CN101411813B - Use of Chinese medicinal composition in preparing medicament for treating chronic systolic heart failure - Google Patents

Use of Chinese medicinal composition in preparing medicament for treating chronic systolic heart failure Download PDF

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CN101411813B
CN101411813B CN2007101632085A CN200710163208A CN101411813B CN 101411813 B CN101411813 B CN 101411813B CN 2007101632085 A CN2007101632085 A CN 2007101632085A CN 200710163208 A CN200710163208 A CN 200710163208A CN 101411813 B CN101411813 B CN 101411813B
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安军永
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Beijing Yiling Pharmaceutical Co ltd
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Hebei Yiling Pharmaceutical Research Institute Co Ltd
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Abstract

The invention provides application of a traditional Chinese medicine composition in preparing a medicine for treating chronic retractable heart failure. The traditional Chinese medicine composition consists of twelve traditional Chinese medicines including ginseng, dogwood and nard, and has the efficacies of supplementing qi, nourishing yin, activating blood, dredging collaterals, clearing heart fire away and tranquillizing; and clinical trials prove that the medicine composition has good curative effect in treating chronic retractable heart failure.

Description

The application of a kind of Chinese medicine composition in preparation treatment systolic heart failure medicine
Technical field
The present invention relates to the application of a kind of Chinese medicine composition in preparation treatment systolic heart failure medicine, belong to the Chinese medicine application.
Background technology
Heart failure is a kind of clinical syndrome of complexity, is that any reason causes that cardiac structure and dysfunction cause cardiac pumping can not satisfy tissue metabolism's demand, or heart only could the normal pathological and physiological condition of pump blood under ventricular filling pressure rising situation.(core that declines prestige. the present Research of systolic heart failure. the special journal of the national doctor in self-important south, the 17th the 1st phase of volume of March in 2004)
The fundamental mechanism that development takes place heart failure is a remodeling ventricle, causes ventricular pump blood hypofunction, is that a kind of sexually transmitted disease (STD) of carrying out becomes, in case take place, later on even without new myocardial damage, clinically is in the stabilization sub stage, but self continuous progress still.In recent years, the western medical treatment systolic heart failure has had new treatment standard.The prolonged application angiotensin-convertion enzyme inhibitor, the patient of stable disease, share beta-blocker, add in case of necessity with aldosterone antagonists, digitalis preparation (yellow being good for, Xu Qiuxiang, single jasmine. therapy of combining Chinese and Western medicine systolic heart failure 42 examples. practical tcm internal medicine magazine, 2007 the 21st the 2nd phases of volume).But the treatment side effect of Western medicine is bigger, and Chinese medicine is being obtained certain achievement aspect the treatment systolic heart failure in recent years.Heart failure belongs to categories such as the traditional Chinese medical science " heart failure disease ", " cardiopalmus ", " obstruction of qi in the chest and cardialgia ", and its cause of disease, pathogenesis are the sick heart disease in place, and the cloudy consumption of the gas of the heart is hindered, and the deficiency of vital energy promotes unable, and deficiency of YIN venation is unfavorable, and hematogenous blockage causes stagnation of heart-blood.Medicine of the present invention has supplementing QI and nourishing YIN, promoting blood circulation to remove obstruction in the collateral, and the effect of clearing away heart-fire for tranquillization is used for the treatment of systolic heart failure clinically and has obtained curative effect preferably.
Chinese patent ZL 02146572.X discloses a kind of pharmaceutical composition for the treatment of Coronary heart disease ventricular early throb and preparation method thereof.The application of unexposed this medicine composite for curing systolic heart failure of this patent, the present invention have been done further research back and have been confirmed that Chinese medicine composition of the present invention is to treating systolic heart failure effectively on the basis of this patented technology.The disclosed content of Chinese patent ZL 02146572.X quotes in full at this.
Summary of the invention
The invention provides the application of a kind of Chinese medicine composition in preparation treatment systolic heart failure medicine, it is characterized in that this Chinese medicine composition is made by following bulk drugs:
Radix Ginseng 45-180 part, Radix Ophiopogonis 50-200 part, Fructus Corni 125-450 part, Radix Salviae Miltiorrhizae 125-450 part, Semen Ziziphi Spinosae (parched) 95-400 part, Herba Taxilli 95-400 part, Radix Paeoniae Rubra 45-200 part, Eupolyphaga Seu Steleophaga 35-150 part, Radix Et Rhizoma Nardostachyos 45-200 part, Rhizoma Coptidis 25-90 part, Fructus Schisandrae Sphenantherae 35-150 part, Os Draconis 75-300 part;
The weight ratio of crude drug is preferably in the Chinese medicine composition of the present invention:
89 parts of Radix Ginsengs, 112 parts of Radix Ophiopogonis, 224 parts of Fructus Corni, 224 parts of Radix Salviae Miltiorrhizaes, 186 parts of Semen Ziziphi Spinosae (parched)s, 186 parts of Herba Taxillis, 89 parts of Radix Paeoniae Rubra, 75 parts of Eupolyphaga Seu Steleophagas, 89 parts of Radix Et Rhizoma Nardostachyos, 45 parts of Rhizoma Coptidis, 67 parts of Fructus Schisandrae Sphenantheraes, 149 parts of Os Draconis;
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
45 parts of Radix Ginsengs, 112 parts of Radix Ophiopogonis, 224 parts of Fructus Corni, 225 parts of Radix Salviae Miltiorrhizaes, 186 parts of Semen Ziziphi Spinosae (parched)s, 186 parts of Herba Taxillis, 89 parts of Radix Paeoniae Rubra, 45 parts of Radix Et Rhizoma Nardostachyos, 35 parts of Eupolyphaga Seu Steleophagas, 45 parts of Rhizoma Coptidis, 67 parts of Fructus Schisandrae Sphenantheraes, 149 parts of Os Draconis;
The weight ratio of crude drug also is preferably in the Chinese medicine composition of the present invention:
90 parts of Radix Ginsengs, 135 parts of Radix Ophiopogonis, 270 parts of Fructus Corni, 200 parts of Radix Salviae Miltiorrhizaes, 150 parts of Semen Ziziphi Spinosae (parched)s, 150 parts of Herba Taxillis, 100 parts of Radix Paeoniae Rubra, 100 parts of Eupolyphaga Seu Steleophagas, 95 parts of Radix Et Rhizoma Nardostachyos, 60 parts of Rhizoma Coptidis, 75 parts of Fructus Schisandrae Sphenantheraes, 150 parts of Os Draconis;
In the application of the present invention, preparation technology that can be routinely (such as model Bi Ting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record) handle the crude drug of Chinese medicine composition of the present invention to obtain its active component, preferably, the active component of this Chinese medicine composition can be made by the following step:
A) people participates in 8 times of amount 70% alcohol reflux three times, and merge extractive liquid, filters, and concentrates, and oven dry is ground into fine powder;
B) Fructus Schisandrae Sphenantherae, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Et Rhizoma Nardostachyos add 8 times of amount 70% alcohol reflux 3 times jointly, and merge extractive liquid, filters, and reclaims ethanol;
C) Eupolyph aga sinesis Walker is broken into fine powder;
D) Radix Ophiopogonis, Semen Ziziphi Spinosae (parched), Herba Taxilli, Radix Paeoniae Rubra, Os Draconis decoct with water 2 times, and merge extractive liquid, filters, with the extracting solution merging behind the step b) recovery ethanol, simmer down to extractum;
E) with step d) gained extractum, add the fine drug powder of step c) gained, oven dry is ground into fine powder, adds step a) gained fine drug powder, and mixing promptly gets this Chinese medicine composition active component.
The invention also discloses that to contain above-mentioned Chinese medicine composition be capsule, tablet, electuary, powder, soft capsule, drop pill or oral liquid as the pharmaceutical preparation of active component.
In the Chinese medicine composition of the present invention, as the latin name of the crude drug of active component and processing method thereof from " Chinese medicine voluminous dictionary " (in July, 1977, front page, Shanghai science tech publishing house) and " Chinese pharmacopoeia (version in 2005, Chemical Industry Press).
Chinese medicine composition of the present invention can also be routinely preparation technology, for example, the preparation process of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record, make the acceptable any conventional dosage form of pharmaceutics, for example capsule, tablet, electuary, powder, soft capsule, drop pill or oral liquid etc.For described dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.
The consumption of Chinese medicine composition of the present invention by active component crude drug gross weight, is 7-28 gram/day, but takes every day once, preferably divides and takes for 2-4 time.
The specific embodiment
Following embodiment is used to illustrate the preparation of Chinese medicine composition of the present invention, but it can not constitute any restriction to scope of the present invention.
Embodiment 1
For the ease of the application of this Chinese medicine composition, this Chinese medicine composition is prepared as capsule
Write out a prescription: Radix Ginseng 89 restrains, restrain Radix Ophiopogonis 112, Fructus Corni 224 restrains, Radix Salviae Miltiorrhizae 224 restrains, Semen Ziziphi Spinosae (parched) 186 restrains, Herba Taxilli 186 restrains, Radix Paeoniae Rubra 89 restrains, Eupolyphaga Seu Steleophaga 75 restrains, Radix Et Rhizoma Nardostachyos 89 restrains, Rhizoma Coptidis 45 restrains, Fructus Schisandrae Sphenantherae 67 restrains, Os Draconis 149 restrain
Preparation method:
A) people participates in 8 times of amount 70% alcohol reflux three times, and 3 hours for the first time, each 2 hours later on, merge extractive liquid, filtered, and concentrates, and oven dry is ground into 80 order fine powders;
B) Fructus Schisandrae Sphenantherae, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Et Rhizoma Nardostachyos add 8 times of amount 70% alcohol reflux 3 times jointly, and merge extractive liquid, filters, and reclaims ethanol;
C) Eupolyph aga sinesis Walker is broken into 80 order fine powders;
D) Radix Ophiopogonis, Semen Ziziphi Spinosae (parched), Herba Taxilli, Radix Paeoniae Rubra, Os Draconis decoct with water 2 times, and merge extractive liquid, filters, with the extracting solution merging behind the step b) recovery ethanol, simmer down to extractum;
E) with step d) gained extractum, add the fine drug powder of step c) gained, oven dry is ground into 80 order fine powders, adds step a) gained fine drug powder, mixing, 1000 capsules of packing into.
Usage and consumption: oral.One time 2~4,3 times on the one.
The test example
The clinical trial of traditional Chinese medicine composition for treating systolic heart failure of the present invention.
For illustrating the clinical efficacy of traditional Chinese medicine composition for treating systolic heart failure of the present invention, use the capsule (to call medicine of the present invention in the following text) that makes by embodiment 1 method to carry out following clinical trial.
1. physical data
Hebei Yi Ling hospital accepts for medical treatment altogether from year June in January, 2006-2007 and expands cardiopathia, coronary heart disease heart failure 244 examples, through clinical manifestation, surface electrocardiogram, ambulatory electrocardiogram, rabat, echocardiography, arrange attached rheumatic heart disease, congenital heart disease and other cardiomyopathy, and through the endocardium cardiac muscle close inspection and (or) coronary arteriography makes a definite diagnosis.According to NYHA grade scale scoring, III level heart merit 201 examples wherein, II level heart merit 43 examples, male's 140 examples, women's 104 examples are divided into treatment group and matched group at random.122 examples (male 70 examples, women 52 examples) are organized in treatment, age 50-82 year, II level heart merit 23 examples, III level heart merit 99 examples.Matched group 122 examples (male 68 examples, women 54 examples), age 48-80 year, II level heart merit 24 examples, III level heart merit 98 examples.Two groups of above each indexs of patient are compared there was no significant difference.
2. Therapeutic Method
Matched group adopts rest, oxygen uptake, the diuresis of limit sodium heart tonifying, ACE inhibitor, improve conventional therapy such as myocardial blood flow.The treatment group adds on the matched group basis with medicine of the present invention (Shijiazhuang Yiling Pharmaceutical Co., Ltd's production), and each 4, every day 3 times, 14 days was 1 course of treatment.
3. efficacy determination
Through 1 course of therapy, according to the increase evaluation cardiac function of patient CO (cardiac output), SV (stroke volume), CI (cardiac index), EF (ejection fraction) and exercise tolerance.Cardiac function improves the II level or the above person of II level is produce effects.Cardiac function improves the I level for effective.Cardiac function no change or deterioration are for invalid.
4. result
4.1 cardiac function
122 examples are organized in treatment, produce effects 81 examples (66.39%), effective 39 examples (31.9%), invalid 2 examples (1.6%), total effective rate 98.29%, 122 examples in the matched group, produce effects 57 examples (46.72%), effective 38 examples (31.1%), invalid 27 examples (22.1%), total effective rate 77.82%.Treatment group obvious effective rate and total effective rate are apparently higher than matched group, through X 2Check, P<0.01.See Table 1
2 groups of cardiac function of table 1 are [example (%)] relatively
Group n Produce effects Effectively Invalid Total effective rate
Treatment group matched group 122 122 81(66.39) 57(46.72) 39(31.9) 38(31.1) 2(1.6) 27(22.1) 120(98.29) 95(77.82)
4.2 heart color doppler ultrasonography kinetocardiogram ejection fraction (EF) relatively sees Table 2
Ejection fraction changes relatively before and after 2 groups of treatments of table 2
Figure S2007101632085D00051
Group n Before the treatment After the treatment Difference
Treatment group matched group 122 122 47.30±10.76 46.93±11.30 ?53.15±10.92?50.44±11.95 ** -5.84±8.93 -3.52±8.34
Annotate:, compare P<0.05 with matched group with preceding relatively P<0.01 of treatment
4.3 toxicity treatment group viewing duration is not seen untoward reaction.
5. conclusion
Medicine of the present invention is made up of 12 flavor Chinese medicines such as Radix Ginseng, Fructus Corni, Radix Et Rhizoma Nardostachyos, has supplementing QI and nourishing YIN, promoting blood circulation to remove obstruction in the collateral, clearing away heart-fire for tranquillization, studies confirm that through modern pharmacology Radix Ginseng increases the energy reserve of depletion cardiac muscle by the protein of the depleted cardiac muscle of promotion and synthesizing of ATP.Above-mentioned clinical research shows that medicine of the present invention has good heart tonifying and improves the myocardial metabolism effect, has good curative effect for the treatment systolic heart failure.

Claims (7)

1. the application of Chinese medicine composition in preparation treatment systolic heart failure medicine is characterized in that this Chinese medicine composition is made by following bulk drugs:
Radix Ginseng 45-180 part, Radix Ophiopogonis 50-200 part, Fructus Corni 125-450 part, Radix Salviae Miltiorrhizae 125-450 part, Semen Ziziphi Spinosae (parched) 95-400 part, Herba Taxilli 95-400 part, Radix Paeoniae Rubra 45-200 part, Eupolyphaga Seu Steleophaga 35-150 part, Radix Et Rhizoma Nardostachyos 45-200 part, Rhizoma Coptidis 25-90 part, Fructus Schisandrae Sphenantherae 35-150 part, Os Draconis 75-300 part.
2. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:
89 parts of Radix Ginsengs, 112 parts of Radix Ophiopogonis, 224 parts of Fructus Corni, 224 parts of Radix Salviae Miltiorrhizaes, 186 parts of Semen Ziziphi Spinosae (parched)s, 186 parts of Herba Taxillis, 89 parts of Radix Paeoniae Rubra, 75 parts of Eupolyphaga Seu Steleophagas, 89 parts of Radix Et Rhizoma Nardostachyos, 45 parts of Rhizoma Coptidis, 67 parts of Fructus Schisandrae Sphenantheraes, 149 parts of Os Draconis.
3. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:
45 parts of Radix Ginsengs, 112 parts of Radix Ophiopogonis, 224 parts of Fructus Corni, 225 parts of Radix Salviae Miltiorrhizaes, 186 parts of Semen Ziziphi Spinosae (parched)s, 186 parts of Herba Taxillis, 89 parts of Radix Paeoniae Rubra, 45 parts of Radix Et Rhizoma Nardostachyos, 35 parts of Eupolyphaga Seu Steleophagas, 45 parts of Rhizoma Coptidis, 67 parts of Fructus Schisandrae Sphenantheraes, 149 parts of Os Draconis.
4. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:
90 parts of Radix Ginsengs, 135 parts of Radix Ophiopogonis, 270 parts of Fructus Corni, 200 parts of Radix Salviae Miltiorrhizaes, 150 parts of Semen Ziziphi Spinosae (parched)s, 150 parts of Herba Taxillis, 100 parts of Radix Paeoniae Rubra, 100 parts of Eupolyphaga Seu Steleophagas, 95 parts of Radix Et Rhizoma Nardostachyos, 60 parts of Rhizoma Coptidis, 75 parts of Fructus Schisandrae Sphenantheraes, 150 parts of Os Draconis.
5. as each described application among the claim 1-4, it is characterized in that the active component of this Chinese medicine composition is made by the following step:
A) people participates in 8 times of amount 70% alcohol reflux three times, and merge extractive liquid, filters, and concentrates, and oven dry is ground into fine powder;
B) Fructus Schisandrae Sphenantherae, Fructus Corni, Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Et Rhizoma Nardostachyos add 8 times of amount 70% alcohol reflux 3 times jointly, and merge extractive liquid, filters, and reclaims ethanol;
C) Eupolyph aga sinesis Walker is broken into fine powder;
D) Radix Ophiopogonis, Semen Ziziphi Spinosae (parched), Herba Taxilli, Radix Paeoniae Rubra, Os Draconis decoct with water 2 times, and merge extractive liquid, filters, with the extracting solution merging behind the step b) recovery ethanol, simmer down to extractum;
E) with step d) gained extractum, add the fine drug powder of step c) gained, oven dry is ground into fine powder, adds step a) gained fine drug powder, and mixing promptly gets this Chinese medicine composition active component.
6. as each described application among the claim 1-4, it is characterized in that the preparation formulation of described Chinese medicine composition is capsule, tablet, electuary, powder, drop pill or oral liquid.
7. application as claimed in claim 5 is characterized in that, the preparation formulation of described Chinese medicine composition is capsule, tablet, electuary, powder, drop pill or oral liquid.
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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1403148A (en) * 2002-10-24 2003-03-19 河北以岭医药研究院有限公司 Medicines composition for treating coronary heart disease ventricular premature beat and its prepn

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1403148A (en) * 2002-10-24 2003-03-19 河北以岭医药研究院有限公司 Medicines composition for treating coronary heart disease ventricular premature beat and its prepn

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
杨义航等.参松养心胶囊治疗慢性收缩性心力衰竭临床观察.《第三届国际络病学大会论文集》.2007,428-429. *

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