CN108403881A - A kind of pharmaceutical composition for treating senile dementia and preparation method thereof and purposes - Google Patents
A kind of pharmaceutical composition for treating senile dementia and preparation method thereof and purposes Download PDFInfo
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Abstract
The present invention provides a kind of pharmaceutical composition for treating senile dementia, the bulk pharmaceutical chemicals that it is matched by following weight are prepared：6~100 parts of grass-leaved sweetflag, 4~80 parts of Radix Polygalae, 4~80 parts of the coptis.The present invention also provides the preparation methods of aforementioned pharmaceutical compositions.The present invention also provides aforementioned pharmaceutical compositions prepare treatment and alleviate senile dementia, vascular dementia, cognition dysfunction disease drug in purposes.The effect of medicine composite for curing senile dementia of the present invention, intelligence development, anti-aging and antifatigue effect are worked as with Radix Polygalae dephasing, and effect for reducing blood fat is dissipated better than Radix Polygalae.It is dissipated compared to Radix Polygalae, the synergistic function between pharmaceutical composition drug of the invention is more obvious, has reduced the number of drug prescription, while also saving the use total amount of bulk pharmaceutical chemicals.
Description
Technical field
The present invention relates to a kind of pharmaceutical compositions and its preparation method and application.
Background technology
Senile dementia is also known as Alzheimer disease (AD), is a kind of nervous system regression of the progress sexual development of onset concealment
Property disease, be clinically mainly shown as cognition dysfunction, activity of daily living decline and mental symptom, be that senile dementia is normal
The type seen.In recent years, with the aging of countries in the world population, the incidence of senile dementia is in steeply rise trend,
The death rate occupies the 4th, is only second to heart disease, tumour and apoplexy.According to statistics, there are about 6,000,000 trouble in China 60 years old or more population
There are senile dementia, illness rate about 5%, and increases with the age and increase.Modern research shows that intracerebral cholinergic system is recognized in adjusting
In terms of knowing function, especially played an important role during learning and memory, " central nervous system cholinergic dysfunction "
It is one of the morbidity hypothesis of AD classics.As neurotransmitter important in animal brain, acetylcholine (Acetylcholine, Ach)
It is played an important role in terms of maintaining learning and memory ability.Acetylcholinesterase (AchE) is the specific hydrolase enzyme of Ach,
It is mainly distributed on hippocampus, top and occipital lobe.Research shows that the Ach secretions of AD patient's intracerebral are reduced, AchE can be used as assessing cholinergic
The marker of damage.Doneppezil Hydrochloride is a kind of AchE inhibitor, can inhibit the degradation of intracerebral Ach, increases local acetyl courage
Alkali concentration, so as to improve the cognitive function and activity of daily living of AD patient
Senile dementia belongs to the scopes such as traditional Chinese medicine " dementia ", " dementia ", " happiness is forgotten ", Chinese medicine think its interpretation of the cause, onset and process of an illness nothing more than empty and
Real two ends mostly cause insufficiency of vital energy and blood, biochemistry passive due to body deficiency due to old age, inernal injuries caused by seven emotions, prolonged illness consumption wound etc., and brains, which lose, supports；
Or spleen fortune loses strong, the turbid interior life of phlegm, blinds clear key；Or phlegm wet accumulate long, it is strongly fragrant and change heat, mental activity disturbed by heat.Healthy tendency virtual loss is AD
Basic reason, the turbid illiteracy key of phlegm is its important pathology link, and heat disturbs the key factor that the mind is aggravation, therefore QI invigorating is had one's ideas straightened out clearly
The heart is the basic principle for treating AD.Radix Polygalae, which dissipates, is《General Records of Holy Universal Relief》It rolls up and treats forgetful classic prescriptions in one eight six, by Radix Polygalae, people
There is QI invigorating to have one's ideas straightened out the effect of clearing away heart-fire for ginseng, Poria cocos, grass-leaved sweetflag, coptis five tastes drug composition, full side, and AD diseases of hitting occur and hair
The deficiency of vital energy makes the crucial interpretation of the cause, onset and process of an illness that phlegm, stagnation of phlegm converting into fire, fire disturb the mind in exhibition, is the effective prescription for treating AD.
However, by the study found that Radix Polygalae dissipates, prescription compatibility of medicines is more complex, and the synergistic function unobvious between drug are held
The waste of medicine material is easily caused, and the reducing blood lipid that Radix Polygalae dissipates is also bad.
Invention content
To solve the above problems, present invention optimizes Radix Polygalaes to dissipate prescription drug compatibility, provides and a kind for the treatment of senile dementia
Pharmaceutical composition.
The pharmaceutical composition of the treatment senile dementia of the present invention, it is characterised in that：The bulk pharmaceutical chemicals that it is matched by following weight
It is prepared：
6~100 parts of grass-leaved sweetflag, 4~80 parts of Radix Polygalae, 4~80 parts of the coptis.
Further, it is the preparation that the bulk pharmaceutical chemicals matched by following weight are prepared into：
6~100 parts of grass-leaved sweetflag, 4~80 parts of Radix Polygalae, 4~80 parts of the coptis.
Further, it is the preparation that the bulk pharmaceutical chemicals matched by following weight are prepared into：
10~50 parts of grass-leaved sweetflag, 8~40 parts of Radix Polygalae, 4~40 parts of the coptis.
Further, it is the preparation that the bulk pharmaceutical chemicals matched by following weight are prepared into：
15~30 parts of grass-leaved sweetflag, 10~20 parts of Radix Polygalae, 6~15 parts of the coptis.
Further, it is the preparation that the bulk pharmaceutical chemicals matched by following weight are prepared into：
20 parts of grass-leaved sweetflag, 14 parts of Radix Polygalae, 6 parts of the coptis.
Wherein, it is activity that aforementioned pharmaceutical compositions, which are by the medicinal powder of bulk pharmaceutical chemicals, the water of bulk pharmaceutical chemicals or extractive with organic solvent,
Ingredient, in addition the preparation that acceptable auxiliary material or complementary ingredient are prepared in pharmacy.
Pharmaceutically acceptable auxiliary material of the present invention refers in addition to the active ingredient (s comprising substance in the formulation, packet
Include but be not limited only to filler (diluent), lubricant (glidant or antitack agent), dispersant, wetting agent, adhesive, adjusting
Agent, solubilizer, antioxidant, bacteriostatic agent, emulsifier, disintegrant etc..Adhesive include syrup, Arabic gum, gelatin, sorbierite,
Tragacanth, cellulose and its derivates (such as microcrystalline cellulose, sodium carboxymethylcellulose, ethyl cellulose or hydroxypropyl methylcellulose
Element etc.), gelatine size, syrup, starch slurry or polyvinylpyrrolidone etc.；Filler include lactose, Icing Sugar, dextrin, starch and its
Derivative, cellulose and its derivates, inorganic calcium salt (such as calcium sulfate, calcium phosphate, calcium monohydrogen phosphate, precipitated calcium carbonate), sorb
Alcohol or glycine etc.；Lubricant includes superfine silica gel powder, magnesium stearate, talcum powder, aluminium hydroxide, boric acid, hydrogenated vegetable oil, poly- second
Glycol etc.；Disintegrant includes starch and its derivative (such as sodium carboxymethyl starch, Explotab, pregelatinized starch, improvement shallow lake
Powder, hydroxypropul starch, cornstarch etc.), polyvinylpyrrolidone or microcrystalline cellulose etc.；Wetting agent includes dodecyl sulphate
Sodium, water or alcohol etc.；Antioxidant packages are containing sodium sulfite, sodium hydrogensulfite, sodium pyrosulfite, dibutyl benzoic acid etc.；Bacteriostatic agent includes
0.5% phenol, 0.3% cresols, 0.5% anesin etc.；Conditioning agent includes hydrochloric acid, citric acid, potassium hydroxide (sodium), citron
Sour sodium and buffer (including sodium dihydrogen phosphate and disodium hydrogen phosphate) etc.；Emulsifier includes Tween-80, aliphatic acid sorb
Smooth, pluronic gram F-68, lecithin, Fabaceous Lecithin etc.；Solubilizer includes Tween-80, bile, glycerine etc..
The pharmaceutically acceptable complementary ingredient, it has certain physiological activity, but the addition of the ingredient will not change
Become leading position of the said medicine in treatment of diseases, and only play auxiliary effect, these auxiliary effects are only pair
The utilization of the ingredient known activity is the usual adjuvant treatment modality of field of medicaments.If by above-mentioned complementary ingredient and the present invention
Compound is used cooperatively, and still should belong to the scope of protection of the invention.
Further, the preparation is oral preparation and/or parenteral drug-delivery preparation；Preferably, the oral preparation is soup
Agent, powder, capsule, tablet, granule, pill, oral solution.
Further, the preparation is decoction, powder, capsule, tablet, granule, pill, oral solution；It is described parenteral
Drug-delivery preparation includes freeze drying powder injection and injection.
The present invention also provides the preparation methods of aforementioned pharmaceutical compositions, it is characterised in that：It includes the following steps：
1) weigh each raw material by weight ratio, beat powder, add water to cook or organic solvent extraction；
2) medicinal powder, water or extractive with organic solvent of bulk pharmaceutical chemicals are taken, and in pharmacy acceptable auxiliary material or it is complementary at
Divide and is prepared into preparation.
Water extract is used as medicine with medicinal powder, is Chinese medicine tradition occupation mode, after water carries, since the soluble end of water is wide, and energy
It is enough to dissolve out most of active ingredient, make drug be easier to be absorbed by the body, drug effect plays faster, such as shape is administered in decoction etc.
Formula；Be used as medicine with original powder, the surface area of medicinal powder is larger, is also beneficial to the absorption of active ingredient in vivo in medicinal material, but medicinal material without
Extraction, active ingredient still need to dissolve out re-absorption in vivo, and the opposite water extract of drug effect performance is slower, but also weakens medicinal material simultaneously
Middle harmful components toxicity caused by human body is suitable for taking for a long time, such as original powder is prepared into pill form of medication.At present
In pharmacy procedure, drug is extracted with use ethanol as solvent and most commonly seen one of extracting mode, ethyl alcohol are
Semi-polarity solvent, solubility property circle can dissolve water-soluble certain ingredients, can also dissolve between polarity and nonpolar solvent
Some ingredients of nonpolar solvent are dissolved in, is usually extracted with ethyl alcohol and is carried instead of decocting to avoid the dissolution of a large amount of invalid components
The concentration and extraction efficiency of high active ingredient, but the price of ethyl alcohol is expensive compared with water, in the big production of modern pharmaceutical industry, in order to save
Production cost is saved, usually or based on decocting.In the case where the water extract of known compositions of the present invention has physiological activity,
Demand when in order to adapt to various productions and use, can optionally water carries, original powder, alcohol extracting or combination thereof method prepare tool
The dosage form of body.
The present invention also provides aforementioned pharmaceutical compositions to prepare treatment and improve senile dementia, vascular dementia, cognition
Purposes in the drug of dysfunction disease.
The present inventor dissipates prescription drug compatibility by optimizing Radix Polygalae, and obtain the present invention contains only grass-leaved sweetflag, Radix Polygalae and Huang
The even pharmaceutical composition of three taste medicines.The effect of medicine composite for curing senile dementia of the present invention, intelligence development, anti-aging and antifatigue
Effect work as with Radix Polygalae dephasing, effect for reducing blood fat better than Radix Polygalae dissipate.It is dissipated compared to Radix Polygalae, pharmaceutical composition drug of the invention
Synergistic function each other is more obvious, has reduced the number of drug prescription, while also saving the use total amount of bulk pharmaceutical chemicals.
Obviously, the above according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field
Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific implementation mode of form by the following examples remakes further specifically the above of the present invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on the above of the present invention
The technology realized all belongs to the scope of the present invention.
Specific implementation mode
The preparation of 1 pharmaceutical composition decoction of the present invention of embodiment
20 parts of grass-leaved sweetflag, 14 parts of Radix Polygalae, 6 parts of the coptis are taken, decoction is soaked, merges extracting solution, is filtered to get decoction.
The preparation of 2 medicinal composition tablets of the present invention of embodiment
6 parts of grass-leaved sweetflag, 4 parts of Radix Polygalae, 4 parts of the coptis are taken, extraction is added water to cook, extracting solution is condensed into medicinal extract, and starch, system is added
Grain, whole grain, tabletting is to get tablet.
The preparation of 3 medicament composition capsule agent of the present invention of embodiment
100 parts of grass-leaved sweetflag, 80 parts of Radix Polygalae, 80 parts of the coptis are taken, extraction is added water to cook, extracting solution is condensed into medicinal extract, is added auxiliary
Material, mixing, granulation dispense to get capsule.
The preparation of 4 drug composition oral liquid of the present invention of embodiment
10 parts of grass-leaved sweetflag, 8 parts of Radix Polygalae, 8 parts of the coptis are taken, decoction is soaked, merges extracting solution, concentration, embedding sterilizes,
Up to oral solution.
The preparation of 5 medicinal composition powders of the present invention of embodiment
50 parts of grass-leaved sweetflag, 40 parts of Radix Polygalae, 40 parts of the coptis are taken, powder is beaten, is sieved, is uniformly mixed to get powder.
The preparation of 6 medicament composition granule agent of the present invention of embodiment
15 parts of grass-leaved sweetflag, 10 parts of Radix Polygalae, 6 parts of the coptis are taken, extraction is added water to cook, extracting solution is condensed into medicinal extract, and auxiliary material is added,
Mixing is pelletized to get granule.
The preparation of the 7 pharmaceutical composition water-bindered pill of the present invention of embodiment
Take 30 parts of grass-leaved sweetflag, 20 parts of Radix Polygalae, 15 parts of the coptis, beat powder, be sieved, be added excipient, water pill, it is dry to get
The water-bindered pill.
The preparation of 8 pharmaceutical composition honeyed bolus of the present invention of embodiment
17 parts of grass-leaved sweetflag, 12 parts of Radix Polygalae, 6 parts of the coptis are taken, powder is beaten, is sieved, honey is added, pill is dry to get honeyed bolus.
Illustrate beneficial effects of the present invention below by way of experimental example：
1 pharmaceutical composition of the present invention of experimental example has anti-dementia effect
1 experiment material and source
1) drug
Aricept (donepezil hydrochloride tablet, 10mg/ pieces), Pharmaceutical Co., Ltd. of health material；
Radix Polygalae dissipates (Radix Polygalae：Poria cocos：Grass-leaved sweetflag：The coptis：Ginseng=4：5：6：4：3) it is attached, to be purchased from Chengdu University of Traditional Chinese Medicine
Chinese medicine pharmacy of hospital；
The present composition (grass-leaved sweetflag：Radix Polygalae：The coptis=20:14:6) it, is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ
Pharmacy.
2) animal
SD rats, male, are purchased from Chengdu and reach large bio tech ltd, animal life by SPF grades, weight (200 ± 20) g
Produce credit number：SCXK (river) 2015-030.Animal feeding is in Chengdu University of Traditional Chinese Medicine's TCM Zang-fu disease laboratory animal room.
3) main agents and instrument
A β 25-35 (Sigma companies)；Rat stereotaxic apparatus, WMT-100Morris water maze video analytic systems
(Chengdu TME Technology Co., Ltd.)；Electronic dental burr (Saeshin Precision Co.Ltd).
2 experimental methods
1) grouping, modeling and administration
After adaptability is raised 1 week, row rats with bilateral hippocampus locating injection.Through 10% chloraldurate intraperitoneal injection of anesthesia
Stereotaxic apparatus, reference are fixed on after (300mg/kg)《The Rat Brain》Determine injection coordinate (3.0mm after bregma, in
2.6mm under 1.8mm, skull surface by line).(blank group gives equivalent life for 2.5 sides μ L/ injection A β 25-35 after the drilling of dentistry bone drill
Manage brine), continue 5min per side injection, then let the acupuncture needle remain at a certain point 5min.After injection, intramuscular injection Benzylpenicillin sodium salt 80,000 U/d, continuous 3d.
Rat after modeling is randomly divided into 5 groups, every group 10, respectively：Blank group (normal control), model group, An Li
Shen group, Radix Polygalae dissipate group, present composition group.Blank group and model group gavage give physiological saline, and each treatment group is given accordingly
Medicine, administration volume be 10mL/kg, administration number of times be one time a day, Aricept group content of dispersion 0.1mg/m L, Radix Polygalae dissipate
The group L of 0.3g/m containing crude drug amount, the present composition group L of 0.2g/m containing crude drug amount continue 8 weeks.
2) Morris water maze laboratories
Therapy lasted 5d, preceding 3d are training period, and 4d is orientation navigation experiment, and 5d tests for space exploration.Platform is put
Be placed in first quartile center, rat respectively second, third, fourth quadrant went swimming, set the time of each quadrant as 120s,
System records rat by camera and finds half space required time (being denoted as escape latency),.If do not found platform, hide
Phase is recorded as 120s, and rat is guided to appear on the stage rest 15s.5d removes platform, records in animal 120s pass through original platform respectively
Area's number and effective district (2 times of ranges of platform diameter) interior residence time.
3 experimental results
1. orientation navigation experiment, compared with blank group, model group rats average escape latency significantly extends (P within the 4th day<
0.01)；Compared with model group, Aricept can be obviously shortened the escape latency (P of rat model<0.01)；Compared with model group,
Radix Polygalae, which dissipates group and the escape latency of present composition group model rat, shortening (P<0.05)；Radix Polygalae dissipates and of the present invention group
Object group comparison among groups no significant difference is closed, is shown in Table 1.
Influence of the table 1 to AD rat escape latencies
Note：Compared with blank group, * * P ﹤ 0.01；Compared with model group, #P ﹤ 0.05, ##P ﹤ 0.01.
2. space search is tested compared with blank group, model group rats pass through Yuanping City's taiwan area number and effective district residence time
Substantially reduce (P<0.01)；Compared with model group, Aricept group rat passes through original platform number and the effective district residence time is bright
It is aobvious to increase (P<0.01)；Radix Polygalae dissipates group and present composition group model rat passes through original platform number and effective district residence time
There is increase (P ＜ 0.05) compared with model group；Radix Polygalae dissipates and present composition comparison among groups no significant difference, is shown in Table 2.
Table 2 passes through AD rats the influence of original platform number and effective district residence time
Note：Compared with blank group, * * P ﹤ 0.01；Compared with model group, #P ﹤ 0.05, ##P ﹤ 0.01.
Above-mentioned experiment can be seen that：
Aricept group, Radix Polygalae dissipate group and present composition group items experimental result is significantly better than that model group, explanation：Far
Will dissipates and the present composition all has different degrees of anti-dementia effect, and the present composition is made with the anti-dementia that Radix Polygalae dissipates
With suitable.Explanation：It is dissipated compared to Radix Polygalae, the synergistic function between pharmaceutical composition drug of the invention is brighter
It is aobvious, drug prescription is reduced the number of, while also saving the use total amount of bulk pharmaceutical chemicals.
2 pharmaceutical composition of the present invention of experimental example has nootropic effect
1 experiment material and source
1) drug
Aricept (donepezil hydrochloride tablet, 10mg/ pieces), Pharmaceutical Co., Ltd. of health material；
Grass-leaved sweetflag and Radix Polygalae (grass-leaved sweetflag：Radix Polygalae=20:14), it is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ Chinese medicine pharmacy；
Radix Polygalae and the coptis (Radix Polygalae：The coptis=14:6), it is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ Chinese medicine pharmacy；
Grass-leaved sweetflag and the coptis (grass-leaved sweetflag：The coptis=20:6), it is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ Chinese medicine pharmacy；
Radix Polygalae dissipates (Radix Polygalae：Poria cocos：Grass-leaved sweetflag：The coptis：Ginseng=4：5：6：4：3) it is attached, to be purchased from Chengdu University of Traditional Chinese Medicine
Chinese medicine pharmacy of hospital；
The present composition (grass-leaved sweetflag：Radix Polygalae：The coptis=20:14:6) it, is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ
Pharmacy.
2) animal
SPF grades of male Kunming strain mices, weight (20 ± 2) g are provided by Chengdu up to large bio tech ltd, animal
Production licence number：SCXK (river) 2015-030.Animal feeding is in Chengdu University of Traditional Chinese Medicine's TCM Zang-fu disease laboratory animal
Room.
3) main agents and instrument
Scopolamine hydrobromide injection (0.3mg/ml) (Xuzhou Lai En pharmaceutcal corporation, Ltds)；Acetylcholinesterase
(AchE) testing cassete, acetylcholine transferase (ChAT) testing cassete, Coomassie brilliant blue albumen test box are purchased from Nanjing and build up life
Object Graduate School of Engineering.
Water maze video analytic system (Chengdu TME Technology Co., Ltd.)；(U.S. Thermo is public for all-wave length readout instrument
Department)；Refrigerated centrifuge (Thermo Fisher companies of the U.S.)；Precision electronic balance (German Sartorius companies)；Whirlpool is mixed
Even device (medical apparatus and instruments factory of Jintan City).
2 experimental methods
1) grouping, modeling and administration
80 Kunming mouses are randomly divided into 8 groups by weight, every group 10, respectively blank group, model group, Aricept
Group, grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and coptis group, grass-leaved sweetflag and coptis group, Radix Polygalae dissipate group and present composition group.Except blank
Group and model group mouse are given outside isometric physiological saline, and corresponding medicine is given by each treatment group, and administration volume is 20mL/
Kg, administration number of times are Aricept group content of dispersion 0.1mg/m L one time a day, and Radix Polygalae dissipates the group L of 0.6g/m containing crude drug amount, grass-leaved sweetflag
With Radix Polygalae group, Radix Polygalae and coptis group, grass-leaved sweetflag and coptis group and the present composition group L of 0.4g/m containing crude drug amount, successive administration
After 10 days, in addition to naive mice injects isodose physiological saline, hyoscine (3mg/ is injected intraperitoneally in remaining each group mouse
Kg Memory acquisition sexual dysfunction model) is prepared.Start Behavior test after modeling 30min, continuing gavage during Behavior test gives
Medicine.
2) Morris water maze laboratories
Experiment is carried out continuously 5 days, and first 3 days are training period, are tested for orientation navigation within the 4th day, are tried for space exploration within the 5th day
It tests.Program and placement platform are set, swimming track is tracked by camera, the time required to record mouse finds and climbs up platform,
That is escape latency.As do not found platform, incubation period is recorded as 90s, and mouse is guided to appear on the stage rest 15s.Remove station within 5th day
Platform sets space search mode, records number, the effective district for entering effective district (2 times of ranges of platform diameter) in animal 90s respectively
It swims in interior residence time, effective district distance.
3) AchE and ChAT determinations of activity
Animal is put to death after Behavior test, plucks full brain and bloodstain is cleaned with ice-cold normal saline, divide at low ambient temperatures
It from cerebral cortex, hippocampal tissue, is fully ground in homogenate tube, 10% brain tissue homogenate is made, centrifuging and taking supernatant preserves
It is spare in -20 DEG C of refrigerators.10% brain tissue homogenate to be measured is taken, matches reagent by kit requirement, colorimetric determination AchE activity,
ChAT activity.
3 experimental results
1) the ethological influence of Memory acquisition sexual dysfunction model mice water maze is caused on hyoscine
1. orientation navigation, in preceding 3 day training period, the average escape latency of each group mouse shows in trend is gradually reduced
The ability that platform is found in the study of each group mouse is improved in all previous learning training.4th day, model group mouse averagely escaped
Keep away incubation period is obviously prolonged (P ＜ 0.01) compared with blank group；Grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and coptis group and grass-leaved sweetflag and coptis group
Mouse average escape latency is compared with model group without significant difference；Aricept group, Radix Polygalae dissipate group and present composition group mouse is flat
Equal escape latency shortens (Aricept group P ＜ 0.01, Radix Polygalae dissipate group and present composition group P ＜ 0.05) compared with model group；Far
Will dissipates group and present composition group mouse average escape latency comparison among groups no significant difference.It is shown in Table 3.
Table 3 causes hyoscine the influence of Memory acquisition sexual dysfunction mouse escape latency
Note：The * * P ＜ 0.01 compared with blank group；Compared with model group#P ＜ 0.05,##P ＜ 0.01.
After 2. space search removes platform, model group mouse surrounds pool wall more and swims, longer in the labyrinth outer shroud residence time,
Less to swim near original platform, movement locus is randomly distributed in each quadrant, effective district residence time, effective district swimming
Distance, with the obvious reduction (P ＜ 0.01) of blank group；Grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and coptis group and grass-leaved sweetflag and the coptis
Group mouse effective district residence time, effective district swimming distance, with model group without significant difference；Aricept group, Radix Polygalae dissipate group and this
Inventive composition group mouse effective district residence time, effective district swimming distance, extend (P ＜ 0.05) compared with model group；Radix Polygalae
Dissipate group and present composition comparison among groups no significant difference.It is shown in Table 4.
Table 4 causes hyoscine the influence of Memory acquisition sexual dysfunction mouse space search
Note：The * * P ＜ 0.01 compared with blank group；Compared with model group##P ＜ 0.01.
2) AchE and ChAT Activity Results experimental result is shown, compared with blank group, AchE in model group Mice brain tissues
Active significantly to increase (P ＜ 0.01), ChAT activity is remarkably decreased (P ＜ 0.01)；Grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and coptis group and
Grass-leaved sweetflag is with AchE, ChAT activity in coptis group Mice brain tissues compared with model group without significant difference；Aricept group, Radix Polygalae dissipate group and
Ach E activity and obvious reduction (Aricept group P ＜ 0.01, the Radix Polygalae of model group in present composition group Mice brain tissues
Dissipate group and present composition group P ＜ 0.05), ChAT activity is significantly raised (P ＜ 0.01)；Radix Polygalae dissipates group and the present composition
Comparison among groups no significant difference.It is shown in Table 5.
Table 5 causes the active influence of Memory acquisition sexual dysfunction Mice brain tissues AchE, ChAT to hyoscine
Note：The * * P ＜ 0.01 compared with blank group；Compared with model group#P ＜ 0.05,##P ＜ 0.01.
Above-mentioned experiment can be seen that：
1) grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and coptis group and grass-leaved sweetflag and coptis group, all experimental results are and model group
Indifference, and present composition group items experimental result is significantly better than that model group, grass-leaved sweetflag and Radix Polygalae group, Radix Polygalae and the coptis
Group and grass-leaved sweetflag and coptis group, explanation：Three taste medicines in the present composition have synergistic make under the proportioning of the present invention
With；
2) Aricept group, Radix Polygalae dissipate group and present composition group items experimental result is significantly better than that model group, explanation：
Radix Polygalae dissipates and the present composition all has different degrees of nootropic effect, and the nootropic effect that the present composition is dissipated with Radix Polygalae
Quite.
To sum up, pharmaceutical composition of the invention has nootropic effect, and nootropic effect is worked as with Radix Polygalae dephasing；Compared to Radix Polygalae
It dissipating, the synergistic function between pharmaceutical composition drug of the invention is more obvious, has reduced the number of drug prescription, while
The use total amount of bulk pharmaceutical chemicals is saved.
3 pharmaceutical composition of the present invention of experimental example has effect for reducing blood fat
1 experiment material and source
1) drug
Simvastatin Tablets (20mg/ pieces), Hubei Guangji Pharmaceutical Co., Ltd.；
Radix Polygalae dissipates (Radix Polygalae：Poria cocos：Grass-leaved sweetflag：The coptis：Ginseng=4：5：6：4：3) it is attached, to be purchased from Chengdu University of Traditional Chinese Medicine
Chinese medicine pharmacy of hospital；
The present composition (grass-leaved sweetflag：Radix Polygalae：The coptis=20:14:6) it, is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ
Pharmacy.
2) animal
SD rats, male, are purchased from Chengdu and reach large bio tech ltd, animal life by SPF grades, weight (200 ± 20) g
Produce credit number：SCXK (river) 2015-030.Animal feeding is in Chengdu University of Traditional Chinese Medicine's TCM Zang-fu disease laboratory animal room.
3) main agents and instrument
Triglycerides (triglyceride, TG) detection kit, cholesterol (total cholesterol, TC) detection
Kit, low density lipoprotein cholesterol (low density lipoprotein-C, LDL-C) detection kit are by Germany
Roche Diagnostics GmbH provides；High-density lipoprotein cholesterol (high density lipoprotein-C, HDL-C) detects
Kit is provided by Beijing Strong Biotechnologies, Inc.；High glucose and high fat feed formula：Basal feed 76.5%, sucrose
10%, lard 10%, sodium taurocholate 1%, cholesterol 2.5% are provided by Chengdu up to large bio tech ltd.
All-wave length readout instrument (Thermo companies of the U.S.)；Refrigerated centrifuge (Thermo Fisher companies of the U.S.)；Accurate electricity
Sub- balance (German Sartorius companies)；Eddy blending machine (medical apparatus and instruments factory of Jintan City)；Automatic clinical chemistry analyzer (Shanghai
Products Co., Ltd of Roche Diagnistics).
2 experimental methods
1) grouping, modeling and administration
After adaptability is raised 1 week, every group 10, it is randomly divided into 5 groups：Blank group (normal control), model group, Simvastatin
Group, Radix Polygalae dissipate group, present composition group.Blank group gives basal feed, other groups give high lipid food, builds hyperlipidemia
Animal model, modeling give pharmaceutical intervention simultaneously.Blank group and model group gavage give physiological saline, and each treatment group is given accordingly
Medicine, administration volume be 10mL/kg, administration number of times be one time a day, simvastatin group content of dispersion 0.2mg/m L, Radix Polygalae
It dissipates the group L of 0.3g/m containing crude drug amount, the present composition group L of 0.2g/m containing crude drug amount and continues 6 weeks.
2) lipids detection
After rat is fed 6 weeks, fasting 12h, side eyeball excise method takes blood, after anti-freezing is handled, centrifuges 10min (3 immediately
000r/min), serum is taken, blood fat is detected.TC, TG, HDL-C are measured with enzymic colorimetric；With Direct Determination LDL-C.
3 experimental results
Compared with blank group, model group rats serum TC, TG, LDL-C are significantly raised, and HDL-C is substantially reduced (P ＜
0.05), show modeling success；Compared with model group, Simvastatin can obviously reduce rat model serum TC, TG, LDL-C and liter
The level (P ＜ 0.01) of high HDL-C；Compared with model group, TC, TG of the scattered group of Radix Polygalae and present composition group model rat,
LDL-C levels are substantially reduced (P ＜ 0.05), and the level of HDL-C is significantly raised (P ＜ 0.05)；The present composition is dissipated with Radix Polygalae
It is compared between group group, TC, TG, LDL-C level of rat model are substantially reduced (P ＜ 0.05), horizontal apparent increase (the P ＜ of HDL-C
0.05).It is shown in Table 6.
Influence of the table 6 to hyperlipidemia rats blood fat
Note：The * P ＜ 0.05 compared with blank group；Compared with model group#P ＜ 0.05,##P ＜ 0.01；Compared with group being dissipated with Radix Polygalae△
P ＜ 0.05.
Above-mentioned experimental result explanation：Pharmaceutical composition and Radix Polygalae of the present invention, which dissipate, different degrees of effect for reducing blood fat, but
The effect for reducing blood fat of pharmaceutical composition of the present invention is substantially better than Radix Polygalae and dissipates (P ＜ 0.05).Explanation：It is dissipated compared to Radix Polygalae, the present invention
Pharmaceutical composition drug between synergistic function it is more obvious, reduced the number of drug prescription, while also saving original
Expect the use total amount of medicine.
4 pharmaceutical composition of the present invention of experimental example has the function of antifatigue and anti-aging
1 experiment material and source
1) drug
Radix Polygalae dissipates (Radix Polygalae：Poria cocos：Grass-leaved sweetflag：The coptis：Ginseng=4：5：6：4：3) it is attached, to be purchased from Chengdu University of Traditional Chinese Medicine
Chinese medicine pharmacy of hospital；
The present composition (grass-leaved sweetflag：Radix Polygalae：The coptis=20:14:6) it, is purchased from Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ
Pharmacy.
2) animal
Male Kunming strain mice, is provided by Chengdu up to large bio tech ltd, animal by SPF grades, weight (20 ± 2) g
Production licence number：SCXK (river) 2015-030, animal feeding is in Chengdu University of Traditional Chinese Medicine's TCM Zang-fu disease laboratory animal
Room.
3) main agents and instrument
D- galactolipins, Beijing Suo Laibao Science and Technology Ltd；Glutathione peroxidase (GSH-Px), superoxides discrimination
Change enzyme (SOD), catalase (CAT), monoamine oxidase (MAO), malonaldehyde (MDA) are purchased from Nanjing and build up bioengineering and grind
Study carefully institute；Absolute ethyl alcohol, glacial acetic acid are that analysis is pure.
All-wave length readout instrument (Thermo companies of the U.S.)；Refrigerated centrifuge (Thermo Fisher companies of the U.S.)；Accurate electricity
Sub- balance (German Sartorius companies)；Eddy blending machine (medical apparatus and instruments factory of Jintan City)；Tired instrument of transfer rod formula (Chengdu Tai Meng
Softcom limited).
2 experimental methods
1) grouping, modeling and administration
48 mouse are randomly divided into 4 groups, every group 12, i.e.,：The scattered group of blank group (normal control), aging model group, Radix Polygalae,
Present composition group.Adaptability gives mouse 5% galactolipin of daily nape part hypodermic injection and establishes aged animal mould after raising 1 week
0.2ml physiological saline is subcutaneously injected in type, injection volume 0.2ml/d, the daily nape part of blank group.Gavage is given after injection of d-galactose
Medicine, administration volume are 20m L/kg, are administered daily 1 time, and Radix Polygalae dissipates the group L of 0.6g/m containing crude drug amount, and present composition group is containing life
Dose 0.4g/m L, blank group and aging model group mouse give isometric physiological saline.The daily same period is injected
With gavage processing, it is carried out continuously 6 weeks.During experiment, test mice freely absorbs feed and drinking water.
2) tired instrument of transfer rod formula is tested
Tired instrument of transfer rod formula can be used to observe co-ordination movement, muscular strength and the endurance of animal.It is when experiment that mouse is inverse main
Rotational axis direction is placed, and adapts to 3min, and velocity of rotation 30r/min is then arranged, starts to test, and record mouse stops on main shaft
The time stayed, in this, as antifatigue achievement.
3) oxidative stress index determining
Tired instrument of transfer rod formula experiment end, test mice fasting 12h.Cervical dislocation puts to death mouse, and brain is taken rapidly on ice platform
Tissue and liver, clean with 4 DEG C of normal saline flushings, filter paper is dried, and is weighed, and is shredded, and is put into homogenizer, and 9 times of amount lifes are added
Brine is managed, is homogenized under condition of ice bath, prepares 10% brain tissue and hepatic homogenate, centrifugation 10min (3 000r/ respectively
Min), supernatant is taken, sets and is saved backup at -80 DEG C.According to kit specification step, the malonaldehyde of brain hepatic tissue is measured respectively
(MDA) content and monoamine oxidase (MAO), glutathione peroxidase (GSH-Px), total number born (T-
SOD) active.
3 experimental results
1) tired instrument of transfer rod formula is tested
The results show that the antifatigue achievement of aging model group is poor compared with blank group (P ＜ 0.01)；Radix Polygalae dissipates and present invention combination
After object is intervened, two groups of achievements are significantly better than model group (P ＜ 0.01)；Radix Polygalae dissipates group with present composition comparison among groups without bright
Significant difference is different.It is shown in Table 7.
Influence of the table 7 to mouse aging tired instrument of transfer rod formula achievement
Note：The * * P ＜ 0.01 compared with blank group；Compared with model group##P ＜ 0.01.
2) oxidative stress index result
As shown in Table 8, aging model group mouse brain, liver organization T-SOD activity be substantially less than Normal group (P ＜
0.01).Compared with aging model group, Radix Polygalae dissipates the T-SOD activity of group, present composition group Mice brain tissues and liver organization
Significantly raised (P ＜ 0.05), group difference is not statistically significant.The MDA content calibrations of aging model group mouse brain, liver organization
Normal control group mice dramatically increases (brain tissue P ＜ 0.05, liver organization P ＜ 0.01).It is small that Radix Polygalae dissipates group, present composition group
Murine brain and liver organization MDA contents are all significantly lower than aging model group (P ＜ 0.05), and group difference is not statistically significant.
As shown in Table 9, aging model group mouse brain, liver organization MAO activity are significantly higher than Normal group (P ＜
0.01), GSH-Px activity is substantially less than Normal group (P ＜ 0.01).Radix Polygalae dissipates group, present composition group mouse and aging
Model group compares, and in addition to the GSH-Px activity pole of liver organization is substantially less than aging model group (P ＜ 0.01), the MAO of brain lives
Property, GSH-Px activity and liver organization MAO activity there were significant differences (P ＜ 0.05).Radix Polygalae dissipates group, present composition group
There was no significant difference for MAO and the GSH-Px activity of mouse brain hepatic tissue between two groups.
Influence of the table 8 to mouse brain, liver organization T-SOD activity and MDA contents
Note：The * P ＜ 0.05 compared with blank group, * * P ＜ 0.01；Compared with model group#P ＜ 0.05.
Table 9 is on mouse brain, the active influence of liver organization MAO, GSH-Px
Note：The * * P ＜ 0.01 compared with blank group；Compared with model group#P ＜ 0.05,##P ＜ 0.01.
Above-mentioned experimental result explanation：Radix Polygalae is dissipated all has preferable antifatigue and anti-aging work with pharmaceutical composition of the present invention
With, and the antifatigue and anti-aging effects effect of pharmaceutical composition of the present invention is worked as with Radix Polygalae dephasing.Explanation：It is dissipated compared to Radix Polygalae,
Synergistic function between the pharmaceutical composition drug of the present invention is more obvious, has reduced the number of drug prescription, while also saving
The about use total amount of bulk pharmaceutical chemicals.
To sum up, the effect of medicine composite for curing senile dementia of the invention, intelligence development, anti-aging and antifatigue effect are equal
Work as with Radix Polygalae dephasing, effect for reducing blood fat is dissipated better than Radix Polygalae.It is dissipated compared to Radix Polygalae, between pharmaceutical composition drug of the invention
Synergistic function it is more obvious, reduced the number of drug prescription, while also saving the use total amount of bulk pharmaceutical chemicals.
Claims (10)
1. a kind of pharmaceutical composition, it is characterised in that：It is prepared by the bulk pharmaceutical chemicals of following weight proportioning：
6~100 parts of grass-leaved sweetflag, 4~80 parts of Radix Polygalae, 4~80 parts of the coptis.
2. pharmaceutical composition according to claim 1, it is characterised in that：It is prepared by the bulk pharmaceutical chemicals that following weight matches
At preparation：
6~100 parts of grass-leaved sweetflag, 4~80 parts of Radix Polygalae, 4~80 parts of the coptis.
3. pharmaceutical composition according to claim 1, it is characterised in that：It is prepared by the bulk pharmaceutical chemicals that following weight matches
At preparation：
10~50 parts of grass-leaved sweetflag, 8~40 parts of Radix Polygalae, 4~40 parts of the coptis.
4. pharmaceutical composition according to claim 1, it is characterised in that：It is prepared by the bulk pharmaceutical chemicals that following weight matches
At preparation：
15~30 parts of grass-leaved sweetflag, 10~20 parts of Radix Polygalae, 6~15 parts of the coptis.
5. pharmaceutical composition according to claim 1, it is characterised in that：It is prepared by the bulk pharmaceutical chemicals that following weight matches
At preparation：
20 parts of grass-leaved sweetflag, 14 parts of Radix Polygalae, 6 parts of the coptis.
6. according to Claims 1 to 5 any one of them pharmaceutical composition, it is characterised in that：It is medicinal powder by bulk pharmaceutical chemicals, original
Expect that the water of medicine or extractive with organic solvent are active constituent, and in pharmacy acceptable auxiliary material or complementary ingredient prepare and
At preparation.
7. according to claim 2~6 any one of them pharmaceutical composition, it is characterised in that：The preparation be oral preparation and/
Or parenteral drug-delivery preparation.
8. pharmaceutical composition according to claim 7, it is characterised in that：The preparation is decoction, powder, capsule, piece
Agent, effervescent tablet, granule, pill, oral solution；The parenteral drug-delivery preparation includes freeze drying powder injection and injection.
9. the preparation method of claim 1~8 any one of them pharmaceutical composition, it is characterised in that：It includes the following steps：
1) weigh each raw material by weight ratio, beat powder, add water to cook or organic solvent extraction；
2) medicinal powder, water or extractive with organic solvent of bulk pharmaceutical chemicals are taken, in addition acceptable auxiliary material or complementary ingredient system in pharmacy
For at preparation.
10. claim 1~8 any one of them pharmaceutical composition is preparing treatment senile dementia and/or vascular dementia,
And/or the purposes in the drug of cognition dysfunction disease and/or reducing blood lipid.
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Cited By (1)
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| CN111840390A (en) * | 2020-09-01 | 2020-10-30 | 北京中医药大学 | Pharmaceutical composition for improving cognitive dysfunction and preparation method thereof |
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| CN101069734A (en) * | 2006-05-10 | 2007-11-14 | 河北天时医药技术开发有限公司 | Chinese medicine composition for vascular cretinism and preparing method therefor |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101069734A (en) * | 2006-05-10 | 2007-11-14 | 河北天时医药技术开发有限公司 | Chinese medicine composition for vascular cretinism and preparing method therefor |
| CN102895432A (en) * | 2011-07-26 | 2013-01-30 | 王登之 | Prescription and preparation method of rejoicing powder having new dosage form |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111840390A (en) * | 2020-09-01 | 2020-10-30 | 北京中医药大学 | Pharmaceutical composition for improving cognitive dysfunction and preparation method thereof |
| CN111840390B (en) * | 2020-09-01 | 2023-03-24 | 北京中医药大学 | Pharmaceutical composition for improving cognitive dysfunction and preparation method thereof |
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