CN107823150A - It is a kind of can rapid dispersion tablet and preparation method thereof - Google Patents
It is a kind of can rapid dispersion tablet and preparation method thereof Download PDFInfo
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- CN107823150A CN107823150A CN201711012205.1A CN201711012205A CN107823150A CN 107823150 A CN107823150 A CN 107823150A CN 201711012205 A CN201711012205 A CN 201711012205A CN 107823150 A CN107823150 A CN 107823150A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/25—Agglomeration or granulation by extrusion or by pressing, e.g. through small holes, through sieves or between surfaces
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/01—Hydrocarbons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
The present invention relates to it is a kind of can rapid dispersion tablet and preparation method thereof, more particularly to it is a kind of be free of disintegrant, the tablet composition of cocoa rapid dispersion and its preparation technology, belong to medicine, field of health care products.The invention discloses it is a kind of can rapid dispersion tablet, be made up of 0.5~900 parts by weight of activated composition, 200~900 parts by weight excipient and 5~30 parts by weight lubricants, wherein active component is water-insoluble active component.It is an advantage of the invention that：The present invention containing insoluble active component is prepared into piece agent rather than liquid dosage form, without insoluble active component to be made to the complicated technology used in liquid preparation, also overcome the phenomenon that can be layered in the product liquid prolonged storage, and with dosage is accurate, steady quality, storage is easy to carry, can swallow and can also take after mixing it with water.
Description
Technical field
The present invention relates to it is a kind of can rapid dispersion tablet and preparation method thereof, more particularly to it is a kind of without disintegrant, can
Rapid dispersion, the tablet composition of the active component containing water-insoluble and its preparation technology, belong to medicine, field of health care products.
Background technology
Current Medicines and Health Product field, type of dosage form is numerous, and every kind of formulation has respective advantage and disadvantage.With other formulations
Compare, solid dosage forms there are many advantages, is widely used.The dosage of solid dosage forms is accurate, and content difference is smaller in medicine；Solid formulation
Type is drying solid, and some oxidizable rotten and deliquescence medicines can be protected by by means of coating, so light, air, moisture
Deng influenceing smaller, steady quality on it；Mechanization production solid formulation, yield is big, and cost is low, and sanitary standard also easily reaches.But
It is that tablet also has some shortcomings.Although conventional tablet and capsule are carried, transported, taking more convenient, the dissolution speed of medicine
Rate is slow compared with solution, powder, and its bioavilability is more slightly worse；It is only applicable to swallow, poorly water-soluble is taken after can not being dissolved in water, right
Difficulty is taken for children, the old man of dysphagia and coma patient.Effervescent tablet be only applicable to it is soluble in water take, Bing Ren
Do not have not taking in the case of water.Powder can be dissolved in water, be taken as liquid, but be generally unsuitable for swallowing, and take
Band is inconvenient.
Because insoluble active component is insoluble in water, it is prepared as liquid dosage form complex process, stores lamination problem for a long time,
And transport carries inconvenience.Insoluble active component is prepared as into tablet can overcome these shortcomings.Contain in conventional tablet
Have disintegrant, can rapid dispersion, but existing disintegrant is mostly to be insoluble in the material of water, if by the tablet containing disintegrant
It is dissolved in water to take to children, the old man of dysphagia or coma patient, a large amount of insoluble disintegrants are suspended in water, increase liquid
Turbidity, bring bad Consumer's Experience.And the convas tablet dissolution velocity without disintegrant is slow, the drug effect used time is not only reached
It is long, and water is not readily dissolved in, only it is beneficial to swallow, is unfavorable for children, the old man of dysphagia or coma patient and takes.So need
A kind of steady quality is prepared, convenient transportation is carried, not only can swallow but also can be dispersed in water quickly the tablet taken as liquid
To make up the blank of this area research.
The content of the invention
In order to solve the above-mentioned technical problem, the present invention provide it is a kind of without disintegrant, can rapid dispersion insoluble activity
Tablet composition of composition and preparation method thereof.
It is a kind of can rapid dispersion tablet, by 0.5~900 parts by weight of activated composition, 200~900 parts by weight excipient and 5
~30 parts by weight lubricants form, and wherein active component is water-insoluble active component.
Preferably, the tablet is by 1~600 parts by weight of activated composition, 500~700 parts by weight excipient and 10~20 weight
Part lubricant composition.
Preferably, excipient is selected from sorbierite, mannitol, soluble starch, dextrin, microcrystalline cellulose, polyethylene glycol, breast
One or more in sugar；It is furthermore preferred that one or more of the excipient in sorbierite, mannitol, lactose, dextrin.
Preferably, lubricant is selected from stearic acid, micronized poloxamers, rich horse odium stearate, polyethylene glycol, dodecyl
One or more in sodium sulphate, Stepanol MG, magnesium laurylsulfate, fumaric acid；It is furthermore preferred that lubricant is selected from firmly
One or more in resin acid, polyethylene glycol, micronized poloxamers, rich horse odium stearate.
Preferably, water-insoluble active component be selected from fish oil microcapsule powder, linseed oil microcapsule powder, strange sub- seed oil microcapsule powder,
Purple Perilla Seed Oil microcapsule powder, camellia seed oil microcapsule powder, pumpkin seed oil microcapsule powder, evening primrose oil microcapsule powder, borage oil microcapsule powder, coconut palm
Oily microcapsule powder, palm-kernel oil microcapsule powder, Seabuckthorm Seed Oil microcapsule powder, hippophae rhamnoides fruit oil microcapsule powder, grape-kernel oil microcapsule powder, olive oil are micro-
One or more in capsule powder, safflower seed oil microcapsule powder.
Preferably, water-insoluble active component is selected from lycopene, epiphysin, vitamin E, Co-Q10, halimasch extraction
Thing, lutein, camellia seed extract, gangliosides, sesame polyphenol, resveratrol, chromium picolinate, octacosanol, carrot
Pigment, red yeast rice, beta carotene, turmeric, curcumin, squalene, magnesium salts, cephalin, phosphatidyl serine, sphingomyelin, lemon
Lemon acid calcium, ferric citrate, natural Beta-carotene, vitamin A, vitamin D, vitamin K1, farnoquinone, selenoprotein, chromium-rich ferment
Mother, astaxanthin, heme iron, Zinc-rich saccharomyces cerevisiae, flaxseed kind hide fiber, sheep placenta, chlorophyll, lutein ester, folic acid, maize
Matter, gekko, Bee Pollen, gynostemma pentaphylla, balsam pear, can salad is uncommon, the tuber of dwarf lilyturf, horse chestnut, Gymnema Sylvestre, Eutrema yunnanenses, valerian, snow
Lotus, flaxseed gum, basyleave, hoveniae semoveniae semen, japanese angelica tree, golden ear, the microcapsule powder of non denatured II collagen types and above-mentioned raw materials
Or the one or more in inclusion compound.
It is furthermore preferred that water-insoluble active component is selected from lycopene, epiphysin, vitamin E, turmeric, curcumin, coenzyme
Q10, armillaria mellea, lutein, lutein ester, camellia seed extract, gangliosides, sesame polyphenol and above-mentioned raw materials
One in microcapsule powder or inclusion compound, fish oil microcapsule powder, linseed oil microcapsule powder, strange sub- seed oil microcapsule powder, Purple Perilla Seed Oil microcapsule powder
Kind is a variety of.
Most preferably, water-insoluble active component is selected from Co-Q10 microcapsule powder, vitamin E microcapsule powder, Co-Q10 inclusion
One or more in thing, vitamin E clathrate.
Preferably, it is a kind of can rapid dispersion tablet, also containing 5~1050 parts by weight water-soluble active components, the water
Soluble active ingredient is selected from collagen, l-cn, Glucosamine, vitamin C, glutathione, L-thiamine, barley
Element, calcium pantothenate, algin, black tea polyphenols, inositol, carob, white of an egg peptide, enzyme modification foreniculin, hydroxycitric acid, hyalomitome
Acid, coriolan, N- formyls tyrasamine, chondroitin sulfate, taurine, calcium gluconate, zinc gluconate, manganese gluconate, Portugal
Grape sugar ferrous iron, grape seed extract, vitamin B1, vitamin B2, vitamin B6, vitamin B12, glucomannans, lipoic acid,
It is water soluble oligosaccharide, chitosan oligosaccharide, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl butyrate, lactalbumin, lactic acid bacteria, double
One in discrimination bacillus, lactobacillus acidophilus, lentinan, GL-B, hericium erinaceum polysaccharide, pachymaran, tremella polysaccharides, oyster peptide
Kind is a variety of.
Preferably, it is a kind of can rapid dispersion tablet, also containing 0.5~45 parts by weight Emulsifier, emulsifying agent is selected from 12
Sodium alkyl sulfate, egg yolk lecithin, PLURONICS F87, Sorbitan Laurate, Sorbitan Oleate, polyoxyethylene sorbitan monoleate, Arabic gum,
One or more in agar, sucrose stearate.
Preferably, it is a kind of can rapid dispersion tablet, be also selected from stevioside containing 30~70 parts by weight flavourings, flavouring
Glycosides, Aspartame, Sucralose, saccharin sodium, honey element, radix glycyrrhizae, acesulfame potassium, A Shasufa, neotame, Tagatose, glycyrrhizic acid two
Sodium, glucose, fructose, sucrose, xylitol, simple syrup, fruit juice syrup, honey, glycerine, sorbierite, mannitol, sweet Momordica grosvenori
Glycosides, oligosaccharide, natural essence, compound essence, natural equivalent essence, fermentation essence, fruit juice powder, natural vegetable juice powder, vegetable
One or more in dish inspissated juice powder, fruit inspissated juice powder, adenosine monophosphate, vitamin C, malic acid, citric acid；More preferably
, flavouring be selected from steviol glycoside, Aspartame, Sucralose, honey element, radix glycyrrhizae, acesulfame potassium, fruit juice powder, malic acid,
One or more in citric acid, oligosaccharide, natural essence.
Preferably, it is a kind of can rapid dispersion tablet, also containing 4~15 parts by weight of binder, described adhesive is selected from poly-
Tie up ketone, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, methylcellulose, ethyl cellulose, gelatin,
One or more in carbomer, starch slurry.
Preferably, it is a kind of can rapid dispersion tablet, also containing 1~15 parts by weight colouring agent, the colouring agent is selected from Jiao
Fried sugar element, carthamin yellow, lemon yellow, sunset yellow, quinoline yellow, purple iron oxide, Black Rouge, Brown Ferric Oxide, red ferric oxide, Huang
One or more in iron oxide, titanium dioxide, indigo, chlorophyll, famille rose, light blue.
Preferably, it is a kind of can rapid dispersion tablet, be also selected from sugarcane containing 3~18 parts by weight coating agents, the coating agent
Sugar, the high molecular polymer of good film-forming property, plasticizer, anticaking agent, opacifier, surfactant, pigment, defoamer, brightener
One or more.
Preferably, the high molecular polymer of good film-forming property is selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl
Sodium cellulosate, polyvinyl pyrrolidone, ethyl cellulose, methylcellulose, hydroxyethyl cellulose, methyl hydroxyethylcellulose,
One or more in polyvinyl alcohol；Preferably, plasticizer is selected from glycerine, tween, polyethylene glycol, propane diols, castor oil, adjacent benzene
One or more in dicarboxylate, lemon triethylenetetraminehexaacetic acid fat；Preferably, anticaking agent is selected from talcum powder, magnesium stearate, dioxy
One or more in SiClx, titanium dioxide；Preferably, opacifier is selected from titanium dioxide；Surfactant is selected from dodecyl
One or more in sodium sulphate, tween, oleic acid, phosphatide.
Preferably, the weight of the tablet is 0.1~2.0 gram/piece；It is furthermore preferred that tablet weight is 0.8~1.5 gram/piece.
Preferably, it is a kind of can rapid dispersion tablet preparation method, it is characterised in that be following either method：
Method one,
All raw materials are weighed, is well mixed, mixture is placed in tablet press machine, direct tablet compressing, tablet is made；
Or method two,
All raw materials are crossed into 80 mesh sieves, dry granulation method, wet method are used after weighing active component, excipient, other auxiliary materials
Particle is made in one kind in granulation, marumerization, then by particle and mix lubricant, tabletting, tablet is made；
The dry granulation method, it is that will weigh up active component, excipient, other auxiliary materials to be well mixed, by mixture with dry
Method granulator is pressed into sheet or tabular, then is ground into sizeable particle, whole grain of sieving；
The wet granulation process, it is that the active component, excipient, other auxiliary materials in addition to adhesive that will be weighed up are put into wet method
It is well mixed in granulator container, sprays into binder solution, binder solution dosage is the 10~15% of the total dosage of solid material,
Material is made into particle；Particle is sent to and excessive caking is crushed in pelletizing machine, sieving, then dries whole grain and produces；Adhesive
Solution concentration is 1%~25%, from binder aqueous solution or adhesive ethanol water；Wetting agent from water or 30%~
70% ethanol water；
The marumerization, it is closed to be that the active component, excipient, other auxiliary materials in addition to adhesive that will be weighed up are put into
Fluid bed in, carrying out fluidisation is well mixed powder；Sprayer unit is started, sprays into binder aqueous solution, droplet is on powder
Cohesion, until required particle size just stops spraying；Finally, by particle drying；Binder aqueous solution concentration is 1%~15%,
Binder aqueous solution dosage is the 10~20% of the total dosage of solid material.
The tablet can also be coated.
The present invention pass through many experiments, is that this tablet composition determines distinctive excipient and lubricant, excipient is excellent
In sorbierite, mannitol, soluble starch, dextrin, microcrystalline cellulose, Macrogol 4000, Macrogol 6000, lactose
One or more, lubricant be selected from stearic acid, micronized poloxamers, rich horse odium stearate, polyethylene glycol, dodecyl sulphur
Sour sodium, Stepanol MG, magnesium laurylsulfate, the one or more of fumaric acid.We have surprisingly found that, are collapsed not adding
In the case of solving agent, from specific excipient and lubricant combination, dispersion effect of the medicine in water is on the contrary more preferably.This be because
For, usual excipients are stickum, after adding disintegrant, excipient it is sticky stronger, it is scattered in water to suppress medicine.Due to
The present invention can be dispersed in water quickly, and can be taken in liquid form, therefore the present invention can not only swallow, can also be for not
Easily swallow patient and be dispersed in water and take, solve the problems, such as that tablet bioavilability is low, difficult swallow patient and can not take.This hair
It is bright such as to take in liquid form, it is redispersed in water when closing on medication, is taken after liquid is shaken up, because tablet is relative to liquid
Body preparation is more stable and is easy to carry.Tablet composition prepared by the present invention is except applied to medicine, health products trade, going back
Emerging field of functional food is can apply to, can not only swallow but also tablet can be dispersed in water as functional food
Beverage is drunk, and it is convenient to carry and take.
It is an advantage of the invention that：The present invention containing insoluble active component is prepared into piece agent rather than liquid dosage form, nothing
Insoluble active component need to be made to the complicated technology used in liquid preparation, also overcomed in the product liquid prolonged storage
The phenomenon that can be layered, and there is dosage accurate, steady quality, storage is easy to carry, can swallow and can also take after mixing it with water.
Describe embodiments of the present invention in detail below in conjunction with embodiment, thereby to the present invention how application technology hand
Section can fully understand and implement according to this to solve technical problem and reach the implementation process of technical effect.It is all according to present disclosure
This area equivalent substitution of progress, belongs to protection scope of the present invention.
Embodiment
Embodiment 1
First, prescription
600 grams of lycopene；5 grams of l-cn；500 grams of sorbierite；10 grams of stearic acid；10 grams of micronized poloxamers；
30 grams of honey element；Hydroxypropyl cellulose 18g；7.2 grams of hydroxypropyl methyl cellulose, 1 gram of vinyl pyrrolidone, 1.8 grams of glycerine,
1 gram of tween, 0.6 gram of titanium dioxide, 0.5 gram of pigment.
2nd, preparation method
Lycopene, l-cn, sorbierite, honey element are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into
In closed fluid bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, it is (dense to spray into hydroxypropyl cellulose aqueous solution
Spend for 15%), droplet condenses on powder, until required particle size is that 20 mesh stop spraying.Finally, by particle drying.So
Particle is mixed with stearic acid, micronized poloxamers afterwards, the piece weight for adjusting tablet press machine is 1.5 grams, and tablet is made in direct tablet compressing,
Tablet is wrapped into coating powder again, and (coating powder is by hydroxypropyl methyl cellulose, vinyl pyrrolidone, glycerine, tween, titanium dioxide
Titanium, pigment composition).
Embodiment 2
First, prescription
8 grams of lutein；400 grams of vitamin E；600 grams of sorbierite；15 grams of stearic acid；45.5 grams of sucrose.
2nd, preparation method
Lutein, vitamin E, sorbierite, stearic acid are weighed by formula and is well mixed, and mixture is placed in tablet press machine
In, after adjustment sheet weight is 1.5 grams, direct tablet compressing, after tablet is made, wrap up sugar-coat.
Embodiment 3
First, prescription
1 gram of epiphysin；700 grams of mannitol；20 grams of stearic acid；11.5 grams of PVP.
2nd, preparation method
Epiphysin, mannitol are crossed into 80 mesh sieves, the raw material weighed up is put into wet method system by the raw material weighed by formula after sieving
It is well mixed in grain machine container, sprays into the PVP aqueous solution (PVP concentration of aqueous solution is 10%), while material is strongly stirred
Mix and be cut knife and be chopped into particle.Particle is sent to and excessive caking is crushed in pelletizing machine, crosses 20 mesh sieves, is then fed into fluidisation
Drying particle in bed.Then particle is mixed with stearic acid, the piece weight for adjusting tablet press machine is 0.8 gram, direct tablet compressing, is made
Tablet.
Embodiment 4
First, prescription
300 grams of vitamin D；0.5 gram of astaxanthin；500 grams of sorbierite；400 grams of soluble starch；Micronized poloxamers
30 grams；PVP 12.5g.
2nd, preparation method
Vitamin D, astaxanthin, sorbierite, soluble starch are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into
In closed fluid bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into the PVP aqueous solution (PVP water
Solution concentration is that 5%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, by particle
Dry.Then particle is mixed with micronized poloxamers, the piece weight for adjusting tablet press machine is 0.1 gram, direct tablet compressing, piece is made
Agent.
Embodiment 5
First, prescription
12 grams of curcumin；200 grams of sorbierite；5 grams of stearic acid；15 grams of steviol glycoside.
2nd, preparation method
Curcumin, sorbierite, stearic acid, steviol glycoside are weighed by formula and is well mixed, and mixture is placed in tablet press machine
In, after adjustment sheet weight is 1.0 grams, direct tablet compressing, tablet is made.
Embodiment 6
First, prescription
900 grams of the tuber of dwarf lilyturf；500 grams of sorbierite；10 grams of stearic acid；Lemon yellow 0.2g.
2nd, preparation method
The tuber of dwarf lilyturf, sorbierite, lemon yellow are crossed into 80 mesh sieves, weighs in the raw material addition dry granulating machine after sieving and mixes by formula
Close uniformly, mixture is pressed into sheet or tabular, then be ground into sizeable particle, cross 40 mesh sieve whole grains；Then by particle
Mixed with stearic acid, the piece weight for adjusting tablet press machine is 0.8 gram, direct tablet compressing, tablet is made.
Embodiment 7
First, prescription
500 grams of Co-Q10 microcapsule powder；600 grams of sorbierite；15 grams of stearic acid；20 grams of Aspartame；Hydroxypropyl methyl fiber
Plain 29g；Lauryl sodium sulfate 0.5g.
2nd, preparation method
Co-Q10 microcapsule powder, sorbierite, Aspartame, lauryl sodium sulfate are crossed into 80 mesh sieves, sieving is weighed by formula
Raw material afterwards is put into closed fluid bed, and carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into hydroxypropyl methyl
Cellulose aqueous solution (concentration 15%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Most
Afterwards, by particle drying.Then particle is mixed with stearic acid, the piece weight for adjusting tablet press machine is 1.0 grams, direct tablet compressing, piece is made
Agent.
Embodiment 8
First, prescription
100 grams of sheep placenta；500 grams of soluble starch；Rich 5 grams of horse odium stearate；20 grams of steviol glycoside；Caramel colorant 30
Gram.
2nd, preparation method
Sheep placenta, soluble starch, steviol glycoside, caramel colorant are crossed into 80 mesh sieves, the raw material after sieving is weighed by formula
Add in dry granulating machine and be well mixed, mixture is pressed into sheet or tabular, then be ground into sizeable particle, cross 40 mesh
Sieve whole grain.Then particle is mixed with good fortune horse odium stearate, the piece weight for adjusting tablet press machine is 2.0 grams, direct tablet compressing, is made
Tablet.
Embodiment 9
First, prescription
200 grams of calcium citrate；900 grams of sorbierite；30 grams of stearic acid；40 grams of Aspartame.
2nd, preparation method
Calcium citrate, sorbierite, Aspartame are crossed into 80 mesh sieves, the raw material that will be weighed up by the raw material being formulated after weighing sieving
It is put into wet granulator container and is well mixed, spraying into 30% ethanol water, (ethanol water dosage is solid material dosage
25%), while material by strong stirring and be cut knife be chopped into particle.Particle, which is sent to, crushes excessive knot in pelletizing machine
Block, 20 mesh sieves are crossed, are then fed into drying particle in fluid bed.Then particle is mixed with stearic acid, adjusts tablet press machine
Piece weight is 1 gram, direct tablet compressing, tablet is made.
Reference examples 1
First, prescription
500 grams of Co-Q10；100 grams of sorbierite；10 grams of stearic acid；20 grams of Aspartame；Hydroxypropyl methyl cellulose
17g。
2nd, preparation method
Co-Q10, sorbierite, Aspartame are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into closed stream
Change in bed, carrying out fluidisation is well mixed powder.Start sprayer unit, spraying into the hydroxypropyl methyl cellulose aqueous solution, (concentration is
15%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, by particle drying.Then
Particle is mixed with stearic acid, the piece weight for adjusting tablet press machine is 1.0 grams, direct tablet compressing, tablet is made.
Reference examples 2
First, prescription
500 grams of Co-Q10；600 grams of dextrin；15 grams of magnesium stearate；20 grams of Aspartame；Hydroxypropyl methyl cellulose 29g.
2nd, preparation method
Co-Q10, dextrin, Aspartame are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into closed fluidisation
In bed, carrying out fluidisation is well mixed powder.Start sprayer unit, spraying into the hydroxypropyl methyl cellulose aqueous solution, (concentration is
15%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, by particle drying.Then
Particle is mixed with magnesium stearate, the piece weight for adjusting tablet press machine is 1.0 grams, direct tablet compressing, tablet is made.
Reference examples 3
First, prescription
500 grams of Co-Q10；600 grams of sorbierite；15 grams of stearic acid；78 grams of sodium carboxymethyl starch；20 grams of Aspartame；Hydroxyl
Propyl methocel 29g.
2nd, preparation method
Co-Q10, sorbierite, sodium carboxymethyl starch, Aspartame are crossed into 80 mesh sieves, the raw material after sieving is weighed by formula
It is put into closed fluid bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into hydroxypropyl methyl cellulose water
Solution (concentration 15%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, general
Grain is dried.Then particle is mixed with stearic acid, the piece weight for adjusting tablet press machine is 1.0 grams, direct tablet compressing, tablet is made.
Physical property test experience
First, tested medicine
1st, the embodiment of the present invention 1 is to the medicine of embodiment 9.
2nd, drugs compared：Reference examples 1 are to the medicine of reference examples 3.
2nd, method of testing
Disintegration time limited detection method：According to《Second annex XA disintegration time limited inspection technique of Chinese Pharmacopoeia 2010 edition》Determine sample
The disintegration time limited of product.Using lift disintegration tester, hanging basket (wherein the sieve aperture internal diameter of screen cloth is 2.0mm) is passed through into the stainless of upper end
Steel shaft is hung on metallic support, is immersed in 1000ml beakers, and adjusts when hanging basket position makes its decline screen cloth away from beaker bottom
25mm, fills the water that temperature is 37 ± 1 DEG C in beaker, and screen cloth is under liquid level at 15mm when regulating liquid surface highly rises hanging basket.
Take test sample 6, in the glass tube for putting above-mentioned hanging basket respectively, often manage respectively plus 1, start disintegration tester immediately and checked.Each
It all should be all disintegrated in 5 minutes, record disintegration time limited.It can not be completely disintegrated if any 1, should separately take 6 retrials, all should meet
Regulation.
3rd, experimental result
Table 1 have recorded the testing result of the disintegration time limited of embodiment and reference examples.
The disintegration time limited of the embodiment of table 1 and reference examples sample
| Sample | Disintegration time limited (second) |
| Embodiment 1 | 395 |
| Embodiment 2 | 351 |
| Embodiment 3 | 340 |
| Embodiment 4 | 419 |
| Embodiment 5 | 312 |
| Embodiment 6 | 407 |
| Embodiment 7 | 305 |
| Embodiment 8 | 376 |
| Embodiment 9 | 338 |
| Reference examples 1 | ＞ 3600 |
| Reference examples 2 | 927 |
| Reference examples 3 | 427 |
The disintegration time limited data of embodiment and reference examples are observed, the disintegration time limited of 9 embodiments is 305 seconds~419 seconds.3
The disintegration time limited of individual reference examples is all higher than the disintegration time limited of each embodiment, and reference examples 1 are more than 3600 seconds, and reference examples 2 are 927 seconds,
Reference examples 3 are 427 seconds.Embodiment 1~9 is free of disintegrant, from specific excipient and lubricant combination；Reference examples 1 are free of
Disintegrant, the amount ranges of the excipient and lubricant protected containing the present invention, wherein excipient dosage beyond the present invention；It is right
2 be free of disintegrant as usual, the dosage of excipient and lubricant is not in the scope of the present invention；Reference examples 3 containing disintegrant,
Excipient and lubricant.By analyzing these data, the dissolution rate of sample of the embodiment of the present invention is fast, and formula is excellent.
The present invention containing insoluble active component is prepared piece agent rather than liquid dosage form by the present invention, without will be insoluble
The complicated technology used in liquid preparation is made in active component, also overcomes showing of being layered in the product liquid prolonged storage
As, and there is dosage accurate, steady quality, storage is easy to carry, can swallow and also take after mixing it with water.By many experiments,
This tablet composition determines distinctive excipient and lubricant, excipient preferably be selected from sorbierite, mannitol, soluble starch,
One or more in dextrin, microcrystalline cellulose, Macrogol 4000, Macrogol 6000, lactose；Lubricant is selected from tristearin
Acid, micronized poloxamers, rich horse odium stearate, polyethylene glycol, lauryl sodium sulfate, Stepanol MG, laruyl alcohol
Magnesium sulfate, fumaric acid one or more in one or more.We have surprisingly found that, are not adding the situation of disintegrant
Under, from specific excipient and lubricant combination, dispersion effect of the medicine in water is on the contrary more preferably.Because the present invention
Excipient be stickum, after adding disintegrant, such excipient it is sticky stronger, it is scattered in water to suppress medicine.Due to
The present invention can be dispersed in water quickly, and can be taken in liquid form, therefore the present invention can not only swallow, can also be for not
Easily swallow patient and be dispersed in water and take, solve the problems, such as that tablet bioavilability is low, difficult swallow patient and can not take.This hair
It is bright such as to take in liquid form, it is redispersed in water when closing on medication, is taken after liquid is shaken up, because tablet is relative to liquid
Body preparation is more stable and is easy to carry.Tablet composition prepared by the present invention is except applied to medicine, health products trade, going back
Emerging field of functional food is can apply to, can not only swallow but also tablet can be dispersed in water as functional food
Beverage is drunk, and it is convenient to carry and take.
The preferred embodiments of the present invention are the foregoing is only, are not intended to limit the invention, for the skill of this area
For art personnel, the present invention can have various modifications and variations.Within the spirit and principles of the invention, that is made any repaiies
Change, equivalent substitution, improvement etc., should be included in the scope of the protection.
Claims (25)
1. it is a kind of can rapid dispersion tablet, it is characterised in that：By 0.5~900 parts by weight of activated composition, 200~900 parts by weight
Excipient and 5~30 parts by weight lubricants composition, wherein active component is water-insoluble active component.
2. it is according to claim 1 it is a kind of can rapid dispersion tablet, it is characterised in that：The tablet is by 1~600 weight
Part active component, 500~700 parts by weight excipient and 10~20 parts by weight lubricants composition.
3. it is according to claim 1 or 2 it is a kind of can rapid dispersion tablet, it is characterised in that：The excipient is selected from mountain
One or more in pears alcohol, mannitol, soluble starch, dextrin, microcrystalline cellulose, polyethylene glycol, lactose.
4. it is according to claim 3 it is a kind of can rapid dispersion tablet, it is characterised in that：The excipient be sorbierite,
One or more in mannitol, lactose, dextrin.
5. it is according to claim 1 or 2 it is a kind of can rapid dispersion tablet, it is characterised in that：The lubricant is selected from hard
Resin acid, micronized poloxamers, rich horse odium stearate, polyethylene glycol, lauryl sodium sulfate, Stepanol MG, bay
One or more in alcohol magnesium sulfate, fumaric acid.
6. it is according to claim 5 it is a kind of can rapid dispersion tablet, it is characterised in that：The lubricant be stearic acid,
One or more in polyethylene glycol, micronized poloxamers, rich horse odium stearate.
7. it is according to claim 1 it is a kind of can rapid dispersion tablet, it is characterised in that：The water-insoluble active component
Selected from fish oil microcapsule powder, linseed oil microcapsule powder, strange sub- seed oil microcapsule powder, Purple Perilla Seed Oil microcapsule powder, camellia seed oil microcapsule powder, south
Melon seeds oil microcapsule powder, evening primrose oil microcapsule powder, borage oil microcapsule powder, cocounut oil microcapsule powder, palm-kernel oil microcapsule powder, Seabuckthorm Seed Oil
Microcapsule powder, hippophae rhamnoides fruit oil microcapsule powder, grape-kernel oil microcapsule powder, olive oil microcapsule powder, one kind in safflower seed oil microcapsule powder or more
Kind.
8. it is according to claim 1 it is a kind of can rapid dispersion tablet, it is characterised in that：The water-insoluble active component
Selected from lycopene, epiphysin, vitamin E, Co-Q10, armillaria mellea, lutein, camellia seed extract, ganglioside
Fat, sesame polyphenol, resveratrol, chromium picolinate, octacosanol, carrot pigment, red yeast rice, beta carotene, turmeric, turmeric
Element, squalene, magnesium salts, cephalin, phosphatidyl serine, sphingomyelin, calcium citrate, ferric citrate, natural carrot
Element, vitamin A, vitamin D, vitamin K1, farnoquinone, selenoprotein, Cr-enriched yeast, astaxanthin, heme iron, zinc-rich ferment
Mother, flaxseed kind hide fiber, sheep placenta, chlorophyll, lutein ester, folic acid, zeaxanthin, gekko, Bee Pollen, gynostemma pentaphylla, hardship
Melon, can salad is uncommon, the tuber of dwarf lilyturf, horse chestnut, Gymnema Sylvestre, Eutrema yunnanenses, valerian, saussurea involucrata, flaxseed gum, basyleave, hoveniae semoveniae semen,
Japanese angelica tree, golden ear, non denatured II collagen types and above-mentioned raw materials microcapsule powder or inclusion compound in one or more.
9. according to claim 7 or 8 it is a kind of can rapid dispersion tablet, it is characterised in that：The water-insoluble activity
It is yellow that composition is selected from lycopene, epiphysin, vitamin E, turmeric, curcumin, Co-Q10, armillaria mellea, lutein, leaf
Plain ester, camellia seed extract, gangliosides, sesame polyphenol and above-mentioned raw materials microcapsule powder or inclusion compound, fish oil microcapsule powder, Asia
One or more in flaxseed oil microcapsule powder, strange sub- seed oil microcapsule powder, Purple Perilla Seed Oil microcapsule powder.
10. it is according to claim 9 it is a kind of can rapid dispersion tablet, it is characterised in that：The water-insoluble activity into
The one or more being selected from Co-Q10 microcapsule powder, vitamin E microcapsule powder, Co-Q10 inclusion compound, vitamin E clathrate.
11. according to claim 1-10 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain 5~1050 weights
Part water-soluble active ingredient is measured, the water-soluble active ingredient is selected from collagen, l-cn, Glucosamine, vitamin
C, glutathione, L-thiamine, barley element, calcium pantothenate, algin, black tea polyphenols, inositol, carob, white of an egg peptide, enzyme modification fennel
Fragrant glycosides, hydroxycitric acid, hyaluronic acid, coriolan, N- formyls tyrasamine, chondroitin sulfate, taurine, calcium gluconate, Portugal
Grape saccharic acid zinc, manganese gluconate, glucose ferrous iron, grape seed extract, vitamin B1, vitamin B2, vitamin B6, vitamin
B12, glucomannans, lipoic acid, water soluble oligosaccharide, chitosan oligosaccharide, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl fourth
Hydrochlorate, lactalbumin, lactic acid bacteria, Bifidobacterium, lactobacillus acidophilus, lentinan, GL-B, hericium erinaceum polysaccharide, Poria cocos are more
One or more in sugar, tremella polysaccharides, oyster peptide.
12. according to any one of claim 1 to 11 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain
Have 0.5~45 parts by weight Emulsifier, described emulsifying agent be selected from lauryl sodium sulfate, egg yolk lecithin, PLURONICS F87,
One or more in Sorbitan Laurate, Sorbitan Oleate, polyoxyethylene sorbitan monoleate, Arabic gum, agar, sucrose stearate.
13. according to any one of claim 1 to 11 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain
Have 30~70 parts by weight flavourings, the flavouring be selected from steviol glycoside, Aspartame, Sucralose, saccharin sodium, honey element,
Radix glycyrrhizae, acesulfame potassium, A Shasufa, neotame, Tagatose, disodium glycyrrhizinate, glucose, fructose, sucrose, xylitol, simple syrup, fruit
Juice syrup, honey, glycerine, sorbierite, mannitol, mogroside, oligosaccharide, natural essence, compound essence, natural equivalent are fragrant
Essence, fermentation essence, fruit juice powder, natural vegetable juice powder, vegetable condensed juice powder, fruit inspissated juice powder, adenosine monophosphate, dimension life
One or more in plain C, malic acid, citric acid.
14. it is according to claim 13 it is a kind of can rapid dispersion tablet, it is characterised in that：The flavouring is selected from stevia rebaudianum
Glucosides, Aspartame, Sucralose, honey element, radix glycyrrhizae, acesulfame potassium, fruit juice powder, malic acid, citric acid, oligosaccharide, day
One or more in right essence.
15. according to any one of claim 1 to 11 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain
There are 4~15 parts by weight of binder, described adhesive is selected from PVP, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl
One or more in sodium cellulosate, methylcellulose, ethyl cellulose, gelatin, carbomer, starch slurry.
16. according to any one of claim 1 to 11 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain
There is 1~15 parts by weight colouring agent, the colouring agent is selected from caramel colorant, carthamin yellow, lemon yellow, sunset yellow, quinoline yellow, purple
In iron oxide, Black Rouge, Brown Ferric Oxide, red ferric oxide, yellow ferric oxide, titanium dioxide, indigo, chlorophyll, famille rose, light blue
One or more.
17. according to any one of claim 1 to 11 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain
Have 3~18 parts by weight coating agents, the coating agent be selected from sucrose, the high molecular polymer of good film-forming property, plasticizer, anticaking agent,
Opacifier, surfactant, pigment, defoamer, the one or more of brightener.
A kind of 18. composition containing collagen according to claim 15, it is characterised in that：Described good film-forming property
High molecular polymer be selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose, polyethylene arsenic cough up alkane
One kind or more in ketone, ethyl cellulose, methylcellulose, hydroxyethyl cellulose, methyl hydroxyethylcellulose, polyvinyl alcohol
Kind.
A kind of 19. composition containing collagen according to claim 17, it is characterised in that：Described plasticizer choosing
One kind or more from glycerine, tween, polyethylene glycol, propane diols, castor oil, diethyl phthalate, lemon triethylenetetraminehexaacetic acid fat
Kind.
A kind of 20. composition containing collagen according to claim 17, it is characterised in that：Described anticaking agent choosing
One or more from talcum powder, magnesium stearate, silica, titanium dioxide.
A kind of 21. composition containing collagen according to claim 17, it is characterised in that：Described opacifier choosing
From titanium dioxide.
A kind of 22. composition containing collagen according to claim 17, it is characterised in that：Described surface-active
One or more of the agent in lauryl sodium sulfate, tween, oleic acid, phosphatide.
23. according to any one of claim 1 to 22 it is a kind of can rapid dispersion tablet, it is characterised in that：It is described
The weight of tablet is 0.1~2.0 gram/piece.
24. it is according to claim 23 it is a kind of can rapid dispersion tablet, it is characterised in that：The weight of the tablet is
0.8~1.5 gram/piece.
25. any one of claim 1 to 24 it is a kind of can rapid dispersion tablet preparation method, it is characterised in that
For following either method：
Method one,
All raw materials are weighed, is well mixed, mixture is placed in tablet press machine, direct tablet compressing, tablet is made；
Or method two,
All raw materials are crossed into 80 mesh sieves, dry granulation method, wet granulation are used after weighing active component, excipient, other auxiliary materials
Particle is made in one kind in method, marumerization, then by particle and mix lubricant, tabletting, tablet is made；
The dry granulation method, it is that will weigh up active component, excipient, other auxiliary materials to be well mixed, by mixture with dry method system
Grain machine is pressed into sheet or tabular, then is ground into sizeable particle, whole grain of sieving；
The wet granulation process, it is that the active component, excipient, other auxiliary materials in addition to adhesive that will be weighed up are put into wet granulation
It is well mixed in machine container, sprays into binder solution, binder solution dosage is the 10~15% of the total dosage of solid material, material
It is made into particle；Particle is sent to and excessive caking is crushed in pelletizing machine, sieving, then dries whole grain and produces；Binder solution
Concentration is 1%~25%, from binder aqueous solution or adhesive ethanol water；Wetting agent selects water or 30%~70% second
Alcohol solution；
The marumerization, it is that the active component, excipient, other auxiliary materials in addition to adhesive that will be weighed up are put into closed stream
Change in bed, carrying out fluidisation is well mixed powder；Sprayer unit is started, sprays into binder aqueous solution, droplet condenses on powder,
Until required particle size just stops spraying；Finally, by particle drying；Binder aqueous solution concentration is 1%~15%, adhesive
Amount of aqueous solution used is the 10~20% of the total dosage of solid material.
The tablet can also be coated.
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