CN104173493A - Pharmaceutical composition with effect of improving sleep as well as preparation method and application of pharmaceutical composition - Google Patents
Pharmaceutical composition with effect of improving sleep as well as preparation method and application of pharmaceutical composition Download PDFInfo
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Abstract
The invention belongs to the technical fields of pharmaceutical preparations and healthcare foods and in particular relates to a pharmaceutical composition with an effect of improving sleep as well as a preparation method of the pharmaceutical composition and application of the pharmaceutical composition in medicines, healthcare foods and foods. The pharmaceutical composition comprises the following raw material medicines of maca, spina date seed, semen boitae, schisandra chinensis and lucid ganoderma. The medicines or healthcare foods are mainly prepared for the crowd suffering from the symptoms such as heart and liver yin-blood deficiency, lack of spirit preservation, body function reduction and poor sleep and have the effects of nourishing the blood and promoting blood circulation and calming heart and soothing nerves, so that the pharmaceutical composition has a healthcare function of improving the sleep. The preparation method is simple and economic in cost, can be used for preparing the medicines and healthcare foods for improving the sleep and has good application prospects and economic benefits.
Description
Technical field
The invention belongs to technical field of medicine and health food technology field, be specifically related to a kind of pharmaceutical composition, preparation method and application in medicine, health food, field of food thereof that improves sleep effect that have.
Background technology
1/3rd times of life are spent in sleep, and sleep is always subject to people's attention with healthy relation.Ancients have the saying of " would rather eat without meat, can not sleep and be insomnia ".Research shows, good sleep can allaying tiredness, refreshes and muscle power, keeps good wakefulness, raising work and the learning efficiency, life-saving.Yet along with increasingly sharpening of social competition, work and rhythm of life are constantly accelerated, and the stress that people bear is increasing, and the sickness rate of insomnia is obvious ascendant trend.The material that Er Ju Chinese Medical Association provides shows, China approximately has 300,000,000 adults to suffer from the sleep disorder such as insomnia and hypersomnia, is mainly distributed in the relative developed regions of China's economic.Worldwide, about 1/3 adult once suffered insomnia's torment, and wherein 1/3 has belonged to severe insomnia, and the mankind's health has been caused to great threat.
Treatment for insomnia is main mainly with Western medicine clinically, Western medicine is the strong and quick-acting advantage of existence effect mostly, but also find in clinical practice, the action time of these medicines is short, and medication intensity is high, although quick result, but easily there is the defect of toxic reaction and side effect in existence mostly, particularly some medicines can produce addiction phenomenon, and therefore, at present the long-term taking class western drug of sleeping peacefully is not all advocated to insomnia's treatment in home and abroad.And in insomnia's daily health caring, although the wider melatonin of health food application at present has certain effect.But its safety and efficacy problem is extremely dispute always.The hormone that fades is a kind of endogenous material, by the adjusting of hormonal system, works, and long-term taking can produce dependency, and takes symptoms such as there will be dizziness.
Theory of Chinese medical science thinks that prosperity and decline and the visceral dysfunction of not having enough sleep to yang blood and qi are relevant, Chinese medicine preparation is more because of its feature that has good effect and do not produce drug dependence, being hopeful exploitation becomes the product of following new improvement sleep, becomes gradually focus and the direction of research a few days ago.
Summary of the invention
For this reason, technical problem to be solved by this invention is to provide a kind of and has the pharmaceutical composition that improves sleep effect, and further discloses its preparation method.
For solving the problems of the technologies described above, the invention provides a kind of pharmaceutical composition that improves sleep effect that has, the crude drug of described pharmaceutical composition consists of: Lepidinm meyenii Walp 3-15 weight portion, Semen Ziziphi Spinosae 3-15 weight portion, Semen Platycladi 2-10 weight portion, Fructus Schisandrae Chinensis 2-10 weight portion, Ganoderma 2-10 weight portion.
Further preferred, the crude drug of described pharmaceutical composition consists of:
Lepidinm meyenii Walp 6 weight portions, Semen Ziziphi Spinosae 12 weight portions, Semen Platycladi 5 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 5 weight portions; Or
Lepidinm meyenii Walp 15 weight portions, Semen Ziziphi Spinosae 3 weight portions, Semen Platycladi 2 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 10 weight portions; Or
Lepidinm meyenii Walp 12 weight portions, Semen Ziziphi Spinosae 6 weight portions, Semen Platycladi 10 weight portions, Fructus Schisandrae Chinensis 5 weight portions, Ganoderma 2 weight portions; Or
Lepidinm meyenii Walp 9 weight portions, Semen Ziziphi Spinosae 9 weight portions, Semen Platycladi 8 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 3 weight portions; Or
Lepidinm meyenii Walp 3 weight portions, Semen Ziziphi Spinosae 15 weight portions, Semen Platycladi 3 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 8 weight portions.
Described pharmaceutical composition adds conventional adjuvant, is prepared into medicine, health food, the food such as clinical acceptable tablet, capsule, mixture, granule, electuary, medicinal tea, powder, solid beverage, oral liquid, soft extract, pill, drop pill, tincture, medicated wine according to conventional method.
The invention also discloses and a kind ofly by aforementioned pharmaceutical compositions, add conventional adjuvant, the pharmaceutical preparation being prepared into according to conventional method or health food, food type.
The invention also discloses a kind of method of preparing aforementioned pharmaceutical compositions, comprise the step that measures Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma according to selected prescription, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
Particularly, described preparation method comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Lepidinm meyenii Walp, Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get Ganoderma and Fructus Schisandrae Chinensis and add soak with ethanol extraction, cross leaching alcohol extract and reclaim after ethanol, concentrating under reduced pressure obtains alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, extracting in water, filters and obtains water extraction liquid, and concentrating under reduced pressure obtains water extracting liquid;
(4), by described alcohol extraction concentrated solution and described water extracting liquid, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
Further, described preparation method comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Lepidinm meyenii Walp, Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get more than Ganoderma and Fructus Schisandrae Chinensis add the soak with ethanol 12h that the concentration of 4-8 times of weight amount is 50%-80%, 30-70 ℃ of forced circulation extracted 1-4h, filter to obtain alcohol extract reclaiming after ethanol, be evaporated to 80 ℃ of relative density 1.10-1.20, obtain alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, add micro-the boiling of 6-10 times of weight water gaging to extract 1-2 time, each 1-3h, filter, merge water extraction liquid, be evaporated to 80 ℃ of relative density 1.10-1.20, obtain water extracting liquid;
(4) described alcohol extraction concentrated solution and described water extracting liquid are mixed, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
Preferably, described preparation method comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Lepidinm meyenii Walp, Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get more than Ganoderma and Fructus Schisandrae Chinensis add the soak with ethanol 12h that the concentration of 6 times of weight amounts is 80%, 60-70 ℃ of forced circulation extracted 1h, filters to obtain alcohol extract reclaiming after ethanol, is evaporated to 80 ℃ of relative densities 1.16, obtains alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, add micro-the boiling of 6 times of weight water gagings to extract 2 times, each 1h, filter, merge water extraction liquid, be evaporated to 80 ℃ of relative densities 1.16, obtain water extracting liquid;
(4), by described alcohol extraction concentrated solution and described water extracting liquid, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
The invention also discloses a kind of by said method, prepared there is the pharmaceutical composition that improves sleep effect.
The invention also discloses pharmaceutical composition and there is in preparation the purposes of improving in sleep effect or the auxiliary medicine that improves sleep effect and health food, food.
Theory of Chinese medical science thinks that poor sleep is relevant to prosperity and decline and the visceral dysfunction of yang blood and qi, dirty in close relations with the heart, liver two.Heart governing blood and vessels, main mind; Blood stored in the liver, hides soul, and god and soul are all to take blood as main matter basis, as < < Ling Shu Miraculous Pivot or Divine Axis Benshen > > speech " the heart governing the vessels, vessel storing spirit ", " blood stored in the liver, bloodhousing mood ".Conscience function is normal, and people's spirit and consciousness is normal, if conscience deficiency of YIN-blood, lack of preservation of spirit, loses one's mind, and visible insomnia is insomnia etc.; Liver-yin, deficiency of liver-blood, lack of preservation of spirit can induced insomnia dreaminess.The crude drug with the pharmaceutical composition that improves sleep effect of the present invention is comprised of Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Sphenantherae, Ganoderma, prescription Main Basis Chinese medical theory, and study with reference to modern pharmacology, mainly for conscience deficiency of YIN-blood, lack of preservation of spirit, body function declines and poor sleep crowd is set, has the effect of nourshing blood and promoting blood circulation, mind tranquilizing and the heart calming, thereby has the health care that improves sleep.
In side, Lepidinm meyenii Walp nutritional labeling is abundant, include rich in protein and branched-chain amino acid, exclusive Lepidinm meyenii Walp alkene and Lepidinm meyenii Walp amide are the nucleuses of nature hormonal system, Lepidinm meyenii Walp can supplement the nutrients, after being absorbed, directly act on hypothalamus and hypophysis cerebri, by maca polysaccharide, Lepidinm meyenii Walp albumen, Lepidinm meyenii Walp alkaloid and various active material nature endocrine regulation system, recover hormone, balance hormone, excite internal organs original function, impel human body from normal diet, to draw more nutrition, activating cell, strengthens immunity; The acid of Semen Ziziphi Spinosae sweet in the mouth is flat, GUIXIN, liver, gallbladder meridian, the moon can nourish heart, the liver benefiting blood and have the effect of calming the nerves, for tranquilizing by nourishing the heart key medicine, as converging, < < book on Chinese herbal medicine says that > > says: " foster the spirit of nobility and calm the nerves, flourish muscle is supported marrow, stomach function regulating activating the spleen "; Semen Platycladi is sweet flat, master enters heart channel, the effect with tranquilizing by nourishing the heart, < < Compendium of Materia Medica > > carry its " gas nourishes heart; profit kidney dry, peace soul determine soul, Fructus Alpiniae Oxyphyllae is allayed excitement; " be used for insufficiency of heart-YIN, the severe palpitation of blood deficiency so that lack of preservation of spirit, restlessness of asrhenia type and insomnia; Trimethyl gallic acid, sweet, temperature, returns lung, the heart, kidney channel, has QI invigorating, kidney calming to effect; Ganoderma is sweet, flat.GUIXIN, lung, liver, kidney channel, have invigorating QI and tranquilization to effect.Zhu Pin share, and plays altogether the effect of nourshing blood and promoting blood circulation, mind tranquilizing and the heart calming.
Pharmaceutical composition of the present invention can extend the length of one's sleep significantly, significantly improves the incidence rate of falling asleep, and significantly shortens Sleep latency simultaneously.According to improving the criterion of the sleep function method of inspection in < < health food check and assessment technique standard > > (version in 2003), can judge that capsule of the present invention has the sleep of improvement effect.Therefore the medicine that the present invention improves sleep to preparation has been opened up a kind of new treatment by Chinese herbs method, and not only effective percentage is high and side effect is low, and processing technology is simple, and economic benefit is high, has good application prospect.
Experimental example
1 materials and methods
1.1 material
(1) given the test agent: the capsule of following embodiment 1 preparation of the present invention, diazepam tablets.Capsule 0.48g/ grain of the present invention, the oral recommended amounts of human body is every day 2 times, each 3, become body weight for humans press 60kg calculating, amount to dosage 48mg/kgbw.Experimental design 5, l0,30 multiple doses are fed mice.By body weight, convert, the basic, normal, high dosage of test group is respectively 240mg/kgbw, 480mg/kgbw, 1440mg/kgbw; Positive control diazepam tablets 70mg/kgbw, adds blank group, totally 5 groups.
(2) experimental animal: NIH mice, SPF level, body weight 14～16g.
(3) key instrument: BS110S electronic balance (Beijing Sai Duolisi balance company limited).
1.2 experimental technique
1.2.1 direct sleep experiments
Get healthy NIH female mice and divide 5 groups every group 30 mices.Test group mice is gastric infusion 30d according to dosage first, diazepam tablets administration 1 time when experiment finishes, and dosage is 70mg/kg, blank group gives equivalent distilled water.After last administration, observe mice and whether occur the phenomenon of sleeping.Sleep be take righting reflex loss as index, when mice is placed in supine position, can right immediately body position.Can not the person of righting as surpassed 30-60s, think and righting reflex loss enter sleep.Righting reflex recovers to be animal awakening, and righting reflex loss is the animal sleep time to recovering during this period of time, records blank group and given the test agent group is fallen asleep number of animals and the length of one's sleep.Comparative control group and test group fall asleep number of animals and the difference between the length of one's sleep.
1.2.2 extend the pentobarbital sodium experiment length of one's sleep
Get healthy NIH female mice and divide 5 groups every group 13 mices.Test group mice is gastric infusion 30d according to dosage first, diazepam tablets administration 1 time when experiment finishes, and dosage is 70mg/kg, blank group gives equivalent distilled water.Before experiment, first carry out preliminary experiment, grope the experiment of the threshold dose of pentobarbital, select 100% mice to fall asleep (righting reflex loss reach 60s more than) but ask the appropriate dose (30-60mg/kg) of long 0.3% pentobarbital sodium while not making to sleep; Then carry out the determination test length of one's sleep.Formal experiment: 40min after last administration (occurring the front 10-15min of peak effect), the dosage 49.5mg/kg of each treated animal abdominal cavity pentobarbital sodium (being undertaken by preliminary experiment dosage), between the time for falling asleep and WA of immediate record animal.Difference between comparative test group and the matched group prolongation length of one's sleep.
1.2.3 pentobarbital sodium sub-threshold dose hypnosis experiment
Get healthy NIH female mice and divide 5 groups every group 30 mices.Test group mice is gastric infusion 30d according to dosage first, diazepam tablets administration 1 time when experiment finishes, and dosage is 70mg/kg, blank group gives equivalent distilled water.Before experiment, first carry out preliminary experiment, first grope the experiment of the threshold dose of pentobarbital, the maximum threshold dose of 0.3% the pentobarbital sodium of selecting that the righting reflex of 80-90% mice do not disappear.Before experiment, with 20 mices, 0.3% pentobarbital sodium 0.09-0.12ml/10g finds out the maximal dose that the righting reflex of 80-90% mice does not disappear.Then formally test, 40min after last administration (occur peak effect before 10-15min), each treated animal abdominal cavity pentobarbital sodium 37.5mg/kg, animal righting reflex loss reaches number of animals more than 1min in immediate record 30min, and records between the time for falling asleep, WA of animal and sleep percentage rate (%).Comparative control group and the test group difference between number of animals of falling asleep.
1.2.4 barbital sodium Sleep latency experiment
Healthy NIH female mice is divided into 5 groups every group 13 mices.Test group mice is gastric infusion 30d according to dosage first, diazepam tablets administration 1 time when experiment finishes, and dosage is 70mg/kg, blank group gives equivalent distilled water.Before experiment, first carry out preliminary experiment, grope the experiment of the threshold dose of barbital sodium, select 100% mice to fall asleep (righting reflex loss reach 1min more than) but do not make the appropriate dose (200-300mg/kg) of the long barbital sodium length of one's sleep.Then formally test: 40min after last administration (occurring the front 10-15min of peak effect), the dosage of each treated animal abdominal cavity 0.2% barbital sodium is 300mg/kg (0.2ml/20g), take righting reflex loss as index, observe the impact of given the test agent on barbital sodium Sleep latency.Difference between comparative test group and the matched group prolongation length of one's sleep.
2 experimental results
The direct sleep experiments result of 2.1 mice
The direct sleep experiments of mice the results are shown in Table 1.From table 1, after last administration, each organizes mice all without falling asleep, and test group and the diazepam group mice mental status are normal, prompting given the test agent to mice without directly sleep effect.
The direct sleep experiments result of table 1 mice (
n=30)
| Group | Dosage (mg/kg) | The number of animals of falling asleep |
| Blank group | Distilled water | 0 |
| Improve sleeping capsule low dosage | 240 | 0 |
| Improve dosage in sleeping capsule | 480 | 0 |
| Improve sleeping capsule high dose | 1440 | 0 |
| Diazepam tablets group | 70 | 0 |
2.2 extend the pentobarbital sodium experimental result length of one's sleep
Extend the pentobarbital sodium experimental result length of one's sleep in Table 2.From table 2, the basic, normal, high dosage group of improving sleeping capsule all can extend the length of one's sleep of mice pentobarbital sodium to some extent, there is good synergism with pentobarbital sodium, with the same period blank group compare, there is significant difference (P<0.05, P<0.01, P<0.001), show to improve the sleeping capsule prolongation pentobarbital sodium experimental result length of one's sleep positive.
The table 2 prolongation pentobarbital sodium experimental result length of one's sleep (
n=13)
| Group | Dosage (mg/kg) | The length of one's sleep (min) |
| Blank group | Equal-volume | 10.39±2.28 |
| Improve sleeping capsule low dosage | 240 | 13.11±3.15* |
| Improve dosage in sleeping capsule | 480 | 16.58±4.89** |
| Improve sleeping capsule high dose | 1440 | 18.61±5.96*** |
| Diazepam tablets group | 70 | 44.11±9.59*** |
Note: with blank group comparison same period * P<0.05, * * P<0.01, * * * P<0.001
2.3 pentobarbital sodium sub-threshold dose hypnosis experimental results
Pentobarbital sodium sub-threshold dose hypnosis experimental result is in Table 3.From table 3, blank group mice has 4 routine mices to fall asleep in 30 examples of injection pentobarbital sodium, basic, normal, high 3 the dosage groups of test group have respectively 10,13,17 routine mices to fall asleep, compare with blank group, the animal incidence rate of falling asleep has significance to increase (P<0.05, P<0.01, P<0.001), shows to improve sleeping capsule pentobarbital sodium sub-threshold dose hypnosis experimental result positive.
Table 3 pentobarbital sodium sub-threshold dose hypnosis experimental result (
n=30)
| Group | Dosage (mg/kg) | The number of animals of falling asleep |
| Blank group | Equal-volume | 4 |
| Improve sleeping capsule low dosage | 240 | 10* |
| Improve dosage in sleeping capsule | 480 | 13** |
| Improve sleeping capsule high dose | 1440 | 17*** |
| Diazepam tablets group | 70 | 33*** |
Note: with blank group comparison same period * P<0.05, * * P<0.01, * * * P<0.001
2.4 barbital sodium Sleep latency experimental results
Barbital sodium Sleep latency experimental result is in Table 4.From table 4, the Sleep latency of the middle and high dosage group of test group mice all obviously shortens, prompting test group and barbital sodium have certain synergism, with the same period blank group compare, there is significant difference (P<0.05, P<0.001), show that the barbital sodium Sleep latency experimental result of test group is positive.
Table 4 barbital sodium Sleep latency experimental result (
n=13)
| Group | Dosage (mg/kg) | Incubation period (min) |
| Blank group | Equal-volume | 27.21±2.76 |
| Improve sleeping capsule low dosage | 240 | 26.35±3.35* |
| Improve dosage in sleeping capsule | 480 | 24.40±4.98** |
| Improve sleeping capsule high dose | 1440 | 19.88±6.66*** |
| Diazepam tablets group | 70 | 14.91±9.58*** |
Note: with blank group comparison same period * P<0.05, * * * P<0.001
3. brief summary
Although pharmaceutical composition of the present invention to mice without directly sleep effect, but the length of one's sleep of pentobarbital sodium mice can be extended significantly, significantly improve the animal incidence rate of falling asleep, significantly shorten the Sleep latency of barbital sodium mice simultaneously, can judge that capsule of the present invention has the sleep of improvement effect.
The specific embodiment
Embodiment 1 capsule
[prescription] Lepidinm meyenii Walp 6kg, Semen Ziziphi Spinosae 12kg, Semen Platycladi 5kg, Fructus Schisandrae Chinensis 2kg, Ganoderma 5kg.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Lepidinm meyenii Walp, Ganoderma section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 6 times of 80% alcohol-pickled spending the night, 60-70 ℃ of reflux, extract, 1h, filters, and reclaims ethanol, is evaporated to relative density 1.16 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 6 times of micro-boiling of purified water and extract 2 times, and each 1h, filters, and merge extractive liquid,, is evaporated to relative density 1.16 (80 ℃ of surveys).Water extracting liquid and alcohol extraction concentrated solution are merged, be concentrated into relative density 1.20 (80 ℃ of surveys).Condensed cream adds appropriate conventional adjuvant drying under reduced pressure, pulverizing, filled capsules, and subpackage, obtains.
Embodiment 2 tablets
[prescription] Lepidinm meyenii Walp 15 weight portions, Semen Ziziphi Spinosae 3 weight portions, Semen Platycladi 2 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 10 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Lepidinm meyenii Walp, Ganoderma section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 4 times of 70% alcohol-pickled spending the night, 50-60 ℃ of reflux, extract, 2h, filters, and reclaims ethanol, is evaporated to relative density 1.20 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 8 times of micro-boiling of purified water and extract 3h, filter, and are evaporated to 1.20 (80 ℃ of surveys).Water extracting liquid and alcohol extraction concentrated solution are merged, be concentrated into relative density 1.25 (80 ℃ of surveys).Whole condensed cream adds appropriate conventional adjuvant drying under reduced pressure, pulverizing, mixes with conventional adjuvant, and tabletting, subpackage, obtains.
Embodiment 3 granules
[prescription] Lepidinm meyenii Walp 12 weight portions, Semen Ziziphi Spinosae 6 weight portions, Semen Platycladi 10 weight portions, Fructus Schisandrae Chinensis 5 weight portions, Ganoderma 2 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Lepidinm meyenii Walp, Ganoderma section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 8 times of 60% alcohol-pickled spending the night, 40-50 ℃ of forced circulation extracted 4h, filters, and reclaims ethanol, is evaporated to relative density 1.18 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 10 times of micro-boiling of purified water and extract 2h, filter, and are evaporated to 1.18 (80 ℃ of surveys).Water extracting liquid and alcohol extraction concentrated solution are merged, be concentrated into eventually relative density 1.22 (80 ℃ of surveys).Whole condensed cream adds appropriate conventional adjuvant mix homogeneously, and cross 20 mesh sieve extruding and granulate, 75 ℃ of oven dry, subpackage, obtains.
Embodiment 4 mixture
[prescription] Lepidinm meyenii Walp 9 weight portions, Semen Ziziphi Spinosae 9 weight portions, Semen Platycladi 8 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 3 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Ganoderma, Lepidinm meyenii Walp section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 6 times of 50% alcohol-pickled spending the night, 30-40 ℃ of forced circulation extracted 2h, filters, and reclaims ethanol, is evaporated to relative density 1.10 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 6 times of micro-boiling of purified water and extract 1.5h, filter, and are evaporated to 1.10 (80 ℃ of surveys).Mixed alcohol is carried condensed cream and water extraction condensed cream, adds appropriate correctives and antiseptic, stirs 20 minutes, and adding water adjustment total weight parts is 60, fill, and sterilizing, obtains.
Embodiment 5 solid beverages
[prescription] Lepidinm meyenii Walp 3 weight portions, Semen Ziziphi Spinosae 15 weight portions, Semen Platycladi 3 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 8 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Ganoderma, Lepidinm meyenii Walp section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 4 times of 50% alcohol-pickled spending the night, 30-40 ℃ of forced circulation extracted 1.5h, filters, and reclaims ethanol, is evaporated to relative density 1.15 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 8 times of micro-boiling of purified water and extract 1h, filter, and are evaporated to 1.15 (80 ℃ of surveys).Water extracting liquid and alcohol extraction concentrated solution are merged, be concentrated into eventually relative density 1.20 (80 ℃ of surveys), add appropriate conventional adjuvant mix homogeneously, spraying is dry, and subpackage, obtains.
Embodiment 6 soft extracts
[prescription] Lepidinm meyenii Walp 3 weight portions, Semen Ziziphi Spinosae 15 weight portions, Semen Platycladi 2 weight portions, Fructus Schisandrae Chinensis 10 weight portions, Ganoderma 2 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma by recipe quantity, Lepidinm meyenii Walp, Ganoderma section, and Semen Ziziphi Spinosae is smashed to pieces.Get Ganoderma, Fructus Schisandrae Chinensis adds 6 times of 80% alcohol-pickled spending the night, 60-70 ℃ of forced circulation extracted 1h, filters, and reclaims ethanol, is evaporated to relative density 1.16 (80 ℃ of surveys).Ganoderma, Fructus Schisandrae Chinensis medicinal residues add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, add 6 times of micro-boiling of purified water and extract 2 times, and each 1h, filters, and merge extractive liquid,, is evaporated to relative density 1.16 (80 ℃ of surveys).Water extracting liquid and alcohol extraction concentrated solution are merged, add the appropriate conventional adjuvants such as sugar refinery to temper to relative density to relative density 1.30 (80 ℃ of surveys), receive cream, cooling, subpackage, obtains.
Embodiment 7 water-honeyed pills
[prescription] Lepidinm meyenii Walp 15 weight portions, Semen Ziziphi Spinosae 3 weight portions, Semen Platycladi 10 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 10 weight portions.
[preparation method] takes Lepidinm meyenii Walp, Fructus Schisandrae Chinensis, Ganoderma pulverizing by recipe quantity, makes mixed powder; Get Semen Ziziphi Spinosae, Semen Platycladi and add 8 times of micro-boiling of purified water and extract 2 times, each 2h, filters, and merge extractive liquid,, is evaporated to 1.25 (80 ℃ of surveys), adds the mix homogeneously such as mixed powder, refined honey diluent, pill piece, and ball bar, round, dry, obtain.
Obviously, above-described embodiment is only for example is clearly described, and the not restriction to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without also giving all embodiments.And the apparent variation of being extended out thus or change are still among the protection domain in the invention.
Claims (10)
1. have a pharmaceutical composition that improves sleep effect, it is characterized in that, the crude drug of described pharmaceutical composition consists of: Lepidinm meyenii Walp 3-15 weight portion, Semen Ziziphi Spinosae 3-15 weight portion, Semen Platycladi 2-10 weight portion, Fructus Schisandrae Chinensis 2-10 weight portion, Ganoderma 2-10 part.
2. pharmaceutical composition as claimed in claim 1, is characterized in that, the crude drug of described pharmaceutical composition consists of:
Lepidinm meyenii Walp 6 weight portions, Semen Ziziphi Spinosae 12 weight portions, Semen Platycladi 5 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 5 weight portions; Or
Lepidinm meyenii Walp 15 weight portions, Semen Ziziphi Spinosae 3 weight portions, Semen Platycladi 2 weight portions, Fructus Schisandrae Chinensis 2 weight portions, Ganoderma 10 weight portions; Or
Lepidinm meyenii Walp 12 weight portions, Semen Ziziphi Spinosae 6 weight portions, Semen Platycladi 10 weight portions, Fructus Schisandrae Chinensis 5 weight portions, Ganoderma 2 weight portions; Or
Lepidinm meyenii Walp 9 weight portions, Semen Ziziphi Spinosae 9 weight portions, Semen Platycladi 8 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 3 weight portions; Or
Lepidinm meyenii Walp 3 weight portions, Semen Ziziphi Spinosae 15 weight portions, Semen Platycladi 3 weight portions, Fructus Schisandrae Chinensis 3 weight portions, Ganoderma 8 weight portions.
3. pharmaceutical composition as claimed in claim 1 or 2, it is characterized in that, described pharmaceutical composition adds conventional adjuvant, is prepared into medicine, health food, the food such as clinical acceptable tablet, capsule, mixture, granule, electuary, medicinal tea, powder, solid beverage, oral liquid, soft extract, pill, drop pill, tincture, medicated wine according to conventional method.
4. by the arbitrary described pharmaceutical composition of claim 1-3, add conventional adjuvant, the preparation being prepared into according to conventional method or health food, food.
5. a method of preparing the arbitrary described pharmaceutical composition of claim 1-3, it is characterized in that, comprise the step that measures Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma according to selected prescription, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
6. preparation method as claimed in claim 5, is characterized in that, comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Lepidinm meyenii Walp, Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get Ganoderma and Fructus Schisandrae Chinensis and add soak with ethanol extraction, cross leaching alcohol extract and reclaim after ethanol, concentrating under reduced pressure obtains alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, extracting in water, filters and obtains water extraction liquid, and concentrating under reduced pressure obtains water extracting liquid;
(4), by described alcohol extraction concentrated solution and described water extracting liquid, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
7. preparation method as claimed in claim 6, is characterized in that, comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Lepidinm meyenii Walp, Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get more than Ganoderma and Fructus Schisandrae Chinensis add the soak with ethanol 12h that the concentration of 4-8 times of weight amount is 50%-80%, 30-70 ℃ of reflux, extract, or forced circulation are extracted 1-4h, filter to obtain alcohol extract reclaiming after ethanol, be evaporated to 80 ℃ of relative density 1.10-1.20, obtain alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, add micro-the boiling of 6-10 times of weight water gaging to extract 1-2 time, each 1-3h, filter, merge water extraction liquid, be evaporated to 80 ℃ of relative density 1.10-1.20, obtain water extracting liquid;
(4), by described alcohol extraction concentrated solution and described water extracting liquid, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
8. the preparation method as described in claim 6 or 7, is characterized in that, comprises the steps:
(1) according to selected prescription, measure Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi, Fructus Schisandrae Chinensis, Ganoderma, get Ganoderma section, Semen Ziziphi Spinosae is smashed to pieces;
(2) get more than Ganoderma and Fructus Schisandrae Chinensis add the soak with ethanol 12h that the concentration of 6 times of weight amounts is 60%-70%, 60-70 ℃ of reflux, extract, 1h, filters to obtain alcohol extract reclaiming after ethanol, is evaporated to 80 ℃ of relative densities 1.16, obtains alcohol extraction concentrated solution;
(3) get the medicinal residues that in step (2), filtration alcohol extract obtains and add Lepidinm meyenii Walp, Semen Ziziphi Spinosae, Semen Platycladi to mix, add micro-the boiling of 6 times of weight water gagings to extract 2 times, each 1h, filter, merge water extraction liquid, be evaporated to 80 ℃ of relative densities 1.16, obtain water extracting liquid;
(4) described alcohol extraction concentrated solution and described water extracting liquid are mixed, be concentrated into 80 ℃ of relative densities 1.20, add conventional adjuvant, according to common process, make acceptable dosage form clinically.
9. what according to the arbitrary described method of claim 5-8, prepare has a pharmaceutical composition that improves sleep effect.
Claim 1-3 arbitrary or described in 9 pharmaceutical composition in preparation, there is the purposes of improving in sleep effect or the auxiliary medicine that improves sleep effect and health food, food.
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Cited By (10)
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| CN104911081A (en) * | 2015-05-28 | 2015-09-16 | 南京泽朗生物科技有限公司 | Health care wine for adjusting sleep |
| CN105124600A (en) * | 2015-08-24 | 2015-12-09 | 杭州娃哈哈科技有限公司 | Composition with a sleep-improving function and application thereof |
| CN106901120A (en) * | 2017-02-10 | 2017-06-30 | 天津金匮堂生物科技有限公司 | A kind of spina date seed solid beverage and preparation method thereof |
| CN107006851A (en) * | 2017-04-18 | 2017-08-04 | 百瑞德（南京）生物科技有限公司 | A kind of health food for improving sleep and preparation method thereof |
| CN108783458A (en) * | 2018-07-14 | 2018-11-13 | 湛江广医医药科技开发有限公司 | Promote the compound ganoderma health food of sleep pleasure mood prevention of depression |
| CN110050971A (en) * | 2019-03-06 | 2019-07-26 | 烟台优达生物技术开发有限公司 | It is a kind of to conduce to sleep and the product formula for adjusting mood and preparation method thereof |
| CN114009773A (en) * | 2021-10-14 | 2022-02-08 | 宁夏医科大学 | Composition with sleep improving effect and preparation method and application thereof |
| CN114073314A (en) * | 2020-08-18 | 2022-02-22 | 四川济生堂药业有限公司 | Composition for preventing or improving sleep disorder |
| CN115813976A (en) * | 2021-12-31 | 2023-03-21 | 亿艾(河南)生物科技有限公司 | Nerve-soothing and relieving plant essential oil and application thereof |
| CN116144446A (en) * | 2021-11-19 | 2023-05-23 | 泸州老窖股份有限公司 | Health care wine for improving sleep function |
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| CN104911081A (en) * | 2015-05-28 | 2015-09-16 | 南京泽朗生物科技有限公司 | Health care wine for adjusting sleep |
| CN105124600A (en) * | 2015-08-24 | 2015-12-09 | 杭州娃哈哈科技有限公司 | Composition with a sleep-improving function and application thereof |
| CN106901120A (en) * | 2017-02-10 | 2017-06-30 | 天津金匮堂生物科技有限公司 | A kind of spina date seed solid beverage and preparation method thereof |
| CN107006851A (en) * | 2017-04-18 | 2017-08-04 | 百瑞德（南京）生物科技有限公司 | A kind of health food for improving sleep and preparation method thereof |
| CN108783458A (en) * | 2018-07-14 | 2018-11-13 | 湛江广医医药科技开发有限公司 | Promote the compound ganoderma health food of sleep pleasure mood prevention of depression |
| CN110050971A (en) * | 2019-03-06 | 2019-07-26 | 烟台优达生物技术开发有限公司 | It is a kind of to conduce to sleep and the product formula for adjusting mood and preparation method thereof |
| CN114073314A (en) * | 2020-08-18 | 2022-02-22 | 四川济生堂药业有限公司 | Composition for preventing or improving sleep disorder |
| CN114073314B (en) * | 2020-08-18 | 2024-05-03 | 四川济生堂药业有限公司 | Composition for preventing or improving sleep disorder |
| CN114009773A (en) * | 2021-10-14 | 2022-02-08 | 宁夏医科大学 | Composition with sleep improving effect and preparation method and application thereof |
| CN116144446A (en) * | 2021-11-19 | 2023-05-23 | 泸州老窖股份有限公司 | Health care wine for improving sleep function |
| CN115813976A (en) * | 2021-12-31 | 2023-03-21 | 亿艾(河南)生物科技有限公司 | Nerve-soothing and relieving plant essential oil and application thereof |
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Application publication date: 20141203 |