CN100544764C

CN100544764C - Neurasthenic Chinese medicine composition of a kind of treatment and preparation method thereof

Info

Publication number: CN100544764C
Application number: CNB200610104276XA
Authority: CN
Inventors: 王秉岐
Original assignee: XIAMEN ZHENQI INVESTMENT AND MANAGEMENT CO Ltd
Current assignee: Golong Medicine Anhui Co ltd
Priority date: 2006-08-09
Filing date: 2006-08-09
Publication date: 2009-09-30
Anticipated expiration: 2026-08-09
Also published as: WO2008019588A1; CN101121016A

Abstract

The invention discloses a kind of pharmaceutical composition for the treatment of depression, insomnia and neurasthenia and preparation method thereof.Said composition is mainly made by Radix Bupleuri, Rhizoma Pinelliae Preparatum, Os Draconis, Concha Ostreae, Caulis Bambusae In Taenia, Rhizoma Coptidis, Rhizoma Zingiberis Recens, Radix Glycyrrhizae Preparata etc.This compositions directly or indirectly adds pharmaceutically acceptable excipient through common process and makes clinical acceptable forms, as tablet, oral liquid, granule, injection etc., this compositions has restoring normal coordination between the heart and kidney, reduce phlegm calm the nerves, dispersing the stagnated live-QI to relieve the stagnation of QI, the effect of sedate with fixed attention.

Description

Neurasthenic Chinese medicine composition of a kind of treatment and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition and preparation method thereof and method of quality control, particularly a kind of Cure for insomnia, melancholy, neurasthenic Chinese medicine composition and preparation method thereof and quality determining method.

Background technology

Insomnia, melancholy, neurasthenia are meant owing to some long-standing Nervous and Mental Factors causes the cerebration hypertonicity, thereby have produced weakening of ergasia ability.Its main clinical characters is to be easy to excitement to be easy to fatigue again.Often, have certain susceptible quality or bad individual character before many patient's diseases with various body senses of discomfort and sleep disorder.Busy life, nervous work, owing to fighting with one's back to the river of entering a higher school, promote or realize that self-value carries out, various offending worries all can make people's cerebral nerve function be at a high speed or the ultrahigh speed running status, in the course of time, cause the nervous function disorder, thereby a series of clinical symptoms appears, as insomnia and dreamful sleep, have a dizzy spell, disease such as forgetful, irritated, fatigue and weakness, insomnia also can cause other serious illness for a long time.Though the treatment medicine to insomnia in the modern medicine is no lack of tens of kinds, it takes the back dependency, addiction more, and also has a lot of other aftereffect behind the medicine, can't fundamentally treat.

Summary of the invention

The object of the invention is to provide a kind of Chinese medicine composition and formulation preparation method thereof, and another purpose of the present invention is to provide the quality determining method and the purposes of this Chinese medicinal composition preparation.

The present invention seeks to be achieved through the following technical solutions:

The crude drug of Chinese medicine composition of the present invention is composed as follows:

Concha Ostreae 4-35 weight portion Os Draconis 4-35 weight portion Radix Bupleuri 2-20 weight portion

Rhizoma Pinelliae Preparatum 5-30 weight portion Caulis Bambusae In Taenia 5-30 weight portion Radix Glycyrrhizae Preparata 1-12 weight portion

Rhizoma Coptidis 0.5-3 weight portion Rhizoma Zingiberis Recens 2-20 weight portion Ramulus Cinnamomi 2-20 weight portion

Radix Paeoniae Alba 2-20 weight portion.

The preferred weight proportioning of the present invention's ten flavor crude drug is as follows:

Concha Ostreae 8 weight portion Os Draconis 30 weight portion Radix Bupleuri 6 weight portions

Rhizoma Pinelliae Preparatum 25 weight portion Caulis Bambusae In Taenia 28 weight portion Radix Glycyrrhizae Preparatas 3 weight portions

Rhizoma Coptidis 1 weight portion Rhizoma Zingiberis Recens 14 weight portion Ramulus Cinnamomi 5 weight portions

The Radix Paeoniae Alba 17 weight portions.

Concha Ostreae 20 weight portion Os Draconis 20 weight portion Radix Bupleuri 10 weight portions

Rhizoma Pinelliae Preparatum 15 weight portion Caulis Bambusae In Taenia 15 weight portion Radix Glycyrrhizae Preparatas 6 weight portions

Rhizoma Coptidis 2 weight portion Rhizoma Zingiberis Recenss 10 weight portion Ramulus Cinnamomi 10 weight portions

The Radix Paeoniae Alba 10 weight portions.

Concha Ostreae 28 weight portion Os Draconis 7 weight portion Radix Bupleuri 16 weight portions

Rhizoma Pinelliae Preparatum 7 weight portion Caulis Bambusae In Taenia 10 weight portion Radix Glycyrrhizae Preparatas 10 weight portions

Rhizoma Coptidis 1.5 weight portion Rhizoma Zingiberis Recenss 5 weight portion Ramulus Cinnamomi 18 weight portions

The Radix Paeoniae Alba 3 weight portions.

The invention described above Chinese medicine composition can also add Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Semen Ziziphi Spinosae (parched), Fructus Jujubae, the Radix Et Rhizoma Rhei (parched) of following weight portion again and be made up of ten five tastes crude drug on the basis of ten flavor crude drug:

Fructus Schisandrae Chinensis 1-14 weight portion Radix Salviae Miltiorrhizae 5-30 weight portion Semen Ziziphi Spinosae (parched) 2-20 weight portion

Fructus Jujubae 1-12 weight portion Radix Et Rhizoma Rhei (parched) 1-10 weight portion.

The preferred weight proportioning is respectively: Fructus Schisandrae Chinensis 3 weight portion Radix Salviae Miltiorrhizaes 9 weight portion Semen Ziziphi Spinosae (parched)s 15 weight portion Fructus Jujubaes 10 weight portion Radix Et Rhizoma Rhei (parched) 3 weight portions; Fructus Schisandrae Chinensis 7 weight portion Radix Salviae Miltiorrhizaes 15 weight portion Semen Ziziphi Spinosae (parched)s 10 weight portion Fructus Jujubaes 6 weight portion Radix Et Rhizoma Rhei (parched) 4.5 weight portions; Or Fructus Schisandrae Chinensis 12 weight portion Radix Salviae Miltiorrhizaes 25 weight portion Semen Ziziphi Spinosae (parched)s 3 weight portion Fructus Jujubaes 4 weight portion Radix Et Rhizoma Rhei (parched) 8 weight portions.

Traditional Chinese medicinal composition raw materials of the present invention adds conventional adjuvant, according to common process, makes clinical acceptable forms, as: capsule, pill, tablet, granule, oral liquid or injection.

Preparation of pharmaceutical compositions method of the present invention is optional following a kind of:

A. get crude drug, decoct with water 2-4 time, add the water of 8-12 crude drug gross weight doubly for the first time, decocted 1-3 hour, and added the water of 8-12 crude drug gross weight doubly for the second time, decocted 0.5-1.5 hour, add the water of 8-12 crude drug gross weight doubly for the third time, decocted 0.5-1 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction, filter, it is 1.2 that filtrate is concentrated into 80 ℃ of-90 ℃ of relative densities, adds ethanol and makes that to contain alcohol amount be 60%, stirs, left standstill 10-16 hour, getting supernatant recovery ethanol and being concentrated into 60 ℃ of-70 ℃ of relative densities is the thick paste of 1.30-1.35, adds conventional adjuvant, makes capsule, pill, tablet, granule, oral liquid or injection according to a conventional method.

B. get crude drug, mixing, be ground into 10～20 order coarse granules, the water that adds 5～7 times crude drug gross weight, with the continuous extraction below 60 ℃ of microwave extracting method 2-4 time, extract carries out centrifugalize, and it is 1.30～1.35 that clean immersion is concentrated into relative density, add conventional adjuvant, make capsule, pill, tablet, granule, oral liquid or injection according to a conventional method.

Preparation of pharmaceutical compositions method of the present invention is preferably as follows a kind of:

A. get crude drug, decoct with water three times, add the water of 10 times crude drug gross weight for the first time, decocted 2 hours, add the water of 8 times crude drug gross weight for the second time, decocted 1 hour, add the water of 8 times crude drug gross weight for the third time, decocted 0.5 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction, filter, it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, adds ethanol and makes that to contain alcohol amount be 60%, stirs, left standstill 12 hours, getting that supernatant reclaims ethanol and be concentrated into 60 ℃ of relative densities is 1.30～1.35 thick paste, adds conventional adjuvant, makes capsule, pill, tablet, granule, oral liquid or injection according to a conventional method.

B. get crude drug, mixing, be ground into 15 order coarse granules, the water that adds 6 times crude drug gross weight, with the continuous extraction below 60 ℃ of microwave extracting method 2 times, extract carries out centrifugalize, and it is 1.35 that clean immersion is concentrated into relative density, add conventional adjuvant, make capsule, pill, tablet, granule, oral liquid or injection according to a conventional method.

The relation of weight portion of the present invention and parts by volume is: grams per milliliter.

Quality determining method of the present invention comprises following discrimination method and/or content assaying method

Discrimination method comprises one or more in the following discriminating:

A; get the 1/3-1/2 of this pharmaceutical composition day taking dose is equivalent to crude drug amount 21～42g, porphyrize; add ethanol 30ml, and room temperature was flooded 1 hour, jolting constantly; filter; filtrate evaporate to dryness, residue add water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting; each 20ml; merge n-butanol extracting liquid, uses the saturated water washing of n-butyl alcohol 1 time, discards water layer; n-butyl alcohol liquid is put evaporate to dryness in the water-bath; residue adds ethanol 1ml makes dissolving, adds aluminium oxide 0.6g and stir evenly drying in water-bath; the 200-300 order of packing into and filling in advance; 1g, on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution; collect eluent; evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

B, get the 1/3-1/2 of this pharmaceutical composition day taking dose, be equivalent to crude drug amount 21～42g, porphyrize adds ethanol 20ml, and room temperature dipping 1 hour filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 50mg, adds methanol 10ml, puts in the water-bath reflux 10 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with 7: 1: 2 n-butyl alcohol-glacial acetic acid-water, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; With the corresponding position of reference substance chromatograph on, show an identical yellow fluorescence speckle;

C, get the 1/3-1/2 of this pharmaceutical composition day taking dose, be equivalent to crude drug amount 21～42g, porphyrize adds ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

Content assaying method in the method for quality control is as follows:

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get 1/6～1/9 of this pharmaceutical composition day taking dose, be equivalent to crude drug amount 5.3～16.1g, porphyrize, mixing is put in the triangular flask, the accurate 50% ethanol 50ml that adds, claim to decide weight, supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% ethanol, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, that is, per unit dosage contains peoniflorin (C23H28O11) must not be less than 8.0mg.

The adult of this pharmaceutical composition solid preparation taking dose on the one is equivalent to crude drug amount 64～96g, and unit dose refers to every of the every ball of every of capsule, pill that conventional method makes, every in tablet, every bag of granule, every of oral liquid or injection etc.

Pharmaceutical composition of the present invention has dispersing the stagnated live-QI to relieve the stagnation of QI, clearing away phlegm eliminating stagnation, the effect of sedate with fixed attention, vexed gloomy, the fullness and distention in the chest and hypochondrium that is applicable to that stagnation of QI due to depression of the liver causes, insomnia anxiety, poor appetite; And neurasthenias such as the turbid little sleep disturbed by dreams of disturbing the heart, disarmony between the heart and kidney of expectorant, upset and mania, fatigue and asthenia, clinical observation group's 308 examples of establishing altogether of three phases, matched group 112 examples.Clinical observation shows: pharmaceutical composition of the present invention is that main neurasthenia has tangible curative effect to insomnia and dreamful sleep, compares with matched group, and total effects obviously is better than YENING CHONGJI (P＜0.01).Control from the typing card, pharmaceutical composition of the present invention is to the turbid heart type of disturbing of expectorant, type of failure of the heart and kidney integrating and type of deficiency of both the heart and spleen all have higher curative effect, and the turbid curative effect of disturbing heart type of expectorant obviously is better than YENING CHONGJI (P＜0.05), illustrate that pharmaceutical composition of the present invention and YENING CHONGJI are all satisfied to this amphitypy curative effect, but from efficient percentage recently, pharmaceutical composition of the present invention is more excellent, and dosage is little, is convenient to take.The type of deficiency of heart-QI and gallbladder-QI case very little, inconvenience is compared.Further observational study after awaiting.From the curative effect of doing well,improving, pharmaceutical composition of the present invention obviously is better than YENING CHONGJI (P＜0.01) to the curative effect of insomnia, dreaminess, and fidgety, dizzy, feeling of fullness in the head, forgetful improvement are better than YENING CHONGJI.

Following experiment and embodiment are used to further specify but are not limited to the present invention.

Experimental example 1 Cure for insomnia, melancholy and neurasthenic clinical research experiment

Observation group: 308 examples, wherein male 138 examples, women 170 examples, age 21-65 year, 44.8 years old mean age, the course of disease 1 month surplus 30 year, average 5.20 years.Traditional Chinese medical science typing is type of deficiency of both the heart and spleen 70 examples, type of failure of the heart and kidney integrating 108 examples, type of deficiency of heart-QI and gallbladder-QI 13 examples, turbid heart type 117 examples of disturbing of expectorant.

Matched group: 112 examples, wherein male 51 examples, women 61 examples, age 29-65 year, 46.87 years old mean age, the course of disease 1 month to 26 years, average 4.12, traditional Chinese medical science typing was type of deficiency of both the heart and spleen 36 examples, type of failure of the heart and kidney integrating 46 examples, type of deficiency of heart-QI and gallbladder-QI 4 examples, turbid heart type 26 examples of disturbing of expectorant.

Case is selected: the selection of falling ill is the neurasthenia of main symptom with the insomnia and dreamful sleep, and gets rid of organic diseases such as the serious heart, liver, kidney, brain.Differential diagnosis in tcm belongs to the turbid heart type of disturbing of (1) expectorant: insomnia and dreamful sleep, and have that a body is heavy, uncomfortable in chest, dizzy, light red tongue, greasy fur, rolling pulse.(2) type of failure of the heart and kidney integrating: dysphoria and insomnia, dreaminess, dizziness, tinnitus, cardiopalmus, forgetful, few Tianjin of xerostomia, soreness of the loins and nocturnal emission or aphtha of the mouth and tongue, red tip of the tongue, thready and rapid pulse.(3) type of deficiency of heart-QI and gallbladder-QI: insomnia and timid, the shortness of breath and lassitude of cardiopalmus, light red tongue, thready and rapid pulse.(4) type of deficiency of both the heart and spleen: insomnia and dreamful sleep and cardiopalmus are divided forgetful, have a dizzy spell, Mental fatigue, lustreless complexion, white and thin fur, thready and weak pulse.

Observation group: pharmaceutical composition of the present invention, each one bag (6 grams are by the embodiment of the invention 1 preparation), every day 2～3 times.

Matched group: YENING CHONGJI, each 20 grams, day clothes 2 times are respectively obeyed 1 time sooner or later.

The course of treatment and points for attention: two groups of patients are all with 7 days one courses of treatment, and every case need take just to be counted the people course of treatment and add up case, take and prohibit the clothes class medicine of sleeping peacefully between this medicine, in order to avoid influence the accuracy of observed result.Observation index: all cases are main symptom with the insomnia and dreamful sleep all,, and carry out classification and observe jointly as observation index in conjunction with picture of the tongue, pulse condition.Neurasthenic other symptom is a time card.Such as dizziness, feeling of fullness in the head, fidgety irritability, forgetful cardiopalmus, spiritlessness and weakness etc., the variation of inferior card is represented with (--) (+) (++).(-) is normal, and (+) is normal, and (++) is severe.

Insomnia classification: (1) 0 grade: asymptomatic.(2) I level: difficulty falling asleep, need half an hour sleeping approximately, or the length of one's sleep is short, the aftersensation health of waking up is lighter, or sleep but not soundly, the time back of sleeping, wake up when waking up easily sleeping.(3) II level: difficulty falling asleep, toss about, need can to fall asleep more than half an hour, early awakening, the aftersensation of waking up be drowsy, fatigue and weak or sleep shallowly, in time, sleep when waking up, and the back of waking up is difficult sleeping.(4) III level: lying awake all night or dormancy and dreaminess, is to sleep non-ly to sleep or do not have enough sleep 3-4 hour, though there is sleep weak, symptoms such as dizziness do not have obvious improvement.

Daydream classification: (1) 0 grade: no dream or few dream.(2) I level: it is more to have a dream.(3) II level: daydream is many, and is still drowsy after waking up.(4) III level: dreamland is diverse and confused, and the back of waking up is drowsy.

Therapeutic outcome

Curative effect determinate standard:

1, cure: it is 0 grade that insomnia is had a dream.

2, produce effects: insomnia is had a dream and is improved more than the secondary, or has a sleepless night to have a dream and improve one-level, and inferior card has disappearances more than half.

3, effective: insomnia is had a dream and is improved more than the one-level, the inferior card not enough half that disappears.

4, invalid: insomnia is had a dream of not having and is improved.

Two, result:

1, total effects sees Table 1

Two groups of total effects comparison sheets 1: example (%)

The result shows: observation group's curative effect with compared utmost point significant difference, curative effect obviously is better than matched group.

2, the curative effect of clinical main pattern of syndrome relatively: see Table 2

The curative effect comparison sheet 2 of clinical main pattern of syndrome

The result shows that pharmaceutical composition of the present invention obviously disturbs heart type neurasthenia curative effect and obviously be better than YENING CHONGJI the turbid heart type neurasthenia curative effect of disturbing of expectorant.And to the curative effect of type of failure of the heart and kidney integrating, type of deficiency of both the heart and spleen, type of deficiency of heart-QI and gallbladder-QI neurasthenia, though efficient be higher than YENING CHONGJI, learn by statistics and handle no significant difference.

3, the doing well,improving degree relatively: see Table 3

Two groups of doing well,improving degree comparison sheets 3

*P＜0.01

The result shows that to the curative effect of insomnia and dreaminess disease, observation group and matched group relatively have utmost point significant difference, and the therapeutic effect of pharmaceutical composition of the present invention to insomnia and dreaminess disease is described, obviously is better than YENING CHONGJI.

4, this group is observed the variation of picture of the tongue and pulse condition, and before and after taking medicine, observation group and matched group all do not have obvious change.

5, the observation of side effect: take back observation group and matched group and any toxicity all do not occur.

Following embodiment all can realize the effect of above-mentioned experimental example.

Specifically execute real mode

Embodiment 1: the preparation of granule

Ramulus Cinnamomi 10kg Radix Paeoniae Alba 10kg Concha Ostreae 20kg

Os Draconis 20kg Radix Bupleuri 10kg Rhizoma Pinelliae Preparatum 15kg

Fructus Schisandrae Chinensis 7kg Caulis Bambusae In Taenia 15kg Radix Salviae Miltiorrhizae 15kg

Semen Ziziphi Spinosae (parched) 10kg Radix Glycyrrhizae Preparata 6kg Fructus Jujubae 6kg

Rhizoma Coptidis 2kg Rhizoma Zingiberis Recens 10kg Radix Et Rhizoma Rhei (parched) 4.5kg

More than 15 flavor crude drug, decoct with water three times, for the first time add 1605 premium on currency, decocted 2 hours, add 1284 premium on currency the second time, decocted 1 hour, adds 1284 premium on currency for the third time, decocted 0.5 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction filters, and it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, add ethanol and make that to contain alcohol amount be 60%, stir, left standstill 12 hours, get supernatant and reclaim ethanol and be concentrated into 60 ℃ of relative densities the thick paste that is 1.30-1.35, vacuum drying is ground into fine powder.Get 1 part of fine powder, 1 part of lactose, 1 part in dextrin adds ethanol, makes granule, and drying sprays into above-mentioned volatile oil, and mixing is made granule.

Embodiment 2: the preparation of granule

Ramulus Cinnamomi 5kg Radix Paeoniae Alba 17kg Concha Ostreae 8kg

Os Draconis 30kg Radix Bupleuri 6kg Rhizoma Pinelliae 25kg

Fructus Schisandrae Chinensis 3kg Caulis Bambusae In Taenia 28kg Radix Salviae Miltiorrhizae 9kg

Semen Ziziphi Spinosae (parched) 15kg Radix Glycyrrhizae Preparata 3kg Fructus Jujubae 10kg

Rhizoma Coptidis 1kg Rhizoma Zingiberis Recens 14kg Radix Et Rhizoma Rhei (parched) 3kg

More than 15 flavor crude drug, decoct with water three times, for the first time add 1770 premium on currency, decocted 2 hours, add 1416 premium on currency the second time, decocted 1 hour, adds 1416 premium on currency for the third time, decocted 0.5 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction filters, and it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, add ethanol and make that to contain alcohol amount be 60%, stir, left standstill 12 hours, get supernatant and reclaim ethanol and be concentrated into 60 ℃ of relative densities the thick paste that is 1.30-1.35, vacuum drying is ground into fine powder.Get 1 part of fine powder, 1 part of lactose, 1 part in dextrin adds ethanol, makes granule, and drying sprays into above-mentioned volatile oil, and mixing is made granule.

Embodiment 3: the preparation of capsule

Concha Ostreae 20kg Os Draconis 20kg Radix Bupleuri 10kg

Rhizoma Pinelliae Preparatum 15kg Caulis Bambusae In Taenia 15kg Radix Glycyrrhizae Preparata 6kg

Rhizoma Coptidis 2kg Rhizoma Zingiberis Recens 10kg Ramulus Cinnamomi 10kg

Radix Paeoniae Alba 10kg

More than ten flavor crude drug, decoct with water three times, for the first time add 1416 premium on currency, decocted 2 hours, add 1416 premium on currency the second time, decocted 1 hour, adds 1133 premium on currency for the third time, decocted 1 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction filters, it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, add ethanol and make that to contain alcohol amount be 60%, stir, left standstill 12 hours, get supernatant and reclaim ethanol and be concentrated into 60 ℃ of relative densities the thick paste that is 1.30-1.35, vacuum drying is ground into fine powder, adds conventional adjuvant, according to common process, make capsule.

Embodiment 4: the preparation of pill

Concha Ostreae 28kg Os Draconis 7kg Radix Bupleuri 16kg

Rhizoma Pinelliae Preparatum 7kg Caulis Bambusae In Taenia 10kg Radix Glycyrrhizae Preparata 10kg

Rhizoma Coptidis 1.5kg Rhizoma Zingiberis Recens 5kg Ramulus Cinnamomi 10kg

Radix Paeoniae Alba 10kg

Get crude drug, mixing is ground into 15 order coarse granules, add water 6 parts by volume, with the continuous extraction below 60 ℃ of microwave extracting method 3 times, extract carries out centrifugalize, it is 1.30～1.35 that clean immersion is concentrated into relative density, adds conventional adjuvant, makes pill according to a conventional method.

Embodiment 5: the preparation of tablet

Ramulus Cinnamomi 10kg Radix Paeoniae Alba 10kg Concha Ostreae 20kg

Os Draconis 20kg Radix Bupleuri 10kg Rhizoma Pinelliae Preparatum 15kg

Get crude drug, mixing is ground into 17 order coarse granules, add water 7 parts by volume, with the continuous extraction below 60 ℃ of microwave extracting method 4 times, extract carries out centrifugalize, it is 1.30～1.35 that clean immersion is concentrated into relative density, adds conventional adjuvant, makes tablet according to a conventional method.

Embodiment 6: the preparation of oral liquid

Concha Ostreae 28kg Os Draconis 7kg Radix Bupleuri 16kg

Rhizoma Coptidis 1.5kg Rhizoma Zingiberis Recens 5kg Ramulus Cinnamomi 18kg

Radix Paeoniae Alba 3kg

Get crude drug, mixing is ground into 20 order coarse granules, add water 7 parts by volume, with the continuous extraction below 60 ℃ of microwave extracting method 2 times, extract carries out centrifugalize, it is 1.30～1.35 that clean immersion is concentrated into relative density, adds conventional adjuvant, makes oral liquid according to a conventional method.

Embodiment 7: the preparation of granule

Concha Ostreae 8kg Os Draconis 30kg Radix Bupleuri 6kg

Rhizoma Pinelliae Preparatum 25kg Caulis Bambusae In Taenia 28kg Radix Glycyrrhizae Preparata 3kg

Rhizoma Coptidis 1kg Rhizoma Zingiberis Recens 14kg Ramulus Cinnamomi 5kg

Radix Paeoniae Alba 17kg

More than ten flavor crude drug, decoct with water 3 times, for the first time add 1644 premium on currency, decocted 1.5 hours, add 1370 premium on currency the second time, decocted 1 hour, adds 1096 premium on currency for the third time, decocted 1 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction filters, and it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, add ethanol and make that to contain alcohol amount be 60%, stir, left standstill 12 hours, get supernatant and reclaim ethanol and be concentrated into 60 ℃ of relative densities the thick paste that is 1.30-1.35, vacuum drying is ground into fine powder.Get 1 part of fine powder, 1 part of lactose, 1 part in dextrin adds ethanol, makes granule, and drying sprays into above-mentioned volatile oil, and mixing is made granule.

Embodiment 8: the discrimination method in the quality testing

A, get the medicament composition granule agent 6g of embodiment 1, be equivalent to crude drug amount 32g porphyrize, add ethanol 30ml, room temperature dipping 1 hour, jolting constantly filters, the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, with the saturated water washing of n-butyl alcohol 1 time, discard water layer, n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue adds ethanol 1ml makes dissolving, add aluminium oxide 0.6g, in water-bath, stir evenly, drying, the 200-300 order of packing into and filling in advance, 1g is on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution, collect eluent, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

B, get the medicament composition granule agent 6g of embodiment 1, be equivalent to crude drug amount 32g porphyrize, add ethanol 20ml, room temperature dipping 1 hour filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 50mg, adds methanol 10ml, puts in the water-bath reflux 10 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with 7: 1: 2 n-butyl alcohol-glacial acetic acid-water, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; With the corresponding position of reference substance chromatograph on, show an identical yellow fluorescence speckle;

C, get the medicament composition granule agent 6g of embodiment 1, be equivalent to crude drug amount 32g porphyrize, add ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

Embodiment 9: the content assaying method in the quality testing

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get the content under the medicament composition granule agent content uniformity item of embodiment 3, porphyrize, mixing, get about 2g, it is fixed to be equivalent to the accurate title of crude drug amount 10.7g, puts in the triangular flask, the accurate 50% ethanol 50ml that adds claims to decide weight, supersound process 30 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with 50% ethanol, shake up, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.

Embodiment 10: quality determining method

A, get the medicament composition granule agent 6g of embodiment 1, be equivalent to crude drug amount 32g and add ethanol 30ml, room temperature dipping 1 hour, jolting constantly filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, use the saturated water washing of n-butyl alcohol 1 time, discard water layer, n-butyl alcohol liquid is put evaporate to dryness in the water-bath, and residue adds ethanol 1ml makes dissolving, adds aluminium oxide 0.6g, in water-bath, stir evenly, drying, the 200-300 order of packing into and filling in advance, 1g, on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution, collect eluent, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

C, get the medicament composition granule agent 6g of embodiment 1, be equivalent to crude drug amount 32g porphyrize, add ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness;

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get the medicament composition granule agent 2g of embodiment 1, be equivalent to crude drug amount 10.7g porphyrize, mixing, get about 2g, the accurate title, decide, and puts in the triangular flask, the accurate 50% ethanol 50ml that adds claims to decide weight, supersound process 30 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with 50% ethanol, shake up, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.

Embodiment 11: quality determining method

A, get the medicament composition capsule agent 4g of embodiment 3, be equivalent to crude drug amount 32g and add ethanol 30ml, room temperature dipping 1 hour, jolting constantly filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, use the saturated water washing of n-butyl alcohol 1 time, discard water layer, n-butyl alcohol liquid is put evaporate to dryness in the water-bath, and residue adds ethanol 1ml makes dissolving, adds aluminium oxide 0.6g, in water-bath, stir evenly, drying, the 200-300 order of packing into and filling in advance, 1g, on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution, collect eluent, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

B, get the medicament composition capsule agent 4g of embodiment 3, be equivalent to crude drug amount 32g porphyrize, add ethanol 20ml, room temperature dipping 1 hour filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 50mg, adds methanol 10ml, puts in the water-bath reflux 10 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with 7: 1: 2 n-butyl alcohol-glacial acetic acid-water, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; With the corresponding position of reference substance chromatograph on, show an identical yellow fluorescence speckle;

C, get the medicament composition capsule agent 4g of embodiment 3, be equivalent to crude drug amount 32g porphyrize, add ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness;

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get the medicament composition capsule agent 1.34g of embodiment 3, be equivalent to crude drug amount 10.7g porphyrize, mixing, the accurate title, decide, and puts in the triangular flask, the accurate 50% ethanol 50ml that adds, claim to decide weight, supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% ethanol, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.

Embodiment 12: quality determining method

A, get the pharmaceutical composition tablet 8g of embodiment 5, be equivalent to crude drug amount 32g and add ethanol 30ml, room temperature dipping 1 hour, jolting constantly filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, use the saturated water washing of n-butyl alcohol 1 time, discard water layer, n-butyl alcohol liquid is put evaporate to dryness in the water-bath, and residue adds ethanol 1ml makes dissolving, adds aluminium oxide 0.6g, in water-bath, stir evenly, drying, the 200-300 order of packing into and filling in advance, 1g, on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution, collect eluent, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

B, get the pharmaceutical composition tablet 8g of embodiment 5, be equivalent to crude drug amount 32g porphyrize, add ethanol 20ml, room temperature dipping 1 hour filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 50mg, adds methanol 10ml, puts in the water-bath reflux 10 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with 7: 1: 2 n-butyl alcohol-glacial acetic acid-water, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; With the corresponding position of reference substance chromatograph on, show an identical yellow fluorescence speckle;

C, get the pharmaceutical composition tablet 8g of embodiment 5, be equivalent to crude drug amount 32g porphyrize, add ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness;

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get the pharmaceutical composition tablet 2.7g of embodiment 5, be equivalent to crude drug amount 10.7g porphyrize, mixing, the accurate title, decide, and puts in the triangular flask, the accurate 50% ethanol 50ml that adds, claim to decide weight, supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% ethanol, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.

Claims

1, a kind of Chinese medicine composition for the treatment of depression, insomnia is characterized in that the crude drug of this Chinese medicine composition consists of:

Radix Paeoniae Alba 2-20 weight portion.

2, Chinese medicine composition as claimed in claim 1 is characterized in that this traditional Chinese medicinal composition raw materials weight proportion is as follows:

The Radix Paeoniae Alba 17 weight portions.

3, Chinese medicine composition as claimed in claim 1 is characterized in that this traditional Chinese medicinal composition raw materials weight proportion is as follows:

The Radix Paeoniae Alba 10 weight portions.

4, Chinese medicine composition as claimed in claim 1 is characterized in that this traditional Chinese medicinal composition raw materials weight proportion is as follows:

The Radix Paeoniae Alba 3 weight portions.

5,, it is characterized in that this pharmaceutical composition also adds following bulk drugs as claim 1,2,3 or 4 described Chinese medicine compositions:

Fructus Schisandrae Chinensis 1-14 weight portion Radix Salviae Miltiorrhizae 5-30 weight portion

Semen Ziziphi Spinosae (parched) 2-20 weight portion Fructus Jujubae 1-12 weight portion

Radix Et Rhizoma Rhei (parched) 1-10 weight portion.

6, Chinese medicine composition as claimed in claim 5 is characterized in that the crude drug that this pharmaceutical composition adds is:

Fructus Schisandrae Chinensis 3 weight portion Radix Salviae Miltiorrhizaes 9 weight portions

Semen Ziziphi Spinosae (parched) 15 weight portion Fructus Jujubaes 10 weight portions

Radix Et Rhizoma Rhei (parched) 3 weight portions.

7, Chinese medicine composition as claimed in claim 5 is characterized in that the crude drug that this pharmaceutical composition adds is:

Fructus Schisandrae Chinensis 7 weight portion Radix Salviae Miltiorrhizaes 15 weight portions

Semen Ziziphi Spinosae (parched) 10 weight portion Fructus Jujubaes 6 weight portions

Radix Et Rhizoma Rhei (parched) 4.5 weight portions.

8, Chinese medicine composition as claimed in claim 5 is characterized in that the crude drug that this pharmaceutical composition adds is:

Fructus Schisandrae Chinensis 12 weight portion Radix Salviae Miltiorrhizaes 25 weight portions

Semen Ziziphi Spinosae (parched) 3 weight portion Fructus Jujubaes 4 weight portions

Radix Et Rhizoma Rhei (parched) 8 weight portions.

9,, it is characterized in that this method is optional following a kind of as the preparation method of claim 1,2,3,4,6,7 or 8 described Chinese medicine compositions:

A. get crude drug, decoct with water 2-4 time, add crude drug gross weight 8-12 water doubly for the first time, decocted 1-3 hour, and added the water of 8-12 crude drug gross weight doubly for the second time, decocted 0.5-1.5 hour, add the water of 8-12 crude drug gross weight doubly for the third time, decocted 0.5-1 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction, filter, it is 1.2 that filtrate is concentrated into 80 ℃ of-90 ℃ of relative densities, adds ethanol and makes that to contain alcohol amount be 60%, stirs, left standstill 10-16 hour, getting supernatant recovery ethanol and being concentrated into 60 ℃ of-70 ℃ of relative densities is the thick paste of 1.30-1.35, adds conventional adjuvant, makes capsule, pill, tablet, granule, oral liquid or injection according to a conventional method;

10, the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that this method is optional following a kind of:

A. get crude drug, decoct with water 2-4 time, add the water of 8-12 crude drug gross weight doubly for the first time, decocted 1-3 hour, and added the water of 8-12 crude drug gross weight doubly for the second time, decocted 0.5-1.5 hour, add the water of 8-12 crude drug gross weight doubly for the third time, decocted 0.5-1 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction, filter, it is 1.2 that filtrate is concentrated into 80 ℃ of-90 ℃ of relative densities, adds ethanol and makes that to contain alcohol amount be 60%, stirs, left standstill 10-16 hour, getting supernatant recovery ethanol and being concentrated into 60 ℃ of-70 ℃ of relative densities is the thick paste of 1.30-1.35, adds conventional adjuvant, makes capsule, pill, tablet, granule, oral liquid or injection according to a conventional method;

11, the preparation method of Chinese medicine composition as claimed in claim 9 is characterized in that the preparation method of capsule is optional following a kind of:

A. get crude drug, decoct with water three times, add the water of 10 times crude drug gross weight for the first time, decocted 2 hours, add the water of 8 times crude drug gross weight for the second time, decocted 1 hour, add the water of 8 times crude drug gross weight for the third time, decocted 0.5 hour; Collect volatile oil in the decoction process simultaneously, collecting decoction, filter, it is 1.2 that filtrate is concentrated into 80 ℃ of relative densities, adds ethanol and makes that to contain alcohol amount be 60%, stirs, left standstill 12 hours, getting that supernatant reclaims ethanol and be concentrated into 60 ℃ of relative densities is 1.30 thick paste, adds conventional adjuvant, makes capsule according to a conventional method;

B. get crude drug, mixing is ground into 15 order coarse granules, the water that adds 6 times crude drug gross weight, with the continuous extraction below 60 ℃ of microwave extracting method 2 times, extract carries out centrifugalize, it is 1.35 that clean immersion is concentrated into relative density, adds conventional adjuvant, makes capsule according to a conventional method.

12, the preparation method of Chinese medicine composition as claimed in claim 10 is characterized in that the preparation method of capsule is optional following a kind of:

13,, it is characterized in that this method comprises a kind of and/or several in the following discriminating as the detection method of claim 6,7 or 8 described Chinese medicine compositions:

A. get the 1/3-1/2 of this pharmaceutical composition day taking dose, be equivalent to crude drug amount 21～42g, porphyrize, add ethanol 30ml, room temperature dipping 1 hour, jolting constantly, filter, filtrate evaporate to dryness, residue add water 20ml makes dissolving, extracts 3 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butanol extracting liquid, use the saturated water washing of n-butyl alcohol 1 time, discard water layer, n-butyl alcohol liquid is put evaporate to dryness in the water-bath, residue adds ethanol 1ml makes dissolving, adds aluminium oxide 0.6g and stir evenly drying in water-bath, the 200-300 order of packing into and filling in advance, 1g is on the internal diameter 10-15mm neutral alumina pillar, with the 60ml ethanol elution, collect eluent, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

B. the get it filled 1/3-1/2 of compositions day taking dose is equivalent to crude drug amount 21～42g, and porphyrize adds ethanol 20ml, and room temperature dipping 1 hour filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 50mg, adds methanol 10ml, puts in the water-bath reflux 10 minutes, filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with 7: 1: 2 n-butyl alcohol-glacial acetic acid-water, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; With the corresponding position of reference substance chromatograph on, show an identical yellow fluorescence speckle;

C. get the 1/3-1/2 of this pharmaceutical composition day taking dose,, be equivalent to crude drug amount 21～42g, porphyrize, add ethanol 30ml, reflux 30 minutes is put coldly, filters, get 10ml, evaporate to dryness, residue add water 10ml makes dissolving, add hydrochloric acid 1ml again, put in the water-bath and heated 30 minutes, immediately cooling, extract 2 times with the ether jolting, each 10ml merges ether extracted liquid, fling to ether, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Et Rhizoma Rhei control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get chrysophanol, emodin reference substance again, add methanol and make the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, upper solution with 15: 5: 1 30-60 ℃ petroleum ether-Ethyl formate-formic acid is developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show 5 identical orange-yellow fluorescence speckles, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

14,, it is characterized in that this method comprises following assay as the detection method of claim 6,7 or 8 described Chinese medicine compositions:

According to high effective liquid chromatography for measuring; Chromatographic condition and system suitability test; With octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05mol/L potassium dihydrogen phosphate was a mobile phase in 14: 86; The detection wavelength is 230nm; Number of theoretical plate calculates by the peoniflorin peak should be not less than 1500; The preparation of reference substance solution: it is an amount of that precision takes by weighing the peoniflorin reference substance, adds 50% ethanol and make every 1ml and contain 0.1mg solution, promptly; The preparation of need testing solution: get 1/6～1/9 of this pharmaceutical composition day taking dose, be equivalent to crude drug amount 5.4～16.1g, porphyrize, mixing is put in the triangular flask, the accurate 50% ethanol 50ml that adds, claim to decide weight, supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% ethanol, filter, get subsequent filtrate, filter with 0.45 μ m microporous filter membrane, promptly; Algoscopy: accurate respectively reference substance solution and each 10ul of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; Per unit dosage contains peoniflorin (C23H28O11) must not be less than 8.0mg.

15, as claim 1,2,3,4,6, the application of 7 or 8 described Chinese medicine compositions in preparation treatment depression, insomnia's medicine.

16, the application of Chinese medicine composition as claimed in claim 5 in preparation treatment depression, insomnia's medicine.

17, application as claimed in claim 15 is characterized in that wherein treating depression and is meant that this compositions has restoring normal coordination between the heart and kidney, reduce phlegm calm the nerves, dispersing the stagnated live-QI to relieve the stagnation of QI or the effect of sedate with fixed attention.