CN100515408C - Zisheng fast dispersion solid preparation and its preparation method - Google Patents
Zisheng fast dispersion solid preparation and its preparation method Download PDFInfo
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- CN100515408C CN100515408C CNB2005100872701A CN200510087270A CN100515408C CN 100515408 C CN100515408 C CN 100515408C CN B2005100872701 A CNB2005100872701 A CN B2005100872701A CN 200510087270 A CN200510087270 A CN 200510087270A CN 100515408 C CN100515408 C CN 100515408C
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Abstract
A fast dispersing solid Chinese medicine for nourishing vital energy is prepared from 18 Chinese-medicinal materials including pilose asiabell root, tuckahoe, liquorice, yam, 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 a kind of fast dispersion solid medicine of supporting life with Chinese medicine patent medicine and preparation method thereof.
Technical background
It is " health standard for traditional Chinese medicines promulgated by the ministries or commissions of the Central Government " side that money is given birth to ball, form by medicines such as Radix Codonopsis, Poria, Radix Glycyrrhizae (system), Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae (stir-fry), Semen Lablab Album (stir-fry), Semen Euryales, Semen Nelumbinis, Fructus Crataegi (charcoal), Massa Medicata Fermentata, Fructus Hordei Germinatus (Jiao), Semen Coicis, Pericarpium Citri Reticulatae, Rhizoma Coptidis, Rhizoma Alismatis, Fructus Amomi Rotundus, Herba Pogostemonis, Radix Platycodoniss, spleen benefiting and stimulating the appetite is arranged, the effect of the antidiarrheal that helps digestion, be used for insufficiency of the spleen discomfort, insufficiency of stomach is not received, and refreshing tired power is weary, and abdominal distention is had loose bowels.In " Ministry of Public Health standard for traditional Chinese medicines ", record living ball of money and deutero-money thereof at present and given birth to ball (concentrated pill), the living ball of spleen invigorating money, the living ball of tonification money etc.:
(1) money is given birth to ball (" Ministry of Public Health standard for traditional Chinese medicines " 05, standard No. WS3-B-1006-91)
[prescription method for making] Radix Codonopsis (stir-fry) 600g, Poria 300g, Radix Glycyrrhizae (system) 100g, Rhizoma Dioscoreae 300g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 600g, Semen Lablab Album (stir-fry) 200g, Semen Euryales 300g, Semen Nelumbinis 200g, Fructus Crataegi (charcoal) 400g, Massa Medicata Fermentata 400g, Fructus Hordei Germinatus (Jiao) 300g, Semen Coicis 600g, Pericarpium Citri Reticulatae 400g, Rhizoma Coptidis 70g, Rhizoma Alismatis 70g, Fructus Amomi Rotundus 70g, Herba Pogostemonis 100g, Radix Platycodonis 100g, more than 18 the flavor, be ground into fine powder, sieve, mixing is used water pill, drying, promptly.
(2) money is given birth to ball (concentrated pill) (" Ministry of Public Health standard for traditional Chinese medicines " 11, standard No. WS3-B-2217-96)
[prescription method for making] Radix Codonopsis (stir-fry) 600g, Poria 300g, Radix Glycyrrhizae (system) 100g, Rhizoma Dioscoreae 300g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 600g, Semen Lablab Album (stir-fry) 200g, Semen Euryales 300g, Semen Nelumbinis 200g, Fructus Crataegi (charcoal) 400g, Massa Medicata Fermentata 400g, Fructus Hordei Germinatus (Jiao) 300g, Semen Coicis 600g, Pericarpium Citri Reticulatae 400g, Rhizoma Coptidis 70g, Rhizoma Alismatis 70g, Fructus Amomi Rotundus 70g, Herba Pogostemonis 100g, Radix Platycodonis 100g, more than 18 the flavor, Rhizoma Dioscoreae, Semen Lablab Album, Semen Euryales, Semen Nelumbinis, Massa Medicata Fermentata, Fructus Hordei Germinatus, Semen Coicis, Fructus Amomi Rotundus and Radix Glycyrrhizae 50g are ground into fine powder, the residue Radix Glycyrrhizae decocts with water secondary, filter, merging filtrate is condensed into relative density greater than 1.30 thick paste; Nine flavors such as all the other Radix Codonopsis are ground into coarse powder, and according to the percolation of fluid extract and extractum, the Rhizoma Atractylodis Macrocephalae, Herba Pogostemonis, Pericarpium Citri Reticulatae and Radix Codonopsis are solvent with 70% ethanol, and Rhizoma Coptidis, Poria, Fructus Crataegi, Rhizoma Alismatis and Radix Platycodonis are solvent with 45% ethanol, carry out percolation.Collect the liquid of filtering respectively, it is the thick paste of 1.30～1.35 (20 ℃) that concentrating under reduced pressure becomes relative density.Above-mentioned each cream, powder are merged, mixing, it is an amount of to add refined honey, pill, oven dry, polishing, promptly.(per 10 balls are equivalent to crude drug 3g.
(3) spleen invigorating money is given birth to ball (" Ministry of Public Health standard for traditional Chinese medicines " 04, standard No. WS3-B-0808-91)
[prescription method for making] Radix Codonopsis 150g, Poria 100g, Radix Glycyrrhizae (processing) 50g, Rhizoma Dioscoreae 100g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 150g, Semen Lablab Album (stir-fry) 75g, Semen Euryales (stir-fry) 75g, Semen Nelumbinis (stir-fry) 100g, Fructus Crataegi (stir-fry) 75g, Massa Medicata Fermentata (stir-fry) 100g, Fructus Hordei Germinatus (stir-fry) 100g, Semen Coicis (stir-fry) 75g, Rhizoma Coptidis (Sucus Zingberis stir-fry) 20g, Fructus Amomi Rotundus 40g, Herba Pogostemonis 50g, Radix Platycodonis 50g, Fructus Amomi 75g, tangerine 100g, more than 18 the flavor, be ground into fine powder, sieve, mixing.Use water pill, drying, promptly.
(4) tonification money is given birth to ball (" Ministry of Public Health standard for traditional Chinese medicines " 07, standard No. WS3-B-1348-93)
[prescription method for making] Radix Ginseng 384g, Poria 192g, Radix Glycyrrhizae 60g, Rhizoma Dioscoreae 192g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 384g, Semen Lablab Album (peeling) 120g, Semen Euryales (parched with bran) 192g, Semen Nelumbinis 120g, Fructus Crataegi cuneatae (stir-fry) 240g, Massa Medicata Fermentata (parched with bran) 240g, Fructus Hordei Germinatus (stir-fry) 192g, Semen Coicis (parched with bran) 384g, Exocarpium Citri Grandis 240g, Rhizoma Coptidis 42g, Rhizoma Alismatis 42g, Fructus Amomi Rotundus 42g, Herba Pogostemonis 60g, Radix Platycodonis 60g, more than 18 the flavor, be ground into fine powder, sieve, mixing.Every 100g powder adds refined honey 130～140g and makes big honeyed pills, promptly.(the heavy 6g of every ball.)
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.
Money is given birth to ball has had launch to sell at home, but in the practice, the weak point that money is given birth to ball is that preparation technology is outmoded, and dosage form is the watered 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 to transform supporting living pill, 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 have a quick disintegration properties give birth to the similar solid preparation of ball effect to money.
Summary of the invention
The invention provides a kind of superfine communication technique and fast dispersion technology particularly give birth to the similar quick dispersible preparation of ball effect to money in conjunction with the new technique that is used for Chinese patent medicine in conjunction with what Chinese patent medicine money gave birth to that the technology of preparing of ball makes, 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:
600 parts of Radix Codonopsis (stir-fry), 300 parts in Poria, 100 parts in Radix Glycyrrhizae (system), 300 parts of Rhizoma Dioscoreaes, 600 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 200 parts of Semen Lablab Albums (stir-fry), 300 parts of Semen Euryaless, 200 parts in Semen Nelumbinis, 400 parts of Fructus Crataegis (charcoal), 400 parts of Massa Medicata Fermentatas, 300 parts in Fructus Hordei Germinatus (Jiao), 600 parts of Semen Coiciss, 400 parts of Pericarpium Citri Reticulataes, 70 parts of Rhizoma Coptidis, 70 parts of Rhizoma Alismatis, 70 parts in Fructus Amomi Rotundus, 100 parts of Herba Pogostemonis, 100 parts of Radix Platycodoniss, or
150 parts of Radix Codonopsis, 100 parts in Poria, 50 parts in Radix Glycyrrhizae (processing), 100 parts of Rhizoma Dioscoreaes, 150 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 75 parts of Semen Lablab Albums (stir-fry), 75 parts of Semen Euryaless (stir-fry), 100 parts of Semen Nelumbinis (stir-fry), 75 parts of Fructus Crataegis (stir-fry), 100 parts of Massa Medicata Fermentatas (stir-fry), 100 parts in Fructus Hordei Germinatus (stir-fry), 75 parts of Semen Coiciss (stir-fry), 20 parts of Rhizoma Coptidis (Sucus Zingberis stir-fry), 40 parts in Fructus Amomi Rotundus, 50 parts of Herba Pogostemonis, 50 parts of Radix Platycodoniss, 75 parts of Fructus Amomis, tangerine 100 parts, or
Radix Ginseng 384g, Poria 192g, Radix Glycyrrhizae 60g, Rhizoma Dioscoreae 192g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 384g, Semen Lablab Album (peeling) 120g, Semen Euryales (parched with bran) 192g, Semen Nelumbinis 120g, Fructus Crataegi cuneatae (stir-fry) 240g, Massa Medicata Fermentata (parched with bran) 240g, Fructus Hordei Germinatus (stir-fry) 192g, Semen Coicis (parched with bran) 384g, Exocarpium Citri Grandis 240g, Rhizoma Coptidis 42g, Rhizoma Alismatis 42g, Fructus Amomi Rotundus 42g, Herba Pogostemonis 60g, Radix Platycodonis 60g
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 according to traditional method as recording method for making in " Ministry of Public Health standard for traditional Chinese medicines ": Radix Codonopsis (stir-fry) 600g, Poria 300g, Radix Glycyrrhizae (system) 100g, Rhizoma Dioscoreae 300g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 600g, Semen Lablab Album (stir-fry) 200g, Semen Euryales 300g, Semen Nelumbinis 200g, Fructus Crataegi (charcoal) 400g, Massa Medicata Fermentata 400g, Fructus Hordei Germinatus (Jiao) 300g, Semen Coicis 600g, Pericarpium Citri Reticulatae 400g, Rhizoma Coptidis 70g, Rhizoma Alismatis 70g, Fructus Amomi Rotundus 70g, Herba Pogostemonis 100g, Radix Platycodonis 100g, more than 18 the flavor, be ground into fine powder, sieve, mixing, promptly.Or above 18 flavors, Rhizoma Dioscoreae, Semen Lablab Album, Semen Euryales, Semen Nelumbinis, Massa Medicata Fermentata, Fructus Hordei Germinatus, Semen Coicis, Fructus Amomi Rotundus and Radix Glycyrrhizae 50g are ground into fine powder, and the residue Radix Glycyrrhizae decocts with water secondary, filters, and merging filtrate is condensed into relative density greater than 1.30 thick paste; Nine flavors such as all the other Radix Codonopsis are ground into coarse powder, and according to the percolation of fluid extract and extractum, the Rhizoma Atractylodis Macrocephalae, Herba Pogostemonis, Pericarpium Citri Reticulatae and Radix Codonopsis are solvent with 70% ethanol, and Rhizoma Coptidis, Poria, Fructus Crataegi, Rhizoma Alismatis and Radix Platycodonis are solvent with 45% ethanol, carry out percolation.Collect the liquid of filtering respectively, it is the thick paste of 1.30～1.35 (20 ℃) that concentrating under reduced pressure becomes relative density.Above-mentioned each cream, powder are merged mixing.
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 the living ball of money, and patent medicine has spleen benefiting and stimulating the appetite, and the effect of the antidiarrheal that helps digestion is used for insufficiency of the spleen discomfort, and insufficiency of stomach is not received, and refreshing tired power is weary, and abdominal distention is had loose bowels.
Medicine in the embodiment of the invention has been carried out experimentation, proved that quick dispersible preparation of the present invention is better than conventional formulation money and gives birth to ball on curative effect, can reach the effect of conventional medicament, more obtained patient's welcome in the use with littler dosage.
The invention has the advantages that: the present invention gives birth on the basis of ball prescription and preparation process in the money of determined curative effect, 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 Zisheng, 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.Money of the present invention is given birth to fast dispersion solid medicine, 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
Radix Codonopsis (stir-fry) 600g, Poria 300g, Radix Glycyrrhizae (system) 100g, Rhizoma Dioscoreae 300g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 600g, Semen Lablab Album (stir-fry) 200g, Semen Euryales 300g, Semen Nelumbinis 200g, Fructus Crataegi (charcoal) 400g, Massa Medicata Fermentata 400g, Fructus Hordei Germinatus (Jiao) 300g, Semen Coicis 600g, Pericarpium Citri Reticulatae 400g, Rhizoma Coptidis 70g, Rhizoma Alismatis 70g, Fructus Amomi Rotundus 70g, Herba Pogostemonis 100g, Radix Platycodonis 100g, more than 18 the flavor, be ground into fine powder, mixing, micronizing, cross 400 orders, per 100 parts of powder and adjuvant are evenly mixed, and powder is pressed full length film (2g), with Xin Feier coating material package clothing, promptly.This product is a dispersible tablet, one time 1～2, drop into and take after disintegrate becomes homogeneous solution in about 150-200ml water; 2～3 times on the one.Preparation prescription sees Table 1:
Table 1 preparation prescription and main evaluation result thereof
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 (stir-fry) 600g, Poria 300g, Radix Glycyrrhizae (system) 100g, Rhizoma Dioscoreae 300g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 600g, Semen Lablab Album (stir-fry) 200g, Semen Euryales 300g, Semen Nelumbinis 200g, Fructus Crataegi (charcoal) 400g, Massa Medicata Fermentata 400g, Fructus Hordei Germinatus (Jiao) 300g, Semen Coicis 600g, Pericarpium Citri Reticulatae 400g, Rhizoma Coptidis 70g, Rhizoma Alismatis 70g, Fructus Amomi Rotundus 70g, Herba Pogostemonis 100g, Radix Platycodonis 100g, more than 18 the flavor, Rhizoma Dioscoreae, Semen Lablab Album, Semen Euryales, Semen Nelumbinis, Massa Medicata Fermentata, Fructus Hordei Germinatus, Semen Coicis, Fructus Amomi Rotundus and Radix Glycyrrhizae 50g are ground into fine powder; The residue Radix Glycyrrhizae decocts with water secondary, filters, and merging filtrate is condensed into relative density greater than 1.30 thick paste; Nine flavors such as all the other Radix Codonopsis are ground into coarse powder, according to the percolation under pharmacopeia fluid extract and the extractum item, the Rhizoma Atractylodis Macrocephalae, Herba Pogostemonis, Pericarpium Citri Reticulatae and Radix Codonopsis are solvent with 70% ethanol, Rhizoma Coptidis, Poria, Fructus Crataegi, Rhizoma Alismatis and Radix Platycodonis are solvent with 45% ethanol, carry out percolation, collect the liquid of filtering respectively, it is the thick paste of 1.30～1.35 (20 ℃) that concentrating under reduced pressure becomes relative density.Above-mentioned each cream, powder are merged, mixing, drying is ground into fine powder; Micronizing is crossed 300 orders; Per 100 parts of powder and adjuvant are evenly mixed, and full length film (2g) is pressed in the back of granulating, promptly.This product is buccal tablet, and is oral, one time 1, or drop into and to take after disintegrate becomes homogeneous solution in about 150-200ml water; 2～3 times on the one.Preparation prescription sees Table 2:
Table 2 preparation prescription and main evaluation result thereof
Embodiment 3
Radix Codonopsis 150g, Poria 100g, Radix Glycyrrhizae (processing) 50g, Rhizoma Dioscoreae 100g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 150g, Semen Lablab Album (stir-fry) 75g, Semen Euryales (stir-fry) 75g, Semen Nelumbinis (stir-fry) 100g, Fructus Crataegi (stir-fry) 75g, Massa Medicata Fermentata (stir-fry) 100g, Fructus Hordei Germinatus (stir-fry) 100g, Semen Coicis (stir-fry) 75g, Rhizoma Coptidis (Sucus Zingberis stir-fry) 20g, Fructus Amomi Rotundus 40g, Herba Pogostemonis 50g, Radix Platycodonis 50g, Fructus Amomi 75g, tangerine 100g, more than 18 flavors, be ground into fine powder; Micronizing is crossed 400 orders; Per 100 parts of powder and adjuvant are evenly mixed, and full length film (2g) is pressed in the back of granulating, promptly.This product is fast disintegrating tablet, and is oral, one time 1～2, or drop into and to take 2～3 times on the one after disintegrate becomes homogeneous solution in about 150-200ml water.Preparation prescription sees Table 3:
Table 3 preparation prescription and main evaluation result thereof
Embodiment 4
Radix Ginseng 384g, Poria 192g, Radix Glycyrrhizae 60g, Rhizoma Dioscoreae 192g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 384g, Semen Lablab Album (peeling) 120g, Semen Euryales (parched with bran) 192g, Semen Nelumbinis 120g, Fructus Crataegi cuneatae (stir-fry) 240g, Massa Medicata Fermentata (parched with bran) 240g, Fructus Hordei Germinatus (stir-fry) 192g, Semen Coicis (parched with bran) 384g, Exocarpium Citri Grandis 240g, Rhizoma Coptidis 42g, Rhizoma Alismatis 42g, Fructus Amomi Rotundus 42g, Herba Pogostemonis 60g, Radix Platycodonis 60g, more than 18 the flavor, be ground into fine powder, sieve; Micronizing is crossed 300 orders; Per 100 parts of powder and adjuvant are evenly mixed, and full length film (2g) is pressed in the back of granulating, promptly.This product is fast disintegrating tablet, and is oral, one time 1～2, or drop into and to take 2～3 times on the one after disintegrate becomes homogeneous solution in about 150-200ml water.Preparation prescription sees Table 4:
Table 4 preparation prescription and main evaluation result thereof
Claims (1)
1. a money is given birth to fast dispersion solid medicine, it is tablet, make by following Chinese medicine raw materials by weight proportion, 600 parts of Radix Codonopsis (parched), 300 parts in Poria, 100 parts in system Radix Glycyrrhizae, 300 parts of Rhizoma Dioscoreaes, 600 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 200 parts of Semen Lablab Album (parched), 300 parts of Semen Euryaless, 200 parts in Semen Nelumbinis, 400 parts of charcoal Fructus Crataegis, 400 parts of Massa Medicata Fermentatas, 300 parts of Fructus Hordei Germinatus (parched to brown)s, 600 parts of Semen Coiciss, 400 parts of Pericarpium Citri Reticulataes, 70 parts of Rhizoma Coptidis, 70 parts of Rhizoma Alismatis, 70 parts in Fructus Amomi Rotundus, 100 parts of Herba Pogostemonis, 100 parts of Radix Platycodoniss 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 be selected from disintegrating agent, adhesive, suspending agent, fluidizer, correctives, the adjuvant of rectifying toner mixes, make preparation with the galenic pharmacy routine techniques, wherein the granularity of principal agent that all uses and adjuvant is all less than 10 μ m particle diameters, and wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone; 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 that 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.
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| CN101376001B (en) * | 2007-08-28 | 2011-06-29 | 朱国战 | Pure medicinal formulation for strengthening spleen and regulating stomach and preparation method thereof |
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| CN102688438B (en) * | 2012-05-31 | 2014-01-08 | 柳玉勇 | Chinese medicinal orally disintegrating tablets for treating infantile diarrhea |
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| CN103704559B (en) * | 2013-12-31 | 2015-12-30 | 陈慧婷 | A kind of Chinese yam lotus seeds Fructus Hordei Germinatus dispersing tablet and preparation method |
| CN103768491B (en) * | 2014-02-21 | 2016-03-09 | 卞玉华 | The application of the raw ball of tonification money in preparation treatment Parkinson's disease companion antidepressant agents |
| CN103768492B (en) * | 2014-02-21 | 2015-12-30 | 杨延庆 | The application of the raw ball of tonification money in preparation treatment hyperlipidemia |
| CN104524409A (en) * | 2014-12-22 | 2015-04-22 | 李剑平 | Traditional Chinese medicine for treating hypotension |
| CN109316598B (en) * | 2018-10-22 | 2022-03-18 | 张守明 | Traditional Chinese medicine, antibacterial peptide and Chinese herbal medicine composite preparation for preventing and treating pig diarrhea as well as preparation method and application |
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