CN104906339B

CN104906339B - It is a kind of that there is the health food granule for improving sleep function

Info

Publication number: CN104906339B
Application number: CN201510257789.3A
Authority: CN
Inventors: 刘玲
Original assignee: Sichuan Jian Zhiyuan Science And Technology Ltd
Current assignee: Sichuan Jian Zhiyuan Science And Technology Ltd
Priority date: 2015-05-20
Filing date: 2015-05-20
Publication date: 2018-04-03
Anticipated expiration: 2035-05-20
Also published as: CN104906339A

Abstract

The invention discloses a kind of health food granule for having and improving sleep function, the health food is prepared by following several components and formed：Siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, Valerian root P.E, passionflower fruit powder.Health food of the present invention is from a variety of integration of drinking and medicinal herbs Chinese herbal medicine effective component extractings such as wilsonii, green tea, lily, valerian, passionflowers, Chinese traditional herbs characteristic and European traditional plant medicine special programs are combined, make various composition reasonable formula, cooperate with shared, slept with improving, alleviate a variety of effects of anxiety, by number of ways, multi-level improve the healthcare function of sleep to reach.

Description

It is a kind of that there is the health food granule for improving sleep function

Technical field

The invention belongs to field of health care food, and more particularly, the present invention relates to a kind of guarantor for having and improving sleep function Health food granule and preparation method thereof.

Background technology

Sleep is a kind of most basic physiological behavior, and ensures physically and mentally healthy essential condition, and sleep-disorder is common Disease and a variety of diseases simultaneous phenomenon.Insomnia belongs to sub-health state, can cause under absent minded, understandability Drop, causes ability to work to decline.Rational psychological counseling is combined the master for having become treatment and having a sleepless night with necessary drug therapy Want means.

Conventional sedative hypnotic drug mainly has two kinds of chemical synthesis class and natural drug.

Tranquilizing soporific synthesis class medicine experienced the stages such as barbiturates, benzodiazepine and the short-acting medicine of non-benzodiazepine Afterwards, although being welcome because convenient and swift, curative for effect by patient, due to " effect of being still drank after a night ", additive and least mistake in the daytime Sleep etc. adverse reaction, have impact on patient's normal work, studying and living, make some patients must not without recourse to the treatment of the traditional Chinese medical science, The sight sought help is invested on the nutrient compositions for improving sleep.

According to the research to improving sleep, most products are all that the epiphysin secreted by pineal body is main component, in Herbal medicine is that the market share improved made of raw material shared by sleep assistant health product is relative also fewer, and Chinese herbal medicine is in health care side Face has unique advantage, to insomniac's therapeutic effect substantially and without readme side effect phenomenon.

Therefore, there are many treatments in the prior art or improve the medicine or health products of sleep, mainly taken off in terms of Western medicine Melanocyte：

Epiphysin (English：Melatonin, also known as beautiful to draw peaceful ketone, suppression melanocyte, melatonin) it is by mammal and people A kind of amine bormones caused by the pineal body of class, a kind of cell for producing melanin (melanin) can be made shinny, thus named For epiphysin.Epiphysin is known to have improvement sleep effect, can shorten awakening time and time for falling asleep before sleeping, improve matter of sleeping Amount, number of awakening in sleep significantly reduce, and shallow to sleep the stage short, and deep sleep stages extend, and the next morning, threshold wake-up value declined.Have stronger Jet lag function.Up to the present, the Ministry of Public Health of China successively have approved 20 kinds (wherein domestic 8 kinds, 12 kinds of imports) and contain The product of epiphysin is as " improving sleep " health food.But epiphysin, which is not for anyone, to be used, and with Research finds that there is other potential hazards for long-term use of melatonin on human body.

And in terms of Chinese medicine it is then the various known combinations for being advantageous to sleep traditional Chinese medicinal components：

As CN104435785A, a kind of Chinese medicine composition, Preparation method and use for being used to treat sleep-disorder, component are Spina date seed, Radix Codonopsis, prepared RHIZOMA PINELLIZE without adju-vant, the dried immature fruit of citron orange, dried orange peel, caulis bambusae in taenian, polygala, oyster, Poria cocos, grass-leaved sweetflag, prepared rhizome of rehmannia, keel, process it is sweet.

And for example CN104256632A, a kind of health products for improving sleep, component is spina date seed, Poria cocos, radix glycyrrhizae, the fruit of Chinese wolfberry, Lily, balloonflower root, fructus amomi.

Various Chinese medicine schemes have problems in that, although starting point is desirable to known be advantageous in sleep by various The combination of medicine component, plays compound action, but last effect is difficult to match in excellence or beauty a simple epiphysin for Western medicine：Slowly effect, Less effective simultaneously.

Also there is the scheme that further Chinese and Western combines simultaneously, with reference to epiphysin and traditional Chinese medicinal components, to play Chinese and Western combination Compound action, or the side-effect problem using Chinese medicine improvement Western medicine：

Attempt to play the compound action that Chinese and Western combines：Such as CN104432033A, a kind of health food for improving sleep and its Preparation method, with epiphysin, milkwort extract, Wild jujube seeds extract, Ganodenna Lucidum P.E, radix paeoniae alba extraction, yam extract, sweet Careless extract, water-soluble pearl are primary raw material.

Attempting to Chinese medicine improves the side-effect problem of Western medicine：And for example CN1394632, a kind of health care food for improving sleep Product, it is characterized in using epiphysin and valerian as primary raw material, by toasting, crushing, sieving, baking, adds starch and rock sugar, Capsule is finally made.The present invention claims effect：It is to organically combine advantage possessed by epiphysin and valerian, to improving sleep tool There is more significant effect, proved by Efficacy experiments, product of the present invention is suitable with epiphysin to overall sleep quality, and to good Property sleep stage is better.

In the patent, valerian：Acrid flavour is bitter, warm-natured, enters the heart, liver two passes through, and cures mainly and calms the nerves, qi-regulating, analgesic.Tests prove that energy Strengthen corticocerebral process of inhibition, lower reflex excitability, release smooth muscle spasm, therefore have calm, syngignoscism, be natural Hypnotic sedative agent.

The patent, which attempts to Chinese medicine, improves the side effect of long-term use of Western medicine, and the clothes of epiphysin are reduced by adding Chinese medicine Dosage, although from final experimental data disclosed in patent it is known that adding Chinese medicine in the program, but mainly work Be still Western medicine epiphysin, meanwhile, although the program reduces the use of epiphysin, be but still unavoidable from epiphysin The problem of long-term use of.

The content of the invention

It is an object of the invention to：A kind of health food of pure Chinese medicine is proposed, can effectively improve sleep.

The object of the invention is realized by following technical proposals：

A kind of health food for improving sleep function consists of the following composition, count by weight percentage：

The siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, Valerian root P.E refer to：By wilsonii, green tea, Extract and obtain in the raw materials such as lily, valerian.Each extract, it is commercially available to buy, and it is known there are a variety of extracting methods, it is various Each extract can be applied to this patent obtained by extracting method, can voluntarily extract.

Alternatively, the auxiliary material includes filler, adhesive, wetting agent, disintegrant, one kind in lubricant or more Kind.

The filler refers to：Add in material and be used for filling weight or the material of volume.Described filler, which is selected from, to form sediment Mixing more than one or both of powder, lactose, dextrin, sucrose, mannitol, microcrystalline cellulose.

Described adhesive refers to：Some drugses powder is smaller, it is necessary to add starch slurry etc. without stickiness or stickiness in itself Emplastic, can just it be set to be glued together, the emplastic at this moment added is known as adhesive.Described adhesive is selected from hydroxyl It is more than one or both of propyl methocel, starch slurry, pregelatinized starch, PVPP, sodium carboxymethylcellulose Mixing.

The wetting agent refers to：Solid material can be made to be more easy to the material being soaked in water.Described wetting agent be selected from distilled water, Mixing more than one or both of ethanol.

The disintegrant refers to, in addition to slow (controlled) release tablet and the tablet of some special roles, in general tablet Disintegrant should all be added.The one kind or two of described disintegrant in starch, microcrystalline cellulose, Ac-Di-Sol The mixing of the kind above.

The lubricant refers to：The general name of glidant, antiplastering aid and (narrow sense) lubricant.Described lubricant is selected from tristearin Mixing more than one or both of acid, magnesium stearate, talcum powder, superfine silica gel powder, glycine.

It is of the invention that there is the health food granule for improving sleep function under purposes background according to the present invention, be with Oral formulations existing for granular form, taking dose scope are 3~5g/d.

Alternatively, health food component composition and its percentage by weight are：

Beneficial effects of the present invention：The health food is prepared for pure Chinese medicine, helps to improve the component slept using a variety of Compatibility forms.

Wherein, lily：It is sweet, it is slightly cold, mild-natured, the thoughts of returning home, stomach two pass through, Yin nourishing and lung moistening, clearing away the heart fire and tranquillizing.The applicant is studying Middle discovery, although lily itself has certain sedation, the effect of clearing heat and nourishing yin moistening lung is generally intended for use primarily in, is not had It is standby significant to improve sleep effect, but after lily and valerian compatibility, and be must be according to the specific proportioning compatibility of the application Afterwards, synergistic function is but generated, relatively single lily or valerian significantly improve effect, and final effect can match in excellence or beauty west The epiphysin of medicine.Meanwhile research is it has further been found that single lily and valerian and other Chinese medicines for becoming known for improving sleep Component compatibility can not all produce synergistic function.

The present invention on the basis of the lily and valerian of nucleus, match somebody with somebody therewith by the selected three kinds components for helping to improve sleep 5, further increase its whole structure：

Wilsonii：Sweet, slight bitter is warm-natured, the thoughts of returning home, lung, kidney, the spleen channel, replenishes qi to invigorate the spleen, tonifies the kidney to relieve mental strain.This taste medicinal material can be mended The gas of heart spleen, and nourishing qi and blood, beneficial will of calming the nerves.The insufficiency of heart and spleen is controlled, the mind loses foster insomnia, forgetful etc..

Green tea：Theanine is the natural amino acid in green-tea extract, and theanine can dramatically increase human brain α ripples, make human body It can resist excited caused by caffeine with quiet state, theanine in relatively loosening.

Passionflower：Passionflower originates in the torrid areas such as South America more, at present in China Taiwan, Fujian, Guangdong and Yunnan etc. There is cultivation in province, and is loved by people.There are many influences to the physiological function of humans and animals, particularly its antianxiety is lived Property is by extensive concern.

Embodiment

Following non-limiting examples are used to illustrate the present invention.

Embodiment 1

The work that there is the health food granule for improving sleep function to be matched by following weight that the embodiment of the present invention 1 provides Property component is prepared：

The siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, Valerian root P.E refer to：By wilsonii, green tea, Extract and obtain in the raw materials such as lily, valerian.In the present embodiment as an example, use siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, by commercially available, such as the siberian Ginseng P.E of the auspicious biological Co., Ltd of Changsha favour, green-tea extract, hundred Close extract, address：The grand flat high-tech park Xiong Tian roads 1 in Changsha, Hunan.

The Valerian root P.E of use, pass through commercially available imported raw material, such as the limited public affairs of Beijing Xinda Noah's ark development in science and technology The Indena Valerian root P.Es of department, address：No. 58 Xinzhou in Fucheng Road, Haidian District, Beijing City Business Building.

The passionflower fruit powder of use, by commercially available, such as the passionfruit of the product International Trading Company Ltd of Beijing four Powder Naturex model MN102480, address：B, FuXing Road, Haidian District, BeiJing City 20.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 45%, microcrystalline cellulose 14% in example.

All raw materials are weighed, are mixed, are pelletized, are dried, produce the health care food of the present invention for having and improving sleep function Product granule.

Health food granule of the present invention is taken, by the Ministry of Public Health《Health food is examined and assessment technique specification》 (version in 2003) evaluation method, Toxicological evaluation experiment is carried out, it is as a result as follows：

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 12g/kg；

(2), three genetic toxicity test results：Salmonella reversion test, mice bone marrow micronucleus, mouse essence The lopsided result of the test of son is feminine gender；

(3), 30 days feeding trial results：Experimental animal growing state is good, hematological examination, biochemical analysis, mainly When histological indications are compared with control group for dirty body, without significant difference.

Safety toxicology result of the test shows that health food granule of the present invention is safe and non-toxic.

Take health food granule of the present invention, foundation《Health food is examined and assessment technique specification》(2003 Version) evaluation method, carry out animal function test：

Adult mice, it is randomly divided into 5 groups, every group 10；Sample basic, normal, high dosage group (0.25g/kg, 0.5g/ are set Kg, 1.5g/kg)；Separately set Normal group (isometric distilled water replacement)；Positive controls (0.5g/kg)；Daily oral filling Stomach, solvent 20mL/kg is administered, after continuous 30 days, test improves the indices of sleep function.

1), to the influence of direct sleep experiments

Each test group gives given the test agent, after negative control group gives same volume solvent, it is observed that after 30min, rights anti- Presence is penetrated, each experimental mice does not occur sleep phenomenon.

2), to the influence of the extension yellow Jackets length of one's sleep

Sample middle dose group can extend the mouse sleep time of yellow Jackets induction, compared with Normal group, difference Statistically significant (P<0.05)；Positive controls, sample high dose group can extend the yellow Jackets inducing mouse length of one's sleep, Compared with Normal group, significant difference (P<0.01), it is shown in Table 1.

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

Each dosage group is to the mouse sleep number induced under yellow Jackets threshold, and compared with Normal group, difference is without statistics Learn meaning (P>0.05), it is shown in Table 1.

4), to the influence of barbital sodium Sleep latency experiment

Sample middle dose group can shorten the mouse dropping asleep latency of barbital sodium hypnosis, compared with Normal group, difference Statistically significant (P<0.05)；Positive controls, sample high dose group can shorten the mouse hypnagogic latency of barbital sodium hypnosis Phase, compared with Normal group, significant difference (P<0.01), it is shown in Table 1.

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Animal test results, health food granule of the present invention, experiment mice is acted on without direct sleep；In, High dose group can extend the mouse sleep time of yellow Jackets induction, and can shorten the mouse hypnagogic latency of barbital sodium hypnosis Phase, with the statistically significant (P of Normal group comparing difference<0.05, P<0.01).Illustrate health food of the present invention Granula has improvement sleep function.

Embodiment 2

The present embodiment is substantially the same manner as Example 1, and its difference is：

The siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, Valerian root P.E refer to：By wilsonii, green tea, Extract and obtain in the raw materials such as lily, valerian.In the present embodiment as an example, use siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, Valerian root P.E, by commercially available.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are mannitol 45%, dextrin 18% in example.

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 11g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Embodiment 3

The present embodiment is substantially the same manner as Example 2, and its difference is：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are microcrystalline cellulose 35%, hydroxypropyl methyl cellulose 25% in example.

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 13g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Embodiment 4

The present embodiment is substantially the same manner as Example 3, and its difference is：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 43%, mannitol 20% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Comparative example：

A, prior art contrasts：

Comparative example A -1:

This comparative example is using a kind of Chinese patent application " health food for improving sleep " application number:02128919.0 disclosure Formula.

(A) Valerian root P.E 80%；

(B) epiphysin 1%；

(C) auxiliary material 19%；

The Valerian root P.E refers to：Obtained by being extracted in valerian raw material.In the present embodiment as an example, the figured silk fabrics used Careless extract, by commercially available.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are rock sugar 12%, starch 7% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

Sample high dose group can extend the mouse sleep time of yellow Jackets induction, compared with Normal group, difference Statistically significant (P<0.05)；Positive controls can extend the yellow Jackets inducing mouse length of one's sleep, with Normal group Compare, significant difference (P<0.01), it is shown in Table 1.

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

Sample high dose group can shorten the mouse dropping asleep latency of barbital sodium hypnosis, compared with Normal group, difference Statistically significant (P<0.05)；Positive controls can shorten the mouse dropping asleep latency of barbital sodium hypnosis, with normal control Group compares, significant difference (P<0.01), it is shown in Table 1.

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Animal test results, health food granule of the present invention, experiment mice is acted on without direct sleep；High agent Amount group can extend the mouse sleep time of yellow Jackets induction, and can shorten the mouse dropping asleep latency of barbital sodium hypnosis, With the statistically significant (P of Normal group comparing difference<0.05).Illustrate that health food granule of the present invention has to change Kind sleep function.

This comparative example is using a kind of Chinese patent application " health food for improving sleep " application number:02128919.0 disclosure Formula, compared with this patent, valerian improves sleeper effect compared with Example 1 with epiphysin coordinated groups in comparative example formula, Effect is slightly weak.

Comparative example A -1#:

(A) epiphysin 1%；

(B) auxiliary material 99%；

Health food of the present invention is taken, by the Ministry of Public Health《Health food is examined and assessment technique specification》(version in 2003) Evaluation method, Toxicological evaluation experiment is carried out, it is as a result as follows：

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 10g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example is using a kind of Chinese patent application " health food for improving sleep " application number:02128919.0 disclosure Formula, compared with this patent, epiphysin independent role effect improves sleep effect compared with comparative example A -1 in the comparative example formula Fruit is suitable, and valerian and epiphysin mating reaction, it improves sleeper effect and is somewhat better than epiphysin independent role, but does not cooperate with Synergistic effect.

B, formula composition contrast：

Comparative example B-1：

This comparative example is substantially the same manner as Example 1, and its difference is：

The siberian Ginseng P.E, green-tea extract, Valerian root P.E refer to：By in the raw materials such as wilsonii, green tea, valerian Extract and obtain.In the present embodiment as an example, the siberian Ginseng P.E used, green-tea extract, Valerian root P.E, pass through city Sell and buy.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are dextrin 44%, starch 20% in example.

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 14g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 1, lacks Bulbus Lilii extract active component, and it improves sleeper effect with respect to embodiment 1 effect gap is notable.

Comparative example B-1#：

The siberian Ginseng P.E, Bulbus Lilii extract, green-tea extract refer to：By in the raw materials such as wilsonii, lily, green tea Extract and obtain.In the present embodiment as an example, the siberian Ginseng P.E used, Bulbus Lilii extract, green-tea extract, pass through city Sell and buy.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are mannitol 50%, hydroxypropyl methyl cellulose 17% in example.

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 15g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 1, lacks Valerian root P.E active component, and it improves sleeper effect with respect to embodiment 1 effect gap is notable.

From the point of view of the comparison of comparative example B-1 and B-1# result and embodiment 1, the effect of embodiment 1 is more than comparative example B-1 With B-1# effect sum, thus prove, the proportioning of embodiment 1 has synergistic function.Effect relatively in, for sleep The sign of effect is experimental group and the difference of Normal group, is the length of one's sleep for length of one's sleep effect specifically The longer the better, and it is difference that experimental group subtracts Normal group that it, which is characterized, be for Sleep latency effect the time it is more short more Good, its sign is the difference that Normal group subtracts experimental group.Therefore, comparative example B-1 and B-1# effect sum is foregoing sleep Time and the respective difference sum of Sleep latency.

Comparative example B-2：

This comparative example is substantially the same manner as Example 2, and its difference is：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 50%, mannitol 23% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 2, lacks Bulbus Lilii extract active component, and it improves sleeper effect with respect to embodiment 2 effect gaps are notable.

Comparative example B-2#：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are microcrystalline cellulose 40%, mannitol 16%, hydroxypropyl methyl cellulose in example 10%.

(1), acute toxinology experiment result：Sample is to the maximal tolerance dose of male and female small white mouse acute oral toxicity test 16g/kg；

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 2, lacks Valerian root P.E active component, and it improves sleeper effect with respect to embodiment 2 effect gaps are notable.

From the point of view of the comparison of comparative example B-2 and B-2# result and embodiment 2, the effect of embodiment 2 is more than comparative example B-2 With B-2# effect sum, thus prove, the proportioning of embodiment 2 has synergistic function.Effect relatively in, for sleep The sign of effect is experimental group and the difference of Normal group, is the length of one's sleep for length of one's sleep effect specifically The longer the better, and it is difference that experimental group subtracts Normal group that it, which is characterized, be for Sleep latency effect the time it is more short more Good, its sign is the difference that Normal group subtracts experimental group.Therefore, comparative example B-2 and B-2# effect sum is foregoing sleep Time and the respective difference sum of Sleep latency.

Comparative example B-3：

This comparative example is substantially the same manner as Example 3, and its difference is：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are sucrose 40%, hydroxypropyl methyl cellulose 20%, superfine silica gel powder 8% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 3, lacks Bulbus Lilii extract active component, and it improves sleeper effect with respect to embodiment 3 effect gaps are notable.

Comparative example B-3#：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 36%, dextrin 20%, hydroxypropyl methyl cellulose 10% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 3, lacks Valerian root P.E active component, and it improves sleeper effect with respect to embodiment 3 effect gaps are notable.

From the point of view of the comparison of comparative example B-3 and B-3# result and embodiment 3, the effect of embodiment 3 is more than comparative example B-3 With B-3# effect sum, thus prove, the proportioning of embodiment 3 has synergistic function.Effect relatively in, for sleep The sign of effect is experimental group and the difference of Normal group, is the length of one's sleep for length of one's sleep effect specifically The longer the better, and it is difference that experimental group subtracts Normal group that it, which is characterized, be for Sleep latency effect the time it is more short more Good, its sign is the difference that Normal group subtracts experimental group.Therefore, comparative example B-3 and B-3# effect sum is foregoing sleep Time and the respective difference sum of Sleep latency.

To sum up, from the typical comparison of the relative embodiment series of comparative example B series, the formula of the application there is collaboration to increase Effect acts on.

C, formulation content contrasts：

Comparative example C-1：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are dextrin 32%, mannitol 20% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Compared with Example 1, Valerian root P.E content is higher than present invention request scope, and its effect is equivalent to right for this comparative example Ratio B-1#, it can thus be appreciated that can not produce synergistic function under the proportioning, improve sleeper effect with respect to the effect gap of embodiment 1 Significantly.

Comparative example C-1#：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 45%, hydroxypropyl methyl cellulose 20% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Compared with Example 2, Valerian root P.E content is less than present invention request scope, and its effect is equivalent to right for this comparative example Ratio B-2#, it can thus be appreciated that can not produce synergistic function under the proportioning, improve sleeper effect with respect to the effect gap of embodiment 2 Significantly.

Comparative example C-2：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are sucrose 38%, mannitol 20% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Compared with Example 2, Bulbus Lilii extract content is higher than present invention request scope, and its effect is equivalent to right for this comparative example Ratio B-2, it can thus be appreciated that can not produce synergistic function under the proportioning, improve sleeper effect with respect to the effect gap of embodiment 2 Significantly.

Comparative example C-2#：

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are sucrose 33%, mannitol 20%, dextrin 10% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Compared with Example 1, Bulbus Lilii extract content is less than present invention request scope, and its effect is equivalent to right for this comparative example Ratio B-1, it can thus be appreciated that can not produce synergistic function under the proportioning, improve sleeper effect with respect to the effect gap of embodiment 1 Significantly.

D, formula contrast：

Comparative example D-1：

The siberian Ginseng P.E, green-tea extract, ginseng extract, Valerian root P.E refer to：By wilsonii, green tea, Extract and obtain in the raw materials such as ginseng, valerian.In the present embodiment as an example, use siberian Ginseng P.E, green-tea extract, Valerian root P.E, by commercially available.The ginseng extract of use, by commercially available, such as the auspicious limited public affairs of biology of Changsha favour The ginseng extract of department, address：The grand flat high-tech park Xiong Tian roads 1 in Changsha, Hunan.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 39%, dextrin 20% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 1, lacks Bulbus Lilii extract, is usually used in the Chinese medicine of sleep from other certain --- Ginseng extract, with Valerian root P.E compatibility, its effect without synergistic function, and improves sleep equivalent to comparative example B-1 Effect is notable with respect to the effect gap of embodiment 1.

Comparative example D-2：

The siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, ginseng extract refer to：By wilsonii, green tea, Extract and obtain in the raw materials such as lily, ginseng.In the present embodiment as an example, use siberian Ginseng P.E, green-tea extract, Bulbus Lilii extract, by commercially available.The ginseng extract of use, by commercially available, such as the auspicious limited public affairs of biology of Changsha favour The ginseng extract of department, address：The grand flat high-tech park Xiong Tian roads 1 in Changsha, Hunan.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are dextrin 33%, mannitol 20%, microcrystalline cellulose 10% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 2, lacks Valerian root P.E, is usually used in the Chinese medicine of sleep from other certain --- Ginseng extract, with Bulbus Lilii extract compatibility, its effect without synergistic function, and improves and slept equivalent to comparative example B-2# Dormancy effect is notable with respect to the effect gap of embodiment 2.

Comparative example D-3：

This comparative example is essentially identical with comparative example A -1, and its difference is：

(A) Bulbus Lilii extract 80%；

(B) epiphysin 1%；

(C) auxiliary material 19%；

The Bulbus Lilii extract refers to：Obtained by being extracted in the raw materials such as lily.In the present embodiment as an example, use Bulbus Lilii extract, by commercially available.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 10%, sucrose 9% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example lacks Valerian root P.E compared with comparative example A -1, from epiphysin, with Bulbus Lilii extract compatibility, changes Kind sleeper effect is suitable with comparative example A's -1# epiphysin independent role effects, and Bulbus Lilii extract does not have additional effect, does not have more Synergistic function, improving sleeper effect relative contrast's example A-1 effects has gap.

Comparative example D-4：

(A) Bulbus Lilii extract 8%；

(B) Valerian root P.E 6%；

(C) auxiliary material 86%.

The Bulbus Lilii extract, Valerian root P.E refer to：Obtained by being extracted in the raw materials such as lily, valerian.In the present embodiment In as an example, use Bulbus Lilii extract, Valerian root P.E, by commercially available.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are starch 56%, dextrin 30% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

Compared with Example 3, prescription only has Valerian root P.E, Bulbus Lilii extract compatibility to this comparative example, lacks wilsonii and carries Thing, green-tea extract, passionflower fruit powder are taken, this comparative example is suitable with embodiment 3, and improves sleeper effect and imitated with respect to embodiment 3 Fruit is slightly weak, illustrates that Valerian root P.E, Bulbus Lilii extract are core components, siberian Ginseng P.E, green-tea extract, passionflower fruit powder Addition be to make something perfect even more perfect, substantial change can't be brought.

Comparative example D-5：

This comparative example is substantially the same manner as Example 4, and its difference is：

The siberian Ginseng P.E, Bulbus Lilii extract, green-tea extract, Valerian root P.E refer to：By wilsonii, lily, Extract and obtain in the raw materials such as green tea, valerian.In the present embodiment as an example, use siberian Ginseng P.E, Bulbus Lilii extract, Green-tea extract, Valerian root P.E, by commercially available.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are sucrose 20%, mannitol 19% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 4, siberian Ginseng P.E, green-tea extract, the content of passionflower fruit powder in prescription Beyond claim scope, this comparative example improvement sleeper effect is slightly weak with respect to the effect of embodiment 4, but it improves sleeper effect and is better than Comparative example D-4.It follows that the content of the siberian Ginseng P.E of the present invention, green-tea extract, passionflower fruit powder has optimal increase Imitate effect.

Comparative example D-6：

The Schisandra chinens P.E, ginseng extract, Bulbus Lilii extract, Valerian root P.E, American ginseng extract refer to：By Extract and obtain in the raw materials such as the fruit of Chinese magnoliavine, ginseng, lily, valerian, American Ginseng.In the present embodiment as an example, the lily used Extract, Valerian root P.E, by commercially available.Ginseng extract, Schisandra chinens P.E, the American ginseng extract of use, lead to Cross commercially available, such as ginseng extract, Schisandra chinens P.E, the American ginseng extract of the auspicious biological Co., Ltd of Changsha favour, ground Location：The grand flat high-tech park Xiong Tian roads 1 in Changsha, Hunan.

The auxiliary material includes the one or more in filler, adhesive, wetting agent, disintegrant, lubricant.In this implementation As an example, its concrete component and its content are sucrose 33%, mannitol 30% in example.

1), to the influence of direct sleep experiments

2), to the influence of the extension yellow Jackets length of one's sleep

3), to the influence of yellow Jackets sub-threshold dose hypnosis experiment

4), to the influence of barbital sodium Sleep latency experiment

The influence that table 1 is tested to improving sleep function

Note：Compared with Normal group, * P<0.05；**P<0.01.

This comparative example compared with Example 1, add other certain be usually used in Chinese medicine --- Schisandra chinens P.E, the people of sleep Conopsea extraction, American ginseng extract, with Valerian root P.E, Bulbus Lilii extract compatibility, its effect is suitable with comparative example D-5, than this Inventive embodiments 1 are weak, but better than comparative example D-4.It follows that Schisandra chinens P.E, ginseng extract, American ginseng extract Synergistic effect, not as the siberian Ginseng P.E of particular requirement of the present invention, green-tea extract and passionflower fruit powder.

Contrast is summarized：

From comparative example B series, after the lily of inventive formulation and valerian compatibility, Synergistic work is generated With, and effect is substantially improved.And by comparative example C series it is further known that, it is necessary to after the specific proportioning compatibility of the application, Synergistic function can be produced, the proportioning of non-invention application can not produce synergistic function, and the present invention program achieves pre- Effect unexpectedly.

From comparative example A, B series, application scheme final effect is better than prior art patent, better than taken off merely black Element.

From comparative example D series, single lily and valerian and other traditional Chinese medicinal components for becoming known for improving sleep are matched somebody with somebody 5, and lily and epiphysin compatibility can not all produce synergistic function, and added in lily and valerian compatibility system Other become known for after improving the traditional Chinese medicinal components slept, and also only have the synergistic effect of the component in itself, increase without possessing collaboration Effect acts on.Meanwhile further checking shows, other traditional Chinese medicinal components for becoming known for improving sleep and lily and valerian compatibility, Not as the siberian Ginseng P.E of particular requirement of the present invention, green-tea extract and passionflower fruit powder compounding effect, moreover, the present invention is special The siberian Ginseng P.E of provisioning request, green-tea extract, the content of passionflower fruit powder have optimal synergistic effect.

The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention All any modification, equivalent and improvement made within refreshing and principle etc., should be included in the scope of the protection.

Claims

1. a kind of have the health food granule for improving sleep function, it is characterised in that component forms and its percentage by weight For：

2. as claimed in claim 1 have the health food granule for improving sleep function, it is characterised in that：The accessory package Include the one or more in colouring agent, flavoring essence, thickener, adhesive, lubricant.

3. as claimed in claim 1 or 2 have the health food granule for improving sleep function, it is characterised in that component forms And its percentage by weight is：

4. as claimed in claim 3 have the health food granule for improving sleep function, it is characterised in that component form and Its percentage by weight is：

5. as claimed in claim 4 have the health food granule for improving sleep function, it is characterised in that component form and Its percentage by weight is：