CN104338017B - Pharmaceutical composition with sleep improvement effect, preparation method and application thereof - Google Patents
Pharmaceutical composition with sleep improvement effect, preparation method and application thereof Download PDFInfo
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- CN104338017B CN104338017B CN201310322083.1A CN201310322083A CN104338017B CN 104338017 B CN104338017 B CN 104338017B CN 201310322083 A CN201310322083 A CN 201310322083A CN 104338017 B CN104338017 B CN 104338017B
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Abstract
The invention discloses a pharmaceutical composition with sleep improvement effect, a preparation method and application thereof. The composition, calculated in terms of weight components, comprises, 9-16 parts of spine date seed, 9-16 parts of acanthopanax, 3-8 parts of Polygala root, and 3-8 parts of rhizoma gastrodiae, and is mainly used for improving sleep. Compared with the prior art, the pharmaceutical composition provided by the invention has the advantages of safe use, exact curative effect, simple prescription and simple making process, thus being suitable for industrial mass production.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition with the effect that improves the health care of sleep and its preparation method and application, belongs to pharmacy
Technical field.
Background technology
The time in all one's life of people about 1/3 is spent in sleep.When people are in sleep state, can make
The brain and body of people are rested, rested and reorganized and recovered.Contribute to the daily working and learning of people.Science improves sleep matter
Amount, is the guarantee of people's normal work learning life.The medicine for improving the health care of sleep at present has a lot, and people also appreciate and use Chinese medicine
Replace Western medicine to carry out the improvement of sleep quality, not only work well, also without addiction symptom, using safety assurance.Therefore, for by
The crowd such as sleep disorder, serious insomnia caused by a variety of causes, with syllabus of putting prevention first, is clearly improved the health care of sleep from having
The raw material of effect, has no toxic side effect and cheap to human body, develops to improve the health care of sleep medicine or health care as major function
Food has good market prospect.
Patent CN200810102529.9 is disclosed to have and improves the health care of sleep health food of function and preparation method thereof, the guarantor
Health food formula is made up of Cortex Acanthopanacis Sessiliflori, Semen Ziziphi Spinosae, Rhizoma Gastrodiae, Radix Polygalae, Gecko, Bulbus Lilii, Fructus Schisandrae Chinensis, and we send out under study for action
Now, Semen Ziziphi Spinosae and Radix Polygalae play the effect of key in quality is improved the health care of sleep, and collocation Central nervous system is contrastimulant
Radix Et Caulis Acanthopanacis Senticosi, Inflammation Zhijing, suppressing the hyperactive liver and subsiding YANG, the Rhizoma Gastrodiae of dispelling wind and removing obstruction in the collateral can obtain good effect, by the prescription to four Chinese medicine
Proportioning carries out conscientious careful screening study, can just obtain that prescription is simple, and action effect is good and the product that has no toxic side effect, non-
Often it is adapted to industrialized big production, product active constituent content is high, stable performance.
The content of the invention
It is an object of the present invention to provide a kind of determined curative effect, prescription are simple, processing technology is easy, be suitable for industrialization
The pharmaceutical composition with the effect that improves the health care of sleep of big production, and the preparation method and application of the pharmaceutical composition.
The pharmaceutical composition with the effect that improves the health care of sleep that the present invention is provided, calculates, by following raw materials according to composition by weight
Medicine is made：9~16 parts of Semen Ziziphi Spinosae, 9~16 parts of Radix Et Caulis Acanthopanacis Senticosi, 3~8 parts of Radix Polygalae, 3~8 parts of Rhizoma Gastrodiae.
Specifically, calculate according to composition by weight, be made up of following raw material medicaments：11~14 parts of Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi 11~
14 parts, 4~6 parts of Radix Polygalae, 4~6 parts of Rhizoma Gastrodiae.
More specifically, calculating according to composition by weight, it is made up of following raw material medicaments：12.5 parts of Semen Ziziphi Spinosae, 12.5 parts of Radix Et Caulis Acanthopanacis Senticosi,
5 parts of Radix Polygalae, 5 parts of Rhizoma Gastrodiae.
The preparation technology of the pharmaceutical composition with the effect that improves the health care of sleep of the present invention is：
（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously, add 8~12
The water boiling and extraction of times weight 1~3 time, each extraction time is 1~3 hour, and before extracting for the 1st time 0.5-1 hours, mistake are soaked
Filter, merging filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 50~70 DEG C is 1.05~1.20, spray dried
It is dry, weigh, it is standby；
（2）Add adjuvant in medicated powder after the drying, with conventional method the preparation formulation of needs is prepared into.
Specifically, the preparation technology of the pharmaceutical composition with the effect that improves the health care of sleep of the present invention is：
（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously, add 10 times of weights
The water boiling and extraction of amount 2 times, each extraction time is 1.5 hours, is soaked 0.5 hour before the 1st extraction, is filtered, and merges filter
Liquid, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 50~70 DEG C is 1.05~1.15, is spray-dried, and weighs, standby
With；
（2）Add adjuvant in medicated powder after the drying, with conventional method the preparation formulation of needs is prepared into.
Obtained active component of the invention can adopt the conventional corresponding preparations method known altogether, add customary adjuvant, such as disintegrate
Agent, lubricant, binding agent etc., make various oral formulations, such as piece, hard capsule, granule, drop pill, soft capsule, oral liquid, excellent
Elect hard capsule as.
The each ingredient properties and its effect that the present invention is used are as follows：
Semen Ziziphi Spinosae：It is sweet in the mouth, mild-natured.GUIXIN, spleen, liver, gallbladder meridian.Nourishing the liver, mind calming, calm the nerves, arresting sweating.Cure mainly restlessness of asrhenia type and insomnia, shy
Throb with fear alarmed and panicky, sweating due to debility.Modern study shows that it has calmness, syngignoscism, stabilizes effect and the effect of cooling of easing pain, wherein effectively
Composition jujuboside can substantially suppress the number of activities of normal mouse, suppress the central excitation effect of amfetamine and reduce rat
Coordination exercise, extend the length of one's sleep.
Radix Et Caulis Acanthopanacis Senticosi：It is acrid in the mouth, hardship, micro-sweet, warm in nature, return liver and kidney channel.Wind-damp dispelling, invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation arteries and veins.Cure mainly wind
Cold-damp numbness, lumbocrural pain, muscles and bones impotence, be slow in action, body void win it is weak etc..Modern medicine research has shown that the action character of Radix Et Caulis Acanthopanacis Senticosi
It is essentially identical with Radix Ginseng, it is allowed to tend to normal function with body disorder is adjusted.Due to pressure disease can be prevented, there is good
Resisting fatigue and the effect for regaining one's vigor, Central nervous system has sedation, can extend hexenoic aldehyde anesthesia duration, reduces hexene
The postanesthetic irritability of aldehyde, while also acting on anticonvulsant.
Radix Polygalae：It is warm in nature, it is bitter in the mouth, pungent, with tranquilize the mind and promote the intelligence, eliminating the phlegm, detumescence function, for the insomnia that disarmony between the heart and kidney causes
Dreaminess, forgetful palpitation with fear, staring spells, expectoration is not well, sore swollen toxin, breast swell and pain.Modern pharmacology research shows that Radix Polygalae is to god
The effect of Jing systems is embodied in calmness, anticonvulsant action, the effect for promoting muscle power and intelligence, dementia and brain protection activity side
, also there is good action effect in face to aspects such as respiratory system, blood pressure, smooth muscle, cardiac muscles in addition.
Rhizoma Gastrodiae：Sweet in the mouth, mild-natured, return liver warp.Inflammation Zhijing, suppressing the hyperactive liver and subsiding YANG, dispelling wind and removing obstruction in the collateral.For dizziness pupil, wind syndrome of head head
Bitterly, numb limbs and tense tendons, hemiplegia, pediatric epilepsy scared wind symptom.Its pharmacological action is mainly manifested in the calm, sleeping of Central nervous,
To cardiovascular blood pressure lowering, expand the aspects such as blood vessel reduce myocardial oxygen consumption, anti inflammatory immunity.
More than synthesis, Semen Ziziphi Spinosae and Radix Et Caulis Acanthopanacis Senticosi are monarch drug in we, Semen Ziziphi Spinosae mind tranquilizing and the heart calming, Radix Et Caulis Acanthopanacis Senticosi blood-activating kidney-tonifying, then
It is aided with ministerial drug Radix Polygalae tranquilize the mind and promote the intelligence, Rhizoma Gastrodiae suppressing the hyperactive liver dredging collateral, the mutual synergism of active component of each medicine reaches calm peace jointly
God, the effect of mind calming nourishing the liver, reach the purpose for improving the health care of sleep, it is adaptable to all kinds of to need the person of improving the health care of sleep.
Medicine used of the invention adopts water boiling and extraction, and extracts active ingredients are complete, while first soaking before extraction
0.5-1 hours, are fully dissolved out active component, are conducive to the carrying out of subsequent technique；Using the side of recovered under reduced pressure during concentration
Method, shortens the operating time, and reduces the destruction and loss of effective ingredient；Using spray dried extract mastic, energy consumption is low, dirt
Dye is little, and moisture evaporation is rapid, drying time is short, saves that devaporation, the technique such as crushing, and quality of item be good, dissolubility is high.In industry
It is very reasonable in big production to change.
With easy dormancy capsule obtained in the preparation method of the pharmaceutical composition with the effect that improves the health care of sleep of the present invention, from root
Improve the health care of sleep on this, and processing technology is simple and convenient, and cost is relatively low.According to clinical verification, drug regimen of the present invention is as a result shown
Thing is simpler than existing product prescription, and improves the health care of sleep that curative effect is more definite, and safety is good.
Specific embodiment：
By the following examples the present invention is further illustrated with experimental example.
First, craft screening research
1st, extracting method is selected
Take Semen Ziziphi Spinosae 900g, Radix Et Caulis Acanthopanacis Senticosi 900g, Radix Polygalae 300g, Rhizoma Gastrodiae 300g to be pulverized and mixed, alcohol reflux is respectively adopted and carries
Take, two methods of water boiling and extraction are extracted, with the syringoside in Saponin A content, the Radix Et Caulis Acanthopanacis Senticosi in Semen Ziziphi Spinosae
The content of tenuifolin, the content of Gastrodin in Gastrodia eleta Bl. in content, Radix Polygalae, extracting solution clarity, filtering complexity is
Index, investigates the extraction ratio of two methods, as a result see the table below 1.
The extracting method of table 1 is selected
Test result indicate that, two methods extracting solution is more transparent, and content difference is little, wherein using water boiling and extraction
Method filter be easier to, cost is relatively low.Therefore it is preferred that the extracting method that boils of decocting.
2nd, the adjuvant screening study of hard capsule
Chinese medicinal ingredients are complicated, containing a large amount of polysaccharose substances, the poor fluidity when oral formulations are made, therefore generally require
The certain diluent of addition and lubricant meet the requirement of filling improving the mobility of medicated powder, and conventional diluent has Semen Maydiss
Starch, sucrose, Microcrystalline Cellulose, dextrin, amylum pregelatinisatum etc., conventional lubricant has magnesium stearate, Pulvis Talci, micropowder silica gel
Deng.We are referred to by investigating to mobility, dissolution, cost effectiveness of medicated powder using above-mentioned diluent and lubricant after prepared etc.
Target research, selects the most suitable mixture of one or more.As a result see the table below：
The supplementary product kind Selection experiment of table 2
| Adjuvant | Mobility | Dissolution | It is economical |
| Corn starch, magnesium stearate | It is bad | It is more difficult | Cheaply |
| Corn starch, Pulvis Talci | It is bad | It is more difficult | Cheaply |
| Sucrose, magnesium stearate | It is bad | It is difficult | Cheaply |
| Sucrose, Pulvis Talci | It is bad | It is difficult | Cheaply |
| Microcrystalline Cellulose, micropowder silica gel | Preferably | It is easier to | It is expensive |
| Microcrystalline Cellulose, magnesium stearate | Preferably | It is easier to | It is more expensive |
| Dextrin, micropowder silica gel | It is good | Easily | It is expensive |
| Dextrin, magnesium stearate | It is good | Easily | Cheaply |
| Dextrin, Pulvis Talci | It is good | It is easier to | Cheaply |
| Amylum pregelatinisatum, micropowder silica gel | Preferably | Easily | It is more expensive |
| Amylum pregelatinisatum, magnesium stearate | Preferably | It is easier to | Cheaply |
Test result indicate that, after considering indices, it can be seen that prepare hard capsule using dextrin and magnesium stearate,
Good product mobility, is difficult adhesion, it is easy to fill, economical rationality.Further investigate consumption：
The supplementary product consumption Selection experiment of table 3
| Adjuvant | Mobility | Dissolution |
| Dextrin：Magnesium stearate=8:1 | It is poor | It is slower |
| Dextrin：Magnesium stearate=9:1 | It is good | It is easier to |
| Dextrin：Magnesium stearate=10:1 | It is good | Easily |
| Dextrin：Magnesium stearate=11:1 | It is good | Easily |
| Dextrin：Magnesium stearate=12:1 | Preferably | It is slower |
As a result show, using dextrin：Magnesium stearate ratio is in 9-11:When between 1, medicated powder mobility and dissolution complexity
It is more satisfactory, wherein dextrin：Magnesium stearate=10:Effect is optimum when 1.
Therefore, select have the preparation method of the pharmaceutical composition for improving the health care of sleep effect as follows：
Embodiment 1：The preparation of tablet
Proportioning raw materials：Semen Ziziphi Spinosae 900g, Radix Et Caulis Acanthopanacis Senticosi 900g, Radix Polygalae 300g, Rhizoma Gastrodiae 300g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 8 times of weight of addition 3 times, each extraction time is 1 hour, is soaked 1 hour before the 1st extraction, is filtered, conjunction
And filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 50 DEG C is 1.05, is spray-dried, weighs, standby；
（2）Add 1% magnesium stearate in medicated powder after the drying for lubricant, plus the Microcrystalline Cellulose of tablet total amount 8%, 12%
Amylum pregelatinisatum is fully mixed, and is pressed into 1500, and film coating is obtained final product.
Usage and dosage：2 times a day, 3 tablets once.
Embodiment 2：The preparation of hard capsule
Proportioning raw materials：Semen Ziziphi Spinosae 1250g, Radix Et Caulis Acanthopanacis Senticosi 1250g, Radix Polygalae 500g, Rhizoma Gastrodiae 500g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 10 times of weight of addition 2 times, each extraction time is 1.5 hours, is soaked 0.5 hour before the 1st extraction, mistake
Filter, merging filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 60 DEG C is 1.05~1.15, is spray-dried, and claims
Weight, it is standby；
（2）Add dextrin 135g and magnesium stearate 13g in medicated powder after the drying, mix homogeneously loads capsule（450mg/
Grain）, polishing, bottling obtains final product hard capsule 1500.
Usage and dosage：2 times a day, every time 3.
Embodiment 3：The preparation of granule
Proportioning raw materials：Semen Ziziphi Spinosae 1600g, Radix Et Caulis Acanthopanacis Senticosi 1600g, Radix Polygalae 800g, Rhizoma Gastrodiae 800g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 12 times of weight of addition 1 time, extraction time is 3 hours, is soaked 0.5 hour before extraction, is filtered, filtrate decompression
The thick paste that the relative density under the conditions of 70 DEG C is 1.20 is recycled to, is spray-dried, weighed, it is standby；
（2）Add dextrin to total amount to be 5000g in medicated powder after the drying, crush, mix, granulation is dried, granulate, bag
Dress.Boiled water is taken after mixing it with water.
Usage and dosage：2 times a day, each 10g.
The preparation of the drop pill of embodiment 4
Proportioning raw materials：Semen Ziziphi Spinosae 1100g, Radix Et Caulis Acanthopanacis Senticosi 1400g, Radix Polygalae 400g, Rhizoma Gastrodiae 600g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 9 times of weight of addition 2 times, each extraction time is 1.5 hours, is soaked 1 hour before the 1st extraction, is filtered,
Merging filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 60 DEG C is 1.05~1.15, is spray-dried, and weighs,
It is standby；
（2）By in the Polyethylene Glycol M6000 that molten condition is added in dried medicated powder, stirring so as to be uniformly dispersed is protected
Warm standby is used；By the melting substrate of mix homogeneously as in attemperator pill dripping machine and substrate is kept in stirring, start is instiled,
The coolant of drop pill molding is done with liquid paraffin or silicone oil；The drop pill by made by takes out from coolant, uses a small amount of dehydrated alcohol
Carry out being placed in the forced air drying under the conditions of 30 ~ 40 DEG C in the disk of stand after Rapid Cleaning, pick ball, glazing, packaging is obtained drop pill 1500
Ball.
Usage and dosage：2 times a day, every time 3
The preparation of the oral liquid of embodiment 5
Proportioning raw materials：Semen Ziziphi Spinosae 1400g, Radix Et Caulis Acanthopanacis Senticosi 1100g, Radix Polygalae 450g, Rhizoma Gastrodiae 550g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 11 times of weight of addition 1 time, extraction time is 3 hours, is soaked 1 hour before extraction, is filtered, and filtrate decompression is returned
Receive to the thick paste that the relative density under the conditions of 70 DEG C is 1.05；
（2）The addition in thick paste adds sucrose, 0.3% sodium benzoate, 0.1% ethyl hydroxybenzoate of preparation total amount 25%, plus thermosol
Solution, lets cool, and adds water to 5000ml, makes oral liquid.
Usage and dosage：2 times a day, each 10ml.
The preparation of the soft capsule of embodiment 6
Proportioning raw materials：Semen Ziziphi Spinosae 1300g, Radix Et Caulis Acanthopanacis Senticosi 1200g, Radix Polygalae 700g, Rhizoma Gastrodiae 400g
Preparation method：（1）Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously,
The water boiling and extraction of 10 times of weight of addition 2 times, each extraction time is 2 hours, is soaked 0.5 hour before the 1st extraction, mistake
Filter, merging filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 60 DEG C is 1.15, is spray-dried, and weighs, standby
With；
（2）Addition in medicated powder after the drying adds Cera Flava appropriate, mixing, and mixture rolls wafer and makes with rotation automatically
1500, it is dried, takes out, with washing with alcohol, be dried 48 hours, obtains final product.
Usage and dosage：2 times a day, every time 3.
The preparation of the low recipe quantity hard capsule of embodiment 7
Proportioning raw materials：Semen Ziziphi Spinosae 800g, Radix Et Caulis Acanthopanacis Senticosi 800g, Radix Polygalae 200g, Rhizoma Gastrodiae 200g
Preparation method：It is prepared by the method according to embodiment 2.
The preparation of the high recipe quantity hard capsule of embodiment 8
Proportioning raw materials：Semen Ziziphi Spinosae 1700g, Radix Et Caulis Acanthopanacis Senticosi 1700g, Radix Polygalae 900g, Rhizoma Gastrodiae 900g
Preparation method：It is prepared by the method according to embodiment 2.
2nd, effect test research
Medicine of the invention used is the allowance of CFDA regulations for medicine, the raw material of health food and can medicine-food two-purpose
Raw material.According to《Health food and assessment technique specification》（2003）Version is to improving the health care of sleep the criterion of functional health care food, Jing
Cross zoopery and human experimentation shows, product made by the present composition has the function of significantly improving the health care of sleep.
The prescription screening of experimental example 1 and zoopery
It is as follows that the present composition improves the health care of sleep function assessment experiment emotion：
1st, materials and methods：
1.1 medicine：Invention formulation：Various test samples are prepared into according to embodiment of the present invention 1-3,7,8 preparation method
Product, numbered samples 1-5；
Control medicine：Medicine is compareed made by the method for CN200810102529.9 embodiments 1 and embodiment 4, it is right to number
According to 1, control 2.
Above given the test agent when in use or grinds or crushes or directly measure, plus distilled water makes certain concentration solution
Gavage.
1.2 experimental animal：ICR kind mices, cleaning grade is provided by Guiyang Medical College Experimental Animal Center.
1.3 experimental technique
1.3.1 96 male and female half and half of the impact mice to spontaneous activity, are randomly divided into 8 groups.1,2 groups of dosages of control
For 0.48g active component/kgd, inventive samples 1-5 group dosages are respectively 6.40,9.33,12.80,5.33,
13.87g crude drugs/kgd, dosage is 40 times of people's consumption.Blank group gives isopyknic normal saline.Continuous gavage
30d, 30min after last dose, by mice spontaneous activity enumerator endoadaptation 5min is put into, and then records the work of mice in 5min
Emotionally condition.
1.3.2 to the impact mice 96 of the pentobarbital sodium length of one's sleep, male and female dual-purpose is randomly divided into 8 groups.Control 1,2
Group dosage is 0.48g active component/kgd, inventive samples 1-5 group dosages are respectively 6.40,9.33,12.80,
5.33rd, 13.87g crude drugs/kgd, dosage is 40 times of people's consumption.Blank group gives isopyknic normal saline.Continuously
Gavage 30d, 30min after last dose, every group of mouse peritoneal injection pentobarbital sodium 40mg/kg.The length of one's sleep of record mice
（It is sleep time from righting reflex loss to recovery time with righting reflex loss as time for falling asleep）.
1.3.3 Dose Effect mice group and give test medicine same 1.3.2 to sleeping under pentobarbital sodium threshold, continuously
Gavage 30d, 30min after last dose, each group animal lumbar injection pentobarbital sodium 30mg/kg, observation gives pentobarbital sodium
Afterwards in 30min there is the number of animals of sleep in each group（With more than righting reflex loss 1min as index）.
2nd, result of the test
The impact result of 2.1 pairs of spontaneous activitys（It is shown in Table 4）
Impact of the table 4 to mice 5min spontaneous activitys
The impact of 2.2 pairs of pentobarbital sodium induced hypnotic time（It is shown in Table 5）
Impact of the table 5 to the pentobarbital sodium inducing mouse length of one's sleep（）
Invention formulation group（Sample 1-3）Compare with blank group：*P<0.01, property that there were significant differences；Invention formulation group
（Sample 1-3）Compare with matched group：# P<0.05.
The impact of 2.3 pairs of pentobarbital sodium sub-threshold dose hypnosis experiments（It is shown in Table 6）
Impact of the table 6 to pentobarbital sodium sub-threshold dose mice sleep incidence rate（）
| Group | Animal number of elements | Sleep number of animals | Sleeping animal incidence rate |
| Blank control group | 12 | 2 | 16.7% |
| Control 1 | 12 | 7 | 58.3% |
| Control 2 | 12 | 8 | 66.7% |
| Sample 1 | 12 | 9 | 75.0%* |
| Sample 2 | 12 | 9 | 75.0%* |
| Sample 3 | 12 | 10 | 83.3%* |
| Sample 4 | 12 | 6 | 50.0% |
| Sample 5 | 12 | 10 | 83.3%* |
Invention formulation group（Sample 1-3）Compare with blank group：*P<0.05, property that there were significant differences.
The impact of 2.4 pairs of pentobarbital sodium Sleep latencies（It is shown in Table 7）
Impact of the table 7 to mice pentobarbital sodium Sleep latency（）
| Group | n | Sleep latency/min | Group | n | Sleep latency/min | |
| Blank control group | 12 | 27.1±5.5 | Sample 2 | 12 | 19.6±4.5** | |
| Control 1 | 12 | 23.4±4.8 | Sample 3 | 12 | 19.1±4.1** | |
| Control 2 | 12 | 22.6±4.7 | Sample 4 | 12 | 23.8±5.0 | |
| Sample 1 | 12 | 20.2±4.3* | Sample 5 | 12 | 19.0±4.4** |
Invention formulation group（Sample 1-3）Compare with blank group：*P<0.05, * * P<0.01.
Conclusion：Above test result indicate that, invention formulation prescription composition reduce in the case of, penta bar can be obviously prolonged
Mouse sleep time, raising pentobarbital sodium sub-threshold dose mice incidence of sleep animals than the induction of appropriate sodium, penta bar ratio of shortening
Appropriate sodium Sleep latency, its effect is also advantageous over reference substance, it was demonstrated that invention formulation has clear improvement the effect of sleep, and in good
Dose-effect relationship；In addition, using hard capsule obtained in low component of the present invention, its therapeutic effect is suitable with control drug, it is high
Component curative effect is not significantly increased, and shows that, using amount ranges of the present invention, rationally, the effect for improving the health care of sleep is good for prescription
It is good.
In addition, preparation made by the present composition rat is without any anaphylaxiss and other are bad anti-during testing
Should, illustrate that the present composition has no adverse effects.
The present composition of experimental example 2 improves the health care of sleep the clinical research of effect
1st, data：The volunteer of the suitable population at 67 ages 30-65 year, wherein man 38, female 29, M-F is
1.3：1, in suitable population overtime work stay up late wait occupation patient account for 39%, teacher 27%, and workman 22%, and other 12%.Test group is sample
1-3 groups amount to 40, matched group 27, without substantially poor in terms of age distribution, the course of disease, state of an illness grade before each group patient treatment
It is different.
2nd, experimental conditions
1.2.1 experimental drug：Investigational agent：What embodiment of the present invention 1-3 was prepared improve the health care of sleep tablet, hard capsule and
Grain, unit dose is 1.6g crude drugs/piece, 2.33g crude drugs/grain, 9.6g crude drugs/bag.Numbered samples 1,2,3.
Comparison medicine：Soft capsule is compareed made by the method for CN200810102529.9 embodiments 1 and embodiment 4, per contains
Active component 700mg, numbering control 1, control 2.
1.2.2 administrated method and flow process：Invention formulation, daily 2 times, 3/piece every time；Granule boiled water is taken after mixing it with water, daily
2 times, every time 1 bag；Control soft capsule, one time a day, 1 every time.The course for the treatment of 1 month.
3rd, result：After taking test medicine one week, under quiet resting state, present composition group has suitable population
The groups of people feel that 93% needs are improved the health care of sleep can quickly into the state of sleeping soundly, and continuous sleep is general to be no less than 8 hours；Comparison medicine
Thing group enters the number of state of sleeping soundly and accounts for 89%.Continuously using after two weeks, suitable population takes this under quiet resting state
The person of getting up in the night to urinate accounts for 19% in the middle of in the tested crowd of bright compositionss, and control drug group accounts for 21%, after continuously taking, and generally enters
Enter normal condition.
Conclusion：Various to improve the health care of sleep crowd after a period of medicine of the present invention is taken, sleep gradually tends towards stability,
Return to normal, be further continued for adhering to that taking rear sleep quality obtains good improvement, action effect is better than control drug.Pass through
Clinical verification, the present composition out have improve the health care of sleep outside effect, moreover it is possible to balancing blood pressure, fatigue alleviating, memory reinforcing
And other effects.
Claims (9)
1. a kind of pharmaceutical composition with the effect that improves the health care of sleep, it is characterised in that：Calculate according to composition by weight, it is by following originals
Material medicine is made：9~16 parts of Semen Ziziphi Spinosae, 9~16 parts of Radix Et Caulis Acanthopanacis Senticosi, 3~8 parts of Radix Polygalae, 3~8 parts of Rhizoma Gastrodiae.
2. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 1, it is characterised in that：According to composition by weight
Calculate, it is made up of following raw material medicaments：11~14 parts of Semen Ziziphi Spinosae, 11~14 parts of Radix Et Caulis Acanthopanacis Senticosi, 4~6 parts of Radix Polygalae, 4~6 parts of Rhizoma Gastrodiae.
3. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 1, it is characterised in that：According to composition by weight
Calculate, it is made up of following raw material medicaments：12.5 parts of Semen Ziziphi Spinosae, 12.5 parts of Radix Et Caulis Acanthopanacis Senticosi, 5 parts of Radix Polygalae, 5 parts of Rhizoma Gastrodiae.
4. according to the arbitrary described pharmaceutical composition with the effect that improves the health care of sleep of claim 1-3, it is characterised in that：Preparation
Preparation method is：
(1) Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously, adds 8~12 times of weights
The water boiling and extraction of amount 1~3 time, each extraction time is 1~3 hour, and before the 1st extraction 0.5-1 hours are soaked, and is filtered,
Merging filtrate, filtrate decompression is recycled to the thick paste that the relative density under the conditions of 50~70 DEG C is 1.05~1.20, is spray-dried, and claims
Weight, it is standby；
(2) add adjuvant in medicated powder after the drying, with conventional method the preparation formulation of needs is prepared into.
5. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 4, it is characterised in that：The preparation side of preparation
Method is：
(1) Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously, 10 times of weight of addition
Water boiling and extraction 2 times, each extraction time is 1.5 hours, is soaked 0.5 hour before the 1st extraction, is filtered, merging filtrate, filter
Liquid recovered under reduced pressure is spray-dried to the thick paste that the relative density under the conditions of 50~70 DEG C is 1.05~1.15, weighs, standby；
(2) add adjuvant in medicated powder after the drying, with conventional method the preparation formulation of needs is prepared into.
6. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 4, it is characterised in that：The preparation is mouth
Formulation.
7. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 6, it is characterised in that：The oral formulations
For granule, hard capsule, tablet, soft capsule or pill.
8. according to the pharmaceutical composition with the effect that improves the health care of sleep described in claim 7, it is characterised in that：The hard capsule
It is prepared：(1) raw material is weighed according to the following ratio：Semen Ziziphi Spinosae 1250g, Radix Et Caulis Acanthopanacis Senticosi 1250g, Radix Polygalae 500g, Rhizoma Gastrodiae 500g；
(2) Semen Ziziphi Spinosae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Rhizoma Gastrodiae raw material are crushed according to decoction pieces size, mix homogeneously, 10 times of weight of addition
Water boiling and extraction 2 times, each extraction time is 1.5 hours, is soaked 0.5 hour before the 1st extraction, is filtered, merging filtrate, filter
Liquid recovered under reduced pressure is spray-dried to the thick paste that the relative density under the conditions of 50~70 DEG C is 1.05~1.15, weighs, standby；
(3) add dextrin 135g, magnesium stearate 13g in medicated powder after the drying, be mixed evenly, make granule, be dried, load glue
Capsule, obtains final product hard capsule 1500.
9. preparing with improvement according to the preparation described in the arbitrary described pharmaceutical composition of claim 1-3 or claim 6
Application in the medicine or health food of sleep effect.
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| CN101549108A (en) * | 2009-05-13 | 2009-10-07 | 陶国闻 | Gastrodia tuber polygala capsules for improving memory and method for preparing same |
| CN103145776A (en) * | 2013-03-08 | 2013-06-12 | 王布公 | Gastrodin extraction method, preparation method of gastrodia elata soft capsules and soft capsules obtained by preparation method |
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| CN101549108A (en) * | 2009-05-13 | 2009-10-07 | 陶国闻 | Gastrodia tuber polygala capsules for improving memory and method for preparing same |
| CN103145776A (en) * | 2013-03-08 | 2013-06-12 | 王布公 | Gastrodin extraction method, preparation method of gastrodia elata soft capsules and soft capsules obtained by preparation method |
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