CN106727728A - It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof - Google Patents
It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof Download PDFInfo
- Publication number
- CN106727728A CN106727728A CN201611133211.8A CN201611133211A CN106727728A CN 106727728 A CN106727728 A CN 106727728A CN 201611133211 A CN201611133211 A CN 201611133211A CN 106727728 A CN106727728 A CN 106727728A
- Authority
- CN
- China
- Prior art keywords
- weight
- weight portion
- ethanol
- pharmaceutical composition
- extract
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4741—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having oxygen as a ring hetero atom, e.g. tubocuraran derivatives, noscapine, bicuculline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
-
- 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
- A61K36/02—Algae
-
- A—HUMAN NECESSITIES
- 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
- A61K2236/33—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
-
- A—HUMAN NECESSITIES
- 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Marine Sciences & Fisheries (AREA)
- Zoology (AREA)
- Alternative & Traditional Medicine (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Molecular Biology (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Pharmaceutical composition of insomnia and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is to determine alkali, asiatic acid as bulk drug with betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass, proportioning is formed, routinely various formulations can be made by preparation process, treatment insomnia is evident in efficacy.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of treat pharmaceutical composition of insomnia and preparation method thereof.
Background technology
Sleep is a kind of most basic physiological behavior, is also to ensure physically and mentally healthy essential condition.Sleep-disorder is common
Disease and various diseases simultaneous phenomenon, prolonged insomnia can bring huge body and mind to damage, have a strong impact on people to patient
Live and work.And it is due to feelings will, diet internal injury or after being ill and old, insufficiency of natural endowment to have a sleepless night, having a guilty consicence, it is sick to wait
Cause, causes the mind to be lost and supports or confused and worried, so as to cause can not often to obtain the class illness that ortho is characterized.Main table
Now for the length of one's sleep, depth deficiency and be unable to dispelling fatigue, regain one's strength and energy, the lighter's difficulty falling asleep, or sleep without
It is intoxicated, sometimes sleeping and sometimes waking, or can not sleep again after waking up, it is heavy then be insomnia all night.Insomnia is one of common clinical disease, though it is not belonging to critical disease
Disease, but people's normal life, work, study and health are hindered, and can aggravate or induce palpitaition, the obstruction of qi in the chest, dizziness, headache, apoplexy
The illnesss such as disease.Obstinate insomnia, long-term pain is brought to patient, or even forms the dependence to sleeping medicine, and is taken for a long time
Can cause iatrogenic disease again with sleeping medicine.Insomnia exists《Interior warp》In be referred to as " insomnia ", " must not sleep ", " must not crouch ", and
Think that insomnia reason mainly has two kinds, one is other illnesss influence, such as cough, vomiting, abdomen completely, must not make one reposal；Two are
Negative and positive of qi and blood is become estranged, and is made one not able person and is slept.Chemical drug improves the health care of sleep rapid-action, but toxic and side effect is big, and some Chinese medicines are slept for improvement
Sleeping has effectively and the characteristics of do not produce dependence, is current and future improves the health care of sleep the development trend of medicine.
Pondsnail：This product is the red amber spiral shell Succinea erythrophana Ancey of amber spiral shell section amber spiro spp animal
Entirety.Can be caught in moist thick grass, under leaf or in riprap, catch after, clean, using fresh herb.【Nature and flavor】It is sweet；It is salty；
It is cold in nature.【Return through】Liver Channel.【Indication】Relieve dizziness, high fever, infantile convulsions, epilepsy, etc. relieving convulsion；Swelling and pain relieving.Main child convulsion；Hemorrhoid；Prolapse of the anus.【Original shape state】It is red
Amber spiral shell, shell is small-sized, 8mm high, 4.5mm wide.Chitin is thin, frangible, translucent, in ovate long cone, there is 3 gyrations, preceding 2
Individual gyration increasess slowly, but slightly protrudes.Body whorl rapid development, especially expands, and its height is about high 4/5 of shell, and shell is top, seam
Zygonema depth, shell surface is faint yellow or yellowish-brown, glossy, with dense careful growth line and gauffer, faucal oval long, outward
Lip is thin, is often damaged, and its top is in an acute angle with body whorl shape, and epipharynx is attached on body whorl, forms unconspicuous callosity portion,
Without umbilical opening.Record in dictionary of medicinal plant.
Oyster dish：This product is the frond of Ulvaceae sea lettuce platymiscium oyster dish Ulva conglobata Kjellm..【Nature and flavor】
It is salty；It is cold.【Return through】Kidney；Lung channel.【Indication】It is clearing heat and detoxicating；Diuresis.Main heatstroke；Goitre；Oedema.【Proterties】Oyster dish,
Frond drying shrinkage is into lumps.After water logging flattening, thallus green, 2-4cm long is intensive to grow thickly, and slightly extends.Thallus drastic crack, splits
Into most slivers or branch, each sliver is overlapped, edge distortion.Thallus top film quality, thick 30-50 μm, bottom thickness 100-
125 μm, base portion is harder, and gas is micro-, lightly seasoned.【Chemical analysis】Frond sulfur-bearing acid polysaccharide (sulfated polysaccharide),
- α-L- the rhamnosides of methyl two (methyl di- α-L-rhamnoside).Record in dictionary of medicinal plant.
Betulic acid（Betulinic acid）：CAS 472-15-1, molecular formula C30H48O3, molecular weight 456.71.【It is raw
Thing activity】It is antitumor（W256）.【Ingredient origin】Date Ziziphus jujuba, tree-like cuckoo Rhododendron
Arboreum, camplotheca acuminata Camptotheca acuminata.
Sanguisorbin II（Ziyuglycoside II）：CAS 35286-59-0, molecular formula C35H56O8, molecular weight
604.81.【Bioactivity】Cool blood, hemostasis.【Ingredient origin】Garden burnet Sanguisorba officinalis.
Mountain edge grass determines alkali（Adlumidine）：CAS 550-49-2, molecular formula C20H17NO6, molecular weight 367.36.【Pharmacology
Effect】Effect with excited uterus.【Ingredient origin】The deep shape mountain edge grass Adlumia fungosa of bloodroot
Greene, lies prostrate raw corydalis Corydalis decumbens (Thunb.) Pers. stem tubers, C. incisa Corydalis
Incisa (Thunb.) Pers. herbs, short sharp corydalis Corydalis mucronifera Maxim.
Asiatic acid（Asiatic acid）：CAS 464-92-6, molecular formula C30H48O5, molecular weight 488.70.【It is biological
Activity】Help to create new connective tissue;Promote wound healing (external application);Promote epidermal cornified;Granulation is stimulated to occur.
【Ingredient origin】Borneol Dryobalanops aromatics, centella Centella asiatica.
4 chemical constitutions of bulk drug：
Mountain edge grass determines alkali（Adlumidine）Betulic acid（Betulinic acid）
Sanguisorbin II（Ziyuglycoside II）Asiatic acid（Asiatic acid）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided it is a kind of it is effective treatment insomnia pharmaceutical composition and its
Preparation method.
The present invention adopts the following technical scheme that realization：
Be made the treatment insomnia pharmaceutical composition bulk drug composition and weight portion be：
Betulic acid 5-15 weight portion Pondsnail 262-268 weight portion oyster dish 222-226 weight portion sanguisorbins II13-16
Weight portion mountain edge grass determines alkali 7-9 weight portion asiatic acid 3-5 weight portions.
The pharmaceutical composition for the treatment of insomnia is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion sanguisorbin II15 weight portions mountain edge grass of 10 weight portion Pondsnail of betulic acid, 264 weight portion oyster dish 224
Determine the weight portion of 8 weight portion asiatic acid of alkali 4.
A kind of pharmaceutical composition for treating insomnia, it is characterised in that pharmaceutical composition can be using the conventional method of galenic pharmacy
Prepare piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating insomnia, it is characterised in that the treatment that pharmaceutical composition is constituted with chemical drugs or Chinese medicine
Insomnia drug.
A kind of preparation method of the pharmaceutical composition for treating insomnia, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Betulic acid 5-15 weight portion Pondsnail 262-268 weight portion oyster dishes 222-226
Weight portion sanguisorbin II13-16 weight portions mountain edge grass determines alkali 7-9 weight portion asiatic acid 3-5 weight portions；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating insomnia, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The weight portion of 10 weight portion Pondsnail of betulic acid, 264 weight portion oyster dish 224 ground
Elm saponin I I15 weight portions mountain edge grass determines the parts by weight of 8 weight portion asiatic acid of alkali 4；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating insomnia, it is characterised in that pharmaceutical composition can use galenic pharmacy
Conventional method prepare piece agent or capsule or dripping pill.
A kind of preparation method of the pharmaceutical composition for treating insomnia, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine
Composition medicament for treating insomnia.
Medicine composite for curing insomnia is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of insomnia and preparation method thereof
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：Betulic acid 10g Pondsnail 264g oyster dishes
224g sanguisorbin II15g mountains edge grass determines alkali 8g asiatic acids 4g；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of insomnia and preparation method thereof
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：Betulic acid 5g Pondsnail 268g oyster dishes
222g sanguisorbin II16g mountains edge grass determines alkali 7g asiatic acids 5g；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of insomnia and preparation method thereof
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：Betulic acid 15g Pondsnail 262g oyster dishes
226g sanguisorbin II13g mountains edge grass determines alkali 9g asiatic acids 3g；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 138g of Example 1, adds starch 128g, mixes, and granulation is dried, plus microcrystalline cellulose 72g, stearic
Sour magnesium 3g, mixes, and is pressed into 1500, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 158g of Example 2, adds starch 271g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid
Magnesium, mixes, and encapsulated 1000, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 130g water-baths and boil molten, add the pharmaceutical composition 10g of embodiment 3, fully stir
Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is -2 DEG C, and drip internal-and external diameter is 7.0/
2.0 (mm/mm), drip is 2.0cm away from liquid level, and drop speed is optimum condition with every point 48 drop, and the cold of dripping pill surface is blotted with cotton
Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7：Treat the pharmaceutical composition of insomnia
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：
The weight portion sanguisorbin II25 weight portions mountain edge grass of betulic acid 22 determines the weight portion of 35 weight portion asiatic acid of alkali 1.
Embodiment 8：Treat the pharmaceutical composition of insomnia
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：
The weight portion sanguisorbin II15 weight portions mountain edge grass of betulic acid 35 determines the weight portion of 20 weight portion asiatic acid of alkali 2.
Embodiment 9：Treat the pharmaceutical composition of insomnia
Treat insomnia pharmaceutical composition bulk drug composition and weight portion be：
The weight portion sanguisorbin II10 weight portions mountain edge grass of betulic acid 26 determines the weight portion of 5 weight portion asiatic acid of alkali 4.
Experimental example 1：Treat the experimental study of insomnia
1 material and method
1.1 experiment materials
Pharmaceutical composition, the pharmaceutical composition of embodiment 1（Lot number 20080615）.
Experimental animal：The cleaning grade ICR healthy male mices that Shanghai Slac Experimental Animal Co., Ltd. provides, license
Card number:SCXK (Shanghai) 2007-0005,18~21g of body weight.Animal is divided into 3 experimental groups by this experiment, and first group is carried out
Direct sleep experiments carry out yellow Jackets sub-threshold dose hypnosis reality with extension yellow Jackets length of one's sleep experiment, second group
Test, the 3rd group carry out barbital sodium Sleep latency experiment.Each experimental group by 40 mouse by body weight be randomly divided into 4 it is small
Group, every group of 10 animals.Feed is purchased from Shanghai Slac Experimental Animal Co., Ltd., and Feed Manufacturing examines quality certification number:
Raise and examine (2008) 04002 in Shanghai.
1.2 dosage choices
This research sets 0.25,0.50 and 3 dosage groups of 1.50g/kg body weight, basic, normal, high dosage group respectively by 12.5,25,
75mg/ml concentration is prepared, and it is blank control group separately to set distilled water.
1.3 methods of administration
Animal is weighed daily, and by the oral gavage of 2.0mL/100g body weight, continuous 30 days.
1.4 instruments and reagent
Stopwatch, yellow Jackets, barbital sodium.
1.5 experimental data statistical methods
The experimental data software statistics of SPSS 10.0, measurement data one-way analysis of variance, through homogeneity test of variance, side
The neat experimental data of difference carries out statistical analysis using LSD methods, and variable is first carried out to heterogeneity of variance or nonnormal experimental data
Conversion is counted again；Enumeration data χ2Inspection.
1.6 experimental techniques
1.6.1 direct sleep experiments
After not secondary gavage, see whether sleep phenomenon occur, sleep with righting reflex loss as index.When mouse is placed in dorsal position
When, can right immediately body position, such as more than 60s can not the person of righting, that is, righting reflex loss is thought, into sleep.Righting reflex is extensive
Animal awakening is again, and righting reflex loss is the animal sleep time to this period is recovered, and records control group and each dosage group
Sleep number of animals and the length of one's sleep.
1.6.2 extension yellow Jackets length of one's sleep experiment
It is in each group animal intraperitoneal injection 45mg/kg body weight yellow Jackets, injection volume after last gavage 15min, are given
0.2mL/20g body weight, is sleep criterion with righting reflex loss, and whether observation given the test agent extends yellow Jackets sleep
Time.
1.6.3 yellow Jackets sub-threshold dose hypnosis experiment
It is in each group animal intraperitoneal injection 30mg/kg body weight yellow Jackets, injection volume after last gavage 15min, are given
0.2mL/20g body weight, with righting reflex loss up to more than 1min for sleep criterion, sleep number of animals in record 30min.
1.6.4 barbital sodium Sleep latency experiment
In after last gavage 15min, each group animal intraperitoneal injection 280mg/kg body weight barbital sodiums are given, injection volume is 0.2mL/
20g body weight, with righting reflex loss as index, influence of the observation given the test agent to barbital sodium Sleep latency.
2 results
2.1 tested materials are directly slept Functional observation result to mouse
The results are shown in Table 1.
Observation result of the tested material of table 1 to the direct sleep effect of mouse
| Group | Number of animals | Original body mass (g) | Opisthosoma weight (g) | Sleep number of animals | Time for falling asleep (s) |
| Control group | 12 | 19.5±1.3 | 38.6±1.7 | 0 | 0 |
| Low dose group | 12 | 19.6±1.4 | 38.8±1.9 | 0 | 0 |
| Middle dose group | 12 | 19.4±1.3 | 38.8±1.5 | 0 | 0 |
| High dose group | 12 | 19.6±1.4 | 38.7±1.7 | 0 | 0 |
Each dosage group sleep number of animals and the length of one's sleep are 0, (P ＞ not statistically significant with control group comparing difference
0.05)。
Influence of 2.2 tested materials to the yellow Jackets inducing mouse length of one's sleep
The tested material can extend the length of one's sleep of the middle and high dosage group mouse of yellow Jackets hypnosis, with control group comparing difference
Statistically significant (P ＜ 0.05) (being shown in Table 2).
Influence of the tested material of table 2 to the yellow Jackets inducing mouse length of one's sleep
| Group | Number of animals | Original body mass (g) | Opisthosoma weight (g) | Time for falling asleep (s) |
| Control group | 12 | 19.0±1.2 | 38.9±2.0 | 1455±165 |
| Low dose group | 12 | 19.1±1.3 | 38.7±2.1 | 1562±173 |
| Middle dose group | 12 | 19.0±1.4 | 38.6±2.2 | 1795±264* |
| High dose group | 12 | 19.3±1.5 | 38.8±1.9 | 1803±266* |
Note：Compare with control group, * P ＜ 0.05.
Influence of 2.3 tested materials to yellow Jackets sub-threshold dose syngignoscism
The results are shown in Table 3.
Influence of the tested material of table 3 to mouse yellow Jackets sub-threshold dose syngignoscism
| Group | Number of animals | Original body mass (g) | Opisthosoma weight (g) | Sleep number of animals | Sleep rate (%) |
| Control group | 12 | 20.0±1.1 | 38.9±2.3 | 2 | 16.7 |
| Low dose group | 12 | 20.2±1.4 | 38.8±2.2 | 1 | 8.3 |
| Middle dose group | 12 | 20.0±1.3 | 38.7±2.1 | 5 | 41.7* |
| High dose group | 12 | 19.9±1.2 | 38.6±2.0 | 6 | 50.0* |
Middle and high dosage group animal sleep number compares with control group, and difference has statistical significance (P<0.05).
Influence of 2.4 tested materials to yellow Jackets sub-threshold dose syngignoscism
The tested material can shorten the dropping asleep latency of the middle and high dosage group mouse of barbital sodium hypnosis, with control group comparing difference
Statistically significant (P ＜ 0.05) (being shown in Table 4).
The influence of table 4 tested material to barbital sodium inducing mouse Sleep latency
| Group | Number of animals | Original body mass (g) | Opisthosoma weight (g) | Sleep latency (min) |
| Control group | 12 | 20.2±1.3 | 39.2±1.8 | 2612±311 |
| Low dose group | 12 | 20.3±1.2 | 39.3±1.9 | 2480±285 |
| Middle dose group | 12 | 20.5±1.2 | 39.2±1.8 | 2056±190* |
| High dose group | 12 | 20.6±1.5 | 39.0±1.7 | 2006±170* |
Note：Compared with control group, * P ＜ 0.05.
Influence of 2.5 tested materials to Mouse Weight
The original body mass Analysis of variance difference of the tested material each group mouse is not statistically significant (P ＞ 0.05), i.e. mouse
Original body mass is more balanced between each group；At the end of experiment, the end of each group mouse is again through statistics, the not statistically significant (P of difference
＞ 0.05), i.e., the tested material on the body weight increase of mouse without influence.
Claims (8)
1. a kind of pharmaceutical composition for treating insomnia, it is characterised in that be made the composition and weight of the bulk drug of the pharmaceutical composition
Part it is：
Betulic acid 5-15 weight portion Pondsnail 262-268 weight portion oyster dish 222-226 weight portion sanguisorbins II13-16
Weight portion mountain edge grass determines alkali 7-9 weight portion asiatic acid 3-5 weight portions.
2. a kind of pharmaceutical composition for treating insomnia according to claim 1, it is characterised in that be made the pharmaceutical composition
The composition and weight portion of bulk drug be：
The weight portion sanguisorbin II15 weight portions mountain edge grass of 10 weight portion Pondsnail of betulic acid, 264 weight portion oyster dish 224
Determine the weight portion of 8 weight portion asiatic acid of alkali 4.
3. a kind of pharmaceutical composition for treating insomnia according to claim 1, it is characterised in that pharmaceutical composition can be used
The conventional method of galenic pharmacy prepares piece agent or capsule or dripping pill.
4. a kind of pharmaceutical composition for treating insomnia according to claim 1, it is characterised in that pharmaceutical composition and chemical drugs
Or the medicament for treating insomnia of Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating insomnia, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Betulic acid 5-15 weight portion Pondsnail 262-268 weight portion oyster dishes 222-226
Weight portion sanguisorbin II13-16 weight portions mountain edge grass determines alkali 7-9 weight portion asiatic acid 3-5 weight portions；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating insomnia according to claim 5, it is characterised in that by following step
It is rapid to prepare：
The composition and weight portion of bulk drug be：The weight portion of 10 weight portion Pondsnail of betulic acid, 264 weight portion oyster dish 224 ground
Elm saponin I I15 weight portions mountain edge grass determines the weight portion of 8 weight portion asiatic acid of alkali 4；
Preparation method：
（1）Betulic acid, Pondsnail, oyster dish, sanguisorbin II, mountain edge grass are taken by bulk drug proportioning and determine alkali, asiatic acid, mix
It is even, with the ethanol of weight percent concentration 22% as solvent, taken in 35 DEG C of temperature extractions, extraction time is 12 times, each extraction time
It is 6 hours, each solvent load is 28 times of bulk drug gross weight, is filtered, obtains dregs of a decoction A and extract solution A, extract solution A reclaims second
Alcohol, is concentrated into relative density 1.11, and filtration, liquid is first washed with water by LK07 large pore resin absorption columns, then with weight hundred
Divide the ethanol solution of specific concentration 46% wash-out LK07 large pore resin absorption columns, collect the ethanol eluate of weight percent concentration 46%, return
Ethanol is received, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 56% as solvent, heating and refluxing extraction 13 times is carried every time
The time is taken for 0.3 hour, each solvent load is 4 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned
Ethanol is received, relative density 1.14 is concentrated into, filtered, liquid is first washed with water by HP-20 large pore resin absorption columns, then with again
Amount percent concentration 88% ethanol solution wash-out HP-20 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 88%
Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating insomnia according to claim 5, it is characterised in that drug regimen
Thing can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating insomnia according to claim 5, it is characterised in that drug regimen
Thing and chemical drugs or Chinese medicine composition medicament for treating insomnia.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611133211.8A CN106727728A (en) | 2016-12-10 | 2016-12-10 | It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611133211.8A CN106727728A (en) | 2016-12-10 | 2016-12-10 | It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106727728A true CN106727728A (en) | 2017-05-31 |
Family
ID=58875887
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201611133211.8A Withdrawn CN106727728A (en) | 2016-12-10 | 2016-12-10 | It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106727728A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106109927A (en) * | 2016-06-30 | 2016-11-16 | 济南星懿医药技术有限公司 | A kind of pharmaceutical composition treating chloasma and preparation method thereof |
| CN106109516A (en) * | 2016-06-30 | 2016-11-16 | 济南星懿医药技术有限公司 | A kind of pharmaceutical composition treating bladder cancer and preparation method thereof |
-
2016
- 2016-12-10 CN CN201611133211.8A patent/CN106727728A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106109927A (en) * | 2016-06-30 | 2016-11-16 | 济南星懿医药技术有限公司 | A kind of pharmaceutical composition treating chloasma and preparation method thereof |
| CN106109516A (en) * | 2016-06-30 | 2016-11-16 | 济南星懿医药技术有限公司 | A kind of pharmaceutical composition treating bladder cancer and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104256632B (en) | A kind of health product improving sleep | |
| CN103405596A (en) | Traditional Chinese medicine for treating sinusitis | |
| CN105998297A (en) | Traditional Chinese medicine composition with effects of moistening intestines and relaxing bowels and preparation method thereof | |
| CN102319294B (en) | Double-vanilla preparation and preparation method thereof | |
| CN103520505B (en) | Traditional Chinese medicine preparation for treating neurasthenia and preparation method thereof | |
| CN102526573A (en) | Medicament for treating child cold | |
| CN105456818A (en) | Traditional Chinese medicine composition containing folium artemisiae argyi and being capable of treating insomnia and preparation method of traditional Chinese medicine composition | |
| CN105519731A (en) | Dried tangerine peel tea effervescent tablet and preparation method thereof | |
| CN104840737B (en) | Chinese medicine composition with qi invigorating and lung moistening effect and its preparation method and application | |
| CN103007145B (en) | Traditional Chinese medicine composition for treating children rotavirus enteritis and preparation method of composition | |
| CN102552440B (en) | Anti-asthmatic and anti-inflammatory medicament and preparation method and application thereof | |
| CN102274428B (en) | Pharmaceutical composition with effect on treating irritable bowel syndrome and preparation method and application thereof | |
| CN106727728A (en) | It is a kind of to treat pharmaceutical composition of insomnia and preparation method thereof | |
| CN102293948A (en) | Preparation for treating children dyspepsia endogenous heat, and preparation method and detection method of preparation | |
| CN104189496A (en) | Traditional Chinese medicine preparation for treating neurasthenia and preparation method thereof | |
| CN115624604B (en) | Traditional Chinese medicine composition for treating climacteric depression and preparation method and application thereof | |
| CN107095977A (en) | A kind of medicament and its pharmaceutical formulation and preparation method with the malicious effect of fire row of dispelling | |
| CN103463401B (en) | Asthma medicine for infants | |
| CN1943657B (en) | A Chinese traditional medicinal composition and its preparation method | |
| CN106177461A (en) | A kind of Chinese medicine and western medicine compound preparation treating neurasthenic syndrome and preparation method | |
| CN105920409A (en) | Medicinal preparation for treating Alzheimer disease and application of medicinal preparation | |
| CN105168397A (en) | Medicine composition for preventing and treating nephrosis | |
| CN105267815A (en) | Spray for treating infant lung-kidney-deficiency type asthma and preparing method thereof | |
| CN104173808B (en) | A kind of Chinese medicine and preparation method thereof for treating flaming-up of the liverfire type hypertension | |
| CN106668121A (en) | Pharmaceutical composition for treating insomnia and preparation method of pharmaceutical composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WW01 | Invention patent application withdrawn after publication | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20170531 |