CN103961646A - Traditional Chinese medicinal preparation composition for nourishing qi and yin and activating blood circulation to remove stasis - Google Patents
Traditional Chinese medicinal preparation composition for nourishing qi and yin and activating blood circulation to remove stasis Download PDFInfo
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Abstract
The invention relates to a granular composition for nourishing qi and yin and activating blood circulation to remove stasis, and particularly relates to a traditional Chinese medicinal granular preparation composition. The composition is prepared from the following raw traditional Chinese medicinal materials: ginseng, radix ophiopogonis, salvia miltiorrhiza, schisandra chinensis, longan pulp, medlar, red peony root, radix achyranthis bidentatae, radix curcumae, costustoot, fingered citron, poria, rhizoma alismatis and liquorice.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition, particularly a kind of yangxinshengmai granule compositions, it is by Radix Ginseng, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Arillus Longan, Fructus Lycii, Radix Paeoniae Rubra, Radix Achyranthis Bidentatae, Radix Curcumae, the Radix Aucklandiae, Fructus Citri Sarcodactylis, Poria, Rhizoma Alismatis, Radix Glycyrrhizae is that crude drug is prepared from.
Background technology:
Obstruction of qi in the chest and cardialgia is due to healthy energy virtual loss, caused, the blood stasis turbid with expectorant such as diet, feelings will, cold-evil, the stagnation of QI, cold coagulation numbness resistance heart arteries and veins, taking Danzhong or left chest ictally feel oppressed, pain is as mainly facing a kind of disease of performance.The lighter accidental of short duration slight chest oppressiveness or dull pain, or be ictal Danzhong or the unclean sense of discomfort of left breast; Severe one sharp ache, or be squeezing sample angor.Often, with cardiopalmus, breathe hard, hypopnea, even dyspnea with rapid and short breath, uneasy in terror, pale complexion, cold spontaneous sweating etc.How by fatigue, heavy meal, cold and excited and bring out, also can be without obvious inducement or morbidity when quiet.
At present treatment is along with patient's number constantly increases, and it is not very desirable that people generally react the medication effect of selling in the market, exists to take effect slowly, and side effect is many, poor stability, the problems such as preparation technology is loaded down with trivial details, on the high side.
In recent years, along with going deep into of clinical research, also occur the Chinese medicine preparation of some treatment relevant diseases, but existing medicine a bit belongs to and cure the symptoms, not the disease on market, some uses expensive composition, some in application process because uncertain therapeutic efficacy is cut and is interrupted using.
In view of this, the inventor develop a kind of taking convenience, effect steadily, determined curative effect, dosage form be stable, quality controllable, and the pure Chinese medicinal preparation having no side effect, to meet the demand of extensive patients.
Summary of the invention:
The Chinese medicinal granular formulation compositions that the invention provides a kind of supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling, it is prepared from as crude drug by following Chinese medicine:
Radix Ginseng, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Arillus Longan, Fructus Lycii, Radix Paeoniae Rubra, Radix Achyranthis Bidentatae, Radix Curcumae, the Radix Aucklandiae, Fructus Citri Sarcodactylis, Poria, Rhizoma Alismatis, Radix Glycyrrhizae
Preferably, compositions of the present invention, is prepared from as crude drug by following Chinese medicine:
Particularly preferred, compositions of the present invention, is prepared from as crude drug by following Chinese medicine:
Most preferred, compositions of the present invention, is prepared from as crude drug by following Chinese medicine:
More than, in composition, weight is calculated with crude drug, and above composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, and the final drug preparation of making, as make 1000 of capsule preparations, 1000, tablet, 1000 grams of granules, oral liquid 1000ml etc.
More than composition, if in grams, can be made into the preparation of 50-1000 taking dose, as tablet, makes 1000, and each taking dose can be 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, each serving using 1-2 bag, can take 62.5-125 time altogether.
More than composition is by weight as proportioning, in the time producing, can increase or reduce according to corresponding proportion, as large-scale production can be taking kilogram as unit, or taking ton as unit, small-scale production also can be taking milligram as unit, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of amount that can corresponding adjustment composition, increases or reduces being no more than 100%, and drug effect is constant.
More than single medicinal material, especially ministerial drug and the adjuvant drug in composition, also can be replaced by the suitable Chinese medicine with the identical property of medicine, and its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine preparation of the present invention is by the raw material of Chinese medicine of above-mentioned formula composition being processed through extraction or other modes, being made pharmaceutically active substance, subsequently, taking this material as raw material, while needs, add medicine acceptable carrier, make according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting respectively raw material of Chinese medicine, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverizing, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the method such as ketone is carried, chromatography obtains, these active substances can be the material of extractum form, can be that dry extract can be also fluid extract, need to determine to make different concentration according to the difference of preparation.
Pharmaceutically active substance in Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical preparation of the present invention, exists with unit dosage form, and described unit dosage form refers to the unit of preparation, as every of tablet, and every capsules of capsule, every bottle of oral liquid, every bag of granule etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, preferably peroral dosage form, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.Most preferably granule.Chinese medicine preparation of the present invention, the preparation of its oral administration can contain conventional excipient, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet if desired.
Applicable filler comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of suitable medicine comprises sodium lauryl sulphate.
Can, by mixing, fill, the method that tabletting etc. are conventional is prepared solid oral composition.Repeatedly mix and can make active substance be distributed in those compositionss of a large amount of filleies of whole use.The form of oral liquid can be for example aqueous or oily suspensions, solution, Emulsion, syrup or elixir, or can be a kind of available water before use or the composite dry products of other suitable carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if need, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this compound can be suspended or dissolve.The preparation of solution, normally by active substance being dissolved in a kind of carrier, being packed into filter-sterilized before a kind of suitable bottle or ampoule, then seals.Adjuvant for example a kind of local anesthetic, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be by freezing this compositions after packing bottle into, and under vacuum, water is removed.
Chinese medicine preparation of the present invention, in the time being prepared into medicament, optionally add applicable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, can take every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
Chinese medicine preparation compositions of the present invention can adopt following methods preparation:
Get Radix Ginseng, with ethanol extraction, extracting solution filters, the concentrated panaxynol extracted extract that obtains of filtrate, and medicine residues of Radix Ginseng and all the other flavour of a drug merge, and decoct with water, and decocting liquid filters, and filtrate is concentrated obtains the water extracted immersing paste, merges two kinds of extractum, obtains pharmaceutically active substance of the present invention.This pharmaceutically active substance separately or mix with medicine acceptable carrier, is made Chinese medicine preparation compositions of the present invention according to galenic pharmacy routine techniques.
Preferably, the preparation method of Chinese medicine composition of the present invention is as follows:
Get Radix Ginseng powder and be broken into coarse powder, doubly measure alcohol reflux 2-4 time of 70-95% (v/v) with 4-10, each 3-5 hour, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water 2-4 time, each 1-3 hour, amount of water is that 4-10 doubly measures, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste, obtain pharmaceutically active substance of the present invention.This pharmaceutically active substance separately or mix with medicine acceptable carrier, is made Chinese medicine preparation compositions of the present invention according to galenic pharmacy routine techniques.
Most preferred, the preparation method of Chinese medicine composition of the present invention is as follows:
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, to obtain final product.
Chinese medicine composition of the present invention, through pharmacodynamic study, has following functions and cures mainly: supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling.For the cloudy obstruction of qi in the chest and cardialgia losing due to blood stasis of the deficiency of vital energy, that disease is seen is uncomfortable in chest, chest pain, cardiopalmus, breathe hard, weak, dry mouth and throat; Coronary heart diseases and angina pectoris is shown in above-mentioned patient.
The present invention also provides a kind of detection method for Chinese medicine preparation compositions of the present invention, the particularly detection method of granular preparation, and for controlling the quality of product, for medicine feature and formula of the present invention, we provide following detection method:
Detection method of the present invention comprises the following steps:
The observation of character, the discriminating of content, the inspection of content, carries out assay to the composition containing, and therefore, the main step of method of quality control of the present invention is:
The observation of character, step is:
[character] this product is brown yellow granule; Sweet in the mouth, micro-hardship.
The discriminating of content, step is:
This product 14g is got in [discriminating] (1), put in apparatus,Soxhlet's, add methanol 80ml, reflux 4 hours, extracting solution is put to room temperature, filter, and with appropriate methanol wash container, cleaning mixture and filtrate merge, evaporate to dryness, residue add water 10ml make dissolve, in dislocation separatory funnel, and with 4ml moisture time washing container, cleaning mixture is incorporated in separatory funnel, with petroleum ether (60～90 DEG C) jolting extraction 3 times, each 20ml, water layer is waved after most petroleum ether, with water saturated n-butyl alcohol jolting extraction 5 times, each 15ml, merge n-butyl alcohol liquid, with ammonia solution jolting washing 2 times, each 20ml, cleaning mixture extracts with same water saturated n-butyl alcohol 15ml jolting successively, merge n-butyl alcohol liquid, evaporate to dryness, residue adds methanol 3ml to be made to dissolve, add magnesia powder 7g, mix thoroughly, put in apparatus,Soxhlet's, add methanol appropriate, heating and refluxing extraction 4 hours, reclaim methanol to dry, residue precision adds methanol 2ml to make broad solution, as need testing solution.Separately get ginsenoside Rb1, Re, Rg1 reference substance, add methanol and make the mixed solution that every 1ml respectively contains 1mg, product solution in contrast.Get again Radix Ginseng control medicinal material 1g, by the preparation method of need testing solution, make control medicinal material solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 2 μ l～4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, taking 10 DEG C of following lower floor's solution of placing of chloroform-methanol-water (75:35:10) as developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 DEG C to be heated to speckle colour developing clear.In test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color.
(2) get this product 7g, the 20ml jolting that adds water makes to dissolve, with dilute hydrochloric acid adjusting PH to 2, centrifugal, get supernatant, extract (50,40,30ml) three times with ether jolting, merge ether solution, wash with water 2 times, each 10ml, ether solution adds appropriate anhydrous sodium sulfate dehydration, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, as need testing solution.Separately get protocatechualdehyde reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica GF254 lamellae, taking chloroform-acetone-formic acid (15:5:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (254nm) and inspect.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
(3) get this product 14g, add methanol 80ml, reflux 1 hour, filter, filtrate evaporate to dryness, residue add water 20ml make dissolve, extract 2 times with water saturated n-butyl alcohol jolting, each 15ml, merges n-butanol extracting liquid, with ammonia solution washing 2 times, each 20ml, divides and gets n-butyl alcohol liquid, evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution.Separately get peoniflorin reference substance, add methanol and make the solution of every 1ml containing 2mg, product solution in contrast.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-acetone-ammonia (4:2:0.5:0.2) as developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and 105 DEG C to be heated to speckle colour developing clear.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
(4) get this product 14g, put in apparatus,Soxhlet's, add dehydrated alcohol 80ml, reflux 2 hours, lets cool, and filters, filtrate adds hydrochloric acid 1ml, and reflux 1.5 hours, lets cool, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 10ml and water 14ml makes to dissolve, in dislocation separatory funnel, extract (30,25ml) 2 times with petroleum ether (60～90 DEG C) jolting, point get petroleum ether liquid, evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, as need testing solution.Separately get oleanolic acid reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin layer chromatography (Chinese Pharmacopoeia version one annex VI B in 2005), draw the each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking normal hexane-chloroform-ethyl acetate-methanol (20:5:4:2) as developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to speckle colour developing at 105 DEG C clear.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
(5) get this product 14g, the 50ml jolting that adds water makes to dissolve, and placement is spent the night, and gets supernatant, extracts 2 times with ether jolting, and each 25ml, merges ether solution, evaporate to dryness, and residue adds ethyl acetate 0.5ml to be made to dissolve, as need testing solution.Separately get Radix Aucklandiae control medicinal material 0.5g, the 10ml that adds diethyl ether, merceration spends the night, filters, filtrate evaporate to dryness, residue adds ethyl acetate 1ml to be made to dissolve, medical material solution in contrast.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, taking cyclohexane extraction-acetone (10:3) as developing solvent, launch, take out, dry, spray is with the mixed solution of 5% vanillin sulfuric acid solution and methanol (1:1), 105 DEG C be heated to speckle develop the color clear.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical blue spot.
(6) get this product 7g, the 20ml that adds water, jolting makes to dissolve, and placement is spent the night, and gets supernatant, and the 25ml jolting that adds diethyl ether is extracted, and divide and get ether solution, evaporate to dryness, residue adds dehydrated alcohol 0.5ml to be made to dissolve, as need testing solution.Separately get Fructus Citri Sarcodactylis control medicinal material 0.5g, the 20ml that adds diethyl ether, merceration spends the night, filters, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, medical material solution in contrast.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate (9:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (365nm) and inspect.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical sapphirine fluorescence speckle.
The inspection of content, step is:
[inspection] should meet every regulation relevant under granule item (annex I C of Chinese Pharmacopoeia version in 2005).
The composition containing is carried out to assay, and step is:
[assay] measured according to high performance liquid chromatography (annex VI D of Chinese Pharmacopoeia version in 2005).
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Methanol: 0.5% glacial acetic acid (5:95) is mobile phase; Detection wavelength is 280nm; Number of theoretical plate calculates and should be not less than 3000 by danshensu peak.
It is appropriate that the preparation precision of reference substance solution takes danshensu sodium reference substance, adds 30% methanol solution and make the solution (be equivalent to every 1ml containing 0.08mg danshensu) of every 1ml containing 0.09mg, to obtain final product.
This product under [content uniformity] check item is got in the preparation of need testing solution.Mix, get 1.2 grams, porphyrize, is placed in 25ml volumetric flask, adds 30% methanol solution appropriate, supersound process (power 250W, frequency 40KHZ) 5 minutes, and standardize solution, adds 30% methanol solution to scale, shakes up, and filters, and gets subsequent filtrate, to obtain final product.
Algoscopy is accurate reference substance solution and the each 20 μ L of need testing solution of drawing respectively, and injection liquid chromatography, measures, and to obtain final product.
Every bag of this product in danshensu (C9H10O5), must not be less than 15mg containing Radix Salviae Miltiorrhizae.
Below data declaration beneficial effect of the present invention by experiment:
One, pharmacodynamic experiment
(1) impact of yangxinshengmai granule agent on Myocardium in Anaesthetized Dogs ischemia
Form Model of Acute Myocardial Ischemia with constriction experiment dog left anterior descending coronary artery, adopt heart external mold electrograph mapping myocardial ischemia scope and degree, Quantitative Histology (N-BT dyeing) method is measured the heart, muscle infarction scope, study the impact of yangxinshengmai granule agent gastric infusion on experimental dog acute myocardial ischemia and myocardial infarction, experimental result shows, the have clear improvement effect of dog acute myocardial ischemia and muscle infarction of yangxinshengmai granule agent tool, alleviate degree of myocardial ischemia (E-ST) and myocardial ischemia scope (N-ST) by epicardial electrogram mapping, obviously dwindle through the infarct shown in N-BT dyeing.
(2) impact of yangxinshengmai granule agent on cardiac hemodynamics of dogs and myocardial oxygen consumption
The impact of this laboratory observation yangxinshengmai granule agent on cardiac hemodynamics of dogs and myocardial oxygen consumption, result shows: yangxinshengmai granule agent can obviously reduce myocardial oxygen consumption, lower the consumption of cardiac muscle to energy, and can obviously increase experimental dog coronary flow, strengthen myocardium blood supply, thereby improve myocardium energy metabolism and the equilibrium of supply and demand
(3) impact of yangxinshengmai granule agent on mice oxytolerant
Show with conventional oxytolerant result of the test, yangxinshengmai granule agent can obviously extend mice hypoxia endurance time, relatively has significant difference P < 0.05 with blank group.
(4) impact of yangxinshengmai granule agent on mice low temperature swimming time
Test mice is put into 10 ± 0.5C frozen water, and to observing tool swimming time, result shows, yangxinshengmai granule agent can extend mice low temperature swimming time 5-10 minute.
(5) impact of yangxinshengmai granule agent on mice autonomic activities
Observe the autonomic activities of mice with mice autonomic activities tester, result shows obviously minimizing autonomic activities number of times of yangxinshengmai granule agent day, has good sedation.
Two, toxicologic study
(1) acute toxicity test
Mouse stomach administration, mtd test proves, accumulated dose is 1600g/kg, is equivalent to 225 times of quantity, without death and toxic reaction.
(2) long term toxicity test
Rat oral gavage administration three months, to rat general state, activity, appetite, body weight, growth promoter have no adverse effects; Blood picture, electrocardiogram and the heart, liver, spleen, lung, kidney, adrenal gland, gastrointestinal and gonad are not all found obvious pathological change, and result confirms, yangxinshengmai granule agent can be pacified and share in clinical.
Three, clinical research
Clinical in the heavier patient of the 20 routine state of an illness, wherein belong to severe heart strand sick, each 9 examples of moderate angina pectoris.With after yangxinshengmai granule agent treatment, angina pectoris attacks number of times degree and nitroglycerin consumption obviously reduce, and it is 50% that electrocardiogram improves effective percentage, and total effective rate is 75%.Improving the anginal while, patient is uncomfortable in chest, cardiopalmus, mistake eye, breathe hard, the symptom such as cyanosis also has clear improvement.
Detailed description of the invention:
Further illustrate by the following examples the present invention, but not as limitation of the present invention.
Embodiment 1
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, obtain granule.
Embodiment 2
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, to obtain final product.
Embodiment 3
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, to obtain final product.
Embodiment 4
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, to obtain final product.
Embodiment 5
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, to obtain final product.
Embodiment 6
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, tabletting, obtains tablet.
Embodiment 7
[method for making] above 14 tastes, get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into the extractum that relative density is 1.10～1.15 (55 DEG C of surveys), merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 (55 DEG C of surveys) thick paste.Get 1 part of thick paste, add 1.5 parts, dextrin, granulate, the encapsulated capsule that obtains.
Claims (10)
1. a Chinese medicine preparation compositions for supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling, it is prepared from as crude drug by following Chinese medicine:
Radix Ginseng, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Arillus Longan, Fructus Lycii, Radix Paeoniae Rubra, Radix Achyranthis Bidentatae, Radix Curcumae, the Radix Aucklandiae, Fructus Citri Sarcodactylis, Poria, Rhizoma Alismatis, Radix Glycyrrhizae.
2. compositions according to claim 1, is characterized in that, is prepared from as crude drug by the Chinese medicine of following weight proportion:
。
3. compositions according to claim 1, is characterized in that, is prepared from as crude drug by the Chinese medicine of following weight proportion:
。
4. compositions according to claim 1, is characterized in that, is prepared from as crude drug by the Chinese medicine of following weight proportion:
。
5. compositions according to claim 1, it is characterized in that, by raw material of Chinese medicine is processed through extraction or other modes, make pharmaceutically active substance, subsequently, taking this material as raw material, while needs, add medicine acceptable carrier, make according to the routine techniques of galenic pharmacy, wherein pharmaceutically active substance, in preparation, shared percentage by weight is 0.1-99.9%, and all the other are medicine acceptable carrier.
6. compositions according to claim 1, it is characterized in that, be any pharmaceutically useful dosage form, be selected from tablet, capsule, oral liquid, suck agent, granule, pill, powder, unguentum, sublimed preparation, suspensoid, powder, injection, suppository, spray, drop, drop pill, patch.
7. the preparation method of compositions claimed in claim 1, is characterized in that, process following steps:
Get Radix Ginseng, with ethanol extraction, extracting solution filters, the concentrated panaxynol extracted extract that obtains of filtrate, and medicine residues of Radix Ginseng and all the other flavour of a drug merge, and decoct with water, and decocting liquid filters, and filtrate is concentrated obtains the water extracted immersing paste, merges two kinds of extractum, obtains pharmaceutically active substance of the present invention.This pharmaceutically active substance separately or mix with medicine acceptable carrier, is made Chinese medicine preparation compositions of the present invention according to galenic pharmacy routine techniques.
8. according to the preparation method of claim 7, it is characterized in that process following steps:
Get Radix Ginseng powder and be broken into coarse powder, doubly measure alcohol reflux 2-4 time of 70-95% with 4-10, each 3-5 hour, filter, it is 1.10～1.15 extractum that filtrate is concentrated into relative density, medicinal residues and all the other flavour of a drug merge, decoct with water 2-4 time, each 1-3 hour, amount of water is that 4-10 doubly measures, merge decocting liquid, filter, it is 1.10～1.15 extractum that filtrate is concentrated into relative density, merge above-mentioned two kinds of extractum, reconcentration to relative density is 1.10～1.15 thick pastes, obtain pharmaceutically active substance of the present invention, this pharmaceutically active substance separately or mix with medicine acceptable carrier, make Chinese medicine preparation compositions of the present invention according to galenic pharmacy routine techniques.
9. according to the preparation method of claim 7, it is characterized in that process following steps:
Get Radix Ginseng powder and be broken into coarse powder, with 8 times of amount 80% alcohol reflux three times, each 4 hours, filter, filtrate is concentrated into 55 DEG C and surveys the extractum that relative density is 1.10～1.15, medicinal residues and all the other flavour of a drug merge, decoct with water three times, 2 hours for the first time, every secondary 1.5 hours, 1 hour for the third time, amount of water is respectively 8 times of amounts, 6 times of amounts and 4 times of amounts, merge decocting liquid, filter, filtrate is concentrated into 55 DEG C and surveys the extractum that relative density is 1.10～1.15, merge above-mentioned two kinds of extractum, it is 1.10～1.15 thick pastes that reconcentration to 55 DEG C is surveyed relative density, get 1 part of thick paste, add 1.5 parts, dextrin, granulate, make 1000g, obtain.
10. the detection method of compositions described in claim 1, comprises the following steps:
The observation of character, the discriminating of content, the inspection of content, carries out assay to the composition containing, wherein:
The observation of character, step is:
[character] this product is brown yellow granule; Sweet in the mouth, micro-hardship,
The discriminating of content, step is:
This product 14g is got in [discriminating] (1), put in apparatus,Soxhlet's, add methanol 80ml, reflux 4 hours, extracting solution is put to room temperature, filter, and with appropriate methanol wash container, cleaning mixture and filtrate merge, evaporate to dryness, residue add water 10ml make dissolve, in dislocation separatory funnel, and with 4ml moisture time washing container, cleaning mixture is incorporated in separatory funnel, with petroleum ether (60～90 DEG C) jolting extraction 3 times, each 20ml, water layer is waved after most petroleum ether, with water saturated n-butyl alcohol jolting extraction 5 times, each 15ml, merge n-butyl alcohol liquid, with ammonia solution jolting washing 2 times, each 20ml, cleaning mixture extracts with same water saturated n-butyl alcohol 15ml jolting successively, merge n-butyl alcohol liquid, evaporate to dryness, residue adds methanol 3ml to be made to dissolve, add magnesia powder 7g, mix thoroughly, put in apparatus,Soxhlet's, add methanol appropriate, heating and refluxing extraction 4 hours, reclaim methanol to dry, residue precision adds methanol 2ml to make broad solution, as need testing solution, separately get ginsenoside Rb1, Re, Rg1 reference substance, add methanol and make the mixed solution that every 1ml respectively contains 1mg, product solution in contrast, get again Radix Ginseng control medicinal material 1g, press the preparation method of need testing solution, make control medicinal material solution, test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 2 μ l～4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, taking 10 DEG C of following lower floor's solution of placing of chloroform-methanol-water (75:35:10) as developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 105 DEG C to be heated to speckle colour developing clear, in test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color,
(2) get this product 7g, the 20ml jolting that adds water makes to dissolve, with dilute hydrochloric acid adjusting PH to 2, centrifugal, get supernatant, with ether jolting extraction three times (50, 40, 30ml), merge ether solution, wash with water 2 times, each 10ml, ether solution adds appropriate anhydrous sodium sulfate dehydration, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, as need testing solution, separately get protocatechualdehyde reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast, test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica GF254 lamellae, taking chloroform-acetone-formic acid (15:5:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (254nm) and inspect, in test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color,
(3) get this product 14g, add methanol 80ml, reflux 1 hour, filter, filtrate evaporate to dryness, residue add water 20ml make dissolve, with water saturated n-butyl alcohol jolting extraction 2 times, each 15ml, merge n-butanol extracting liquid, with ammonia solution washing 2 times, each 20ml, divide and get n-butyl alcohol liquid, evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution, separately get peoniflorin reference substance, add methanol and make the solution of every 1ml containing 2mg, product solution in contrast, test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-acetone-ammonia (4:2:0.5:0.2) as developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, 105 DEG C to be heated to speckle colour developing clear, in test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color,
(4) get this product 14g, put in apparatus,Soxhlet's, add dehydrated alcohol 80ml, reflux 2 hours, let cool, filter, filtrate adds hydrochloric acid 1ml, reflux 1.5 hours, let cool, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 10ml and water 14ml makes to dissolve, in dislocation separatory funnel, with petroleum ether (60～90 DEG C) jolting extraction 2 times (30, 25ml), divide and get petroleum ether liquid, evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, as need testing solution, separately get oleanolic acid reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast, test according to thin layer chromatography (Chinese Pharmacopoeia version one annex VI B in 2005), draw the each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking normal hexane-chloroform-ethyl acetate-methanol (20:5:4:2) as developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, be heated to speckle colour developing at 105 DEG C clear, in test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color,
(5) get this product 14g, the 50ml jolting that adds water makes to dissolve, placement is spent the night, get supernatant, with ether jolting extraction 2 times, each 25ml, merge ether solution, evaporate to dryness, residue adds ethyl acetate 0.5ml to be made to dissolve, as need testing solution, separately get Radix Aucklandiae control medicinal material 0.5g, 10ml adds diethyl ether, merceration spends the night, filter, filtrate evaporate to dryness, residue adds ethyl acetate 1ml to be made to dissolve, medical material solution in contrast, test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw above-mentioned need testing solution 10 μ l, control medicinal material solution 1 μ l, put respectively on same silica gel g thin-layer plate, taking cyclohexane extraction-acetone (10:3) as developing solvent, launch, take out, dry, spray is with the mixed solution of 5% vanillin sulfuric acid solution and methanol (1:1), 105 DEG C to be heated to speckle colour developing clear, in test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical blue spot,
(6) get this product 7g, 20ml adds water, jolting makes to dissolve, placement is spent the night, get supernatant, the 25ml jolting that adds diethyl ether is extracted, divide and get ether solution, evaporate to dryness, residue adds dehydrated alcohol 0.5ml to be made to dissolve, as need testing solution, separately get Fructus Citri Sarcodactylis control medicinal material 0.5g, 20ml adds diethyl ether, merceration spends the night, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml to be made to dissolve, medical material solution in contrast, test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2005), draw the each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate (9:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (365nm) and inspect, in test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical sapphirine fluorescence speckle,
The inspection of content, step is:
[inspection] should meet every regulation relevant under granule item (annex I C of Chinese Pharmacopoeia version in 2005),
The composition containing is carried out to assay, and step is:
[assay] measured according to high performance liquid chromatography (annex VI D of Chinese Pharmacopoeia version in 2005),
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Methanol: 0.5% glacial acetic acid (5:95) is mobile phase; Detection wavelength is 280nm; Number of theoretical plate calculates and should be not less than 3000 by danshensu peak,
It is appropriate that the preparation precision of reference substance solution takes danshensu sodium reference substance, adds 30% methanol solution and make the solution (be equivalent to every 1ml containing 0.08mg danshensu) of every 1ml containing 0.09mg, to obtain final product,
This product under [content uniformity] check item is got in the preparation of need testing solution, mixes, and gets 1.2 grams, porphyrize, is placed in 25ml volumetric flask, adds 30% methanol solution appropriate, supersound process (power 250W, frequency 40KHZ) 5 minutes, standardize solution, add 30% methanol solution to scale, shake up, filter, get subsequent filtrate, obtain
Algoscopy is accurate reference substance solution and the each 20 μ L of need testing solution of drawing respectively, and injection liquid chromatography, measures, and to obtain final product.
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| CN110579539A (en) * | 2019-07-11 | 2019-12-17 | 神威药业集团有限公司 | Establishing method of fingerprint of Huaganjian tea |
| CN116370556A (en) * | 2023-05-24 | 2023-07-04 | 秦皇岛市山海关药业有限责任公司 | Traditional Chinese medicine composition for promoting blood circulation to remove blood stasis, tonifying qi and soothing nerves and preparation method thereof |
| CN116999533A (en) * | 2023-08-16 | 2023-11-07 | 秦皇岛市山海关药业有限责任公司 | Heart-nourishing and pulse-activating granule, preparation method thereof and application thereof in antidepressant product |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110579539A (en) * | 2019-07-11 | 2019-12-17 | 神威药业集团有限公司 | Establishing method of fingerprint of Huaganjian tea |
| CN110579539B (en) * | 2019-07-11 | 2021-08-06 | 神威药业集团有限公司 | Establishing method of fingerprint of Huaganjian tea |
| CN116370556A (en) * | 2023-05-24 | 2023-07-04 | 秦皇岛市山海关药业有限责任公司 | Traditional Chinese medicine composition for promoting blood circulation to remove blood stasis, tonifying qi and soothing nerves and preparation method thereof |
| CN116370556B (en) * | 2023-05-24 | 2024-03-22 | 秦皇岛市山海关药业有限责任公司 | Traditional Chinese medicine composition for promoting blood circulation to remove blood stasis, tonifying qi and soothing nerves and preparation method thereof |
| CN116999533A (en) * | 2023-08-16 | 2023-11-07 | 秦皇岛市山海关药业有限责任公司 | Heart-nourishing and pulse-activating granule, preparation method thereof and application thereof in antidepressant product |
| CN116999533B (en) * | 2023-08-16 | 2024-06-07 | 秦皇岛市山海关药业有限责任公司 | Heart-nourishing and pulse-activating granule, preparation method thereof and application thereof in antidepressant product |
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