CN1233361C - Traditional Chinese medicine composition for treating cardiovascular disease - Google Patents

Abstract

The present invention relates to a traditional Chinese medicine composition for treating cardiovascular disease, especially coronary heart disease, which is prepared form 30 to 120 parts by weight of astragalus root, 18 to 80 parts by weight of rehmannia root, 12 to 60 parts by weight of ophiopogon root, 6 to 40 parts by weight of Chinese magnoliavine fruit, 18 to 72 parts by weight of red peony root and 12 to 60 parts by weight of cassia twig.

Description

A kind of Chinese medicine composition for the treatment of cardiovascular disease

Invention field

The present invention relates to a kind of treatment cardiovascular disease, especially the Chinese medicine composition of coronary heart disease, cardiomyopathy etc. is called the flourish granule of the heart again.

Background technology

National first population cause of the death statistical result (1984) and 8 years monitoring and statistics results of preceding 10 causes of the death of China resident in 1989 all disclose: China population underlying cause of death center disease of ZANG-organs ranks first since the seventies.Domestic and international in recent years experiment and the clinical research about anti-myocardial damage (necrosis), promotion tissue repair has some new progresses.The research of compound recipe SHENGMAI SAN, coronary disease II number is more deep.But the experimentation of the rat myocardial necrosis due to relevant Chinese herb prevention isoproterenol report is very few.Shanghai College of Traditional Chinese Medicine proves tentatively that with Herba Leonuri treatment rat isoproterenol myocardial ischemia this medicine can improve or recover the electrocardiogram of ischemic myocardial, coronary blood flow increasing.The achievement in research proof Folium Crataegi total flavones of Hunan Medical University can resist the rat myocardial ischemia due to the isoproterenol.The Provincial Medicine Research Institute, Jilin with Radix Ginseng different parts Saponin to the protective effect of rat myocardial necrosis studies have shown that the Radix Ginseng different parts all has protective effect to the rat myocardial necrosis, be good with the Herba Herminii saponin especially.Hospital of report Shanghai Medical Univ attached Xinhua in 1987 finds that from set up amycin cardiomyopathy animal model with rat SHENGMAI SAN has a preventive and therapeutic effect to amycin is myocardiac.Reported that the Shanghai Medical Univ angiocardiopathy institute experimentized to myocarditis with the qi-invigorating herb Radix Astragali and the clinical research confirmation Radix Astragali has protective effect to cardiac damage in 1988.Huashan hospital of report Shanghai Medical Univ in 1989 treats infraction with the Radix Astragali, not only can improve cardiac function, can obviously reduce myocardial infarction patient case fatality rate again.Xiyuan Hospital, Chinese Medicine Academy of China's Chinese herbal medicine is being done a large amount of work aspect the research of the protective effect of cultivating the myocardial cell ischemia injury since 1979.With regard to the above research of doing, generally speaking on the degree of depth and systematic study, also need improve, strive for working out the new drug of preventing and treating myocardial necrosis with motherland's medicine and pharmacology characteristic.

It is the main treatment myocardial necrosis with " blood circulation promoting and blood stasis dispelling " that the inventor studies have shown that single, is difficult to obtain good result.The inventor thinks that myocardial necrosis is because Rong Wei lacks of proper care, and cardiac muscle loses lubricious, due to exopathogen is invaded.So abide by the rule of treatment that Difficult Classic " decreases its heart person; transfer its Rong Wei "; thereby the flourish supporing yang QI invigorating of the compound recipe heart, Yin-heart nurishing that design is formed with medicines such as the Radix Astragali, Radix Rehmanniae, Ramulus Cinnamomi; with cardiac nutrition; in order to do the heart-yin Xu Zhen; heart-yang must be answered, and exempts from the effect of infringement and reach " the flourish heart is set upright " protecting myocardial cell.

Summary of the invention

Therefore purpose of the present invention provides a kind of effective treatment cardiovascular disease, the especially Chinese medicine composition of coronary heart disease, cardiomyopathy etc.

Compositions of the present invention comprises following raw material (by weight):

Radix Astragali 30-120 Radix Rehmanniae 18-80 12-60 Radix Ophiopogonis

Fructus Schisandrae Chinensis 6-40 Radix Paeoniae Rubra 18-72 Ramulus Cinnamomi 12-60

Compositions of the present invention preferably includes (by weight):

Radix Astragali 40-90 Radix Rehmanniae 25-55 16-40 Radix Ophiopogonis

Fructus Schisandrae Chinensis 12-30 Radix Paeoniae Rubra 25-50 Ramulus Cinnamomi 16-40

Compositions of the present invention more preferably comprises (by weight):

Radix Astragali 50-70 Radix Rehmanniae 30-45 20-30 Radix Ophiopogonis

Fructus Schisandrae Chinensis 12-25 Radix Paeoniae Rubra 30-45 Ramulus Cinnamomi 20-30.

Function cures mainly: supporing yang, QI invigorating, yin nourishing.Be used for flaccidity of the heart-yang, coronary artery disease with deficiency of both qi and yin.Card is seen sensation of oppression and faint pain in the chest, and shortness of breath and palpitation is had a dizzy spell, tiredness with no desire to speak, lustreless complexion etc.

Radix Astragali head is stated from " herbal classic "." book on Chinese herbal medicine is newly organized " carries the Radix Astragali can " go into meridian of Hand-SHAO YIN "; " book on Chinese herbal medicine meets the source " carries: " Radix Astragali, all void of energy tonifying five ZANG-organs "; " Records of Tradition Chinese and Western Medicine in Combination " carries: " Radix Astragali can QI invigorating, doublely can rise gas, and kind temperature atmosphere (being pectoral qi) is in the heart sunk "; The Radix Astragali is the QI invigorating key medicine, and the BUZHONG YIQI TANG that Li Dongyuan formulates according to the purport of Huangdi's Internal Classics " damage person's benefit ", " diseases caused by over-strain should be treated by warming " is a monarch drug with Radix Astragali QI invigorating in the side.Radix Rehmanniae head is stated from " herbal classic "." medical science invention " carries: " Radix Rehmanniae start with few the moon ", " main cardiopathia "; " big bright book on Chinese herbal medicine " carries: Radix Rehmanniae " it is bad to control palpitation with fear labor, and cardiopulmonary decrease "; Treatise on Febrile Diseases is controlled the card of irregularly intermittent and regularly intermittent pulse severe palpitation with zhigancao decoction, and the heart-yin is nourished with the Radix Rehmanniae by the side.

Ramulus Cinnamomi head is stated from " herbal classic "." book on Chinese herbal medicine is looked for the truth " carries Ramulus Cinnamomi " go into the flesh table, double go into conscience "; " the Changsha medicine is separated " carries " Ramulus Cinnamomi go into liver man and the promoting the circulation of blood branch, walk meridians and reach Rong Yu "; Speech in the Compendium of Material Medica " the hot sweet big heat of Ramulus Cinnamomi can be declared and lead hundred medicines, promoting blood circulation ".Transferring its Rong Wei method head to see the 53rd " in distinguishing that TAI YANG syndrome is controlled " and " Medical Treasures of the Golden Chamber " it " arthralgia due to stagnation of blood asthenia arteries and veins disease also control the 6th " of treatise on Febrile Diseases original text, all is that monarch drug is intended different channels and transferred its battalion to defend with Ramulus Cinnamomi, opens the beginning of the harmonizing nutrient QI and difensive QI rule of treatment.

We are monarch with the Radix Astragali, and the QI invigorating heart tonifying is with the heart-yang that shakes, and medicines such as Radix Rehmanniae are that the minister assistant is moistened the heart-yin, cardiac nutrition, the benefit blood of being indecisive and changeable, and Ramulus Cinnamomi guides all efficacy of a drug to reach cardiac muscle for making.Then gather the merit of " the flourish heart is set upright " of supporing yang QI invigorating, Yin-heart nurishing protection cardiac muscle altogether.

Can compositions of the present invention be made any dosage form of suitable clinical use, for example granule, pill, tablet, powder, capsule, oral liquid etc. according to conventional method.

For example a kind of method comprises that collecting decoction filters with described raw material water decoction one or many, and filtrate decompression is condensed into fluid extract, and drying is granulated again.

For example another kind of method comprises that collecting decoction filters, and concentrates, and makes oral liquid with described raw material water decoction one or many.

Specific embodiment

Followingly the present invention is described, it should be understood that these embodiment only are used for illustrative purposes, are not construed as limiting the invention with reference to embodiment.

Embodiment 1

Radix Astragali 606g Radix Rehmanniae 364g 242g Radix Ophiopogonis

Fructus Schisandrae Chinensis 182g Radix Paeoniae Rubra 364g Ramulus Cinnamomi 242g

Above Six-element decocts with water three times, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate decompression is concentrated into the clear paste that relative density is 1.26 (60 ℃), add ethanol and make that to contain alcohol amount be 75%, supernatant is got in cold preservation 48 hours, filter, filtrate recycling ethanol, and be concentrated into the clear paste that relative density is 1.38 (60 ℃), it is an amount of to add sucrose and dextrin, and mixing is made granule, drying is made 1000g, promptly.

Embodiment 2

Radix Astragali 725g Radix Rehmanniae 335g 202g Radix Ophiopogonis

Fructus Schisandrae Chinensis 162g Radix Paeoniae Rubra 384g Ramulus Cinnamomi 212g

More than six hide, decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate decompression is concentrated into the clear paste that relative density is 1.26 (60 ℃), add ethanol and make that to contain alcohol amount be 75%, supernatant is got in cold preservation 48 hours, filter, filtrate recycling ethanol, and be concentrated into the clear paste that relative density is 1.38 (60 ℃), it is an amount of to add sucrose and dextrin, and mixing is made granule, drying is made 1000g, promptly.

Embodiment 3

Radix Astragali 535g Radix Rehmanniae 325g 232g Radix Ophiopogonis

Fructus Schisandrae Chinensis 182g Radix Paeoniae Rubra 354g Ramulus Cinnamomi 222g

Above Six-element decocts with water three times, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and is concentrated into thick paste, and oven dry is pulverized, and incapsulates.

Embodiment 4

Radix Astragali 535g Radix Rehmanniae 325g 232g Radix Ophiopogonis

Fructus Schisandrae Chinensis 182g Radix Paeoniae Rubra 354g Ramulus Cinnamomi 222g

Above Six-element decocts with water three times, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and makes oral liquid.

One, the flourish treatment of heart myocardial damage phase ii clinical trial

1, clinical myocardial damage patient 404 examples that cause because of various organic heart diseasies of observing altogether of physical data, the thoracic obstruction (coronary heart disease, angina pectoris, hypertensive cardiopathy etc.) 326 examples, cardiopalmus (cardiomyopathy, myocarditis etc.) 78 examples, wherein male 233 examples, woman's 171 examples, M-F is 1.36: 1.Wherein the strict table of random number of 200 routine inpatients is divided into 1 group of the flourish treatment of the heart (hereinafter to be referred as 1 group of treatment), 100 examples, and propranolol treatment group (hereinafter to be referred as matched group) 100 examples are done contrast for two groups and are observed.All the other 204 examples do not enter the table of random number grouping, but also the patient of flourish treatment is 2 groups of the flourish treatments of the heart (hereinafter to be referred as 2 groups of treatments) diligently, out-patient's 64 examples wherein, inpatient 140 examples, 1 group of the treatment of clothes heart honor and 2 groups of 304 routine patients that combine of treatment are referred to as flourish treatment group (hereinafter to be referred as the treatment group) the patient's sex of the heart, age, source see Table 1,2:

Table 1 patient sex, age and the course of disease distribute

Group	The man	The woman	Mean age (year)	Average course of disease (year)
					Matched group	62	38	55.71(18-35)	4.47(0.2-25)
Treat 1 group	55	45	55.47(15-79)	4.06(0.1-20)
					Treat 2 groups	116	88	56.14(25-82)	4.09(0.1-30)

Table 2

The patient comes source distribution

Group	Outpatient service	Be in hospital	Inpatient's ratio (%)
				Matched group	0	100	100
Treat 1 group	0	100	100
				Treat 2 groups	64	140	68.38

From table 1,2 as can be seen, matched group is compared at aspects such as sex, age, the courses of disease for 1,2 groups with the treatment group, and is similar substantially.

2, study subject is selected 1. tcm diagnosis, dialectical standard and foundation thereof: according to the flourish phase ii clinical trial plan of heart requirement, according to the function of heart honor, select the patient of all flaccidity of the heart-yang that meets the thoracic obstruction (coronary heart disease), cardiopalmus (other heart disease), type of deficiency of both QI and YIN to be the flourish clinical study subject of the heart.Differential diagnosis in tcm: thoracic obstruction dull pain, shortness of breath and palpitation, have a dizzy spell, tiredness with no desire to speak, lustreless complexion, body of the tongue is red partially, pulse condition is thin and delicate or knot generation according to " new Chinese medicine clinical research guideline ".2. Western medicine diagnose standard and foundation thereof: " coronary heart disease " is according to " name of ischemic heart desease and diagnostic criteria "---International Society of Cardiology and association and World Health Organization's clinical name standardization associating specialist paper (Circulation59:607,1979); Other heart disease all by the same period heart disease diagnosis standard determine.3. case inclusion criteria: meet outside above-mentioned 1,2 specified standard by the requirement of the second stage of clinical program is all, the study subject indispensability has electrocardiogram S-T section, T ripple to become the myocardial damage patient of warp.4. case exclusion standard: with in the room or intraventricular block and other be enough to cause Secondary cases S-T section.T ripple changer.

3, the test method case observation carries out in strict accordance with the phase ii clinical trial plan.404 routine patients' grouping is undertaken by above grouping.1. instructions of taking and dosage: the flourish each 10g of the heart, every day 3 times, propranolol dinitrate tablets, each 10mg, every day 3 times.2. course of treatment: all are tried case all with 1 course of treatment of 6 weeks, serving as 1 course of treatment to sum up unit.3. observation item: all are tried symptom, sign and lab index before and after the treatment of case itemized record: comprise chest pain, cardiopalmus, feel suffocated, dizzy, breathe hard, picture of the tongue, pulse condition, the blood pressure heart rate rhythm of the heart, heart x-ray, Electrocardioscopy; Blood, routine urinalysis, liver, kidney function test; Part patient detects blood plasma lipide peroxide (LPO) content, blood rbc superoxide dismutase (SOD) activity.The honor of the special observation heart is to the Acute Hemodynamic treatment effect of patients with congestive heart failure with to patients with coronary heart disease hemodynamics, rheol influence.And tightly observe untoward reaction and toxicity, side effect after the medication.

Result of the test

Criterion of therapeutical effect and foundation thereof: the criterion of therapeutical effect that the plan of the flourish treatment of heart myocardial damage phase ii clinical trial is formulated, according to " new Chinese medicine clinical research guideline ".The therapeutic effect evaluation of myocardial damage is divided into following 3 grades.Produce effects: respectively lead S-T section, T ripple of clinical symptom disappearance, electrocardiogram recovered the obvious improver of normal ECG (being become upright etc. by inversion as the T ripple).Effectively: doing well,improving is more than 1 grade or 1 grade, though electrocardiogram has improvement, does not reach standard, and as S-T section decline 0.05 ~ 0.1mV that the S-T section that descends goes back up to more than the 0.05mV or raises, the T ripple is shoaled by inversion or be low flat, or upright by low flat change; Though electrocardiogram does not have improvement, the obvious improver of clinical symptoms.Invalid: symptom and electrocardiogram all do not have the improver.

Clinical total effects matched group and 1 group of treatment, the therapeutic effect of treatment group is pressed the clinical efficacy standard determination that the phase ii clinical trial plan is formulated, and analyzes contrast, and the result sees table 3 for details:

Flourish each group of table 3 heart compares with the matched group curative effect

Effect	Matched group	Treat 1 group	The treatment group
				Produce effects	26	33	86
Effectively	55	59	203
				Invalid	19	8	15
Add up to	100	100	304
				Total effective rate (%)	81.00	92.00	95.06

Treat 1 group and matched group comparison, analyze P＞0.05 with Ridit

Find out that by table 3 the matched group total effective rate is 81.00%, treating 1 group of total effective rate is 92.00%, treatment group total effective rate 95.06%, illustrate that 1 group of treatment, treatment group and matched group more all are better than matched group, analyze through Ridit for two groups that are divided into by table of random number, treat 1 group with matched group there was no significant difference (P＞0.05) relatively.

ECG curative effect result sees table 4 for details.Show 1 group of treatment and treatment group and matched group when treating myocardial damage from table 4, close to Electrocardiographic clinical effective rate.

Flourish each group of table 4 heart compares with the matched group ECG curative effect

Effect	Matched group	Treat 1 group	The treatment group
				Produce effects	31	33	86
Effectively	28	31	104
				Invalid	41	36	114
Add up to	100	100	304
				Total effective rate (%)	59.00	64.00	62.50

Clinical therapeutic effect of syndrome result sees table 5,6 for details:

1 group of disease curative effect of table 5 matched group and treatment relatively

Effect	Matched group						Treat 1 group
													Chest pain	Cardiopalmus	Feel suffocated	Dizzy	Breathe hard	Add up to	Chest pain	Cardiopalmus	Feel suffocated	Dizzy	Breathe hard	Add up to
		78	63	62	43	57	303	75	71	57	57	73													333
Produce effects													61	54	46	30	41	232	68	62	46	48	61	285
	Effectively	11	5	10	6	8	40	5	7	7	4	7													30
Add up to													72	59	56	36	49	272	73	69	53	52	68	315
	Effectively fill in	92.3 1	93.6 5	90.3 2	83.7 2	85.9 0	89.7 6	97.3 3	97.1 8	92.9 8	91.2 3	93.1 5													95.5 9

Treat 1 group and matched group comparison, analyze P＞0.05 with Ridit

Show heart honor when improving myocardial damage from table 5, patient's clinical disease is also had clear improvement, analyze its effect through Ridit and significantly be better than matched group (P＜0.05).

The disease curative effect of table 6 treatment group

Effect	Chest pain 233	Cardiopalmus 241	Feel suffocated 212	Dizzy 203	Breathe hard 250	Add up to 1139
							Produce effects	203	224	193	184	228	1032
Effectively	12	12	11	11	17	63
							Add up to	215	236	204	195	245	1095
Effective percentage (%)	92.27	97.93	96.23	96.06	98.00	96.14

Show heart honor when improving patient's myocardial damage from table 6, the influence that clinical disease also is significantly improved to blood pressure, heart rate sees table 7,8 for details:

Blood pressure (X meansigma methods ± s) relatively before and after flourish each group of table 7 heart and the matched group

	Group	Before the treatment	After the treatment	t	P
						Systolic pressure (kpa)	Matched group	18.95±2.88	17.05±2.03	3.72	＜0.01
Treat 1 group	18.34±2.80	17.35±2.11	3.52	＜0.05
					The treatment group		17.88±2.89	16.97±2.10	2.78	＜0.05
Diastolic pressure (kpa)	Matched group	11.55±1.74	10.64±1.15	3.05							＜0.01
					Treat 1 group	11.19±1.48	10.61±1.25	2.80	＜0.05
	The treatment group	11.04±1.43	10.51±1.61	2.63						＜0.05

Flourish each group of table 8 heart with to (the X meansigma methods ± s) of changes in heart rate before and after the group treatment

Group	Before the treatment	After the treatment	t	P
					Matched group	84.60±13.71	73.79±9.67	4.86	＜0.01
Treat 1 group	81.98±13.41	78.63±8.92	2.06	＞0.05
					The treatment group	83.21±13.52	76.47±9.03	1.65	＞0.05

Treat 1 group and the variation comparison of treatment of control group front and back, t=4.40, P＜0.01.

Find that from table 7 each group all has regulating action to patient's blood pressure.Table 8 shows that matched group has the effect of remarkable inhibition heart rate, makes decreased heart rate, and flourish each group of the heart does not then have this effect, treat 1 group with matched group relatively, significant differences (P＜0.01) is arranged.

1. laboratory checking index changes treats 1 group and 2 groups of blood, routine urinalysis with matched group patient treatment front and back of treatment and does not have influence.2. heart x-ray diagnosis is treated 1 group and treatment group and is not had obvious influence with matched group patient treatment front and back X line.3. the heart flourish with the influence of propranolol to erythrocyte sod enzyme and blood plasma LPO: carried out the analysis contrast before and after the treatment to treating 1 group and matched group, the result sees table 9,10 for details:

Erythrocyte sod variation before and after 1 group of table 9 treatment and the matched group (SOD U/mg Hb, the x meansigma methods ± s)

	Group	N	Before the treatment	After the treatment	t	P
							High value group	Matched group	10	1222.53±43.70	1129.53±43.70	1.40	＞0.05
Treat 1 group	12	1189.00±29.64	1107.00±36.60	1.10	＞0.05
						The low value group		Matched group	20	824.63±26.53	869.68±29.35	1.69	＞0.05
Treat 1 group	18	862.00±21.53	1002.00±42.37	2.48	＜0.01

The low value group compares u=6.47, P＜0.01 for two groups

Blood plasma LPO variation comparison before and after 1 group of treatment of control group of table 10 treatment (nmolMAD/ml, the x meansigma methods ± s)

	Group	N	Before the treatment	After the treatment	t	P
							High value group	Matched group	9	2.75±0.19	12.60±0.17	0.58	＞0.05
Treat 1 group	10	2.72±0.16	2.04±0.21	2.60	＜0.05
						The low value group		Matched group	21	1.34±0.08	1.44±0.11	0.71	＞0.05
Treat 1 group	20	1.36±0.09	1.47±0.11	0.70	＞0.05

High value is organized two groups relatively: u=10, P＜0.01

Find that from table 10,11 heart honor has rising low value group patient SOD enzymatic activity, reduce the effect of high value group LPO content, and propranolol is not have this regulating action, two groups relatively have significant differences (P＜0.01).

1. analysis of adverse reactions observes by the flourish treatment 304 routine patients of the heart, and the patient feels sick in take medicine just 3 routine xerostomias, 2 examples, 2 routine loose stool, 2 routine constipation, but disappears in the back of continuing to take medicine, and does not see other untoward reaction and toxicity, side effect.2. heart honor to there not being influence before and after patient liver, the renal function curing, is learned by statistics and is handled p＜0.05 when the treatment myocardial damage, illustrates that heart honor is to harmless before and after patient liver, the renal function curing, to body safety.

Heart honor can improve cardiac function to the influence of the cardiac function effect according to the flourish supporing yang QI invigorating of the heart, Yin-heart nurishing, and the effect of cardiac function has further been observed in this test again.

Use the SWAN-GANZ catheterization, observing patient's hemodynamics after taking heart honor changes, 32 routine chronic congestion heart failure patient 1～4h after taking medicine, reduction MPAP is arranged, PCWP, improve CI, improve the effect of cardiac function, its result has significant difference with the drinking-water contrast, adopt ZXG-40 noinvasive cardiovascular function diagnostic apparatus, the patients with coronary heart disease of 30 routine myocardial damages has been carried out the cardiac function of the flourish treatment of heart front and back, the variation of microcirculation and blood viscosity is observed, and shows that tentatively heart honor has the heart pump of enhancing function, improve Coronary Perfusion Pressure, strengthen myocardial flow, reduce whole blood viscosity, the effect of microcirculation improvement.

Conclusion

The myocardial damage that different reason organic heart diseasies cause clinically corresponding symptom occurs, itself or cardiac insufficiency, S-T can appear in electrocardiogram, the T ripple changes, by middle-aged and elderly people common.Chinese medicine thinks that primary disease belongs to the thoracic obstruction and cardiopalmus category, and is many because the motive is deficient, and blood is not due to the reason such as Rong Xin.Heart honor has supporing yang QI invigorating, Yin-heart nurishing, cardiac nutrition, alleviates the function of myocardial necrosis, the treatment rule that clinical treatment " decreases its heart person, transfers its Rong Wei " by Chinese medicine.To 304 routine myocardial damage patient experimental observation results be: produce effects 86 examples, effective 203 examples, invalid 15 examples, total effective rate 95.06%.Electrocardiogram produce effects 86 examples, effective 104 examples, invalid 114 examples, total effective rate 62.50%.By 1 group of the flourish treatment of the heart and each 100 routine comparative observation of contrast medicine propranolol matched group, the curative effect that total effects that the flourish treatment of the heart is 1 group and disease curative effect are better than the propranolol matched group.In the 304 routine patients that take the flourish treatment group of the heart, except that there being 9 routine patients to occur xerostomia, constipation and the diarrhoea other untoward reaction and toxicity, side effect not taking place at the initial stage of taking medicine.

The flourish treatment of heart myocardial damage patient experimental observation shows, this medicine has no adverse effects to patient's routine blood test and liver, renal function.The clinical trial of the flourish treatment of heart myocardial damage is observed and is shown, this medical instrument has the good functions such as patient's clinical symptoms, blood pressure regulation, improvement cardiac muscle microcirculation disturbance of improving, to then not obviously influence of heart rate.Also observe simultaneously, this medicine has the blood rbc of raising SOD enzymatic activity, reduces the effect of blood plasma LPO content, and its effect obviously is better than contrasting the medicine propranolol, illustrates that this medicine has the myocardium effect that resists damage and promote the myocardial cell reparation of raising.Show that by part patient's hemodynamics is observed heart honor has the pulmonary artery pressure of reduction and its wedge pressure of pulmonary capillary, raising heart row blood index etc. improves the effect of cardiac function, shows that heart honor has positive inotropic action.So we can affirm: heart honor is the active drug of the myocardial damage that causes of the various organic heart diseasies of treatment, and clinical total effective rate is 95.06%; Electrocardiogram total effective rate 62.50%.The flourish no toxicity, side effect of the heart facilitates patients.

Two, the clinical trial of the flourish treatment of heart myocardial ischemia

Data and method

Since November nineteen ninety, diligently flourish treatment is organized: male 33 examples as treatment because of inpatient 52 examples of myocardial ischemia due to the various heart diseases, woman's 19 examples, at 19～74 years old age (average 49.8 years old), the cause of disease has angina pectoris, old myocardial infarction 21 examples, acute myocardial infarction 6 examples, hypertensive cardiopathy 3 examples, cardiomyopathy 11 examples, myocarditis 10 examples, rheumatic heart disease 1 example.Matched group 15 examples are all with propranolol treatment, wherein male 7 examples, women 8 examples, age 13-72 year (average 43.8 years old), coronary heart disease 8 examples, cardiomyopathy 5 examples, rheumatic heart disease 2 examples.

The each patient is admitted to hospital after detailed medical history-taking, have a medical check-up, the film making of electrocardiogram, heart, echocardiography, part patient has also done myocardial enzymes, angiocardiography inspection.Coronary heart disease is undertaken by the WHO diagnostic criteria, other heart disease all by the same period cardiovascular diagnosis standard determine.Electrocardiogram criterion: S-T section rising 〉=0.1mV, descending is horizontal type or declivity type 〉=0.05mV, the smooth or inversion of T popin.

Heart honor is made up of a few flavor Chinese medicines such as the Radixs Astragali, and by the marmite slow fire boiling of traditional Chinese medical science traditional method, front and back decoct twice medicinal liquid mixing, and concentrated acid becomes per ampoule 10ml, each 20ml.3 times/d, 4 weeks were 1 course of treatment.Propranolol 5-10mg, 3 times/d, 4 weeks were 1 course of treatment.The each patient respectively does 1 part of 12 lead electrocardiogram 1,2,3,4 weekends before medication, after the medication, and part patient respectively inspects myocardial enzymes by ready samples before and after medication.

The curative effect determinate standard produce effects: transference cure, electrocardiogram S-T section, T ripple recover normal; Effectively: doing well,improving, electrocardiogram S-T section or T ripple have two above recoveries of leading normally or partly to improve (flattened by inversion as the T ripple, the S-T section is by more than the former decline level rising 0.05mV); It is invalid: though symptom has part to improve S-T section, T ripple no change.

The result

Heart honor is 89.07% (seeing Table 11) to the effective percentage of doing well,improving, and electrocardiogram produce effects 9.68% is effective 32.25%, and is invalid 58.07%, electrocardiogram total effective rate 41.93%.The effective percentage that propranolol improves symptom is 68.57% (seeing Table 12), electrocardiogram obvious effective rate 39.99%, invalid 60.01%.

Doing well,improving situation before and after the flourish treatment 52 routine myocardial ischemia of table 11 heart

		Dizzy	Cardiopalmus	Breathe hard	Uncomfortable in chest	Inappetence	Weak	Add up to example inferior
									Before the treatment		15	38	23	40	18	13	147
After the treatment	Improve	15	32	18	38	14	11	128
									Do not improve	0	6	5	2	2	2	19

Table 12 propranolol is treated 15 routine myocardial ischemia front and back doing well,improving situations

		Dizzy	Cardiopalmus	Breathe hard	Uncomfortable in chest	Inappetence	Weak	Add up to example inferior
									Before the treatment		3	14	7	5	4	2	35
After the treatment	Improve	2	13	4	3	1	1	24
									Do not improve	1	1	3	2	3	1	11

Myocardial damage, myocardial ischemia are clinical common performances due to coronary heart disease and other heart disease, previously many grade with vasodilation, beta-blocker, calcium antagonist improved myocardial ischemia, myocardial damage, Chinese medicine aspect use the treatment of " activating blood circulation to dissipate blood stasis " prescription all to obtain certain curative effect more.Heart Rong Ze starts with from " the flourish heart is set upright ", and the mechanism of the flourish treatment of animal experiment proof heart myocardial ischemia is to improve myocardium microcirculation, promotes myocardial metabolism; improve blood gst enzyme contents level; participate in oxidation-reduction system, thereby play the protection cardiac muscle, and improve cardiac muscle anoxybiotic toleration.As everyone knows, propranolol then is with decreasing heart rate, lowers myocardial contraction, reduces myocardial oxygen consumption, and improves cardiac muscle to anoxybiotic tolerance.Clinical observation shows that heart honor all has certain curative effect to myocardial ischemia, myocardial damage due to the various heart diseases, but to myocardial ischemia, myocardial damage better efficacy due to myocarditis, the angina pectoris.The flourish determined curative effect of the heart.All be better than propranolol aspect the symptom electrocardiogram improving, and easy to use, have no side effect.Heart honor is compared with the DIAOXINXUE KANG that Chengdu, Sichuan produces, and the former is 87.07% for the symptom effective percentage, and the latter 87.8%, and both are similar.Electrocardiogram effective percentage heart honor 41.93%, DIAOXINXUE KANG 50%.This may be relevant with the flourish short treating period that uses of the heart.

Three, the contrast test of heart honor and propranolol treatment myocardial damage heart disease curative effect

Myocardial damage patient 84 examples that the clinical data clinical observation causes because of the thoracic obstruction (coronary heart disease).Observe for the systematicness that guarantees to treat, all cases all derive from the inpatient, and wherein 60 routine patients are divided into the flourish treatment of the heart in strict accordance with table of random number and organize 30 examples (hereinafter to be referred as the treatment group), do contrast for two groups and observe.All the other do not enter the table of random number grouping, but the also flourish diligently 24 routine patients that treat are the flourish open treatment group of the heart.

Treatment is organized among the 30 routine patients, male 14 examples, women 16 examples, the oldest 75 years old, minimum 43 years old, 57.6 years old mean age.The course of disease is the longest 20 years, and is the shortest 0.25.

Among the matched group 30 routine patients, male's 18 examples, women's 12 examples, oldest 75 years old, minimum 0.1 year.

Test method

1, instructions of taking and dosage treatment group are taken heart honor, each 0.42g*5 capsules, every day 3 times, matched group propranolol dinitrate tablets, each 10mg/ sheet, every day 3 times.

2, the course of treatment all to be tried case be a course of treatment with 6 weeks all, serving as a course of treatment to sum up unit.

3, observation item heart rate, sign such as blood pressure, picture of the tongue, pulse condition and blood, routine urinalysis, biochemical indicators such as liver function, and tightly observe untoward reaction and the toxicity, side effect that occurs after the medication.

Result of the test

1, criterion of therapeutical effect and foundation thereof

2, formulate the plan of the flourish treatment of heart injury of myocardium phase ii clinical trial according to " new Chinese medicine clinical research guideline ", the therapeutic effect evaluation of myocardial damage is divided into 3 grades:

Produce effects: respectively lead S-T section, T ripple of clinical symptom disappearance, electrocardiogram recovered normal or electrocardiogram obviously improves (becoming low equality by inversion as the T ripple).

Effectively: doing well,improving one-level or more than the one-level, though electrocardiogram has improvement, do not reach standard, go back up to more than the 0.05mV as the S-T section that descends, or the S-T section decline 0.05-0.01mV that raises, the T ripple is flat or flatly become upright by low by being inverted step-down; Though or electrocardiogram does not have improvement, the obvious improver of clinical symptoms.

Invalid: symptom and electrocardiogram all do not have obvious improver.

A, clinical total course of treatment the results are shown in Table 13

The flourish total effective rate 93.33% of the heart, 63.335%, two group of curative effect of propranolol aggregate efficiency compares, and the treatment group is better than matched group, and significant difference (P＜0.01) is arranged.

Table 13 treatment group and matched group curative effect are relatively

Group	n	Produce effects	Effectively	Total effective rate
					The treatment group	30	12(40.00％)	16(53.33％)	28(93.33％)
Matched group	30	7(23.33％)	12(40.00％)	19(63.33％)

* through x ²Check: x ²=9.93, p＜0.01

B, ECG curative effect the results are shown in Table 14:

Table 14 treatment group and matched group ECG curative effect are relatively

Group	n	Produce effects	Effectively	Invalid	Effective percentage (%)
						The treatment group	30	11	8	11	63.33
Matched group	30	6	11	5	56.67

As can be seen from Table 14, two groups that electrocardiogram is improved situation is similar.

C, clinical disease efficacy result see Table 15:

The curative effect of table 15 treatment group and the clinical syndrome of matched group relatively

	Matched group						The treatment group
													Effect	Chest pain 28	Cardiopalmus 26	Feel suffocated 29	Dizzy 15	Breathe hard 20	Add up to 118	Chest pain 28	Cardiopalmus 24	Feel suffocated 27	Dizzy 19	Breathe hard 22	Add up to 120
Produce effects	30	17	14	10	6	67	19	15	19	12	20	25
													Effectively	5	7	3	2	7	29	7	8	7	5	1	28
Add up to	25	24	22	12	13	96	26	23	26	17	21	113
													Effective percentage (%)	89. 29	92 .30	75. 86	80. 00	65. 00	21. 35	92. 86	95. 83	96. 47	89. 47	95. 45	94. 17

Through x ²Check: x=1.32, p＜0.05

D, to the influence of blood pressure, heart rate

Our primary part observation treatment group and matched group patient blood pressure and changes in heart rate situation, two groups of blood pressure effects that all show the patient that has some improvement then do not have obvious influence to patient's heart rate treatment group, matched group then has significant decreased heart rate effect.The results are shown in Table 16:

Table 16 treatment group and matched group are to the influence of blood pressure (x meansigma methods ± s)

	Group	N	Before the treatment	After the treatment	t	P
							Systolic pressure	Matched group	30	18.34±2.63	17.91±1.74	2.14	＜0.05
Treat 1 group	30	19.34±2.57	17.26±1.90	3.46	＜0.001
						Diastolic pressure		Matched group	30	11.52±1.53	10.62±1.27	2.7	＜0.05
Treat 1 group	30	11.89±1.92	10.70±1.79	2.97	＜0.01

E, laboratory checking index change hepatic and renal function before and after 1. treatment group and the matched group and blood, routine urinalysis is not seen significant change.2. treatment group and matched group in patient's breast sheet, cardiothoracic ratio unusual person carried out before and after the treatment observation relatively, observation shows, the unusual person of two groups of patients' cardiothoracic ratio does not have significant change after 1 course of treatment, and effective percentage is respectively more also zero difference of 9.90% and 12.50%, two group of treatment back.3. treatment group, matched group are to the influence of erythrocyte superoxide dismutase (SOD) and peroxide plasma (LPO).In clinical, we compare SOD and the LPO before and after treatment group, the matched group patient, find that heart honor has the effect of rising low value group patient SOD and the high value group patient blood plasma LPO of reduction.

The relation of F, course of disease curative effect is from the experimental data analysis, in the treatment group produce effects 12 routine courses of disease, its morbidity of 8 examples is arranged in 2 years, account for produce effects patient's 66.68%, illustrate that disease time and curative effect have significant dependency, the course of disease is short more, it is good more to take this drug effect fruit, in 2 routine invalid cases, and 5 years medical history 1 examples, 7 years case 10 examples also illustrate that curative effect is relevant with the course of disease.

Therapeutic effect and age do not have obvious relation.

Conclusion

1, should flourishly diligently treat the myocardial damage patient that the thoracic obstruction (coronary heart disease) causes, clinical observation, 54 examples, produce effects 21 examples, effective 27 examples, total effective rate 90.74% are organized in treatment, electrocardiogram produce effects 19 examples, effective 17 examples, total effective rate 66.67% compares at random through 30 routine treatment groups and 30 routine matched groups, effect obviously is better than the propranolol matched group, and has no adverse reaction and the toxic and side effects generation.

2, heart honor is in treatment myocardial damage patient procedure, and to patient's blood, routine urinalysis, liver, renal function do not have obvious influence.

3, the flourish treatment of heart myocardial damage shows that through clinical observation this medical instrument has the effect of supporing yang QI invigorating, Yin-heart nurishing.

Show by clinical observation, this medicine has the therapeutic effect that improves the erythrocyte sod enzymatic activity and reduce blood plasma LPO content, has the myocardium microcirculation disturbance of adjusting, improve Electrocardiographic effect, the blood pressure of regulating patient is also arranged simultaneously, recover the equilibrated function of patient's each internal organs of body, reach the effect of treatment myocardial damage.

Four, oral heart honor is to the clinical trial of patients with coronary heart disease plasma viscosity influence

Object this paper is selected in 105 routine patients, age 55-70 year, and male 70 examples, women 35 examples are all made a definite diagnosis by the WHO diagnostic criteria for coronary heart disease.The angina pectoris history of attack is arranged in the recent period, the blood drawing chemical examination high blood viscosity on an empty stomach of wherein being admitted to hospital: male 45 examples, women 20 examples (for adopting the chemical examination of NXE-1 type cone and plate viscometer before taking medicine).

The 2ml that draws blood on an empty stomach before method is taken medicine to selected patient adopts the chemical examination of NXE-1 type cone and plate viscometer, method of administration: the flourish granule of the oral heart, every day three times, behind the course of treatment 40d, 2ml once more on an empty stomach draws blood, still adopt the cone and plate viscometer chemical examination, data are adopted the classified statistics analysis.

The relevant significant t-test of statistics.

The results are shown in Table 17,18:

Plasma viscosity before and after table 17 is taken medicine (nPa-s, x ± s)

	n	The preceding blood of taking medicine	After taking medicine	The P value
					The man	70	1.61±0.11	1.57±0.05	＜0.05
The woman	45	1.48±0.07	1.42±0.11	＜0.05

Plasma viscosity before and after table 18 high blood viscosity patient takes medicine (nPa-s, x ± s)

	n	The preceding blood of taking medicine	After taking medicine	The P value
					The man	45	1.68±0.14	1.59±0.16	＜0.05
The woman	20	1.54±0.13	1.42±0.15	＜0.05

Can find above data statistic analysis and relevant significance test: 1. obey the heart after flourish 40 days, two groups of plasma viscosities of men and women all reduce, with take medicine before with the gender group significance test significant difference is arranged.2. high blood viscosity patient plasma viscosity equally also reduces, with general patients with gender group significance test there was no significant difference.Heart honor can reduce patient's plasma viscosity, and is relevant with the flourish pharmacological action of the heart own: the activity of rising people's erythrocyte sod enzyme.Reduce people's LPO (lipid peroxide) contents level.Reduce animal FFA (free fatty).Reduce animal aliphatic peroxide-TBA value.Heart honor can delay the evolution process of coronary heart disease to the preventive effect that has of coronary heart disease, prevents the generation of myocardial infarction.

Five, heart honor is to patients with coronary heart disease hemodynamic, rheol influence

ZXG-4C noinvasive cardiovascular function diagnostic apparatus (production of Anhui Electronic Computer Factory) is adopted in this research, and the non-invasive detection has been carried out in the aspects such as cardiac function, vascular function, microcirculation function parameter and blood viscosity parameter before and after the honor of the patients with coronary heart disease clothes heart.

The materials and methods patients with coronary heart disease is all determined by the WHO diagnostic criteria.Male 18 examples, women 12 examples, 56.8 years old mean age, angina pectoris 15 examples, cardiac arrhythmia 10 examples, complicated hypertension 10 examples are treated in motive honor to 30 routine patients with coronary heart disease in March, 1993 to July.All detect cardiac functional parameter all in abnormal ranges before the case treatment.The course of disease is the shortest 21 days, and is the longest 15 years.Flourish each 1 bag of the heart 3 times/d, is obeyed 1 course of treatment (42d), other dilator of stopping using during the treatment altogether.Use ZXG-4C noinvasive cardiovascular function diagnostic apparatus before and after the treatment, from hemodynamic Research on The Rheology angle, to patient's cardiac function, vascular function, microcirculation function and blood viscosity parameter detect and verify.

The result as seen from Table 19, careful flourish treatment back patient's pulse frequency (PR), the spray blood impedance (VER) of left chamber, myocardial oxygen consumption (HOV) all significantly slows down or reduce (P＜0.05 or P＜0.005); Whenever the stroke volume of fighting (SV), heartbeat index (SWI), cardiac index (CI), the effective pump power in left chamber (VPE), left ventricle energy effective utilization rate (EWK), arteria coronaria are fought perfusion pressure (CCP), myocardial blood for consumption rate (CMBR) be significantly increased (P＜0.05 or P＜0.01 or P＜0.001).As seen from Table 20, careful flourish treatment back patient's pulmonary artery pressure (PAP), pulmonary vascular resistance (PAR), blood vessel elasticity flare factor (FEX), week resistance (TPR) always, the equal highly significant of standard week resistance (SPR) reduce (P＜0.005 or P＜0.001).As seen from Table 21, careful flourish treatment back patient's whole blood viscosity and reduced blood viscosity all have remarkable reduction (P＜0.05 or P＜0.01).As seen from Table 22, patient's microcirculation turnover rate (MHR) microcirculation half update time (MRT), microcirculation mean residence time (MST) all significantly reduce (P＜0.05 or P＜0.01) after the careful flourish treatment.

The honor of table 19 heart is to the influence of heart function parameter (x ± s)

Project	Normal value	Before the treatment	After the treatment	P
					PR	70 ± 10 times/minute	71.17±1.987	68.6±1.947	＜0.005
SV	80-90ml/L	71.85±1.98	92.31±1.76	＜0.05
					SWI	70-90Gm/b/m 2	68.78±1.872	82.035±1.192	＜0.05
CI	3-7L/min/m 2	2.840±0.227	3.757±0.159	＜0.01
					VPE	1.8kg/b	1.756±0.161	2.027±0.0635	＜0.05
HOV	21.85-40.79ml/min	41.48±1.923	39.63±1.771	＜0.05
					EWK	0.28-0.30	0.2739±0.0073	0.2935±0.07739	＜0.05
VER	160-220dyn.s.cm 2	230.26±7.50	1.883±7.49	＜0.005
					CCP	6.65-9.31kpa	6.057±0.663	8.037±0.543	＜0.001
CMBR	≥1	0.8307±0.0126	1.144±0.0123	＜0.001

The honor of table 20 heart is to the influence of blood vessel parameter (x ± s)

Project	Normal value	Before the treatment	After the treatment	P
					FEK	0.35-0.55	0.2424±0.0263	0.407±0.053	＜0.005
PAP	2-4kpa	4.670±0.1287	2.633±0.08436	＜0.005
					PAR	100-300dyn.s.cm -5	303.87±43.64	164.206±26.5	＜0.005
TPR	800-1300dyn.s.cm -5	1569.5±128.908	1191.1±58.54	＜0.005
					SPR	900-1400dyn.s.cm -5	1565.2±120.146	1135.9±63.726	＜0.005

The honor of table 21 heart is to the influence of blood viscosity parameter (x ± s)

Project	Normal value	Before the treatment	After the treatment	P
					η	3-4mpa.s	4.7501±0.0078	3.2723±0.1298	＜0.05
ηr	3-4mpa.s	4.367±0.434	3.395±0.164	＜0.01

The honor of table 22 heart is to the influence of circulatory function parameter (x ± s)

Project	Normal value	Before the treatment	After the treatment	P
					MHR	0.04-0.08	0.06628±0.01973	0.0461±0.00202	＜0.05
MRY	10-20S	24.895±2.7209	18.257±1.604	＜0.05
					MST	15-30S	33.46±2.48	23.404±1.429	＜0.02

Brief summary

Can improve the rich perfusion pressure (CCP) of coronary artery, myocardial oxygen consumption is reduced, myocardial blood recovers normal for the consumption rate, and myocardium blood-pumping function obviously improves.Heart honor may be relevant with its improvement cardiac muscle biochemical metabolism to cardiac pump function mechanism.Heart honor can reduce left chamber pump blood impedance (VER), lung A presses (PAP), total week resistance (TPR) etc., thereby the improvement of prompting cardiac pump function is also relevant with its blood vessel dilating effect.Heart honor can reduce whole blood viscosity and reduction whole blood viscosity and microcirculation improvement function.

Claims (8)

1, a kind of Chinese medicine composition that is used for the treatment of cardiovascular disease, make by following raw material by weight:

Radix Astragali 30-120 Radix Rehmanniae 18-80 12-60 Radix Ophiopogonis

Fructus Schisandrae Chinensis 6-40 Radix Paeoniae Rubra 18-72 Ramulus Cinnamomi 12-60.

2,, it is characterized in that the weight portion of described raw material is according to the Chinese medicine composition that is used for the treatment of cardiovascular disease of claim 1:

Radix Astragali 40-90 Radix Rehmanniae 25-55 16-40 Radix Ophiopogonis

Fructus Schisandrae Chinensis 12-30 Radix Paeoniae Rubra 25-50 Ramulus Cinnamomi 16-40.

3,, it is characterized in that the weight portion of described raw material is according to the Chinese medicine composition that is used for the treatment of cardiovascular disease of claim 2:

Radix Astragali 50-70 Radix Rehmanniae 30-45 20-30 Radix Ophiopogonis

Fructus Schisandrae Chinensis 12-25 Radix Paeoniae Rubra 30-45 Ramulus Cinnamomi 20-30.

4, according to each Chinese medicine composition among the claim 1-3, wherein said cardiovascular disease is a coronary heart disease.

5, according to each Chinese medicine composition among the claim 1-3, wherein said cardiovascular disease is a cardiomyopathy.

6,, be characterised in that it is any peroral dosage form that is suitable for clinically according to each Chinese medicine composition among the claim 1-3.

7, the method for each Chinese medicine composition among the preparation claim 1-3 comprises described raw material water is decocted one or many, and collecting decoction filters, and filtrate decompression is condensed into fluid extract, and drying is granulated again.

8, the method for each Chinese medicine composition among the preparation claim 1-3 comprises described raw material water is decocted one or many that collecting decoction filters, and concentrates, and makes oral liquid.