Preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof
Technical field
The invention belongs to traditional Chinese medicine preparation technical field, be specifically related to a kind of preventing and treating Alzheimer disease Chinese medicine
Composition and preparation method thereof and containing the medicine of described composition or health products.
Background technology
China has been enter into aging population society, and statistics shows, by the end of the year 2014, China 60 years old
Above elderly population have reached 2.12 hundred million, account for the 15.5% of total population, and China becomes the aged big country in the whole world.According to report
Road, in the elderly of whole world over-65s, 10% suffers from senile dementia, and the illness rate of more than 80 years old is high
Reach 20%.Senile dementia (Alzheimer disease Alzheimer's disease is called for short AD) has become the mankind and has continued
The fourth-largest killer after heart disease, cancer, apoplexy.Epidemiology survey shows, China at least 6,000,000
Above patients with Alzheimer disease, annual medical expenses are at least more than 30,000,000,000 yuan.
Modern medicine study shows, the pathogenesis of Alzheimer disease is extremely complex, relate to polygenes defect,
Ambient influnence, neurotoxin, Apoptosis, oxidative stress, β-AP (β amyloid proteins) assemble, inflammation
Reaction, Ca2+Multiple links and the aspects such as multisystem retrogression such as overload, cholinergic.For alzheimer '
Silent sick pathogenesis, medicine mainly has anticholinesterase, glutamate receptor short of money currently on the market
Anti-agent, calcium ion antagonist, free radical scavenger and antioxidant, estrogen etc..Said medicine is main
Based on chemical drugs, toxic and side effect is bigger.2010 European " about AD treatment guidelines " are pointed out, AD
First-selection anticholinesterase during drug therapy.But owing to AD needs Long-term taking medicine, and cholinesterase suppresses
Resistance phenomenon after agent long-term taking.In view of current Western medicine to the limitation of AD result for the treatment of, bad reaction with
And the complexity of the AD cause of disease, giving full play to characteristic and the advantage of traditional Chinese medicine, whole synthesis is recuperated under medical treatment, too many levels,
Mutiple Targets plays a role, thus develop safe and effective prevention and treatment Alzheimer disease new Chinese medicine/
Health products, imperative, extremely the most urgent.
AD etiology and pathogenesis is set forth by existing patent, but is not yet formed and understand systematicly.As special in China
Profit CN 105056151 A in disclose a kind of pill treating Alzheimer disease, its be by following each in
Medicine mass parts is fabricated to pill than combination: cornu bubali 15 parts, 15 parts of cultivated land, the root of bidentate achyranthes 20 parts, grass-leaved sweetflag
15 parts, turtle shell 20 parts, calcined oyster shell 30 parts, cape jasmine 15 parts, root tuber of aromatic turmeric 15 parts, dried orange peel 15 parts, the leaves of pulse plants
Perfume 15 parts, 10 parts of the leaf of bamboo, isatis root 15 parts, honeysuckle 15 parts.At Chinese patent CN 104997943
Disclosing a kind of Chinese medicine for treating Alzheimer disease in A, it is by the bulk drug of following weight proportion
Material is prepared from: canton salomonia herb 10 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 10 parts, rattletop 10 parts, obcordate aspidopterys stem 18 parts, madder
Grass 18 parts, Polygonum multiflower knotweed 20 parts, gal mutter fragrant 10 parts.Disclosed in Chinese patent CN 104069424 A
A kind of Chinese medicine with treatment Alzheimer disease, it is made up of the bulk drug of following weight portion: Morinda officinalis
5-20, grass-leaved sweetflag 5-20 part, root tuber of aromatic turmeric 5-30 part, Radix Astragali 5-30 part, polygala root 1-20 part.
In view of AD is furtherd investigate and the raising of understanding by modern medicine, we are according to clinical accumulation for many years
Verify with scientific research, it is provided that the present invention.
Summary of the invention
It is an object of the invention to overcome the above-mentioned deficiency of prior art, it is provided that a kind of preventing and treating Alzheimer disease
Chinese medicine composition and preparation method thereof, less-than-ideal to solve existing preventing and treating treatment of alzheimer curative effect
Technical problem.
Another object of the present invention is to provide a kind of medicine preventing and treating Alzheimer disease or health products, to provide
A kind of product preventing and treating Alzheimer disease determined curative effect.
In order to realize foregoing invention purpose, the embodiment of the present invention is on the one hand, it is provided that a kind of preventing and treating alzheimer '
Silent sick Chinese medicine composition.Described preventing and treating Alzheimer disease Chinese medicine composition contains phosphatidylserine 1~12
Weight portion, possibly together with the traditional Chinese medicinal components of following weight portion:
Ginseng 10~180 parts, rhizoma Gastrodiae 10~200 parts, ginkgo leaf 30~240 parts, polygala root 10~200 parts,
Galangal 10~120 parts;Or
Ginseng 10~180 parts and following Chinese medicinal material extract: Rhizoma Gastrodiae extract 10~200 parts of extracts, silver
Apricot leaf extract 30~240 parts, milkwort extract 10~200 parts and galangal rhizome extract 10~120 parts;
Or
Ginseng 10~180 parts, rhizoma Gastrodiae 10~200 parts, ginkgo leaf 30~240 parts, polygala root 10~200 parts
With galangal 10~the Chinese medicinal material extract of 120 parts.
The embodiment of the present invention is on the other hand, it is provided that a kind of preparation preventing and treating Alzheimer disease Chinese medicine composition
Method.Described method comprises the steps:
The phosphatidylserine contained by Alzheimer disease Chinese medicine composition and described Chinese medicine is prevented and treated according to the present invention
Component weighs each tcm components material;
Carry out at batch mixing with described phosphatidylserine component after the described Chinese medicine weighed is carried out pulverization process
Reason;Or
Pharmaceutically acceptable solvent is used to soak the rhizoma Gastrodiae weighed, ginkgo leaf, polygala root, galangal Chinese medicine
Carry out extraction process after process, collect extract;By described extract concentration, be dried process after with phosphorus
The ginseng of acyl serine and crushed process carries out mixing treatment;Or
Carry out at extraction after carrying out using pharmaceutically acceptable solvent immersion treatment by the described Chinese medicine weighed
Reason, collects extract;Mix with phosphatidylserine after described extract concentration, dry process
Material processes.
Embodiment of the present invention another further aspect, it is provided that a kind of medicine preventing and treating Alzheimer disease or health products,
Including pharmaceutically acceptable auxiliary material, also include that the present invention of effective dose prevents and treats Alzheimer disease Chinese traditional medicine composition
Thing or the preventing and treating Alzheimer disease Chinese medicine composition Chinese traditional medicine composition prepared by the preparation method of composition of the present invention
Thing.
Compared with prior art, the present invention prevents and treats Alzheimer disease Chinese medicine composition with rhizoma Gastrodiae as monarch drug in a prescription, people
Ginseng, ginkgo leaf be ministerial drug, polygala root and galangal be adjuvant (each medicinal material is the Chinese medicine of integration of drinking and medicinal herbs,
Safety non-toxic, health food and food are conventional), coordinate phosphatidylserine, make each component help according to the monarch and his subjects
Make effect, Alzheimer disease is had good preventive and therapeutic effect, proves through clinical testing, of the present invention group
Compound can improve Spatial learning ability and the space exploration ability of Alzheimer disease kunming mice, increases big
RNA and the Nissl body burden of Cerebral cortex and hippocampal pyramidal cell, and its effect presents a certain amount effect and closes
System, improves brain nucleic acid metabolism and protein anabolism, promotes regulation cerebral cortex and the RNA metabolism of hippocampus,
Improve and regulate and control metabolism and the neuronal structure in learning and memory key brain district of whole neuron, play pre-
Preventing and the effect for the treatment of Alzheimer disease, therefore, preventing and treating Alzheimer disease Chinese medicine composition has tonifying liver
Supporting marrow, the effects such as dredging collateral reduces phlegm, brain healthy, clinic can significantly improve memory and mild cognition impairment.
The present invention prevents and treats the preparation method of Alzheimer disease Chinese medicine composition by each component according to fixing step
Process, thus ensure that composition quality so as to get preventing and treating Alzheimer disease Chinese medicine composition
Having the effects such as tonifying liver supports marrow, and dredging collateral reduces phlegm, brain healthy, clinic can significantly improve memory and mild cognitive
Dysfunction, and efficacy stability, safety non-toxic, quality controllable, low cost, commercial viability is good.
The present invention prevents and treats the medicine of Alzheimer disease or health food due to the present invention's containing effective dose
Chinese medicine composition, therefore, has the effects such as obvious tonifying liver supports marrow, and dredging collateral reduces phlegm, brain healthy, clinical
Memory and mild cognition impairment, the drug effect of preventing and treating Alzheimer disease, and safety non-toxic can be significantly improved
Side effect.
Detailed description of the invention
In order to make the purpose of the present invention, technical scheme and advantage clearer, below in conjunction with embodiment,
The present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to
Explain the present invention, be not intended to limit the present invention.
The weight of each component that the embodiment of the present invention is noted in the disclosure not only may refer to the tool of each component
Body burden, it is also possible to represent the proportionate relationship of weight between each component, therefore, as long as implement according to the present invention
The content of each component of example specification composition scales up or reduces all open at embodiment of the present invention specification
Within the scope of.Specifically, the weight portion described in embodiment of the present invention specification can be μ g, mg, g,
Unit of weight known to the field of medicaments such as kg, it is of course possible to regard percentage by weight as.
From the point of view of Chinese medicine, Alzheimer disease basic pathogenesis is that essence thanks to marrow subtracts, deficiency of qi and blood, the tired numbness of phlegm
Resistance brain network, causes unit god impaired, god's machine appraxia.Trace it to its cause on the one hand owing to internal organs void declines, caused by liver and kidney deficiency,
Brains lose supports, and causes god's machine appraxia;On the other hand, old function is not normal, and phlegm-turbidity and blood stasis blood blocks, clearly
Key loses supports.The outer actual situation of its characteristic of disease two kinds, asthenic symptoms are relevant to the five internal organs, main duty dirty in spleen, kidney two, wrap
Include damage of kidney-essence and spleen insufficiency, but based on deficiency of kidney-essence;Real example then incorporates in internal qi and blood, body fluid
Running smooth, the most then change tired, one-tenth phlegm, numbness resistance brain network, illiteracy close clear key.The two can interact again simultaneously,
Sthenia symptoms caused by asthenia, because of real wound just, continues, and holds concurrently mutually as disease, the card of one-tenth simulataneous insufficiency and excessive.For this disease, clinical normal
Reducing phlegm based on kidney tonifying, the present invention, on the basis of further investigation pathogenesis, proposes treat from liver, mends
Liver supports marrow, be aided with promoting blood circulation and removing blood stasis, eliminate the phlegm have one's ideas straightened out, the side such as brain healthy medicine, clinical observation result is notable for many years.
Based on the cognition to Alzheimer disease basic pathogenesis, on the one hand, embodiments provide one
Preventing and treating Alzheimer disease Chinese medicine composition.In one embodiment, embodiment of the present invention preventing and treating Alzheimer
Sick Chinese medicine composition contains phosphatidylserine 1~12 weight portion, possibly together with the traditional Chinese medicinal components of following weight portion:
Ginseng 10~180 parts, rhizoma Gastrodiae 10~200 parts, ginkgo leaf 30~240 parts, polygala root 10~200 parts, height
Galingal 10~120 parts.
In another embodiment, embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition contains phosphatidyl
Serine 1~12 weight portion, possibly together with the traditional Chinese medicinal components of following weight portion: ginseng 10~180 parts and as follows
Chinese medicinal material extract: Rhizoma Gastrodiae extract 10~200 parts of extracts, ginkgo biloba p.e 30~240 parts, remote
Will extract 10~200 parts and galangal rhizome extract 10~120 parts.
In another embodiment, embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition contains phosphatidyl
Serine 1~12 weight portion, possibly together with the traditional Chinese medicinal components of following weight portion: ginseng 10~180 parts, rhizoma Gastrodiae
10~200 parts, ginkgo leaf 30~240 parts, polygala root 10~200 parts and galangal 10~the Chinese medicine of 120 parts
Material extract.
Therefore, this preventing and treating Alzheimer disease Chinese medicine composition is with rhizoma Gastrodiae as monarch drug in a prescription, and ginseng, ginkgo leaf are minister
Medicine, polygala root and galangal are adjuvant, coordinate phosphatidylserine, have Alzheimer disease good
Preventive and therapeutic effect.
Wherein, monarch drug in a prescription rhizoma Gastrodiae nature and flavor are sweet flat, enter Liver Channel.There is dispelling wind and relieving convulsion, antirheumatic, anti-epileptic, resist
Faint from fear, the effect such as calm and antispastic, be mainly used in treatment headache dizziness clinically, extremity numbness, children's shy
Wind, epilepsy clonus and lockjaw etc..Its principle active component be Gastrodin, vanillyl alcohol, vanillin,
Parahydroxyben-zaldehyde and to hydroxy-benzyl alcohol etc..Research shows, rhizoma Gastrodiae has expansion blood vessel, strengthens blood vessel elasticity,
Improve the effect of basilar arterial blood supply;Can be by repairing brain cell injury, protecting the cerebrovascular, improve hippocampus
The pharmacological actions such as synaptic plasticity damage, suppression Apoptosis of Hippocampal Neurons, prevent and treat senile dementia;Increase
Brain tissue hemoperfusion, alleviates cerebral ischemia re-pouring injured, and the level of regulation neurotransmitter, regulation part declines
The expression of uneducated person correlation gene and weaken apoptosis pathway, plays cerebral protection;Gastrodin and gastrodia elata polysaccharide,
Promote cellular immunity and humoral immunity, play antioxidation comprehensively, effectively remove serum, brain and other groups
The MDA knitted, improves the activity of multiple antioxidase.Along with deepening continuously that it is studied, closely
Find over Nian that Gastrodin can enter in brain through blood-brain barrier, and be decomposed into rapidly in brain, blood and liver
Gastrodigenin, retains in the tissue with the form of Gastrodigenin, has removing free radical, anti-oxidant, suppression
Axoneure apoptosis etc. act on, and have certain curative effect to AD.
Ginseng, taste hardship sweet, micro-, property is put down, is returned lung, spleen, the heart channel of Hang-Shaoyin.Shennong's Herbal is classified as ginseng
Top grade, say that " main tonifying five zang organs, peace spirit, determine soul, only palpitation with fear, improving eyesight, happy intelligence development, long clothes has for it
Make light of one's life by commiting suicide the effect prolonged life." modern study expanded effect of ginseng further, the people represented as tonic
Ginseng, great many of experiments and clinical research find, it has effect of preventing and treating senile dementia.Doctor thinks more, people
Ginseng and compound preparation thereof can prevent and treat senile dementia, mainly by the method such as nourishing qi and blood, kidney tonifying, essence replenishing so that
Senile dementia patients memory, directive force, comprehension are obviously improved.Research shows, the anti-punish-old of ginseng
Dementia is mainly realized by following mechanism: the content of acetylcholine, promotion brain protein and core in raising brain
The synthesis of acid, improve hippocampus neuronal function, antagonism calcium overload, promote cranial nerve cell growth etc..
Ginkgo leaf, property is sweet, bitter, puckery, flat, and the thoughts of returning home, lung channel have promoting blood circulation and removing blood stasis, remove obstruction in channels to relieve pain, hold back
Lung is relievingd asthma, relieving diarrhea with astringents, changes the effect of turbid lipopenicillinase.Its main component GINKGO BILOBA EXTRACT, has expansion crown dynamic
Arteries and veins, improve CF, allevating angina pectoris, reducing blood lipid, lipid peroxidation inhibition, promotion brain blood flow and improvement
Brain metabolism etc. act on.Modern times are widely used in treatment high fat of blood, hypertension, coronary heart diseases and angina pectoris, the cerebrovascular
Spasm, elderly cerebral dysfunction, brain injury sequela and apoplexy sequelae etc..Phase late 1980s,
Moral, Fa Deng state develop the various preparation of ginkgo biloba p.e in succession, and with its medicine of modern pharmacology technique study
Reason effect, finds various active material, such as: Gingko yellow ketoside, ginkgolides and Bilobalide etc..Wherein
Gingko yellow ketoside has expansion of cerebral vascular, reduces cerebral vascular resistance, minimizing capillary permeability, increase brain
Vascular flow, effect of scavenging radical.Ginkgolides is platelet-activating factor antagonist, can reduce blood and stick
Spend, improve blood flowing characteristic.Ginkgo biloba p.e is obviously improved the symptom of senile dementia, delays senility
Process, removes free radical, the cytotoxicity of suppression amyloid-beta, improves nerve cell degenerative lesion,
Treatment delays senile dementia, cognitive disorder, memory disorders, aphasis, disorientation, the disturbance of emotion etc.
Symptom has significantly effect.
Phosphatidylserine is described as " the intelligence battalion that after choline and " docosapentaenoic acid " DHA is the most emerging
Support element ", it is the active material of cell membrane, is particularly present in brain cell.Have and improve nerve cell merit
Can, the conduction of regulation nerve impulse, promote brain memory function, owing to it has good lipophilicity, inhale
Blood-brain barrier can be run through after receipts and enter brain, play VSMC of releiving, increase brain blood supply
Effect.With advancing age, brain phosphatidylserine and other important chemical substances can be gradually for people
Reduce, thus cause memory, cognitive power to weaken.The appropriate phosphatidylserine that supplements can increase brain bur number
Glucose metabolism in mesh, the mobility of brain cell membrane and promotion brain cell, so that brain cell is more active, promotees
Enter notice to concentrate, stepping up vigilance property and memory.
Rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal are and can be used as health care food through health ministry approval
The raw material of product.Phosphatidylserine is the new resource food of health ministry approval in 2010.Said composition from
Traditional Chinese medical science conditioning and doctor trained in Western medicine nutritional point, multi-level too many levels multipath conditioning and treating Alzheimer disease, effect
Clearly, effective and safe has no side effect.
As a preferred embodiment, the described ginseng contained by above-mentioned preventing and treating Alzheimer disease Chinese medicine composition
30~90 parts, rhizoma Gastrodiae 30~100 parts, ginkgo leaf 60~120 parts, polygala root 30~100 parts, galangal 30~
60 parts, phosphatidylserine 2~8 parts.
In a particular embodiment, the described ginseng 20 contained by above-mentioned preventing and treating Alzheimer disease Chinese medicine composition
Part, 60 parts of rhizoma Gastrodiae, ginkgo leaf 60 parts, polygala root 40 parts, galangal 30 parts, phosphatidylserine 6
Part.
Above-mentioned prescription is by optimizing the compatibility content of each medicinal material component so that each component plays monarch effect,
The compatibility balance of prescription further so that embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition has
The effects such as tonifying liver supports marrow, and dredging collateral reduces phlegm, brain healthy, clinic can significantly improve memory and mild cognitive function
Obstacle, thus improve embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition drug effect.It addition, each medicine
It is conventional that material is the Chinese medicine of integration of drinking and medicinal herbs, safety non-toxic, health food and food, therefore has no side effect.
It addition, the extract in the various embodiments described above can be can by the corresponding Chinese medicine employing medicine in prescription
The solvent accepted carries out extraction process acquisition.In a preferred embodiment, this extraction process is to be boiled by described solvent
Extraction process under the conditions of boiling or heat boiling, can also use other acceptable extracting method certainly.
In a particular embodiment, under the conditions of solvent boils or heat is seethed with excitement, the time of extraction process is 0.5-2.0h.
In another specific embodiment, the gross weight of described Chinese medicine is 1:(6-15 with the weight ratio of described solvent);
Further, the time of described immersion treatment is 0-1.0h.By the control to process conditions, right to realize
Extract medicine effect composition and the control of content, to give the preventing and treating Alzheimer that the embodiment of the present invention provides
The clinical drug effect that sick Chinese medicine composition is good.
Another further aspect, on the basis of the invention described above embodiment, the embodiment of the present invention provides mentioned above anti-
Control following several preparation methods of Alzheimer disease Chinese medicine composition.
In one embodiment, the embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition preparation method include as
Lower step:
Step S01: the embodiment of the present invention as described above prevents and treats Alzheimer disease Chinese medicine composition institute
The ginseng, phosphatidylserine and the described traditional Chinese medicinal components that contain weigh each tcm components material;
Step S02: the described Chinese medicine weighed in step S01 is carried out after pulverization process with described phosphatidyl
Serine component carries out mixing treatment.
Wherein, component contained by Alzheimer disease Chinese medicine composition and each group are prevented and treated described in above-mentioned steps S01
Divide content as described above, in order to save length, do not repeat them here.
Pulverization process in above-mentioned steps S02 can according to field of Chinese medicines conventional method pulverization process, as according to
The requirement of powder carries out pulverization process, and in a particular embodiment, the mixture after pulverizing crosses 60~100 mesh sieves.
In another embodiment, embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition preparation method includes
Following steps:
Step S03: the embodiment of the present invention as described above prevents and treats Alzheimer disease Chinese medicine composition institute
The ginseng, phosphatidylserine and the described traditional Chinese medicinal components that contain weigh each tcm components material;
Step S04: use medicine can accept the rhizoma Gastrodiae weighed, ginkgo leaf, polygala root, galangal Chinese medicine
Solvent immersion treatment after carry out extraction process, collect extract;By described extract concentration, it is dried
After process, the ginseng with phosphatidylserine and crushed process carries out mixing treatment.
Wherein, above-mentioned steps S03 is as described in above-mentioned steps S01, in order to save length, at this no longer
Repeat.
In above-mentioned steps S04, medicine is used to can accept rhizoma Gastrodiae, ginkgo leaf, polygala root, galangal Chinese medicine
Solvent immersion treatment make Chinese medicine material infiltration so that steaming effective efficiency composition therein, and shorten steaming
Evaporate the time of process, thus improve efficiency.Distillation process is directly carried out after immersion treatment.
In one embodiment, in this step S04 by the rhizoma Gastrodiae weighed, ginkgo leaf, polygala root, galangal
Medicinal material uses in the step of pharmaceutically acceptable solvent immersion treatment, described rhizoma Gastrodiae, ginkgo leaf, polygala root, height
Galingal Chinese medicine gross weight is 1:(6-15 with the weight ratio of described solvent);Or in a further embodiment,
The time of described immersion treatment is 0-1.0h.By prescription component and the consumption of solvent and the control of soak time,
To improve extracted amount and extraction rate.In a particular embodiment, this immersion treatment is to soak under enclosed environment
Bubble processes.
In one embodiment, the extraction process of this step S04 is to be heat-treated solvent mixture, as added
Heat makes solvent boiling carry out extraction process.In a further embodiment, the time of solvent boiling extraction process
Control as 0.5-2.0h.Wherein, this extraction process can at least be carried out once.
Therefore, in a particular embodiment, in this step S04 by the rhizoma Gastrodiae weighed, ginkgo leaf, polygala root,
It is by rhizoma Gastrodiae, ginkgo that galangal Chinese medicine carries out extraction process after using pharmaceutically acceptable solvent immersion treatment
Leaf, polygala root, galangal Chinese medicine add in described solvent, and under enclosed environment, after immersion treatment, ebuillition of heated carries
Take 0.5-2.0h, filter;The filter residue described solvent of addition carries out ebuillition of heated second extraction 0.5-2.0h.Wherein,
The weight ratio of described rhizoma Gastrodiae, ginkgo leaf, polygala root, galangal Chinese medicine gross weight and described solvent be but not only
It is only 1:(6-15);The time of described immersion treatment is but not just for 0-1.0h;Filter residue adds described molten
Matchmaker is but not only with described rhizoma Gastrodiae, ginkgo leaf, polygala root, galangal Chinese medicine gross weight and described solvent
Weight ratio be 1:(5-10) ratio described filter residue is added in described solvent.
In the various embodiments described above, the described solvent in this step S04 is water or ethanol water.Select such solvent
Can not only effectively extract the active ingredient of efficacy of drugs, moreover it is possible to make the extract safety extracted, low cost.
In above-mentioned steps S04, concentration is to extract solvent partly or completely to remove.Real one
Executing in example, the temperature of described concentration controls as 50-99 DEG C.The concentration of this temperature, is possible not only to
Avoid effective ingredient destroyed or volatilize and cause drug effect to reduce, moreover it is possible to effectively removing partly or entirely
Solvent.Concentration preferably use reduced pressure concentration on the one hand it can be avoided that high temperature and cause partial function to become
Divide and be decomposed and lost efficacy, on the other hand can effectively accelerate the volatilization of moisture, shorten the time of concentration.
In this step S04, above-mentioned dry process can be destroyed in the active ingredient not destroying extraction or
The drying mode that on the premise of volatilization, this area is conventional.In described in one, this is dried and is processed as at spray drying
Reason;Wherein, the vapo(u)rizing temperature of described spray drying treatment is: 150-210 DEG C, and outlet temperature is 60-99 DEG C.
In this step S04, the ginseng of crushed process be by size-reduced process after ginseng cross 60~200 mesh
Sieve.
Mixing treatment in this step S04 is so that each component mixes, and therefore, its mixing treatment is permissible
It is that by the mixing treatment mode that this area of this purpose is conventional.
In another embodiment, embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition preparation method includes
Following steps:
Step S05: the embodiment of the present invention as described above prevents and treats Alzheimer disease Chinese medicine composition institute
The ginseng, phosphatidylserine and the described traditional Chinese medicinal components that contain weigh each tcm components material;
Step S06: carry out the described Chinese medicine weighed using pharmaceutically acceptable solvent immersion treatment laggard
Row extraction process, collects extract;By described extract concentration, be dried process after with phosphatidyl silk ammonia
Acid carries out mixing treatment.
Wherein, above-mentioned steps S05 is as described in above-mentioned steps S01, in order to save length, at this no longer
Repeat.
Immersion treatment, extraction process and extract concentration and dry process in above-mentioned steps S06 are equal
Immersion treatment, extraction process and extract concentration as described in above step S06 and dry place
Reason, in order to save length, does not repeats them here.
Therefore, each component is pressed by the preparation method of embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition
Process according to fixing step, thus ensure that the quality of composition so that effective component extracting content is steady
Fixed so as to get preventing and treating Alzheimer disease Chinese medicine composition efficacy stability, safety non-toxic, quality controllable.
Low cost, commercial viability is good.
Another further aspect, the embodiment of the present invention prevents and treats Alzheimer disease Chinese medicine composition and preparation side thereof above
On the basis of method, additionally provide a kind of medicine preventing and treating Alzheimer disease or health food.In an embodiment
In, medicine or the health food of embodiment of the present invention preventing and treating Alzheimer disease include pharmaceutically acceptable auxiliary material,
Also include effective dose embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition mentioned above or by
Prepared by embodiment of the present invention preventing and treating Alzheimer disease Chinese medicine composition preparation method mentioned above preventing and treating Ah
Alzheimer's disease Chinese medicine composition.
Wherein, the effective dose of this preventing and treating Alzheimer disease Chinese medicine composition refers to therapeutically effective amount, refers to
Be enough to individuality display benefit or the amount of the compound of the present invention of clinical meaning.Those skilled in the art will
Understanding, the actual amount of administration or dosage and administration time-histories will depend upon which that the character of treated disease is with serious
Property, the age of treated experimenter and general status and administering mode etc..
In one embodiment, the embodiment of the present invention is prevented and treated contained by medicine or the health food of Alzheimer disease
Pharmaceutically acceptable auxiliary material refers to well known by persons skilled in the art be suitable for any auxiliary of specific mode of administration
Material.As in a particular embodiment, this pharmaceutically acceptable auxiliary material can include can preventing and treating with the embodiment of the present invention
One or more pharmaceutically acceptable carrier, solvent, figurations of Alzheimer disease Chinese medicine composition compatibility
Agent, buffer, stabilizer, adjuvant, prodrug and treatment can benefit from preventing and treating Alzheimer disease or enhancing
The other therapeutic agents of above-mentioned preventing and treating Alzheimer disease Chinese medicine composition activity.
It should be appreciated that above-mentioned each auxiliary material should be nontoxic, do not disturb or do not damage the embodiment of the present invention
The effect of above-mentioned preventing and treating Alzheimer disease Chinese medicine composition.It addition, can be according to above-mentioned selected by this auxiliary material
The embodiment preventing and treating medicine of Alzheimer disease or the existence formulation of health food and select flexibly.
It addition, the medicine of above-mentioned preventing and treating Alzheimer disease or health food can be individually dosed, it is also possible to
Other composition administering drug combinations if necessary.
In one embodiment, according to medicine or the health care food of the invention described above embodiment preventing and treating Alzheimer disease
The mode of administration of product, can select pharmaceutically acceptable auxiliary material to prevent and treat Alzheimer disease with effective dose flexibly
Chinese medicine composition is prepared as different dosage form, such as mixture, oral liquid, capsule, tablet, pill, powder,
Arbitrary formulation in pulvis or granule.
Therefore, the embodiment of the present invention preventing and treating medicine of Alzheimer disease or health products are due to containing effective dose
Preventing and treating Alzheimer disease Chinese medicine composition mentioned above, therefore, the embodiment of the present invention preventing and treating A Erci
Extra large silent sick medicine or health products have significantly preventing and treating Alzheimer disease drug effect, and the nontoxic pair of long-term taking is made
With, clinical compliance is good.
Below by way of preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof specific embodiment to the present invention
It is described further.
Embodiment 1
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 50 parts of rhizoma Gastrodiae, ginseng 170 parts, ginkgo leaf 120 parts, polygala root
60 parts, galangal 30 parts, phosphatidylserine 6 parts.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S11: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
60 mesh sieves individually pulverized by S12: ginseng, and Ginseng Root Powder is standby;Remaining Chinese medicine mixes, extracting in water two
Secondary, add 12 times amount water for the first time, boil extraction 1.5 hours, second time adds 8 times amount water, boils extraction 1 hour,
Merge twice extract;
S13: extract is filtered, is evaporated to relative density about 1.10;Being spray-dried, spray powder adds
Phosphatidylserine, Ginseng Root Powder, obtain preventing and treating Alzheimer disease Chinese medicine composition.
Embodiment 2
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 150 parts of rhizoma Gastrodiae, ginseng 60 parts, ginkgo leaf 40 parts,
Polygala root 20 parts, galangal 60 parts, phosphatidylserine 10 parts.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S21: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
The mixing of S22: Chinese medicine is put 70% alcohol reflux and is extracted, and adds 12 times amount 70% ethanol for the first time, extracts 1.5
Hour, second time adds 8 times amount 70% ethanol, extracts 1 hour, merges twice extract;
S23: reduced pressure concentration extract, drying under reduced pressure, dry extract is pulverized;Add phosphatidylserine.
Embodiment 3
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 10 parts of rhizoma Gastrodiae, ginseng 180 parts, ginkgo leaf 240 parts, far
Will 100 parts, galangal 20 parts, phosphatidylserine 1 part.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S31: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
200 mesh sieves individually pulverized by S31: ginseng, and Ginseng Root Powder is standby;Residue Chinese medicine is mixed, adds water
Extracting secondary, add 15 times amount water for the first time, boil extraction 2.0 hours, second time adds 10 times amount water, boils
Boiling is extracted 1.5 hours, merges twice extract;
S33: concentrated extracting solution, drying under reduced pressure, dry extract is pulverized, and adds ginseng fine powder, phosphatidylserine
Carry out mixing treatment.
Embodiment 4
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 60 parts of rhizoma Gastrodiae, ginseng 20 parts, ginkgo leaf 60 parts, polygala root
40 parts, galangal 30 parts, phosphatidylserine 6 parts.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S41: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
80 mesh sieves individually pulverized by S42: ginseng, and Ginseng Root Powder is standby;Remaining Chinese medicine mixes, and adds water and carries
Taking secondary, add 10 times amount water for the first time, boil extraction 1.5 hours, second time adds 8 times amount water, boils and carry
Take 1.0 hours, merge twice extract;
S43: extract concentrates, and is spray-dried;Spray powder adds phosphatidylserine, Ginseng Root Powder mixes
Material processes.
Embodiment 5
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 140 parts of rhizoma Gastrodiae, ginseng 10 parts, ginkgo leaf 30 parts, far
Will 80 parts, galangal 60 parts, phosphatidylserine 7 parts.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S51: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
S51: Chinese medicine mixing and water adding extracts secondary, adds 12 times amount water for the first time, boils extraction 2.0 hours,
Second time adds 8 times amount water, boils extraction 1.0 hours, merges twice extract;
S53: extract concentrates, and is spray-dried;Add phosphatidylserine mixing.
Embodiment 6
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 30 parts of rhizoma Gastrodiae, ginseng 10 parts, ginkgo leaf 40 parts, polygala root
40 parts, galangal 40 parts, phosphatidylserine 12 parts.
The present embodiment preventing and treating Alzheimer disease Chinese medicine composition preparation method:
S61: take rhizoma Gastrodiae, ginseng, ginkgo leaf, polygala root, galangal, phosphatidyl serine by metering ratio;
80 mesh sieves pulverized by S62: Chinese medicine;Add phosphatidylserine, mixing, obtain powder finished product.
Embodiment 7
The present embodiment provides one preventing and treating Alzheimer disease Chinese medicine composition and preparation method thereof.This preventing and treating Ah
The prescription of Alzheimer's disease Chinese medicine composition contains 180 parts of rhizoma Gastrodiae, ginseng 70 parts, ginkgo leaf 70 parts,
Polygala root 200 parts, galangal 60 parts, phosphatidylserine 3 parts.
Clinical testing
1. test unit
Gerontological Research Center institute of Shenzhen.
2. experiment purpose
Research present composition prevention and treatment Alzheimer disease, the function of improvement memory.
3. experiment material
Sample 1 by Shenzhen's Gerontological Research Center provided (prepare gained Chinese medicine composition by embodiment 4,
Add auxiliary material and be prepared as tablet), outward appearance is brown sheet, and human oral's recommended amounts is 0.8g/ sheet, each 3,
Three times a day, calculate with everyone 60kg body weight, equivalent dosage 0.12g/kg.bw.
Chinese medicine composition is provided by Shenzhen's Gerontological Research Center and (fills a prescription by embodiment 4, deduct phosphatide
Acyl serine, remaining prepares gained by embodiment 4), outward appearance is brown sheet, and human oral's recommended amounts is 0.75g/
Sheet, each 3, three times a day, calculates with everyone 60kg body weight, equivalent dosage 0.11g/kg.bw.
Phosphatidylserine is provided by bio tech ltd of AOC, Shaanxi, and human oral's recommended amounts is
600mg/ days, calculate with people's 60kg body weight, equivalent dosage 10mg/kg.bw.
Huperzine-A Tablets, Tests for Uniformity is provided by Simcere Pharmaceutical Co., Ltd., 0.05mg/ sheet, one time 4,2 times on the one,
Calculate with everyone 60kg body weight, equivalent dosage 0.007mg/kg.bw.
4. experimental technique
4.1 dosage are arranged
Each sample dosage arranges and is shown in Table 1.Each dosage group sample is through dissolved dilution and is settled to suitable gavage volume.
Table 1 is by body weight conversion dosage
4.2 test method
4.2.1 learning and memory behavior animal experiment
Animal adaptability starts experiment packet after raising 3d observes.Experiment point memory acquisition disturbance model and memory
Reproduce Disorder Model two batches, the every batch of animal for research 80, mouse is randomly divided into Normal group, model
Control group, sample 1 high, medium and low dosage group, Chinese medicine composition group, phosphatidylserine group, huperzine
First group, often group 10, gives corresponding preparations gavage, every day 1 time, continuous 7d according to packet situation.
4.2.1.1 the preparation of memory acquisition disturbance model and test hyoscine (3mg/kg, ip) are prepared memory and are obtained
Obtain Disorder Model.Animal used as test gives corresponding tested material 30d continuously by packet situation, and 30d gives tested
After thing 30min, model control group, sample 1 high, medium and low dosage group, Chinese medicine composition group, phosphatidyl
Serine group, huperzine group all carry out lumbar injection with hyoscine (3mg/kg), start after 10min
Step dow n test is trained.After 31d is to tested material 30min, test Memory result with step dow n test.
4.2.1.2 the preparation of reproducibility dysmnesia model and group experiment 40% ethanol (0.1mL/10g, ig) preparation note
Recall reproduction Disorder Model.Animal used as test gives corresponding tested material 30d continuously by packet situation, and 30d gives
After reagent 30min, carry out darkness avoidance test training.After 31d is to tested material 30min, model control group,
Sample 1 high, medium and low dosage group, Chinese medicine composition group, phosphatidylserine group, huperzine group are all used
The amount gavage of 40% ethanol 0.1mL/10g body weight, tests Memory result after 30min.
4.2.1.3 mouse is placed in diving tower instrument by step down test, after adapting to environment 5min, puts down gently on platform,
When animal jumps off four limbs contact copper grid from diving tower, i.e. giving 40V alternating voltage stimulates.Mouse is the most anti-
Should be that rebound platform is to hide noxious stimulation.Animal may jump off platform, after being shocked by electricity again or repeatedly
Rebound platform again.Jump off platform biped contact copper grid with mouse and be designated as errors number, so train 5min.24h
After carry out the test of Memory result.By on mouse horizontalization platform, record its incubation period resting on security platform
(SL) number of times (errors number) and shocked by electricity in 3min, if mouse rests on more than 3min on platform,
Its incubation period is in terms of 180s.
4.2.1.4 keep away 30min after dark test last is administered and train mouse, mouse face hole dorsad is put into bright
Room, starts timer.Animal is shocked by electricity through entrance darkroom, hole, clocks and is automatically stopped.Take out mouse,
Record mouse runs into the time needed for electric shock from putting into entrance darkroom, bright room, and this is incubation period.Recast after 24h
Test, the number of shocks recording incubation period and 5min that every animal enters darkroom (is introduced into darkroom in 5min
Person, incubation period is in terms of 300s).
4.2.2 related brain areas RNA and Nissl body quantitatively detect
4.2.2.1 section of drawing materials is administered observation and learning and memory detects after terminating, and often organizes and take at random in step-through test
Mouse 8,1% carbrital (40mg/Kg body weight, lumbar injection) open chest anesthetized, left ventricle master
Arterial cannulation ligatures, and physiological saline 50mL rinses, continuous with cold paraformaldehyde glutaraldehyde perfusion fixer filling
Note is fixing, takes brain and fixes 2h (4 DEG C) in perfusion liquid, then enters 20% sucrose cushion (0.1M, pH7.4)
Middle 24h (4 DEG C), AO freezing microtome hat serial section, thick 30 μm of sheet, section is collected in 0.1MPBS
In stand-by.
4.2.2.2 film-making is hatched
4.2.2.2.1RNA histochemical staining Elias method: section goes downwards to water;Enter dye liquor (0.5% methyl green
10mL adds croak promise peaceful Y 20mg) 37 DEG C of constant incubator 1h;0 DEG C-2 DEG C distillation washing 2min;Tertiary fourth
Alcohol is washed;Tert-butyl alcohol dehydration 2 times, 3min/ time;Dimethylbenzene transparent neutral natural gum mounting is (to photo Rnase
Liquid (8mg Rnase is dissolved in 10mL distilled water) 37 DEG C digestion 1h reenters dye liquor).
4.2.2.2.2Nissl body stained slice enters dimethylbenzene degreasing 2 times, each 3min, comes downwards to water;1%
37 DEG C of 10min of cresyl viollet dye liquor;70% ethanol 3 times, 1min/ time;95% ethanol 3 times, 1min/ time;Nothing
Water-ethanol 3 times, 1min/ time;Transparent 2 times of dimethylbenzene, 5min/ time;Neutral gum mounting.
The most quantitatively detection quantitative analysis uses LM ZEISS Axiotron research microscope, JVC
KY-F30B3-CCD Variocam freezing photorecorder and Kontron IBAS 2.0 automatic image andlysing system.
Cerebral cortex measured zone selects the layer III i.e. external pyramidal layer of cortex of temporal lobe, and hippocampus measures CA1 district
Cones, the respectively optical density of RNA and Nissl body cell chemical reactant in detection unit are, with
The OD value subtracting background OD of positive reaction thing is worth to the OD value (COD) of correction, i.e. product
The each index of the every example of actual light density randomly draws section 3, cuts into slices in measuring region random measurement 3 for every
The visual field, all measurements complete under same optical condition.
4.3 test data statistics
Data means standard deviation (mean ± SD) represents, uses SPSS17.0 software statistics, between each group
Comparison independent samples t-test, has significant difference when between P < 0.05, then explanation group.
5. experimental result
The impact on model mice learning and memory behavior of 5.1 compositions
5.1.1 composition is on mouse step down test incubation period, the impact of errors number
From table 2, comparing with model group, the mouse diving tower of each administration group all has a certain degree of incubation period
Extending, errors number reduces, wherein, and sample 1 dosage group high, middle, Chinese medicine composition group and huperzine
The incubation period of first group and errors number and model group ratio, difference has statistical significance (P < 0.05).Result table
Bright, composition, Chinese medicine composition and huperzine have significant facilitation to the acquisition of memory.
Reciprocation character is analyzed, to dosage group, Chinese medicine composition group and phosphatidylserine group in sample 1
Being analyzed, Chinese medicine composition uses with phosphatidyl serine compatibility, and effect is better than both and is used alone, and
There is the effect (E of Synergistic in bothDosage group in sample 1>EChinese medicine composition+EPhosphatidylserine)。
Table 2 composition on the impact of mouse step down test incubation period and errors number (N=10)
(memory acquisition disturbance model)
Note: compare with normal group, * P < 0.05;Compare with model group, #P < 0.05
5.1.2 mouse is kept away the impact secretly testing incubation period, errors number by composition
From table 3, comparing with model group, the mouse of each administration group is kept away all to be had a certain degree of dark incubation period
Extending, errors number reduces.Wherein, sample 1 high, medium and low dosage group, Chinese medicine composition group, phosphide
The incubation period of acyl serine group and huperzine group and model group ratio, difference has statistical significance
(P<0.05);Sample dosage group high, middle, Chinese medicine composition group and the errors number of huperzine group and mould
Type group ratio, difference has statistical significance (P < 0.05).Result shows, composition, Chinese medicine composition, phosphorus
Ester acyl serine and huperzine have significant facilitation to the reproducing processes of memory.
Reciprocation character is analyzed, to dosage group, Chinese medicine composition group and phosphatidylserine group in sample 1
Being analyzed, Chinese medicine composition and phosphatidyl serine compatibility use, and extend and keep away effect in dark incubation period and be better than two
Person is used alone, and both exist the effect (E of SynergisticDosage group in sample 1>EChinese medicine composition+EPhosphatidylserine)。
Table 3 composition mouse is kept away dark test incubation period and errors number impact (N=10)
(reproducibility dysmnesia model)
Note: compare with normal group, * P < 0.05;Compare with model group, #P < 0.05
5.2 compositions are to model mice related brain areas RNA and Nissl body qualitative, quantitative
From table 4 result, in normal mice neuron especially cortex and hippocampal pyramidal neurons RNA and
Nissl body burden is the abundantest, shows that its related Neurons cell metabolism is vigorous, model group RNA and Nissl
Body burden significantly reduces, and shows that its cell metabolism exists obstacle, and sample 1 each dosage group all can be to some extent
Improve model mouse cortex of temporal lobe and hippocampal pyramidal cell RNA and the content of Nissl body, show said composition energy
Significantly improve senile dementia mouse nucleic acid metabolism and protein anabolism, and improve with this and regulate and control whole nerve
The metabolism of unit, plays prevention and the effect for the treatment of Alzheimer disease.
Table 4 composition is to model mouse cortex of temporal lobe is outer and Hippocampal CA 1 cones RNA, Nissl body contains
Amount impact (N=8)
Note: compare with normal group, * P < 0.05;Compare with model group, ##P < 0.01, #P < 0.05
From above-mentioned experimental result, research finds in the preventing and treating Alzheimer disease that the embodiment of the present invention provides
Drug composition can improve Spatial learning ability and the space exploration ability of Alzheimer disease kunming mice, increases
RNA and the Nissl body burden of high cerebral cortex and hippocampal pyramidal cell, and its effect presents certain
Dose-effect relationship, improves brain nucleic acid metabolism and protein anabolism, promotion regulation cerebral cortex and hippocampus
RNA metabolism, improves and regulates and controls the metabolism of whole neuron and the neuron knot in learning and memory key brain district
Structure, plays prevention and the effect for the treatment of Alzheimer disease.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all at this
Any amendment, equivalent and the improvement etc. made within bright spirit and principle, should be included in the present invention
Protection domain within.