CN100346798C - Traditional Chinese medicine active part composition for curing cardio and cerebral vascular disease and its preparing method - Google Patents
Traditional Chinese medicine active part composition for curing cardio and cerebral vascular disease and its preparing method Download PDFInfo
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Abstract
The present invention relates to a traditional Chinese medicine active part composition for treating cardiovascular and cerebrovascular diseases and a preparing method thereof. The medicine composition is prepared from total danshen root phenolic acid (salvianolic acid B magnesium salt reaches 50% above) and total saponin of milkvetch root (astragaloside reaches over 2%) according to a certain proportion. The compound medicine produced by the present invention enhances the pharmacological action and the clinical curative effect of the traditional Chinese medicine, simultaneously lowers the contents of impurities and can be made into various preparations. The medicine of the present invention is used for treating coronary heart disease, angina pectoris, myocardial ischemia, heart failure, arrhythmia, cerebral infarction and cerebral ischemia, and makes the compound traditional Chinese medicine safe, effective, stable, controllable and convenient.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of composition and method of making the same that is used for the treatment of the effective ingredient in Chinese of cardiovascular and cerebrovascular disease, specifically pharmaceutical composition that Radix Astragali total glycosides is formed in the total salvianolic acid in the salviamiltiorrhizabung and the Radix Astragali and preparation method thereof.
Background technology
Radix Salviae Miltiorrhizae is the Chinese medicine of traditional simply blood circulation promoting and blood stasis dispelling, a large amount of effective ingredient that studies show that Radix Salviae Miltiorrhizae are total salvianolic acid, wherein the effect of salvianolic acid B magnesium is the strongest, and traditional water extraction method can not obtain the higher total salvianolic acid of salvianolic acid B, can only be its catabolite danshensu and toxic component protocatechualdehyde.
The Radix Astragali is traditional simply qi-invigorating herb, and pharmacological action shows that Radix Astragali total glycosides can improve myocardial ischemia, protection cardiovascular and cerebrovascular vessel, microcirculation improvement.Astragaloside content in medical material has only 0.04%, and traditional method is difficult to purification and obtains.
The traditional Chinese medical science thinks that qi depression to blood stasis is a main cause of cardiovascular and cerebrovascular vessel morbidity, forms Chinese medicine compound with the Radix Astragali and Radix Salviae Miltiorrhizae and is used for the qi depression to blood stasis cardiovascular and cerebrovascular disease, and is evident in efficacy.But traditional Chinese medicine compound exists and becomes to be hard to tell, and mechanism is not clear, the difficult control of quality, the unsteady shortcoming of curative effect.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition of forming by the effective site of the salviamiltiorrhizabung and the Radix Astragali, i.e. modern Chinese medicine compound recipe, its definite ingredients, curative effect is reliable, easy to control the quality, can be used for treating cardiovascular and cerebrovascular disease, and propose this preparation of drug combination method.
The effective ingredient in Chinese compositions that the present invention proposes is to be that former material assembly forms by total salvianolic acid that extracts from Radix Salviae Miltiorrhizae and the Radix Astragali total glycosides that extracts from the Radix Astragali.
This effective ingredient in Chinese compositions, its proper proportioning (by weight) is:
1 part of total salvianolic acid (containing salvianolic acid B magnesium more than 50%),
Radix Astragali total glycosides (containing astragaloside more than 20%) 0.1-1 part.
The cardiovascular and cerebrovascular disease that above-mentioned Chinese medicine composition is controlled comprises: coronary heart disease, angina pectoris, myocardial ischemia, heart failure, arrhythmia, cerebral infarction, cerebral ischemia etc.
The present invention also comprises above-mentioned effective ingredient in Chinese preparation of compositions method.
To Radix Salviae Miltiorrhizae, carry out percolation with acetone and extract, through the macroporous resin column purification, can obtain containing the total salvianolic acid of salvianolic acid B magnesium more than 50%.
To the Radix Astragali, use water extraction, through macroporous resin column aqueous alkali eluting, obtain containing the Radix Astragali total glycosides of astragaloside more than 20%.With these two kinds of effective sites,, promptly can be made into various preparations by aforementioned proportioning and after adding corresponding adjuvant mixing.
Described preparation can be injectable powder, injection, tablet, slow releasing tablet, drop pill, electuary, capsule, slow-release micro-pill.Described adjuvant is the conventional adjuvant of various preparations.
Among the present invention, the extraction purification concrete steps of total salvianolic acid and Radix Astragali total glycosides are as follows:
1. salvianolic acid extracts purification
Salvianolic acid character instability is met violent condition such as acid, alkali, heat and can be degraded, so employing mild condition, percolation that efficient is high.Yield and purity thereof with salvianolic acid B magnesium are index, and to influencing the principal element of salvianolic acid yield: soak time is carried out L by three factors, three levels before used acetone concentration, amount, the percolation
9(3
3) orthogonal test.Result of the test shows that better, use amount is more than 10 times of Radix Salviae Miltiorrhizae weight to acetone concentration between 50～70%, and the soak time influence is little, generally more than 20 minutes.
With the acetone percolate, be concentrated to original volume about 1/10 after, to there not being the acetone flavor, after adding the low amounts of water dilution, by than adsorbance 1: 1 (amount of resin and medical material amount) by macroporous resin column, first with the deionized-distilled water eluting, again with the 20-40% alcoholic solution eluting of column volume more than 10 times, collect eluent, promptly get the salvianolic acid composition.With high concentration ethanol liquid flush away oil-soluble impurities, carry out the next round purification more again.
The salvianolic acid composition is to thermally labile, so adopt freezing and drying lyophilization to carry out concentrate drying.Remove ethanol in low temperature (＜50 ℃) concentrating under reduced pressure, continue to be concentrated into about 1/10 of original volume, with 0.45 μ m filtering with microporous membrane, concentrated solution is according to conventional freeze-dry process :-50 ℃ pre-freeze 3-4 hour,-10 ℃ of lyophilizing, be warming up to 20 ℃ of insulations 2-3 hour, final yellow loose crystalline powder.Wherein, containing salvianolic acid B magnesium reaches more than 50%.
2 Radix Astragali total glycosidess extract purification
Radix Astragali total glycosides all has certain dissolubility in water, and Radix Astragali saponin is to thermally-stabilised, so heating reflux method is adopted in the extraction of Radix Astragali total glycosides.Yield with astragaloside is an index, to three principal elements: extraction time, extraction time and three factors of solvent load, three horizontal L
9(3
3) orthogonal test.Result of the test shows, 15 times in water is more than the amount, and reflux, extract, is more than 2 times, and each 40-80 minute comparatively suitable.
Because of mainly containing the saccharide water-solubility impurity in the water extraction of astragalus membranaceus, in aqueous solution, macroporous adsorbent resin has the good adsorption selectivity to Organic substance, and method that can Solid-Phase Extraction is removed carbohydrate content in the absorption Radix Astragali saponin.Water extraction of astragalus membranaceus by than adsorbance 1: 1 (amount of resin and medical material amount) by macroporous resin column, first with the deionized-distilled water eluting, again with 15 times with upper volume alkaline solution eluting, continue with 20% alcoholic solution eluting, with the 70-90% ethanol elution, collect eluent again, be Radix Astragali total glycosides.Use 95% ethanol regenerating resin post at last, carry out the next round purification.70-90% ethanol elution partial concentration is to small size (1 volume aqueous solution contains 5 times of amount medical materials), and centrifugal, precipitation promptly gets astragaloside, is the A part.After the supernatant concentration, the 75-85% ethanol precipitation, the centrifugal precipitation of removing, supernatant concentration gets the B part to doing.A, B two parts are merged, be Radix Astragali total glycosides, wherein the content of astragaloside is more than 20%.Detection is followed the tracks of through HPLC-ELSD in other eluting positions of macroporous adsorptive resins, does not all detect astragaloside.
The pharmacodynamics test of total salvianolic acid and Radix Astragali total glycosides compositions:
For the total salvianolic acid of investigating different proportionings and the drug effect of Radix Astragali total glycosides, find the prescription of optimum curative effect, the design different tests is observed total salvianolic acid and Radix Astragali total glycosides cause myocardial infarction model to the dog coronary artery ligation therapeutical effect.The proportioning of experimental selection is (total salvianolic acid/Radix Astragali total glycosides) 10/0,10/3,10/5,10/7,10/10,10/15,0/10, and its dosage is total is 1mg/kg; Other adds negative control normal saline group, positive control Diltiazem group, totally 9 groups.
Test is carried out with reference to the method for relevant reported literature.The variation of 30min, 60min, 90min, 120min, 180min record epicardial electrogram after administration respectively.The epicardial electrogram observation index: the summation (∑ ST) with lead number (NST) and ST section lift-off value more than the ST section rising 2mV is the variation of index observing administration front and back, and calculating myocardium degree of ischemia (∑ ST) and scope (NST).To compare before different time measured value and the medication after the medication, between different time variation percentage rate (being 100% before the medication) is organized after the medication, compare.
Every treated animal number is 5, gives total salvianolic acid/Radix Astragali total glycosides 1.0mg/kg (facing with preceding with the fresh preparation of normal saline), and the positive control pharmaceutical quantities is 0.5mg/kg, and negative control group is given the normal saline of 1.0mg/kg, the equal intravenous injection single-dose of three.Observe the dog epicardial electrogram, be after the administration 0～3 hour observing time.
Experimental result is as follows:
1, total salvianolic acid and Radix Astragali total glycosides are to the influence of degree of myocardial ischemia (epicardial electrogram ∑ ST): behind the coronary ligation, the outer electrograph ST section summation (∑ ST) of the heart obviously raises.∑ ST raises and reaches 26.5 ± 12.1% during normal saline group 120min; All can alleviate degree of myocardial ischemia behind total salvianolic acid and the Radix Astragali total glycosides intravenously administrable, wherein 10/5,10/7 and 10/10 group and positive controls ∑ ST significantly descend (P＜0.01), and certain dose relationship is arranged.Effect continues to 180min from administration, and more all there were significant differences for each time point and normal saline group (P＜0.01).Experimental result sees Table 1.
Experimental result shows that total salvianolic acid and Radix Astragali total glycosides intravenously administrable have significant therapeutic effect to the acute myocardial ischemia degree that the dog coronary ligation causes, and should act on relevant with drug ratio.
The statistical test that changes before and after the administration is done the between group variable analytical control with each group different time points changing value and the same time point changing value of normal saline group.
2, total salvianolic acid and Radix Astragali total glycosides are to the influence of myocardial ischemia scope (epicardial electrogram N-ST): total salvianolic acid and Radix Astragali total glycosides can dwindle the myocardial ischemia scope, reduce the N-ST value, act on sustainable 180min.Wherein 10/3,10/5,10/7 group and positive controls and normal saline group with time point relatively, there were significant differences (P＜0.05) or utmost point significant difference (P＜0.01), 10/10 group of significant difference (P＜0.05) when 60min only.Experimental result sees Table 2.
Experimental result shows that total salvianolic acid and Radix Astragali total glycosides intravenous injection can significantly reduce the myocardial ischemia scope, and should act on relevant with drug ratio.
3, total salvianolic acid and Radix Astragali total glycosides are learned the influence that detects to the quantitative tissue of myocardial infarct size: learn with quantitative tissue and detect myocardial infarct size and promptly show that with N-BT dyeing total salvianolic acid is consistent with the result of epicardial electrogram mensuration to the influence of myocardial infarct size with Radix Astragali total glycosides.Total salvianolic acid and Radix Astragali total glycosides intravenous injection all can reduce myocardial infarct size.Wherein 10/5,10/7,10/10 group and positive controls and normal saline group relatively, there were significant differences (P＜0.05) or utmost point significant difference (P＜0.01), 10/15 group only to " infarct/whole-heartedly " significant difference (P＜0.05).Experimental result sees Table 3.
Experimental result shows that the myocardial infarct size that total salvianolic acid and Radix Astragali total glycosides intravenously administrable cause the dog coronary ligation has significant improvement effect, and should act on relevant with drug ratio.Experimental result proves, total salvianolic acid and Radix Astragali total glycosides intravenous injection can significantly reduce the degree of the myocardial ischemia of coronary ligation dog, dwindle the myocardial ischemia scope, it is consistent that quantitative tissue is learned the result who detects with epicardial electrogram mensuration, compare with the normal saline matched group, infarct significantly dwindles, and proves that the myocardial infarction that total salvianolic acid and Radix Astragali total glycosides intravenous injection cause the dog coronary artery ligation has the obvious treatment effect.Experimental result proves that also the proportioning of total salvianolic acid and Radix Astragali total glycosides is influential to drug effect, and from interpretation, the best proportioning of total salvianolic acid and Radix Astragali total glycosides should be 10/3～10/7.
The specific embodiment
Embodiment 1:
Get Radix Salviae Miltiorrhizae 10kg, begin percolation after soaking 30min with 70% acetone of 10 times of amounts, the percolate concentrating under reduced pressure is not to there being the acetone flavor, dilutes concentrated solution with the water of proper volume, according to passing through the AB-8 macroporous resin column, promptly use 10kg macroporous resin packed column than adsorbance 1: 1 (amount of resin and medical material amount).With 4 times of volume deionized-distilled water eluting,, collect eluent earlier, promptly get the salvianolic acid composition again with 10 times of column volumes, 20% alcoholic solution eluting.40 ℃ of concentrating under reduced pressure are removed ethanol, continue to be concentrated into 1/10 of original volume, and with 0.45 filtering with microporous membrane, concentrated solution is by following technology lyophilizing :-50 ℃ of pre-freezes 4 hours ,-10 ℃ of lyophilizing are warming up to 20 ℃ of insulations 3 hours, obtain yellow loose crystal type powder then.Wherein containing salvianolic acid B magnesium reaches more than 50%.
After astragalus root 10kg pulverizes, the water reflux, extract, is three times in the heating and refluxing extraction jar, each 1h, merge extractive liquid,, join on the AB-8 macroporous adsorptive resins, with 100 liters deionized-distilled water eluting saccharide, carry out eluting with 50 liter 0.1% sodium hydrate aqueous solution again, continue and decolour with 50 liter 20% ethanol eluting, again with 25 liter 75% ethanol eluting Radix Astragali saponin, eluent is concentrated to small size, centrifugal precipitate A part 5.435 grams that obtain, and adding ethanol to alcohol concentration in mother solution is 70%, centrifugal, get supernatant, obtain the B part behind the concentrate drying, obtain Radix Astragali total saponins after A part and B are partially mixed.Wherein contain astragaloside more than 20%.
Get salvianolic acid extract 5.8g, Radix Astragali total glycosides 1.7g mixes the back with an amount of water for injection dissolving, with mannitol 7.5g, according to conventional freeze-dry process lyophilizing, promptly gets the injection lyophilized powder.
Embodiment 2:
Get Radix Salviae Miltiorrhizae 10kg, begin percolation after soaking 30min with 50% acetone of 10 times of amounts, the percolate concentrating under reduced pressure is not to there being the acetone flavor, dilutes concentrated solution with the water of proper volume, according to passing through the AB-8 macroporous resin column, promptly use 10kg macroporous resin packed column than adsorbance 1: 1 (amount of resin and medical material amount).With 4 times of volume deionized-distilled water eluting,, collect eluent earlier, promptly get the salvianolic acid composition again with 12 times of column volumes, 30% alcoholic solution eluting.45 ℃ of concentrating under reduced pressure are removed ethanol, continue to be concentrated into 1/10 of original volume, and with 0.45 filtering with microporous membrane, concentrated solution is by following technology lyophilizing :-50 ℃ of pre-freezes 3 hours ,-10 ℃ of lyophilizing are warming up to 20 ℃ of insulations 2 hours, obtain yellow loose crystal type powder then.Wherein containing salvianolic acid B magnesium reaches more than 50%.
After astragalus root 10kg pulverizes, the water reflux, extract, is three times in the heating and refluxing extraction jar, each 1h, merge extractive liquid,, join on the D101 macroporous adsorptive resins, with 100 liters deionized-distilled water eluting saccharide, carry out eluting with 50 liter 0.1% potassium hydroxide aqueous solution again, continue and decolour with 50 liter 20% ethanol eluting, again with 25 liter 90% ethanol eluting Radix Astragali saponin, eluent is concentrated to small size, centrifugal precipitate A part 5.754 grams that obtain, and adding ethanol to alcohol concentration in mother solution is 70%, centrifugal, get supernatant, obtain the B part behind the concentrate drying, obtain Radix Astragali total saponins after A part and B are partially mixed.Wherein contain astragaloside more than 20%.
Get salvianolic acid extract 10g, add the dissolving of injection water; Get Radix Astragali total glycosides 6g, add the dissolving of injection water.Merge two parts solution, be mixed with the 1000ml medicinal liquid according to a conventional method, filter, fine straining, embedding, sterilization, check gets 20ml/ and props up totally 50 of injections.
Table 1 dog coronary ligation to the influence of epicardial electrogram ST section summation (∑ ST) (mV, x ± SD, n=5)
| Group | Dosage | Index | 0min | 30min | 60min | 90min | 120min | 180min |
| Physiological saline diltiazem hydrochloride 1,0/0 1,0/3 1,0/5 1,0/7 10,/10 10,/15 0/10 | 1ml/kg 0.5mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg | X ± SD variation % x ± SD variation % x ± SD changes % x ± SD variation % x ± SD variation % x ± SD variation % x ± SD variation % x ± SD and changes % x ± SD and change % | 332.8±120.5 278.9±124.6 317.6±103.0 349.4±113.1 351.6±151.41 266.2±128.8 272.5±67.7 351.0±127.1 311.5±149.0 | 366.0±133.2 10.6±6.0 180.0±134.0 -42.4±21.3 *** 289.9±107.4 2.9±2.2 318.9±118.4 12.9±5.2 230.0±96.1 -25.3±16.4 *** 151.8±104.0 -45.9±18.1 *** 194.2±98.4 -48.0±18.2 *** 303.0±104.7 22.6±12.0 282.9±85.3 17.9±8.9 | 411.9±178.5 22.2±12.4 177.4±140.7 -43.8±21.1 *** 246.7±110.2 8.0±5.6 261.8±121.4 18.0±5.6 229.8±104.4 -29.2±10.5 *** 158.0±84.7 -48.5±21.7 *** 208.4±122.4 -43.7±26.9 *** 294.9±148.6 18.6±12.5 294.1±125.0 24.6±11.7 | 412.0±185.0 21.8±15.0 176.6±155.0 -45.0±24.0 *** 294.0±83.1 16.8±10.0 323.1±92.1 21.8±11.0 245.5±117.6 -31.1±11.6 *** 150.7±83.4 -51.4±25.4 *** 210.4±103.4 -44.3±30.1 *** 282.2±115.4 20.3±11.2 300.2±87.9 21.0±12.2 | 422.8±172.3 26.5±12.1 177.5±135.9 -42.7±18.5 *** 261.2±77.9 9.2±6.7 287.2±85.9 19.2±6.7 226.5±97.7 -32.4±12.3 *** 180.7±93.3 -45.9±20.2 *** 216.1±98.4 -40.7±21.9 *** 260.9±80.9 26.9±13.5 325.4±108.5 13.9±8.7 | 398.4±140.1 23.0±20.6 204.3±146.8 -33.0±24.0 *** 243.6±92.1 11.1±7.5 267.6±101.0 17.1±5.5 208.9±84.6 -35.6±14.6 *** 160.7±107.9 -49.6±21.7 *** 223.6±108.0 -39.7±18.9 *** 318.6±138.3 27.3±15.5 238.7±71.1 13.1±7.5 |
Compare with the normal saline group:
*P＜0.05,
* *P＜0.01
Table 2 dog coronary ligation to the influence of myocardial infarct size (N-ST) (point, x ± SD, n=5)
| Group | Dosage | 0min | 30min | 60min | 90min | 120min | 180min |
| Physiological saline diltiazem hydrochloride 1,0/0 1,0/3 1,0/5 1,0/7 10,/10 10,/15 0/10 | 1ml/kg changes % 0.5mg/kg variation % 1mg/kg variation % 1mg/kg variation % 1mg/kg variation % 1mg/kg and changes % 1mg/kg variation % 1mg/kg variation % 1mg/kg variation % | 28.4±1.3 26.6±2.1 26.6±3.7 26.7±1.5 26.8±2.1 28.1±1.6 28.6±2.6 26.8±1.9 28.0±4.7 | 28.6±2.1 0.6±3.0 18.8±5.0 -29.9±13.8 *** 22.4±3.2 -15.0±12.7 21.8±7.1 -26.1±10.0 *** 18.0±5.7 -22.6±11.7 *** 17.8±3.6 -26.9±9.9 *** 22.9±5.6 -12.0±10.7 25.9±7.6 -7.2±11.0 23.4±4.2 -14.0±11.7 | 28.6±1.7 0.7±2.9 18.0±3.7 -32.3±13.2 *** 23.2±3.1 -12.2±10.7 23.0±7.1 -21.6±9.4 *** 17.8±6.1 -23.5±9.8 *** 16.6±3.8 -28.6±13.5 *** 25.7±7.4 -13.2±5.9 ** 26.7±6.4 -10.0±13.7 24.2±4.1 -11.2±9.7 | 28.4±1.1 0.2±7.4 17.6±4.9 -34.0±17.3 *** 23.6±2.3 -10.2±12.4 25.2±5.8 -13.2±9.0 ** 17.8±5.4 -23.7±16.8 *** 17.8±5.8 -27.9±15.6 *** 26.2±7.8 -8.1±10.0 24.2±9.8 -8.3±10.1 24.6±3.3 -9.2±8.4 | 28.4±1.5 0.2±8.1 17.4±3.8 -34.8±12.5 *** 22.4±2.6 -14.5±14.9 22.0±7.0 -25.4±9.9 *** 13.6±3.2 -27.7±8.0 *** 17.6±3.6 -28.0±10.2 *** 26.6±9.0 -7.5±10.9 26.6±8.0 -8.2±14.0 23.4±3.6 -13.5±13.9 | 27.8±1.5 -1.8±10.0 17.2±5.4 -35.4±19.4 *** 23.2±2.2 -11.9±9.7 22.8±5.2 -22.0±13.5 *** 12.8±5.3 -30.7±7.7 *** 16.6±4.0 -29.5±9.1 *** 24.6±8.9 -10.9±13.0 27.6±6.9 -1.4±6.5 24.2±3.2 -10.9±8.7 |
Compare with the normal saline group:
*P＜0.05,
* *P＜0.01
Myocardial infarct size behind the table 3 dog coronary ligation (x ± SD, n=5)
| Group | Dosage | Infarct/(%) whole-heartedly | Infarct/left ventricle (%) |
| Physiological saline diltiazem hydrochloride 1,0/0 1,0/3 1,0/5 1,0/7 10,/10 10,/15 0/10 | 1ml/kg 0.5mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg 1mg/kg | 13.7±2.1 6.7±1.5 *** 10.2±4.6 11.4±6.0 9.8±2.3 ** 7.1±1.8 *** 11.3±2.1 ** 11.2±2.3 ** 12.0±4.8 | 22.8±3.5 10.9±2.0 *** 16.3±8.1 19.5±7.2 11.6±4.8 ** 9.5±2.8 *** 15.0±2.3 ** 18.0±8.2 18.8±7.9 |
Claims (4)
1, a kind of effective ingredient in Chinese compositions for the treatment of cardiovascular and cerebrovascular disease is characterized in that by total salvianolic acid that extracts and the Radix Astragali total glycosides that extracts be that crude drug is prepared from from the Radix Astragali from Radix Salviae Miltiorrhizae, wherein, the weight proportion of crude drug is:
Contain 1 part of the total salvianolic acid of salvianolic acid B magnesium more than 50%,
Contain astragaloside Radix Astragali total glycosides 0.1-1 part more than 20%;
Contain the total salvianolic acid of salvianolic acid B magnesium more than 50% and extract acquisition by following step from Radix Salviae Miltiorrhizae: carry out percolation with acetone and extract, acetone concentration is between 50～70%, and use amount is more than 10 times of Radix Salviae Miltiorrhizae weight, and soak time is more than 20 minutes; With the acetone percolate, be concentrated to about 1/10 of original volume, to there not being the acetone flavor, after adding the low amounts of water dilution,, first by amount of resin and 1: 1 ratio adsorbance of medical material amount with the deionized-distilled water eluting by macroporous resin column, again with the 20-40% alcoholic solution eluting of column volume more than 10 times, collect eluent, promptly get the salvianolic acid composition; With high concentration ethanol liquid flush away oil-soluble impurities, carry out the next round purification more again; Adopt freezing and drying lyophilization to carry out concentrate drying; Final yellow loose crystalline powder wherein contains salvianolic acid B magnesium and reaches more than 50%;
Contain the Radix Astragali total glycosides of astragaloside more than 20% and extract acquisition by following step from the Radix Astragali: use water extraction, water is 15 times of the Radix Astragali more than the amount, and reflux, extract, is more than 2 times, each 40-80 minute; Water extraction of astragalus membranaceus by amount of resin and 1: 1 ratio adsorbance of medical material amount by macroporous resin column, first with the deionized-distilled water eluting, again with 15 times with upper volume alkaline solution eluting, continue with 20% alcoholic solution eluting, with the 70-90% ethanol elution, collect eluent again, be Radix Astragali total glycosides; Use 95% ethanol regenerating resin post at last, carry out the next round purification; Wherein the content of astragaloside is more than 20%.
2, effective ingredient in Chinese compositions according to claim 1 is characterized in that total salvianolic acid: Radix Astragali total glycosides is 1: 0.3----1: 0.7.
3, effective ingredient in Chinese compositions according to claim 1 and 2 is characterized in that adding corresponding adjuvant, is injectable powder, injection, tablet, slow releasing agent, drop pill, electuary, capsule, slow-release micro-pill.
4, a kind of effective ingredient in Chinese preparation of compositions method of treatment cardiovascular and cerebrovascular disease as claimed in claim 1 or 2, it is characterized in that carrying out percolation with acetone extracts, through the macroporous resin column purification, obtain containing the total salvianolic acid of salvianolic acid B magnesium more than 50%; Use water extraction,, obtain containing the Radix Astragali total glycosides of astragaloside more than 20% through macroporous resin column aqueous alkali eluting; These two kinds of effective sites by aforementioned proportioning and after adding corresponding adjuvant mixing, are promptly made various preparations; Wherein:
When extracting the purification total salvianolic acid, acetone concentration is between 50～70%, and use amount is more than 10 times of Radix Salviae Miltiorrhizae weight, and soak time is more than 20 minutes; With the acetone percolate, be concentrated to about 1/10 of original volume, to there not being the acetone flavor, after adding the low amounts of water dilution,, first by amount of resin and 1: 1 ratio adsorbance of medical material amount with the deionized-distilled water eluting by macroporous resin column, again with the 20-40% alcoholic solution eluting of column volume more than 10 times, collect eluent, promptly get the salvianolic acid composition; With high concentration ethanol liquid flush away oil-soluble impurities, carry out the next round purification more again; Adopt freezing and drying lyophilization to carry out concentrate drying; Final yellow loose crystalline powder wherein contains salvianolic acid B magnesium and reaches more than 50%;
When extracting Radix Astragali total glycosides, water is 15 times of the Radix Astragali more than the amount, and reflux, extract, is more than 2 times, each 40-80 minute; Water extraction of astragalus membranaceus by amount of resin and 1: 1 ratio adsorbance of medical material amount by macroporous resin column, first with the deionized-distilled water eluting, again with 15 times with upper volume alkaline solution eluting, continue with 20% alcoholic solution eluting, with the 70-90% ethanol elution, collect eluent again, be Radix Astragali total glycosides; Use 95% ethanol regenerating resin post at last, carry out the next round purification; Wherein the content of astragaloside is more than 20%.
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| CNB021550042A CN100346798C (en) | 2002-12-19 | 2002-12-19 | Traditional Chinese medicine active part composition for curing cardio and cerebral vascular disease and its preparing method |
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| CNB021550042A CN100346798C (en) | 2002-12-19 | 2002-12-19 | Traditional Chinese medicine active part composition for curing cardio and cerebral vascular disease and its preparing method |
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| CN1425430A CN1425430A (en) | 2003-06-25 |
| CN100346798C true CN100346798C (en) | 2007-11-07 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100367969C (en) * | 2003-07-29 | 2008-02-13 | 上海博泰医药科技有限公司 | Injection formulation of astragalus root saponin and its preparation mehod |
| JP2006232698A (en) * | 2005-02-23 | 2006-09-07 | Suzuka Univ Of Medical Science | Preventing or treating medicine of cerebral stroke or late sequela of the same by using salvianolic acid b as main component |
| CN101143164B (en) * | 2006-09-14 | 2010-12-15 | 山西太行药业股份有限公司 | Medicinal composition for treating coronary heart disease and preparation process thereof |
| CN101293009A (en) * | 2007-04-23 | 2008-10-29 | 北京本草天源药物研究院 | Pharmaceutical composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1242986A (en) * | 1999-07-05 | 2000-02-02 | 济南三九益民制药有限责任公司 | Use of B magnesium tanphenolate in pharmacy |
| CN1283482A (en) * | 2000-06-09 | 2001-02-14 | 安徽天洋药业有限公司 | Medicinal composition for treating cardiovascular disease and its preparing process |
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| CN1242986A (en) * | 1999-07-05 | 2000-02-02 | 济南三九益民制药有限责任公司 | Use of B magnesium tanphenolate in pharmacy |
| CN1283482A (en) * | 2000-06-09 | 2001-02-14 | 安徽天洋药业有限公司 | Medicinal composition for treating cardiovascular disease and its preparing process |
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