CN101658626A - Chinese herba preparation for treating depression - Google Patents
Chinese herba preparation for treating depression Download PDFInfo
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- CN101658626A CN101658626A CN200910084305A CN200910084305A CN101658626A CN 101658626 A CN101658626 A CN 101658626A CN 200910084305 A CN200910084305 A CN 200910084305A CN 200910084305 A CN200910084305 A CN 200910084305A CN 101658626 A CN101658626 A CN 101658626A
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Abstract
The invention discloses a Chinese herba preparation for treating depression. The Chinese herba preparation is prepared by the following raw materials in parts by weight: 10-14 parts of rhizoma anemarrhenae, 13-17 parts of radix rehmanniae, 8-12 parts of radix paeoniae alba, 23-27 parts of keel, 28-32 parts of oyster, 8-12 parts of golden cypress, 10-14 parts of gardenia, 10-14 parts of wolfberry fruit and 10-14 parts of macrocarpium fruit. The Chinese herba preparation has favorable effect in treating depression, little reverse reaction, light degree, small side effect, good tolerance and highobedience for patients to take the medicine.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation that is used for the treatment of depression, more precisely is the Chinese medicine preparation that treatment has the depression of obvious sleep disorder.
Background technology
Depression is a kind of common frdquently encountered disease, and World Health Organization's statistics patients with depression accounts for the 3-5% of whole world population, is equivalent to 1.2-2 hundred million people.In western countries such as the U.S., Germany, 10% resident has depressed tendency.And in country and area underdeveloped, the population ratio that has the depression dominant character is higher, and some are local even reached 20%.Message from psychiatric department branch of Chinese doctors'associations shows: the present patients with depression of China has 3,000 ten thousand approximately.
Because of all burdens that depression brought make the whole world all can lose the output value of 2%-5% every year.According to World Health Organization's statistics, with regard to the disease burden, depression has become the fourth-largest disease in the world at present, and expecting the year two thousand twenty may will become the human second largest illness that is only second to cardiovascular disease.
Depression is as the more and more outstanding mental illness of society, and numerous medicines have curative effect preferably to depression, but in clinical practice, various untoward reaction appear in Western medicine inevitably, as has xerostomia, blurred vision, memory dysfunction etc.Although in recent years, because pharmaceutical technology is constantly reformed, the side reaction of the antidepressant drug of a new generation reduces, but part patient still certain untoward reaction can occur, influence the compliance of patient treatment, even be forced to therapy discontinued for this reason, and therefore seek the medicine of treatment by Chinese herbs depression with Chinese quintessence of Chinese culture, be the common hope of pursuing of doctor and patient.
Summary of the invention
At above-mentioned situation, the purpose of this invention is to provide a kind of Chinese medicine preparation for the treatment of depression, especially treatment has the Chinese medicine preparation of the depression of obvious sleep disorder, can effectively treat depression, and side effect can be dropped to minimum.
To achieve these goals, the present invention adopts the Rhizoma Anemarrhenae, the Radix Rehmanniae, the Radix Paeoniae Alba, Os Draconis, Concha Ostreae, Cortex Phellodendri, Fructus Gardeniae, Fructus Lycii, Fructus Corni reasonable compatibility, be processed into the Chinese medicine preparation for the treatment of depression through science, the weight portion proportioning is respectively: Rhizoma Anemarrhenae 10-14 weight portion, Radix Rehmanniae 13-17 weight portion, Radix Paeoniae Alba 8-12 weight portion, Os Draconis 23-27 weight portion, Concha Ostreae 28-32 weight portion, Cortex Phellodendri 8-12 weight portion, Fructus Gardeniae 10-14 weight portion, Fructus Lycii 10-14 weight portion, Fructus Corni 10-14 weight portion.
Described Chinese medicine preparation is a said dosage form on any materia medica.
Described dosage form is a capsule, tablet, granule, oral liquid, pill, powder, sublimed preparation, any pharmaceutical dosage form in the unguentum.
Beneficial effect of the present invention is:
Antidepressant good effect of the present invention, untoward reaction is few, and degree is light, and side effect is little.Patient take medicine better tolerance, compliance height.
The specific embodiment
Below in conjunction with embodiment and practical situation the present invention is elaborated.
The prescription requirement according to the present invention, in the weight portion proportioning Rhizoma Anemarrhenae 10 weight portions, the Radix Rehmanniae 13 weight portions, the Radix Paeoniae Alba 8 weight portions, Os Draconis 23 weight portions, Concha Ostreae 28 weight portions, Cortex Phellodendri 8 weight portions, Fructus Gardeniae 10 weight portions, Fructus Lycii 10 weight portions, Fructus Corni 10 weight portions, be mixed and made into Chinese medicine preparation.
Fire mutually, Os Draconis, Concha Ostreae suppressing the hyperactive liver and subsiding YANG, tranquillizing and allaying excitement fall clearly in the moon of the Radix Rehmanniae, the Radix Paeoniae Alba, Fructus Lycii, Fructus Corni nourishing the liver and kidney in above-mentioned prescription, the Rhizoma Anemarrhenae, Cortex Phellodendri, Fructus Gardeniae consolidating YIN.Above-mentioned science compatibility can reach nourishing YIN to lower pathogenic fire jointly, tranquilizing to ease mentle strain, thus make depression be able to effective treatment.
Below the effect of mouse experiment and clinical practice treatment depression has all been obtained fully proving.
The pharmacodynamics pharmacological toxicology is learned situation
According to bureau of drug administration of People's Republic of China (PRC) new drug research guideline, show that after deliberation changing Chinese medicine preparation has inhibitory action to nervus centralis, the appropriate sleeping number of subliminal hypnosis dosage of receiving of experiment mice penta crust is obviously increased, the sleep time-lag action is arranged.Show through animal acute toxicity test, be equivalent to 300 times of people's clinical application amount with this Chinese medicine preparation suspension to mouse stomach, mice does not have movable unusual, does not more see death, so as safe as a house during this Chinese medicine preparation oral administration.This Chinese medicine preparation long term toxicity test studies show that this Chinese medicine preparation does not have influence to the normal growth growth of rat, and the every index of hemogram checking is all in normal range, and this Chinese medicine preparation has no adverse effects to the hemopoietic function of rat, does not damage hepatic and renal function.The all no abnormal pathologic of main organs pathological examination changes, and illustrates that this Chinese medicine preparation is very safe.
In order further to estimate the clinical efficacy of this Chinese medicine preparation, 65 routine depressive patients are observed, and to establish Fourth Ring class antidepressant-myputiline be matched group that the observation of system has been carried out in its curative effect, safety and side effect, and situation is as follows:
1, alternative
1.1 go into the group standard: age 18-60 year, meet ICD-10 and the diagnostic criteria of CCMD-3 depression, Hamilton depressive scale (Hamilton depression scale, HAMD, 24 versions) scoring is 〉=20 minutes, self rating depressive scale (self-rating scale for depression, SDS) scoring 〉=50, body and lab testing normal (having responsible doctor to determine whether it can go into group when slight abnormality is arranged) when the patient goes into to organize, ECG does not have significantly unusual; Do not take various medicines, the signature Informed Consent Form.
1.2 exclusion standard: serious suicidal tendency or merge other serious mental sickness, the person that the serious adverse reaction occurs during the treatment; Serious physical disease after one's own heart, liver, kidney disease, has epilepsy, angle closure glaucoma and prostate hyperplasia, and gestation or women breast-feeding their children had similar drug allergy history in the past, were rejected.
1.3 come off and interrupt criteria: sb.'s illness took a turn for the worse, because of untoward reaction stops treatment voluntarily or is considered as the case that comes off because of serious adverse reaction stops therapist, and the statistics untoward reaction.
1.4 case is selected to carry out the test of Hamilton depressive scale concordance, r=0.90 before the group.
1.5 physical data is included 69 routine patients in altogether by above-mentioned condition, 4 examples that come off, actual 65 examples of finishing.
These Chinese medicine preparation group 32 examples, male's 14 examples, women's 18 examples; Age 18-60 year, average (37.49 ± 10.53) year, average course of disease (33.46 ± 13.21) month, this depression time (7.12 ± 1.79) month.Go into to organize base line HAMD total points 33.67 ± 9.96, clinical diagnosis unipolar depression 13 examples of showing effect, two-phase paralepsy 15 examples, other depression 4 examples.
Matched group (maprotiline) 33 examples.Male's 16 examples, women's 17 examples; Age 18-58 year, average (41.42 ± 11.59) year, average course of disease (32.38 ± 13.96) month, this depression time (8.04 ± 1.38) month.Go into to organize base line HAMD total points 36.43 ± 6.45, clinical diagnosis unipolar depression 20 examples of showing effect, two-phase paralepsy 6 examples, other depression 7 examples.Two groups of above every t check comparisons between two groups, diversity does not have significance (P＞0.05)
2, the administrated method and the course of treatment
2.1 treatment is cleaned the after date patient through a week and is entered two groups (Chinese medicine preparation group and matched group maprotiline groups) at random
According to the table of random number administration.Oral this Chinese medicine preparation of this Chinese medicine preparation group, preparation is a Chinese medicinal granule, each 1 bag (10g), every day 2 (each 1 time sooner or later), totally 6 weeks; The 1st week of matched group to 100mg every day, increases and decreases dosage according to the state of an illness and side reaction size with the maprotiline dosage escalation later on.Dosage is between every day 100-250mg, and average dosage is (164 ± 59.84) mg, obeys for 6 weeks altogether.Do not conform to other treatment during the treatment.
2.2 2 weeks, 4 weeks, 6 weeks respectively adopt HAMD, SDS, anxiety self-appraisal scale (SAS), Asberg side reaction scale and the clinical global impression scale (CGI) of observation index before treatment and in the therapeutic process carries out curative effect and side reaction scoring.HAMD subtracts branch rate=(total points before the treatment-treatment back total points)/preceding total points of treatment.The HAMD24 item is reduced 7 silver by international standard: (1) anxiety/body ratio, (2) body weight, (3) disturbance in cognition, (4) day and night change (5) sluggishness, (6) sleep disorder, (7) feeling of despair, the relatively variation (being factorial analysis) of each factor score value before and after the treatment
The preceding two groups of patients' of CGI scale evaluation treatment the degree that is in a bad way (SI), curative effect general comment (GI) when treatment finishes, and calculate therapeutic index (EI, EI=curative effect score value/side reaction score value).Laboratory inspection comprises liver function, electrocardiogram, routine blood test, routine urinalysis, body temperature, blood pressure etc., reenters to check (laboratory inspection projects are all in normal range before two groups of patient treatments) when group and research finish
2.3 criterion of therapeutical effect: HAMD subtracts branch rate 〉=75% and is recovery from illness, and 〉=50% for marked improvement, and 〉=30% for advancing, and＜30% is invalid.
2.4 the whole data of statistical procedures are analyzed with SPSS10.0 software.Group difference adopts the independent sample t check, and difference adopts paired sample t check in the group, and the non parametric tests of two independent samples is adopted in clinical general curative effect evaluation.
The result
1. therapeutic evaluation: Chinese drug-treated group and matched group all subtract branch rate＞50% at treatment HAMD at the 4th weekend and reach marked improvement.Treat HAMD evaluation at the 6th weekend Chinese drug-treated group 14 examples of fully recovering, matched group 16 examples; Chinese drug-treated group marked improvement 12 examples, matched group 12 examples; Chinese drug-treated group progress 5 examples, matched group 5 examples (table 1).
Table 1: general curative effect compares (example, percentage ratio) before and after the patients with depression treatment
Annotate: the case load of obvious effective rate=recovery from illness+produce effects accounts for the percentage ratio of respectively organizing the sample book
Chinese drug-treated group obvious effective rate: 81.40% matched group obvious effective rate: 84.90% chi-square value: 0.584 Chinese drug-treated group obvious effective rate 81.40%; Matched group 84.90%; Two groups are relatively, X2=0.300, and P=0.58＞0.05 difference does not have significance (table 1).
Comparing difference does not also have significance (P＞0.05) (table 2) between two groups of SDS scale score value groups.
Table 3: the variation (branch) of each factor scores of HRSD before and after the patients with depression treatment (± S)
Each factorial analysis of HAMD scale relatively, finding does not have significant difference (table 3) between two groups before and after whole 7 factor in treatment.
Table 3: the variation (branch) that SDS divides before and after the patients with depression treatment (± S)
The phase that this Chinese medicine preparation and maprotiline are described is imitated time and whole therapeutic equivalence.
2. different time SAS, Asberg situation and analysis of adverse reactions (table 4,5) before and after two groups of patient treatments
Table 4: the variation (branch) that SAS divides before and after the patients with depression treatment (± S)
Table 5: the variation (branch) that the side effect of Asberg antidepressant divides before and after the patients with depression treatment (± S)
* and matched group be P＜0.01 relatively
Two groups of SAS scale score values are for all obviously descending before the treatment for the 2nd weekend from treating, and continue to for the 6th weekend always, and there was no significant difference (P＞0.0) relatively between group.Illustrate that the Chinese medicine preparation group is identical to the curative effect of patient anxiety's symptom with maprotiline.Therapeutic process Chinese drug-treated group Asberg scale score value continues to descend gradually, and significantly is lower than matched group, and significant difference (P＜0.01) is arranged.Control group A sberg scale score value rose to some extent at the 2nd weekend, descended gradually thereafter.Illustrate the patient take this Chinese medicine preparation after untoward reaction very little, and the maprotiline side effect is bigger, as time passes, the patient adapts to gradually to this medicine and Asberg scale score value descends gradually, and according to the difference ordering before two groups of patient's each symptom score values at the 2nd weekend and the treatment, the most serious side reaction of maprotiline is xerostomia successively, constipation, cardiopalmus, drowsiness, dizziness, headache, dysuria is perspired orthostatic collapse etc.
3. two groups of clinical general curative effect evaluations of patient relatively see Table 6
Table 6: two groups of patient CGI/comparisons (± S)
* and matched group be P=0.004＜0.01 relatively
Treat preceding two groups of patient SI and treatment back GI difference does not have significance, but since the side reaction of maprotiline obviously greater than the Chinese medicine preparation group, so Chinese medicine preparation group EI is significantly higher than matched group (P＜0.01)
4, conclusion
The present invention is sure to curative effect of depression, the 6th weekend HAMD on average to subtract the branch rate be 71.26 ± 15.68, with maprotiline quite (77.26 ± 14.20).The obvious effective rate that the present invention treats depression is 81.4%, and is close with maprotiline (84.9%).Subtract branch rate and SDS scale score value from the HAMD scale, onset time of the present invention was 2 weeks, and onset time is identical with maprotiline with whole curative effect.This result shows that also the present invention is also effective to anxiety symptom, and is from SAS scale score value, also suitable with the maprotiline curative effect.Simultaneously from the factorial analysis of HAMD scale relatively, two medicines are to the there was no significant difference that improves of body and anxiety, and then explanation the present invention is sure to the therapeutical effect of anxiety symptom.
More than experiment shows that untoward reaction of the present invention is slight, and patient's compliance in therapeutic process is good.Compare with maprotiline, anticholinergic untoward reaction such as xerostomia, constipation do not appear in the present invention, and maprotiline has tangible anticholinergic untoward reaction in therapeutic process, and patient so therapy discontinued are arranged, therefore the present invention and maprotiline relatively have clear superiority on the therapeutic index.In addition, do not find that the present invention has the harmful effect of pair heart, and the epilepsy incident does not take place.Treatment front and back electrocardiogram, blood, routine urinalysis and liver function test are all normal, illustrate that the present invention does not find serious adverse reactions such as liver function injury and cardiac toxicity.
Antidepression curative effect of the present invention affirms that bad reaction is few, mild degree. Patient's tolerance of taking medicine Good, compliance is high, is fit to clinical practice.
Claims (3)
1, a kind of Chinese medicine preparation for the treatment of depression is characterized in that, it is to be made by following Chinese medicinal raw materials in portion by weight:
Rhizoma Anemarrhenae 10-14 weight portion
Radix Rehmanniae 13-17 weight portion
Radix Paeoniae Alba 8-12 weight portion
Os Draconis 23-27 weight portion
Concha Ostreae 28-32 weight portion
Cortex Phellodendri 8-12 weight portion
Fructus Gardeniae 10-14 weight portion
Fructus Lycii 10-14 weight portion
Fructus Corni 10-14 weight portion.
2, Chinese medicine preparation according to claim 1 is characterized in that: described Chinese medicine preparation is a said dosage form on any materia medica.
3, Chinese medicine preparation according to claim 2 is characterized in that: described dosage form is a capsule, tablet, granule, oral liquid, pill, powder, sublimed preparation, any pharmaceutical dosage form in the unguentum.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910084305A CN101658626A (en) | 2009-05-20 | 2009-05-20 | Chinese herba preparation for treating depression |
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| CN200910084305A CN101658626A (en) | 2009-05-20 | 2009-05-20 | Chinese herba preparation for treating depression |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103229870A (en) * | 2013-05-06 | 2013-08-07 | 河南中医学院 | Depression-resolving health-care tea for preventing and treating depressive disorder and production method of health-care tea |
| CN110101787A (en) * | 2019-05-31 | 2019-08-09 | 张大志 | One kind clear away heart-fire it is strongly fragrant limber up, preparation method and applications |
| RU2697672C1 (en) * | 2016-01-13 | 2019-08-16 | Найн Б Ко., Лтд. | Composition for preventing, alleviating or treating menopausal syndrome in females, containing loganin or derivatives thereof as an active ingredient |
-
2009
- 2009-05-20 CN CN200910084305A patent/CN101658626A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103229870A (en) * | 2013-05-06 | 2013-08-07 | 河南中医学院 | Depression-resolving health-care tea for preventing and treating depressive disorder and production method of health-care tea |
| RU2697672C1 (en) * | 2016-01-13 | 2019-08-16 | Найн Б Ко., Лтд. | Composition for preventing, alleviating or treating menopausal syndrome in females, containing loganin or derivatives thereof as an active ingredient |
| US11116781B2 (en) | 2016-01-13 | 2021-09-14 | Nine B Co., Ltd. | Composition, containing Loganin or a derivative thereof as an active ingredient for preventing, remedying, or treating female climacteric syndrome |
| CN110101787A (en) * | 2019-05-31 | 2019-08-09 | 张大志 | One kind clear away heart-fire it is strongly fragrant limber up, preparation method and applications |
| CN110101787B (en) * | 2019-05-31 | 2021-04-06 | 张大志 | Heart-clearing and depression-relieving powder, preparation method and application thereof |
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Application publication date: 20100303 |