CN101091738A - Composition of medicine in use for treating cardiovascular disease and cerebrovascular disease, and preparation method - Google Patents
Composition of medicine in use for treating cardiovascular disease and cerebrovascular disease, and preparation method Download PDFInfo
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- CN101091738A CN101091738A CN 200610200606 CN200610200606A CN101091738A CN 101091738 A CN101091738 A CN 101091738A CN 200610200606 CN200610200606 CN 200610200606 CN 200610200606 A CN200610200606 A CN 200610200606A CN 101091738 A CN101091738 A CN 101091738A
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- crospolyvinylpyrrolidone
- silica gel
- hydroxypropyl methylcellulose
- radix notoginseng
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Abstract
The present invention discloses a Chinese medicine composition for preventing and curing angiocardiopathy and cerebrovascular disease. Said Chinese medicine composition is made up by using notoginseng total saponin as main raw material, after some proper auxiliary materials are added in the main raw material; said medicine composition can be made into various dosage forms.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, especially a kind of Chinese medicine composition of preventing and treating cardiovascular and cerebrovascular disease and preparation method thereof that is used to belongs to the field of Chinese medicines.
Background technology
Cardiovascular and cerebrovascular disease is modern society's serious threat human health, and one of serious disease that number of the infected tops the list also is the disease that mainly causes death.This disease is clinical common frdquently encountered disease, and disease is seen palpitation and uneasiness, discomfort uncomfortable in chest, and stabbing pain over the chest, angor are fixed and are not moved, and go into Night Watch very, dizzy headache; Coronary heart disease, myocardial infarction, cerebral arteriosclerosis, cerebral thrombosis etc. are seen above-mentioned syndrome more.Research and develop a kind of medicine for the treatment of this type of disease is the direction that medical worker makes great efforts always.Serious day by day along with China's aged tendency of population, the demand of cardiovascular and cerebrovascular disease medication also can sharply increase.
At the field of Chinese medicines, 'Xuesaitong ' formulation series is arranged, multiple cardiovascular and cerebrovascular disease and peripheral neuropathy there are the soft ideal curative effect that is.But existing medicine and preparation remain in more deficiency, and comprising: 1, drug absorption is slow, and bioavailability is low; 2, clinical application range is narrow, and the solid that is not suitable for swallowing is difficult that patient uses.
Through consulting document, in application number 02133464.1, a kind of preparation technology of dispersible tablet is disclosed, but national drug food Surveillance Authority medicine is evaluated the center and clearly stipulated: dispersible tablets of Chinese medicine will be made the mensuration of drug dissolution, and following problem will occur by the product that this preparation technology obtains:
1, drug dissolution can not reach the pharmacopeia required standard;
2, in the tabletting process, pressure control range is narrower, and pressure is more higher, and dispersing uniformity exceeds the requirement of pharmacopeia regulation, the bad control of commercial production.
Summary of the invention
One of purpose of the present invention provides a kind of new pharmaceutical composition, is used for the treatment of cardiovascular and cerebrovascular disease; Another object of the present invention provides this preparation of drug combination method.
The present invention seeks to be achieved through the following technical solutions.
This pharmaceutical composition is that the total Saponin that extracts in the root by panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen is that primary raw material is made, behind the adjuvant that is suited, be made into various preparations clinical and that pharmacy is feasible, comprise tablet, capsule, granule, dispersible tablet, soft capsule, injection etc.
Proving that through pharmaceutical research Radix Notoginseng total arasaponins has many-sided biological activity, is a kind of active drug of preventing and treating cardiovascular disease.Aspects such as its effect mainly shows heart tonifying, coronary artery dilator, coronary blood flow increasing, improves myocardial metabolism, free radical resisting, anticoagulant, calcium antagonism.Clinical trial proves that also then Radix Notoginseng total arasaponins is made preparation (sheet, capsule, injection) has ideal curative effect to multiple cardiovascular and cerebrovascular disease and peripheral neuropathy.
Clinical practice for convenience, reach quick-acting purposes, the inventor preferably makes dispersible tablet with this medicine, and this moment, the weight proportion of supplementary material was: 50～100 parts of Radix Notoginseng total arasaponinss, 120～240 parts of microcrystalline Cellulose, 10～80 parts of crospolyvinylpyrrolidone, 5～50 parts of low-substituted hydroxypropyl celluloses, 1～10 part of Aspartane, 1～10 part of hydroxypropyl methylcellulose, 40%～80% ethanol is an amount of, 1～5 part of micropowder silica gel or magnesium stearate, 5～30 parts of carboxymethylstach sodium.
Corresponding preparation process is: the supplementary material pulverize separately is become fine powder, take by weighing Radix Notoginseng total arasaponins, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, mix homogeneously by prescription; Get hydroxypropyl methylcellulose, the water swollen is added in the alcoholic solution, makes the alcoholic solution of 1～3% hydroxypropyl methylcellulose, make wetting agent system soft material with this solution, 30 mesh sieves are granulated, and wet granular carries out drying under 50 ℃ of conditions, with 30 mesh sieve granulate, add micropowder silica gel or magnesium stearate, Aspartane and carboxymethylstach sodium, mixing, tabletting promptly gets dispersible tablet of the present invention.
Supplementary material proportioning after preferred is: 50 parts of Radix Notoginseng total arasaponinss, 185 parts of microcrystalline Cellulose, 40 parts of crospolyvinylpyrrolidone, 10 parts of low-substituted hydroxypropyl celluloses, 1 part of Aspartane, 1 part of hydroxypropyl methylcellulose, 50% ethanol is an amount of, 1 part of micropowder silica gel, 12 parts of carboxymethylstach sodium.
Corresponding preparation process is: the supplementary material pulverize separately is become fine powder, take by weighing Radix Notoginseng total arasaponins, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, mix homogeneously by prescription; Get hydroxypropyl methylcellulose, the water swollen is added in 50% alcoholic solution, makes 50% alcoholic solution of 1% hydroxypropyl methylcellulose, make wetting agent system soft material with this solution, 30 mesh sieves are granulated, and wet granular carries out drying under 50 ℃ of conditions, with 30 mesh sieve granulate, add micropowder silica gel, Aspartane and carboxymethylstach sodium, mixing, tabletting promptly gets dispersible tablet of the present invention.
Below by screening process and verification method effect of the present invention is described.
Preparation research of the present invention comprises the step of following order:
The selection of different disintegrating agents
The used disintegrating agent kind of dispersible tablet is a lot, but different medicines and different disintegrating agent proportionings, its disintegrate influential effect is very big, so screen the disintegrate effect of different disintegrating agents earlier.With Radix Notoginseng total arasaponins 50g, filler, the disintegrating agent pressed in the table 1 mix, and granulate drying, tabletting with 1% hydroxypropyl emthylcellulose.
The different prescription of table 1 proportioning is formed table
| Composition | Prescribed regimen | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |
| Total saponins (g) | 50 | 50 | 50 | 50 | 50 | 50 |
| PVPP(g) | 40 | 40 | - | 60 | 40 | - |
| L-HPC(g) | - | 40 | 40 | - | 60 | 40 |
| CMS-Na(g ) | 40 | - | 40 | 40 | - | 60 |
| MCC(g) | 170 | 170 | 170 | 150 | 150 | 150 |
| Dispersing uniformity | 66s | 54s | 126s | 43s | 55s | 110s |
Annotate: crospolyvinylpyrrolidone-PVPP; Low-substituted hydroxypropyl cellulose-L-HPC, carboxymethylstach sodium-CMS-Na:, microcrystalline Cellulose-MCC
The result shows, and is best with PVPP disintegrate effect, secondly is low-substituted hydroxypropyl cellulose; From the addition of disintegrating agent, the addition of PVPP increases, and disintegrate is accelerated.The addition of CMS-Na, L-HPC increases, the disintegrate DeGrain.
The selection of hydrophilic adhesive
The granule that adopts polyvidone or hydroxypropyl methylcellulose to make, surperficial tool hydrophilic, easily moistening, the infiltration of moisture behind the tabletting, the tablet easy disintegrating also helps the stripping of medicine.But itself viscosity is bigger, and majority is applied to conventional tablet.This product adopts the dilute alcohol solution of polyvidone and hydroxypropyl emthylcellulose, and consumption is generally the 1-2% of recipe quantity.By above-mentioned prescription 1 batching, granulate with different binding agents, make finished product.By test, the dilute alcohol solution of hydroxypropyl emthylcellulose is made binding agent, and compression molding is good, and disintegrate is qualified, and consumption is less.Concrete result of the test sees Table 2.
The different binding agent mouldabilities of table 2 are table as a result
| Binding agent | Mouldability | Dispersing uniformity | Consumption |
| 50% ethanol of 1% polyvidone | Generally | Be uniformly dispersed in 3 minutes | Sheet heavily increases by 2% |
| 50% alcoholic solution of 1% hydroxypropyl emthylcellulose | Fine | 1.2 minute be uniformly dispersed | Sheet heavily increases by 0.7% |
| 5% starch slurry | Fine | Be uniformly dispersed in 6 minutes | Sheet heavily increases by 6% |
The selection of fluidizer
According to research reports, mobility of particle is a critical nature in the solid pharmaceutical preparation technology.Fluidizer commonly used has micropowder silica gel, magnesium stearate.Consider that magnesium stearate is a hydrophobicity, can increase disintegration; Adopt micropowder silica gel to make fluidizer, it can improve the flowability of granule or powder effectively when pelletizing press sheet or direct powder compression.Simultaneously, can significantly improve the disintegrate and the dissolution rate of insoluble drug behind the silanol base on the silica gel surface absorption medicine.The micropowder silica gel consumption can quicken the disintegrate of tablet 1% when above, helps the stripping of medicine.
The investigation of disintegrating agent adding method
Add in the disintegrating agent and be meant before granulating and add, add and add in the dried granule before being meant tabletting.Dispersible tablet often adopts disintegrating agent to add also in both and adds, and adds a kind of disintegrating agent in having plenty of, and adds another kind.Adding disintegrating agent, to make the tablet disintegrate be coarse grain, plays a part disintegrate first, in then to make the disintegrate of coarse granule secondary with disintegrating agent be fine grained, uniform particles is dispersed in the solution.
Test method:
1. get Radix Notoginseng total arasaponins 50g, add crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 10g, microcrystalline Cellulose 190g, with 50% alcohol granulation of 1% hydroxypropyl emthylcellulose, drying, granulate adds micropowder silica gel 1g, tabletting.
2. get Radix Notoginseng total arasaponins 50g, add crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 10g, microcrystalline Cellulose 180g, with 50% alcohol granulation of 1% hydroxypropyl emthylcellulose, drying, granulate, add crospolyvinylpyrrolidone 10g, add micropowder silica gel 1g, tabletting.
3. get Radix Notoginseng total arasaponins 50g, add crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 10g, microcrystalline Cellulose 180g, with 50% alcohol granulation of 1% hydroxypropyl emthylcellulose, drying, granulate, add carboxymethyl starch sodium 10g, add micropowder silica gel 1g, tabletting.
The results are shown in Table 3.
Table 3 disintegrating agent adding method is investigated table as a result
| Index | ① | ② | ③ |
| Dispersing uniformity | 2.5 minute | 1.4 minute | 1.5 minute |
Result of the test shows that adding disintegrating agent can improve dispersing uniformity to a great extent, adds crospolyvinylpyrrolidone and carboxymethyl starch sodium to the dispersing uniformity influence not quite.Consider that the crospolyvinylpyrrolidone price is more expensive, so select to add carboxymethyl starch sodium.
Determining of moulding process
By the research of test and documents and materials, crospolyvinylpyrrolidone and low-substituted hydroxypropyl cellulose are used, the disintegrate better effects if.For making things convenient for the patient to take, can add an amount of correctives; And drug dissolution is relevant with the grain diameter size, and particle diameter is more little, and the medicine stripping is fast more.The wet grain of dispersible tablet requires below 1mm (18 order), and dried granule granulate requires below 0.6mm (30 order).So determine technology be: get Radix Notoginseng total arasaponins fine powder 50g, add crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 10g, microcrystalline Cellulose 185g, mixing is with 50% alcohol granulation of 1% hydroxypropyl emthylcellulose; Dry (50 ℃), granulate add aspartame 1g, micropowder silica gel 1g, and it is an amount of to add carboxymethyl starch sodium, and to total amount 300g, mixing is pressed into 1000.Meet every regulation under the dispersible tablet item by test this product.
Hygroscopicity is checked
4 parts of granules before the pressure sheet, each 2g, the accurate title, decide, and places 4 weighing botles that have been dried to constant weight respectively, be placed on respectively in the exsiccator of constant humidity (humidity environment that variable concentrations sulphuric acid causes), room temperature is 26 ℃ again, after 1 hour, take out, weigh, calculate hygroscopic capacity.The result shows, RH＞55% o'clock, and this product hygroscopicity is stronger, and then hygroscopicity is not strong when following 40% for RH, for guaranteeing that tabletting carries out smoothly, should control relative humidity in the production below 40%.
The investigation of mobility of particle
The mensuration of angle of repose: get the surface plate of a diameter 80.0mm, a funnel is fixed on the support, end opening is over against the surface plate center, high 60.0mm, get then granule by it from the funnel under the spontaneous current, till obtaining the highest cone, record the cone height, calculate angle of repose.After measured, be 32 degree this particulate angle of repose, shows that mobility of particle is good.
Three batches of pilot scale sample preparations
According to above preferred technology, test agent is in pilot-scale production in three batches, and the product that obtains is pressed the official method inspection, and the medicine stripping reaches more than 70% of labelled amount in the time of 5 minutes; Pressure control range broad in the tabletting process, its dispersing uniformity also meet the pharmacopeia regulation.This technology advanced person is described, feasible, be suitable for big production.
The specific embodiment
[prescription] Radix Notoginseng total arasaponins 50g
[method for making] gets Radix Notoginseng total arasaponins fine powder 50g, adds crospolyvinylpyrrolidone 40g, low-substituted hydroxypropyl cellulose 10g, and microcrystalline Cellulose 185g, mixing is granulated with 50% alcoholic solution of 1% hydroxypropyl emthylcellulose; Dry (50 ℃), granulate add aspartame 1g, micropowder silica gel 1g, and it is an amount of to add carboxymethyl starch sodium, and to total amount 300g, mixing is pressed into 1000.
Dissolution is got 5 of this product, according to dissolution method (two appendix XC of Chinese Pharmacopoeia version in 2000 three therapeutic methods of traditional Chinese medicine), with water 250ml is solvent, rotating speed is that per minute 100 changes ± 1 commentaries on classics, and operation in accordance with the law is in the time of 5 minutes, it is an amount of to get solvent, cross microporous filter membrane (0.45 μ m), measure, calculate every stripping quantity according to high performance liquid chromatography (Chinese Pharmacopoeia version appendix in 2000 VID).Limit is 75% of a labelled amount, should be up to specification.
Dispersing uniformity is got 2 of this product, puts jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, 3 minutes all disintegrate and by No. 2 the sieve.
Stability: test agent is observed three batch samples by the room temperature reserved sample observing method and the accelerated test of heating by under the listing terms of packing in three batches of Xuesaitong dispersible tablet.(1) room temperature reserved sample observing method: (25 ± 2 ℃, RH=60% ± 10%) at ambient temperature, carry out continuous 12 months study on the stability at the appointed time; (2) accelerated test of heating: (T=40 ± 2 ℃ under the constant temperature and humidity condition, RH=75% ± 5%), sample is placed with in the saturated exsiccator of saturated sodium-chloride, is placed on again in 40 ℃ of calorstats), carry out continuous 6 months study on the stability at the appointed time.The result shows, an inspection such as its character, discriminating, assay and tablet weight variation, dispersing uniformity, dissolution, microbial limit, and every index has no significant change, and illustrates that this sample is stable.Tentative this product effect duration is 1.5 years.
Claims (7)
1. pharmaceutical composition that is used to prevent and treat cardiovascular and cerebrovascular disease is characterized in that this pharmaceutical composition is that the total Saponin that extracts in the root by panax araliaceae plant is that primary raw material is made.
2. pharmaceutical composition as claimed in claim 1 is characterized in that being made into various preparations clinical and that pharmacy is feasible, comprises tablet, capsule, granule, dispersible tablet, soft capsule, injection.
3. pharmaceutical composition as claimed in claim 2 when it is characterized in that being made into preparation, also comprises corresponding auxiliary material in the crude drug.
4. as claim 1,2 or 3 described pharmaceutical compositions, supplementary material weight when it is characterized in that being made into dispersible tablet consists of: 50～100 parts of Radix Notoginseng total arasaponinss, 120～240 parts of microcrystalline Cellulose, 10～80 parts of crospolyvinylpyrrolidone, 5～50 parts of low-substituted hydroxypropyl celluloses, 1～10 part of Aspartane, 1～10 part of hydroxypropyl methylcellulose, 40%～80% ethanol is an amount of, 1～5 part of micropowder silica gel or magnesium stearate, 5～30 parts of carboxymethylstach sodium.
5. pharmaceutical composition as claimed in claim 4, supplementary material optimum ratio when it is characterized in that being made into dispersible tablet is: 50 parts of Radix Notoginseng total arasaponinss, 185 parts of microcrystalline Cellulose, 40 parts of crospolyvinylpyrrolidone, 10 parts of low-substituted hydroxypropyl celluloses, 1 part of Aspartane, 1 part of hydroxypropyl methylcellulose, 50% ethanol is an amount of, 1 part of micropowder silica gel, 12 parts of carboxymethylstach sodium.
6. prepare the method for medicament combination dispersible tablet as claimed in claim 4, it is characterized in that:
A) supplementary material: 50～100 parts of Radix Notoginseng total arasaponinss, 120～240 parts of microcrystalline Cellulose, 10～80 parts of crospolyvinylpyrrolidone, 5～50 parts of low-substituted hydroxypropyl celluloses, 1～10 part of Aspartane, 1～10 part of hydroxypropyl methylcellulose, 40%～80% ethanol is an amount of, 1～5 part of micropowder silica gel or magnesium stearate, 5～30 parts of carboxymethylstach sodium;
B) preparation process: the supplementary material pulverize separately is become fine powder, take by weighing Radix Notoginseng total arasaponins, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, mix homogeneously by prescription; Get hydroxypropyl methylcellulose, the water swollen is added in the alcoholic solution, makes the alcoholic solution of 1～3% hydroxypropyl methylcellulose, make wetting agent system soft material with this solution, 30 mesh sieves are granulated, and wet granular carries out drying under 50 ℃ of conditions, with 30 mesh sieve granulate, add micropowder silica gel or magnesium stearate, Aspartane and carboxymethylstach sodium, mixing, tabletting promptly gets dispersible tablet of the present invention.
7. prepare the method for medicament combination dispersible tablet as claimed in claim 5, it is characterized in that:
A) supplementary material: 50 parts of Radix Notoginseng total arasaponinss, 185 parts of microcrystalline Cellulose, 40 parts of crospolyvinylpyrrolidone, 10 parts of low-substituted hydroxypropyl celluloses, 1 part of Aspartane, 1 part of hydroxypropyl methylcellulose, 50% ethanol is an amount of, 1 part of micropowder silica gel, 12 parts of carboxymethylstach sodium;
B) preparation process: the supplementary material pulverize separately is become fine powder, take by weighing Radix Notoginseng total arasaponins, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, mix homogeneously by prescription; Get hydroxypropyl methylcellulose, the water swollen is added in 50% alcoholic solution, makes 50% alcoholic solution of 1% hydroxypropyl methylcellulose, make wetting agent system soft material with this solution, 30 mesh sieves are granulated, and wet granular carries out drying under 50 ℃ of conditions, with 30 mesh sieve granulate, add micropowder silica gel, Aspartane and carboxymethylstach sodium, mixing, tabletting promptly gets dispersible tablet of the present invention.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105055476A (en) * | 2015-08-24 | 2015-11-18 | 江苏红瑞制药有限公司 | Radix notoginseng saponin dispersible tablet and preparing method thereof |
| CN113069426A (en) * | 2021-04-09 | 2021-07-06 | 海南海力制药有限公司 | Preparation method of Xuesaitong dispersion tablet and Xuesaitong dispersion tablet |
-
2006
- 2006-06-23 CN CN 200610200606 patent/CN101091738A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105055476A (en) * | 2015-08-24 | 2015-11-18 | 江苏红瑞制药有限公司 | Radix notoginseng saponin dispersible tablet and preparing method thereof |
| CN105055476B (en) * | 2015-08-24 | 2019-01-15 | 江苏红瑞制药有限公司 | A kind of Xuesaitong dispersible tablet and preparation method thereof |
| CN113069426A (en) * | 2021-04-09 | 2021-07-06 | 海南海力制药有限公司 | Preparation method of Xuesaitong dispersion tablet and Xuesaitong dispersion tablet |
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Open date: 20071226 |