CN102940768B - Composition for improving sleep and preparation method and application thereof - Google Patents
Composition for improving sleep and preparation method and application thereof Download PDFInfo
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- CN102940768B CN102940768B CN201210536780.2A CN201210536780A CN102940768B CN 102940768 B CN102940768 B CN 102940768B CN 201210536780 A CN201210536780 A CN 201210536780A CN 102940768 B CN102940768 B CN 102940768B
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Abstract
The invention relates to a composition for improving sleep and a preparation method and application thereof. The composition comprises the following components in parts by weight: 400 to 700 parts of tuckahoe, 350 to 650 parts of seed of wild jujube, 250 to 550 parts of lily, 100 to 250 parts of ginseng and 40 to 200 parts of schisandra. The five gouts of Chinese medicament raw materials are reasonably matched, and the raw materials achieve a good synergistic effect according to the given component proportion, namely each Chinese medicament exerts the effect; the composition has a remarkable effect on the aspect of improving the sleep and is superior to the prior art, namely the formula is optimal, the process is reasonable, the active ingredients are extracted completely, and the treatment effect of the composition is well exerted; the composition does not have adverse response and is high in safety; and the equipment is simple, the cost is low, and industrialized production can be realized.
Description
Technical field
The present invention relates to medicine or Halth-care composition field, particularly, relate to a kind of compositions of improving sleep, and its preparation method and application.
Background technology
Sleep disorder refers to occur the performance of Deviant Behavior in the undesired and sleep of amount of sleep, is that sleep and awakening normal rhythm replace disorderly performance.Can be caused by many factors, normal relevant with physical disease, comprise dyssomnias and parasomnias.Sleep is closely bound up with people's health, and long-term insomnia can cause brain dysfunction, and health is caused to multiple harm, has a strong impact on physical and mental health.Show according to investigation, a lot of people suffer from the obstacle of sleep aspect or the disease relevant with sleep, and adult there will be the ratio of sleep disorder up to 30%.Expert points out that sleep is the extremely important physiological function that maintains human life, essential to human body.Therefore, sleep disorder must cause enough attention.
At present, all kinds of improvement sleep products that market is popular, mostly remove to seek formula in poor aspect round the clock from calmness, hypnosis and adjusting.Health promoting product taking melatonin as primary raw material is only adapted to night job person, need to get jet lag, person in middle and old age's (because melatonin secretion reduces), if crowd's medicine is residual larger daytime, have dizziness and the unstable side effect that waits of walking, and may bring danger compared with weak person to older, health.But, cause sleep disorder to have from many-sided factor, such as ailing, brain is continuous is overexcited or fatigue, stress, emotion setback, fear, neurasthenia, spiritual irriate etc.And in most cases, poor rule is upset just sleep disorder in nascent a kind of form of expression round the clock, the not cause of disease.The sleep disorder that poor rule confusion causes round the clock is still more after all at majority, and recovers poor rule round the clock and can not solve the basic reason of sleep disorder.Therefore, can not obtain the long-term favor of consumer.Therefore,, in conjunction with Chinese medical theory, the compositions of developing and fundamentally solve sleep disorder, improving sleep is imperative.
Chinese patent application CN 03135481.5 discloses a kind of pure natural health-care product that improves sleep.The medicine material of these health product has Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Semen Coicis, Bulbus Lilii, Fructus Lycii, Poria, Caulis Polygoni Multiflori, Semen Platycladi, Radix Polygalae, Fructus Tritici Levis, Fructus Jujubae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, and its preparation comprises raw materials medicament extracting solution, produces extractum, prepares health product siccative and four steps of packaging.
Chinese patent application CN 201010532922.9 discloses the one decompression composition and method of making the same of releiving, and said composition is mainly made up of the raw material of following portions by weight: Semen Ziziphi Spinosae (parched) 5-30 part, Radix Angelicae Sinensis 5-30 part, Poria 5-30 part, Cortex et Radix Polygalae (processed) 1-15 part, Rhizoma Chuanxiong 5-30 part, Fructus Schisandrae Chinensis 1-15 part, Bulbus Lilii 10-45 part, Radix Salviae Miltiorrhizae 10-45 part, Caulis Polygoni Multiflori 10-45 part, Semen Platycladi 5-30 part, Rhizoma Acori Graminei 1-15 part, Cortex Albiziae 10-45 part; Its preparation method is that the medical material of above-mentioned formula consumption is concentrated after water extract-alcohol precipitation.Above composition prescription amount is large, and preparation technology is loaded down with trivial details.
Summary of the invention
One of object of the present invention is to provide a kind of compositions of improving sleep.
Another object of the present invention is to provide a kind of preparation method of described compositions.
Another object of the present invention is to provide described compositions to improve the medicine of sleeping or/and the application in health product in preparation.
A kind of compositions of improving sleep provided by the invention, comprises the component of following weight portion: 400 ~ 700 parts, Poria, 350 ~ 650 parts of Semen Ziziphi Spinosaes, 250 ~ 550 parts of Bulbus Liliies, 40 ~ 200 parts of 100 ~ 250 parts of Radix Ginsengs and Fructus Schisandrae Chinensis.
The compositions of improvement sleep provided by the invention, preferably, comprises the component of following weight portion: 500 ~ 600 parts, Poria, 450 ~ 550 parts of Semen Ziziphi Spinosaes, 350 ~ 450 parts of Bulbus Liliies, 80 ~ 160 parts of 120 ~ 220 parts of Radix Ginsengs and Fructus Schisandrae Chinensis.
The compositions of improvement sleep provided by the invention, preferably, comprises the component of following weight portion: 530 ~ 570 parts, Poria, 480 ~ 520 parts of Semen Ziziphi Spinosaes, 380 ~ 420 parts of Bulbus Liliies, 100 ~ 140 parts of 150 ~ 190 parts of Radix Ginsengs and Fructus Schisandrae Chinensis.
The compositions of improvement sleep provided by the invention, more preferably, comprises the component of following weight portion: 550 parts, Poria, 500 parts of Semen Ziziphi Spinosaes, 400 parts of Bulbus Liliies, 120 parts of 170 parts of Radix Ginsengs and Fructus Schisandrae Chinensis.
The compositions of improvement sleep of the present invention, also comprises adjuvant.
Present composition adjuvant used is the conventional adjuvant of this area.
The compositions of improvement sleep of the present invention, its dosage form is acceptable dosage form on pharmacy or health product.
Wherein, on pharmacy or health product, acceptable dosage form is: capsule, tablet, granule, oral liquid or pill.Preferably capsule.
The preparation method of described compositions provided by the invention, comprises the following steps:
1) part Radix Ginseng powder in described ratio is broken into fine powder, for subsequent use;
2) get Semen Ziziphi Spinosae, the Fructus Schisandrae Chinensis of the remaining Radix Ginseng of step 1) and described ratio, with ethonal extraction, filtrate recycling ethanol is also condensed into clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) alcohol extraction medicinal residues decoct with water, filtrate is condensed into clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) merge, drying under reduced pressure, pulverizes, and sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, to obtain final product.
The preparation method of compositions of the present invention, further, comprises the following steps:
1) get in described ratio 50% ~ 65% Radix Ginseng, crushed after being dried, crosses 90 ~ 110 mesh sieves and becomes fine powder, for subsequent use;
2) get Semen Ziziphi Spinosae, the Fructus Schisandrae Chinensis alcohol reflux 2 ~ 4 times of the remaining Radix Ginseng of step 1) and described ratio, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 5 ~ 7 times of amounts of Fructus Schisandrae Chinensis at every turn, each extraction 1 ~ 2 hour, filter, merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) alcohol extraction medicinal residues decoct with water 2 ~ 4 times, add the water of Poria, Bulbus Lilii and 6 ~ 10 times of amounts of alcohol extraction medicinal residues at every turn, each decoction 1 ~ 2 hour, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) merge, in 50 ~ 80 DEG C of drying under reduced pressure, pulverize, cross 70 ~ 90 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, to obtain final product.
In above-mentioned preparation method:
In described step 1), pulverize Radix Ginseng and preferably cross 100 mesh sieves.
In described step 1), the temperature of dry Radix Ginseng is 50 ~ 70 DEG C, preferably 60 DEG C.
In described step 1), the fine powder that adopts Co 60 radiation sterilization to pulverize.
Described step 2) ethanol used reach 65 ~ 75%(percentage by volume containing alcohol amount), preferably 70%.
Described step 2) preferably extract 2 times, add the ethanol of 6 times of amounts at every turn, extract 1.5 hours at every turn.
Described step 3) is the water of 6 ~ 8 times of amounts preferably, more preferably decocts 2 times, adds the water of 8 times of amounts at every turn, decocts 1.5 hours at every turn.
Described step 4) is preferable over 60 ~ 70 DEG C of drying under reduced pressure, more preferably 65 DEG C.
Described step 4) is preferably crossed 80 mesh sieves, and powder gets dry extract.
If compositions of the present invention is made capsule, in described step 5), obtain after dried cream powder, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C are dry, and 14 mesh sieve granulate, incapsulate shell, obtain capsule finished product.
Preparation method of the present invention, can maximize the effective ingredient that extracts each flavour of a drug, thereby improves drug effect.Poria water decoction has good sedative-hypnotic effect; Water extraction after Semen Ziziphi Spinosae alcohol extraction, has significant calmness and hypnosis and anticonvulsant action; Bulbus Lilii water extraction liquid can obviously extend pentobarbital sodium length of one's sleep, and sub-threshold dose pentobarbital sleep rate is significantly improved; In order to prevent the product moisture absorption after preparation, simultaneously Panax's valuable medicinal, therefore adopt part to pulverize, the method for water extraction after part alcohol extraction, utilizes wherein saponin, saccharide etc. to the effective active component of central nervous system better; Water extraction after Fructus Schisandrae Chinensis alcohol extraction, can obviously reduce mice autonomic activities number of times, increase hypnosis of pentobarbital sodium of subthreshold dose number of elements, extend above threshold dosage pentobarbital sodium in mice length of one's sleep, make it in prescription, bring into play better its calmness, syngignoscism.
Described compositions provided by the invention is prepared into medicine or health product, can be used to improve sleep.
In compositions provided by the invention: Poria: property slightly sweet flavor is flat, enters the heart, lung, spleen, kidney channel.There is promoting diuresis to eliminate damp pathogen, spleen invigorating, effect of mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Semen Ziziphi Spinosae: nature and flavor are sweet, sour, flat, return liver, gallbladder, heart channel.There is the tonifying liver of nourishing heart, mind tranquilizing and the heart calming, arresting sweating, the effect of promoting the production of body fluid.For restlessness of asrhenia type and insomnia, palpitation with fear dreaminess, the empty hyperhidrosis of body, Tianjin wound is thirsty.
Bulbus Lilii: sweet in the mouth, cold in nature, GUIXIN, lung meridian.There is nourishing YIN and moistening the lung, effect of clearing away heart-fire for tranquillization.For deficiency of YIN cough caused by dryness, chronic cough hemoptysis, fidgets due to deficiency palpitation with fear, insomnia and dreamful sleep, absentminded.
Radix Ginseng: sweet in the mouth, micro-hardship, tepor.Return spleen, lung, the heart, kidney channel.Have strongly invigorating primordial QI, multiple arteries and veins is admittedly de-, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, effect of the Fructus Alpiniae Oxyphyllae of calming the nerves.For weak body and prostration, cold extremities faint pulse, deficiency of qi and blood, palpitation with fear insomnia etc.
Fructus Schisandrae Chinensis: sour in the mouth, sweet, temperature, returns lung, the heart, kidney channel.There is convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, effect of kidney calming.For chronic cough dyspnea due to deficiency, Tianjin wound is thirsty, palpitation and insomnia etc.
That is to say, in compositions of the present invention, Poria spleen invigorating mind calming; Semen Ziziphi Spinosae reinforcing the heart nourishing the liver and mind tranquilizing and the heart calming; Bulbus Lilii nourishing YIN and moistening the lung clearing away heart-fire for tranquillization; Ginseng qi-tonifying mind calming; Fructus Schisandrae Chinensis supplementing QI for promoting the production of body fluid, kidney calming; All medicines share, and play altogether the merit of mind tranquilizing and the heart calming, supplementing QI and nourishing YIN.By across-the-board regulation function of human body, thereby reach the effect that collaborative improvement is slept, realize and improve insomnia crowd's sleep quality and the object of quality of life.
In a word, the present invention is undertaken reasonably combined by above-mentioned five kinds of raw material of Chinese medicine, the composition proportion providing makes raw material play good synergism, and each Chinese medicine has been given play to its effect, combines to improve aspect sleep effect remarkable, be better than prior art, prescription is more optimized, and technique is more reasonable, and what active component was extracted is more complete, bring into play better the curative effect of compositions, reduced again dose simultaneously; And have no adverse reaction, safety is very high; The property of medicine relaxes, and can not cause drug dependence, can for a long time relievedly take.Related equipment is simple, and cost is lower, can realize suitability for industrialized production.
Detailed description of the invention
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
The embodiment of the present invention is raw materials used all can buy from the market.The multiple of the present invention's second alcohol and water used is weight multiple.
The kind of the present invention's adjuvant used and consumption can be that the routine of this area is selected.
Embodiment 1: capsule
1, compositions composition:
Poria 550g, Semen Ziziphi Spinosae 500g, Bulbus Lilii 400g, Radix Ginseng 170g, Fructus Schisandrae Chinensis 120g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get Radix Ginseng 100g, 60 DEG C of crushed after being dried, cross 100 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 70% alcohol reflux 2 times of the remaining Radix Ginseng of step 1) (70g) and above-mentioned weight, add the etoh solvent of Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1.5 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 2 times, add the water of Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) merge, in 65 DEG C of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C are dry, and 14 mesh sieve granulate, incapsulate shell, polishing, and packaging, inspection, gets product: make 1000, every dress 0.4g; Significant composition and content: every 100g is containing total saponins 0.7g.
Embodiment 2: tablet
1, compositions composition:
Poria 530g, Semen Ziziphi Spinosae 520g, Bulbus Lilii 380g, Radix Ginseng 190g, Fructus Schisandrae Chinensis 100g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 95g, 50 DEG C of crushed after being dried, cross 90 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 75% alcohol reflux 3 times of the remaining Radix Ginseng of step 1) (95g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 7 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1 hour, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 4 times, add the water of Poria, Bulbus Lilii and 7 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 2 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 65 DEG C of drying under reduced pressure, pulverize, cross 85 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, add starch, dextrin, Sodium Hydroxymethyl Stalcs (to be respectively 3% of Radix Ginseng fine powder and dried cream powder gross weight, 1% and 1%), mix, use 75% alcohol granulation, dry, add magnesium stearate (for Radix Ginseng fine powder and dried cream powder gross weight 2%), mix, granulate, tabletting.
Embodiment 3: granule
1, compositions composition:
Poria 570g, Semen Ziziphi Spinosae 480g, Bulbus Lilii 420g, Radix Ginseng 150g, Fructus Schisandrae Chinensis 140g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 97.5g, 55 DEG C of crushed after being dried, cross 110 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 65% alcohol reflux 4 times of the remaining Radix Ginseng of step 1) (52.5g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 5 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 2 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 3 times, add the water of Poria, Bulbus Lilii and 6 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1 hour, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 65 DEG C of drying under reduced pressure, pulverize, cross 75 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, add 75% ethanol to do binding agent, add stevioside and soluble starch (be respectively Radix Ginseng fine powder and dried cream powder gross weight 2% and 5%), mix, be pressed into granule.
Embodiment 4: pill
1, compositions composition:
Poria 500g, Semen Ziziphi Spinosae 450g, Bulbus Lilii 450g, Radix Ginseng 120g, Fructus Schisandrae Chinensis 170g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 72g, 65 DEG C of crushed after being dried, cross 100 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 70% alcohol reflux 2 times of the remaining Radix Ginseng of step 1) (48g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1.5 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 2 times, add the water of Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 65 DEG C of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, add the refined honey pill of 1.0 ~ 1.2 times of Radix Ginseng fine powder and dried cream powder gross weights.
Embodiment 5: capsule
1, compositions composition:
Poria 600g, Semen Ziziphi Spinosae 550g, Bulbus Lilii 350g, Radix Ginseng 220g, Fructus Schisandrae Chinensis 70g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 132g, 70 DEG C of crushed after being dried, cross 100 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 70% alcohol reflux 2 times of the remaining Radix Ginseng of step 1) (88g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1.5 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 2 times, add the water of Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 65 DEG C of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C are dry, and 14 mesh sieve granulate, incapsulate shell, polishing, and packaging, inspection, gets product.
Embodiment 6: capsule
1, compositions composition:
Poria 400g, Semen Ziziphi Spinosae 650g, Bulbus Lilii 250g, Radix Ginseng 250g, Fructus Schisandrae Chinensis 40g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 210g, 60 DEG C of crushed after being dried, cross 100 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 70% alcohol reflux 2 times of the remaining Radix Ginseng of step 1) (140g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1.5 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 2 times, add the water of Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 60 DEG C of drying under reduced pressure, pulverize, cross 90 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C are dry, and 14 mesh sieve granulate, incapsulate shell, polishing, and packaging, inspection, gets product.
Embodiment 7: capsule
1, compositions composition:
Poria 700g, Semen Ziziphi Spinosae 350g, Bulbus Lilii 250g, Radix Ginseng 100g, Fructus Schisandrae Chinensis 200g.
2, preparation method:
1) by each raw material clean system respectively, be up to the standards; Get the Radix Ginseng of 60g, 60 DEG C of crushed after being dried, cross 100 mesh sieves and become fine powder, adopt Co 60 radiation sterilization, for subsequent use;
2) get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis 70% alcohol reflux 2 times of the remaining Radix Ginseng of step 1) (40g) and above-mentioned weight, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum at every turn, each extraction 1.5 hours, filter (medicinal residues preservation), merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 DEG C of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) alcohol extraction medicinal residues decoct with water 2 times, add the water of Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum at every turn, each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 DEG C of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) by step 2) and the clear paste of step 3) mix, in 70 DEG C of drying under reduced pressure, pulverize, cross 70 mesh sieves, powder gets dry extract;
5) the Radix Ginseng fine powder of step 1) and the dried cream powder of step 4) are mixed, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C are dry, and 14 mesh sieve granulate, incapsulate shell, polishing, and packaging, inspection, gets product.
Experimental example 1: function test
1 materials and methods
1.1 samples: by the capsule of embodiment 1, specification 0.4g/ grain.The oral recommendation consumption of people is everyone (adult) every day 2 times, each 3, and become body weight for humans press 60kg calculating, amounting to dosage is 40mg/kg BW.Getting capsule 's content tests.
1.2 laboratory animals and grouping: select 192 of the SPF level healthy adult NIH kind female mices of Guangdong Medical Lab Animal Center breeding, body weight is 18 ~ 22 grams.Every 48 mices are 1 group, totally 4 groups, carry out respectively directly sleep test, the test length of one's sleep of prolongation pentobarbital sodium, pentobarbital sodium sub-threshold dose hypnosis test, the test of barbital sodium Sleep latency.
1.3 experimental situation conditions: laboratory animal room temperature: 22 ~ 25 DEG C, relative humidity: 55 ~ 70%.
1.4 dosage are selected and sample treatment: recommend consumption according to the human body of this sample, if 200,400,800mg/kg BW(is equivalent to respectively human body and recommends 5,10,20 times of consumption) test group of 3 dosage, establish a negative control group, every group of 12 animals simultaneously.Take respectively 2.0,4.0,8.0g sample, each adding distil water is to 200mL, mix, be made into 10,20, the suspension of 40mg/mL concentration, give respectively corresponding dosage treated animal gavage, gavage volume is 0.2mL/10g BW, matched group gives isopyknic distilled water, every day gavage once, continuously gavage 30 days.
1.5 key instruments and reagent:
Instrument: animal platform balance, electronic analytical balance, stopwatch etc.
Reagent: pentobarbital sodium, barbital sodium, purchased from Chemical Reagent Co., Ltd., Sinopharm Group.
1.6 experimental techniques:
1.6.1 directly sleep test: giving the sleep quality of observing mice after last sample, exceeding 60 seconds and be judged to enter sleep with the righting reflex loss of animal, righting reflex recovers to be animal awakening.Result is carried out statistical analysis with X2 inspection.As test group is fallen asleep, number of animals and the length of one's sleep increase and there were significant differences with negative control group, judge that this result of the test is positive.
1.6.2 extend test pentobarbital sodium length of one's sleep: to last sample after 20 minutes, each treated animal is through lumbar injection pentobarbital sodium 45mg/kg BW, and injection volume is 0.2mL/20g BW.Taking the righting reflex loss of animal as index, observe tested material and can extend pentobarbital sodium length of one's sleep.Result is carried out statistical analysis with variance analysis.As extended than negative control group the length of one's sleep of test group mice and having statistical significance, judge that this result of the test is positive.
1.6.3 pentobarbital sodium sub-threshold dose hypnosis test: giving last sample after 20 minutes, each treated animal is through lumbar injection pentobarbital sodium 30mg/kg BW.Observe the sleep quality of mice in 30 minutes, for falling asleep, record the number of animals of falling asleep of each group with the more than 60 seconds person of righting reflex loss, calculate the animal incidence rate of falling asleep.Result X2 check analysis.Fall asleep animal incidence rate higher than negative control group and have statistical significance as test group, judging that this result of the test is positive.
1.6.4 barbital sodium Sleep latency test: injection volume is 0.2mL/20g BW to each treated animal through lumbar injection barbital sodium 300mg/kg BW giving after last sample 20 minutes.Taking righting reflex loss as index, observe animal subject and can shorten barbital sodium Sleep latency.Result is carried out statistical analysis with variance analysis.As the Sleep latency of test group mice shortens than negative control group and has statistical significance, judge that this result of the test is positive.
1.7 results are judged
If extend the binomial positive in the pentobarbital sodium experiment length of one's sleep, pentobarbital sodium sub-threshold dose hypnosis experiment, three experiments of barbital sodium Sleep latency experiment, and without obviously directly sleep effect, can judge that this given the test agent has the effect of the sleep function of improvement.
2 results
The impact of 2.1 samples on Mouse Weight
Table 1: capsule of the present invention improves sleep function test mice body weight
* note: the experiment of the each dosage group of P value representation is initial, Mouse Weight and weightening finish and the matched group comparison in mid-term and latter stage, and there are no significant for difference.
Table 2: capsule of the present invention improves sleep function test mice body weight
* note: the experiment of the each dosage group of P value representation is initial, Mouse Weight and weightening finish and the matched group comparison in mid-term and latter stage, and there are no significant for difference.
From table 1, table 2, experiment just, experiment mid-term, between the Mouse Weight of the each dosage group of experiment sample in latter stage and experimental session weight of mice and negative control group, compare, there are no significant for difference (P>0.05), shows that this sample has no significant effect the body weight gain of mice.
The direct sleep effect of 2.2 samples
As seen from Table 3, per os gives the capsule 30 days of the embodiment 1 of mice various dose, and each dosage group does not all have animal to occur righting reflex loss, and all animals does not all enter sleep state, points out this sample there is no direct inducing mouse sleep effect.
Table 3: the capsule mice of the present invention result of the test of directly sleeping
2.3 samples are on the pentobarbital sodium impact of the length of one's sleep
Table 4: capsule of the present invention extends the pentobarbital sodium result of the test length of one's sleep
Visible through table 4, per os gives the capsule 30 days of the embodiment 1 of mice various dose, all extend than negative control group the length of one's sleep of each dosage group mice, the difference of height wherein, middle dosage group and negative control group has significance (P<0.01 and P<0.05 respectively), points out this sample to have and extends the pentobarbital sodium effect of the length of one's sleep.
The impact of 2.4 samples on pentobarbital sodium sub-threshold dose syngignoscism
As seen from Table 5, per os gives the capsule 30 days of the embodiment 1 of mice various dose, the animal of each dosage group falls asleep rate higher than negative control group, high dose group wherein and the difference of negative control group have significance (P<0.05), point out the pentobarbital sodium of this sample and sub-threshold dose to have collaborative syngignoscism.
Table 5: capsule pentobarbital sodium sub-threshold dose hypnosis result of the test of the present invention
2.5 samples are on the preclinical impact of barbital sodium hypnosis
Table 6: capsule pentobarbital sodium Sleep latency result of the test of the present invention
As seen from Table 6, per os gives the capsule 30 days of the embodiment 1 of mice various dose, the Sleep latency of each dosage group mice is all than the shortening of negative control group, and the difference of height, middle dosage group and negative control group has very significant (P<0.01), point out this sample to there is the effect of shortening barbital sodium Sleep latency.
3 results are judged
Respectively with 200,400,800mg/kg BW(is equivalent to human body and recommends 5,10,20 times of consumption) capsule of the embodiment 1 of dosage is continuously to mouse stomach 30 days, can extend pentobarbital sodium length of one's sleep, collaborative pentobarbital sodium sub-threshold dose syngignoscism, shorten barbital sodium Sleep latency, without directly sleep effect, without impact, point out this sample to there is the effect of the sleep function of improvement to the body weight gain of mice.
Experimental example 2: safety testing
1 materials and methods
The capsule of 1.1 samples: embodiment 1, specification: 0.4g/ grain, put shady and cool dry and comfortable ventilation and preserve.The oral recommendation consumption of people is everyone (adult) every day 2 times, each 3, and become body weight for humans press 60kg calculating, amounting to dosage is 40mg/kg BW.Getting capsule 's content tests.
1.2 laboratory animals and environment: the healthy Kunming mouse of clean level is bred by Guangxi Medical University's medical experiment animal center, SPF level SD kind rat is bred by Guangdong Medical Lab Animal Center, and the Quality of Experimental Animals quality certification number is respectively: 0001069(mice), 0042719(rat).Laboratory animal occupancy permit number: SYXK osmanthus 2007-0003.Laboratory animal room temperature: 22～25 DEG C, relative humidity: 55～70%.
1.3 chmice acute Oral toxicities tests: adopt maximum dosage-feeding test method(s), select 20 of the Kunming mouses of body weight 18～22g, male and female half and half.Before test, animal fasting 16 hours, does not limit drinking-water.Take 40.0g sample, adding distil water, to 100mL, mixes, is made into the suspension of 400mg/mL concentration, then gives animal gavage 3 times (every minor tick 4h), and each gavage amount is 0.4mL/20g BW, and adding up to dosage is 24000mg/kg BW.After gavage, observe, record the poisoning manifestations of animal.Weigh weekly once, observe two time-of-weeks, off-test is dissected animal and is carried out gross examination of skeletal muscle.Press the acute toxicity power of toxicity grading standard evaluation tested material.
1.4Ames test: employing is tested through identifying satisfactory Salmonella typhimurium histidine defect type TA97a, TA98, TA100, tetra-kinds of bacterial strains of TA102.Under aseptic technique, with sterile purified water using sample be made into respectively 50,10,2,0.4, a 0.08mg/mL5 concentration is as tested solution, after autoclaving (0.103Mpa 20min) is processed, be for experiment.
With the rat liver microsomes enzyme (S of Polychlorinated biphenyls induction
-9) as Metabolic Activation of Cyclophosphamide.Adopt flat board to mix method, in the top layer culture medium of insulation, add successively 0.1mL test strain enrichment liquid, 0.1mL tested material solution and 0.5mL S
-9mixed liquor (in the time of needs metabolism activation), pours into after mixing on bottom culture medium flat plate.5 test doses are respectively 5000,1000,200,40,8ug/ ware, establish from beaming back simultaneously and become contrast, solvent control and the contrast of positive mutagens.Become contrast except not adding sample from beaming back, all the other conditions are identical with sample sets.Solvent control substitutes sample with sterile purified water, and all the other conditions are identical with sample sets.The various bacterial strains of each dosage group all make 3 parallel wares.At 37 DEG C, cultivate 48 hours, count the clump count of every ware.A whole set of test repeats to do twice under the same conditions.If returning of tested material becomes clump count increase and exceedes from beaming back and become the more than 2 times of clump count, and the person that has dose-response relationship, be the mutagenesis testing positive.
1.5 mouse marrow cell micro nuclear tests: adopt 24 hours twice, interval per os administration by gavage to test.Selecting body weight is 50 of the kunming mices of 25～30g, is divided at random 5 groups, 10 every group, and male and female half and half.3 dosage of test group establish respectively 12000,6000,3000mg/kg BW, and with the negative contrast of distilled water, the cyclophosphamide (cp) of 42mg/kg BW dosage is made positive control.Take respectively 40.0,20.0,10.0g sample, each adding distil water is to 100mL, mix, be made into 400,200, the suspension of 100mg/mL concentration, then press the volume of 0.6mL/20gBW to animal gavage, negative control group is filled with to isopyknic distilled water, and positive controls is filled with to isopyknic 1.4mg/mL cyclophosphamide solution.After giving for the second time sample, animal is put to death in cervical vertebra dislocation in 6 hours, gets bone marrow of sternum calf serum and dilutes smear, and methanol is fixed, Giemsa dyeing.
Under optical microscope, every animal 1000 polychromatic erythrocytes of counting (PCE), micronuclear rates, in the PCE permillage containing micronucleus, is counted 200 polychromatic erythrocytes simultaneously, calculates the ratio (PCE/NCE) of polychromatic erythrocyte and mature erythrocyte.Adopt the statistical disposition of Poisson distribution mean relative method.As the micronuclear rates of test group increases than negative control group, and there are obvious dose-response relationship and statistical significance, are positive findings.
1.6 mouse sperm deformities tests: selecting body weight is 50 of the Male Kunming strain mice of 25～35g, is divided at random 5 groups, 10 every group.3 dosage of test group establish respectively 12000,6000,3000mg/kg BW, and with the negative contrast of distilled water, the cyclophosphamide (cp) of 42mg/kg BW dosage is made positive control.Take respectively 40.0,20.0,10.0g sample, each adding distil water is to 100mL, mix, be made into 400,200, the suspension of 100mg/mL concentration, then press the volume of 0.6mL/20g BW to animal gavage, negative control group is filled with to isopyknic distilled water, and positive controls is filled with to isopyknic 1.4mg/m cyclophosphamide solution.Every day gavage once, continuous 5 days.Last is put to death animal on the 30th day after to sample, gets the sperm smear of epididymis, and methanol is fixed, Yihong dyeing.Under optical microscope, every zoometer counts up to 1000 of whole sperms, calculates rate of teratosperm, adopts χ
2inspection statistics processing.As the rate of teratosperm of test group increases than negative control group, and there are obvious dose-response relationship and statistical significance, are positive findings.
1.7 rat 30 days feeding trials
1.7.1 dosage is selected to give mode with tested material: select 80 of SD kind rats, male and female half and half, male Mus body weight 69.8 ± 6.3g, female Mus body weight 69.2 ± 6.4g.Animal is divided into 4 groups at random, i.e. negative control group and 3 test group, 20 every group, male and female half and half.3 test group dosage is made as respectively 4000,3000,2000mg/kg BW, is equivalent to respectively 100,75,50 times of human body recommended dose.Take respectively 200.0,150.0,100.0g sample, each adding distil water is to 500mL, mix, be made into 400.0,300.0,200.0mg/mL concentration solution, press the volume of 1.0mL/100g BW to corresponding dosage treated animal gavage, negative control group is filled with the distilled water to equivalent, every day gavage once, continuously gavage 30 days.
1.7.2 experimental technique: all animals of experimental session give normal diet, single cage is raised, the drinking-water of freely ingesting.Observe activity and the growing state of animal every day, add weekly food 2 times, record, to appetite and surplus appetite, claims weekly body weight one time, calculates weekly food-intake and food utilization.The 30th day animal overnight fasting, claims animal body weight on an empty stomach on the 31st day, then puts to death rat, adopts 2 parts of blood samples, and a blood anticoagulant detects Hb, RBC, WBC and classification, PLT etc. with blood counting instrument; Another part of not anticoagulant of blood separation of serum, uses test kit and semi-automatic analyser to detect the projects such as serum AST, ALT, BUN, Cr, TC, TG, Glu, TP, Alb.After blood sampling, dissect animal, carry out gross examination of skeletal muscle, get the internal organs such as liver, kidney, spleen and testis and weigh, calculate dirty/body ratio, get the internal organs such as liver, kidney, spleen, Stomach duodenum, testis and ovary and carry out histopathologic examination.In the time each dosage treated animal made to gross examination not finding obvious pathological changes and Biochemical index change, only carry out the histopathological examination of the main organs of high dose group and control animals, as found, centering, low dose group corresponding organ and tissue check pathological changes.
1.7.3 experimental data statistics: application SPSS statistical software carries out one factor analysis of variance.In the time of statistical analysis, first data are carried out to homogeneity test of variance, if variance is neat, adopt one factor analysis of variance totally to compare, find differences and carry out comparing between two between multiple dosage groups and matched group mean with Dunnett inspection again.If heterogeneity of variance carries out the conversion of suitable variable to data, meet after homogeneity test of variance, add up by the data after changing; If translation data does not reach the neat requirement of variance yet, use rank test instead and carry out statistical analysis.
2 results
2.1 acute oral toxicity test
Table 1-1: the acute toxicity tests of capsule of the present invention to mice
From table 1-1, give after mouse stomach taking the sample of maximum dosage-feeding (dosage is as 24000mg/kg BW), growth of animal is good, has no body weight and is affected.Tested mice has been showed no poisoning symptom, observes 14 days without animal dead.Animal, gross examination of skeletal muscle are dissected in off-test, the main organs such as liver,kidney,spleen, the heart, lung, stomach, intestinal are showed no obvious abnormalities change, according to the acute toxicity grading criteria in " health food inspection and assessment technique specification " (version in 2003), the acute oral toxicity of this sample belongs to nontoxic level.
2.2Ames test
Table 2-1: capsules A mes result of the test of the present invention (for the first time)
Note: 1, above result (clump count) is the means standard deviation of 3 plates.
2, positive control: TA97a+S9, TA98+S9, TA100+S9 adopt 2-aminofluorene (dosage is 10ug/ ware); TA98-S9 adopts daunorubicin (dosage is 6ug/ ware); TA97a-S9, TA102-S9 adopt fenaminosulf (dosage is 50ug/ ware); TA100-S9 adopts sodium azide (dosage is 1.5ug/ ware); TA102+S9 adopts 1,8-dihydroxy to fear quinone (dosage is 50ug/ ware).Table 3-1 is same.
From table 2-1, table 3-1, to TA97a, TA98, TA100, tetra-kinds of test strains of TA102, no matter whether add S-9, the change clump count that returns of the each dosage group of sample does not all exceed the twice that becomes clump count from beaming back, also without dose-response relationship, represent that this tested material mutagenesis testing result is negative.
Table 3-1: capsules A mes result of the test of the present invention (for the second time)
Note: above result (clump count) is the means standard deviation of 3 plates.
2.3 mouse marrow cell micro nuclear test
Table 4-1: the impact of the bone marrow cell micronucleus incidence rate of capsule of the present invention on mice
Note: * * represents this group and negative control group comparison, difference has utmost point significance (P<0.01); The each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05); Cp is cyclophosphamide.
From table 4-1, bone marrow cell micronucleus rate and the negative control group comparison of the each dosage group of sample mice, there are no significant for difference (P>0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P<0.01).Having no this sample has damage the medullary cell of mice.
2.4 mouse sperm deformity tests
Table 5-1: the impact of invention capsule on Sperm Abnormalities of Mice
Note: * * represents this group and negative control group comparison, difference has utmost point significance (P<0.01); The each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05); Cp is cyclophosphamide.
From table 5-1, sample does not produce obvious change to Sperm Abnormalities of Mice, the rate of teratosperm of the each dosage group of sample and negative control group comparison, there are no significant for difference (P>0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P<0.01).Have no this sample mouse sperm is produced to deformity effect.
2.5 rat 30 days feeding trials
2.5.1 animal generally shows: experimental session, and each treated animal growth promoter is good, and having no animal has Deviant Behavior and poisoning manifestations, and each treated animal is all without dead.
2.5.2 the impact of sample on rat body weight and food utilization
The results are shown in Table 6-1～table 11-1, with 4000,3000, the capsule of the present invention of 2000mg/kg BW dosage is to rat oral gavage 30 days, experimental session, body weight, gain in weight, food-intake and always food-intake, food utilization and total foodstuff utilization rate and the matched group comparison weekly weekly weekly of the each dosage group of sample male and female Mus, there are no significant for difference (P>0.05), shows that body weight gain and the food utilization of this sample to rat has no significant effect.
Table 6-1: the impact of Capsule in Rats body weight of the present invention
Note: the natural law of * the 4 week is 9 days, lower same.Each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 7-1: the impact of the 1st week body weight gain of Capsule in Rats of the present invention and food utilization
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 8-1: the impact of the 2nd week body weight gain of Capsule in Rats of the present invention and food utilization
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 9-1: the impact of the 3rd week body weight gain of Capsule in Rats of the present invention and food utilization
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 10-1: the impact of the 4th week body weight gain of Capsule in Rats of the present invention and food utilization
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 11-1: the impact of Capsule in Rats total foodstuff utilization rate of the present invention
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
2.5.3 the impact of sample on rat serum conventional index
Table 12-1: 30 days feeding trials of capsule of the present invention finish rat serum conventional index check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 13-1: 30 days feeding trials of capsule of the present invention finish rat serum conventional index check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
From table 12-1, table 13-1, with 4000,3000, the capsule of the present invention of 2000mg/kg BW dosage is to rat oral gavage 30 days, the each dosage group of sample is female, the hemoglobin of male rat, erythrocyte sum, total white blood cells and classification, platelet count and matched group comparison, there are no significant for difference (P>0.05), shows that this sample has no significant effect the routine blood test index of rat.
2.5.4 the impact of sample on rat blood biochemical indicator
The results are shown in Table 14-1, table 15-1, with 4000,3000, the capsule of the present invention of 2000mg/kg BW dosage is to rat oral gavage 30 days, the each dosage group of sample is female, the serum glutamic oxalacetic transaminase of male rat, glutamate pyruvate transaminase, blood urea nitrogen, creatinine, cholesterol, triglyceride, total protein, albumin, blood glucose and matched group comparison, there are no significant for difference (P>0.05), shows that this sample has no significant effect the blood parameters of rat.
Table 14-1: 30 days feeding trials of capsule of the present invention finish rat blood biochemical indicator check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 15-1: 30 days feeding trials of capsule of the present invention finish rat blood biochemical indicator check result
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
2.5.5 the impact of sample on Rats Organs and Tissues weight and internal organs/body weight ratio
The results are shown in Table 16-1, table 17-1, with 4000,3000, the capsule of the present invention of 2000mg/kg BW dosage is to rat oral gavage 30 days, the liver,kidney,spleen of the each dosage group of sample rat, male Mus testicular weight regulating liver-QI/body, kidney/body, spleen/body, male Mus testis/body ratio and matched group comparison, there are no significant for difference (P>0.05), shows that organ weights and the internal organs/body weight ratio of this sample to rat has no significant effect.
Table 16-1: the impact of Capsule in Rats organ weights of the present invention
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
Table 17-1: the impact of Capsule in Rats internal organs/body weight ratio of the present invention
Note: each dosage group and negative control group comparison in table, there are no significant for difference (P>0.05).
2.5.6 dissect gross examination of skeletal muscle and histological examination result
Experiment finishes to dissect animal, and the each treated animal of gross examination of skeletal muscle is not all found obvious pathological changes.Therefore only select the high dose group of sample and the main organs of control animals to carry out tissue pathological slice inspection, the results are shown in Table 18-1～table 24-1.Result demonstration, high dose group and matched group respectively have the visible slight inflammatory cell infiltration in the liver portal area of 1 male rat; Matched group has the visible a small amount of protein cast of the Renal Cortex portion of 1 female rats; Above lesion tissue belongs to the spontaneous light-duty pathological changes of animal, and the liver organization lesion degree of two treated animals is similar, is due to sample therefore can get rid of; Other organs tissue has no histopathology and changes, and shows the above-mentioned organs and tissues harmless effect of this sample to rat.
Table 18-1: 30 days feeding trial rat liver histopathological examination results of capsule of the present invention
Table 19-1: 30 days feeding trial rat kidney histopathological examination results of capsule of the present invention
Table 20-1: 30 days feeding trial Rats Spleen histopathological examination results of capsule of the present invention
Table 21-1: 30 days feeding trial rat stomach histopathological examination results of capsule of the present invention
Table 22-1: 30 days feeding trial rat preduodenal histopathological examination results of capsule of the present invention
Table 23-1: the 30 days male Mus testis tissue of feeding trial rat pathological examination results of capsule of the present invention
Table 24-1: the 30 days female Mus ovary tissue of feeding trial rat pathological examination results of capsule of the present invention
3 brief summaries
Sample taking maximum dosage-feeding (dosage is as 24000mg/kg Bw) gives after mouse stomach, and having no animal has poisoning symptom and death, and acute oral toxicity belongs to nontoxic level.Three genetic toxicity tests (Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test) result is all negative.30 days feeding trials, with 4000,3000,2000mg/kg BW(is equivalent to respectively human body and recommends 100,75,50 times of consumption) sample of 3 dosage is continuously to rat oral gavage 30 days, experimental session animal growth is good, body weight, gain in weight, food-intake, food utilization, routine blood test index, blood parameters, organ weights and internal organs/body weight ratio etc. and matched group comparison, the difference that there are no significant (P>0.05) of each dosage group rat; Gross anatomy observation has no the abnormal change relevant with sample with histopathological examination.Point out this sample to feed for 30 days the every observation index of rat is not produced to toxic and side effects.
Adopt the compositions of embodiment 2 ~ 7 preparations to carry out above-mentioned experiment with method.Result shows: the compositions for improving sleep prepared by the present invention has similar effect to the compositions of embodiment 1, wherein, and taking the effect of embodiment 1 as optimum.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (8)
1. improve a compositions for sleep, formed by the component of following weight portion: 550 parts, Poria, 500 parts of Semen Ziziphi Spinosaes, 400 parts of Bulbus Liliies, 120 parts of 170 parts of Radix Ginsengs and Fructus Schisandrae Chinensis;
Described compositions is prepared by the following method and is obtained:
1) get in described ratio 50%～65% Radix Ginseng, crushed after being dried, crosses 90～110 mesh sieves and becomes fine powder, for subsequent use;
2) get step 1) Semen Ziziphi Spinosae, the Fructus Schisandrae Chinensis alcohol reflux of remaining Radix Ginseng and described ratio 2～4 times, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 5～7 times of amounts 65～75% of Fructus Schisandrae Chinensis at every turn, each extraction 1～2 hour, filter, merging filtrate, filtrate recycling ethanol to be concentrated into relative density be 1.30～1.35 clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) alcohol extraction medicinal residues decoct with water 2～4 times, add the water of Poria, Bulbus Lilii and 6～10 times of amounts of alcohol extraction medicinal residues at every turn, each decoction 1～2 hour, filter, merging filtrate, it is 1.30～1.35 clear paste that filtrate decompression is concentrated into relative density, for subsequent use;
4) by step 2) and step 3) clear paste merge, in 50～80 DEG C of drying under reduced pressure, pulverize, cross 70～90 mesh sieves, powder gets dry extract;
5) by step 1) Radix Ginseng fine powder and step 4) dried cream powder mix, to obtain final product.
2. compositions according to claim 1, is characterized in that, the dosage form of described compositions is acceptable dosage form on pharmacy or health product.
3. compositions according to claim 2, is characterized in that, the dosage form of described compositions is: capsule, tablet, granule, oral liquid or pill.
4. compositions according to claim 3, is characterized in that, the dosage form of described compositions is capsule.
5. the preparation method of the compositions described in claim 1～4 any one, is characterized in that, comprises the following steps:
1) get in described ratio 50%～65% Radix Ginseng, crushed after being dried, crosses 90～110 mesh sieves and becomes fine powder, for subsequent use;
2) get step 1) Semen Ziziphi Spinosae, the Fructus Schisandrae Chinensis alcohol reflux of remaining Radix Ginseng and described ratio 2～4 times, add the ethanol of Radix Ginseng, Semen Ziziphi Spinosae and 5～7 times of amounts 65～75% of Fructus Schisandrae Chinensis at every turn, each extraction 1～2 hour, filter, merging filtrate, filtrate recycling ethanol to be concentrated into relative density be 1.30～1.35 clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) alcohol extraction medicinal residues decoct with water 2～4 times, add the water of Poria, Bulbus Lilii and 6～10 times of amounts of alcohol extraction medicinal residues at every turn, each decoction 1～2 hour, filter, merging filtrate, it is 1.30～1.35 clear paste that filtrate decompression is concentrated into relative density, for subsequent use;
4) by step 2) and step 3) clear paste merge, in 50～80 DEG C of drying under reduced pressure, pulverize, cross 70～90 mesh sieves, powder gets dry extract;
5) by step 1) Radix Ginseng fine powder and step 4) dried cream powder mix, to obtain final product.
6. the preparation method of compositions according to claim 5, is characterized in that, described step 2) extract 2 times, add the ethanol of 6 times of amounts 70% at every turn, extract 1.5 hours at every turn; Described step 3) decoct 2 times, add the water of 8 times of amounts at every turn, decoct 1.5 hours at every turn.
7. according to the preparation method of the compositions described in claim 5 or 6, it is characterized in that, compositions made to capsule, step 5) in obtain after dried cream powder, make soft material with 75% ethanol, 16 mesh sieves are granulated, and 60 DEG C dry, 14 mesh sieve granulate, incapsulate shell, obtain capsule finished product.
8. the medicine that the compositions described in claim 1～4 any one is improved sleep in preparation is or/and the application in health product.
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| CN103751511A (en) * | 2014-02-13 | 2014-04-30 | 北京世纪中康医药科技有限公司 | Powder for improving sleeping |
| CN104013690A (en) * | 2014-06-20 | 2014-09-03 | 苏州法莫生物技术有限公司 | Traditional Chinese medicine for improving sleeping |
| CN105325795A (en) * | 2014-08-08 | 2016-02-17 | 深圳华大基因研究院 | Health food and preparation method thereof |
| CN105125845A (en) * | 2015-09-06 | 2015-12-09 | 吉林大学 | Health care food for improving sleep status |
| CN105076332A (en) * | 2015-09-08 | 2015-11-25 | 张丽雯 | Biscuit capable of reducing insomnia and making method thereof |
| CN105995425A (en) * | 2016-05-16 | 2016-10-12 | 广州市好孝心医疗器械有限公司 | Medicinal and edible composition with function of improving sleep, and application of composition |
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| CN301899949S (en) * | 2011-11-01 | 2012-05-02 | 吉林一正药业集团有限公司 | Medicine Packaging Box (Wuwei Lily Capsules) |
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