CN104491242B - A kind of pharmaceutical composition and its preparation method and application for treating cognition dysfunction - Google Patents
A kind of pharmaceutical composition and its preparation method and application for treating cognition dysfunction Download PDFInfo
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Abstract
The invention belongs to technical field of traditional Chinese medicines, specifically provide a kind of pharmaceutical composition for treating cognition dysfunction, its bulk pharmaceutical chemicals is formed by red stilbene, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm compatibility, the ranging from red stilbene 10-100 parts by weight of its weight proportion, radix scutellariae 8-80 parts by weight, rhodiola root 5-60 parts by weight, grass-leaved sweetflag 5-60 parts by weight, earthworm 3-50 parts by weight.The present invention also provides the preparation method of the pharmaceutical composition and particular uses.Pharmaceutical composition of the present invention is the experiment proved that the ability of learning and memory of vascular dementia rats model can be significantly improved, reduce the activity of MDA and MAO in hippocampal tissue and serum, the mouse pia mater local microcirculation obstacle caused by norepinephrine can be improved in various degree, make arteriole blood vessel dilatation, blood flow is speeded, the experimental results showed that pharmaceutical composition of the present invention has apparent therapeutic effect to vascular dementia.
Description
Technical field
The present invention relates to a kind of pharmaceutical compositions for treating cognition dysfunction, old more particularly, to a kind for the treatment of and alleviation
The pharmaceutical composition and its preparation method and application of dementia or vascular dementia, belongs to technical field of traditional Chinese medicines.
Background technology
Dementia refers to chronic acquired progressive syndrome of intelligent disorder, clinically based on the hypophrenia that slowly occurs
Feature is wanted, with different degrees of personality change, it is one group of clinical syndrome rather than a kind of independent disease.Dull-witted hair
Raw more more slowly concealments, core symptom is based on hypomnesia.Early stage often will appear nearly memory disorders, learn new things
Ability obviously decline, it is slowness of thinking, poor with the further development of the state of an illness, to the comprehension and judgment of general things
Worse and worse, attention is increasingly damaged, and may occur in which time, place and disturbance of orientation to person.Dementia can be divided into according to its cause of disease
Degenerative Dementia and non denatured disease are dull-witted, wherein based on senile dementia and Onset of Vascular Dementia.
Vascular dementia (vascular dementia, VD) is meant in ischemic, hemorrhagic and acute and chronic ischemic hypoxia
One based on higher nerve cognition dysfunction group generated on the basis of brain tissue damage caused by cranial vascular disease is acquired
The clinical syndrome of intelligence damage.Incidence of this disease in China reaches 1.1%~3.0% according to the literature, and age of onset is more
It concentrates between 50-60 Sui, age of onset tends to middle agedization in recent years, and male is more than women.Clinical early symptom can go out
Existing dizziness of having a headache, sleep disturbance cannot be oriented, misinterpretation with when anything crops up forgetful, calculate force difference, also tend to be accompanied by mental
The symptom of disease, if any illusion, vain hope, depressive state or lather etc..Vascular dementia is can uniquely to prevent so far
Dementia, as early treatment can have invertibity.Peripheral vasodilation agent, cholinesterase are mostly used at present for the treatment of this disease
Inhibitor and Neuroprotective Agents carry out anti symptom treatment.
Traditional Chinese medicine has full appreciation to vascular dementia position, the cause of disease, the interpretation of the cause, onset and process of an illness, and differentiation of tcm theory thinks this disease
It is mainly shown as the lesion of " god ", it is believed that phlegm, the stasis of blood, wind, fire, poison are to lead to the key factor of this disease, and the kidney essense deficiency of vital energy, liver kidney essense
Thanks to, spleen kidney deficiency is the core of morbidity, this disease is to belong to asthenia in origin and asthenia in superficiality.According to specifically facing, card is dialectical to be divided into deficiency of kidney-essence by this disease
Card, turbid phlegm blocking the clear orifices card, syndrome of static blood blocking collaterals, syndrome of upper hyperactivity of liver yang, burning hot interior Sheng card, stagnant turbid stay of internal organs demonstrate,prove 7 types such as gentle anemia asthenic symptoms, point
Not Xuan Yong Bushen Yisui Tang, the Pill of Anemarrhena, Phellodendrom and Rehmannia, turn slow-witted and determine intelligence soup, Huanshao pill, guipi decoction, chinkuei shin chewan pills, Longdan Xiegan Tang, Huang
Connect Detoxication Decoction, wash heart soup, turn slow-witted pellet, referring to and be confused the classics sides such as soup, TONGQIAOHUOXUE Decoction, Taohong Siwu Tang progress partner treatment, successively
It is true to obtain satisfied clinical efficacy.
Currently, the emphasis for being increasingly becoming new drug development for treating the Chinese patent drug of this disease.Chinese patent
ZL02110340.2 discloses a kind of drug for preventing and treating cerebral vascular dementia, which is by ginseng 3-9g, three
Seven 3-9g, Schisandra chinensis 3-9g, Fructus Corni 6-15g, prepared rehmannia root 10-30g, RADIX POLYGONI MULTIFLORI PREPARATA 10-20g, cordyceps sinensis 5-10g, stir-baked CORTEX EUCOMMIAE
10-15g, pilose antler 1-3g, leech 1.5-3g, Rhizoma Acori Graminei 5-10g, Radix Polygalae 3-10g, Radix Salviae Miltiorrhizae 3-15g and tortoiseshell 10-30g compositions；
Chinese patent ZL200410102580.1 discloses a kind of Chinese medicine for treating blood vessel nature feeble-mindedness, which is by Huperzia serrata
120-180, trilliaceae 100-180, fleabane flower 120-180, calamus 80-120, gynostemma pentaphylla 120-180, ginkgo leaf 180-220, day
Numb 80-120, worm clothing 80-120, American Ginseng 30-70, Radix Notoginseng 30-80 and Moschus 3-8 compositions；Chinese patent
ZL201310734509.4 discloses a kind of Chinese patent drug and preparation method thereof for treating vascular dementia, which is by radix rehmanniae preparata
15-20 parts, 10-15 parts of dogwood fruit, 8-12 parts of Radix Astragali, 12-18 parts of Radix Salviae Miltiorrhizae, 9-15 parts of safflower, 9-15 parts of Rhizoma Chuanxiong, caulis bambusae in taenian 6-12
Part, 4-10 parts of compositions of 6-12 parts of grass-leaved sweetflag and Radix Glycyrrhizae.Although above-mentioned patent has different therapeutic effects to vascular dementia,
It is that said medicine is more, its impurity content more difficult to control in industrialized production.In addition, the therapeutic effect of above-mentioned formula is more
It is single, in addition to there is therapeutic effect to vascular dementia, direct therapeutic effect is had no to Other diseases.
Invention content
It is an object of the invention to solve the deficiencies in the prior art, a kind of pharmaceutical composition for treating vascular dementia is provided
Object.The purpose of the present invention is what is be achieved through the following technical solutions：
A kind of pharmaceutical composition for treating cognition dysfunction, it is made of following raw material and weight ratio：Red stilbene 10-
100 parts by weight, radix scutellariae 8-80 parts by weight, rhodiola root 5-60 parts by weight, grass-leaved sweetflag 5-60 parts by weight, earthworm 3-50 parts by weight；It is excellent
The weight part ratio of selection of land, each raw material is：Red stilbene 20-80 parts by weight, radix scutellariae 15-60 parts by weight, rhodiola root 10-40 weights
Measure part, grass-leaved sweetflag 10-40 parts by weight, earthworm 5-30 parts by weight；Preferably, the weight part ratio of each raw material is：Red stilbene
40-60 parts by weight, radix scutellariae 20-50 parts by weight, rhodiola root 15-30 parts by weight, grass-leaved sweetflag 15-30 parts by weight, earthworm 8-20 weight
Part；Preferably, the weight part ratio of each raw material is：50 parts by weight of red stilbene, 40 parts by weight of radix scutellariae, 20 weight of rhodiola root
Part, 20 parts by weight of grass-leaved sweetflag, 10 parts by weight of earthworm；Preferably, the weight part ratio of each raw material is：12 weight of red stilbene
Part, 9 parts by weight of radix scutellariae, 6 parts by weight of rhodiola root, 6 parts by weight of grass-leaved sweetflag, 3 parts by weight of earthworm.
A kind of side for the pharmaceutical composition preparing the treatment cognition dysfunction described in the above-mentioned any one claim of power
Method, it is characterised in that：It includes the following steps：S1：Raw material is weighed by component and weight ratio；S2：After mixing by raw material, add
Enter pharmaceutically acceptable auxiliary material and is prepared into pharmaceutically common pharmaceutical preparation.
Pharmaceutically acceptable auxiliary material of the present invention includes starch, magnesium stearate, dextrin and microcrystalline cellulose.
Pharmaceutical preparation of the present invention is tablet, capsule, granule, pill, powder or oral solution.To make above-mentioned dose
Type can be realized, pharmaceutically acceptable auxiliary material need to be added when preparing these dosage forms, such as：Filler, disintegrant, lubricant,
Suspending agent, adhesive, sweetener, corrigent, preservative, matrix etc..Filler includes：It is starch, pregelatinized starch, lactose, sweet
Reveal alcohol, chitin, microcrystalline cellulose, sucrose etc.；Disintegrant includes：Starch, pregelatinized starch, microcrystalline cellulose, carboxymethyl form sediment
Powder sodium, crosslinked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium etc.；Lubricant includes：It is stearic
Sour magnesium, lauryl sodium sulfate, talcum powder, silica etc.；Suspending agent includes：Polyvinylpyrrolidone, microcrystalline cellulose, sugarcane
Sugar, agar, hydroxypropyl methyl cellulose etc.；Adhesive includes starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl cellulose
Deng；Sweetener includes：Saccharin sodium, aspartame, sucrose, honey element, enoxolone etc.；Corrigent includes：Sweetener and various
Essence；Preservative includes：Parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene be fixed,
Eucalyptus oil etc.；Matrix includes：PEG6000, PEG4000, insect wax etc..
Pharmaceutical composition of the present invention is the application prepared for treatment in cognition dysfunction drug, it is preferable that described
Cognition dysfunction is vascular dementia.
The red stilbene of pharmaceutical composition of the present invention, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm are 2010 editions《Chinese Pharmacopoeia》The
One Chinese medicine recorded or its processed product.The dry root of red stilbene legume Hedysarum polybotrys Hand.-Mazz, Gan Wen, returns spleen, lung channel have and mend
Superficies-consolidating, diuretic and maintain drug, apocenosis, the effect of expelling pus and promoting granulation；Radix scutellariae be labiate radix scutellariae root, bitter cold, return lung, stomach, courage,
Large intestine, bladder warp have the function of heat-clearing and damp-drying drug, purging intense heat and detonicating, cooling blood and hemostasis；Rhodiola root is the plant of Crassulaceae rhodiola
Object, it is cold, sweet, puckery, it is distributed in lung channel, have the function of tonifying Qi clearing lung-heat, intelligence development nourishing heart, controlling of bleeding with astringents and eliminating stasis to subdue swelling；Grass-leaved sweetflag day south
The dry rhizome of star section plant grass-leaved sweetflag, acrid, bitter, warm, the thoughts of returning home, stomach, with dampness elimination appetizing, slit phlegm of having one's ideas straightened out, inducing resuscitation intelligence development
Effect；Earthworm be Ju Yin sections animal Pheretima aspergillum, popular Pheretimatschiliensis, power simulation or the hirudo leech of the blind Pheretimatschiliensis of comb, it is salty,
It is cold, Return liver, spleen, bladder warp, have the function of heat-clearing arresting convulsion, dredging collateral relieving asthma, diuresis.
Pharmaceutical composition of the present invention passes through the advantageous effect that pharmacodynamics is verified：Pharmaceutical composition of the present invention can be carried significantly
The ability of learning and memory of high vascular dementia rats model reduces the activity of MDA and MAO in hippocampal tissue and serum, can not
Improve the mouse pia mater local microcirculation obstacle caused by norepinephrine with degree, makes arteriole blood vessel dilatation, blood flow
It speeds, the results showed that pharmaceutical composition of the present invention has apparent therapeutic effect to vascular dementia.Meanwhile medicine group of the present invention
The index and spleen index and thymus index of mouse can be significantly improved by closing object, show that pharmaceutical composition of the present invention can improve exempting from for body
Epidemic disease power.In addition, pharmaceutical composition of the present invention has the preferable property taken into account, have to the patient with mental disorder different degrees of
Therapeutic effect.
Specific implementation mode
Technical scheme of the present invention is described in further detail with reference to specific embodiment, but protection scope of the present invention is not
It is confined to as described below.
Embodiment 1
Raw material red stilbene 10g, radix scutellariae 8g, rhodiola root 5g, grass-leaved sweetflag 5g, earthworm 3g are weighed, supplementary product starch 30g granulations are added,
Magnesium stearate 2g, dextrin 15g, microcrystalline cellulose 15g, are uniformly made particle, and tabletting obtains tablet.
Embodiment 2
Raw material red stilbene 100g, radix scutellariae 80g, rhodiola root 60g, grass-leaved sweetflag 60g, earthworm 50g are weighed, supplementary product starch 350g is added
Particle is uniformly made in granulation, magnesium stearate 30g, dextrin 150g, microcrystalline cellulose 150g, and tabletting obtains tablet.
Embodiment 3
Raw material red stilbene 20g, radix scutellariae 15g, rhodiola root 10g, grass-leaved sweetflag 10g, earthworm 5g are weighed, supplementary product starch 60g systems are added
Particle is uniformly made in grain, magnesium stearate 5g, dextrin 30g, microcrystalline cellulose 30g, and tabletting obtains tablet.
Embodiment 4
Raw material red stilbene 80g, radix scutellariae 60g, rhodiola root 40g, grass-leaved sweetflag 40g, earthworm 30g are weighed, supplementary product starch 250g is added
Particle is uniformly made in granulation, magnesium stearate 25g, dextrin 120g, microcrystalline cellulose 120g, and tabletting obtains tablet.
Embodiment 5
Raw material red stilbene 40g, radix scutellariae 20g, rhodiola root 15g, grass-leaved sweetflag 15g, earthworm 8g are weighed, supplementary product starch 100g systems are added
Particle is uniformly made in grain, magnesium stearate 10g, dextrin 50g, microcrystalline cellulose 50g, and tabletting obtains tablet.
Embodiment 6
Raw material red stilbene 60g, radix scutellariae 50g, rhodiola root 30g, grass-leaved sweetflag 30g, earthworm 20g are weighed, supplementary product starch 200g is added
Particle is uniformly made in granulation, magnesium stearate 20g, dextrin 100g, microcrystalline cellulose 100g, is packed into capsule, obtains capsule.
Embodiment 7
Raw material red stilbene 50g, radix scutellariae 40g, rhodiola root 20g, grass-leaved sweetflag 20g, earthworm 10g are weighed, supplementary product starch 500g is added
Particle is uniformly made in granulation, magnesium stearate 10g, dextrin 250g, microcrystalline cellulose 250g, is packed into capsule, obtains capsule.
Embodiment 8
Raw material red stilbene 12g, radix scutellariae 9g, rhodiola root 6g, grass-leaved sweetflag 6g, earthworm 3g are weighed, supplementary product starch 35g granulations are added,
Particle is uniformly made in magnesium stearate 3g, dextrin 20g, microcrystalline cellulose 20g, is packed into capsule, obtains capsule.
Embodiment 9
Raw material red stilbene 10g, radix scutellariae 8g, rhodiola root 5g, grass-leaved sweetflag 5g, earthworm 3g are weighed, supplementary product starch 30g granulations are added,
Particle is uniformly made in magnesium stearate 2g, dextrin 15g, microcrystalline cellulose 15g, is packed into capsule, obtains capsule.
Embodiment 10
Raw material red stilbene 100g, radix scutellariae 80g, rhodiola root 60g, grass-leaved sweetflag 60g, earthworm 50g are weighed, conventional pharmaceutical adjuvants are added
Powder is prepared.
Embodiment 11
Raw material red stilbene 20g, radix scutellariae 15g, rhodiola root 10g, grass-leaved sweetflag 10g, earthworm 5g are weighed, conventional pharmaceutical adjuvants system is added
It is standby to obtain powder.
Embodiment 12
Raw material red stilbene 80g, radix scutellariae 60g, rhodiola root 40g, grass-leaved sweetflag 40g, earthworm 30g are weighed, conventional pharmaceutical adjuvants are added
Granule is prepared.
Embodiment 13
Raw material red stilbene 40g, radix scutellariae 20g, rhodiola root 15g, grass-leaved sweetflag 15g, earthworm 8g are weighed, conventional pharmaceutical adjuvants system is added
It is standby to obtain pill.
Embodiment 14
Raw material red stilbene 60g, radix scutellariae 50g, rhodiola root 30g, grass-leaved sweetflag 30g, earthworm 20g are weighed, conventional pharmaceutical adjuvants are added
Oral solution is prepared.
Embodiment 15
Raw material red stilbene 50g, radix scutellariae 40g, rhodiola root 20g, grass-leaved sweetflag 20g, earthworm 10g are weighed, conventional pharmaceutical adjuvants are added
Decoction is prepared.
Embodiment 16
Raw material red stilbene 12g, radix scutellariae 9g, rhodiola root 6g, grass-leaved sweetflag 6g, earthworm 3g are weighed, supplementary product starch 35g granulations are added,
Particle is uniformly made in magnesium stearate 3g, dextrin 20g, microcrystalline cellulose 20g, is packed into capsule, obtains capsule.
Beneficial effects of the present invention are proved below by specific pharmacy test：
One, the experiment of the anti-angiogenic dementia rats model of pharmaceutical composition of the present invention
1 experiment material
1.1 experimental animal
SPF grades of SD rats, half male and half female, weight range 180-220g, by Sichuan Academy of Medical Sciences's Animal Experimental Study
It is provided, animal credit number：SCXK (river) 2012-21, in 22-25 DEG C of room temperature, relative humidity is raised under the conditions of 50-60%
It supports, free water is ingested.
1.2 drugs and reagent：
Nimodipine tablet, the manufacture of Jiangsu Ju Rong pharmacy Group Co., Ltd, lot number 100213；MDA, MAO kit, Nanjing
Build up bioengineering institute, lot number 20091106,20091107.
Red-spotted stonecrop brain-care capsule：Prescription is made of red stilbene, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm, and dosage ratio is：
Red stilbene 4：Radix scutellariae 3：Rhodiola root 2：Grass-leaved sweetflag 2：Earthworm 1.Weigh red stilbene 120g, radix scutellariae 90g, rhodiola root 60g, grass-leaved sweetflag 60g,
Imperial 30g is added 5 times and measures water decoction 2 times, decoct 1.5 hours every time, merges decocting liquid twice, concentrated medicament is extremely by crude drug gauge
Calculate the liquid of 1g/ml.
1.3 experiment key instruments：
MT-200 water mazes, Chengdu TME Technology Co., Ltd.
2 experimental methods
It is prepared by 2.1 models
Rat permanently ligatures bilateral common carotid arteries using 2-VO methods, and blank group only detaches bilateral common carotid arteries, do not ligature,
Postoperative daily 100,000 unit of im benzylpenicillin sodium for injection of every rat is anti-infective, totally 3 days, notices that moisturizing, Postoperative are protected in art
Temperature, it is postoperative freely raise January after animal be grouped administration.
2.2 groupings and administration
Modeling rat SD rats 50 are divided into model control group, Nimodipine positive controls, examination by weight stratified random
High dose group, experiment middle dose group, experiment low dose group are tested, optionally takes 10 same batch of rats as blank control group, using filling
Stomach is administered, and is first formulated as calculating the liquid of 1g/ml by crude drug amount by drug of the present invention, part liquid is then taken to be diluted to 0.5g/
The liquid of ml, then the liquid that takes part 0.5g/ml liquid equivalent to be diluted to 0.25g/ml.Each group animal by 1ml/100g weight/
Its ig is administered, and high dose fills the liquid of a concentration of 1g/ml, and middle dosage fills the liquid of a concentration of 0.5g/ml, and low dosage fills a concentration of
The liquid of 0.25g/ml.Model control group, blank control group give normal saline, successive administration 15 days, in experiment the 11st
Water maze Behavior Test is proceeded by after day administration, carries out orientation navigation experiment within first 4 days, is gone within the 5th day platform to carry out space and is searched
Rope is tested.
2.3Morris water mazes test learning and memory in rats ability
MT-200 water mazes pond is bisected into 4 quadrants, and platform is located at SW quadrants center, and 24 DEG C of water temperature, the water surface is higher than flat
Platform 1.5cm, with milk to opaque in water, rat enters water in SW quadrants centre position towards pool wall daily, and experimental period is
120s, preceding 4 days orientation navigations automatically record its incubation period by instrument, and platform residence time, platform stop distance, by platform
Number is calculated as 120s if rat does not find platform in 120s, stops 10s on all equal platforms of rat to enhance memory after experiment；Experiment
It totally 5 days, removes within the 5th day platform, carries out space search experiment, time 120s, in space search, its manually recorded incubation period, and
It is automatically recorded by instrument and stops distance by platform number, platform residence time, platform.It the results are shown in Table 1.
The active measurement of 2.4 rat hippocampus, Content of MDA, MAO
It after each group animal learning memory behavior experimental test, takes hippocampal tissue to freeze immediately spare, take blood and divides
From serum, illustrate to carry out rat hippocampus, Content of MDA and the active detections of MAO by kit.It the results are shown in Table 2 and table 3.
3 experimental results
The influence of 3.1 pairs of rat spatial search capabilities
Influence of 1 medicament composing prescription of table to VD rat model Spatial memory abilities
Note：Compared with model group, * P<0.05；**P<0.01.
As shown in Table 1, compared with model control group, the escape that the high, medium and low dosage group of drug can significantly shorten rat is latent
Phase (p<0.05), and increase rat in 120s by platform number (p<0.05), platform residence time (p<0.05), platform
Stop distance (p<0.05).
3.2 on Rat hippocampus, Content of MDA, the active influences of MAO
Table 2 is on Rat hippocampus MDA contents, the active influences of MAO
Note：Compared with model group, * P<0.05；**P<0.01.
Table 3 is on rat blood serum MDA contents, the active influences of MAO
Note：Compared with model group, * P<0.05；**P<0.01.
By table 2 and table 3 it is found that compared with model control group, the high, medium and low dosage group of drug, Nimodipine group can significantly drop
Low Rat hippocampus, Content of MDA, MAO activity (p<0.05；p<0.01).
4, conclusion
Pharmaceutical composition of the present invention can significantly improve the ability of learning and memory of vascular dementia model, reduce hippocampal tissue
With the activity of MDA in serum and MAO, show that pharmaceutical composition of the present invention has apparent treatment to vascular dementia rat models
Effect.Two, pharmaceutical composition of the present invention tests mouse soft bus wire
1 experiment material
1.1 experimental animal：
KM mouse 60,20 ± 2g of weight, age of mouse 45~50 days, half male and half female is tested by Sichuan Academy of Medical Sciences
Institute of Botany provides, animal credit number：SCXK (river) 2008-24, in 22-24 DEG C of room temperature, light and shade period 12h/12h conditions
Lower raising, free water are ingested.
1.2 drugs and reagent：
Nimodipine tablet, the manufacture of Jiangsu Ju Rong pharmacy Group Co., Ltd, lot number 080218；Liquor epinephrinae bitartratis ophthalmicus noradrenaline
Plain injection, Shanghai Hefeng Pharmaceutical Co., Ltd. produce, lot number：0360602；
Red-spotted stonecrop brain-care capsule：Prescription is made of red stilbene, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm, and dosage ratio is：
Red stilbene 4：Radix scutellariae 3：Rhodiola root 2：Grass-leaved sweetflag 2：Earthworm 1.Weigh red stilbene 120g, radix scutellariae 90g, rhodiola root 60g, grass-leaved sweetflag 60g,
Imperial 30g is added 5 times and measures water decoction 2 times, decoct 1.5 hours every time, merges decocting liquid twice, concentrated medicament is extremely by crude drug gauge
Calculate the liquid of 1g/ml.
1.3 experiment key instruments and reagent：
XTW-CTV microcirculation color TV microscopes, the production of Beijing Tyke Instrument Ltd.；
2 experimental methods
Mouse 50 is taken, 5 groups, i.e. agent in blank control group, Nimodipine control group, experiment high dose group, experiment are divided into
Drug of the present invention, using gastric infusion, is first formulated as calculating 1g/ml by crude drug amount by amount group, experiment low dose group by every group 10
Liquid, then take part liquid to be diluted to the liquid of 0.5g/ml, then part 0.5g/ml liquid equivalent is taken to be diluted to 0.25g/
The liquid of ml, each group animal press 0.2ml/10g body weight/day gastric infusions, and high dose fills the liquid of a concentration of 1g/ml, middle dosage
The liquid of a concentration of 0.5g/ml is filled, low dosage fills the liquid of a concentration of 0.25g/ml.After successive administration 7 days, intraperitoneal injection 1%
After yellow Jackets anesthesia, ventral decubitus head is fixed, and calvarium hits exactly skin T-shape and cuts, with 3mm outside sagittal suture, under coronal suture
Centered on 3mm, skull is raised with knife blade, exposure pia mater forms the cranium window of a diameter about 5mm, physiological saline is added
Start to test after 20ul, post surgery stabilization 30min, entire process of testing keeps 37 DEG C of animal heat.Experimental animal is placed in micro- follow
A diameter of 30~50um arterioles blood vessel is selected under ring microscope, stablizes 30min, surveys pipe diameter size, then be added dropwise 0.1%
NA10ul, with XTW-CTV microcirculation color TV microscopes by means of JS micrometer oculars be observed continuously be added dropwise NA after 3,9min
When arteriole blood vessels caliber size variation.Simultaneously observe normal pia mater and be added dropwise 0.1%NA after microcirculation color, often regard
Wild intertexture number of outlet.It the results are shown in Table 4,5.
3 experimental results
Influence of 3.1 drugs to mouse pial arteriole blood vessels caliber
Influence of the table 4 to mouse pial arteriole blood vessels caliber
Note：Compared with blank control group, * P < 0.05, * * P < 0.01
Influence of the table 5 to mouse pia mater capilary intertexture number of outlet is (per the visual field)
Note：Compared with blank control group, * P < 0.05, * * P < 0.01
By 4~5 visible positive controls of table, drug test high dose group, experiment middle dose group and experiment low dose group phase
The mouse pia mater local microcirculation barrier caused by norepinephrine can be improved in various degree for blank control group
Hinder, arteriole blood vessel dilatation, blood flow is made to speed, increases per visual field intertexture net number.
Three, the influence of pharmaceutical composition A PP transgenic mice ability of learning and memory of the present invention
1 experiment material
1.1 experimental animal
3 monthly age APP695V717I transgenic mices are purchased from Chinese Academy of Medical Sciences's Animal Experimental Study center, purchase simultaneously
With monthly age C57BL/6J mouse as normal control, in 22-25 DEG C of room temperature, relative humidity is raised under the conditions of 50-60%, freely
Drinking-water is ingested.
1.2 drugs and reagent：
Red-spotted stonecrop brain-care capsule：Prescription is made of red stilbene, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm, and dosage ratio is：
Red stilbene 4：Radix scutellariae 3：Rhodiola root 2：Grass-leaved sweetflag 2：Earthworm 1.Weigh red stilbene 120g, radix scutellariae 90g, rhodiola root 60g, grass-leaved sweetflag 60g,
Imperial 30g is added 5 times and measures water decoction 2 times, decoct 1.5 hours every time, merges decocting liquid twice, concentrated medicament is extremely by crude drug gauge
Calculate the liquid of 1g/ml.
Main agents and instrument：A β radioimmunoassay kits are purchased from Tianjin Jiuding Medical Biological Engineering Co., Ltd.
Image analysis system is u s company Image-pro Plus, and microcomputer Multi probe counter is purchased from Beijing Nuclear Instrument Factory's (model：
FJ630G/12).Morris water mazes, Chengdu TME Technology Co., Ltd..
2 experimental methods
2.1 groupings and administration
It is divided into model group, experiment high dose group according to table of random number, tests middle dose group, experiment low dose group, every group
10.Normal group：Selection 10 is with monthly age C57BL/6J mouse as Normal group.Control group and model group give to steam
Distilled water gavage.Using gastric infusion, first drug of the present invention is formulated as to calculate the liquid of 1g/ml by crude drug amount, then takes part
Liquid is diluted to the liquid of 0.5g/ml, then the liquid for taking part 0.5g/ml liquid equivalent to be diluted to 0.25g/ml.Each group animal
By 0.2ml/10g body weight/day gastric infusions, high dose fills the liquid of a concentration of 1g/ml, and middle dosage fills a concentration of 0.5g/ml's
Liquid, low dosage fill the liquid of a concentration of 0.25g/ml.Into every trade when Normal group, model and administration group gavage to 11 monthly age
To learn the measurement of detection and cerebral cortex A β contents.
2.2Morris water maze test
Training 2 times daily of each group mouse, are trained 6 days altogether.4-6d in each group mouse Morris water maze operations is averaged
Swimming time and average swim distance are as the index for weighing its ability of learning and memory.
2.3A β assays
Mouse cortex is removed under ice bath, is homogenized with Tris-HCl buffer solutions, 8000r/min centrifuges 10min, and supernatant is taken to detect
A β contents.In strict accordance with the A β kit specifications operation of nine ancient cooking vessel medicine bioengineering Co., Ltds of Tianjin, as a result by counting
The A β content ng/mgpro that device is corrected).
3 experimental results
3.1Morris water maze test
Compared with the control group, swimming time and distance are obviously prolonged (P< to model group;0.05)；By red-spotted stonecrop brain-care
Large dosage and middle dose group shorten (P< compared with the swimming time of model group after capsule for treating;0.05), swimming distance has shortening trend.
It is shown in Table 6.
6 medicament composing prescription of table compares the detection of each group mice behavior
Note：Compared with model group, * P<0.05；**P<0.01.
3.2 cerebral cortex A β contents
The content of model group cerebral cortex solubility A β obviously increases (P< compared with control group;0.01)；Red-spotted stonecrop brain-care capsule
Each dosage group can substantially reduce the content (P< of model mouse soluble A β;0.01).It is shown in Table 7.
Influence of 7 medicament composing prescription of table to each group Cerebral Cortex A β contents
Note：Compared with model group, * P<0.05；**P<0.01.
The experimental results showed that red-spotted stonecrop brain-care capsule can be obviously improved the ability of learning and memory of APP transgenic mices,
There is stronger therapeutic effect to vascular dementia.
Four, influence of the pharmaceutical composition of the present invention to immune function
1 experiment material
1.1 experimental animal：
KM mouse 40, weight are 20 ± 2g, age of mouse 45~50 days, half male and half female, by Sichuan Academy of Medical Sciences's reality
Institute of Botany offer, animal credit number are provided：SCXK (river) 2008-24, in 22-24 DEG C of room temperature, light and shade period 12h/12h items
It is raised under part, free water is ingested.
1.2 experimental drug
Red-spotted stonecrop brain-care capsule, prescription are made of red stilbene, radix scutellariae, rhodiola root, grass-leaved sweetflag and earthworm, dosage ratio
For：4：3：2：2：1.Red stilbene 120g, radix scutellariae 90g, rhodiola root 60g, grass-leaved sweetflag 60g, earthworm 30g are weighed, 5 times of amount water are added and decoct
It 2 times, decocts 1.5 hours every time, merges decocting liquid twice, concentrated medicament to the liquid for calculating 1g/ml by crude drug amount.2 experiment sides
Method
By mouse by weight and gender be randomly divided into Normal group, drug high dose group of the present invention, middle dosage combination it is low
Drug of the present invention is first formulated as calculating the liquid of 1g/ml by crude drug amount, is then taken portion by four groups of dosage group using gastric infusion
Drug dispensing liquid is diluted to the liquid of 0.5g/ml, then the liquid for taking part 0.5g/ml liquid equivalent to be diluted to 0.25g/ml.Each group is dynamic
Object presses 0.2ml/10g body weight/day gastric infusions, and high dose fills the liquid of a concentration of 1g/ml, and middle dosage fills a concentration of 0.5g/ml
Liquid, low dosage fills the liquid of a concentration of 0.25g/ml, the physiological saline of Normal group gavage equivalent.Successive administration 8 weeks
Afterwards, influence of the observation each group to immune organ, inspection target are index and spleen index and thymus index.Index and spleen index=spleen weight/
Weight × 100%；Thymus index=thymic weight/weight × 100%.
3 experimental results
Experimental result is shown in Table 8.
The comparison of 8 each group mouse different organs index of table
Note：Compared with Normal group, * P<0.05；**P<0.01.
As shown in Table 8, compared with Normal group, pharmaceutical composition of the present invention can significantly improve mouse index and spleen index and
Thymus index shows that pharmaceutical composition of the present invention helps to improve the immunity of body.
Five, drug of the present invention tests mouse tail suspension method depression model
(1) test drug
Blank group：Distilled water；Fluoxetine hydrochloride group：Pharmaceutical Co Ltd, Changzhou Pharmaceutical Factory No.4,10mg/ pieces；Reserpine injection：
Changchun Changqing Pharmaceutical Group Co., Ltd., 1ml:1mg/ branch；Red-spotted stonecrop brain-care capsule, prescription is by red stilbene, radix scutellariae, red scape
It, grass-leaved sweetflag and earthworm composition, dosage ratio is：4：3：2：2：1.Weigh red stilbene 120g, radix scutellariae 90g, rhodiola root 60g, stone Chang
Pu 60g, earthworm 30g are added 5 times of amount water and decoct 2 times, decoct 1.5 hours every time, merge decocting liquid twice, and concentrated medicament is to pressing
Crude drug amount calculates the liquid of 1g/ml.
(2) experiment grouping, method and result
Animal is weighed before experiment, numbers, is randomly divided into blank control group, Fluoxetine hydrochloride group, red-spotted stonecrop brain-care glue
Capsule high dose group, middle dose group and low dose group are divided into 5 groups.Blank control group is only given steaming during entire experiment
Distilled water, Fluoxetine hydrochloride group give gavage according to 0.02g/kg dosage, and high dose, middle dosage and low dose group press 0.2ml/
10g body weight/day gastric infusions, high dose fill the liquid of a concentration of 1g/ml, and middle dosage fills the liquid of a concentration of 0.5g/ml, low dose
Amount fills the liquid of a concentration of 0.25g/ml.
1. influence of the single-dose to rat force swimming test
50 Kunming mouses are chosen, are all male, 20 ± 2g of weight is randomly divided into 6 groups by weight, and each group is distinguished daily
Gastric infusion is primary.After 30min is administered in each group animal, by mouse tail away from the steel for being pasted on diameter 1cm at sharp 1cm with adhesive plaster
Guan Shang folds mouse tail distortion, then makes somebody a mere figurehead steel pipe, and it is in upside down shape to make mouse, and head is away from table top 5cm or so, often
It is separated with partition board between two mouse, it is made not interfere with each other, observe the accumulative motionless time (stationarity indices in every animal 6min
For animal, all limbs are motionless in addition to breathing).It the results are shown in Table 9.
Influence of the 9 red-spotted stonecrop brain-care capsule single-dose of table to rat force swimming test
The results show that each high, medium and low dosage group single-dose of experimental group has significantly the rat force swimming test dead time
Shortening has statistical significance.
2. influence of the multiple dosing to rat force swimming test
50 Kunming mouses are chosen, are all male, 20 ± 2g of weight is randomly divided into 5 groups by weight, and each group is distinguished daily
Gastric infusion is primary.Continuous gavage 7 days, after 30min is administered in each group animal, by mouse tail away from being pasted on adhesive plaster at sharp 1cm
On the steel pipe of diameter 1cm, folds mouse tail distortion, then make somebody a mere figurehead steel pipe, it is in upside down shape to make mouse, and head is away from platform
Face 5cm or so is separated between every two mouse with partition board, it is made not interfere with each other, and is observed accumulative motionless in every animal 6min
Time (stationarity indices is that animal all limbs in addition to breathing are motionless).It the results are shown in Table 10.
Influence of the 10 red-spotted stonecrop brain-care capsule multiple dosing of table to rat force swimming test
The results show that each experimental group multiple dosing, which has the rat force swimming test dead time significantly to shorten, has statistics
Meaning.The experimental results showed that red-spotted stonecrop brain-care capsule, which has, alleviates depressed effect.
Dementia patients also tend to the symptom with mental disorder other than cognition dysfunction, if any illusion, absurd
Think, the symptoms such as depressive state or lather.It is experimentally confirmed, red-spotted stonecrop brain-care capsule has vascular dementia good
While therapeutic effect, good therapeutic effect is all had to vascular dementia simultaneous phenomenon illusion, vain hope and depressive symptom.
Claims (8)
1. a kind of pharmaceutical composition for treating vascular dementia, it is characterised in that：It is made of following raw material and weight ratio：It is red
Stilbene 10-100 parts by weight, radix scutellariae 8-80 parts by weight, rhodiola root 5-60 parts by weight, grass-leaved sweetflag 5-60 parts by weight, earthworm 3-50 weight
Part.
2. a kind of pharmaceutical composition for treating vascular dementia according to claim 1, it is characterised in that：Each original
The weight part ratio of material is：Red stilbene 20-80 parts by weight, radix scutellariae 15-60 parts by weight, rhodiola root 10-40 parts by weight, grass-leaved sweetflag 10-
40 parts by weight, earthworm 5-30 parts by weight.
3. a kind of pharmaceutical composition for treating vascular dementia according to claim 1, it is characterised in that：Each original
The weight part ratio of material is：Red stilbene 40-60 parts by weight, radix scutellariae 20-50 parts by weight, rhodiola root 15-30 parts by weight, grass-leaved sweetflag 15-
30 parts by weight, earthworm 8-20 parts by weight.
4. a kind of pharmaceutical composition for treating vascular dementia according to claim 1, it is characterised in that：Each original
The weight part ratio of material is：50 parts by weight of red stilbene, 40 parts by weight of radix scutellariae, 20 parts by weight of rhodiola root, 20 parts by weight of grass-leaved sweetflag, earthworm
10 parts by weight.
5. a kind of pharmaceutical composition for treating vascular dementia according to claim 1, it is characterised in that：Each original
The weight part ratio of material is：12 parts by weight of red stilbene, 9 parts by weight of radix scutellariae, 6 parts by weight of rhodiola root, 6 parts by weight of grass-leaved sweetflag, 3 weight of earthworm
Measure part.
6. a kind of pharmaceutical composition preparing the treatment vascular dementia described in any one of Claims 1 to 5 claim
Method, it is characterised in that：It includes the following steps：
S1：Raw material is weighed by component and weight ratio；
S2：After mixing by raw material, pharmaceutically acceptable auxiliary material is added and is prepared into pharmaceutically common pharmaceutical preparation.
7. a kind of preparation method of pharmaceutical composition for treating vascular dementia according to claim 6, it is characterised in that：
The pharmaceutically acceptable auxiliary material includes starch, magnesium stearate, dextrin and microcrystalline cellulose.
8. a kind of preparation method of pharmaceutical composition for treating vascular dementia according to claim 6, it is characterised in that：
The pharmaceutical preparation is tablet, capsule, granule, pill, powder or oral solution.
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| CN102379914A (en) * | 2011-10-19 | 2012-03-21 | 张占军 | Pharmaceutical composition for treating Alzheimer disease (AD), and preparation method and application thereof |
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