CN100556419C - A kind of dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component and preparation method thereof - Google Patents
A kind of dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component and preparation method thereof Download PDFInfo
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- CN100556419C CN100556419C CNB200510013268XA CN200510013268A CN100556419C CN 100556419 C CN100556419 C CN 100556419C CN B200510013268X A CNB200510013268X A CN B200510013268XA CN 200510013268 A CN200510013268 A CN 200510013268A CN 100556419 C CN100556419 C CN 100556419C
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Abstract
The invention provides a kind of Radix Salviae Miltiorrhizae and Sanchi effective-component dispersible tablet and preparation method thereof of containing, it is made up of Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins and filler, disintegrating agent and other adjuvants, and wherein Radix Salviae Miltiorrhizae total phenolic acids (contain salvianolic acid B and must not be less than 60%) is 1 with the weight ratio of Radix Notoginseng total arasaponins (contain Radix Notoginseng total arasaponins and must not be less than 60%): 0.5-2.Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins: filler, disintegrating agent and other adjuvants are 1: 1-5.Better ratio is 1: 2-3.Disintegrating agent: filler is 1: 2-6.Better ratio is 1: 3-5.The present invention is to provide the dispersible tablet that herbal mixture effective site is formed, with high content of technology, effective substance is clear and definite, and dosage form advanced person is rapid-action, and effect is strong, and the bioavailability height is suitable for treating cardiovascular system diseases.
Description
Technical field
The present invention relates to a kind of herbal mixture effective site dispersible tablet for the treatment of cardiovascular disease and preparation method thereof.A kind of specifically pellet seven effective site dispersible tablets that contain Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins and preparation method thereof.
Background technology
The present invention writes out a prescription according to being the Chinese medicine DANQI PIAN, is the Chinese patent medicine commonly used of treatment cardiovascular disease, and " ministry standard " the 1st recorded, and is made up of Radix Salviae Miltiorrhizae, Radix Notoginseng, and wherein Radix Salviae Miltiorrhizae is a monarch drug, and Radix Notoginseng is a ministerial drug.Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge; Radix Notoginseng is the dry root of panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen; Has promoting tissue regeneration by removing blood stasis, reducing swelling and alleviating pain, promoting blood circulation to restore menstrual flow, the function of the relieving restlessness that clears away heart-fire; Borneolum Syntheticum then has the refreshment of having one's ideas straightened out, the dispel effect of pain of heat clearing away.Be used for cardiovascular and cerebrovascular diseases such as angina pectoris.
Main effective ingredient has water soluble ingredient and liposoluble constituent two big classes in the Radix Salviae Miltiorrhizae: liposoluble constituent is a diterpene quinone, mainly is TANSHINONES, tanshinone, cryptotanshinone etc.; Water soluble ingredient is a phenolic acid compound, is the active main matter of Radix Salviae Miltiorrhizae cardiovascular system pharmacology basis, mainly contains salvianolic acid, danshensu, protocatechualdehyde etc.Pharmacological research shows that the salvianolic acid constituents has antiplatelet aggregative activity, anti-thrombosis function, microcirculation improvement effect, anti-oxidative damage effect and multipath performance myocardium protecting action.Salvianolic acid B resists myocardial ischemia, and antiplatelet aggregation improves heart microvascular endothelial cell, myocardial cell hypoxia-bearing capability, alleviates the effect of inflammatory factor to the infringement of endothelium, myocardial cell.Radix Salviae Miltiorrhizae have the effect of dwindling myocardial infarct size and alleviating lesion degree, also has the effect of protection superoxide dismutase and glutathione peroxidase.
Main effective ingredient in the Radix Notoginseng is a saponin, has water solublity.Can obviously reduce myocardium zmount of oxygen consumption, improve myocardial ischemia, reduce the activity of lactic acid dehydrogenase; dwindle the myocardial ischemia area, the damage of protection myocardial ischemia-reperfusion stream reduces whole blood viscosity, plasma viscosity, erythrocyte sedimentation rate; anticoagulant reduces blood coagulation.
At present, this side has dosage forms such as tablet, granule, capsule, soft capsule, injection, and preparation is crude extract, does not still have the new drug of this side's effective part extract combination.
Summary of the invention
Be to improve the technical merit of Chinese medicine preparation, guarantee safety of clinical administration, effective and quality controllable, the invention provides a kind of steady quality, rapid-action, bioavailability is high, the clear and definite tablet formulation of effective substance and preparation method thereof.
The technical solution adopted in the present invention is: a kind of dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component, and it is made up of Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins and filler, disintegrating agent and other adjuvants, wherein:
Radix Salviae Miltiorrhizae total phenolic acids (contain salvianolic acid B and must not be less than 60%) is 1 with the weight ratio of Radix Notoginseng total arasaponins (contain Radix Notoginseng total arasaponins and must not be less than 60%): 0.5-2.
Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins: filler, disintegrating agent and other adjuvants are 1: 1-5.Better ratio is 1: 2-3.
Disintegrating agent: filler is 1: 2-6.Better ratio is 1: 3-5.
The addition of micropowder silica gel is the 1-5% of whole prescription.Better ratio is 2-3%.
The addition of magnesium stearate is the 0.1-5% of whole prescription.Better ratio is 0.2-0.3%.
Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins obtain by the following method: with water or 1-99% arbitrary proportion ethanol is that solvent extracts Radix Salviae Miltiorrhizae, pseudo-ginseng separately or Radix Salviae Miltiorrhizae, pseudo-ginseng mixing back are extracted, after extracting solution concentrates, through the macroporous adsorbent resin separation and purification, concentrate, promptly.
Wherein, 1-99% arbitrary proportion ethanol is preferably 10-90%, is preferably 30-80%.
Wherein, macroporous adsorbent resin can be HPD-100, D101, AB-8 or LSA-30.
Radix Salviae Miltiorrhizae total phenolic acids is the assay index with the salvianolic acid B, adopts high effective liquid chromatography for measuring content, chromatographic condition: C
18Post (200 * 4.6mm, 5 μ m), mobile phase: (33: 9: 56: 2), flow velocity 1.0mL/min detected wavelength 280nm to methanol-acetonitrile-water-glacial acetic acid; The ginseng phenolic acid B is no less than 60%.Radix Notoginseng total arasaponins is with the ginsenoside Rg
1With ginsenoside Rb
1. Panax Notoginseng saponin R
1Be the assay index, Radix Notoginseng total arasaponins is no less than 60%, adopts high effective liquid chromatography for measuring content, and chromatographic condition is: C
18Post (200 * 4.6mm), mobile phase: acetonitrile-water gradient elution; Detect wavelength 203nm.
The preparation method that contains Radix Salviae Miltiorrhizae and Sanchi effective-component dispersible tablet:
Get Radix Salviae Miltiorrhizae total phenolic acids, Radix Notoginseng total arasaponins and mix with filler, disintegrating agent and other adjuvants in proportion, tabletting, promptly. wherein tablet hardness is controlled at the 2-15 kilogram, is preferably the 3-8 kilogram.
For further specifying good effect of the present invention, adopt the dispersible tablet of the present invention's preparation to carry out following experiment:
(1) disintegration time mensuration:
The dispersible tablet that makes as stated above carries out disintegration time mensuration, and results sample is all disintegrates within 2 minutes.
(2) Radix Salviae Miltiorrhizae and Sanchi effective-component dispersible tablet and the comparative experiments of commercially available DANQI PIAN agent dissolution: commercially available DANQI PIAN:
Disintegration time: 40 minutes
Dissolution rate:
| Time (minute) | 5 | 10 | 20 | 30 | 45 |
| Dissolution % | 25.5 | 40.1 | 55.2 | 74.2 | 85.3 |
Radix Salviae Miltiorrhizae that the embodiment of the invention 1 is made and Sanchi effective-component dispersible tablet
Disintegration time: 2 minutes
Dissolution rate:
| Time (minute) | 1 | 2 | 3 |
| Dissolution % | 64.2 | 86.8 | 99.4 |
Can prove by above experiment: the dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component of the present invention is compared its advantage with dosage forms such as existing tablet, granule, capsule, soft capsule, injections and is:
(1). medicine of the present invention is an effective ingredient in Chinese group new drug, and effective ingredient is clear and definite, is convenient to quality control; Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins are main effective ingredient, and one-tenth is distinguished one from the other, and quality control is accurate, have improved
(2). the present invention is a dispersible tablet, is a kind of modern Chinese medicine novel form, and medicine is all disintegrates in 3 minutes, and is rapid-action, and effect is strong, and the bioavailability height is suitable for treating cardiovascular system diseases.
(3). this product is a peroral dosage form, takes, transports, stores conveniently, steady quality, no injection shortcoming in these areas.
Further specify beneficial effect of the present invention below by pharmacodynamic experiment:
Radix Salviae Miltiorrhizae of the present invention and Sanchi effective-component dispersible tablet pharmacodynamic experiment are the methods that adopts ligation rat coronary artery anterior descending branch, cause the animal model of acute experiment myocardial ischemia, and observe its influence to myocardial ischemia scope, serum biochemistry index.Result of the test shows:
(1). can obviously reduce the electrocardiogram S-T section that causes after the rat ligation branch of coronary artery and raise, administration group S-T section is raised and significantly is lower than the blank group.
(2). can improve experimental acute myocardial ischemia degree due to the ligation rat coronary artery anterior descending branch, dwindle myocardial infarct size, the infarct size of administration group accounts for the left ventricle area and is significantly less than the blank group.
(3). have and reduce the active effect that raises of serum lactate dehydrogenase (SLD), administration group serum lactate dehydrogenase (SLD) content significantly is lower than the blank group.
Conclusion: Radix Salviae Miltiorrhizae of the present invention and Sanchi effective-component dispersible tablet have the better protect effect to acute myocardial ischemia.Can reduce because the electrocardiogram S-T section that myocardial ischemia causes is raised, dwindle because the myocardial ischemia scope that infraction causes lowers serum lactate dehydrogenase (SLD) content.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only is indicative, means that never it limits the scope of the invention by any way.
Embodiment 1
Get Radix Salviae Miltiorrhizae, pseudo-ginseng is an amount of, mixes the back and adds concentration 60% soak with ethanol 24h, moves in the percolator, with the speed percolation of 0.6mL/min, collects percolate, being evaporated to does not have the alcohol flavor.Concentrated solution is by HPD-100 type macroporous adsorptive resins purification, and with 4BV distilled water eluting, reuse 60% ethanol 6BV eluting is collected 60% ethanol elution, and concentrating under reduced pressure earlier, (measuring the ginseng phenolic acid B is 70%, and Radix Notoginseng total arasaponins is 65%) spray drying.Get spray drying powder 25g, microcrystalline Cellulose 37.5g, crosslinked polyethylene pyrrole sieve alkane ketone 11g, micropowder silica gel 1.25g, magnesium stearate 0.25g mixing, tabletting, the hard polyethylene pyrrole of tablet sieve alkane ketone 11g, micropowder silica gel 1.25g, magnesium stearate 0.25g mix, tabletting, tablet hardness are controlled at the 5-7 kilogram.The result: be 2 minutes disintegration.
Embodiment 2
Get Radix Salviae Miltiorrhizae, pseudo-ginseng equivalent, use 50% alcohol heating reflux 1h respectively, leach medicinal liquid, medicinal residues are the same to be extracted once again, merges medicinal liquid, and being evaporated to does not have alcohol flavor (0.1MP, 60 ℃).Divide other Radix Notoginseng and Radix Salviae Miltiorrhizae concentrated solution, the Radix Salviae Miltiorrhizae concentrated solution is by SPD-100 type macroporous adsorptive resins (200mL) purification, and with 4BV distilled water eluting, reuse 30% ethanol 6BV eluting is collected 30% ethanol elution, and concentrating under reduced pressure (0.1MP, 60 ℃) earlier; The Radix Notoginseng concentrated solution is by SPD-100 type macroporous adsorptive resins (200mL) purification, and with 4BV distilled water eluting, reuse 70% ethanol elution is collected 70% ethanol elution, and concentrating under reduced pressure (0.1MP, 60 ℃ earlier; ) merging Radix Salviae Miltiorrhizae and Radix Notoginseng concentrated solution (measuring the ginseng phenolic acid B is 71%, and Radix Notoginseng total arasaponins is 65%), spray drying.Get spray drying powder 25g, microcrystalline Cellulose 40g, crosslinked polyethylene pyrrole sieve alkane ketone 7.5g, micropowder silica gel 2.25g, magnesium stearate 0.25g mixing, tabletting, tablet hardness is controlled at the 4-6 kilogram.The result: be 2 minutes disintegration.
Embodiment 3
Get Radix Salviae Miltiorrhizae, pseudo-ginseng equivalent, mix the back and add concentration 30% alcohol heating reflux 1h, leach medicinal liquid, medicinal residues are the same to be extracted once again, merge medicinal liquid, being evaporated to does not have alcohol flavor (0.1MP, 60 ℃), concentrated solution is by LSA-30 type macroporous adsorbent resin (600mL) purification, with 4BV distilled water eluting, reuse 50% ethanol 6BV eluting is collected 50% ethanol elution earlier, and concentrating under reduced pressure (measuring the ginseng phenolic acid B is 71%, and Radix Notoginseng total arasaponins is 63%).Get spray drying powder 25g, microcrystalline Cellulose 39g, crosslinked polyethylene pyrrole sieve alkane ketone 9g, micropowder silica gel 1.5g, magnesium stearate 0.5g mixing, tabletting, tablet hardness is controlled at the 7-9 kilogram.The result: be 2.5 minutes disintegration.
Claims (5)
1, a kind of dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component, it is made up of the raw material of following weight fraction: Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins: filler, disintegrating agent and other adjuvants are 1: 1-5;
Disintegrating agent wherein: filler is 1: 2-6;
Described filler is selected from microcrystalline Cellulose; Disintegrating agent is selected from crospolyvinylpyrrolidone; Other adjuvants are medicinal micropowder silica gel and magnesium stearate;
The weight ratio of Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins is 1: 0.5-2;
Described Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins it be with water or 30-80% ratio ethanol be solvent Radix Salviae Miltiorrhizae, pseudo-ginseng are extracted separately or will Radix Salviae Miltiorrhizae, pseudo-ginseng mixes the back and extracts, after extracting solution concentrates, through HPD-100, D101, AB-8 or the separation and purification of LSA-30 macroporous adsorbent resin, concentrate, promptly.
2, as claims 1 described Radix Salviae Miltiorrhizae and Sanchi effective-component dispersible tablet, wherein Radix Salviae Miltiorrhizae total phenolic acids and Radix Notoginseng total arasaponins: filler, disintegrating agent and other adjuvants are 1: 2-3; Disintegrating agent: filler is 1: 3-5.
3, a kind of method for preparing claim 1 or 2 each described Radix Salviae Miltiorrhizaes and Sanchi effective-component dispersible tablet is characterized in that:
(1) get Radix Salviae Miltiorrhizae, pseudo-ginseng is an amount of, mixes the back and adds concentration 60% soak with ethanol 24h, moves in the percolator, with the speed percolation of 0.6mL/min, collects percolate, being evaporated to does not have the alcohol flavor.Concentrated solution is by HPD-100 type macroporous adsorptive resins purification, and with 4BV distilled water eluting, reuse 60% ethanol 6BV eluting is collected 60% ethanol elution, and concentrating under reduced pressure earlier, and measuring salvianolic acid B is 70%, and Radix Notoginseng total arasaponins is 65%, spray drying;
(2) get spray drying powder 25g, microcrystalline Cellulose 37.5g, crosslinked polyethylene pyrrole sieve alkane ketone 11g, micropowder silica gel 1.25g, magnesium stearate 0.25g mixing, tabletting, tablet hardness is controlled at the 5-7 kilogram, and measuring disintegration is 2 minutes.
4, a kind of method for preparing claim 1 or 2 each described Radix Salviae Miltiorrhizaes and Sanchi effective-component dispersible tablet is characterized in that:
(1) gets Radix Salviae Miltiorrhizae, pseudo-ginseng equivalent, use 50% alcohol heating reflux 1h respectively, leach medicinal liquid, medicinal residues are the same to be extracted once again, merges medicinal liquid, at 0.1MP, 60 ℃, being evaporated to does not have the alcohol flavor, gets Radix Notoginseng and Radix Salviae Miltiorrhizae concentrated solution respectively, the Radix Salviae Miltiorrhizae concentrated solution is by 200ml SPD-100 type macroporous adsorptive resins purification, with 4BV distilled water eluting, reuse 30% ethanol 6BV eluting is collected 30% ethanol elution earlier, and at 0.1MP, 60 ℃ of concentrating under reduced pressure; The Radix Notoginseng concentrated solution is by 200ml SPD-100 type macroporous adsorptive resins purification, earlier with 4BV distilled water eluting, reuse 70% ethanol elution, collect 70% ethanol elution, and at 0.1MP, 60 ℃ of concentrating under reduced pressure, merge Radix Salviae Miltiorrhizae and Radix Notoginseng concentrated solution, measuring salvianolic acid B is 71%, and Radix Notoginseng total arasaponins is 65%, spray drying;
(2) get spray drying powder 25g, microcrystalline Cellulose 40g, crosslinked polyethylene pyrrole sieve alkane ketone 7.5g, micropowder silica gel 2.25g, magnesium stearate 0.25g mixing, tabletting, tablet hardness is controlled at the 4-6 kilogram, and measuring disintegration is 2 minutes.
5, a kind of method for preparing claim 1 or 2 each described Radix Salviae Miltiorrhizaes and Sanchi effective-component dispersible tablet is characterized in that:
(1) gets Radix Salviae Miltiorrhizae, pseudo-ginseng equivalent, mix the back and add concentration 30% alcohol heating reflux 1h, leach medicinal liquid, medicinal residues are the same to be extracted once again, merges medicinal liquid, at 0.1MP, 60 ℃, being evaporated to does not have the alcohol flavor, and concentrated solution is by 600ml LSA-30 type purification with macroreticular resin, earlier with 4BV distilled water eluting, reuse 50% ethanol 6BV eluting is collected 50% ethanol elution, and concentrating under reduced pressure, measuring salvianolic acid B is 71%, and Radix Notoginseng total arasaponins is 63%;
(2) get spray drying powder 25g, microcrystalline Cellulose 39g, crosslinked polyethylene pyrrole sieve alkane ketone 9g, micropowder silica gel 1.5g, magnesium stearate 0.5g mixing, tabletting, tablet hardness is controlled at the 7-9 kilogram, and measuring disintegration is 2.5 minutes.
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| CNB200510013268XA CN100556419C (en) | 2005-04-04 | 2005-04-04 | A kind of dispersible tablet that contains Radix Salviae Miltiorrhizae and Sanchi effective-component and preparation method thereof |
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| CN100556419C true CN100556419C (en) | 2009-11-04 |
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