CN1840044A - Medicine for treating insomnia and preparation method thereof - Google Patents
Medicine for treating insomnia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating insomnia and process for preparation, wherein the composition is prepared from amber 1-4 weight parts, wild or spiny jujuba seed 6-10 weight parts, tuber of multiflower knotweed 6-10 weight parts, albizia bark 6-10 weight parts, ruby mica 2-6 weight parts, draconic dentes 2-6 weight parts, polygala root 0.5-3 weight parts, acorus gramineus soland 0.5-3 weight parts, rehamnnia root 1-4 weight parts, coptis root 1-4 weight parts, Chinese angelica root 0.5-3 weight parts, and poria cocos wolf 0.5-3 weight parts.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, specifically medicine of a kind of Cure for insomnia and preparation method thereof belongs to technical field of Chinese medicines.
Background technology
At present, along with the continuous progress of society, the continuous development of science and technology, competition be day apparent fierceness also, forces people's rhythm of life to be accelerated, and people's stress is also just increasing, and the phenomenon of not having enough sleep is more and more general.Owing to do not have enough sleep and various diseases such as the excessive insomnia who causes of stress, depression, neurosis, schizophrenia sharply rise because sickness rate increases day by day, be called as " invisible healthy killer ".According to statistics, at present there are 1,600 ten thousand people in the whole nation approximately just like the patient of insomnia, depression and other mental sickness, has every year 250000 people to die from suicide approximately, and the insomnia rate in the American population is 32%～35%, Japan is 20%, Australia is 20%～25%.There is data to show, because of sleep disorder (insomnia) causes that the ratio of mental disease is up to 90%.Therefore, mental sickness such as insomnia, depression has been a serious medical problem that presses for solution.
The basic definition of insomnia is a sleep disorder, just often can not obtain normal sleep.The sleep specialist thinks, insomnia is a kind of sleep quality of certain time a kind of state unsatisfactory, often show as have difficulty in going to sleep, can not fall asleep, keep dyskoimesis, too early or intermittence wake up etc., generally be rendered as initial insomnia, be interrupted insomnia and three characteristics of terminal point insomnia.Short-term sleep restriction can cause carbohydrate tolerance to go down, and may be an independent hazard factor that is formed with symtomatic diabetes, does not have enough sleep to produce adverse effect to carbohydrate metabolism and endocrine function.Competent sleep except can allaying tiredness, also with the human body immunity improving ability, strengthen resist the disease ability closely related.
Insomnia in Chinese medicine, be commonly referred to be insomnia, insomnia, insomnia crouch, must not doss etc.The traditional Chinese medical science is early on the books to insomnia, the content that Zhang Zhongjing has enriched " interior warp " to the clinical disease of being insomnia and method of treatment, as: " SHAO YIN syndrome, more than two or three days, vexation must not crouch, the Chinese goldthread colla corii asini decoction master it." (" Treatise on Febrile Diseases is distinguished SHAO YIN syndrome arteries and veins card and controls ")." the puzzled greatly opinion of Ling Shu Miraculous Pivot or Divine Axis " described the pathogenesis of " unable to close the eyes " in more detail." the evil visitor of Ling Shu Miraculous Pivot or Divine Axis " piece of writing more proposes concrete method of treatment and square medicine to " unable to close the eyes ".The origin cause of formation of insomnia be it is generally acknowledged with to ponder over factors such as overstrain, interior sad spleen, disarmony between the heart and kidney, hyperactivity of fire caused by deficiency of YIN, liver-yang disturbance, the heart and gallbladder deficiency of vital energy and disorder of the stomach relevant.Its disease performance can be divided into deficiency and excess two classes substantially.Its empty person, pathogenesis or be deficiency of both the heart and spleen, so that malaise; Or kidney yin consumption hinders, can not on help in the heart, heart-yang is solely high, heart-fire can not meet at kidney down, disturbs and gods and can not falling asleep; Or hinder in feelings will, liver is lost bar and reaches, stagnated QI transforming into fire, and yang hyperactivity is cloudy hinders, and the disturbance mind consequently is insomnia; Or timidness due to deficiency of the heart, easily frightened when anything crops up, irritability and having a sleepless night.The true person that has a sleepless night, its pathogenesis or because of angry impairing the liver, liver is lost bar and reaches, stagnated QI transforming into fire, disturbing the mind upwards and being insomnia; Or because of disorder of the stomach leading to insomnia with restlessness; Or phlegm-damp stops up and to hold back middle Jiao, and the strongly fragrant heat of giving birth to of a specified duration is disturbed and dysphoria and insomnia on the expectorant heat.
At present, the method for Cure for insomnia generally includes following two kinds: (1) uses the sedative hypnotic drug treatment; (2) non-drug therapy mainly contains the behavior therapy, relaxation therapy, cognitive therapy and phototherapy etc.But Drug therapy is still the main method of present Cure for insomnia.
The traditional Chinese medical science is according to the characteristics of insomnia, and the normal prescription that adopts has Decoction of Gentiana for Purging the Liver-fire, GUIPI TANG, Cinnabar Sedative Pill, tranquilizing the mind ball etc.Except that said medicine, Chinese patent medicine commonly used at present also has Tianwang Buxin Dan, ANSHEN BUXIN WAN, kidney-brain-nourishing tablet, three BAODAN, Xuefu ecchymosis eliminating pill, Radix Et Caulis Acanthopanacis Senticosi tablet and Pill of Magnetitum and Cinnabari etc.Western medical treatment insomnia is main uses calm, hypnotic drug, and it mainly is divided into three major types: 1, benzodiazepine: this class drug main will have chlordiazepoxide, stabilizes, oxazepans, nitrodiazepam, tavor etc.; 2, barbiturates: this class medicine mainly contains phenobarbital, sodium phenobarbital etc.; 3, other miscellanies: as Paraldehyde, water and chloral, glutethimide, methaqualone, chlorpromazine, promethazine etc.Sleeping pill is that a class produces inhibitory action to the central nervous system, can cause calm and hypnotic medicine, and its sedation there is no strict difference in syngignoscism.
At present, many in the Chinese patent medicine of Cure for insomnia with some old prescriptions, not being suitable for nowadays diversified is the state of an illness, the more modern big production of incompatibility, and the mineral medicine of the tranquillization with heavy prescription of employing more than in the Chinese patent medicine of these Cure for insomnias such as Cinnabaris etc., in Cure for insomnia, can cause to a certain degree infringement to the person again.All there is following problem in all Western medicine at present: the sleeping pill that (1) is nearly all, long-term use continuously all can produce toleration and dependency.Suddenly drug withdrawal meeting produces symptoms such as thirsting for this medicine, irritability, insomnia, somatic tremor, perspiration, palpitating speed; (2) benzene class medicine, especially action time long sedative hypnotic drug, with after carry over effect is often arranged, that inferior heliacal rising shows is dizzy, sleepy, lassitude, drowsy etc.Mental experiment shows, patient night takes after this type of medicine second day afternoon 1 time, the response speed of measuring patient obviously slows down, I also am unaware of the existence of this infringement, for being engaged in machine work or high-risk work crowd, have potential danger especially! Therefore, the patient who takes medicine, take medicine the same day with time daily can not steering vehicle and operate machine, to avoid accident; (3) other central depressant things as antihistaminic, analgesic and ethanol etc., with benzene class medicine and time spent, can strengthen the inhibitory action to nervus centralis, particularly with the same time spent of ethanol, cental system are had coordinate repression, serious consequence can occur; (4) barbiturates and two chloral antipyrines can not be used to suffer from the patient of acute intermittent hematoporphyria; (5) unsuitable for children uses sleeping pill, and intelligence is had side effect, for elderly patients, then should use cautiously, because confusion may occur after the medication; (6) the careful usefulness of the hepatic and renal function person of going down, liver function serious hindrance person forbidding, especially barbiturate; (7) women breast-feeding their children and anemia of pregnant woman should not use.
Ideal sedative hypnotic drug should possess following condition: (1) is sleep inducing rapidly; (2) to not influence of Sleep architecture; Drug residue free effect in (3) second days; (4) do not influence memory function, comprise and do not forget symptom; (5) breathing there is not inhibitory action; (6) life-time service does not have drug dependence or drug withdrawal symptom; (7) there is not interaction with ethanol and other drug.Should say also do not have a kind of medicine of sleeping peacefully to meet these conditions fully up to now, so development meets the ideal sedative hypnotic drug of above-mentioned condition and the important topic that preparation is modern medicine study as far as possible.
Summary of the invention
At present, still there is very big demand in people to the medicine of the littler Cure for insomnia of better efficacy, side effect.The inventor is through research repeatedly, and the checking repeatedly by clinical trial, has found the oral medicinal herb medicine of the Cure for insomnia that better effect is arranged finally, thereby has finished the present invention.
The Chinese medicine composition that the purpose of this invention is to provide a kind of Cure for insomnia.
Another object of the present invention has provided the preparation method of this Chinese medicine composition.
The present invention selects succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori and Cortex Albiziae to make up, and makes each efficacy of drugs produce synergism these drug regimens, thereby can effectively play the effect of Cure for insomnia.Wherein select succinum to be because its sweet in the mouth, levelling, GUIXIN liver, mainly contain the petchem and the volatile oil of diabietionlic acid, but tranquillizing and allaying excitement, promoting blood circulation to remove blood stasis, inducing diuresis for treating stranguria syndrome; Semen Ziziphi Spinosae contains three cuts class, flavonoid, alkaloid, organic acid etc., has tranquilizing by nourishing the heart, an effect of the arresting sweating that promotes the production of body fluid.Cortex Albiziae contain Zao and tannin, the property of medicine is gentle, has the effect of the resolving depression of calming the nerves, promoting blood circulation and detumescence.Caulis Polygoni Multiflori has another name called Caulis Polygoni Multiflori, and sweet in the mouth, property are flat, the GUIXIN Liver Channel, the effect of have liver and kidney tonifying, nourish essence and blood, loosening bowel to relieve constipation, detoxifcation being calmed the nerves.
For reaching better therapeutic, medicine of the present invention also makes up with Concha Margaritifera, Dens Draconis, Radix Polygalae, Rhizoma Acori Graminei.This is because Concha Margaritifera contains calcium carbonate, several amino acids, organic matter and small amount of magnesium, ferrum, silicate etc., salty in the mouth, and cold in nature, the GUIXIN Liver Channel has the suppressing the hyperactive liver relieving palpitation, and the feelings liver makes eye bright, the effect of removing dampness antacid.Dens Draconis contains calcium carbonate, calcium phosphate, and puckery, cool in nature, GUIXIN Liver Channel can tranquilizing minds, suppressing the hyperactive liver and subsiding YANG, convergence be astringent or styptic treatment for spontaneous sweating.Radix Polygalae, bitter in the mouth, suffering, warm in nature, the GUIXIN lung meridian has the Fructus Alpiniae Oxyphyllae of calming the nerves, and eliminates the phlegm and has one's ideas straightened out, the effect of dissipation carbuncle.Rhizoma Acori Graminei contains volatile oil, and it is mainly beta-Asarone, α-asaricin, and contains saccharide, organic acid, aminoacid etc.Have and eliminate phlegm for resuscitation, mind tranquilizing and the heart calming, the effect of removing dampness for regulating stomach.The said medicine assistant helps monarch-minister drug, can play the effect that increases curative effect.
In order to obtain optimum curative effect, medicine of the present invention also can add Radix Rehmanniae, Rhizoma Coptidis, Radix Angelicae Sinensis, Poria because the effect that Radix Rehmanniae has clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting on the basis of said medicine.Rhizoma Coptidis can heat clearing and damp drying, eliminating fire and detoxication.Radix Angelicae Sinensis nourishes blood, the effectiveness of loosening bowel to relieve constipation.Poria has promoting diuresis to eliminate damp pathogen, the effect of spleen-benefiting mind-tranquilizing.Above-mentioned 12 flavor medicines make up, and the effect of Cure for insomnia is stronger, curative effect the best.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all to have better curative effect and without any side effects in the following weight parts scope.
In order to realize purpose of the present invention, following tool technical scheme is proposed:
A kind of medicine of Cure for insomnia, it mainly is to be made by the following weight proportion raw material:
Succinum 1～4 weight portion, Semen Ziziphi Spinosae 6～10 weight portions, Caulis Polygoni Multiflori 6～10 weight portions, Cortex Albiziae 6～10 weight portions, Concha Margaritifera 2～6 weight portions, Dens Draconis 2～6 weight portions, Radix Polygalae 0.5～3 weight portion, Rhizoma Acori Graminei 0.5～3 weight portion.
Wherein the optimum weight proportioning of each component is:
Succinum 1.5～3 weight portions, Semen Ziziphi Spinosae 7～9 weight portions, Caulis Polygoni Multiflori 7～9 weight portions, Cortex Albiziae 7～9 weight portions, Concha Margaritifera 3～5 weight portions, Dens Draconis 3～5 weight portions, Radix Polygalae 1～2.5 weight portion, Rhizoma Acori Graminei 1～2.5 weight portion.
Also be added with in the wherein said raw material:
Radix Rehmanniae 1～4 weight portion, Rhizoma Coptidis 1～4 weight portion,
Radix Angelicae Sinensis 0.5～3 weight portion, Poria 0.5～3 weight portion.
Wherein the optimum amount of each component is:
Radix Rehmanniae 1.5～3 weight portions, Rhizoma Coptidis 1.5～3 weight portions,
Radix Angelicae Sinensis 1～2.5 weight portion, Poria 1～2.5 weight portion.
A kind of method for preparing the medicine of Cure for insomnia, it comprises the following steps:
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 1～4 weight portion, Semen Ziziphi Spinosae 6～10 weight portions,
Caulis Polygoni Multiflori 6～10 weight portions, Cortex Albiziae 6～10 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 50%～95% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 45～50 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 2～6 weight portions, Dens Draconis 2～6 weight portions, Radix Polygalae 0.5～3 weight portion, Rhizoma Acori Graminei 0.5～3 weight portion and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 50%～95% ethanol and carries out precipitate with ethanol, reclaim ethanol, 45～50 ℃ dry down, make dry extract 2, standby;
(6) merge dry extract 1, dry extract 2, it is ground into medicated powder, just be prepared into the active component of medicine of the present invention.
The method of the medicine of above-mentioned preparation Cure for insomnia wherein also comprises the following steps:
Take by weighing the active component that medicated powder that Radix Rehmanniae 1～4 weight portion, Rhizoma Coptidis 1～4 weight portion, Radix Angelicae Sinensis 0.5～3 weight portion, Poria 0.5～3 parts by weight of crushed to 100 order fineness make and the medicated powder mix homogeneously in the step (6) just have been prepared into medicine of the present invention.
Described a kind of method for preparing the medicine of Cure for insomnia is that the medicine activity component that the makes snap fit capsule of packing into is made capsule.
Described a kind of method for preparing the medicine of Cure for insomnia, ethanol extraction is three times in described step (2) and the step (5), for the first time with 8 times of amount alcohol refluxs 2 hours, measure alcohol refluxs 1.5 hours, measured alcohol refluxs 1 hour with 4 times for the third time with 6 times for the second time.
In the preparation method of compound medicine agent in the present invention, can adopt ethanol, isopropyl alcohol, propanol or butanols etc. to use pure class always, but wherein preferably use ethanol, and to be to use volume ratio in the ethanol extraction step be 50%～90% ethanol.
Described a kind of method for preparing the medicine of Cure for insomnia decocts with water three times in the described step (4), adds 8 times of amount decoctions of water 2 hours the first time, adds 6 times of amount decoctions of water 1.5 hours for the second time, adds 4 times of amount decoctions of water 1 hour for the third time.
Described ethanol adds the ratio that doubled amount is the weight between ethanol or water and the medicine that adds of doubled amount and water.
Semen Ziziphi Spinosae of the present invention can give birth to, fry dual-purpose, preferably fries usefulness, because fry with property temperature partially, and the person that is applicable to the deficiency of both the heart and spleen, and suitable little stir-fry, stir-fry for a long time then loses sedative action.
Radix Rehmanniae described in the medicine of the present invention should be used Radix Rehmanniae, and described Dens Draconis should be used Dens Draconis.
The medicine of Cure for insomnia provided by the present invention, it is characterized in that raw materials used by described weight part ratio, and the preparation method of Chinese formulated products is made medicament routinely, as pill, powder, tablet, capsule, oral liquid, drop pill etc., also material medicine can be developed into powder, mix homogeneously is made powder and is directly taken after mixing it with water.But these are not limited to protection scope of the present invention.
Advantage of the present invention and benefit: medicine of the present invention has tranquilizing the mind, clearing away heat and cooling blood, and the effect such as have one's ideas straightened out of eliminating the phlegm, it has overcome the weak point of existing Chinese medicine and Western medicine.By clinical checking repeatedly, this medicine can be treated multiple insomnia, and depression and other mental sickness are had the auxiliary treatment effect.Take medicine of the present invention for a long time continuously and can not produce toleration and dependency, and time morning of taking medicine can not occur because the caused dizziness of drug residue, sleepy, lassitude, phenomenon such as drowsy.Because medicine property of medicine gentleness of the present invention through clinical trial and animal experiment checking, has no side effect, and is suitable for insomnia's treatment of child, old people, the renal function person of going down, hepatic insufficiency person, age of sucking and the pregnant woman of growth and development stage, the cure rate height.
Medicine of the present invention is effectively treated with multiple composition and is alleviated insomnia; suitable crowd is wider; alleviated the side effect that the heavy dose of use of single component may bring; in Cure for insomnia disease; can strengthen the defencive function dirty, and depression, neurosis and other mental sickness are had the auxiliary treatment effect Liver and kidney.
The specific embodiment
Further set forth medicine of the present invention and preparation method thereof and beneficial effect by following examples, press the medicine of the Cure for insomnia of the present invention of following proportioning preparation,, all can reach described effect by the clinical experiment checking.These test examples have comprised the animal experiment and the clinical observation test of medicine of the present invention.
The preparation of the capsule of embodiment 1 medicine of the present invention
Active component in this prescription is filled in the capsule shells of different materials and can be made into special capsules such as hard capsules, soft capsule and enteric coated capsule etc.
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 2.5 weight portions, Semen Ziziphi Spinosae 8 weight portions,
Caulis Polygoni Multiflori 7 weight portions, Cortex Albiziae 6 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 95% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 45 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 4.5 weight portions, Dens Draconis 5 weight portions, Radix Polygalae 2 weight portions, Rhizoma Acori Graminei 2 weight portions and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 95% ethanol and carries out precipitate with ethanol, reclaim ethanol, 45 ℃ dry down, make dry extract 2, standby;
(7) merge dry extract 1, dry extract 2 in, it is ground into the active component that makes medicine of the present invention behind the medicated powder;
(8) medicine activity component that makes is packed into snap fit capsule.
The preparation tablets of embodiment 2 medicines of the present invention
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 1 weight portion, Semen Ziziphi Spinosae 6 weight portions,
Caulis Polygoni Multiflori 6 weight portions, Cortex Albiziae 8 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 50% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 45 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 2 weight portions, Dens Draconis 2 weight portions, Radix Polygalae 0.5 weight portion, Rhizoma Acori Graminei 0.5 weight portion and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 50% ethanol and carries out precipitate with ethanol, reclaim ethanol, 45 ℃ dry down, make dry extract 2, standby;
(6) take by weighing Radix Rehmanniae 1 weight portion, Rhizoma Coptidis 1 weight portion, Radix Angelicae Sinensis 0.5 weight portion, Poria 0.5 parts by weight of crushed to 100 order fineness to getting medicated powder, standby;
(7) merge dry extract 1, dry extract 2 in, with its be ground into behind the powder with step (6) in the medicated powder mix homogeneously just be prepared into the active component of medicine of the present invention.
(8) medicine activity component that makes is mixed tabletting with tablet adjuvant commonly used.
The preparation of the pill of embodiment 3 medicines of the present invention
Main active component in this prescription is made ball shape preparation, be divided into common (large and small) ball shape preparation and little dropping pill formulation.The binding agent difference of using can be made into honeyed pill, the watered pill, paste pill, wax pill and concentrated pill etc.
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 4 weight portions, Semen Ziziphi Spinosae 10 weight portions,
Caulis Polygoni Multiflori 10 weight portions, Cortex Albiziae 10 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 75% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 50 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 6 weight portions, Dens Draconis 6 weight portions, Radix Polygalae 3 weight portions, Rhizoma Acori Graminei 3 weight portions and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 75% ethanol and carries out precipitate with ethanol, reclaim ethanol, 50 ℃ dry down, make dry extract 2, standby;
(6) take by weighing Radix Rehmanniae 4 weight portions, Rhizoma Coptidis 4 weight portions, Radix Angelicae Sinensis 3 weight portions, Poria 3 parts by weight of crushed to 100 order fineness to getting medicated powder, standby;
(7) merge dry extract 1, dry extract 2 in, with its be ground into behind the powder with step (6) in the medicated powder mix homogeneously just be prepared into the active component of medicine of the present invention.
(8) medicine activity component that makes is added suitable binding agent and adjuvant is made spherical preparation.
The preparation of the granule of embodiment 4 medicines of the present invention
Primary raw material in this prescription is made solubility, suspension type or effervescency granular formulations, can directly take, take again after the also available solution dissolving.
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 3 weight portions, Semen Ziziphi Spinosae 9 weight portions,
Caulis Polygoni Multiflori 8 weight portions, Cortex Albiziae 7 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 90% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 50 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 4 weight portions, Dens Draconis 4 weight portions, Radix Polygalae 1.5 weight portions, Rhizoma Acori Graminei 1.5 weight portions and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 90% ethanol and carries out precipitate with ethanol, reclaim ethanol, 50 ℃ dry down, make dry extract 2, standby;
(6) take by weighing Radix Rehmanniae 2 weight portions, Rhizoma Coptidis 3 weight portions, Radix Angelicae Sinensis 1.5 weight portions, Poria 2 parts by weight of crushed to 100 order fineness to getting medicated powder, standby;
(7) merge dry extract 1, dry extract 2 in, with its be ground into behind the powder with step (6) in the medicated powder mix homogeneously just be prepared into the active component of medicine of the present invention.
(8) medicine activity component that makes is added ethanol and do binding agent, add starch and do filler, be pressed into granule.
Medicine of the present invention is carried out zoopery, its drug effect is carried out repetition test, the experimental basis of science is provided for this medicine.
1, laboratory animal: 40 of Kunming mouses, average weight 20 (g) is male.
2, experiment grouping: mice is divided into four groups, and 5 times, 10 times, 30 times of human body recommended dose that are respectively medicine of the present invention are basic, normal, high dosage group and blank group.
3, experimentation: 5 times, 10 times, 30 times waters of the human body recommended dose of medicine of the present invention are mixed with equal volume liquid, irritate stomach through the mice mouth; Blank group water replaces medicine of the present invention, and the filling body of stomach is long-pending, number of times is identical with basic, normal, high dosage group.When finishing, carry out the detection of every index, measurement result sees Table 1, table 2:
Give behind the mouse stomach 30 minutes, meter record mice sleep situation the results are shown in Table 1:
Table 1 animal sleep situation
| Grouping | Number of animals (only) | The number of animals of not sleeping (only) | Sleep number of animals (only) |
| Dosage group high dose group in the blank group low dose group | 10 10 10 10 | 9 2 1 0 | 1 8 9 10 |
Table 1 result shows, medicine of the present invention inducing mouse sleep fast and effectively.
In administration after 30 minutes, every mice is positioned over respectively in 20 * 20 the carton, make it adapt to 2 minutes after, the meter record is walked about in its 2 minutes time and praise two forelimb number of times, the results are shown in Table 2 and shows:
Time of walking about of table 2 mice and praise two forelimb number of times situations
| Grouping | Number of animals (only) | Walk about the time (second/only) | Praise number of times (inferior/only) |
| Dosage group high dose group in the blank group low dose group | 10 10 10 10 | 52±8 28±11 26±10 23±8 | 36±10 22±8* 18±11 14±9* |
*: compare with the blank group, there were significant differences.
Medicine of the present invention can reduce the time of walking about of mice significantly and praise two forelimb number of times (P＜0.05), has effective sedation.
Further describe medicine of the present invention below by the clinical practice example.
1, diagnostic criteria:
Relevant 51.0 insomnias (307.4 in China's mental sickness classification schemes and the diagnostic criteria second edition revised edition (CCMD-2-R); F51.0) diagnostic criteria is as follows:
Surpassing 1 hour can not fall asleep, or SAN deficiency of time 5 hours, repeatedly wakes up and change therebetween, discomforts such as tired, insobriety, headache, dizziness are arranged after getting up, and the persistent period is longer, influences work and life, can be diagnosed as the insomnia.
2, efficacy assessment standard: carry out efficacy evaluation with reference to related content in " the disease of tcm diagnosis criterion of therapeutical effect " of State Administration of Traditional Chinese Medicines's issue in 1994.
Cure: insomnia disappears, and the time for falling asleep and the length of one's sleep are normally promptly sleeping within an hour, and the SAN time was above 5 hours.
Produce effects: insomnia makes moderate progress, and the time for falling asleep and the length of one's sleep are normal substantially.
Invalid: insomnia does not have significant change, and the time for falling asleep and the length of one's sleep are undesired.
3, the experimenter includes standard in:
Among the outpatient, 18 years old～65 years old is insomniac after diagnosing, and wherein under-18s, over-65s, are taken medicine or the food relevant with pharmic function of the present invention in a short time at serious primary disease, psychotic, and influence is to except the judgement person as a result.
4, grouping:
Meet the 150 routine insomnia experimenters that the experimenter includes standard in, be divided into treatment group, matched group and blank group at random, every group 50 routine insomnia experimenter, wherein treatment group is taken medicine of the present invention, and usage is adjusted accordingly according to dosage form is different with consumption; Matched group is taken commodity medicine YINAO ANSHEN BAO, and usage and consumption are with the treatment group; The blank group is taken blank placebo, and usage and consumption are with the treatment group.
(1) treatment group: male's 17 examples, women's 33 examples, minimum 34 years old of age, maximum 65 years old, average 42.76 ± 7.41 years old, average course of disease 1.21 ± 0.79 years.
(2) matched group: male's 19 examples, women's 31 examples, minimum 32 years old of age, maximum 65 years old, average 40.50 ± 8.25 years old, average course of disease 1.26 ± 0.65 years.
(3) blank group: male's 20 examples, women's 30 examples, minimum 35 years old of age, maximum 65 years old, average 41.42 ± 9.28 years old, average course of disease 1.50 ± 1.60 years.
Application examples 1
Utilize this medicine capsule of embodiment 1 preparation, be treatment group usage and consumption: take after mixing it with hot water, one time 2, three times on the one, continuous use three months, observe the curative effect, patient's cardinal symptom improvement situation sees Table 3:
Table 3 cardinal symptom is improved
| Cardinal symptom | Example number/group | The treatment group | Matched group | The blank group | ||||||
| Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | ||
| It is forgetful to change wake up tired the dizziness in morning in back, headache of the dreaminess of waking up at difficulty falling asleep night | 50 50 50 50 50 50 | 28 32 35 30 34 31 | 19 18 14 18 16 17 | 3 0 1 2 0 2 | 18 18 16 20 15 19 | 11 17 15 10 18 12 | 21 15 19 20 17 19 | 0 0 0 0 0 0 | 3 3 2 0 1 2 | 47 47 48 50 49 48 |
Wherein, patient's clinical symptoms is improved situation: treatment group cure rate is 63.3%, and total effective rate is 97.3%; The matched group cure rate is 35.3%, and total effective rate is 44.7%; The cure rate of blank group is 0, and total effective rate is 3.7%.
Table 4 sleep quality
| Group | The example number | Average time for falling asleep | The average length of one's sleep |
| Treatment group matched group blank group | 50 50 50 | 19.6 minutes 49.7 minutes 82.8 minutes | 7.1 hours # 6.3 hour 4.5 hours |
Compare #P＜0.05 between group
As shown in table 4, the average time for falling asleep of treatment group is significantly shorter than matched group and blank group, is longer than matched group and blank group the average length of one's sleep.
Application examples 2
Utilize this medicinal tablet of embodiment 2 preparation, be treatment group usage and consumption: take after mixing it with hot water, one time 2, three times on the one, continuous use three months, observe the curative effect, patient's cardinal symptom improvement situation sees Table 5:
Table 5 cardinal symptom is improved
| Cardinal symptom | Example number/group | The treatment group | Matched group | The blank group | ||||||
| Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | ||
| It is forgetful to change wake up tired the dizziness in morning in back, headache of the dreaminess of waking up at difficulty falling asleep night | 50 50 50 50 50 50 | 35 36 33 30 31 37 | 15 13 14 18 18 11 | 0 1 3 2 1 2 | 16 14 19 17 21 18 | 14 25 15 19 11 16 | 20 11 16 14 18 16 | 0 0 0 0 0 0 | 2 1 1 3 0 2 | 48 49 49 47 50 48 |
Wherein, patient's clinical symptoms is improved situation: treatment group cure rate is 67.3%, and total effective rate is 97.0%; The matched group cure rate is 35.0%, and total effective rate is 68.3%; The cure rate of blank group is 0, and total effective rate is 3%.
Table 6 sleep quality
| Group | The example number | Average time for falling asleep | The average length of one's sleep |
| The treatment group | 50 | 18.4 minute | 7.4 hour # |
| Matched group blank group | 50 50 | 52.1 minutes 85.6 minutes | 6.0 hours 4.3 hours |
Compare #P＜0.05 between group
As shown in table 6, the average time for falling asleep of treatment group is significantly shorter than matched group and blank group, is longer than matched group and blank group the average length of one's sleep.
Application examples 3
Utilize this bolus of drug of embodiment 3 preparations, be treatment group usage and consumption: take after mixing it with hot water, one time 2 ball, three times on the one, continuous use three months, observe the curative effect, patient's basic condition sees Table 7:
Table 7 cardinal symptom is improved
| Cardinal symptom | Example number/group | The treatment group | Matched group | The blank group | ||||||
| Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | ||
| It is forgetful to change wake up tired the dizziness in morning in back, headache of the dreaminess of waking up at difficulty falling asleep night | 50 50 50 50 50 50 | 30 32 39 34 32 34 | 20 16 8 16 16 15 | 0 2 3 0 2 1 | 12 16 14 19 17 15 | 16 21 19 15 15 15 | 22 13 17 16 18 20 | 0 0 0 0 0 0 | 1 2 0 4 3 1 | 49 48 50 46 47 49 |
Wherein, patient's clinical symptoms is improved situation: treatment group cure rate is 67.0%, and total effective rate is 97.5%; The matched group cure rate is 31.0%, and total effective rate is 64.7%; The cure rate of blank group is 0, and total effective rate is 3.7%.
Table 8 sleep quality
| Group | The example number | Average time for falling asleep | The average length of one's sleep |
| Treatment group matched group blank group | 50 50 50 | 18.0 minutes 49.8 minutes 74.3 minutes | 7.3 hours # 5.6 hour 4.6 hours |
Compare #P＜0.05 between group
As shown in table 8, the average time for falling asleep of treatment group is significantly shorter than matched group and blank group, is longer than matched group and blank group the average length of one's sleep.
Application examples 4
Utilize this medicinal granule of embodiment 4 preparations, be treatment group usage and consumption: take after mixing it with hot water, a 18g, three times on the one, continuous use three months, observe the curative effect, patient's basic condition sees Table 9:
Table 9 cardinal symptom is improved
| Cardinal symptom | Example number/group | The treatment group | Matched group | The blank group | ||||||
| Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | Cure | Produce effects | Invalid | ||
| It is forgetful to change wake up tired the dizziness in morning in back, headache of the dreaminess of waking up at difficulty falling asleep night | 50 50 50 50 50 50 | 30 37 32 36 33 31 | 18 11 17 14 16 19 | 2 2 1 0 1 0 | 21 11 13 18 14 20 | 9 26 20 15 17 14 | 20 13 17 17 19 16 | 0 0 0 0 0 0 | 1 2 3 1 2 0 | 49 48 47 49 48 50 |
Wherein, patient's clinical symptoms is improved situation: treatment group cure rate is 66.3%, and total effective rate is 98.0%; The matched group cure rate is 32.3%, and total effective rate is 66.0%; The cure rate of blank group is 0, and total effective rate is 3.3%.
Table 10 sleep quality
| Group | The example number | Average time for falling asleep | The average length of one's sleep |
| Treatment group matched group blank group | 50 50 50 | 17.9 minutes 50.1 minutes 82.3 minutes | 7.5 hours # 6.0 hour 4.2 hours |
Compare #P＜0.05 between group
As shown in table 10, the average time for falling asleep of treatment group is significantly shorter than matched group and blank group, is longer than matched group and blank group the average length of one's sleep.
In a word, in above clinical trial, the treatment group is promptly taken medicine group of the present invention, and average cure rate is 65.98%, and average effectiveness level is 97.45%.Illustrate that medicine of the present invention has the effect of significant Cure for insomnia, the cure rate height, rare awake back is tired, inferior dizziness in morning, headache, symptom such as forgetful proves drug residue free.Without any side effects and ill symptoms generation in animal experiment and clinical trial.
Claims (9)
1, a kind of medicine of Cure for insomnia is characterized in that, it mainly is to be made by the following weight proportion raw material:
Succinum 1～4 weight portion, Semen Ziziphi Spinosae 6～10 weight portions, Caulis Polygoni Multiflori 6～10 weight portions,
Cortex Albiziae 6～10 weight portions, Concha Margaritifera 2～6 weight portions, Dens Draconis 2～6 weight portions,
Radix Polygalae 0.5～3 weight portion, Rhizoma Acori Graminei 0.5～3 weight portion.
2, the medicine of a kind of Cure for insomnia according to claim 1 is characterized in that, the weight proportion of each raw material is:
Succinum 1.5～3 weight portions, Semen Ziziphi Spinosae 7～9 weight portions, Caulis Polygoni Multiflori 7～9 weight portions,
Cortex Albiziae 7～9 weight portions, Concha Margaritifera 3～5 weight portions, Dens Draconis 3～5 weight portions,
Radix Polygalae 1～2.5 weight portion, Rhizoma Acori Graminei 1～2.5 weight portion.
3, the medicine of a kind of Cure for insomnia according to claim 1 and 2 is characterized in that, also is added with in the wherein said raw material:
Radix Rehmanniae 1～4 weight portion, Rhizoma Coptidis 1～4 weight portion,
Radix Angelicae Sinensis 0.5～3 weight portion, Poria 0.5～3 weight portion.
4, the medicine of a kind of Cure for insomnia according to claim 3 is characterized in that, wherein the consumption of each component is:
Radix Rehmanniae 1.5～3 weight portions, Rhizoma Coptidis 1.5～3 weight portions,
Radix Angelicae Sinensis 1～2.5 weight portion, Poria 1～2.5 weight portion.
5, a kind of method for preparing the medicine of Cure for insomnia is characterized in that it comprises the following steps:
(1) take by weighing following traditional Chinese medicines and make raw material:
Succinum 1～4 weight portion, Semen Ziziphi Spinosae 6～10 weight portions,
Caulis Polygoni Multiflori 6～10 weight portions, Cortex Albiziae 6～10 weight portions, standby;
(2) succinum, Semen Ziziphi Spinosae, Caulis Polygoni Multiflori, the Cortex Albiziae after will taking by weighing adds 50%～95% ethanol and carries out reflux, extract,, reclaims extracting solution, and with extracting solution by 120 order stainless steel sift net filtrations;
(3) extracting solution with step (2) reclaims ethanol, and is dry under 45～50 ℃, makes dry extract 1, standby;
(4) take by weighing Concha Margaritifera 2～6 weight portions, Dens Draconis 2～6 weight portions, Radix Polygalae 0.5～3 weight portion, Rhizoma Acori Graminei 0.5～3 weight portion and decoct with water, extracting solution is by 120 order stainless steel sift net filtrations;
(5) extracting solution of step (4) is added 50%～95% ethanol and carries out precipitate with ethanol, reclaim ethanol, 45～50 ℃ dry down, make dry extract 2, standby;
(6) merge dry extract 1, dry extract 2, it is ground into medicated powder, just be prepared into the active component of medicine of the present invention.
6, a kind of method for preparing the medicine of Cure for insomnia according to claim 5 is characterized in that, wherein also comprises the following steps:
Take by weighing the active component that medicated powder that Radix Rehmanniae 1～4 weight portion, Rhizoma Coptidis 1～4 weight portion, Radix Angelicae Sinensis 0.5～3 weight portion, Poria 0.5～3 parts by weight of crushed to 100 order fineness make and the medicated powder mix homogeneously in the step (6) just have been prepared into medicine of the present invention.
7, according to claim 5 or 6 described a kind of methods that prepare the medicine of Cure for insomnia, it is characterized in that, the medicine activity component that the makes snap fit capsule of packing into is made capsule.
8, according to claim 5 or 6 described a kind of methods that prepare the medicine of Cure for insomnia, it is characterized in that, ethanol extraction is three times in described step (2) and the step (5), for the first time with 8 times of amount alcohol refluxs 2 hours, measure alcohol refluxs 1.5 hours, measured alcohol refluxs 1 hour with 4 times for the third time with 6 times for the second time.
9, according to claim 5 or 6 described a kind of methods that prepare the medicine of Cure for insomnia, it is characterized in that, decoct with water three times in the described step (4), add 8 times of amount decoctions of water 2 hours the first time, add 6 times of amount decoctions of water 1.5 hours for the second time, add 4 times of amount decoctions of water 1 hour for the third time.
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| CN102716360A (en) * | 2012-06-20 | 2012-10-10 | 李良 | Acacia bark traditional Chinese medicine decoction for alleviating insomnia and preparation method thereof |
| CN101485796B (en) * | 2008-01-14 | 2013-05-29 | 北京亚东生物制药有限公司 | Chinese medicinal composition for treating insomnia as well as preparation method thereof |
| CN103416532A (en) * | 2013-07-12 | 2013-12-04 | 苏州市天灵中药饮片有限公司 | Calming tea |
| CN104398703A (en) * | 2014-12-19 | 2015-03-11 | 青岛百瑞吉生物工程有限公司 | Traditional Chinese medicine preparation for treating insomnia as well as preparation method and application thereof |
| CN105168792A (en) * | 2015-10-27 | 2015-12-23 | 刘斌 | Brain-boosting nerve-soothing medicine |
| CN107115478A (en) * | 2017-06-19 | 2017-09-01 | 湖北泽仁康生物科技有限公司 | A kind of Chinese medicine composition, its preparation method and application for treating insomnia |
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| CN1555877A (en) * | 2004-01-02 | 2004-12-22 | 徐海飞 | Brain nourishing memory strengthening additive of hair care liquid |
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| CN101485796B (en) * | 2008-01-14 | 2013-05-29 | 北京亚东生物制药有限公司 | Chinese medicinal composition for treating insomnia as well as preparation method thereof |
| CN102716360A (en) * | 2012-06-20 | 2012-10-10 | 李良 | Acacia bark traditional Chinese medicine decoction for alleviating insomnia and preparation method thereof |
| CN103416532A (en) * | 2013-07-12 | 2013-12-04 | 苏州市天灵中药饮片有限公司 | Calming tea |
| CN104398703A (en) * | 2014-12-19 | 2015-03-11 | 青岛百瑞吉生物工程有限公司 | Traditional Chinese medicine preparation for treating insomnia as well as preparation method and application thereof |
| CN105168792A (en) * | 2015-10-27 | 2015-12-23 | 刘斌 | Brain-boosting nerve-soothing medicine |
| CN108245409A (en) * | 2016-12-27 | 2018-07-06 | 王芳 | A kind of instruments for medicine acupuncture and moxibustion tool for preventing insomnia |
| CN107115478A (en) * | 2017-06-19 | 2017-09-01 | 湖北泽仁康生物科技有限公司 | A kind of Chinese medicine composition, its preparation method and application for treating insomnia |
| CN110151877A (en) * | 2019-07-05 | 2019-08-23 | 河南中医药大学第一附属医院 | A traditional Chinese medicine granule for treating tumor-related insomnia |
| CN110151877B (en) * | 2019-07-05 | 2021-04-13 | 河南中医药大学第一附属医院 | Traditional Chinese medicine granule for treating tumor-related insomnia |
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| CN100394951C (en) | 2008-06-18 |
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