CN103006838B - Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases - Google Patents
Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine extracts in parts by weight: 20-40 parts of salvia miltiorrhiza extracts, 1-3 parts of notoginseng extracts, and 20-40 parts of hawthorn extracts.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belong to the field of Chinese medicines.
Background technology:
Cardiovascular and cerebrovascular disease is the serious disease of harm humans health and life, is called " the No.1 killer of the mankind " by World Health Organization (WHO).In China, annual nearly 1,950,000 new cardiovascular patients, have nearly 1,560,000 people to die from cardiovascular disease, and cardiovascular and cerebrovascular disease causes the rate of dying and reached 35%, occupies various diseases and causes first of the rate of dying.Cardiovascular patient 500-700 ten thousand people of existence, wherein 75% leave different deformity, cause heavy burden to society and family.Ended for the end of the year 2000,60 years old above old man of China has 1.3 hundred million.Within 40 years old, above middle-aged and elderly people is the group of people at high risk of cardiovascular and cerebrovascular disease, every increase of age 10 years old, and Patients with Cardiovascular/Cerebrovascular Diseases will be how one times, 70 years old above old people, the prevalence of cardiovascular and cerebrovascular disease approaches 100%.Along with the raising of living standard, the change of dietary structure, the increase of operating pressure, cardiovascular and cerebrovascular disease is tending towards rejuvenation, and it is not within minority that the person between twenty and fifty of one's late 30s send out patient.More and more pay attention to from now on the raising of quality of life along with people, the understanding of cardiovascular and cerebrovascular disease harm will progressively be deepened, and hospitalization expense costliness, will there is increasing Patients with Cardiovascular/Cerebrovascular Diseases to take the method cure diseases of chemoprophylaxis and treatment.
Traditional Chinese patent medicine mostly is the semifinished product that pulverizing medicinal materials becomes former medicated powder or only slightly carries, and has that effective component content is low, dose is large, absorb not exclusively, bioavailability is low, drug effect performance is slow, carry the deficiencies such as inconvenient.Along with improving constantly of scientific and technical development and new drug development level, the continuous application of new theory, new technique, new technology, new equipment, traditional Chinese patent medicine is not in full conformity with the requirement of the modernization of Chinese medicine.Compositions involved in the present invention is made up of Radix Salviae Miltiorrhizae, Radix Notoginseng, Fructus Crataegi, wherein monarch drug Radix Salviae Miltiorrhizae, GUIXIN, Liver Channel, there is blood circulation promoting and blood stasis dispelling, pain relieving removing heat from blood, relieving restlessness clears away heart-fire, effect of nourishing blood to tranquillize the mind, remarkable to coronary heart disease and curative effect to treat angina pectoris, be one of the most frequently used medicine for the treatment of coronary disease with traditional Chinese medicine.Ministerial drug Radix Notoginseng returns liver, stomach warp, has effect of promoting blood circulation and hemostasis, blood stasis dispelling analgesic therapy, expelling pathogenic factors from muscles for reducing heat, can increase coronary artery blood flow, stablizes the rhythm of the heart, improve microcirculation.Adjuvant drug Fructus Crataegi has promoting blood circulation to remove blood stasis, effect of the circulation of qi promoting of reducing phlegm, appetite-stimulating indigestion-relieving, the stagnant removing food stagnancy of change, auxiliary adjustment blood glucose, blood fat, and meanwhile, conditioning patient's gastrointestinal function, controls the heart and protects again stomach; Adjuvant drug coordinates the minor symptom of monarch drug ministerial drug treatment patients with coronary heart disease, improves quality of life of coronary heart disease cases.
Prior art is varied to the processing mode of Chinese medicine, but become curative effect good Chinese drug preparation, the quality of the pharmaceutical preparations is high, shelf time is long, good stability, the beautiful Chinese medicine preparation of outward appearance difficulty is a lot, the present invention passes through on the basis of existing technology to Radix Salviae Miltiorrhizae, Radix Notoginseng, Fructus Crataegi carries out craft screening, select a kind of selected extraction, purification, process for refining, remove Radix Salviae Miltiorrhizae, Radix Notoginseng, in Fructus Crataegi, most of impurity also retains the effective ingredient of each flavour of a drug to greatest extent, make tablet with this effective ingredient, capsule, drop pill, the dosage forms such as granule, can meet better the medication demand of Patients with Cardiovascular/Cerebrovascular Diseases.
Summary of the invention:
The object of the present invention is to provide a kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
The present invention is implemented by following scheme:
A Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease, is characterized in that, this pharmaceutical composition is made up of the Chinese medicine extract of following proportioning:
Radix Salviae Miltiorrhizae extract 20～40 weight portions, Radix Notoginseng extract 1～3 weight portion, Fructus Crataegi extract 20～40 weight portions.
Preferably, this pharmaceutical composition is made up of the raw material of Chinese medicine medicine of following proportioning:
Radix Salviae Miltiorrhizae extract 30 weight portions, Radix Notoginseng extract 2 weight portions, Fructus Crataegi extract 30 weight portions.
More than in composition, if weight taking gram as unit of weight, above composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, 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 composition of the present invention is that making pharmaceutically active substance is extract of the present invention by raw material of Chinese medicine is processed through extraction or other modes, subsequently, taking this material as raw material, while needs, add medicine acceptable carrier, make Chinese medicine preparation 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 composition 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, capsule, oral liquid, suck agent, granule, pill, powder, unguentum, sublimed preparation, suspensoid, powder, injection, suppository, ointment, plaster, cream, spray, drop, patch, drop pill.Preparation of the present invention, preferably peroral dosage form, as: capsule, tablet, oral liquid, granule etc.
Chinese medicine composition 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 composition 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, ethanol, water etc.
Chinese medicine composition 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.
Compositions of the present invention is preferably by raw material of Chinese medicine medicine Radix Salviae Miltiorrhizae, Radix Notoginseng, and Fructus Crataegi is extracted respectively and obtains extract, taking three kinds of extracts as active constituents of medicine, is prepared into the pharmaceutical preparation that is applicable to taking.
Wherein, extracting method is as follows:
The extracting method of Radix Salviae Miltiorrhizae is as follows:
Radix Salviae Miltiorrhizae ethanol extraction, acid for adjusting pH to 1.5 for extracting solution～4.2, cooling, to filter, macroporous resin column on filtrate, first washes with water, then uses ethanol elution, collects ethanol elution, concentrated, dry, obtains Radix Salviae Miltiorrhizae extract;
The extracting method of Radix Notoginseng is as follows:
Radix Notoginseng water or ethanol extraction, extracting liquid filtering, anion-exchange resin column on filtrate, with ethanol elution, collects eluent; Macroporous resin column on eluent, first washes with water, then uses ethanol elution, collects ethanol elution; Concentrated, dry, obtain Radix Notoginseng extract;
Wherein the extracting method of Fructus Crataegi is as follows:
Fructus Crataegi water extraction, extracting solution filters, and macroporous resin column on filtrate, first washes with water, then uses ethanol elution, collects ethanol elution; Concentrated, dry, obtain Fructus Crataegi extract.
Preferably, extracting method is as follows:
1, get the Radix Salviae Miltiorrhizae of salvia piece or pulverizing, add 40%～70% alcohol heating reflux and extract 2～4 times, add 5～7 times of water gagings of medical material weight, each 0.5～2 hour at every turn; Merge extractive liquid,, is 1.5～4.2 to let cool with acid for adjusting pH, centrifugal or filter, get clear liquor or filtrate and go up the macroporous resin column that resin volume is equivalent to 2～4 times of crude drugs, first water rinses, and water lotion discards, use again 85～95% ethanol elutions of 2～3 times of column volumes, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add 2-6 times of water gaging of medical material weight or the extraction of 10%～90% alcohol heating reflux or supersound extraction 1～3 time, each 1-3 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, with 40%～70% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 40%～70% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
Described Fructus Crataegi extract is prepared by following method: the Fructus Crataegi of getting pulverizing, warm macerating 1-3h adds water, heating and refluxing extraction or supersound extraction 2～4 times, extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first water rinses, use again 50%～70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
Preferred, extracting method is as follows:
1, get the Radix Salviae Miltiorrhizae of salvia piece or pulverizing, add 50%～60% alcohol heating reflux and extract 3 times, add 6 times of water gagings of medical material weight, each 1 hour at every turn; Merge extractive liquid,, is 2.5～3.5 to let cool with acid for adjusting pH, centrifugal or filter, get clear liquor or filtrate and go up the macroporous resin column that resin volume is equivalent to 3 times of crude drugs, first water rinses, and water lotion discards, use again 90% ethanol elution of 2.5 times of column volumes, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add 4 times of water gagings of medical material weight or the extraction of 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, with 50%～60% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 50%～60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 4 times of water gaging warm macerating 2h of medical material weight, heating and refluxing extraction or supersound extraction 3 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
The present invention further comprises, three kinds of extracts that extract with said method are mixed as active constituents of medicine, is prepared into the pharmaceutical preparation that is applicable to taking.
According to the present invention, in Radix Salviae Miltiorrhizae extract, content of Danshensu is 3%～10%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50%～75%, and content of danshinolic acid B is 20%～45%.In Radix Notoginseng extract, content of the total saponins in radix notoginseng is 60%～98%.The flavone content of hawthorn of Fructus Crataegi extract is 20%～50%.
Below data further illustrate beneficial effect of the present invention by experiment.
Drug efficacy study
Refining XINKESHU PIAN function of resisting myocardial ischemia research
Medicine and reagent: be subject to test product: refining XINKESHU PIAN (tablet prepared by the preparation method of the embodiment of the present invention 1), lot number: 110901; Positive control drug (FUFANG DANSHEN DIWAN, lot number 100921).Lidocaine hydrochloride injection (lidocaine hydrochlorate injection), lot number 20110904, Shangdong Hualu Pharmaceutical Co., Ltd. produces; 3% pentobarbital sodium (sodium pentobarbital), lot number 101013, the real development in science and technology company limited in length and breadth in north; 1% triphenyltetrazolium chloride (TTC), lot number 1215B32, SIGMA company product; 0.2% heparin sodium injection, lot number 110811, Shandong Lukang Cisen Pharmaceutical Co., Ltd.Lactic acid dehydrogenase (LDH) test kits: lot number 110042, creatine kinase (CK) test kits: lot number 100673, is Beijing Zhongsheng Beikong Biological Science & Technology Co., Ltd. and produces.
Animal: hybrid dog, male and female dual-purpose, body weight: 12.4 ± 1.9kg, is provided by Shandong University's Experimental Animal Center.
Instrument: SC-3 type electric pulmotor (Shanghai Medical Equipment Factory); MFV-3200 type electromagnetic flowmeter (Japanese photoelectricity product); RM-6000 channel polygraph (Japanese photoelectricity product); Steellex LG-R-80D type blood viscosity instrument (Zhong Qinshidi scientific instrument company limited).
Step: animal, with pentobarbital sodium 30mg/kg intravenous injection anesthesia, separates left carotid, intubate Bonding pressure transducer, recording blood pressure.Tracheal intubation is carried out assisted respiartion.Along left side, the 4th intercostal is opened breast, seam pericardium bed.Separate aortic arch, place electromagnetic flowmeter probe, measure cardiac output.Apex of the heart intubate, Bonding pressure transducer, measures intraventricular pressure.Seam put 16 lead epicardial lead connect ecg amplifier, record visceral pericardium electrocardiogram.Abdominal part opening, separates duodenum for administrable.Indices is stablized after 15min, records normal value as the front data of experiment, adopt two step ligation method ligation arteria coronaria left anterior descending branches, and in formal ligation administration at once, model group is given the normal saline with the capacity of grade.Respectively before ligation, at once, after ligation 5,10,15,30,45,60,90,120,150,180 min record visceral pericardium electrocardiogram in ligation; Before ligation and ligation after 30,60,120,180min records animal hemodynamic index; Respectively at 180 min time point heart extracting bloods before pre-bundle and after ligation, measure LDH and CK content in whole blood viscosity and serum.When off-test, core dirty, be on average cut into five from the apex of the heart to ligation point, 1%TTC dyeing, takes pictures, and picture is inputted to computer, the ratio with image analysis software calculating infarct size with Suo Qie cardiac muscular tissue area.
Result
One, the impact on myocardial ischemia aspect
From table 1, table 2, with model group comparison, after positive control drug 160mg crude drug/kg administration 15 minutes, the scope of myocardial ischemia started to dwindle, and after administration, the above results of 30 minutes points and model group relatively have significant difference; When administration 5 minutes, the order of severity of myocardial ischemia and model group be existing alleviation relatively, putting two groups of these indexs in 30 minutes has significant difference, although degree of ischemia and model group comparison do not have statistical significance after 30 minutes, but still maintains reduced levels until experiment finishes; After ischemia 3 hours, in myocardial infarction percentage ratio and serum, LDH, CK level are all starkly lower than model group.
Be subject to after test product 320mg crude drug/kg administration, the scope of each time point myocardial ischemia, ischemia after 3 hours myocardial infarction ratio all similar to model group with LDH, CK level in serum, although the degree of myocardial ischemia decreases in the short time compared with model group after ligation, between two groups, there is no significant difference.Be subject within 5 minutes, to start to see after the self administration of medication/ligation of reagent 160mg crude drug/kg group that the scope of animal cardiac muscle ischemia dwindles, and maintain all the time this level, wherein after ligation, 10,15,30,45,60,120,180 minutes point ischemia scopes and model group relatively have significant difference; When administration/ligation 5 minutes, the relatively more existing institute of the order of severity of myocardial ischemia and model group is alleviated, and maintains reduced levels all the time until experiment finishes, and wherein 30 and 60 minutes are put significant difference between two groups; Myocardial infarction ratio and serological index and model group more also have significant difference.Similar to heavy dose group, be subject to reagent 80mg crude drug/kg group myocardial ischemia scope close with model group, and within after the self administration of medication/ligation of the myocardial ischemia order of severity 5 minutes, start to alleviate to some extent, although relatively there is no statistical significance with model group, but still maintain reduced levels until experiment finishes; Though myocardial infarction ratio and model group comparison decrease, and there is no statistical significance, (LDH, CK) is similar to model group for serological index.
ECG ST segment statistical result shows, is subject to degree and the scope comparison of each time point myocardial ischemia of reagent 160mg crude drug/kg group and positive control drug 160mg crude drug/kg group, difference that there are no significant; LDH, also there was no significant difference of CK level in myocardial infarction ratio between two groups and serum.
After positive drug administration, can alleviate degree of ischemia; dwindle ischemia scope, show function of resisting myocardial ischemia, and be subject to dose form in reagent to reveal better ischemia resisting effect; in ischemia scope; there is certain fluctuation in positive drug, and middle dosage effect is stable, maintains all the time reduced levels; in degree of ischemia; compared with positive drug, middle dosage shows better protective effect in the ischemia starting stage, and it is low that ST section is raised more positive group of numerical value.As can be seen here, aspect resisting myocardial ischemia, in refining XINKESHU PIAN, dosage has definite curative effect, and is better than FUFANG DANSHEN DIWAN.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in detail.
Embodiment 1
1, get Radix Salviae Miltiorrhizae, pulverize, add 60% alcohol heating reflux and extract 3 times, add 6 times of water gagings of medical material weight, each 1 hour at every turn; Merge extractive liquid,, is 2.8 to let cool with acid for adjusting pH, centrifugal, gets the macroporous resin column that resin volume on clear liquor is equivalent to 3 times of crude drugs, and first water rinses, and water lotion discards, then uses 90% ethanol elution of 2.5 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get Radix Notoginseng, pulverize, add the 50% alcohol heating reflux extraction of 3 times of amounts of medical material weight or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, uses 60% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 4 times of water gaging warm macerating 2h of medical material weight, heating and refluxing extraction or supersound extraction 3 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
4,1-3 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, tabletting, coating, makes 1000, to obtain final product.
Embodiment 2
The 1-3 of embodiment 1 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add Icing Sugar, starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation agent 1000g.
Embodiment 3
The 1-3 of embodiment 1 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granule processed, incapsulates 1000.
Embodiment 4
1, get salvia piece, add 40%% alcohol heating reflux and extract 2 times, add 5 times of amounts of medical material weight, each 0.5 hour at every turn; Merge extractive liquid,, with acid for adjusting pH be 1.5, let cool, centrifugal or filter, get the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 2 times of crude drugs, first water rinses, water lotion discards, then uses 85% ethanol elution of 2 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add 2 times of water gaging heating extraction of medical material weight 1 time, 1 hour, extracting solution concentrating under reduced pressure, centrifugal, get clear liquor; Anion-exchange resin column on clear liquor, uses 40% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 40% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 2 times of water gaging warm macerating 1h of medical material weight, heating and refluxing extraction 2 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, first water rinses, then uses 50% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
1-3 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, tabletting, coating, makes 1000, to obtain final product.
Embodiment 5
1, get the Radix Salviae Miltiorrhizae of pulverizing, add 70% alcohol heating reflux and extract 4 times, add 7 times of amounts of medical material weight, each 2 hours at every turn; Merge extractive liquid,, is 4.2 to let cool with acid for adjusting pH, centrifugal or filter, and gets the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 4 times of crude drugs, and first water rinses, and water lotion discards, then uses 95% ethanol elution of 3 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add 6 times of amount 90% ethanol ultrasonic extraction of medical material weight 3 times, each 3 hours, extracting solution concentrating under reduced pressure, filtered, and anion-exchange resin column on filtrate, uses 70% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 70% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 6 times of water gaging warm macerating 3h of medical material weight, supersound extraction 4 times, each 3 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, and first water rinses, then uses 70% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
1-3 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, tabletting, coating, makes 1000, to obtain final product.
Embodiment 6
1, get the Radix Salviae Miltiorrhizae of salvia piece or pulverizing, add 50% alcohol heating reflux and extract 3 times, add 6 times of water gagings of medical material weight, each 1 hour at every turn; Merge extractive liquid,, is 2.5 to let cool with acid for adjusting pH, centrifugal or filter, and gets the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 3 times of crude drugs, and first water rinses, and water lotion discards, then uses 90% ethanol elution of 2.5 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, get the Radix Notoginseng of pulverizing, add 4 times of water gagings of medical material weight or the extraction of 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, uses 50% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 50% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 4 times of water gaging warm macerating 2h of medical material weight, heating and refluxing extraction or supersound extraction 3 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
1-3 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, tabletting, coating, makes 1000, to obtain final product.
Embodiment 7
1, get the Radix Salviae Miltiorrhizae of salvia piece or pulverizing, add 60% alcohol heating reflux and extract 3 times, add 6 times of water gagings of medical material weight, each 1 hour at every turn; Merge extractive liquid,, is 3.5 to let cool with acid for adjusting pH, centrifugal or filter, and gets the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 3 times of crude drugs, and first water rinses, and water lotion discards, then uses 90% ethanol elution of 2.5 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, get the Radix Notoginseng of pulverizing, add 4 times of water gagings of medical material weight or the extraction of 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, uses 60% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Fructus Crataegi of pulverizing, add 4 times of water gaging warm macerating 2h of medical material weight, heating and refluxing extraction or supersound extraction 3 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets the upper macroporous resin column of clear liquor or filtrate, first water rinses, then uses 60% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
1-3 is walked to Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Fructus Crataegi extract 600g that make and mix, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, tabletting, coating, makes 1000, to obtain final product.
The refining XINKESHU PIAN of table 1. is to Myocardium in Anaesthetized Dogs ischemia scope (N
sT) impact (X ± SD)
Moment result corresponding to model group compared, * P<0.05
The impact (X ± SD, mV) that the refining XINKESHU PIAN of table 2. is raised epicardial electrogram ST section due to Myocardium in Anaesthetized Dogs ischemia
Moment result corresponding to model group compared, * P<0.05
The impact (X ± SD) of the refining XINKESHU PIAN of table 3. on anesthetized dog coronary ligation myocardial infarct size after 3 hours
| ? | Dosage (mg crude drug/kg) | Number of animals | Ischemia scope (%) |
| Model group | -- | 10 | 3.6±1.3 |
| Positive group | 160 | 5 | 1.4±1.1* |
| Heavy dose of group | 320 | 5 | 3.8±4.6 |
| Middle dosage group | 160 | 5 | 1.9±0.5* |
| Small dose group | 80 | 5 | 2.0±2.0 |
Compared with model group, * P<0.05
The refining XINKESHU PIAN of table 4. on anesthetized dog coronary ligation after the impact (X ± SD, U/L) of LDH level in serum
| ? | Dosage (mg crude drug/kg) | Number of animals | Before ligation | After ligation 3 hours | Difference before and after ligation |
| Model group | -- | 10 | 64.9±18.1 | 141.4±22.3 | 76.5±25.1 |
| Positive group | 160 | 5 | 72.5±13.0 | 125.2±26.3 | 52.7±25.5* |
| Heavy dose of group | 320 | 5 | 67.0±29.4 | 140.4±22.4 | 73.4±36.7 |
| Middle dosage group | 160 | 5 | 75.4±23.8 | 121.6±23.1 | 46.2±12.2* |
| Small dose group | 80 | 5 | 79.2±26.3 | 159.2±26.7 | 80.4±36.3 |
Compared with model group, * P<0.05
The refining XINKESHU PIAN of table 5. on anesthetized dog coronary ligation after the impact (X ± SD, U/L) of CK level in serum
| ? | Dosage (mg crude drug/kg) | Number of animals | Before ligation | After ligation 3 hours | Difference before and after ligation |
| Model group | -- | 11 | 311.4±132.2 | 1740.9±579.9 | 1429.5±651.0 |
| Positive group | 160 | 5 | 224.4±65.7 | 963.0±382.2* | 738.6±370.2* |
| Heavy dose of group | 320 | 5 | 247.2±67.9 | 1965.4±600.8 | 1718.2±593.7 |
| Middle dosage group | 160 | 5 | 403.8±88.9 | 1110.2±242.2* | 706.4±232.2* |
| Small dose group | 80 | 5 | 367.6±145.8 | 1684.4±583.6 | 1316.8±518.1 |
Compared with model group, * P<0.05.
Claims (5)
1. a Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease, is characterized in that, this pharmaceutical composition is made up of the Chinese medicine extract of following proportioning: Radix Salviae Miltiorrhizae extract 20～40 weight portions, and Radix Notoginseng extract 1～3 weight portion, Fructus Crataegi extract 20～40 weight portions,
Wherein, the preparation method of Radix Salviae Miltiorrhizae extract is as follows:
Radix Salviae Miltiorrhizae ethanol extraction, acid for adjusting pH to 1.5 for extracting solution～4.2, cooling, to filter, macroporous resin column on filtrate, first washes with water, then uses ethanol elution, collects ethanol elution, concentrated, dry, obtains Radix Salviae Miltiorrhizae extract; Wherein, the preparation method of Radix Notoginseng extract is as follows:
Radix Notoginseng water or ethanol extraction, extracting liquid filtering, anion-exchange resin column on filtrate, with ethanol elution, collects eluent; Macroporous resin column on eluent, first washes with water, then uses ethanol elution, collects ethanol elution; Concentrated, dry, obtain Radix Notoginseng extract;
Wherein, the preparation method of Fructus Crataegi extract is as follows:
Fructus Crataegi water extraction, extracting solution filters, and macroporous resin column on filtrate, first washes with water, then uses ethanol elution, collects ethanol elution; Concentrated, dry, obtain Fructus Crataegi extract;
Wherein in Radix Salviae Miltiorrhizae extract, content of Danshensu is 3%～10%, and Radix Salviae Miltiorrhizae total phenolic acids content is 50%～75%, and content of danshinolic acid B is 20%～45%;
Wherein in Radix Notoginseng extract, content of the total saponins in radix notoginseng is 60%～98%;
Wherein the flavone content of hawthorn of Fructus Crataegi extract is 20%～50%.
2. Chinese medicine composition as claimed in claim 1, is characterized in that, this pharmaceutical composition is made up of the Chinese medicine extract of following proportioning:
Radix Salviae Miltiorrhizae extract 30 weight portions, Radix Notoginseng extract 2 weight portions, Fructus Crataegi extract 30 weight portions.
3. a Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease, is characterized in that, this pharmaceutical composition is made up of the Chinese medicine extract of following proportioning: Radix Salviae Miltiorrhizae extract 20～40 weight portions, and Radix Notoginseng extract 1～3 weight portion, Fructus Crataegi extract 20～40 weight portions,
Described Radix Salviae Miltiorrhizae extract is prepared by following method: get the Radix Salviae Miltiorrhizae of salvia piece or pulverizing, add 40%～70% alcohol heating reflux and extract 2～4 times, add the ethanol of 5～7 times of amounts of medical material weight, each 0.5～2 hour at every turn; Merge extractive liquid,, with acid for adjusting pH be 1.5～4.2, let cool, centrifugal or filter, get the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 2～4 times of crude drugs, first water rinses, water lotion discards, then uses 85～95% ethanol elutions of 2～4 times of column volumes, collects eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Described Radix Notoginseng extract is prepared by following method: add 2-6 times of water gaging of medical material weight or the extraction of 10%～90% alcohol heating reflux or supersound extraction 1～3 time, and each 1-3 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or filtrate; The upper anion-exchange resin column of clear liquor or filtrate, with 40%～70% ethanol elution, collects eluent; Macroporous resin column on eluent, first water rinses, then uses 40%～70% ethanol elution, collects ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract;
Described Fructus Crataegi extract is prepared by following method: the Fructus Crataegi of getting pulverizing, warm macerating 1-3h adds water, heating and refluxing extraction or supersound extraction 2～4 times, extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first water rinses, use again 50%～70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Fructus Crataegi extract.
4. according to the Chinese medicine composition described in claim 1 or 3, it is characterized in that, described compositions is tablet, capsule, drop pill, granule, injection.
5. the application of the Chinese medicine composition described in claim 1 or 3 in the medicine of preparation treatment cardiovascular and cerebrovascular disease.
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