CN109908309A - A kind of Chinese medicine composition that treating Schizophrenia, preparation method and application - Google Patents
A kind of Chinese medicine composition that treating Schizophrenia, preparation method and application Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine compositions for treating Schizophrenia, preparation method and application, belong to technical field of traditional Chinese medicines, the Chinese medicine composition is made of trigone, curcuma zedoary, Rhizoma Chuanxiong, radix achyranthis bidentatae, safflower, Radix Angelicae Sinensis, radix paeoniae rubra, radix bupleuri, rhizoma cyperi, the dried immature fruit of citron orange, dried orange peel, radix rehmanniae recen, the tuber of pinellia, perilla seed, campanulaceae, ten Six-element Chinese medicine of Radix Glycyrrhizae；The special function of the traditional chinese medicine composition of the invention " qi and blood " and " liver-brain ", are based on schizophrenia pathogenesis syndrome characteristics, based on eliminating evil, take into account righting；Based on blood-activating and qi-promoting, resolving sputum is taken into account, is adjusted based on smooth qi and blood, tune mind is taken into account, can effectively treat Schizophrenia.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of Chinese medicine composition for treating Schizophrenia, system
Preparation Method and application.
Background technique
Schizophrenia is a kind of severe psychiatric diseases of current threat human health, more than between twenty and fifty period onset, disease
Because not yet clear, obstacle and the cerebration for showing as many aspects such as perception, thinking, emotion, behavior are uncoordinated.The course of disease is moved more
Prolong, be generally not present the disturbance of consciousness and dysnusia, has the tendency that the possibility of chronicity and decline.The schizoid cause of disease is still
End illustrates completely, and current confirmable some influence factors do not have specific causality to disease.Relatively generally acknowledged sight at present
Point is that susceptible quality and external undesirable element lead to the generation of disease by inherent biological factor collective effect.It is undesirable
The social psychologies factor such as life event, economic situation, premorbid personality, may be played in schizophrenic onset induction and
Facilitation.Schizophrenia substantially belongs to Chinese medicine mental diseases " insane, mad disease " scope, it is believed that congenital constitution, emotional stimulation are
An important factor for insane, mad disease morbidity, feelings will is unsuccessful, functional activity of QI being not smooth, imbalance of yin and yang, leads to disorder of qi and blood, and qi depression to blood stasis destroys
Coordination between mind and the brain mind of the five internal organs, is the Etiological interpretation of the cause, onset and process of an illness of manic-depressive psychosis.
With the quickening of modern life rhythm, the stress that people face is increasing, schizoid disease incidence
It is continuously increased, and is not influenced by sex, race, area, culture.According to statistics, schizoid in worldwide population coverage
Lifetime prevalence is close to 1%.The data announced are shown within Chinese Center for Disease Control and Prevention 2009, and all kinds of phrenoblabias in China are suffered from
Person has as many as 100,000,000 people, and wherein patient with severe symptoms is more than 16,000,000, wherein being greatly schizophreniac.Schizophrenia
Disease has seriously affected the physical and mental health of the people, not only gives sufferers themselves, but also cause pole to patient home and place community
Big burden has seriously affected the stability and development of society.If do not obtained timely treatment, disease symptoms bring very big pain to patient
Hardship, the daily study of patient, work, viability are impaired, and student leaves school because learning ability declines, suspends schooling, adult because of the energy that works
Power is impaired and loses the job, and does not know to care for household, cannot undertake the responsibility of family.Some develops to mental deterioration shape
State causes mental disorder.Sometimes it is influenced by mental symptoms such as illusion, vain hope, paralogia, emotional handicaps, patient may go out
Now injure the behavior of oneself and other people.Mental health proposes the concept of " tertiary prevention ", and primary prevention refers to from the cause of disease
It taking measures in terms of pathogenesis, prevents the generation of disease, secondary prevention refers to early detection, early diagnosis and early treatment, three
Grade prevention refers to prevention recurrence and prevents deformity.Wherein early detection, early intervention, early treatment are very heavy for schizophrenia
It wants, with sufficient dosage, the antipsychotics extensive use clinically of pedicure journey, schizophrenia has obtained effective control
System and improvement, but Drug side reaction caused by prolonged application antipsychotics, seriously restrict the compliance of patient's treatment, from
And influence clinical therapeutic efficacy.
Chinese medicine composition has the unique advantages such as multicomponent, multiple target point and Small side effects, in recent years, in being total to for Chinese medicine scholar
Under making great efforts, traditional Chinese medicine makes great progress to schizoid Therapy study and significant progress.It was verified that first
Hair schizophrenia is the optimal vigor point of this disease of chinese medicine intervention, with the starting sufferer of TCM Therapy diagnosis and treatment schizophrenia
Person (goes to a doctor for the first time after the onset of i.e., does not take the drugs of mental department such as antipsychotic drug, antidepressants, mood stabilizers, total course of disease is not
More than 60 months), it is whether examining because on dialectical, or on Selection drug, all there is rigorous process of analyzing mentally.Therefore, it visits
A kind of effective schizoid Chinese medicine composition for the treatment of is sought, traditional Chinese medicine can be greatly expanded and treat starting schizophrenia
The TCM theory of disease is conducive to the subjective symptom impression for improving first episode schizophrenia group, improves its clinical treatment
It is efficient.
Summary of the invention
The present invention in order to solve still to lack at present it is a kind of safely and effectively, clinical treatment, can be significant using more generally accepted
Improve the schizoid drug of starting qi stagnation and blood stasis type for inducing, aggravating due to emotional factors, and provides and a kind of treat head
Send out Chinese medicine composition, preparation method and application schizoid.
The present invention is achieved by the following technical solution.
A kind of Chinese medicine composition for treating Schizophrenia, the raw material including following parts by weight: 30~50 parts of Radix Angelicae Sinensis,
50~70 parts of trigone, 50~70 parts of curcuma zedoary, 20~40 parts of the dried immature fruit of citron orange, 25~35 parts of Rhizoma Chuanxiong, 20~40 parts of radix bupleuri, radix paeoniae rubra 15~30
Part, 20~40 parts of radix rehmanniae recen, 20~40 parts of campanulaceae, 15~30 parts of Radix Glycyrrhizae, 15~30 parts of rhizoma cyperi, 10~25 parts of the tuber of pinellia, perilla seed
15~35 parts, 15~25 parts of radix achyranthis bidentatae, 15~25 parts of safflower, 15~25 parts of dried orange peel.
Preferably, the Chinese medicine composition of the treatment Schizophrenia, the raw material including following parts by weight: Radix Angelicae Sinensis 40
Part, 60 parts of trigone, 60 parts of curcuma zedoary, 30 parts of the dried immature fruit of citron orange, 30 parts of Rhizoma Chuanxiong, 30 parts of radix bupleuri, 20 parts of radix paeoniae rubra, 30 parts of radix rehmanniae recen, 30 parts of campanulaceae,
20 parts of Radix Glycyrrhizae, 20 parts of rhizoma cyperi, 20 parts of the tuber of pinellia, 30 parts of perilla seed, 20 parts of radix achyranthis bidentatae, 20 parts of safflower, 20 parts of dried orange peel.
The preparation method of the Chinese medicine composition of the treatment Schizophrenia, comprising the following steps:
The raw material of following parts by weight: 30~50 parts of Radix Angelicae Sinensis, 50~70 parts of trigone, 50~70 parts of curcuma zedoary, the dried immature fruit of citron orange is weighed respectively
20~40 parts, 25~35 parts of Rhizoma Chuanxiong, 20~40 parts of radix bupleuri, 15~30 parts of radix paeoniae rubra, 20~40 parts of radix rehmanniae recen, 20~40 parts of campanulaceae,
15~30 parts of Radix Glycyrrhizae, 15~30 parts of rhizoma cyperi, 10~25 parts of the tuber of pinellia, 15~35 parts of perilla seed, 15~25 parts of radix achyranthis bidentatae, safflower 15~25
Part and 15~25 parts of dried orange peel；
By above-mentioned each raw material cleaning, drying, it is ground into fine powder, is sieved, is mixed, capsule is packed into, the starting spirit for the treatment of is made
The Chinese medicinal composition capsules of Split disease.
Application of the Chinese medicine composition in terms of starting qi stagnation and blood stasis type schizophrenia drug is treated in preparation.
The pharmacological function of each raw material in the Chinese medicine composition of the treatment Schizophrenia:
Radix Angelicae Sinensis: property is sweet, pungent, warm；Return liver, the heart, the spleen channel；With replenishing and activating blood, the effect of menstruction regulating and pain relieving, moisturizing dryness and lubricating intestine；
Trigone: property is pungent, bitter, puts down；Return liver, the spleen channel, there is the effect of breaking blood and promoting the circulation of qi, clearing stagnation and killing pain；
The dried immature fruit of citron orange: property is bitter, pungent, sour, temperature；Returns spleen, stomach meridian have the effect of relieving stagnant Qi disperse accumulation, eliminating phlegm and dispersing mass；
Rhizoma Chuanxiong: property is acrid in flavour and warm in nature；Return liver, gallbladder, pericardium channel, there is the effect of blood-activating and qi-promoting, wind-expelling pain-stopping；
Radix bupleuri: it is bitter in taste, slightly cold, return liver, gallbladder channel, have and inducing diaphoresis in, the effect of soothing the liver rising Yang；
Radix paeoniae rubra: bitter, cold nature, return liver warp have the effect of clearing heat and cooling blood, removing blood stasis and acesodyne；
Glutinous rehmannia: property is sweet, trembles with fear, and return heart, liver and kidney channel have clearing heat and cooling blood, yin-nourishing, the effect of promoting the production of body fluid；
Campanulaceae: property is bitter, pungent, puts down, distributed in lung channel, has the effect of promoting the dispersing function of the lung, relieving sore-throat, eliminating the phlegm, apocenosis；
Radix Glycyrrhizae: property sweet and neutral, return heart, lung, spleen, stomach meridian have and invigorate the spleen and benefit qi, clearing heat and detoxicating, expelling phlegm and arresting coughing, relieving spasm to stop pain,
The effect of coordinating the drug actions of a prescription；
Rhizoma cyperi: property is pungent, slight bitter, micro- sweet and neutral, returns liver, spleen, tri-jiao channel, has soothing liver-qi stagnation, regulating the flow of QI to ease the stomach, menstruction regulating and pain relieving
The effect of；
The tuber of pinellia: property is acrid in flavour and warm in nature, toxic, returns spleen, stomach, lung channel, has the effect of eliminating dampness and eliminating phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass；
Perilla seed: property is acrid in flavour and warm in nature, distributed in lung channel, has sending down abnormally ascending dissolving phlegm, the effect of relievining asthma；
Radix achyranthis bidentatae: property is bitter, sweet, sour, puts down, returns liver and kidney channel, has dispelling stasis of blood and stimulating the menstrual flow, nourishing liver and kidney, strengthening the bones and muscles, inducing diuresis for treating strangurtia draws blood
The effect of downlink；
Safflower: property is acrid in flavour and warm in nature, converge to heart and liver channels, has the effect of blood circulation, removing blood stasis and acesodyne；
Dried orange peel: property hardship, acrid in flavour and warm in nature, return lung, the spleen channel have regulating qi-flowing for strengthening spleen, eliminating dampness and eliminating phlegm effect；
Curcuma zedoary: property is pungent, bitter, and temperature returns liver, the spleen channel.With breaking blood and promoting the circulation of qi, clearing stagnation and killing pain.Not only enter blood system, but also enter gas point；Both
Energy dissipating blood stasis with potent drugs, and energy promoting qi circulation and relieving pain, can use the above-mentioned disease for controlling the caused lumps in the chest and abdomen of qi depression to blood stasis, menostasis and trusted subordinate's stasis caused pain.
It often mutually must be used with trigone, to enhance the function of broken stasis of blood eliminating mass analgesic.
The schizoid cure mechanism of traditional Chinese medicine composition for treating of the present invention:
Traditional Chinese medicine viewpoint thinks that qi depression to blood stasis leads to schizoid generation, and ancient Chinese medicine doctor is in treatment schizophrenia
Card Shi Duocong " convulsive seizure due to phlegm-fire " argument is started with.But it is actually rare to face schizophreniac caused by simple convulsive seizure due to phlegm-fire in card, often and miscellaneous
The card of the stagnation of the circulation of vital energy, blood stasis, with qi depression to blood stasis diagnosis and treatment, since feelings will is unsuccessful, stagnation of liver qi, qi depression to blood stasis is stopped in hemostasis convulsive seizure due to phlegm-fire
In chest, block train of thought, to belong to the obstruction of the circulation of vital energy, blood stasis, phlegm strongly fragrant more, and three strongly fragrant have.
Based on the pathogenic factor of above-mentioned schizophrenia disease, radix bupleuri, Rhizoma Chuanxiong, rhizoma cyperi, radix bupleuri are selected for the obstruction of the circulation of vital energy in the present invention
Soothing liver-qi stagnation, Rhizoma Chuanxiong, rhizoma cyperi vital energy regualting and blood circulation-promoting, keeps the obstruction of the circulation of vital energy logical, and all gas is smooth；Safflower, radix achyranthis bidentatae, Radix Angelicae Sinensis, three are selected for blood stasis
Rib, curcuma zedoary, safflower, radix achyranthis bidentatae tool are invigorated blood circulation, by the stasis of blood, the function of dredging collateral, dissipate blood stasis must, and blood network must be logical, add Radix Angelicae Sinensis blood circulation promoting and enriching simply,
Make complete square dissolving stasis without hurt just, enrich blood and do not stay the stasis of blood, the function of trigone, curcuma zedoary and blood-activating and qi-promoting, gas row then blood, then gas is smooth for blood；
For the strongly fragrant selection dried orange peel of phlegm, the tuber of pinellia, the dried immature fruit of citron orange, perilla seed, dried orange peel, the tuber of pinellia, the dried immature fruit of citron orange, purple perilla play the function of qi-regulating, eliminating dampness, resolving sputum altogether
Effect, makes phlegm is strongly fragrant must solve, phlegm is cooled down freely.In the treatment, in line with control phlegm control the stasis of blood must first regulating the qi flowing in the channels, mutually take into account, the principle that complements one another,
Each traditional Chinese medicinal components, which share, which makes irritability relax, hemostasis is dispelled, phlegm is solidifying disappears, so that reaching ideal improve treats schizoid effect,
In addition, campanulaceae is not only ensuringd proper downward flow of the blood, but also priming downlink, all medicines can be drawn and guide drugs to illness station and obtain good effect with coordinating the drug actions of a prescription, tonifying spleen benefit
Gas, clearing heat and detoxicating effect make promoting flow of qi and blood circulation stagnation resolvation without hurting healthy tendency, are indispensable one in important composition of the invention
Taste Chinese medicine.
Compared with prior art, the present invention has the following advantages: the present invention, with Chinese medicine angle, analysis leads to spirit point
Split the basic reason of disease: the obstruction of the circulation of vital energy, blood stasis, phlegm are strongly fragrant, and from this three aspect, pointedly select traditional Chinese medicine ingredients, are controlling respectively
While the treatment obstruction of the circulation of vital energy, blood stasis, phlegm are strongly fragrant, mutually take into account, complements one another between Chinese medicine composition each component, medicinal peace, nourishing heart tune
Liver adjusts its feelings will, tranquillizing the mind by relieving convulsion, to reach the schizoid effect of ideal treatment, can especially improve due to
The Schizophrenia that emotional factors are induced, aggravated, common amentia, emotional lability are cryed and laugh by turns, without any apparent reason, and wild talk is sung heartily, mad
Hot-tempered uneasiness, angry more speeches, suspicious kind worry or it is absurd see absurd hear starting qi depression to blood stasis that vain hope and insomnia etc. are main clinical manifestation
Type schizophrenia.
Specific embodiment
In order to enable those skilled in the art to more fully understand, technical solution of the present invention is practiced, below with reference to specific
The invention will be further described for embodiment and data, but illustrated embodiment is not as a limitation of the invention.
Embodiment 1
A kind of to treat the schizoid Chinese medicine composition of starting qi stagnation and blood stasis type, by mass, every part of drug is by working as
Return 40g, trigone 60g, curcuma zedoary 60g, dried immature fruit of citron orange 30g, Rhizoma Chuanxiong 30g, radix bupleuri 30g, radix paeoniae rubra 20g, radix rehmanniae recen 30g, campanulaceae 30g, Radix Glycyrrhizae
20g, rhizoma cyperi 20g, tuber of pinellia 20g, perilla seed 30g, radix achyranthis bidentatae 20g, safflower 20g, dried orange peel 20g are made, and the above ten Six-elements Chinese medicine is net
Choosing, is dried, crushed into fine powder, is sieved, and mixes, and is packed into capsule, and Chinese medicinal capsule 1000 is made.
Embodiment 2
A kind of to treat the schizoid Chinese medicine composition of starting qi stagnation and blood stasis type, by mass, every part of drug is by working as
Return 30g, trigone 50g, curcuma zedoary 70g, dried immature fruit of citron orange 25g, Rhizoma Chuanxiong 25g, radix bupleuri 25g, radix paeoniae rubra 20g, radix rehmanniae recen 30g, campanulaceae 30g, Radix Glycyrrhizae
20g, rhizoma cyperi 20g, tuber of pinellia 15g, perilla seed 20g, radix achyranthis bidentatae 25g, safflower 20g, dried orange peel 25g are made, and the above ten Six-elements Chinese medicine is net
Choosing, is dried, crushed into fine powder, is sieved, and mixes, and is packed into capsule, and Chinese medicinal capsule 1000 is made.
Embodiment 3
A kind of to treat the schizoid Chinese medicine composition of starting qi stagnation and blood stasis type, by mass, every part of drug is by working as
Return 40g, trigone 50g, curcuma zedoary 50g, dried immature fruit of citron orange 30g, Rhizoma Chuanxiong 25g, radix bupleuri 30g, radix paeoniae rubra 20g, radix rehmanniae recen 30g, campanulaceae 40g, Radix Glycyrrhizae
20g, rhizoma cyperi 20g, tuber of pinellia 25g, perilla seed 35g, radix achyranthis bidentatae 20g, safflower 20g, dried orange peel 25g are made, and the above ten Six-elements Chinese medicine is net
Choosing, is dried, crushed into fine powder, is sieved, and mixes, and is packed into capsule, and Chinese medicinal capsule 1000 is made.
Below made from the embodiment 1 for Chinese medicinal capsule, passes through clinical test verifying and treat schizoid effect.
A kind of character for the Chinese medicine composition for treating Schizophrenia of the present invention:
This product is capsule, and content is yellowish-brown powder, and smell micro-perfume is sweet in flavor.
A kind of identification of Chinese medicine composition for treating Schizophrenia of the invention:
1, this product content 5g is taken, ethyl alcohol 20ml, heating and refluxing extraction 30min are added, is filtered, filtrate is evaporated, and residue adds water
1ml makes to dissolve, and the n-butanol being saturated with water shakes 3 times, and each 15ml merges n-butanol liquid, is washed with water 2 times, each 10ml,
Washing lotion is discarded, point takes n-butanol liquid to set and is concentrated into appropriate (about 1ml) in water-bath, add appropriate aluminium oxide, mix thoroughly, sets and is done in water-bath
It is dry, it on neutral alumina pillar (200 mesh, 1g, internal diameter 1cm), is eluted with ethyl alcohol 50ml, collects eluent, be evaporated, residue
Add methanol 0.5ml, make to dissolve, as reference substance solution, tested according to thin-layered chromatography, draw each 4 μ l of above-mentioned solution, put respectively in
On same silica gel g thin-layer plate, with chloroform-ethyl acetate-methyl alcohol-formic acid (40:5:10:0.2) for solvent, it is unfolded, takes out, dry in the air
Dry, spray is heated to the aobvious point of spot clearly, in position corresponding with control chromatography in sample chromatogram with 5% vanillin-sulfuric acid solution
It sets, shows identical bluish violet spot.
2, this product content 5g is taken, 80% acetone 20ml, close plug are added, shaking 15min is stood, and filtering is concentrated into about 5ml,
As test solution.Separately take safflower control medicinal material 0.5g；It is made in the same way of control medicinal material solution.It tests, inhales according to thin-layered chromatography
Each 5 μ l of above two solution is taken, is put on the silica gel H thin plate in same using sodium carboxymethylcellulose as binder respectively, with acetic acid
Ethyl ester-the position formic acid-water-methanol (7:2:3:0.4) solvent, expansion, taking-up are dried.In sample chromatogram, with control medicinal material
On the corresponding position of chromatography, the spot of same color is shown.
3, this product content 5g is taken, add diethyl ether 40ml, is heated to reflux 20min, filters, and filtrate volatilizes, and residue adds acetic acid second
Ester 2ml makes to dissolve, as test solution.Each 0.5g of reference material Ligusticum chuanxiong, Radix Angelicae Sinensis separately is taken, is made in the same way of Rhizoma Chuanxiong and Radix Angelicae Sinensis
Control medicinal material solution.It is tested according to thin-layered chromatography, draws above-mentioned solution 2-5 μ l, put respectively on same silica gel g thin-layer plate, with
The position normal hexane-ethyl acetate (9:1) solvent is unfolded, and takes out, dries, set and inspect under ultraviolet radiator (365nm), test sample color
In spectrum, on position corresponding with reference medicine chromatography, same color fluorescence spot is shown.
A kind of administration mode of Chinese medicine composition for treating Schizophrenia of the invention: it is oral, 3 times a day, one
It secondary 5 or follows the doctor's advice.
The specification and holding conditions of a kind of Chinese medicine composition for treating Schizophrenia of the invention: every 0.40g,
It is sealed.
The embodiment of the traditional chinese medicine composition of the invention can pass through following experimental verification its advantages:
Clinical test part
One, case selection standard
1 diagnostic criteria and its foundation
Western medicine diagnostic criteria is subject to " Chinese Spirit Obstacles classification system and diagnostic criteria the 3rd edition (CCMD-3) "；Chinese medicine
Diagnostic criteria is subject to " People's Republic of China's traditional Chinese medicine industry standard disease Standardization of diagnosis and curative effect " (ZY/T001.1-94).
1.1 Western medicine diagnostic criteria
(1) symptom standard: at least following 2 not secondary to the disturbance of consciousness, disturbance of intelligence, mood elevation or low,
Simple form Split disease adds regulation.
1. recurrent verbal auditory ballucination；
2. apparent loosening of association, the split of thought, speech be discontinuous or poverty of thought or poverty of content of thought；
3. thought is inserted into, is withdrawn, being sent out, thinking is interrupted or forced thinking；
4. passively, being controlled, or known clearly experience；
5. primay delusion (including delusional perception, delusional mood) or other absurd vain hopes；
6. thinking logic perversion, morbid symbolic thinking or onomatolalia；
7. paramania, or it is apparent apathy；
8. tonic symptoms, strange behavior, or unwise behavior；
9. apparent hypobulia or shortage.
(2) serious standard: insight obstacle, and there is social function to be badly damaged or can not effectively be talked.
(3) course of disease standard:
1. meeting illness standard and serious standard at least having continued 1 month, simple form is stated otherwise；
2. not being able to satisfy if meeting the symptom standard of Split disease and affective disorders simultaneously when affective symptom is relieved to
When affective disorders symptom standard, division symptom need to continue symptom standard at least 2 weeks or more that meet Split disease, can examine
Break as Split disease；
3. going to a doctor for the first time after the onset, the drugs of mental department such as antipsychotic drug, antidepressants, mood stabilizers are not taken, always
The course of disease is no more than 60 months；
(4) it exclusion criteria: excludes spirit caused by organic mental disorders and psychoactive drug substance and non-addictive substance and hinders
Hinder.The Split disease patient not yet alleviated should diagnose side by side if suffering from aforementioned two classes disease in this item again.
1.2 tcm diagnosis standard
(1) diagnosis basis
1. there is amentia, cry and laugh by turns, without any apparent reason, wild talk is sung heartily, manic uneasiness, do not keep away it is close and distant, hit the person ruin the spirit such as object, language,
Manner abnormal state；
2. having emotional stimulation, wish unsuccessful or the risk factors such as brain trauma, or there is family history；
3. excluding person caused by drug reason.
(2) card marquis classification
It demonstrate,proves in marquis's classification, this disease is divided into phlegm-fire disturbing spirit, fire Sheng impairment of yin and three type of stagnation of QI-blood, and in of the invention one group
It is qi stagnation and blood stasis type therein that drug composition, which improves with curer, and card marquis shows themselves in that
1. dysphoria is uneasy, angry more speeches, very then going to a high place and singing；
2. or absurd hear absurd is seen；
3. complexion is secretly stagnant；
4. painful chest and hypochondrium is bored；
5. palpitaition of having a headache；
6. purplish tongue has ecchymosis, wiry and frequent pulse or thin puckery.
2 state of an illness standards of grading
2.1 Concise Psychiatric Scale (BPRS)
Concise Psychiatric Scale (BPRS) shares 18 symptom projects (summary of project particular content), is mainly used for nearly one week
Mental symptom evaluation, wherein (1), (2), (4), (5), (8), (9), (10), (11), (12), (15) and (18) item is inspection item, according to the oral account of patient
Part.It (3) is (6), (7), (13), (14), (16), (17), observation item, behavior expression scoring of the patient in talks according to the observation.Scoring etc.
Grade is 1-7 grades.0 is not survey；1 asymptomatic；2 be very light or suspicious；3 be slight；4 be moderate；5 be weighting；6 be severe；7 are
It is extremely heavy.If 1 grade is 1 point, total score is 18-126 points, and total score is higher, and the state of an illness is heavier.
2.2 BPRS Factor minutes
BPRS scale Factor minute can reflect the syndrome of disease.Factor minute is calculated as the sum of project total score divided by project
Number.The project of each factor are as follows:
1. anxiety ((1) (2) (5) (9))
2. lack cordiality ((3) (13) (16) (18))
3. the disturbance of thought ((4) (8) (12) (15))
4. activity ((6) (7) (17))
5. ((10) (11) (14)) hostile suspect
2.3 Syndrome in TCM marquis's standards of grading
1 Syndrome in TCM marquis's standards of grading of table
2.4 Syndrome Scale
(1) BPRS total score is classified
Slight 18-54 points of moderate 55-90 divides severe 91-126 points
(2) BPRS Factor minute is classified
Slight 1-2 points of moderate 3-4 divides severe 5-7 points
(3) tcm symptom is classified
Slight 1 point of moderate, 2 points of severes 3 are divided
3 test case standards
3.1 are included in standard
(1) all to meet the diagnosis of this disease and Syndrome Differentiation of Traditional Chinese Medicine standard person；
(2) stopping relevant administration one month or more person.
3.2 exclusion criteria
(1) brain organic psychosis；
(2) physical disease caused by mental disorder；
(3) psychoactive drug substance and dependent/non-dependent substance caused by mental disorder；
(4) symptom meets the diagnostic criteria of schizophrenia and affective disorders, but schizoid disease simultaneously
Journey is shorter than the course of disease of affective disorders, or long less than two weeks persons；
(5) there are a primary diseases such as serious cardiovascular and cerebrovascular, liver and hemopoietic system, intractable diabetes and there are diabetes
Neuropathy subjects.
3.3 fall off and reject case
(1) to Chinese medicine composition allergy of the invention；
(2) other drugs are shared；
(3) all not meet the standard of being included in, it does not take medicine by regulation, can not determine that curative effect or data be not congruent and affect the treatment or pacify
Full property judgement person.
Two, test method
1 test follows principle
This research follows random, control, double blind principle.
2 test case loads and grouping
Case order of packets number is generated by computer.Select to be diagnosed as schizophrenia (qi stagnation and blood stasis type) case as clinic
Observe case.
3 test methods
This research uses double-blind study.Select Risperidone (trade name: Risperidal) as positive control medicine, 2 times a day, often
Secondary 3mg takes orally.Treatment group's drug is the Chinese medicine capsules in the present invention, 3 times a day, 5 tablets each time, is taken orally.
The 4 test courses for the treatment of
The treatment course for the treatment of group and positive controls is 4 weeks.
Three, observation index
1 safety observation:
1.1 general observation projects；
1.2 blood, urine, feces are conventional；
1.3 hearts, Liver and kidney function inspection；
1.4 blood pressure measurement.
The observation of 2 health giving qualities
2.1 Syndrome in TCM marquis observation；
2.2BPRS overall score
2.3 BPRS Factor minutes.
3 adverse reactions observation:
3.1 side effect of digestive tract: Nausea and vomiting, loss of appetite etc..
3.2 other systemic adverse reactions；
3.3 allergic reactions: fash, pruitus etc..
Four, curative effect determinate standard
Criterion is according to " People's Republic of China's traditional Chinese medicine industry standard disease Standardization of diagnosis and curative effect " (ZY/T001.1-
94) and BPRS scores.
1 cure: language, manner, look are restored normally, can normally handle day-to-day work, BPRS integrate reduction by 90% with
On；
2 improve: look stable, and language, manner are normal, or have improvement, and BPRS integral reduces 30%-89%；
3 are not cured: language, manner, look are without improvement.
Five, statistical method
The significance test of 1 quantitative response data is examined with t；
The significance test X of 2 qualitative response data2It examines.
Six, test result
1 general information comparative study
1.1 age distribution situations
2 age of table (year) distribution situation (example/%)
It can be obtained, treatment group's minimal ages 16 years old, max age 76 years old, average age 45.11 ± 21.12 years old, be compareed by table 2
Group minimal ages 18 years old, max age 72 years old, average age 46.08 ± 20.50 years old, and two groups are compared through significance test, X2
=0.67, P > 0.5 is comparable.
1.2 course of disease distribution situations
3 course of disease of table (moon) distribution situation (example/%)
It can be obtained by table 3, the treatment group most short course of disease 3 months, the longest course of disease 368 months, average course of disease 54.12 ± 51.68
Month；Control group most the short course of disease 3 months, the longest course of disease 400 months, average course of disease 58.26 ± 52.49 months, and two groups of warps are significant
Property examine compare, X2=2.11, P > 0.5 is comparable.
1.3 state of an illness distribution situations
4 state of an illness weight of table is classified situation (example/%)
It can be obtained by table 4, two groups are compared through significance test, X2=2.00, P > 0.5 is comparable.
1.4 Sex distribution situations
5 Sex distribution situation of table
It can be obtained by table 5, two groups are compared through significance test, X2=0.30, P > 0.5 is comparable.
2 Clinical efficacy comparisons
2.1 total effects comparable situations
6 total effects comparable situation of table (example/%)
It can be obtained by table 6, the total effective rate (improvement+healing) for the treatment of group is 96.19%, cure rate 85.72%, control group
Total effective rate (improvement+healing) be 72.38%, cure rate 60.95%.Two groups through X2Inspection is compared, X2=13.53, P <
0.005, show treatment group's significant difference compared with the control group, illustrates Chinese medicine composition of the invention to schizoid total treatment
Effect is better than control group Risperidone.
2.2 tcm symptoms improve situation
7 tcm symptom of table improves situation comparable situation
It can be obtained by table 7, be compared before and after treatment group, treatment group and control group can significantly improve that headache, dysphoria are angry, absurd see
It is absurd hear, dark stagnant, chest side of body is swollen logical, palpitaition the symptom of complexion.Two groups of carry out comparison among groups, treatment group to headache, dysphoria it is angry, absurd
See that absurd news, complexion is secretly stagnant, chest side of body is swollen, and logical symptom improves, hence it is evident that be better than control group (P < 0.01)；Improvement for palpitaition symptom,
(P > 0.05) not statistically significant between treatment group and control group.
3 test safety evaluatio situations
The influence situation of 3.1 pairs of Liver and kidney functions
Liver and kidney function comparable situation after table 8 is treated
It can be obtained by table 8, after treatment group patient takes the traditional chinese medicine composition of the invention, Liver and kidney function inspection is showed no significantly
Abnormal change (check object is same case group before treatment and after treatment).
3.2 pairs of blood, urine, feces routine inspection influence
Blood, urine, feces routine inspection comparable situation after table 9 is treated
It can be obtained by table 9, treatment group patient is after traditional Chinese medicine composition for treating of the invention, and blood, urine, feces routine inspection are not
See apparent abnormal change (check object is same case group before treatment and after treatment).
The influence of 3.3 pairs of electrocardiograms, blood pressure
Electrocardiogram, blood pressure comparable situation after table 10 is treated
It can be obtained by table 10, after traditional Chinese medicine composition for treating of the invention, ECG examination discovery has before treatment for treatment group
3 slight deficiency myocardial blood supplies only have 2 slight deficiency myocardial blood supplies after treatment, remaining has no apparent anomalous variation；Blood pressure
It checks discovery, there is 2 mild hypertensions before treatment, only have 1 slight mild hypertension after treatment, remaining has no apparent exception
Variation (check object is same case group before treatment and after treatment).
3.4 adverse reaction
The timely anti symptom treatment situation of 11 adverse reaction of table
It can be obtained by table 11, treatment group is during traditional Chinese medicine composition for treating of the invention, and in treatment group 105, only 1 goes out
It now has a stomach upset, loss of appetite symptom, does not do drug withdrawal processing, take symptom after the full course for the treatment of is discontinued and disappear automatically.
3.5 cases exit, are lost to follow-up, proposing situation
12 case of table exits, is lost to follow-up, rejecting expression condition table
It can be obtained by table 12, during treatment, treatment group and control group respectively have 2 cases lost to follow-up.
Pharmacodynamic study part
1 experimental material
1.1 experimental animal
Kun Ming mice, weight 18g-20g, half male and half female are provided by Heilongjiang Province, experimental center, institute for drug control, are closed
Lattice card number: black dynamic word 00101001.Wistar rat, weight 200g ± 20g, half male and half female, by Chinese Academy of Agricultural Sciences Ha Er
Shore veterinary institute Experimental Animal Center provides, quality certification number: black dynamic word P00101004.
1.2 experimental drugs and reagent
It is of the invention it is a kind of have effects that the Chinese medicine composition for treating starting qi stagnation and blood stasis type schizophrenia be by Radix Angelicae Sinensis,
Trigone, curcuma zedoary, the dried immature fruit of citron orange, Rhizoma Chuanxiong, radix bupleuri, radix paeoniae rubra, glutinous rehmannia, campanulaceae, Radix Glycyrrhizae, rhizoma cyperi, the tuber of pinellia, perilla seed, radix achyranthis bidentatae, safflower, dried orange peel
Composition is capsule.
Yellow Jackets (lot number: 000702), Beijing cultivate people of ability Fine Chemical Works production；Hyoscine (raw material) Harbin system
The production of four factory of medicine；Macromolecule right rotary glycoside (Dextarn50in SWeden), lot number: 17-0302-01；Amino acid Ethyl formate
(lot number: 000422), the production of Solution on Chemical Reagents in Shanghai factory；(lot number: 001203), Nangong pharmaceutical factory, Hebei province is raw for Fufang Danshen Pian
It produces；Anshen Bunao mixture (lot number: 010911), the production of pharmaceutical factory, Jilin Aodong.XZ-4 type mouse ambulatory activity count device；I type of LW-
Water maze auto-controller.
2 experiment contents and method
The experiment of 2.1 pairs of mouse autonomic activities times influences
18-20g Kunming mouse 50 are selected, half male and half female is randomly divided into 5 groups by weight, and every group 10, respectively greatly
Dosage experiments group, middle dosage experimental group, low dosage experimental group, positive drug control group (Anshen Bunao mixture) and blank control group.
The daily gastric infusion of each group mouse 1 time, administration capacity are 0.5ml/20g, and blank control group is given same volume distilled water, continuously given
Medicine 7 days, after last dose 1 hour, mouse is arranged by Latin square sequence, is put into XZ-4 type mouse ambulatory activity count device
It is interior, observe and record mouse autonomic activities number in 10 minutes.Statistical analysis is carried out, experimental result is shown in Table 13.
Influence situation of the table 13 to mouse autonomic activities number
Note: compared with blank control group,**P<0.01。
It can be obtained by table 13, Chinese medicine composition of the invention can be substantially reduced mouse autonomic activities number, with blank control
Group is compared, and is had significant difference (P < 0.01).
The influence of 2.2 pairs of yellow Jackets sub-threshold dose syngignoscisms
Kunming mouse 50 are selected, all male, is randomly divided into 5 groups by weight, every group 10, respectively large dosage is real
Test group, middle dosage experimental group, low dosage experimental group, positive drug control group (Anshen Bunao mixture) and blank control group.Each group is small
The daily gastric infusion of mouse 1 time, administration capacity are 1ml/20g, and blank control group gives same volume distilled water, successive administration 7 days, in
After last dose 1 hour, be injected intraperitoneally 0.5% yellow Jackets 50mg/kg (subthreshold hypnotic dosage), with administration after in 15 minutes
Mouse righting reflex loss up to 1 minute or more number of mice as sleep index.Sleep mouse number is recorded, statistics is carried out
Analysis, experimental result are shown in Table 14.
Influence situation of the table 14 to pentobarbital sodium sub-threshold lull dosage
Note: compared with blank control group,*P<0.05。
It can be obtained by table 14, the traditional chinese medicine composition of the invention can aid in mice sleep, compared with the control group, have conspicuousness
Difference (P < 0.05).
The influence situation of 2.3 pairs of yellow Jackets syngignoscisms
Kunming mouse 50 are selected, all male, is randomly divided into 5 groups by weight, every group 10, respectively large dosage is real
Test group, middle dosage experimental group, low dosage experimental group, positive drug control group (Anshen Bunao mixture) and blank control group.Each group is small
The daily gastric infusion of mouse 1 time, administration capacity are 1ml/20g, and blank control group gives same volume distilled water, successive administration 7 days, in
After last dose 1 hour, 0.5% yellow Jackets 50mg/kg of the intraperitoneal injection (hypnotic of animal generation righting reflex loss
Amount), observation mice sleep incubation period (to the time of righting reflex loss since administration) and maintenance sleeping time.It is counted
Credit analysis, experimental result are shown in Table 15.
Influence situation of the table 15 to yellow Jackets syngignoscism
Note: compared with blank control group,**P<0.01。
It can be obtained by table 15, the traditional chinese medicine composition of the invention is able to extend the sleeping time of mouse, the sleep quality of mouse is improved,
Compared with the control group, there is significant difference (P < 0.01).
The influence situation of 2.4 pairs of plasma viscosities and surface activity of blood platelet and aggregation
This research selects Wistar rat 50, all male, is randomly divided into 5 groups by weight, and every group 10, respectively greatly
Dosage experiments group, middle dosage experimental group, low dosage experimental group, positive drug control group (Fufang Danshen Pian) and saline control
Group.The schizophrenia rats that MK-801 (dizopine maleate) establishes hypoglutamatergic are continuously injected using low dosage
Model, optimum amount 0.1mg/kg, ideal modeling administration time are 14 days.Injection MK-801 gives rat imprevision simultaneously
Property stress stimulation, daily a kind, random arrangement prevents rat from predicting the stimulation of next day, to avoid adaptability is generated, stimulation
Time totally 14 days.Final injection second day, adrenalin hydrochloride injection is subcutaneously injected, totally 2 times, is spaced 4h.In aforementioned manners
Simulate schizophrenia (qi stagnation and blood stasis type) rat model.The daily gastric infusion of each group rat 1 time, blank control group gives consubstantiality
Product distilled water successive administration 7 days, after last dose 1 hour, rat is put to death and takes blood, carry out plasma viscosity and blood platelet
The detection of surface-active and aggregation.Through statistical analysis, experimental result is shown in Table 16, table 17.
Influence situation of the table 16 to plasma viscosity
Note: compared with saline control group,*P<0.05；**P<0.01。
Influence situation of the table 17 to surface activity of blood platelet and aggregation
Note: compared with saline control group,*P<0.05；**P<0.01。
As shown in Table 16, one group of Chinese medicine composition of the invention can obviously inhibit plasma viscosity, with saline control
Group, which compares, significant difference (P < 0.01 or P < 0.05)；Positive drug control group (Fufang Danshen Pian) can also inhibit blood plasma than viscous
Degree, with there is significant difference (P < 0.05) compared with saline control group.As shown in Table 17, one group of Chinese traditional medicine composition of the invention
Object can obviously inhibit blood platelet expansion type, have significant difference (P < 0.05) compared with saline control group, and make blood platelet
Aggregation number is decreased obviously (P < 0.01)；Positive drug control group (Fufang Danshen Pian) also can obviously inhibit blood platelet expansion type,
There is significant difference (P < 0.05) compared with saline control group, and platelet aggregation number is made to be decreased obviously (P < 0.01).
One group of Chinese medicine composition of the invention inhibits the raised effect of plasma viscosity to be better than Fufang Danshen Pian, and two groups of comparing differences have aobvious
Work property meaning (P < 0.05), the influence to Platelet, two groups are compared that there was no significant difference.
Acute toxicity testing part
1 experiment purpose
Acute toxicity evaluation is made to one group of Chinese medicine composition of the invention, provides experimental basis for data for clinical drug use.
2 experimental materials
2.1 test medicines:
One kind of this experiment has effects that treating the Chinese medicine composition of Schizophrenia (qi stagnation and blood stasis type) is by working as
Return, trigone, the dried immature fruit of citron orange, Rhizoma Chuanxiong, radix bupleuri, radix paeoniae rubra, glutinous rehmannia, campanulaceae, Radix Glycyrrhizae, rhizoma cyperi, the tuber of pinellia, perilla seed, radix achyranthis bidentatae, safflower, dried orange peel group
At for capsule.
Usage and dosage: it is oral, it is adult 5 tablets each time, 3 times a day.Adult (based on 50kg) day dosage is 0.135g/
kg。
2.2 experimental animals:
Kun Ming mice, weight 19g-21g, half male and half female are provided by Heilongjiang Province, experimental center, institute for drug control.It is dynamic
Object quality certification number: black dynamic word 00101001.
The preparation of 2.3 laboratory samples:
A certain amount of Capsule content is weighed, is put into mortar and is ground into fine powder, water is added to mix well, a certain concentration is made
Drug suspension.It is tested through prerun, 25% drug suspension is its maximum suitable concentration.
Dosage is calculated by the fine drug powder weight of the every kg weight of animal.
3 experimental methods and result
The measurement of 3.1 median lethal doses (LD50):
(1) prerun is tested: purpose is to obtain the dosage range for causing the death rate of animal 0% and 100%, formal real to arrange
It tests.
Kunming mouse 20, half male and half female is randomly divided into three groups by weight, gender, a gastric infusion, dosage
By geometric progression arrangement.Fail to find the dosage range or 100% death rate that cause the death rate of animal 0% and 100% through experiment
Dosage.
(2) formal experiment: selecting weight is healthy Kunming mouse 20 of 19g-21g, half male and half female, through breeding observing
Afterwards for testing.Mouse fasting 12 hours, can't help water before testing.20 DEG C -22 DEG C of experimental temperature, using with clinical consistent stomach-filling
Administration route, 35% drug suspension at once and are observed continuously 7 by the dosage of 0.8ml/20g (10g/kg), after administration
It.
Formal experimental result: do not observe that mouse has apparent undue toxicity response situation, without dead mouse in 7 days.Cause
Administration concentration (25%) and administration volume (0.8ml/20g) have reached the maximum, therefore this experiment fails to measure intragastric administration on mice medicine
The LD50 of object suspension.
3.2 maximum tolerance determination
Choose healthy Kunming mouse 20 that weight is 19g-21g, half male and half female, for testing after breeding observing.
Mouse fasting 12 hours, can't help water before testing.20 DEG C -22 DEG C of experimental temperature, using with clinical consistent gastric infusion approach, with
The drug suspension of maximum concentration (25%) and maximum volume (0.8ml/20g is equivalent to 10g/kg) that animal is resistant to, 24 is small
When be administered twice in succession, be spaced 5 hours, at once and be observed continuously 7 days after administration.
Measurement result: mouse appearance, behavioral activity, the state of mind, appetite, stool, urine, fur, secretion are not observed
The toxic reactions such as object；None dead mouse within 7 days；Also apparent abnormal response situation is not observed.
Calculating and always giving within 24 hours dose is 20g/kg (capsule 's content medicinal powder amount), and adult (based on 50kg) is clinical daily
Pharmaceutical quantities are 6.75g/50kg (i.e. 0.135g/kg), extrapolate multiple (multiple=20/ for being equivalent to clinical day dosage
0.135=148 times) it is greater than 100 times, show that said preparation toxicity is lower, safe range is larger.
A kind of have effects that treat the Chinese medicine group of starting qi stagnation and blood stasis type schizophrenia in conclusion provided by the invention
Object is closed, can improve due to emotional factors induction, aggravate, with starting qi stagnation and blood stasis type spirit point of obvious abnormal state of mind performance
Disease is split, especially with amentia, emotional lability is cryed and laugh by turns, without any apparent reason, and wild talk is sung heartily, manic uneasiness, angry more speeches, suspicious kind worry,
Or it is absurd see it is absurd hear vain hope and insomnia etc. be main clinical manifestation illness, unite and control it.And Chinese medicine composition all medicines share,
Special function " qi and blood " and " liver-brain ", are based on schizophrenia pathogenesis syndrome characteristics, based on eliminating evil, take into account righting；Blood-activating and qi-promoting
Based on, resolving sputum is taken into account, is adjusted based on smooth qi and blood, tune mind is taken into account.
Obviously, various changes and modifications can be made to the invention without departing from essence of the invention by those skilled in the art
Mind and range.In this way, if these modifications and changes of the present invention belongs to the range of the claims in the present invention and its equivalent technologies
Within be also intended to include these modifications and variations.
Claims (4)
1. a kind of Chinese medicine composition for treating Schizophrenia, which is characterized in that be made of raw material from the following weight: when
Return 30~50 parts, 50~70 parts of trigone, 50~70 parts of curcuma zedoary, 20~40 parts of the dried immature fruit of citron orange, 25~35 parts of Rhizoma Chuanxiong, 20~40 parts of radix bupleuri,
15~30 parts of radix paeoniae rubra, 20~40 parts of radix rehmanniae recen, 20~40 parts of campanulaceae, 15~30 parts of Radix Glycyrrhizae, 15~30 parts of rhizoma cyperi, the tuber of pinellia 10~25
Part, 15~35 parts of perilla seed, 15~25 parts of radix achyranthis bidentatae, 15~25 parts of safflower, 15~25 parts of dried orange peel.
2. the Chinese medicine composition for the treatment of Schizophrenia as described in claim 1, which is characterized in that by following parts by weight
Raw material be made: it is 40 parts of Radix Angelicae Sinensis, 60 parts of trigone, 60 parts of curcuma zedoary, 30 parts of the dried immature fruit of citron orange, 30 parts of Rhizoma Chuanxiong, 30 parts of radix bupleuri, 20 parts of radix paeoniae rubra, raw
It is 30 parts of glutinous rehmannia, 30 parts of campanulaceae, 20 parts of Radix Glycyrrhizae, 20 parts of rhizoma cyperi, 20 parts of the tuber of pinellia, 30 parts of perilla seed, 20 parts of radix achyranthis bidentatae, 20 parts of safflower, old
20 parts of skin.
3. the preparation method of the Chinese medicine composition for the treatment of Schizophrenia as described in claim 1, which is characterized in that packet
Include following steps:
Weigh the raw material of following parts by weight respectively: 30~50 parts of Radix Angelicae Sinensis, 50~70 parts of trigone, 50~70 parts of curcuma zedoary, the dried immature fruit of citron orange 20~
40 parts, 25~35 parts of Rhizoma Chuanxiong, 20~40 parts of radix bupleuri, 15~30 parts of radix paeoniae rubra, 20~40 parts of radix rehmanniae recen, 20~40 parts of campanulaceae, Radix Glycyrrhizae
15~30 parts, 15~30 parts of rhizoma cyperi, 10~25 parts of the tuber of pinellia, 15~35 parts of perilla seed, 15~25 parts of radix achyranthis bidentatae, 15~25 parts of safflower and
15~25 parts of dried orange peel；
By above-mentioned each raw material cleaning, drying, it is ground into fine powder, is sieved, is mixed, capsule is packed into, the starting schizophrenia for the treatment of is made
The Chinese medicinal composition capsules of disease.
4. Chinese medicine composition as described in claim 1 is in terms of starting qi stagnation and blood stasis type schizophrenia drug is treated in preparation
Using.
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| ARMANDO L. MORERA-FUMERO ET AL.: "Role of Melatonin in Schizophrenia", 《INT. J. MOL. SCI.》 * |
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| CN110934984A (en) * | 2020-01-05 | 2020-03-31 | 刘锁奎 | Traditional Chinese medicine composition for treating auditory hallucination |
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