CN105456587A - Medicine preparation for treating insomnia - Google Patents

Medicine preparation for treating insomnia Download PDF

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Publication number
CN105456587A
CN105456587A CN201610038097.4A CN201610038097A CN105456587A CN 105456587 A CN105456587 A CN 105456587A CN 201610038097 A CN201610038097 A CN 201610038097A CN 105456587 A CN105456587 A CN 105456587A
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parts
radix
insomnia
pharmaceutical preparation
cure
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王传秀
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Qingdao Yuntian Biotechnology Co Ltd
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Qingdao Yuntian Biotechnology Co Ltd
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Abstract

A medicine preparation for treating the insomnia is prepared from, by weight, 10-20 parts of radix angelica sinensis, 10-20 parts of poria cocos, 8-15 parts of rhizoma acori graminei, 15-25 parts of jujube kernels, 8-15 parts of dried roots of polygala tenuifolia, 8-15 parts of safflower carthamus, 10-20 parts of tuber fleeceflower stems, 10-20 parts of rehmannia glutinosa, 8-15 parts of roasted rhizoma atractylodis macrocephalae, 8-15 parts of roots of common peony, 8-15 parts of radix paeoniae alba, 10-20 parts of albizia flower, 8-15 parts of peach kernels, 15-25 parts of prepared aconite roots and 5-10 parts of raw keel. Roots of common peony and radix paeoniae alba in the preparation complement each other so that the sedative-hypnotic function can be enhanced; the preparation is mainly used for tranquilizing mind by nourishing heart, and regulating qi and blood. The preparation is rapid in effect on treating insomnia symptoms and relieving clinical symptoms, capable of treating both symptoms and root causes, low in relapse rate after cure, convenient to use, free of toxic and side effects and convenient to apply and popularize.

Description

A kind of pharmaceutical preparation of Cure for insomnia
Technical field
The invention belongs to tcm field, especially relate to pharmaceutical preparation of a kind of Cure for insomnia and preparation method thereof.
Background technology
Insomnia is modal sleep disordered disease, refers to poor sleeping quality, and affects routine work and life.In today of social rhythm's quickening, intensified competition, insomnia has become a kind of very general phenomenon.China has the adult more than 1/3 to suffer insomnia puzzlement every year.Insomnia can cause patient anxiety, depression or the feared state of mind, and causes ergasia efficiency to decline, and hinders social function.Have a sleepless night relevant with day by day increasing of the sickness rate of cardiovascular disease, mental sickness and case fatality rate, bring a series of social problem simultaneously, as accident, absence from work without reason etc., day by day become the killer threatening human health, so World Health Organization (WHO) and domestic and international expert pay much attention to the Diagnosis and Treat of insomnia in recent years.
The cause of disease complexity of insomnia is various, the immunotherapy targeted autoantibody being not only a certain concrete cause of disease or protopathy can solve, pathogenesis is complicated, neither a certain mediator theory or regulatory pathway can explain clear completely, it is the globality disease of a system complex, need adjustment and recover the normal physiological cycle of sleep and run phase rule round the clock, reaching the homeostasis of environment.
In the treatment of doctor trained in Western medicine, conventional Benzodiazepines and Non-benzodiazepine hypnotic drug.The choice drug that Non-benzodiazepine hypnotic drug zolpidem can be used as Primary insomnia mentioned by Americanism obstacle diagnosis and statistic handbook the 4th edition (DSM2 IV).Antipsychotics Cure for insomnia easily has a rebound and withdrawal symptom, and long-term a large amount of use can produce toleration and dependency.
Chinese medicine thinks that insomnia causes often obtaining the class disease that ortho sleep is feature, also known as " being insomnia ", " insomnia ", " must not crouch ", " unable to close the eyes " etc. due to lack of preservation of spirit or uneasiness.Chinese medicine has the unique advantage of personalized treatment and diagnosis and prescription, add interior oral administration and the acupuncture such as flexile treatment skill such as decoction cream side, massage, sunken cord, press the external treatmenies such as cave, dipping, drug application, make the treatment of Chinese medicine to insomnia have the great room for maneuver and good curative effect.
Summary of the invention
The present invention is in conjunction with dialectical to insomnia of the traditional Chinese medical science, and consideration Chinese prescription, has allocated the pharmaceutical preparation of Cure for insomnia effectively of a kind of heart tonifying and tranquilizing, QI and blood regulating.
Specifically, technical scheme of the present invention is achieved in that
A pharmaceutical preparation for Cure for insomnia, comprises according to weight fraction ratio: Radix Angelicae Sinensis 10-20 part, PORIA from Yunnan of China 10-20 part, Rhizoma Acori Graminei 8-15 part, Semen Ziziphi Spinosae 15-25 part, Cortex et Radix Polygalae (processed) 8-15 part, Flos Carthami 8-15 part, Caulis Polygoni Multiflori 10-20 part, Radix Rehmanniae Preparata 10-20 part, Rhizoma Atractylodis Macrocephalae (parched) 8-15 part, Radix Paeoniae Rubra 8-15 part, Radix Paeoniae Alba 8-15 part, Flos Albiziae 10-20 part, Semen Persicae 8-15 part.
In order to obtain good technique effect further, a kind of pharmaceutical preparation of Cure for insomnia, also comprises Radix Aconiti Lateralis Preparata 15-25 part, Os Draconis 5-10 part.
In order to obtain good technique effect further, a kind of pharmaceutical preparation of Cure for insomnia, above each composition according to weight ratio is: Radix Angelicae Sinensis 15 parts, PORIA from Yunnan of China 15 parts, Rhizoma Acori Graminei 10 parts, Semen Ziziphi Spinosae 20 parts, Cortex et Radix Polygalae (processed) 10 parts, 10 parts, Flos Carthami, Caulis Polygoni Multiflori 15 parts, 15 parts, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 10 parts, Radix Paeoniae Rubra 10 parts, the Radix Paeoniae Alba 10 parts, Flos Albiziae 15 parts, 10 parts, Semen Persicae, Radix Aconiti Lateralis Preparata 20 parts, Os Draconis 8 parts.
In order to obtain good technique effect further, a kind of pharmaceutical preparation of Cure for insomnia, above each composition according to weight ratio is: Radix Angelicae Sinensis 18 parts, PORIA from Yunnan of China 12 parts, Rhizoma Acori Graminei 12 parts, Semen Ziziphi Spinosae 22 parts, Cortex et Radix Polygalae (processed) 12 parts, 12 parts, Flos Carthami, Caulis Polygoni Multiflori 18 parts, 18 parts, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 12 parts, Radix Paeoniae Rubra 12 parts, the Radix Paeoniae Alba 12 parts, Flos Albiziae 12 parts, 9 parts, Semen Persicae.
A pharmaceutical preparation for Cure for insomnia, the application of described pharmaceutical preparation in medicament for treating insomnia.
A pharmaceutical preparation for Cure for insomnia, described pharmaceutical preparation is prepared into granule, powder, capsule, pill, tablet and clinically acceptable dosage form.
The moulding process that medicine of the present invention prepares different dosage form only used is different with adjuvant, and effective ingredient is the same, and therapeutic effect is also identical or approximate.And the first-selected external preparation of preparation, the adjuvant of granule can be in multitudinous Icing Sugar, Carboxymethyl cellulose sodium, dextrin and correctives etc. to be selected; Powder can be selected from starch, kaolin, calcium phosphate, precipitated calcium carbonate etc.; The adjuvant of capsule can be selected from silicon dioxide, sucrose, HPC, microcrystalline Cellulose, pregelatinized Starch, lactose, Icing Sugar, carboxymethylstach sodium, carmethose, hypromellose etc.; The adjuvant of pill can be selected from starch, microcrystalline Cellulose, pregelatinized Starch etc.; The adjuvant of tablet can be selected from starch, dextrin, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, lactose, Icing Sugar, carboxymethylstach sodium etc.
The pharmacological action of Chinese medicine used in the present invention:
Radix Angelicae Sinensis, sweet in the mouth and weighing, therefore specially can enrich blood, its gas is light and pungent, therefore again can promoting the circulation of blood, and invigorating middle warmer has, and having benefit in row, is the key medicine in blood.Thus, it can be enriched blood, and can invigorate blood circulation again, both can stimulate the menstrual flow, again can be active.Having maincenter sedation containing multiple inorganic elements Radix Angelicae Sinensis volatile oils such as volatile oil organic acid saccharide vitamin aminoaciduria pyrimidine adenine choline and calcium zinc phosphorus selenium, is first excited rear suppression to medulla oblongata.
PORIA from Yunnan of China, can spleen invigorating, again can eliminating dampness by diuresis, and for having loose bowels caused by insufficiency of the spleen dysfunction of the spleen in transportation and transformation, leukorrhagia, application Poria has the effect of giving consideration to both the incidental and fundamental, controls the adjuvant of the deficiency of vital energy, can tranquilizing by nourishing the heart, therefore can be used for the diseases such as irritability, cardiopalmus, insomnia.
Rhizoma Acori Graminei, removing dampness is whetted the appetite, eliminating phlegm of having one's ideas straightened out, and refreshment Fructus Alpiniae Oxyphyllae, regulates the flow of vital energy, and invigorates blood circulation, and loose wind, dries.Control syncope due to accumulation of phlegm, calentura coma, forgetful, deafness with qi stagnation, ambition is unhappy, stomachache, stomachache, anemofrigid-damp arthralgia.Containing volatile oil, be wherein mainly: α-asaricin, beta-Asarone, trans-4 propenyl veratrole etc., and containing saccharide, organic acid, aminoacid etc., have calmness and anticonvulsant action, Rhizoma Acori Graminei water decoction, water decoction-alcohol sedimentation liquid, beta-Asarone all can reduce spontaneous activity in mice, strengthens the central excitation effect of the syngignoscism volatile oil energy antagonism ephedrine of pentobarbital, and can reduce body temperature, water decoction principle active component is α-asaricin, the convulsions caused by energy antagonism pentetrazole.
Semen Ziziphi Spinosae, mends brain-strengthening, food can reinforcing the heart blood, nourishing the brain and improving intelligence, hearing-improing and eyesight improving, strong muscles and bones.Easily antiperspirant, the thin weak person of body eat to be suitable for neurasthenia, body void.Containing triterpenes flavonoid alkaloid organic acid etc., Semen Ziziphi Spinosae has the effect of tranquilizing by nourishing the heart hypnosis arresting sweating, is the common medicine of Cure for insomnia, has obvious synergism with multiple sedative hypnotic.
Cortex et Radix Polygalae (processed), toil is warm in nature, property is kind lead off sensible, can happily gas and mind tranquilizing and the heart calming, kidney qi can be led to and strong will is not forgotten, for restoring normal coordination between the heart and kidney, stabilize mind, Fructus Alpiniae Oxyphyllae knows by force.For the insomnia and dreamful sleep that disarmony between the heart and kidney causes, forgetful palpitation with fear, staring spells.Containing senega-saponin A, B, C, D, E, F, G, polygalytol, N-acetylaminohydroxyphenylarsonic acid D-Glucose and tenuidine, fatty oil, resin etc., have hypnosis and stronger anticonvulsant action, payta has synergism to barbiturate.
Flos Carthami, nature and flavor are gentle, promoting blood circulation to restore menstrual flow, scattered silt pain relieving.
Caulis Polygoni Multiflori, property is put down nontoxic, sweet and slightly bitter taste, enters the heart, Liver Channel, has effect of tranquilizing and blood nourishing, dispelling wind and removing obstruction in the collateral, nourishing blood to tranquillize the mind effect, for the insomnia caused by deficiency of YIN insufficiency of blood.
Radix Rehmanniae Preparata, sweet, tepor, returns liver, kidney channel, enriches blood, YIN nourishing, and spermatogenesis mends marrow, and health-care, agent first of enriching blood, for blood deficiency and yellow complexion, dizzy cardiopalmus, insomnia etc.
Rhizoma Atractylodis Macrocephalae (parched), invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis.
Radix Paeoniae Rubra, bitter, be slightly cold, return Liver Channel, clearing away heat and cooling blood, eliminating stasis to stop pain.The Radix Paeoniae Alba, returns liver, spleen channel, nourishes blood and seeks, relieving spasm to stop pain, yin fluid astringing suppressing the hyperactive liver, and nourish blood yin fluid astringing, suppressing liver-YANG.Radix Paeoniae Rubra is the root of wild herbaceous peony, and the Radix Paeoniae Alba is that the root of plantation Radix Paeoniae removes the xylem of root bark after decocting in water; Radix Paeoniae Rubra pain relieving cures mainly congestion pain, and Radix Paeoniae Alba pain relieving cures mainly hypochondriac pain due to stagnation of liverQI, stomachache, blood deficiency passages through which vital energy circulates, loses the anxious pain of foster contraction, and Radix Paeoniae Rubra is good at blood circulation promoting and blood stasis dispelling, again can purging liver-fire, and inducing diuresis for treating stranguria syndrome, treatment congestion is demonstrate,proved, overabundant liver-fire syndrome, stranguria with blood etc.
The Radix Paeoniae Alba is longer than and nourishes blood, can rub again liver, astringing YIN to stop sweating, treatment syndrome of deficiency of blood, syndrome of upper hyperactivity of liver yang, night sweat due to yin deficiency etc. Radix Paeoniae Rubra is containing glycoside parts such as paeoniflorin, Lactiflorin., oxypaeoniflorin, the Radix Paeoniae Alba has tonifying blood and regulating menstruation, yin nourishing suppressing the hyperactive liver, relieving spasm to stop pain, astringing YIN to stop sweating, containing paeoniflorin, Albiflorin, oxypaeoniflorin, paeoniflorin etc., also containing trace element, volatilization wet goods.Paeoniflorin has calmness, analgesia, convulsion and cooling effect, obviously can extend the length of one's sleep that hexobarbitone sodium causes, peonol extract can extend the length of one's sleep that pentobarbital sodium causes, paeoniflorin and Radix Paeoniae extractum can distinguish antagonism pentetrazole and the caused convulsions of strychnine, and can reduce normal body temperature and heating.
Flos Albiziae, nature and flavor are sweet, flat, Shu Yu, regulate the flow of vital energy, calm the nerves, active, nourish blood, melancholy that YIN nourishing kidney, the improving eyesight that clears away heart-fire are applicable to climacteric syndrome be angry, fidgets due to deficiency uneasiness, insomnia forgetfulness etc.
Semen Persicae, sweet flat, the bitter in the mouth of property, enters lung, liver, large intestine channel, blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.
Radix Aconiti Lateralis Preparata, pungent, sweet, hot greatly, GUIXIN, kidney, spleen channel, for excess of YIN gram sun, loss of YANG due to profuse perspiration, vomiting and diarrhoea, it is inverse to faint, cold extremities faint pulse, trusted subordinate's cold type of pain, and deficiency and coldness is vomited and diarrhoea, YIN-cold edema, yang deficiency diseases caused by exogenous pathogenic factor.
Os Draconis, sweet, puckery, flat, astringing QI is by wet, and only night sweat, calms the nerves, unsmoothing the sperm and stopping bleeding, and for dreaminess insomnia, cardiopalmus is moved cautious, coma, and infantile convulsion is twitched.
Radix Paeoniae Rubra and the Radix Paeoniae Alba in we, both are use mainly with mutual reinforcement between, and to strengthen effect of tranquilizing soporific, this prescription is based on tranquilizing by nourishing the heart, QI and blood regulating.To the symptom of Cure for insomnia, alleviating clinical symptoms, to get effect fast, treating both the principal and secondary aspects of a disease, and recurrence rate after healing is low, and easy to use, have no side effect, easy to utilize.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1: a kind of pharmaceutical preparation of Cure for insomnia, each composition according to weight ratio is:
Radix Angelicae Sinensis 15 grams, PORIA from Yunnan of China 15 grams, Rhizoma Acori Graminei 10 grams, Semen Ziziphi Spinosae 20 grams, Cortex et Radix Polygalae (processed) 10 grams, 10 grams, Flos Carthami, Caulis Polygoni Multiflori 15 grams, 15 grams, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 10 grams, Radix Paeoniae Rubra 10 grams, the Radix Paeoniae Alba 10 grams, Flos Albiziae 15 grams, 10 grams, Semen Persicae, Radix Aconiti Lateralis Preparata 20 grams, Os Draconis 8 grams.
Above pharmaceutical preparation is prepared into decoction agent, and preparation method is as follows:
Get above Chinese medicine conventionally to carry out decocting twice, the time is respectively 1 hour and 40 minutes, is divided into two parts after decocting by after twice decoction mix homogeneously, sooner or later respectively takes portion.
Embodiment 2: a kind of pharmaceutical preparation of Cure for insomnia, each composition according to weight ratio is:
Radix Angelicae Sinensis 18 grams, PORIA from Yunnan of China 12 grams, Rhizoma Acori Graminei 12 grams, Semen Ziziphi Spinosae 22 grams, Cortex et Radix Polygalae (processed) 12 grams, 12 grams, Flos Carthami, Caulis Polygoni Multiflori 18 grams, 18 grams, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 12 grams, Radix Paeoniae Rubra 12 grams, the Radix Paeoniae Alba 12 grams, Flos Albiziae 12 grams, 9 grams, Semen Persicae.
Above pharmaceutical preparation is prepared into pill, and preparation method is as follows:
(1) decoct with water twice by above-mentioned weight ratio weighting raw materials, add 8 times of water gagings at every turn, first time decocts 1 hour, and second time decocts 40 minutes, and merging filtrate, after filtration, is dried to fine powder, crosses 100 mesh sieves; (2) by celphere (the 30-40 object granule made by mixing with sugar and starch), coating granulator is placed in; (3) with polyvinylpyrrolidone (PVP) ethanol for wet adhesive, 100 object granule-PVP solid dispersion are added with certain speed, make it adhere to celphere surface equably; (4) dry, screening 20-40 mesh sieve piller, to obtain final product.
Embodiment 3: a kind of pharmaceutical preparation of Cure for insomnia, each composition according to weight ratio is:
Radix Angelicae Sinensis 12 grams, PORIA from Yunnan of China 10 grams, Rhizoma Acori Graminei 8 grams, Semen Ziziphi Spinosae 15 grams, Cortex et Radix Polygalae (processed) 15 grams, 15 grams, Flos Carthami, Caulis Polygoni Multiflori 20 grams, 20 grams, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 15 grams, Radix Paeoniae Rubra 15 grams, the Radix Paeoniae Alba 8 grams, Flos Albiziae 18 grams, 12 grams, Semen Persicae, Radix Aconiti Lateralis Preparata 15 grams, Os Draconis 5 grams.
Above pharmaceutical preparation is prepared into tablet, and preparation method is as follows:
The Chinese medicine getting above amount decocts, decoct rear medicinal liquid to concentrate, be concentrated into finite concentration (proportion is about 1:1), 1.1 times of ethanol put are added after cold, abundant mixing, placement is spent the night, make it precipitate, get its supernatant (filtering if desired) next day, a small amount of 52% ethanol of precipitate is cleaned, washing liquid and filtrate merge, after decompression recycling ethanol, to be concentrated to adding certain water gaging during finite concentration. mixing leaves standstill certain hour, make precipitation complete, rate mistake, filtrate low-temperature evaporation is to paste, suitable dextrin is added in powdered extract powder, pregelatinized Starch, magnesium stearate, adjuvant, after mixing, add be pressed into progressively whole to satisfactory granularity, carry out tabletting, obtain tablet.
Embodiment 4: a kind of pharmaceutical preparation of Cure for insomnia, each composition according to weight ratio is:
Radix Angelicae Sinensis 20 grams, PORIA from Yunnan of China 20 grams, Rhizoma Acori Graminei 15 grams, Semen Ziziphi Spinosae 25 grams, Cortex et Radix Polygalae (processed) 15 grams, 8 grams, Flos Carthami, Caulis Polygoni Multiflori 10 grams, 10 grams, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 15 grams, Radix Paeoniae Rubra 15 grams, the Radix Paeoniae Alba 10 grams, Flos Albiziae 10 grams, 8 grams, Semen Persicae, Radix Aconiti Lateralis Preparata 15 grams, Os Draconis 10 grams.
Above pharmaceutical preparation is prepared into powder, and preparation method is as follows:
The Chinese medicine more than measured conventionally decocts, decoct rear medicinal liquid to carry out being concentrated into the concentration that proportion is 1:1.2, 1.5 times of ethanol put are added after cold, abundant mixing, placement is spent the night, make it precipitate, get its supernatant next day, a small amount of 50% ethanol of precipitate is cleaned, washing liquid and filtrate merge, after decompression recycling ethanol, to be concentratedly put cold place to finite concentration time shift and leave standstill certain hour, make precipitation complete, rate mistake, filtrate low-temperature evaporation is to paste, suitable starch and calcium phosphate adjuvant is added in powdered extract powder, after mixing, cross 200 mesh sieves, obtain powder.
Embodiment 5: zoopery
5.1, animal modeling
Get healthy clean level mice 70, be numbered, random selecting 6 is blank group, and all the other carry out animal modeling: it is for subsequent use that fenclonine (PCPA) is configured to 30mg/mL suspension with alkalescence normal saline (pH7-8).In lumbar injection PCPA suspension in morning every day (1mL/100g), inject 2d continuously, after the 1st lumbar injection 28 ~ 30h, animal occurs that circadian rhythm disappears, daytime, frequent activity, had obviously different from blank group, showed insomnia mice modeling success.The alkalescence normal saline of blank group lumbar injection same volume.
5.2, grouping and administration
The mice of insomnia model is divided into 5 groups at random, and often organize 10, be respectively model group, Western medicine group, Chinese medicine high dose group, middle dosage group and low dose group, the Therapeutic Method often organized is:
Blank group and model group are filled with isopyknic normal saline;
Chinese medicine high dose group, every day to mouse stomach, according to 100mg.kg -1dosage gavage every day once; ;
Dosage group in Chinese medicine, every day to mouse stomach, according to 70mg.kg -1dosage gavage every day once;
Chinese medicine low dose group, every day to mouse stomach, according to 30mg.kg -1dosage gavage every day once;
Western medicine group, stable, dosage is 0.2mg/kg, every day gavage once.
5.3, index observing
5.3.1 resisting fatigue experiment
After continuous treatment 7d, cut-off footpath is about 0.6cm, be about thin rod into 100cm, vertical fixing, be placed in the round basin central authorities that is marked with water, rat is put in the place being about 30cm apart from excellent top, make it head-up catch thin rod, with stopwatch record its due to tired and persistent period before sliding on rod.Every rat experiment 3 times, is as the criterion with 3 meansigma methodss.
5.3.2, the length of one's sleep
Observational technique: whether there will be movable minimizing after observing animals administer, quiet, drowsiness or sleep, sleep with righting reflex (Rightreflex) disappearance for index, be placed on gently down on black sheet iron by animal back, iron sheet keeps 30, and vibrate gently, if the downward posture of animal back keeps more than 30 seconds, then think time of righting reflex loss, record righting reflex loss.Observe the time of the white mice righting reflex loss of tested each medicine group, last administration is after 1 hour, observed and recorded dropping asleep latency (sleeping duration) and sleep time (righting reflex loss is to the time of recovering).
5.4, experimental result
5.4.1 anti-fatigue test
Can be found out by table 1: compared with blank group, the model group mice pole-climbing time obviously shortens.After treatment, all there is prolongation in various degree the mice pole-climbing time of each medicine group, and the effect of its Chinese medicine and western medicine group and Chinese medicine high dose group is the most obvious, and in Chinese medicine low dose group and Chinese medicine, dosage group is also all improved.
The each medicine group of table 1 is on the impact of mice pole-climbing time
Group Before treatment-pole-climbing time (s) After treatment-pole-climbing time (s)
Blank group 26±2 25±2
Model group 12±1 * 13±1 *
Western medicine group 13±2 # 20±2 ##
Chinese medicine low dose group 12±1 ## 15±1 #
Dosage group in Chinese medicine 13±1 # 17±2 #
Chinese medicine high dose group 12±2 # 20±3 ##
Note:
Compare with blank group, *p<0.05, *represent p<0.01
Compare with model group, #p<0.05, ##p<0.01
5.4.2 each group of impact on mouse sleep time
Can be found out by table 2: with blank group ratio, the dropping asleep latency of model group mice extends, and sleep time shortens, and after Drug therapy, sleep quality obviously improves, especially Western medicine group and Chinese medicine high dose group curative effect best.
Each group of table 2 is on mice time for falling asleep and the impact of the length of one's sleep
Group Hypnagogic latency time (dividing) Sleep time (dividing)
Blank group 3.7±1.2 19.7±2.1
Model group 11.5±1.3 * 10.7±1.2 *
Western medicine group 5.3±2.1 # 17.6±2.0 #
Chinese medicine low dose group 6.3±1.6 ## 15.2±1.7 ##
Dosage group in Chinese medicine 7.8±1.3 # 17.8±2.5 #
Chinese medicine high dose group 4.1±2.0 # 19.4±2.2 #
Note:
Compare with normal group, *p<0.05, *represent p<0.01
Compare with model group, #p<0.05, ##p<0.01
Embodiment 6: clinical experiment
6.1 physical data
Accept patient 178 example because having a sleepless night medical during in JIUYUE, 2013 to 2015 year October for medical treatment, wherein male 69 example, women 108 example, age 28-69 year, 47 years old mean age.Have a sleepless night according to following standard diagnostics: the subjective diagnosis of insomnia: 1. sleep physiology dysfunction (comprise have difficulty in going to sleep, insomnia-middle, Yi Xing, dreaminess, early awakening, wake up after not easily sleep again); 2. the symptom such as daytime dizzy, weak, drowsiness, lassitude is caused by sleep disorder disturbs; 3. only there is sleep to reduce and be not considered as insomnia without daytime discomfort (Short sleeper).The objective diagnosis standard of insomnia judges according to polysomnogram result: 1. Sleep latency extends: time for falling asleep is more than 30min; 2. sleep maintains obstacle: the awakening time increases (every night more than 30min); 3. total sleep time shortens: be usually less than 6h.
6.2, therapeutic scheme
Patient in this clinical trial is divided into 2 groups, is respectively Chinese drug-treated group and stable group, is a course for the treatment of with 14 days.
Chinese drug-treated group: be the pharmaceutical preparation of prescription of the present invention, take before sleeping;
Western medicine group: be oral sleeping pill Chinese mugwort department logical sequence, each 2mg, once-a-day, by specification is taken.
6.3, criterion of therapeutical effect
According to the standard of " the clinical trial guideline of new Chinese medicine Cure for insomnia ".
Clinical recovery: recover normal the length of one's sleep or Nighttime sleep more than 6 hours, sleep deep, spirit after waking up
Plentifully.
Effective: sleep is clearly better, and increases by more than 3 hours the length of one's sleep, Depth of sleep increases.
Effective: symptom alleviates, the length of one's sleep, comparatively front increase was less than 3 hours.
Invalid: after treatment, insomnia is not improved or instead adds severe one.
6.4, therapeutic outcome
The results are shown in Table 3, through statistical analysis, two groups compare, and the obvious effective rate of Chinese drug-treated group, a little more than Western medicine group (table 3), has significant difference (P<0.05).
The therapeutic outcome of table 3 liang group medicine
Group Cure Effective Effectively Invalid Obvious effective rate
Western medicine group (89 example) 27 50 9 3 96.6％
Chinese drug-treated group (89 example) 31 46 11 1 98.9％
6.5 model case
Case 1: Lee, female, 48 years old, to our hospital in January, 2014, main suit: have difficulty in going to sleep, easily wake up after sleeping, length of one's sleep every day, daytime was weak less than 5 hours, did things out of spirits.After soliciting sufferers themselves's agreement, entered group, have a blood test routine, hepatic and renal function is normal, defecation is conventional, blood glucose, normal ECG, give pharmaceutical preparation of the present invention, after 2 courses for the treatment of of medication, symptom alleviates, the length of one's sleep, clinical appraisal, for curing, was visited after January without recurrence more than 6 hours.
Case 2: Chen, man, 35 years old, to our hospital in December, 2013, main suit: operating pressure is large, the length of one's sleep is few, often could fall asleep by eating sleeping pill, wanting to nurse one's health with Chinese medicine, after soliciting sufferers themselves's agreement, entered group, have a blood test routine, hepatic and renal function is normal, defecation is conventional, blood glucose, normal ECG, gives pharmaceutical preparation of the present invention, and enjoin patient take a good rest, note after work loosening, after treating 1 course for the treatment of, symptom alleviates, 2 courses for the treatment of of continual cure, do not recur in 2 months after drug withdrawal, clinical appraisal is for curing.

Claims (6)

1. a pharmaceutical preparation for Cure for insomnia, is characterized in that: comprise following Chinese crude drug according to weight fraction ratio: Radix Angelicae Sinensis 10-20 part, PORIA from Yunnan of China 10-20 part, Rhizoma Acori Graminei 8-15 part, Semen Ziziphi Spinosae 15-25 part, Cortex et Radix Polygalae (processed) 8-15 part, Flos Carthami 8-15 part, Caulis Polygoni Multiflori 10-20 part, Radix Rehmanniae Preparata 10-20 part, Rhizoma Atractylodis Macrocephalae (parched) 8-15 part, Radix Paeoniae Rubra 8-15 part, Radix Paeoniae Alba 8-15 part, Flos Albiziae 10-20 part, Semen Persicae 8-15 part.
2. the pharmaceutical preparation of a kind of Cure for insomnia according to claim 1, is characterized in that: described Chinese crude drug also comprises Radix Aconiti Lateralis Preparata 15-25 part, Os Draconis 5-10 part.
3. a kind of pharmaceutical preparation of Cure for insomnia according to claim 1 or 2, is characterized in that: described Chinese crude drug according to weight ratio is: Radix Angelicae Sinensis 15 parts, PORIA from Yunnan of China 15 parts, Rhizoma Acori Graminei 10 parts, Semen Ziziphi Spinosae 20 parts, Cortex et Radix Polygalae (processed) 10 parts, 10 parts, Flos Carthami, Caulis Polygoni Multiflori 15 parts, 15 parts, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 10 parts, Radix Paeoniae Rubra 10 parts, the Radix Paeoniae Alba 10 parts, Flos Albiziae 15 parts, 10 parts, Semen Persicae, Radix Aconiti Lateralis Preparata 20 parts, Os Draconis 8 parts.
4. a kind of pharmaceutical preparation of Cure for insomnia according to claim 1 or 2, is characterized in that: described Chinese crude drug according to weight ratio is: Radix Angelicae Sinensis 18 parts, PORIA from Yunnan of China 12 parts, Rhizoma Acori Graminei 12 parts, Semen Ziziphi Spinosae 22 parts, Cortex et Radix Polygalae (processed) 12 parts, 12 parts, Flos Carthami, Caulis Polygoni Multiflori 18 parts, 18 parts, Radix Rehmanniae Preparata, Rhizoma Atractylodis Macrocephalae (parched) 12 parts, Radix Paeoniae Rubra 12 parts, the Radix Paeoniae Alba 12 parts, Flos Albiziae 12 parts, 9 parts, Semen Persicae.
5. a kind of pharmaceutical preparation of Cure for insomnia according to claim 1 or 2, is characterized in that: the application in medicament for treating insomnia is being prepared in described pharmaceutical preparation.
6. a kind of pharmaceutical preparation of Cure for insomnia according to claim 1,2, is characterized in that: described pharmaceutical preparation is prepared into granule, powder, capsule, pill, tablet and clinically acceptable dosage form.
CN201610038097.4A 2016-01-20 2016-01-20 Medicine preparation for treating insomnia Withdrawn CN105456587A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101417033A (en) * 2008-11-25 2009-04-29 山西省长治精神病院 Traditional Chinese medicine for treating insomnia
CN102342992B (en) * 2011-10-14 2013-04-17 孙丰卿 Chinese medicinal composition for treating insomnia and preparation method of preparation thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101417033A (en) * 2008-11-25 2009-04-29 山西省长治精神病院 Traditional Chinese medicine for treating insomnia
CN102342992B (en) * 2011-10-14 2013-04-17 孙丰卿 Chinese medicinal composition for treating insomnia and preparation method of preparation thereof

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