CN108066471A - A kind of composition for improving sleep and its preparation method and application - Google Patents
A kind of composition for improving sleep and its preparation method and application Download PDFInfo
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- CN108066471A CN108066471A CN201711457558.2A CN201711457558A CN108066471A CN 108066471 A CN108066471 A CN 108066471A CN 201711457558 A CN201711457558 A CN 201711457558A CN 108066471 A CN108066471 A CN 108066471A
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- 231100000027 toxicology Toxicity 0.000 description 1
- 229940125725 tranquilizer Drugs 0.000 description 1
- 239000003204 tranquilizing agent Substances 0.000 description 1
- 229930182493 triterpene saponin Natural products 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 231100000889 vertigo Toxicity 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- YEFOAORQXAOVJQ-UHFFFAOYSA-N wuweizischun A Natural products C1C(C)C(C)(O)CC2=CC(OC)=C(OC)C(OC)=C2C2=C1C=C(OC)C(OC)=C2OC YEFOAORQXAOVJQ-UHFFFAOYSA-N 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
Classifications
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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)
- A61K36/79—Schisandraceae (Schisandra family)
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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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)
- A61K36/57—Magnoliaceae (Magnolia family)
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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)
- A61K36/69—Polygalaceae (Milkwort family)
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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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
-
- 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)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- 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 or decoction
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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
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- 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
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Abstract
The present invention relates to a kind of compositions for improving sleep and preparation method thereof, include the raw material that following parts by weight match：5~50 parts of spina date seed, 5~50 parts of the vine of multiflower knotweed, 5~40 parts of Radix Salviae Miltiorrhizae, 5~40 parts of Radix Polygalae, 5~30 parts of Schisandra chinensis.The complete all medicines in side of the invention coordinate, nourishing yin and nourishing blood, restoring normal coordination between heart and kidney, play the work(of mental-tranquilization altogether.Said composition by the raw material through water extract-alcohol precipitation, concentrate, gained finished product, which can be used as, improves sleep drug or health products, and safe, target user is extensive, convenient to take, has exact effect, is suitble to long-term use.The composition provided by the invention for improving sleep, using Chinese medicine as raw material, half-life period is substantially reduced compared with Western medicine, and bio-toxicity is low, and can effectively avoid drug tolerance and additive.
Description
Technical field
The present invention relates to medicine and technical field of health care food, more particularly to a kind of composition and its system for improving sleep
Preparation Method and application.
Background technology
Insomnia, that is, be insomnia, be ortho cannot be obtained, using the length of one's sleep, depth and dispelling fatigue act on deficiency as
A kind of main illness, is mainly shown as the length of one's sleep, depth deficiency, the lighter's difficulty falling asleep or sleep but not soundly, sometimes sleeping and sometimes waking or
It cannot sleep again after waking up, it is heavy then be insomnia all night, often seriously affect people’s lives quality and health.Body illness such as heart disease, kidney
Disease, asthma, canker, arthritis, osteoarthropathy, enterogastritis, hypertension, sleep apnea syndrome, thyroid function are high
Into, nocturnal myoclonus syndrome, cerebral disease etc. can trigger disease insomnia, strong light in riding vehicle, ship, aircraft or bedroom, noise,
Supercooling or overheat etc. environment change physiological can be caused to have a sleepless night, anxiety, dysphoria, it is depressed or life, work with
Pressure and social environment variation of study etc. can cause the dysfunction of nervous system, cause the dysfunction of brain, cause
Psychological insomnia.At present, sub-health population is more and more, and rhythm of life is progressively accelerated, and people’s lives pressure gradually increases, from
And more and more people is caused to be perplexed by insomnia.Sleep insufficiency is a kind of potential threat to health, the people of insomnia by
In being chronically at sleep insufficiency state, seriously perceptible aspect is caused to change, such as visual field variation, photis, immune function reduction, digestion
Function and hypogona dism, decrease of memory, short-tempered, personality change, can also induce hypertension, coronary heart disease, apoplexy, glycosuria
Disease, women then cause the diseases such as dry skin, menstrual disorder.
Ancient Chinese medicine doctor thinks the etiology and pathogenesis of insomnia using inernal injuries caused by seven emotions as Etiological, the internal organs that are related to not unfaithful intention, spleen,
Liver, courage, kidney, the interpretation of the cause, onset and process of an illness, which always belongs to battalion, to be defended and becomes estranged, and imbalance of yin and yang cannot receive sun for disease this or the deficiency of Yin or the overabundance of yang must not enter the moon.Mesh
Benzodiazepine and non-benzodiazepine sedative hypnotic drugs object are commonly used in preceding western medicine insomnia.Though there is the effect of fine in terms of insomnia is treated,
But it has the following problems：First, there is biological half-life, medicament residue was by second day, the spirit of influence second day and work, two
It is to generate tolerance and additive, long term usage all standing, it may appear that bounce and have a sleepless night and give up effect, form vicious circle.
The content of the invention
For existing treatment insomnia with drug biological half-life length and with tolerance and addicted problem, this hair
It is bright that a kind of composition for improving sleep is provided.
And the present invention also provides a kind of preparation methods for the composition for improving sleep.
And the present invention also provides a kind of composition for improving sleep as the application for improving sleep drug or health products.
To achieve the above object of the invention, the embodiment of the present invention employs following technical solution：
A kind of composition for improving sleep includes the raw material of following parts by weight proportioning：5~50 parts of spina date seed, the vine of multiflower knotweed 5
~50 parts, 5~40 parts of Radix Salviae Miltiorrhizae, 5~40 parts of Radix Polygalae, 5~30 parts of Schisandra chinensis.
Compared with the prior art, Chinese medicine study, hair of the composition provided by the present invention for improving sleep according to insomnia
Cause of disease because and theory of traditional Chinese medical science, with spina date seed, vine of multiflower knotweed nourishing heart is cloudy, beneficial liver blood and antitoxic heart-soothing and sedative, is pacified with Radix Salviae Miltiorrhizae cooling and activating blood, blood-nourishing
God is had one's ideas straightened out with Radix Polygalae eliminating the phlegm, antitoxic heart-soothing and sedative, is aided with Schisandra chinensis and is held back smart nourshing kidney, nourishing generate fluid.The complete all medicine cooperations in side, nourishing yin and nourishing blood,
Restoring normal coordination between heart and kidney plays the work(of mental-tranquilization altogether.In addition, the composition provided by the invention for improving sleep, using Chinese medicine as raw material,
Half-life period is substantially reduced compared with Western medicine, and bio-toxicity is low, and can effectively avoid drug tolerance and additive.
The present invention also provides a kind of preparation method for the composition for improving sleep, the compositions for improving sleep
By the raw material through water extract-alcohol precipitation, concentrate.
The preparation method process is first passed through the extraction that water puies forward promoting active ingredient in raw material, is led to by water extraction and alcohol precipitation method
Crossing alcohol precipitation is extracted the ingredient soluble easily in water and alcohol such as Alkaloids in Plants salt, glucoside, organic acid, amino acid, polysaccharide
Come, remove its insoluble matter, finally obtain clear liquid.By concentrating to control the concentration of product, in favor of being processed further
Or it uses.
The present invention also provides a kind of composition for improving sleep as the application for improving sleep drug or health products.
The present invention is safe, and target user is extensive, convenient to take, has exact effect, is suitable as health food
It is long-term use of.
Specific embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, below in conjunction with specific embodiment, to this
Invention is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, not
For limiting the present invention.
The embodiment of the present invention provides a kind of composition for improving sleep, includes the raw material of following parts by weight proportioning：Wild jujube
5~50 parts of benevolence, 5~50 parts of the vine of multiflower knotweed, 5~40 parts of Radix Salviae Miltiorrhizae, 5~40 parts of Radix Polygalae, 5~30 parts of Schisandra chinensis.
Compared with the prior art, the composition provided by the present invention for improving sleep is reasonable under the guidance of traditional Chinese medical theory
Compatibility, within support outer, by tonifying liver spleen, mental-tranquilization QI invigorating, the physical intelligence of enhancing, the viscera function and qi and blood of patient can be adjusted
The operation of body fluid fundamentally releases sufferer, and giving consideration to both the incidental and fundamental adjusts body health comprehensively, improves the effect of sleeping to reach, fits
Patient is closed to take the long period.In addition, the composition provided by the invention for improving sleep, using Chinese medicine as raw material, half-life period
It is substantially reduced compared with Western medicine, bio-toxicity is low, and can effectively avoid drug tolerance and additive.
Spina date seed is sweet, and taste is put down, the thoughts of returning home, spleen, Liver Channel, antitoxic heart-soothing and sedative, nourishing the liver, arrest sweating.Contain spina date seed soap in spina date seed
A variety of flavonoids active materials such as a variety of saponinses and swertisin, flavonoid glycoside such as glycosides A, B, B1, white firelight or sunlight resin acid, white firelight or sunlight lipidol, also
Containing the mineral elements such as substantial amounts of vitamin C and calcium, zinc, iron, there are many pharmacological actions to tranquilizing soporific, it is emerging maincenter to be inhibited
It puts forth energy, has synergistic effect with a variety of hypnotic sedative agents, can effectively solve the problem that insomnia, promote sleep quality, alleviate headache, dizziness, tired
Phenomena such as exhausted, and the malaise symptoms such as anxiety, anxiety, depression, failure of memory, neurasthenia can be alleviated, and it is secondary without any poison
Effect and dependence, can help people really to realize the sleep of natural health.Spina date seed water-soluble extractive has confrontation
Convulsion effect caused by pentylenetetrazol and confrontation caffeine effect.
The vine of multiflower knotweed is mild-natured, sweet and slightly bitter taste, converge to heart and liver channels, nourishing heart, calms the nerves, dredging collateral, wind-dispelling, can take a tonic or nourishing food to build up one's health cloudy blood, nourishing heart peace
God suitable for insomnia, has no peace of mind, the diseases such as vertigo, hidrosis, deficiency of blood bodily pain, in terms of tranquilizing soporific and amobarbital
Sodium has shared apparent synergistic effect.Anthraquinone analog compound in the vine of multiflower knotweed has apparent inhibition mouse autonomic activities, and increase is slept
The effects that dormancy.The vine of multiflower knotweed matches somebody with somebody spina date seed, can enhance taste the heart-yin, the effect of calming heart god.
Radix Salviae Miltiorrhizae bitter, cold nature, converge to heart and liver channels, promoting blood circulation is inducing meastruation to relieve menalgia, relieving restlessness that clears away heart-fire, cool blood to disappear carbuncle, to maincenter
Nerve has calm and analgesic activity, improves the debilitating insomnia of nerve.Danshensu, Radix Salviae Miltiorrhizae acid, protocatechuic acid and original in Radix Salviae Miltiorrhizae
Youngster looks into the phenolic compounds such as aldehyde, can inhibit mouse autonomic activities, increases sleep.Danshinolic acid has improvement result to memory disorders.It is red
Spina date seed cooperation is participated in available for palpitation and severe palpitation, insomnia.Radix Salviae Miltiorrhizae and Schisandra chinensis compatibility are after decocting, available for treating neurasthenia
Radix Salviae Miltiorrhizae can enhance function for assisting sleep with vine of multiflower knotweed compatibility.Radix Salviae Miltiorrhizae is shared with the vine of multiflower knotweed, can play the synergistic effect for increasing sleep.
Radix Polygalae is warm-natured, bitter, pungent, the thoughts of returning home, kidney, lung channel, tranquilize the mind and promote the intelligence, Xie Yu, property be apt to lead off it is sensible, can happily gas and
Antitoxic heart-soothing and sedative and kidney qi can be led to and strong will is not forgotten, available for insomnia and dreamful sleep caused by breakdown of the normal physiological coordination between the heart and the kidney, forgetful palpitation with fear is wandering.
Triterpene saponin substance in Radix Polygalae, there are many effect, can promote muscle power and intelligence, influence neurotrophic to nervous system
The factor.The natural premise drug containing TMCA, can extend the mouse yellow Jackets length of one's sleep, polygalic acid in Radix Polygalae water extract
F Noncompetition inhibition CAMP phosphodiesterases, can extend hexobarbital administration mouse the length of one's sleep, therefore Radix Polygalae to bar
There is synergistic effect than appropriate class drug.Polygalic acid has dopamine and serotonin receptors antagonist properties in vitro, can be used as peace
Determine the possibility of agent.Radix Polygalae Aqueous extracts Rats With Memory and conduct disorder also caused by basal forebrain nuclear damage have certain reparation
Effect has the function of physique strengthening and intelligence benefiting and the regional metabolism of enhancing brain, has protective effect to brain.
Schisandra chinensis is warm-natured, sour, sweet, distributed in lung channel, the heart channel of Hang-Shaoyin, kidney channel, convergence astringent method, nourishing generate fluid, kidney calming.Schisandra chinensis
Contain schizandrin and vitamin C, resin, tannin and a small amount of carbohydrate.Schisandra chinensis is known as extensive central inhibitory action, and has
The characteristics of stable effect.Deoxyschizandrin in Schisandra chinensis also has tranquilizing effect, and a variety of active ingredients is coordinated in adjusting
Pivot nervous system.Be equal with spina date seed with can be used for heart deficiency of the kidney void caused by dysphoria palpitaition, insomnia and dreamful sleep.Schisandra chinensis can extend bar
It faints from fear than the appropriate length of one's sleep, confrontation electroconvulsive shock and chemically, effect is similar to tranquilizer.Still there are analgesic activity, work of flaccid muscles
With.
The embodiment of the present invention also provides a kind of preparation method for the composition for improving sleep, the composition for improving sleep
By the raw material through water extract-alcohol precipitation, concentrate.
The preparation method process is first passed through the extraction that water puies forward promoting active ingredient in raw material, is led to by water extraction and alcohol precipitation method
Crossing alcohol precipitation is extracted the ingredient soluble easily in water and alcohol such as Alkaloids in Plants salt, glucoside, organic acid, amino acid, polysaccharide
Come, remove its insoluble matter, finally obtain clear liquid.By concentrating to control the concentration of product, in favor of being processed further
Or it uses.
Specifically, the step is：
Step a, each raw material components are weighed by raw material proportioning, is filtered after extracting in water, concentrated；
Step b, add in ethyl alcohol, stand, take supernatant, by the supernatant concentrate to get；
It is further preferred that in being extracted described in the step a, the method for the extraction is extracted to decoct, the extraction
Number for 2~3 times, every time 2~3 it is small when, each dosage of the water is 6~10 times of the gross mass of the raw material, extraction
After filter, merging filtrate.The extracting method can form funneling effect by repeatedly decocting decocting solution, accelerate extract
The dissolution of middle active ingredient improves extraction efficiency.
It is further preferred that concentration described in the step a to be concentrated under reduced pressure, be concentrated into relative density for 1.10~
1.40, it is possible to reduce ethanol consumption if liquid is excessively dilute, need to use substantial amounts of ethyl alcohol, so as to cause to waste, if overrich, during alcohol precipitation
It is present with a large amount of precipitation little Yi package active ingredients, causes damages.
It is further preferred that it is that the mixed liquor after addition ethyl alcohol is made to be reached containing amount of alcohol that ethyl alcohol is added in described in the step b
To 40~60wt%, which can make the macromolecule impurity in solution be precipitated and stay in precipitation.
It is further preferred that the temperature stood described in the step b is 8~12 DEG C, the time is 12~36h.Low temperature can
To promote that the sedimentation of precipitation is precipitated, make solution boundary apparent, convenient for the operation of Aspirate supernatant, by adding in ethyl alcohol sufficient standing
After precipitation, low molecule active ingredient is still dissolved in dilute alcohol solution, and macromolecule impurity is then precipitated and stays in precipitation, so as to obtain essence
The supernatant of system.
It is further preferred that concentration described in the step b to be concentrated under reduced pressure, be concentrated into relative density for 1.05~
1.40, concentration increases in solution after concentration, convenient for a variety of oral formulations are made.
Oral system is made it is further preferred that being further included in the preparation method and excipient being added into step b products therefroms
Agent, the oral formulations include hard capsule, soft capsule, tablet, granule, powder, pill, oral liquid.Oral system is made
It is more convenient for taking after agent.
In order to better illustrate embodiment of the present invention, illustrated below by embodiment is further.
Embodiment 1
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 40g, vine of multiflower knotweed 40g, Radix Salviae Miltiorrhizae 30g, Radix Polygalae 30g, Schisandra chinensis 25g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 3h are weighed by raw material proportioning, each amount of water is that raw material is total
6 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 60%, and when 10 DEG C of standings 12 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；After gained medicinal extract is spray-dried, dextrin 10g and magnesium stearate 1g is added in, mixes to uniform, pours into glue
Hard capsule is made in capsule.
Embodiment 2
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 30g, Radix Salviae Miltiorrhizae 15g, Radix Polygalae 15g, Schisandra chinensis 10g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
10 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 16 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；Vegetable oil 15g and beeswax 6g is added in, mixes to uniform, is pressed into soft capsule, soft capsule is made.
Embodiment 3
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 10g, Radix Salviae Miltiorrhizae 15g, Radix Polygalae 25g, Schisandra chinensis 25g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 14 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；After gained medicinal extract is spray-dried, dextrin 8g and starch 4g is added in, is mixed to uniform, tabletting, piece is made
Agent.
Embodiment 4
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 40g, Radix Salviae Miltiorrhizae 10g, Radix Polygalae 20g, Schisandra chinensis 5g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 3h are weighed by raw material proportioning, each amount of water is that raw material is total
10 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 18 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；Dextrin 7g is added in, is mixed to uniform, wet granulation, up to granule after drying.
Embodiment 5
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 30g, Radix Salviae Miltiorrhizae 20g, Radix Polygalae 20g, Schisandra chinensis 15g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
6 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 60%, and when 10 DEG C of standings 20 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；Starch 12g and honey 8g is added in, is mixed to uniform, pill, pill is made.
Embodiment 6
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 30g, Radix Salviae Miltiorrhizae 30g, Radix Polygalae 30g, Schisandra chinensis 30g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 24 are small, Aspirate supernatant depressurizes dense
Contraction obtains medicinal extract；After gained medicinal extract is spray-dried, divide pouch-packaged, powder is made.
Embodiment 7
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 50g, vine of multiflower knotweed 50g, Radix Salviae Miltiorrhizae 40g, Radix Polygalae 40g, Schisandra chinensis 30g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 24 are small, Aspirate supernatant depressurizes dense
Contraction obtains concentrate；It adds in honey 8g, Aspartame 0.3g, sodium benzoate 0.007g, after mixing, adds in purified water 12g dilutions,
Deployed liquid boils, refrigerated overnight, filtering, filling, and oral liquid is made in sterilizing.
Embodiment 8
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 30g, vine of multiflower knotweed 30g, Radix Salviae Miltiorrhizae 30g, Radix Polygalae 30g, Schisandra chinensis 15g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 24 are small, Aspirate supernatant depressurizes dense
Contraction obtains concentrate；It adds in honey 7.5g, Aspartame 0.2g, sodium benzoate 0.008g, after mixing, it is dilute to add in purified water 13g
It releases, deployed liquid boils, refrigerated overnight, filtering, filling, and oral liquid is made in sterilizing.
Embodiment 9
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 20g, vine of multiflower knotweed 20g, Radix Salviae Miltiorrhizae 10g, Radix Polygalae 10g, Schisandra chinensis 5g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 24 are small, Aspirate supernatant depressurizes dense
Contraction obtains concentrate；It adds in honey 10g, Aspartame 0.4g, sodium benzoate 0.005g, after mixing, it is dilute to add in purified water 10g
It releases, deployed liquid boils, refrigerated overnight, filtering, filling, and oral liquid is made in sterilizing.
Embodiment 10
An embodiment of the present invention provides a kind of compositions for improving sleep, include the raw material that following parts by weight match：Acid
Jujube kernel 40g, vine of multiflower knotweed 40g, Radix Salviae Miltiorrhizae 25g, Radix Polygalae 25g, Schisandra chinensis 20g.
Preparation method：
Step a, each raw material components, extracting in water 2 times, each 2h are weighed by raw material proportioning, each amount of water is that raw material is total
8 times of weight, filtering merge extracting solution, are concentrated under reduced pressure into dilute cream；
Step b, adding in ethyl alcohol makes mixed liquor alcohol content reach 40%, and when 10 DEG C of standings 24 are small, Aspirate supernatant depressurizes dense
Contraction obtains concentrate；It adds in honey 12.5g, Aspartame 0.5g, sodium benzoate 0.004g, after mixing, it is dilute to add in purified water 8g
It releases, deployed liquid boils, refrigerated overnight, filtering, filling, and oral liquid is made in sterilizing.
Embodiment 11
Present embodiments provide a kind of toxicological experiment for the composition for improving sleep.Test specimen：Mouth prepared by embodiment 7
Take liquid.
1st, acute toxicity test in mice：Cleaning grade Kunming mouse 20 is selected, 18~22 grams of weight, half male and half female is pressed
MTD methods are tested.Dosage is 15000mg/kg.bw (using distilled water as solvent, similarly hereinafter), using isometric administration by gavage
Interior gavage when small of (0.2ml/10g.bw) 24, is observed continuously two weeks.Record poisoning manifestations and death condition.
2nd, rat acute toxicity test：Select cleaning grade SD rats 20,180~220 grams of weight, half male and half female, by MTD
Method is tested.Dosage is 15000mg/kg.bw, using isometric administration by gavage (0.2ml/10g.bw) 24 it is small when interior once fill
Stomach is observed continuously two weeks.Record poisoning manifestations and death condition.
3rd, genetic toxicity test：
(1) Salmonella reversion test：This experiment uses tablet incorporation methods, is divided to plus with being not added with two kinds of S-9 mixed liquors.Dosage is respectively
0.005th, 0.025,0.25,1.0,5.0mg/ wares, separately set blank control, solvent control (distilled water) and positive controls.It is positive
Control group uses 2-AF20ug/ wares, 2,4,7-TNFone1ug/ wares, NaN32.5ug/ wares, mitomycin C 4.0ug/ wares, 1,8-
Dihydroxy anthraquinone 50ug/ wares, each dosage group make 3 plates, and repetition is done twice.Strain for T A97 (a), T A98, T A100,
Tetra- plants of bacterium of TA102.
(2) mice bone marrow micronucleus：Selection cleaning grade Kunming mouse 50,25-30 grams of weight,
It is randomly divided into five groups, every group 10, half male and half female；If three dosage groups：2500th, 5000,10000mg/kg weight, while set the moon
Property control group (distilled water) and positive controls (CP 40mg/kg), each group be spaced 24 it is small when twice to sample, give sample second
Bone marrow of sternum film-making is taken when 6 is small afterwards, every animal counts 1000 polychromatic erythrocytes, calculates its microkernel incidence.
(3) mouse inbred strain：Cleaning grade male Kunming strain mice 25 is selected, 30-35 grams of weight is randomly divided into
Five groups, every group five；If three dosage groups：2500th, 5000,10000mg/kg weight, while set negative control group (distilled water)
It is continuous orally to give sample 5 days with positive controls (CP 40mg/kg).Animal is put to death to sample meter within the 35th day, take bilateral attached from for the first time
Testis film-making, every animal count 1000 sperms, calculate abnormal rate.
(4) 30 days feeding trials：Cleaning grade SD rats 80, weight 50-70g are selected, half male and half female is random to be grouped, single
Cage is raised.Tested material sets three test doses, and respectively 2.5g/kg weight, 5.0g/kg weight, 10.0g/kg weight (are equivalent to
100 times of recommended amounts), if a negative control group.Tested material is incorporated into feeding each group animal in basal feed respectively, continuously
30 days.The food-intake of rat is calculated by the 10% of its weight, and contained tested material is respectively 2.5%, 5.0%, 10.0% in feed,
Negative control group only gives basal feed.The equal ad lib of each group animal and drinking-water during nursing claim weekly mouse weight and record feeding
Expect consumption once, experiment latter stage adopts tail blood and carries out hematology and biochemical analysis.Observation index has growth and development, food profit
It is (after separation serum complete using corresponding reagent box and F1 types with, hematological examination (being measured using blood counting instrument), biochemical analysis
Automatic biochemistry analyzer measures).It tests latter stage and puts to death rat, solution takes liver,spleen,kidney, testis (ovary) is weighed, and calculates internal organs system
Then number carries out histopathologic examination's (paraffin section) to liver, kidney, stomach, intestines.
Originally the experimental results showed that, the present composition is all higher than 15000mg/ to the MTD of the big mouse of two kinds of genders
Kg.bw illustrates product nontoxicity；Three mutagenicity test results are negative；30 days feeding trial indices of rat are showed no
It is abnormal.
Embodiment 12
Present embodiments provide a kind of pharmacodynamic study experiment of composition for improving sleep.
1st, experimental animal：Cleaning grade female KM kind mouse, 18~22g of weight.
2nd, laboratory sample：The fine powder of medicinal extract after drying obtained by 2 step b of embodiment；Claming capsule, Jilin Province's Kang Fu medicines
Industry, lot number 20100104.
3rd, dosage selects：Daily 1.0g/kg.bw is low dosage to mouse, then respectively sets one by 2 times of low dosage and 3 times
A dosage group, i.e. 2.0g/kg.bw (middle dosage) and 3.0g/kg.bw (high dose)；Blank group is to distilled water；Control group, which is given, pacifies
Refreshing capsule 1.25g/kg.bw, continuous isometric gavage tested material 21 days, measures each index.
4th, experimental method：
(1) the mouse sleep time experiment of yellow Jackets induction is extended：Last gives distilled water blank group, claming capsule
Yellow Jackets 80mg/kg.bw, injection volume 0.2ml/ is injected intraperitoneally after forty minutes, to each group animal in control group and tested material
20g, using righting reflex loss as index, record tested material extends the yellow Jackets length of one's sleep.
(2) yellow Jackets sub-threshold dose hypnosis test：Last give distilled water blank group, claming capsule control group and by
It tries object after forty minutes, yellow Jackets maximum sub-threshold dose 70mg/kg.bw is injected intraperitoneally to each group animal, injection volume is
0.2ml/20g, with righting reflex loss 1 minute and above for standard, sleep number of animals in record 30 minutes.
5th, result
(1) to the influence of mouse weight, it the results are shown in Table 1：
1 each group mouse weight table of table
Table 1 the result shows that, the present composition of orally administration mouse doses 21 days, weight and claming capsule pair
Compare that there was no significant difference according to group, blank group, illustrate this composition on mouse weight without influence.
(2) extend the experiment of the yellow Jackets inducing mouse length of one's sleep, the results are shown in Table 2：
Influence of the table 2 to the extension yellow Jackets inducing mouse length of one's sleep
* the P ＜ 0.05 compared with blank group
By table 2 as it can be seen that the present composition of orally administration mouse various dose 21 days, the length of one's sleep middle and high dosage
Group is apparently higher than blank group and with significant difference.
(3) yellow Jackets sub-threshold dose hypnosis test, the results are shown in Table 3：
Influence of the table 3 to sub-threshold dose yellow Jackets inducing mouse sleep incidence
* the P ＜ 0.05 compared with water blank group
By table 3 as it can be seen that the present composition of orally administration mouse various dose 21 days, sleep incidence high dose group are bright
It is aobvious to be higher than control group and with significant difference (P ＜ 0.05).
Conclusion：The present composition of orally administration mouse various dose 21 days can be obviously prolonged yellow Jackets induction
Mouse sleep time, improve the mice sleep incidence of sub-threshold dose yellow Jackets induction, can determine that said composition has
Improve sleep effect.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
Any modification, equivalent substitution or improvement made within refreshing and principle etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of composition for improving sleep, it is characterised in that：Include the raw material of following parts by weight proportioning：Spina date seed 5~50
Part, 5~50 parts of the vine of multiflower knotweed, 5~40 parts of Radix Salviae Miltiorrhizae, 5~40 parts of Radix Polygalae, 5~30 parts of Schisandra chinensis.
2. the composition according to claim 1 for improving sleep, it is characterised in that：Include the original of following parts by weight proportioning
Material：10~40 parts of spina date seed, 10~40 parts of the vine of multiflower knotweed, 10~30 parts of Radix Salviae Miltiorrhizae, 10~30 parts of Radix Polygalae, 5~25 parts of Schisandra chinensis.
3. the composition according to claim 1 for improving sleep, it is characterised in that：Include the original of following parts by weight proportioning
Material：20~40 parts of spina date seed, 20~40 parts of the vine of multiflower knotweed, 10~25 parts of Radix Salviae Miltiorrhizae, 10~25 parts of Radix Polygalae, 5~20 parts of Schisandra chinensis.
4. the composition according to claim 1 for improving sleep, it is characterised in that：Include the original of following parts by weight proportioning
Material：35 parts of spina date seed, 30 parts of the vine of multiflower knotweed, 20 parts of Radix Salviae Miltiorrhizae, 20 parts of Radix Polygalae, 15 parts of Schisandra chinensis.
5. the composition according to claim 1 for improving sleep, it is characterised in that：Include the original of following parts by weight proportioning
Material：30 parts of spina date seed, 30 parts of the vine of multiflower knotweed, 15 parts of Radix Salviae Miltiorrhizae, 15 parts of Radix Polygalae, 10 parts of Schisandra chinensis.
6. a kind of claim 1-5 any one of them improves the preparation method of the composition of sleep, which is characterized in that described to change
The composition of kind sleep by the raw material through water extract-alcohol precipitation, concentrate.
7. the preparation method of the composition according to claim 6 for improving sleep, which is characterized in that specifically include following step
Suddenly：
Step a, each raw material components are weighed by raw material proportioning, is filtered after extracting in water, concentrated；
Step b, add in ethyl alcohol, stand, take supernatant, by the supernatant concentrate to get.
8. the preparation method of the composition according to claim 7 for improving sleep, which is characterized in that institute in the step a
State in extraction, the method for the extraction is extracted to decoct, and the number of the extraction is 2~3 times, every time 2~3 it is small when, the water
Each dosage be 6~10 times of gross mass of the raw material, filtered after extraction, merging filtrate；And/or
Concentration described in the step a is concentrated into relative density as 1.10~1.40 to be concentrated under reduced pressure；And/or
It is that the mixed liquor after addition ethyl alcohol is made to reach 40~60wt% containing amount of alcohol that ethyl alcohol is added in described in the step b；And/or
The temperature stood described in the step b is 8~12 DEG C, and the time is 12~36h；And/or
Concentration described in the step b is concentrated into relative density as 1.05~1.40 to be concentrated under reduced pressure.
9. the preparation method of the composition according to claim 7 for improving sleep, which is characterized in that further include to step b
Excipient is added in products therefrom, oral formulations are made, the oral formulations include hard capsule, soft capsule, tablet, particle
Agent, powder, pill, oral liquid.
10. any one of the claim 1-5 compositions for improving sleep are as the application for improving sleep drug or health products.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101032560A (en) * | 2006-07-15 | 2007-09-12 | 广西玉林制药有限责任公司 | Chinese medicine composition for treating somnipathy and preparing method thereof |
| CN101062161A (en) * | 2007-05-29 | 2007-10-31 | 沈信堂 | Traditional Chinese medicine for curing neurasthenia |
| CN102397351A (en) * | 2010-09-10 | 2012-04-04 | 北京润德康医药技术有限公司 | Traditional Chinese medicine composition for treating insomnia |
| CN106038792A (en) * | 2016-07-19 | 2016-10-26 | 国药集团同济堂（贵州）制药有限公司 | Medicinal composition for treating insomnia and preparation method thereof |
| CN106344677A (en) * | 2016-12-05 | 2017-01-25 | 张广生 | Ointment for treating neurasthenia |
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- 2017-12-28 CN CN201711457558.2A patent/CN108066471A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101032560A (en) * | 2006-07-15 | 2007-09-12 | 广西玉林制药有限责任公司 | Chinese medicine composition for treating somnipathy and preparing method thereof |
| CN101062161A (en) * | 2007-05-29 | 2007-10-31 | 沈信堂 | Traditional Chinese medicine for curing neurasthenia |
| CN102397351A (en) * | 2010-09-10 | 2012-04-04 | 北京润德康医药技术有限公司 | Traditional Chinese medicine composition for treating insomnia |
| CN106038792A (en) * | 2016-07-19 | 2016-10-26 | 国药集团同济堂（贵州）制药有限公司 | Medicinal composition for treating insomnia and preparation method thereof |
| CN106344677A (en) * | 2016-12-05 | 2017-01-25 | 张广生 | Ointment for treating neurasthenia |
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