CN103006769A - Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases and preparation method thereof Download PDFInfo
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- CN103006769A CN103006769A CN2013100024923A CN201310002492A CN103006769A CN 103006769 A CN103006769 A CN 103006769A CN 2013100024923 A CN2013100024923 A CN 2013100024923A CN 201310002492 A CN201310002492 A CN 201310002492A CN 103006769 A CN103006769 A CN 103006769A
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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 pueraria 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 " human No.1 killer " 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 for society and family.Ended for the end of the year 2000, the old man of China more than 60 years old has 1.3 hundred million.Middle-aged and elderly people more than 40 years old 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, the old people more than 70 years old, the prevalence of cardiovascular and cerebrovascular disease is near 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 the 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 is progressively deepened, and the hospitalization expense is expensive, will have 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, the drug effect performance is slow, carry the deficiencies such as inconvenient.Along with the development of science and technology and improving constantly of 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 comprised of Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Puerariae, monarch drug Radix Salviae Miltiorrhizae wherein, GUIXIN, Liver Channel, have blood circulation promoting and blood stasis dispelling, pain relieving removing heat from blood, relieving restlessness clears away heart-fire, the 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, Radix Puerariae are returned liver, stomach warp, have the 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, stablize the rhythm of the heart, improve microcirculation.The monarch drug ministerial drug cooperatively interacts, and the various cardinal symptoms for the treatment of patients with coronary heart disease are improved the patients with coronary heart disease cardiac function, and the while resolving depression is brought down a fever, analgesic therapy is calmed the nerves.
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, Radix Puerariae carries out craft screening, has selected a kind of selected extraction, purification, process for refining removes Radix Salviae Miltiorrhizae, Radix Notoginseng, most of impurity also keeps the effective ingredient of each flavour of a drug to greatest extent in the Radix Puerariae, make tablet with this effective ingredient, capsule, drop pill, the dosage forms such as granule can satisfy the medication demand of Patients with Cardiovascular/Cerebrovascular Diseases better.
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 kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease is characterized in that, this pharmaceutical composition is made by the Chinese medicine extract of following proportioning:
Radix Salviae Miltiorrhizae extract 20～40 weight portions, Radix Notoginseng extract 1～3 weight portion, Radix Puerariae extract 20～40 weight portions.
Preferably, this pharmaceutical composition is made by the raw material of Chinese medicine medicine of following proportioning:
Radix Salviae Miltiorrhizae extract 30 weight portions, Radix Notoginseng extract 2 weight portions, Radix Puerariae extract 30 weight portions.
In the above composition, if weight take 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 in tablet, granule 1000 grams, oral liquid 1000ml etc.
If above composition in grams, can be made into the preparation of 50-1000 taking dose, as tablet, makes 1000, and each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, each serving using the 1-2 bag, can take 62.5-125 time altogether.
Above composition is by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, can be take kilogram as unit such as large-scale production, or take ton as unit, small-scale production also can be take milligram as unit, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and such as serious symptom or light disease, fat or modest patient, the proportioning of the amount that can corresponding adjustment forms increases or reduces being no more than 100%, and drug effect is constant.
Single medicinal material in the above composition, especially ministerial drug and adjuvant drug also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine composition of the present invention, be by with raw material of Chinese medicine through extracting or other modes are processed, making pharmaceutically active substance is extract of the present invention, subsequently, take this material as raw material, add the medicine acceptable carrier when needing, 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 pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester are carried, the methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be fluid extract, make different concentration according to the different needs decisions of preparation.
Pharmaceutically active substance in the Chinese medicine composition of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the 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, such 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, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule etc.
Chinese medicine composition of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
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 suitable acceptable wetting agent of medicine comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Repeatedly mix active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of before use available water or other suitable composite dry products of 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 necessary, 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 chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, then sealing.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 after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Chinese medicine composition of the present invention, when being prepared into medicament, optionally add suitable 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-, the 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, but takes every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
Compositions of the present invention is preferably with raw material of Chinese medicine medicine Radix Salviae Miltiorrhizae, Radix Notoginseng, and Radix Puerariae extracts respectively and obtains extract, take three kinds of extracts as active constituents of medicine, is prepared into the pharmaceutical preparation that is fit to take.
Wherein said extract, extracting method is as follows:
The extracting method of Radix Salviae Miltiorrhizae is as follows:
The Radix Salviae Miltiorrhizae ethanol extraction, extracting solution cools off with acid for adjusting pH to 1.5～4.2, filters, and macroporous resin column on the filtrate washes with water first, uses ethanol elution again, collects ethanol elution, and concentrated, drying namely gets 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 the filtrate is used ethanol elution, collects eluent; Macroporous resin column on the eluent washes with water first, uses ethanol elution again, collects ethanol elution; Concentrated, drying gets Radix Notoginseng extract;
The extracting method of Radix Puerariae is as follows:
The Radix Puerariae ethanol extraction, extracting solution filters, and macroporous resin column on the filtrate washes with water first, uses ethanol elution again, collects ethanol elution; Concentrated, drying gets Radix Puerariae extract.
Preferably, extracting method is as follows:
1, gets 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, and is centrifugal or filter, get clear liquor or filtrate and go up the macroporous resin column that the resin volume is equivalent to 2～4 times of crude drugs, first water flushing, water lotion discards, use again 85～95% ethanol elutions of 2～3 times of column volumes, collect eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add the extraction of 2-6 times of water gaging of medical material weight or 10%～90% alcohol heating reflux or supersound extraction 1～3 time, each 1-3 hour, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate with 40%～70% ethanol elution, is collected eluent; Macroporous resin column on the eluent, 40%～70% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add that medical material weight 2-6 measures doubly that 30%～70% alcohol heating reflux extracts or supersound extraction 2～4 times, each 0.5-1.5 hour, the extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first water flushing, use again 40%～70% ethanol elution, collect ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
Preferred extracting method is as follows:
1, gets 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, and is centrifugal or filter, get clear liquor or filtrate and go up the macroporous resin column that the resin volume is equivalent to 3 times of crude drugs, first water flushing, water lotion discards, use again 90% ethanol elution of 2.5 times of column volumes, collect eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, get the Radix Notoginseng of pulverizing, add the extraction of 4 times of water gagings of medical material weight or 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate with 50%～60% ethanol elution, is collected eluent; Macroporous resin column on the eluent, 50%～60% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add the 50% alcohol heating reflux extraction of 4 times of amounts of medical material weight or supersound extraction 3 times, each 1 hour, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, 50%～60% ethanol elution is used in elder generation's water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
The present invention further comprises, three kinds of extract mixture cooperations will extracting with said method are active constituents of medicine, are prepared into the pharmaceutical preparation that is fit to take.
According to the present invention, content of Danshensu is 3%～10% in the Radix Salviae Miltiorrhizae extract, and Radix Salviae Miltiorrhizae total phenolic acids content is 50%～75%, and content of danshinolic acid B is 20%～45%.Content of the total saponins in radix notoginseng is 60%～98% in the Radix Notoginseng extract.Radix Puerariae isoflavone content is 70%～90% in the Radix Puerariae extract.
Below data further specify beneficial effect of the present invention by experiment.
Drug efficacy study
Refining XINKESHU PIAN function of resisting myocardial ischemia research
Medicine and reagent: be subjected to test product: refining XINKESHU PIAN (tablet of the method preparation of the embodiment of the 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 in length and breadth development in science and technology company limited 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: the hybrid dog, the 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 (middle diligent generation Supreme Being's scientific instrument company limited).
Step: animal separates left carotid, intubate Bonding pressure transducer, recording blood pressure with pentobarbital sodium 30mg/kg intravenous injection anesthesia.Tracheal intubation is carried out assisted respiartion.The 4th intercostal is opened breast along the left side, seam pericardium bed.Separate aortic arch, place the electromagnetic flowmeter probe, measure cardiac output.Apex of the heart intubate, the Bonding pressure transducer is measured intraventricular pressure.Seam is put 16 epicardial leads of leading and is connected ecg amplifier, record visceral pericardium electrocardiogram.The abdominal part opening separates the standby administrable of duodenum.After indices was stablized 15min, the record normal value adopt two steps ligation method ligation arteria coronaria left anterior descending branch, and at once administration of formal ligation, model group was given the normal saline with the capacity of grade as the front data of experiment.Respectively before ligation, ligation at once, after the ligation 5,10,15,30,45,60,90,120,150,180 min record visceral pericardium electrocardiogram; Before ligation and after the ligation 30,60,120,180min record animal hemodynamic index; Respectively at 180 min time point heart extracting bloods before the pre-bundle and after the ligation, measure LDH and CK content in whole blood viscosity and the serum.Core during off-test dirty, on average be cut into five from the apex of the heart to ligation point, 1%TTC dyeing is taken pictures, and picture is inputted computer, with the ratio of image analysis software calculating infarct size with cut cardiac muscular tissue area.
The result
One, on the impact of myocardial ischemia aspect
By table 1, as seen from Table 2, with model group relatively, after positive control drug 160mg crude drug/kg administration 15 minutes, the scope of myocardial ischemia began to dwindle, the above results of 30 minutes points and model group relatively have significant difference after the administration; Administration is in the time of 5 minutes, the order of severity of myocardial ischemia and model group be existing the 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 keeps reduced levels until experiment finishes; Behind the ischemia 3 hours, LDH, CK level all are starkly lower than model group in myocardial infarction percentage ratio and the serum.
After being subjected to test product 320mg crude drug/kg administration, the scope of each time point myocardial ischemia, ischemia LDH in myocardial infarction ratio and the serum after 3 hours, CK level are all similar to model group, although the degree of myocardial ischemia is compared after ligation with model group and decreased in the short time, there is not significant difference between two groups.Be subjected to after the self administration of medication/ligation of reagent 160mg crude drug/kg group to begin namely to see in 5 minutes that the scope of animal cardiac muscle ischemia dwindles, and maintain all the time this level, wherein 10,15,30,45,60,120,180 minutes point ischemia scopes and model group relatively have significant difference after the ligation; Administration/ligation is in the time of 5 minutes, and the order of severity of myocardial ischemia and model group be existing the alleviation relatively, and keeps reduced levels all the time until experiment finishes, and wherein 30 and 60 minutes are put significant difference is arranged between two groups; Myocardial infarction ratio and serological index and model group more also have significant difference.Similar to the heavy dose group, be subjected to reagent 80mg crude drug/kg group myocardial ischemia scope close with model group, and beginning in 5 minutes is alleviated to some extent after the self administration of medication/ligation of the myocardial ischemia order of severity, although relatively there is not statistical significance with model group, but still keep reduced levels until experiment finishes; Though myocardial infarction ratio and model group comparison decrease, and do not have statistical significance, (LDH, CK) is similar to model group for serological index.
The ECG ST segment statistical result shows, is subjected to reagent 160mg crude drug/kg group and degree and the scope of each time point myocardial ischemia of positive control drug 160mg crude drug/kg group to compare difference that there are no significant; Also there was no significant difference of LDH, CK level in myocardial infarction ratio between two groups and the serum.
Can alleviate degree of ischemia after the positive drug administration; dwindle the ischemia scope, show function of resisting myocardial ischemia, and be subjected to that dose form reveals better ischemia resisting effect in the reagent; on the ischemia scope; certain fluctuation appears in positive drug, and middle dosage effect is stable, keeps all the time reduced levels; on the degree of ischemia; compare with positive drug, middle dosage shows better protective effect in the ischemia starting stage, and it is low that the ST section is raised the positive group of numerical value.This shows, aspect resisting myocardial ischemia, dosage has definite curative effect in the refining XINKESHU PIAN, and is better than FUFANG DANSHEN DIWAN.
The specific embodiment
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1
1, gets 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, and is centrifugal, gets the macroporous resin column that resin volume on the clear liquor is equivalent to 3 times of crude drugs, first water flushing, and water lotion discards, and uses 90% ethanol elution of 2.5 times of column volumes again, collects eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get Radix Notoginseng, pulverize, add the extraction of 4 times of water gagings of medical material weight or 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate is used 60% ethanol elution, collects eluent; Macroporous resin column on the eluent, 60% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get Radix Puerariae, pulverize, add the 50% alcohol heating reflux extraction of 4 times of amounts of medical material weight or supersound extraction 3 times, each 1 hour, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, 50% ethanol elution is used in elder generation's water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
4, Radix Salviae Miltiorrhizae extract 600g, the Radix Notoginseng extract 40g, the Radix Puerariae extract 600g that the 1-3 step are made mix, and add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, and tabletting, coating is made 1000, and get final product.
Embodiment 2
The 1-3 of embodiment 1 is gone on foot Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, the Radix Puerariae extract 600g mixing that makes, 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 gone on foot Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, the Radix Puerariae extract 600g mixing that makes, add starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granule processed incapsulates 1000.
Embodiment 4
1, gets 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, is 1.5 with acid for adjusting pH, lets cool, and the macroporous resin column that the upper resin volume of clear liquor or filtrate is equivalent to 2 times of crude drugs is got in centrifugal or filtration, first water flushing, and water lotion discards, and uses 85% ethanol elution of 2 times of column volumes again, collects eluent; The eluent concentrating under reduced pressure, drying namely gets 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, the extracting solution concentrating under reduced pressure, centrifugal, get clear liquor; Anion-exchange resin column on the clear liquor is used 40% ethanol elution, collects eluent; Macroporous resin column on the eluent, 40% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add 2 times of amounts of medical material weight, 30% alcohol heating reflux and extract each 0.5 hour 2 times, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, 40%～ethanol elution is used in elder generation's water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g that the 1-3 step is made mix, and add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, and tabletting, coating is made 1000, and get final product.
Embodiment 5
1, gets 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, and is 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, first water flushing, and water lotion discards, and uses 95% ethanol elution of 3 times of column volumes again, collects eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add 6 times of amounts of medical material weight, 90% ethanol ultrasonic extraction 3 times, each 3 hours, the extracting solution concentrating under reduced pressure filtered, and anion-exchange resin column on the filtrate is used 70% ethanol elution, collects eluent; Macroporous resin column on the eluent, 70% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add 6 times of amounts of medical material weight, 70% ethanol ultrasonic extraction 4 times, each 1.5 hours, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, and 70% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g that the 1-3 step is made mix, and add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, and tabletting, coating is made 1000, and get final product.
Embodiment 6
1, gets 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, and is 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, first water flushing, and water lotion discards, and uses 90% ethanol elution of 2.5 times of column volumes again, collects eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, get the Radix Notoginseng of pulverizing, add the extraction of 4 times of water gagings of medical material weight or 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate is used 50% ethanol elution, collects eluent; Macroporous resin column on the eluent, 50% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add the 50% alcohol heating reflux extraction of 4 times of amounts of medical material weight or supersound extraction 3 times, each 1 hour, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, 50% ethanol elution is used in elder generation's water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g that the 1-3 step is made mix, and add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, and tabletting, coating is made 1000, and get final product.
Embodiment 7
1, gets 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, and is 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, first water flushing, and water lotion discards, and uses 90% ethanol elution of 2.5 times of column volumes again, collects eluent; The eluent concentrating under reduced pressure, drying namely gets Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, get the Radix Notoginseng of pulverizing, add the extraction of 4 times of water gagings of medical material weight or 50% alcohol heating reflux or supersound extraction 2 times, each 2 hours, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate is used 60% ethanol elution, collects eluent; Macroporous resin column on the eluent, 60% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add the 50% alcohol heating reflux extraction of 4 times of amounts of medical material weight or supersound extraction 3 times, each 1 hour, the extracting solution concentrating under reduced pressure, the upper macroporous resin column of clear liquor or filtrate is got in centrifugal or filtration, 60% ethanol elution is used in elder generation's water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g that the 1-3 step is made mix, and add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granulation, and tabletting, coating is made 1000, and get final product.
The refining XINKESHU PIAN of table 1. is to Myocardium in Anaesthetized Dogs ischemia scope (N
ST) impact (X ± SD)
Constantly result corresponding to model group compares * P＜0.05
The impact (X ± SD, mV) that the refining XINKESHU PIAN of table 2. is raised epicardial electrogram ST section due to the Myocardium in Anaesthetized Dogs ischemia
Constantly result corresponding to model group compares * P＜0.05
The refining XINKESHU PIAN of table 3. is on the impact of anesthetized dog coronary ligation myocardial infarct size after 3 hours (X ± SD)
| ? | Dosage (the 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 |
Compare * P＜0.05 with model group
The refining XINKESHU PIAN of table 4. on the anesthetized dog coronary ligation after the impact (X ± SD, U/L) of LDH level in the serum
| ? | Dosage (the mg crude drug/kg) | Number of animals | Before the ligation | After the ligation 3 hours | Difference before and after the 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 |
Compare * P＜0.05 with model group
The refining XINKESHU PIAN of table 5. on the anesthetized dog coronary ligation after the impact (X ± SD, U/L) of CK level in the serum
| ? | Dosage (the mg crude drug/kg) | Number of animals | Before the ligation | After the ligation 3 hours | Difference before and after the 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 |
Compare * P＜0.05 with model group.
Claims (10)
1. a Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease is characterized in that, this pharmaceutical composition is made by the Chinese medicine extract of following proportioning:
Radix Salviae Miltiorrhizae extract 20～40 weight portions, Radix Notoginseng extract 1～3 weight portion, Radix Puerariae extract 20～40 weight portions.
2. Chinese medicine composition as claimed in claim 1 is characterized in that, this is characterized in that, this pharmaceutical composition is made by the raw material of Chinese medicine medicine of following proportioning:
Radix Salviae Miltiorrhizae extract 30 weight portions, Radix Notoginseng extract 2 weight portions, Radix Puerariae extract 30 weight portions.
3. Chinese medicine composition as claimed in claim 1 is characterized in that, described compositions is with raw material of Chinese medicine medicine Radix Salviae Miltiorrhizae, Radix Notoginseng, and Radix Puerariae extracts respectively and obtains extract, take three kinds of extracts as active constituents of medicine, is prepared into the pharmaceutical preparation that is fit to take.
4. Chinese medicine composition as claimed in claim 3 is characterized in that, described extract, and extracting method is as follows:
Wherein the extracting method of Radix Salviae Miltiorrhizae is as follows:
The Radix Salviae Miltiorrhizae ethanol extraction, extracting solution cools off with acid for adjusting pH to 1.5～4.2, filters, and macroporous resin column on the filtrate washes with water first, uses ethanol elution again, collects ethanol elution, and concentrated, drying gets Radix Salviae Miltiorrhizae extract;
Wherein the extracting method of Radix Notoginseng is as follows:
Radix Notoginseng water or ethanol extraction, extracting liquid filtering, anion-exchange resin column on the filtrate is used ethanol elution, collects eluent; Macroporous resin column on the eluent washes with water first, uses ethanol elution again, collects ethanol elution; Concentrated, drying gets Radix Notoginseng extract;
Wherein the extracting method of Radix Puerariae is as follows:
The Radix Puerariae ethanol extraction, extracting solution filters, and macroporous resin column on the filtrate washes with water first, uses ethanol elution again, collects ethanol elution; Concentrated, drying gets Radix Puerariae extract.
5. Chinese medicine composition as claimed in claim 3 is characterized in that, described extract, and extracting method is as follows:
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 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, and is centrifugal or filter, get clear liquor or filtrate and go up the macroporous resin column that the resin volume is equivalent to 2～4 times of crude drugs, first water flushing, water lotion discards, use again 85～95% ethanol elutions of 2～4 times of column volumes, collect eluent; The eluent concentrating under reduced pressure, drying gets Radix Salviae Miltiorrhizae extract.
Described Radix Notoginseng extract is prepared by following method: add the extraction of 2-6 times of water gaging of medical material weight or 10%～90% alcohol heating reflux or supersound extraction 1～3 time, and each 1-3 hour, the extracting solution concentrating under reduced pressure, clear liquor or filtrate are got in centrifugal or filtration; The upper anion-exchange resin column of clear liquor or filtrate with 40%～70% ethanol elution, is collected eluent; Macroporous resin column on the eluent, 40%～70% ethanol elution is used in first water flushing again, collects ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Notoginseng extract.
Described Radix Puerariae extract is prepared by following method: the Radix Puerariae of getting pulverizing, add that medical material weight 2-6 measures doubly that 30%～70% alcohol heating reflux extracts or supersound extraction 2～4 times, each 0.5-1.5 hour, the extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first water flushing, use again 40%～70% ethanol elution, collect ethanol elution; The eluent concentrating under reduced pressure, drying gets Radix Puerariae extract.
6. Chinese medicine composition as claimed in claim 5 is characterized in that, wherein content of Danshensu is 3%～10% in the Radix Salviae Miltiorrhizae extract, and Radix Salviae Miltiorrhizae total phenolic acids content is 50%～75%, and content of danshinolic acid B is 20%～45%.
7. Chinese medicine composition as claimed in claim 5 is characterized in that, wherein content of the total saponins in radix notoginseng is 60%～98% in the Radix Notoginseng extract.
8. Chinese medicine composition as claimed in claim 5 is characterized in that, wherein Radix Puerariae isoflavone content is 70%～90% in the Radix Puerariae extract.
9. Chinese medicine composition according to claim 1 is characterized in that, described compositions is tablet, capsule, drop pill, granule, oral agents, injection.
10. the application of Chinese medicine composition claimed in claim 1 in the medicine of preparation treatment cardiovascular and cerebrovascular disease.
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