CN1453028A - Chinese medicine for treating vascular dementia and its prepn - Google Patents

Abstract

The Chinese medicine for treating vascular dementia is prepared with 12 kinds of Chinese medicinal materials including gastrodia tuber, hooked uncaria, abalone shell, eucommia bark, parasitic loranthus, etc. and through extracting the effective components, and preparing the extractives into granule, capsule, tablet and other proper forms. The Chinese medicine for treating vascular dementia has the functions of calming the liver, suppressing the sthenic Yang, and invigorating liver and kidney and thus has excellent curative effect.

Description

A kind of Chinese medicine for the treatment of vascular dementia and preparation method thereof

Technical field

The invention belongs to the Chinese drug preparation field, relate to a kind of Chinese medicine for the treatment of vascular dementia and preparation method thereof.

Background technology

Vascular dementia is by the chronic brain syndrome due to the vascular lesion, and is clinical in memory and other cognition dysfunction, such as judgment, directive force, computing power, Integrated Understanding power etc., and above-mentioned performance repeatedly occurs with palsy and is the ladder sample and changes into feature. Onset is anxious, and emotion easily fluctuates, and personality disorder late period appears in irritability. Often with neurological symptom and sign, such as hemiplegia, aphasia, appraxia, agnosia etc., history of hypertension is arranged more. The alleged apoplexy dementia of the traditional Chinese medical science namely belongs to this scope.

Dementia patients is because of memory and other Cognitive function damages, and attenuating or the forfeiture of social functional activity ability and basic activity of daily living not only cause great misery to patient's spirit and health, and family and society have also been caused great burden. Relevant dull-witted illness rate, European and American countries report over-65s is about 3.0-5.0%, is 4.6-13.9% more than 70 years old, and wherein senile dementia accounts for 50-60%, and vascular is silly can to account for 15%, and both have (mixed type) concurrently and account for 10%; In Japan, vascular dementia accounts for about 60% of all senile dementias; Most research data shows that the incidence of disease of vascular dementia was 700,000 people/years. Because dementia occurs in the elderly mostly, in aging population society, the absolute number of elderly population no matter, or the ratio of elderly population is all increasing rapidly, in China, and comprehensive generaI investigation to 11 city and countries, among the elderly more than 60 years old, the incidence of disease of vascular dementia is 3,42/,100,000 populations, and its illness rate at city and country is respectively 4,78/,100,000 and 1,40/,100,000, this shows the height of its incidence of disease.

Though modern medicine has carried out a large amount of research from each different field to cerebral vascular dementia, his etiology and pathogenesis is still not fully aware of. Be the replacement therapy of suiting the medicine to the illness with regard to its treatment, use at present the more anticholinesterase that has, such as Tacrine; Cerebral vasodilator is Duxil, Nimodipine; The brain metabolism Reinforcing agent is such as piracetam; Neurotrophic factor etc. These treatments have some improvement to dementia man memory and cognitive function, but efficient not high, toxic and side effect is large, and must take throughout the year, and expense is high. And traditional traditional Chinese medicine utilizes its unique theoretical system and abundant practical experience that this disease has also been done deep discussion, think that its morbidity principle mainly is old deficiency of kidney-essence, with factors such as diet, feelings will, work and rests, and cause conscience spleen renal dysfunction, the qi and blood grain is lost, essential resistance of turbid phlegm, the liver-yang upper punch, its sick position is at brain, it is the functional disturbance of conscience spleen kidney, it is marked in the turbid stasis of blood of phlegm, covers and closes clearly key, causes refreshing machine appraxia. Liver belonging to Yin in physique and Yang in function, the deficiency of liver-yin and kidney-yin, water files to nourish wood wants, the moon sun not processed and cause liver-yang hyperactivity, positive wind transmission is moving, wind-yang and up-boring violates in the heart that then gods are unclear, violate in brain then refreshing machine become deaf and retardation of thinking occurs, when anything crops up forgetful.

As from the foregoing, can take full advantage of natural resources of Chinese medicinal materials from thinking calming the liver, that tonify the liver and kidney, the Chinese prescription for the treatment of vascular dementia is studied.

Summary of the invention

The object of the present invention is to provide a kind for the treatment of by Chinese herbs agent with the effect for the treatment of vascular dementia, it has effect calming the liver, that tonify the liver and kidney.

Another object of the present invention provides the preparation method of the Chinese medicine of this treatment ephrosis.

Chinese medicine of the present invention is made by following component: (consumption is weight portion)

Rhizoma Gastrodiae 330～750, yncaria stem with hooks 330～750, the shell of seaear 330～750, the bark of eucommia 330～750,

Parasitic loranthus 330～750, fushen 330～750, the vine of multiflower knotweed 330～750, sophora flower 150～430,

Cape jasmine 150～430, the root of large-flowered skullcap 150～430, radix cyathulae 280～570, motherwort 330～750.

Prescription preferred weight (part) ratio range of preparation Chinese medicine of the present invention is:

Rhizoma Gastrodiae 480～630, yncaria stem with hooks 480～630, the shell of seaear 480～630, the bark of eucommia 480～630,

Parasitic loranthus 480～630, fushen 480～630, the vine of multiflower knotweed 480～630, sophora flower 200～350,

Cape jasmine 200～340, the root of large-flowered skullcap 200～340, radix cyathulae 330～500, motherwort 480～630.

The optimum weight of Chinese medicine of the present invention (part) proportioning is:

Rhizoma Gastrodiae 530-540, yncaria stem with hooks 530-540, shell of seaear 530-540, bark of eucommia 530-540,

Parasitic loranthus 530-540, fushen 530-540, vine of multiflower knotweed 530-540, sophora flower 260-270,

Cape jasmine 260-270, root of large-flowered skullcap 260-270, radix cyathulae 390-410, motherwort 530-540.

The party has calming the liver, tonify the liver and kidney, the function of intelligence promoting and tranquilization, cure mainly syndrome of upper hyperactivity of liver yang by in wind-induced hypophrenia such as forgetful, retardation of thinking, directive force, computing power are poor, understand many mistakes, even aphasia, appraxia etc., companion hemiplegia, dizziness and headache, fidgety irritability, insomnia, bitter taste, dry throat, tongue is red, tongue is yellow, wiry and frequent pulse or chord length are strong, or blood vessel nature feeble-mindedness is light, the moderate person that has the above-mentioned symptom.

The production method that above-mentioned each component is made medicine of the present invention is:

1. the extraction of effective ingredient in the medicinal material, concentrated:

(1) first hook taking rattan, parasitic loranthus, motherwort, the vine of multiflower knotweed alcohol reflux that adds 3～7 times of (w/v) 50～95% extracts 2～5 times, the each backflow 0.8～2 hour, merging extract, is that decompression distillation is concentrated into ethanol relative density 0.09～1.15 (50 ℃ of surveys) under the condition of 0.04～0.08MPa in vacuum. Add 40～60 ℃ of dissolved in distilled water of 1～4 times (v/v) amount, the limit edged stirs, filter, leave and take filtrate a, precipitation adds the distillation of identical multiple and temperature and washes 1～4 time, filter, precipitation discards, and filtrate merges to get filtrate b, then merging filtrate a and b, be reduced pressure concentration under the condition of 0.04～0.08MPa in vacuum, it is for subsequent use to get concentrate;

(2) then get the shell of seaear and add first that 6～9 times of (w/v) water is capable and fry in shallow oil 8～45min after, adding hydration with all the other seven flavor medicine materials fries in shallow oil 1～3 time, first fries in shallow oil and adds 7～15 times in water, fried in shallow oil 1～3 hour, second fries in shallow oil 6～12 times of amounts of water that add, fried in shallow oil 0.5～2 hour, liquid filters, merging filtrate and be to be evaporated to relative density 0.90～1.15 (50 ℃ of surveys) under the condition of 0.04～0.08MPa in vacuum, high speed centrifugation is 8～45 minutes under 2000～3700 rev/mins condition, leave and take supernatant, precipitation discards;

(3) concentrate of gained in top (1) and the supernatant of (2) middle gained are merged, under the condition of vacuum 0.04～0.08MPa, be evaporated to the medicinal extract of relative density 1.14～1.20, the thin medicinal powder of spray-dried one-tenth;

2. the preparation of medicament: with above-mentioned thin medicinal powder and the excipients mixing that suits, adopt conventional method to make required formulation.

Above-mentioned thin medicinal powder can adopt following technique to make required formulation:

(1) gets the thin medicinal powder that lactose powder, beta-schardinger dextrin-and above-mentioned spray-drying make, respectively with 0.8～3.2: 0.2～0.9: 3.2～7.8 ratio mixing, then add 0.3～0.8% flavouring stevioside glycosides and 0.1～0.3% dolomol, mixing, granulate with the extruding of 70kg pressure dry method, make the finished particle agent of 1000g part; Perhaps

(2) get the thin medicinal powder that above-mentioned spray-drying makes, a kind of or its any combination in lactose powder, dextrin or the starch of adding 3～6%, filled capsules behind the mixing (capsule varies in size, and can be No. 1, No. 0 etc.) is made capsule; Perhaps

(3) get the thin medicinal powder that above-mentioned spray-drying makes, add 3～6% starch or the flavouring stevioside glycosides of dextrin and 0.3～0.8% and 0.1～0.3% dolomol, compressing tablet namely gets tablet.

The medicament of the present invention that adopts above-mentioned technique to make, test rating is as follows:

Proterties: khaki particle or tablet, little, the little sweet little hardship of flavor of gas;

Differentiate: rhizoma Gastrodiae should detect Gastrodin and rhizoma Gastrodiae control medicinal material spot,

Motherwort should detect the stachydrine hydrochloride spot

Cape jasmine should detect the cape jasmine spot

The root of large-flowered skullcap should detect the scutelloside spot

Sophora flower should detect the rutin spot

Hygiene: total number of bacteria (individual/g)＜100

Total number of molds (individual/g)＜50

Colibacillus, the mite that lives do not detect

Assay: Gastrodin 〉=0.15

The Chinese medicine that adopts this prescription to make carries out zooperal results suggest: long term toxicity test show animal used as test through medication in 180 days there are no obvious toxic-side effects, pharmacodynamics test shows that memory that its can overturn ammonia bromic acid hyoscine and ethanol cause obtains and memory keeps infringement, can suppress the generation of lipid peroxide LOP, improve the vigor of SOD in serum, obviously shorten the movement locus of cerebral ischemia memory deficits in mice and search out the safety movement time.

The specific embodimentEmbodiment 1: the present invention treats the clinical efficacy of the Chinese medicine of blood vessel spare dementia effect

Adopt Duxil that Chinese herbal granules that prescription of the present invention makes and French Shi Weiya company produce in several routine II phase clinical researches in 100: 100 that hospital carries out such as Attached Hospital, Changchun Chinese Medicinal College, particular content and report the test are as follows: test objective

By clinical testing, observe curative effect and its security to human body of this Granules in Treating vascular dementia liver-Yang sthenia type and make preliminary assessment, and do paired observation with known effective medicine, recommend clinical medicine dose. Physical data

Through x²Statistics and t inspection statistics, the following aspects: outpatient service and inpatient; The gender distributes; Age distribution; Schooling; The course of disease distributes; The state of an illness distributes; Treatment group and control group be cognitive function, capacity integration before medication; Memory, directive force, computing power integration before treatment group and the control group medication; Treatment group and control group are demonstrate,proved Hou Jifen in the traditional Chinese medical science, and difference that there are no significant has comparativity. Standard and the foundations thereof such as diagnosis, traditional Chinese medical science card marquis, case selection, efficacy determination

The 4th edition (DSM-IV-R American Psychiatry Association 1994) dull-witted diagnostic criteria of the A diagnosis of dementias standard adopting by equivalent U.S. " mental illness diagnostic and statistical manual ":

1 cognitive function obstacle shows that memory disorders and Cognitive function damage possess following one (aphasia, appraxia, agnosia, abstract thinking or judgment infringement) at least.
	2 above-mentioned two class cognitive function obstacles have obviously disturbed occupation and doings, or with individual on compared obviously in the past and went down.
3 just do not occur among the course of disease of delirium.
	4 above-mentioned infringements can not be explained with other spirit and thymopathy (such as depression card, Schizophrenia etc.).

B dementia degree criterion adopting by equivalent clinical dementia evaluation form (CDR, Hughes CD, et, al.Br J Psychiatry1982; Morris J, et al.Nerokogy1993):

1 CDR=0.5 is suspicious dementia	2 CDR=1.0 are slight dull-witted
		3 CDR=2.0 are that moderate is dull-witted	4 CDR=3.0 are that severe is dull-witted

C vascular dementia diagnostic criteria is with reference to NINDS-AIREN vascular dementia diagnostic criteria (Roman GC, et al.Neurology1993):

1 dementia
	2 have evidence (CT or the MRI confirmation: the single cerebral infarction at focal sign, multiple cerebral infarction and lacunar infarction, important position) of cerebrovascular disease
3 above-mentioned two kinds of infringements have apparent causal connection (to occur dull-witted after clear and definite palsy in 6 months; The cognitive function decline appears suddenly, or fluctuate sample, carrying out property of ladder sample Cognitive function damage)

D traditional Chinese medical science card marquis diagnostic criteria: " the dull-witted guideline of clinical investigations of new Chinese medicine treatment " with reference to nineteen ninety-five Ministry of Health of the People's Republic of China's formulation drafts the dialectical standard of syndrome of upper hyperactivity of liver yang scalar quantization:

Hypophrenia, dizzy, headache, irritated irritability, insomnia, bitter taste in the mouth and dry throat, tinnitus, soreness and weakness of waist and knees, palpitaition, red tongue with yellowish fur, wiry and frequent pulse etc.

Hypophrenia is defined as without, suspicious, slight, moderate, severe by the CDR scale, respectively note " 0,1,2,3,4 " minute. All the other occurrence frequencies by each symptom be divided into " without, idol (≤2 times/week) arranged, often have (〉=3 times/week,＜7 times/week=, always (sustainable existence or every day all show effect) " 4 grades, note " 0,1,2,3 " minute respectively.

E antidiastole standard

1 adopting by equivalent Hachinski ischemic amount grade form (HIS, Hachinski VC, et al.Lancet1974) difference cerebral vascular dementia (VD) is senile dementia with Alzheimer disease (AD), and 〉=7 minutes persons that mark are vascular dementia. 5,6 are divided into Mixed dementia, and≤4 are divided into Alzheimer disease.
	Depression except the 2 adopting by equivalent Cornel SDSs (Howieson et al.J Am Geriatric Society1997), 〉=8 are divided into depression.

F case inclusive criteria

1 meets vascular dementia NINDS-AIREN diagnostic criteria	With interior appearance, morbidity continued more than 3 months the scoring of Hachinski ischemic amount 〉=7 minutes palsy 6 months in 2 dull-witted morbidities
		3 dementia degrees are slight (CDR=1.0) or moderate (CDR=2.0)	4 Chinese medical discriminations are syndrome of upper hyperactivity of liver yang

G gets rid of standard

The Mixed dementia that 1 Hachinski ischemic amount grade form (HIS) scoring divides for 5-6 and≤4 minutes Alzheimer disease.	2 vascular dementia severe (CDR=3.0) patients.
		The dementia that occurs after 3 cerebral hemorrhages or the large tracts of land cortex district infraction.	4 patients with serious neurologic impairment are such as various aphasias, agnosia etc.
5 merge to have the inclination, serious primary disease, the mental patients such as brain, liver, kidney and hemopoietic system.	6 ages are person below 45 years old or more than 80 years old. 7 those who are allergic to this drug.

The rejecting of H case and the standard that comes off

1 includes rear discovery in does not meet inclusive criteria or not by the case of testing program regulation medication, need give rejecting.
	2 include case in serious adverse events occurs, develops complications and should not continue in reception test, the blind trial by the case of unblinding, withdraws from voluntarily or does not finish the whole course for the treatment of and affect the treatment or case that security is judged, all should be considered as coming off.

I ends test standard

Do not finish and allergic reaction or serious adverse reaction person occur 1 course for the treatment of, should end test; But super past tense person's 1/2 course for the treatment of should add up curative effect.
	2 duration of test patients appearance should be ended test because of the hazard event that cognitive impairment increases the weight of to cause; But surpassed 1/2 the course for the treatment of person should add up invalid.

Test method

A tests design: adopt multi-center clinical trial and parallel double blind controling test at random. Treatment group is 1: 1 with the ratio of control group disease. Taking continuously 90 days is a course for the treatment of. In baseline point (treatment before), end of the final point (after the treatment) with treat and respectively observe 1 time following index mid-term. Two groups for the treatment of the last fortnights begin to withdraw all Chinese and Western nootropicses and this sick medicine of other treatment until finish the course for the treatment of. Require 1/3 above inpatient, 1/2 above patient follows up a case by regular visits to.

B tests medication: get the granule that makes by following embodiment 2 methods and be the test medication, the Duxil that French Les Laboratoires servier is produced is the contrast medication.

C tests grouping: the principle of strictly following at random double blinding.

D Observation on compliance: be to patient's compliance detail record. Observation index: (test group and control group are all done, and each checks once before and after the test)

1 security observation: general physical examination; Blood, urine, just routine inspection; Electrocardiogram, liver, kidney function test.
			The observation of 2 health giving qualities	Leading indicator	Cognitive function: with simple and easy Mental status schedule (MMSE-R, Folstein, NF, et al.J Psychiatry 1975) estimate directive force, computing power and notice before and after the patient treatment, namely should memory and the variations such as delay memory, language.
Capacity; With Blessd behavior rating scale (BDS; G.Blessed 1986) estimate that activity of daily living changes before and after the patient treatment, custom change, personality, interest, drive change.
	Card Hou Zhibiao	Tcm symptom such as hypophrenia, the companion has a dizzy spell, headache, irritated irritability, insomnia, bitter taste in the mouth and dry throat, tinnitus, the waist knee is originally soft, palpitaition, red tongue with yellowish fur, wiry and frequent pulse etc. (hypophrenia according to the CDR scale be divided into without, suspicious, light, in, severe, respectively note " 0,1,2,3,4 " minute; Other occurrence frequency by each symptom is divided into " have, often have, always without, idol " 4 grades, respectively note " 0,1,2,3 " minute. )
Index of correlation				Hemorheology; Blood fat; Brain circular blood stream state; All cases all need through CT or MRI proof the cerebral infarction focus is arranged.

Curative effect determinate standard

Dull-witted curative effect determinate standard: with reference to " the dull-witted guideline of clinical investigations of new Chinese medicine treatment " of nineteen ninety-five promulgation. Must be divided into main reference index with MMSE-R, adopt Nimodipine method computing formula: (integration before (before integration after the treatment-treatment) ÷ treatment) * 100% is expressed as a percentage. Evaluation criteria: basic controlling is near full marks; Produce effects 〉=20%; Effectively 〉=12%; Invalid＜12%, worsen 〉=-20%.
	The cognitive function curative effect determinate standard: basic controlling is near full marks; Produce effects 〉=20%; Effectively 〉=12%; Invalid＜12%, worsen 〉=-20%.
The capacity curative effect determinate standard: basic controlling 〉=85%; Produce effects 〉=30%; Effectively 〉=10%; Invalid＜10%, worsen 〉=-20%.
	Card marquis curative effect determinate standard is with reference to dull-witted curative effect determinate standard, produce effects: after the treatment symptom integral value descend with treatment before symptom average product score value relatively 〉=2/3; Effectively: symptom integral value decline 1/2-2/3; Invalid: integration descends≤1/3.
The safety evaluatio standard: according to following classification, judge in detail time of origin, symptom, duration, degree, treatment measures and the extinction time of bad reaction, and the relation of judgement and medicine. Classification is as follows, 1 grade: safety, without any bad reaction; 2 grades: safer, if any bad reaction, need not do any processing, can continue administration; 3 grades: safety problem is arranged, moderate bad reaction is arranged, can continue administration after processing; 4 grades: because test is ended in bad reaction.

Efficacy analysis group number of cases basic controlling produce effects enabledisable worsens total effective rate (%) treatment group 100 0 16 33 49 0 49.0 control groups 100 0 16 34 31 0 50.0 through Ridit analysis, u=0.05 P＞0.05 after two groups of case medications of efficacy analysis A; Treatment group and control group after medication, the curative effect there was no significant difference. Cognitive function integral contrast (MMSE-R integration) group number of cases is before and after treatment in the difference group before and after the treatment of two groups of cases of B

Compare t=0.75 P＞0.05 explanation treatment group and control group between t P treatment group 100 16.0 ± 2.9 18.1 ± 3.2 2.3 ± 1.2 3.06 P＜0.01 control group 100 15.3 ± 3.5 17.5 ± 3.7 2.3 ± 1.2 2.79 P＜0.01 liang group after medication, compare the cognitive function curative effect in the group and utmost point significant difference is arranged, comparative cognition function curative effect there was no significant difference between group. Capacity integral contrast (BDS integration) group number of cases is before and after treatment in the difference group before and after the treatment of two groups of cases of C

Compare t=1.06, P＞0.05 between t P treatment group 100 21.1 ± 4.2 19.1 ± 4.9 2.2 ± 1.1 2.24 P＜0.05 control group 100 20.3 ± 4.9 18.2 ± 3.9 2.2 ± 0.9 2.52 P＜0.05 liang group; Treatment group and control group are described after medication, comparing the capacity integration in the group has significant difference, comparative cognition function curative effect there was no significant difference between group. Two groups of case memory of D, computing power, directive force integral contrast group number of cases memory computing power directive force treatment group treatment front 100 3.10 ± 0.90 1.90 ± 0.69 6.13 ± 1.27

Treatment rear 100 3.73 ± 0.93^*     2.05±0.72    7.23±1.44 ^**Treatment of control group front 100 2.93 ± 1.07 1.66 ± 0.78 5.95 ± 1.68

Treatment rear 100 3.38 ± 1.13^*     1.82±0.80    7.43±1.45 ^**Annotate: this group own control^*P＜0.05， ^**＜0.01; Compare P between group all＞0.05; Treatment group and control group relatively have significant difference in memory, the directive force integration group after medication, compare memory, computing power, directive force integration there was no significant difference between group. Syndrome situation analysis syndrome group number of cases integration onset time before and after the treatment of two groups of cases of E, (day) extinction time (my god) hypophrenia treatment group treated front 100 2.05 ± 0.22 32.50 ± 4.63^ΔΔ          0.00±0.00

Treatment rear 100 1.85 ± 0.43^*

Treatment of control group front 100 2.10 ± 0.30 39.06 ± 5.84^ΔΔ          0.00±0.00

Treatment rear 100 1.70 ± 0.56^**The treatment group of having a dizzy spell treatment front 100 1.83 ± 0.68 31.21 ± 4.56 57.50 ± 5.00

Treatment rear 100 1.14 ± 0.35^**

Treatment of control group front 100 1.70 ± 0.61 31.75 ± 4.38 53.75 ± 9.47

Treatment rear 100 1.31 ± 0.53^**Headache treatment group treatment front 100 1.22 ± 0.43 33.08 ± 4.80^ΔΔ          57.78±3.63 ^Δ

Treatment rear 100 1.00 ± 0.00

Treatment of control group front 100 1.08 ± 0.28 39.29 ± 5.35^ΔΔ          52.50±5.24 ^Δ

100 1.00 ± 0.00 fidgety irritability treatment group treatment front 100 1.64 ± 0.57 34.17 ± 6.24 59.00 ± 2.24 after the treatment

Treatment rear 100 1.21 ± 0.42^**

Treatment of control group front 100 1.59 ± 0.50 33.75 ± 6.94 60.00 ± 0.00

100 1.10 ± 0.50 loses eye treatment group treatment front 100 1.59 ± 0.57 34.72 ± 7.92 59.29 ± 1.89 after the treatment

Treatment rear 100 1.20 ± 0.41^*

Treatment of control group front 100 1.71 ± 0.62 35.48 ± 6.69 60.00 ± 0.00

100 1.12 ± 0.33 bitter taste in the mouth and dry throat treatment group treatment front 100 1.82 ± 0.56 30.29 ± 4.53 after the treatment^Δ      53.75±7.85

Treatment rear 100 1.26 ± 0.62^**

Treatment of control group front 100 1.61 ± 0.60 35.00 ± 6.61^Δ      60.00±0.00

100 1.51 ± 0.61 tinnitus treatment group treatment front 100 1.35 ± 0.48 33.33 ± 6.16 58.75 ± 3.54 after the treatment^ΔΔ

Treatment rear 100 1.24 ± 0.44

Treatment of control group front 100 1.08 ± 0.28 36.88 ± 8.43 46.25 ± 7.50^ΔΔ

100 1.07 ± 0.27 soreness and weakness of waist and knees treatment group treatment front 100 1.38 ± 0.49 34.64 ± 7.20 59.29 ± 1.89 after the treatment^ΔΔ

Treatment rear 100 1.13 ± 0.34^*

Treatment of control group front 100 1.53 ± 0.57 32.78 ± 5.21 53.57 ± 6.27^ΔΔ

Treatment rear 100 1.22 ± 0.52^*Palpitaition treatment group treatment front 100 1.18 ± 0.50 33.57 ± 8.52 57.50 ± 6.12

Treatment rear 100 1.13 ± 0.50

Treatment of control group front 100 1.11 ± 0.47 36.25 ± 7.50 58.75 ± 2.50

100 1.13 ± 0.52 tongue picture treatment group treatment front 100 1.00 ± 0.00 30.00 ± 6.07 100.00 ± 8.11 after the treatment

Treatment rear 100 1.00 ± 0.00

Treatment of control group front 100 1.00 ± 0.00 31.25 ± 4.66 44.69 ± 6.18

100 1.00 ± 0.00 pulse condition treatment group treatment front 100 1.00 ± 0.00 31.47 ± 4.24 42.35 ± 5.15 after the treatment

Treatment rear 100 1.00 ± 0.00

Treatment of control group front 100 1.00 ± 0.00 34.00 ± 5.07 46.00 ± 4.71

Treatment rear 100 1.00 ± 0.00

Annotate: this group own control^*P＜0.05， ^**P＜0.01; Two groups of contrast Δ P＜0.05, Δ Δ P＜0.01.

Pass through Clinical observation, this granule and known drug Duxil have been obtained basically identical curative effect at aspects such as observing cognitive function, capacity, memory, computing power and directive force, obviously be better than Duxil in curative effect aspect the traditional Chinese medical science card marquis, and can significantly improve the unusual index of Hemorheology and lipid aspects. By statistics, the total effective rate of this granule is 52.38%, and the total effective rate of control group is 52.50%, two group of there was no significant difference; Traditional Chinese medical science card marquis aspect, this particle total effective rate is 80.95%, and the control group total effective rate is 57.50%, and treatment group obviously is better than control group; Hemorheology aspect, two kinds of medicines can improve obviously all that WBV is lowly cut, plasma viscosity, packed cell volume (P＜0.01), and treatment group can obviously be improved the WBV height and cut (P＜0.05). Wherein the treatment group curative effect obviously is better than control group (P＜0.01) aspect the plasma viscosity improving, this explanation this granule on general curative effect is better than Duxil, before and after the treatment group safety indexes treatment relatively, after the treatment and control group there are no significant difference, illustrate that medicine is safe and reliable aspect security.Embodiment 2: the present invention treats the preparation method of the Chinese herbal granules of vascular dementia

Take by weighing raw material (g) by following proportioning

Rhizoma Gastrodiae 450 yncaria stems with hooks 450 shells of seaear 450 barks of eucommia 450

Parasitic loranthus 450 fushens 450 vines of multiflower knotweed 450 sophoras flower 200

Cape jasmine 200 roots of large-flowered skullcap 200 radix cyathulaes 350 motherworts 450

The alcohol reflux that elder generation hook taking rattan, parasitic loranthus, motherwort, the vine of multiflower knotweed add 3.5 times of (w/v) 90% extracts 3 times, each backflow 1.2h, merging extract, is that decompression distillation is concentrated into ethanol relative density 1.030 (50 ℃ of surveys) under the condition of 0.05Mpa in vacuum. Add 50 ℃ of dissolved in distilled water of 2 times (v/v) amount, the limit edged stirs, filter, leave and take filtrate a, precipitation adds h1 ℃ of distillation of identical multiple and washes 2 times, filter, precipitation discards, and filtrate merges to get filtrate b, then merging filtrate a and b, be that decompression distillation is concentrated under the condition of 0.05Mpa in vacuum, it is for subsequent use to get concentrate;

Get the shell of seaear and add 7 times of water and be decocted first and add hydration with all the other seven flavor medicines behind the 20min and fry in shallow oil twice, add 12 times of water gagings for the first time, fried in shallow oil 2 hours, for the second time add 10 times of water gagings, fry in shallow oil 1.5h, liquid filters, it is centrifugal that filtrate is concentrated into relative density 1.030 (50 ℃ of surveys), and precipitation discards, and leaves and takes supernatant;

Above-mentioned concentrate and supernatant are merged, and are the medicinal extract that is evaporated to relative density 1.15 under the condition of 0.08Mpa in vacuum, the thin medicinal powder of spray-dried one-tenth;

Get the thin medicinal powder that lactose powder, beta-schardinger dextrin-and above-mentioned spray-drying make, respectively with 2: 0.5: 5 ratio mixing, then add 0.5% flavouring stevioside glycosides and 0.2% dolomol, mixing, granulate with the extruding of 70kg pressure dry method, make the finished product of 1000g part, three times on the one, each serving using 5g.Embodiment 3: the present invention treats the preparation method of the Chinese medicine capsules of vascular dementia

Take by weighing raw material (g) by following proportioning

Rhizoma Gastrodiae 550 yncaria stems with hooks 550 shells of seaear 550 barks of eucommia 550

Parasitic loranthus 550 fushens 550 vines of multiflower knotweed 550 sophoras flower 280

Cape jasmine 320 roots of large-flowered skullcap 300 radix cyathulaes 450 motherworts 550

Elder generation hook taking rattan, parasitic loranthus, motherwort, the vine of multiflower knotweed add 5 times of (w/v) 78% alcohol reflux extract 2 times, the each backflow 1.5 hours, merging extract, is that decompression distillation is concentrated into ethanol relative density 1.040 (50 ℃ of surveys) under the 0.06Mpa pressure condition in vacuum. Add 45 ℃ of dissolved in distilled water of 3 times (v/v) amount, the limit edged stirs, filter, leave and take filtrate a, precipitation adds the C distillation of identical multiple and temperature and washes 3 times, filter, precipitation discards, and filtrate merges to get filtrate b, then merging filtrate a and b, be that decompression distillation is concentrated under the 0.06Mpa pressure condition in vacuum, it is for subsequent use to get concentrate;

Then after getting the shell of seaear and adding first 6 times of capable 25min of frying in shallow oil of (w/v) water, adding hydration with all the other seven flavor medicine materials fries in shallow oil 2 times, add for the first time 9 times of water gagings, fried in shallow oil 1.5 hours, and added 7 times of water gagings for the second time, fry in shallow oil 0.8h, liquid filters, it is centrifugal that filtrate is concentrated into relative density 1.040 (50 ℃ of surveys), and precipitation discards, and leaves and takes supernatant;

Above-mentioned concentrate and supernatant are merged, and are the medicinal extract that the 0.08Mpa condition is evaporated to relative density 1.17 at the pressure vacuum degree, the thin medicinal powder of spray-dried one-tenth;

With the thin medicinal powder of spray-drying gained, add 3～6% lactose powder mixing, fill No. 1 capsule and get final product, three times on the one, each serving with 6～8.Embodiment 4: the present invention treats the preparation method of the Chinese medicinal tablet of vascular dementia

Take by weighing raw material (g) by following proportioning

Rhizoma Gastrodiae 650 yncaria stems with hooks 650 shells of seaear 650 barks of eucommia 650

Parasitic loranthus 650 fushens 650 vines of multiflower knotweed 650 sophoras flower 380

Cape jasmine 380 roots of large-flowered skullcap 360 radix cyathulaes 520 motherworts 650

The alcohol reflux that elder generation hook taking rattan, parasitic loranthus, motherwort, the vine of multiflower knotweed add 6 times of amount (w/v) 70% extracts 3 times, the each backflow 2 hours, merging extract, is that decompression distillation is concentrated into ethanol relative density 1.050 (50 ℃ of surveys) under the 0.07Mpa condition in vacuum. Add 55 ℃ of dissolved in distilled water of 4 times (v/v) amount, the limit edged stirs, filter, leave and take filtrate a, precipitation adds the distillation of identical multiple and temperature and washes 4 times, filter, precipitation discards, and filtrate merges to get filtrate b, then merging filtrate a and b, be that decompression distillation is concentrated under the 0.07Mpa condition in vacuum, it is for subsequent use to get concentrate;

Then after getting the shell of seaear and adding first 8 times of capable 30min of frying in shallow oil of (w/v) water, adding hydration with all the other seven flavor medicine materials fries in shallow oil 2 times, add for the first time 13 times of water gagings, fried in shallow oil 2.5 hours, and added 11 times of water gagings for the second time, fry in shallow oil 1.8h, liquid filters, it is centrifugal that filtrate is concentrated into relative density 1.050 (50 ℃ of surveys), and precipitation discards, and leaves and takes supernatant;

Above-mentioned concentrate and supernatant are merged, and are the medicinal extract that is evaporated to relative density 1.20 under the condition of 0.07Mpa in vacuum, the thin medicinal powder of spray-dried one-tenth;

With the thin medicinal powder of spray-drying gained, add the flavouring stevioside glycosides of 5% starch and 0.6% and 0.2% dolomol, compressing tablet and get final product. Three times on the one, each 6～8.

Claims (9)

1. a Chinese medicine for the treatment of vascular dementia is characterized in that it is the medicament of being made by the raw material of following weight portion proportioning

Rhizoma Gastrodiae 330～750, yncaria stem with hooks 330～750, the shell of seaear 330～750, the bark of eucommia 330～750,

Parasitic loranthus 330～750, fushen 330～750, the vine of multiflower knotweed 330～750, sophora flower 150～430,

Cape jasmine 150～430, the root of large-flowered skullcap 150～430, radix cyathulae 280～570, motherwort 330～750.

2. the Chinese medicine for the treatment of vascular dementia according to claim 1, wherein the weight portion proportioning of each raw material is

Rhizoma Gastrodiae 480～630, yncaria stem with hooks 480～630, the shell of seaear 480～630, the bark of eucommia 480～630,

Parasitic loranthus 480～630, fushen 480～630, the vine of multiflower knotweed 480～630, sophora flower 200～350,

Cape jasmine 200～340, the root of large-flowered skullcap 200～340, radix cyathulae 330～500, motherwort 480～630.

3. the Chinese medicine for the treatment of vascular dementia according to claim 1, wherein the weight portion proportioning of each raw material is

Rhizoma Gastrodiae 530-540, yncaria stem with hooks 530-540, shell of seaear 530-540, bark of eucommia 530-540,

Parasitic loranthus 530-540, fushen 530-540, vine of multiflower knotweed 530-540, sophora flower 260-270,

Cape jasmine 260-270, root of large-flowered skullcap 260-270, radix cyathulae 390-410, motherwort 530-540.

4. according to claim 1, the Chinese medicine of 2 or 3 described treatment vascular dementias, it is characterized in that said medicament is said formulation on any pharmacy.

5. the Chinese medicine for the treatment of vascular dementia according to claim 4 is characterized in that said medicament is granule, capsule or tablet.

6. method for preparing the Chinese medicine for the treatment of vascular dementia is characterized in that having following processing step:

(1) take by weighing raw material according to following weight portion proportioning:

Rhizoma Gastrodiae 480～630, yncaria stem with hooks 480～630, the shell of seaear 480～630, the bark of eucommia 480～630,

Parasitic loranthus 480～630, fushen 480～630, the vine of multiflower knotweed 480～630, sophora flower 200～350,

Cape jasmine 200～340, the root of large-flowered skullcap 200～340, radix cyathulae 330～500, motherwort 480～630;

(2) extraction of effective ingredient in the medicinal material, concentrated:

A. getting first the alcohol reflux that the above-mentioned yncaria stem with hooks that takes by weighing, parasitic loranthus, motherwort, the vine of multiflower knotweed add 3～7 times of (w/v) 50～95% extracts 2～5 times, the each backflow 0.8～2 hour, merging extract, is that decompression distillation is concentrated into ethanol relative density 0.09～1.15 (50 ℃ of surveys) under the condition of 0.04～0.08MPa in vacuum. Add 40～60 ℃ of dissolved in distilled water of 1～4 times (v/v) amount, the limit edged stirs, filter, leave and take filtrate a, precipitation adds the distillation of identical multiple and temperature and washes 1～4 time, filter, precipitation discards, and filtrate merges to get filtrate b, then merging filtrate a and b, be reduced pressure concentration under the condition of 0.04～0.08MPa in vacuum, it is for subsequent use to get concentrate;

B. after then getting the shell of seaear and adding first that 6～9 times of (w/v) water is capable and fry in shallow oil 8～45min, adding hydration with all the other seven flavor medicine materials fries in shallow oil 1～3 time, first fries in shallow oil and adds 7～15 times in water, fried in shallow oil 1～3 hour, second fries in shallow oil 6～12 times of amounts of water that add, fried in shallow oil 0.5～2 hour, liquid filters, merging filtrate and be to be evaporated to relative density 0.90～1.15 (50 ℃ of surveys) under the condition of 0.04～0.08MPa in vacuum, high speed centrifugation is 8～45 minutes under 2000～3700 rev/mins condition, leave and take supernatant, precipitation discards;

C. the supernatant with gained among the concentrate of gained among the top A and the B merges, and is evaporated to the medicinal extract of relative density 1.14～1.20 under the condition of vacuum 0.04～0.08MPa, the thin medicinal powder of spray-dried one-tenth;

(3) above-mentioned thin medicinal powder and the excipients mixing that suits adopt conventional method to make required formulation.

7. method as claimed in claim 6 is characterized in that the weight portion proportioning of the raw material that takes by weighing is:

Rhizoma Gastrodiae 480～630, yncaria stem with hooks 480～630, the shell of seaear 480～630, the bark of eucommia 480～630,

Parasitic loranthus 480～630, fushen 480～630, the vine of multiflower knotweed 480～630, sophora flower 200～350,

Cape jasmine 200～340, the root of large-flowered skullcap 200～340, radix cyathulae 330～500, motherwort 480～630.

8. method as claimed in claim 6 is characterized in that the weight portion proportioning of the raw material that takes by weighing is:

Rhizoma Gastrodiae 530-540, yncaria stem with hooks 530-540, shell of seaear 530-540, bark of eucommia 530-540,

Parasitic loranthus 530-540, fushen 530-540, vine of multiflower knotweed 530-540, sophora flower 260-270,

Cape jasmine 260-270, root of large-flowered skullcap 260-270, radix cyathulae 390-410, motherwort 530-540.

9. such as claim 6,7 or 8 described methods, it is characterized in that above-mentioned thin medicinal powder adopts following technique to make required formulation:

(1) gets the thin medicinal powder that lactose powder, beta-schardinger dextrin-and above-mentioned spray-drying make, respectively with 0.8～3.2: 0.2～0.9: 3.2～7.8 ratio mixing, then add 0.3～0.8% flavouring stevioside glycosides and 0.1～0.3% dolomol, mixing, granulate with the extruding of 70kg pressure dry method, make the finished particle agent of 1000g part; Perhaps

(2) get the thin medicinal powder that above-mentioned spray-drying makes, a kind of or its any combination in lactose powder, dextrin or the starch of adding 3～6% is filled capsule behind the mixing, make capsule; Perhaps

(3) get the thin medicinal powder that above-mentioned spray-drying makes, add 3～6% starch or the flavouring stevioside glycosides of dextrin and 0.3～0.8% and 0.1～0.3% dolomol, compressing tablet namely gets tablet.