CN105194301A - Traditional Chinese medicine preparation for treating chronic cardiac failure - Google Patents
Traditional Chinese medicine preparation for treating chronic cardiac failure Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating chronic cardiac failure, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is mainly prepared from the following raw materials: peach kernels, salviae miltiorrhizae, cassia twig, ginseng, astragalus membranaceus, schisandra chinensis, ligusticum wallichii, polyporus umbellatus, rhizoma atractylodis macrocephalae, jujubes, radix ophiopogonis, cortex acanthopanacis, fructus aurantii immaturus, angelica sinensis and flos carthami. The traditional Chinese medicine preparation has a significant treatment effect on the chronic cardiac failure, and has the technical advantages that recuperation is combined with treatment; both symptoms and root causes are treated; the traditional Chinese medicine preparation is good in treatment effect, free of toxic or side effect, and suitable for long-term medication; and the survival quality of a patient is significantly improved. In addition, the defects that the traditional Chinese medicine is inconvenient to take are overcome; and the preparation technology is simple, convenient, low in cost, stable in medicine effect, easy to popularize and apply and high in social value.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of Chinese medicine preparation of chronic heart failure.
Background technology
Heart failure is the myocardial damage because any reasons such as myocardial infarction, cardiomyopathy, hemodynamics overload, inflammation cause, and causes the change of cardiac structure and function, finally causes ventricular pump blood or full hypofunction.Clinical main manifestations is dyspnea, weak and body retention.Chronic heart failure (CHF) refers to the heart failure state of sustainable existence, can stablize, worsens or lose compensatory.Current doctor trained in Western medicine is to the treatment of chronic heart failure from short-term hemodynamics/pharmaceutical practice such as diuresis, heart tonifying, expansion blood vessels, and transfer the strategy that is long-term, prosthetic based on neuroendocrine inhibitor to, object is the biological property changing failure heart.But therapeutic effect is not very desirable, and the side effect of some method is very large, fails to improve life in patients.
Heart failure belongs to the category of " cardiopalmus ", " palpitation with a distress feeling ", " edema ", " breathing with cough ", " phlegm retention " in tcm clinical practice.Chinese medicine thinks that the first onset of heart failure is how dirty at cardiopulmonary two, and disease then involves spleen kidney for a long time.Its basic reason is that body is empty, especially relevant with heart deficiency of spleen-YANG and kidneyYANG.Often due to sensation exopathogen, overstrain is exaggerated, feelings will is hindered, pregnancy and delivery and bringing out.The deficiency of the lung can not regulating fluid apssage, insufficiency of the spleen can not transmitting and distributing the fluids, then disturbance in functioning of QI of suffering from a deficiency of the kidney, so that water is wet stops gathering, and forms edema, as aqueous vapor penetrates lung, then impairment of purifying and descending function of the lung, gas superinverse and breathing with cough, the heart attacked by pathogenic water then cardiopalmus, failure of the kidney in receiving QI then exhale inhale few, shortness of breath with anaerosis.The differentiation of symptoms and signs for classification of syndrome of Chinese traditional treatment chronic heart failure is as follows:
1, type of deficiency of both QI and YIN.
Main symptom: shortness of breath and palpitation, has a dizzy spell, weak, dry mouth and tougue, insomnia night sweat, and red tongue tongue is few, thready and rapid pulse or knot generation.Method for the treatment of: supplementing QI and nourishing YIN.
2, deficiency of heart-YANG and kidney-YANG type.
Main symptom: shortness of breath and palpitation, aversion to cold and cold limbs, oliguria edema, purplish complexion, bluish lip tongue is dark, and tongue is white, deep-thready pulse or knot generation.Method for the treatment of: warming YANG to promote diuresis.
3, blood stasis numbness type.
Main symptom: shortness of breath and palpitation, ambition twinge, die Blausucht, complexion is dark red, edema of lower limbs, the dark ecchymosis of tongue, and tongue is greasy in vain, hesitant pulse knot generation.Method for the treatment of: blood circulation promoting and blood stasis dispelling.
4, phlegm-heat obstructing lung type.
Main symptom: shortness of breath and palpitation, coughing and wheezing, can not put down sleeping, coughs up yellow thick expectorant or expectorant blood and glues difficulty and cough, oliguria, edema, red tongue with yellowish and greasy fur, slippery and rapid pulse.Method for the treatment of: removing heat-phlegm, the capable water of lung qi dispersing.
5, deficiency of YANG QI off-type.
Main symptom: breathe dyspnea with rapid and short breath, can not put down sleeping, dysphoria, opening mouth and lifting shoulder due to dyspnea, greasy sweating, extreme cold of the limbs or faintness delirium, purplish tongue is dark, and tongue is few, and faint and thready pulse wild.Method for the treatment of: recuperating depleted YANG and rescuing the patient from collapse.
Summary of the invention
The technical problem to be solved in the present invention is, develops a kind of Chinese medicine preparation chronic heart failure being had to good therapeutic effect.
In order to solve the problems of the technologies described above, the technical scheme that inventor takes is, in Traditional Chinese medical theory on the basis of the dialectical cognition of chronic heart failure, in conjunction with the ill feature of tcm clinical practice experience for many years and modern, the collocation of research and practice medical material and consumption repeatedly, has finally invented a brand-new Chinese prescription and this prescription has been made the preparation method of finished product Chinese medicine preparation.The Chinese medicine preparation be made up of this prescription has therapeutic effect significantly to chronic heart failure, compared with prior art, shows outstanding technical advantage.This Chinese prescription is expressed as with weight portion:
Semen Persicae 10-34 part, Radix Salviae Miltiorrhizae 15-45 part, Ramulus Cinnamomi 7-20 part, Radix Ginseng 7-24 part, Radix Astragali 12-40 part, Fructus Schisandrae Chinensis 7-21 part, Rhizoma Chuanxiong 7-27 part, Polyporus 8-35 part, Rhizoma Atractylodis Macrocephalae 8-30 part, Fructus Jujubae 6-20 part, Radix Ophiopogonis 7-29 part, Cortex Acanthopancis 6-17 part, Fructus Aurantii Immaturus 6-19 part, Radix Angelicae Sinensis 7-26 part, Flos Carthami 4-13 part.
In invention practice process, two prescription proportionings with better curative effect are expressed as with weight portion respectively:
1,22 parts, Semen Persicae, Radix Salviae Miltiorrhizae 30 parts, Ramulus Cinnamomi 13 parts, Radix Ginseng 15 parts, the Radix Astragali 25 parts, Fructus Schisandrae Chinensis 14 parts, Rhizoma Chuanxiong 17 parts, Polyporus 21 parts, the Rhizoma Atractylodis Macrocephalae 19 parts, 13 parts, Fructus Jujubae, Radix Ophiopogonis 18 parts, Cortex Acanthopancis 11 parts, Fructus Aurantii Immaturus 12 parts, Radix Angelicae Sinensis 16 parts, 8 parts, Flos Carthami.
2,24 parts, Semen Persicae, Radix Salviae Miltiorrhizae 32 parts, Ramulus Cinnamomi 14 parts, Radix Ginseng 13 parts, the Radix Astragali 26 parts, Fructus Schisandrae Chinensis 15 parts, Rhizoma Chuanxiong 15 parts, Polyporus 20 parts, the Rhizoma Atractylodis Macrocephalae 18 parts, 12 parts, Fructus Jujubae, Radix Ophiopogonis 19 parts, Cortex Acanthopancis 13 parts, Fructus Aurantii Immaturus 13 parts, Radix Angelicae Sinensis 17 parts, 7 parts, Flos Carthami.
The preparation method above-mentioned Chinese prescription being made Chinese medicine preparation is following steps:
(1), each taste Chinese crude drug is taken by Chinese prescription of the present invention;
(2), by Rhizoma Atractylodis Macrocephalae parch, pulverize levigate, cross 80-120 mesh sieve, obtain fine powder, for subsequent use;
(3), by Radix Salviae Miltiorrhizae, Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Cortex Acanthopancis, Fructus Aurantii Immaturus, Flos Carthami, pulverize respectively, the concentration adding 4-14 times of weight after mixing is 55-85% ethanol, soaks 6-18 hour, backflow decocts, extract 2 times, each 1-6 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.13-1.16, for subsequent use;
(4), by Semen Persicae, Ramulus Cinnamomi, Rhizoma Chuanxiong, Polyporus, Fructus Jujubae, Radix Ophiopogonis, Radix Angelicae Sinensis pulverize respectively, after mixing, add the purified water of 4-15 times of weight, backflow decoction 3 times, each 1-5 hour, filters, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.13-1.16, for subsequent use;
(5), by concentrated solution obtained in step (3) and (4) merge, and the fine powder of step (2) is added concentrated solution, mix homogeneously, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.34-1.38, is Chinese medical concrete;
(6), modern general Chinese medicine preparation technology is utilized, step (5) gained Chinese medical concrete is made the Chinese medicine finished product preparation of clinical needs, as dosage forms such as pill (containing honeyed pill, the watered pill), tablet, granule, capsule (containing soft capsule), powder, syrup and decoctions.
The source of Chinese prescription of the present invention Chinese crude drug used, meridian distribution of property and flavor, special efficacy:
Semen Persicae: this product is the dry mature seed of rosaceous plant Fructus Persicae or Prunus davidiana.Bitter in the mouth, sweet, property is put down; GUIXIN, liver, large intestine channel; Blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.
Radix Salviae Miltiorrhizae: this product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.Bitter in the mouth, cold nature; GUIXIN, Liver Channel; Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.
Ramulus Cinnamomi: this product is the dry twig of canella Cortex Cinnamomi.Acrid in the mouth, sweet, warm in nature; GUIXIN, lung, urinary bladder channel; Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.
Radix Ginseng: this product is the dry root of Araliaceae Radix Ginseng.Sweet in the mouth, micro-hardship, property is put down; Return spleen, lung, heart channel; Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid, and calms the nerves.
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
Fructus Schisandrae Chinensis: this product is the dry mature fruit of magnoliaceae schisandra or schisandra chinensis.Sour in the mouth, sweet, warm in nature; Return lung, the heart, kidney channel; Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.
Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong.Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.
Polyporus: this product is the dry sclerotia of On Polyporaceae Polyporus.Sweet in the mouth, light, property is put down; Return kidney, urinary bladder channel; Promoting diuresis to eliminate damp pathogen.
The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp; Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.
Fructus Jujubae: this product is the dry mature fruit of Rhamnaceae jujube Fructus Jujubae.Sweet in the mouth, warm in nature; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.
Radix Ophiopogonis: this product is the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf).Sweet in the mouth, micro-hardship, cold nature; GUIXIN, lung, stomach warp; YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.
Cortex Acanthopancis: this product is the dry root bark of Araliaceae acanthopanax gracilistylus.Acrid in the mouth, hardship, warm in nature; Return liver, kidney channel; Wind-damp dispelling, invigorating the liver and kidney, bone and muscle strengthening.
Fructus Aurantii Immaturus: this product is the dry young fruit of rutaceae Citrus aurantium Linn. and variety or Fructus Citri sinensis.Bitter in the mouth, pungent, sour, warm in nature; Return spleen, stomach warp; Dispelling the stagnated QI removing food stagnancy, loose painful abdominal mass of reducing phlegm.
Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica.Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Flos Carthami: call red indigo plant flower, thorn Flos Carthami, Compositae, Flos Carthami platymiscium.Acrid in the mouth, warm in nature; Enter the heart, Liver Channel; Promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving.
The prescription analysis of Chinese prescription of the present invention:
Chinese prescription of the present invention is with Radix Salviae Miltiorrhizae, the Radix Astragali, Semen Persicae, Polyporus, Radix Ginseng for monarch drug, and stasis-dispelling and pain-killing, invigorating QI to consolidate the body surface resistance, blood circulation promoting and blood stasis dispelling, promoting diuresis to eliminate damp pathogen, multiple arteries and veins take off admittedly; With Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Fructus Schisandrae Chinensis for ministerial drug, blood-activating and qi-promoting, invigorating the spleen and benefiting QI, lung moistening clear away heart-fire, kidney calming; With Fructus Jujubae, Cortex Acanthopancis, Radix Angelicae Sinensis, Fructus Aurantii Immaturus for adjuvant drug, invigorating the spleen and replenishing QI, the kidney invigorating bone strengthening, enrich blood invigorate blood circulation, loose painful abdominal mass of reducing phlegm; With Ramulus Cinnamomi, Flos Carthami for making medicine, promoting the flow of QI-blood by warming the meridian, promoting blood circulation to restore menstrual flow; The all medicines of monarch coordinate, complement each other, negative and positive are harmonious, thus reach that stasis-dispelling and pain-killing, invigorating QI to consolidate the body surface resistance, blood circulation promoting and blood stasis dispelling, promoting diuresis to eliminate damp pathogen, multiple arteries and veins are admittedly de-, blood-activating and qi-promoting, kidney calming, the kidney invigorating bone strengthening, enrich blood invigorate blood circulation, the effect such as promoting the flow of QI-blood by warming the meridian, for chronic heart failure, there is curative effect significantly.
The present invention also discloses a kind of purposes of above-mentioned Chinese medicine preparation, i.e. the purposes of above-mentioned Chinese medicine preparation in preparation chronic heart failure medicine.The clinical trial display of Chinese medicine preparation of the present invention, after treatment, matched group blood stream of patients kinetic parameter is improved, but there was no significant difference, test group is significantly improved; Compare with after treatment of control group, the indices of two test group all has significant differences, illustrates significantly to be better than matched group improving test group in cardiac systolic function.And the average obvious effective rate of test group is 80.95%, be 2.3 times of matched group, the average total effective rate of test group is 96%, higher than matched group 18.2 percentage points, therapeutic effect is remarkable, rapid-action, drug side effect is low, and can be used as chronic heart failure drug use, clinical generalization value is high.
Compared with prior art, Chinese medicine preparation of the present invention mainly contains following technical advantage:
1, conditioning combines with treatment, can treating both the principal and secondary aspects of a disease, and therapeutic effect is good;
2, have no side effect, be applicable to long-term prescription, and can life in patients be improved;
3, overcome the shortcoming that Chinese medicine inconvenience is taken, and preparation process is easy, cost is low, efficacy stability, be easy to apply, social value is large.
Detailed description of the invention
In order to check the feasibility of prescription and preparation technology, and be follow-up test pilot production sample, inventor have chosen the practice production that several groups of representational proportioning raw materials carry out granule.
Embodiment 1
Granule is produced with the arbitrary value within the scope of prescription and best technological parameter
(1), by Chinese prescription of the present invention take Semen Persicae 1000g, Radix Salviae Miltiorrhizae 4500g, Ramulus Cinnamomi 800g, Radix Ginseng 2300g, Radix Astragali 1200g, Fructus Schisandrae Chinensis 2100g, Rhizoma Chuanxiong 2700g, Polyporus 900g, Rhizoma Atractylodis Macrocephalae 2900g, Fructus Jujubae 700g, Radix Ophiopogonis 800g, Cortex Acanthopancis 1700g, Fructus Aurantii Immaturus 600g, Radix Angelicae Sinensis 2600g, Flos Carthami 700g;
(2), by Rhizoma Atractylodis Macrocephalae parch, pulverize levigate, cross 90 mesh sieves, obtain fine powder, for subsequent use;
(3), by Radix Salviae Miltiorrhizae, Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Cortex Acanthopancis, Fructus Aurantii Immaturus, Flos Carthami, pulverize respectively, the concentration adding 11 times of weight after mixing is 65% ethanol, soaks 10 hours, backflow decocts, extract 2 times, each 4 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.13-1.16, for subsequent use;
(4), by Semen Persicae, Ramulus Cinnamomi, Rhizoma Chuanxiong, Polyporus, Fructus Jujubae, Radix Ophiopogonis, Radix Angelicae Sinensis pulverize respectively, after mixing, add the purified water of 12 times of weight, backflow decoction 3 times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.13-1.16, for subsequent use;
(5), by concentrated solution obtained in step (3) and (4) merge, and the fine powder of step (2) is added concentrated solution, mix homogeneously, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.34-1.38, is Chinese medical concrete;
(6), utilize modern general Chinese medicine preparation technology, step (5) gained Chinese medical concrete is made granule, and specification amounts to crude drug content: 0.52g crude drug/g granule.
Embodiment 2
With value and the best technological parameter production granule of optimum ratio 1
(1), by Chinese prescription of the present invention take Semen Persicae 2200g, Radix Salviae Miltiorrhizae 3000g, Ramulus Cinnamomi 1300g, Radix Ginseng 1500g, Radix Astragali 2500g, Fructus Schisandrae Chinensis 1400g, Rhizoma Chuanxiong 1700g, Polyporus 2100g, Rhizoma Atractylodis Macrocephalae 1900g, Fructus Jujubae 1300g, Radix Ophiopogonis 1800g, Cortex Acanthopancis 1100g, Fructus Aurantii Immaturus 1200g, Radix Angelicae Sinensis 1600g, Flos Carthami 800g;
(2), by Rhizoma Atractylodis Macrocephalae parch, pulverize levigate, cross 90 mesh sieves, obtain fine powder, for subsequent use;
(3), by Radix Salviae Miltiorrhizae, Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Cortex Acanthopancis, Fructus Aurantii Immaturus, Flos Carthami, pulverize respectively, the concentration adding 11 times of weight after mixing is 65% ethanol, soaks 10 hours, backflow decocts, extract 2 times, each 4 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.13-1.16, for subsequent use;
(4), by Semen Persicae, Ramulus Cinnamomi, Rhizoma Chuanxiong, Polyporus, Fructus Jujubae, Radix Ophiopogonis, Radix Angelicae Sinensis pulverize respectively, after mixing, add the purified water of 12 times of weight, backflow decoction 3 times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.13-1.16, for subsequent use;
(5), by concentrated solution obtained in step (3) and (4) merge, and the fine powder of step (2) is added concentrated solution, mix homogeneously, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.34-1.38, is Chinese medical concrete;
(6), utilize modern general Chinese medicine preparation technology, step (5) gained Chinese medical concrete is made granule, and specification amounts to crude drug content: 0.52g crude drug/g granule.
Embodiment 3
With value and the best technological parameter production granule of optimum ratio 2
(1), by Chinese prescription of the present invention take Semen Persicae 2400g, Radix Salviae Miltiorrhizae 3200g, Ramulus Cinnamomi 1400g, Radix Ginseng 1300g, Radix Astragali 2600g, Fructus Schisandrae Chinensis 1500g, Rhizoma Chuanxiong 1500g, Polyporus 2000g, Rhizoma Atractylodis Macrocephalae 1800g, Fructus Jujubae 1200g, Radix Ophiopogonis 1900g, Cortex Acanthopancis 1300g, Fructus Aurantii Immaturus 1300g, Radix Angelicae Sinensis 1700g, Flos Carthami 700g;
(2), by Rhizoma Atractylodis Macrocephalae parch, pulverize levigate, cross 90 mesh sieves, obtain fine powder, for subsequent use;
(3), by Radix Salviae Miltiorrhizae, Radix Ginseng, the Radix Astragali, Fructus Schisandrae Chinensis, Cortex Acanthopancis, Fructus Aurantii Immaturus, Flos Carthami, pulverize respectively, the concentration adding 11 times of weight after mixing is 65% ethanol, soaks 10 hours, backflow decocts, extract 2 times, each 4 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.13-1.16, for subsequent use;
(4), by Semen Persicae, Ramulus Cinnamomi, Rhizoma Chuanxiong, Polyporus, Fructus Jujubae, Radix Ophiopogonis, Radix Angelicae Sinensis pulverize respectively, after mixing, add the purified water of 12 times of weight, backflow decoction 3 times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.13-1.16, for subsequent use;
(5), by concentrated solution obtained in step (3) and (4) merge, and the fine powder of step (2) is added concentrated solution, mix homogeneously, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.34-1.38, is Chinese medical concrete;
(6), utilize modern general Chinese medicine preparation technology, step (5) gained Chinese medical concrete is made granule, and specification amounts to crude drug content: 0.52g crude drug/g granule.
In order to verify the safety of Chinese medicine preparation of the present invention, inventor has carried out toxicity test with the granule that embodiment 1-3 produces
(1), acute toxicity test
1, tested medicine: the granule manufactured by embodiment of the present invention 1-3, adds purified water and is modulated into magma, for subsequent use.
2, experimental animal: regular grade NIH mice, body weight 21g ± 4g, male and female half and half, female mice is all without pregnant.From Shanghai, raw prosperous laboratory animal cultivation company limited buys experimental animal.
3, to mouse stomach Chinese medicine granules of the present invention, when given low reaches 764.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 2 hours recover normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
4, result of the test shows: the maximum dosage-feeding of mouse stomach granule of the present invention is 764.5g crude drug/kg/d(LD
50> 764.5g crude drug/kg).Chinese medicine clinical application every day total amount of the present invention is 0.39g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach granule of the present invention is 1960.3 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
(2), long term toxicity test
1, test objective: the toxic reaction of viewing test animal after long-term edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.
2, test material:
(1), animal: select adult healthy SD rat 180, original body mass 231 ± 11g, male and female half and half, female rats is all without pregnant.From Shanghai, raw prosperous laboratory animal cultivation company limited buys experimental animal.
(2), medicine: the granule manufactured by embodiment of the present invention 1-3, adds purified water and be modulated into magma, for subsequent use.Per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount, and dosage is 7.8g crude drug/kg/d.
3, test method
(1), by 180 SD rats be divided into 4 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1200-1400g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.
(2), medication
With the magma of the made granule modulation of embodiment 1-3, respectively to wherein 3 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage equal-volume normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.
(3), test item and the time
General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.
Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).
Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na
+), blood potassium (K
+), blood calcium (Ca
+) and β
2-microglobulin.
Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β
2-MG(renal tubular function obstacle sensitive indicator).
System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.
4, result of the test
The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine granules of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this granule for patient.
In order to verify the curative effect of Chinese medicine preparation of the present invention further, inventor has carried out clinical trial with the granule that embodiment 2 and embodiment 3 are produced:
1, basic document
The patient of clinical trial, from certain city second the People's Hospital's Cardiological, is outpatient service or the inpatient of this institute, and test is divided into matched group, test group 1 and test group 2, the patient accepted for medical treatment is made a definite diagnosis suffers from chronic heart failure, and meet this clinical trial conditions, entered to organize matched group, test group 1 and test group 2 at random, test group 1 enters group and completes test 63 people, man 38 people, female 25 people, age 49-67 year, 59.8 years old mean age, course of disease 1-22, average course of disease 11.2; Test group 2 enters group and completes test 63 people, male 37 people, female 26 people, age 45-67 year, 57.5 years old mean age, course of disease 1-21, average course of disease 11.4 years; Matched group enters group and completes test 63 people, male 39 people, female 24 people, age 46-68 year, 59.2 years old mean age, course of disease 1-20, average course of disease 11.6 years.Two groups of ages, sex, the course of disease and complication (disease) all have comparability P > 0.05 through statistical disposition.
2, diagnostic criteria
In the guideline of diagnostic criteria reference China Medical Science Press's in May, 2002 first edition " traditional Chinese medical science Clinical Researches of New Drugs guideline " about the clinical research of heart failure, new Chinese medicine treatment blood stasis due to qi deficiency differential diagnosis in tcm standard.
3, medication is tested
Contrast medicine: QiLi capsule, the accurate word Z20040141 of traditional Chinese medicines, Shijiazhuang Yiling Pharmaceutical Co., Ltd.
Investigational agent: the granule that the embodiment of the present invention 2, embodiment 3 are produced, specification: 0.52g crude drug/g granule.
4, test method
The oral contrast medicine of matched group, one time 4,3 times on the one, more than 4 hours, interval; The granule that the oral embodiment of the present invention 2 of test group 1 is produced, the granule that the oral embodiment of the present invention 3 of test group 2 is produced, a 15g, 3 times on the one, more than 4 hours, interval; Within 2 weeks, be a course for the treatment of, two groups of patients treat 4 courses for the treatment of simultaneously.
5, the standard of curative effect evaluation
Efficacy evaluation is with reference to " study of tcm new drug guideline ":
Effective: cardiac function improves more than 2 ranks, but does not reach I grade standard;
Effective: cardiac function improves 1 rank, but do not reach I grade of state;
Invalid: cardiac function improves fails to control less than 1 rank and chronic heart failure symptom.
6, therapeutic outcome
Cardiac function situation before and after observation index treatment, and measure Left Ventricular Ejection Fraction (EF) with using color Doppler echocardiography, cardiac output per minute (CO), cardiac index (CI).After treatment all terminates, by therapeutic outcome statistical analysis as shown in table 1, table 2.
The comparison sheet of the two groups of blood stream of patients's kinetic parameters in front and back treated by table 1
Note: * P < 0.05 compared with before treatment; & P < 0.05 compared with matched group.
Treatment first three groups patient bleeds kinetic parameter there was no significant difference (P > 0.05), has comparability; After treatment, matched group blood stream of patients kinetic parameter is improved, but there was no significant difference (P > 0.05); Test group is significantly improved (* P < 0.05).Compare with after treatment of control group, the indices of two test group all has significant differences (& P < 0.05), illustrates significantly to be better than matched group improving test group in cardiac systolic function.
Table 2 therapeutic outcome statistical analysis table
Table 2 result shows, and the average obvious effective rate of test group is 80.95%, and be 2.3 times of matched group, the average total effective rate of test group is 96%, higher than matched group 18.2 percentage points, illustrates that the curative effect of test group is obviously better than matched group.Carry out above-mentioned clinical trial to other embodiments of the invention, also achieve the therapeutic effect of highly significant, namely Chinese medicine preparation of the present invention has very significant curative effect in chronic heart failure.
7, conclusion
From above-mentioned two item numbers according to relatively, compared with prior art, Chinese medicine preparation of the present invention has very significant technical advantage, and the present invention achieves breakthrough technological progress and scientific payoffs, and its creativeness clearly.
Claims (4)
1. the Chinese medicine preparation of a chronic heart failure, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: Semen Persicae 10-34 part, Radix Salviae Miltiorrhizae 15-45 part, Ramulus Cinnamomi 7-20 part, Radix Ginseng 7-24 part, Radix Astragali 12-40 part, Fructus Schisandrae Chinensis 7-21 part, Rhizoma Chuanxiong 7-27 part, Polyporus 8-35 part, Rhizoma Atractylodis Macrocephalae 8-30 part, Fructus Jujubae 6-20 part, Radix Ophiopogonis 7-29 part, Cortex Acanthopancis 6-17 part, Fructus Aurantii Immaturus 6-19 part, Radix Angelicae Sinensis 7-26 part, Flos Carthami 4-13 part.
2. the Chinese medicine preparation of chronic heart failure according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: 22 parts, Semen Persicae, Radix Salviae Miltiorrhizae 30 parts, Ramulus Cinnamomi 13 parts, Radix Ginseng 15 parts, the Radix Astragali 25 parts, Fructus Schisandrae Chinensis 14 parts, Rhizoma Chuanxiong 17 parts, Polyporus 21 parts, the Rhizoma Atractylodis Macrocephalae 19 parts, 13 parts, Fructus Jujubae, Radix Ophiopogonis 18 parts, Cortex Acanthopancis 11 parts, Fructus Aurantii Immaturus 12 parts, Radix Angelicae Sinensis 16 parts, 8 parts, Flos Carthami.
3. the Chinese medicine preparation of chronic heart failure according to claim 1, it is characterized in that, described Chinese medicine preparation is prepared from by the Chinese crude drug of following weight portion: 24 parts, Semen Persicae, Radix Salviae Miltiorrhizae 32 parts, Ramulus Cinnamomi 14 parts, Radix Ginseng 13 parts, the Radix Astragali 26 parts, Fructus Schisandrae Chinensis 15 parts, Rhizoma Chuanxiong 15 parts, Polyporus 20 parts, the Rhizoma Atractylodis Macrocephalae 18 parts, 12 parts, Fructus Jujubae, Radix Ophiopogonis 19 parts, Cortex Acanthopancis 13 parts, Fructus Aurantii Immaturus 13 parts, Radix Angelicae Sinensis 17 parts, 7 parts, Flos Carthami.
4. the Chinese medicine preparation of the chronic heart failure according to any one of claim 1-3, is characterized in that: the dosage form of described Chinese medicine preparation is pill, tablet, granule, capsule, powder, syrup or decoction.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105998633A (en) * | 2016-07-23 | 2016-10-12 | 刘建飞 | Traditional Chinese medicine preparation for treating chronic cardiac failure |
| CN108524816A (en) * | 2018-05-27 | 2018-09-14 | 滨州越佳医药科技有限公司 | A kind of Chinese medicine preparation for treating heart failure |
| CN113730501A (en) * | 2021-09-23 | 2021-12-03 | 吴绍伟 | A topical Chinese medicinal composition for the treatment of heart failure |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104173986A (en) * | 2014-09-02 | 2014-12-03 | 庞化云 | Traditional Chinese medicine for treating heart failure |
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| CN104173986A (en) * | 2014-09-02 | 2014-12-03 | 庞化云 | Traditional Chinese medicine for treating heart failure |
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| 杜铁民: "中西医结合治疗冠心病心力衰竭35例疗效观察", 《新疆中医药》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105998633A (en) * | 2016-07-23 | 2016-10-12 | 刘建飞 | Traditional Chinese medicine preparation for treating chronic cardiac failure |
| CN108524816A (en) * | 2018-05-27 | 2018-09-14 | 滨州越佳医药科技有限公司 | A kind of Chinese medicine preparation for treating heart failure |
| CN113730501A (en) * | 2021-09-23 | 2021-12-03 | 吴绍伟 | A topical Chinese medicinal composition for the treatment of heart failure |
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