CN103006769B - 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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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 harm humans health and the serious disease of life, is called " mankind's number one killer " by World Health Organization (WHO).In China, nearly 195 Wan Xinfa cardiovascular patients every year, have nearly 1,560,000 people to die from cardiovascular disease, cardiovascular and cerebrovascular disease causes the rate of dying and reaches 35%, occupies various diseases and causes first of the rate of dying.Cardiovascular patient 500-700 ten thousand people of existence, wherein 75% leaves different deformity, causes heavy burden to 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.The middle-aged and elderly people of more than 40 years old is the group of people at high risk of cardiovascular and cerebrovascular disease, and the age often increases by 10 years old, and Patients with Cardiovascular/Cerebrovascular Diseases will how one times, and the old people of more than 70 years old, the prevalence of cardiovascular and cerebrovascular disease is close to 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.From now on along with people more and more pay attention to the raising of quality of life, the understanding of cardiovascular and cerebrovascular disease harm is progressively deepened, and hospitalization expense will be expensive, by the method cure diseases having increasing Patients with Cardiovascular/Cerebrovascular Diseases to take chemoprophylaxis and treatment.
Traditional Chinese patent medicine mostly is the semifinished product that pulverizing medicinal materials becomes former medicated powder or only slightly carries, have that effective component content is low, dose be large, absorb not exclusively, bioavailability is low, drug effect play comparatively 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 made up of Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Puerariae, wherein monarch drug Radix Salviae Miltiorrhizae, GUIXIN, Liver Channel, there is blood circulation promoting and blood stasis dispelling, pain relieving removing heat from blood, clear away heart-fire relieving restlessness, 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 return liver, stomach warp, have 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.Monarch drug ministerial drug cooperatively interacts, and the various cardinal symptoms for the treatment of patients with coronary heart disease, improve patients with coronary heart disease cardiac function, and simultaneously resolving depression is brought down a fever, analgesic therapy calms the nerves.
The processing mode of prior art to Chinese medicine is varied, but become curative effect excellent Chinese drug preparation, the quality of the pharmaceutical preparations is high, shelf time is long, good stability, the beautiful Chinese medicine preparation difficulty of outward appearance 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, have selected a kind of selected extraction, purification, process for refining, remove Radix Salviae Miltiorrhizae, Radix Notoginseng, in Radix Puerariae, most of impurity also retains the effective ingredient of each flavour of a drug to greatest extent, tablet is made with this effective ingredient, capsule, drop pill, the dosage forms such as granule, the medication demand of Patients with Cardiovascular/Cerebrovascular Diseases can be met 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:
Treat a Chinese medicine composition for cardiovascular and cerebrovascular disease, it 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 portion, Radix Notoginseng extract 1 ~ 3 weight portion, Radix Puerariae extract 20 ~ 40 weight portion.
Preferably, this pharmaceutical composition is made up of the raw material of Chinese medicine medicine of following proportioning:
Radix Salviae Miltiorrhizae extract 30 weight portion, Radix Notoginseng extract 2 weight portion, Radix Puerariae extract 30 weight portion.
More than in composition, if weight is with gram for unit of weight, above composition can be made into pharmaceutical preparation 1000 doses, described 1000 doses of fingers, the final drug preparation made, as made capsule preparations 1000, and 1000, tablet, granule 1000 grams, oral liquid 1000ml etc.
More than form, if in grams, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be 1-20 sheet, can take 50-1000 time altogether.As granule, making 125 bags, each serving using 1-2 bag, can take 62.5-125 time altogether.
More than composition is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as large-scale production can by kilogram in units of, or in units of ton, small-scale production also can in units of milligram, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion is through that science screening obtains, and for especial patient, as serious symptom or mild, fat or modest patient, can the proportioning of amount of corresponding adjustment composition, and increase or reduce being no more than 100%, drug effect is constant.
Single medicinal material more than in composition, especially ministerial drug and adjuvant drug, also can be replaced by the suitable Chinese medicine with the identical property of medicine, its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine composition of the present invention is by being processed through extraction or other modes by raw material of Chinese medicine, making pharmaceutically active substance and extract of the present invention, subsequently, with this material for raw material, when needing, add medicine acceptable carrier, make Chinese medicine preparation according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can be obtained by the common raw material of Chinese medicine that extracts, also can obtain by other means, as: by pulverizing, squeezing, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the material that method obtains, these active substances can be extractum form such as ketone is carried, chromatography, can be dry extract also can be 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 in the formulation shared percentage by weight can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical preparation of the present invention, exists in a unit, and described unit dosage form refers to the unit of preparation, as every sheet of tablet, and every capsules of capsule, every bottle of oral liquid, granule every bag 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 containing conventional excipient, and 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.
The filler be suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate.Suitable lubricant comprises, such as magnesium stearate.The suitable acceptable wetting agent of medicine comprises sodium lauryl sulphate.
By mixing, fill, the method that tabletting etc. are conventional prepares solid oral composition.Repeatedly mix and active substance can be made to be distributed in those compositionss of a large amount of filler of whole use.
The form of oral liquid can be such as aqueous or oily suspensions, solution, Emulsion, syrup or elixir, or can be the composite dry products of a kind of available water before use or other suitable carrier.This liquid preparation can containing conventional additive, such as suspending agent, such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agent, such as lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), the oily ester of the such as ester of almond oil, fractionated coconut oil, such as glycerol, propylene glycol or ethanol; Antiseptic, such as para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if need, can containing conventional flavouring agent or coloring agent.
For injection, the fluid unit dosage form 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 is normally by being dissolved in a kind of carrier by active substance, filter-sterilized before being loaded a kind of suitable bottle or ampoule, then seals.Adjuvant such as a kind of local anesthetic, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, by freezing for this compositions after loading bottle, and under vacuo water can be removed.
Chinese medicine composition of the present invention, applicable medicine acceptable carrier is optionally added when being prepared into medicament, 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 its derivates, 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 according to the situation determination usage and dosage of patient, can take three every day in use, 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, and Radix Notoginseng, Radix Puerariae extracts respectively and obtains extract, with three kinds of extracts for active constituents of medicine, is prepared into the pharmaceutical preparation being applicable to taking.
Wherein said extract, extracting method is as follows:
The extracting method of Radix Salviae Miltiorrhizae is as follows:
Radix Salviae Miltiorrhizae ethanol extraction, extracting solution acid for adjusting pH, to 1.5 ~ 4.2, cools, and 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;
The extracting method of Radix Puerariae is as follows:
Radix Puerariae ethanol extraction, extracting solution, filter, macroporous resin column on filtrate, first washes with water, then uses ethanol elution, collects ethanol elution; Concentrated, dry, obtain Radix Puerariae 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 medical material weight 5 ~ 7 times of water gagings, 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 resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 2 ~ 4 times, first rinse with water, water lotion discards, use 85 ~ 95% ethanol elutions of 2 ~ 3 times of column volumes again, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract.
2, get the Radix Notoginseng of pulverizing, add medical material weight 2-6 times water gaging or 10% ~ 90% alcohol heating reflux and extract or supersound extraction 1 ~ 3 time, each 1-3 hour, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, with 40% ~ 70% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 40% ~ 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 2-6 times amount 30% ~ 70% alcohol heating reflux to extract or supersound extraction 2 ~ 4 times, each 0.5-1.5 hour, extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first rinse with water, use 40% ~ 70% ethanol elution again, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae 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 medical material weight 6 times of water gagings, 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 resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 3 times, first rinse with water, water lotion discards, use 90% ethanol elution of 2.5 times of column volumes again, collect 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 medical material weight 4 times of water gagings or 50% alcohol heating reflux and extract or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, with 50% ~ 60% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 50% ~ 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 4 times amount 50% alcohol heating reflux and extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ~ 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
The present invention comprises further, mixes the three kinds of extracts extracted with said method as active constituents of medicine, is prepared into the pharmaceutical preparation being 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%.In Radix Puerariae extract, Radix Puerariae isoflavone content is 70% ~ 90%.
Beneficial effect of the present invention is further illustrated below by way of experimental data.
Drug efficacy study
Refining XINKESHU PIAN function of resisting myocardial ischemia research
Medicine and reagent: by test product: refining XINKESHU PIAN (tablet prepared by the method for 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 Products; 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: experimental 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, is separated left common carotid, intubate Bonding pressure transducer, recording blood pressure.Tracheal intubation carries out assisted respiartion.Along left side, the 4th intercostal opens breast, seam pericardium bed.Be separated 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 epicardial electrocardiogram.Abdominal part opening, is separated duodenum for administrable.After indices stablizes 15min, record normal value, as data before experiment, adopts two step ligation method ligation arteria coronaria left anterior descending branches, and in formal ligation administration at once, model group gives 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 epicardial electrocardiogram in ligation; 30,60,120,180min record animal hemodynamic indexs before ligation and after ligation; 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.Core during off-test dirty, be on average cut into five from the apex of the heart to ligation point, 1%TTC dyes, and takes pictures, picture is inputted computer, calculates infarct size and Suo Qie cardiac muscular tissue area ratio with image analysis software.
Result
One, on the impact of myocardial ischemia aspect
From table 1, table 2, compare with model group, after positive control drug 160mg crude drug/kg administration 15 minutes, the scope of myocardial ischemia starts to reduce, and after administration, the above results of 30 minutes points compares with model group significant difference; During administration 5 minutes, the order of severity of myocardial ischemia compares existing alleviation with model group, there is significant difference in 30 minutes points, two groups of these indexs, although degree of ischemia compares with model group and do not have statistical significance after 30 minutes, but still maintain reduced levels until experiment terminates; Ischemia is after 3 hours, and in myocardial infarction percentage ratio and serum, LDH, CK level is all starkly lower than model group.
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.The range shorter namely seeing animal cardiac muscle ischemia within 5 minutes, is started by after reagent 160mg crude drug/kg group self administration of medication/ligation, and maintain this level all the time, wherein after ligation, 10,15,30,45,60,120,180 minutes point ischemia scopes compare with model group and have significant difference; During administration/ligation 5 minutes, the order of severity of myocardial ischemia compares existing alleviation with model group, and maintains reduced levels all the time until experiment end, wherein has significant difference between 30 and 60 minutes point two groups; Myocardial infarction ratio and serological index more also have significant difference with model group.Similar to heavy dose group, close with model group by reagent 80mg crude drug/kg group myocardial ischemia scope, and after the self administration of medication/ligation of the myocardial ischemia order of severity 5 minutes start to alleviate to some extent, there is no statistical significance although compare with model group, but still maintain reduced levels until experiment terminates; Decrease though myocardial infarction ratio compares with model group, do not have statistical significance, serological index (LDH, CK) is similar to model group.
ECG ST segment statistical result shows, compares, difference that there are no significant by the degree of reagent 160mg crude drug/kg group and each time point myocardial ischemia of positive control drug 160mg crude drug/kg group and scope; LDH, CK level also there was no significant difference in myocardial infarction ratio between two groups and serum.
Degree of ischemia can be alleviated after positive drug administration; reduce ischemia scope, show function of resisting myocardial ischemia, and reveal better ischemia resisting effect by dose form in reagent; in ischemia scope; there is certain fluctuation in positive drug, and middle dosage effect is stablized, and maintains reduced levels all the time; 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 raises more positive group of numerical value.As can be seen here, in 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 medical material weight 6 times of water gagings, 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 crude drug 3 times, and first rinse with water, 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 medical material weight 4 times of water gagings or 50% alcohol heating reflux and extract or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, use 60% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get Radix Puerariae, pulverize, add medical material weight 4 times amount 50% alcohol heating reflux and extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
4, obtained for 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, add the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 1000, to obtain final product.
Embodiment 2
Obtained for the 1-3 of embodiment 1 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds Icing Sugar, starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule 1000g.
Embodiment 3
Obtained for the 1-3 of embodiment 1 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds starch, the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, granule processed, incapsulate 1000.
Embodiment 4
1, get salvia piece, add 40%% alcohol heating reflux and extract 2 times, add medical material weight 5 times amount at every turn, each 0.5 hour; Merge extractive liquid, is 1.5 with acid for adjusting pH, lets cool, centrifugal or filtration, and get resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 2 times, first rinse with water, 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 medical material weight 2 times of water gaging heating extraction 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 rinses with water, then uses 40% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 2 times amount 30% alcohol heating reflux and extract 2 times, each 0.5 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 40% ~ ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
Obtained for 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 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 medical material weight 7 times amount at every turn, each 2 hours; Merge extractive liquid, is 4.2 to let cool with acid for adjusting pH, centrifugal or filter, and get the macroporous resin column that clear liquor or the upper resin volume of filtrate are equivalent to crude drug 4 times, first rinse with water, 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 medical material weight 6 times amount 90% ethanol ultrasonic extraction 3 times, each 3 hours, extracting solution concentrating under reduced pressure, filter, anion-exchange resin column on filtrate, uses 70% ethanol elution, collects eluent; Macroporous resin column on eluent, first rinses with water, then uses 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 6 times amount 70% ethanol ultrasonic extraction 4 times, each 1.5 hours, extracting solution concentrating under reduced pressure, centrifugal or filtration, get clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
Obtained for 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 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 medical material weight 6 times of water gagings, each 1 hour at every turn; Merge extractive liquid, is 2.5 to let cool with acid for adjusting pH, centrifugal or filter, and get the macroporous resin column that clear liquor or the upper resin volume of filtrate are equivalent to crude drug 3 times, first rinse with water, 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 medical material weight 4 times of water gagings or 50% alcohol heating reflux and extract or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, use 50% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 50% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 4 times amount 50% alcohol heating reflux and extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
Obtained for 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 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 medical material weight 6 times of water gagings, each 1 hour at every turn; Merge extractive liquid, is 3.5 to let cool with acid for adjusting pH, centrifugal or filter, and get the macroporous resin column that clear liquor or the upper resin volume of filtrate are equivalent to crude drug 3 times, first rinse with water, 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 medical material weight 4 times of water gagings or 50% alcohol heating reflux and extract or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, use 60% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract.
3. get the Radix Puerariae of pulverizing, add medical material weight 4 times amount 50% alcohol heating reflux and extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
Obtained for 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds the right amount of auxiliary materials such as low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 1000, to obtain final product.
Table 1. refines XINKESHU PIAN to Myocardium in Anaesthetized Dogs ischemia scope (N
sT) impact (X ± SD)
Compared with the corresponding moment result of model group, * P<0.05
The impact (X ± SD, mV) that XINKESHU PIAN is raised epicardial electrogram ST section caused by Myocardium in Anaesthetized Dogs ischemia refined by table 2.
Compared with the corresponding moment result of model group, * P<0.05
The impact (X ± SD) of XINKESHU PIAN on anesthetized dog coronary ligation myocardial infarct size after 3 hours refined by table 3.
| 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 impact (X ± SD, U/L) of XINKESHU PIAN on LDH level in serum after anesthetized dog coronary ligation refined by table 4.
| 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 impact (X ± SD, U/L) of XINKESHU PIAN on CK level in serum after anesthetized dog coronary ligation refined by table 5.
| 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. treat a Chinese medicine composition for cardiovascular and cerebrovascular disease, it is characterized in that, this pharmaceutical composition is made up of the Chinese medicine extract of following proportioning: Radix Salviae Miltiorrhizae extract 30 weight portion, Radix Notoginseng extract 2 weight portion, Radix Puerariae extract 30 weight portion,
Radix Salviae Miltiorrhizae extract is prepared by following method: the Radix Salviae Miltiorrhizae getting salvia piece or pulverizing, adds 40% ~ 70% alcohol heating reflux and extracts 2 ~ 4 times, add medical material weight 5 ~ 7 times amount ethanol, 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 resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 2 ~ 4 times, first rinse with water, water lotion discards, use 85 ~ 95% ethanol elutions of 2 ~ 4 times of column volumes again, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Described Radix Notoginseng extract is prepared by following method: add medical material weight 2-6 times water gaging or 10% ~ 90% alcohol heating reflux and extract or supersound extraction 1 ~ 3 time, each 1-3 hour, extracting solution concentrating under reduced pressure, centrifugal or filter, and gets clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, with 40% ~ 70% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 40% ~ 70% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract;
Described Radix Puerariae extract is prepared by following method: the Radix Puerariae getting pulverizing, add medical material weight 2-6 times amount 30% ~ 70% alcohol heating reflux to extract or supersound extraction 2 ~ 4 times, each 0.5-1.5 hour, extracting solution concentrating under reduced pressure, centrifugal or filter, get the upper macroporous resin column of clear liquor or filtrate, first rinse with water, use 40% ~ 70% ethanol elution again, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae 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 in Radix Puerariae extract, Radix Puerariae isoflavone content is 70% ~ 90%.
2. Chinese medicine composition according to claim 1, is characterized in that, Radix Salviae Miltiorrhizae extract is prepared by following method: the Radix Salviae Miltiorrhizae getting salvia piece or pulverizing, adds 50% ~ 60% alcohol heating reflux and extracts 3 times, adds medical material weight 6 times amount ethanol, 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 resin volume on clear liquor or filtrate and be equivalent to the macroporous resin column of crude drug 3 times, first rinse with water, water lotion discards, use 90% ethanol elution of 2.5 times of column volumes again, collect eluent; Eluent concentrating under reduced pressure, dry, obtain Radix Salviae Miltiorrhizae extract;
Radix Notoginseng extract is prepared by following method: the Radix Notoginseng of getting pulverizing, gets the Radix Notoginseng of pulverizing, adds medical material weight 4 times of water gagings or 50% alcohol heating reflux and extracts or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, and gets clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, with 50% ~ 60% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 50% ~ 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract;
Radix Puerariae extract is prepared by following method: the Radix Puerariae getting pulverizing, add medical material weight 4 times amount 50% alcohol heating reflux to extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ~ 60% ethanol elution, collect ethanol elution, eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract.
3. Chinese medicine composition according to claim 1, is characterized in that, is prepared by following methods:
(1) get Radix Salviae Miltiorrhizae, pulverize, add 60% alcohol heating reflux and extract 3 times, add medical material weight 6 times amount ethanol, 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 crude drug 3 times, and first rinse with water, 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 medical material weight 4 times of water gagings or 50% alcohol heating reflux and extract or supersound extraction 2 times, each 2 hours, extracting solution concentrating under reduced pressure, centrifugal or filter, get clear liquor or filtrate; Clear liquor or the upper anion-exchange resin column of filtrate, use 60% ethanol elution, collect eluent; Macroporous resin column on eluent, first rinses with water, then uses 60% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Notoginseng extract;
(3) get Radix Puerariae, pulverize, add medical material weight 4 times amount 50% alcohol heating reflux and extract or supersound extraction 3 times, each 1 hour, extracting solution concentrating under reduced pressure, centrifugal or filtration, gets clear liquor or the upper macroporous resin column of filtrate, first rinse with water, then use 50% ethanol elution, collect ethanol elution; Eluent concentrating under reduced pressure, dry, obtain Radix Puerariae extract;
Obtained for above-mentioned 1-3 step Radix Salviae Miltiorrhizae extract 600g, Radix Notoginseng extract 40g, Radix Puerariae extract 600g are mixed, adds appropriate low-substituted hydroxypropyl cellulose, make granule, tabletting, coating, make 1000, to obtain final product.
4. Chinese medicine composition according to claim 1 and 2, is characterized in that, described compositions is tablet, capsule, drop pill, granule, oral agents, injection.
5. the application of the Chinese medicine composition described in claim 1 or 2 in the medicine of preparation treatment cardiovascular and cerebrovascular disease.
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| CN1714836A (en) * | 2004-06-30 | 2006-01-04 | 天津天士力制药股份有限公司 | Use of medicine in preparing medicine for treating anti-aspirin |
| CN101085006A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing kudzuvine root for treating cardiovascular diseases and its preparation |
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| CN1923229B (en) * | 2005-08-31 | 2011-01-12 | 山东轩竹医药科技有限公司 | Pharmaceutical composition comprising notoginseng extract, Danshen extract and puerarin |
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| CN1557467A (en) * | 2004-02-09 | 2004-12-29 | 周宝义 | Extraction and concentration combined pure Chinese medicinal preparation for treating cardiovascular diseases |
| CN1714836A (en) * | 2004-06-30 | 2006-01-04 | 天津天士力制药股份有限公司 | Use of medicine in preparing medicine for treating anti-aspirin |
| CN101085006A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing kudzuvine root for treating cardiovascular diseases and its preparation |
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