CN102416101A - Chinese medicinal composition for treating heart failure and preparation method as well as application thereof - Google Patents
Chinese medicinal composition for treating heart failure and preparation method as well as application thereof Download PDFInfo
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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
Technical field
The invention belongs to Chinese medicine preparation, particularly relate to a kind of Chinese medicine composition of treating 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 complicacy, also is the various cardiopathic serious stages, and its sickness rate is high, and 5 annual survival rates and malignant tumor are similar.According to World Health Organization's statistics, the sickness rate of heart failure in the crowd is 1.5%-5.6%, and over-65s reaches 6.4%, and its sickness rate doubled in per ten years.According to Chinese cardiovascular health research, China's heart failure prevalence is 0.9%, China's 50 tame inpatient of hospital investigation, and the heart failure admission rate only accounts for cardiovascular diseases's's same period 20%, but mortality rate accounts for 40%, and the prompting prognosis is serious.Along with the transformation of modern medicine to heart failure treatment idea, its admission rate and mortality rate etc. have all shown downward trend, how further to reduce the morbidity and the mortality rate of heart failure, improve patient's life quality, are the difficult point and the focuses of control at present and research.
Heart failure belongs to categories 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 a deficiency in origin and excess in superficiality, and deficiency in origin is main with the deficiency of vital energy, mark real with blood stasis, diseases caused by retention of fluid, expectorant is turbid is main.In the 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 through the retrospective analysis to nearly 20 years Chinese traditional treatment heart failure documents; Domestic 30 multidigit experts distinguish the integrated analysis of controlling the heart failure suggestion; And the investigation of clinical epidemiology result of Efficiency in Buildings in Tianjin Area 200 many cases patients with heart failure shows that 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 is obtaining considerable progress to the research of primary disease aspect etiology and pathogenesis, diagnosis and treatment rule, medicine and the zoopery.But the also pathogenesis theories such as the deficiency of vital energy or blood stasis due to qi deficiency that are limited to of research in recent years more.Aspect drug research, for heart failure, according to the characteristics of incidence of present clinical patients, many according to the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs under motherland's medical science organic conception, it is main adopting benefiting QI for activating blood circulation, and it is in the majority with promoting the flow of QI in the collateral by warming the meridian to hold concurrently.Existing Chinese patent medicine is to the treatment of heart failure, or QI invigorating warming YANG or supplementing QI and nourishing YIN or the like, and treatment emphasizes particularly on different fields, but lacks the special Chinese medicine preparation of benefiting QI for activating blood circulation diuretic effect, so this Chinese medicine composition has value for clinical application and wide market application prospect.On the clinical application method, mostly clinical is the usage that adopts decoction, causes the liposoluble constituent of flavour of a drug, volatile ingredient to lose seriously, has influenced the clinical efficacy of compound recipe.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition of treating heart failure and preparation method thereof and application; Said composition is the Chinese medicine composition of clinical prevention and treatment heart failure; This method for preparing has overcome the drawback of conventional dosage forms such as decoction; In the hope of improving the clinical symptoms of heart failure patient, reduce the mortality rate of heart failure patient.
For realizing above-mentioned purpose, the technical scheme that the present invention adopts provides a kind of Chinese medicine composition of treating heart failure, and 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 had pharmaceutic adjuvant.
A kind of method for preparing of treating the Chinese medicine composition of heart failure is provided simultaneously, and this Chinese medicine composition is used to treat heart failure.
Effect of the present invention is the drawback that this Chinese medicine composition has overcome conventional dosage forms such as decoction; Adopt the method for water extraction; Keep the effective ingredient that has clinical efficacy in the compositions, adopted high-efficiency dynamic circulation extraction equipment, extracted effective ingredient to greatest extent; Guaranteed its clinical efficacy, the prevention that heart failure blood stasis due to qi deficiency water retention is demonstrate,proved obviously is superior to similar medicine with therapeutical effect.
Clinical efficacy is the result show, take this Chinese medicine composition after, traditional Chinese medical science disease 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 the equal tool produce effects of blood stasis due to qi deficiency water retention card all items index; Self more all have clear improvement in body of the tongue, tongue fur, all index group of pulse condition; Tcm syndrome compares with matched group at an index treatment back, and treatment group total effective rate and cure-remarkable-effectiveness rate all obviously are superior to matched group; Treatment back heart failure function scoring total effective rate and cure-remarkable-effectiveness rate treatment group all are higher than matched group, treat back tcm syndrome total effective rate and cure-remarkable-effectiveness rate treatment group apparently higher than matched group.Explain that its clinical therapeutic efficacy of this Chinese medicine composition obviously is superior to existing similar medicine.
The safety of this Chinese medicine composition and untoward reaction aspect, zoopery and clinical observation on the therapeutic effect all show, this Chinese medicine composition is safe and reliable, have no adverse reaction.
The specific embodiment
In conjunction with embodiment Chinese medicine composition of treatment heart failure of the present invention and preparation method thereof is specified with using.
The pharmacodynamics experimentation has disclosed the mechanism of this Chinese medicine composition prevention and treatment heart failure before clinical:
Chinese medicine composition extractum treatment administration all has tangible optimum regulating action to ligation rat coronary artery anterior descending branch forms the rat of chronic heart failure gradually after one month cardiac systolic function, diastolic function, heart configuration, hemodynamics; Gastric infusion can obviously reduce Angiotensin II, the level of ET of heart failure rat, thereby suppresses neuroendocrine activation; Chinese medicine composition extractum repeatedly gastric infusion all has improvement in various degree to left ventricular ejection mark, LVED, the Left ventricular mass index of heart failure rat; In a word, this Chinese medicine composition possibly change AngII, ET level through regulating, and then performance reverses the effect that ventricle is reinvented.
The present invention is according to traditional Chinese medical science traditional theory; The symptom of analysis heart failure blood stasis due to qi deficiency water retention card: this type of patient is uncomfortable in chest except that having, the weakness with emaciation weak breath, extremity edema, fatigue and weak, most and be seen in that, dizziness dark like lip, chest pain, extremity or general edema, cardiopalmus, pale tongue with thin fur are white, body of the tongue ecchymosis petechia, deep-thready pulse or slow or tie disease for essential resistance of turbid phlegm.Heart failure belongs to categories 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 a deficiency in origin and excess in superficiality, and deficiency in origin is main with the deficiency of vital energy, mark real with blood stasis, diseases caused by retention of fluid, expectorant is turbid is main.In the 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.According to the morbific characteristics of primary disease, establish Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, the principle of treatment of diuretic in view of the above.
This Chinese medicine composition is that basic reef knot closes clinical experience and adds to simplify to cut out and form this Chinese medicine composition with the SHENGMAI SAN of golden Zhang Yuansu.SHENGMAI SAN is made up of Radix Ophiopogonis, Radix Ginseng, Fructus Schisandrae Chinensis.The function supplementing QI and nourishing YIN, arresting sweating is given birth to arteries and veins.Cure mainly impairment of both QI and YIN, the limbs asthenia, the lazy speech of breathing hard, xerostomia is done thirsty, the hyperhidrosis deficient pulse; The lung being damaged by lasted cough, QIYINLIANGXU, the few expectorant of dry cough, lack of appetite is become thin, the deficiency-heat dyspnea with rapid and short breath, the spontaneous perspiration of breathing hard, dry mouth and tougue is a little less than the faint and thready pulse; Or after skin infection burst, pus went out many, and gas is cloudy all empty, the xerostomia dyspnea with rapid and short breath, and dysphoria, it is not peaceful to doss.
This Chinese medicine composition is according to the pathogenic characteristic of clinical common heart failure patient: deficiency in origin and excess in superficiality, deficiency in origin are main with the deficiency of vital energy, mark real with blood stasis, diseases caused by retention of fluid, expectorant is turbid is main.This Chinese medicine composition adopts the method for Yiqi and vein recovery, heart tonifying, diuretic, is aided with the article 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, and assistant is given birth to the article of Feng, regulating the flow of QI to ease the stomach with yin nourishing.This Chinese medicine composition on the basis of Yiqi and vein recovery principle of treatment, the article 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; Prescription is rigorous, has Yiqi and vein recovery, regulating the flow of QI to ease the stomach; Heart tonifying, the effect of diuretic is used 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 the Chinese medicine composition, living Feng nourish blood, Radix Astragali invigorating QI to consolidate the body surface resistance, diuresis, and the similar Radix Ginseng of Radix Et Caulis Acanthopanacis Senticosi merit, air making-up and spleen enlivening, the kidney warming are calmed the nerves, and three medicines are monarch drug altogether;
The Radix Salviae Miltiorrhizae nourshing blood and promoting blood circulation, the 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;
Feng is given birth in yin nourishing Radix Ophiopogonis, and Fructus Aurantii regulating the flow of QI to ease the stomach, the stagnant relieving distension of row are adjuvant drug altogether.
Quan Fangjiu flavor is that basis side adds and simplifies sanction and come with the SHENGMAI YIN, and consumption is gentle, and full side's compatibility is rigorous, and cautiously grasping pathogenesis is played 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 card.This type of patient is uncomfortable in chest except that having, the weakness with emaciation weak breath, extremity edema, fatigue and weak, most and be seen in that, dizziness dark like lip, chest pain, extremity or general edema, cardiopalmus, pale tongue with thin fur are white, body of the tongue ecchymosis petechia, deep-thready pulse or slow or tie disease for essential resistance of turbid phlegm.
Chinese medicine composition of the present invention includes following flavour of a drug and forms:
Constitute by 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 had pharmaceutic adjuvant.
Said Radix Codonopsis means a kind of of Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, Radix Pseudostellariae.
The enough Semen Persicaes of said Radix Salviae Miltiorrhizae flavour of a drug ability, a kind of of Flos Carthami substitute; Said Radix Astragali flavour of a drug can use Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, a kind of of Radix Pseudostellariae to substitute; The enough Cortex Acanthopanciss of said Radix Et Caulis Acanthopanacis Senticosi flavour of a drug ability, a kind of of Cortex Periplocae substitute.
The contained pharmaceutic adjuvant of Chinese medicine composition of the present invention can use dextrin, starch, lactose etc., and the best is a dextrin.
The multi-functional extraction concentrator of dynamic circulation that the method for preparing of Chinese medicine composition of the present invention adopts, the concrete operations step is following:
A) water extraction: the Chinese medicine composition that above-mentioned flavour of a drug constitute is put in the water extraction jar, added the 6-12 times of water yield of said Chinese medicine composition by weight, the best is that the decocting of 8 times of amounts boils 2-3 time; Best for decocting 2 times; Each time is 1-4 hour, and the best is 2 hours, and boiling back steam pressure is 0.03-0.04Mpa; Collecting decoction filters;
Perhaps
A ") water extraction: the Carapax Trionycis described in the Chinese medicine composition that just above-mentioned flavour of a drug constitute is put in the water extraction jar; add 6-12 times of water gaging of Carapax Trionycis by weight, the best is that the decocting of 8 times of amounts boils 1 time, and the time is 1-4 hour; the best is 2 hours, and boiling back steam pressure is 0.03-0.04Mpa; The described Chinese medicine composition Radix Codonopsis of 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 jar that aforementioned Carapax Trionycis puts, add 6-12 times of water gaging of said Chinese medicine composition by weight, the best is that the decocting of 8 times of amounts boils 2-3 time; The best is 2 times; Each time is 1-4 hour, and the best is 2 hours, and boiling back steam pressure is 0.03-0.04Mpa; Merge decocting liquid, filter;
Perhaps
A) water extraction: Radix Codonopsis, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Radix Salviae Miltiorrhizae, Poria, Semen Lepidii (Semen Descurainiae), Radix Ophiopogonis, Fructus Aurantii in the Chinese medicine composition of above-mentioned flavour of a drug formation are put in the water extraction jar, add 6-12 times of water gaging of said Chinese medicine composition by weight, the best is that the decocting of 8 times of amounts boils 2-3 time; The best is 2 times; Each time is 1-4 hour, and the best is 2 hours, and boiling back steam pressure is 0.03-0.04Mpa; Collecting decoction filters;
B) concentrate: a) step water extraction filtrating is put in the concentration tank, be concentrated into thick paste, thickening temperature is 50-100 ℃;
C) precipitate with ethanol: concentrated solution is put in the Alcohol-settling tank, slowly adds 95% ethanol and makes it contain alcohol amount to reach 50%-75%, and the best is 65%, after fully stirring, leaves standstill 8-20 hour, and the best is 12 hours, filters;
D) reclaim ethanol: filtrating is put in the reclaim under reduced pressure jar, 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 ℃, vacuum-0.06-0.09Mpa, thickening temperature 40-100 ℃, the best is 50-65 ℃, gets water extract.
Perhaps
Through b) after step concentrates, do not carry out c) step precipitate with ethanol and d) step reclaims ethanol, directly carries out e) step pulverizes.
E) pulverize: d) spissated thick paste vacuum drying in the step, vacuum is-0.06Mpa～0.09Mpa, and temperature is 50-100 ℃, and the best is 60 ℃, is ground into fine powder 80-120 order; Perhaps the described turtle ' s carapace powder of claim 1 is broken into fine powder 80-120 order, the Carapax Trionycis fine powder is joined d) in the step in the spissated thick paste, mix homogeneously, incorporation time is 10-50 minute, the best is 30 minutes; Vacuum drying, vacuum be-0.06Mpa～0.09Mpa, and temperature is 50-100 ℃, and the best is 60 ℃, is ground into fine powder 80-120 order;
F) preparation of tablet:
A ') above-mentioned with e) add the pharmaceutic adjuvant of the 50%-100% that contains fine powder amount in the step fine powder, pharmaceutic adjuvant can use dextrin, starch, lactose etc., and the best is 75.5% dextrin; Sieve, mix homogeneously, incorporation time is 10-50 minute, the best is 30 minutes;
B ') will use 92% alcohol granulation with the fine powder of pharmaceutic adjuvant mix homogeneously, and add the 30%-55% that amount of alcohol is a fine powder amount, the best is 43%, and the granulation time is 3-10 minute;
C ') with b ') wet granular in the step is tiled in and carries out drying in the drying baker, and the shop layer thickness is 1-2cm, and baking temperature is 50-100 ℃;
D ') with dried granule granulate, using the order number is 14 purpose screen cloth granulate;
E ') adds 0.3%-0.6% magnesium stearate, mix homogeneously in the granule that will put in order;
F ') process tablet with the tablet machine tabletting, every 0.4-0.6g, the best is 0.5g.
Chinese medicine composition of the present invention:
1) meet (" an appendix I of Chinese pharmacopoeia version in 2010 D) to each item regulation relevant under the tablet item;
2) limit test of microbe meets the regulation of Chinese Pharmacopoeia;
3) under room temperature was preserved, the effect duration of this Chinese medicine composition was 12 months.
In the f step of Chinese medicine composition method for preparing of the present invention, can extract be processed pill, powder, granule, mixture, soft extract, capsule or syrup.The Chinese medicine composition of said method for preparing preparation is used to treat 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing 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, make tablet according to the method for preparing of above-mentioned Chinese medicine composition.
By the above proportion of respectively writing out a prescription, according in the above-mentioned Chinese medicine composition method for preparing a), b), c), d), e) method extract, can be made into capsule then as follows:
F) capsular preparation:
A ') with above-mentioned e) add the pharmaceutic adjuvant of the 50%-100% that contains fine powder amount in the step fine powder, pharmaceutic adjuvant can use a kind of of dextrin, starch, lactose, and the best is 75.5% dextrin; Sieve, mix homogeneously, incorporation time is 10-50 minute, the best is 30 minutes;
B ') will use 92% alcohol granulation with the fine powder of pharmaceutic adjuvant mix homogeneously, and add the 30%-55% that amount of alcohol is a fine powder amount, the best is 43%, and the granulation time is 3-10 minute;
C ') with b ') wet granular in the step is tiled in and carries out drying in the drying baker, and the shop layer thickness is 1-2cm, and baking temperature is 50-100 ℃;
D ') with dried granule granulate, using the order number is 14 purpose screen cloth granulate;
E ') encapsulated, every capsules dress 0.4-0.6g, the best is 0.5g.
According in the above-mentioned Chinese medicine composition method for preparing a), b), c), d), e) method extract a '), b ') method mix, granulate c '), d ') dry, the granulate of method, can be made into granule; Or directly packing is processed powder; Add water dosing, fill, sterilization and can be made into mixture; Add that syrup is mixed, sterilization, the canned syrup that can be made into; Adding refined honey closes 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 is processed concentrated pill, paste pill; According to above-mentioned Chinese medicine composition a), b), c), d), e) method extract a ') method mix, adds an amount of Mel mixing and can be made into soft extract.
More than be optimum implementation with embodiment 3,10.
Its method of quality control of Chinese medicine composition with most preferred embodiment 3,10 preparations:
A) should meet each item relevant under tablet item regulation (" appendix ID of Chinese pharmacopoeia version in 2010).
B) limit test of microbe meets the regulation of Chinese Pharmacopoeia.
C) under room temperature was preserved, the effect duration of this Chinese medicine composition was 12 months.
The toxicity test of this Chinese medicine composition
1, acute toxicity test:
Chinese medicine composition extractum is pressed 150g/kg and is given the mouse stomach administration, does not have dead the generation, does not see movable unusual.Be equivalent to 3 times/day of clinical consumption, 6/inferior, everyone calculates more than 800 times by 50kg.Chinese medicine composition extractum is pressed 80g/kg and is given the rat oral gavage administration, does not have dead the generation, does not also see that activity is unusual, is equivalent to more than 400 times of clinical consumption.
2, long term toxicity test:
Chinese medicine composition extractum with 40,20,10g/Kg/ day give the continuous gastric infusion of rat 3 months, hematological indices is not had obvious influence; Blood parameters also there is not obvious influence; Organ coefficient, histopathologic examination also do not find tangible pathological change.
Below to explaining with the clinical practice of above-mentioned traditional Chinese medicine composition for treating heart failure.
Through implementing the clinical trial protocol of State Food and Drug Administration's reply; Heart failure patient has been carried out the disease of uncomfortable in chest, weakness with emaciation weak breath, fatigue and weak, dizziness, extremity or general edema, cardiopalmus; The clinical observation of item such as tcm syndrome integration, tcm syndrome single index, total effects, tcm syndrome curative effect; Compare with this Chinese medicine composition and contrast medicine in the research; Therapeutic evaluation standard according to the current international practice is estimated it, and the result shows that this Chinese medicine composition is the effective and safe innerwear Chinese medicine preparation of 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 examples, wherein 90 examples are organized in treatment, each 6; Every day 3 times; Around taking, observe that the patient is uncomfortable in chest, situation of change before and after the treatment of weakness with emaciation weak breath, fatigue and weak, dizziness, extremity or general edema, cardiopalmus, tcm syndrome integration, tcm syndrome single index, total effects, tcm syndrome curative effect and body of the tongue, tongue fur, all index of pulse condition, the result shows:
1, returned to after patient's treatment uncomfortable in chest 0 fen and 1 fen person is 72 examples, account for 80%; Returned to 0 fen after the weakness with emaciation weak breath treatment and 1 fen person is 73 examples, account for 81%; Returning to the 0-2 person of branch after the fatigue and weak treatment is 81 examples, accounts for 90%; Return to the 0-2 person of branch after the dizzy treatment and account for 82%; Return to the 0-2 person of branch after extremity or the general edema treatment and account for 78%; Return to the 0-2 person of branch after the cardiopalmus treatment and account for 83%;
2, before and after the treatment patient comprehensive function level relatively, returning to 0-2 behind patient's comprehensive function horizontal stretcher, to divide horizontal person be 54%;
3, patient's picture of the tongue, pulse condition integration relatively have significance to recover after body of the tongue, tongue fur and the pulse condition three card treatments before and after the treatment;
4, treatment back patient's total effects compares, and the total effective rate after the treatment is 91.3%, and obvious effective rate is 45%;
5, the total effective rate after treatment back patient's tcm syndrome curative effect is relatively treated is 90.00%, and cure-remarkable-effectiveness rate treatment group is 44%;
6, treatment back patient group and matched group total effects are relatively seen table 1:
Table 1
Annotate: two groups are compared P＜0.01
Untoward reaction does not all take place in the therapeutic process and after the treatment in 7, patient safety property index there was no significant difference (P＞0.05) before and after the treatment.
Above each item index and matched group compare, and each item index and the clinical efficacy of this Chinese medicine composition all are superior to contrasting medicine, and treatment back patient's each item index obviously is superior to similar medicine with the doing well,improving situation.
8, this traditional Chinese medicine composition for treating heart failure model case one example:
Zhang, the man, 57 years old, people from Tanggu, Tianjin, because of " uncomfortable in chest, breathe hard, edema of pair of lower extremities, showed effect repeatedly 11 years, increase the weight of the companion can not put down crouched 6 days ", be admitted to hospital on April 12nd, 2008.P94 time/minute R25 time/minute BP80/50mmHg of human health screening: T36.2C, limited during flat crouching, two pulmonary respiration sounds are thick, bottom right lung audible and tiny moist rales.Apex beat is in left five intercostal anterior axillary lines, and heart circle obviously enlarges, audible and galloping horse sound, and 3/6 grade of systolic murmur of two Tricuspid valve audibles, P2＞A2,6cm under the liver rib, 8cm under the sword, two lower limb slightly refer to the concavity edema.
Auxiliary examination:
Electrocardiogram: hole rule, left bundle branch block fully.
Color Sonography: LA49mm, LV83mm, A62*42mm, RV40mm, EF32%.
Clinical diagnosis:
Western medicine diagnose: dilated cardiomyopathy heart failure III.
Tcm diagnosis: cardiopalmus (blood stasis due to qi deficiency water retention card).
Method of treatment: Yiqi and vein recovery, regulating the flow of QI to ease the stomach, heart tonifying, diuretic.
The side medicine: use this traditional Chinese medicine composition for treating, each 6, every day 3 times, treated for 4 weeks after; The patient can put down for sleeping in, and remarkable improvement uncomfortable in chest is breathed hard and obviously alleviated, and edema of pair of lower extremities disappears basically; Blood pressure is raised to 110/80mmHg, continues to observe one week of treatment, and heart failure is controlled and left hospital.
Claims (8)
1. Chinese medicine composition that is used to treat heart failure, it is characterized in that: 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 had pharmaceutic adjuvant.
2. Chinese medicine composition according to claim 1 is characterized in that: said Radix Codonopsis means a kind of of Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, Radix Pseudostellariae.
3. Chinese medicine composition according to claim 1 is characterized in that: the enough Semen Persicaes of said Radix Salviae Miltiorrhizae flavour of a drug ability, a kind of of Flos Carthami substitute; Said Radix Astragali flavour of a drug can use Radix Ginseng, Radix Ginseng, Radix Ginseng Rubra, wild ginseng, Radix Panacis Quinquefolii, a kind of of Radix Pseudostellariae to substitute; The enough Cortex Acanthopanciss of said Radix Et Caulis Acanthopanacis Senticosi flavour of a drug ability, a kind of of Cortex Periplocae substitute.
4. Chinese medicine composition according to claim 1 is characterized in that: said pharmaceutic adjuvant is one of dextrin, starch, lactose.
5. method for preparing of treating the Chinese medicine composition of heart failure, its method may further comprise the steps:
A) water extraction: the Chinese medicine composition that above-mentioned flavour of a drug constitute is put in the water extraction jar, and the 6-12 times of water gaging that adds said Chinese medicine composition by weight decocts 2-3 time, and each time is 1-4 hour, and boiling back steam pressure is 0.03-0.04Mpa, and collecting decoction filters;
Perhaps
A ") water extraction: the Carapax Trionycis in the Chinese medicine composition of above-mentioned flavour of a drug formation is put in the water extraction jar, and the 6-12 times of water gaging that adds Carapax Trionycis by weight decocts 1 time, and the time is 1-4 hour, and boiling back steam pressure is 0.03-0.04Mpa; The described Chinese medicine composition Radix Codonopsis of 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 jar that aforementioned Carapax Trionycis puts; The 6-12 times of water gaging that adds said Chinese medicine composition by weight decocts 2-3 time; Each time is 1-4 hour; Boiling back steam pressure is 0.03-0.04Mpa, merges decocting liquid, filters;
Perhaps
A) water extraction: Radix Codonopsis, Radix Et Caulis Acanthopanacis Senticosi, the Radix Astragali, Radix Salviae Miltiorrhizae, Poria, Semen Lepidii (Semen Descurainiae), Radix Ophiopogonis, Fructus Aurantii in the Chinese medicine composition of above-mentioned flavour of a drug formation are put in the water extraction jar; The 6-12 times of water gaging that adds said Chinese medicine composition by weight decocts 2-3 time; Each time is 1-4 hour; Boiling back steam pressure is 0.03-0.04Mpa, and collecting decoction filters;
B) concentrate: above-mentioned arbitrary a) step water extraction filtrating is put in the concentration tank, be concentrated into thick paste, thickening temperature is 50-100 ℃;
C) precipitate with ethanol: concentrated solution is put in the Alcohol-settling tank, slowly adds 95% ethanol and makes it contain alcohol amount to reach 50%-75%, after fully stirring, left standstill 8-20 hour, filter;
D) reclaim ethanol: filtrating is put in the reclaim under reduced pressure jar, decompression recycling ethanol, and being concentrated into relative density is 1.10-1.20, the thick paste that temperature is 85 ℃, vacuum-0.06～0.09Mpa, gets water extract by thickening temperature 40-100 ℃;
Perhaps
Through b) after step concentrates, do not carry out c) step precipitate with ethanol and d) step reclaims ethanol, directly carries out e) step pulverizes;
E) pulverizing: with d) spissated thick paste vacuum drying in the step, vacuum is-0.06Mpa～0.09Mpa that temperature is 50-100 ℃, is ground into fine powder 80-120 order; Perhaps the described turtle ' s carapace powder of claim 1 is broken into fine powder 80-120 order, the Carapax Trionycis fine powder is joined d) in the step in the spissated thick paste, mix homogeneously, incorporation time is 10-50 minute; Vacuum drying, vacuum are-0.06Mpa～0.09Mpa that temperature is 50-100 ℃, is ground into fine powder 80-120 order;
F) preparation of tablet:
A ') with e) add the pharmaceutic adjuvant of the 50%-100% that contains fine powder amount in the step fine powder; Sieve, mix homogeneously, incorporation time is 10-50 minute;
B ') will use 92% alcohol granulation with the fine powder of pharmaceutic adjuvant mix homogeneously, and add the 30%-55% that amount of alcohol is a fine powder amount, the granulation time is 3-10 minute;
C ') with b ') wet granular in the step is tiled in and carries out drying in the drying baker, and the shop layer thickness is 1-2cm, and baking temperature is 50-100 ℃;
D ') with dried granule granulate, using the order number is 14 purpose screen cloth granulate;
E ') adds 0.3%-0.6% magnesium stearate, mix homogeneously in the granule that will put in order;
F ') processes tablet with the tablet machine tabletting, every 0.4-0.6g.
6. the Chinese medicine composition of processing according to claim 1 or 5 is characterized in that: said Chinese medicine composition:
1) meet (" an appendix I of Chinese pharmacopoeia version in 2010 D) to each item regulation relevant under the tablet item;
2) limit test of microbe meets the regulation of Chinese Pharmacopoeia;
3) under room temperature was preserved, the effect duration of this Chinese medicine composition was 12 months.
7. method according to claim 5 is characterized in that: in the f step of said this method, can extract be processed pill, powder, granule, mixture, soft extract, capsule or syrup.
8. according to the Chinese medicine composition of the said method for preparing preparation of claim 5, be used to treat heart failure.
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| CN105998244A (en) * | 2016-08-03 | 2016-10-12 | 吴伦 | Chinese medicinal preparation for chronic heart failure |
| CN105998244B (en) * | 2016-08-03 | 2018-03-16 | 黑龙江中医药大学 | A kind of Chinese medicine preparation for chronic heart failure |
| CN106138714A (en) * | 2016-08-31 | 2016-11-23 | 毛静远 | A kind of Chinese medicine preparation treating heart failure with preserved ejection fraction |
| CN106138714B (en) * | 2016-08-31 | 2019-10-11 | 毛静远 | A kind of Chinese materia medica preparation for treating heart failure with preserved ejection fraction |
| CN107343925A (en) * | 2017-08-08 | 2017-11-14 | 广西中医药大学第附属医院 | A kind of Chinese medicine composition of chronic heart failure and preparation method thereof |
| CN107343925B (en) * | 2017-08-08 | 2020-10-13 | 广西中医药大学第一附属医院 | Traditional Chinese medicine composition for treating chronic heart failure and preparation method thereof |
| CN112716998A (en) * | 2020-12-31 | 2021-04-30 | 天津中医药大学第一附属医院 | Traditional Chinese medicine preparation for treating pulmonary hypertension |
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