CN102416101B - Chinese medicinal composition for treating heart failure and preparation method thereof - Google Patents

Abstract

The invention provides a Chinese medicinal composition for treating heart failure. The composition includes the following herbal medicines in parts by weight: 65-185 parts of codonopsis pilosula, 65-185 parts of acanthopanax root, 65-185 parts of astragalus root, 65-185 parts of root of red-rooted salvia, 15-185 parts of turtle shell, 50-150 parts of tuckahoe, 30-130 parts of semen lepidii, 50-150 parts of dwarf lilyturf root, 30-130 parts of bitter orange and medicinal auxiliary materials. Meanwhile, the invention provides a preparation method of the Chinese medicinal composition for treating heart failure. The Chinese medicinal composition is used for treating the heart failure. The Chinese medicinal composition has the effects of overcoming the defects of the conventional formulations of medicinal broth and the like; by using a water extraction method, active ingredients with a clinical curative effect in the composition are remained; by using high-efficiency dynamic loop extraction equipment, the active ingredients are extracted to the greatest extent; and thus, the clinical curative effect of the composition is guaranteed, and the prevention and treatment effect of the composition on qi deficiency, blood stasis and water retention symptoms of the heart failure is obviously superior to those of similar medicaments.

Description

Chinese medicine composition for the treatment of heart failure and preparation method thereof

Technical field

The invention belongs to Chinese medicine preparation, particularly relate to a kind of Chinese medicine composition for the treatment of heart failure and preparation method thereof and application.

Background technology

Heart failure (heart failure) is one of clinical common serious symptom, is a kind of clinical symptom group of complexity, and be also various cardiopathic severe stage, its sickness rate is high, 5 annual survival rates and malignant tumor similar.According to World Health Organization's statistics, the sickness rate of heart failure in crowd is 1.5%-5.6%, and over-65s reaches 6.4%, and its sickness rate doubles for every ten years.According to Chinese cardiovascular health research, China's heart failure prevalence is 0.9%, China's 50 hospital medical surveys, and heart failure admission rate only accounts for cardiovascular diseases's's same period 20%, but mortality rate accounts for 40%, and prompting prognosis is serious.Along with modern medicine is to the transformation of heart failure treatment idea, its admission rate and mortality rate etc. all show downward trend, how to reduce morbidity and the mortality rate of heart failure further, improve the life quality of patient, are difficult point and the focus of control and research at present.

Heart failure belongs to the category such as motherland's medical science " cardiopalmus ", " palpitation with a distress feeling ", " the syndrome of dyspnea ", " edema ", " phlegm retention ", and the pathogenesis of modern common recognition is deficiency in origin and excess in superficiality, and deficiency in origin is based on the deficiency of vital energy, and mark is real turbid based on blood stasis, diseases caused by retention of fluid, expectorant.In heart failure pathological process, the deficiency of vital energy is this, and the stasis of blood, water, expectorant are the pathological product of deficiency of vital energy secondary, run through the whole story in the whole course of disease.We are by the retrospective analysis to nearly 20 years Chinese traditional treatment heart failure documents, domestic 30 multidigit experts distinguish the integrated analysis controlling heart failure suggestion, and the investigation of clinical epidemiology result display of Efficiency in Buildings in Tianjin Area 200 many cases patients with heart failure, blood stasis due to qi deficiency water retention card is the common pattern of syndrome of heart failure.

In recent years, the traditional Chinese medical science, to the research of primary disease, achieves considerable progress in etiology and pathogenesis, diagnosis and treatment rule, medicine and zoopery.But research in recent years also more is limited to the Pathogenesis Theory such as the deficiency of vital energy or blood stasis due to qi deficiency.In drug research, for heart failure, according to the characteristics of incidence of current clinical patients, many according to the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs under motherland's medical overall idea, adopt benefiting QI for activating blood circulation to be main, hold concurrently in the majority with promoting the flow of QI in the collateral by warming the meridian.Existing Chinese patent medicine is to the treatment of heart failure, or QI invigorating warming YANG or supplementing QI and nourishing YIN etc., and treatment emphasizes particularly on different fields, but lacks the special Chinese medicine preparation of benefiting QI for activating blood circulation diuretic effect, and therefore this Chinese medicine composition has value for clinical application and wide market application foreground.In clinical application method, mostly clinical be the usage adopting decoction, causes the liposoluble constituent of flavour of a drug, volatile ingredient to lose serious, have impact on the clinical efficacy of compound recipe.

Summary of the invention

The object of the invention is to provide a kind of Chinese medicine composition for the treatment of heart failure and preparation method thereof and application, said composition is the Chinese medicine composition of clinical prevention and treatment heart failure, this preparation method overcomes the drawback of the conventional dosage forms such as decoction, to improving the clinical symptoms of heart failure patient, reduce the mortality rate of heart failure patient.

For achieving the above object, the technical solution used in the present invention is to provide a kind of Chinese medicine composition for the treatment of heart failure, wherein: said composition includes following flavour of a drug by weight:

Radix Codonopsis 65-185, Radix Et Caulis Acanthopanacis Senticosi 65-185, Radix Astragali 65-185, Radix Salviae Miltiorrhizae 65-185, Carapax Trionycis 15-185, Poria 50-150, Semen Lepidii (Semen Descurainiae) 30-130, Radix Ophiopogonis 50-150, Fructus Aurantii 30-130, also have pharmaceutic adjuvant.

There is provided a kind of preparation method for the treatment of the Chinese medicine composition of heart failure, this Chinese medicine composition is used for the treatment of heart failure simultaneously.

Effect of the present invention is the drawback that this Chinese medicine composition overcomes the conventional dosage forms such as decoction, adopt the method for water extraction, remain in compositions the effective ingredient with clinical efficacy, adopt high-efficiency dynamic circulating extraction device, extract effective ingredient to greatest extent, ensure that its clinical efficacy, obviously similar drugs is better than to the preventive and therapeutic action of heart failure blood stasis due to qi deficiency water retention card.

Clinical efficacy result shows, after taking this Chinese medicine composition, TCM syndrome is uncomfortable in chest, chest pain, dizziness, breathe hard, extremity edema, fatigue and weak, cardiopalmus, pale tongue with thin fur be white, deep-thready pulse or slow etc. meets blood stasis due to qi deficiency water retention, and to demonstrate,prove all the equal tool of index effective; Self more all have clear improvement in body of the tongue, tongue fur, pulse condition all index group; Compare with matched group after tcm syndrome all index treatment, treatment group total effective rate and cure-remarkable-effectiveness rate are all obviously better than matched group; After treatment, heart failure function score total effective rate and cure-remarkable-effectiveness rate treatment group are all higher than matched group, and after treating, tcm syndrome total effective rate and cure-remarkable-effectiveness rate treatment group are apparently higher than matched group.Illustrate that its clinical therapeutic efficacy of this Chinese medicine composition is obviously better than existing similar drugs.

The safetyandsideeffect aspect of this Chinese medicine composition, zoopery and clinical observation on the therapeutic effect all show, and this Chinese medicine composition is safe and reliable, have no adverse reaction.

Detailed description of the invention

Chinese medicine composition for the treatment of heart failure of the present invention and preparation method thereof and application are described in detail in conjunction with the embodiments.

Preclinical pharmacodynamics of San experimentation discloses the mechanism of this Chinese medicine composition prevention and therapy heart failure:

Chinese medicine composition extractum therapeutic administratp forms the cardiac systolic function of the rat of chronic heart failure gradually after one month to Banded Rats anterior descending coronary, diastolic function, heart configuration, hemodynamics all have obvious optimum regulating action; Gastric infusion, obviously can reduce Angiotensin II, the level of ET of Heart Failure Wistar Rats, thus suppress neuroendocrine activation; Chinese medicine composition extractum repeatedly gastric infusion all has improvement in various degree to the Left Ventricular Ejection Fraction of Heart Failure Wistar Rats, LVED (Left Ventricular End Systolic Dimension), Left ventricular mass index; In a word, this Chinese medicine composition can change AngII, ET level by regulating, and then plays the effect reversing Ventricular Remodeling.

The present invention is according to traditional Chinese medical science traditional theory, dissect the symptom of heart failure blood stasis due to qi deficiency water retention card: this type of patient apart from outside uncomfortable in chest, weakness with emaciation weak breath, extremity edema, fatigue and weak, most and be seen in that as dark in lip, dizziness, chest pain, extremity or general edema, cardiopalmus, pale tongue with thin fur are white, body of the tongue ecchymosis petechia, deep-thready pulse or disease that is slow or that tie for essential resistance of turbid phlegm.Heart failure belongs to the category such as motherland's medical science " cardiopalmus ", " palpitation with a distress feeling ", " the syndrome of dyspnea ", " edema ", " phlegm retention ".The etiology and pathogenesis majority of heart failure is deficiency in origin and excess in superficiality, and deficiency in origin is based on the deficiency of vital energy, and mark is real turbid based on blood stasis, diseases caused by retention of fluid, expectorant.In heart failure pathological process, the deficiency of vital energy is this, and the stasis of blood, water, expectorant are the pathological product of deficiency of vital energy secondary, run through the whole story in the whole course of disease.Accordingly according to the feature that primary disease causes a disease, establish Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, the principle for the treatment of of diuretic.

This Chinese medicine composition reef knot based on the SHENGMAI SAN of golden Zhang Yuansu closes clinical experience addition or subtraction of changes and forms this Chinese medicine composition.SHENGMAI SAN is made up of Radix Ophiopogonis, Radix Ginseng, Fructus Schisandrae Chinensis.Function supplementing QI and nourishing YIN, the raw arteries and veins of arresting sweating.Cure mainly impairment of both QI and YIN, limbs asthenia, lazy speech of breathing hard, xerostomia is done thirsty, hyperhidrosis deficient pulse; The lung being damaged by lasted cough, QIYINLIANGXU, the few expectorant of dry cough, lack of appetite is become thin, deficiency-heat dyspnea with rapid and short breath, spontaneous perspiration of breathing hard, dry mouth and tougue, and faint pulse is thin and delicate; Or after skin infection bursts, pus goes out many, and gas is cloudy all empty, and xerostomia dyspnea with rapid and short breath, dysphoria, dosses not peaceful.

This Chinese medicine composition is according to the pathogenic characteristic of clinical common heart failure patient: deficiency in origin and excess in superficiality, and deficiency in origin is based on the deficiency of vital energy, and mark is real turbid based on blood stasis, diseases caused by retention of fluid, expectorant.This Chinese medicine composition adopts the method for Yiqi and vein recovery, heart tonifying, diuretic, is aided with the product of promoting diuresis to eliminate damp pathogen, blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, nourishing YIN for suppressing the hyperactive YANG, helps with the product of the raw Feng of yin nourishing, regulating the flow of QI to ease the stomach.This Chinese medicine composition is on the basis of Yiqi and vein recovery principle for the treatment of, the product of compatibility promoting diuresis to eliminate damp pathogen, nourshing blood and promoting blood circulation, nourishing YIN for suppressing the hyperactive YANG, regulating the flow of QI to ease the stomach, its compatibility is reasonable, and prescription is rigorous, has Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, effect of diuretic, for chronic heart failure, rheumatic heart disease and myocardial infarction, or old people's cardiac insufficiency.

Chinese medicine composition of the present invention is made up of Radix Codonopsis, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Radix Salviae Miltiorrhizae, Carapax Trionycis, Poria, Semen Lepidii (Semen Descurainiae), Radix Ophiopogonis, Fructus Aurantii.

Radix Codonopsis invigorating the spleen and replenishing QI in Chinese medicine composition, raw Feng nourish blood, Radix Astragali invigorating QI to consolidate the body surface resistance, diuresis, the similar Radix Ginseng of Radix Et Caulis Acanthopanacis Senticosi merit, and air making-up and spleen enlivening, the kidney warming are calmed the nerves, and three medicines are monarch drug altogether;

Radix Salviae Miltiorrhizae nourshing blood and promoting blood circulation, Carapax Trionycis nourishing YIN for suppressing the hyperactive YANG, Semen Lepidii (Semen Descurainiae) eliminating pathogen from the lung for relieving asthma, line water detumescence, Poria inducing diuresis to remove edema, spleen invigorating eliminating dampness by diuresis, mind calming are ministerial drug altogether;

The raw Feng of yin nourishing Radix Ophiopogonis, Fructus Aurantii regulating the flow of QI to ease the stomach, the stagnant relieving distension of row are adjuvant drug altogether.

Full side nine taste, square addition or subtraction of changes based on SHENGMAI YIN, consumption is gentle, and full side's compatibility is rigorous, and cautiously grasping pathogenesis, plays Yiqi and vein recovery altogether, regulating the flow of QI to ease the stomach, heart tonifying, the merit of diuretic.

This Chinese medicine composition function: Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, diuretic.

Cure mainly: heart failure blood stasis due to qi deficiency water retention is demonstrate,proved.This type of patient apart from outside uncomfortable in chest, weakness with emaciation weak breath, extremity edema, fatigue and weak, most and be seen in that as dark in lip, dizziness, chest pain, extremity or general edema, cardiopalmus, pale tongue with thin fur are white, body of the tongue ecchymosis petechia, deep-thready pulse or disease that is slow or that tie for essential resistance of turbid phlegm.

Chinese medicine composition of the present invention includes following flavour of a drug composition:

Be made up of following flavour of a drug by weight:

Radix Codonopsis 65-185, Radix Et Caulis Acanthopanacis Senticosi 65-185, Radix Astragali 65-185, Radix Salviae Miltiorrhizae 65-185, Carapax Trionycis 15-185, Poria 50-150, Semen Lepidii (Semen Descurainiae) 30-130, Radix Ophiopogonis 50-150, Fructus Aurantii 30-130, also have pharmaceutic adjuvant.

Described Radix Codonopsis means the one of Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, Radix Pseudostellariae.

Described Radix Salviae Miltiorrhizae flavour of a drug can use the one of Semen Persicae, Flos Carthami to substitute; Described Radix Astragali flavour of a drug can use the one of Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, Radix Pseudostellariae to substitute; Described Radix Et Caulis Acanthopanacis Senticosi flavour of a drug can use the one of Cortex Acanthopancis, Cortex Periplocae to substitute.

Contained by Chinese medicine composition of the present invention, pharmaceutic adjuvant can use dextrin, starch, lactose etc., and the best is dextrin.

The multi-functional extraction concentrator of dynamic circulation of the preparation method employing of Chinese medicine composition of the present invention, concrete operation step is as follows:

A) water extraction: the Chinese medicine composition that above-mentioned flavour of a drug are formed is put in water extraction tank, add the 6-12 times of water yield of described Chinese medicine composition by weight, the best is soak by water 2-3 time of 8 times amount, best is decoction 2 times, each time is 1-4 hour, and the best is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa, collecting decoction, filters;

Or

A ") water extraction: the Carapax Trionycis described in Chinese medicine composition that just above-mentioned flavour of a drug are formed is put in water extraction tank; add 6-12 times of water gaging of Carapax Trionycis by weight, the best is the soak by water 1 time of 8 times amount, and the time is 1-4 hour; the best is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa; Chinese medicine composition Radix Codonopsis according to claim 1, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Radix Salviae Miltiorrhizae, Poria, Semen Lepidii (Semen Descurainiae), Radix Ophiopogonis, Fructus Aurantii are put in the water extraction tank that aforementioned Carapax Trionycis puts, add 6-12 times of water gaging of described Chinese medicine composition by weight, the best is soak by water 2-3 time of 8 times amount, the best is 2 times, each time is 1-4 hour, and the best is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa, merge decocting liquid, filter;

Or

A) water extraction: the Radix Codonopsis in the Chinese medicine composition form above-mentioned flavour of a drug, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Radix Salviae Miltiorrhizae, Poria, Semen Lepidii (Semen Descurainiae), Radix Ophiopogonis, Fructus Aurantii are put in water extraction tank, add 6-12 times of water gaging of described Chinese medicine composition by weight, the best is soak by water 2-3 time of 8 times amount, the best is 2 times, each time is 1-4 hour, and the best is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa, collecting decoction, filters;

B) concentrated: put in concentration tank by a) step water extraction filtrate, be concentrated into thick paste, thickening temperature is 50-100 DEG C;

C) precipitate with ethanol: concentrated solution is put in Alcohol-settling tank, slowly add 95% ethanol and make its alcohol content reach 50%-75%, the best is 65%, and after fully stirring, leave standstill 8-20 hour, the best is 12 hours, filters;

D) ethanol is reclaimed: filtrate is put in reclaim under reduced pressure tank, decompression recycling ethanol, and being concentrated into relative density is 1.10-1.20, the best is 1.15, the thick paste that temperature is 85 DEG C, vacuum-0.06-0.09Mpa, thickening temperature 40-100 DEG C, the best is 50-65 DEG C, obtains water extract.

Or

After b) step concentrates, do not carry out c) step precipitate with ethanol and d) step recovery ethanol, directly carry out e) step and pulverize.

E) pulverize: by thick paste vacuum drying concentrated in d) step, vacuum is-0.06Mpa ~ 0.09Mpa, and temperature is 50-100 DEG C, and the best is 60 DEG C, is ground into fine powder 80-120 order; Or turtle ' s carapace powder according to claim 1 is broken into fine powder 80-120 order, joined by Carapax Trionycis fine powder in thick paste concentrated in d) step, mix homogeneously, incorporation time is 10-50 minute, and the best is 30 minutes; Vacuum drying, vacuum is-0.06Mpa ~ 0.09Mpa, and temperature is 50-100 DEG C, and the best is 60 DEG C, is ground into fine powder 80-120 order;

F) preparation of tablet:

A ') above-mentionedly will add the pharmaceutic adjuvant of the 50%-100% containing fine powder amount in e) step fine powder, pharmaceutic adjuvant can use dextrin, starch, lactose etc., and the best is the dextrin of 75.5%; Sieve, mix homogeneously, incorporation time is 10-50 minute, and the best is 30 minutes;

B ') by the fine powder of mixing homogeneously with pharmaceutic adjuvant 92% alcohol granulation, add the 30%-55% that amount of alcohol is fine powder amount, the best is 43%, and Granulation time is 3-10 minute;

C ') by b ') wet granular in step is laid in drying baker and carries out drying, overlay thickness is 1-2cm, and baking temperature is 50-100 DEG C;

D ') by dried granule granulate, be 14 object screen cloth granulate with order number;

E ') add 0.3%-0.6% magnesium stearate, mix homogeneously by whole good granule;

F ') make tablet with tabletting machine, every sheet 0.4-0.6g, the best is 0.5g.

Chinese medicine composition of the present invention:

1) (" Chinese Pharmacopoeia " version in 2010 annex I D) is met to every regulation relevant under tablet item;

2) limit test of microbe meets the regulation of Chinese Pharmacopoeia;

3) under room temperature is preserved, the effect duration of this Chinese medicine composition is 12 months.

In the f step of Chinese medicine composition preparation method of the present invention, extract can be made pill, powder, granule, mixture, soft extract, capsule or syrup.Chinese medicine composition prepared by described preparation method, is used for the treatment of heart failure.

Embodiment 1

Radix Codonopsis 65, Radix Et Caulis Acanthopanacis Senticosi 65, the Radix Astragali 65, Radix Salviae Miltiorrhizae 65, Carapax Trionycis 65, Poria 50, Semen Lepidii (Semen Descurainiae) 30, Radix Ophiopogonis 50, Fructus Aurantii 30, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 2

Radix Codonopsis 185, Radix Et Caulis Acanthopanacis Senticosi 185, the Radix Astragali 185, Radix Salviae Miltiorrhizae 185, Carapax Trionycis 185, Poria 150, Semen Lepidii (Semen Descurainiae) 130, Radix Ophiopogonis 150, Fructus Aurantii 130, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 3

Radix Codonopsis 125, Radix Et Caulis Acanthopanacis Senticosi 125, the Radix Astragali 125, Radix Salviae Miltiorrhizae 125, Carapax Trionycis 125, Poria 100, Semen Lepidii (Semen Descurainiae) 83.3, Radix Ophiopogonis 100, Fructus Aurantii 83.3, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 4

Radix Codonopsis 175, Radix Et Caulis Acanthopanacis Senticosi 175, the Radix Astragali 175, Radix Salviae Miltiorrhizae 175, Carapax Trionycis 175, Poria 130, Semen Lepidii (Semen Descurainiae) 110, Radix Ophiopogonis 130, Fructus Aurantii 110, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 5

Radix Codonopsis 75, Radix Et Caulis Acanthopanacis Senticosi 75, the Radix Astragali 75, Radix Salviae Miltiorrhizae 75, Carapax Trionycis 75, Poria 60, Semen Lepidii (Semen Descurainiae) 40, Radix Ophiopogonis 60, Fructus Aurantii 40, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 6

Radix Codonopsis 145, Radix Et Caulis Acanthopanacis Senticosi 145, the Radix Astragali 145, Radix Salviae Miltiorrhizae 135, Carapax Trionycis 145, Poria 110, Semen Lepidii (Semen Descurainiae) 90, Radix Ophiopogonis 110, Fructus Aurantii 90, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 7

Radix Codonopsis 115, Radix Et Caulis Acanthopanacis Senticosi 115, the Radix Astragali 105, Radix Salviae Miltiorrhizae 115, Carapax Trionycis 105, Poria 90, Semen Lepidii (Semen Descurainiae) 70, Radix Ophiopogonis 90, Fructus Aurantii 70, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 8

Radix Codonopsis 65, Radix Et Caulis Acanthopanacis Senticosi 65, the Radix Astragali 65, Radix Salviae Miltiorrhizae 65, Carapax Trionycis 15, Poria 50, Semen Lepidii (Semen Descurainiae) 30, Radix Ophiopogonis 50, Fructus Aurantii 30, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 9

Radix Codonopsis 185, Radix Et Caulis Acanthopanacis Senticosi 185, the Radix Astragali 185, Radix Salviae Miltiorrhizae 185, Carapax Trionycis 75, Poria 150, Semen Lepidii (Semen Descurainiae) 130, Radix Ophiopogonis 150, Fructus Aurantii 130, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 10

Radix Codonopsis 125, Radix Et Caulis Acanthopanacis Senticosi 125, the Radix Astragali 125, Radix Salviae Miltiorrhizae 125, Carapax Trionycis 41.7, Poria 100, Semen Lepidii (Semen Descurainiae) 83.3, Radix Ophiopogonis 100, Fructus Aurantii 83.3, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 11

Radix Codonopsis 175, Radix Et Caulis Acanthopanacis Senticosi 175, the Radix Astragali 175, Radix Salviae Miltiorrhizae 175, Carapax Trionycis 65, Poria 130, Semen Lepidii (Semen Descurainiae) 110, Radix Ophiopogonis 130, Fructus Aurantii 110, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 12

Radix Codonopsis 75, Radix Et Caulis Acanthopanacis Senticosi 75, the Radix Astragali 75, Radix Salviae Miltiorrhizae 75, Carapax Trionycis 25, Poria 60, Semen Lepidii (Semen Descurainiae) 40, Radix Ophiopogonis 60, Fructus Aurantii 40, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 13

Radix Codonopsis 145, Radix Et Caulis Acanthopanacis Senticosi 145, the Radix Astragali 145, Radix Salviae Miltiorrhizae 135, Carapax Trionycis 55, Poria 110, Semen Lepidii (Semen Descurainiae) 90, Radix Ophiopogonis 110, Fructus Aurantii 90, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

Embodiment 14

Radix Codonopsis 115, Radix Et Caulis Acanthopanacis Senticosi 115, the Radix Astragali 105, Radix Salviae Miltiorrhizae 115, Carapax Trionycis 35, Poria 90, Semen Lepidii (Semen Descurainiae) 70, Radix Ophiopogonis 90, Fructus Aurantii 70, also has pharmaceutic adjuvant.By above prescription ratio, obtain tablet according to the preparation method of above-mentioned Chinese medicine composition.

By above each prescription proportion, extract according to method a), b), c), d), e) in above-mentioned Chinese medicine composition preparation method, then can be made into capsule as follows:

F) preparation of capsule:

A ') pharmaceutic adjuvant of the 50%-100% containing fine powder amount will be added in above-mentioned e) step fine powder, pharmaceutic adjuvant can use the one of dextrin, starch, lactose, and the best is the dextrin of 75.5%; Sieve, mix homogeneously, incorporation time is 10-50 minute, and the best is 30 minutes;

B ') by the fine powder of mixing homogeneously with pharmaceutic adjuvant 92% alcohol granulation, add the 30%-55% that amount of alcohol is fine powder amount, the best is 43%, and Granulation time is 3-10 minute;

C ') by b ') wet granular in step is laid in drying baker and carries out drying, overlay thickness is 1-2cm, and baking temperature is 50-100 DEG C;

D ') by dried granule granulate, be 14 object screen cloth granulate with order number;

E ') encapsulated, every capsules dress 0.4-0.6g, the best is 0.5g.

Extract according to method a), b), c), d), e) in above-mentioned Chinese medicine composition preparation method, a '), b ') method mixing, granulate, c '), d ') dry, the granulate of method, can be made into granule; Or directly packaging makes powder; Add water dosing, fill, sterilizing can be made into mixture; Add that syrup is mixed, sterilizing, cannedly can be made into syrup; Add refined honey conjunction a small bay in a river and can be made into honeyed pill; Extract and fine drug powder add water or sweet water pill can be made into the watered pill, water-honeyed pill; Or general reference makes concentrated pill, paste pill; Extract according to method a), b), c), d), e) of above-mentioned Chinese medicine composition, a ') method mixing, add the mixing of appropriate Mel and can be made into soft extract.

Above with embodiment 3,10 for optimum implementation.

Its method of quality control of Chinese medicine composition with prepared by most preferred embodiment 3,10:

A) every regulation (" Chinese Pharmacopoeia " version in 2010 annex ID) relevant under tablet item should be met.

B) limit test of microbe meets the regulation of Chinese Pharmacopoeia.

C) under room temperature is preserved, the effect duration of this Chinese medicine composition is 12 months.

The toxicity test of this Chinese medicine composition

1, acute toxicity test:

Chinese medicine composition extractum presses 150g/kg to mouse stomach administration, occurs without dead, has no movable abnormal.Be equivalent to 3 times/day of quantity, 6 pieces/times, everyone calculates more than 800 times by 50kg.Chinese medicine composition extractum presses 80g/kg to rat oral gavage administration, occurs without dead, also has no movable abnormal, is equivalent to more than 400 times of quantity.

2, long term toxicity test:

Chinese medicine composition extractum with 40,20,10g/Kg/ day to the continuous gastric infusion of rat 3 months, hematological indices is had no significant effect; Blood parameters is also had no significant effect; Organ coefficient, histopathologic examination also do not find obvious pathological change.

Be illustrated with the clinical practice of above-mentioned traditional Chinese medicine composition for treating heart failure below.

By implementing the clinical trial protocol of State Food and Drug Administration's reply, heart failure patient is carried out to the disease of uncomfortable in chest, weakness with emaciation weak breath, fatigue and weak, dizziness, extremity or general edema, cardiopalmus, the clinical observation of the items such as Chinese medicine syndrome integral, tcm syndrome single index, total effects, tcm syndrome curative effect, in research with this Chinese medicine composition with contrast medicine and compare, evaluate it according to the standard of curative effect evaluation of the current international practice, result shows the effectively innerwear Chinese medicine preparation of safety that this Chinese medicine composition is treatment heart failure blood stasis due to qi deficiency water retention card.

Adopt randomized, double-blind layering counter point, clinical observation Patients With Chronic Heart Failure 162 example, wherein treatment group 90 example, each 6, every day 3 times, take surrounding, situation of change before and after the treatment observing patient uncomfortable in chest, weakness with emaciation weak breath, fatigue and weak, dizziness, extremity or general edema, cardiopalmus, Chinese medicine syndrome integral, tcm syndrome single index, total effects, tcm syndrome curative effect and body of the tongue, tongue fur, pulse condition all index, result shows:

1, return to 0 point after patient's treatment uncomfortable in chest and 1 point of person is 72 examples, account for 80%; Weakness with emaciation weak breath returns to 0 point after treating and 1 point of person is 73 examples, accounts for 81%; Returning to the 0-2 person of dividing after fatigue and weak treatment is 81 examples, accounts for 90%; Return to the 0-2 person of dividing after dizzy treatment and account for 82%; Extremity or general edema return to the 0-2 person of dividing after treating and account for 78%; Return to the 0-2 person of dividing after cardiopalmus treatment and account for 83%;

2, before and after treatment, patient's comprehensive function level compares, and returns to 0-2 and divide horizontal person to be 54% after patient's comprehensive function horizontal stretcher;

3, patient's picture of the tongue, pulse condition integral contrast before and after treatment, has significance to recover after body of the tongue, tongue fur and pulse condition three demonstrate,proves treatment;

4, after treatment, patient's total effects compares, and the total effective rate after treatment is 91.3%, and obvious effective rate is 45%;

5, the total effective rate after treatment after the treatment of patient's tcm syndrome comparitive study is 90.00%, and cure-remarkable-effectiveness rate treatment group is 44%;

6, after treatment, patient group compares in table 1 with matched group total effects:

Table 1

Note: two groups are compared P < 0.01

7, all there is not untoward reaction in therapeutic process and after treatment in patient safety index there was no significant difference (P > 0.05) before and after treatment.

Above indices compares with matched group, and the indices of this Chinese medicine composition and clinical efficacy are all better than contrasting medicine, and after treatment, patient's indices and symptom improvement situation are obviously better than similar drugs.

8, this traditional Chinese medicine composition for treating heart failure model case one example:

Zhang, man, 57 years old, Tianjin seismic network people, because of " uncomfortable in chest, breathe hard, edema of pair of lower extremities, recurrent exerbation 11 years, increases the weight of companion and can not put down sleeping 6 days ", be admitted to hospital on April 12nd, 2008.Human health screening: T36.2C P94 beat/min R25 beat/min BP80/50mmHg, limited when putting down sleeping, two pulmonary respiration sound is thick, bottom right lung audible and tiny moist rales.Apex beat is in left five intercostal anterior axillary lines, and heart circle obviously expands, audible and galloping horse sound, and two Tricuspid valve audible 3/6 grade systolic murmurs, P2 > A2,6cm under liver rib, 8cm under sword, two lower limb slightly refer to concavity edema.

Auxiliary examination:

Electrocardiogram: Dou Lv, complete left bundle branch block.

Color Sonography: LA49mm, LV83mm, A62*42mm, RV40mm, EF32%.

Clinical diagnosis:

Western medicine diagnose: CHF in Patients with Dilated III.

Tcm diagnosis: cardiopalmus (blood stasis due to qi deficiency water retention card).

Method for the treatment of: Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, diuretic.

Side's medicine: use this traditional Chinese medicine composition for treating, each 6, every day 3 times, after treating 4 weeks, patient can put down sleeping, remarkable improvement uncomfortable in chest, and breathe hard and obviously alleviate, edema of pair of lower extremities disappears substantially, blood pressure is raised to 110/80mmHg, continues to observe treatment one week, and heart failure controls and leaves hospital.

Claims (3)

1. be used for the treatment of a Chinese medicine composition for heart failure, it is characterized in that: this Chinese medicine composition is made up of the crude drug by following parts by weight:

Radix Codonopsis 65-185, Radix Et Caulis Acanthopanacis Senticosi 65-185, Radix Astragali 65-185, Radix Salviae Miltiorrhizae 65-185, Carapax Trionycis 15-185, Poria 50-150, Semen Lepidii (Semen Descurainiae) 30-130, Radix Ophiopogonis 50-150, Fructus Aurantii 30-130, also have pharmaceutic adjuvant, the preparation method of described Chinese medicine composition comprises the following steps:

A) water extraction: above-mentioned traditional Chinese medicinal composition raw materials is put in water extraction tank, add the 8 times amount soak by water 2 times of described traditional Chinese medicinal composition raw materials by weight, each time is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa, collecting decoction, filters;

B) concentrated: put in concentration tank by the water extraction filtrate of a) step, be concentrated into thick paste, thickening temperature is 50-100 DEG C;

C) precipitate with ethanol: put in Alcohol-settling tank by the concentrated solution of b) step, slowly add 95% ethanol and make its alcohol content reach 65%, after fully stirring, leaves standstill 12 hours, filters;

D) ethanol is reclaimed: put in reclaim under reduced pressure tank by the filtrate of c) step, decompression recycling ethanol, being concentrated into relative density is 1.10-1.20, the thick paste that temperature is 85 DEG C, vacuum-0.06 ~-0.09Mpa, and thickening temperature 50-65 DEG C, obtains water extract;

E) pulverize: by the water extract vacuum drying in d) step, vacuum is-0.06Mpa ~-0.09Mpa, and temperature is 50-100 DEG C, is ground into fine powder 80-120 order;

F) preparation of tablet:

A') pharmaceutic adjuvant of the 50%-100% containing fine powder amount will be added in e) step fine powder; Sieve, mix homogeneously, incorporation time is 10-50 minute;

B') by a') fine powder 92% alcohol granulation of mixing homogeneously with pharmaceutic adjuvant in step, add the 30%-55% that amount of alcohol is fine powder amount, Granulation time is 3-10 minute;

C') by b') wet granular in step is laid in drying baker and carries out drying, and overlay thickness is 1-2cm, and baking temperature is 50-100 DEG C;

D') by dried granule granulate, be 14 object screen cloth granulate with order number;

E') 0.3%-0.6% magnesium stearate is added, mix homogeneously by whole good granule;

F') tablet is made with tabletting machine, every sheet 0.4-0.6g.

2. the Chinese medicine composition being used for the treatment of heart failure according to claim 1, is characterized in that: described pharmaceutic adjuvant is one of dextrin, starch, lactose.

3. the preparation method being used for the treatment of the Chinese medicine composition of heart failure according to claim 1, its method comprises the following steps:

A) water extraction: traditional Chinese medicinal composition raw materials according to claim 1 is put in water extraction tank, add the 8 times amount soak by water 2 times of described traditional Chinese medicinal composition raw materials by weight, each time is 2 hours, and after boiling, steam pressure is 0.03-0.04Mpa, collecting decoction, filters;

B) concentrated: put in concentration tank by the water extraction filtrate of a) step, be concentrated into thick paste, thickening temperature is 50-100 DEG C;

C) precipitate with ethanol: put in Alcohol-settling tank by the concentrated solution of b) step, slowly add 95% ethanol and make its alcohol content reach 65%, after fully stirring, leaves standstill 12 hours, filters;

D) ethanol is reclaimed: put in reclaim under reduced pressure tank by the filtrate of c) step, decompression recycling ethanol, being concentrated into relative density is 1.10-1.20, the thick paste that temperature is 85 DEG C, vacuum-0.06 ~-0.09Mpa, and thickening temperature 50-65 DEG C, obtains water extract;

E) pulverize: by the water extract vacuum drying in d) step, vacuum is-0.06Mpa ~-0.09Mpa, and temperature is 50-100 DEG C, is ground into fine powder 80-120 order;

F) preparation of tablet:

A') pharmaceutic adjuvant of the 50%-100% containing fine powder amount will be added in e) step fine powder; Sieve, mix homogeneously, incorporation time is 10-50 minute;

B') by a') fine powder 92% alcohol granulation of mixing homogeneously with pharmaceutic adjuvant in step, add the 30%-55% that amount of alcohol is fine powder amount, Granulation time is 3-10 minute;

C') by b') wet granular in step is laid in drying baker and carries out drying, and overlay thickness is 1-2cm, and baking temperature is 50-100 DEG C;

D') by dried granule granulate, be 14 object screen cloth granulate with order number;

E') 0.3%-0.6% magnesium stearate is added, mix homogeneously by whole good granule;

F') tablet is made with tabletting machine, every sheet 0.4-0.6g.