CN101439079B - Preparation method of Chinese medicine granule containing total saponins in astragalus - Google Patents
Preparation method of Chinese medicine granule containing total saponins in astragalus Download PDFInfo
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- CN101439079B CN101439079B CN2007101503173A CN200710150317A CN101439079B CN 101439079 B CN101439079 B CN 101439079B CN 2007101503173 A CN2007101503173 A CN 2007101503173A CN 200710150317 A CN200710150317 A CN 200710150317A CN 101439079 B CN101439079 B CN 101439079B
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- radix astragali
- total saponins
- astragali total
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a traditional Chinese medicine granular preparation method with astragalus total saponin. Traditional Chinese medicine spheroidized particles are prepared by using the astragalus total saponin and a pharmaceutically acceptable carrier. The shapes of the traditional Chinese medicine spheroidized particles are spherical or similar to spheres, and the density of the traditional Chinese medicine spheroidized particles ranges from 0.6 g/ml to 1.3 g/ml. A single dose of the spheroidized particles is small, the medicine taking is convenient, and the granular preparation can be used as a semifinished product of capsules and can also be used for developing sustained and controlled release preparations of traditional Chinese medicine.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof, be specifically related to a kind of Chinese medicinal granule that contains Radix Astragali total saponins and preparation method thereof.
Background technology
Background technology
First of each big disease of cardiovascular and cerebrovascular disease row, the serious harm human body is healthy, and the sequela that is caused is also brought very big misery to patient and family members, becomes the social problem of a worth extensive concern.Coronary flow is an important indicator of estimating the control myocardial ischemia drug, and external coronary flow is measured can observe the influence of medicine to coronary resistance.Anoxia enduring is that medicine improves body tissue (particularly cerebral tissue and heart tissue) hypoxia-bearing capability, improves one of important mechanisms of energy metabolism.Countries in the world medicine worker constantly studies, develops the medicine of cardiovascular and cerebrovascular disease, and the cardiovascular and cerebrovascular disease patient can effectively be treated.The medicine that is used to treat cardiovascular disease at present is more, the Chinese medicine Radix Astragali, and slightly warm in nature has the effect of invigorating QI to consolidate the body surface resistance, and Radix Astragali total saponins is one of its main active.Experimentation confirms that Radix Astragali total saponins can obviously improve the myocardial contractility of heart infarction dog, increases coronary flow, cardiac function is had protective effect, but the Radix Astragali total saponins molecular weight is big, and dissolubility is little in water, is unfavorable for the performance of drug effect.
The traditional preparation process method of Chinese medicinal granule is to adopt dry method or wet method to process the particulate material of certain particle size Chinese medicine or its extract, when supplying the patient to use with mixing in water for oral taking or swallow.The defective of at present common several kinds of granule preparation technologies and existence thereof: 1. conventional particles preparation technology; Because Chinese medical concrete viscosity is higher, there are problems such as particulate drug loading is low, outward appearance is not attractive in appearance, mouthfeel is poor, the easy moisture absorption mostly in the method for preparing of conventional particles.2. comparatively popular at present fluidized bed granulation technology is that drug powder and various adjuvant are packed in the container, is blown into the air-flow of preference temperature through sieve plate from the bed bottom; Make material mix homogeneously under fluidized state; Begin evenly to spray into binder liq then, powder begins the coalescence granulating, through spraying and drying repeatedly; When granular size meets the requirements, stop spraying, continue dry.This technology can be reduced to the adjuvant amount more than 50% by traditional 80%; The single dose of the grain products of preparation generally can be reduced to 3g to 5g by traditional 10g; But this technology can not thoroughly solve the problem of viscosity of Radix Astragali total saponins; Used adjuvant can not further reduce, and single agent dose is bigger, and patient's compliance is relatively poor; And use this kind method to be not suitable for processing solid preparations such as capsule; Adopting the granule of fluidized bed granulation technology at present commonly used preparation in addition is cellular, irregular shape; Moisture absorption is more common, and inconvenience is preserved; Particulate specific surface area is bigger, is not suitable for coating.3. also having Chinese medicine or plant amedica extract use fluidized-bed process manufacturing particle diameter is the research of the micropill technology of 700～1500 μ m; But this technology all is that medicine is processed dry powder; Water or other mixing material are as binding agent; Add medicine dry powder while spraying into liquid adhesive, process micropill.The micropill dissolve scattered time limit that at present adopts this explained hereafter is generally all at 40 minutes, and defective such as production process is comparatively complicated, cost is high, the influence factor is more (for example when air humidity is big, can not make), loss is bigger.4. also have to adopt in formulation art and extrude round or extrude the technology that spheronization is made micropill or spheroidal particle, this technology makes the goods support large usage quantity, and drug loading is general below 25%, and dissolve scattered time limit is more than 30 minutes.5. in formulation art, spray or side pressure spray process at the bottom of the fluid bed of employing are also arranged, make Western medicine micropill or spheroidal particle, be used for the exploitation of slow releasing preparation more, so development product generally has slow controlled release characteristics, do not possess the rapid release characteristic.
The rapid release of Chinese medicine and quick acting are importances of the modernization of Chinese medicine, adopt the Chinese medicine of manufacturing of the present invention or plant amedica granule to have fast instant diffusing characteristic.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicinal granule that contains Radix Astragali total saponins.
Another object of the present invention is to provide a kind of method for preparing that contains the Chinese medicinal granule of Radix Astragali total saponins.
Radix Astragali total saponins can adopt at present common method for distilling to extract its effective ingredient in the bright medicine of this law, but the following method for distilling of preferred in the present invention employing extracts: get the Radix Astragali, add in the ethanol that contains NaHCO3 and extract; Merge extractive liquid,, decompression recycling ethanol, concentrated solution is crossed macroporous adsorptive resins; With the NaOH flushing, extremely neutral with deionized water rinsing then earlier, the flushing of reuse low-concentration ethanol; With the high concentration ethanol flushing, collect the high concentration ethanol eluent at last, cross anion-exchange resin column.Merge effluent and high concentration ethanol eluent, reclaim ethanol, the dried Radix Astragali total saponins of concentrated solution.
The method for distilling of Radix Astragali total saponins the best is following in the bright medicine of this law: get the Radix Astragali, add 7 times of amounts and contain 0.5%NaHCO
370% ethanol, extract each 2 hours 2 times; Merge 2 times extracting solution; In 1.5 times of volumes of 65 degrees centigrade of decompression recycling ethanol to medical material amounts, concentrated solution is crossed the AB-8 macroporous adsorptive resins handled well (weight resin be medical material amount 1/2), and the control flow velocity is 0.5 times of column volume per hour.Afterwards with 4 times of volumes of 1%NaOH flushing, the control flow velocity is 1 times of column volume per hour, then with deionized water rinsing to neutrality; 4 times of volumes of reuse 30% alcohol flushing; Use 2.5 times of volumes of 95% alcohol flushing at last, collect 95% ethanol elution, cross the D-941 anion-exchange resin column handle well (weight resin be medical material amount 1/2); Use 1.5 times of column volumes of 95% alcohol flushing afterwards, the control flow velocity is 0.5 times of column volume per hour.Merge effluent and 95% ethanol elution, decompression recycling ethanol, the dried Radix Astragali total saponins of concentrated solution (content is higher than 70%).
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins and realizes through following technical scheme:
Processed by Radix Astragali total saponins and pharmaceutically acceptable carrier, wherein Radix Astragali total saponins accounts for 40～90% of percentage by weight, and pharmaceutically acceptable vehicle weight percentage composition is 10～60%.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, preferably realizes through following technical scheme:
Weight percentage by Radix Astragali total saponins is 70～80%, and pharmaceutically acceptable vehicle weight percentage composition is 20～30%.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and the best realizes through following technical scheme:
Weight percentage by Radix Astragali total saponins is 70～80%, and pharmaceutically acceptable vehicle weight percentage composition is 20～30%.
Pharmaceutically acceptable carrier of the present invention can be any preparation Chinese medicinal granule pharmaceutically acceptable carrier commonly used or conventional, and for example: diluent (filler) includes but not limited to sucrose, dextrin, starch, lactose, mannitol, xylitol, chitosan, SHUANGQITANG, soluble starch, Pulvis Talci or water solublity dextrin etc.; Disintegrating agent includes but not limited to starch, sodium carboxymethyl cellulose (CMS-Na), microcrystalline Cellulose (MCC), micropowder silica gel, hydroxypropyl starch, soluble starch, water solublity dextrin; Inclusion agents includes but not limited to alpha-cyclodextrin (α-CD), beta-schardinger dextrin-(β-CD) and N-LOK modified starch etc.; Wetting agent (binding agent) includes but not limited to water, ethanol, polyvinylpyrrolidone (polyvidone), hydroxypropyl cellulose, Polyethylene Glycol above-mentioned adjuvant function such as diluent such as (PEG); Disintegrating agent, wetting agent by the function address, are viscosity modifier in this patent; Preferably microcrystalline cellulose (MCC), micropowder silica gel, Polyethylene Glycol, Pulvis Talci, chitosan; Pulvis Talci, the above-mentioned pharmaceutically acceptable carrier of polyvidone can use separately, also can unite use.Persons of ordinary skill in the art may appreciate that the following emerging pharmaceutically acceptable carrier that can be used for preparing Chinese medicinal granule,, also should be included in protection scope of the present invention if can realize the object of the invention.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and described pharmaceutically acceptable carrier preferably one or more in sucrose, dextrin, starch, lactose, mannitol, xylitol, chitosan, SHUANGQITANG, soluble starch, Pulvis Talci, water solublity dextrin sodium carboxymethyl cellulose (CMS-Na), microcrystalline Cellulose (MCC), micropowder silica gel, hydroxypropyl starch, ethanol, hydroxypropyl cellulose, Polyethylene Glycol, chitosan, polyvidone is united use.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and described pharmaceutically acceptable carrier is preferably: crystalline cellulose element, micropowder silica gel, Polyethylene Glycol, Pulvis Talci, chitosan, Pulvis Talci, polyvidone.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins; Described granule comprises master batch and is positioned at the shell on the master batch, and profile be spherical or type sphere, and bulk density is 0.6～1.3g/m; Dissolve scattered time limit is 0.4～5 minute, and active constituents of medicine is included among master batch and/or the shell.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and its particle diameter is 700～1500 μ m.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and said granule also contains coating, and the weight of coating materials accounts for 2～5wt% of granule gross weight.
The Chinese medicinal granule that the present invention contains Radix Astragali total saponins adopts the fluidized bed granulation technology to granulate; Common fluidized bed granulation technology is directly packed into powdered substance and is granulated as bed material in the container of fluid bed; And the present invention forms with pharmaceutically acceptable preparing carriers, perhaps is prepared from pharmaceutically acceptable carrier and corresponding Radix Astragali total saponins dry powder.
The present invention contains the method for preparing of the Chinese medicinal granule of Radix Astragali total saponins, and step is following:
(1) it is an amount of to get Radix Astragali total saponins;
(2) preparation of master batch: i. gets an amount of pharmaceutically acceptable carrier, the perhaps mixture of itself and Radix Astragali total saponins dry powder, and crushing screening obtains the satisfactory material of granularity; Ii. get the material of a part of step I, drop in spray of fluid bed side or the end spray pot, other gets it filled and learns acceptable carrier and/or Radix Astragali total saponins and add water and be mixed with slurry; Adopt spray of fluid bed side or end pressure spray process to spray into, and sift out granule, again parent nucleus is dropped in the pot as parent nucleus; Continue to spray and state slurry; The material of remaining step I is sprinkled into fine powder in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, filter out the satisfactory master batch of particle diameter;
(3) preparation of product: it is an amount of to get master batch, and acceptable carrier is an amount of, and Radix Astragali total saponins is an amount of; Above-mentioned acceptable carrier is added in the above-mentioned Radix Astragali total saponins, and it is subsequent use as slurry to mix into suspension; Above-mentioned master batch is dropped in the fluid bed side spray pot, and above-mentioned slurry slowly sprays into, and all sprays into to slurry, processes spheroidal particle.
The present invention contains the method for preparing of the Chinese medicinal granule of Radix Astragali total saponins, and preferred steps is following:
(1) it is an amount of to get Radix Astragali total saponins;
(2) preparation of master batch: the mixture of getting dextrin and starch weight ratio and being 1: 1 is crossed 200 mesh sieves, and wherein 60-65wt% drops in the fluid bed side spray pot as bed material; 10-15wt% dextrin and starch mixture, amount to the Radix Astragali total saponins that accounts for the 15wt% of master batch weight after the dry weight; Add water and be mixed with slurry and spray into, and sift out particle diameter be 180～250 μ m granules as parent nucleus, again parent nucleus is dropped in the pot; Continue to spray and state slurry; In the dusting rifle, the dextrin of surplus and the fine powder of starch mixture are sprinkled into simultaneously, the particle diameter of parent nucleus is grown up, the master batch that filters out particle diameter and be 450～600 μ m is subsequent use;
(3) preparation of product: get master batch 450g; The Radix Astragali total saponins of 300g; With the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with the Radix Astragali total saponins weight ratio: the PVP-K30 weight ratio is 2: 5; Use dehydrated alcohol with a kind of solution that is formulated as concentration as 15wt% in above-mentioned viscosity adjustment agent polyethylene glycol 6000 or HPMC and the PVP-K30 mixture; Add in the Radix Astragali total saponins; After the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 19wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
The present invention contains in the method for preparing of Chinese medicinal granule of Radix Astragali total saponins, and the temperature of charge of the spheroidal particle that can said method be obtained is controlled at 37～45 ℃; Transparent coating material water is made into the coating solution of 7.5% (g/ml) again, according to the amount of theory weightening finish 3wt% coating solution is sprayed into coating, process spheroidal particle, its bulk density is 0.76g/ml, and dissolve scattered time limit is 25～180 seconds.
The present invention contains in the method for preparing of Chinese medicinal granule of Radix Astragali total saponins, No. 2 capsules of spheroidal particle fill that can said method be obtained, and the 250mg/ grain is processed capsule.
" setting of dosage form in the Chinese pharmacopoeia, and in order to distinguish different with technology such as micropill, microcapsules in conjunction with the characteristic of present technique preparing product, was named above-mentioned granule and is spheroidized particle according to version in 2005.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, outside it coating can also be arranged, and the weight of coating materials accounts for the 2-5% of granule gross weight.During the spheroidized particle coating, obviously low (plain particles coating, coating materials consumption are 20-30% to the more common granule coating of the consumption of coating materials, and spheroidized particle coating materials consumption then can be reduced to 2-5% with the adjuvant amount.As required; Coating can be common film coating, also can be enteric film coating, slow controlled release coat etc., and coating materials can be the commonly used or conventional coating materials in any this area; Select according to different needs, the coating process can be carried out according to the conventional method in this area.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, directly uses except can be used as common granule, can also be as intermediate; Be prepared into dosage forms such as capsule; As granule use etc., can be prepared into sustained-release preparation in addition, positioning release medicine preparation etc.
The present invention contains the Chinese medicinal granule of Radix Astragali total saponins, and preferred said granule is processed conventional capsule agent or sustained-release preparation.
Spheroidized particle of the present invention has the following advantages:
1. the consumption of adjuvant is few, therefore causes single dose little, and the general each dose of patient is that 0.1～4g gets final product, and can reduce the fear that the patient takes medicine and produced heavy dose.
2. outward appearance is good, granule of the present invention spherical in shape or type spherical, smooth surface rounding, the control of suitable product design quality.
3. physical characteristic is good, prepares in the process at spheroidal particle, and mobility of particle is good, causes that particle size distribution is regular, the fine and close anti-extruding of quality, and wear-resistant, density is big, and (bulk density is 0.6～1.3g/ml), specific surface area is little (has only 0.01～0.03m
2/ g).
4. dissolve scattered time limit is short, and the spheroidal particle dissolve scattered time limit of the present invention that adopts this type of prescription to make is short, is generally 0.4～5 minute.
5. granularity test: according to 2000 editions pharmacopeia regulations, get granule 5 bags of (bottle) or multiple dose packing granule 1 bags (bottle) of single dose packing, claim to decide weight, put in the medicine sieve and sieve.When sieving, will sieve and keep level, about come and go and sieved gently 3 minutes.Can not and can must not cross 8.0% through a sieve through the granule and the powder summation of No. four sieves.Granule of the present invention can not and can meet the pharmacopeia regulation through the granule and the powder summation of No. four sieves through a sieve, and its numerical value is no more than 5.5%.
6. melting test: according to 2000 editions pharmacopeia regulations, get medicinal granule test sample 10g of the present invention, add 20 times of hot water, stirred 5 minutes, observe immediately.Soluble granule is answered off-bottom.
These characteristics can improve patient's the row of complying with, and makes the application of packaging technique become possibility, thereby has solved the moisture absorption (critical wettability is promoted to 85% by 60% of plain particles) of Chinese medicine, problem such as stable; In addition, spheroidized particle of the present invention uses except can be used as common granule, can also be as intermediate or granule, and fill becomes dosage forms such as capsule, can be prepared into sustained-release preparation in addition, positioning release medicine preparation etc.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further described, following this embodiment only is used to the present invention is described and the present invention is not limited.
Embodiment 1
Get the Radix Astragali, add 70% ethanol that 7 times of amounts contain 0.5%NaHCO3, extract each 2 hours 2 times.Merge 2 times extracting solution, in 1.5 times of volumes of 65 degrees centigrade of decompression recycling ethanol to medical material amounts, concentrated solution is crossed the AB-8 macroporous adsorptive resins handled well (weight resin be medical material amount 1/2), and the control flow velocity is 0.5 times of column volume per hour; Afterwards with 4 times of volumes of 1%NaOH flushing, the control flow velocity is 1 times of column volume per hour, then with deionized water rinsing to neutrality, 4 times of volumes of reuse 30% alcohol flushing are used 2.5 times of volumes of 95% alcohol flushing at last; Collect 95% ethanol elution, cross the D-941 anion-exchange resin column handle well (weight resin be medical material amount 1/2), use 1.5 times of column volumes of 95% alcohol flushing afterwards, the control flow velocity is 0.5 times of column volume per hour.Merge effluent and 95% ethanol elution, decompression recycling ethanol, the dried Radix Astragali total saponins of concentrated solution (content is higher than 70%).
The preparation of master batch: the weight ratio of getting dextrin and starch is that 1: 1 mixture is crossed 200 mesh sieves; Wherein 65% as in the bed material input fluid bed side spray pot; Other gets starch and adds water and be mixed with starch slurry (15%) and spray into as slurry, and sifts out granule (particle diameter is 180-250 μ) as parent nucleus, parent nucleus is dropped in the pot again; Continue the spray starch slurry; 35% the dextrin of remainder and the fine powder of starch are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 450 μ-600 μ to filter out particle diameter.
The preparation of product: get master batch 450g, microcrystalline Cellulose (200 order) 50g, polyethylene glycol 6000 (heating and melting)
500G, Radix Astragali total saponins 320g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and adding water, to mix into solid content be 30% binding agent; Master batch is dropped in the fluid bed side spray pot; Slurry is slowly sprayed into; Constantly be dried to simultaneously slurry and all spray into and process spheroidal particle, temperature of charge is controlled at 55 degrees centigrade, and coating material OPAGLOS 2 waters that reuse is transparent are made into 7.5% coating solution; Amount according to theory weightening finish 3% sprays into coating with coating solution, processes spheroidal particle.
Embodiment 2
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: the mixture of getting micropowder silica gel and chitosan weight ratio and being 1: 1 is crossed 200 mesh sieves; Wherein 65% as in the bed material input fluid bed side spray pot; Other gets PVP K30 and adds water, extract, is mixed with bonding agent-spray into as slurry, and sift out particle diameter be 120-180 μ granule as parent nucleus, again parent nucleus is dropped in the pot; Continue the spray starch slurry; 35% the micropowder silica gel of remainder and the fine powder of chitosan are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 200 μ-300 μ to filter out particle diameter.
The preparation of product: get master batch 300g, microcrystalline Cellulose (200 order) 250g, micropowder silica gel 14g, Radix Astragali total saponins 200g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and it is subsequent use as slurry to mix into uniform suspension; Master batch is dropped in the fluid bed side spray pot; Slurry is slowly sprayed into, constantly be dried to simultaneously slurry and all spray into and process spheroidal particle, coating material OPAGLOS 2 waters that reuse is transparent are made into 7.5% coating solution; Amount according to theory weightening finish 3% sprays into coating with coating solution, processes spheroidal particle.
Embodiment 3
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: the mixture of getting dextrin and starch weight ratio and being 1: 1 is crossed 200 mesh sieves; Wherein 65% as in the bed material input fluid bed side spray pot; Other gets starch, extract (account for after giving money as a gift master batch weight 15%) and adds water and be mixed with slurry and spray into, and sifts out granule (particle diameter is 180～250 μ) as parent nucleus, parent nucleus is dropped in the pot again; Continue the spray starch slurry; 35% the dextrin of remainder and the fine powder of starch are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 300 μ～400 μ to filter out particle diameter.
The preparation of product: get master batch 450g, microcrystalline Cellulose (200 order) 50g, polyethylene glycol 6000 (heating and melting)
500G, Radix Astragali total saponins 1000g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and adding water, to mix into solid content be 30% binding agent; Master batch is dropped in the fluid bed side spray pot; Slurry is slowly sprayed into, constantly be dried to simultaneously slurry and all spray into and process spheroidal particle, temperature of charge is controlled at 55 degrees centigrade; Coating material OPAGLOS 2 waters that reuse is transparent are made into 7.5% coating solution; Amount according to theory weightening finish 3% sprays into coating with coating solution, processes spheroidal particle, and bulk density is 0.76g/ml; With No. 2 capsules of the spheroidal particle fill that obtains, every dress 0.125g processes 10000 of capsules.
Embodiment 4
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: the mixture of getting dextrin and microcrystalline Cellulose weight ratio and being 1: 1 is crossed 200 mesh sieves; Wherein 65% as in the bed material input fluid bed side spray pot; Other gets PVP K30 and adds water and be mixed with bonding agent (5%) and spray into as slurry, and sift out particle diameter be 180～250 μ granules as parent nucleus, again parent nucleus is dropped in the pot; Continue the spray starch slurry; 35% the dextrin of remainder and the fine powder of microcrystalline Cellulose are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 300 μ～400 μ to filter out particle diameter.
The preparation of product: get master batch 1000g, add Radix Astragali total saponins 750g, 5% polyvidone solution, adding water, to mix into solid content be that 30% suspension is subsequent use as slurry; Master batch is dropped in the fluid bed side spray pot; Slurry is slowly sprayed into, constantly be dried to simultaneously slurry and all spray into and process spheroidal particle, coating material OPAGLOS 2 waters that reuse is transparent are made into 7.5% coating solution; Amount according to theory weightening finish 3% sprays into coating with coating solution, processes spheroidal particle.
Embodiment 5
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: the mixture of getting dextrin and microcrystalline Cellulose weight ratio and being 2: 1 is crossed 100 mesh sieves; Wherein 75% as in the bed material input fluid bed side spray pot; Other gets PVP K30 and adds water, extract, is mixed with bonding agent-spray into as slurry, and sift out particle diameter be 100-200 μ granule as parent nucleus, again parent nucleus is dropped in the pot; Continue the spray starch slurry; 35% the dextrin of remainder and the fine powder of microcrystalline Cellulose are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 200 μ-300 μ to filter out particle diameter.
The preparation of product: get master batch 800g, microcrystalline Cellulose 190g, micropowder silica gel 35g, Radix Astragali total saponins 450g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and it is subsequent use as slurry to mix into uniform suspension; Master batch is dropped in the fluid bed side spray pot, slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 6
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: the mixture of getting micropowder silica gel and Pulvis Talci weight ratio and being 1: 1 is crossed 200 mesh sieves; Wherein 50% as in the bed material input fluid bed side spray pot; Other gets PVP K30 and adds water, extract, is mixed with bonding agent-spray into as slurry, and sift out particle diameter be 120-180 μ granule as parent nucleus, again parent nucleus is dropped in the pot; Continue the spray starch slurry; 35% micropowder silica gel and talcous fine powder of remainder is sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 200 μ-300 μ to filter out particle diameter.
The preparation of product: get master batch 300g, microcrystalline Cellulose (200 order) 250g, micropowder silica gel 14g, Radix Astragali total saponins 300g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and it is subsequent use as slurry to mix into uniform suspension; Master batch is dropped in the fluid bed side spray pot, slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 7
It is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
The preparation of master batch: taking polyethylene glycol and chitosan weight ratio are that 1: 1 mixture is crossed 200 mesh sieves; Wherein 65% as in the bed material input fluid bed side spray pot; Other gets PVP K30 and adds water, extract, is mixed with bonding agent and sprays into as slurry, and sift out particle diameter be 120-180 μ granule as parent nucleus, again parent nucleus is dropped in the pot; Continue the spray starch slurry; 35% the Polyethylene Glycol of remainder and the fine powder of chitosan are sprinkled in the dusting rifle simultaneously, the particle diameter of parent nucleus is grown up, it is subsequent use at the master batch of 200 μ-300 μ to filter out particle diameter.
The preparation of product: get master batch 700g, microcrystalline Cellulose (200 order) 300g, micropowder silica gel 20g, Radix Astragali total saponins 430g; Microcrystalline Cellulose and micropowder silica gel are added in the Radix Astragali total saponins, and it is subsequent use as slurry to mix into uniform suspension; Master batch is dropped in the fluid bed side spray pot, slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 8:
1, it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
2, the preparation of master batch: get dextrin and starch (1: 1) mixture and cross 200 mesh sieves; Wherein 65wt% drops in the fluid bed side spray pot, other get starch add water be mixed with starch slurry (15%, g/ml) spray into as slurry; And sift out granule (particle diameter is 180～250 μ m) as parent nucleus; Again parent nucleus is dropped in the pot, continue to spray and state starch slurry, remaining 35% the dextrin and the fine powder of starch (1: 1) mixture are sprinkled in the dusting rifle simultaneously; The particle diameter of parent nucleus is grown up, and it is subsequent use at the master batch of 450～600 μ m to filter out particle diameter.
3, the selection of viscosity adjustment agent
A. get above-mentioned Radix Astragali total saponins, be diluted to the diluent that viscosity is 6.0～9.8MpaS with the alcoholic solution of 60% (ml/ml).
B. get 1 above-mentioned diluent, drop on the microscope slide, hang, solid cicatrix surface, liquid evaporation back does not have complete film, and viscosity is less, is prone to scrape with powdery, and it is serious to play powder.
C. the viscosity according to cicatrix among the b is little, film property is poor, intensity is little, be prone to characteristics such as powder; Select viscosity adjustment agent; Experiment shows can select HPMC: PVP-K30 (2: 5) mixture to adjust agent as viscosity, and also can select polyethylene glycol 6000 is viscosity adjustment agent.
D. selection and Radix Astragali total saponins weight ratio are 7: 25 HPMC: PVP-K30 (2: 5) mixture is viscosity adjustment agent; Perhaps selection and Radix Astragali total saponins weight ratio are that 18: 25 polyethylene glycol 6000 is viscosity adjustment agent, are increased to 16MPaS to material viscosity by 9.0MPaS.
4, the preparation of spheroidal particle of the present invention
A. get master batch 450g, with the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC: PVP-K30 (2: 5) mixture, the Radix Astragali total saponins of 340g with the Radix Astragali total saponins weight ratio;
B. use dehydrated alcohol with a kind of solution that is formulated as concentration as 5wt% in the above-mentioned viscosity adjustment agent, add in the Radix Astragali total saponins, after the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 19wt%, as slurry;
C. master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle; Temperature of charge is controlled at 37～45 ℃; Again transparent coating material water is made into the coating solution of 7.5% (g/ml), coating solution is sprayed into coating, process spheroidal particle according to the amount of theory weightening finish 3wt%; Its bulk density is 0.76g/ml, and dissolve scattered time limit is 30 seconds.
With No. 2 capsules of the spheroidal particle fill that obtains among the step c, the 250mg/ grain is processed capsule.
Embodiment 9
1, it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
2, the preparation of master batch: get xylitol and carboxymethyl starch sodium (1: 1) mixture and cross 200 mesh sieves; Wherein 60wt% drops in the fluid bed side spray pot, and other gets 10wt% xylitol and carboxymethyl starch sodium (1: 1) mixture and Radix Astragali total saponins (after amounting to dry weight, accounting for the 15wt% of master batch weight) and adds water and be mixed with slurry and spray into; And sift out granule (particle diameter is 180～250 μ m) as parent nucleus; Again parent nucleus is dropped in the pot, continue to spray and state slurry, in the dusting rifle, the xylitol of remaining 30wt% and the fine powder of carboxymethyl starch sodium (1: 1) mixture are sprinkled into simultaneously; The particle diameter of parent nucleus is grown up, and the master batch that filters out particle diameter and be 280～450 μ m is subsequent use.
3, the preparation of product: get master batch 450g; The Radix Astragali total saponins of 440g, with the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, use dehydrated alcohol that above-mentioned viscosity adjustment agent polyethylene glycol 6000 is formulated as the solution of concentration as 15wt%; Add in the Radix Astragali total saponins; After the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 19wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 10
1, it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
2, the preparation of master batch: get lactose and hydroxypropyl starch (1: 1) mixture and cross 200 mesh sieves; Wherein 60wt% drops in the fluid bed side spray pot, and other gets 10wt% lactose and hydroxypropyl starch (1: 1) mixture and Radix Astragali total saponins (after amounting to dry weight, accounting for the 15wt% of master batch weight) and adds water and be mixed with slurry and spray into; And sift out granule (particle diameter is 180～250 μ m) as parent nucleus; Again parent nucleus is dropped in the pot, continue to spray and state slurry, in the dusting rifle, the lactose of remaining 30wt% and the fine powder of hydroxypropyl starch (1: 1) mixture are sprinkled into simultaneously; The particle diameter of parent nucleus is grown up, and the master batch that filters out particle diameter and be 180～250 μ m is subsequent use.
3, the preparation of product: get master batch 850g, the Radix Astragali total saponins of 500g, with the Radix Astragali total saponins weight ratio be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC: the PVP-K30 weight ratio is 2: 5; Use dehydrated alcohol that above-mentioned viscosity adjustment agent HPMC is formulated as the solution of concentration as 15wt% with the PVP-K30 mixture, in the adding Radix Astragali total saponins, after the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 20wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 11
1, it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
2, the preparation of master batch: get dextrin and mannitol (3: 1) mixture and cross 200 mesh sieves; Wherein 64wt% drops in the fluid bed side spray pot, and other gets 16wt% dextrin and mannitol mixture and Radix Astragali total saponins (after amounting to dry weight, accounting for the 10wt% of master batch weight) and adds water and be mixed with slurry and spray into; And sift out granule (particle diameter is 180～250 μ m) as parent nucleus; Again parent nucleus is dropped in the pot, continue to spray and state slurry, in the dusting rifle, the dextrin of remaining 20wt% and the fine powder of mannitol mixture are sprinkled into simultaneously; The particle diameter of parent nucleus is grown up, and the master batch that filters out particle diameter and be 450～600 μ m is subsequent use.
3, the preparation of product: get master batch 500g, the Radix Astragali total saponins of 500g, with the Radix Astragali total saponins weight ratio be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC: the PVP-K30 weight ratio is 2: 5; Use dehydrated alcohol that above-mentioned viscosity adjustment agent HPMC is formulated as the solution of concentration as 15wt% with the PVP-K30 mixture, in the adding Radix Astragali total saponins, after the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 20wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 12
1, it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
2, the preparation of master batch: get dextrin and mannitol (2: 1) mixture and cross 200 mesh sieves; Wherein 65wt% drops in the fluid bed side spray pot, and other gets 25wt% dextrin and mannitol mixture and Radix Astragali total saponins (after amounting to dry weight, accounting for the 10wt% of master batch weight) and adds water and be mixed with slurry and spray into; And sift out granule (particle diameter is 180～250 μ m) as parent nucleus; Again parent nucleus is dropped in the pot, continue to spray and state slurry, in the dusting rifle, the dextrin of remaining 10wt% and the fine powder of mannitol mixture are sprinkled into simultaneously; The particle diameter of parent nucleus is grown up, and the master batch that filters out particle diameter and be 450～600 μ m is subsequent use.
3, the preparation of product: get master batch 450g; The Radix Astragali total saponins of 800g, with the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, use dehydrated alcohol that above-mentioned viscosity adjustment agent polyethylene glycol 6000 is formulated as the solution of concentration as 15wt%; Add in the Radix Astragali total saponins; After the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 19wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Embodiment 13
(1) it is an amount of to get the Radix Astragali total saponins that obtains according to embodiment 1 method;
(2) preparation of master batch: the mixture of getting dextrin and starch weight ratio and being 1: 1 is crossed 200 mesh sieves, and wherein 60-65wt% drops in the fluid bed side spray pot as bed material; 10-15wt% dextrin and starch mixture, amount to the Radix Astragali total saponins that accounts for the 15wt% of master batch weight after the dry weight; Add water and be mixed with slurry and spray into, and sift out particle diameter be 180～250 μ m granules as parent nucleus, again parent nucleus is dropped in the pot; Continue to spray and state slurry; In the dusting rifle, the dextrin of surplus and the fine powder of starch mixture are sprinkled into simultaneously, the particle diameter of parent nucleus is grown up, the master batch that filters out particle diameter and be 450～600 μ m is subsequent use;
(3) preparation of product: get master batch 450g; The Radix Astragali total saponins of 300g; With the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with the Radix Astragali total saponins weight ratio: the PVP-K30 weight ratio is 2: 5; Use dehydrated alcohol with a kind of solution that is formulated as concentration as 15wt% in above-mentioned viscosity adjustment agent polyethylene glycol 6000 or HPMC and the PVP-K30 mixture; Add in the Radix Astragali total saponins; After the mixing, adding 60% (ml/ml) ethanol, to transfer to solids content be 19wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
Claims (4)
1. method for preparing that contains the Chinese medicinal granule of Radix Astragali total saponins is characterized in that step is following:
(1) it is an amount of to get Radix Astragali total saponins;
(2) preparation of master batch: the mixture of getting dextrin and starch weight ratio and being 1: 1 is crossed 200 mesh sieves, and wherein 60-65wt% drops in the fluid bed side spray pot as bed material; 10-15wt% dextrin and starch mixture, amount to the Radix Astragali total saponins that accounts for the 15wt% of master batch weight after the dry weight; Add water and be mixed with slurry and spray into, and sift out particle diameter be 180～250 μ m granules as parent nucleus, again parent nucleus is dropped in the pot; Continue to spray and state slurry; In the dusting rifle, the dextrin of surplus and the fine powder of starch mixture are sprinkled into simultaneously, the particle diameter of parent nucleus is grown up, the master batch that filters out particle diameter and be 450～600 μ m is subsequent use;
(3) preparation of product: get master batch 450g; The Radix Astragali total saponins of 300g; With the Radix Astragali total saponins weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with the Radix Astragali total saponins weight ratio: the PVP-K30 weight ratio is 2: 5; Use dehydrated alcohol with a kind of solution that is formulated as concentration as 15wt% in above-mentioned viscosity adjustment agent polyethylene glycol 6000 or HPMC and the PVP-K30 mixture; Add in the Radix Astragali total saponins; After the mixing, adding 60%ml/ml ethanol, to transfer to solids content be 19wt%, as slurry; Master batch is dropped in the fluid bed side spray pot, above-mentioned slurry is slowly sprayed into, constantly be dried to slurry simultaneously and all spray into and process spheroidal particle.
2. the method for preparing that contains the Chinese medicinal granule of Radix Astragali total saponins according to claim 1; It is characterized in that prepared granule comprises master batch and is positioned at the shell on the master batch; Profile is spherical or type sphere; Bulk density is 0.6～1.3g/m, and dissolve scattered time limit is 0.4～5 minute, and active constituents of medicine is included among master batch and/or the shell.
3. the method for preparing that contains the Chinese medicinal granule of Radix Astragali total saponins according to claim 1 is characterized in that its particle diameter of prepared granule is 700～1500 μ m.
4. the method for preparing that contains the Chinese medicinal granule of Radix Astragali total saponins according to claim 1 is characterized in that prepared granule also contains coating, and the weight of coating materials accounts for 2～5wt% of granule gross weight.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1559472A (en) * | 2004-03-02 | 2005-01-05 | 北京乾露春科技有限公司 | Astragalus injection Chinese medicinal preparation and its preparation method |
| CN1600319A (en) * | 2003-09-23 | 2005-03-30 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular and cerebrovascular diseases |
| CN1682862A (en) * | 2005-02-24 | 2005-10-19 | 四川科伦药业股份有限公司 | Method for preparing astragalus root saponin |
| CN1736406A (en) * | 2004-08-20 | 2006-02-22 | 中国人民解放军军事医学科学院毒物药物研究所 | The preparation method that contains the preparation of Radix Morindae Officinalis extract |
-
2007
- 2007-11-22 CN CN2007101503173A patent/CN101439079B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1600319A (en) * | 2003-09-23 | 2005-03-30 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular and cerebrovascular diseases |
| CN1559472A (en) * | 2004-03-02 | 2005-01-05 | 北京乾露春科技有限公司 | Astragalus injection Chinese medicinal preparation and its preparation method |
| CN1736406A (en) * | 2004-08-20 | 2006-02-22 | 中国人民解放军军事医学科学院毒物药物研究所 | The preparation method that contains the preparation of Radix Morindae Officinalis extract |
| CN1682862A (en) * | 2005-02-24 | 2005-10-19 | 四川科伦药业股份有限公司 | Method for preparing astragalus root saponin |
Non-Patent Citations (3)
| Title |
|---|
| 南京中医药大学.黄芪药理作用.《中药大辞典》.2006,2812. * |
| 潘家祯等.中药球形药丸制备新方法.《中成药》.2000,第22卷(第3期),181-184. * |
| 黄俊斌.黄芪注射液中黄芪总皂苷的含量测定.《时珍国医国药》.2001,第12卷(第5期),394-395. * |
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| Publication number | Publication date |
|---|---|
| CN101439079A (en) | 2009-05-27 |
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