CN104337920B - Traditional Chinese medicine composition for improving sleep quality - Google Patents
Traditional Chinese medicine composition for improving sleep quality Download PDFInfo
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- CN104337920B CN104337920B CN201410572308.3A CN201410572308A CN104337920B CN 104337920 B CN104337920 B CN 104337920B CN 201410572308 A CN201410572308 A CN 201410572308A CN 104337920 B CN104337920 B CN 104337920B
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Abstract
The invention relates to a traditional Chinese medicine composition for improving sleep quality. The active ingredients of the traditional Chinese medicine composition for improving sleep quality are prepared from main raw and auxiliary materials: spina date seeds, ginseng, lucid ganoderma, polygala tenuifolia and fructus schizandrae. According to conventional pharmaceutical methods, pharmaceutically acceptable auxiliary materials or auxiliary components are added to prepare a clinically acceptable conventional internal preparation (a health product) in pharmaceutics, including troches, tea bags, granules, capsules, pills and oral solutions. The traditional Chinese medicine composition provided by the invention is simple in prescription and has the characteristics of convenience in use and improvement of sleep quality. The traditional Chinese medicine composition provided by the invention is stable in preparation process, controllable in quality, good in repeatability and suitable for large-scale production.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition improving the health care of sleep quality.
Background technology
Have a sleepless night for clinically one of common disease, with the effect of the length of one's sleep, depth and dispelling fatigue not enough as primary symptom.Have into
Sleep difficulty, dreaminess, easily wake up with a start, multiple situations such as early awakening, sleep are deep or are insomnia all night.Often insomnia can give people to bring greatly
Spirit and sensual misery, many discomforts such as dizzy, tinnitus is forgetful, absent minded occur, have a strong impact on people
Quality of life.
Traditional Chinese medicine thinks, the ortho of people be Yinyang from however regular conversion results." sleeping, this is cloudy, god
It is main, and Shen Anze sleeps, and refreshing uneasiness is then insomnia "；And " vim and vigour person, the god of people ", above give in the heart that then the mind must be supported, be hidden in liver then
Liver body is soft, changes and is essence, is built in kidney, and the mind intersects then mind to be stabilized.And the cause of disease being insomnia is then intricate, symptom actual situation
It can be seen that, but clinical many disturbing with perverse trend, or ying-qi is not enough（For pondering over, overstrain, weakness due to chronic disease, seven feelings become estranged etc. and to cause, especially with mistake
Happiness, cross anger, cross think or excessively sad for common）Caused for common.Kidney,liver,spleen, courage, in the heart, are often involved in sick position, and pathological change is the overabundance of yang
The deficiency of Yin, negative and positive are lost and are handed over.Chinese traditional treatment is principle with balanced human's negative and positive, adjustment internal organs qi and blood, is conceived to whole body conditioning, and careful card is asked
Cause, diagnosis and treatment.
To the treatment having a sleepless night mainly based on hypnotic drug, also assuasive medicine is also used for current people
Clinic, these medicines belong to nerve and control sleep, have instant effect, the features such as action time is short.But long-term taking is also easy to produce
Drug dependence and toxic and side effect, such as hypnotic have dependence with additive, toxic and side effect is big, can suppress breathing, make memory
Go down, unsuitable Long-Time Service；Formula of biological agent is single, can not be fully absorbed again and comprehensively, thoroughly control curative effect it is difficult to reach
Really.Traditional Chinese medicine is started with from the integrally-regulated of body, less to human body toxic and side effect, no drug dependence.So invention is a kind of
The Chinese herbal medicine compositions improving the health care of sleep are significant.
Content of the invention
In order to overcome the above-mentioned deficiency of prior art, the present invention provides a kind of component simple, and active component is clear and definite, stability
Good, the quality controllable Chinese medicine composition improving sleep quality.
For this reason, adopting the following technical scheme that：
A kind of pharmaceutical composition improving the health care of sleep, its active component is made up of the bulk drug of following weight proportioning：Wild jujube
150 220 parts of benevolence, 30 80 parts of ginseng, 40 80 parts of glossy ganoderma, 40 80 parts of polygala root, 30 80 parts of the fruit of Chinese magnoliavine.
Further preferred, it is made up of the active component of following weight portion：180 parts of spina date seed, 50 parts of ginseng, glossy ganoderma 70
Part, 50 parts of polygala root, 50 parts of the fruit of Chinese magnoliavine.
According to conventional pharmaceutical method, add pharmaceutically acceptable auxiliary material or complementary composition, make clinically permissible
Accept, described conventional oral preparations in described routine in pharmacy, including oral liquid, tea in bag, granule, capsule
Agent, pill or tablet.
The present invention has certain effect to improving model mice sleep quality, and judge index mainly has yellow Jackets to sleep
Latency, the prolongation yellow Jackets length of one's sleep and yellow Jackets sub-threshold dose sleep rate, especially to yellow Jackets
The impact of sub-threshold dose becomes apparent from, and compared with negative control group, high dose group sleep number of animals increase has pole significant difference,
Middle dose group sleep number of animals increase has significant difference.
In addition to having functions that to improve the health care of sleep quality, ingredient also has good nutritive value and health care work(to the present invention
Energy.The spina date seed wherein having the title of " fruit sleeps in China " cures mainly vexed insomnia, spontaneous sweating；The ginsenoside that ginseng includes is to regulation
The central nervous system of people, treatment the nervous system disease have good therapeutic effect；Glossy ganoderma is also effective sleeping medicine of allaying excitement, right
Maincenter plays good effect；Polygala root is used for insomnia and dreamful sleep, wandering；The fruit of Chinese magnoliavine also has treatment spontaneous sweating effect.This
The bright preparation made does not contain chemical hypnotic composition, determined curative effect, safe ready.
Spina date seed：Sweet, sour, mild-natured.There is nourishing the liver, calming heart, calm the nerves, effect of arrest sweating.Control restlessness of asrhenia type and insomnia, palpitation with fear is seized with terror
Sad, polydipsia, abnormal sweating.《Do not record》：" master is vexatious must not to sleep, navel pain up and down, and blood turns to be let out long, abnormal sweating polydipsia, bowl spares, beneficial irritability, hard muscle
Bone, helps cloudy gas, makes us fertile strong.”《This warp》：" main trusted subordinate's fever and chills, evil knot gas gathers, painful limbs, arthritis with fixed pain caused by dampness.”
Ginseng：Mild-natured, sweet, slight bitter, tepor.Returns spleen, lung channel, the heart channel of Hang-Shaoyin.Have and reinforce vital energy, veins takes off admittedly, tonifying spleen benefit
Lung, promotes the production of body fluid to quench thirst, tranquilize the mind and promote the intelligence.Cure mainly that internal lesion caused by overexertion is deficient, food, stool lingering diarrhea, the disease of empty cough and asthma rush are told in deficiency of food, burnout, gastric disorder causing nausea.
Glossy ganoderma：Property for sweet, flat.Cure mainly consumptive disease, cough, asthma, insomnia, indigestion, malignant tumour etc..Thin to human liver cancer
Born of the same parents have CDCC, also can suppress the release of histamine, have hepatoprotective effect and have anti-allergic effects etc..Glossy ganoderma is extracted
Thing energy exciting motion suppresses, and so that motility is reduced, and so that the coordinated movement of various economic factors is lacked of proper care, assumes dose-dependent town disease effect, to ring
Barbital sleep effect can curtail sleep, and can extend the time that central stimulant caffeine causes spasm and death, these knots
Fruit shows, glossy ganoderma is in that inhibition acts on to maincenter.
Polygala root：Warm in nature, bitter, pungent, there is tranquilize the mind and promote the intelligence, eliminating the phlegm, the function of detumescence, the insomnia causing for breakdown of the normal physiological coordination between the heart and the kidney
Dreaminess, forgetful palpitation with fear, wandering, expectoration is not well, sore swollen toxin, mastosis.《Book on Chinese herbal medicine is just》Record, polygala root, the wholwe-hearted kidney of work(,
Therefore can relieving palpitation only shy, the peace that exorcises evil spirits dream, Yang strengthening and life essence tonifying, strong will power-assisted.
The fruit of Chinese magnoliavine：Nature and flavor temperature, sour, sweet.There is astringent or styptic treatment for spontaneous sweating, the nourishing generate fluid of convergence, effect of kidney calming.《This warp》Record,
The fruit of Chinese magnoliavine " main beneficial gas, tonifying for the deficiency, Qiang Yin, beneficial man's essence ".To the insomnia improving old deficiency of heart-blood, the heart qi deficiency, breakdown of the normal physiological coordination between the heart and the kidney
Palpitaition all has good action.Deoxyschizandrin, schisanhenol are respectively provided with antioxidation, can remove free radical, suppression peroxidating
Lipid is formed.Additionally, fruit of Chinese magnoliavine energy reduce serum cholesterol, increase protein content in brain and liver, all show with anti-aging
Effect.
Brief description
Fig. 1 is the present invention and documents（200710021857.1）To the contrast extending the yellow Jackets hypnosis time；
Fig. 2 is the present invention and documents（200710021857.1）Shadow to yellow Jackets sub-threshold dose syngignoscism
Ring contrast；
Fig. 3 is the present invention and documents（200710021857.1）Impact contrast to barbital sodium Sleep latency.
In every group of other block diagram in Fig. 1-Fig. 3, the column on the left side is the result of the present invention, and the column on the right is
Documents（200710021857.1）Result.
Specific embodiment
Embodiment 1
A kind of Chinese medicine composition improving the health care of sleep quality, it is made up of the active component of following weight portion：Spina date seed 220
Part, 30 parts of ginseng, 50 parts of glossy ganoderma, 60 parts of polygala root, 40 parts of the fruit of Chinese magnoliavine.
Embodiment 2
A kind of Chinese medicine composition improving the health care of sleep quality, it is made up of the active component of following weight portion：Spina date seed 180
Part, 40 parts of ginseng, 80 parts of glossy ganoderma, 70 parts of polygala root, 30 parts of the fruit of Chinese magnoliavine.
Embodiment 3
A kind of Chinese medicine composition improving the health care of sleep quality, it is made up of the active component of following weight portion：Spina date seed 160
Part, 80 parts of ginseng, 60 parts of glossy ganoderma, 40 parts of polygala root, 80 parts of the fruit of Chinese magnoliavine.
Embodiment 4
A kind of Chinese medicine composition improving the health care of sleep quality, it is made up of the active component of following weight portion：Spina date seed 150
Part, 60 parts of ginseng, 40 parts of glossy ganoderma, 80 parts of polygala root, 70 parts of the fruit of Chinese magnoliavine.
Embodiment 5
A kind of Chinese medicine composition improving the health care of sleep quality, it is made up of the active component of following weight portion：Spina date seed 180
Part, 50 parts of ginseng, 70 parts of glossy ganoderma, 50 parts of polygala root, 50 parts of the fruit of Chinese magnoliavine.
Currently preferred preparation technology is the preparation of oral liquid：
Prepared by oral liquid：Weigh the spina date seed of embodiment formula ratio respectively, ginseng, glossy ganoderma, polygala root, the fruit of Chinese magnoliavine put many work(
In energy extractor, extracted 2 times with 8 times amount 75% alcohol reflux, 2 h every time, filter, merge filtrate twice, the dregs of a decoction are standby.Alcohol extracting
Liquid decompression recycling ethanol to no alcohol taste and continues to be concentrated into relative density for 1.05 ~ 1.08（60 DEG C of mensure）, obtain alcohol extracting concentrate.
The alcohol extracting dregs of a decoction add 8 times amount water boiling and extraction 2 times, each 1.5h.Filter, merge filtrate twice, filter residue is abandoned it, obtained Aqueous extracts.Will
Aqueous extracts are 0.08Mpa in vacuum, and temperature is evaporated to relative density 1.05 ~ 1.08 under conditions of being 70 ~ 80 DEG C（60
DEG C measure）, obtain water extracting liquid.Alcohol extracting concentrate and water extracting liquid are merged, refrigeration standing 48h.By the concentration after refrigeration
Liquid is filtered, and obtains filtrate, and filter residue discards.Filtrate is put in Agitation Tank, adds appropriate Sucralose, fully dissolve, then
Plus purified water is settled to enough, it is uniformly mixed, obtains preparation liquid.It is centrifuged with ultracentrifuge, centrifugal rotational speed is
15000r/min, discards precipitation, makes oral liquid, 10ml/ bottle, obtains final product.People's oral recommended dose props up for 10ml/, and 3 times a day,
1 every time.
Prepared by granule：Component medicinal material is selected after cleaning, is extracted as merging medicinal extract shape with alcohol extracting and water extraction technology, plus
Appropriate pharmaceutical excipient mixing, make every gram of product and be equivalent to the particle of 5 grams of crude drug and obtain final product.People's oral recommended dose is
3g/ bag, 3 times a day, 1 bag every time.
Prepared by capsule：Component medicinal material is selected after cleaning, is extracted as merging medicinal extract shape with alcohol extracting and water extraction technology, so
It is dried, pulverizes with spray drying or hypobaric drying method afterwards；Plus appropriate pharmaceutical excipient mixing, to make every gram of product suitable
In the particle of primary crude drug 12.5g, it is filled in edible capsule and obtains final product, specification is 0.4g/ grain.People's oral recommended dose is daily
3 times, 4 every time.
Prepared by tablet：Component medicinal material is selected after cleaning, is extracted as merging medicinal extract shape with alcohol extracting and water extraction technology, then
It is dried, pulverizes with spray drying or hypobaric drying method；Plus appropriate pharmaceutical excipient mixing, make every gram of product and be equivalent to
The particle of primary crude drug 12.5g, the tablet being pressed into predetermined weight obtains final product, and specification is 0.4g/ grain.People's oral recommended dose is daily
3 times, 4 tablets once.
Prepared by tea in bag：Component medicinal material is selected after cleaning, is extracted as merging medicinal extract shape with alcohol extracting and water extraction technology, so
It is dried, pulverizes with spray drying or hypobaric drying method afterwards；Ovendry power is broken into meal, then mixes with extract powder,
Load and obtain final product among bubble tea bag bag.
The production technology of above-mentioned preparation method and various application forms belongs to existing known technology.
Efficacy test research of the present invention
1 materials and methods
1.1 sample：By the oral liquid of present invention preparation, people's oral recommended dose props up for 10ml/, and 3 times a day, and every time 1
?.With distilled water, oral liquid is made into test desired concn.
Beverage including angelica and dried orange peel for improving sleep quality（The patent No. 200710021857.1）：The drink being prepared from by its specific implementation method
Material.
1.2 animal used as test：Healthy ICR mouse, male, body weight 18 ~ 22g（Sichuan Academy of Medical Sciences's Animal Experimental Study
There is provided）, quality certification number is scxk（River）2013-15.
1.3 dosage and packet：Animal used as test is randomly divided into 4 groups, every group 12.If the 200th, 100,50ml/kgb.wt./d
It is respectively high, medium and low dosetest group（It is respectively equivalent to 5 times, 10 times, 20 times of clinical dosage）, separately set distilled water as feminine gender
Control group.Each group all daily oral gavage give tested material once, continuous 30 days, gavage capacity was 0.2ml/10g.bw.
1.4 instruments and reagent：Yellow Jackets, barbital sodium（Analysis is pure）Import dispenses.
2 experimental techniques
2.1 direct sleep laboratory last gavages terminate latter 15 minutes, and control group is observed little after giving equal-volume distilled water
The sleep quality of mouse, was judged to more than 60 seconds enter sleep with the righting reflex loss of animal, reverts to awakening with righting reflex, turn over
It is the animal sleep time that normal reflection disappears to recovering this period, records sleep number of mice and the length of one's sleep.
2.2 prolongation yellow Jackets length of one's sleep test last gavages terminate latter 15 minutes, to each group animal through abdominal cavity
Injection yellow Jackets 45mg/kg.bw, injection volume 0.1ml/10g.bw, with the righting reflex loss of animal as index, record penta
The barbital sodium length of one's sleep, observe given the test agent and can extend the yellow Jackets length of one's sleep.
2.3 yellow Jackets sub-threshold dose hypnosis test last gavages terminate latter 15 minutes, to each group animal through abdominal cavity
Injection yellow Jackets 35mg/kg.bw, injection volume 0.1ml/10g.bw, observe the sleep quality of mouse in 30 minutes, to right
Areflexia more than 60 seconds is sleep standard, the mouse number that in record 30min, each group is fallen asleep.
2.4 barbital sodium Sleep latency experiment last gavages terminate latter 15 minutes, to each group animal through lumbar injection
Barbital sodium 245mg/kg, injection volume 0.1ml/10g.bw, with animal righting reflex loss as index, record mice sleep is hidden
Phase, observe given the test agent and can shorten barbital sodium Sleep latency.
3 statistical analyses
With spss11.0 version software, experimental result is carried out with one-way analysis of variance, P ＜ 0.05, P ＜ 0.01 represents respectively
There is significant difference and pole significant difference.
4 experimental results
4.1 direct sleep behaviors are observed after giving mouse various dose sample, and sleeping all does not occur in each dosage group animal
Phenomenon, shows this sample to mouse no directly sleep effect.
The impacts of 4.2 pairs of prolongation yellow Jackets hypnosis times as it can be seen from table 1 tested material is high, middle dose group and
Negative control group is compared, and mouse sleep time significantly improves（P ＜ 0.05）, show that tested material has collaborative work to yellow Jackets
With being shown in Table 1.
Table 1 tested material extends yellow Jackets length of one's sleep result of the test
Note：* represent（P ＜ 0.05）；* represents（P ＜ 0.01）
The impact tested material of 4.3 pairs of yellow Jackets sub-threshold dose syngignoscisms make each dosage group sleep mouse number with
Dosage increases and increases, and compared with negative control group, high dose group sleep number of animals increase has pole significant difference（P ＜
0.01）, middle dose group sleep number of animals increase has significant difference（P ＜ 0.05）, show that tested material has association to yellow Jackets
Same-action, is shown in Table 2.
The impact to yellow Jackets sub-threshold dose syngignoscism for table 2 tested material
Note：* represent（P ＜ 0.05）；* represents（P ＜ 0.01）
Compared with negative control group, the sleep of tested material high dose group is latent for the impact of 4.4 pairs of barbital sodium Sleep latencies
The shortening of volt phase has pole significant difference（P ＜ 0.01）, show that tested material and barbital sodium have synergy, be shown in Table 3.
The preclinical impact on barbital sodium of table 3 tested material
Note：* represent（P ＜ 0.05）；* represents（P ＜ 0.01）
4.5 with the research of the effect contrast of Application No. 200710021857.1 beverage including angelica and dried orange peel for improving sleep quality
The patent prescription of Application No. 200710021857.1 is Radix Angelicae Sinensis, Poria cocos, ginseng, dried orange peel, the fruit of Chinese magnoliavine, polygala root, acid
Jujube kernel, the root of large-flowered skullcap, Chinese herbaceous peony, the fruit of Chinese wolfberry, the seed of Chinese dodder, glossy ganoderma, the seed of Oriental arborvitae, Radix Glycyrrhizae.The present invention and Application No. 200710021857.1
Patent compare that prescription is simple, body, the internal organs burden of patient can be reduced；Chemical composition is simple, strengthens pharmaceutical efficacy and curative effect；
Composition coexists few, result of extraction is good.Additionally, prescription of the present invention has played the cheap and good-quality advantage of Chinese medicine, adhere to traditional Chinese medicine use
Medicine principle, rigorous prescription, evident in efficacy.Concrete contrast test is as follows：
4.5.1 to the comparative study extending the yellow Jackets hypnosis time
As shown in figure 1, wherein * * represents（P ＜ 0.01）；* represent（P ＜ 0.05）.
It will be seen from figure 1 that under high dose group, oral liquid and Application No. 200710021857.1 prepared by the present invention
Beverage including angelica and dried orange peel for improving sleep quality is compared, can be extremely notable（P ＜ 0.01）Extend the yellow Jackets length of one's sleep, in, under low dose group
Can be notable（P ＜ 0.05）Improve the yellow Jackets length of one's sleep, illustrate that the pharmaceutical composition that improves the health care of sleep that the present invention provides acts on
Effect is better than the beverage including angelica and dried orange peel for improving sleep quality of the patent No. 200710021857.1.
4.5.2 the impact to yellow Jackets sub-threshold dose syngignoscism
As shown in Fig. 2 wherein * * represents（P ＜ 0.01）；* represent（P ＜ 0.05）.
Figure it is seen that under high and low dose group, oral liquid and Application No. prepared by the present composition
200710021857.1 beverage including angelica and dried orange peel for improving sleep quality compare, can be notable（P ＜ 0.05）Improve the quantity of sleep mouse, this is described
What invention provided improves the health care of sleep the including angelica and dried orange peel for improving sleep quality drink that pharmaceutical composition action effect is better than the patent No. 200710021857.1
Material.
4.5.3 the impact to barbital sodium Sleep latency
As shown in Fig. 2 wherein * * represents（P ＜ 0.01）；* represent（P ＜ 0.05）.
From figure 3, it can be seen that under high and low dose group, what the present invention provided improves the health care of sleep the mouth of pharmaceutical composition preparation
Take liquid compared with the beverage including angelica and dried orange peel for improving sleep quality of Application No. 200710021857.1, can be extremely notable（P ＜ 0.01）Shorten bar ratio
Appropriate sodium Sleep latency, illustrates that the pharmaceutical composition action effect that improves the health care of sleep that the present invention provides is better than the patent No.
200710021857.1 beverage including angelica and dried orange peel for improving sleep quality.
5 discussion
From entirely test as can be seen that what the present invention provided the Chinese medicine composition improving the health care of sleep quality has collaborative prolongation little
The mouse length of one's sleep, the effect of shortening barbital sodium Sleep latency, and old with the Radix Angelicae Sinensis of Application No. 200710021857.1
Pico-ampere dormancy beverage is compared, and has notable or extremely significant sleeping effect.
Claims (3)
1. a kind of Chinese medicine composition improving the health care of sleep quality it is characterised in that：Its active component is former by following weight proportioning
Material medicine composition：150 220 parts of spina date seed, 30 80 parts of ginseng, 40 80 parts of glossy ganoderma, 40 80 parts of polygala root, the fruit of Chinese magnoliavine 30 80
Part.
2. a kind of Chinese medicine composition improving the health care of sleep quality according to claim 1 it is characterised in that：Its active component is
It is made up of the raw material of following weight proportioning：180 parts of spina date seed, 50 parts of ginseng, 70 parts of glossy ganoderma, 50 parts of polygala root, 50 parts of the fruit of Chinese magnoliavine.
3. a kind of Chinese medicine composition improving the health care of sleep quality according to claim 1 and 2 it is characterised in that：With spina date seed,
Ginseng, glossy ganoderma, polygala root, the fruit of Chinese magnoliavine are bulk drug, add pharmaceutically acceptable auxiliary material conventionally to make and clinically may be used
With accepting, described oral liquid in pharmacy, tea in bag, granule, capsule, pill or tablet.
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