heating of Radix Polygoni Multiflori Preparata, the Cortex Eucommiae, Radix Cyathulae three tastes decocts and extracts 2 times, each 1.5 hours, decoction liquor filters, filtrate is concentrated into the clear paste that relative density is 1.12 (60～65 DEG C), and clear paste adds ethanol to be made to reach 60% containing alcohol amount, stirs evenly, leave standstill, filter, decompression filtrate recycling ethanol is also concentrated into relative density 1.30 (60～65 DEG C), obtains extractum B; Merge extractum A and extractum B, vacuum drying, obtains dry extract, pulverizes, and obtains dry extract 97.5g.

(3) divide and get two kinds of dry extracts, respectively with reference under " Chinese Pharmacopoeia " 2010 editions, 2005 editions one each medical material item and pertinent literature content assaying method carry out the assay of each active component.Result: new technology and former technique gained active substance have actual variance on kind and content: cannot detect Ramulus Uncariae cum Uncis alkali in former technique extract, isorhynchophylline content is also very humble, it extracts the rate of transform is only 7.45%; Bilobalide, stilbene glucoside isoreactivity component content are far from each other, and oleanolic acid, content of danshinolic acid B are also deposited large larger difference; The new technology active component rate of transform greatly improves, and total solid matters yield reduces by 30.56% than former technique gained solids yield, and active component purity is higher.Therefore the medicine that extracts preparation by two kinds of different process, actual is two kinds of different medicines, its active component composition, content, ratio are all different.Two kinds of technique active component are more as shown in table 1:

The variation of table 1 new technology and former technique active component

2, the comparative study of pharmacodynamics for the treatment of arteriosclerosis

The former purposes of this compound recipe is mainly the control of cerebral arteriosclerosis.Cerebral arteriosclerosis is substantially identical with whole body atherosclerosis everywhere, and main change is steatosis and the cholesterol deposits of endarterium deep layer, forms atherosclerotic plaque and various secondary affection, and pathogeny is very complicated.Experiment adopts hypertension complicated with hyperlipemia method to set up rat brain arteriosclerosis model, and cerebral index, brain water content, cerebrovascular and the histopathology morphologic variation of the medicine by observing two kinds of different process manufactures to cerebral arteriosclerosis animal illustrates that new technology is for the beneficial effect that improves this compound treatment arteriosclerosis.

Get 100 of the clean level of body weight 200 ± 20g SD rats, be divided at random Sham-operated control group, four groups of solvent control groups, former technique group, new technology group, 25 every group.Rat fasting (can't help water) 12h, after 10% chloral hydrate intraperitoneal injection of anesthesia, Sham-operated control group row bilateral renal arteries exclusion, narrowless, feed common feedstuffs; Other three groups of row Bilateral Renal aortic stenosis operations, make its narrow approximately 3/4, cause rat renovascular hypertension model, and after operation 1 week, gavage is warmed to the high lipoprotein emulsion 10mL/kg (containing 7% cholesterol, 15% Adeps Sus domestica, 2% sodium cholate and 1% propylthiouracil) of 35 DEG C, every day 1 time, totally 14 weeks, make the cerebral arteriosclerosis model of hypertension complicated with hyperlipemia.

Perform the operation after 7 weeks, former technique group and new technology group are all by 2.44g crude drug/kg gastric infusion: divide prepared extract while getting new technology, the comparison of former technique active constituents of medicine, add respectively appropriate soluble starch and produce the drug powder containing 8g crude drug/g, respectively by drug powder 0.305g/kg gastric infusion (being equivalent to 2.44g crude drug/kg), face the used time to be made into suspension with distilled water; Sham operated rats and solvent control group gavage give equivalent distilled water.Successive administration is observed the variation of rat behavior, cerebral edema, cerebral infarction, tectology after 8 weeks, data are carried out to significance test.

Rat behavior changes and carries out behavior scoring with reference to 5 points of standards of grading processed of Zea Longa: 0 point, and normal, without abnormal symptom; 1 point, can not full extension offside fore paw; 2 points, turn-take laterally; 3 points, topple over to offside; 4 points, can not spontaneously walk, loss of consciousness.Then broken end is got Mus brain fast, a part (10 every group) point another name left and right brain hemisphere weight in wet base, put in 160 DEG C of baking boxs and claim dry weight after 24 hours, calculate as follows brain water content: brain water content (%)=(weight in wet base-dry weight)/weight in wet base × 100%; A part (10 every group) cuts the crown brain sheet of thick about 2mm in anterior commissure plane, be placed at once 2%TTC solution, hatch 30 minutes for 37 DEG C, infarct presents white, non-infarct presents redness, measure each district area with planimeter (C63 image analysis system), and calculate infarct and account for the percentage ratio of full brain; Another part (2～5 every group) is made Histomorphological: cerebral tissue after fixing, the crown brain that cuts, conventional dehydration, paraffin embedding film-making, HE dyeing, light microscopic inspection.

Result of the test: (1) impact on rat behavior: rats in sham-operated group is without abnormal symptom, and behavior scoring is 0; Solvent control group, appearance can not full extension offside fore paw or the nerve injury symptom of turn-taking laterally or toppling over to offside, and behavior scoring is 2.4 ± 0.7; Former technique group medicine can significantly reduce rat behavior scoring, and behavior scoring is 1.2 ± 0.59, relatively has significant difference (P < 0.001) with solvent control group; New technology group behavior scoring is 0.65 ± 0.41, significantly lower than solvent control group and former technique group (P < 0.001, P < 0.05).Experimental result shows: former technique group and new technology group all can significantly be improved rat behavior quality, and the new technology group of equal crude drug dosage is improved successful and is better than former technique group, and experimental result is in table 2.

The comparative study of table 2 on rat behavior scoring impact

Note: with relatively * * * P < 0.001 of solvent control group, with relatively #P < 0.05 of former technique group

(2) impact on brain water content: the brain water content highly significant of solvent control group is higher than sham operated rats (P < 0.001), and experimental animal model moulding is successful; The brain water content of former technique group is lower than solvent control group (P < 0.05); The brain water content of new technology group is significantly lower than solvent control group (P < 0.001), lower than former technique group (P < 0.05), with sham operated rats there was no significant difference (P > 0.05).Experimental result shows: former technique group and new technology group medicine all can reduce brain animal sclerosis rat cerebral tissue water content, alleviate brain hemisphere edema degree, the new technology group effect of equal crude drug dosage is better than former technique group (P < 0.05).The results are shown in Table 3.

The comparative study of table 3 on brain water content impact

Note: with relatively #P < 0.05 of sham operated rats, ###P < 0.001; With relatively * P < 0.05 of solvent control group (model group), * * * P < 0.001; With relatively △ P < 0.05 of former technique group.

(3) impact on cerebral infarct volume: sham operated rats cerebral tissue is without infraction, and infraction phenomenon appears in solvent control group cerebral tissue, and infarct volume accounts for 29.55% of full brain; Compared with solvent control group, former technique group can effectively be dwindled cerebral tissue infarct size (P < 0.05), new technology group can significantly be dwindled cerebral tissue infarct volume (P < 0.001), declines respectively 27.14%, 48.83% compared with solvent control group.Experimental result shows, under equal crude drug dosage, new technology group has better cerebral infarction therapy effect (P < 0.01) than former technique group.Experimental result is in table 4.

The impact of table 4 on cerebral infarct volume

Note: with the comparison of solvent control group, * * * P < 0.001; Compare ##P < 0.01 with former technique group

(4) impact on tectology: with sham operated rats comparison, the visible many places of the cerebral tissue focal tissue degeneratiaon of large area or the necrosis of solvent control group rat, there is obvious degeneration or necrosis in most neuroganglions, the endotheliocyte of the arterial intima in cerebral tissue is popularity degeneration, necrosis, comes off, the visible fibrous cap sample of tube wall deposit bud shape is given prominence to and hypertrophy, shows that cerebral tissue ischemic lesions and cerebrovascular arteriosclerosis symptom form.With the comparison of solvent control group, the above-mentioned pathological changes situation of two administration groups obviously alleviates, its Central Plains technique group minority neuroganglion degeneration or necrosis, and neurocyte swelling becomes circle, and Nissl body reduces, part vacuolar degeneration, there is glial cells hyperplasia (reparation) in new technology group, glial nodule forms, normal around, giant pyramidal cells is without degeneration, cerebral tissue focal tissue degeneratiaon area and number and the obvious minimizing of former technique group or disappearance, neuroganglion degeneration obviously reduces, blood vessel endothelium is substantially complete, the fibrous cap sample hypertrophy of tube wall also obviously reduces, in blood vessel, deposit bud shape is outstanding disappears substantially with hypertrophy, show obviously to have suppressed after medication the formation of cerebral tissue ischemic lesions and cerebrovascular arteriosclerosis symptom, and new technology group brain cerebral tissue ischemic lesions and cerebrovascular arteriosclerosis symptom are significantly light than former technique group.

3, improve the comparative study of pharmacodynamics of old spirit degeneration symptom

This compound recipe can be used for the control of the senile vascular spirit degenerative diseases such as the hypophrenia due to cerebral arteriosclerosis, vascular dementia, experiment is with the positive contrast medicine of Dihydroergotoxine Mesylate, by determination experiment mouse monoamine oxidase, MAO (MAO) activity, oxygen-derived free radicals (SOD), NO level and NOS activity, medicine prepared by two kinds of techniques compares research for the curative effect of improving these symptoms.

Get 50 of the SD rats of body weight 200 ± 20g, be divided at random 5 groups of blank groups, model group, new technology group, former technique group, Dihydroergotoxine Mesylate group (abbreviation positive controls).Except blank group, other four groups of, 10% chloral hydrate intraperitoneal injection of anesthesia (3ml/kg), permanent ligation bilateral common carotid arteries is set up model.

Experimental technique: except blank group and model group, each its three groups of rat administration in modeling, every day, gavage gave new technology drug suspension (2.44g crude drug/kg), former technique group drug suspension (2.44g crude drug/kg), Dihydroergotoxine Mesylate 0.5mg/kg, continuous 30 days respectively.Experiment finishes to measure cerebral tissue MDA content and SOD activity: get mice 0.1ml and grind, adding 0.9ml normal saline fully grinds and makes homogenate again, 4 DEG C of centrifugal 4500rpm15min, get supernatant, adopt respectively thiobarbituricacidα-method and xanthine oxidase to measure.Measure NO, NOS content: 1g and normal saline are in 0.1g simultaneously: the homogenate of 1ml ratio, centrifugal 10 minutes of 3000rpm, gets supernatant and is placed in-20 DEG C of refrigerators to be measured, and reference reagent box description is strictly carried out.

Experimental result: 1. three medication group medicines can suppress MAO activity (with relatively P < 0.001 of model group), reduce the decomposition of monoamine neurotransmitter, promote learning and memory function, stress sensitive strengthens, the effect of new technology group is better than former technique group (P < 0.05), with positive controls effect there was no significant difference (P > 0.05); 2. three medication group medicines all can improve VD mouse brain tissue oxygen free radical (SOD) content, and the effect of new technology group is better than positive controls and former technique group (P < 0.05); 3. with the comparison of blank group, the active persistence of NO level and NOS increases (P < 0.001), the neurotoxicity of prompting NO has participated in the formation of VD, the activity decreased of NOS after three groups of Drug therapys in Cerebral Cortex tissue, NO is generated and discharges content obviously to reduce, new technology group drug effect is better than former technique group (P < 0.05), with positive controls there was no significant difference (P > 0.05).

Monoamine oxidase, MAO (MAO) is active to be increased with age growth, and cause that in brain, changes of Catecholamine Content changes, promote physiological activity imbalance, the relation of it and study and attention is very close, in aging and VD patient tissue, MAO is active raises, oxidation Decomposition monoamine neurotransmitter, impact study and attention, be one of old neurodegenerative disease reason; Oxygen-derived free radicals (SOD) plays an important role in the pathological change process of VD; Nitric oxide (NO) is a kind of gaseous matter, it is simple in structure and extremely unstable, easily diffusion, reactive strong, biological half-life is short, disperse Yu Genao district in nervus centralis, has the cerebral blood flow of adjusting, participates in the multiple effect such as synaptic plasticity, neurotoxicity and struvite infringement, with study, remember closely related.

Experimental result shows: this compound medicine is degenerated, lost after acute and chronic angiopathy function, the hypophrenia, vascular dementia for senescence spirit and has good preventive and therapeutic effect, and new technology group medicine can effectively improve the improvement effect of this compound recipe to above-mentioned symptom.It is as shown in the table:

5 Ge Zu rat cerebral tissue specific activitys

Note: with blank group comparison: * * * P < 0.001; With model group comparison: #p < 0.05; ##P < 0.01; ###P < 0.001; With positive controls comparison: △ p < 0.05; With former technique group comparison :@p < 0.05.

4, the pharmacodynamic experiment of senile dementia prevention and cure research

In this compound recipe of the abundant extraction and application of Technology of the present invention medical material for senile dementia have preventive and therapeutic effect the fat-soluble height such as Ramulus Uncariae cum Uncis alkali, isorhynchophylline, stilbene glucoside, TANSHINONES, iso tanshinone, bilobalide, genipin, easily see through the active component of blood brain barrier, many target spots multipath ground senile dementia prevention and cure, its effect is confirmed by AD mice animal pharmacodynamic experiment due to D-galactose.

D-galactose is current generally acknowledged senile dementia (AD) mice modeling method, and D-galactose can inducing neural unit degeneration, causes subacute Model of Dementia; And amyloid beta (β-amyloid protein, A β) gathering and neurofibrillary tangles be the main pathological change of AD, also be the nucleus of senile plaque, the gathering of A β can cause rising, inflammatory reaction, apoptosis and the neurodegenerative diseases of oxygen-derived free radicals, and A β plays vital initial and pivotal role in the pathogenic process of senile dementia.The generation that suppresses at present A β is the major programme for the treatment of AD.This is studied to inject and gives D-galactose and build AD mouse model, and tests and measure mouse brain by Mice water maze and organize A β changes of contents to evaluate medicine prepared by this patent preparation method preventive and therapeutic effect to AD.

Get 60 of the Kunming mouses of 2～3 months ages of Mus, body weight 32 ± 2g, male and female half and half, by body weight be divided at random control blank group, treatment blank group, prevent and treat model control group, treat model control group, prevent and treat group, 6 groups for the treatment of groups, every group of 10 mices; Control blank group and treatment blank group all give normal saline, and all the other 4 groups of injection of d-galactose every day (120mg/kg)+sodium nitrite (90mg/kg), continuous 2 months, set up model.Prevent and treat group gavage in modeling and give new technology group medicine (2.44g crude drug/kg), once a day, after 30 days, get control blank group, prevent and treat model control group and control group mice carries out Mice water maze experiment and organizes A β content with measured by radioimmunoassay mouse brain.All the other 3 treated animals are after modeling, treatment blank group and treatment model control group give normal saline, treatment group is by (2.44g crude drug/kg) dosage, gavage gives new technology group medicine, once a day, after continuous 30 days, carry out Mice water maze experiment and organize A β content with measured by radioimmunoassay mouse brain.

Mice water maze experiment: labyrinth round diameter 80cm, high 44cm, safety board diameter 8cm, high 20cm, completes directed swimming test according to mice Morris water maze device and tracking system instrument description, stops that to exceed 2s be successfully on safety board, train every day 2 times, totally 4 days is escape latency from entering water to arriving time of safety board, records animal swimming track.

Measured by radioimmunoassay mouse brain is organized A β content: experiment finishes, and disconnected neck is put to death mice, separates cerebral tissue, prepares single cell suspension, and cell lysis detects the content of A β in each processed group according to the description operation of A β radioimmunoassay kits.

Experimental data is carried out to t inspection, result: 1. prevent and treat model control group and compare with control blank group, there is the prolongation of significance (P < 0.001) in the escape latent time of preventing and treating model group, platform is crossed over number of times utmost point significance and is reduced (P < 0.001), the expression of A β significantly raise (P < 0.001) in mouse brain tissue; Control group with prevent and treat model group comparison, (the P < 0.01 that improves of significance crossed over number of times and all obtains by the escape latent time of mice and platform; P < 0.01), in cerebral tissue also there is obvious decline (P < 0.001) in the expression of A β.2. treating model control group compares with treatment blank group, there is the prolongation (P < 0.001) of utmost point significance in the escape latent time for the treatment of model group, platform is crossed over the minimizing (P < 0.001) of number of times utmost point significance, the expression of A β significantly raise (P < 0.001) in mouse brain tissue; Treatment group and the comparison for the treatment of model group, the escape latent time of mice and platform leap number of times obtain (the P < 0.05 that improves of significance; P < 0.05), in cerebral tissue also there is obvious decline (P < 0.001) in the expression of A β.Result shows that this product can significantly reduce mouse brain and organize A β content, and mice AD is had to good preventive and therapeutic effect.In table 6, table 7.

What the experiment of table 6 control group Mice water maze and A β expressed affects result comparison

Note: with relatively #P < 0.05 of blank group, ##P < 0.01, ###P < 0.001; With relatively * P < 0.05 of model control group, * * P < 0.01; * * P < 0.001.

What the experiment of table 7 treatment group Mice water maze and A β expressed affects result comparison

Note: with relatively #P < 0.05 of blank group, ##P < 0.01, ###P < 0.001; With relatively * P < 0.05 of model control group, * * P < 0.01, * * * P < 0.001.

Detailed description of the invention:

Further set forth the preparation method of medicine of the present invention below by embodiment.But the present invention is not limited to these embodiment.

The preparation of 1 compound recipe hard capsule of embodiment

Get 180 parts of Folium Ginkgos, 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, 60 parts of ethanol that add 8 times of amounts of medicinal raw material weight, be 70% containing alcohol amount of Ramulus Uncariae Cum Uncis, heating and refluxing extraction 2 times, each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol is also evaporated to relative density 1.20～1.35 (60～65 DEG C), obtains extractum A.

Get 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, add the water heating of 8 times of amounts of medicinal raw material weight to decoct extraction 2 times, each 1.5 hours, merge extractive liquid,, filter, filtrate decompression is concentrated into the concentrated solution of relative density 1.10～1.25 (60～65 DEG C); Concentrated solution adds ethanol to be made to reach 60% containing alcohol amount, stirs evenly, and leaves standstill 8～24 hours, filters, and decompression filtrate recycling ethanol is also concentrated into relative density 1.20～1.35 (60～65 DEG C), obtains extractum B.

Merge extractum A and extractum B, vacuum drying, obtains dry extract, gets dry extract and is broken into fine powder, adds appropriate amount of starch, mixes, and with ethanol granulation, dry, 20 mesh sieve granulate, add appropriate silicon dioxide and magnesium stearate or Pulvis Talci, mix, and capsule charge, to obtain final product.

The preparation of 2 compound granular agent of embodiment

Get 180 parts of Folium Ginkgos, 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, 60 parts of ethanol that add 6 times of amounts of medicinal raw material weight, be 85% containing alcohol amount of Ramulus Uncariae Cum Uncis, heating and refluxing extraction 2 times, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol vacuum film are concentrated into the extractum A of relative density 1.10～1.20 (60～65 DEG C).

Get 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, add the water heating of 10 times of amounts of medicinal raw material weight to decoct extraction 3 times, each 1 hour, merge extractive liquid,, filtered, and filtrate vacuum film is concentrated into the concentrated solution of relative density 1.08～1.25; Concentrated solution adds ethanol to be made to reach 70% containing alcohol amount, stirs evenly, and cold preservation 12～36 hours, filters, and decompression filtrate recycling ethanol is also concentrated into the extractum B of relative density 1.10～1.20 (60～65 DEG C).

Merge extractum A and extractum B, spraying is dry, obtains extract powder, gets extract powder and adds appropriate soluble starch, stevioside, mix, and granulation, dry, 16 mesh sieve granulate, subpackage, to obtain final product.

The preparation of 3 compound tablet of embodiment

Get 180 parts of Folium Ginkgos, 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, 60 parts of ethanol that add 12 times of amounts of medicinal raw material weight, be 60% containing alcohol amount of Ramulus Uncariae Cum Uncis, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filters, and filtrate recycling ethanol thin film concentration are to the thick extractum of relative density 1.15～1.35 (60～65 DEG C), belt vacuum drying, obtain dry extract, dry extract is broken into fine powder, obtains dry extract A.

Get 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, add the water heating of 6 times of amounts of medicinal raw material weight to decoct extraction 3 times, each 1.5 hours, merge extractive liquid,, filter, filtrate thin film concentration is to the concentrated solution of relative density 1.10～1.25 (60～65 DEG C); Concentrated solution adds ethanol to be made to reach 80% containing alcohol amount, stirs evenly, and leaves standstill 8～24 hours, filter, decompression filtrate recycling ethanol thin film concentration are to the thick extractum of relative density 1.1～1.35 (60～65 DEG C), belt vacuum drying, obtain dry extract, dry extract is broken into fine powder, obtains dry extract B.

Get extract powder A and extract powder B, add appropriate amount of starch, mix, granulation, dry, granulate, adds appropriate magnesium stearate or Pulvis Talci, tabletting, coating, subpackage and get final product.

The preparation of 4 compound capsules agent of embodiment

Get the ethanol that 60 parts of 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, Ramulus Uncariae Cum Uncis add 6 times of amounts of medicinal raw material weight, heating and refluxing extraction 2 times, each 3 hours, merge extractive liquid,, filter filtrate recycling ethanol, extractum vacuum drying, obtain dry extract, dry extract is broken into fine powder, obtains extract powder A.

Get 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, add the water heating of 8 times of amounts of medicinal raw material weight to decoct extraction 2 times, each 2 hours, merge extractive liquid,, filter, filtrate decompression is concentrated into the concentrated solution of relative density 1.10～1.25 (60～65 DEG C); Concentrated solution adds ethanol to be made to reach 85% containing alcohol amount, stirs evenly cold preservation 8～24 hours, extract supernatant, supernatant decompression recycling ethanol is also concentrated into the thick extractum of relative density 1.1～1.35 (60～65 DEG C), vacuum drying, obtain dry extract, dry extract is broken into fine powder, obtains extract powder B.

Get 1.6 parts of extract powder A, extract powder B and Folium Ginkgo extract, mix, add the soybean oil of 1.2 times of amounts of extract powder and the Cera Flava of 0.02 times of amount, homogenizing, mix, fill, is pressed into soft capsule, 18～30 DEG C of dryness finalizations, wash away soft capsule appearance oil reservoir with ethanol, 18～30 DEG C dry, takes out, and to obtain final product.

Claims (3)

1. the preparation method of a Chinese medicine compound, this Chinese medicine compound prescription medical material is made up of 60 parts of 180 parts of Folium Ginkgos, 180 parts of Radix Polygoni Multiflori Preparatas, 90 parts of Fructus Ligustri Lucidi, 90 parts of Radix Salviae Miltiorrhizaes, 90 parts of the Cortexs Eucommiae, 90 parts of Radix Cyathulaes, Ramulus Uncariae Cum Uncis by weight, and its preparation method is characterised in that:

(1) Folium Ginkgo, Fructus Ligustri Lucidi, Radix Salviae Miltiorrhizae, the Ramulus Uncariae Cum Uncis got in prescription weight proportion add 30～96% alcohol heating reflux extraction 1～4 time, add amount of alcohol and be 3～18 times of medical material weight, each return time is 0.5～5 hour, and extracting solution reclaims ethanol concentrated, obtains extractum A;

(2) getting the heating that adds water of Radix Polygoni Multiflori Preparata, the Cortex Eucommiae, the Radix Cyathulae of prescription in weight proportion decocts and extracts 1～4 time, amount of water is 3～20 times of medical material weight, each decocting time is 0.5～4 hour, after decoction liquor is concentrated, add ethanol to reaching 30～90% containing alcohol amount, room temperature or cold preservation are placed and within 6～56 hours, are made precipitation, leaching supernatant decompression recycling ethanol is also concentrated, obtains extractum B;

(3) extractum A and extractum B merge dry or are dried separately respectively, obtain dry extract, and dry extract is pulverized, and obtain dry extract;

(4) (3) gained dry extract added on pharmaceutics to acceptable adjuvant and adopt conventional formulation method to make hard capsule, soft capsule, tablet, granule.

(5) Folium Ginkgo of prescription in raw medicinal material also can be directly with the Folium Ginkgo extract sold on market for preparation, the weight portion of Folium Ginkgo extract is 0.5%～20% of Folium Ginkgo weight portion.

2. the preparation method of a kind of Chinese medicine compound as claimed in claim 1 and the application in senile dementia prevention and cure, is characterized in that described simmer down to concentrating under reduced pressure, thin film concentration or the vacuum film one in concentrated; Described extract dry method is the one in the dry or airpillow-dry of constant pressure and dry, drying under reduced pressure, spraying.

3. the Chinese medicine compound as described in claim 1 and 2 and the prepared medicine of preparation method have preventive and therapeutic effect to senile dementia.