CN102940768A - 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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- CN102940768A CN102940768A CN2012105367802A CN201210536780A CN102940768A CN 102940768 A CN102940768 A CN 102940768A CN 2012105367802 A CN2012105367802 A CN 2012105367802A CN 201210536780 A CN201210536780 A CN 201210536780A CN 102940768 A CN102940768 A CN 102940768A
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Landscapes
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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 the performance of Deviant Behavior occur in the undesired and sleep of amount of sleep, is the alternately disorderly performance of sleep and awakening normal rhythm.Can be caused by many factors, normal relevant with physical disease, comprise dyssomnias and parasomnias.Sleep is healthy closely bound up with the people's, and long-term insomnia can cause brain dysfunction, and health is caused 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 the adult ratio of sleep disorder can occur up to 30%.The expert points out to sleep and is the extremely important physiological function of keeping human life, and is essential to human body.Therefore, sleep disorder must cause enough attention.
At present, all kinds of improvement sleep products that the market is popular mostly remove to seek prescription in poor aspect round the clock from calmness, hypnosis and adjusting.Health promoting product take melatonin as primary raw material only is adapted to night job person, need to get jet lag, person in middle and old age's (because melatonin secretion reduces) have dizziness and the unstable side effect that waits of walking if crowd's medicine is residual larger daytime, may bring danger than weak person to older, health.Yet, 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 that sleep disorder is not the cause of disease in nascent a kind of form of expression round the clock.The sleep disorder that causes of poor rule confusion and recovers the basic reason that poor rule round the clock can not solve sleep disorder after all not at majority round the clock still more.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 the raw materials medicament extracting solution, produces extractum, prepares the health product siccative and packs four steps.
Chinese patent application CN 201010532922.9 discloses a kind of decompression composition and method of making the same of releiving, and said composition is mainly made by 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 through concentrated behind the water extract-alcohol precipitation with the medical material of above-mentioned prescription consumption.Above composition prescription amount is large, and preparation technology is loaded down with trivial details.
Summary of the invention
One of purpose 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 purpose of the present invention is to provide described compositions to improve the medicine of sleep or/and the application in the 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 in 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 in 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 in 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 in 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.
The used adjuvant of the present composition 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 the health product.
Wherein, acceptable dosage form is on pharmacy or the health product: capsule, tablet, granule, oral liquid or pill.Preferred capsule.
The preparation method of described compositions provided by the invention may further comprise the steps:
1) part Radix Ginseng powder in the 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, use ethonal extraction, filtrate recycling ethanol also is condensed into clear paste, and is for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) the alcohol extraction medicinal residues decoct with water, filtrate is condensed into clear paste, and is for subsequent use;
4) with step 2) and the clear paste of step 3) merge, drying under reduced pressure is pulverized, and sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), and get final product.
The preparation method of compositions of the present invention further, may further comprise the steps:
1) get in the described ratio 50% ~ 65% Radix Ginseng, crushed after being dried is crossed 90 ~ 110 mesh sieves and become fine powder, and is for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) and described ratio is with alcohol reflux 2 ~ 4 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 5 ~ 7 times of amounts of Fructus Schisandrae Chinensis, the each extraction 1 ~ 2 hour, filter, merging filtrate, filtrate recycling ethanol and to be concentrated into relative density be 1.30 ~ 1.35(60 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) the alcohol extraction medicinal residues decoct with water 2 ~ 4 times, the water that at every turn adds Poria, Bulbus Lilii and 6 ~ 10 times of amounts of alcohol extraction medicinal residues, the each decoction 1 ~ 2 hour, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste of step 3) merge, in 50 ~ 80 ℃ of drying under reduced pressure, pulverize, cross 70 ~ 90 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), and get final product.
In the above-mentioned preparation method:
In the described step 1), pulverize Radix Ginseng and preferably cross 100 mesh sieves.
In the described step 1), the temperature of dry Radix Ginseng is 50 ~ 70 ℃, preferred 60 ℃.
In the described step 1), the fine powder that adopts the Co 60 radiation sterilization to pulverize.
Described step 2) the alcohol amount that contains of used ethanol reaches 65 ~ 75%(percentage by volume), preferred 70%.
Described step 2) preferably extracts 2 times, add the ethanol of 6 times of amounts at every turn, extracted 1.5 hours at every turn.
The water of preferred 6 ~ 8 times of amounts of described step 3) 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 ℃ of drying under reduced pressure, more preferably 65 ℃.
Described step 4) is preferably crossed 80 mesh sieves, and powder gets dry extract.
If compositions of the present invention is made capsule, in the described step 5), obtain dried cream powder after, make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, 14 mesh sieve granulate incapsulate shell, namely get 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.The Poria water decoction has preferably sedative-hypnotic effect; Water extraction after the Semen Ziziphi Spinosae alcohol extraction has significant calmness and hypnosis and anticonvulsant action; Bulbus Lilii water extraction liquid can obviously prolong pentobarbital sodium length of one's sleep, and sub-threshold dose pentobarbital sleep rate is significantly improved; For the product moisture absorption after preventing from preparing, Panax's valuable medicinal simultaneously, therefore adopt part to pulverize, the method for water extraction after the part alcohol extraction utilizes wherein saponin, saccharide etc. to the effective active component of central nervous system better; Water extraction after the Fructus Schisandrae Chinensis alcohol extraction, can obviously reduce mice autonomic activities number of times, increase the hypnosis of pentobarbital sodium of subthreshold dose number of elements, prolong 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 the compositions provided by the invention: Poria: the property slightly sweet flavor is flat, enters the heart, lung, spleen, kidney channel.Has promoting diuresis to eliminate damp pathogen, spleen invigorating, the effect of mind calming.Be used for the edema oliguria, the phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in the loose stool, irritability, palpitation with fear insomnia.
Semen Ziziphi Spinosae: nature and flavor are sweet, sour, flat, return liver, gallbladder, heart channel.Has the tonifying liver of nourishing heart, mind tranquilizing and the heart calming, arresting sweating, the effect of promoting the production of body fluid.Be used for restlessness of asrhenia type and insomnia, the 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.Has nourishing YIN and moistening the lung, the effect of clearing away heart-fire for tranquillization.Be used 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, little hardship, tepor.Return spleen, lung, the heart, kidney channel.Have strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung promotes the production of body fluid and nourishes blood, the effect of the Fructus Alpiniae Oxyphyllae of calming the nerves.Be used 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 is returned lung, the heart, kidney channel.Has convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the effect of kidney calming.Be used for the chronic cough dyspnea due to deficiency, Tianjin wound is thirsty, palpitation and insomnia etc.
That is to say, in the 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; The 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 the across-the-board regulation function of human body, thereby reach the effect that collaborative improvement is slept, realize improving insomnia crowd's sleep quality and the purpose of quality of life.
In a word, the present invention carries out above-mentioned five kinds of raw material of Chinese medicine reasonably combined, the composition proportion that provides is so that raw material has played good synergism, and namely each Chinese medicine has been given play to its effect, combines to improve aspect the sleep effect remarkable, be better than prior art, namely prescription is more optimized, and technique is more reasonable, with active component extract 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.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
The embodiment of the invention is raw materials used all can buy from the market.The multiple of the used second alcohol and water of the present invention is the weight multiple.
The kind of the used adjuvant of the present invention and consumption can be that the routine of this area is selected.
Embodiment 1: capsule
1, compositions forms:
Poria 550g, Semen Ziziphi Spinosae 500g, Bulbus Lilii 400g, Radix Ginseng 170g, Fructus Schisandrae Chinensis 120g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get Radix Ginseng 100g, 60 ℃ of crushed after being dried are crossed 100 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (70g) and above-mentioned weight is with 70% alcohol reflux 2 times, the etoh solvent that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 2 times, the water that at every turn adds Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste of step 3) merge, in 65 ℃ of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, and 14 mesh sieve granulate incapsulate shell, polishing, packing, check gets product: make 1000, every dress 0.4g; Significant composition and content: every 100g contains total saponins 0.7g.
Embodiment 2: tablet
1, compositions forms:
Poria 530g, Semen Ziziphi Spinosae 520g, Bulbus Lilii 380g, Radix Ginseng 190g, Fructus Schisandrae Chinensis 100g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 95g, 50 ℃ of crushed after being dried are crossed 90 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (95g) and above-mentioned weight is with 75% alcohol reflux 3 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 7 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 4 times, the water that at every turn adds Poria, Bulbus Lilii and 7 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 2 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 65 ℃ of drying under reduced pressure, pulverize, cross 85 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), adding starch, dextrin, Sodium Hydroxymethyl Stalcs (are respectively 3% of Radix Ginseng fine powder and dried cream powder gross weight, 1% and 1%), mixing is used 75% alcohol granulation, drying, add magnesium stearate (for Radix Ginseng fine powder and dried cream powder gross weight 2%), mixing is granulated tabletting.
Embodiment 3: granule
1, compositions forms:
Poria 570g, Semen Ziziphi Spinosae 480g, Bulbus Lilii 420g, Radix Ginseng 150g, Fructus Schisandrae Chinensis 140g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 97.5g, 55 ℃ of crushed after being dried are crossed 110 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (52.5g) and above-mentioned weight is with 65% alcohol reflux 4 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 5 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 3 times, the water that at every turn adds Poria, Bulbus Lilii and 6 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1 hour, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 65 ℃ of drying under reduced pressure, pulverize, cross 75 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), add 75% ethanol and do binding agent, add stevioside and soluble starch (be respectively Radix Ginseng fine powder and dried cream powder gross weight 2% and 5%), mixing is pressed into granule.
Embodiment 4: pill
1, compositions forms:
Poria 500g, Semen Ziziphi Spinosae 450g, Bulbus Lilii 450g, Radix Ginseng 120g, Fructus Schisandrae Chinensis 170g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 72g, 65 ℃ of crushed after being dried are crossed 100 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (48g) and above-mentioned weight is with 70% alcohol reflux 2 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 2 times, the water that at every turn adds Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 65 ℃ of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), 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 forms:
Poria 600g, Semen Ziziphi Spinosae 550g, Bulbus Lilii 350g, Radix Ginseng 220g, Fructus Schisandrae Chinensis 70g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 132g, 70 ℃ of crushed after being dried are crossed 100 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (88g) and above-mentioned weight is with 70% alcohol reflux 2 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 2 times, the water that at every turn adds Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 65 ℃ of drying under reduced pressure, pulverize, cross 80 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, and 14 mesh sieve granulate incapsulate shell, polishing, packing, check gets product.
Embodiment 6: capsule
1, compositions forms:
Poria 400g, Semen Ziziphi Spinosae 650g, Bulbus Lilii 250g, Radix Ginseng 250g, Fructus Schisandrae Chinensis 40g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 210g, 60 ℃ of crushed after being dried are crossed 100 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (140g) and above-mentioned weight is with 70% alcohol reflux 2 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 2 times, the water that at every turn adds Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 60 ℃ of drying under reduced pressure, pulverize, cross 90 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, and 14 mesh sieve granulate incapsulate shell, polishing, packing, check gets product.
Embodiment 7: capsule
1, compositions forms:
Poria 700g, Semen Ziziphi Spinosae 350g, Bulbus Lilii 250g, Radix Ginseng 100g, Fructus Schisandrae Chinensis 200g.
2, preparation method:
1) each raw material is made respectively only, be up to the standards; Get the Radix Ginseng of 60g, 60 ℃ of crushed after being dried are crossed 100 mesh sieves and become fine powder, adopt the Co 60 radiation sterilization, and are for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) (40g) and above-mentioned weight is with 70% alcohol reflux 2 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 6 times of amounts of Fructus Schisandrae Chinensis raw material sum, the 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 ℃ of survey) clear paste, for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of above-mentioned weight) the alcohol extraction medicinal residues decoct with water 2 times, the water that at every turn adds Poria, Bulbus Lilii and 8 times of amounts of alcohol extraction medicinal residues raw material sum, the each decoction 1.5 hours, filter, merging filtrate, it is 1.30 ~ 1.35(60 ℃ of survey that filtrate decompression is concentrated into relative density) clear paste, for subsequent use;
4) with step 2) and the clear paste mixing of step 3), in 70 ℃ of drying under reduced pressure, pulverize, cross 70 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, and 14 mesh sieve granulate incapsulate shell, polishing, packing, check gets product.
Experimental example 1: function test
1 materials and methods
1.1 sample: by the capsule of embodiment 1, specification 0.4g/ grain.Human oral recommends consumption to be everyone (adult) every day 2 times, and each 3, become body weight for humans to press 60kg calculating, amounting to dosage is 40mg/kg BW.Getting capsule 's content tests.
1.2 laboratory animal 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.Per 48 mices are 1 group, totally 4 groups, and the test of directly sleeping respectively, 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 condition: laboratory animal room temperature: 22 ~ 25 ℃, relative humidity: 55 ~ 70%.
1.4 dosage is selected and sample treatment: the human body according to this sample is recommended consumption, 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 simultaneously a negative control group, every group of 12 animals.Take by weighing respectively 2.0,4.0, the 8.0g sample, each adding distil water is to 200mL, mixing, be made into 10,20, the suspension of 40mg/mL concentration, give respectively corresponding dosage treated animal gavage, the gavage volume is 0.2mL/10g BW, matched group gives isopyknic distilled water, every day gavage once, continuously gavage is 30 days.
1.5 key instrument and reagent:
Instrument: animal platform balance, electronic analytical balance, stopwatch etc.
Reagent: pentobarbital sodium, barbital sodium, available from Chemical Reagent Co., Ltd., Sinopharm Group.
1.6 experimental technique:
1.6.1 directly sleep test: observe the sleep quality of mice after giving the last sample, surpass 60 seconds and be judged to the righting reflex loss of animal and enter sleep, righting reflex recovers to be the animal awakening.The result carries out statistical analysis with the X2 check.Such as the sleeping number of animals of test group and increase the length of one's sleep and there were significant differences with negative control group, judge that namely this result of the test is positive.
1.6.2 the prolongation pentobarbital sodium test length of one's sleep: giving the 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.Take the righting reflex loss of animal as index, observe tested material and can prolong pentobarbital sodium length of one's sleep.The result carries out statistical analysis with variance analysis.As prolonging than negative control group length of one's sleep of test group mice and statistical significance being arranged, judge that namely this result of the test is positive.
1.6.3 pentobarbital sodium sub-threshold dose hypnosis test: giving the 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, the person is as sleeping more than 60 seconds take righting reflex loss, and the sleeping number of animals of each group of record is calculated sleeping animal incidence rate.Result's X2 check analysis.Be higher than negative control group and statistical significance is arranged such as the sleeping animal incidence rate of test group, judge that namely this result of the test is positive.
1.6.4 barbital sodium Sleep latency test: injection volume was 0.2mL/20g BW to each treated animal through lumbar injection barbital sodium 300mg/kg BW in 20 minutes after giving the last sample.Take righting reflex loss as index, observe animal subject and can shorten the barbital sodium Sleep latency.The result carries out statistical analysis with variance analysis.Shorten than negative control group and statistical significance is arranged such as the Sleep latency of test group mice, judge that namely this result of the test is positive.
1.7 the result judges
If prolong 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
2.1 sample is on the impact of Mouse Weight
Table 1: capsule of the present invention improves sleep function test mice body weight
* annotate: each the dosage group experiment of P value representation is initial, Mouse Weight and the weightening finish and 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
* annotate: each the dosage group experiment of P value representation is initial, Mouse Weight and the weightening finish and matched group comparison in mid-term and latter stage, and there are no significant for difference.
By table 1, as seen from Table 2, experiment just, experiment mid-term, compare between the Mouse Weight of experiment each dosage group of sample in latter stage and experimental session weight of mice and negative control group, there are no significant for difference (P〉0.05), show that this sample has no significant effect the body weight gain of mice.
2.2 the direct sleep effect of sample
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 righting reflex loss to occur, and namely all animals does not all enter sleep state, points out this sample not have direct inducing mouse sleep effect.
Table 3: the capsule mice of the present invention result of the test of directly sleeping
2.3 sample is on the pentobarbital sodium impact of the length of one's sleep
Table 4: capsule of the present invention prolongs the pentobarbital sodium result of the test length of one's sleep
Through as seen from Table 4, per os gives the capsule 30 days of the embodiment 1 of mice various dose, all prolong 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 (respectively P＜0.01 and P＜0.05), points out this sample to have and prolongs the pentobarbital sodium effect of the length of one's sleep.
2.4 sample is on the impact of 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 sleeping rate of the animal of each dosage group is 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 that collaborative syngignoscism is arranged.
Table 5: capsule pentobarbital sodium sub-threshold dose hypnosis result of the test of the present invention
2.5 sample is 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), points out this sample to have the effect of shortening the barbital sodium Sleep latency.
3 results judge
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 prolong pentobarbital sodium length of one's sleep, collaborative pentobarbital sodium sub-threshold dose syngignoscism, shorten the barbital sodium Sleep latency, without directly sleep effect, without impact, point out this sample to have 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 sample: embodiment 1, specification: the 0.4g/ grain, put shady and cool dry and comfortable ventilation and preserve.Human oral recommends consumption to be everyone (adult) every day 2 times, and each 3, become body weight for humans to press 60kg calculating, amounting to dosage is 40mg/kg BW.Getting capsule 's content tests.
1.2 laboratory animal and environment: the healthy Kunming mouse of cleaning level is by Guangxi Medical University's medical experiment animal center breeding, SPF level SD kind rat is bred by Guangdong Medical Lab Animal Center, and the Quality of Experimental Animals quality certification number is respectively: the 0001069(mice), the 0042719(rat).Laboratory animal occupancy permit number: SYXK osmanthus 2007-0003.The laboratory animal room temperature: 22～25 ℃, relative humidity: 55～70%.
1.3 chmice acute Oral toxicity test: adopt the maximum dosage-feeding test method(s), select 20 of the Kunming mouses of body weight 18～22g, male and female half and half.The animal fasting is 16 hours before the test, does not limit drinking-water.Take by weighing the 40.0g sample, adding distil water is to 100mL, mixing, 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.Observe, record the poisoning manifestations of animal after the gavage.Weigh weekly once, observe two time-of-weeks, off-test is dissected animal and is carried out gross examination of skeletal muscle.The acute toxicity of pressing toxicity grading standard evaluation tested material is strong and weak.
1.4Ames test: employing is tested through identifying satisfactory Salmonella typhimurium histidine defect type TA97a, TA98, TA100, four kinds of bacterial strains of TA102.Under aseptic technique, with sterile purified water with 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.
Rat liver microsomes enzyme (the S that induces with Polychlorinated biphenyls
-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 (when the needs metabolism activation) is poured into behind the mixing on the bottom culture medium flat plate.5 test doses are respectively 5000,1000,200,40, the 8ug/ ware, establish simultaneously from beaming back to become contrast, solvent control and the contrast of positive mutagens.Become contrast except not adding the 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 are all made 3 parallel wares.37 ℃ of lower cultivations 48 hours, count the clump count of every ware.A whole set of test repeats to do twice under the same conditions.If the clump count that return to become of tested material increases to surpass from beaming back and becomes more than 2 times of clump count, and the person that has the dose-response relationship, be the mutagenesis testing positive.
1.5 mouse marrow cell micro nuclear test: adopt the 24 hours twice per os administration by gavage in interval 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 by weighing respectively 40.0,20.0, the 10.0g sample, each adding distil water is to 100mL, mixing, be made into 400,200, the suspension of 100mg/mL concentration, then press the volume of 0.6mL/20gBW to the 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.Animal is put to death in cervical vertebra dislocation in 6 hours after giving for the second time sample, gets bone marrow of sternum and dilutes smear with calf serum, and methanol is fixed, Giemsa dyeing.
Under optical microscope, every animal counting 1000 polychromatic erythrocytes (PCE), micronuclear rates is counted 200 polychromatic erythrocytes simultaneously to contain the PCE permillage of micronucleus, calculates the ratio (PCE/NCE) of polychromatic erythrocyte and mature erythrocyte.Adopt the statistical disposition of Poisson distribution mean relative method.Micronuclear rates such as test group increases than negative control group, and obvious dose-response relationship and statistical significance are arranged, and is positive findings.
1.6 mouse sperm deformity test: 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 by weighing respectively 40.0,20.0, the 10.0g sample, each adding distil water is to 100mL, mixing, be made into 400,200, the suspension of 100mg/mL concentration, then press the volume of 0.6mL/20g BW to the 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 was put to death animal on the 30th day after to sample, got 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 is processed.Rate of teratosperm such as test group increases than negative control group, and obvious dose-response relationship and statistical significance are arranged, and is positive findings.
1.7 30 days feeding trials of rat
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 by weighing respectively 200.0,150.0, the 100.0g sample, each adding distil water is to 500mL, mixing, 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 is 30 days.
1.7.2 experimental technique: all animals of experimental session give normal diet, and 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 claims weekly body weight one time to appetite and surplus appetite, calculates weekly food-intake and food utilization.The 30th day animal overnight fasting claimed on an empty stomach body weight of animal on the 31st day, then put to death rat, adopted 2 parts of blood samples, and a blood anticoagulant detects Hb, RBC, WBC and classification, PLT etc. with blood counting instrument; Not anticoagulant of another part blood separation of serum detects serum AST, ALT, BUN, Cr, TC, TG, Glu, the projects such as TP, Alb with test kit and semi-automatic analyser.Dissect animal after the blood sampling, 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.When each dosage treated animal made gross examination do not find 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 finding that then centering, low dose group corresponding organ and tissue check pathological changes.
1.7.3 experimental data statistics: use the SPSS statistical software and carry out one factor analysis of variance.When statistical analysis, first data are carried out homogeneity test of variance, if variance is neat, adopt one factor analysis of variance totally to compare, find differences and carry out comparing in twos between a plurality of dosage groups and matched group mean with the Dunnett check again.If heterogeneity of variance then carries out the conversion of suitable variable to data, satisfy homogeneity test of variance after, add up with 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: capsule of the present invention is to the acute toxicity tests of mice
From table 1-1 as seen, give mouse stomach take the sample of maximum dosage-feeding (dosage is as 24000mg/kg BW) after, 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 check and assessment technique standard " (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)
Annotate: 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 the 10ug/ ware); TA98-S9 adopts daunorubicin (dosage is the 6ug/ ware); TA97a-S9, TA102-S9 adopt fenaminosulf (dosage is the 50ug/ ware); TA100-S9 adopts sodium azide (dosage is the 1.5ug/ ware); TA102+S9 adopts 1,8-dihydroxy to fear quinone (dosage is the 50ug/ ware).Table 3-1 is same.
From table 2-1, table 3-1 as seen, to TA97a, TA98, TA100, four kinds of test strains of TA102, no matter whether add S-9, returning of each dosage group of sample becomes the bacterium colony number average above certainly beaming back the twice that becomes clump count, 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)
Annotate: above result (clump count) is the means standard deviation of 3 plates.
2.3 mouse marrow cell micro nuclear test
Table 4-1: capsule of the present invention is on the impact of the bone marrow cell micronucleus incidence rate of mice
Annotate: * * represents this group and negative control group relatively, and difference has utmost point significance (P＜0.01); Each dosage group of sample and negative control group compare, there are no significant for difference (P〉0.05); Cp is cyclophosphamide.
From table 4-1 as seen, the bone marrow cell micronucleus rate of each dosage group mice of sample and negative control group compare, 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 test
Table 5-1: the invention capsule is on the impact of Sperm Abnormalities of Mice
Annotate: * * represents this group and negative control group relatively, and difference has utmost point significance (P＜0.01); Each dosage group of sample and negative control group compare, there are no significant for difference (P〉0.05); Cp is cyclophosphamide.
From table 5-1 as seen, sample does not produce obvious change to Sperm Abnormalities of Mice, the rate of teratosperm of each dosage group of sample and negative control group are relatively, 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 the deformity effect.
2.5 30 days feeding trials of rat
2.5.1 animal generally shows: experimental session, 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 sample is on the impact of 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, weekly body weight of each dosage group male and female Mus of sample, gain in weight, weekly food-intake and total food-intake, food utilization and total foodstuff utilization rate and matched group be relatively weekly, there are no significant for difference (P〉0.05), show that this sample has no significant effect body weight gain and the food utilization of rat.
Table 6-1: the impact of Capsule in Rats body weight of the present invention
Annotate: the natural law in the 4th week of * is 9 days, and is lower same.Each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
Table 7-1: the impact of Capsule in Rats the 1st all body weight gains of the present invention and food utilization
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
Table 8-1: the impact of Capsule in Rats the 2nd all body weight gains of the present invention and food utilization
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
Table 9-1: the impact of Capsule in Rats the 3rd all body weight gains of the present invention and food utilization
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
Table 10-1: the impact of Capsule in Rats the 4th all body weight gains of the present invention and food utilization
Annotate: each dosage group and negative control group compare in the 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
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
2.5.3 sample is on the impact of rat serum conventional index
Table 12-1: 30 days feeding trials of capsule of the present invention finish rat serum conventional index check result
Annotate: each dosage group and negative control group compare in the 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
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
From table 12-1, table 13-1 as seen, with 4000,3000, the capsule of the present invention of 2000mg/kg BW dosage is to rat oral gavage 30 days, each dosage group of sample is female, the hemoglobin of male rat, erythrocyte sum, total white blood cells and classification thereof, platelet count and matched group comparison, there are no significant for difference (P〉0.05), show that this sample has no significant effect the routine blood test index of rat.
2.5.4 sample is on the impact of 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, 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 relatively, there are no significant for difference (P〉0.05), show 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
Annotate: each dosage group and negative control group compare in the 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
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
2.5.5 sample is on the impact of 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 each dosage group rat of sample, male Mus testicular weight regulating liver-QI/body, kidney/body, spleen/body, male Mus testis/body ratio and matched group are relatively, there are no significant for difference (P〉0.05), show that this sample has no significant effect the organ weights of rat and internal organs/body weight ratio.
Table 16-1: the impact of Capsule in Rats organ weights of the present invention
Annotate: each dosage group and negative control group compare in the table, there are no significant for difference (P〉0.05).
Table 17-1: the impact of Capsule in Rats internal organs of the present invention/body weight ratio
Annotate: each dosage group and negative control group compare in the 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 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 the tissue pathological slice inspection, the results are shown in Table 18-1～table 24-1.Result's 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 section 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 the sample therefore can get rid of; The other organs tissue has no histopathology and changes, and shows that this sample is to the harmless effect of above-mentioned organs and tissues of rat.
Table 18-1: 30 days feeding trial rat livers of capsule of the present invention histopathological examination result
Table 19-1: 30 days feeding trial rat kidney of capsule of the present invention histopathological examination result
Table 20-1: 30 days feeding trial Rats Spleen of capsule of the present invention histopathological examination result
Table 21-1: 30 days feeding trial rat stomach of capsule of the present invention histopathological examination result
Table 22-1: 30 days feeding trial rat preduodenals of capsule of the present invention histopathological examination result
Table 23-1: 30 days male Mus testis tissues of feeding trial rat of capsule of the present invention pathological examination result
Table 24-1: 30 days female Mus ovary tissues of feeding trial rat of capsule of the present invention pathological examination result
3 brief summaries
After giving mouse stomach take the sample of maximum dosage-feeding (dosage is as 24000mg/kg Bw), having no animal has poisoning symptom and death, and acute oral toxicity belongs to nontoxic level.The result is all negative for three genetic toxicity tests (Salmonella reversion test, mouse marrow cell micro nuclear test, mouse sperm deformity test).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, the experimental session animal growth is good, the body weight of each dosage group rat, gain in weight, food-intake, food utilization, routine blood test index, blood parameters, organ weights and internal organs/body weight ratio etc. compare with matched group, difference that there are no significant (P〉0.05); The gross anatomy observation has no the abnormal change relevant with sample with histopathological examination.Point out this sample to feed in 30 days the every observation index of rat is not produced toxic and side effects.
Adopt the compositions of embodiment 2 ~ 7 preparations to carry out above-mentioned experiment with method.The result shows: the compositions that being used for of the present invention preparation improved sleep has similar effect to the compositions of embodiment 1, wherein, and take 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 all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (10)
1. compositions of improving sleep comprises the component of following weight portion: 400 ~ 700 parts in 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.
2. compositions according to claim 1 is characterized in that, comprises the component of following weight portion: 500 ~ 600 parts in 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; Preferably, described compositions comprises the component of following weight portion: 530 ~ 570 parts in 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.
3. compositions according to claim 1 and 2 is characterized in that, comprises the component of following weight portion: 550 parts in Poria, 500 parts of Semen Ziziphi Spinosaes, 400 parts of Bulbus Liliies, 120 parts of 170 parts of Radix Ginsengs and Fructus Schisandrae Chinensis.
4. the described compositions of any one is characterized in that according to claim 1 ~ 3, and the dosage form of described compositions is acceptable dosage form on pharmacy or the health product.
5. compositions according to claim 4 is characterized in that, the dosage form of described compositions is: capsule, tablet, granule, oral liquid or pill; Preferred capsule.
6. the preparation method of the described compositions of claim 1 ~ 5 any one is characterized in that, may further comprise the steps:
1) part Radix Ginseng powder in the 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, use ethonal extraction, filtrate recycling ethanol also is condensed into clear paste, and is for subsequent use;
3) get Poria, Bulbus Lilii and the step 2 of described ratio) the alcohol extraction medicinal residues decoct with water, filtrate is condensed into clear paste, and is for subsequent use;
4) with step 2) and the clear paste of step 3) merge, drying under reduced pressure is pulverized, and sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), and get final product.
7. the preparation method of compositions according to claim 6 is characterized in that, may further comprise the steps:
1) get in the described ratio 50% ~ 65% Radix Ginseng, crushed after being dried is crossed 90 ~ 110 mesh sieves and become fine powder, and is for subsequent use;
2) Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis of getting the remaining Radix Ginseng of step 1) and described ratio is with alcohol reflux 2 ~ 4 times, the ethanol that at every turn adds Radix Ginseng, Semen Ziziphi Spinosae and 5 ~ 7 times of amounts 65 ~ 75% of Fructus Schisandrae Chinensis, the each extraction 1 ~ 2 hour, filter, merging filtrate, filtrate recycling ethanol and 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) the 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, decocted 1 ~ 2 hour at every turn, filter, it is 1.30 ~ 1.35 clear paste that merging filtrate, filtrate decompression are concentrated into relative density, for subsequent use;
4) with step 2) and the clear paste of step 3) merge, in 50 ~ 80 ℃ of drying under reduced pressure, pulverize, cross 70 ~ 90 mesh sieves, powder gets dry extract;
5) with the Radix Ginseng fine powder of step 1) and the dried cream powder mixing of step 4), and get final product.
8. the preparation method of compositions according to claim 7 is characterized in that, described step 2) extract 2 times, add the ethanol of 6 times of amounts 70% at every turn, extracted 1.5 hours at every turn; Described step 3) decocts 2 times, adds the water of 8 times of amounts at every turn, decocts 1.5 hours at every turn.
9. the preparation method of the described compositions of any one is characterized in that according to claim 6 ~ 8, and compositions is made capsule, obtain dried cream powder in the step 5) after, make soft material with 75% ethanol, 16 mesh sieves are granulated, 60 ℃ of dryings, 14 mesh sieve granulate incapsulate shell, namely get capsule finished product.
10. the described compositions of claim 1 ~ 5 any one is improved the medicine of sleep or/and the application in the health product in preparation.
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| CN113115940A (en) * | 2021-03-26 | 2021-07-16 | 青岛海生洋润生物科技有限公司 | Heart calming and sleep aiding composition as well as preparation method and application thereof |
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| CN109364183A (en) * | 2018-12-29 | 2019-02-22 | 张晶莹 | A kind of Chinese materia medica preparation and preparation method thereof for treating insomnia |
| CN109925356A (en) * | 2019-04-19 | 2019-06-25 | 东莞东阳光保健品研发有限公司 | A kind of Chinese medicine composition, preparation and application thereof |
| CN110101789A (en) * | 2019-06-05 | 2019-08-09 | 森隆药业有限公司 | The Chinese materia medica preparation for treating insomnia |
| CN110638945A (en) * | 2019-09-26 | 2020-01-03 | 宁波德康生物制品有限公司 | Nerve-soothing and sleep-aiding substitutional tea and preparation method thereof |
| CN113115940A (en) * | 2021-03-26 | 2021-07-16 | 青岛海生洋润生物科技有限公司 | Heart calming and sleep aiding composition as well as preparation method and application thereof |
| CN113826896A (en) * | 2021-09-23 | 2021-12-24 | 营养屋(成都)生物医药有限公司 | Health food for improving sleep and preparation method thereof |
| CN113827698A (en) * | 2021-09-23 | 2021-12-24 | 华南农业大学 | Sleep-promoting compound and application thereof |
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