CN107737207A - Pharmaceutical composition with antidepressant effect and its production and use - Google Patents
Pharmaceutical composition with antidepressant effect and its production and use Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/69—Polygalaceae (Milkwort family)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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Abstract
The invention discloses one kind to be used for antidepressant pharmaceutical composition and its production and use.The pharmaceutical composition of the present invention is made up of the parts by weight of ginseng 10~70, the parts by weight of grass-leaved sweetflag 30~120, the parts by weight of Poria cocos 50~220, the parts by weight of polygala 15~50, the parts by weight of rosemary volatile oil 0.5~2 and the parts by weight of rose flowers volatile oil 0.5~2.The pharmaceutical composition antidepressant effect of the present invention is notable.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition with antidepressant effect, the preparation method and use of said composition are further related to
On the way.
Background technology
Lead the side of forgetting and see the Tang Dynasty SUN Si miao earliest《Essential Recipes for Emergent Use Worth A Thousand Gold volumes the 14th (small internal organs)》, by polygala, people
Ginseng, Poria cocos, calamus composition.It is more to lead the derivative prescription for the side of forgetting, such as dingzhi pills, sedate piller, bushing soup, does not forget to dissipate, far
Will dissipates, tranquillizing pill etc..At present, the treatment for being applied to a variety of diseases is expanded in these classical prescriptions, and such as anxiety, forgetful, depressed, words and deeds are different
Often, senile dementia etc..The side of forgetting and its traditional formulation method of related derivative prescription are led as powder, pill is made after crushing, or
Water decoction is made in the direct decocting of person.
In the modern study for leading the side of forgetting and its related prescription, be related to mostly optimization to medicine composition and ratio and
Lead and the new prescription that flavour of a drug are added and subtracted to obtain is carried out on the basis of the side of forgetting.For the formulation method of the medicine of basic prescription, generally bag
Include the direct comminuting method of medicinal material, water extraction method, water extraction and alcohol precipitation method etc.；In addition, some prior arts are also included grass-leaved sweetflag therein
The step of extracting volatile oil.Prior art emphasizes particularly on different fields in relevant disease is treated, but whole structure still has much room for improvement.
The content of the invention
It is an object of the invention to provide one kind be based on pharmaceutical composition, and the pharmaceutical composition is obtained based on leading the side of forgetting,
But antidepressant effect is more notable.
Another object of the present invention is to provide the preparation method of described pharmaceutical composition, the medicine that the preparation method obtains
The antidepressant effect of compositions is more preferably.
It is still another object of the present invention to provide a kind of pharmaceutical preparation containing aforementioned pharmaceutical compositions.
A further object of the present invention is the purposes for providing described pharmaceutical composition.
The purpose of the present invention is achieved by the following technical solution：
One kind be used for antidepressant pharmaceutical composition, its by the parts by weight of ginseng 10~70, the parts by weight of grass-leaved sweetflag 30~120,
The parts by weight of Poria cocos 50~220, the parts by weight of polygala 15~50, the parts by weight of rosemary volatile oil 0.5~2 and rose flowers volatile oil 0.5
~2 parts by weight are made.
According to the pharmaceutical composition of the present invention, it is preferable that described pharmaceutical composition is by the parts by weight of ginseng 20~60, grass-leaved sweetflag
40~100 parts by weight, the parts by weight of Poria cocos 60~200, the parts by weight of polygala 18~40, the parts by weight of rosemary volatile oil 1~2 and rose
The parts by weight of flowers volatile oil 0.5~1 are made.
According to the pharmaceutical composition of the present invention, it is preferable that described pharmaceutical composition is made up of following component：
The parts by weight of ginseng 20, the parts by weight of grass-leaved sweetflag 100, the parts by weight of Poria cocos 200, the parts by weight of polygala 20, rosemary volatile oil 2
Parts by weight and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 60, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 60, the parts by weight of polygala 40, the weight of rosemary volatile oil 1
Measure part and the parts by weight of rose flowers volatile oil 0.5；Or
The parts by weight of ginseng 32, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 160, the parts by weight of polygala 40, rosemary volatile oil 2
Parts by weight and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 32, the parts by weight of grass-leaved sweetflag 80, the parts by weight of Poria cocos 160, the parts by weight of polygala 32, rosemary volatile oil 2
Parts by weight and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 20, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 70, the parts by weight of polygala 18, the weight of rosemary volatile oil 1
Measure part and the parts by weight of rose flowers volatile oil 0.5.
In the present invention, the rosemary volatile oil is to extract rosemary using steam distillation super critical extraction
The volatile oil arrived.The rose flowers volatile oil is to wave rose using what steam distillation super critical extraction was extracted to obtain
Hair oil.
The present invention also provides the preparation method of aforementioned pharmaceutical compositions.According to an embodiment of the invention, the medicine
The preparation method of compositions comprises the following steps：
(1) ginseng, grass-leaved sweetflag, Poria cocos and polygala are obtained aqueous extract, the water is extracted by the use of water as solvent extraction
Liquid concentrates, and then dries, obtains water extract；
(2) rosemary volatile oil and rose flowers volatile oil are obtained into volatile oil clathrate compound with cyclodextrin encapsulated；
(3) water extract is well mixed with the volatile oil clathrate compound, obtains described pharmaceutical composition.
According to another implementation of the invention, the preparation method of described pharmaceutical composition comprises the following steps：
Ginseng, grass-leaved sweetflag and polygala are extracted volatile oil by (1 '), obtain Mixed chaotic sequences and the dregs of a decoction；
(2 ') with cyclodextrin encapsulated, are volatilized the Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil
Oily inclusion compound；
The dregs of a decoction and Poria cocos by the use of water as solvent extraction, are obtained aqueous extract, the aqueous extract are concentrated by (3 '),
Dry, obtain water extract；
The volatile oil clathrate compound is well mixed by (4 ') with the water extract, obtains described pharmaceutical composition.
In step (1 '), it is well mixed after the ginseng, grass-leaved sweetflag and polygala can be extracted to volatile oil respectively, obtains institute
Mixed chaotic sequences are stated, volatile oil is extracted after the ginseng, grass-leaved sweetflag and polygala can also being mixed, obtains the mixed volatilization
Oil.In the present invention, the method for extracting volatile oil can be steam distillation or super critical extraction.According to one of the present invention
Embodiment, the method for the extraction volatile oil is steam distillation, including：The ginseng, grass-leaved sweetflag and polygala are added into water
Steam distillation is carried out, amount of water is 8~15 times of the ginseng, grass-leaved sweetflag and polygala gross weight and measured, preferably 10~14 times
Amount；Distillation time is 4~7 hours, preferably 5~6 hours, obtains Mixed chaotic sequences and extract solution；The extract solution filtration, is obtained
To decoction and the dregs of a decoction.According to an embodiment of the invention, the method for the extraction volatile oil is super critical extraction, bag
Include：By ginseng, grass-leaved sweetflag and polygala, volatile oil is extracted using supercritical carbon dioxide extraction method, 45~65 DEG C of Extracting temperature is excellent
Elect 50~60 DEG C as；Extract 25~32mPa of pressure, preferably 28~30mPa；Extraction time is 60~120min, preferably 80
~100min, obtain the Mixed chaotic sequences.
In step (2 '), the Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil can be pasted with ring respectively
After spermatophore closes, it is well mixed, obtains volatile oil clathrate compound.According to one preferred embodiment of the invention, the mixing is waved
With cyclodextrin encapsulated after hair oil, rosemary volatile oil and rose flowers volatile oil are well mixed, volatile oil clathrate compound is obtained；It is preferred that
Ground, the cyclodextrin is beta-schardinger dextrin, and the dosage of the beta-schardinger dextrin is the Mixed chaotic sequences, rosemary volatile oil and rose
2~6 times of rare flowers volatile oil gross weight, preferably 3.5~5 times.
In step (3 '), the method for the extraction can be decocting method, reflux extraction or ultrasonic extraction, and be preferably
Decocting method or reflux extraction.In the present invention, it is preferable that extracting in water 1~4 time after mixing the dregs of a decoction and Poria cocos, preferably
For 2~3 times；Each amount of water is 5~15 times of amounts of ginseng, grass-leaved sweetflag, polygala and Poria cocos gross weight, and preferably 6~8 times are measured；
Each extraction time is 0.5~3 hour, preferably 1~2 hour, obtains the aqueous extract.A kind of according to the present invention implements
Mode, extracting in water 2~3 times after the dregs of a decoction and Poria cocos are mixed, each amount of water is ginseng, grass-leaved sweetflag, polygala and Poria cocos
6~8 times of amounts of gross weight, each extraction time is 1~2 hour, obtains the aqueous extract.
According to an embodiment of the invention, in step (1 '), the method for extracting volatile oil is steam distillation；Step
Suddenly (3 ') also include：The aqueous extract is well mixed with the decoction, mixed liquor is obtained, the mixed liquor is concentrated, so
After dry, obtain water extract.
According to an embodiment of the invention, the preparation method of described pharmaceutical composition includes：By ginseng, grass-leaved sweetflag and
Polygala uses extraction by steam distillation volatile oil, and amount of water is 12 times of amounts of ginseng, grass-leaved sweetflag and polygala gross weight, during extraction
Between be 5 hours, obtain Mixed chaotic sequences and extract solution；The extract solution filtration, obtains decoction and the dregs of a decoction；By the mixed volatilization
Oil, rosemary volatile oil and rose flowers volatile oil are well mixed, and are added beta-cyclodextrin inclusion compound, be dry, pulverize, obtain at 60 DEG C
Volatile oil clathrate compound, wherein, the dosage of beta-schardinger dextrin is that the Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil are total
4 times of amounts of weight；The dregs of a decoction are mixed with Poria cocos, added water to cook 2 times, each amount of water is ginseng, grass-leaved sweetflag, polygala and Fu
8 times of amounts of Siberian cocklebur gross weight, each decocting time are 1 hour, and filtration, filtrate merges with above-mentioned decoction, concentrates, dry, pulverize, obtain
To water extract；The water extract is well mixed with the volatile oil clathrate compound, obtains described pharmaceutical composition.
According to another implementation of the invention, the preparation method of described pharmaceutical composition includes：By ginseng, grass-leaved sweetflag
With polygala using supercritical carbon dioxide extraction method extraction volatile oil, Extracting temperature is 50 DEG C, and extraction pressure is 28mPa, extraction
Time is 90min, obtains Mixed chaotic sequences and the dregs of a decoction；By the Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil
It is well mixed, beta-cyclodextrin inclusion compound is added, is dried at 60 DEG C, is then crushed, obtain volatile oil clathrate compound, wherein, β-ring paste
The dosage of essence is 5 times of amounts of the Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil gross weight；By the dregs of a decoction with
Poria cocos mixes, and adds water to cook 2 times, and each amount of water is 8 times of amounts of ginseng, grass-leaved sweetflag, polygala and Poria cocos gross weight, is decocted every time
Time is 1 hour, filtration, obtains aqueous extract, the aqueous extract is concentrated, and then dries and crushes, obtains water extract；
The water extract is well mixed with the volatile oil clathrate compound, obtains described pharmaceutical composition.
The present invention also provides one kind and is used for antidepressant pharmaceutical preparation, the pharmaceutical preparation include aforementioned pharmaceutical compositions with
Pharmaceutically acceptable auxiliary material.The formulation of described pharmaceutical preparation is unlimited, but preferably peroral dosage form, such as soft capsule, hard
Capsule, pill, tablet, granule, powder etc..The pharmaceutically acceptable auxiliary material includes but is not limited to starch, dextrin, sugarcane
Sugar, microcrystalline cellulose, lactose, Macrogol 4000, Macrogol 6000, vegetable oil, beeswax etc..
The present invention also provides the purposes that described pharmaceutical composition is used to prepare antidepressant.
In the present invention, the rosemary volatile oil of proper ratio is added on the basis of ginseng, grass-leaved sweetflag, Poria cocos, polygala
With rose flowers volatile oil, so as to enhance the antidepression curative effect of pharmaceutical composition；And compared with traditional preparation methods, the present invention carries
The volatile oil component in medicinal material has been taken, except the grass-leaved sweetflag rich in volatile oil, has also especially been extracted ginseng and the volatile oil of polygala
Composition, so as to which the antidepressant effect of the pharmaceutical composition of the present invention is significantly better than conventional method (such as crude drug comminuting method) preparation
Pharmaceutical composition.
Embodiment
With reference to specific embodiment, the present invention is further illustrated, but protection scope of the present invention is not limited to
This.
In the present invention, ginseng is Araliaceae ginseng Panax ginseng C.A.Mey. dry root and rhizome.Far
Will is milk wort polygala Polygala tenuifolia Willd.'s or ovum leaf polygala Polygala sibirica L.
Dry root.Grass-leaved sweetflag is acorus gramineus araceae plant Acorus tatarinowii Schott dry rhizome.Poria cocos is more
Pore fungi section fungi Poria cocos Poria cocos (Schw.) Wolf dry sclerotia.Rosemary is derived from Labiatae Rosmarinus plant fan
Repeatedly fragrant Rosmarinus officinalis L. roses are that drying for rosaceous plant rose Rosa rugasa Thunb. is spent
Flower bud.
Embodiment 1
Ginseng 200g, grass-leaved sweetflag 1000g and polygala 200g are taken, is well mixed, coarse powder is ground into, using steam distillation
Volatile oil is extracted, amount of water 19.6kg, 6 hours extraction times, Mixed chaotic sequences and extract solution is obtained, extract solution is filtered,
Obtain decoction and the dregs of a decoction；Mixed chaotic sequences are well mixed with rosemary volatile oil 20g, rose flowers volatile oil 10g, add volatilization
The beta-cyclodextrin inclusion compound of oily 5 times of amounts of gross weight, dry, pulverize in 55 DEG C~60 DEG C, obtains volatile oil clathrate compound；The dregs of a decoction and Poria cocos
Added water to cook 2 times after 2000g mixing, each amount of water be 30.6kg, and each decocting time is 1 hour, is filtered, filtrate with it is above-mentioned
Decoction merges, and concentration, dry, pulverize, obtains water extract；The water extract is well mixed with volatile oil clathrate compound, obtained
Pharmaceutical composition.
Embodiment 2
Ginseng 600g, grass-leaved sweetflag 400g and polygala 400g are taken, is well mixed, coarse powder is ground into, using steam distillation
Volatile oil is extracted, amount of water 16.8kg, 5 hours extraction times, Mixed chaotic sequences and extract solution is obtained, extract solution is filtered,
Obtain decoction and the dregs of a decoction；Mixed chaotic sequences are well mixed with rosemary volatile oil 10g, rose flowers volatile oil 5g, add volatilization
The beta-cyclodextrin inclusion compound of oily 4 times of amounts of gross weight, dry, pulverize in 55 DEG C~60 DEG C, obtains volatile oil clathrate compound；The dregs of a decoction and Poria cocos
After 600g mixing plus water refluxing extraction 2 times, each amount of water be 16kg, and each extraction time is 1 hour, is filtered, filtrate with it is upper
Decoction merging is stated, concentration, dry, pulverize, obtain water extract；The water extract is well mixed with volatile oil clathrate compound, obtained
To pharmaceutical composition.
Embodiment 3
Ginseng 320g, grass-leaved sweetflag 400g, polygala 400g are taken, is well mixed, is ground into coarse powder, is placed in supercritical carbon dioxide
The extraction kettle of abstraction instrument, 55 DEG C of Extracting temperature, pressure 30mPa is extracted, extraction time 90min, obtains Mixed chaotic sequences and the dregs of a decoction；
Mixed chaotic sequences are well mixed with rosemary volatile oil 20g, rose flowers volatile oil 10g, add 6 times of amounts of volatile oil gross weight
Beta-cyclodextrin inclusion compound, it dry, pulverize in 55 DEG C~60 DEG C, obtain volatile oil clathrate compound；The dregs of a decoction mix with Poria cocos 1600g, add water
Decoct 3 times, each amount of water is 27.2kg, and each decocting time is 1 hour, obtains aqueous extract, concentrates, dry, pulverize, obtain
To water extract；The water extract is well mixed with volatile oil clathrate compound, obtains pharmaceutical composition.
Embodiment 4
Ginseng 320g, grass-leaved sweetflag 800g, polygala 320g are taken, is well mixed, is ground into coarse powder, is placed in supercritical carbon dioxide
The extraction kettle of abstraction instrument, 50 DEG C of Extracting temperature, pressure 28mPa is extracted, extraction time 90min, obtains Mixed chaotic sequences and the dregs of a decoction；
Mixed chaotic sequences are well mixed with rosemary volatile oil 20g, rose flowers volatile oil 10g, add 5 times of amounts of volatile oil gross weight
Beta-cyclodextrin inclusion compound, it dry, pulverize in 55 DEG C~60 DEG C, obtain volatile oil clathrate compound；The dregs of a decoction mix with Poria cocos 1600g, add water
Decocting 2 times, each amount of water is 24.32kg, and each decocting time is 1 hour, obtains aqueous extract, concentrates, dry, pulverize,
Obtain water extract；The water extract is well mixed with volatile oil clathrate compound, obtains pharmaceutical composition.
Embodiment 5
Using ginseng 200g, grass-leaved sweetflag 400g, Poria cocos 700g and polygala 180g by the use of water as solvent extraction 2 times, add water every time
It is respectively 2h, 1h to measure as 14.8kg, extraction time, obtains aqueous extract, the aqueous extract is concentrated, and dries, obtains water extraction
Take thing；Rosemary volatile oil 10g and rose flowers volatile oil 5g are well mixed, add β-ring paste of 5 times of amounts of volatile oil gross weight
Spermatophore closes, and dry, pulverize in 55 DEG C~60 DEG C, obtains volatile oil clathrate compound；Water extract is mixed with volatile oil clathrate compound
It is even, obtain pharmaceutical composition.
Embodiment 6
By pharmaceutical composition 500g made from the method for embodiment 1, lactose 500g is added, is well mixed, dry-pressing granulation, is obtained
Granule.
Embodiment 7
By pharmaceutical composition 260g made from the method for embodiment 2, add starch 70g, be well mixed, by the use of 85% ethanol as
Wetting agent, granulation, less than 60 DEG C dryings, whole grain, filled hard capsules, obtains hard capsule.
Embodiment 8
By pharmaceutical composition 400g made from the method for embodiment 3, starch 200g, sodium carboxymethyl starch 50g are added, mixing is equal
It is even, using 80% ethanol as wetting agent, pelletize, dry, whole grain, add magnesium stearate 30g, be well mixed, tabletting, film coating,
Obtain tablet.
Embodiment 9
By pharmaceutical composition made from the method for embodiment 4 and starch by weight 1:1 is well mixed, obtains powder.
Embodiment 10
By pharmaceutical composition 100g made from the method for embodiment 5, soybean oil 300g is added, beeswax 50g, heating stirring is equal
It is even, soft capsule is pressed into, obtains soft capsule.
Comparative example 1
Ginseng 32g, grass-leaved sweetflag 80g, Poria cocos 160g, polygala 32g are taken, fine powder is ground into, obtains pharmaceutical composition.
Comparative example 2
Ginseng 320g, grass-leaved sweetflag 800g, polygala 320g are taken, is well mixed, is ground into coarse powder, is placed in supercritical carbon dioxide
The extraction kettle of abstraction instrument, 50 DEG C of Extracting temperature, pressure 28mPa is extracted, extraction time 90min, obtains Mixed chaotic sequences and the dregs of a decoction；
Mixed chaotic sequences are added to the beta-cyclodextrin inclusion compound of 5 times of amounts, dry, pulverize in 55 DEG C~60 DEG C, obtain volatile oil clathrate compound；Medicine
Slag mixes with Poria cocos 1600g, adds water to cook 2 times, and each amount of water is 24.32kg, and each decocting time is 1 hour, obtains water
Extract solution, concentration, dry, pulverize, obtain water extract；The water extract is well mixed with volatile oil clathrate compound, obtains medicine
Compositions.By the pharmaceutical composition and starch by weight 1:1 is well mixed, obtains powder.
Experimental example
The antidepressant effect of the pharmaceutical composition of the present invention is demonstrated by the test of pesticide effectiveness.Experimental method and result are such as
Under：
1. animal and material
Kunming mouse, SPF levels are female, 20 ± 2g of body weight, in the Fourth Military Medical University of P.L.A experimental animal
The heart provides.
Corticotropin (ACTH) ELISA detection kit (Bioisystech Co., Ltd is built up in Nanjing)
Electronic balance (Minqiao Precision Scientific Instruments Co., Ltd., Shanghai)
The continuous spectrum ELIASAs of Spevoramax 190 (molecule instrument company of the U.S.)
KDC-1044 low speed centrifuges (Anhui Zhong Kezhongjia scientific instrument Co., Ltd)
DHP-9162 types electro-heating standing-temperature cultivator (one permanent Science and Technology Ltd. of Shanghai)
DHG-9075A types electric heating constant-temperature blowing drying box (one permanent Science and Technology Ltd. of Shanghai)
Hisense refrigerating refrigerator BCD-301WT/A (Hisense Company Limited)
Compare 1 group of test liquid：The pharmaceutical composition of comparative example 1 is taken, adds distilled water to be prepared into every 1ml raw medicinal herbs containing 0.2g
Suspension, produce.
Compare 2 groups of test liquids：The powder of comparative example 2 is taken, adds distilled water to be prepared into the suspension of every 1ml raw medicinal herbs containing 0.2g
Liquid, produce.
Experimental group test liquid：Powder in Example 9, distilled water is added to be prepared into the suspension of every 1ml raw medicinal herbs containing 0.2g
Liquid, produce.
2. test method
2.1 mouse weights and Behavior Test
The mouse 50 for adapting to experimental situation is taken, male and female half and half, 10 is chosen and is only used as blank group, 40 progress modelings.It is real
Test and start the previous day and weigh the body weight of every mouse respectively and make a record, mouse is put into 50ml centrifuge tubes by modeling daily after starting
In, tube wall is carved with diameter 0.4cm aperture, it is ensured that well-ventilated, constraint ttom of pipe is placed with lining cloth, to absorb the excretion of animal
Thing.Mouse causes the injury on macroscopic body in the activity in space limited in pipe that fetters, and places into room temperature
Under water-bath reclaimed water be dipped at mouse xiphoid-process, contained water logging 1 hour, carries out modeling in continuous 7 days daily.Modeling mouse is divided into mould
Type group, 1 group of contrast, contrast 2 groups and test group, every group 10.Blank group and the daily gavage 5mLkg of model group mouse- 1Steaming
Distilled water；Compare 1 group and 2 groups of control gives 1 group of test liquid of control and control 2 groups of test liquids respectively, dosage is daily 1.0gkg-1；Experimental group gives the experimental group test liquid of the present invention, and dosage is daily 1.0gkg-1.In addition to blank group, model group, control 1
Group, 2 groups of control and experimental group daily administration continue to give constraint water logging 1 hour simultaneously, continuous two weeks, weigh within every 7 days every small
Mouse body weight once, calculates changes of weight rate.Open field test and forced swim test are carried out after two weeks.
2.2 mouse syrup preference degree experimental methods
After the raising of mouse adaptability, the intake training of 1% sucrose is carried out, i.e., is first fed simultaneously with 1% sucrose water and drinking water
48h, then prohibit water 24h, in m seq (as the 0th day) 8: 00~9: 00 freely drink to mouse simultaneously 1% sucrose water and
The common 1h of drinking water, and its intake is recorded respectively.The early morning 8 at the 1st, 2,3 weekend in experiment respectively:00~9:1h is surveyed when 00
Interior 1% sucrose water intake and drinking water intake.
3. observation index
3.1 body weight detect：
Weigh every mouse weight once within every 7 days, record mouse weight change.
3.2 open field test
1d and 22d before the test, the change of each group mouse behavior is studied with open field test.Mouse is put into open field test
The center of case, the lattice number for being run by bottom center passed through in record mouse 5min, rearings (including counterfort station
Vertical and stick-up) number and reason hair number, test and carried out in darkroom, quiet environment.
3.3 forced swimming test
Carry out forced swimming test within 22nd day.Mouse is singly only put into diameter 18cm, high 40cm lucite cylinder, put
In in sound insulation camera bellows, depth of water 20cm in cylinder, water temperature is room temperature.By the activity of camera acquisition and recording mouse, observe in 5min
The swimming situation of mouse, count the time that mouse is motionless in 5min.To float it is motionless and only by head be maintained on the water surface without
It is determined as indeterminate state of swimming as by this state of water logging.Calculate accumulative dead time percentage.
The measure of 3.4 plasma adrenocorticotropic hormones (ACTH)
After open field test and forced swimming test terminate, blood is taken, is put into the anticoagulant tube containing EDTA, under 4 DEG C of environment
2h is stood, 3000r/min centrifugations 15min takes upstream blood plasma pipettor gun head to suction out and is put into test tube, in -20 DEG C of preservations, enzyme
Linked immunosorbent assay measure blood plasma adrenotrophic hormone is horizontal.
3.5 syrup, pure water consumption measure
1% sucrose water uptake ratio=[1% sucrose water intake/(1% sucrose water intake+drinking water intake)] ×
100%.
4. result of the test
4.1 mouse weight
From table 1, the 0th day, the 7th day each group mouse weight no significant difference, but by the 7th day, modeling each group animal body
Weight is obvious to be reduced；In modeling the 21st day, compared with model group, experimental group substantially increased with control group mice body weight, had significantly
Sex differernce (P ＜ 0.05), the incrementss of experimental group body weight are higher than control group.
The mouse weight result of variations of table 1
| Group | Number of cases (only) | 0th day (g) | 7th day (g) | 14th day (g) | 21st day (g) |
| Blank group | 10 | 20.09±1.28 | 22.13±1.14 | 24.10±1.12 | 25.52±1.23 |
| Model group | 10 | 20.17±1.21 | 21.30±1.26 | 22.39±1.14* | 23.41±1.30* |
| Compare 1 group | 10 | 19.83±1.15 | 21.23±1.31 | 22.97±1.20 | 24.00±1.19△ |
| Compare 2 groups | 10 | 19.93±1.02 | 21.35±1.15 | 23.15±1.16 | 24.12±1.22△ |
| Experimental group | 10 | 20.01±1.09 | 21.55±1.21 | 23.39±1.25 | 24.41±1.14△ |
Note：Compared with blank group,*P ＜ 0.05；Compared with model group,△P ＜ 0.05.
4.2 open field test
From table 2, compared with blank group, model group mouse passes through lattice number, standing number and reason hair number and significantly reduced,
Difference is statistically significant (P ＜ 0.05)；Compared with model group, experimental group passes through lattice number, standing time with control group mice, level
Number and reason hair number substantially increase, and difference is statistically significant (P ＜ 0.05).Experimental group passes through lattice than control group mice level
Number, standing number and reason hair number increase, and show that the present invention is better than comparative example in terms of the Degree of Depression of model mice is improved.
The mouse open field test score of table 2 compares
Note：Compared with blank group,*P ＜ 0.05；Compared with model group,△P ＜ 0.05.
4.3 forced swimming test
From table 3, compared with blank group, model group adds up the dead time statistically significant (the P ＜ of percentage difference
0.01)；Compared with model group, experimental group forced swimming dead time percentage has significant difference (P ＜ 0.01), and control group is strong
Compeling non-swimming time percentage has significant difference (P ＜ 0.05), shows that the present invention is improving the Degree of Depression of model mice
Aspect is better than comparative example.
The mouse of table 3 adds up dead time percentage
| Group | Number of cases (only) | Accumulative dead time percentage |
| Blank group | 10 | 37.12±7.34 |
| Model group | 10 | 65.46±6.15** |
| Compare 1 group | 10 | 55.35±6.53△ |
| Compare 2 groups | 10 | 54.11±6.76△ |
| Experimental group | 10 | 48.31±8.32△△ |
Note：Compared with blank group,**P ＜ 0.01；Compared with model group,△P ＜ 0.05；Compared with model group,△△P ＜
0.01。
The measure of 4.4 plasma adrenocorticotropic hormones (ACTH)
From table 4, compared with blank group, model group plasma ACTH concentration is significantly raised, the statistically significant (P of difference
＜ 0.01)；Compared with model group, experimental group plasma ACTH concentration is significantly raised, there is significant difference (P ＜ 0.01), control group
Plasma ACTH concentration is significantly raised, there is significant difference (P ＜ 0.05), shows that the present invention is improving the Degree of Depression of model mice
Aspect is better than comparative example.
The mice plasma ACTH concentration of table 4 compares
| Group | Number of cases (only) | ACTH(pg/ml) |
| Blank group | 10 | 28.35±5.24 |
| Model group | 10 | 44.45±6.36** |
| Compare 1 group | 10 | 36.12±3.87△ |
| Compare 2 groups | 10 | 34.42±3.43△ |
| Experimental group | 10 | 31.24±3.37△△ |
Note：Compared with blank group,**P ＜ 0.01；Compared with model group,△P ＜ 0.05；Compared with model group,△△P ＜
0.01。
4.5 sucrose water preference degree
From table 5, each group mouse sucrose water preference degree compares that there was no significant difference before modeling；Model group mouse is in modeling
14th day, the intake of the 21st day significantly reduces (P ＜ 0.05) compared with before modeling；Compared with model group, experimental group is with compareing
Group mouse intake showed increased, difference are statistically significant (P ＜ 0.05).The intake of experimental group sucrose water is more than control
Group.
The mouse sucrose water preference degree of table 5 compares
Note：Compared with blank group,*P ＜ 0.05；Compared with model group,△P ＜ 0.05.
As fully visible, Chinese medicine composition of the present invention can increase depression model mouse weight, improve model mice sucrose water
Intake, hence it is evident that improve model mice plasma ACTH concentration；Open field test behaviouristics shows that Chinese medicine composition of the present invention can show
Write increase model group mouse and pass through lattice number, standing number and reason hair number；Forced swim test shows that the present invention can dramatically increase
Model mice dead time percentage.The present invention can obviously improve the Degree of Depression of model mice, and there is good antidepression to make
With.
The present invention is not limited to above-mentioned embodiment, in the case of without departing substantially from the substantive content of the present invention, this area skill
Any deformation, improvement, the replacement that art personnel are contemplated that each fall within the scope of the present invention.
Claims (10)
1. one kind be used for antidepressant pharmaceutical composition, it is characterised in that described pharmaceutical composition by the parts by weight of ginseng 10~70,
The parts by weight of grass-leaved sweetflag 30~120, the parts by weight of Poria cocos 50~220, the parts by weight of polygala 15~50, the weight of rosemary volatile oil 0.5~2
Part and the parts by weight of rose flowers volatile oil 0.5~2 are made.
2. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition is by the weight of ginseng 20~60
Part, the parts by weight of grass-leaved sweetflag 40~100, the parts by weight of Poria cocos 60~200, the parts by weight of polygala 18~40, the weight of rosemary volatile oil 1~2
Amount part and the parts by weight of rose flowers volatile oil 0.5~1 are made.
3. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition is made up of following component：
The parts by weight of ginseng 20, the parts by weight of grass-leaved sweetflag 100, the parts by weight of Poria cocos 200, the parts by weight of polygala 20, the weight of rosemary volatile oil 2
Part and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 60, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 60, the parts by weight of polygala 40, the parts by weight of rosemary volatile oil 1
With the parts by weight of rose flowers volatile oil 0.5；Or
The parts by weight of ginseng 32, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 160, the parts by weight of polygala 40, the weight of rosemary volatile oil 2
Part and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 32, the parts by weight of grass-leaved sweetflag 80, the parts by weight of Poria cocos 160, the parts by weight of polygala 32, the weight of rosemary volatile oil 2
Part and the parts by weight of rose flowers volatile oil 1；Or
The parts by weight of ginseng 20, the parts by weight of grass-leaved sweetflag 40, the parts by weight of Poria cocos 70, the parts by weight of polygala 18, the parts by weight of rosemary volatile oil 1
With the parts by weight of rose flowers volatile oil 0.5.
4. the preparation method of the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that the medicine group
The preparation method of compound comprises the following steps：
(1) ginseng, grass-leaved sweetflag, Poria cocos and polygala are obtained into aqueous extract by the use of water as solvent extraction, the aqueous extract is dense
Contracting, then dries, obtains water extract；
(2) rosemary volatile oil and rose flowers volatile oil are obtained into volatile oil clathrate compound with cyclodextrin encapsulated；
(3) water extract is well mixed with the volatile oil clathrate compound, obtains described pharmaceutical composition.
5. the preparation method of the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that the medicine group
The preparation method of compound comprises the following steps：
Ginseng, grass-leaved sweetflag and polygala are extracted volatile oil by (1 '), obtain Mixed chaotic sequences and the dregs of a decoction；
The Mixed chaotic sequences, rosemary volatile oil and rose flowers volatile oil with cyclodextrin encapsulated, are obtained volatile oil bag by (2 ')
Compound；
The dregs of a decoction and Poria cocos by the use of water as solvent extraction, are obtained aqueous extract, the aqueous extract concentrated, then by (3 ')
Dry, obtain water extract；
The volatile oil clathrate compound is well mixed by (4 ') with the water extract, obtains described pharmaceutical composition.
6. preparation method according to claim 5, it is characterised in that：
In step (1 '), the method for the extraction volatile oil is steam distillation, including：By the ginseng, grass-leaved sweetflag and remote
Will adds water to carry out steam distillation, and amount of water is 8~15 times of amounts of the ginseng, grass-leaved sweetflag and polygala gross weight；Distillation time
For 4~7 hours, Mixed chaotic sequences and extract solution are obtained；The extract solution filtration, obtains decoction and the dregs of a decoction；Or
In step (1 '), the method for the extraction volatile oil is super critical extraction, including：Ginseng, grass-leaved sweetflag and polygala are adopted
Volatile oil, 45~65 DEG C of Extracting temperature are extracted with supercritical carbon dioxide extraction method；Extract 25~32mPa of pressure；Extraction time
For 60~120min, the Mixed chaotic sequences are obtained.
7. preparation method according to claim 5, it is characterised in that in step (2 '), the Mixed chaotic sequences, fan are changed
Beta-cyclodextrin inclusion compound is used after fragrant volatile oil and rose flowers volatile oil are well mixed, obtains volatile oil clathrate compound；The beta-schardinger dextrin
Dosage be the Mixed chaotic sequences, 2~6 times of rosemary volatile oil and rose flowers volatile oil gross weight.
8. preparation method according to claim 5, it is characterised in that in step (3 '), the method for extraction for decocting method or
Reflux extraction；The preparation method of the aqueous extract is：Extracting in water 1~4 time after the dregs of a decoction and Poria cocos are mixed, every time
Amount of water is 5~15 times of amounts of ginseng, grass-leaved sweetflag, polygala and Poria cocos gross weight, and each extraction time is 0.5~3 hour, is obtained
The aqueous extract.
9. one kind is used for antidepressant pharmaceutical preparation, it is characterised in that the pharmaceutical preparation includes being appointed according to claims 1 to 3
Pharmaceutical composition and pharmaceutically acceptable auxiliary material described in one.
10. the pharmaceutical composition according to any one of claims 1 to 3 is used for the purposes for preparing antidepressant.
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| CN113966837A (en) * | 2021-11-30 | 2022-01-25 | 烟台新时代健康产业有限公司 | Health food with anxiolytic and antidepressant functions |
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