CN102793781A - Anti-depression medicinal composition - Google Patents
Anti-depression medicinal composition Download PDFInfo
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- CN102793781A CN102793781A CN2012102592334A CN201210259233A CN102793781A CN 102793781 A CN102793781 A CN 102793781A CN 2012102592334 A CN2012102592334 A CN 2012102592334A CN 201210259233 A CN201210259233 A CN 201210259233A CN 102793781 A CN102793781 A CN 102793781A
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Abstract
The invention relates to an anti-depression composition which comprises a centella extract, a morida officinalis how polysaccharide extract, citalopram and/or escitalopram. The composition can be used for preparing various medicinal preparations, such as solid preparations and/or liquid preparations, wherein the solid preparations comprise tablets, granules, capsules, drop pills, soft capsules and the like; and the liquid preparation comprises an oral solution, an injection, injection powder and the like. The medicinal composition which is produced into various preparations has an excellent anti-depression effect, can be used for avoiding adverse influence of other components in morinda officinalis due to the morida officinalis how polysaccharide extract, and has an unexpected prominent effect in improving sexual dysfunctions caused by medicines.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, relate in particular to a kind of medicine composition for treating depression.
Background technology
Depression (depression) is the main type of affective disorders; Be a kind of low with remarkable and persistent mental state be the syndrome of principal character; It shows mainly that low, the speech of being in a bad mood reduces, spirit, bradykinesia, and normal self-accusation is from crime, even suicide attempts etc.Along with the aggravation of many emergent factors, depression has become the commonly encountered diseases of modern society, high morbidity, and its sickness rate is soaring rapidly.Large-scale in the world epidemiological study shows that " depression " is number four at present in world's disabling condition, have 3% one 5% lifelong prevalence at least, will be number two to the year two thousand twenty, is only second to ischemic heart desease.
At present, the chemicals curative effect is obvious in the medicine of treatment depression, and universally recognized is two types of medicines: the classical antidepressants of the first generation: comprise oxidase inhibitor (MAOI) and tricyclic antidepressant (TCA) and second filial generation novel antidepressant.Wherein, use SSRI class medicine the most generally in the second filial generation novel antidepressant thing at present, comprise fluoxetine, paroxetine, Sertraline, fluvoxamine, citalopram, escitalopram.Be characterized in that the anticholinergic untoward reaction is little, little to the influence of internal organs such as cardiovascular, sedation is lighter, and patient tolerability is good, taking convenience.SSRI class medicine main adverse reactions is a gastrointestinal reaction, also has headache, insomnia, erythra and sexual dysfunction etc. in addition.
Wherein, citalopram and escitalopram can cause patient's untoward reaction such as sexual dysfunction.For sexual dysfunction, the sexual dysfunction type that is mainly concerned with has libido to reduce, the shortage of ejaculation delay or orgasm etc.Citalopram overall incidence 73%, escitalopram increase to optimal dosage after treating for 8 weeks, as a result sexual dysfunction rate escitalopram group 49%＞duloxetine group 33%＞placebo group 17%; Treated sexual dysfunction rate escitalopram group 44%＞duloxetine group 33%＞placebo group 25% 8 months.Thus, sexual dysfunction rate tendency is escitalopram＞duloxetine＞placebo.Along with social progress, the degree of susceptibility of patient's sexual function more and more receives publicity, because depression is the disease that needs long-term treatment, the basic goal of treatment is not only to want Symptomatic control, and the recovery of function and the raising of quality of life also will be arranged.So the problem of the sexual dysfunction that solution citalopram and escitalopram cause satisfies the needs of patient for antidepressant effect simultaneously, becomes a vital task.At present also to the efficacious therapy of the sexual dysfunction related reactions of citalopram and/or escitalopram with prevent and treat method.
On the other hand, citalopram is effective equally for the patient of endogenous and non-endogenous depression, but its antidepressant effect is set up after week at 2-4 usually.And depression is the mental sickness that a kind of sickness rate is high, homicide rate is high.But aspect treatment, the problem that traditional antidepressant drug often exists onset to lag behind.In numerous antidepressant drugs, the antidepressant drug that is acknowledged as " rapid-action " at present is also few in number.Onset time is grown the greatest drawback that is considered to current antidepressant drug.Symptom can be alleviated rapidly after most patients with depression hoped to treat, but traditional antidepressant drug on average needs the ability onsets of 2 ~ 4 weeks, causes part patient drug withdrawal without authorization when the treatment initial stage does not take effect, subtracts medicine, even with regard to this abandoning cure.Shorten onset time and improve one of important leverage of patients with depression treatment compliance beyond doubt, and can also shorten whole treatment cycle, thereby alleviate patient's misery and medical economics burden.Therefore, clinically press for that onset is faster, the more stable antidepressant drug of long-term efficacy improves patient's treatment satisfaction.
Accelerate the misery that antidepressant drug onset time can alleviate patients with depression to greatest extent, reduce the suicide risk, and improve the treatment compliance.The rapid-action meaning of antidepressant drug mainly also is to improve the cure rate of patient's anaphase.Existing clinical research confirmation, the fast more patient of treatment produce effects, cure rate is high more.1 all produce effects and 4 ~ 6 week ability produce effects patients' cure rate is respectively about 60% ~ 70% and 20%.
So study a kind of prescription, make that medicine can quick acting, and reduce the untoward reaction of medicine, have great importance.
Summary of the invention
The problem that the present invention need solve provides a kind of medicine composition for treating depression, and said composition has quick, good antidepressant effect on the one hand, can improve drug-induced sexual dysfunction on the other hand.
A kind of medicine composition for treating depression, active component is composed of the following components:
Herba Centellae extract 1-100 weight portion, polysaccharides from morinda officinalis how extract 1-100 weight portion,
Citalopram 1-10 weight portion and/or escitalopram 0.5-5 weight portion;
Wherein, Herba Centellae total glycosides content 10-95% in the Herba Centellae extract;
Radix Morindae Officinalis polyoses content 10-99% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are that purity is the chemicals between the 90-110%.
Wherein, Herba Centellae; Be samphire; Volatile oil component in the Herba Centellae is carried out gas chromatography one mass spectrometry analysis, therefrom isolate 45 kinds of compositions, content is higher has caryophyllene (caryophyllene), farnesol (farnesol), elemene (elemene) and longifolene (Longifolene) etc.; The mice blepharoptosis experiment due to wild experiment and the antagonism reserpine is tested, opened to employing mice forced swimmings such as Cao Wei is luxuriant experiment, mouse tail suspension; Respectively with mice dead time, autonomic activities number and antagonistic rate as evaluation index, find that asiatic centella total triterpenic acid, asiatic acid, Madecassic acid all can significantly shorten the mice forced swimming dead time, the outstanding tail dead time, have antidepressant effect.
Herba Centellae extract: have another name called: Total Of Triterpenes Asiaticosides, another name: asiaticoside is the herb of Umbelliferae Gotu Kola platymiscium Herba Centellae, through extracting the triterpenoid saponin that makes.This product contains multiple triterpenes, wherein comprises α-Amyrin structure.Main component is Asiaticoside, asiatic acid and Madecassic acid.Wherein commercially available specification comprises that Herba Centellae total glycosides content is respectively 10-95 weight % (HPLC mensuration).Xi'an greenery Remedy Research Limited Asiaticoside content on sale is 10%, 20% and 40% Herba Centellae extract product.
Radix Morindae Officinalis Morinda officinalis How is a Rubiaceae Radix Morindae Officinalis platymiscium.Cui Chengbin etc. are separated to 5 antidepressant activity compositions from the Chinese medicine Radix Morindae Officinalis, through chemistry and method of spectroscopy, be accredited as succinic acid, anti-this sugar, 1F one fruit anti-this sugar of furyl glycosyl and inulin type hexa polyose and seven polysaccharide respectively.Discussion Radix Morindae Officinalis oligosaccharide such as Li Yunfeng have protective effect and bring into play the antidepressant function the PCI2 cell of corticosterone damage; While Radix Morindae Officinalis oligosaccharide (MOs) (mainly being inulin type hexa polyose, seven polysaccharide) can significantly shorten the dead time during rat and the mandatory swimming of mice; At the acquired helpless depression model of rat; MOs significantly reduces the escape frequency of failure of rat, shows that MOs has antidepressant effect.Wherein, the commercially available product that polyoses content that kindness bio tech ltd in Fujian etc. provides is arranged at 10-70 weight %.
Citalopram (Citalopram) is a kind of antidepressants of very strong selectivity 5-hydroxy tryptamine reuptake inhibithors (SSRI) type; Its drug form is citalopram hydrobromate (Citalopram Hydrobromide), and commodity " Cipramil " by name (Celexa).Be usually used in the depressibility mental disorder clinically.
Escitalopram (English: Escitalopram also is called Escitalopram) is from citalopram, to separate the S type isomer of purifying.Two kinds of compositions are arranged in the citalopram, the citalopram of the citalopram of S type and R type, but have only the isomer of S type just effective in cure.
Show that after deliberation the oligosaccharide in the Radix Morindae Officinalis has the effect of kidney invigorating and YANG supporting.Oligosaccharide can promote the property vigor of fruit bat in the Radix Morindae Officinalis, but the effect of the water extract kidney invigorating and YANG supporting of Radix Morindae Officinalis is not obvious, possibly be the effect that the composition in the water extract has disturbed the kidney invigorating and YANG supporting of Radix Morindae Officinalis oligosaccharide in the Radix Morindae Officinalis.Therefore the polysaccharides from morinda officinalis how extract that extracts through appropriate method among the present invention, this polyoses extract can be strengthened the kidney invigorating and YANG supporting effect and the antidepressant effect of Radix Morindae Officinalis, has unexpected outstanding effect.Can obviously improve and take the sexual dysfunction that citalopram and escitalopram cause, promote patient's quality of life.
In above-mentioned prescription, Herba Centellae extract, polysaccharides from morinda officinalis how extract, citalopram and escitalopram all have antidepressant effect, and the polysaccharides from morinda officinalis how extract has the effect of tonifying YANG.Because citalopram and/or escitalopram are acting through the absorption again that suppresses 5-hydroxy tryptamine, and the antidepressant effect mechanism of polysaccharides from morinda officinalis how extract is different therewith.Therefore avoid the 5-hydroxy tryptamine syndrome to a certain extent, improved drug-induced sexual dysfunction simultaneously.
In addition,, avoided traditional antidepressant drug, relied on the accumulation of intravital 5-hydroxy tryptamine like citalopram and escitalopram, thereby bring into play antidepressant effect because polysaccharides from morinda officinalis how extract antidepressant has unique mechanism of action, and the delayed action that brings.In first week of treatment; Just can bring into play antidepressant effect, have tangible improvement for the therapeutic effect of depressive patient, thereby reduced patient personal dangerousness before the drug effect when begin treatment; Having improved patient's compliance, is the real Gospel of patient.
The specific embodiment
The present invention is preferred, and a kind of antidepressant pharmaceutical composition is composed of the following components:
Herba Centellae extract 5-50 weight portion, polysaccharides from morinda officinalis how extract 5-50 weight portion,
Citalopram 1 weight portion and/or escitalopram 0.5 weight portion;
Wherein, Herba Centellae total glycosides content is 20-80% in the Herba Centellae extract;
The Radix Morindae Officinalis polyoses content is 50-90% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are that purity is the chemicals between the 90-110%.
The present invention more preferably, a kind of antidepressant pharmaceutical composition, composed of the following components:
Herba Centellae extract 5 weight portions, polysaccharides from morinda officinalis how extract 5 weight portions,
Citalopram 1 weight portion and/or escitalopram 0.5 weight portion
Wherein, Herba Centellae total glycosides content is 50-60% in the Herba Centellae extract;
The Radix Morindae Officinalis polyoses content is 70-90% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are that purity is the chemicals between the 95-105%;
Citalopram is a citalopram hydrobromate, and escitalopram is the oxalic acid escitalopram.
Above-mentioned medicine composition for treating depression can be processed solid preparation and/or liquid preparation; Wherein, solid preparation is selected from any in the group of being made up of tablet, granule, capsule, drop pill and soft capsule etc., and liquid preparation is selected from any in the group of being made up of oral liquid, injection and injectable powder etc.
In above-mentioned medicine composition for treating depression, wherein,
Herba Centellae extract adopts: the alcohol heating reflux method is extracted Herba Centellae, and merge extractive liquid, concentrates; Make thick extractum, behind thick extractum dilute with water, through macroporous resin adsorption; Use the eluent eluting; Concentrate eluant, drying under reduced pressure makes, and perhaps uses the Herba Centellae extract of commercially available Herba Centellae total glycosides content as 10-95 weight %;
The polysaccharides from morinda officinalis how extract adopts: heating reflux method water is carried Radix Morindae Officinalis, and merge extractive liquid, uses the absorption of macropore weak basic anion exchange resin; The eluent eluting concentrates percolation liquid and eluent, uses alcohol deposition method; Deposition is separated out polysaccharide, filters; The dry product that gets perhaps uses the polysaccharides from morinda officinalis how extract of commercially available polysaccharides from morinda officinalis how content at 10-99 weight %;
Above-mentioned medicine composition for treating depression is preferably:
Herba Centellae extract adopts following method to extract: the Herba Centellae pulverizing medicinal materials is processed coarse powder, adds 95 volume % alcohol reflux 2 times, each 3 hours, filters; Merging filtrate, filtrate decompression concentrate to reclaim and obtain thick extractum, add 2-10 times of volume water gaging of medical material amount; The allotment medicinal liquid filters, AB-8 macroporous resin adsorption filtrating; Use the 20-60 volume % ethanol elution of 4-8 times of column volume, concentrate eluant, drying under reduced pressure gets extract powder;
The polysaccharides from morinda officinalis how extract adopts following method to extract: Radix Morindae Officinalis plant herb is ground into the 10-100 order, and with the method for reflux, 8-20 times of water gaging extracts 2 hours time; Extract merge extractive liquid,, last D941 type macropore weak basic anion exchange resin 3 times; Water is eluted to the eluent color and shoals, and collects percolation liquid and water lotion, removes the water of 40-80 volume % behind the concentrating under reduced pressure; In concentrated solution, add 2-6 times of volume of ethanol, left standstill 12 hours, deposition; Separate out polysaccharide, filter, the dry product that gets.
Above-mentioned medicine composition for treating depression, more preferably:
Herba Centellae extract adopts following method to extract: the Herba Centellae pulverizing medicinal materials is processed coarse powder, adds 95 volume % alcohol reflux 2 times, each 3 hours, filters; Merging filtrate, filtrate decompression concentrate to reclaim and obtain thick extractum, add 5 times of volume water gagings of medical material amount; The allotment medicinal liquid filters AB-8 macroporous resin adsorption medicinal liquid; Use 40 volume % ethanol elutions of 6 times of column volumes, concentrate eluant, drying under reduced pressure gets extract powder;
The polysaccharides from morinda officinalis how extract adopts following method to extract: Radix Morindae Officinalis plant herb is ground into 80 orders, and with the method for reflux, 10 times of water gagings extract 2 hours time; Extract 3 times, merge extractive liquid,, last D941 type macropore weak basic anion exchange resin, water is eluted to the eluent color and shoals; Collect percolation liquid and water lotion, remove 80% water behind the concentrating under reduced pressure, in concentrated solution, add 4 times of volume of ethanol, left standstill 12 hours; Deposition is separated out polysaccharide, filters, the dry product that gets.
Use Herba Centellae extract, the polysaccharides from morinda officinalis how extract of method for preparing can satisfy the prescription for preparing antidepressant composition of the present invention; Improve the sexual dysfunction that citalopram and/or escitalopram cause; Alleviate adverse effect, strengthen antidepressant effect.
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and down can make amendment with form or replace without departing from the spirit and scope of the present invention, but these modifications and replacing all fall in protection scope of the present invention the details of technical scheme of the present invention.
Embodiment 1 contains the tablet of medicine composition for treating depression of the present invention
The assay of Herba Centellae total glycosides in the Herba Centellae extract: use ultraviolet spectrophotometer method, adopt 276 nm wavelength to measure the trap of test sample.Use standard solution bioassay standard curve, according to the trap of need testing solution content according to the Herba Centellae total glycosides in the regression equation calculation test sample.
The polysaccharides from morinda officinalis how assay: preparation glucose standard solution, use the phenolsulfuric acid method to handle, the bioassay standard curve obtains regression equation.(C * D), wherein, W is polyoses content (mg), and C is the concentration of glucose (mg/ml) of refining polysaccharides from morinda officinalis how storing solution, and D is the dilution factor of polysaccharide to use the polysaccharides from morinda officinalis how titer to measure conversion factor: f=W/.Use polysaccharides from morinda officinalis how extract sample preparation test sample, the phenolsulfuric acid method is handled, and measures trap.According to the glucose content in the regression equation calculation need testing solution, be calculated as follows the polyoses content in the sample: polyoses content (%)=(C * D * f)/W * 100%.C is with the concentration (μ g/ml) of glucose meter in the polysaccharide need testing solution; D is the dilution factor of polysaccharide; F is a conversion factor; W is the weight of polysaccharide.
Citalopram and/or escitalopram are measured content according to target level of product quality.
The preparation of 1 Herba Centellae extract and polysaccharides from morinda officinalis how extract
Herba Centellae extract adopts following method to extract: the Herba Centellae pulverizing medicinal materials is processed coarse powder, adds 95 volume % alcohol reflux 2 times, each 3 hours, filters; Merging filtrate, filtrate decompression concentrate to reclaim and obtain thick extractum, add 5 times of volume water gagings of medical material amount, the allotment medicinal liquid; Filter AB-8 macroporous resin adsorption medicinal liquid, 40 volume % ethanol elutions of 6 times of column volumes of use; Concentrate, drying under reduced pressure gets extract powder, is 55% through the content of measuring Herba Centellae total glycosides in the powder.
The polysaccharides from morinda officinalis how extract adopts following method to extract: Radix Morindae Officinalis plant herb is ground into 80 orders, and with the method for reflux, 10 times of water gagings extract 2 hours time; Extract 3 times, merge extractive liquid,, last D941 type macropore weak basic anion exchange resin, water is eluted to the eluent color and shoals; Collect percolation liquid and water lotion, remove 80% water behind the concentrating under reduced pressure, in concentrated solution, add 4 times of volume of ethanol, left standstill 12 hours; Deposition is separated out polysaccharide, filters, the dry product that gets; Middle polyoses content through measuring Radix Morindae Officinalis polyoses extract in the product is 78%.
The proportioning of 2 medicine composition for treating depression
Herba Centellae extract 5 weight portions, polysaccharides from morinda officinalis how extract 5 weight portions,
Citalopram 1 weight portion and/or escitalopram 0.5 weight portion;
Wherein, Herba Centellae total glycosides content is 55% in the Herba Centellae extract, and polyoses content is 78% in the polysaccharides from morinda officinalis how extract; Citalopram is a citalopram hydrobromate; Commercially available article purity is 98.5%, and escitalopram is the oxalic acid escitalopram, and commercially available article purity is 98.2%.
3 preparations contain the tablet of medicine composition for treating depression in 2
With Herba Centellae extract in 2, polysaccharides from morinda officinalis how extract, citalopram hydrobromate and/or oxalic acid escitalopram mix homogeneously; Add amylopectin 5 weight portions, microcrystalline Cellulose 2.5 weight portions, sodium carboxymethyl cellulose 0.5 weight portion; Dextrin 1 weight portion is pulverized, and crosses 120 mesh sieves.Use 5% PVP to prepare soft material, granulate, drying, granulate adds magnesium stearate 0.1 weight portion, mix homogeneously, tabletting promptly gets, and tablet weight is the 0.40-0.45g/ sheet.
Antidepressant tablet and the curative effect between the Cipramil (citalopram sheet) of preparation among embodiment 2 embodiment 1, toleration, side effect and to the contrast of the influence of sexual function
1 material and method
1.1 object of study
Selection meets being in hospital or the out-patient of Chinese mental sickness classification and diagnostic criteria second edition (CCMD-II) paralepsy diagnostic criteria.There are not serious body and brain organic disease, Hamilton SDS (HAMD, 17) >=16.Go into to organize case 40 examples, male 22 examples, women 18 examples; In order to get rid of climacteric, old interference to sexual function, (45 years old female patient is if there is the confusion of the menstrual cycle to have selected the patient in 18-45 year in this research; Do not go into group yet), in stadium (7.2 ± 6.5) year, 2 examples come off.
1.2 medicine
Experimental group uses the antidepressant tablet for preparing among the embodiment 1, and (every contains Herba Centellae extract 100mg; Polysaccharides from morinda officinalis how extract 100mg, citalopram hydrobromate 20mg), matched group uses Cipramil; Xian-Janssen Pharmaceutical Ltd. produces, and specification is the 20mg/ sheet.
1.3 research method
Open evaluation of clinical curative effect.Went into the inactive various psychotropic drugs in group back 3 days, the antidepressant tablet and the Cipramil of preparation are oral administration among the embodiment 1, and one day three times, fixed dosage.During the treatment, in case of necessity, only allow to share benzene phenodiazine azole medicine.
1.4 curative effect, toleration, side effect evaluation reach the influence to sexual function
1.4.1 efficacy evaluation
At 1,2,4,6 weekends before treatment and after the treatment, carry out HAMD, clinical efficacy general comment table (CGI) evaluation.Subtract the branch rate by HAMD and judge curative effect: subtract branch rate>=80% and be recovery from illness, 50%-80% is a produce effects, and 25%-50% (comprising 50%) is for effective, and≤25% is invalid.Criterion of therapeutical effect by physician and patient work out with reference to Chinese Society of Neurology and Psychiatry is accomplished the general curative effect evaluation jointly.All scale evaluations are by accomplishing through the physician after the scale evaluation training.
1.4.2 side effect evaluation
1.4.2.1 before treatment, reach the side effect rating scale (TESS) that weekend is looked into psychotropic therapy in treatment back 1,2,4,6.And in treating before and after look blood, urine, stool routine, liver, renal function and electrocardiogram each 1 time.Treatment is accomplished the toleration evaluation by physician and patient by following standard after finishing jointly: toleration fabulous (without any side effects), and good (have side effect; The patient is influenced not quite); Not good enough (side effect being arranged, bigger to patient's influence) can't tolerate (side effect is greater than curative effect).
1.4.2.2 questionnaire is investigated two groups of patients' sexual function problem, the description standard of sexual function problem adopts the standard of Wiegel.
3 periods of two groups of patients have mainly been assessed, i.e. sexual function problem after normal condition, ill back and the treatment.Normal condition refers to first depressive disorder outbreak the first half, is meant before the clothes antidepressants of ill back the state of an illness after ill the heaviest 1 month, is meant the 6th weekend of taking two kinds of antidepressants respectively after taking medicine.Investigate the sexual function problem that above-mentioned 3 periods occur, like hyposexuality, property detest, sexual excitation problem, sexual intercourse is uncomfortable, climax suppresses, the sexual intercourse gratification is bad and the sexual relationship gratification is bad patient's example number and the increase and decrease of ratio.
2 results
2.1 physical data
The matched group list is treated with Cipramil, goes into 20 patients of group altogether, wherein has 1 patient to come off.Experimental group uses the antidepressant tablet of preparation among the embodiment 1 to treat, and goes into 20 patients of group altogether, wherein has 1 patient to come off.
2.2 therapeutic evaluation
2.2.1 total effects uses the HAMD scoring, write down every patient treatment respectively before, the HAMD scoring at 1 weekend of treatment, 2 weekends, 4 weekends and 6 weekends.Matched group 8 examples of fully recovering altogether, produce effects 5 examples, effective 3 examples, invalid 3 examples, total effective rate 84.2%, experimental group 9 examples of fully recovering altogether, produce effects 4 examples, effective 4 examples, invalid 2 examples, total effective rate 89.5%.Matched group and experimental group total effective rate do not have marked difference.
In order to estimate intuitively, the patient's of each time point HAMD value is added respectively with average, carry out the calculating that subtracts the branch rate of each time point then respectively, thereby carry out overall assessment.
Table 1 HAMD value evaluation result:
The onset time of the antidepressant tablet for preparing among conclusion: the embodiment 1 is more Zao than Cipramil group, treats for first week with regard to onset.
2.2.2 two groups are carried out the comparisons that CGI-SI estimates, and write down respectively before every patient treatment and the treatment CGI-SI scoring at 6 weekends.
Table 2 CGI-SI evaluation result
| Time | Matched group | Experimental group |
| Before the treatment | 6.07±1.81 | 6.22±1.69 |
| After the treatment | 2.51±1.03 | 2.20±0.97 |
Conclusion: through the comparison to the forward and backward CGI-SI evaluation of estimate of two groups of patient treatments, experimental group and matched group are not significantly distinguished for the clinical efficacy of treatment patient depressive state.
2.2.3 each stage TESS evaluation result of two groups of patients relatively: write down the TESS scoring at 2 weekends of every patient treatment, 4 weekends and 6 weekends respectively, carry out the drug side effect evaluation.
Each time point TESS scoring of table 3
| Time | Matched group | Experimental group |
| 2 weekends | 5.77±3.84 | 5.82±3.61 |
| 4 weekends | 5.34±4.13 | 5.29±3.99 |
| 6 weekends | 5.15±4.20 | 5.17±3.82 |
Toleration is estimated:
Table 4 toleration is estimated catalog
Remarks: group 1 is experimental group: promptly use the tablet among the embodiment 1 to treat
Group 2 is matched group: promptly use Cipramil to treat.
Conclusion: through the comparison of the TESS value of two groups of patient's different time points, can find out that two groups of side effect incidence rates after patient's medication are suitable, the toleration after two groups of patient's medications is also suitable.
2.2.4 questionnaire is investigated two groups of patients' sexual function issue table
Table 5 liang group patient sexual function issue table
Remarks: the sample number of normal condition and ill after-stage is totally 40 examples, and the back of taking medicine is case because existence 2 examples come off, and the matched group sample number is 19 examples, and the experimental group sample number is 19 examples, and experimental group and matched group compare, * p＜0.05.
Conclusion: the antidepressant tablet according to the preparation of the method for embodiment 1 can significantly improve the sexual dysfunction that citalopram causes.
Claims (7)
1. medicine composition for treating depression, active component is composed of the following components:
Herba Centellae extract 1-100 weight portion, polysaccharides from morinda officinalis how extract 1-100 weight portion,
Citalopram 1-10 weight portion and/or escitalopram 0.5-5 weight portion;
Wherein, Herba Centellae total glycosides content 10-95% in the Herba Centellae extract;
Radix Morindae Officinalis polyoses content 10-99% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are the chemicals between the purity 90-110%.
2. pharmaceutical composition according to claim 1, active component is composed of the following components:
Herba Centellae extract 5-50 weight portion, polysaccharides from morinda officinalis how extract 5-50 weight portion,
Citalopram 1 weight portion and/or escitalopram 0.5 weight portion;
Wherein, Herba Centellae total glycosides content is 20-80% in the Herba Centellae extract;
The Radix Morindae Officinalis polyoses content is 50-90% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are the chemicals between the purity 90-110%.
3. pharmaceutical composition according to claim 1, active component is composed of the following components:
Herba Centellae extract 5 weight portions, polysaccharides from morinda officinalis how extract 5 weight portions,
Citalopram 1 weight portion and/or escitalopram 0.5 weight portion;
Wherein, Herba Centellae total glycosides content is 50-60% in the Herba Centellae extract;
The Radix Morindae Officinalis polyoses content is 70-90% in the polysaccharides from morinda officinalis how extract;
Citalopram and/or escitalopram are that purity is the chemicals between the 95-105%;
Citalopram is a citalopram hydrobromate, and escitalopram is the oxalic acid escitalopram.
4. according to the pharmaceutical composition of claim 1-3 described in each, it is characterized in that this pharmaceutical composition can process solid preparation and/or liquid preparation; Wherein, solid preparation is selected from any in the group of being made up of tablet, granule, capsule, drop pill and soft capsule, and liquid preparation is selected from any in the group of being made up of oral liquid, injection and injectable powder.
5. according to the pharmaceutical composition of claim 1-3 described in each, wherein,
Herba Centellae extract adopts: the alcohol heating reflux method is extracted Herba Centellae, and merge extractive liquid, concentrates; Make thick extractum, behind thick extractum dilute with water, through macroporous resin adsorption; Use the eluent eluting; Concentrate eluant, drying under reduced pressure makes, and perhaps uses the Herba Centellae extract of commercially available Herba Centellae total glycosides content as 10-95 weight %;
The polysaccharides from morinda officinalis how extract adopts: heating reflux method water is carried Radix Morindae Officinalis, and merge extractive liquid, uses the absorption of macropore weak basic anion exchange resin; The eluent eluting concentrates percolation liquid and eluent, uses alcohol deposition method; Deposition is separated out polysaccharide, filters; The dry product that gets perhaps uses the polysaccharides from morinda officinalis how extract of commercially available polysaccharides from morinda officinalis how content at 10-99 weight %.
6. pharmaceutical composition according to claim 5, wherein,
Herba Centellae extract adopts following method to extract: the Herba Centellae pulverizing medicinal materials is processed coarse powder, adds 95 volume % alcohol reflux 2 times, each 3 hours, filters; Merging filtrate, filtrate decompression concentrate to reclaim and obtain thick extractum, add 2-10 times of volume water gaging of medical material amount; The allotment medicinal liquid filters, AB-8 macroporous resin adsorption filtrating; Use the 20-60 volume % ethanol elution of 4-8 times of column volume, concentrate eluant, drying under reduced pressure gets extract powder;
The polysaccharides from morinda officinalis how extract adopts following method to extract: Radix Morindae Officinalis plant herb is ground into the 10-100 order, and with the method for reflux, 8-20 times of water gaging extracts 2 hours time; Extract merge extractive liquid,, last D941 type macropore weak basic anion exchange resin 3 times; Water is eluted to the eluent color and shoals, and collects percolation liquid and water lotion, removes the water of 40-80 volume % behind the concentrating under reduced pressure; In concentrated solution, add 2-6 times of volume of ethanol, left standstill 12 hours, deposition; Separate out polysaccharide, filter, the dry product that gets.
7. pharmaceutical composition according to claim 6, wherein,
Herba Centellae extract adopts following method to extract: the Herba Centellae pulverizing medicinal materials is processed coarse powder, adds 95 volume % alcohol reflux 2 times, each 3 hours, filters; Merging filtrate, filtrate decompression concentrate to reclaim and obtain thick extractum, add 5 times of volume water gagings of medical material amount; The allotment medicinal liquid filters AB-8 macroporous resin adsorption medicinal liquid; Use 40 volume % ethanol elutions of 6 times of column volumes, concentrate, drying under reduced pressure gets extract powder;
The polysaccharides from morinda officinalis how extract adopts following method to extract: Radix Morindae Officinalis plant herb is ground into 80 orders, and with the method for reflux, 10 times of water gagings extract 2 hours time; Extract 3 times, merge extractive liquid,, last D941 type macropore weak basic anion exchange resin, water is eluted to the eluent color and shoals; Collect percolation liquid and water lotion, remove 80% water behind the concentrating under reduced pressure, in concentrated solution, add 4 times of volume of ethanol, left standstill 12 hours; Deposition is separated out polysaccharide, filters, the dry product that gets.
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