CN103705774A - Compound composition with effect of treating depression as well as preparation method and application thereof - Google Patents
Compound composition with effect of treating depression as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a compound composition with the effect of treating depression as well as a preparation method and an application thereof. The compound composition is prepared from the following raw materials: 10-20 parts of liquorice, 12-30 parts of wheat, 5-10 parts of jujube, 10-20 parts of flos albiziae, 5-10 parts of polygala. According to the pathogenesis of depression, under the guidance of theory of traditional Chinese medicine, the compound composition provided by the invention is obtained by a large number of experimental screening for treatment based on syndrome differentiation, experimental results show that the compound composition provided by the invention can have the multiple-link and multiple-target-point antidepressant effect. The agent for soothing the nerves and dispelling melancholy, nourishing the heart and relieving restlessness is finally prepared through the combination of all the medicines. Pharmacology experiment and clinical experiment results show that the compound composition provided by the invention is reliable in clinical effect, high in cure rate, and good in patient compliance, has a good treatment effect on depression, and does not have toxic or side effect after long-term use, so that the medication is safe.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of compound with Cure of depression effect and its preparation method and application.
Background technology
Depression is a kind of mental illness being in a very depressed state as outstanding symptom, belongs to a kind of common disease of psychiatric department, and each age level can occur, and is outbreak repeatedly, the feature of intermission serviceable condition.Pathomechanism is mainly due to the neurotransmitter function imbalances such as the interior 5-hydroxy tryptamine of brain, norepinephrine.Its clinical manifestation is depressed, former Cup of tea feelings or activity are lost interest, there is no happy sense, deficient in energy, fatiguability, work efficiency declines, sleep quality declines, early awakening and lying awake all night even, and appetite and libido decline, have constipation, weight decline, anxiety, fear, bradykinesia, even can be therefore disheartened and produce the idea of committing suiside or behavior etc.Once depression diagnosis is clear and definite, should be according to patient's concrete condition application psychotherapy, naturopathy and (or) Drug therapy.
The pressure of the aspects such as the fast pace of the modern life and spirit, psychology, obviously improves the sickness rate of depression.Serious physical disease, chronic disease, brain organic disease is easily brought out or cause depression; wherein in internal medicine patient, depression incidence is 12%-36%; depressed person occurs Parkinson disease is 50%-70%, and post-stroke depression incidence rate is 30%-60%, and senile dementia depression incidence is 10%-40%; Child morbidity rate is 1%.
Yet still do not have at present a kind of effective Therapeutic Method can be fully up to expectations aspect curative effect, untoward reaction and prevention of recurrence, approximately 15% patient, with suicidal tendency, have caused very large impact to social stability and economic development.World Health Organization (WHO) (WHO) predicts the year two thousand twenty depression will become second largest disabling disease.Therefore, the research of antidepressant drug is more and more subject to people's attention.
At present, the clinical treatment of depression mainly relies on chemical synthetic drug.Because this type of medicine of long-term taking there will be serious toxic and side effects, many patients are usually forced to stop treatment, therefore, find and develop desirable antidepressant from natural drug and Chinese medicinal formulae, more and more cause the concern of researcher.In recent years, the correlational study that Chinese scholars is carried out at the field of Chinese medicines has been obtained gratifying progress Chinese medicine compound and has been had the advantages that composition is many, effect link is many, target spot is many, although single component content is low, acts on not obvious, but can work by many target spots, produce Synergy.Both make up the low shortcoming of effective component content, also reduced side effect.Therefore, also more and more extensive for the antidepressant effect of Study of Traditional Chinese Medicine compound recipe, studying at present more ancient prescription has BANXIA HOUPU TANG, XIAOYAO POWDER and Danzhi Xiaoyao San etc.
The clinical selective 5-HT reuptake inhibitor of antidepressant drug (SSRI) of using at present, selective N E/5-HT reuptake inhibitor (SNRIs), oxidase inhibitor (MAOI), selective N E reuptake inhibitor (NRIs), NE energy and specificity 5-HT can antidepressant drugs (NaSSA).
Selective serotonin reuptake inhibitor (SSR I) is first-selected antidepressants clinically at present, prozac is that it represents medicine, by presynaptic membrane 5-HT being absorbed again to the strong inhibition effect of pump, and synaptic space 5-HT concentration is raise, promote the transmission of 5-HT neurotransmitter, play antidepressant effect, clinical efficacy is good.But because untoward reaction is many, compliance is poor, expensively restricted its clinical practice, especially, concerning the patients with depression with somatization, side reaction can increase the weight of patient's psychological burden undoubtedly, and patient can think that the state of an illness does not take a turn for the better and increases the weight of on the contrary.
In human body, MAO increased along with the age, and monoamine material (NE, 5-HT, the DA etc.) degraded that makes to have important physiological function by Deamination loses activity, and may be a kind of etiological treatment measure with MAOI treatment patients with senile depression.Patients with senile depression is often with anxiety, pain and other somatizations, and application MAOI can obtain effective,, reversibility A-MAO especially of new generation represents that medicine moclobemide has more advantage.This medicine acardia toxicity and anticholinergic effect, without untoward reaction such as postural hypotension, body weight increase and sexual dysfunctions, do not damage memory.But suffer from hypertensive gerontal patient, should limit edible a large amount of cheese food products, mental disorder, phacochromacytoma, patients suffered from hyperthyroidism forbidding.
Selective N E/5-HT reuptake inhibitor (SNRIs), it represents that medicine has venlafaxine etc.Venlafaxine onset is rapid, and the half-life is short, is NE/5-HT double inhibitor, and more wide application is in the depressive disorder causing because of one item deficiency.Devanand etc. carry out the open research of the old dysthymia patient of venlafaxine.Patient takes venlafaxine 12 weeks, and therapeutic dose is more flexible, and maximal dose reaches 300mg/d.Enter to organize patient's 23 examples, 18 routine patients have completed research.Result shows that 60.9% patient is effective, and 47.8% reaches clinical cure, and before entering group, symptom is heavier, and treated effect is better, the better tolerance of patient to medicine, but not good enough to the patient's curative effect with cardiovascular disease.
Selective N E reuptake inhibitor (NRIs) reboxetine (Rebox etine) is selective and specific NE reuptake inhibitor, affinity to norepinephrine α 1 or α 2, histamine H 1, dopamine D 2, malicious deep alkali cholinoceptor is little, adverse reaction rate low [3].This product absorbs rapidly, and the elimination half-life is 13h, and cytochrome P 450 Enzyme system is to this product without effect, and mainly through renal excretion, so drug interaction is less.The confirmation of the research such as Versiani report, reboxetine is effective to the long-term treatment of depression, and relapse rate is low, and toleration is also better.Due to the inhibitory action that reboxetine absorbs NE again, increased the utilization to NE of nervus centralis and peripheral nervous system, can cause trembling, the untoward reaction such as tachycardia and urine retention.
It represents that medicine has mirtazapine (mirtazapine) etc. NE energy and specificity 5-HT energy antidepressant drug (NaSSA).The main mechanism of mirtazapine is for strengthening transmission and special retardance 5-HT2 and the 5-HT3 receptor of NE, 5-HT energy; antagonism maincenter adrenergic nerve presynaptic α 2 autoreceptors and heterogeneous receptor; histamine H_1 receptor is also had to antagonism to a certain degree, and to have sedation relevant with it for this; Simultaneously mirtazapine has moderate antagonism to periphery adrenergic nerve alpha-2 receptor, and this and this medicine causes that postural hypotension is related sometimes.In the research of a comparison mirtazapine (15-60mg/d) and citalopram (20-60mg/d) [5], 2 kinds of medicines have all shown good antidepressant effect and angst resistance effect, but the onset time of mirtazapine is faster, more obvious to the improvement of sleep disorder.
All antidepressant drugs that doctor trained in Western medicine is used for the treatment of clinically have untoward reaction substantially, can cause allergy and drug withdrawal syndrome in various degree, thereby affect conversely its curative effect, and make patient be difficult to adhere to medication.Western medicine drug effect has instantaneity, with there being effect, stop acting on disappearance, must dependence continue for a long time the guarantee therapeutic effect of taking medicine, must cause part patient to be difficult to adhere to long-term taking Western medicine, symptom takes a turn for the better with regard to drug withdrawal, can not eat and just not eat, therefore the relapse rate of depression is still very high, serious harm human physical and mental health and quality of life, bring serious burden to family and society, so strengthen the control of depression, performance Chinese medicine treatment must aim at the pathogenesis of disease, the advantages such as natural drug is comparatively safe are excavated motherland's medical science and are comprised middle distinguished veteran doctors of TCM experience, development can long-term taking, high-efficiency low-toxicity, dosage is less, dosage form is newer, the medicine that bioavailability is high, it is the important topic that medicine sector faces.
Summary of the invention
Goal of the invention: the object of the invention is in order to solve the deficiencies in the prior art, provide a kind of proportioning scientific and reasonable, there is good Cure of depression effect, and safe and reliable, the Traditional Chinese medicine compound composition that untoward reaction is low, another object of the present invention is to provide preparation method and the application thereof of this compound.
Technical scheme: in order to realize above object, the technical scheme that the present invention takes is:
A compound with Cure of depression effect, it is to be made by the raw material of following parts by weight:
10～20 parts, Radix Glycyrrhizae, 12～30 parts of Semen Tritici aestivis, 5～10 parts, Fructus Jujubae, 10～20 parts of Flos Albiziaes, 5～10 parts of Radix Polygalaes.
As preferred version, the above-described compound with Cure of depression effect, it is to be made by the raw material of following parts by weight:
10～15 parts, Radix Glycyrrhizae, 12～24 parts of Semen Tritici aestivis, 6～10 parts, Fructus Jujubae, 10～15 parts of Flos Albiziaes, 5～8 parts of Radix Polygalaes.
As another preferred version, the above-described compound with Cure of depression effect, it is to be made by the raw material of following parts by weight:
15 parts, Radix Glycyrrhizae, 18 parts of Semen Tritici aestivis, 10 parts, Fructus Jujubae, 10 parts of Flos Albiziaes, 10 parts of Radix Polygalaes.
As another preferred version, the above-described compound with Cure of depression effect, it is to be made by the raw material of following parts by weight:
12 parts, Radix Glycyrrhizae, 18 parts of Semen Tritici aestivis, 9 parts, Fructus Jujubae, 10 parts of Flos Albiziaes, 10 parts of Radix Polygalaes.
The compound with Cure of depression effect of the present invention, is prepared into granule by the extract of each raw material and pharmaceutically acceptable carrier, powder, tablet, capsule, pill or mixture.
The present invention adds carrier lactose or corn starch the extract fine powder of compound when making tablet, adds magnesium stearate lubricant while needing, mix homogeneously, and then tabletting is made tablet.
The present invention, when making capsule, adds carrier lactose or corn starch mix homogeneously, granulate, the then encapsulated capsule of making the extract fine powder of compound.
The present invention is when granulation agent, and the extract fine powder of compound and diluent lactose or corn starch mix homogeneously, granulate, is dried granulation agent.
The preparation method with the compound of Cure of depression effect of the present invention, comprises the following steps:
(1) extracting liquorice, Semen Tritici aestivi, Fructus Jujubae, Flos Albiziae, Radix Polygalae first by weight, soak 0.5～1 hour, then the water that adds 6 to 12 times of amounts of medical material weight, decocts each 1～2 hour 2～3 times, collecting decoction, filter, standing 12～24 hours of filtrate, filters, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol make containing alcohol amount be 60%～80%, mix, cold preservation 24～48 hours, filters, and filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, after drying under reduced pressure, be prepared into granule, powder, tablet, capsule, pill or mixture with pharmaceutically acceptable carrier.
Through pharmacological evaluation and clinical experiment result, show, the present invention screens by great many of experiments the effect that the Traditional Chinese medicine compound composition obtaining has good control depression, the application of the compound with Cure of depression effect of the present invention in preparing Cure of depression medicine.
Beneficial effect: compared to the prior art the compound with Cure of depression effect provided by the invention has the following advantages:
The compound with Cure of depression effect provided by the invention, according to the pathogenesis of depression, under the guidance of Chinese medical theory, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is screened and is obtained Traditional Chinese medicine compound composition of the present invention by great many of experiments, experimental result shows, Traditional Chinese medicine compound composition provided by the invention, can too many levels, many target spots antidepressant effect.Radix Glycyrrhizae eliminating heart-fire in side and stomach function regulating is monarch, Semen Tritici aestivi is sweet, be slightly cold, enter the heart, and the relieving restlessness of nourishing heart is minister, Fructus Jujubae invigorating the spleen and replenishing QI, easing up the urgency with moist and sweet drugs is assistant; Flos Albiziae contains Herba Albiziae glycoside, tannin, and resolving stagnation for tranquilization, nourishing YIN and invigorating YANG, the appetizing of regulating the flow of vital energy, activating collaterals to relieve pain, for irritability, melancholy insomnia, controls pent-up uncomfortable in chest, and insomnia is forgetful, acute conjunctivitis, energy settling five organs, and will; Radix Polygalae energy mind tranquilizing and the heart calming, is the good merchantable brand of stable mind, the multiplex malaise of controlling disarmony between the heart and kidney, and palpitation with fear is uneasy, the diseases such as insomnia forgetfulness, all medicines share, the agent of the resolving depression that becomes to calm the nerves altogether, the relieving restlessness of nourishing heart.Take a broad view of full side, selected medicinal flavor is gentle, and cold warm compatibility is proper, not warm not dry, and modern pharmacological research has the effect that improves hypothalamus 5-HT level, thereby more effectively prevents and treats depression.Clinical experiment result shows, Traditional Chinese medicine compound composition provided by the invention, and clinical effectiveness is reliable, drug safety, patient dependence is good, and depression is had to good therapeutic effect, is better than the compound recipe that Radix Glycyrrhizae, Semen Tritici aestivi and Fructus Jujubae form, and long-term taking has no side effect.
The specific embodiment
According to following embodiment, the present invention may be better understood.Yet, those skilled in the art will readily understand, the described concrete material proportion of embodiment, process conditions and result thereof be only for the present invention is described, and should also can not limit the present invention described in detail in claims.
Embodiment 1
A compound 1, with Cure of depression effect, it is to be made by the raw material of following parts by weight:
Radix Glycyrrhizae 12g, Semen Tritici aestivi 18g, Fructus Jujubae 9g, Radix Polygalae 10g, Flos Albiziae 10g.
The preparation method 2, with the compound of Cure of depression effect, comprises the following steps:
(1) extracting liquorice 12g, Semen Tritici aestivi 18g, Fructus Jujubae 9g, Radix Polygalae 10g, Flos Albiziae 10g, first adds 10 times of water gagings of medical material gross weight and soaks 1 hour, then decocts 1 hour, medicinal residues add 8 times of amounts again and decoct 1 hour, merge secondary decocting liquid, filter standing 24 hours of filtrate, filter, being concentrated into relative density is 1.14～1.16(60 ℃) clear paste.
(2) get above-mentioned clear paste and add ethanol and make to be 60%, to mix containing alcohol amount, cold preservation 24 hours, filters, and filtrate recycling ethanol is to without alcohol taste, and to be concentrated into relative density be 1.20～1.22(60-65 ℃), standby;
(3) get above-mentioned extractum, in 1:2～3 ratio, add the right amount of auxiliary materials such as dextrin, fluidized bed granulation, granulation.
Embodiment 2
A compound 1, with Cure of depression effect, it is to be made by the raw material of following parts by weight:
Radix Glycyrrhizae 15g, Semen Tritici aestivi 18g, Fructus Jujubae 10g, Flos Albiziae 10g, Radix Polygalae 10g.
The preparation method 2, with the compound of Cure of depression effect, comprises the following steps:
(1) first by weight, extracting liquorice 15g, Semen Tritici aestivi 18g, Fructus Jujubae 10g, Flos Albiziae 10g, Radix Polygalae 10g, add up the water soaking 0.5 hour of 12 times of amounts of medical material for the first time, then decoct 1 time, each 1 hour, the decocting that adds up for the second time 8 times of amounts of medical material boiled 1 time, 2 hours, collecting decoction, filter, standing 24 hours of filtrate, filters, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol and make to be 80%, to mix containing alcohol amount, cold preservation 48 hours, filter, filtrate recycling ethanol is to without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, drying under reduced pressure, add purified water, fill, 10ml/ bottle, 100 ℃ of flowing steam sterilizations 30 minutes, obtain.
Embodiment 3
A compound 1, with Cure of depression effect, it is to be made by the raw material of following parts by weight:
Radix Glycyrrhizae 20g, Semen Tritici aestivi 30g, Fructus Jujubae 10g, Flos Albiziae 20g, Radix Polygalae 10g.
The preparation method 2, with the compound of Cure of depression effect, comprises the following steps:
(1) first extracting liquorice 20g, Semen Tritici aestivi 30g, Fructus Jujubae 10g, Flos Albiziae 20g, Radix Polygalae 10g, the water soaking 1 hour that adds up for the first time 10 times of amounts of medical material, then decocts each 2 hours 1 time, the decocting that adds up for the second time 8 times of amounts of medical material boils 1 time, 1 hour, collecting decoction, filtered, standing 24 hours of filtrate, filter, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol and make to be 70%, to mix containing alcohol amount, cold preservation 48 hours, filters, and filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, drying under reduced pressure, adds starch appropriate, granulate, dry, sieve, add appropriate fluidizer, tabletting, obtains tablet.
Embodiment 4
A compound 1, with Cure of depression effect, it is to be made by the raw material of following parts by weight:
15 parts, Radix Glycyrrhizae, 24 parts of Semen Tritici aestivis, 10 parts, Fructus Jujubae, 15 parts of Flos Albiziaes, 8 parts of Radix Polygalaes.
The preparation method 2, with the compound of Cure of depression effect, comprises the following steps:
(1) first 15 parts of extracting liquorices, 24 parts of Semen Tritici aestivis, 10 parts, Fructus Jujubae, 15 parts of Flos Albiziaes, 8 parts of Radix Polygalaes, the water soaking 0.5 hour that adds up for the first time 12 times of amounts of medical material, then decocts each 1 hour 1 time, the decocting that adds up for the second time 10 times of amounts of medical material boils 1 time, 1 hour, collecting decoction, filtered, standing 24 hours of filtrate, filter, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol and make to be 75%, to mix containing alcohol amount, cold preservation 48 hours, filter, filtrate recycling ethanol is to without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, drying under reduced pressure, add appropriate amount of starch, granulate, dry, encapsulated, obtain capsule.
Embodiment 5
A compound 1, with Cure of depression effect, it is to be made by the raw material of following parts by weight:
Radix Glycyrrhizae 10g, Semen Tritici aestivi 12g, Fructus Jujubae 6g, Flos Albiziae 10g, Radix Polygalae 5g.
The preparation method 2, with the compound of Cure of depression effect, comprises the following steps:
(1) first extracting liquorice 10g, Semen Tritici aestivi 12g, Fructus Jujubae 6g, Flos Albiziae 10g, Radix Polygalae 5g, the water soaking 0.5 hour that adds up for the first time 8 times of amounts of medical material, then decocts each 1 hour 1 time, the decocting that adds up for the second time 10 times of amounts of medical material boils 1 time, 1 hour, collecting decoction, filtered, standing 24 hours of filtrate, filter, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol and make to be 80%, to mix containing alcohol amount, cold preservation 24 hours, filter, filtrate recycling ethanol is to without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, drying under reduced pressure, add appropriate amount of starch, granulate, dry, encapsulated, obtain capsule.
Embodiment 6
1 clinical data
The patients with depression that 1.1 physical data are made a definite diagnosis 100 examples is divided into treatment group and matched group at random.Treatment group 35 examples: male 21 examples, female's 14 examples, year at age (47.4 ± 15.3), the course of disease (8.4 ± 8.6) year, 3 examples that come off (because no longer going to a doctor and come off); Matched group: 1:30 example: male 20 examples, female's 10 examples, year at age (46.1 ± 10.1), the course of disease (6.9 ± 6.1) year, matched group 2:35 example: male 22 examples, female's 13 examples, age (46.5 ± 14.1) year, the course of disease (6.7 ± 6.4) year, 4 examples that come off (because patient is no longer medical and not resistance to side effect comes off).2 groups of patient's physical data compare no difference of science of statistics.All cases are all from Gulou Hospital Attached to Medical College of Nanjing Univ. (the attached drum tower Clinical Medical Institute of Nanjing University of Traditional Chinese Medicine).
The diagnosis of the doctor trained in Western medicine of 1.2 diagnostic criterias and inclusive criteria depression
Standard: every continue depressed more than 2 weeks and possess simultaneously in following 94 with regard to diagnosable be depression.Its syndrome can be summarized as function (first 3), psychology (in 3) and body (latter 3) 3 aspects: to daily routines forfeiture interest or without happiness sense; Energy obviously goes down, causeless lasting tired sense; Psychomotor activity is sluggish or movable obviously to be reduced; Too low or the self-accusation of self evaluation, or has feeling of guilt, can reach vain hope degree; Association's difficulty or conscious ability of thinking significantly decline; Repeatedly there is thoughts of suicide or have suicide; Insomnia, the modal patient of being has difficulty in going to sleep, or early awakening, after waking up, be difficult to again fall asleep, dreaminess; Inappetence or body weight obviously alleviate; Libido obviously goes down.The tcm clinical practice of primary disease shows as absentminded, and malaise is suspicious easily frightened, and sad melancholy is kind cries, being happy and angry uncertainly, or stretch oneself and yawn constantly, or dance for joy.Scolding is scolded and is shouted etc., pale tongue, stringy pulse.Diagnostic tool adopts HAMD (HAMD scale) scoring.Get rid of language and faculty of understanding obstacle, merge the depression that severe cardiac, liver, renal insufficiency, organic psychosis, constitutional depression and other diseases cause, and the person that do not use medicine in accordance with regulations.
2 Therapeutic Method
2.1 treatment groups: the Chinese medicine compound that the embodiment of the present invention 1 preparation provides.1 dose of every day, decocting, minutes 2 times are oral.
2.2 matched groups 1: by Radix Glycyrrhizae 12g, Semen Tritici aestivi 18g, the Chinese medicine compound that Fructus Jujubae 9g forms, prepares by embodiment 1 method, 1 dose of every day, decocting, minutes 2 times are oral.
Matched group 2: oral hydrochloride Fluoxetine capsule (Pharmaceutical Co Ltd, Changzhou Pharmaceutical Factory No.4 produce, 10mg/ sheet) treatment, morning 1 time every day, each 20mg.Be 6 weeks 2 groups of courses for the treatment of.The treatments such as interior other antidepressant of stopping using of research phase, psychosis and electricity tic.
3 observation of curative effect
3.1 efficacy evaluation methods
1,2,4,6 weekends before treatment and after treatment, carry out HAMD scoring, by HAMD, subtract a minute rate and judge curative effect: subtract minute rate >=75% as fully recovering, >=50% for show into, >=25% is progress, < 25% is invalid.The criterion of therapeutical effect of being worked out with reference to Chinese Society of Neurology and Psychiatry by physician and patient completes general curative effect evaluation jointly, and all Measuring scale assessings complete by the attending doctor after Measuring scale assessing training.
3.2 side effect assessment methods
1,2,4, the 6 side effect rating scales (TESS) of looking into psychotropic therapy weekend before treatment and after treatment, and in treatment before and after look blood, urine, stool routine, liver, renal function and electrocardiogram respectively 1 time.
3.3 statistical methods adopt SPSS10.0 statistical software to analyze.Enumeration data adopts chi-square criterion, and measurement data adopts t check.
3.4 therapeutic outcome
3.4.1 total effects evaluation: latter 6 weeks for the treatment of, treatment group effective percentage is 84.3%, matched group 1 effective percentage is 79.4%, contrast: 2 effective percentage are 83.8%, and specific experiment the results are shown in Table 1.
Table 1 treatment group and matched group Clinical efficacy comparison
3.4.2HAMD evaluation result: before 7d, 14d after 2 groups of treatments, 28d, 42d and treatments, HAMD scoring relatively declines, and all has significant differences (P < 0.01), but between group with period there was no significant difference relatively also, in Table 2.Result shows, treatment group and matched group are all along with the prolongation of the course for the treatment of, and HAMD total points significantly reduces, and HAMD subtracts a minute rate and significantly increases.
Before and after table 2 treatment, HAMD scale score changes relatively (x ± s)
3.5 side effect and untoward reaction evaluation result
3.5.1TESS side effect scale evaluation result is in Table 3.Treat 6 weeks, treatment group TESS scoring is (3.6 ± 1.7) minute, and matched group TESS scoring is (12.7 ± 3.5) minute, apparently higher than treatment group, has highly significant difference (P < 0.01).The common untoward reaction for the treatment of group is: constipation (6%), perspire (18%), xerostomia (27%), intense (3%), insomnia (11%) and emotion melancholy (14%), and the symptom of untoward reaction is lighter, without anti symptom treatment; The common untoward reaction of matched group is: xerostomia (45%), constipation (30%), blurred vision (31%), tachycardia (24%), headache (4%).
The comparison of table 3 each course for the treatment of of TESS evaluation result (minute, x ± s)
3.5.2 lab testing treatment group blood, urine, stool routine inspection and electrocardiogram, renal function are not all found obviously abnormal; Matched group has 1 routine ECG ST section to change, and other do not find obviously abnormal.
Above clinical experiment result shows, Traditional Chinese medicine compound composition provided by the invention has the effect of good control depression, and show by contrast and experiment, Traditional Chinese medicine compound composition drug effect provided by the invention is obviously better than Radix Glycyrrhizae, the Chinese medicine compound that Semen Tritici aestivi and Fructus Jujubae form.And Traditional Chinese medicine compound composition untoward reaction provided by the invention is starkly lower than existing fluoxetine Hydrochloride medicine, and clinical application is safer.
The antidepressant effect research of 7 pairs of behavioral despair mices of embodiment
1. materials and methods
1.1 animals: SPF level ICR mice, male and female half and half, body weight 18～22g, freely drinks water and ingests, and animal and feedstuff are purchased from Zhejiang Academy of Medical Sciences Experimental Animal Center.
1.2 medicines and sample configuration
Tested medicine: the embodiment of the present invention 2 and enforcement 3 Traditional Chinese medicine compound compositions that prepare, be diluted to 0.2g, 0.4g before use.0.8g, the medicinal liquid of 1.6g/ml is stand-by.
Matched group 1: the extract that Radix Glycyrrhizae 15g, Semen Tritici aestivi 18g and Fructus Jujubae 10g prepare by embodiment 2 preparation methoies;
Matched group 2: the extract that Radix Glycyrrhizae 20g, Semen Tritici aestivi 30g, Fructus Jujubae 10g prepare by embodiment 3 preparation methoies;
Positive drug group: fluoxetine (fluoxetine, Li Lai Suzhou pharmaceutical Co. Ltd, drug batch number: 9919A, specification 20mg/ capsules) purchased from Nanjing first sign Zai Kang pharmacy, strip before use 3 capsules, add 30ml0.5%CMC-Na solution, grind, suspendible becomes 2mg/ml medicinal liquid stand-by.
1.3 grouping and administrations
By SPF level ICR mice random packet, male and female half and half,, are respectively model group (normal saline) by 10 every group; Positive controls (fluoxetine, 20.0mgkg-1); Embodiment 2 and the enforcement 3 Traditional Chinese medicine compound composition 2g/kg groups that prepare, 4g/kg group, 8g/kg group, 16g/kg group, compound recipe 32g/kg group.Matched group 1 and matched group 2 dosage 32g/kg groups, gavage (ig) administration 0.1ml/10g.
1.4 Tail suspension test
After last administration 1.5h, mouse tail is fixed with clip apart from the about 1cm of end place, it is hung upside down on the cross bar apart from ground 15cm left and right, animal is for overcoming undesired position struggle activity, but after movable a period of time, occur that discontinuity is motionless, show disappointed state, accumulative total is respectively organized the dead time in 6min.
1.5 force mouse swimming test
After last administration 2h, mice is put in to diameter 18cm, depth of water 15cm, in the container that water temperature is 25 ℃, measure the floating motionless time of mice within 6min (be that mice stops struggling in water, or animal is floating state, only has tiny limb motion to keep head to keep afloat).
1.6 date processing
Experimental data all represents with Mean ± SEM, relatively adopts t check between group.
2. experimental result
2.1 Tail suspension test
In classical mouse tail suspension depression model, single gives relative medicine, Traditional Chinese medicine compound composition provided by the invention is 16.0, under 32.0gkg-1 dosage, significantly shorten the mouse tail suspension dead time (P ﹤ 0.05 or P ﹤ 0.01), and effect is better than the compound that Radix Glycyrrhizae, Semen Tritici aestivi and Fructus Jujubae form.Specific experiment result is as table 4.
The impact of table 4 Traditional Chinese medicine compound composition on the motionless experiment of mouse tail suspension
#: compare P<0.01 with model group; *: compare P<0.05 with model group; *: compare P<0.01 with model group
2.2 force mouse swimming test
Mice occurs that in forced swimming model floating motionless state has reflected the desperate behavior of animal, fluoxetine 20.0mgkg-1, Traditional Chinese medicine compound composition provided by the invention is 16.0, under 32.0g crude drug kg-1 dosage, the mice forced swimming dead time can obviously be shortened (P ﹤ 0.06), show that Traditional Chinese medicine compound composition provided by the invention has antidepressant effect on this model, and effect is better than the compound that Radix Glycyrrhizae, Semen Tritici aestivi and Fructus Jujubae form, specific experiment result is as table 5.
The impact of table 5 Traditional Chinese medicine compound composition on the motionless experiment of mice forced swimming
#: compare P<0.01 with model group; *: compare P<0.05 with model group; *: compare P<0.01 with model group
Above experimental result shows, Traditional Chinese medicine compound composition provided by the invention, in the model experiment of mice behavioral despair, has obvious antidepressant effect.
Above embodiment is only explanation technical conceive of the present invention and feature; its object is to allow person skilled in the art understand content of the present invention and implemented; can not limit the scope of the invention with this; all equivalences that spirit is done according to the present invention change or modify, and all should be encompassed in protection scope of the present invention.
Claims (7)
1. a compound with Cure of depression effect, is characterized in that, it is to be made by the raw material of following parts by weight:
10～20 parts, Radix Glycyrrhizae, 12～30 parts of Semen Tritici aestivis, 5～10 parts, Fructus Jujubae, 10～20 parts of Flos Albiziaes, 5～10 parts of Radix Polygalaes.
2. the compound with Cure of depression effect according to claim 1, is characterized in that, it is to be made by the raw material of following parts by weight:
10～15 parts, Radix Glycyrrhizae, 12～24 parts of Semen Tritici aestivis, 6～10 parts, Fructus Jujubae, 10～15 parts of Flos Albiziaes, 5～8 parts of Radix Polygalaes.
3. the compound with Cure of depression effect according to claim 1, is characterized in that, it is to be made by the raw material of following parts by weight:
15 parts, Radix Glycyrrhizae, 18 parts of Semen Tritici aestivis, 10 parts, Fructus Jujubae, 10 parts of Flos Albiziaes, 10 parts of Radix Polygalaes.
4. the compound with Cure of depression effect according to claim 1, is characterized in that, it is to be made by the raw material of following parts by weight:
12 parts, Radix Glycyrrhizae, 18 parts of Semen Tritici aestivis, 9 parts, Fructus Jujubae, 10 parts of Flos Albiziaes, 10 parts of Radix Polygalaes.
5. according to the compound with Cure of depression effect described in claim 1 to 4 any one, it is characterized in that, the extract of each raw material and pharmaceutically acceptable carrier are prepared into granule, powder, tablet, capsule, pill or mixture.
6. the preparation method of the compound with Cure of depression effect described in claim 1 to 4 any one, is characterized in that, comprises the following steps:
(1) first by parts by weight extracting liquorice, Semen Tritici aestivi, Fructus Jujubae, Flos Albiziae, Radix Polygalae described in claims 1 to 3, soak 0.5～1 hour, then the water that adds 6 to 12 times of amounts of medical material weight, decocts each 1～2 hour 2～3 times, collecting decoction, filter, standing 12～24 hours of filtrate, filters, when filtrate is concentrated into 60～65 ℃, the clear paste that relative density is 1.14～1.16;
(2) get the clear paste that step (1) makes, add ethanol make containing alcohol amount be 60%～80%, mix, cold preservation 24～48 hours, filters, and filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.20～1.22 while being concentrated into 60～65 ℃, after drying under reduced pressure, be prepared into granule, powder, tablet, capsule, pill or mixture with pharmaceutically acceptable carrier.
7. the application of the compound with Cure of depression effect described in claim 1 to 4 any one in preparation control depression medicine.
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Application publication date: 20140409 |