CN106031772A - Composition having sleep improving function, and preparation method thereof - Google Patents
Composition having sleep improving function, and preparation method thereof Download PDFInfo
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- CN106031772A CN106031772A CN201510115279.2A CN201510115279A CN106031772A CN 106031772 A CN106031772 A CN 106031772A CN 201510115279 A CN201510115279 A CN 201510115279A CN 106031772 A CN106031772 A CN 106031772A
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- radix salviae
- salviae miltiorrhizae
- ziziphi spinosae
- semen
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Abstract
The present invention discloses a composition having a sleep improving function, and a preparation method thereof. The composition is prepared from gastrodia elata, a ziziphus jujuba mill.var.spinosa extract, a platycladus orientalis seed extract, and a salvia miltiorrhiza extract according to a certain weight ratio, and can be prepared into any one of commonly used preparations, preferably oral preparations. The composition of the present invention has the sleep improving function.
Description
Technical field
The present invention relates to a kind of there is compositions improving sleep function and preparation method thereof, belong to health food
Technical field.
Background technology
Increasingly violent along with social competition, the quickening of work rhythm, insomniac's number showed increased, insomnia
Just drastically influence the life of people, work and physical and mental health, become people life in a kind of common disease and
The inducement of other body illnesses, therefore sleep quality problem is increasingly paid close attention to by people.
Sleep is a kind of most basic physiological behavior, is also to ensure able-bodied essential condition.Abundance, high
The sleep of quality can effectively recover the muscle power of people and mental, makes human body keep good state.Sleep disorder
Refer to exception and the exception of sleep matter of amount of sleep or when sleep, some clinical symptoms occur, as sleep reduces
Or hypersomnia, sleep walking etc., wherein most commonly seen with insomnia.Insomnia is a kind of chronic disease, and sickness rate is high,
Treatment difficulty, insomnia may result in fatigue, absent minded, reduces working and learning efficiency.Have a strong impact on people
Orthobiosis.Long-term insomnia can also result in anxiety, depression, endocrine disturbance, neural official can syndrome
Deng.Western medicine sleeping quasi drugs toxic and side effects is relatively big at present, can produce certain dependence while treatment insomnia
Property, therefore seek the effective and safe and reliable health food improving sleep function and become health food development
One and important developing direction.Natural health care with Chinese herbal medicine as raw material, has definite
Health-care effect, and safety is high, can long-term taking, it is possible to meet the demand of people's daily health caring.Therefore,
Develop natural high-quality, competitive improvement sleep health food, good market prospect will be had.
Applicant retrieves Application No. 201310055945.9 " Rhizoma Gastrodiae Semen Ziziphi Spinosae complex capsule " (hereinafter referred to as
" existing patented technology ") it is technology immediate with the present invention.The present invention compares therewith, Rhizoma Gastrodiae in prescription
Use pharmaceutical decocting piece, preparation technology is directly ground to Rhizoma Gastrodiae powder and is used as medicine；Radix Salviae Miltiorrhizae extract is used to replace existing
Having the Poria extract in patented technology, Semen Ziziphi Spinosae is the key medicine for the treatment of insomnia in the present invention, and Semen Platycladi is also
The basic pharmaceutical of relieving insomnia, compatibility Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae can mutual Synergistic, common play improvement and sleep
Sleep, improve the effect of sleep quality；The drug effect of the two is compared by the present invention simultaneously, and result shows, this
Invent the technology contents claimed with existing patented technology entirely different, and the present composition is slept in improvement
Dormancy aspect is better than this existing patented technology.
Summary of the invention
It is an object of the present invention to provide a kind of compositions having and improving sleep function.
Another object of the present invention there is provided the preparation method of said composition.
The present invention is achieved by the following technical solutions:
The present invention is made up of the raw material of following weight parts:
Rhizoma Gastrodiae 10-70 part, Semen Ziziphi Spinosae extract 3-40 part, Semen Platycladi extract 1-30 part, Radix Salviae Miltiorrhizae extract
Thing 15-50 part.
It is preferably:
Rhizoma Gastrodiae 20-50 part, Semen Ziziphi Spinosae extract 5-20 part, Semen Platycladi extract 3-15 part, Radix Salviae Miltiorrhizae extract
Thing 10-30 part.
More preferably:
33.3 parts of Rhizoma Gastrodiae, Semen Ziziphi Spinosae extract 10 parts, Semen Platycladi extract 8 parts, Radix Salviae Miltiorrhizae extract 20 parts.
In the present invention, the mechanism of action of each component is as follows:
Rhizoma Gastrodiae: for the dry tuber of orchid Rhizoma Gastrodiae Gastrodia elata B1..Its property is sweet, flat, returns
Liver Channel.There is endogenous wind stopping relieving convulsion, suppressing liver-YANG, effect of dispelling wind and removing obstruction in the collateral.For infantile convulsion, epilepsy clonus,
Tetanus, has a dizzy spell, hands and feet caused by paralysis, numb limbs and tense tendons, rheumatic arthralgia.Modern pharmacological research shows Rhizoma Gastrodiae
There is the pharmacological actions such as convulsion, hypnotic, antiinflammatory, enhancing immunologic function and slow down aging.
The research Rhizoma Gastrodiae such as Qi Lijuan improves in the experimentation of sleep function, selects Healthy female kunming mice every
It per os gavage Rhizoma Gastrodiae (75,750 and 2250mg/kgBW), observes direct sleep effect, gives tested continuously
Carry out after thing 30d extending experiment pentobarbital sodium length of one's sleep, pentobarbital sodium sub-threshold dose hypnosis experiment and
Barbital sodium sleep latency is tested.Result Rhizoma Gastrodiae can work in coordination with pentobarbital sodium sub-threshold dose syngignoscism (P ＜ 0.05)
With shorten barbital sodium Sleep latency (P ＜ 0.01), but without extending effect pentobarbital sodium length of one's sleep
(P ＞ 0.05) and directly improve sleep effect (P ＞ 0.05), conclusion shows that Rhizoma Gastrodiae has improvement sleep merit to mice
Energy.
Semen Ziziphi Spinosae: for Rhamnaceae plant Ziziphi Spinosae Ziziphus jujube Mi 11.var spinosa (Bunge) Hu
The dry mature seed of ex H.F.Chou.Its sweet in the mouth, acid, property is flat, GUIXIN, liver, gallbladder meridian.Have and nourish heart
The liver benefiting, calm the nerves, effect of arresting sweating.Cure mainly palpitation and insomnia, the card such as body void hyperhidrosis, be treatment heart-liver blood deficiency it
Cardiopalmus, the key medicine of insomnia.Semen Ziziphi Spinosae described in " Bencao Jingshu " can mend courage, therefore the most main fidgets due to deficiency, vexed
Insomnia.
The sedative-hypnotic effect of the observation jujuboside such as Chen Baiquan: jujuboside high, medium and low dosage group
Can substantially suppress normal mouse spontaneous activity, be allowed to movable number of times and reduce, the central excitation of amfetamine can be suppressed
Effect, hence it is evident that increase the sleep number of animals of pentobarbital sodium sub-threshold lull dosage.
Semen Platycladi: for the drying and ripening of Cupressaceae plant Cacumen Platycladi Platycladus orientalis (L.) Franco
Kernel.Semen Platycladi is parts of generic medicinal plants, and applicating history is long, begins to be loaded in Shennong's Herbal, is classified as
Product.Its sweet in the mouth, property is flat, GUIXIN, kidney, large intestine channel.There are tranquilizing by nourishing the heart, arresting sweating, effect of loosening bowel to relieve constipation.
Semen Platycladi the experiment proved that the effect improving sleep.Li Haisheng etc. use polysomnogram graphy method,
It is changed to the differentiation index of sleep stage with electroencephalogram (EEG), electromyogram (EMG), (EDG) difference, have studied
The impact on cat awakening-sleep rhythm of the Semen Platycladi folk prescription.After cat lumbar injection Semen Platycladi folk prescription injection, cat
In sleep procedure, compared with control experiment group, the S sleep phase extend, the most shallow sleep the phase extend, out-phase
Sleep period change not statistically significant.It follows that the effective ingredient after Semen Platycladi alcohol method is extracted can make
The S sleep time lengthening of cat, points out its effective ingredient to contribute to the sleep of cat, and makes the sound sleep time obvious
Extend, the most notable to antisecosis effect.
Radix Salviae Miltiorrhizae: for the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge..Red
Ginseng is in use for a long time in China as Chinese medicine, begins to be loaded in Shennong's Herbal, is listed in top grade.Radix Salviae Miltiorrhizae has
Having blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, the relieving restlessness that clears away heart-fire, effect of removing heat from blood eliminating carbuncle, for obstruction of qi in the chest and cardialgia, gastral cavity abdomen is coerced
Bitterly, pyretic arthralgia pain, dysphoria and insomnia, the disease such as menoxenia.
Practise virtuous treasured Radix Salviae Miltiorrhizae Injection Anmian point injection for curing intractable insomnia evident in efficacy.By random for 112 examples
Being divided into two groups, treatment group 56 example uses the injection of Radix Salviae Miltiorrhizae Injection Anmian point, and matched group 56 example applies Chinese mugwort department azoles
Logical sequence is treated.Through 1 the course for the treatment of 20d treatment, treatment group total effective rate 85.70%, matched group total effective rate 51.60%,
Clinical efficacy treatment group is better than matched group (P ＜ 0.05).
In the present composition, Rhizoma Gastrodiae, Semen Ziziphi Spinosae, Semen Platycladi, Radix Salviae Miltiorrhizae all have improvement sleep, relieving insomnia
Effect.It is on the basis of existing theory of Chinese medical science, filters out the prescription that can be effectively improved sleep, carries out
Scientific compatibility, plays its mutual synergism, and wherein Semen Ziziphi Spinosae is the key medicine for the treatment of insomnia, and Semen Platycladi is also
The basic pharmaceutical of relieving insomnia, compatibility Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae can mutual Synergistic, common performance improve sleep,
Improve the effect of sleep quality.
Instant component can use the conventional method of Chinese medicine preparation to be prepared as the preparation of any routine, including mouth
Formulation, external preparation, injection etc..These crude drug such as can be ground into powder mix homogeneously；Can
To be added water respectively by the crude drug of described weight portion or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract, or use process for purification, such as, decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography,
Carbon dioxide supercritical extraction method, steam distillation carry out being refining to obtain extract.
When using said medicine, both can use with the medicine being equivalent to described weight proportion for raw material respectively
Clean, be dried, pulverize, be mixed to get and meet the granule of formulation requirements granularity or powder is directly taken.Also may be used
Through suitably process after add medicinal auxiliary with the medicine being equivalent to described weight proportion relation for raw material with employing
Material, is made into various preparation as required.During being prepared as preparation by above-mentioned raw materials medicine, above-mentioned former
Material medicine can be adopted and process with the following method: the crude drug of described weight portion is directly pulverized to obtain medicinal powder；
Add water respectively or the ethanol extraction of variable concentrations or use decoction and alcohol sedimentation technique, centrifuging, steam distillation
Extract to obtain extract；Adoptable concrete operations and/or use when above-mentioned effective medicinal ingredient is extracted
Method, both can be with the ingredient of described each proportional quantities as raw material, extract its effective medicinal one-tenth respectively
Decomposite mode after point, it would however also be possible to employ the most jointly extract after mixing by each medicine material of described proportional quantities
Mode.Ideal required when using different extraction means, equipment and extract or optimal Extracting temperature,
The actual conditionses such as solvent load, extraction time, extraction time, then can be sieved by test according to practical situation
Select and find.
A kind of method of any of the above all can prepare the active component of the present composition, this active component
Can directly be used as medicine and take or add acceptable adjuvant on pharmaceutics required preparation is produced in conventional fashion into.
As conventional tablet (dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, effervescent can be made
Sheet), capsule (hard capsule, soft capsule), granule, pill (drop pill), the solid preparation such as powder
The oral drugs of form, it is also possible to make the mouth of the liquid forms such as syrup, medicated wine, tincture, oral liquid
Take medicine thing；Can also make unguentum, gel, ointment, cataplasma, emplastrum, liniment, lotion,
The external used medicine of the external preparation forms such as liniment.Therefore, in this pharmaceutical composition in addition to effective ingredient, also
Can be containing pharmaceutically acceptable adjuvant.
The preparation technology of the preparations such as tablet described here, capsule, granule relates to adopting of granulating process
With wet granulation or one-step palletizing.
Adjuvant described here, can be different according to different preparations, as tablet, capsule,
Live in diluent conventional in the solid preparations such as granule, disintegrating agent, excipient, binding agent, lubricant, surface
Property agent, filler etc.；Surfactant conventional in the liquid forms such as syrup, oral liquid, dilution
Agent, preservative, stabilizer, correctives, thickening agent, fluidizer etc.；In the external such as gel, ointment
Acceptable oil base conventional in dosage form, aqueous matrix, preservative, antioxidant, wetting agent, transdermal
Absorption enhancer, surfactant etc..
Its conventional adjuvant such as starch, lactose, sucrose, dextrin, maltodextrin, Icing Sugar, microcrystalline Cellulose,
Mannitol, xylitol, Polyethylene Glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol,
Polyvinylpyrrolidone, Heavy Magnesium Carbonate, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, Methyl cellulose
Element, ethyl cellulose, carboxymethylstach sodium, hydroxypropyl cellulose, PVP K30, kaolin, pregelatinated form sediment
Powder, magnesium stearate, Pulvis Talci, micropowder silica gel, stevioside, glycine betaine, aspartame, citric acid,
Glycyrrhizin, saccharin sodium, crystal sugar, Mel, citric acid, sodium bicarbonate, sodium carbonate, carrageenan, agar,
Gelatin, sodium alginate, xanthan gum, guar gum, tragcanth, arabic gum, locust bean gum, thorn Firmiana platanifolia (Linn. f.) Marsili
Glue, stearic acid, glyceryl monostearate, polyacrylamide, cross linked sodium polyacrylate, polyvinyl alcohol,
Carbomer, sorbic acid, potassium sorbate, ethyl hydroxybenzoate, benzyl alcohol, nipalgin, thimerosal, dimethyl are sub-
Sulfone, azone, triethanolamine, sodium hydroxide, glycerol, propylene glycol, BHT, BHA, sodium lauryl sulphate,
Tweens, spans etc..
In order to make each component of said composition can preferably play drug effect, preferably weight portion of the present invention is joined
The component of ratio takes following preparation method, but cannot be used for limiting the scope of the invention.
The preparation method of the present composition is as follows:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain medicinal powder；Or add water or the ethanol extraction of variable concentrations,
Extracting solution concentrate drying obtains crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, post layer further
Analysis method, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination and carry out suitably
Extract is obtained after Jing Zhi；The Semen Ziziphi Spinosae of above-mentioned medicinal powder or crude extract or extract and described weight portion extracts
Thing, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and are not added with or add appropriate amount of auxiliary materials, routinely technique system
Become acceptable preparation on pharmaceutics.
The preparation method of present composition tablet is as follows:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate filler, correctives, mixing, add suitable
Amount binding agent, mixing, pelletize, be dried, granulate, add moderate lubrication agent, mixing, tabletting, coating or
Not coating, obtains tablet.
Wherein, filler refer to starch, mannitol, pregelatinized Starch, dextrin, lactose, maltodextrin,
One or more in microcrystalline Cellulose；Preferably lactose, maltodextrin.
Correctives refers to aspartame, citric acid, stevioside, glycine betaine, glycyrrhizin, sucrose, saccharin
One or more in sodium；Preferably aspartame, citric acid.
Binding agent refers to that ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, polyvidone are water-soluble
One or more in liquid, polyvidone alcoholic solution；Preferably polyvidone alcoholic solution, refers in particular to 5% poly-dimension
Ketone K30 ethanol solution.
Lubricant refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci；Preferably stearic
Acid magnesium.
The preparation method of present composition tablet is:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
The preparation method of present composition granule is:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate amount of auxiliary materials, mixing, pelletize, are dried, granulate,
Obtain granule.
Heretofore described Semen Ziziphi Spinosae extract, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract can be by buying
Commercially available product or take following methods to obtain:
Semen Ziziphi Spinosae extract: taking Semen Ziziphi Spinosae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Ziziphi Spinosae extract.
Semen Platycladi extract: taking Semen Platycladi and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Platycladi extract.
Radix Salviae Miltiorrhizae extract: taking Radix Salviae Miltiorrhizae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains and slightly carries
Thing；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, CO 2 supercritical further
Extraction, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned
Crude extract or extract are Radix Salviae Miltiorrhizae extract.
It is preferably:
Semen Ziziphi Spinosae extract: taking Semen Ziziphi Spinosae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 is little
Time, extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder,
It is Semen Ziziphi Spinosae extract.
Semen Platycladi extract: take Semen Platycladi and add 6-12 times amount water extraction 1-4 time, each 1-3 hour, extracts
Liquid merges, and filters, and filtrate decompression dry, pulverize into fine powder, is Semen Platycladi extract.
Radix Salviae Miltiorrhizae extract: take Radix Salviae Miltiorrhizae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 hour,
Extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder, i.e.
For Radix Salviae Miltiorrhizae extract.
Only obtained through refining to the present invention method of above-mentioned preparation method is enumerated, but this should not be interpreted as system of the present invention
Preparation Method is only limited to above-mentioned cited method.
The detailed description of the invention of form by the following examples, makees the most in detail the foregoing of the present invention
Describe in detail bright.But this should not being interpreted as, the scope of the above-mentioned theme of the present invention is only limitted to below example.All bases
The technology realized in foregoing of the present invention belongs to the scope of the present invention.
Detailed description of the invention
Embodiment 1
Rhizoma Gastrodiae 333g, Semen Ziziphi Spinosae extract 100g, Semen Platycladi extract 80g, Radix Salviae Miltiorrhizae extract 200g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 2
Rhizoma Gastrodiae 200g, Semen Ziziphi Spinosae extract 200g, Semen Platycladi extract 30g, Radix Salviae Miltiorrhizae extract 300g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 3
Rhizoma Gastrodiae 500g, Semen Ziziphi Spinosae extract 50g, Semen Platycladi extract 150g, Radix Salviae Miltiorrhizae extract 100g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 4
Rhizoma Gastrodiae 100g, Semen Ziziphi Spinosae extract 400g, Semen Platycladi extract 10g, Radix Salviae Miltiorrhizae extract 500g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 5
Rhizoma Gastrodiae 700g, Semen Ziziphi Spinosae extract 30g, Semen Platycladi extract 300g, Radix Salviae Miltiorrhizae extract 150g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate lactose, maltodextrin, aspartame, lemon
Lemon acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate, add
Enter appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 6
Rhizoma Gastrodiae 350g, Semen Ziziphi Spinosae extract 120g, Semen Platycladi extract 60g, Radix Salviae Miltiorrhizae extract 180g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate mannitol, dextrin, sucrose, mixing, add
Enter appropriate sodium carboxymethyl cellulose, hydroxypropyl cellulose, mixing, pelletize, be dried, granulate, add appropriate
Pulvis Talci, micropowder silica gel, mixing, tabletting, coating, obtain tablet.
Embodiment 7
Rhizoma Gastrodiae 300g, Semen Ziziphi Spinosae extract 90g, Semen Platycladi extract 90g, Radix Salviae Miltiorrhizae extract 210g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate microcrystalline Cellulose, pregelatinized Starch, manna
Alcohol, lactose, glycine betaine, mixing, add appropriate amount of starch slurry, mixing, pelletize, be dried, granulate, add
Appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 8
Rhizoma Gastrodiae 400g, Semen Ziziphi Spinosae extract 110g, Semen Platycladi extract 100g, Radix Salviae Miltiorrhizae extract 250g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate starch, dextrin, microcrystalline Cellulose, A Si
Ba Tian, betanin, mixing, add appropriate polyvidone aqueous solution, mixing, pelletize, be dried, granulate, add
Enter appropriate Pulvis Talci, micropowder silica gel, mixing, tabletting, obtain tablet.
Embodiment 9
Rhizoma Gastrodiae 333g, Semen Ziziphi Spinosae extract 100g, Semen Platycladi extract 80g, Radix Salviae Miltiorrhizae extract 200g
The Rhizoma Gastrodiae taking described weight portion adds 8 times amount water extraction 3 times, each 2 hours, and extracting solution merges, mistake
Filter, filtrate decompression dry, pulverize into fine powder, obtains Rhizoma Gastrodiae extract, extracts with the Semen Ziziphi Spinosae of described weight portion
Thing, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate microcrystalline Cellulose, maltodextrin, mixed
Even, add ethanol in proper amount, mixing, pelletize, be dried, granulate, add appropriate magnesium stearate, mixing, pressure
Sheet, obtains tablet.
Embodiment 10
Rhizoma Gastrodiae 333g, Semen Ziziphi Spinosae extract 100g, Semen Platycladi extract 80g, Radix Salviae Miltiorrhizae extract 200g
The Rhizoma Gastrodiae taking described weight portion adds 10 times amount water extraction 2 times, each 2 hours, and extracting solution merges, mistake
Filter, filtrate decompression dry, pulverize into fine powder, obtains Rhizoma Gastrodiae extract, extracts with the Semen Ziziphi Spinosae of described weight portion
Thing, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, add appropriate lactose, maltodextrin, aspartame,
Citric acid, mixing, add appropriate 5% PVP K30 ethanol solution, mixing, pelletize, be dried, granulate,
Add appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 11
Rhizoma Gastrodiae 250g, Semen Ziziphi Spinosae extract 150g, Semen Platycladi extract 100g, Radix Salviae Miltiorrhizae extract 250g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add lactose, mannitol in right amount, mixing, alcohol granulation,
It is dried, granulate, obtains granule.
Embodiment 12
Rhizoma Gastrodiae 330g, Semen Ziziphi Spinosae extract 100g, Semen Platycladi extract 100g, Radix Salviae Miltiorrhizae extract 200g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add sucrose, aspartame, and dextrin is appropriate, mixing, second
Alcohol is pelletized, and is dried, granulate, obtains granule.
Embodiment 13
Rhizoma Gastrodiae 340g, Semen Ziziphi Spinosae extract 90g, Semen Platycladi extract 90g, Radix Salviae Miltiorrhizae extract 220g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate amount of auxiliary materials, mixing, pelletize, are dried, encapsulated,
Obtain capsule.
Embodiment 14
Rhizoma Gastrodiae 320g, Semen Ziziphi Spinosae extract 110g, Semen Platycladi extract 70g, Radix Salviae Miltiorrhizae extract 210g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate amount of auxiliary materials, mixing, make pill.
Embodiment 15
Rhizoma Gastrodiae 400g, Semen Ziziphi Spinosae extract 210g, Semen Platycladi extract 160g, Radix Salviae Miltiorrhizae extract 320g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and make powder according to common process.
Embodiment 16
Rhizoma Gastrodiae 333g, Semen Ziziphi Spinosae extract 100g, Semen Platycladi extract 80g, Radix Salviae Miltiorrhizae extract 200g
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and dissolve with solvent, make oral liquid system according to common process
Agent.
Semen Ziziphi Spinosae extract in above example 1-16, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract may each be
Following methods is taked to obtain:
Semen Ziziphi Spinosae extract: taking Semen Ziziphi Spinosae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Ziziphi Spinosae extract；
It is preferably: take Semen Ziziphi Spinosae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 hour, carry
Taking liquid to merge, filter, decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder, is
Semen Ziziphi Spinosae extract.
Semen Platycladi extract: taking Semen Platycladi and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Platycladi extract；
Being preferably: take Semen Platycladi and add 6-12 times amount water extraction 1-4 time, each 1-3 hour, extracting solution merges,
Filtering, filtrate decompression dry, pulverize into fine powder, is Semen Platycladi extract.
Radix Salviae Miltiorrhizae extract: taking Radix Salviae Miltiorrhizae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains and slightly carries
Thing；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, CO 2 supercritical further
Extraction, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned
Crude extract or extract are Radix Salviae Miltiorrhizae extract；
It is preferably: take Radix Salviae Miltiorrhizae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 hour, extracts
Liquid merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder, is pellet
Conopsea extraction.
Or, Semen Ziziphi Spinosae extract, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract are obtained by buying commercially available product.
According to foregoing, without departing under basic fundamental thought premise of the present invention, common according to this area
Technological know-how and customary means, it is clear that the amendment of other various ways can also be made, replace and change.
The beneficial effect of of the present invention compositions be expanded on further by following experiment:
1, test material
Animal: cleaning grade Wistar mice, body weight 18-22g.
Test group 1: prepared by the embodiment of the present invention 1, is made into desired concn with distilled water and is for experiment；
Test group 2: prepared by the embodiment of the present invention 2, is made into desired concn with distilled water and is for experiment；
Test group 3: prepared by the embodiment of the present invention 3, is made into desired concn with distilled water and is for experiment；
Negative control group: distilled water；
Positive controls: Rhizoma Gastrodiae Semen Ziziphi Spinosae complex capsule (Patent No. 201310055945.9), with distillation
Water is made into desired concn and is for experiment.
2, test method
2.1 extend the pentobarbital sodium experiment length of one's sleep
Normal mouse is randomly divided into 5 groups by body weight, i.e. 3 test group (test group 1, test group 2, tests
Group 3), negative control group, positive controls, often group 15, test and carry out night.The gavage of test group
Amount is every 20g body weight 0.4ml, and negative control group fills the distilled water of equivalent, and positive controls fills the Rhizoma Gastrodiae of equivalent
Semen Ziziphi Spinosae complex capsule content solution.Giving tested material 30 days continuously, last is to 30min warp after animal subject
Lumbar injection pentobarbital sodium 30mg/kg BW, is judged to enter sleep with righting reflex loss 60s of animal,
Observe tested material and can extend pentobarbital sodium length of one's sleep.
2.2 pentobarbital sodium sub-threshold dose hypnosis experiments
Normal mouse is randomly divided into 5 groups by body weight, i.e. 3 test group (test group 1, test group 2, tests
Group 3), negative control group, positive controls, often group 15, test and carry out night.The gavage of test group
Amount is every 20g body weight 0.4ml, and negative control group fills the distilled water of equivalent, and positive controls fills the Rhizoma Gastrodiae of equivalent
Semen Ziziphi Spinosae complex capsule content solution.Giving tested material 30 days continuously, last is trans-abdominal to 30min after tested material
Chamber injection pentobarbital sodium 15mg/kg BW, is judged to enter sleep, meter with righting reflex loss 60s of animal
Count and sleep animal incidence rate.
3, experimental result
3.1 extend the pentobarbital sodium experiment length of one's sleep: be shown in Table 1.
The impact of table 1 tested material sleep direct on mice ()
* represent there is significant (P ＜ 0.05) with negative control group comparing difference
* represents there is pole significant (P ＜ 0.01) with negative control group comparing difference
As seen from Table 1, the length of one's sleep of each test group mice all extends than negative control group, and right with feminine gender
Difference according to group is respectively provided with pole significant (P ＜ 0.01)；Positive controls and the difference of negative control group
There is significant (P ＜ 0.05), show that the present composition has the notable pentobarbital sodium that extends and sleeps
The effect of time, and effect is better than positive controls.
3.2 pentobarbital sodium sub-threshold dose hypnosis experiments: be shown in Table 2.
The impact on mice sleep incidence rate of table 2 tested material
* table does not have significant (P ＜ 0.05) with negative control group comparing difference
* represents there is pole significant (P ＜ 0.01) with negative control group comparing difference
As seen from Table 2, the sleep animal incidence rate of each test group is higher than negative control group, and and negative control
The difference of group is respectively provided with significant (P ＜ 0.01)；Positive controls has with the difference of negative control group
Significant (P ＜ 0.05), shows that the pentobarbital sodium of sub-threshold dose is had promotion to urge by the present composition
The effect slept, and effect is better than positive controls.
Embodiment of the present invention 4-16 has carried out similar test, result and the above results phase the most according to the method described above
With.
4, conclusion
After the mouse stomach present composition, compare with negative control group, can significantly extend pentobarbital sodium and sleep
The dormancy time, and the pentobarbital sodium of sub-threshold dose is had the effect promoting hypnosis, and difference has pole significance
Meaning (P ＜ 0.01).The prompting present composition has the function improving sleep.
Claims (12)
1. one kind has the compositions improving sleep function, it is characterised in that it is by the group of following weight portion
It is grouped into: Rhizoma Gastrodiae 10-70 part, Semen Ziziphi Spinosae extract 3-40 part, Semen Platycladi extract 1-30 part, Radix Salviae Miltiorrhizae
Extract 15-50 part.
Compositions the most according to claim 1, it is characterised in that it is by the component of following weight portion
Composition: Rhizoma Gastrodiae 20-50 part, Semen Ziziphi Spinosae extract 5-20 part, Semen Platycladi extract 3-15 part, Radix Salviae Miltiorrhizae carry
Take thing 10-30 part.
3. the preparation method of compositions described in claim 1 or 2, it is characterised in that it is prepared:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain medicinal powder；Or add water or the ethanol extraction of variable concentrations,
Extracting solution concentrate drying obtains crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, post layer further
Analysis method, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination and carry out suitably
Extract is obtained after Jing Zhi；The Semen Ziziphi Spinosae of above-mentioned medicinal powder or crude extract or extract and described weight portion extracts
Thing, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and are not added with or add appropriate amount of auxiliary materials, routinely technique system
Become acceptable preparation on pharmaceutics.
Preparation method the most according to claim 3, it is characterised in that described preparation refer to tablet,
Granule, capsule, pill, powder, oral liquid.
Preparation method the most according to claim 4, it is characterised in that tablet is prepared:
The Rhizoma Gastrodiae taking described weight portion directly pulverizes to obtain Rhizoma Gastrodiae powder, with the Semen Ziziphi Spinosae extract of described weight portion,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate filler, correctives, mixing, add suitable
Amount binding agent, mixing, pelletize, be dried, granulate, add moderate lubrication agent, mixing, tabletting, coating or
Not coating, obtains tablet.
Preparation method the most according to claim 4, it is characterised in that tablet is prepared:
The Rhizoma Gastrodiae taking described weight portion adds 6-12 times amount water extraction 1-4 time, each 1-3 hour, and extracting solution closes
And, filtering, filtrate decompression dry, pulverize into fine powder, obtains Rhizoma Gastrodiae extract, with the Ziziphi Spinosae of described weight portion
Core extract, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract mix, and add appropriate filler, correctives, mixed
Even, add suitable amount of adhesive, mixing, pelletize, be dried, granulate, add moderate lubrication agent, mixing, pressure
Sheet, coating or not coating, obtain tablet.
7. according to the preparation method described in claim 5 or 6, it is characterised in that described filler refers to
One in starch, mannitol, pregelatinized Starch, dextrin, lactose, maltodextrin, microcrystalline Cellulose or
More than one；Correctives refer to aspartame, citric acid, stevioside, glycine betaine, glycyrrhizin, sucrose,
One or more in saccharin sodium；Binding agent refers to ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxyl
One or more in propyl cellulose, PVP K30 aqueous solution, PVP K30 alcoholic solution；Profit
Lubrication prescription refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
Preparation method the most according to claim 7, it is characterised in that described filler refer to lactose,
Maltodextrin；Correctives refers to aspartame, citric acid；Binding agent refers to PVP K30 alcoholic solution；Profit
Lubrication prescription refers to magnesium stearate.
Compositions the most according to claim 1 and 2, it is characterised in that described Semen Ziziphi Spinosae extract,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract are prepared obtaining:
Semen Ziziphi Spinosae extract: taking Semen Ziziphi Spinosae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Ziziphi Spinosae extract；
Semen Platycladi extract: taking Semen Platycladi and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains
Crude extract；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide super further
Critical extraction, steam distillation one or more be used in combination suitably refine after extract；
Above-mentioned crude extract or extract are Semen Platycladi extract；
Radix Salviae Miltiorrhizae extract: taking Radix Salviae Miltiorrhizae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains and slightly carries
Thing；Or use decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, CO 2 supercritical further
Extraction, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned
Crude extract or extract are Radix Salviae Miltiorrhizae extract.
Compositions the most according to claim 9, it is characterised in that described Semen Ziziphi Spinosae extract,
Semen Platycladi extract, Radix Salviae Miltiorrhizae extract are prepared obtaining:
Semen Ziziphi Spinosae extract: taking Semen Ziziphi Spinosae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 is little
Time, extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder,
It is Semen Ziziphi Spinosae extract；
Semen Platycladi extract: take Semen Platycladi and add 6-12 times amount water extraction 1-4 time, each 1-3 hour, extracts
Liquid merges, and filters, and filtrate decompression dry, pulverize into fine powder, is Semen Platycladi extract；
Radix Salviae Miltiorrhizae extract: take Radix Salviae Miltiorrhizae and add 6-12 times amount 50-95% ethanol extraction 1-4 time, each 1-3 hour,
Extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, drying under reduced pressure, is ground into fine powder, i.e.
For Radix Salviae Miltiorrhizae extract.
11. compositionss according to claim 1 and 2, it is characterised in that described Semen Ziziphi Spinosae extracts
Thing, Semen Platycladi extract, Radix Salviae Miltiorrhizae extract obtain by buying commercially available product.
Compositions described in 12. claim 1 or 2 has in the health food improving sleep function for preparation
Application.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107362288A (en) * | 2016-05-13 | 2017-11-21 | 珠海宝德润生健康科技有限公司 | It is a kind of that there is composition for improving sleep function and preparation method thereof |
| CN107375460A (en) * | 2017-07-21 | 2017-11-24 | 成都柏图生物科技有限公司 | It is a kind of that there is improvement sleep, antifatigue, anti-aging pharmaceutical composition and preparation method |
| CN107723821A (en) * | 2017-11-08 | 2018-02-23 | 唐卫兵 | A kind of preparation method for helping sleep face liber |
| CN112617548A (en) * | 2020-12-25 | 2021-04-09 | 海南娜古芳沉香科技有限公司 | Kyara extract for preparing latex pillow for improving sleep, preparation method and latex pillow prepared from Kyara extract |
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| CN102309565A (en) * | 2011-09-16 | 2012-01-11 | 刘德胜 | Traditional Chinese medicine composition for improving sleep and preparation method thereof |
| CN102657715A (en) * | 2012-05-17 | 2012-09-12 | 双飞人制药（中国）有限公司 | Drug combination with function of improving sleep |
| CN103083560A (en) * | 2013-02-21 | 2013-05-08 | 汤臣倍健股份有限公司 | Tall gastrodia tuber and wild jujube seed composite capsules |
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| CN101850001A (en) * | 2009-03-31 | 2010-10-06 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function of improving sleep and preparation method thereof |
| CN101569338A (en) * | 2009-06-12 | 2009-11-04 | 郭志忠 | Health tea for resisting anxiety, relieving depression and improving sleep |
| CN102309565A (en) * | 2011-09-16 | 2012-01-11 | 刘德胜 | Traditional Chinese medicine composition for improving sleep and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107362288A (en) * | 2016-05-13 | 2017-11-21 | 珠海宝德润生健康科技有限公司 | It is a kind of that there is composition for improving sleep function and preparation method thereof |
| CN107375460A (en) * | 2017-07-21 | 2017-11-24 | 成都柏图生物科技有限公司 | It is a kind of that there is improvement sleep, antifatigue, anti-aging pharmaceutical composition and preparation method |
| CN107723821A (en) * | 2017-11-08 | 2018-02-23 | 唐卫兵 | A kind of preparation method for helping sleep face liber |
| CN112617548A (en) * | 2020-12-25 | 2021-04-09 | 海南娜古芳沉香科技有限公司 | Kyara extract for preparing latex pillow for improving sleep, preparation method and latex pillow prepared from Kyara extract |
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Application publication date: 20161019 |