CN100418534C - Traditional Chinese medicine active part compound preparation for curing cardiac and cerebral vascular diseases and its preparing method - Google Patents
Traditional Chinese medicine active part compound preparation for curing cardiac and cerebral vascular diseases and its preparing method Download PDFInfo
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- CN100418534C CN100418534C CNB021550034A CN02155003A CN100418534C CN 100418534 C CN100418534 C CN 100418534C CN B021550034 A CNB021550034 A CN B021550034A CN 02155003 A CN02155003 A CN 02155003A CN 100418534 C CN100418534 C CN 100418534C
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- radix notoginseng
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- total glycosides
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Abstract
The present invention relates to a traditional Chinese medicine effective position compound preparation for treating cardio-cerebrovascular diseases and a preparing method thereof. The compound preparation is compounded from total red sage root phenolic acid extracted from red sage root, and notoginseng total glycosides extracted from notoginseng according to a certain mixing proportion. The compound medicine of the present invention enhances the pharmacological action and the clinical curative effect of the traditional Chinese medicine, and simultaneously lowers the contents of impurities. The compound medicine can be made into various preparations, and is used for treating cerebral infarction, cerebral ischemia, coronary heart disease, angina pectoris, myocardial ischemia, myocardial infarction, heart failure, arrhythmia, etc. The present invention achieves the purpose that the modern compound traditional Chinese medicine is 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 for the treatment of the effective ingredient in Chinese of cardiovascular and cerebrovascular disease, specifically pharmaceutical composition of forming by total salvianolic acid in the salviamiltiorrhizabung and the Radix Notoginseng total glycosides in the Radix Notoginseng and preparation method thereof.
Background technology
Radix Salviae Miltiorrhizae is the Chinese medicine of traditional simply blood circulation promoting and blood stasis dispelling, and a large amount of studies show that, the effective ingredient of Radix Salviae Miltiorrhizae is a total salvianolic acid, and wherein the effect of salvianolic acid B magnesium is the strongest, and traditional water extraction can not obtain containing the more total salvianolic acid of salvianolic acid B.
Radix Notoginseng is traditional simply dissipating blood stasis hemostasis, the Chinese medicine of subduing swelling and relieving pain.A large amount of studies show that the effective ingredient of Radix Notoginseng is a Radix Notoginseng total glycosides.The Radix Notoginseng total glycosides content that extracts with traditional extracting method is not high, and impurity is more, and the untoward reaction after patient's medication is more, and particularly during injecting drug use, it is particularly important that this problem just seems.
The traditional Chinese medical science thinks that qi depression to blood stasis is a main cause of cardiovascular and cerebrovascular disease morbidity, and the Chinese medicine compound of forming with Radix Salviae Miltiorrhizae, Radix Notoginseng is used for the qi depression to blood stasis cardiovascular and cerebrovascular disease, and is evident in efficacy.But traditional Chinese medicine compound exists to become to be hard to tell, 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 salviamiltiorrhizabung, Radix Notoginseng, i.e. modern Chinese medicine compound preparation, its definite ingredients, easy to control the quality, curative effect is reliable, can be used for treating cardiovascular and cerebrovascular disease.And the preparation method of this compound Chinese medicinal preparation proposed.
The effective ingredient in Chinese compound preparation 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 Notoginseng total glycosides that extracts from Radix Notoginseng.
This effective ingredient in Chinese compound preparation, its proper proportioning (by weight) is:
1 part of total salvianolic acid (containing salvianolic acid B magnesium more than 50%)
Radix Notoginseng total glycosides (contain the ginsenoside Rg1, Rb1, R1 account for more than 50%) 0.1-15 part,
The cardiovascular and cerebrovascular disease that above-mentioned Chinese medicine composition is controlled comprises: cerebral infarction, cerebral ischemia, coronary heart disease, angina pectoris, myocardial ischemia, myocardial infarction, heart failure, arrhythmia etc.
The invention allows for the preparation method of above-mentioned active component composition.
To Radix Salviae Miltiorrhizae, carry out percolation with acetone and extract, again through purification by macroporous resin, obtain containing the total salvianolic acid of 50% above salvianolic acid B magnesium.
To Radix Notoginseng, carry out percolation with ethanol and extract, again through purification by macroporous resin, obtain containing 50% above Radix Notoginseng total glycosides extract.
Above-mentioned 2 kinds of components are mixed corresponding various adjuvant again by proportioning, can make various compound preparations.
Described preparation can be injection, transfusion, injectable powder, tablet, capsule, slow releasing tablet, drop pill, electuary, microgranule.
The described auxiliary conventional adjuvant of various preparations that is.
Among the present invention, the extraction tools for purification body step of total salvianolic acid and Radix Astragali total glycosides is 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, better, the solvent use amount is a Radix Salviae Miltiorrhizae weight more than 10 times 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 the alcoholic solution 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, contain salvianolic acid B magnesium this more than 50%.
2. Radix Notoginseng total glycosides extracts purification
Radix Notoginseng total glycosides water soluble and ethanol are considered and are contained a large amount of starch in the Radix Notoginseng, should not adopt the ethanol of water and low concentration, in order to avoid gelatinizing.So select 55%～95% ethanol as extracting solvent, take following three kinds of extracting method: percolation, infusion process, decoction alcohol precipitation method, selected on this basis concentration of alcohol, extracting method and ethanol consumption carry out three factors, three horizontal L as 3 factors investigating
9(3
3) test.The result shows that what have the greatest impact is extracting method, secondly is concentration of alcohol, and the ethanol consumption then influences very little, and the effect of percolation is best.
Percolate, be concentrated to about 1/10 of original volume, add the low amounts of water dilution, by passing through macroporous resin column than adsorbance 1: 1 (amount of resin and medical material amount), earlier with the deionized-distilled water eluting, with column volume 20-40% alcoholic solution eluting more than 10 times, collect the alcoholic solution eluent again, concentrate promptly.Wherein ginsenoside Rg1, Rb1, R1 account for more than 50%.
The pharmacodynamics test of total salvianolic acid and Radix Notoginseng total glycosides compositions:
For the total salvianolic acid of investigating different proportionings and the drug effect of Radix Notoginseng total glycosides, find the prescription of optimum curative effect, the design different tests is observed total salvianolic acid and Radix Notoginseng total glycosides cause myocardial infarction model to the dog coronary artery ligation therapeutical effect.The proportioning of experimental selection is (total salvianolic acid/Radix Notoginseng total glycosides) 10/0,1/1,1/3,1/7,1/10,1/15,0/10, and its dosage is total is 1mg/kg; Other adds negative control normal saline group, positive control Diltiazem group, totally 9 groups.
Testing the method for relevant reported literature carries out.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 Notoginseng 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 Notoginseng 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 Notoginseng total glycosides intravenously administrable, wherein 1/1,1/3,1/7 and 1/10 group and positive controls ∑ ST significantly descend (P＜0.01), and certain dose relationship is arranged.Effect continues to 180min from administration 30min, 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 Notoginseng 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 Notoginseng total glycosides are to the influence of myocardial ischemia scope (epicardial electrogram N-ST): total salvianolic acid and Radix Notoginseng total glycosides can dwindle the myocardial ischemia scope, reduce the N-ST value, act on sustainable 180min.Wherein 1/1,1/3,1/7 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), 1/10 group of significant difference (P＜0.05) when 60min only.Experimental result sees Table 2.
Experimental result shows that total salvianolic acid and Radix Notoginseng 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 Notoginseng 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 Notoginseng total glycosides.Total salvianolic acid and Radix Notoginseng total glycosides intravenous injection all can reduce myocardial infarct size.Wherein 1/1,1/3,1/7 group and positive controls and normal saline group relatively, there were significant differences (P＜0.05) or utmost point significant difference (P＜0.01), 1/10 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 Notoginseng 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 Notoginseng 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 Notoginseng 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 Notoginseng total glycosides is influential to drug effect, and from interpretation, the best proportioning of total salvianolic acid and Radix Notoginseng total glycosides should be 1/3～1/7.
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 contain salvianolic acid B magnesium more than 50%.
The 10kg Radix Notoginseng powder is broken into coarse powder (20～40 order),, behind the alcohol dipping 24h with 10 times of amounts 75%,, collects percolate with the slow percolation of per kilogram per minute 2ml speed by the percolation that Chinese Pharmacopoeia records; The concentrating under reduced pressure percolate adds the suitable quantity of water dilution to 1/10 of original volume, by passing through the AB-8 macroporous resin column than adsorbance 1: 1 (amount of resin and medical material amount), first deionized-distilled water eluting with 5 times of volumes, 20% ethanol elution of 12 times of column volumes of reuse is collected eluent, and concentrating under reduced pressure promptly.Wherein contain ginsenoside Rg1, Rb1, more than the R150%.
Get salvianolic acid extract 2g, Radix Notoginseng total glycosides 6g mixes the back with an amount of water for injection dissolving, with mannitol 8g, 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 contain salvianolic acid B magnesium more than 50%.
The 10kg Radix Notoginseng powder is broken into coarse powder (20～40 order),, behind the alcohol dipping 12h with 12 times of amounts 75%,, collects percolate with the slow percolation of per kilogram per minute 3ml speed by the percolation that Chinese Pharmacopoeia records; The concentrating under reduced pressure percolate adds the suitable quantity of water dilution to 1/10 of original volume, by passing through the D101 macroporous resin column than adsorbance 1: 1 (amount of resin and medical material amount), first deionized-distilled water eluting with 4 times of volumes, 40% ethanol elution of 10 times of column volumes of reuse is collected eluent, and concentrating under reduced pressure promptly.Wherein contain ginsenoside Rg1, Rb1, more than the R150%.
Get salvianolic acid extract 2g, add the dissolving of injection water; Get Radix Notoginseng total glycosides 14g, 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 3 dog coronary ligation is to the influence (x ± SD, n=5/group) of N-BT dyeing mensuration myocardial infarct size
*P＜0.05,
* *Compare with the normal saline group P＜0.01
Claims (6)
1. effective ingredient in Chinese compound preparation for the treatment of cardiovascular and cerebrovascular disease is characterized in that by total salvianolic acid that extracts and the Radix Notoginseng total glycosides that extracts be that former material assembly forms from Radix Notoginseng from Radix Salviae Miltiorrhizae; The weight proportion of material component is:
Contain 1 part of the total salvianolic acid of salvianolic acid B magnesium more than 50%,
Contain ginsenoside Rg1, the above Radix Notoginseng total glycosides 0.1-15 part of Rb1, R150%.
2. effective ingredient in Chinese compound preparation according to claim 1, it is characterized in that the weight proportion of material component is: total salvianolic acid: Radix Notoginseng total glycosides is 1: 3-1: 7.
3. effective ingredient in Chinese compound preparation according to claim 1 and 2 is characterized in that adding corresponding adjuvant, becomes injection, transfusion, injectable powder, tablet, capsule, slow releasing tablet, drop pill, electuary, microgranule.
4. the preparation method of the effective ingredient in Chinese compound preparation of a treatment cardiovascular and cerebrovascular disease as claimed in claim 1 or 2, it is characterized in that,, carry out percolation with acetone and extract Radix Salviae Miltiorrhizae, through purification by macroporous resin, obtain containing the total salvianolic acid of 50% above salvianolic acid B magnesium again; To Radix Notoginseng, carry out percolation with ethanol and extract, again through purification by macroporous resin, obtain containing the Radix Notoginseng total glycosides extract of 50% above ginsenoside Rg1, Rb1, R1; With two kinds of effective sites, mix by weight ratio, promptly make required compound preparation.
5. preparation method according to claim 4, when it is characterized in that extracting salvianolic acid, acetone concentration is between 50～70%, and the solvent use amount is a Radix Salviae Miltiorrhizae weight more than 10 times, and soak time is 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 by macroporous resin column, earlier with the deionized-distilled water eluting, again with the 20-40% alcoholic solution eluting of column volume more than 10 times, collect the alcoholic solution 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.
6. preparation method according to claim 4 when it is characterized in that extracting Radix Notoginseng total glycosides, selects 55%～95% ethanol as extracting solvent; Percolate, be concentrated to original volume about 1/10 after, add low amounts of water dilution, by passing through macroporous resin column at 1: 1, earlier with the deionized-distilled water eluting, again with column volume 20-40% alcoholic solution eluting more than 10 times than adsorbance, collect the alcoholic solution eluent, concentrate promptly.
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| CN100418534C true CN100418534C (en) | 2008-09-17 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1294927C (en) * | 2004-08-19 | 2007-01-17 | 文山壮族苗族自治州三七科学技术研究所 | Liver disease treating medicine |
| CN100450496C (en) * | 2004-12-14 | 2009-01-14 | 李捍雄 | Compound preparation of notoginseng and safflower for treating cardiovascular and cerebrovascular diseases |
| CN100484543C (en) * | 2004-12-21 | 2009-05-06 | 四川迪康科技药业股份有限公司 | Medicament composition for treating hepatitis, prepartion method and use |
| 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 |
| CN101073598B (en) * | 2006-05-17 | 2012-05-30 | 天津药物研究院 | Medicinal composition for treating cardiovascular and cerebrovascular disease and its preparation |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083819A (en) * | 1993-05-11 | 1994-03-16 | 富宁制药厂 | Notoginseng total saponin medicines and preparation method thereof |
| 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 |
| CN1349818A (en) * | 2001-10-24 | 2002-05-22 | 沈阳药科大学 | Effective part group in red sage mixture and its delayed release prepn. medicinal use and prepn process |
| CN1470255A (en) * | 2002-07-22 | 2004-01-28 | 王智民 | Preparation extracted from the root of red-rooted solvia and pseudo-ginseng and its compound preparation and medical use |
-
2002
- 2002-12-19 CN CNB021550034A patent/CN100418534C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083819A (en) * | 1993-05-11 | 1994-03-16 | 富宁制药厂 | Notoginseng total saponin medicines and preparation method thereof |
| 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 |
| CN1349818A (en) * | 2001-10-24 | 2002-05-22 | 沈阳药科大学 | Effective part group in red sage mixture and its delayed release prepn. medicinal use and prepn process |
| CN1470255A (en) * | 2002-07-22 | 2004-01-28 | 王智民 | Preparation extracted from the root of red-rooted solvia and pseudo-ginseng and its compound preparation and medical use |
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