CN101711847B - Oral traditional Chinese medicine preparation for treating melancholia and anxiety neurosis - Google Patents
Oral traditional Chinese medicine preparation for treating melancholia and anxiety neurosis Download PDFInfo
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Abstract
The invention relates to an oral traditional Chinese medicine preparation for treating melancholia and anxiety neurosis, which is prepared by adopting the following raw materials of traditional Chinese medicines in parts by weight: 15+/-3 of roasted astragalus root, 10+/-2 of American ginseng, 10+/-2 of white atractylodes rhizome, 10+/-2 of tall gastrodia tuber, 10+/-2 of medlar, 10+/-2 of prepared rehmannia root, 10+/-2 of white peony root, 10+/-2 of radix salviae miltiorrhizae, 10+/-2 of angelica, 10+/-2 of rhizoma ligustici wallichii, 10+/-2 of herba epimedii, 15+/-3 of spine date seed, 10+/-2 of tuckahoe, 10+/-2 of rhizoma anemarrhenae, 10+/-2 of rhizoma cyperi, 10+/-2 of radix bupleuri, 10+/-2 of TurmericRoot-tuber and 6+/-1.2 of roasted licorice. The observation of clinical curative effect proves that the total effective rate of the invention for treating the anxiety neurosis is 92.2%; the total effective rate of the invention for treating the melancholia is 91.0%. The curative effect of the oral traditional Chinese medicine preparation is similar to the curative effect of the western medicines of buspirone for treating the anxiety neurosis and fluoxetine for treating the melancholia. Moreover, the traditional Chinese medicine preparation has no obvious toxic or side effect and can be taken for a long time. The preparation has small dose, easy release of the effective components of the medicine, quick absorption, full exertion of the medicine effect, convenient carrying and easy taking and is beneficial to large-scale production.
Description
Technical field
The present invention belongs to medicinal preparation, a kind of oral Chinese medicine preparation for the treatment of depression, anxiety neurosis that particularly adopts natural material to make.
Background technology
Depression and anxiety neurosis are the principal diseases of harm humans Mental Health, quickening along with modern life rhythm, depression and anxiety neurosis are the gesture that spreads, age of onset descends year by year, morbidity the crowd enlarge year by year, according to World Health Organization's prediction, to the year two thousand twenty, depression will become the second largest disease that is only second to cardiovascular disease.Recently, according to statistics, reach 2,600 ten thousand the morbidity crowd of the various depression of China, wherein teenager has accounted for bigger ratio, and therefore, the research and development antidepressant drug has important economic and social benefit.
Depression and anxiety neurosis resemble a pair of twin brothers, normal sick altogether the existence, are difficult to sometimes differentiate.The sick altogether investigation in the U.S. whole nation finds that the current incidence rate of suffering from depression altogether of generalized anxiety disorder (GAD) patient is 39%, and dysthymia is 22%.Equally, have among the patient of lifelong GAD diagnosis, suffer from depression altogether and account for 62%, suffer from dysthymia altogether and account for 39%, feel the anxiety that weight does not wait and have in the patients with depression up to the people more than 90%.In treatment in the past, often bias toward an aspect.We consider when prescription and want that both are double to control, so, we by using the multiple health of stilbene ginseng, have all obtained curative effect more satisfactorily to depression, anxiety neurosis model and clinical observation on the therapeutic effect.
At present, antidepressant and anxiolytic drugs mainly comprise tricyclic antidepressants, benzene phenodiazine clinically
Chemicalses such as class, serotonin cell reabsorption inhibitor, oxidase inhibitor, though depression and anxiety to various degree have certain therapeutical effect, but also exist the bigger drawback of toxic and side effects, influenced the prolonged application of treatment to a certain extent.Seek effective, safe antidepressant and anxiolytic drugs from natural drug, become the important directions of antidepressant and anxiety research, a large amount of clinical trials has also confirmed antidepressants sexual of plant origin.Aspect the depression and anxiety and related symptoms disease thereof that China's tradition Chinese medicine with application experience in thousand causes at the treatment a variety of causes, the rich experience record is arranged, a large amount of compound recipes and single medicinal material see in the medical works in each period, these prescriptions have also obtained using widely in modern clinical practice, obtain ideal curative effect, obtained affirming of patient.Therefore, from traditional Chinese medicine, research and excavation antidepressant and anxiolytic drugs are shortcuts with Chinese characteristics, help forming the original new drug with independent intellectual property right.Carried out systematic study at the antidepressant in traditional Chinese medicine and the effective compound recipe of anxiety and single medicinal material, through animal experiment screening to multiple compound recipe, found to have the Chinese medicine compound of definite effect, carried out systematic analysis on this basis, effective site and effective ingredient have been found, for the research and development of original new drug are laid a good foundation.
Summary of the invention
The oral Chinese medicine preparation of treatment depression provided by the invention, anxiety neurosis, main effect is nourishing the liver and kidney, replenishing YIN and removing heat, dispersing the stagnated live-QI to relieve the stagnation of QI, tranquilizing by nourishing the heart; In addition, can also regulate the health immune function, improve central nervous system function, effectively eliminate dysphoria, insomnia cardiopalmus, Tidal fever with perspiration, headache and dizzy etc.The proved recipe of clinical life-time service was a decoction in the past, and patient takes and carry very inconvenient, had prepared a kind of taking with easy to carry for this reason, stable in properties, and quality controllable, the Chinese medicinal capsule agent of determined curative effect is for clinical use.
The present invention realizes by the following technical solutions:
A kind of oral Chinese medicine preparation for the treatment of depression, anxiety neurosis, it adopts the raw material of Chinese medicine of following weight parts to make: Radix Astragali Preparata 15 ± 3, Radix Panacis Quinquefolii 10 ± 2, the Rhizoma Atractylodis Macrocephalae 10 ± 2, Rhizoma Gastrodiae 10 ± 2, Fructus Lycii 10 ± 2, Radix Rehmanniae Preparata 10 ± 2, the Radix Paeoniae Alba 10 ± 2, Radix Salviae Miltiorrhizae 10 ± 2, Radix Angelicae Sinensis 10 ± 2, Rhizoma Chuanxiong 10 ± 2, Herba Epimedii 10 ± 2, Semen Ziziphi Spinosae 15 ± 3, Poria 10 ± 2, the Rhizoma Anemarrhenae 10 ± 2, Rhizoma Cyperi 10 ± 2, Radix Bupleuri 10 ± 2, Radix Curcumae 10 ± 2, Radix Glycyrrhizae Preparata 6 ± 1.2.
This prescription is the prescription of treatment asthenia insomnia, GUIXIN, Liver Channel.Radix Panacis Quinquefolii, Radix Astragali strengthening the body resistance in the side, enhancing human body immunity power; Radix Rehmanniae Preparata, Fructus Lycii, the strong waist kidney tonifying of Herba Epimedii are monarch drug altogether.Radix Panacis Quinquefolii, the spleen reinforcing of Radix Astragali QI invigorating are assisted in the Rhizoma Atractylodis Macrocephalae, Poria spleen invigorating eliminating dampness by diuresis; Radix Angelicae Sinensis, the Radix Paeoniae Alba are nourished blood and seek and be ministerial drug.The Rhizoma Gastrodiae suppressing the hyperactive liver to relieve the wind syndrome, it is dizzy to be used to have a headache; But Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Rhizoma Anemarrhenae YIN nourishing are transferred liver, the pathogenic fire purging heat clearing away, and blood-activating and qi-promoting, making it tonify without causing stagnation is adjuvant drug.The Semen Ziziphi Spinosae tranquillizing and allaying excitement, tonifying liver nourishes heart; Be used for restlessness of asrhenia type and insomnia, palpitation with fear dreaminess, staring spells; Radix Bupleuri, Radix Curcumae, Rhizoma Cyperi dispersing the stagnated live-QI to relieve the stagnation of QI, regulating the flow of vital energy is messenger drug.The card of we's insufficiency of vital energy and blood of controlling, with shortness of breath and fatigue, palpitation and insomnia is had a dizzy spell, light red tongue, thready pulse without strength is a primary symptom.Pathogenesis causes QI and blood deficiency for lacking of proper care after being ill, and the heart is become homeless foster, and suitable vigorate qi and replenish the blood is controlled in the liver Tibetan of becoming homeless.Advantage of the present invention is a pure Chinese medicinal preparation, has that strengthening the body resistance, arresting convulsion are calmed the nerves, benefiting QI and nourishing blood, keeps fit the effect of beneficial will, kidney-tonifying and brain tonic.Can improve the cell and the humoral immune function of body, resisting fatigue, anti-stress promotes body recovery.Cure mainly many anxious kind worries, emotional lability, psychentonia, anxiety agitation, dizziness headache, insomnia and dreamful sleep, extremity asthenia, the lazy speech of breathing hard, inappetence, severe palpitation etc.Be used for insomnia, depression and anxiety neurosis that a variety of causes causes.So, every because of in void can not train liver, liver-yin lose to be supported, heart Trouble insomnias etc. all can select for use we to treat.
Preparation dose of the present invention is little, and effective ingredient is easy to discharge, absorb soon, and the bioavailability height, messenger drug usefulness is enough given full play to.This volumes of formulation is little, is easy to carry, and preserves and takes conveniently.And can be mass-produced.
The specific embodiment
The present invention realizes by the following technical solutions: the Chinese crude drug of this Chinese medicine preparation is formed and consumption is: Radix Astragali Preparata 15g, Radix Panacis Quinquefolii 10g, Rhizoma Atractylodis Macrocephalae 10g, Rhizoma Gastrodiae 10g, Fructus Lycii 10g, Radix Rehmanniae Preparata 10g, Radix Paeoniae Alba 10g, Radix Salviae Miltiorrhizae 10g, Radix Angelicae Sinensis 10g, Rhizoma Chuanxiong 10g, Herba Epimedii 10g, Semen Ziziphi Spinosae 15g, Poria 10g, Rhizoma Anemarrhenae 10g, Rhizoma Cyperi 10g, Radix Bupleuri 10g, Radix Curcumae 10g, Radix Glycyrrhizae Preparata 6g.
The present invention adopts the Chinese medicinal capsule agent, and content is a chocolate brown powder, bitter in the mouth, little perfume (or spice).0.3g/ grain, its usage and dosage is: oral, and the each 3-4 grain of usual amounts, every day 3 times.
1, Chinese medicinal capsule agent clinical treatment anxiety neurosis observation of curative effect
The physical data case is selected from December, 2006～2008 year June the mental sickness centre of prevention and cure outpatient service prescription on individual diagnosis patient of the court entire PLA, selected patient all meets CCMD-3 and the diagnostic criteria of DSM-IV generalized anxiety disorder, Manifest Anxiety Scale (HAMARS) score 〉=18, no physical disease and brain organic disease, get rid of other mental sickness, use the benzene phenodiazine in the treatment instead
Class person rejects.Handle difference by treatment, be divided into Chinese medicinal capsule agent group and buspirone group.Chinese medicinal capsule agent group: 64 examples, male 28 examples, women 36 examples, year mean age (35.24 ± 11.58), minimum 25 years old, maximum 50 years old; Average course of disease (8.6 ± 5.7) moon, the shortest 6 months, the longest 17 months.Buspirone group: 54 examples, male 23 examples, women 31 examples, year mean age (36.22+11.17), minimum 24 years old, maximum 51 years old; Average course of disease (8.7 ± 5.4) moon, the shortest 5 months, the longest 18 months.Physical data is learned (X 2 test and t check) processing difference by statistics between two groups does not have significance (P＞0.05), has comparability.
Method Chinese medicinal capsule agent group, each 3, every day 3 times; Buspirone (5mg/ sheet) group, first every day in week, 15～20mg divided clothes three times.The 2nd～6 the week every day 30mg, divide clothes three times, be for 6 weeks two groups of courses of treatment.
Curative effect assessment clinical efficacy is evaluated by China's existing " mental sickness efficacy assessment standard ", evaluation criteria divides level Four: recovery from illness (mental symptom complete obiteration), produce effects (cardinal symptom disappearance), effectively (sx or part disappear), invalid (symptom do not have improve or increase the weight of), each evaluation of before the treatment and treatment back (the 6th week) once.After administration, carry out HAMAR 50% and 6 week back CGI-I Clinical Global Impression scorings respectively weekly, the HAMAR score subtract the branch rate 50% or more or the CGI-I scoring be 1 minute (produce effects) or 2 minutes (effectively), evaluate by two psychiatric department doctors with long years of standing and rich experience.Before treatment, contrast with the laggard promoting the circulation of blood of treatment, routine urinalysis, liver function, kidney merit, blood glucose, electrocardiogram, electroencephalogram, body weight, blood pressure determination.
Statistical analysis total data SPSS11.0 software analysis is with mean+SD (x ± s) expression.The group difference one factor analysis of variance, the curative effect X 2 test.
The result
The curative effect assessment is through the treatment of 6 weeks, and two groups are all obtained obvious curative effects, and its clinical efficacy is learned by statistics and handled there was no significant difference (p＞0.05).See Table 1.
Agent of table 1 Chinese medicinal capsule and buspirone clinical efficacy are relatively
Annotate: compare p＞0.05 between group
HAMA depression scale and CGI scale evaluation result, two groups through 6 week treatment back HAMA, and than subtracting branchs obvious (p＜0.01) before the treatment, the CGI score is less than 2 more than 90%, and therapeutic effect is sure, compares there was no significant difference between two groups.(p＞0.05) sees Table 2.
Agent of table 2 Chinese medicinal capsule and buspirone HAMA and CGI scale evaluation result
Annotate: preceding relatively a represents (p＜0.01) with treatment, and compare between group: b represents that (p＜0.05, c represent (p＞0.05)
Untoward reaction comparison Chinese medicinal capsule agent group in treatment untoward reaction 6 examples occur and accounts for (9.52%), and the buspirone group has 16 examples and accounts for (29.62%), and two groups relatively have significant difference (p＜0.01), and two groups are not had serious adverse reaction, see Table 3.No abnormality seens such as two groups of blood of lab testing, routine urinalysis, liver function blood glucose change.Chinese medicinal capsule agent group sinus tachycardia 2 examples, sinus bradycardia 1 example.ECG change 5 examples appear in the buspirone group, performance sinus tachycardia 4 examples, right bundle branch block 1 example.Two groups are not all had serious ECG change.
Agent of table 3 Chinese medicinal capsule and buspirone untoward reaction are relatively
Annotate: represent (p＜0.01) than b between group
2, Chinese medicinal capsule agent clinical treatment depression observation of curative effect
Depression is a kind of common mental sickness, and morbidity is increases trend, has a strong impact on patient's ability to work and quality of life, and committing suiside can appear in weight person.Bring serious adverse consequences for I, family and society.Therefore, the treatment of depression has been the important topic that clinical medicine and society pay attention to.In recent years, novel antidepressant thing 5-HT reuptake inhibitor (SSRI) is constantly come out, pharmacological action 5-HT reuptake inhibitor is main, because of untoward reaction, price is expensive partially, clinical practice is restricted, have not yet to see the sure antidepressant pure Chinese medicinal preparation of curative effect, this Chinese medicinal capsule agent is a pure Chinese medicinal preparation, clinical practice obtains obvious curative effects, do not see tangible untoward reaction, for further observing its clinical efficacy and safety, we compare with the classical medicine fluoxetine of the depression of domestic extensive use.
Object and method
The object case is that in December, 2006～2007 year April is I the mental sickness centre of prevention and cure inpatient of the entire PLA of institute, totally 65 examples, male 27 examples, women 38 examples, 25～50 years old age, average 33 ± 13.58 years old, meet CCCMD-3 and the diagnostic criteria of DSM-IV depression, HAMD depression scale (HAMDRS) score 〉=20, no physical disease, the brain organic disease, the course of disease 1～38 month, average 8 ± 8.7 months.Two groups in sex, the age, and the course of disease, there was no significant differences such as type (p＞0.05) see Table 1
Table 1 physical data relatively
Annotate: compare x between group
2Check.
bp＞0.05
Method 65 routine patients are divided into two groups at random by the time of being admitted to hospital, Chinese medicinal capsule agent group 33 examples, fluoxetine group 32 examples.Medication: administration after a week cleans, each 4 of Chinese medicinal capsule agent group, every day 3 times, fluoxetine group 20mg every day once obeys the morning.Be for 6 weeks two groups of courses of treatment.
Curative effect assessment clinical efficacy is evaluated by China's existing " mental sickness efficacy assessment standard ", evaluation criteria divides level Four: recovery from illness (mental symptom complete obiteration), produce effects (cardinal symptom disappearance), effectively (sx or part disappear), invalid (symptom does not have improvement or increases the weight of).The scale evaluation, each evaluation of before the treatment and treatment back once.Carry out HAMDRS, CGI (Clinical Global Impression), TESS (side reaction scale) evaluation respectively.By two psychiatric department doctor with long years of standing and rich experience evaluations, concordance is preferably arranged, Kappa coefficient=0.78.Before treatment, contrast with the laggard promoting the circulation of blood of treatment, routine urinalysis, liver function, kidney merit, blood glucose, electrocardiogram, electroencephalogram, body weight, blood pressure determination.
The result
The curative effect assessment is through the treatment of 6 weeks, and two groups are all obtained obvious curative effects, and its clinical efficacy is learned by statistics and handled there was no significant difference (p＞0.05).See Table 2.
Agent of table 2 Chinese medicinal capsule and fluoxetine clinical efficacy are relatively
Compare between group,
aP＞0.05
HAMD depression scale and CGI scale evaluation result, two groups are divided all than have clear improvement before treating (p＜0.01) through 6 week treatment back HAMD and CGI.Compare there was no significant difference (p＞0.05) between two groups.Chinese medicinal capsule agent and fluoxetine therapeutic equivalence are described.The results are shown in Table 3.
Agent of table 3 Chinese medicinal capsule and fluoxetine HAMD depression scale and CGI scale evaluation result
Annotate: relatively preceding with the treatment of this group,
dP＜0.01; Compare with the fluoxetine group
eP＞0.05
Untoward reaction is Chinese medicinal capsule agent group 8 (15.1%) in treatment relatively, and there have 3 examples to occur to be drowsy, 2 routine sleepy senses, and 3 routine weight increase are not seen other untoward reaction.The fluoxetine group has 12 (37.5%) examples and untoward reaction occurs, two groups relatively have significant difference (p＜0.01), main clinical manifestation from the untoward reaction of TESS scale, fluoxetine is mainly the cholinolytic side reaction: xerostomia, blurred vision, headache, insomnia etc., the tolerance of patient's multipotency, need not special handling, major part is died away.The Chinese medicinal capsule agent does not then have the anticholinergic side reaction, and two groups are not all had serious adverse reaction.
Two groups of untoward reaction of table 4 Chinese medicinal capsule agent group (n=33) and fluoxetine group (n=32) are (routine number) relatively
No abnormality seens such as two groups of blood of lab testing, routine urinalysis, liver function blood glucose change.
Chinese medicinal capsule agent group sinus tachycardia 2 examples, sinus bradycardia 1 example.ECG change 5 examples appear in the fluoxetine group, performance sinus tachycardia 4 examples, right bundle branch block 1 example.Two groups are not all had serious ECG change.
Is 92.2% by the agent of above clinical observation on the therapeutic effect proof Chinese medicinal capsule to anxiety neurosis treatment total effective rate, equates (p＞0.01) with the Western medicine buspirone curative effect of treatment anxiety neurosis.And the Chinese medicinal capsule agent does not have obvious toxic and side effects.The Chinese medicinal capsule agent is 91.0% to the treating depression total effective rate, equates (p＞0.01) with the Western medicine fluoxetine curative effect of treatment depression.And the Chinese medicinal capsule agent do not have obvious toxic and side effects, can take for a long time.
The Chinese medicinal capsule agent is through the acute toxicity mtd test, the day maximum tolerated dose of this medicine mouse stomach administration is 39.0g/kg, because the every gram medicated powder of this medicine is equivalent to crude drug 2.3g, so the day maximum tolerated dose of this medicine mouse stomach administration is 89.7g crude drug/kg, being equivalent to approximately to be grown up, (650 times of 0.138g crude drug/kg) show that it is safe that this medicine uses to clinical consumption per day in the clinical dose scope of regulation.
Claims (2)
1. an oral Chinese medicine preparation for the treatment of depression, anxiety neurosis is characterized in that adopting the raw material of Chinese medicine of following weight parts to make: Radix Astragali Preparata 15 ± 3, Radix Panacis Quinquefolii 10 ± 2, the Rhizoma Atractylodis Macrocephalae 10 ± 2, Rhizoma Gastrodiae 10 ± 2, Fructus Lycii 10 ± 2, Radix Rehmanniae Preparata 10 ± 2, the Radix Paeoniae Alba 10 ± 2, Radix Salviae Miltiorrhizae 10 ± 2, Radix Angelicae Sinensis 10 ± 2, Rhizoma Chuanxiong 10 ± 2, Herba Epimedii 10 ± 2, Semen Ziziphi Spinosae 15 ± 3, Poria 10 ± 2, the Rhizoma Anemarrhenae 10 ± 2, Rhizoma Cyperi 10 ± 2, Radix Bupleuri 10 ± 2, Radix Curcumae 10 ± 2, Radix Glycyrrhizae Preparata 6 ± 1.2.
2. a kind of oral Chinese medicine preparation for the treatment of depression, anxiety neurosis according to claim 1 is characterized in that adopting the raw material of Chinese medicine of following weight parts to make: Radix Astragali Preparata 15, Radix Panacis Quinquefolii 10, the Rhizoma Atractylodis Macrocephalae 10, Rhizoma Gastrodiae 10, Fructus Lycii 10, Radix Rehmanniae Preparata 10, the Radix Paeoniae Alba 10, Radix Salviae Miltiorrhizae 10, Radix Angelicae Sinensis 10, Rhizoma Chuanxiong 10, Herba Epimedii 10, Semen Ziziphi Spinosae 15, Poria 10, the Rhizoma Anemarrhenae 10, Rhizoma Cyperi 10, Radix Bupleuri 10, Radix Curcumae 10, Radix Glycyrrhizae Preparata 6.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101890135B (en) * | 2010-07-12 | 2011-11-09 | 浙江工业大学 | Antidepressant traditional Chinese medicine composition and application thereof |
| CN102198253B (en) * | 2011-05-27 | 2012-09-05 | 上海市中医医院 | Traditional Chinese medicine composition for resisting depression, and preparation method as well as application thereof |
| CN102327557A (en) * | 2011-09-10 | 2012-01-25 | 田开勇 | Anxiety-removing calming traditional Chinese medicine decoction for treating anxiety neurosis |
| CN102552436B (en) * | 2012-01-10 | 2014-05-07 | 上海市中医医院 | Medicine for treating anxiety and depressive disorder as well as application of medicine |
| CN103520640B (en) * | 2013-10-17 | 2015-04-08 | 王锦蓉 | Traditional Chinese medicine for treating depression |
| CN105999078A (en) * | 2016-06-28 | 2016-10-12 | 邓子永 | Traditional Chinese medicine preparation for treating depression, capsule and preparation method thereof |
| CN115475221A (en) * | 2021-05-31 | 2022-12-16 | 邬浩荣 | Traditional Chinese medicine and oral liquid for giving up mental drugs |
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| CN1682989A (en) * | 2005-02-21 | 2005-10-19 | 李有田 | Chinese medicine for treating depression |
| CN101015654A (en) * | 2007-03-07 | 2007-08-15 | 中国人民解放军第三医院 | Oral traditional Chinese medicine preparation for treating depression and dysphoria |
| CN101244208A (en) * | 2008-03-25 | 2008-08-20 | 中国人民解放军第三医院 | Method of preparing traditional Chinese medicine preparation for treating melancholia and anxiety neurosis |
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| CN1682989A (en) * | 2005-02-21 | 2005-10-19 | 李有田 | Chinese medicine for treating depression |
| CN101015654A (en) * | 2007-03-07 | 2007-08-15 | 中国人民解放军第三医院 | Oral traditional Chinese medicine preparation for treating depression and dysphoria |
| CN101244208A (en) * | 2008-03-25 | 2008-08-20 | 中国人民解放军第三医院 | Method of preparing traditional Chinese medicine preparation for treating melancholia and anxiety neurosis |
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