CN101439084B - Chinese medicine granule containing agastache extract and preparation method thereof - Google Patents
Chinese medicine granule containing agastache extract and preparation method thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a traditional Chinese medicine granular preparation with ageratum 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 Herba Pogostemonis extract and preparation method thereof.
Background technology
The ageratum prescription comes from " formulary of peaceful benevolent dispensary volume two " contained huoxiang zhengqi powder, and main medicine is formed has Herba Pogostemonis, Rhizoma Atractylodis, the Rhizoma Pinelliae, Cortex Magnoliae Officinalis, Pericarpium Arecae, the Radix Angelicae Dahuricae, Folium Perillae, Poria, Pericarpium Citri Reticulatae, Radix Platycodonis, Radix Glycyrrhizae.Have in the harmony in the exterior of separating, the effect of eliminating turbid pathogen with aromatics is mainly used in affection of exogenous wind-cold, in humidity hysteresis is arranged or experiences heat-damp in summer, see exterior syndromes such as cold and heat headache outward, in have vexed, the indigestion and loss of appetite vomiting and nausea of breast abdominal distention, stomachache have loose bowels tastelessness greasy fur, the card of wet resistance such as relaxed and soft pulse.We are usually used in common cold of gastrointestinal type, acute gastroenteritis or dyspepsia etc. and have above-mentioned patient.In addition, the treatment that this prescription is used for pestilence (epidemic diseases) is offered promptly on the books at ancient Chinese prose, and " Wang Kentang is said, and epidemic disease person is that the air-flow that day row is ferocious and stern is capable like " Treatise on Febrile Diseases detailed outline volume seven ".The not positive person of all 4 o'clock orders is to have this gas also capable.If the people feels it, then long children is similar and sick, infects mutually again, and its work is similar with typhoid fever.Right typhoid fever gets because of cold, and this is a pestilential pathogen, can not discuss also together with cold, and method is when warding off diffusing pestilential pathogen, and it is main setting upright gas.Ruo Duori does not understand, and what disease of the pathogenic heat change of disease should become in the disease bar from typhoid fever and select for use.It is then different only to disperse medicine.All decoctions of dispersing, huoxiang zhengqi powder ...All available.”
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 Herba Pogostemonis extract.
Another object of the present invention is to provide a kind of method for preparing that contains the Chinese medicinal granule of Herba Pogostemonis extract.
The present invention contains the Chinese medicinal granule of Herba Pogostemonis 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 obtained according to following method by following materials of weight proportions: Rhizoma Atractylodis 80～240g, Pericarpium Citri Reticulatae 80～240g, Cortex Magnoliae Officinalis 80～240g, the Radix Angelicae Dahuricae 120～360g, Poria 120～360g, Pericarpium Arecae 120～360g, Rhizoma Pinelliae 80～240g, Radix Glycyrrhizae extractum 10～30g, patchouli oil 0.8～2.4ml and Folium perillae acutae oil 0.4～2.0ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 12～36 hours with 50～80% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 60～90 ℃ of warm macerating 2 times, 1.5～4.5 hours for the first time, 1～3 hour for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 8～20g, decocte with water 2 times, 1.5～4.5 hours for the first time, 1～3 hour for the second time; Pericarpium Arecae decocte with water 1.5～4 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
The present invention contains the Chinese medicinal granule of Herba Pogostemonis 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 obtained according to following method by following materials of weight proportions: Rhizoma Atractylodis 120～200g, Pericarpium Citri Reticulatae 120～200g, Cortex Magnoliae Officinalis 120～200g, the Radix Angelicae Dahuricae 180～300g, Poria 180～300g, Pericarpium Arecae 180～300g, Rhizoma Pinelliae 120～200g, Radix Glycyrrhizae extractum 15～25g, patchouli oil 1.2～2.0ml and Folium perillae acutae oil 0.5～1.6ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 20～30 hours with 55～65% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 75～85 ℃ of warm macerating 2 times, 2～4 hours for the first time, 1.5～2.5 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 10～15g, decocte with water 2 times, 2.5～3.5 hours for the first time, 1.5～2.5 hours for the second time; Pericarpium Arecae decocte with water 2.5～3.5 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract.
The present invention contains the Chinese medicinal granule of Herba Pogostemonis 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 obtained according to following method by following materials of weight proportions: Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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 Herba Pogostemonis 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 Herba Pogostemonis 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 Herba Pogostemonis 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/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 Herba Pogostemonis extract, and its particle diameter is 700～1500 μ m.
The present invention contains the Chinese medicinal granule of Herba Pogostemonis 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 Herba Pogostemonis 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 Herba Pogostemonis extract, and step is following:
(1) preparation of extract: Rhizoma Atractylodis 80～240g, Pericarpium Citri Reticulatae 80～240g, Cortex Magnoliae Officinalis 80～240g, the Radix Angelicae Dahuricae 120～360g, Poria 120～360g, Pericarpium Arecae 120～360g, Rhizoma Pinelliae 80～240g, Radix Glycyrrhizae extractum 10～30g, patchouli oil 0.8～2.4ml and Folium perillae acutae oil 0.4～2.0ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 12～36 hours with 50～80% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 60～90 ℃ of warm macerating 2 times, 1.5～4.5 hours for the first time, 1～3 hour for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 8～20g, decocte with water 2 times, 1.5～4.5 hours for the first time, 1～3 hour for the second time; Pericarpium Arecae decocte with water 1.5～4 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract;
(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 extract extractum of the present invention is an amount of; Above-mentioned acceptable carrier is added in the invention described above extract extractum, 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 Herba Pogostemonis extract, and preferred steps is following:
(1) preparation of extract: it is subsequent use to get Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention 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 extract extractum 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 450～600 μ m is subsequent use;
(3) preparation of product: get master batch 450g; The extract extractum of the present invention of 10000 dosage; With extract extractum weight ratio of the present invention be 18: 25 polyethylene glycol 6000; Perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with extract extractum 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 extract extractum 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.
The present invention contains in the method for preparing of Chinese medicinal granule of Herba Pogostemonis 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 seconds.
The present invention contains in the method for preparing of Chinese medicinal granule of Herba Pogostemonis 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 Herba Pogostemonis 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 Herba Pogostemonis 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 Herba Pogostemonis 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 extraction of extractum: it is subsequent use to get Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml: it is subsequent use to get Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml:
Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and considers the liquid concentrating under reduced pressure and becomes thick paste, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract;
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, Chinese medicine extract 1000g of the present invention. Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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.Bulk density is 0.76g/ml.With No. 2 capsules of the spheroidal particle fill that obtains, every dress 0.125g processes capsule.
Embodiment 2
The extraction of extractum: Rhizoma Atractylodis 80g, Pericarpium Citri Reticulatae 80g, Cortex Magnoliae Officinalis 240g, Radix Angelicae Dahuricae 120g, Poria 360g, Pericarpium Arecae 120g, Rhizoma Pinelliae 80g, Radix Glycyrrhizae extractum 10g, patchouli oil 0.8ml, Folium perillae acutae oil 0.4ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 12 hours with 50% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 60 ℃ of warm macerating 2 times, 1.5 hours for the first time, 1 hour for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 8g, decocte with water 2 times, 1.5 hours for the first time, 1 hour for the second time; Pericarpium Arecae decocte with water 1.5 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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, v2000g; Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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
The extraction of extractum: Rhizoma Atractylodis 240g, Pericarpium Citri Reticulatae 240g, Cortex Magnoliae Officinalis 80g, Radix Angelicae Dahuricae 120g, Poria 360g, Pericarpium Arecae 360g, Rhizoma Pinelliae 240g, Radix Glycyrrhizae extractum 10g, patchouli oil 2.4ml, Folium perillae acutae oil 0.5ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae, Cortex Magnoliae Officinalis add 45% alcohol reflux twice, and each 4 hours, merge extractive liquid, filters, and reclaims ethanol, and was subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 36 hours with 50～80% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 90 ℃ of warm macerating 2 times, 4.5 hours for the first time, 3 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 20g, decocte with water 2 times, 4.5 hours for the first time, 3 hours for the second time; Pericarpium Arecae decocte with water 4 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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, Chinese medicine extract 500g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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.
Embodiment 4
The extraction of extractum: it is subsequent use to get Rhizoma Atractylodis 100g, Pericarpium Citri Reticulatae 240g, Cortex Magnoliae Officinalis 200g, Radix Angelicae Dahuricae 150g, Poria 150g, Pericarpium Arecae 300g, Rhizoma Pinelliae 120g, Radix Glycyrrhizae extractum 15g, patchouli oil 1.0ml, Folium perillae acutae oil 1.2ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 14 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 65 ℃ of warm macerating 2 times, 2 hours for the first time, 3 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 10g, decocte with water 2 times, 4.5 hours for the first time, 1 hour for the second time; Pericarpium Arecae decocte with water 2 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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, in 5% the polyvidone solution, add Chinese medicine extract of the present invention an amount of (being equivalent to 50 kilograms of medical materials); In 5% the polyvidone solution, add that extractum is an amount of, 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 extraction of extractum: it is subsequent use to get Rhizoma Atractylodis 120g, Pericarpium Citri Reticulatae 120g, Cortex Magnoliae Officinalis 120g, Radix Angelicae Dahuricae 300g, Poria 300g, Pericarpium Arecae 180g, Rhizoma Pinelliae 120g, Radix Glycyrrhizae extractum 15g, patchouli oil 1.2ml, Folium perillae acutae oil 0.5ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 20 hours with 55% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 75 ℃ of warm macerating 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 10g, decocte with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time; Pericarpium Arecae decocte with water 2.5 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract.
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, Chinese medicine extract 833g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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
The extraction of extractum: it is subsequent use to get Rhizoma Atractylodis 200g, Pericarpium Citri Reticulatae 200g, Cortex Magnoliae Officinalis 200g, Radix Angelicae Dahuricae 180g, Poria 180g, Pericarpium Arecae 180, Rhizoma Pinelliae 120g, Radix Glycyrrhizae extractum 25g, patchouli oil 2.0ml, Folium perillae acutae oil 1.6ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, the Radix Angelicae Dahuricae, Cortex Magnoliae Officinalis add 45～95% alcohol reflux 2 times, and each 1 hour, merge extractive liquid, filters, and reclaims ethanol, and was subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 30 hours with 65% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 85 ℃ of warm macerating 2 times, 4 hours for the first time, 2.5 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 15g, decocte with water 2 times, 3.5 hours for the first time, 2.5 hours for the second time; Pericarpium Arecae decocte with water 3.5 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract.
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, Chinese medicine extract 300g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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
The extraction of extractum: it is subsequent use to get Rhizoma Atractylodis 130g, Pericarpium Citri Reticulatae 180g, Cortex Magnoliae Officinalis 120g, Radix Angelicae Dahuricae 180g, Poria 180g, Pericarpium Arecae 150g, Rhizoma Pinelliae 110g, Radix Glycyrrhizae extractum 10g, patchouli oil 10ml, Folium perillae acutae oil 1.0ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 30 hours with 65% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 75 ℃ of warm macerating 2 times, 2 hours for the first time, 2.5 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 15g, decocte with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time; Pericarpium Arecae decocte with water 2.5 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract.
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, Chinese medicine extract 100g of the present invention; Microcrystalline Cellulose and micropowder silica gel are added in the extractum, 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, the extraction of extract extractum of the present invention
It is subsequent use to get Rhizoma Atractylodis 140g, Pericarpium Citri Reticulatae 150g, Cortex Magnoliae Officinalis 160g, Radix Angelicae Dahuricae 190g, Poria 200g, Pericarpium Arecae 220g, Rhizoma Pinelliae 120g, Radix Glycyrrhizae extractum 16g, patchouli oil 1.3ml, Folium perillae acutae oil 1.3ml; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 22 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 75 ℃ of warm macerating 2 times, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 15g, decocte with water 2 times, 2.5 hours for the first time, 1 hour for the second time; Pericarpium Arecae decocte with water 2 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape; Add patchouli oil, Folium perillae acutae oil, mixing, preparation cost invention Chinese medicine extract.
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, and other gets starch and adds water and be mixed with starch slurry (15%; G/ml) spray into as slurry, and sift out granule (particle diameter is 180～250 μ m), again parent nucleus is dropped in the pot as parent nucleus; 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, 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 invention described above extract extractum, 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 extract extractum weight ratio of the present invention are 7: 25 HPMC: PVP-K30 (2: 5) mixture is viscosity adjustment agent; Perhaps selection and extract extractum weight ratio of the present invention 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
A. get master batch 450g, with extract extractum weight ratio of the present invention be 18: 25 polyethylene glycol 6000, perhaps be 7: 25 HPMC: PVP-K30 (2: 5) mixture, the extract extractum of the present invention of 10000 dosage with extract extractum weight ratio of the present invention;
B. use dehydrated alcohol with a kind of solution that is formulated as concentration as 15wt% in the above-mentioned viscosity adjustment agent, add in the extract extractum of the present invention, 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 25 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, the extraction of extractum: Rhizoma Atractylodis 180g, Pericarpium Citri Reticulatae 180g, Cortex Magnoliae Officinalis 180g, Radix Angelicae Dahuricae 260g, Poria 260g, Pericarpium Arecae 260g, Rhizoma Pinelliae 180g, Radix Glycyrrhizae extractum 22g, patchouli oil 1.8ml, Folium perillae acutae oil 1.2ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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 extract extractum of the present invention (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 extract extractum of the present invention of 10000 dosage, with extract extractum weight ratio of the present invention 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 extract extractum 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.
Embodiment 10
1, the extraction of extractum: Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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 extract extractum of the present invention (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 extract extractum of the present invention of 5000 dosage, with extract extractum weight ratio of the present invention 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 and PVP-K30 mixture are formulated as the solution of concentration as 15wt%, add in the extract extractum of the present invention, 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, the extraction of extractum: Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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 extract extractum of the present invention (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 extract extractum of the present invention of 15000 dosage, with extract extractum weight ratio of the present invention 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 and PVP-K30 mixture are formulated as the solution of concentration as 15wt%, add in the extract extractum of the present invention, 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, the extraction of extractum: Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, Folium perillae acutae oil 0.8ml are subsequent use; (b), Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae are respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item,, flood and carry out percolation after 24 hours as solvent with 60% ethanol, collect percolate, reclaim ethanol, medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 hours, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention Chinese medicine extract.
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 extract extractum of the present invention (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 extract extractum of the present invention of 10000 dosage, with extract extractum weight ratio of the present invention 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 extract extractum 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.
Claims (5)
1. method for preparing that contains the Chinese medicinal granule of Herba Pogostemonis extract is characterized in that step is following:
(1) preparation of extract: the Cortex Magnoliae Officinalis 160g, Radix Angelicae Dahuricae 240g, Poria 240g, Pericarpium Arecae 240g, Rhizoma Pinelliae 160g, Rhizoma Zingiberis 13.5g, Radix Glycyrrhizae extractum 20g, patchouli oil 1.6ml, the Folium perillae acutae oil 0.8ml that get Rhizoma Atractylodis 160g, Pericarpium Citri Reticulatae 160g, processed with Rhizoma Zingiberis Recens are subsequent use; Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Angelicae Dahuricae as solvent, flood and carry out percolation after 24 hours with 60% ethanol respectively according to the percolation under Chinese Pharmacopoeia nineteen ninety-five version appendix I0 fluid extract and the extractum item, collect percolate, reclaim ethanol, and medicinal liquid is subsequent use; Behind the Poria decocting in water, 80 ℃ of warm macerating 2 times, 3 hours for the first time, 2 hours for the second time, extracting juice; Rhizoma Pinelliae is used cold water soak, changes water once in per 8 hours, and after bubble extremely passed through the heart, other added Rhizoma Zingiberis 13.5g, decocte with water 2 times, 3 hours for the first time, 2 hours for the second time; Pericarpium Arecae decocte with water 3 hours merges above-mentioned medicinal liquid, filters, and filtrating is concentrated into the thick paste shape, adds Radix Glycyrrhizae extractum, patchouli oil, Folium perillae acutae oil, mixing; Preparation cost invention 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 extract extractum 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 450～600 μ m is subsequent use;
(3) preparation of product: get master batch 450g; The extract extractum of the present invention of 10000 dosage; With extract extractum weight ratio of the present invention be 18: 25 polyethylene glycol 6000; Perhaps be 7: 25 HPMC and PVP-K30 mixture, wherein HPMC with extract extractum 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 extract extractum of the present invention; After the mixing, adding 60% 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 Herba Pogostemonis extract according to claim 1, the temperature of charge of the spheroidal particle that it is characterized in that said method is 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 seconds.
3. like the said method for preparing that contains the Chinese medicinal granule of Herba Pogostemonis extract of claim 2, it is characterized in that the 250mg/ grain is processed 10000 of capsules with No. 2 capsules of spheroidal particle fill of said method acquisition.
4. the method for preparing that contains the Chinese medicinal granule of Herba Pogostemonis extract 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.
5. the method for preparing that contains the Chinese medicinal granule of Herba Pogostemonis extract according to claim 1 is characterized in that prepared granule particle diameter is 700～1500 μ m.
6 contain the method for preparing of the Chinese medicinal granule of Herba Pogostemonis extract according to claim 1, it 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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| CN1565591A (en) * | 2003-07-07 | 2005-01-19 | 天津天士力制药股份有限公司 | Preparation and usage of |
| 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 |
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| CN1565591A (en) * | 2003-07-07 | 2005-01-19 | 天津天士力制药股份有限公司 | Preparation and usage of |
| 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 |
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| Title |
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| 宋顺宗 等.利用流化床制备中药包衣颗粒的工艺研究.《时珍国医国药》.2007,第18卷(第11期),2714-2715. * |
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