CN101049338A - Composition of Chinese traditional medicine for treating cardiovascular disease and cerebrovascular disease - Google Patents
Composition of Chinese traditional medicine for treating cardiovascular disease and cerebrovascular disease Download PDFInfo
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- CN101049338A CN101049338A CN 200610066729 CN200610066729A CN101049338A CN 101049338 A CN101049338 A CN 101049338A CN 200610066729 CN200610066729 CN 200610066729 CN 200610066729 A CN200610066729 A CN 200610066729A CN 101049338 A CN101049338 A CN 101049338A
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Abstract
A Chinese medicine for treating the cardiovascular and cerebrovascular diseases is prepared from astragalus root and safflower in weight ratio of 1:1.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease, particularly is the Chinese medicine preparation of feedstock production with Radix Astragali and Flos Carthami.
Background technology:
The Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalus membranaceus var.mongholicus Hsiao.
The Radix Astragali: mainly contain astragalin I, Acetylastragaloside I, IsoastragalosideI II etc., pharmacological action mainly contains:
1. to immune effect: but the special and non-specific immunologic function of enhancing body.
2. to the influence of organism metabolism: the cells physiological metabolism is strengthened.
3. to the influence of blood system: obvious anticoagulant.
4. hypotensive effect, microcirculation improvement.
5. antiinflammatory action.
To serum sickness nephritis urine albumen amount is obviously descended, nephropathy alleviates, and obvious diuresis is arranged.
6. strong effect
Resisting fatigue, anti-hypoxia, low temperature resistant and high temperature action are arranged, radiation resistance is arranged, obviously prolong endurance, weight increase, total serum protein, albumin increases, and strengthens the liver detrimental resistance, and blood glucose is had dual regulation, and bone resorption is had inhibitory action.
7. anti-aging effects is arranged: but delaying cell aging.
8. antibiotic, antiviral, antitumor action are arranged.
9. hepatoprotective effect.
10. nervus centralis there are calmness, stable effect.
The main place of production of the Radix Astragali is Hunyuan County, Shanxi, Guyang County, the Inner Mongol and Tumote Right Banner cultivation.Collecting time is the 10-11 month.
Flos Carthami is the dried floral of feverfew Flos Carthami Carthamus tinctorius L..
Flos Carthami contains carthamin, Carthamus yellow.Fatty oil claims safflower oil in addition, is Palmic acid. the stearic acid arachidic acid. and linoleic acid. linolenic acid. oleic acid or the like oils.Acrid in the mouth. warm in nature, be the traditional Chinese medical science traditional gynecological good medicine commonly used.The ancient medical book of China is as " Bencao Jingshu ". and " book on Chinese herbal medicine converges and says ". " book on Chinese herbal medicine is stated hook unit ". in " Amplification on Materia Medica addendum " and " medicine words justice " full and accurate record and argumentation are arranged all.Can stimulate the menstrual flow and control blood, can complementary energy rush down, can break and to support, feasible leading.And different effects arranged because of instructions about how to take medicine are different.
The main place of production of Flos Carthami is Xinjiang, and collecting time is 6～July.
In recent years, along with going deep into of clinical research, occurred the Chinese medicine preparation of a lot of treatment cardiovascular and cerebrovascular diseases on the market, but existing medicine belongs to a bit and cures the symptoms, not the disease, some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
In view of this, the inventor develop a kind of taking convenience, effect steadily, determined curative effect, dosage form is stable, quality controllable and the Chinese medicine preparation of the treatment cardiovascular and cerebrovascular disease that has no side effect, to satisfy the demand of extensive patients.
The inventor by with Radix Astragali and Flos Carthami in conjunction with prescription, prepare successfully a kind of Chinese medicine preparation that is used for the treatment of cardiovascular and cerebrovascular disease, especially for the treatment of coronary heart disease, overcome the defective of prior art, obtained beyond thought effect.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease, said preparation is that raw material is made by the Chinese medicine astragalus and Flos Carthami, and the part by weight of Radix Astragali and Flos Carthami is 1-10: 10-1, preferably 1-5: 5-1, more preferably 1-3: 3-1, most preferably 1: 1.
In more than forming, the weight of medicine is calculated with crude drug, with weight portion as proportioning, when producing, can proportionally increase or reduce, as large-scale production can be unit with the kilogram, or is unit with the ton, and small-scale production can be a unit with gram or milligram also, 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 as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Raw material of Chinese medicine in more than forming can be replaced with 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 preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this active substance is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, 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 a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutical preparation of the present invention, the pharmaceutical dosage forms of unit dose preferably, can make any pharmaceutically useful dosage form when making pharmaceutical preparation, these dosage forms are selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, freeze-dried powder, suppository, ointment, plaster, cream, spray, drop, patch.Preferably injection preparation form, most preferably injection formulation.
Pharmaceutical preparation of the present invention can add some medicine acceptable carriers as required, can adopt the galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as pharmaceutically active substance is mixed with the medicine acceptable carrier.Described medicine acceptable carrier is selected from: mannitol, sorbitol, sorbic acid or potassium salt, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, the EDTA disodium, EDTA calcium sodium, 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, propylene glycol, ethanol, soil temperature 60-80, span-80, Cera Flava, lanoline, liquid paraffin, hexadecanol, gallate ester, agar, triethanolamine, basic amino acid, carbamide, allantoin, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention is determined usage and dosage according to patient's situation in use.
Chinese medicine preparation of the present invention, when making medicament, the medicament of unit dose can contain pharmaceutically active substance 0.1-1000mg of the present invention, and all the other are pharmaceutically acceptable carrier.Pharmaceutically acceptable carrier can be the 0.1-99.9% of total formulation weight amount by weight.
The most preferred prescription of the present invention is listed in the embodiment of the invention.
The pharmaceutically active substance that prescription of the present invention is made, preferably adopt following method preparation:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
The mixture of above Radix Astragali extract and Flos Carthami extract is a pharmaceutically active substance of the present invention.
The preferred injection of the present invention, its preferred manufacturing procedure is as follows:
The preparation of the red injection of stilbene:
The preferred lyophilization injectable powder of the present invention, its preferred manufacturing procedure is as follows:
The preparation of injection stilbene red freeze dried powder: get 100g Radix Astragali extract lyophilized powder and 100g Flos Carthami extract lyophilized powder, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
In the above lyophilization injectable powder, can add an amount of medicine acceptable carrier according to the needs of preparation.
The present invention also comprises, the method for quality control of preferred injection of the present invention, and its method is: adopt high performance liquid chromatography to set up the saponin component of Milkvetch Root and the finger printing of flavone and glycoside composition thereof; Adopt high performance liquid chromatography to set up the assay of the S-A Hydroxysafflor yellow A of flos carthami, adopt high performance liquid chromatography to set up the finger printing of flos carthami simultaneously.
When the quality of working sample, the finger printing of above-mentioned standard and the finger printing of sample are compared, be up-to-standard sample when consistent.
Further comprising the steps of in the method for quality control of the present invention:
Character:, its character is described in detail according to the characteristics of finished product.
Differentiate: adopting thin layer chromatography, is contrast with the astragaloside, has set up the discriminating of the Radix Astragali in the finished product; Adopting thin layer chromatography, is contrast with the S-A Hydroxysafflor yellow A, has set up the discriminating of Flos Carthami in the finished product.
Check: set up inspections such as content uniformity in the finished product, clarity, particulate matter, pH value, protein, tannin, heavy metal, arsenic salt, oxalates, potassium ion, resin, residue on ignition, moisture, aseptic, pyrogen, haemolysis and cohesion, macroporous adsorbent resin organic residue, and stipulated to limit the quantity of accordingly.
Assay: adopt spectrophotography to set up the assay of total saponins in the finished product, and every of regulation this product contains Radix Astragali total saponins and is not less than 27mg in astragaloside; Adopt high performance liquid chromatography to set up the assay of S-A Hydroxysafflor yellow A in the finished product, and every of regulation this product contain Flos Carthami and is not less than 18mg in S-A Hydroxysafflor yellow A.
The research data of drug standard material S-A Hydroxysafflor yellow A: provide extraction, separation method, physicochemical property, the structure of drug standard material S-A Hydroxysafflor yellow A to identify and assay.
Because often there is stable underproof problem in Chinese medicine injection with preparation, Chinese medicine preparation of the present invention has overcome this defective, and through technical process of the present invention, the injection of making has good stable.Below for the stability experiment data: sample wherein is according to the method preparation of the embodiment of the invention 1.
020101 crowd of accelerated test result of table 1 sample
| 0 month | January | February | March | June | ||
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Check | Moisture content | 6.3 | 6.2 | 6.5 | 7.3 | 7.9 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
020102 crowd of accelerated test result of table 2 sample
| 0 month | January | February | March | June | |
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
| Check | Moisture content | 6.2 | 6.6 | 6.8 | 7.4 | 8.2 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
020103 crowd of accelerated test result of table 3 sample
| 0 month | January | February | March | June | ||
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Check | Moisture content | 6.6 | 6.6 | 6.5 | 7.1 | 7.8 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
Result of the test shows that three batches of pilot samples were placed 6 months under relative humidity 75% ± 5% accelerated test condition at 40 ℃ ± 2 ℃, the equal conformance with standard regulation of every index.
(2), for a long time examination keeps sample: the examination that keeps sample has for a long time been carried out 1 year, and every index is all up to specification, the results are shown in Table 4-6.The test that keeps sample is for a long time proceeded, with the effect duration of examination this product.
020101 batch in the table 4 sample result of the test that keeps sample for a long time
| 0 month | March | June | JIUYUE | December | ||
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Check | Moisture content | 6.3 | 6.5 | 6.7 | 7.4 | 7.6 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
020102 batch in the table 5 sample result of the test that keeps sample for a long time
| 0 month | March | June | JIUYUE | December | ||
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Check | Moisture content | 6.2 | 6.8 | 6.9 | 7.2 | 7.5 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
020103 batch in the table 6 sample result of the test that keeps sample for a long time
| 0 month | March | June | JIUYUE | December | ||
| Character | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Check | Moisture content | 6.6 | 6.7 | 6.9 | 7.2 | 7.2 |
| Disintegration | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
Result of the test shows, three batches of pilot samples are at 25 ℃ ± 2 ℃, following 12 months of relative humidity 60% ± 10% condition, the equal conformance with standard regulation of every index.
Below further specify beneficial effect of the present invention by injection of the present invention is carried out pharmacodynamic experiment.
The experimental drug thing is the injection of the present invention of the method for optimizing preparation in the embodiment of the invention, and positive control is the GUANXINNING ZHUSHEYE of listing.Experimental result is as follows:
One, to the influence of anesthetized dog myocardial oxygen consumption
The result shows: the quiet notes of each dosage group of injection of the present invention back significantly reduces myocardial oxygen consumption; Obviously reduce myocardium oxygen uptake rate, increase coronary flow, action intensity and dosage have certain relation.Injection high dose group of the present invention can reduce total peripheral resistance, increases the dog cardiac output.Experimental result shows that injection of the present invention can obviously increase anesthetized dog cardiac output, coronary flow; Reduce coronary resistance; Reduce total peripheral resistance; Obviously reduce myocardium oxygen uptake rate and myocardial oxygen consumption.See Table 1
Two, to the hemodynamic influence of anesthetized dog
Experimental result shows, in injection of the present invention (2,6, the 12g/kg) scope, to the hematodinamics index of anesthetized dog: heart rate (HR), systolic pressure (BPs), diastolic pressure (BPd), mean arterial pressure (BPm), left ventricular systolic pressure (LVSP), left ventricular diastolic pressure LVDP (KPa), the maximum rate of change of left ventricular systolic pressure (± dp/dtmax), ventricular end diastolic pressure (LVEDP) all do not make significant difference.
Three, the dog coronary artery ligation is caused the therapeutical effect of myocardial infarction model
Experimental result shows, the quiet notes of injection of the present invention (2,6,12g/kg) can significantly reduce the degree of myocardial ischemia behind the dog coronary ligation, the scope of dwindling myocardial ischemia, and action intensity and dosage have certain relation; It is consistent with the epicardial electrogram measurement result that quantitative tissue is learned testing result, compares with the solvent control matched group, and injection of the present invention can significantly reduce infarction size.Injection of the present invention can also significantly reduce the degree that serum lactate dehydrogenase (SLD) behind the dog coronary ligation, creatine kinase raise; Primary cellular defect when pointing out it to alleviate myocardial ischemia has protective effect to myocardial cell.Experimental result shows that degree of myocardial ischemia and scope when injection of the present invention can significantly alleviate the dog myocardial infarction reduce infarction size.See Table 2
Four, the protective effect that rat myocardial ischemia and reperfusion is damaged
The result shows that LDH, CK overflowed when injection of the present invention can obviously suppress due to the ischemia-reperfusion rat myocardium from injury, reduces Serum LDH, CK activity, dwindles myocardial infarction area weight, and damage has protective effect to rat myocardial ischemia and reperfusion.See Table 3
Five, to the rheol influence of rabbit blood
The result shows: behind injection 3g crude drug of the present invention/quiet notes of kg auricular vein, with comparison there was no significant difference before the administration, compare with the blank group, then can significantly reduce rabbit whole blood viscosity (P＜0.05) under low shear rate; 9g crude drug/kg group is relatively preceding with administration, low cut, in cut under two shear rates, whole blood viscosity significantly reduces (P＜0.05), compare with the blank group, low, in whole blood viscosity is all had highly significant reduction effect (P＜0.01) under two shear rates, remarkable reduction (P＜0.05) is arranged under high shear rate; 18g crude drug/kg group is relatively preceding with administration, under low shear rate, reduce highly significant (P＜0.01), under middle and high two shear rates, significantly reduce whole blood viscosity (P＜0.05), and compare, highly significant influence (P＜0.01) is all arranged under high, medium and low shear rate with the blank group.See Table 4
Six, to the influence of rabbit platelet aggregation
The result shows, injection rabbit auricular vein injection 3g/kg, 9g/kg of the present invention and 18g/kg all can significantly reduce the inductive platelet aggregation rate of ADP, the maximum accumulative suppression ratio of platelet is respectively-14.0 ± 3.9% ,-25.5 ± 8.7% and-36.1 ± 5.7%, conclusion: injection of the present invention has the obvious suppression effect to the inductive rabbit platelet aggregation of ADP.See Table 5
The specific embodiment:
By the following examples, further specify the present invention, but not as limitation of the present invention.
Embodiment 1
Prescription: 10 kilograms of the Radixs Astragali, 10 kilograms on Flos Carthami, 1000 of preparation freeze drying injections.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
Embodiment 2
Prescription: 10 kilograms of the Radixs Astragali, 10 kilograms on Flos Carthami, 1000 of preparation injection of solution agent, every 2ml.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, and adds 1800ml water for injection and makes dissolving, adds 0.3% active carbon, and 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, promptly.
Embodiment 3
Prescription: 1 kilogram of the Radix Astragali, 10 kilograms on Flos Carthami, 1000 of preparation freeze-dried powders.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
Embodiment 4
Prescription: 10 kilograms of the Radixs Astragali, 1 kilogram on Flos Carthami, 1000 of preparation freeze drying injections.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
Embodiment 5
Prescription: 5 kilograms of the Radixs Astragali, 1 kilogram on Flos Carthami, 1000 of preparation freeze-dried powders.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
Embodiment 6
Prescription: 1 kilogram of the Radix Astragali, 5 kilograms on Flos Carthami, 1000 of preparation freeze drying injections.
Method for making:
The preparation of Radix Astragali extract: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter.Merge 3 times filtrate, be evaporated to relative density 1.10～1.15 (50 ℃), be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount.Inclining supernatant, the centrifugal filtration of medicinal residues.Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15 (50 ℃).Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05 (50 ℃), add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05 (50 ℃), and freezing or spray drying promptly gets the Radix Astragali extract xeraphium.
The preparation of Flos Carthami extract: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter.Merge 3 times filtrate, be evaporated to relative density 1.05～1.10 (50 ℃), filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05 (50 ℃), add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05 (50 ℃), freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
Above Radix Astragali extract and Flos Carthami extract mixes, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, after being cooled to room temperature, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, and adds injection and is diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
Embodiment 7
Prescription: 10 kilograms of the Radixs Astragali, 10 kilograms on Flos Carthami, 1000 in preparation tablet.
Method for making:
The preparation of Radix Astragali extract: (with embodiment 1)
The preparation of Flos Carthami extract: (with embodiment 1)
Above Radix Astragali extract and Flos Carthami extract mixes, and it is an amount of to add starch, and the ethanol moistening is granulated, and drying adds magnesium stearate, mixing, tabletting, coating, packing.Promptly.
Embodiment 8
Prescription: 10 kilograms of the Radixs Astragali, 10 kilograms on Flos Carthami, 1000 of preparation capsules.
Method for making:
The preparation of Radix Astragali extract: (with embodiment 1)
The preparation of Flos Carthami extract: (with embodiment 1)
Above Radix Astragali extract and Flos Carthami extract mixes, and it is an amount of to add starch, and the ethanol moistening is granulated, and drying adds magnesium stearate, and mixing divides to install to capsule No. 1.Promptly.
Embodiment 9
Prescription: 10 kilograms of the Radixs Astragali, 10 kilograms on Flos Carthami, preparation granule 1000 grams.
Method for making:
The preparation of Radix Astragali extract: (with embodiment 1)
The preparation of Flos Carthami extract: (with embodiment 1)
Above Radix Astragali extract and Flos Carthami extract mixes, and it is an amount of to add dextrin, and Icing Sugar is an amount of, and the ethanol moistening is granulated, drying, and packing, promptly
Table 1 injection of the present invention is to dog myocardial oxygen consumption (mL/min.100g
-1) influence (x ± s, n=5)
| Group | Dosage | Index | Before the administration | After the administration | |||||
| 0min | 5min | 15min | 30min | 60min | 90min | 120min | |||
| Dosage high dose in the solvent control perhexiline injection low dosage | 10ml/kg 6g/kg 2g/kg 6g/kg 12g/kg | X ± SD changes % x ± SD variation % x ± SD variation % x ± SD and changes % x ± SD and change % | 215.1±24.0 203.4±18.9 206.5±13.8 211.5±12.2 209.4±13.9 | 217.0±21.2 1.05±2.12 201.4±16.5 -0.90±2.51 204.2±17.0 -1.15±4.04 206.3±13.0 -2.45±1.47 209.9±14.8 0.20±2.04 | 213.0±24.0 0.95±0.80 198.0±17.9 -2.63±1.84 199.9±15.3 -3.26±2.41 200.5±14.9 -5.26±2.16* 191.8±14.0 -8.42±2.34** | 211.7±21.4 -1.47±1.96 190.5±21.3 -6.36±4.87* 199.3±11.8 -3.44±1.39 198.3±16.9 -6.34±3.29* 189.3±20.0 -9.68±6.13** | 212.1±21.9 -1.28±1.79 194.4±24.0 -4.49±5.55 199.6±15.4 -3.42±1.50 198.8±17.0 -6.11±2.83 180.3±12.8 -13.8±4.13** | 211.8±19.6 -1.31±2.54 194.4±22.9 -4.53±4.63 203.5±13.9 -1.46±1.37 199.0±17.5 -6.12±5.09 185.2±17.6 -11.6±4.59** | 214.7±25.4 -0.23±1.26 192.4±20.3 -5.42±3.69 205.9±16.7 -0.35±2.56 200.0±18.5 -5.56±4.39 183.5±16.7 -12.4±4.03** |
*P＜0.05,
*Compare with the solvent control group P＜0.01
Table 2 is annotated the influence of injection of the present invention to dog coronary ligation epicardial electrogram ST section summation (∑ ST)
(mV, x ± SD, n=5/group)
| Group | Dosage | Index | Before the administration | After the administration | |||||
| 0min | 5min | 15min | 30min | 60min | 90min | 120min | |||
| Dosage high dose in the solvent control perhexiline contrast low dosage | 10ml/kg 6g/kg 2g/kg 6g/kg 12g/kg | X ± SD changes % x ± SD variation % x ± SD variation % x ± SD and changes % x ± SD and change % | 189.6±89.5 179.0±42.5 133.0±39.1 187.2±48.2 181.0±46.0 | 186.0±50.8 12.2±43.5 163.2±30.9 -7.74±7.15 138.2±39.7 5.74±23.3 201.0±86.8 4.41±28.9 152.6±33.5 -14.3±10.6 | 221.4±79.6 25.5±26.8 140.6±41.5 -21.0±13.9* 150.6±73.1 12.4±33.5 178.2±74.2 -7.67±20.1 120.2±51.5 -32.0±21.6** | 222.8±82.4 25.3±25.9 123.2±41.6 -32.0±9.50** 133.4±74.3 -3.48±26.3 144.4±64.1 -25.1±21.8* 94.4±49.7* -47.4±20.6** | 230.4±73.7 34.0±40.8 128.0±41.8* -29.3±8.32** 101.4±38.2** -24.2±11.9** 120.6±39.8* -35.8±13.5** 88.6±38.7** -50.2±17.8** | 219.6±105.4 17.4±12.6 134.2±35.3 -25.3±4.45* 118.6±51.3 -11.9±29.4 137.6±50.6 -27.5±16.8** 90.2±47.7* -49.8±19.9** | 203.4±94.5 9.22±10.5 173.2±56.2 -3.84±19.5 134.6±35.2 8.69±42.8 130.4±70.0 -33.0±22.7 96.0±44.6 -46.3±19.5* |
*P＜0.05,
*Compare with the solvent control group P＜0.01
Table 3 injection of the present invention is to the influence of rat heart ischemical reperfusion injury
( x±s，n＝10)
| Group | Dosage | CK(U/dL) | LDH(U/dL) | Infarct/(%) whole-heartedly |
| Dosage group high dose group in the sham operated rats normal saline group positive drug GUANXINNING ZHUSHEYE group low dose group | 5ml/kg 5ml/kg 18g/kg 6g/kg 18g/kg 36g/kg | 527.8±98.2 1109.6±254.4 △△ 798.0±102.1 ** 899.5±137.8 * 804.3±126.0 ** 713.7±158.5 ** | 584.4±113.5 1071.6±174.9 △△ 793.8±172.8 ** 885.8±150.6 ** 802.1±119.8 ** 707.2±147.1 ** | 0±0 32.0±4.1 △△ 24.1±2.4 ** 25.8±3.5 ** 23.8±4.2 ** 21.5±2.9 ** |
Table 4 injection of the present invention to the influence of rabbit whole blood viscosity (mPa.s) (x ± SD, n=5)
| Group | Dosage | Before the administration | After the administration | ||||
| Low cutting | In cut | Height is cut | Low cutting | In cut | Height is cut | ||
| Dosage group rate of change % high dose group rate of change % among the blank group rate of change % perhexiline injection rate of change small dose group rate of change % | 10ml/kg 9g crude drug/kg 3g crude drug/kg 9g crude drug/kg 18g crude drug/kg | 5.68±0.29 7.05±0.89 6.28±1.02 7.29±0.75 7.34±0.84 | 3.70±0.21 4.19±0.47 3.88±0.41 4.31±0.39 4.36±0.46 | 3.16±0.17 3.44±0.34 3.31±0.28 3.59±0.35 3.65±0.38 | 5.69±0.28 0.32±2.50 5.84±0.75 # -16.9±6.12** 5.64±0.83 -10.1±2.73* 6.01±0.81 # -17.7±6.12** 5.48±0.54 ## -25.1±3.92** | 3.65±0.18 -1.02±5.71 3.58±0.35 # -14.5±3.57** 3.58±0.34 -7.49±1.43 3.72±0.37 # -13.8±5.69** 3.57±0.28 # -17.9±6.28** | 3.13±0.13 -0.84±5.38 3.09±0.26 -9.84±3.49* 3.07±0.21 -7.15±2.24 3.17±0.33 -11.7±4.31* 3.01±0.38 # -17.3±6.84** |
* P＜0.05, * * P＜0.01 and solvent control group are relatively;
#P＜0.05,
##P＜0.01 is relatively preceding with administration
Table 5 injection of the present invention is to the influence of the inductive family of ADP rabbit platelet maximum agglutination rate (%, x ± SD)
| Group | Number of animals (only) | Before the administration | After the administration | Reduction rate % |
| The heavy dose of group of dosage group 9g/kg 18g/kg positive drug GUANXINNING ZHUSHEYE 6g/kg among the solvent control group small dose group 3g/kg | 6 6 6 6 6 | 64.3±6.2 62.8±6.9 63.2±6.6 64.7±5.2 63.2±7.9 | 65.3±4.2 53.9±5.7 **△△ 46.8±4.7 **△△ 41.3±4.5 **△△ 45.1±6.2 **△△ | 1.8±5.1 -14.0±3.9 **△△ -25.5±8.7 **△△ -36.1±5.7 **△△ -28.3±8.6 **△△ |
Claims (10)
1, a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease is characterized in that, is that raw material is made with Radix Astragali and Flos Carthami.
2, the preparation of claim 1 is characterized in that, Radix Astragali and Flos Carthami weight proportion is as follows: 1-10: 10-1.
3, the preparation of claim 1 is characterized in that, Radix Astragali and Flos Carthami weight proportion is as follows: 1-5: 5-1.
4, the preparation of claim 1 is characterized in that, Radix Astragali and Flos Carthami weight proportion is as follows: 1: 1.
5, the preparation of claim 1, it is characterized in that dosage form is selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, soft capsule, oral liquid, suck agent, granule, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, freeze-dried powder, suppository, ointment, plaster, cream, spray, drop, patch.
6, the preparation of claim 1 is characterized in that, dosage form is an injection preparation.
7, the preparation method of the preparation of claim 1 is characterized in that, the process following steps: Radix Astragali and Flos Carthami is processed through extraction or other modes, make pharmaceutically active substance, with this active substance is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.
8, the preparation method of claim 7 is characterized in that, wherein the Radix Astragali extracts through following steps: Radix Astragali decoction pieces adds 8 times of amount deionized waters and soaked 1 hour, and heating decocts extracted 3 hours, filtered filtrate for later use; Medicinal residues add 6 times of amount deionized waters again, decoct and extract 2 times, each 2 hours, filter; Merge 3 times filtrate, be evaporated to relative density 1.10～1.15, be cooled to room temperature, add 95% ethanol and reach 60%, cold preservation 12 hours to containing the alcohol amount; Inclining supernatant, the centrifugal filtration of medicinal residues; Merge supernatant and filtrate, decompression recycling ethanol also is concentrated into relative density 1.10～1.15; Concentrated solution adds 0.5 times of water gaging dilution, injects D
101In the macroporous resin column, earlier use the deionized water eluting, continue and use 30% ethanol elution, reuse 70% ethanol elution, collect 70% ethanol elution, be concentrated into relative density 1.01～1.05, add the water of equimultiple, cold preservation 12 hours, filter, filtrate is concentrated into relative density 1.01～1.05, and freezing or spray drying promptly gets the Radix Astragali extract xeraphium; Wherein Flos Carthami extracts through following steps: the Flos Carthami crude drug adds 12 times of amount deionized waters, and 90 ℃ were extracted 0.5 hour, filtered filtrate for later use; Medicinal residues add 10 times of amount deionized waters again, decoct and extract 2 times, each 0.5 hour, filter; Merge 3 times filtrate, be evaporated to relative density 1.05～1.10, filter, filtrate is injected D
101In the macroporous resin column, use earlier the deionized water eluting, reuse 5% ethanol elution is collected 5% ethanol elution, is concentrated into relative density 1.01～1.05, add 5 times of amount 95% ethanol, cold preservation 12 hours filters, and filtrate recycling ethanol also is concentrated into relative density 1.01～1.05, freezing or spray drying promptly gets the Flos Carthami extract xeraphium.
9, the preparation method of claim 7 is characterized in that, described preparation is the injection freeze-dried preparation, its preparation method is as follows: get 100g Radix Astragali extract lyophilized powder and 100g Flos Carthami extract lyophilized powder, add 1800ml water for injection and make dissolving, add 0.3% active carbon, 80 ℃ were stirred 30 minutes, be cooled to room temperature after, filter with the filter paper plate earlier, reuse 0.2 μ m microporous filter membrane filters, add injection and be diluted with water to 2000ml, canned, every 2ml, lyophilization, promptly.
10, the application of 1 of claim preparation in the treatment cardiovascular and cerebrovascular disease.
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| CN1733070A (en) * | 2004-07-09 | 2006-02-15 | 贵阳云岩西创药物科技开发有限公司 | Chinese medicinal preparation for treating cardiovascular and cerebrovascular diseases and its preparing process |
| CN1279919C (en) * | 2004-08-13 | 2006-10-18 | 张正生 | Pharmaceutical compositions containing ginsenoside, safflor yellow and its preparation and application |
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| CN102370902A (en) * | 2010-08-25 | 2012-03-14 | 天津天士力制药股份有限公司 | Medicament for treating kidney diseases and preparation method thereof |
| CN102370902B (en) * | 2010-08-25 | 2015-02-11 | 天士力制药集团股份有限公司 | Medicament for treating kidney diseases and preparation method thereof |
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