CN106668121A - Pharmaceutical composition for treating insomnia and preparation method of pharmaceutical composition - Google Patents

Pharmaceutical composition for treating insomnia and preparation method of pharmaceutical composition Download PDF

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CN106668121A
CN106668121A CN201611133212.2A CN201611133212A CN106668121A CN 106668121 A CN106668121 A CN 106668121A CN 201611133212 A CN201611133212 A CN 201611133212A CN 106668121 A CN106668121 A CN 106668121A
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pharmaceutical composition
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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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)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A61K36/355—Lonicera (honeysuckle)
    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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    • A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • 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
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61K2236/39—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
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • 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

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Abstract

The invention discloses a pharmaceutical composition for treating insomnia and a preparation method of the pharmaceutical composition. The pharmaceutical composition is prepared from the raw material medicines of bengal waterdropwort herb, cynanchagenin, Lonicera caerulea and betulinic acid in proportion, can be prepared into various dose forms by virtue of conventional preparation processes and has a remarkable treatment effect to the insomnia.

Description

Treat pharmaceutical composition of insomnia and preparation method thereof
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.
Lonicera caerulea：It is Caprifoliaceae woodbine Lonicera caerulea Lonicera caerulea L.var .edulis Turcdz. the fruit of Ex Herd..Gathered after 8-9 month fruit maturations, dried.【Nature and flavor】Bitter；It is cool in nature.【Indication】Clearly Thermal detoxification；Dissipate carbuncle detumescence.Main furunculosis；Acute mastitis；Acute appendicitis；Erysipelas；Damp-heat dysentery.【Pharmacological action】Antihypertensive effect：Lonicera caerulea is concentrated Every 80ml of fruit juice, duodenal tube administration, the blood pressure to normotensive anesthetized dog has no significant effect, but to drip-feed Adrenalin hydrochloride makes the elevated dog of blood pressure, and 26 minutes blood pressures start slow decline after administration, and 2 hourly averages decline 3.58kPa （27mmHg）, and the hypertension of non-medication group animal is hardly reduced.The characteristics of Lonicera caerulea juice antihypertensive effect is rapid-action, effect It is gentle and lasting, have no adverse reaction.【Former phytomorph】Lonicera caerulea machaka, 1.5m high.Sprout by hair, old branch rufous, Often there is the stipule of big shape plate-like in vigorous branches section portion.Leaf opposite；Petiole is extremely short；Leaf ground paper matter, blade Long Circle, ovate Long Circle, ovum Shape is oval, dilute avette, 2-5cm long, 1-3cm wide, and tip is sharp or slightly blunt, basal circular, the nearly full edge of leaf margin, has cilium, two sides Dredge by raw undercoat, below middle arteries hair it is closeer, it is sometimes several without hair.Total bennet 2-10mm long；Bract bar shaped, 2-3 times of a length of calyx tube； Corolla yellow-white, tubular infundibulate, 1-1.3cm long, outer by pubescence, base portion has shallow capsule, sliver 5；Stamen 5, slightly stretch out corolla it Outward；Style is stretched out outside corolla without hair.Berry is black-and-blue, oval, 1.5cm is about, slightly by white powder.The month at florescence 5-6, fruiting period 8-9 Month.Record in dictionary of medicinal plant.
Mengzi Chinese celery：This product is the herb of Umbelliferae Chinese celery platymiscium Mengzi Chinese celery Oenanthe riuularis Dunn. Summer harvests, and cleans, and dries.【Nature and flavor】Taste is pungent；Micro-sweet；It is mild-natured.【Return through】Return stomach；Spleen；Bladder warp.【Indication】Stomach invigorating disappears Product；Reducing fever and causing diuresis；Subdhing swelling and detoxicating.Main chronic gastritis；Dyspepsia is had a stomachache；Gonorrhoea；Drench pain；Treating swelling and pain by traumatic injury；Deficiency of blood wind toxin.【Proterties】This The many shrinkages of product are agglomerating.Stem is elongated, and few branch, frangible, the complete blade pinnation of leaf-shrinkage, sliver is narrow, linear or ovate Lanceolar, leaf has long handle.Light weight is crisp, and gas is fragrant, taste micro-pungent, hardship.【Former phytomorph】Perennial herb, 30-70cm high.Complete stool Glabrous.Stem is upright, and bottom is crawled, single or have a small number of branches.Petiole 4-6cm long, the wide triangle of blade profile or triangle Shape, 4.5-6cm long, 3.5-6cm wide, a pinniform drastic crack, dilute two times pinnation；The lower portion of the stem leaf sliver is avette, and sliver is returned at end Incise shape sawtooth in 1-1.5cm long, 0.5cm wide, edge；Stem upper leaf end time sliver is linear, full edge.Universal umbel basidixed, Peduncle 2-5cm long；Without phyllary；Umbrella spoke 6-7, upright or development；Involucel piece is linear, most；Umbellule spends 20 Yu Duo；Calyx tooth lanceolar；Petal is from color, obovate；Style basic circle taper, style is upright or fork with.Diachenium is oval, long 2mm, 1mm wide, the middle rib of incline and heel swell, and heel is linear；There is oil pipe 1 in per rib groove, there is oil pipe 2 in symphysis face.Florescence 5-7 Month, the fruiting period 7-8 months.Record in dictionary of medicinal plant.
Goose egg-shell：This product belongs to the ovum of animal man goose Anser cygnoides domestica Brisson. for Anatidae wild goose Shell.During edible goose egg, eggshell is collected, cleaned, dried or dry.【Nature and flavor】It is sweet；It is light；It is flat.【Return through】Lung channel.【Indication】Pull out Malicious apocenosis；Regulating qi-flowing for relieving pain.Main ulcer purulence is burst into hardly possible；Hernia；Difficult labour.【Proterties】Fragment shape is presented, outer surface white is slightly coarse more, It is easily rupturable；Inner surface is smooth, and matter is crisp frangible.Gas is micro-, lightly seasoned.Record in dictionary of medicinal plant.
Qingyanshengenin（Qingyangshengenin）：CAS 84745-94-8, molecular formula C28H36O8, molecular weight 500.58.【Bioactivity】Anti-inflammatory, traumatic injury, it is anticonvulsion.【Ingredient origin】Asclepiadaceae Cynanchum plant wallich swallowwort root.
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.
2 structures of bulk drug：
Betulic acid（Betulinic acid）Qingyanshengenin（Qingyangshengenin）.
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：
Mengzi Chinese celery 124-128 weight portion goose egg-shell 120-122 weight portion Qingyanshengenin 12-16 weight portion Lonicera caeruleas 110-118 weight portion betulic acid 6-8 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 of 14 weight portion Lonicera caerulea of Mengzi Chinese celery 126 weight portion goose egg-shell, 121 weight portion Qingyanshengenin 114 The weight portion of betulic acid 7.
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：Mengzi Chinese celery 124-128 weight portion goose egg-shell 120-122 weight portion Cynanchum otophyllum Schneids Aglycon 12-16 weight portion Lonicera caerulea 110-118 weight portion betulic acid 6-8 weight portions；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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 of 126 weight portion goose egg-shell of Mengzi Chinese celery, 121 weight portion Qingyanshengenin 14 The weight portion of 114 weight portion betulic acid of amount part Lonicera caerulea 7；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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：Chinese celery 126g goose egg-shells 121g is blue or green for Mengzi Sun ginseng aglycon 14g Lonicera caerulea 114g betulic acids 7g；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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：Chinese celery 124g goose egg-shells 122g is blue or green for Mengzi Sun ginseng aglycon 12g Lonicera caerulea 118g betulic acids 6g；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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：Chinese celery 128g goose egg-shells 120g is blue or green for Mengzi Sun ginseng aglycon 16g Lonicera caerulea 110g betulic acids 8g；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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 100g of Example 1, adds starch 200g, mixes, and granulation is dried, plus microcrystalline cellulose 100g, stearic Sour magnesium 10g, mixes, and is pressed into 1000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 100g of Example 2, adds starch 300g, 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 100g water-baths and boil molten, add the pharmaceutical composition 15g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 3 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.5cm away from liquid level, and drop speed is optimum condition with every point 60 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Experimental example 1：Treat the experimental study of insomnia
1 material and method
1.1 experiment material
Pharmaceutical composition, the pharmaceutical composition of embodiment 1（Lot number 20080724）.
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 choice
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 method 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 technique
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 is tested
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 19.2±1.0 38.5±1.5 0 0
Low dose group 12 19.1±1.1 38.6±1.8 0 0
Middle dose group 12 19.2±1.2 38.7±1.7 0 0
High dose group 12 19.3±1.2 38.8±1.6 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 19.4±1.1 38.0±1.8 1468±168
Low dose group 12 19.2±1.2 38.8±2.1 1544±169
Middle dose group 12 19.3±1.3 38.2±2.3 1786±275*
High dose group 12 19.2±1.1 38.4±1.9 1790±256*
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 20.2±1.2 38.6±2.1 2 16.7
Low dose group 12 20.3±1.1 38.5±2.1 2 16.7
Middle dose group 12 20.1±1.1 38.4±2.2 4 33.3*
High dose group 12 20.3±1.3 38.4±2.3 5 41.7*
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 20.3±1.2 39.0±1.9 2634±306
Low dose group 12 20.2±1.1 39.1±1.8 2512±287
Middle dose group 12 20.4±1.3 38.9±1.7 2122±188*
High dose group 12 20.5±1.4 39.0±2.0 2034±177*
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：
Mengzi Chinese celery 124-128 weight portion goose egg-shell 120-122 weight portion Qingyanshengenin 12-16 weight portion Lonicera caeruleas 110-118 weight portion betulic acid 6-8 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 of 14 weight portion Lonicera caerulea of Mengzi Chinese celery 126 weight portion goose egg-shell, 121 weight portion Qingyanshengenin 114 The weight portion of betulic acid 7.
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：Mengzi Chinese celery 124-128 weight portion goose egg-shell 120-122 weight portion Cynanchum otophyllum Schneids Aglycon 12-16 weight portion Lonicera caerulea 110-118 weight portion betulic acid 6-8 weight portions；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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 of 126 weight portion goose egg-shell of Mengzi Chinese celery, 121 weight portion Qingyanshengenin 14 The weight portion of 114 weight portion betulic acid of amount part Lonicera caerulea 7；
Preparation method：
（1）Mengzi Chinese celery, goose egg-shell, Qingyanshengenin, Lonicera caerulea, betulic acid are taken by bulk drug proportioning, is mixed, with weight hundred Divide the ethanol of specific concentration 35% as solvent, taken in 37 DEG C of temperature extractions, extraction time is 10 times, 17 hours each extraction times, every time Solvent load is 17 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.08, filtration, liquid is first washed with water by LKS02 large pore resin absorption columns, then with the second of weight percent concentration 26% Alcoholic solution elutes LKS02 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 26%, reclaims ethanol, and concentration is dry It is dry, obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 57% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.4 hour, each solvent load is 20 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 1.12 is concentrated into, filtered, liquid is first washed with water, then use weight by S-8 large pore resin absorption columns The ethanol solution of percent concentration 49% elutes S-8 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 49%, returns Ethanol is received, 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.
CN201611133212.2A 2016-12-10 2016-12-10 Pharmaceutical composition for treating insomnia and preparation method of pharmaceutical composition Withdrawn CN106668121A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106038797A (en) * 2016-06-30 2016-10-26 济南星懿医药技术有限公司 Pharmaceutical composition for preventing and treating bladder cancer
CN106138563A (en) * 2016-06-30 2016-11-23 济南星懿医药技术有限公司 A kind of pharmaceutical composition treating bladder cancer

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106038797A (en) * 2016-06-30 2016-10-26 济南星懿医药技术有限公司 Pharmaceutical composition for preventing and treating bladder cancer
CN106138563A (en) * 2016-06-30 2016-11-23 济南星懿医药技术有限公司 A kind of pharmaceutical composition treating bladder cancer

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Application publication date: 20170517