CN101439082B - Chinese medicine granule containing sophora root extract and preparation method thereof - Google Patents
Chinese medicine granule containing sophora root extract and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine granular preparation with shrubby sophora extract and a preparation method thereof. Traditional Chinese medicine spheroidized particles are prepared by using a traditional Chinese medicine extract 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 Sophorae Flavescentis extract and preparation method thereof.
Background technology
Viral myocarditis (VMC) is that children's especially is prone to suffer from by the change of matter between myocardial cell degeneration that causes behind the virus infringement cardiac muscle and cardiac muscle.According to interrelated data: sickness rate that at present should disease is day by day soaring, is only second to coronary heart disease, rheumatic heart disease etc., and mostly ill object be young and middle-aged, has had a strong impact on people's life.
Almost various viruses all can cause viral myocarditis, wherein with COxsackie, influenza, dust can, poliomyelitis, parotitis, adenovirus be main, and be especially common with coxsackie B group myocarditis.Numerous clinical data promptings, viral myocarditis can be converted into dilated cardiomyopathy (DCM), and therefore the timely treatment for viral myocarditis just seems particularly important.
Mainly be divided into tcm therapy and western medicine therapy for the treatment of viral myocarditis is clinical.
Western medicine therapy:At present, doctor trained in Western medicine mainly relies on pharmacotherapy, and the medicine of use mainly contains ATP, Vc, inosine etc.Because the active drug of vacant weary kill virus targetedly and adjustment immunity, the life-time service medicine very easily produces untoward reaction such as liver, kidney, is unfavorable for long-term treatment.
Tcm therapy:Motherland's medical science is of long standing and well established to the understanding of viral myocarditis, can trace back to " interior warp " the earliest.Viral myocarditis is the doctor trained in Western medicine name of disease, can belong to the categories such as " cardiopalmus, the thoracic obstruction " for the traditional Chinese medical science according to its primary symptom, the cause of disease, sick position, is a kind of commonly encountered diseases, frequently-occurring disease.The clinical method commonly used of modern Chinese medicine is a lot, comprises acupuncture and Drug therapy etc.Li Rui etc. [acupuncture cooperates treatment by Chinese herbs viral myocarditis 25 examples, the clinical magazine of acupuncture, 11 (4): 18-19] adopt Chinese medicine to cooperate acupuncture therapy to treat 25 routine viral myocarditis patients, have obtained good effect.The traditional Chinese medical science is a lot of to the Therapeutic Method of viral myocarditis, takes the dialectical method of controlling of executing to treat to different typings.The square medicine of main typing and use is following: pyretic toxicity is invaded heart type and is adopted the Lonicerae and Forsythiae Powder plus-minus; Type of deficiency of both QI and YIN adopts the zhigancao decoction plus-minus; The deficiency of heart-QI type adopts Ramuli Cinnamomi and Glycyrrhizae Decoction to close to protect first Tonga to subtract and treats; The phlegm resistance type closes the ERCHEN TANG plus-minus with GUALOUXIEBAI TANG; Qi stagnation and blood stasis type uses the decoction for removing blood stasis plus-minus.
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 Chinese medicine extract; 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 Sophorae Flavescentis extract.
Another object of the present invention is to provide a kind of method for preparing that contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract.
The present invention contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract and realizes through following technical scheme:
Processed by Chinese medicine extract and pharmaceutically acceptable carrier, wherein Chinese medicine extract accounts for 40～90% of percentage by weight, and pharmaceutically acceptable vehicle weight percentage composition is 10～60%; Described Chinese medicine extract is processed by following materials of weight proportions: Radix Panacis Quinquefolii 1～10%, Radix Sophorae Flavescentis 1～50%, Radix Salviae Miltiorrhizae 1～20%, Ramulus Cinnamomi 1～20%, Herba Visci 1～50%, Fructus Crataegi 1～40%, Radix Glycyrrhizae 1～20%;
Wherein Chinese medicine extract obtains according to following step: (1) Radix Sophorae Flavescentis adds the dilute hydrochloric acid percolation, and percolate is crossed resin, and resin is used water elution, and pure eluting is adopted in ammonia alkalization back, and eluent reclaims alcohol, is condensed into extractum; (2) Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii add NaHCO
3Solution extracts, and extracting solution adds ethanol precipitation, leaves standstill, and filters, and filtrating concentrating reclaimed ethanol, is condensed into extractum; (3) all the other medicine extracting in waters filter, and filtrating is condensed into extractum; (4) above-mentioned extractum is mixed, process Chinese medicine extract of the present invention.
The present invention contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract, preferably realizes through following technical scheme:
Weight percentage by Chinese medicine extract is 70～80%, and pharmaceutically acceptable vehicle weight percentage composition is 20～30%; Wherein said Chinese medicine extract is processed by following materials of weight proportions: Radix Panacis Quinquefolii 2～5%, Radix Sophorae Flavescentis 10～40%, Radix Salviae Miltiorrhizae 5～15%, Ramulus Cinnamomi 5～15%, Herba Visci 10～35%, Fructus Crataegi 10～30%, Radix Glycyrrhizae 5～15%;
Wherein Chinese medicine extract obtains according to following step: the dilute hydrochloric acid concentration in the said step (1) is 0.1～0.5%; The percolate flow velocity is 1～5ml/min in the said step (1); Resin in the said step (1) is an acid cation exchange resin; The pH of alkalization ammonia is 10～12 in the said step (1); Eluting alcohol is C in the said step (1)
1～C
5Lower alcohol; The concentration of pure eluting is 70～90% in the said step (1); NaHCO in the said step (2)
3The concentration of solution is 0.1～0.5%; Concentration of ethanol is 50～70% in the middle precipitate with ethanol solution of said step (2).
The present invention contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract, and the best realizes through following technical scheme:
Weight percentage by Chinese medicine extract is 70～80%, and pharmaceutically acceptable vehicle weight percentage composition is 20～30%; Wherein Chinese medicine extract is processed by following materials of weight proportions: Radix Panacis Quinquefolii 4%, Radix Sophorae Flavescentis 29%, Radix Salviae Miltiorrhizae 9%, Ramulus Cinnamomi 9%, Herba Visci 23%, Fructus Crataegi 17%, Radix Glycyrrhizae 9%;
Wherein Chinese medicine extract obtains according to following step: in the said step (1) water elution to pH be 6.8～7.2.
Chinese medicine extract described in the present invention; Can obtain according to method provided by the invention; Also can get like the preparation of methods such as decocting method, infusion process, percolation, circumfluence method, water extract-alcohol precipitation, alcohol extracting-water precipitating according to the conventional or commonly used method in present technique field; Can be extractum, also can be the effective site of further extraction separation acquisition or the compositions of effective site.
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 Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract; 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/ml; 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 Sophorae Flavescentis extract, and its particle diameter is 700～1500 μ m.
The present invention contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract 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 Chinese medicine extract dry powder.
The present invention contains the method for preparing of the Chinese medicinal granule of Radix Sophorae Flavescentis extract, and step is following:
(1) preparation of Chinese medicine extract of the present invention: (1) Radix Sophorae Flavescentis adds the dilute hydrochloric acid percolation, and percolate is crossed resin, and resin is used water elution, and pure eluting is adopted in ammonia alkalization back, and eluent reclaims alcohol, is condensed into extractum; (2) Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii add NaHCO
3Solution extracts, and extracting solution adds ethanol precipitation, leaves standstill, and filters, and filtrating concentrating reclaimed ethanol, is condensed into extractum; (3) all the other medicine extracting in waters filter, and filtrating is condensed into extractum; (4) above-mentioned extractum is mixed, process Chinese medicine extract of the present invention;
(2) preparation of master batch: i. gets an amount of pharmaceutically acceptable carrier, the perhaps mixture of itself and Chinese medicine extract 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 Chinese medicine extract 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 active component of the present invention is an amount of; Above-mentioned acceptable carrier is added in the invention described above active component, 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 Sophorae Flavescentis extract, and preferred steps is following:
(1) preparation of Chinese medicine extract of the present invention: (1) Radix Sophorae Flavescentis adds 0.1～0.5% dilute hydrochloric acid percolation, and the flow velocity of filtering is 1～5ml/min, percolate peracidity cation exchange resin, and resin is used water elution, and using pH is that C is adopted in 10～12 ammonia alkalization back
1～C
5Lower alcohol eluting, the concentration of pure eluting are 70～90%, reclaim alcohol, are condensed into extractum; (2) Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, adding concentration is 0.1～0.5%NaHCO
3Solution extracts, and it is 50～70% ethanol precipitations that extracting solution adds concentration, leaves standstill, and filters, and filtrating concentrating reclaimed ethanol, is condensed into extractum; (3) all the other medicine extracting in waters filter, and filtrating is condensed into extractum; (4) above-mentioned extractum is mixed, process Chinese medicine extract of the present invention;
(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 active component of the present invention 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 450～600gm is subsequent use;
(3) preparation of product: get master batch 450g; The active component of the present invention of 300g; With active component weight ratio of the present invention be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with active component weight ratio of the present invention: 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 active component of the present invention; 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.
In the preparation process of active component of the present invention, the addition of Rhizoma Chuanxiong is 5～15% of the prescription total amount in the said step (a), and the powder particle diameter of Hirudo, Rhizoma Chuanxiong is 130～170 μ m; Decocting number of times in the said step (b) is 1～4 time, and amount of water is 6～10 times of dose, and the time is 1～3 hour; It is 1.0～1.5 that its water extract is concentrated into relative density, and alcoholic acid addition is to make its concentration reach 40～80%; After reclaiming ethanol, concentrated extract to relative density is 1.0～1.5; Alcohol reflux is 1～4 time in the said step (c), and alcohol adding amount is 6～10 times of dose, and the time is 1～3 hour, and behind the recovery ethanol, concentrated extract to relative density is 1.0～1.5.
The present invention contains in the method for preparing of Chinese medicinal granule of Radix Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract, No. 2 capsules of spheroidal particle fill that can said method be obtained, and the 250mg/ grain is processed 10000 of capsules.
" 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 Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract, 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 Sophorae Flavescentis extract, 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
The preparation of active component of the present invention: get Radix Panacis Quinquefolii 138g, Radix Sophorae Flavescentis 736g, Radix Salviae Miltiorrhizae 230g, Ramulus Cinnamomi 138g, Herba Visci 437g, Fructus Crataegi 437g, Radix Glycyrrhizae 184g; With dilute hydrochloric acid (0.1%) percolation, flow velocity is 1ml/min with the Radix Sophorae Flavescentis medical material, acid cation exchange resin on the percolate, and distilled water is eluted to pH6.8, adds ammonia (pH10) alkalization, and methanol-eluted fractions, concentration are 70%, concentrate recovery methanol and become extractum; Get Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, add NaHCO
3Solution (0.1%) extracts, and adds ethanol precipitation, makes the determining alcohol of precipitate with ethanol solution reach 50%, filters, and filtrating concentrating reclaimed ethanol and become extractum; All the other medicine extracting in waters filter, and are condensed into extractum, mix homogeneously, preparation cost invention active component.
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 50g, microcrystalline Cellulose (200 order) 5g, polyethylene glycol 6000 (heating and melting)
50G, active component 32g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the active component of the present invention, 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
The preparation of active component of the present invention: get Radix Panacis Quinquefolii 184g, Radix Sophorae Flavescentis 782g, Radix Salviae Miltiorrhizae 230g, Ramulus Cinnamomi 184g, Herba Visci 299g, Fructus Crataegi 299g, Radix Glycyrrhizae 322g; With dilute hydrochloric acid (0.2%) percolation, flow velocity is 2ml/min with the Radix Sophorae Flavescentis medical material, acid cation exchange resin on the percolate, and distilled water is eluted to pH6.9, adds ammonia (pH10.5) alkalization, ethanol elution, concentration is 75%, concentrates recovery ethanol and becomes extractum; Get Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, add NaHC0
3Solution (0.2%) extracts, and adds ethanol precipitation, makes the determining alcohol of precipitate with ethanol solution reach 55%, filters, and filtrating concentrating reclaimed ethanol and become extractum; All the other medicine extracting in waters filter, and are condensed into extractum, mix homogeneously, preparation cost invention active component.
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 30g, microcrystalline Cellulose (200 order) 25g, micropowder silica gel 6g, active component 20g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the active component of the present invention, 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.Particulate bulk density 0.93g/ml is with No. 00 capsule of the spheroidal particle fill that obtains.
Embodiment 3
The preparation of active component of the present invention: get: Radix Panacis Quinquefolii 100g, Radix Sophorae Flavescentis 667.5g, Radix Salviae Miltiorrhizae 200g, Ramulus Cinnamomi 200g, Herba Visci 532.5g, Fructus Crataegi 400g, Radix Glycyrrhizae 200g; With dilute hydrochloric acid (0.3%) percolation, flow velocity is 3ml/min with the Radix Sophorae Flavescentis medical material, acid cation exchange resin on the percolate, and distilled water is eluted to pH7.0, adds ammonia (pH11) alkalization, the propanol eluting, concentration is 80%, concentrates recovery methanol and becomes extractum; Get Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, add NaHCO
3Solution (0.3%) extracts, and adds ethanol precipitation, makes the determining alcohol of precipitate with ethanol solution reach 60%, filters, and filtrating concentrating reclaimed ethanol and become extractum; All the other medicine extracting in waters filter, and are condensed into extractum, mix homogeneously, preparation cost invention active component.
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 45g, microcrystalline Cellulose (200 order) 5g, polyethylene glycol 6000 (heating and melting)
35G, active component 30g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the active component of the present invention, 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.
Embodiment 4
The preparation of active component of the present invention: get Radix Panacis Quinquefolii 69g, Radix Sophorae Flavescentis 575g, Radix Salviae Miltiorrhizae 184g, Ramulus Cinnamomi 230g, Herba Visci 621g, Fructus Crataegi 414g, Radix Glycyrrhizae 207g; With dilute hydrochloric acid (0.4%) percolation, flow velocity is 4ml/min with the Radix Sophorae Flavescentis medical material, acid cation exchange resin on the percolate, and distilled water is eluted to pH7.1, adds ammonia (pH11.5) alkalization, the butanols eluting, concentration is 85%, concentrates the recovery butanols and becomes extractum; Get Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, add NaHCO
3Solution (0.4%) extracts, and adds ethanol precipitation, makes the determining alcohol of precipitate with ethanol solution reach 65%, filters, and filtrating concentrating reclaimed ethanol and become extractum; All the other medicine extracting in waters filter, and are condensed into extractum, mix homogeneously, preparation cost invention active component.
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 invention active component 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
The preparation of active component of the present invention: get: Radix Panacis Quinquefolii 46g, Radix Sophorae Flavescentis 552g, Radix Salviae Miltiorrhizae 276g, Ramulus Cinnamomi 276g, Herba Visci 483g, Fructus Crataegi 391g, Radix Glycyrrhizae 276g; With dilute hydrochloric acid (0.5%) percolation, flow velocity is 5ml/min with the Radix Sophorae Flavescentis medical material, acid cation exchange resin on the percolate, and distilled water is eluted to pH7.2, adds ammonia (pH12) alkalization, the amylalcohol eluting, concentration is 90%, concentrates the recovery amylalcohol and becomes extractum; Get Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, add NaHCO
3Solution (0.5%) extracts, and adds ethanol precipitation, makes the determining alcohol of precipitate with ethanol solution reach 70%, filters, and filtrating concentrating reclaimed ethanol and become extractum; All the other medicine extracting in waters filter, and are condensed into extractum, mix homogeneously, preparation cost invention active component.
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, invention active component 450g; Microcrystalline Cellulose and micropowder silica gel are added in the invention active component, 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 active component of the present invention 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, invention active component 300g; Microcrystalline Cellulose and micropowder silica gel are added in the invention active component, 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 active component of the present invention that obtains according to embodiment 2 methods;
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-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 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, invention active component 430g; Microcrystalline Cellulose and micropowder silica gel are added in the invention active component, 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 active component of the present invention that obtains according to embodiment 3 methods;
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 the foregoing invention active component, 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 invention active component weight ratio are 7: 25 HPMC: PVP-K30 (2: 5) mixture is viscosity adjustment agent; Perhaps selection and invention active component 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 invention active component weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC: PVP-K30 (2: 5) mixture, the invention active component of 340g with invention active component 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 invention active component, 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 active component of the present invention that obtains according to embodiment 4 methods;
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 invents active component (after amounting to dry weight, accounting for the 15wt% of master batch weight) and add 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 invention active component of 440g, with invention active component weight ratio be 18: 25 polyethylene glycol 6000, uses dehydrated alcohol that above-mentioned viscosity is adjusted the agent polyethylene glycol 6000 and is formulated as the solution of concentration as 15wt%; Add in the invention active component; 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 active component of the present invention that obtains according to embodiment 5 methods;
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 invents active component (after amounting to dry weight, accounting for the 15wt% of master batch weight) and add 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 invention active component of 500g, with invention active component 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, add and invent in the active component, 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 active component of the present invention that obtains according to embodiment 3 methods;
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 invents active component (after amounting to dry weight, accounting for the 10wt% of master batch weight) and add 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 invention active component of 500g, with invention active component 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, add and invent in the active component, 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 active component of the present invention that obtains according to embodiment 2 methods;
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 invents active component (after amounting to dry weight, accounting for the 10wt% of master batch weight) and add 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 invention active component of 800g, with invention active component weight ratio be 18: 25 polyethylene glycol 6000, uses dehydrated alcohol that above-mentioned viscosity is adjusted the agent polyethylene glycol 6000 and is formulated as the solution of concentration as 15wt%; Add in the invention active component; 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 active component of the present invention 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 invention active component 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 invention active component of 300g; With invention active component weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with invention active component 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 invention active component; 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 (6)
1. a Chinese medicinal granule that contains Radix Sophorae Flavescentis extract is processed by Chinese medicine extract and pharmaceutically acceptable carrier, and the weight percentage that it is characterized in that Chinese medicine extract is 70～80%, and pharmaceutically acceptable vehicle weight percentage composition is 20～30%; Wherein said Chinese medicine extract is processed by following materials of weight proportions: Radix Panacis Quinquefolii 2～5%, Radix Sophorae Flavescentis 10～40%, Radix Salviae Miltiorrhizae 5～15%, Ramulus Cinnamomi 5～15%, Herba Visci 10～35%, Fructus Crataegi 10～30%, Radix Glycyrrhizae 5～15%;
The method for preparing of said Chinese medicinal granule is following:
(1) preparation of Chinese medicine extract: 1. Radix Sophorae Flavescentis adds 0.1～0.5% dilute hydrochloric acid percolation, and the flow velocity of filtering is 1～5ml/min, percolate peracidity cation exchange resin, and resin is used water elution, and using pH is that C is adopted in 10～12 ammonia alkalization back
1～C
5Lower alcohol eluting, the concentration of pure eluting are 70～90%, reclaim alcohol, are condensed into extractum; 2. Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, adding concentration is 0.1～0.5%NaHCO
3Solution extracts, and it is 50～70% ethanol precipitations that extracting solution adds concentration, leaves standstill, and filters, and filtrating concentrating reclaimed ethanol, is condensed into extractum; 3. all the other medicine extracting in waters filter, and filtrating is condensed into extractum; 4. above-mentioned extractum is mixed, process described Chinese medicine extract;
(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 active component 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 active component of 300g; With the active component weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with the active component 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 active component; 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 Chinese medicinal granule that contains Radix Sophorae Flavescentis extract according to claim 1, the weight percentage that it is characterized in that Chinese medicine extract is 70～80%, pharmaceutically acceptable vehicle weight percentage composition is 20～30%; Wherein Chinese medicine extract is processed by following materials of weight proportions: Radix Panacis Quinquefolii 4%, Radix Sophorae Flavescentis 29%, Radix Salviae Miltiorrhizae 9%, Ramulus Cinnamomi 9%, Herba Visci 23%, Fructus Crataegi 17%, Radix Glycyrrhizae 9%;
Wherein Chinese medicine extract obtains according to following step: in the said step (1) water elution to pH be 6.8～7.2.
3. the Chinese medicinal granule that contains Radix Sophorae Flavescentis extract according to claim 1; It is characterized in that described 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.
4. the Chinese medicinal granule that contains Radix Sophorae Flavescentis extract according to claim 1 is characterized in that its particle diameter is 700～1500 μ m.
5. the Chinese medicinal granule that contains Radix Sophorae Flavescentis extract according to claim 1 is characterized in that said granule also contains coating, and the weight of coating materials accounts for 2～5wt% of granule gross weight.
6. each said method for preparing that contains the Chinese medicinal granule of Radix Sophorae Flavescentis extract of claim 1～5; It is characterized in that step is following: the preparation of (1) Chinese medicine extract: 1. Radix Sophorae Flavescentis adds 0.1～0.5% dilute hydrochloric acid percolation; The flow velocity of filtering is 1～5ml/min; Percolate peracidity cation exchange resin, resin is used water elution, and using pH is that C is adopted in 10～12 ammonia alkalization back
1～C
5Lower alcohol eluting, the concentration of pure eluting are 70～90%, reclaim alcohol, are condensed into extractum; 2. Radix Salviae Miltiorrhizae and Radix Panacis Quinquefolii, adding concentration is 0.1～0.5%NaHCO
3Solution extracts, and it is 50～70% ethanol precipitations that extracting solution adds concentration, leaves standstill, and filters, and filtrating concentrating reclaimed ethanol, is condensed into extractum; 3. all the other medicine extracting in waters filter, and filtrating is condensed into extractum; 4. above-mentioned extractum is mixed, process described Chinese medicine extract;
(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 active component 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 active component of 300g; With the active component weight ratio be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC and PVP-K30 mixture with the active component weight ratio, wherein the HPMC: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 active component; 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.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1513542A (en) * | 2002-12-31 | 2004-07-21 | 天津天士力制药股份有限公司 | Chinese medicinal preparation for treating viral myocarditis and its making method |
| CN1965986A (en) * | 2006-08-10 | 2007-05-23 | 黄志良 | Medicinal decoction for treating viral myocarditis and method for preparing same |
| CN101020008A (en) * | 2007-01-29 | 2007-08-22 | 李运乃 | Specific heart protecting herb tea prepn for preventing and treating acute viral myocarditis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1513542A (en) * | 2002-12-31 | 2004-07-21 | 天津天士力制药股份有限公司 | Chinese medicinal preparation for treating viral myocarditis and its making method |
| CN1965986A (en) * | 2006-08-10 | 2007-05-23 | 黄志良 | Medicinal decoction for treating viral myocarditis and method for preparing same |
| CN101020008A (en) * | 2007-01-29 | 2007-08-22 | 李运乃 | Specific heart protecting herb tea prepn for preventing and treating acute viral myocarditis |
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