CN1785339A - Whites fast dispersion solid preparation and its preparation method - Google Patents
Whites fast dispersion solid preparation and its preparation method Download PDFInfo
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- CN1785339A CN1785339A CN 200510087260 CN200510087260A CN1785339A CN 1785339 A CN1785339 A CN 1785339A CN 200510087260 CN200510087260 CN 200510087260 CN 200510087260 A CN200510087260 A CN 200510087260A CN 1785339 A CN1785339 A CN 1785339A
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Abstract
A fast dispersing solid Chinese medicine for treating leukorrhagia is prepared from 5 Chinese-medicinal materials including phellodendron bark, white peony root, Chinese argelica root, cyperus tuber, etc through crushing or extracting, superfine pulverizing, and mixing with disintegrant, adhesive, suspending aid, flowing aid, flavouring and coloring agent.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly relate to fast dispersion solid medicine of a kind of and Chinese medicine patent medicine leucorrhea and preparation method thereof.
Technical background
The BAIDAI WAN prescription comes from " BAIDAI WAN " of the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation, and the side is made up of Cortex Phellodendri, Cortex Ailanthi, the Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Cyperi medicines such as (vinegar systems), and clearing away damp-heat is arranged, and leukorrhagia stopping purgation merit is used for the treatment of damp invasion of lower energizer, leucorrhea with red and white discharge.Now make warming the meridian BAIDAI WAN, compound recipe BAIDAI WAN, dehumidifying BAIDAI WAN, regulating menstruation BAIDAI WAN etc. according to different indications with the prescription of deriving again, at present " that records in Chinese pharmacopoeia and " the Ministry of Public Health standard for traditional Chinese medicines " has:
1, BAIDAI WAN (" Chinese pharmacopoeia 2000 version one one)
[prescription and method for making] Cortex Phellodendri (wine stir-fry) 150g, Cortex Ailanthi 300g, Radix Paeoniae Alba 100g, Radix Angelicae Sinensis 100g, Rhizoma Cyperi (vinegar system) 50g, the above five tastes, except that Cortex Ailanthi, four flavors such as all the other Cortex Phellodendris are ground into fine powder, sieve mixing.Cortex Ailanthi decocts with water secondary, and collecting decoction filters, and filtrate is concentrated in right amount (meal with wine stays the part coating) and an amount of water pill, uses the concentrated solution coating, drying, and polishing, promptly.
2, the warming the meridian BAIDAI WAN (" Ministry of Public Health drug standard Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation ", WS3-B-1858-94)
[prescription and method for making] Cornu Cervi Degelatinatum (vinegar stir-fry) 150g, Concha Ostreae (forging) 143.8g, Stamen Nelumbinis 62.5g, Pericarpium Citri Reticulatae (system) 62.5g, Os Draconis (forging) 62.5g, Cortex Phellodendri (salt stir-fry) 50g, the Rhizoma Atractylodis Macrocephalae (parching with earth) 87.5g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 50g, Semen Juglandis 14.1g, Poria 87.5g, Radix Paeoniae Rubra 50g, Semen Plantaginis (stir-fry) 62.5g, Radix Bupleuri 37.5g, Rhizoma Atractylodis (parched with bran) 62.5g, more than 14 the flavor, be ground into fine powder, sieve, mixing.Every 100g powder adds refined honey 35～50g and an amount of water, general ball, drying; Or add refined honey 100～120g and make big honeyed pills, promptly.
3, the compound recipe BAIDAI WAN (" the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ", WS3-B-1183-92)
[prescription and the method for making] Rhizoma Atractylodis Macrocephalae (parched with bran) 60g, Radix Bupleuri 15g, Stamen Nelumbinis 18g, Radix Patriniae heterophyllae 30g, Concha Ostreae 18g, Os Draconis 18g, Radix Ginseng 30g, Radix Glycyrrhizae (processing) 30g, Flos Celosiae Cristatae 30g, Pericarpium Citri Reticulatae 15g, Rhizoma Dioscoreae 60g, Poria 36, Radix Angelicae Sinensis (processed with wine) 30g, Fructus Psoraleae (salt stir-fry) 30g, Semen Euryales (stir-fry) 30g, more than ten five tastes, be ground into fine powder, sieve, mixing.Every 100g powder adds refined honey 130～150g and makes big honeyed pills, promptly.
4, the dehumidifying BAIDAI WAN (" the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ", WS3-B-1407-93)
[prescription and method for making] Radix Codonopsis 80g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 100g, Rhizoma Dioscoreae 100g, Radix Paeoniae Alba 50g, Semen Euryales 50g, Semen Plantaginis (stir-fry) 50g, Radix Angelicae Sinensis 30g, Rhizoma Atractylodis 30g, Pericarpium Citri Reticulatae 30g, Semen Ginkgo core 50g, Herba Schizonepetae (charcoal) 15g, Radix Bupleuri 12g, Cortex Phellodendri (charcoal) 12g, Radix Rubiae 12g, Endoconcha Sepiae 40g, Concha Ostreae (forging) 40g, more than ten Six-elements, be ground into fine powder, sieve, mixing.Use water pill, do bath, promptly.
5, regulating menstruation BAIDAI WAN (" the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ", WS3-B-1821-94)
[prescription and method for making] Radix Codonopsis 52g, Air Bladder pseudosciaenae seu Acipenser (system) 21g, Folium Artemisiae Argyi (vinegar system) 26g, Os Draconis 26g, Cortex Moutan 21g, Rhizoma Polygonati Odorati 26g, Rhizoma Curculiginis 26g, Radix Paeoniae Alba 31g, Herba Epimedii 16g, Fructus Ligustri Lucidi 26g, Semen Euryales 21g, Fructus Psoraleae 16g, Rhizoma Alismatis 26g, Radix Polygoni Multiflori Preparata 33g, Herba Cynomorii (steaming) 16g, Herba Taxilli (processed with salt) 31g, Fructus Chaenomelis 26g, Herba Dendrobii 10g, Semen Cuscutae (saline system) 31g, Colla Corii Asini 26g, Radix Achyranthis Bidentatae 26g, Carapax Et Plastrum Testudinis (vinegar system) 52g, Concha Ostreae (forging) 26g, Radix Angelicae Sinensis 52g, Fructus Rosae Laevigatae 21g, Poria 39g, Rhizoma Dioscoreae 31g, Radix Dipsaci 26g, Magnetitum (forging) 31g, Radix Aucklandiae 21g, Pericarpium Citri Reticulatae 21g, Fructus Rubi 26g, Fructus Schisandrae Chinensis 16g, Radix Glehniae 20g, more than 34 the flavor, be ground into fine powder, sieve, mixing.Every 100g powder adds refined honey 30～45g and an amount of water, general ball, and drying, promptly
Superfine communication technique is meant the material particles more than 3 millimeters is crushed to process below 100 microns.Researcher thinks, because granular size develops to miniaturization, thus can cause surface area and porosity to increase very significantly, so the micronizing body has unique physics and chemical property.For example, have fine solubility, dispersibility, adsorptivity, chemism etc., so application is very extensive.Studies show that all available micronizing apparatus processing of raw material such as many edible animals and plants, microorganism, medicine become superfine powder, the medicine of miniaturization has very strong surface adsorption power and affinity, therefore, has good dispersibility and dissolubility, assimilates easily.
Dispersible preparation is that a kind of water that do not need in the oral cavity can disintegrate or dissolved preparation fast.Requirement has: 1. in the oral cavity rapidly disintegrate, no grittiness, good mouthfeel, swallow easily, to the oral mucosa nonirritant.Should stipulate under the character item in the quality standard: disintegrate rapidly, no grittiness, good mouthfeel in the oral cavity; 2. set up suitable disintegration time mensuration method and limit, and be incorporated into standard; 3. to insoluble medicine, should set up suitable dissolution determination method and limit; 4. other should meet general rule requirement under the tablet item.The characteristics of dispersible preparation are fast: 1. absorption is fast, bioavailability is high; 2. instructions of taking does not need water 3. intestinal is residual few, few side effects; 4. avoid the first pass effect of liver sausage.
BAIDAI WAN has had launch to sell at home, but in the practice, the weak point of BAIDAI WAN is that preparation technology is outmoded, and dosage form is a water-honeyed pill, uses inconvenience, brings many troubles for the patient of old, children and dysphagia.The present invention adopts superfine communication technique and quick dispersion technology that the leucorrhea pill is transformed, transformation process has overcome the difficulty that Chinese medicine preparation faces in the modified form process, particularly superfine communication technique and quick dispersion technology are applied to the difficulty that Chinese patent medicine faces, as moisture absorption, instability, defective such as technology is loaded down with trivial details is groped through screening and technology, under the constant situation of Chinese medicine preparation, prepared a kind of solid preparation similar to the BAIDAI WAN effect with quick disintegration properties.
Summary of the invention
The invention provides a kind of superfine communication technique and quick dispersion technology in conjunction with the new technique that is used for Chinese patent medicine, the quick dispersible preparation of particularly making in conjunction with the technology of preparing of Chinese patent medicine BAIDAI WAN similar to the BAIDAI WAN effect obtained beyond thought effect.Quick dispersible preparation of the present invention be with the Chinese medicine principal agent through after pulverizing and/or extracting processing, with at least a disintegrating agent with meet water to form full-bodied swelling adjuvant formulated, said preparation is met water disintegrate and form uniform viscosity suspension rapidly.
The quick dispersible preparation of the present invention, the prescription of its Chinese medicine part is composed as follows:
(1) Cortex Phellodendri (wine stir-fry) is 150 parts, 300 parts of Cortex Ailanthis, 100 parts of the Radix Paeoniae Albas, 100 parts of Radix Angelicae Sinensis, 50 parts of Rhizoma Cyperis (vinegar system); Or
(2) Cornu Cervi Degelatinatum (vinegar stir-fry) is 150 parts, 143.8 parts of Concha Ostreaes (forging), 62.5 parts of Stamen Nelumbiniss, 62.5 parts of Pericarpium Citri Reticulataes (system), 62.5 parts of Os Draconis (forging), 50 parts of Cortex Phellodendris (salt stir-fry), 87.5 parts of the Rhizoma Atractylodis Macrocephalaes (parching with earth), 50 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 14.1 parts of Semen Juglandis, 87.5 parts in Poria, 50 parts of Radix Paeoniae Rubra, 62.5 parts of Semen Plantaginiss (stir-fry), 37.5 parts of Radix Bupleuri, 62.5 parts of Rhizoma Atractylodis (parched with bran); Or
(3) 80 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis (parched with bran) are 100 parts, 100 parts of Rhizoma Dioscoreaes, 50 parts of the Radix Paeoniae Albas, 50 parts of Semen Euryaless, 50 parts of Semen Plantaginiss (stir-fry), 30 parts of Radix Angelicae Sinensis, 30 parts of Rhizoma Atractylodis, 30 parts of Pericarpium Citri Reticulataes, 50 parts of Semen Ginkgo core, 15 parts of Herba Schizonepetae (charcoal), 12 parts of Radix Bupleuri, 12 parts of Cortex Phellodendris (charcoal), 12 parts in Radix Rubiae, 40 parts of Endoconcha Sepiaes, 40 parts of Concha Ostreaes (forging); Or
(4) Radix Codonopsis is 52 parts, 21 parts in Air Bladder pseudosciaenae seu Acipenser (system), 26 parts of Folium Artemisiae Argyis (vinegar system), 26 parts of Os Draconis, 21 parts of Cortex Moutans, 26 parts of Rhizoma Polygonati Odorati, 26 parts of Rhizoma Curculiginises, 31 parts of the Radix Paeoniae Albas, 16 parts of Herba Epimedii, 26 parts of Fructus Ligustri Lucidi, 21 parts of Semen Euryaless, 16 parts of Fructus Psoraleaes, 26 parts of Rhizoma Alismatis, 33 parts of Radix Polygoni Multiflori Preparatas, 16 parts of Herba Cynomoriis (steaming), 31 parts of Herba Taxillis (processed with salt), 26 parts of Fructus Chaenomeliss, 10 parts of Herba Dendrobiis, 31 parts of Semen Cuscutae (saline system), 26 parts in Colla Corii Asini, 26 parts of Radix Achyranthis Bidentataes, 52 parts of Carapax Et Plastrum Testudiniss (vinegar system), 26 parts of Concha Ostreaes (forging), 52 parts of Radix Angelicae Sinensis, 21 parts of Fructus Rosae Laevigatae, 39 parts in Poria, 31 parts of Rhizoma Dioscoreaes, 26 parts of Radix Dipsacis, 31 parts of Magnetitums (forging), 21 parts of the Radix Aucklandiae, 21 parts of Pericarpium Citri Reticulataes, 26 parts of Fructus Rubies, 16 parts of Fructus Schisandrae Chinensis, 20 parts of Radix Glehniaes;
More than form, part is a weight portion, calculates with crude drug, if with the gram is unit, can be made into 1000 agent medicine preparations, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000g, oral liquid 1000ml etc. also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be a unit with milli part also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of can corresponding adjustment forming increases or reduce being no more than 100%.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Its adjuvant of quick dispersible preparation of the present invention is significant to the present invention, and adjuvant of the present invention is selected from disintegrating agent, adhesive, suspending (thickening) agent, fluidizer, correctives, rectifys toner.Wherein suspending (thickening) agent, strong toner add according to the needs of preparation, if preparation does not need, just do not add.
The used adjuvant of the present invention obtains through screening, wherein disintegrating agent is selected from, super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (polyvinylpolypyrrolidone, PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na, CCNa), low-substituted hydroxypropyl cellulose (LHPC) etc.For the less starch of swellbility, microcrystalline Cellulose etc. can guarantee the quick disintegrate of preparation (also can use under＜3min) the situation, but preferably swellbility greater than the disintegrating agent of 5ml/g.Adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC); Suspending agent is selected from xanthan gum, Ka Baimu (CARBOMER), HPMC, melon glue.Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate.Correctives is selected from various essence, as Apis essence, green tea essence, Fructus Citri tangerinae essence, apple essence, flavoring pineapple essence, grape essence etc.Strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
The present invention also provides the preparation method of quick dispersible preparation of the present invention, this preparation method comprises, Chinese medicine pulverizing medicinal materials and/or extraction with above proportioning, ground product or extract obtain product after drying, through micronizing, obtain medicinal powder or the extract powder of particle diameter less than 75 μ m, this powder is as active constituents of medicine, mixed in the proper ratio with adjuvant through micronizing, make quick dispersible preparation of the present invention with the preparation technique of galenic pharmacy routine.Chinese medicine pulverizing medicinal materials described in this method can be as " one one of Chinese pharmacopoeia version in 2000 according to traditional method, Cortex Phellodendri (wine stir-fry) 150g, Cortex Ailanthi 300g, Radix Paeoniae Alba 100g, Radix Angelicae Sinensis 100g, Rhizoma Cyperi (vinegar system) 50g, the above five tastes, except that Cortex Ailanthi, four flavors such as all the other Cortex Phellodendris are ground into fine powder, sieve mixing.Cortex Ailanthi decocts with water secondary, and collecting decoction filters, and filtrate is concentrated, dry, mixing obtains.
Described extraction can use decocting in water to extract, alcohol reflux, and ethanol percolation extracts, and the decocting in water precipitate with ethanol extracts, and any one in the multiple extracting method such as alcohol heavy extraction to boil water selected to use as required, and preferably decocting in water extracts.Decocting in water adopts and adds water 10-15 doubly, and decocting boils 2-3 time, and 1-3 hour for the first time, 1-3 hour for the second time, 1-3 hour for the third time, collecting decoction filtered, and concentrate drying obtains extract extractum.
In order to provide preparation good quick dispersive ability, need the granularity of strict control active constituents of medicine and adjuvant, just grain diameter is little.Therefore, the process characteristic of preparation of the present invention is, before the preparations shaping active constituents of medicine and adjuvant is all carried out micronization; Its objective is the wettability that increases the powder particle surface, promote the medicine stripping.The present invention adopts the method for micronizing, obtains Chinese medicine medicinal powder or the Chinese medicine extract of particle diameter less than 75 μ m, then with particle diameter quite or littler adjuvant is mixed evenly makes pharmaceutical preparation.For tablet, can adopt powder straight forming, wet granulation molding or dry granulation molding to prepare.
Superfine communication technique of the present invention, principal agent of the present invention and adjuvant are processed into particle diameter less than 75 μ m by existing superfine grinding method, are preferably less than 30 μ m, most preferably be micro powder granule less than 10 μ m, at present, micronization technology has two kinds of chemical method and Mechanical Method.Chemical synthesis can make micron order, submicron order even nano level powder body.The mechanical crushing method cost is low, output is big, be the preparation ultrafine powder main means, now large-scale application in commercial production.Micronizing can be divided into dry pulverization process and waterproof pulverization: different according to the principle that produces crush force in the crushing process, dry pulverization process has several forms such as air-flowing type, dither formula, screw (rod) mill formula, paddle type mill and Self-milling; Waterproof pulverization mainly is colloid mill and homogenizer.The present invention can obtain the product of particle diameter less than 75 μ m by above arbitrary method, preferably uses air-flow dry powder comminuting method.
Therefore, the disintegrating agent of the present invention in material principal agent of guaranteeing to use and adjuvant, adhesive, suspending (thickening) agent, fluidizer, correctives, to rectify toner etc. evenly mixed under all having less than the situation of 75 μ m particle diameters, the preparation solid preparation; Said preparation also has the high dispersive characteristic when being beneficial to absorption, can better absorb, and can take with solid form, also can add to take after making preparation be distributed in the liquid behind the liquid when taking, as use mixing in water for oral taking.
Quick dispersible preparation of the present invention, the part by weight of its principal agent and adjuvant is 100: 1～600, preferably 100: 50-400, more preferably 100: 100-200, wherein the part by weight of principal agent and disintegrating agent is 100: 10～500, preferably 100: 100-400, more preferably 100: 200-300.
Quick dispersible preparation of the present invention includes but not limited to fast disintegrating tablet as oral cavity disintegration tablet, and it can directly place the oral cavity, disperses by saliva, and disintegrate rapidly, no grittiness, good mouthfeel are beneficial to and swallow in the oral cavity.Also can be made into dispersible tablet, disperse fast in water, its dispersion liquid does not have grittiness, good mouthfeel, absorbs rapidly.
The weight proportion of principal agent of the present invention and adjuvant is preferably following proportioning:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending (thickening) agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
Rectify toner.0-2 part
Wherein, preferred disintegrating agent is super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), microcrystalline Cellulose.Preferred adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC).Preferred fluidizer is a differential silica gel.Preferred correctives is Apis essence, green tea essence.
Most preferred prescription composition of the present invention is listed in the embodiment of the invention.
Quick dispersible preparation of the present invention, its Chinese medicine preparation is identical with BAIDAI WAN, and clearing away damp-heat is arranged, and leukorrhagia stopping purgation merit is used for the treatment of damp invasion of lower energizer, leucorrhea with red and white discharge.
Medicine in the embodiment of the invention has been carried out experimentation, proved that quick dispersible preparation of the present invention is better than the conventional formulation BAIDAI WAN on curative effect, can reach the effect of conventional medicament, more obtained patient's welcome with littler dosage.
The invention has the advantages that: the present invention is on the basis of the BAIDAI WAN prescription of determined curative effect and preparation process, adopt vanguard technology technology such as superfine communication technique, increased the dispersion of medical material effectively, and use quickly disintegrated adjuvant, make preparation have the feature of quick dispersion and very big degree of scatter simultaneously, thereby it is convenient that the more former dosage form of medicine is taken, by quick disintegrate (＜3min) reach the purpose that improves bioavailability.Can put into when dispersible tablet uses and take after water disperses, or directly place mouth, become liquid apace, and for this series products of leucorrhea preparation, be particularly suitable for making preparation of the present invention, can solve as dysphagia person (especially old man, child), or the patient's medication problem under the special environment that can not obtain water, provide a great convenience.Wherein particle diameter less than the medicinal powder of 75 μ m or the extract powder adjuvant identical or littler with particle diameter mixed be key factor of the present invention.
Outside the requirement to corresponding drug standard of the quality evaluation of quickly disintegrated solid preparation and official preparation general rule, preparation disintegration time high spot reviews content, disintegration time＜3min.
It has taking convenience, absorption is fast, bioavailability is high and untoward reaction is few, and steady quality is non-hygroscopic, technology is simple etc., the patient who is particularly suitable for old, children and dysphagia takes, and can characteristics such as produce with conventional tablet production technology and equipment, is a kind of good novel form.
The specific embodiment
With specific embodiment the present invention is elaborated below.Whites fast dispersion solid preparation of the present invention, and the solid preparation with quick disintegrate feature (as dispersible tablet) of the side of deriving is to make by the represented method of following embodiment, and involved method is the technological means that those skilled in the art can grasp and use.Following examples are implementation example of the present invention, and the part embodiment for claim of the present invention should not be construed as the restriction to claim of the present invention of going up in all senses.
Embodiment 1
Cornu Cervi Degelatinatum (vinegar stir-fry) 150g, Concha Ostreae (forging) 143.8g, Stamen Nelumbinis 62.5g, Pericarpium Citri Reticulatae (system) 62.5g, Os Draconis (forging) 62.5g, Cortex Phellodendri (salt stir-fry) 50g, the Rhizoma Atractylodis Macrocephalae (parching with earth) 87.5g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 50g, Semen Juglandis 14.1g, Poria 87.5g, Radix Paeoniae Rubra 50g, Semen Plantaginis (stir-fry) 62.5g, Radix Bupleuri 37.5g, Rhizoma Atractylodis (parched with bran) 62.5g, more than 14 the flavor micronizing, mixing; Per 100 parts of powder and adjuvant are evenly mixed, and the back tabletting of granulating is with Xin Feier coating material package clothing, promptly.See Table 1:
Table 1 preparation prescription and main evaluation result thereof
| The principal agent amount 1 | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other 2 | Disintegration time/min |
| 100 | CMS-Na/20 CMS-Na/50 CMS-Na/80 CMS-Na/100 CMS-Na/150 | HPMC/3 | Differential silica gel/1 | 1 | 1.1 0.8 0.6 0.5 0.5 |
Annotate: (1) is 100 parts with the principal agent amount, and other supplementary product consumption is a relative quantity, umber; (2) other is the tender agent etc. of distinguishing the flavor of.(down together)
Embodiment 2
Radix Codonopsis 52g, Air Bladder pseudosciaenae seu Acipenser (system) 21g, Folium Artemisiae Argyi (vinegar system) 26g, Os Draconis 26g, Cortex Moutan 21g, Rhizoma Polygonati Odorati 26g, Rhizoma Curculiginis 26g, Radix Paeoniae Alba 31g, Herba Epimedii 16g, Fructus Ligustri Lucidi 26g, Semen Euryales 21g, Fructus Psoraleae 16g, Rhizoma Alismatis 26g, Radix Polygoni Multiflori Preparata 33g, Herba Cynomorii (steaming) 16g, Herba Taxilli (processed with salt) 31g, Fructus Chaenomelis 26g, Herba Dendrobii 10g, Semen Cuscutae (saline system) 31g, Colla Corii Asini 26g, Radix Achyranthis Bidentatae 26g, Carapax Et Plastrum Testudinis (vinegar system) 52g, Concha Ostreae (forging) 26g, Radix Angelicae Sinensis 52g, Fructus Rosae Laevigatae 21g, Poria 39g, Rhizoma Dioscoreae 31g, Radix Dipsaci 26g, Magnetitum (forging) 31g, Radix Aucklandiae 21g, Pericarpium Citri Reticulatae 21g, Fructus Rubi 26g, Fructus Schisandrae Chinensis 16g, Radix Glehniae 20g, more than 34 the flavor, be ground into fine powder, micronizing is crossed 300 orders; Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 2:
Table 2 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Disintegration time/min |
| 100 | CMS-Na/40 | PVP/3 | 0.7 |
Embodiment 3
Radix Codonopsis 80g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 100g, Rhizoma Dioscoreae 100g, Radix Paeoniae Alba 50g, Semen Euryales 50g, Semen Plantaginis (stir-fry) 50g, Radix Angelicae Sinensis 30g, Rhizoma Atractylodis 30g, Pericarpium Citri Reticulatae 30g, Semen Ginkgo core 50g, Herba Schizonepetae (charcoal) 15g, Radix Bupleuri 12g, Cortex Phellodendri (charcoal) 12g, Radix Rubiae 12g, Endoconcha Sepiae 40g, Concha Ostreae (forging) 40g, more than ten Six-elements, be ground into fine powder, sieve micronizing, cross 400 orders, sieve, mixing; Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 3:
Table 3 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other | Disintegration time/min |
| 100 | CMS-Na/45 | PVP/4 | Differential silica gel/1 | 1 | 0.6 |
Embodiment 4
Cortex Phellodendri (wine stir-fry) 150g, Cortex Ailanthi 300g, Radix Paeoniae Alba 100g, Radix Angelicae Sinensis 100g, Rhizoma Cyperi (vinegar system) 50g, the above five tastes, except that Cortex Ailanthi, four flavors such as all the other Cortex Phellodendris are ground into fine powder, sieve; Cortex Ailanthi decocts with water secondary, and collecting decoction filters, and the filtrate concentrate drying is pulverized, and with aforementioned fine powder mixing, micronizing, crosses 300 orders; Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 4:
Table 4 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other | Disintegration time/min |
| 100 | CMS-Na/55 | PVP/3 | Differential silica gel/1 | 1 | 0.7 |
Claims (10)
1. a whites fast dispersion solid preparation is made by following Chinese medicine raw materials by weight proportion, 150 parts of Cortex Phellodendris (wine stir-fry), 300 parts of Cortex Ailanthis, 100 parts of the Radix Paeoniae Albas, 100 parts of Radix Angelicae Sinensis, 50 parts of Rhizoma Cyperis (vinegar system); It is characterized in that, described fast dispersion solid medicine is after above-mentioned Chinese medicine is pulverized or extracted, carry out micronizing, obtain principal agent, this principal agent mixes with the adjuvant that is selected from disintegrating agent, adhesive, suspending agent, fluidizer, correctives, strong toner, make preparation with the galenic pharmacy routine techniques, wherein the granularity of principal agent that all uses and adjuvant is all less than 75 μ m particle diameters.
2. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 30 μ m particle diameters.
3. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 10 μ m particle diameters.
4. the fast dispersion solid medicine of claim 1, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
5. the fast dispersion solid medicine of claim 1 is characterized in that, is tablet, and it is composed as follows:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
Rectify toner.0-2 part
6. the preparation method of the described fast dispersion solid medicine of claim 1 is characterized in that, the process following steps:
(1) get respectively distinguish the flavor of medical material or decoction pieces according to the Chinese medicine preparation in the claim 1, after pulverizing or extracting, carry out the micronizing of granularity less than 75 μ m particle diameters, standby;
(2) resulting micropowders identical or littler with particle diameter is selected from following adjuvant: disintegrating agent, adhesive, suspending agent, fluidizer, correctives or strong toner mix homogeneously are prepared into preparation.
7. preparation method according to claim 6, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
8. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and adjuvant is 100: 1～600 in the preparation.
9. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and disintegrating agent is 100: 10～500 in the preparation.
10. according to the described preparation method of claim 6, it is characterized in that described preparation is a tablet, adopt powder straight forming, wet granulation molding or dry granulation molding.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100872608A CN100515458C (en) | 2005-07-28 | 2005-07-28 | Fast dispersion solid preparation for treating leukorrhea and its preparation method |
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| CNB2005100872608A CN100515458C (en) | 2005-07-28 | 2005-07-28 | Fast dispersion solid preparation for treating leukorrhea and its preparation method |
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| CN1785339A true CN1785339A (en) | 2006-06-14 |
| CN100515458C CN100515458C (en) | 2009-07-22 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103071086A (en) * | 2013-01-21 | 2013-05-01 | 郜峦 | Traditional Chinese medicine preparation for treating gynecological leukorrheal diseases |
| CN103655972A (en) * | 2013-12-02 | 2014-03-26 | 常州科立信医疗器械有限公司 | Preparation method and application of leucorrhea tablets |
-
2005
- 2005-07-28 CN CNB2005100872608A patent/CN100515458C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103071086A (en) * | 2013-01-21 | 2013-05-01 | 郜峦 | Traditional Chinese medicine preparation for treating gynecological leukorrheal diseases |
| CN103655972A (en) * | 2013-12-02 | 2014-03-26 | 常州科立信医疗器械有限公司 | Preparation method and application of leucorrhea tablets |
| CN103655972B (en) * | 2013-12-02 | 2015-11-25 | 顾祥茂 | Leucorrhea sheet suppresses the application in human lung adenocarcinoma GLC-82 cell proliferation in preparation |
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| Publication number | Publication date |
|---|---|
| CN100515458C (en) | 2009-07-22 |
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Address after: 1266 No. 330052 Nanchang Huiren Jiangxi economic and Technological Development Zone Avenue. Patentee after: JIANGXI HUIREN PHARMACEUTICAL CO.,LTD. Address before: 330043 1189 Yingbin Avenue, Nanchang, Jiangxi Patentee before: Jiangxi Huiren Pharmaceutical Co.,Ltd. |
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