Summary of the invention
Purpose of the present invention just is to avoid and overcomes the shortcoming and defect of prior art and a kind of Chinese medicine composition for the treatment of viral myocarditis is provided, and this Chinese medicine composition is evident in efficacy, taking convenience, short treating period, no obvious sequela.
A kind of Chinese medicine composition for the treatment of viral myocarditis involved in the present invention, it mainly is to be made by following bulk drugs: the Radix Astragali, Radix Ophiopogonis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Flos Carthami.
For reaching better therapeutic, medicine of the present invention is also combined with Radix Puerariae, Radix Saposhnikoviae, Fructus Aurantii, Flos Lonicerae, Folium Isatidis.
For obtaining best curative effect, medicine of the present invention also can add Radix Glycyrrhizae on the basis of said medicine.
Viral myocarditis relates to categories such as the traditional Chinese medical science " cardiopalmus ", " palpitation with a distress feeling ", " thoracic obstruction ", the Chinese medicine viral myocarditis has special advantages, the inventor is according to for many years the treatment experience of this disease and experimentation being confirmed, holding concurrently with the detoxifcation with supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling, calming heart and tranquilizing mind is method, draft with the Radix Astragali, Radix Ophiopogonis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Flos Carthami, etc. kinds of traditional Chinese medicines, be processed into granule through science, treatment is with syndrome of deficiency of both qi and yin or to hold the stasis of blood under the arm be that the viral myocarditis effect of main clinical manifestation is preferable.
The present invention is through clinical verification for many years and through repeatedly the zoopery confirmation is evident in efficacy and definite.Chinese medicine is thought evil drug-pedlar's heart, decreases that cloudy to feel frustrated be this sick pathogenesis key.So commonly clinically have palpitation, breathe hard, disease such as vexed the time, again with the performance of breast shoulder pain, according to deficiency and excess of " interior warp " " deficiency syndrome should be treated by tonifying method, sthenia syndrome requiring purgation " and the principle of controlling, be to cause a disease originally in the treatment at this medicine deficiency of both QI and YIN, blood stasis is in the target pathogenic characteristic of the heart for causing a disease, adopt supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling is main prescription, and the Radix Astragali is monarch in the side, tonification vigour rouses oneself heart-yang; Minister reaches the effect of replenishing YIN and blood, calming heart and tranquilizing mind, blood circulation promoting and blood stasis dispelling with Radix Ophiopogonis, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Flos Carthami, cooperates the effect of the capable supplementing QI and nourishing YIN blood stasis dispelling of monarch drug.But wherein help the breast sun of holding back with Radix Puerariae, Radix Saposhnikoviae, Fructus Aurantii Xuan Changmeng, QI invigorating Gu Wei, harmonizing the functional activities of vital QI, be equipped with Flos Lonicerae, Folium Isatidis heat-clearing and toxic substances removing, remove the residual scorchingly hot heresy of epidemic disease of not using up, make with the invigorating middle warmer of Radix Glycyrrhizae QI invigorating, relieving spasm to stop pain, and the energy coordinating the actions of various ingredients in a prescription is played supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling, calming heart and tranquilizing mind altogether, is held concurrently with the effect of detoxifcation.The present invention selects the above-mentioned raw materials medicine to make up, and makes each efficacy of drugs produce synergism, thereby effectively treats hypertension.
The consumption of its drug component of oral Chinese medicine compositions of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all to have better curative effect in the following weight parts scope:
Radix Astragali 20-40 part, Radix Ophiopogonis 15-30 part, Radix Angelicae Sinensis 15-30 part, Radix Paeoniae Alba 15-30 part, Rhizoma Chuanxiong 5-15 part, Radix Salviae Miltiorrhizae 5-15 part, Flos Carthami 3-10 part.
Preferred weight part scope is: Radix Astragali 30-35 part, Radix Ophiopogonis 20-25 part, Radix Angelicae Sinensis 20-25 part, Radix Paeoniae Alba 20-25 part, Rhizoma Chuanxiong 10-15 part, Radix Salviae Miltiorrhizae 10-15 part, Flos Carthami 5-8 part.
Drug component weight portion of the present invention can also be Radix Astragali 20-40 part, Radix Ophiopogonis 15-30 part, Radix Angelicae Sinensis 15-30 part, Radix Paeoniae Alba 15-30 part, Rhizoma Chuanxiong 5-15 part, Radix Salviae Miltiorrhizae 5-15 part, Flos Carthami 3-10 part, Radix Puerariae 5-15 part, Radix Saposhnikoviae 5-15 part, Fructus Aurantii 5-15 part, Flos Lonicerae 15-30 part, Folium Isatidis 15-30 part, Radix Glycyrrhizae 5-15 part.
Medicine of the present invention further the weight portion of each component be Radix Astragali 30-35 part, Radix Ophiopogonis 20-25 part, Radix Angelicae Sinensis 20-25 part, Radix Paeoniae Alba 20-25 part, Rhizoma Chuanxiong 10-15 part, Radix Salviae Miltiorrhizae 10-15 part, Flos Carthami 5-8 part, Radix Puerariae 10-15 part, Radix Saposhnikoviae 10-15 part, Fructus Aurantii 10-15 part, Flos Lonicerae 20-25 part, Folium Isatidis 20-25 part, Radix Glycyrrhizae 10-15 part.
The weight portion of each crude drug that the present invention more optimizes is 33 parts of the Radixs Astragali, 22 parts of Radix Ophiopogonis, 22 parts of Radix Angelicae Sinensis, 22 parts of the Radix Paeoniae Albas, 11 parts of Rhizoma Chuanxiongs, 11 parts of Radix Salviae Miltiorrhizaes, 5.6 parts on Flos Carthami, 11 parts of Radix Puerariaes, 11 parts of Radix Saposhnikoviaes, 11 parts of Fructus Aurantiis, 22 parts of Flos Loniceraes, 22 parts of Folium Isatidiss, 11 parts in Radix Glycyrrhizae.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations, as pill, powder, tablet, capsule, oral liquid etc.
In sum, this reasonable recipe, curative effect are reliable, are effective prescriptions of treatment viral myocarditis.Supplementing QI and nourishing YIN of the present invention, promoting blood circulation and detoxication.Be used for the viral myocarditis course of disease and surpass one month acute stage light-duty and convalescent period, the light medium-sized genus deficiency of both QI and YIN of lag phase and have the stagnant heat card concurrently, disease sees cardiopalmus, breathes hard, uncomfortable in chest or chest pain, weak, insomnia, dreaminess person.
The specific embodiment
By the following examples, the beneficial effect of medicine of the present invention is further set forth in pharmacodynamics test and clinical trial.
Embodiment:
Prescription: Radix Astragali 330g, Radix Ophiopogonis 220g, Radix Angelicae Sinensis 220g, Radix Paeoniae Alba 220g, Rhizoma Chuanxiong 110g, Radix Salviae Miltiorrhizae 110g, Flos Carthami 56g, Flos Lonicerae 220g, Folium Isatidis 220g, Radix Puerariae 110g, Radix Saposhnikoviae 110g, Fructus Aurantii 110g, Radix Glycyrrhizae 110g
Method for making: by technical scheme of the present invention, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Saposhnikoviae, Fructus Aurantii are added water extracted volatile oil 4 hours for 4 times, aqueous solution filters, and medicinal residues add 7 times in water, decoct 1 hour, and collecting decoction is concentrated into relative density and is 1.15 (50 ℃), and is standby.The Radix Astragali, Radix Salviae Miltiorrhizae, Flos Lonicerae, Radix Puerariae add 5,4,3 times of amount alcohol successively with 60% alcohol reflux, and 2 hours for the first time, for the second time, each 1.5 hours for the third time, merge extractive liquid, filtered filtrate for later use.The five tastes and above-mentioned two kinds of medicinal residues merging such as all the other Radix Ophiopogonis decoct with water three times, add 8 successively, 7,6, times water gaging, 2 hours for the first time, for the second time, each 1 hour for the third time, collecting decoction, filter, it is 1.15~1.20 (50 ℃) that filtrate is concentrated into relative density, and the gained concentrated solution merges during with said extracted volatile oil, mixing, put coldly, add ethanol and make and contain alcohol amount and reach 60%, standing over night, filter, precipitation is stirred with a small amount of 60% ethanol and is washed once, filters, and alcohol extracts such as the filtrate and the above-mentioned Radix Astragali merge, reclaim ethanol, being concentrated into relative density is 1.22~1.24 (50 ℃), add appropriate amount of auxiliary materials (press adjuvant: extractum=1: 1), spray granulation, volatile oil is diluted with small amount of ethanol, be sprayed in the dried granule covered and enclosed 4 hours, cold drying equably, granulate is made 1000g promptly.
Function cures mainly: supplementing QI and nourishing YIN, promoting blood circulation and detoxication.Be used for the viral myocarditis course of disease and surpass one month acute stage light-duty and convalescent period, the light medium-sized genus deficiency of both QI and YIN of lag phase and have the stagnant heat card concurrently, disease sees cardiopalmus, breathes hard, uncomfortable in chest or chest pain, weak, insomnia, dreaminess person.
Usage and consumption: take after mixing it with water, 3 years old, one time 1/4 bag, 4-6 year, one time 1/2 bag, 7-10 year, one time 3/4 bag, more than 10 years old and the adult, one time 1 bag, 2 times on the one, one after each meal.
Specification: every packed 15g.
Usage and dosage: one time 3,3 times on the one.
Pharmacodynamics test:
1. external anti-CB
3The virus result of the test shows: this product is to infecting CB
3The rat neonatal rat myocardial cell and the Vero cell of virus have significant protective effect, can stop CB
3The virus absorption surface enters cell and produces direct deactivation.The medication group can obviously reduce the lesion degree of cultured cell, reduces the myocardial cell virus titer that infects, and is good dose-effect relationship.
2. anti-CB in the body
3The virus result of the test shows: this product is to CB
3Virogenetic mice viral myocarditis has significant protective effect, can improve neutralizing antibody concentration in the mice body, obviously suppresses Vero necrocytosis rate, and it suppresses percentage rate can reach 400%, and obviously reduces administration group mice serum virus titer.Pathological examination shows that the pathological change of administration group mouse cardiac muscle cell is significantly less than the virus control group, and prompting has therapeutical effect to viral myocarditis.
3. the test of open chest anesthetized cardiac hemodynamics of dogs shows: this product can obviously reduce arteriotony and total peripheral resistance; Reduce coronary resistance, increase coronary flow; Reduce left indoor pressure, left chamber EDP, ± dp/dtmax; Increase cardiac output, cardiac index and SI; And reduce myocardium coefficient of oxygen utilization and oxygen consumption index.Heart rate and electrocardiogram there is not obvious shadow noon.In sum, this medicine can reduce load before and after the heart, reduces cardiac work, and increases the blood supply of cardiac muscle oxygen supply, reduces myocardial oxygen consumption, though weaken myocardial contraction, does not reduce cardiac output, and the heart of viral myocarditis is had certain protective role.
4. the test of Acute Myocardial Ischemia in Rats that anti-isoproterenol brings out shows: the ECG change and the pathological change of the Acute Myocardial Ischemia in Rats that this product can obviously be resisted isoproterenol and brought out.
5. the test of anti-pituitrin brought out myocardial ischemia shows: the ECG change of the Acute Myocardial Ischemia in Rats that this product can obviously be resisted pituitrin and brought out.
6. white mice normal pressure hypoxia endurance test shows: this product can obviously improve the hypoxia-bearing capability under the normal pressure, prolongs the mice time-to-live.
7. the arrhythmia test confirms: this product can obviously be resisted the ECG change of the rat ventricular that is brought out by barium chloride, and its suppression ratio can reach 78%, and heart is had good protective action.
Therefore, can think that from results of pharmacodynamic test this product has anti-CB
3Virus, protecting myocardial cell increases the blood supply oxygen supply of cardiac muscle, improves myocardial ischemia and antiarrhythmic effect, is the medicine of a comparatively ideal treatment viral myocarditis, and the result of clinical trial has also further proved its curative effect.
The result of the test of acute toxicity and long term toxicity
Acute toxicity test: give this product medicated powder by the disposable filling stomach of white mice, maximum concentration 35%, the maximum gastric capacity 0.4ml/10g that irritates, dosage 14g/kg (every g medicated powder is equivalent to the 10g crude drug), observed 7 days continuously, do not find any toxic reaction, because of concentration and dosage can't increase, so fail to measure the LD of this medicine
50
Maximum tolerance determination: with maximum concentration, the maximum gastric capacity of irritating, mice lavage administration 3 times, 5 hours at interval, to observe continuously then 7 days, none example is dead.Medicated powder dosage is>42g/kg. day (every g medicated powder is equivalent to the 10g crude drug), calculate the clinical consumption per day that is equivalent to be grown up by kg body weight 420 times.
Long term toxicity test: whether toxigenicity reacts in order to observe long-term prescription, give rat this product medicated powder respectively and raise clothes, by adult 70 times of clinical consumption per day and 35 times (being 7g/kg/ day and 3.5g/kg/ day), in 8 weeks of successive administration, do not see that behavior, feed, the body weight of rat occurs unusually, with the matched group ratio, routine blood test, hepatic and renal function, all no abnormal change of various important organs, in institute's dosage scope, do not found any toxicity of this product.Acute and chronic toxicity test by animal confirms that this product drug safety scope is bigger, is a kind of safe and reliable compound preparation.
Clinical trial:
Applicant of the present invention to medicine of the present invention carry out at random, double blinding, multicenter contrast clinical trial.Include several 450 examples of the total example of test in, actual finishing observed several 450 examples of example, wherein observes adult's 290 examples, test group 215 examples, matched group 75 examples; Observe child's 160 examples, test group 119 examples, matched group 41 examples.
One, test case standard
(1) include the case standard in:
1. meet the viral myocarditis diagnosis.
2. the state of an illness is limited to light, medium-sized case.
3. acute stage (adopt existing doctor trained in Western medicine routine treatment, acute stages treated is included in after making stable disease in one month), convalescent period, lag phase by stages.
4. 3 years old≤child≤14 years old, the adult was≤45 years old in 14 years old.
5. meet hold concurrently stagnant heat card of traditional Chinese medical science cardiopalmus deficiency of both QI and YIN.
(2) get rid of the case standard:
1. suffer from hyperthyroidism, beta receptor hyperfunctioning and influence other disease of heart, as the rheumatic heart
Myositis, toxic myocarditis, coronary heart disease, connective tissue disease, metabolic disease etc.
2. heavy myocarditis, heart failure, severe arrhythmia, hyperpyrexia etc.
3. gestation or women breast-feeding their children.
4. be associated with serious primary disease such as cerebrovascular, liver, kidney and hemopoietic system, the psychotic.
5. age: child<3 years old,>45 years old person is grown up.
(3) reject the case standard:
1. end the experimenter because of irritated or other untoward reaction, be not counted in the row of curative effect of medication statistics, but count among the untoward reaction evaluation.
2. other unprovoked curative effect of medication is former thereby withdraw from the experimenter.
3. all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
Two, clinical test results shows:
(1), comprehensive therapeutic effect:
1. adult: viral myocarditis (cardiopalmus deficiency of both QI and YIN hold concurrently stagnant heat) adult patient 290 examples are observed in clinical trial, test group 215 examples wherein, matched group 75 examples.This product is 45.6% to the apparent more rate of the comprehensive therapeutic effect of adult patient, and total effective rate is 85.1; It is 34.7% that the comprehensive treatment of matched group shows the rate of healing, and total effective rate is 74.7%.Both compare, P<0.05, and there were significant differences.Test group obviously is better than matched group to adult's comprehensive therapeutic effect.
2. child: viral myocarditis (cardiopalmus deficiency of both QI and YIN hold concurrently stagnant heat) child patient 160 examples are observed in clinical trial, test group 119 examples wherein, matched group 41 examples.This product is 49.58% to the apparent more rate of the comprehensive therapeutic effect of child patient, and total effective rate is 90.76%; It is 41.46% that the comprehensive treatment of matched group shows the rate of healing, and total effective rate is 80.49%.Both compare, P>0.05, no difference of science of statistics.Test group shows the rate of healing and total effective rate is better than matched group.
(2), ECG curative effect:
1. this product improves significantly to adult's resting electrocardiogram, and the resting electrocardiogram effective percentage is 60.00%, and matched group is 52.00%, and both compare, P>0.05, and no significant difference, test group electrocardiogram effective percentage is better than matched group; To the ventricular premature contraction effect of having clear improvement of being grown up, showing more, rate is: 51.61%, and total effective rate is: 83.87%, matched group shows more rate 43.33%, total effective rate 80.00%, both compare, no difference of science of statistics.Test group is better than matched group to the rate of healing that shows that ambulatory electrocardiogram has.
2. this product improves significantly to child's resting electrocardiogram, and effective percentage is 58.82%, matched group effective percentage 48.78%, and both compare no difference of science of statistics, and test group is better than matched group to the child's electrocardiogram effective percentage; This product also can obviously be improved child's cardiopalmus patient's tcm syndrome, to the effect that also has clear improvement of unusual picture of the tongue and pulse condition, can partly improve patient's unusual sign.
(3), tcm syndrome
1. this product can obviously be improved adult diseases viral myocarditis (cardiopalmus) patient's tcm syndrome, to the effect that also has clear improvement of unusual picture of the tongue and pulse condition, can partly improve patient's unusual sign.Test group tcm syndrome curative effect cure rate is 60.47%, and total effective rate is: 87.44%; Matched group shows more, and rate is: 40.00%, and total effective rate is 77.33%, both contrasts, P<0.05, test group obviously is better than matched group to the curative effect of adult's tcm syndrome.
2. this product can obviously be improved children virus myocarditis (cardiopalmus) tcm syndrome, and tcm syndrome curative effect cure rate is 63.03%, and total effective rate is: 89.08%; Matched group shows more, and rate is: 58.54%, and total effective rate is 85.37%, both compare no difference of science of statistics.
Clinical test results shows: myocardium recovering particles treatment viral myocarditis is safely and effectively.