CN106309612A - Traditional Chinese medicinal composition for treating mental and psychological problems accompanying arrhythmia - Google Patents
Traditional Chinese medicinal composition for treating mental and psychological problems accompanying arrhythmia Download PDFInfo
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- CN106309612A CN106309612A CN201510353561.4A CN201510353561A CN106309612A CN 106309612 A CN106309612 A CN 106309612A CN 201510353561 A CN201510353561 A CN 201510353561A CN 106309612 A CN106309612 A CN 106309612A
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Abstract
The invention discloses applications of Xinkeshu preparation in preparing medicines for treating the mental and psychological problems such as anxiety and depression accompanying arrhythmia, and a preparation method. A traditional Chinese medicinal composition is prepared from the following raw materials by weight: 300-900 g of radix puerariae, 300-900 g of fructus crataegi, 300-900 g of radix salviae milti orrhizae, 20-60 g of radix notoginseng, and 20-60 g of radix aucklandiae. The invention further discloses a preparation method in preparing the medicines for treating the mental and psychological problems such as anxiety and depression accompanying arrhythmia by adopting the Xinkeshu preparation. During the treatment course for treating patients of the Xinkeshu preparation, the result shows that the symptoms of arrhythmia of the patients suffering from arrhythmia are obviously alleviated after the patients take the Xinkeshu preparation, and meanwhile, the psychological problems including anxiety and depression are obviously alleviated.
Description
Technical field:
The present invention relates to the new treatment use of a kind of Chinese medicine, exist particularly to Chinese medicine heart compositions of can relaxing
Treat the application in terms of the psychiatric problems such as the adjoint anxiety of patients with arrhythmia, depression.
Background technology:
Arrhythmia is common cardiovascular disease, shows as premature beat, tachycardia, bradycardia, very more
Quiver to room speed, room.Recently research have indicated that psychologic factors can affect cardiac electrical activity by number of mechanisms,
Its pathogenesis is complicated, multipath, and central nervous system exists regulation stress cause ventricular arrhythmia
Particular path, the flat factors such as electrocardio instability, anxiety, anxiety that cause of blood plasma homopyrocatechol aqueous amine induce crown
Arteriospasm, platelet is activated, and makes Myocardial Perfusion change and causes cardiac muscle electrical stability to change.Press down
The mental maladjustment such as strongly fragrant, anxiety are the independent hazard factors of ventricular arrhythmia, there are some researches prove a lot of rhythm of the heart
Not normal patient is attended by mental illness, last century the eighties, Katz finds that the ventricular premature contraction of 53% is with burnt
The mental disorders such as worry are relevant.Provinces and cities of China 5 1220 example is merged organic cardiopathic Patients with Ventricular Premature Beats
Investigation finds that the patient of 27% has obvious depressive symptom.And the mental maladjustment such as depression, anxiety not only reduce trouble
The quality of life of person, and increase cardiovascular event and mortality rate.
Medicine is the main method of the mental maladjustment such as treatment depression, anxiety, and antidepressant, anxiety agent mainly wrap
Include tricyclic antidepressants (TCA), serotonin reuptake inhibitor (SSRIs) and norepinephrine and 5-hydroxy tryptamine
Reuptake inhibitor (SNRI) etc., if drug ineffective or when not being resistant to, galvanic shock is a kind of non-
The most effective method.But both treatment meanss all have arrhythogenic side effect, it is clear that be unsuitable for the heart
Restrain not normal patient to use.
Through clinical practice in 30 years, fertile China XINKESHU PIAN confirmed that treatment coronary heart disease effect stability is reliable, the present invention anticipates
Outer discovery, fertile China XINKESHU PIAN is incessantly evident in efficacy to arrhythmia, anxiety, the depression to patient simultaneously
Improve significantly Deng unhealthy emotion, meet while " diplocardia effect " i.e. treat arrhythmia, right
The psychology (emotion) of patient also has certain regulation effect.
Summary of the invention:
The present invention provides a kind of heart can relax the new therapeutic use of preparation, and described new therapeutic use is arrhythmia
The unhealthy emotions such as the adjoint anxiety of patient, depression.
Substantial amounts of clinician feeds back patient after taking fertile China XINKESHU PIAN, generally sensation arrhythmia symptom
Substantially alleviate, and feel and be in a cheerful frame of mind.Doctor also sends out in return visit and thinks that patient is emotionally stable, anxiety,
The unhealthy emotions such as depression significantly improve.
It is below clinical research data:
1 object and method
1.1 object of study
Sieved in attached Shandong hospital of Shandong University officers ward, Cardiological unit patients in 2014 to 2015 years
Select arrhythmia to merge psychological problems patient 100 example, at random patient is divided into by medical order treatment group and comparison
Group.Treatment group 50 example, the maleest 33 examples, female 17 example；28 years old age～76 years old, 53 years old mean age；Take place frequently room
Property premature beat 12 example, frequent premature ventricular beats 15 example, atrial fibrillation 17 example, artrial premature beat ventricular premature contraction 3 example, have a common boundary
Property premature beat 1 example, supraventricular tachycardia 2 example.Matched group 50 example, the maleest 31 examples, female 19 example, 26 years old age～
79 years old, 51.5 years old mean age；Frequent atrial premature beats secondary 11 example, frequent premature ventricular beats 17 example, atrial fibrillation 16 example,
Artrial premature beat ventricular premature contraction 1 example, junctional premature beat 2 example, supraventricular tachycardia 3 example.Two groups sex,
The aspect no significant difference (P ＞ 0.05) such as age, the course of disease and state of an illness weight, have comparability.
Inclusion criteria: meet had palpitation, symptom uncomfortable in chest, it is that arrhythmia causes that electrocardiogram confirms, continue 1 month with
Upper person；Application Hamilton is depressed, Manifest Anxiety Scale (HAMD, HAMA) carries out psychometry, HAMD
Scale total score >=20 point and HAMA scale total score >=14 point person.
Exclusion standard: including: turn out to be acute myocardial infarction, hyperthyroid heart disease, the leanest the most on inspection
The arrhythmia that blood, electrolyte disturbance, digitalism, cardiac function IV level etc. cause.2. allergic constitution and
To multi-medicament allergy sufferers.3. psychotic, a large amount of Smoking And Drinking patient.4. gestation and women breast-feeding their children.
5. 3 grades of hypertension or belong to high-risk above person.
1.2 research method
Treatment group is administered orally XINKESHU PIAN (Shandong China Wo Medicine Co's offer) three times a day,
Each 4；Matched group is administered orally each 9g of WENXIN KELI, three times a day, oral happiness 20mg the most happy every day；
It is 4 weeks the course for the treatment of.
3 observation index and method
3.1 arrhythmia condition improvements
Before taking medicine, taking medicine 4 weeks checks respectively for electrocardiogram and ambulatory electrocardiogram, observe the most uncomfortable in chest, cardiopalmus before and after taking medicine,
Degree is reduced etc. alleviation degree and the attack times of symptom.Efficacy evaluation (1) is effective: arrhythmia disappears or reduces
More than 90%, normal ECG or be obviously improved, clinical symptom disappearance or be obviously improved.(2) effective: arrhythmia is relatively
Improving more than 50% before treatment, electrocardiogram improves, and clinical symptoms major part disappears or alleviates.(3) invalid: arrhythmia
Outbreak is without alleviating, and electrocardiogram and symptom are improved inconspicuous or increase the weight of.
3.2 anxieties are improved with depressive state
Depressed severity, Manifest Anxiety Scale (HAMA) are evaluated in application Hamilton depressive scale (HAMD)
Evaluation occurs together anxiety degree, and as curative effect index.Before treatment, treat and respectively carry out 14 weekends
Secondary scale score.After psychotherapy, the deduction rate of HAMA, HAMD is as index, curative effect is divided into effective
(deduction rate ＞ 75%), effectively (75% >=deduction rate ＞ 25%), invalid (deduction rate≤25%) 3 grades.Deduction rate=(control
Mark after HAMA or HAMD mark-treatment before treating) front mark × 100% of/treatment.
Statistical method:
All of statistical test all uses SPSS13.0 statistical software, and P value will be recognized less than or equal to 0.05
Difference by being checked has statistical significance.Different Sets of Measurement Datas will use mean ± standard deviation to unite
Meter describes.
4 results
Arrhythmia condition improvement (being shown in Table 1) before and after 4.12 groups of treatments
Before and after the treatment of 12 groups of table, arrhythmia symptom compares
| Group | n | Effective | Effectively | Invalid |
| Treatment group | 50 | 18 | 29 | 3 |
| Matched group | 50 | 11 | 32 | 7 |
Two groups of comparitive study, P ＜ 0.05, there is significant difference.
4.2 anxiety-depression condition improvement degree compare (be shown in Table 3, table 4)
Before and after the treatment of 22 groups of table, anxiety degree change is compared
| Group | n | Effective | Effectively | Invalid |
| Treatment group | 50 | 10 | 31 | 9 |
| Matched group | 50 | 5 | 28 | 17 |
Before and after the treatment of 32 groups of table, Degree of Depression change is compared
| Group | n | Effective | Effectively | Invalid |
| Treatment group | 50 | 12 | 34 | 4 |
| Matched group | 50 | 7 | 31 | 12 |
Two groups of comparitive study, P ＜ 0.05, there is significant difference
To this end, the present invention provides a kind of unhealthy emotions such as the adjoint anxiety of patients with arrhythmia, depression for the treatment of
Chinese medicine composition, said composition is made up of pharmaceutically active substance and pharmaceutically acceptable carrier, wherein said medicine
Active substances is made up of the raw material of Chinese medicine of following weight proportion:
[prescription] Radix Puerariae 300-900g, Fructus Crataegi 300-900g, Radix Salviae Miltiorrhizae 300-900g, Radix Notoginseng 20-60g, the Radix Aucklandiae
20-60g
Most preferably consist of:
[prescription] Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g
In composition described above, the weight of each taste medicine calculates with crude drug, and above-mentioned formula composition can be made into medicine system
Agent 1000 doses.The final drug preparation that described dose of finger is made, as capsule 1000 doses refers to capsule preparations 1000
Grain, 1000 doses of tablet refers to 1000, tablet, is granule 1000 grams for granule, and oral liquid refers to mouth
Take liquid 1000ml etc..
Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as
Large-scale production can by kilogram in units of, or in units of ton, small-scale production can also be with milligram as list
Position, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, such as serious symptom or light
Disease, fat or modest patient, the proportioning of the amount of composition can be adjusted accordingly, be increased or decreased less than 100%,
Drug effect is constant.
Raw material of Chinese medicine in composition described above, especially adjuvant drug and make medicine can have the identical property of medicine with suitable
Chinese medicine is replaced, and its medicine effect of the Chinese medicine preparation after replacement is constant.
The Chinese medicine composition of the present invention, is that the raw material of Chinese medicine by being formed by above-mentioned formula is through extracting or other
Mode is processed, and makes pharmaceutically active substance, and subsequently, with this material as raw material, adding medicine when needing can connect
The carrier being subject to, makes according to the routine techniques of galenic pharmacy.During described active substance can be by extracting respectively
Medicine raw material obtains, it is also possible to obtained by the common raw material of Chinese medicine that extracts, it is also possible to obtain by other means,
As: by pulverizing, squeeze, calcine, grind, sieving, percolation, extraction, water carry, alcohol extraction, ester carry,
The methods such as ketone carries, chromatography obtain, these active substances can be able to be dry extract to be the material of extractum form
Can also be fluid extract, determine to make different concentration according to different needs of preparation.
The pharmaceutical dosage forms of the pharmaceutical composition of the present invention, preferably unit dose, in the medicine system of making
Can make any pharmaceutically useful dosage form during agent, these dosage forms are selected from: tablet such as: conventional tablet, coated tablet
Agent, film coated tablet, enteric coated tablet；Capsule is such as: hard capsule, soft capsule；And oral liquid,
Suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection,
Suppository, ointment, plaster, cream, spray, drop, patch.
The Chinese medicine composition of the present invention preferably oral dosage form, most preferably tablet.
The Chinese medicine composition of the present invention, can add some pharmaceutically acceptable carriers as required, can adopt
This Chinese medicine preparation is prepared, as mixed with pharmaceutically acceptable carrier by pharmaceutically active substance with galenic pharmacy routine techniques
Close.Described pharmaceutically acceptable carrier is selected from: mannitol, sorbitol, sorbic acid or potassium salt, pyrosulfurous acid
Sodium, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A,
Vitamin C, vitamin E, vitamin D, azone, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, monoacidic base gold
Belong to carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid,
Sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, sweet ammonia
Acid, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate,
Gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, soil temperature 60-80, span-80, Cera Flava, sheep
Hair fat, liquid paraffin, hexadecanol, gallate ester, agar, triethanolamine, basic amino acid, urine
Element, allantoin, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, β-ring is stuck with paste
Essence, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc..
The Chinese medicine preparation compositions of the present invention, when making medicament, the medicament of unit dose can contain the present invention
Pharmaceutically active substance 0.1-1000mg, remaining is pharmaceutically acceptable carrier.Pharmaceutically acceptable carrier
Can be the 0.1-99.9% of total formulation weight amount by weight.
The compositions of the present invention determines usage and dosage according to the situation of patient in use, such as 1-3 time on the one.One
Secondary 1-10 sheet/grain etc..
Detailed description of the invention:
Further illustrate the present invention by the following examples, but not as limitation of the present invention.
The preparation of embodiment 1 tablet
[prescription] Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g
[preparation method] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and remaining Fructus Crataegi, Radix Puerariae add 60% ethanol
After warm macerating 30 minutes, heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol
Extract, decompression recycling ethanol, filter, filtrate is standby；Radix Salviae Miltiorrhizae boiling secondary, 2 hours for the first time,
1.5 hours for the second time, merge decoction liquor, filter, above-mentioned filtrate is mixed homogeneously with decoction liquor, is concentrated into phase
To density 1.24～1.26 (75 DEG C～80 DEG C surveys).Extractum is mixed with fine powder, makes granule, be dried, tabletting,
Coating, to obtain final product.
The preparation of embodiment 2 capsule
[prescription] Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g
[preparation method] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and remaining Fructus Crataegi, Radix Puerariae add 60% ethanol
After warm macerating 30 minutes, heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol
Extract, decompression recycling ethanol, filter, filtrate is standby；Radix Salviae Miltiorrhizae boiling secondary, 2 hours for the first time,
1.5 hours for the second time, merge decoction liquor, filter, above-mentioned filtrate is mixed homogeneously with decoction liquor, is concentrated into phase
To density 1.24～1.26 (75 DEG C～80 DEG C surveys).Extractum and fine powder are mixed, makes granule, encapsulated and get final product.
The preparation of embodiment 3 dispersible tablet
[prescription] Radix Puerariae 300g, Fructus Crataegi 300g, Radix Salviae Miltiorrhizae 300g, Radix Notoginseng 20g, Radix Aucklandiae 20g
[preparation method] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and remaining Fructus Crataegi, Radix Puerariae add 60% ethanol
After warm macerating 30 minutes, heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol
Extract, decompression recycling ethanol, filter, filtrate is standby；Radix Salviae Miltiorrhizae boiling secondary, 2 hours for the first time,
1.5 hours for the second time, merge decoction liquor, filter, above-mentioned filtrate is mixed homogeneously with decoction liquor, is concentrated into phase
To density 1.24～1.26 (75 DEG C～80 DEG C surveys).Extractum is mixed with fine powder, makes granule, be dried, tabletting,
Coating, to obtain final product.
The preparation of embodiment 4 coated tablet
[prescription] Radix Puerariae 900g, Fructus Crataegi 900g, Radix Salviae Miltiorrhizae 900g, Radix Notoginseng 60g, Radix Aucklandiae 60g
[preparation method] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and remaining Fructus Crataegi, Radix Puerariae add 60% ethanol
After warm macerating 30 minutes, heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol
Extract, decompression recycling ethanol, filter, filtrate is standby；Radix Salviae Miltiorrhizae boiling secondary, 2 hours for the first time,
1.5 hours for the second time, merge decoction liquor, filter, above-mentioned filtrate is mixed homogeneously with decoction liquor, is concentrated into phase
To density 1.24～1.26 (75 DEG C～80 DEG C surveys).Extractum is mixed with fine powder, makes granule, be dried, tabletting,
Coating, to obtain final product.
Claims (9)
1. treat a Chinese medicine composition for the psychiatric problems such as the adjoint anxiety of arrhythmia, depression, institute
Stating Chinese medicine composition, its formula is Radix Puerariae 300-900g, Fructus Crataegi 300-900g, Radix Salviae Miltiorrhizae 300-900g, Radix Notoginseng 20-60g,
Radix Aucklandiae 20-60g.
Chinese medicine composition the most according to claim 1, it is characterised in that not only evident in efficacy to arrhythmia,
The unhealthy emotions such as the anxiety of patient, depression are improved significantly simultaneously, meet " diplocardia effect ".
Chinese medicine composition the most according to claim 1, it is characterised in that its formula is Radix Puerariae 600g, Fructus Crataegi 600
G, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g.
Chinese medicine composition the most according to claim 1, it is characterised in that described compositions is XINKESHU PIAN.
Chinese medicine composition the most according to claim 1, it is characterised in that described compositions is XINKESHU JIAONANG.
Chinese medicine composition the most according to claim 1, it is characterised in that described compositions is that the heart can relax coated tablet.
Chinese medicine composition the most according to claim 1, it is characterised in that described compositions is that the heart can relax film-coat
Sheet.
Chinese medicine composition the most according to claim 1, it is characterised in that the instructions of taking of described compositions is one
Day 1-3 time, a 1-10 sheet/grain.
Chinese medicine composition the most according to claim 1, it is characterised in that method for preparing tablet thereof therein is as follows:
Take Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g, 1/3 Fructus Crataegi, Radix Notoginseng, the Radix Aucklandiae
Being ground into fine powder, remaining Fructus Crataegi, Radix Puerariae added 60% ethanol warm macerating after 30 minutes, heating and refluxing extraction secondary, and
One time 2.5 hours, 2 hours for the second time, merging alcohol extract, decompression recycling ethanol, filter, filtrate is standby；Red
Participate in soak by water secondary, 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, by above-mentioned filter
Liquid is mixed homogeneously with decoction liquor, is concentrated into relative density 1.24～1.26, extractum and fine powder is mixed, and makes
Grain, is dried, tabletting, coating, to obtain final product.
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| CN102145060A (en) * | 2011-04-14 | 2011-08-10 | 山东沃华医药科技股份有限公司 | Dual-cordis effect of Xin Keshu |
| CN104161840A (en) * | 2014-09-02 | 2014-11-26 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation in preparation of medicine for treating coronary heart disease combined arrhythmia with psychological problems of anxiety and depression and preparation method of Xinkeshu preparation |
| CN104173496A (en) * | 2014-09-02 | 2014-12-03 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation in preparing medicine for treating hypertension with coronary heart disease with accompany of anxiety and mental depression problems and preparation method of Xinkeshu preparation |
| CN104189144A (en) * | 2014-09-02 | 2014-12-10 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation to preparation of medicine for treating hypertension and psychological problems of anxiety and depression and preparation method of Xinkeshu preparation |
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2015
- 2015-06-24 CN CN201510353561.4A patent/CN106309612A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102145060A (en) * | 2011-04-14 | 2011-08-10 | 山东沃华医药科技股份有限公司 | Dual-cordis effect of Xin Keshu |
| CN104161840A (en) * | 2014-09-02 | 2014-11-26 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation in preparation of medicine for treating coronary heart disease combined arrhythmia with psychological problems of anxiety and depression and preparation method of Xinkeshu preparation |
| CN104173496A (en) * | 2014-09-02 | 2014-12-03 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation in preparing medicine for treating hypertension with coronary heart disease with accompany of anxiety and mental depression problems and preparation method of Xinkeshu preparation |
| CN104189144A (en) * | 2014-09-02 | 2014-12-10 | 山东沃华医药科技股份有限公司 | Application of Xinkeshu preparation to preparation of medicine for treating hypertension and psychological problems of anxiety and depression and preparation method of Xinkeshu preparation |
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Application publication date: 20170111 |