CN1240424C - Chinese medicine for treating vascular dementia and its prepn - Google Patents

Abstract

The present invention discloses new traditional Chinese medicine for treating vascular dementia, which uses twelve traditional Chinese medicines comprising rhizoma gastrodiae, gambir plant, sea-ear shell, eucommia, Chinese taxillus herb, Indian bread with hostwood, tuber fleeceflower stem, sophora flower, cape jasmine fruit, baical skullcap root, cyathulae, motherwort herb and the like as raw materials. Various effective components in the raw materials are respectively extracted according to the different properties of each traditional Chinese medicine, and then the extract is prepared into suitable medicine preparations, such as granules, capsules, tablets, etc. The traditional Chinese medicine for treating vascular dementia has the functions for calming the liver, suppressing yang and nourishing the liver and kidney, and has good effects for treating vascular dementia and hyperactivity of the liver yang.

Description

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

Technical field

The invention belongs to the Chinese medicine 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 cognitive dysfunction, as judgment, orientation force, computing power, comprehensive faculty of understanding etc., and occurs above-mentioned performance repeatedly with apoplexy 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,, history of hypertension is arranged as hemiplegia, aphasia, apraxia, agnosia etc. with neurological symptom and sign more.The alleged apoplexy dementia of the traditional Chinese medical science promptly belongs to this scope.

Dementia patients is because of memory and other Cognitive function damagies, and the attenuating or the forfeiture of social function mobility 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 prevalence, 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 alzheimer disease 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; The most studies data shows that the sickness rate of vascular dementia was 700,000 people/years.Because dementia occurs in the old people mostly, in aged tendency of population society, the absolute number of aging population no matter, still the ratio of aging population is all increasing rapidly, in China, and comprehensive generaI investigation to 11 cities and rural area, among the old people more than 60 years old, the sickness rate of vascular dementia is 3,42/,100,000 populations, and its prevalence in city and rural area is respectively 4,78/,100,000 and 1,40/,100,000, this shows the height of its sickness rate.

Though modern medicine has carried out a large amount of research from each different field to vascular dementia, his cause of disease and pathogeny are still not fully aware of.Be the replacement therapy of suiting the medicine to the illness with regard to its treatment, use the more cholinesterase inhibitor that has at present, as tacrine; Cerebral vasodilator is duxil, nimodipine; The brain metabolism reinforcing agent is as piracetam; Neurotrophic factor etc.These treatments have some improvement to dementia man memory and cognitive function, but effective percentage is not high, and toxic and side effects is big, and must take throughout the year, the expense height.And traditional Chinese medicine utilizes its unique theoretical system and rich practice experience that this disease has also been done deep discussion, think that its morbidity principle mainly is old deficiency of kidney-essence,, and cause the imbalance of conscience spleen renal function with factors such as diet, feelings will, work and rests, QI and blood is poor loses, essential resistance of turbid phlegm, the liver-yang upper punch, its sick position is at brain, it is the functional disorder of conscience spleen kidney, it is marked in the turbid stasis of blood of expectorant, covers and closes key clearly, causes refreshing machine apraxia.The liver body is cloudy and with sun, the hepatic and renal YIN deficiency, and the kidney failing to nourish the liver is wanted, and the moon is not made sun and is caused excessive rising of liver-YANG, and positive wind-transformation is moved, and wind-yang and up-boring violates in the heart that then gods are unclear, violates in the then refreshing machine of brain and becomes deaf and retardation of thinking occurs, and is forgetful when anything crops up.

As from the foregoing, can make full use of natural resources of Chinese medicinal materials, the Chinese prescription of treatment vascular dementia is studied from the thinking of suppressing the hyperactive liver and subsiding YANG, liver and kidney tonifying.

Summary of the invention

The object of the present invention is to provide a kind of treatment by Chinese herbs agent with the effect of treatment vascular dementia, it has the effect of suppressing the hyperactive liver and subsiding YANG, liver and kidney tonifying.

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

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

Rhizoma Gastrodiae 330～750, Ramulus Uncariae Cum Uncis 330～750, Concha Haliotidis 330～750, the Cortex Eucommiae 330～750,

Herba Taxilli 330～750, Poria cum Radix Pini 330～750, Caulis Polygoni Multiflori 330～750, Flos Sophorae 150～430,

Fructus Gardeniae 150～430, Radix Scutellariae 150～430, Radix Cyathulae 280～570, Herba Leonuri 330～750.

Formula optimization weight (part) ratio range of preparation Chinese medicine of the present invention is:

Rhizoma Gastrodiae 480～630, Ramulus Uncariae Cum Uncis 480～630, Concha Haliotidis 480～630, the Cortex Eucommiae 480～630,

Herba Taxilli 480～630, Poria cum Radix Pini 480～630, Caulis Polygoni Multiflori 480～630, Flos Sophorae 200～350,

Fructus Gardeniae 200～340, Radix Scutellariae 200～340, Radix Cyathulae 330～500, Herba Leonuri 480～630.

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

Rhizoma Gastrodiae 530-540, Ramulus Uncariae Cum Uncis 530-540, Concha Haliotidis 530-540, Cortex Eucommiae 530-540,

Herba Taxilli 530-540, Poria cum Radix Pini 530-540, Caulis Polygoni Multiflori 530-540, Flos Sophorae 260-270,

Fructus Gardeniae 260-270, Radix Scutellariae 260-270, Radix Cyathulae 390-410, Herba Leonuri 530-540.

This side has suppressing the hyperactive liver and subsiding YANG, the function of liver and kidney tonifying, intelligence promoting and the mind tranquilizing, cure mainly syndrome of upper hyperactivity of liver yang by in wind-induced hypophrenia such as forgetful, retardation of thinking, orientation force, computing power are poor, understand many mistakes, even aphasia, apraxia etc., companion hemiplegia, dizziness and headache, fidgety irritability, insomnia, bitter taste, dry pharynx, red tongue, yellow fur, wiry and frequent pulse or chord length are strong, or vascular dementia is light, the moderate person that has the above-mentioned symptom.

Above-mentioned each component is made medicine production method of the present invention is:

1. the extraction of active ingredient in the medical material, concentrated:

(1) first hook taking rattan, Herba Taxilli, Herba Leonuri, Caulis Polygoni Multiflori add the alcohol reflux 2～5 times of 3～7 times of (w/v) 50～95%, the each backflow 0.8～2 hour, merge extractive liquid, is that distilling under reduced pressure 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, filtrate merge filtrate b, merging filtrate a and b then, be concentrating under reduced pressure under the condition of 0.04～0.08MPa in vacuum, concentrated solution is standby;

(2) get Concha Haliotidis then and add earlier 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, fries in shallow oil 1～3 hour, and second fries in shallow oil 6～12 times of amounts of water that add, fried in shallow oil 0.5～2 hour, medicinal 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, and high speed centrifugation is 8～45 minutes under 2000～3700 rev/mins condition, leave and take supernatant, precipitation discards;

(3) concentrated solution 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 extractum of relative density 1.14～1.20, the thin medicated powder of spray-dried one-tenth;

2. medicaments preparation:, adopt conventional method to make required dosage form with above-mentioned thin medicated powder and suitable excipient mixing.

Above-mentioned thin medicated powder can adopt following technology to make required dosage form:

(1) gets the thin medicated 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, add 0.3～0.8% correctives stevioside and 0.1～0.3% magnesium stearate then, mixing, granulate with the extruding of 70kg pressure dry method, make the finished particle agent of 1000g part; Perhaps

(2) get the thin medicated powder that above-mentioned spray drying makes, a kind of or its combination in any 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 medicated powder that above-mentioned spray drying makes, add 3～6% starch or the correctives stevioside of dextrin and 0.3～0.8% and 0.1～0.3% magnesium stearate, tabletting promptly gets tablet.

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

Character: khaki granule or tablet, feeble QI, the little sweet little hardship of flavor;

Differentiate: Rhizoma Gastrodiae should detect gastrodine and Rhizoma Gastrodiae control medicinal material speckle,

Herba Leonuri should detect the stachydrine hydrochloride speckle

Fructus Gardeniae should detect the Fructus Gardeniae speckle

Radix Scutellariae should detect the baicalin speckle

Flos Sophorae should detect the rutin speckle

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

Total number of molds (individual/g)＜50

Colibacillus, the demodicid mite that lives do not detect

Assay: gastrodine 〉=0.15

The Chinese medicine that adopts this prescription to make carries out zooperal results suggest: long term toxicity test shows that laboratory animal do not see that through medication in 180 days obvious toxic-side effects is arranged, pharmacodynamics test shows that memory that its can overturn ammonia bromic acid scopolamine 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 mouse memory obstacle and search out the safety movement time.

The specific embodiment

Embodiment 1: the present invention treats the clinical efficacy of the Chinese medicine of vascular dementia effect

The routine II phase clinical researches in 100: 100 that the duxil that adopts Chinese medicine granules that prescription of the present invention makes and French Shi Weiya company to produce carries out in hospitals of a few family such as Attached Hospital, Changchun Chinese Medicinal College, particular content and result are reported as follows:

Test objective

By clinical trial, observe curative effect and its safety of this granule treatment vascular dementia liver-Yang sthenia type and make preliminary assessment, and do paired observation with known active drug to human body, recommend clinical medicine dose.

Physical data

Through x ²Statistics 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 matched group be cognitive function, behavioral competence integration before medication; Memory, orientation force, computing power integration before treatment group and the matched group medication; Treatment group and matched group are at Syndrome in TCM marquis integration, and difference that there are no significant has comparability.

Standard and foundations thereof such as diagnosis, Syndrome in TCM marquis, case selection, efficacy determination

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

1 cognitive dysfunction shows that dysmnesia and Cognitive function damage possess following one (aphasia, apraxia, agnosia, abstract thinking or judgment infringement) at least.
	2 above-mentioned two class cognitive dysfunction 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 (as depression card, Schizophrenia etc.) with other spirit and thymopathy.

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

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

The diagnostic criteria of C vascular dementia is with reference to the diagnostic criteria of NINDS-AIREN vascular dementia (Roman GC, et al.Neurology 1993):

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

D Syndrome in TCM marquis diagnostic criteria: " the dull-witted clinical research guideline 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 of the waist and knees, cardiopalmus, red tongue with yellow fur, wiry and frequent pulse etc.

Hypophrenia by the CDR scale be defined as not having, suspicious, slight, moderate, severe, note " 0,1,2,3,4 " is divided respectively.All the other occurrence frequencies by each symptom be divided into " do not have, idol has (≤2 times/week), often have (〉=3 times/week,＜7 times/week=, always (continue to exist or all show effect every day) " 4 grades, note " 0,1,2,3 " is divided respectively.

E Differential Diagnosis standard

1 adopting by equivalent Hachinski ischemia amount grade form (HIS, Hachinski VC, et al.Lancet1974) difference vascular dementia (VD) is an alzheimer disease with Alzheimer (AD), and 〉=7 fens persons that mark are vascular dementia.5,6 are divided into the Combination dementia, and≤4 are divided into the Alzheimer disease.
	Depression except the 2 adopting by equivalent Cornel depression scale (Howiesor et al.J Am Geriatric Society1997), 〉=8 are divided into depression.

The F case is included standard in

1 meets vascular dementia NINDS-AIREN diagnostic criteria	With interior appearance, morbidity continued more than 3 months the scoring of Hachinski ischemia amount 〉=7 minutes apoplexy 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

The G exclusion standard

1Hachinski ischemia amount grade form (HIS) scoring is the Combination dementia of 5-6 branch and≤4 minutes Alzheimer.	2 vascular dementia severe (CDR=3.0) patients.
		The dementia that 3 cerebral hemorrhages or large tracts of land cortical areas infraction back occur.	4 patients with serious neurologic impairment are as various aphasias, agnosia etc.
5 merge to have the inclination, serious primary disease, psychotics such as brain, liver, kidney and hemopoietic system.	6 ages are person below 45 years old or more than 80 years old.7 pairs of this medicine allergy sufferers.

The rejecting of H case and the standard that comes off

1 includes the back in finds not meet the standard of including in or not by the case of testing program regulation medication, need give rejecting.
	2 include case in serious adverse events takes place, develops complications and should not continue in reception test, the blind trial by broken blind case, withdraw from voluntarily or do not finish the whole course of treatment and affect the treatment or case that safety is judged, all should be considered as coming off.

I ends test standard

Do not finish and anaphylaxis or serious adverse reaction person occur 1 course of treatment, should end test; But super past tense person's 1/2 course of treatment 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 of treatment person should add up invalid.

Test method

A EXPERIMENTAL DESIGN: adopt multi-center clinical trial and parallel double blind controling test at random.The treatment group is 1: 1 with the ratio of matched group disease.Taking 90 days continuously is a course of treatment.In baseline point (treatment before), end of the final point (treatment back) with treat and respectively observe 1 time following index mid-term.The medicine that two groups of treatment the last fortnights begin to withdraw all Chinese and Western nootropicses and other treatment primary disease finished until the course of treatment.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 randomized, double-blind is followed in strictness.

The D compliance is observed: be to patient's compliance itemized record.

Observation index: (test group and matched group are all done, and each is checked once before and after the test)

1 safety observation: general physical examination; Blood, urine, just routine examination; Electrocardiogram, liver, kidney function test.
			The observation of 2 health giving qualities	Leading indicator	Cognitive function: with simple and easy mental status examination table (MMSE-R, Folstein, NF, et al.J Psychiatry 1975) orientation force, computing power and the attention before and after the evaluate patient treatment, promptly should memory and variations such as delay memory, language.
Behavioral competence: with Blessd behavior rating scale (BDS; G.Blessed 1986) activity of daily living changes before and after the evaluate 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 is lost the people, bitter taste in the mouth and dry throat, tinnitus, the waist knee joint is originally soft, cardiopalmus, red tongue with yellow fur, wiry and frequent pulse etc.(hypophrenia according to the CDR scale be divided into nothing, suspicious, light, in, severe, note " 0,1,2,3,4 " is divided respectively; Other occurrence frequency by each symptom is divided into " do not have, idol has, often have, always " 4 grades, and note " 0,1,2,3 " is divided respectively.)
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 clinical research guideline of new Chinese medicine treatment " of nineteen ninety-five promulgation.Must be divided into the main reference index with MMSE-R, adopt nimodipine method computing formula: (integration before (before treatment back integration-treatment) ÷ treatment) * 100%, represent with percent.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 behavioral competence 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: treatment back 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.
Safety evaluatio standard: according to following classification, judge time of origin, symptom, persistent period, degree, treatment measures and the extinction time of untoward reaction in detail, and the relation of judgement and medicine.Classification is as follows, 1 grade: safety, there is not any untoward reaction; 2 grades: compare safety,, need not do any processing, can continue administration if any untoward reaction; 3 grades: safety problem is arranged, moderate untoward reaction is arranged, can continue administration after processing; 4 grades: because of test is ended in untoward reaction.

Efficacy analysis

Efficacy analysis after two groups of case medications of A

Group	The example number	Basic controlling	Produce effects	Effectively	Invalid	Worsen	Total effective rate (%)
								Treatment group matched group	100 100	0 0	16 16	33 34	49 31	0 0	49.0 50.0

Analyze u=0.05 P＞0.05 through Ridit; Treatment group and matched group after medication, the curative effect there was no significant difference.

The cognitive function integration compares (MMSE-R integration) before and after two groups of case treatments of B

Group	The example number	Before the treatment	After the treatment	Difference	T P in the group
						Treatment group matched group	100 100	16.0±2.9 15.3±3.5	18.1±3.2 17.5±3.7	2.3±1.2 2.3±1.2	3.06 P＜0.01 2.79 P＜0.01

Compare t=0.75 P＞0.05 explanation treatment group and matched group between two groups after medication, comparing the cognitive function curative effect in the group has utmost point significant difference, comparative cognition function curative effect there was no significant difference between group.

The behavioral competence integration compares (BDS integration) before and after two groups of case treatments of C

Group	The example number	Before the treatment	After the treatment	Difference	T P in the group
						Treatment group matched group	100 100	21.1±4.2 20.3±4.9	19.1±4.9 18.2±3.9	2.2±1.1 2.2±0.9	2.24 P＜0.05 2.52 P＜0.05

Compare t=1.06, P＞0.05 between two groups; Treatment group and matched group are described after medication, comparing the behavioral competence 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, orientation force integration are relatively

Group		The example number	Memory	Computing power	Orientation force
						Treatment group matched group	After treating before the preceding treatment of the treatment back treatment	100 100 100 100	3.10±0.90 3.73±0.93 * 2.93±1.07 3.38±1.13 *	1.90±0.69 2.05±0.72 1.66±0.78 1.82±0.80	6.13±1.27 7.23±1.44 ** 5.95±1.68 7.43±1.45 **

Annotate: this group own control ^*P＜0.05, ^*＜0.01; Compare P between group all＞0.05; Treatment group and matched group relatively have significant difference in memory, the orientation force integration group after medication, compare memory, computing power, orientation force integration there was no significant difference between group.

Syndrome situation analysis before and after two groups of case treatments of E

Syndrome	Group		The example number	Integration	Onset time (my god)	Extinction time (my god)
							Hypophrenia have a dizzy spell the headache fidgety irritability	Treatment group treatment of control group group treatment of control group group treatment of control group group control group	The treatment before the treatment after the treatment before the treatment after the treatment before the treatment after the treatment before the treatment after the treatment before the treatment after the treatment before the treatment after the treatment before the treatment after the treatment before the treatment after	100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100	2.05±0.22 1.85±0.43 * 2.10±0.30 1.70±0.56 ** 1.83±0.68 1.14±0.35 ** 1.70±0.61 1.31±0.53 ** 1.22±0.43 1.00±0.00 1.08±0.28 1.00±0.00 1.64±0.57 1.21±0.42 ** 1.59±0.50 1.10±0.50	32.50±4.63 △△ 39.06±5.84 △△ 31.21±4.56 31.75±4.38 33.08±4.80 △△ 39.29±5.35 △△ 34.17±6.24 33.75±6.94	0.00±0.00 0.00±0.00 57.50±5.00 53.75±9.47 57.78±3.63 △ 52.50±5.24 △ 59.00±2.24 60.00±0.00

Lose eye treatment group treatment preceding 100 1.59 ± 0.57 34.72 ± 7.92 59.29 ± 1.89

Treatment back 100 1.20 ± 0.41 ^*

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

Treatment back 100 1.12 ± 0.33

Bitter taste in the mouth and dry throat treatment group treatment preceding 100 1.82 ± 0.56 30.29 ± 4.53 ^△53.75 ± 7.85

Treatment back 100 1.26 ± 0.62 ^*

Treatment of control group preceding 100 1.61 ± 0.60 35.00 ± 6.61 ^△60.00 ± 0.00

Treatment back 100 1.51 ± 0.61

Tinnitus treatment group treatment preceding 100 1.35 ± 0.48 33.33 ± 6.16 58.75 ± 3.54 ^{△ △}

Treatment back 100 1.24 ± 0.44

Treatment of control group preceding 100 1.08 ± 0.28 36.88 ± 8.43 46.25 ± 7.50 ^{△ △}

Treatment back 100 1.07 ± 0.27

Soreness of the waist and knees treatment group treatment preceding 100 1.38 ± 0.49 34.64 ± 7.20 59.29 ± 1.89 ^{△ △}

Treatment back 100 1.13 ± 0.34 ^*

Treatment of control group preceding 100 1.53 ± 0.57 32.78 ± 5.21 53.57 ± 6.27 ^{△ △}

Treatment back 100 1.22 ± 0.52 ^*

Cardiopalmus treatment group treatment preceding 100 1.18 ± 0.50 33.57 ± 8.52 57.50 ± 6.12

Treatment back 100 1.13 ± 0.50

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

Treatment back 100 1.13 ± 0.52

Picture of the tongue treatment group treatment preceding 100 1.00 ± 0.00 30.00 ± 6.07 100.00 ± 8.11

Treatment back 100 1.00 ± 0.00

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

Treatment back 100 1.00 ± 0.00

Pulse condition treatment group treatment preceding 100 1.00 ± 0.00 31.47 ± 4.24 42.35 ± 5.15

Treatment back 100 1.00 ± 0.00

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

Treatment back 100 1.00 ± 0.00

Annotate: this group own control ^*P＜0.05, ^*P＜0.01; Two groups of contrasts ^△P＜0.05, ^{△ △}P＜0.01.

Observe by clinical trial, this granule and known drug duxil have been obtained the curative effect of basically identical at aspects such as observing cognitive function, behavioral competence, memory, computing power and orientation force, obviously be better than duxil in curative effect aspect the Syndrome in TCM marquis, and can significantly improve the abnormal index of hemorheology and lipid aspects.By statistics, the total effective rate of this granule is 52.38%, and the total effective rate of matched group is 52.50%, two group of there was no significant difference; Syndrome in TCM marquis aspect, this granule total effective rate is 80.95%, and the matched group total effective rate is 57.50%, and the treatment group obviously is better than matched group; Hemorheology aspect, two kinds of medicines can improve obviously all that whole blood viscosity is lowly cut, plasma viscosity, packed cell volume (P＜0.01), and the treatment group can obviously be improved the whole blood viscosity height and cut (P＜0.05).Wherein treatment group curative effect obviously is better than matched 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, treatment back and matched group there are no significant difference, illustrate that medicine is safe and reliable aspect safety.

Embodiment 2: the present invention treats the preparation method of the Chinese medicine granules of vascular dementia

Take by weighing raw material (g) by following proportioning

Rhizoma Gastrodiae 450 Ramulus Uncariae Cum Uncis 450 Concha Haliotidis 450 Cortexs Eucommiae 450

Herba Taxilli 450 Poria cum Radix Pinis 450 Caulis Polygoni Multiflori 450 Flos Sophoraes 200

Fructus Gardeniae 200 Radix Scutellariaes 200 Radix Cyathulaes 350 Herba Leonuris 450

Elder generation hook taking rattan, Herba Taxilli, Herba Leonuri, Caulis Polygoni Multiflori add the alcohol reflux 3 times of 3.5 times of (w/v) 90%, the 1.2h that at every turn refluxes, and merge extractive liquid, is that distilling under reduced pressure 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, filtrate merge filtrate b, merging filtrate a and b then, be that distilling under reduced pressure concentrates under the condition of 0.05Mpa in vacuum, concentrated solution is standby;

Get Concha Haliotidis 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, medicinal 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 concentrated solution and supernatant are merged, and are the extractum that is evaporated to relative density 1.15 under the condition of 0.08Mpa in vacuum, the thin medicated powder of spray-dried one-tenth;

Get the thin medicated powder that lactose powder, beta-schardinger dextrin-and above-mentioned spray drying make, respectively with 2: 0.5: 5 ratio mixing, add 0.5% correctives stevioside and 0.2% magnesium stearate then, mixing, granulate with the extruding of 70kg pressure dry method, make the finished product of 1000g part, three times on the one, take 5g at every turn.

Embodiment 3: the present invention treats the preparation method of the Chinese medicinal capsule agent of vascular dementia

Take by weighing raw material (g) by following proportioning

Rhizoma Gastrodiae 550 Ramulus Uncariae Cum Uncis 550 Concha Haliotidis 550 Cortexs Eucommiae 550

Herba Taxilli 550 Poria cum Radix Pinis 550 Caulis Polygoni Multiflori 550 Flos Sophoraes 280

Fructus Gardeniae 320 Radix Scutellariaes 300 Radix Cyathulaes 450 Herba Leonuris 550

Elder generation hook taking rattan, Herba Taxilli, Herba Leonuri, Caulis Polygoni Multiflori add 5 times of (w/v) 78% alcohol reflux 2 times, the each backflow 1.5 hours, merge extractive liquid, is that distilling under reduced pressure 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, filtrate merge filtrate b, merging filtrate a and b then, in vacuum is that distilling under reduced pressure concentrates under the 0.06Mpa pressure condition, and it is standby to get concentrated solution;

After getting Concha Haliotidis then and adding 6 times of capable 25min of frying in shallow oil of (w/v) water earlier, 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, medicinal 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 concentrated solution and supernatant are merged, be evaporated to the extractum of relative density 1.17, the thin medicated powder of spray-dried one-tenth for the 0.08Mpa condition at the pressure vacuum degree;

With the thin medicated powder of spray drying gained, add 3～6% lactose powder mixing, fill No. 1 capsule promptly, three times on the one, take 6～8 at every turn.

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 Ramulus Uncariae Cum Uncis 650 Concha Haliotidis 650 Cortexs Eucommiae 650

Herba Taxilli 650 Poria cum Radix Pinis 650 Caulis Polygoni Multiflori 650 Flos Sophoraes 380

Fructus Gardeniae 380 Radix Scutellariaes 360 Radix Cyathulaes 520 Herba Leonuris 650

Elder generation hook taking rattan, Herba Taxilli, Herba Leonuri, Caulis Polygoni Multiflori add the alcohol reflux 3 times of 6 times of amount (w/v) 70%, reflux 2 hours at every turn, and merge extractive liquid, is that distilling under reduced pressure 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, filtrate merge filtrate b, merging filtrate a and b then, in vacuum is that distilling under reduced pressure concentrates under the 0.07Mpa condition, and it is standby to get concentrated solution;

After getting Concha Haliotidis then and adding 8 times of capable 30min of frying in shallow oil of (w/v) water earlier, 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, medicinal 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 concentrated solution and supernatant are merged, and are the extractum that is evaporated to relative density 1.20 under the condition of 0.07Mpa in vacuum, the thin medicated powder of spray-dried one-tenth;

With the thin medicated powder of spray drying gained, add the correctives stevioside of 5% starch and 0.6% and 0.2% magnesium stearate, tabletting is promptly.Three times on the one, each 6～8.

Claims (8)

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

Rhizoma Gastrodiae 330～750, Ramulus Uncariae Cum Uncis 330～750, Concha Haliotidis 330～750, the Cortex Eucommiae 330～750,

Herba Taxilli 330～750, Poria cum Radix Pini 330～750, Caulis Polygoni Multiflori 330～750, Flos Sophorae 150～430,

Fructus Gardeniae 150～430, Radix Scutellariae 150～430, Radix Cyathulae 280～570, Herba Leonuri 330～750.

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

Rhizoma Gastrodiae 480～630, Ramulus Uncariae Cum Uncis 480～630, Concha Haliotidis 480～630, the Cortex Eucommiae 480～630,

Herba Taxilli 480～630, Poria cum Radix Pini 480～630, Caulis Polygoni Multiflori 480～630, Flos Sophorae 200～350,

Fructus Gardeniae 200～340, Radix Scutellariae 200～340, Radix Cyathulae 330～500, Herba Leonuri 480～630.

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

Rhizoma Gastrodiae 530～540, Ramulus Uncariae Cum Uncis 530～540, Concha Haliotidis 530～540, the Cortex Eucommiae 530～540,

Herba Taxilli 530～540, Poria cum Radix Pini 530～540, Caulis Polygoni Multiflori 530～540, Flos Sophorae 260～270,

Fructus Gardeniae 260～270, Radix Scutellariae 260～270, Radix Cyathulae 390～410, Herba Leonuri 530～540.

4. according to the Chinese medicine of claim 1,2 or 3 described treatment vascular dementia, it is characterized in that said medicament is granule, capsule or tablet.

5. 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 the following weight parts proportioning:

Rhizoma Gastrodiae 480～630, Ramulus Uncariae Cum Uncis 480～630, Concha Haliotidis 480～630, the Cortex Eucommiae 480～630,

Herba Taxilli 480～630, Poria cum Radix Pini 480～630, Caulis Polygoni Multiflori 480～630, Flos Sophorae 200～350,

Fructus Gardeniae 200～340, Radix Scutellariae 200～340, Radix Cyathulae 330～500, Herba Leonuri 480～630;

(2) extraction of active ingredient in the medical material, concentrated:

A. get the above-mentioned Ramulus Uncariae Cum Uncis that takes by weighing earlier, Herba Taxilli, Herba Leonuri, Caulis Polygoni Multiflori adds 50～95% the alcohol reflux 2～5 times of 3～7 times of volumes of medical material weight, the each backflow 0.8～2 hour, merge extractive liquid,, be that distilling under reduced pressure is concentrated into that to survey the ethanol relative densities at 50 ℃ be 0.09～1.15 under the condition of 0.04～0.08Mpa in vacuum, 40～60 ℃ of dissolved in distilled water that add 1～4 times of volume, 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, filtrate merge filtrate b, merging filtrate a and b then, be concentrating under reduced pressure under the condition of 0.04～0.08Mpa in vacuum, concentrated solution is standby;

B. getting water that Concha Haliotidis adds 6～9 times of volumes of medical material weight earlier then is decocted first behind 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, fries in shallow oil 1～3 hour, and second fries in shallow oil 6～12 times of amounts of water that add, fried in shallow oil 0.5～2 hour, medicinal liquid filters, merging filtrate and be to be evaporated under the condition of 0.04～0.08Mpa that to survey relative densities at 50 ℃ be 0.90～1.15 in vacuum, and 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 concentrated solution of gained among the top A and the B merges, and is evaporated to the extractum of relative density 1.14～1.20 under the condition of vacuum 0.04～0.08Mpa, the thin medicated powder of spray-dried one-tenth;

(3) above-mentioned thin medicated powder and suitable excipient mixing adopt conventional method to make required dosage form.

6. method as claimed in claim 5 is characterized in that the weight portion proportioning of the raw material that takes by weighing is:

Rhizoma Gastrodiae 480～630, Ramulus Uncariae Cum Uncis 480～630, Concha Haliotidis 480～630, the Cortex Eucommiae 480～630,

Herba Taxilli 480～630, Poria cum Radix Pini 480～630, Caulis Polygoni Multiflori 480～630, Flos Sophorae 200～350,

Fructus Gardeniae 200～340, Radix Scutellariae 200～340, Radix Cyathulae 330～500, Herba Leonuri 480～630.

7. method as claimed in claim 5 is characterized in that the weight portion proportioning of the raw material that takes by weighing is:

Rhizoma Gastrodiae 530～540, Ramulus Uncariae Cum Uncis 530～540, Concha Haliotidis 530～540, the Cortex Eucommiae 530～540,

Herba Taxilli 530～540, Poria cum Radix Pini 530～540, Caulis Polygoni Multiflori 530～540, Flos Sophorae 260～270,

Fructus Gardeniae 260～270, Radix Scutellariae 260～270, Radix Cyathulae 390～410, Herba Leonuri 530～540.

8. as claim 5,6 or 7 described methods, it is characterized in that above-mentioned thin medicated powder adopts following technology to make required dosage form:

(1) gets the thin medicated 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, add 0.3～0.8% correctives stevioside and 0.1～0.3% magnesium stearate then, mixing, granulate with the extruding of 70kg pressure dry method, make the finished particle agent of 1000g part; Perhaps

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

(3) get the thin medicated powder that above-mentioned spray drying makes, add 3～6% starch or the correctives stevioside of dextrin and 0.3～0.8% and 0.1～0.3% magnesium stearate, tabletting promptly gets tablet.