CN101081272A - Medicine for treating dumps emotional handicap type disease - Google Patents
Medicine for treating dumps emotional handicap type disease Download PDFInfo
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Abstract
The medicine for treating depression and other mental disturb diseases is prepared with chlorimipramine, sulpiride, sodium valproate, borneol and Chinese herbal medicine extractum prepared with nutagrass flatsedge rhizome, arisaema with bile, wild jujube seed and other Chinese medicinal materials. The medicine consists of chemically synthetic medicine and Chinese herbal medicine component, and has synergistic treating effect, less toxic side effect, and good patient's compliance.
Description
Technical field
The present invention relates to a kind of medicine that is used for the treatment of depressive state, sleep disorder, forces dumps emotional handicap type diseases such as symptom, neurasthenia, climacteric syndrome, chronic fatigue syndrome, specifically be exactly a kind of by a kind ofly calming the nerves of combining of chemical synthetic drug and vegetable Chinese herbal medicine, regulate the flow of vital energy, the composition of medicine of resolving depression.
Background technology
Depressive state, sleep disorder, forcing dumps emotional handicap type diseases such as symptom, neurasthenia, climacteric syndrome, chronic fatigue syndrome, is the able-bodied commonly encountered diseases of harm humans, frequently-occurring disease.With regard to depression, its lifetime prevalence is 6.1%～9.5%, and the patient will go to a doctor repeatedly, thereby causes serious financial burden.In addition, patient's work capacity is reduced.Psychic pain as for bringing for patient and family thereof then more is difficult to describe in words.
Dumps emotional handicap type disease is one group of syndrome, comprises multiple sings and symptoms, relates to body and two aspects of psychology.The former comprises that sleep disorder, appetite change, feeling of fatigue, sense of discomfort, libido change, vegetative nerve function changes, psychomotor activity is slow or is intense etc.; Mental symptoms comprises depressed, forfeiture self-respect or have, attention from crime sense can not concentrate or irresolute, suicide idea or attempt etc. are arranged.Interrelated between these symptoms, have certain Basic of Biology (CCMD-3).Belong to categories such as the epilepsy in motherland's medical science, slow-witted disease, heart-wind syndrome, Bulbus Lilii syndrome, show as pale tongue or dark, white and thin fur, stringy pulse or carefully heavy or heavy number etc.
According to the numeral of delivering in the world psychosis association annual meeting of holding in Beijing, present global patients with depression every year is with 13% rate of increase cumulative year after year.China has people's existence mental maladjustment in various degree of 5% at present approximately, and 13 ‰ people suffers from mental sickness in various degree.Not long ago one group of data of Gong Buing then were, the prevalence of Chinese mental sickness from 70, the eighties middle and late stage 3.2～7.3 ‰ rise to present 15.56 ‰.
At present, treat depressive state, sleep disorder clinically, force symptom, during dumps emotional handicap type disease such as neurasthenia, climacteric syndrome, chronic fatigue syndrome, the multiselect chemical synthetic drug is as Benzodiazepines (BZ), tricyclic antidepressants (TCAs), tetracyclic antidepressant, selective serotonin reuptake inhibitor (SSRI
s) and mood stabilizers etc.But the effective dose curve of these medicines and the orthogonal thereto fork of toxic reaction curve of self that is to say when medicine reaches effective dose, and its toxic reaction also increases thereupon, cause patient's compliance to reduce.Be exactly selective serotonin reuptake inhibitor (SSRI
s) the also untoward reaction of various degrees, and cost an arm and a leg, most of patients is difficult to accept.
Summary of the invention
Technical problem to be solved by this invention is, a kind of determined curative effect is provided, and no obvious adverse reaction is cheap, the medicine of the treatment dumps emotional handicap type disease that patient's compliance is high.
A kind of medicine for the treatment of dumps emotional handicap type disease, described medicine is made up of following raw materials in percentage by weight: Clomipramine 1.67～2.23%, sulpiride 2.23～4.45%, sodium valproate 2.23～4.45%, Borneolum Syntheticum 2～6%, vegetable Chinese herbal medicine extractum 82.87～91.87%
Vegetable Chinese herbal medicine extractum is wherein made by the following weight proportion raw material,
Rhizoma Cyperi 5～15 weight portions
Arisaema Cum Bile 3～9 weight portions
Semen Ziziphi Spinosae 5～15 weight portions
Rhizoma Acori Graminei 4～12 weight portions
Radix Et Rhizoma Rhei 9～18 weight portions
Cortex Albiziae 4～12 weight portions
Caulis Polygoni Multiflori 5～15 weight portions
Herba Epimedii 5～15 weight portions
Fructus Aurantii Immaturus 5～15 weight portions
Radix Bupleuri 3～9 weight portions
Fructus Schisandrae Chinensis 5～15 weight portions
Radix Angelicae Sinensis 4～12 weight portions
Semen Persicae 3～9 weight portions
Rhizoma Chuanxiong 3～9 weight portions.
The present invention's medicine is based on modern pharmacological research, in conjunction with motherland's medical science dialectical the executing of such disease controlled and the Therapeutic Principle, to treat depressive state, sleep disorder, force symptom, the neurasthenia, climacteric syndrome, chronic fatigue syndrome etc. with the chemical synthetic drug of dumps emotional handicap type disease with have soothing the liver, regulate the flow of vital energy, resolving depression, reduce phlegm, have one's ideas straightened out, the vegetable Chinese herbal medicine of calming the nerves organically is combined into a kind of medicine, make the compatibility of this each component of medicine can reduce the consumption of chemical synthetic drug, its toxic and side effects of antagonism, can on curative effect, produce good synergism again, and can give full play to the chemical synthetic drug symptomatic treatment, produce effects is fast, and dialectical the executing of vegetable Chinese herbal medicine controlled etiological treatment, the characteristics that get rid of illness and dig up the roots.
The present invention's medicine is combined into a kind of medicine with each component by selected ratio range, cheap, it is more convenient that patient is taken, improve patient's compliance, make patient can take medicine of the present invention for a long time, the people can not tolerate its untoward reaction and therapy discontinued and do not cause due to illness, thereby the untoward reaction that has solved for a long time because of chemical synthetic drug has a strong impact on patient's compliance, thus the thorny problem of puzzlement clinical application.
Antidepressants Clomipramine in the present invention's the drug component, neuroleptic drug sulpiride be treat depressive state, sleep disorder clinically, force symptom, the medicine of dumps emotional handicap type disease determined curative effect such as neurasthenia, climacteric syndrome, chronic fatigue syndrome, two medicines share more can promote curative effect, and has weakened the stronger untoward reaction of Clomipramine relatively.Sodium valproate can be stablized mental state, prevention of recurrence.Three medicines and usefulness make it more adapt to treatment to dumps emotional handicap type disease.
The present invention's medicine has also been avoided looking into the medicine name because of taking multiple medicine, has been checked the trouble that metering etc. is brought, thereby has also avoided because of taking the serious consequence that wrong medicine brings.
The specific embodiment
Further specify the present invention below.
The preferred weight proportioning of making each raw material of vegetable Chinese herbal medicine extractum is,
Rhizoma Cyperi 6～9 weight portions
Arisaema Cum Bile 3～6 weight portions
Semen Ziziphi Spinosae 8～12 weight portions
Rhizoma Acori Graminei 8～12 weight portions
Radix Et Rhizoma Rhei 10～15 weight portions
Cortex Albiziae 6～12 weight portions
Caulis Polygoni Multiflori 8～12 weight portions
Herba Epimedii 6～12 weight portions
Fructus Aurantii Immaturus 6～9 weight portions
Radix Bupleuri 3～6 weight portions
Fructus Schisandrae Chinensis 10～15 weight portions
Radix Angelicae Sinensis 6～12 weight portions
Semen Persicae 3～6 weight portions
Rhizoma Chuanxiong 3～6 weight portions.
Above-mentioned optimum ratio scope makes each component have better synergism.
Each amounts of components ratio range of the present invention's medicine is through prolonged and repeated practice, screens definitely with Orthogonal Method, multidigit level method, has guaranteed characteristics such as curative effect height, untoward reaction that medicine of the present invention has be little.
The present invention's medicine can be made into tablet, capsule, electuary and other peroral dosage form.
The preparation method of the capsule of the present invention's medicine is, at first prepare vegetable Chinese herbal medicine extractum, take by weighing each raw material of vegetable Chinese herbal medicine by proportioning, cut after rinsing well or smash to pieces, add water to submerge, the Radix Et Rhizoma Rhei list is put, and soaks after 2～3 hours, decocts 1～2 hour (Radix Et Rhizoma Rhei under decocting after 0.5～1 hour), filter, take out filtrate; And then add water, and decocted 1～2 hour, filter, merge filtrate twice.Filtrate after merging is concentrated with the cryogenic vacuum method, to the thick paste shape, dry, be ground into fine powder, cross 80～100 mesh sieves, stand-by.
Then, powdered Clomipramine, sulpiride, sodium valproate, Borneolum Syntheticum and comminuted plants Chinese herbal medicine extractum are stirred, make the present invention's medicine by proportioning.
Medicine after the above-mentioned stirring can be incapsulated, by every capsules 450mg medicated powder, the capsule of packing into No. 0, make every capsules include Clomipramine 7.5mg～10mg, sulpiride 10mg～20mg, sodium valproate 10mg～20mg, Borneolum Syntheticum 9mg～27mg, vegetable Chinese herbal medicine extractum 372.92mg～413.42mg, make the capsule of the present invention's medicine.
Also the medicine after the above-mentioned stirring can be made other peroral dosage forms such as tablet, electuary, preparation method is identical with the preparation method of existing other tablet, electuary etc.
Capsular instructions of taking in the present invention's the medicine is: oral, 1～2/d of beginning can be cumulative to 3～6/d, 7～10/d when being in a bad way, and maximal dose is no more than 14/d.Child, old people reduce by half and take.Should be therapeutic dose when adding to the symptom basic controlling gradually from low dosage, this therapeutic dose need adhere to taking 2～3 months behind the transference cure, to consolidate curative effect, more slowly decrement to maintenance dose, i.e. 2～4/d.The maintenance dose of falling ill for the first time need adhere to taking 2 years, and morbidity was for the second time kept 5 years, during when not having the recurrence sign, can consider drug withdrawal.
The present invention's medicine should not and be used with MAOI, anticholinergic, Flos Caryophylli and goods thereof.
It below is the clinical observation material of the present invention's medicine.
Case is selected: meet the diagnostic criteria of CCMD-3 depression, get rid of brain organic disease and physical disease.Be divided into two groups at random, i.e. seminar and matched group.Seminar (take the present invention's medicine, administrated method is with above-mentioned): totally 64 examples, male 16 examples, woman's 48 examples, 20～76 years old age, average 48.56 ± 15.42 years old, the course of disease 1 month～42 months, average 5.69 ± 50.74 months, the HAMD scoring was 28.78 ± 5.92 minutes before the treatment.Matched group (is taken Clomipramine, sulpiride, sodium valproate simultaneously, administrated method is by its description separately): 64 examples, wherein male 19 examples, woman's 45 examples, 18 years old～76 years old age, average 47.39 ± 16.17 years old, the course of disease 1 month～45 months, average 5.74 ± 51.59 months, the HAMD scoring was 27.88 ± 5.01 minutes before the treatment.Before two groups of treatments HAMD scoring and physical data by statistics credit analyse demonstration difference there are no significant (p＞0.05), have comparability.Detect routine blood test, electrocardiogram, liver function etc. before and after the treatment.Its sex, age, the course of disease, the order of severity etc. are learned by statistics and are handled there was no significant difference (p＞0.05).Interrupt and dropping situations: in the seminar 4 examples because of the other reasons therapy discontinued, 3 routine therapy discontinued in the matched group and coming off.
Follow the trail of 60 routine patients and take this drug condition and see that 58 examples of fully recovering (96.7%) show into 1 example (1.7%), progressive 1 example (1.7%), invalid 0 example (0.0%), total effective rate is 100%; There are 56 routine patients to take medicine 0.5 year～1 year, do not have because of not tolerating its side reaction drug withdrawal person.
Curative effect and untoward reaction assessment: by 1 attending doctor and 1 associate chief physician before patient treatment and the treatment back use GI evaluation curative effect among HAMD and 6 months clinical efficacy general comment (CGI) 1,2,4,6,8 weekends respectively, TESS evaluates side reaction.Before the treatment and treatment back have a blood test respectively for 2,4,8 weekends routine, routine urinalysis, liver function, electrocardiogram etc.
Curative effect adopts the level Four evaluation, subtracts the evaluation of branch rate branch level Four, recovery from illness: subtract branch 75%～100% according to the HAMD scale; Show into: 50%～74%; Progressive: as to subtract branch 25%～49%; Invalid: as to subtract branch＜25%.
Statistical method: adopt t check, Ridit check, x
2Check.
Clinical efficacy: observe through 8 weeks, seminar's 38 examples (63.3%) of fully recovering show into 15 examples (25%), progressive 4 examples (6.7%), and invalid 3 examples (5%), total effective rate is 95%; Matched group 35 examples (57.4%) of fully recovering show into 14 examples (23%), progressive 8 examples (13.1%), and invalid 4 examples (6.5%), total effective rate is a relatively there was no significant difference (p＞0.05) of 93%, two group of curative effect, sees table 1 for details; The HAMD scoring relatively sees Table 2.
Table 1 liang group patient clinical efficacy is (routine number) relatively
| Group | Recovery from illness | Show into | Progressive | Invalid | Obvious effective rate |
| Seminar's matched group | 38 35 | 15 14 | 4 8 | 3 4 | 88.33％ 80.33％ |
Annotate:, compare x between two groups through the Ridit check
2=0.581, p＞0.05
Table 2 liang 8 week of group treatment front and back HAMD scoring relatively
| Time | Seminar (n=60) | Matched group (n=61) | ||
| Scoring | Subtract branch rate (%) | Scoring | Subtract branch rate (%) | |
| The 8th weekend of the 6th weekend the 4th weekend the 2nd weekend the 1st weekend after the treatment before the treatment | 28.7±5.6 23.0±3.6 ** 18.3±5.3 ** 14.4±4.3 ** 9.9±4.8 ** 8.3±4.4 ** | --- 15.3±3.7 24.2±6.7 39.3±7.1 69.1±7.6 81.1±11.5 | 27.8±4.9 △ 24.8±5.8 *△ 20.1±7.7 ** 17.8±5.2 **△△ 12.5±5.5 **△ 11.4±6.9 ** | --- 14.9±4.9 22.6±5.4 37.7±6.8 67.8±7.6 76.3±9.7 △ |
Annotate: relatively preceding through the t check with treatment, * p＜0.05, * * p＜0.01; Compare △ p＜0.05, △ △ p＜0.01 between two groups
As seen from Table 2, the HAMD scoring all has remarkable decline behind two groups of patient treatments before treating, and along with the prolongation decline of treatment time is more obvious, treating 8 all backs and treating preceding comparing difference has highly significant (p＜0.05).Marking with matched group HAMD in treatment seminar at the 1st weekend the significance of difference (p＜0.05) promptly occurs, and the 4th weekend is difference highly significant (P＜0.01) then, later on i.e. balance gradually.Subtract the branch rate from two groups, during to the 8th weekend, the significance of difference (p＜0.05) just appears in seminar and matched group, proves absolutely that seminar's antidepressant effect is better than matched group, and rapid-action.
Take chemicals dosage situation, see Table 3 for two groups
Table 3 a liang group is taken the chemicals situation analysis
| The n=60 of seminar | Matched group n=61 | |||||
| Medicine | Minimum dose (mg) | Maximal dose (mg) | On average | Minimum dose (mg) | Maximal dose (mg) | On average |
| Clomipramine sulpiride sodium valproate | 25 100 200 | 75 200 300 | 51.17±18.78 152.46±35.85 231.67±46.91 | 75 200 200 | 250 400 600 | 131.97±44.52 ** 286.89±64.49 ** 332.77±83.10 ** |
Annotate: through the t check, two groups of patients take drug dose relatively, * p＜0.05, * * p＜0.01
Untoward reaction: discover that seminar adds up to 11 examples (18.3%) and untoward reaction occurs, matched group has 43 examples (70.5%) untoward reaction to occur, and two groups of comparing differences have highly significant (x
2=33.30, p＜0.01), seminar's untoward reaction has blurred vision, giddy, weight increase etc., and symptom is lighter, and the patient can tolerate, and need not special handling, and along with the passing of treatment time, the part untoward reaction weakens gradually or disappears.And the matched group untoward reaction has xerostomia, constipation, headache, giddy, feels sick, blurred vision, dysuria, tremble, ECG change, liver function change etc., see table 4 for details
Table 4 liang group treatment back untoward reaction is (n) relatively
| Untoward reaction | The n=60 of seminar | Matched group n=61 | ||
| The example number | ％ | The example number | ％ | |
| The dizzy drowsiness nasal obstruction of somnolence of feeling sick of the dry mouth and constipation eye-blurred dysuria body weight of trembling increases ECG change | 3 0 12 1 1 16 2 2 3 0 5 7 | 5.0 0 20.0 1.7 1.7 26.7 3.3 3.3 5.0 0 8.0 11.7 | 51 ** 47 ** 29 ** 8 * 2 13 7 32 ** 19 ** 21 ** 3 24 ** | 83.6 77.1 47.5 13.1 3.3 21.3 11.5 52.5 31.2 34.4 4.92 39.3 |
Annotate: through x
2* p＜0.05, * * p＜0.01 are compared in check between two groups
Find out that from above chart and statistical analysis curative effect of medication of the present invention is better than the pure chemistry synthetic drug, its side reaction is slight.
Embodiment 1
1, takes by weighing Rhizoma Cyperi 750g, Arisaema Cum Bile 450g, Semen Ziziphi Spinosae 750g, Rhizoma Acori Graminei 600g, Radix Et Rhizoma Rhei 900g, Cortex Albiziae 600g, Caulis Polygoni Multiflori 500g, Herba Epimedii 750g, Fructus Aurantii Immaturus 450g, Radix Bupleuri 450g, Fructus Schisandrae Chinensis 750g, Radix Angelicae Sinensis 500g, Semen Persicae 450g, Rhizoma Chuanxiong 450g, cut after rinsing well or smash to pieces, add pure water and soaked 2 hours, the Radix Et Rhizoma Rhei list is put, decoct 1.5 hours (decoct and add Radix Et Rhizoma Rhei after 1 hour), filter, take out filtrate; Medicinal residues add pure water and decocted 1 hour again, filter, and merge filtrate twice.Filtrate cryogenic vacuum after merging is concentrated into the thick paste shape, and oven dry is pulverized, and crosses 100 mesh sieves, and is stand-by.
2, accurately take by weighing powdered chlorine third 16.7g of the miaow Qin, sulpiride 22.3g, sodium valproate 22.3g, Borneolum Syntheticum 20g, the Chinese medical concrete 918.7g after pulverizing, fully mixing.
3, incapsulate by every 450mg.
Below 4 embodiment, preparation method is all with embodiment 1.Just each proportion of raw materials varies in weight, and sees Table 5, table 6.
Contained group component among table 5 embodiment 2～5
| Component | Embodiment (weight g) | |||
| Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | |
| Clomipramine sulpiride sodium valproate Borneolum Syntheticum Chinese medical concrete | 167g 250g 250g 200g 9133g | 223g 300g 300g 400g 8777g | 200g 445g 445g 400g 8510g | 223g 445g 445g 600g 8287g |
The material proportional quantity of preparation vegetable Chinese herbal medicine extractum among table 6 embodiment 2～5
| Component | Embodiment (weight g) | |||
| Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | |
| Rhizoma cyperi arisaema cum bile spina date seed grass-leaved sweetflag rheum officinale cortex albiziae Polygonum multiflower knotweed barrenwort dried immature fruit of citron orange radix bupleuri fruit of Chinese magnoliavine Radix Angelicae Sinensis peach kernel Ligusticum wallichii | 6kg 3kg 6kg 6kg 10kg 6kg 6kg 10kg 6kg 3kg 10kg 6kg 3kg 3kg | 15kg 6kg 15kg 11kg 15kg 10kg 15kg 15kg 15kg 6kg 15kg 12kg 6kg 6kg | 8kg 8kg 8kg 12kg 10kg 12kg 8kg 8kg 12kg 8kg 8kg 8kg 5kg 5kg | 12kg 9kg 12kg 8kg 18kg 8kg 12kg 12kg 8kg 6kg 12kg 9kg 8kg 8kg |
Claims (3)
1, a kind of medicine for the treatment of dumps emotional handicap type disease, it is characterized in that, described medicine is made up of following raw materials in percentage by weight: Clomipramine 1.67～2.23%, sulpiride 2.23～4.45%, sodium valproate 2.23～4.45%, Borneolum Syntheticum 2～6%, vegetable Chinese herbal medicine extractum 82.87～91.87%
Vegetable Chinese herbal medicine extractum is wherein made by the following weight proportion raw material,
Rhizoma Cyperi 5～15 weight portions
Arisaema Cum Bile 3～9 weight portions
Semen Ziziphi Spinosae 5～15 weight portions
Rhizoma Acori Graminei 4～12 weight portions
Radix Et Rhizoma Rhei 9～18 weight portions
Cortex Albiziae 4～12 weight portions
Caulis Polygoni Multiflori 5～15 weight portions
Herba Epimedii 5～15 weight portions
Fructus Aurantii Immaturus 5～15 weight portions
Radix Bupleuri 3～9 weight portions
Fructus Schisandrae Chinensis 5～15 weight portions
Radix Angelicae Sinensis 4～12 weight portions
Semen Persicae 3～9 weight portions
Rhizoma Chuanxiong 3～9 weight portions.
2, the medicine of treatment dumps emotional handicap type disease as claimed in claim 1 is characterized in that, the weight proportion of making each raw material of vegetable Chinese herbal medicine extractum is,
Rhizoma Cyperi 6～9 weight portions
Arisaema Cum Bile 3～6 weight portions
Semen Ziziphi Spinosae 8～12 weight portions
Rhizoma Acori Graminei 8～12 weight portions
Radix Et Rhizoma Rhei 10～15 weight portions
Cortex Albiziae 6～12 weight portions
Caulis Polygoni Multiflori 8～12 weight portions
Herba Epimedii 6～12 weight portions
Fructus Aurantii Immaturus 6～9 weight portions
Radix Bupleuri 3～6 weight portions
Fructus Schisandrae Chinensis 10～15 weight portions
Radix Angelicae Sinensis 6～12 weight portions
Semen Persicae 3～6 weight portions
Rhizoma Chuanxiong 3～6 weight portions.
3, the medicine of treatment dumps emotional handicap type disease as claimed in claim 1 is characterized in that, described medicine is tablet, capsule, electuary and other peroral dosage form.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178849A (en) * | 2010-07-20 | 2011-09-14 | 朱友文 | Chinese medicine preparation for treating insomnia and preparation method thereof |
| WO2011148203A1 (en) * | 2010-05-28 | 2011-12-01 | Maja Novak | Formulation based on sulpiride and a synergistic homeopathic composition for treatment of depressive syndrome |
| CN102421428A (en) * | 2009-05-12 | 2012-04-18 | 株式会社爱茉莉太平洋 | Composition for preventing hair loss or for stimulating hair growth |
-
2006
- 2006-06-01 CN CNB2006100445496A patent/CN100493556C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102421428A (en) * | 2009-05-12 | 2012-04-18 | 株式会社爱茉莉太平洋 | Composition for preventing hair loss or for stimulating hair growth |
| US8952060B2 (en) | 2009-05-12 | 2015-02-10 | Amorepacific Corporation | Composition for preventing hair loss or for stimulating hair growth |
| WO2011148203A1 (en) * | 2010-05-28 | 2011-12-01 | Maja Novak | Formulation based on sulpiride and a synergistic homeopathic composition for treatment of depressive syndrome |
| CN102178849A (en) * | 2010-07-20 | 2011-09-14 | 朱友文 | Chinese medicine preparation for treating insomnia and preparation method thereof |
| CN102178849B (en) * | 2010-07-20 | 2013-03-20 | 朱友文 | Chinese medicine preparation for treating insomnia and preparation method thereof |
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