Summary of the invention
The objective of the invention is at above-mentioned deficiency, a kind of health food that is used to improve sleep is provided.
Health food of the present invention is that the pure natural walnut oil that filters out from motherland medicine treasure-house, Fructus Schisandrae Chinensis, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi, Semen Ziziphi Spinosae etc. are raw material, with reference to the modern pharmacological research achievement, strengthen its synergism by the theory of Chinese medical science scientific composition, and behind the special process effective component extracting refining forming, reach the purpose of improving sleep preferably.
Health food of the present invention, it is to be made by the raw material of following weight parts:
Walnut oil 5-50 part, Fructus Schisandrae Chinensis 5-50 part, Herb Gynostemmae Pentaphylli 5-30 part, Radix Et Caulis Acanthopanacis Senticosi 5-50 part, Semen Ziziphi Spinosae 5-40 part.
Walnut oil is a kind of nutritional oil of preciousness, and delicious delicate fragrance is nutritious, has kept the nourishing healthy and the pharmacological effect of Semen Juglandis.In developed countries such as America and Europes, edible walnut oil has become a kind of propensity to consume, and the U.S. also is assigned therein as spaceman food.
The Semen Juglandis main body of oil is that acid is closed in insatiable hungers such as oleic acid, linoleic acid plus linolenic acid, especially linoleic acid content is the highest, reach 58-68%, in addition, walnut oil also contains the mineral element and the multiple vitamin to the human body beneficial such as VA, VE of needed by human such as potassium, sodium, zinc.
Experiment showed, that walnut oil has the rat cerebral ischemia of improvement, the effect of hypnotic.Have the nutrition cranial nerve cell, regulate neuro vegetative effect.Experiment shows that also walnut oil can significantly promote the hypnosis of mice pentobarbital sodium, illustrates that walnut oil has the effect of hypnotic.
Fructus Schisandrae Chinensis is the dry mature fruit of magnoliaceae schisandra, and its main active component is a schizandrin, comprises deoxyschizandrin, schisandrin B, schisandrol etc.In addition, also contain volatile oil, organic acid and vitamin, mineral element and alkaloids.Have abundant nutritive value and medical care effect widely.
Experimentation shows: Chinese Magnoliavine Fruit alcohol extract can obviously prolong the length of one's sleep of mice pentobarbital sodium, reduce the mice autonomic activities, and strengthen reserpine and pentobarbital sodium inhibitory action to autonomic activities, antagonism caffeine, amfetamine have central inhibitory action widely to the excitation of autonomic activities.
Experiment also shows, the convulsions that the Fructus Schisandrae Chinensis ethanol extract can resist galvanic shock and anti-central stimulants to cause also has regulating action to animal and human's nervous function, has the sedation of significantly sleeping peacefully.
Herb Gynostemmae Pentaphylli is a Cucurbitaceae Gynostemma herbaceous plant, contains the dammarane type gypenoside of kind more than 80 and the similar skeleton of ginsenoside, in addition, also contains mineral elements such as 17 seed amino acids and zinc, molybdenum, ferrum.
Improving aspect the sleep, experiment shows that gypenoside can suppress the white mice voluntary activity significantly, and the white mice voluntary activity strengthens due to the antagonism caffeine, strengthens the hypnosis time of pentobarbital sodium hypnosis sub-threshold dose white mice.The gypenoside SH-6 that Herb Gynostemmae Pentaphylli contains can suppress the autonomic activities of white mice, increase the sleep rate of pentobarbital sodium sub-threshold dose white mice and prolong the length of one's sleep of pentobarbital sodium sleep dosage white mice, show that Herb Gynostemmae Pentaphylli has tangible calmness, syngignoscism.
Radix Et Caulis Acanthopanacis Senticosi is the dry root and rhizome of Araliaceae Radix Et Caulis Acanthopanacis Senticosi.Its main component is pharmaceutical component and various trace elements such as saponin, polysaccharide, flavone.
Experiment shows, the mouse sleep time that Radix Et Caulis Acanthopanacis Senticosi can the significant prolongation amobarbital sodium causes; Regulate central nervous system's excitement and process of inhibition, improve the blood supply in brain situation, promote the metabolism and the reparation of brain cell.Can improve sleep quality, guarantee the sleep duration.Experimental result proves that also the Radix Et Caulis Acanthopanacis Senticosi preparation can tranquillizing and allaying excitement, makes the people sleeping in advance, increases the length of one's sleep and the degree of depth.
Semen Ziziphi Spinosae is the dry mature seed of Rhamnaceae plant Ziziphi Spinosae, and its main component is Semen Ziziphi Spinosae saponin, swertisin, betulic acid and ferulic acid, vitamin C etc.
Experimental result shows: Semen Ziziphi Spinosae has significant sedative-hypnotic effect, its jujuboside that contains can suppress the spontaneous activity of normal mouse and amfetamine central excitation mice, reduce the coordination ability of rat, strengthen the inhibitory action of pentobarbital sodium the central nervous system.The Semen Ziziphi Spinosae total flavonoids that contains can reduce spontaneous activity in mice, and significant prolongation above threshold dosage pentobarbital sodium causes the sleep number of animals and the length of one's sleep, can resist the mice excitation that amfetamine causes.
Health food of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral formulations.
Another object of the present invention provides the preparation method of this health food.
Above-mentioned each component raw material is made the preparation method of health food of the present invention, comprise the steps:
(1) choose the walnut oil that meets specification requirement, and will meet Fructus Schisandrae Chinensis, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi and the Semen Ziziphi Spinosae clean back section of specification requirement, standby;
(2) Fructus Schisandrae Chinensis of described weight portion is added 90% ethanol of 4-6 times of weight, reflux, extract, is 1-3 time under 100 ℃ of conditions, and each extraction time 0.5-1.5 hour, the merge extractive liquid, after-filtration must filtrate and filtering residue, and filtering residue discards; Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions; Thick paste after under 70 ℃, 0.7Mpa condition dry 24 hours, is ground into 120 order fine powders, the Fructus Schisandrae Chinensis extrat dried cream powder;
(3) Herb Gynostemmae Pentaphylli of described weight portion is added 80% ethanol of 6-10 times of weight, reflux, extract, is 2-4 time under 90 ℃ of conditions, and each extraction time 1-3 hour, the merge extractive liquid, after-filtration must filtrate and filtering residue, and filtering residue discards; Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions; Thick paste after under 70 ℃, 0.7Mpa condition dry 24 hours, is ground into 120 order fine powders, the Herb Gynostemmae Pentaphylli extract dried cream powder;
(4) Radix Et Caulis Acanthopanacis Senticosi of described weight portion is added 60% ethanol of 8-12 times of weight, reflux, extract, is 1-3 time under 90 ℃ of conditions, and each extraction time 0.5-1.5 hour, the merge extractive liquid, after-filtration must filtrate and filtering residue, and filtering residue discards; Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions; Thick paste after under 70 ℃, 0.7Mpa condition dry 24 hours, is ground into 120 order fine powders, the Radix Et Caulis Acanthopanacis Senticosi extract dried cream powder;
(5) Semen Ziziphi Spinosae of described weight portion is added 60% ethanol of 6-10 times of weight, reflux, extract, is 2-4 time under 90 ℃ of conditions, and each extraction time 1-2 hour, the merge extractive liquid, after-filtration must filtrate and filtering residue, and filtering residue discards; Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions; Thick paste after under 70 ℃, 0.7Mpa condition dry 24 hours, is ground into 120 order fine powders, the Semen Ziziphi Spinosae extract dried cream powder;
(6) with the walnut oil of described weight portion and (2) gained Fructus Schisandrae Chinensis extrat dried cream powder, (3) gained Herb Gynostemmae Pentaphylli extract dried cream powder, (4) gained Radix Et Caulis Acanthopanacis Senticosi extract dried cream powder and (5) gained Semen Ziziphi Spinosae extract dried cream powder mix homogeneously, promptly.
Required various conventional adjuvant was made any conventional peroral dosage form when health food of the present invention can add the preparation different dosage form, as soft capsule, hard soft capsule, granule, tablet or oral liquid etc.
Health food of the present invention shows through effect experiment, toxicological experiment and stability experiment, and remarkable, nontoxic, the good stability of its effect is taken confirmation through majority and had good improvement sleep effect, and easily is absorbed by the body, and can take for a long time.Have prescription uniqueness, reasonable recipe, characteristics such as function is remarkable, safe and reliable, taking dose is little, the complete maturation of preparation method, bioavailability height.
The specific embodiment
Below in conjunction with embodiments of the invention and test example the present invention is further described, but the present invention is not limited to embodiment, those of ordinary skills do some modification with technical solution of the present invention, still in protection domain of the present invention.
Embodiment 1-5: health food preparation of soft capsule of the present invention
The weight proportion of each raw material sees Table 1 among each embodiment.
Table 1
Embodiment number |
Walnut oil (kg) |
Fructus Schisandrae Chinensis (kg) |
Herb Gynostemmae Pentaphylli (kg) |
Radix Et Caulis Acanthopanacis Senticosi (kg) |
Semen Ziziphi Spinosae (kg) |
Cera Flava (kg) |
1 |
5 |
5 |
5 |
5 |
5 |
0.05 |
2 |
10 |
15 |
8 |
20 |
15 |
0.6 |
3 |
30 |
40 |
20 |
40 |
30 |
1 |
4 |
40 |
45 |
25 |
45 |
35 |
1.5 |
5 |
50 |
50 |
30 |
50 |
40 |
2 |
Prepare the used adjuvant of health food soft capsule of the present invention (suspending agent) and can select the raw material of following weight parts for use:
Cera Flava 0.05-2 part.
The raw material weight proportioning for preparing the used capsule material of health food soft capsule of the present invention is:
1 part in gelatin; Glycerol 0.2-0.6 part; 1 part in water.
Its preparation method is (with embodiment 3 is example, and other embodiment is except that raw material consumption difference, and preparation method is substantially the same manner as Example 3):
(1) choose the walnut oil that meets specification requirement, and will meet Fructus Schisandrae Chinensis, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi and the Semen Ziziphi Spinosae clean back section of specification requirement, standby.
(2) the 40kg Fructus Schisandrae Chinensis is put into extraction pot, add 90% ethanol of 5 times of weight 200kg, reflux, extract, is 2 times under 100 ℃ of conditions, and each 1 hour extraction time, the merge extractive liquid, after-filtration gets filtrate and filtering residue, and filtering residue discards.Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions.Thick paste is put into vacuum drying oven, under 70 ℃, 0.7Mpa condition, after dry 24 hours, is ground into 120 order fine powders, the Fructus Schisandrae Chinensis extrat dried cream powder.
(3) Herb Gynostemmae Pentaphylli of 20kg is put into extraction pot, add 80% ethanol of 8 times of weight 160kg, reflux, extract, is 3 times under 90 ℃ of conditions, and each 2 hours extraction times, the merge extractive liquid, after-filtration gets filtrate and filtering residue, and filtering residue discards.Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions.Thick paste is put into vacuum drying oven, under 70 ℃, 0.7Mpa condition, after dry 24 hours, is ground into 120 order fine powders, the Herb Gynostemmae Pentaphylli extract dried cream powder.
(4) Radix Et Caulis Acanthopanacis Senticosi of 40kg is put into extraction pot, add 60% ethanol of 10 times of weight 400kg, reflux, extract, is 2 times under 90 ℃ of conditions, and each 1 hour extraction time, the merge extractive liquid, after-filtration gets filtrate and filtering residue, and filtering residue discards.Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions.Thick paste is put into vacuum drying oven, under 70 ℃, 0.7Mpa condition, after dry 24 hours, is ground into 120 order fine powders, the Radix Et Caulis Acanthopanacis Senticosi extract dried cream powder.
(5) the 30kg Semen Ziziphi Spinosae is put into extraction pot, add 60% ethanol of 8 times of weight 240kg, reflux, extract, is 3 times under 90 ℃ of conditions, and each extraction time 1-2 hour, the merge extractive liquid, after-filtration got filtrate and filtering residue, and filtering residue discards.Filtrate reduced vacuum under 60 ℃, 0.07Mpa condition is concentrated, be concentrated into that relative density is the thick paste of 1.30-1.33 under 50 ℃ of conditions.Thick paste is put into vacuum drying oven, under 70 ℃, 0.7Mpa condition, after dry 24 hours, is ground into 120 order fine powders, the Semen Ziziphi Spinosae extract dried cream powder.
(6) 30Kg walnut oil, 1Kg Cera Flava are placed material-compound tank, after 35 ℃ of mixing of constant temperature are stirred, (2) gained Fructus Schisandrae Chinensis extrat dried cream powder, (3) gained Herb Gynostemmae Pentaphylli extract dried cream powder, (4) gained Radix Et Caulis Acanthopanacis Senticosi extract dried cream powder and (5) gained Semen Ziziphi Spinosae extract dried cream powder are added wherein, continue to stir 20-30 minute, make mixing of materials even, 100 orders filter.Material after the filtration is squeezed in the degassing tank, under 35 ℃ of constant temperature, pressure 60-70mmHg vacuum, stirs 30-45 minute at a slow speed with the degassing, and the material after the degassing is squeezed in the heat-preserving container, gets soft capsule content.Be incubated in 35 ℃, in order to pelleting.
(7) get the soft capsule material batching, make the soft capsule packaging material routinely.Earlier glycerol and water are put into glue pot and be warming up to 70-80 ℃, the back that stirs adds gelatin, continues stirring 2-3 hour until color even under this temperature.Stir degassing 20-30 minute when being evacuated down to 60-70mmHg in the jar, squeeze into after the degassing and be incubated in the heat-preserving container, left standstill 2-3 hour, in order to giving vent to anger in 60 ℃.
(8) soft capsule packaging material and (6) gained soft capsule content that (7) are prepared, respectively in two hoppers of suction pelleting, debugging machine is after the capacity of thickness, the uniformity and every seed lac ball of capsule skin meets the requirements, and compacting is produced continuously, gets health food soft capsule of the present invention.
Raw materials used source and technical specification among each embodiment:
Fructus Schisandrae Chinensis, Herb Gynostemmae Pentaphylli, Radix Et Caulis Acanthopanacis Senticosi, Semen Ziziphi Spinosae: commercial, each raw material all should meet the specification requirement of a regulation of Pharmacopoeia of People's Republic of China version in 2005.
Walnut oil: available from Hengyang Lv Yuan agricultural processing company limited, the regulation of accord with Q/HYLY01-2004 walnut oil.
The health food soft capsule of making by embodiment 1-5 of the present invention after testing, every net content 0.5g, every contains deoxyschizandrin and is no less than 0.5mg, and total saponins is no less than 7.45mg, and all other indexs all meet the related standards regulation of country about health food.
Eating method: oral, every day 2 times, each 2.
The test example: health food of the present invention improves the sleep function check
For examining or check the sleep function that improves of health food of the present invention, with the 2kg health food soft capsule of the present invention of embodiment 3 gained 0.5g/ grains (hereinafter to be referred as: soft capsule) serve sea market preventive medicine academy, according to Ministry of Public Health " health food check and assessment technique standard " (version in 2003), check it to improve sleep function.Survey report is as follows:
1, sample character:
Content is the sepia oily liquids.
2, animal origin:
Kunming kind white mice, credit number: SCXK (Shanghai) 2002-0010, body weight 18-22g, male, the cleaning level animal that provides by Chinese Academy of Sciences's Shanghai Experimental Animal Center.The temperature 20-25 of laboratory animal breeding room ℃, relative humidity 40-70%, the animal feeding material is provided by the two lion laboratory animal feed technology Services Co., Ltd in Suzhou.
3, dosage design:
0.17,0.33,1.0g/kg sample human body recommended dose is 2g/60kg every day, and basic, normal, high three dosage groups are established in this experiment:, be equivalent to 5 times, 10 times and 30 times of human body recommended dose respectively, other establishes 2% sucrose fatty acid ester solvent control group.
4, sample treatment:
Sample thief 0.17,0.33,1.0g add 2% sucrose fatty acid ester respectively to 20ml, make into even suspension, basic, normal, high three dosage, for the examination.
5, give the sample approach:
Irritate stomach, irritate gastric capacity 0.4ml/20g.b.w.
6, experimental technique and result:
6.1 sample is tested the influence of the weight of animals: the results are shown in Table 2.
Table 2 sample is to the influence of the weight of animals
Group |
Number of animals (only) |
Body weight (gram) |
At the beginning of the test |
Test mid-term |
The test end |
Matched group |
40 |
20.1±1.02 |
28.4±1.60 |
33.7±1.44 |
0.17g/kg |
40 |
20.2±0.99 |
28.7±1.33 |
33.3±1.60 |
0.33g/kg |
40 |
19.8±1.16 |
28.2±1.40 |
33.0±1.54 |
1.0g/kg |
40 |
20.1±1.10 |
28.4±1.38 |
33.2±1.71 |
By table 2 as seen, each dosage treated animal body weight of sample is compared difference that there are no significant with matched group.
6.2 directly sleep test:
Get 40 of mices, be divided into four groups at random, 10 every group, design according to dosage gives sample, reach more than 1 minute as sleeping criterion with the mice righting reflex loss, righting reflex loss be the length of one's sleep to recovering during this period of time, observe irritate stomach after each group fall asleep the number of animals and the length of one's sleep.The results are shown in Table 3.
Table 3 sample is to the animal influence of the direct length of one's sleep
The dosage group |
Number of animals (only) |
The length of one's sleep (second) |
Sleeping number of animals (only) |
Matched group |
10 |
0±0 |
0 |
0.17g/kg |
10 |
0±0 |
0 |
0.33g/kg |
10 |
0±0 |
0 |
1.0g/kg |
10 |
0±0 |
0 |
By table 3 as seen, each dosage group of sample is compared difference that there are no significant with matched group.
6.3 prolong the pentobarbital sodium test length of one's sleep:
Select 40 of mices for use, be divided into four groups at random, every group 10, give sample 30 days continuously, irritate stomach after 15 minutes, give the pentobarbital sodium lumbar injection of each treated animal 50mg/kg.b.w in the 30th day sample, injection volume is 0.2ml/20g.b.w, reach more than 1 minute as sleeping criterion with the mice righting reflex loss, righting reflex loss is the length of one's sleep to recovering during this period of time, observes each treated animal length of one's sleep.The results are shown in Table 4.
Table 4 is the influence of pentobarbital sodium inducing mouse length of one's sleep of dosage above threshold
The dosage group |
Number of animals (only) |
Time for falling asleep (second) |
The length of one's sleep (second) |
Matched group |
10 |
286±159 |
1888±659 |
0.17g/kg |
10 |
276±160 |
1934±1068 |
0.33g/kg |
10 |
245±119 |
2046±923 |
1.0g/kg |
10 |
232±112 |
3286±662
* |
*(through variance analysis) compared in P<0.05 with matched group
By table 4 as seen, sample 1.0g/kg treated animal is compared with matched group the length of one's sleep under above threshold the dosage nembutal is induced, and significant difference is arranged.
6.4 pentobarbital sodium sub-threshold dose hypnosis test:
Select 40 of mices for use, be divided into four groups at random, every group 10, give sample 30 days continuously, irritate stomach after 15 minutes in the doomsday, give the pentobarbital sodium lumbar injection of each treated animal 30mg/kg.b.w, injection volume is 0.2ml/20g.b.w, reach more than 1 minute as sleeping criterion with the mice righting reflex loss, observe and the number of animals of sleep takes place for each treated animal in the pentobarbital sodium 30 minutes.The results are shown in Table 5.
The influence of the pentobarbital inducing mouse sleep incidence rate of table 5 sub-threshold dose
The dosage group |
Number of animals (only) |
Sleeping number of animals (only) |
Matched group |
10 |
0 |
0.17g/kg |
10 |
3 |
0.33g/kg |
10 |
4 |
1.0g/kg |
10 |
6
* |
*(through X 2 test) compared in P<0.05 with matched group
By table 5 as seen, the sleeping number of animals of sample 1.0kg/kg treated animal under the sub-threshold dose pentobarbital sodium is induced compared with matched group, and significant difference is arranged.
6.5 barbital sodium sleep latency test:
Select 40 of mices for use, be divided into four groups at random, every group 10, give sample 30 days continuously, irritate stomach after 15 minutes in the doomsday, give the barbital sodium lumbar injection of each treated animal 250mg/kg.b.w, injection volume is 0.2ml/20g.b.w, reach more than 1 minute as the criterion of sleeping with the mice righting reflex loss, observe each treated animal preclinical situation of sleeping of giving.The results are shown in Table 6.
Table 6 pentobarbital sodium is to the preclinical influence of animal sleep
The dosage group |
Number of animals (only) |
Sleep incubation period (second) |
Matched group |
10 |
1663±605 |
0.17g/kg |
10 |
1450±432 |
0.33g/kg |
10 |
1284±330 |
1.0g/kg |
10 |
1052±205
* |
*(through variance analysis) compared in P<0.05 with matched group
By table 6 as seen, the sleep of sample 1.0g/kg dosage treated animal is compared with matched group incubation period, and significant difference is arranged.
7.0 sum up:
Per os gave the sample soft capsule 30 days continuously, experimental result shows: sample can obviously prolong the length of one's sleep behind the animal injection pentobarbital sodium, sleeping number of animals behind the increase injection pentobarbital sodium sub-threshold dose, sleep incubation period behind the shortening injection barbital sodium, and do not have obviously directly sleep effect.
Conclusion: health food soft capsule of the present invention has the significant sleep function that improves to mice.