CN101816766B - Chinese medicinal composition for treating tristimania - Google Patents
Chinese medicinal composition for treating tristimania Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating tristimania, which is prepared into certain formulations by taking curcuma longa, St John's wort and ginseng as raw materials, and extracting and separating the raw materials by using 0-75 percent ethanol. An animal toxicity test result shows that 284 times of an adult dosage of the medicinal composition for lavaging a mouse causes no acute toxicity reactions; a pharmacodynamic study shows that the medicinal composition can significantly perform antagonism on acinesia and hypothermia, induced by reserpoid, of a tristimania model mouse, and can increase the number of autonomic activities and the dead time for tail suspension and swimming, induced by the tail suspension and forced swimming, of a desperate animal model. A clinical research result shows that by adopting a Hamilton rating scale for depression (HAMD) to evaluate the depression severity which serves as the primary therapeutic effect index, a treatment group obtains a significant curative effect, the effective rate is 92.3 percent, and compared with a control group, the medicinal composition has significant differences but has no toxic and side effects. The medicinal composition can be prepared into medically acceptable oral preparations, such as tablets, capsules (soft capsules or hard capsules), granules and the like; and the clinical curative effect and the pharmacodynamic study prove that the medicinal composition has the functions of smoothing the liver to alleviate mental depression and relieving mental stresses, and is an effective special medicament for treating the tristimania.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of medicine for the treatment of depression, specifically the Chinese medicine composition of forming by Rhizoma Curcumae Longae, Herba Hyperici perforati, Radix Ginseng.
Background technology
Depression is a kind of common emotion and mental disorder disease, and along with the quickening of social life rhythm, depression has become the disease occurred frequently of current society.World Health Organization's statistics in 2005, the prevalence of various depressions accounts for 11% of global population.Show that according to China's Epidemiological study in 2003 China has 3,600 ten thousand patients with depression at least, wherein only has 5% severe patient to accept associated treatment.Many serious symptom patients with depression are arranged because of in time not carrying out the regular treatment committed suicide.According to death toll in 2003 according to one's analysis, China has 28.7 ten thousand population committed suicides every year at least.Suicide is the 5th cause of the death in the population of China, is first cause of the death of 15～34 years old crowd.Therefore, the drug research of reinforcement treatment depression has important society and economic implications.
Treatment for depression, at present doctor trained in Western medicine adopts 5-hydroxy tryptamine reuptake depressant, monoamine oxidase inhibitor, phenyl piperazines, 5-hydroxy tryptamine-norepinephrine reuptake inhibitor, aminoketones, tricyclic antidepressants, Fourth Ring sends 7 class antidepressants such as piperazine azatropylidene class more, but synthetic antidepressants exist mostly that the antidepressant spectrum is narrow, toxic and side effects big, the medicine valency high and defective such as easy recurrence.Therefore, both at home and abroad aspect exploitation, more and more pay attention to traditional drugs (more than 2,000 year historical Chinese herbal medicine particularly arranged), even also truly have some the traditional drugs of curative effect as main force's medicine for the treatment of depression with the American-European countries that the exploitation synthetic drug is good in the development of antidepressants.
Depressed card belongs to the melancholia category of the traditional Chinese medical science, and disease is complicated and changeable, and the most common be Liver depression and Qi stagnation, how to cause owing to feelings will is upset, and its pathogenesis ought be aspect two of deficiency of heart-QI and depression of liver-QI.Medicine many based on regulate the flow of vital energy, eliminate the phlegm, calm the nerves, have one's ideas straightened out, class such as invigorating the heart and spleen.Chinese medicine compound has the advantages that composition is many, the effect link is many, target spot is many, and multicomponent synergism, has remedied the low characteristics of active constituent content, has reduced side effect.Therefore, development antidepressant good effect, side effect little, be fit to take for a long time and safe and reliable Chinese medicine composition has become current research focus.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition and preparation thereof that is used for the treatment of depression.
The present invention treats the pharmaceutical composition of depression, and raw materials used weight proportion can be 0.5～2 part in Rhizoma Curcumae Longae, 0.8～2.5 part of Herba Hyperici perforati, 0.5～2 part of Radix Ginseng.
Aforementioned pharmaceutical compositions is taken after can decocting, also can water or ethanol extraction after take.
The preparation method of drug combination preparation of the present invention can adopt the conventional method of pharmaceutical field, uses conventional pharmaceutic adjuvant to carry out.For example adopt conventional method that carrier or adjuvant commonly used on extract and any one or more than one pharmaceutics are mixed, make various peroral dosage forms then.Described carrier is excipient, filler, diluent, lubricant, wetting agent, disintegrating agent, surfactant, antiseptic, sweeting agent, aromatic etc. for example.Particularly, for example starch, dextrin, lactose, microcrystalline Cellulose, hydroxypropyl methylcellulose, Polyethylene Glycol, magnesium stearate, micropowder silica gel, glucose, mannitol, xylitol, glycine etc. of described carrier.
As required, pharmaceutical composition of the present invention can be made into the preparation that is suitable for oral medication, can be following arbitrary dosage form: tablet, capsule, soft capsule, granule, drop pill, dispersible tablet, oral cavity disintegration tablet, pill, oral liquid etc.
Another object of the present invention is that a kind of preferred manufacturing procedure also is provided, and the preparation method of the Chinese medicine composition of treatment depression or depressive state promptly is provided, and this method comprises the steps:
Select 0.5～2 part in Rhizoma Curcumae Longae for use, 0.8～2.5 part of Herba Hyperici perforati, 0.5～2 part of Radix Ginseng adds 0～70% ethanol, extracts 2～3 times, adds 4～12 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and also concentrates, and drying is pulverized, as the raw material of composite preparation.
Another purpose of the present invention is to have proved the application of this pharmaceutical composition at aspects such as treatment depressions.The present invention's three medicines share, and have the function of soothing liver-QI for relieving depression, mind tranquilizing and the heart calming.The pharmacological research of the compositions that this side is extracted shows that said composition all has the anti-inhibitory action of specificity to multiple depression model, and the monoamine neurotransmitter in the depressed animal brain that can significantly raise, and monoamine transmitters is exhausted due to the antagonism reserpine.
The specific embodiment
For the present invention is further described in detail, provide specific embodiment, but only the present invention is illustrated in conduct, rather than in order to limit the scope of the invention.
The granule dosage form of embodiment 1 pharmaceutical composition of the present invention
Adopt conventional preparation granule method, get 0.5 part in Rhizoma Curcumae Longae, 0.8 part of Herba Hyperici perforati, 0.5 part of Radix Ginseng is soaked after 0.5 hour and is extracted 2 times, and amount of water is respectively 10 times, 8 times, extracted 2 hours for the first time, extracted 1.5 hours for the second time, filter, merging filtrate, concentrate, dry, add right amount of auxiliary materials, mixing after pulverizing, granulate, sieve, drying makes the drug combination preparation of granule dosage form.
The Tabules of embodiment 2 pharmaceutical compositions of the present invention
Adopt the conventional method for preparing tablet, get 1 part in Rhizoma Curcumae Longae, 1 part of Herba Hyperici perforati, 1 part of Radix Ginseng adds 70% soak with ethanol and extracts 2 times after 0.5 hour, and amount of water is respectively 6 times, 4 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter, merging filtrate, concentrate, dry, add right amount of auxiliary materials, mixing after pulverizing, granulate, sieve drying, through further tabletting, drying promptly makes the drug combination preparation of Tabules with the granule that makes.
The capsule dosage form of embodiment 3 pharmaceutical compositions of the present invention
Adopt the conventional method for preparing capsule, get 2 parts in Rhizoma Curcumae Longae, 1.5 parts of Herba Hyperici perforatis, 2 parts of Radix Ginsengs, add 60% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times, extracts 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, mixing is granulated, sieve, drying incapsulates shell with the granule that makes, make capsule, promptly make the drug combination preparation of capsule formulation.
The drops of embodiment 4 present compositions
Preparation: the technology that adopts conventional preparation drop pill, get 1 part in Rhizoma Curcumae Longae, 2.2 parts of Herba Hyperici perforatis, 1 part of Radix Ginseng adds 50% soak with ethanol and extracts 2 times after 0.5 hour, and amount of water is respectively 6 times, 4 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the drop pill of this pharmaceutical composition.
The soft capsule dosage form of embodiment 5 present compositions
Preparation: adopt the technology of conventional preparation soft capsule, get 1.5 parts in Rhizoma Curcumae Longae, 1.5 parts of Herba Hyperici perforatis, 2 parts of Radix Ginsengs, add 50% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times, extracts 2 hours for the first time, extracted 1 hour for the second time, filter, merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, mixing, make capsule casing material with gelatin, be pressed into soft capsule, make the soft capsule of this pharmaceutical composition.
The micropill dosage form of embodiment 6 present compositions
Preparation: the technology that adopts conventional preparation micropill, get 1 part in Rhizoma Curcumae Longae, 1 part of Herba Hyperici perforati, 1.5 parts of Radix Ginsengs add 50% soak with ethanol and extract 2 times after 0.5 hour, and amount of water is respectively 6 times, 4 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the micropill of this pharmaceutical composition.
The oral cavity disintegration tablet of embodiment 7 present compositions
Preparation: the technology that adopts conventional preparation oral cavity disintegration tablet, get 1.5 parts in Rhizoma Curcumae Longae, 1.5 parts of Herba Hyperici perforatis, 2 parts of Radix Ginsengs add 50% soak with ethanol and extract 2 times after 0.5 hour, and amount of water is respectively 6 times, 4 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the oral cavity disintegration tablet of this pharmaceutical composition.
The dispersible tablet of embodiment 8 present compositions
Preparation: the technology that adopts conventional preparation dispersible tablet, get 1 part in Rhizoma Curcumae Longae, 0.8 part of Herba Hyperici perforati, 2 parts of Radix Ginsengs add 70% soak with ethanol and extract 2 times after 0.5 hour, and amount of water is respectively 6 times, 4 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the dispersible tablet of this pharmaceutical composition.
The test of pesticide effectiveness of embodiment 9 present compositions
The purpose of this test is to observe the therapeutical effect of the present composition to the mice depression model.Present composition A, B, C all adopt extractum, and the time spent is prepared desired concn with pure water, and other reagent chemicalses have the reserpine injection, 1mg/ml, and lot number: 081017 people pharmaceutical Co. Ltd of Guangdong nation produces.Fluoxetine, specification 20mg/ sheet, lot number: A509291, LillyS.A produces.
Compositions A: get 2 parts in Rhizoma Curcumae Longae, 2.2 parts of Herba Hyperici perforatis, 2 parts of Radix Ginsengs, add 70% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times, extracts 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, drying gets compositions A dry extract after the pulverizing.
Compositions B: get 1 part in Rhizoma Curcumae Longae, 1 part of Herba Hyperici perforati, 1 part of Radix Ginseng, add 50% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 8 times, 6 times, extracts 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, drying gets compositions B dry extract after the pulverizing.
Compositions C: get 0.5 part in Rhizoma Curcumae Longae, 0.8 part of Herba Hyperici perforati, 0.5 part of Radix Ginseng is soaked after 0.5 hour and is extracted 2 times, and amount of water is respectively 12 times, 10 times, extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate, concentrate, drying gets compositions C dry extract after the pulverizing.
Laboratory animal: male ICR mouse is provided by west, Shanghai pul-Bi Kai laboratory animal company limited.Laboratory animal production licence number: SCXK (Shanghai) 2008-0016.The laboratory animal environmental facility quality certification number: SYXK (Hunan) 2009-0001.
This test data is all with the EXCEL software processes.
Experimental apparatus: ZZ-6 mice autonomic activities instrument, Chengdu TME Technology Co., Ltd.
1, to the influence of the depression model mice of reserpine induction
(1) to the depression model mice behavioristics of reserpine induction and the influence of body temperature
1) to the depression model mice lapsus palpebrae superioris of reserpine induction and motion can not behavior influence
Get ♂ ICR mice, SPF level, 100, body weight 18-22g is divided into 5 groups at random, 20 every group: promptly blank group, model group, prozac 0.013g/kg group, the present invention 0.2,0.4,0.8g/kg group, every day, gastric infusion was 1 time, and blank group gives the equal-volume pure water with model group, irritate the long-pending 20ml/kg of being of body of stomach, successive administration 25 days.Lumbar injection reserpine 4mg/kg in the time of administration in the 22nd day, 1h, 2h, 6h are put in animal and observe the number of animals that eye alkali is closed in each group on the support behind the injection reserpine, and relatively eye alkali closes and close the difference degree (eye alkali closes and close grade scoring standard reference Xu Shuyun chief editor " pharmacological experimental methodology " P809 page or leaf) of grade between each group.And after to reserpine 2h, 4h, 6h, animal is prevented referring to central authorities in vain in the circle of diameter 7.5cm, observed 15 seconds, write down each treated animal and still stayed in the interior number of animals of circle in 15 seconds, and carry out the statistical processing.
The influence of the depression model mice catacleisis degree of table 1 pair reserpine induction (x ± S, n=20)
Annotate with model group and compare
*P＜0.05,
*P＜0.01.
As known from Table 1, with model group relatively, after the administration of fluoxetine group 1, the 2h animal eyelid degree of closing significantly reduces, difference has statistical significance (P＜0.05 or P＜0.01); After the administration of compositions A, B, C group 1, the 2h animal eyelid degree of closing significantly reduces, difference has statistical significance (P＜0.05).Prompting, compositions A, B, C have the effect of the depression model mice catacleisis degree that reduces reserpine induction.
Depression model mice zero paper of table 2 pair reserpine induction go too far rate influence (x ± S, n=20)
Annotate: compare with the blank group,
#P＜0.05,
##P＜0.01; Compare with model group
*P＜0.05,
*P＜0.01.
As known from Table 2, with the blank group relatively, the model group animal zero paper rate (2h, 4h, 6h behind the medicine) that goes too far significantly is reduced to 40% (P＜0.01), shows the modeling success.With model group relatively, the fluoxetine group behind medicine 2, the 4h zero paper rate number of animals that goes too far significantly increases, through X
2Check difference has statistical significance (P＜0.01); Compositions A, B, C organize in 2,4h zero paper goes too far number of animals and percentage rate all significantly increases, through X
2Check difference has statistical significance (P＜0.05 or P＜0.01).Prompting, compositions A, B, C have the go too far effect of rate of depression model mice zero paper that increases reserpine induction.
2) influence that the depression model mouse temperature of reserpine induction is reduced
Grouping is the same with administration.The 22nd day administration before measurement basal body temperature (anus temperature); Administration is lumbar injection reserpine 4mg/kg simultaneously, and 6h, 24h survey the anus temperature respectively 1 time behind the injection reserpine.Calculate administration front and back body temperature and self body temperature difference, relatively with t check carrying out statistics.
The influence of the depression model mouse temperature of table 3 pair reserpine induction (℃, x ± S, n=20)
Annotate: compare before and after the administration (modeling)
▲P＜0.05,
▲ ▲P＜0.01.
Relatively, compare between group with model group
*P＜0.05,
*P＜0.01. compares with blank group
#P＜0.05,
##P＜0.01.
As known from Table 3, injection reserpine modeling in the time of the last administration, with the blank group relatively and modeling (administration) preceding self relatively, model group after modeling 6,24h body temperature significantly reduces, difference has statistical significance (P＜0.01), shows that model is successful.Fluoxetine group and model group compare, and 6h, 24h body temperature obviously raise after the animal drugs, and difference has statistical significance (P＜0.05); Modeling (administration) is preceding self compares, difference not statistically significant (P＞0.05), and prompting, fluoxetine has the effect of elevation model animal heat.Compositions A, B, C group compare with model group, 6h behind medicine, body temperature obviously raises, difference has statistical significance (P＜0.05 or P＜0.01), modeling (administration) is preceding self compares, difference not statistically significant (P＞0.05), prompting compositions A, B, C have the effect of elevation model animal heat.
2, to the influence of acquired desperate model mice
1) to acquired desperate model mice spontaneous activity and the influence of outstanding tail dead time
Get 90 of ♂ ICR mices, SPF level, body weight 18-22g, be divided into 6 groups at random, every group 15: promptly blank group, model group, prozac 0.013g/kg group, the present invention 0.2,0.4 the 0.8g/kg group is except that the blank group, other are respectively organized in the 1st day every Mus of experiment and hang tail test and mandatory swimming test in advance, to induce depression model.In inductive the 2nd day beginning gastric infusion, the blank group gave the equal-volume pure water with model group, irritated the long-pending 20ml/kg of being of body of stomach, and administration every day 1 time also repeats outstanding tail and swimming test, continuous 7 days.1h after the last administration, animal was put in the spontaneous activity instrument 7 minutes, the spontaneous activity number of times of record back 5min per minute, check between the result organizes with the t check analysis.
The influence of table 4 pair acquired desperate model mice spontaneous activity (x ± S, n=15)
Annotate: compare with the blank group
#P＜0.05,
##Compare with model group P＜0.01
*P＜0.05,
*P＜0.01.
As known from Table 4, model group compares with blank group, and model group independent activity of animals digital display work reduces, and the outstanding tail dead time obviously increases, and difference has statistical significance (P＜0.05 or P＜0.01), shows the modeling success.Compare with model group, the movable number of fluoxetine treated animal obviously increases, and the outstanding tail dead time reduces difference statistical significance (P＜0.01); Compositions A, B, the movable number average of C treated animal obviously increase, and the outstanding tail dead time reduces difference statistical significance (P＜0.05 or P＜0.01).Prompting, compositions A, B, C have the effect of outstanding tail dead time of the acquired desperate model mice of minimizing.
2) to the influence of the non-swimming time of acquired desperate model mice
Grouping is the same with administration.1h after the last administration individually vertically puts into 3000ml beaker forced swimming with mice.Mice is put into the tube 6min that swims, keep the motionless state time (s) in the 4min of record back.
The influence of the non-swimming time of table 5 pair acquired desperate model mice (x ± S, n=15, S)
Annotate: compare with the blank group
#P＜0.05,
##Compare with model group P＜0.01
*P＜0.05,
*P＜0.01.
As known from Table 6, compare with the blank group, model group animal non-swimming time significantly increases, and difference has statistical significance (P＜0.01), prompting, modeling success.Compare with model group, fluoxetine group and compositions A, B, C treated animal non-swimming time all shorten, and difference has statistical significance (P＜0.05).Prompting compositions A, B, C have the effect that reduces acquired desperate model mice non-swimming time.
Pharmacological tests shows that the present invention significantly depression model mouse movement of antagonism reserpine induction can not reach the body temperature reduction, and outstanding tail and the inductive desperate animal model autonomic activities number of forced swimming, outstanding tail and non-swimming time are increased.Prompting the present invention has tangible antidepressant effect.
The acute toxicity test research of embodiment 10 present compositions
1 experiment purpose is observed the acute toxic reaction of 1 administration of pharmaceutical composition, measures median lethal dose(LD 50) (LD50) or maximum tolerated dose (MTD).
2 experiment materials
2.1 medicine
The clinical plan of pharmaceutical composition is 2.85g with dosage adult consumption every day, be mixed with the solution that concentration is 0.284g/ml with distilled water during experiment, but this concentration has been the Cmax of gastric infusion.
2.2 animal
The ICR mice, the SPF level is provided by west, Shanghai pul-Bi Kai laboratory animal company limited, and the laboratory animal production licence number is SCXK (Shanghai) 2008-0016.20～25 ℃ of animal feeding room temperatures, relative humidity 50～70%.Experimental situation facility credit number: SYXK (Hunan) 2009-0001.
3 methods
Trial test: get 4 of animals, water 14h is can't help in ♀ ♂ half and half fasting, with maximum drug level 0.284g/ml medicinal liquid, once gives animal maximum volume 40ml/kg and tests.Observe and the record reaction of animals, as do not have death and can carry out formal test.
Formal test: carry out mtd test according to pre-test result, get 40 of ICR mices, body weight (18.4 ± 1.2) g, ♀ ♂ half and half, water is can't help in fasting before the test, is divided into 2 groups by sex body weight stratified random behind the 14h, gives pure water, pharmaceutical composition 11.36g/kg respectively, volume is 40ml/kg time, 1 gastric infusion in 1 day.Observe animals survived situation in animal behavior activity, feces, diet and hair color and the 14d, weighing the weight of animals during off-test, anatomic observation animal viscera situation every day after the administration.
If no special instructions, the result of the test that is obtained is all carried out the processing of t test statistics.
4 results
Mice behavior, autonomic activities, diet and the hair color of pure water group and pharmaceutical composition group have no significant change; Mice all survives in 14 days; Dissect perusal, the no abnormal changes of internal organs such as mouse core, liver, spleen, lung, kidney; Mice weight increase (table 6).
The acute toxicity test in mice result of table 6 pharmaceutical composition
5 conclusions
Pharmaceutical composition is with Cmax, and maximum volume was given mouse stomach 1 time on 1st, and dosage is 11.36g/kg, animal dead do not occur, can not survey LD
50, therefore think that the maximum tolerated dose of pharmaceutical composition mouse stomach is 11.36g/kg.Pharmaceutical composition recommendation Coming-of-Age Day consumption is 2.85g, and by the body weight conversion, the maximum dosage-feeding of pharmaceutical composition mouse stomach is equivalent to 284 times of 70 kilograms of clinical consumptions of adult.Press the body surface area conversion, the maximum dosage-feeding of pharmaceutical composition mouse stomach is equivalent to 30.7 times of 70 kilograms of clinical consumptions of adult.Result of the test shows that pharmaceutical composition does not observe tangible toxic reaction for the mouse stomach administration with maximum concentration and maximum administration volume.
Embodiment 11 present compositions treatment depression 52 routine clinical observation on the therapeutic effect
1 data and method
1.1 all observation cases of object of study are The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine and second Affiliated Hospital in July, 2009 to 2009 year December outpatient service patients with depression, meet Chinese mental disorder classification and the diagnostic criteria of the 3rd edition (CCMD-3) depression of diagnostic criteria, 17 Hamilton depressive scales (HAMD) total points 〉=18 minutes.Observe 52 routine patients altogether, be divided into treatment at random and organize 26 examples, male 14 examples, women 12 examples, year mean age (36.3 ± 6.9); Matched group 26 examples, male 15 examples, women 11 examples, year mean age (34.1 ± 6.4).The equal zero difference of HAMD total points (P＞0.05) before two groups of sexes, age, the treatment.Get rid of other organic reasons or drug-induced Secondary cases depressive disorder patient; Serious hepatorenal disease and hyperpietic are arranged; The patient that suicide risk and tendency are arranged according to diagnosis; Gestation or breast-feeding female.
1.2 Therapeutic Method
1.2.1 treatment group
The treatment group gives the tablet by the prepared one-tenth of compositions of Rhizoma Curcumae Longae, hat leaf Fructus Forsythiae, three kinds of Chinese medicines of Radix Ginseng.Usage: oral, each 4, every day 3 times.
1.2.2 matched group
Matched group list fluoxetine.Usage: each 1, every day 1 time.
1.3 efficacy evaluation
Made 17 Hamilton scales (HAMD) respectively in 1,2,4 month before treatment and after the treatment, subtract the observation index of branch as curative effect with front and back, subtract branch rate 〉=75% and be recovery from illness, 50%～74% is marked improvement, and 25%～49% is progress, and＜25% is invalid.
1.4 statistical procedures
All data represent that with x ± s the SPSS15.0 statistical software carries out statistical procedures.Relatively adopt the ANOVA variance analysis between many groups, relatively adopt the independent sample t check between group.Be judged as statistical significance with bilateral P＜0.05.
2 results
2.1 the HAMD total points relatively before and after two groups of treatments
Relatively preceding with treatment, two groups of treatment back each month HAMD scorings all significantly descend than before treating, and difference has statistical significance (P＜0.01); Compare with matched group, the treatment group is treated HAMD scoring in back 4 months and is all obviously descended than matched group, and difference has statistical significance (P＜0.05), and visible treatment group effect is better than matched group (seeing Table 1).
The HAMD total points compares (x ± S, n=26 divide) before and after the table 1 liang group treatment
Annotate: compare with matched group
▲P＜0.05; Relatively preceding with treatment
△ △P＜0.01.
2.2 two groups of curative effects relatively
Observed result shows, treatment group 11 examples of fully recovering, and marked improvement 9 examples, progressive 4 examples, invalid 2 examples, effective percentage is 92.3%; Matched group 9 examples of fully recovering, marked improvement 8 examples, progressive 6 examples, invalid 3 examples, effective percentage is 88.5%, its curative effect treatment group is better than matched group.
Table 2 liang group curative effect comparison (n=26, %)
2.3 untoward reaction
Treated for the 6th weekend, it is dizzy that matched group has 2 examples to occur in therapeutic process, and 1 example occurs drowsiness, gives influence treatment after the anti symptom treatment, and the treatment group does not have untoward reaction to take place.
3 discuss
Depression (Depression) is a kind of common mental maladjustment disease, can cause by a variety of causes, clinical manifestation with depressed, interest goes down, happy sense disappearance is a cardinal symptom, at present mainly use 5-hydroxy tryptamine reuptake depressant, monoamine oxidase inhibitor, phenyl piperazines, 5-hydroxy tryptamine-norepinephrine reuptake inhibitor, aminoketones, tricyclic antidepressants, Fourth Ring to send 7 class antidepressants such as piperazine azatropylidene class, but synthetic antidepressants exist mostly that the antidepressant spectrum is narrow, toxic and side effects big, the medicine valency high and easy defective such as recurrence to the treatment of this disease.Depressed card belongs to the melancholia category of the traditional Chinese medical science, and disease is complicated and changeable, and the most common be Liver depression and Qi stagnation, how causes owing to feelings will is upset, more than conventional medicament is treated based on regulate the flow of vital energy, eliminate the phlegm, calm the nerves, have one's ideas straightened out, class medicine such as invigorating the heart and spleen.Rhizoma Curcumae Longae of the present invention, hat leaf Fructus Forsythiae, Radix Ginseng three medicines share, and have the function of soothing liver-QI for relieving depression, mind tranquilizing and the heart calming.Clinical showing, Chinese medicine composition of the present invention can make the state of an illness obviously improve, and compares with matched group, and curative effect is better than matched group; Aspect untoward reaction, Chinese medicine composition of the present invention shows than the better safety of matched group, does not have untoward reaction to take place.
Clinical efficacy, pharmacodynamic study result show that pharmaceutical composition of the present invention is the active drug of treatment depression.
Claims (8)
1. Chinese medicine composition that is used for the treatment of depression, it is characterized in that: it is to be made by following Chinese medicinal raw materials in portion by weight: 0.5～2 part in Rhizoma Curcumae Longae, 0.8～2.5 part of Herba Hyperici perforati, 0.5～2 part of Radix Ginseng.
2. the Chinese medicine composition that is used for the treatment of depression according to claim 1 is characterized in that following Chinese medicinal raw materials in portion by weight makes: 1 part in Rhizoma Curcumae Longae, 1.0～1.6 parts of Herba Hyperici perforatis, 1 part of Radix Ginseng.
3. the Chinese medicine composition that is used for the treatment of depression according to claim 1 and 2 is characterized in that and will add 0～70% ethanol in the crude drug, extracts 2～3 times, adds 4～12 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrates preparation.
4. the Chinese medicine composition that is used for the treatment of depression according to claim 1 and 2 is characterized in that said composition makes tablet, capsule, soft capsule, granule, drop pill, dispersible tablet, oral cavity disintegration tablet, pill, oral liquid.
5. preparation method that is used for the treatment of the Chinese medicine composition of depression is characterized in that: select 0.5～2 part in Rhizoma Curcumae Longae for use, and 0.8～2.5 part of Herba Hyperici perforati, 0.5～2 part of Radix Ginseng adds 0～70% ethanol, extracts 2～3 times, adds 4～12 times at every turn and measures solvents; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrates preparation.
6. preparation method according to claim 5 is characterized in that adding 0～70% ethanol, extracts 2 times, adds 4～10 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrates preparation.
7. preparation method according to claim 6 is characterized in that adding 0～70% ethanol, extracts 2 times, adds the solvent that 6-10 doubly measures for the first time, extracts 2 hours, adds the solvent that 4-8 doubly measures for the second time, extracts 1 hour; Extracting solution filters, and reclaims solvent and concentrates preparation.
8. according to the described preparation method of one of claim 5-7, it is characterized in that adding 70% ethanol extraction.
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| CN103372174B (en) * | 2012-04-27 | 2016-05-18 | 王宇红 | A kind of herbal mixture that is used for the treatment of depression |
| CN104784280A (en) * | 2015-01-13 | 2015-07-22 | 中国人民解放军第四军医大学 | A liver-soothing mental depression-alleviating medicine, a preparing method thereof and applications of the medicine |
| CN109512972A (en) * | 2018-10-15 | 2019-03-26 | 湖南中医药大学 | A kind of prevention and treatment breast cancer merges Chinese medicine composition, preparation method and the purposes of depression |
| CN116159101A (en) * | 2020-06-24 | 2023-05-26 | 鲁南新时代生物技术有限公司 | Traditional Chinese medicine composition and preparation method and application thereof |
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