CN107823168A - A kind of rapidly-soluble tablet and preparation method thereof - Google Patents

A kind of rapidly-soluble tablet and preparation method thereof Download PDF

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Publication number
CN107823168A
CN107823168A CN201711012203.2A CN201711012203A CN107823168A CN 107823168 A CN107823168 A CN 107823168A CN 201711012203 A CN201711012203 A CN 201711012203A CN 107823168 A CN107823168 A CN 107823168A
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China
Prior art keywords
soluble
water
rapidly
tablet
weight
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许伯慧
陈曼
佘佐彦
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Beijing 3 Biological Technology Co Ltd
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Beijing 3 Biological Technology Co Ltd
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Priority to CN201711012203.2A priority Critical patent/CN107823168A/en
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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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/385—Concentrates of non-alcoholic beverages
    • A23L2/39—Dry compositions
    • A23L2/395—Dry compositions in a particular shape or form
    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/015—Inorganic compounds
    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/03—Organic compounds
    • 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
    • A23P10/28—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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof

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  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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Abstract

The present invention relates to a kind of rapidly-soluble tablet and preparation method thereof, more particularly to it is a kind of be free of disintegrant, rapidly dissolvable tablet composition and its preparation technology, belong to medicine, field of health care products.The invention discloses a kind of rapidly-soluble tablet, it is characterised in that：Substantially it is made up of 10~2100 parts by weight of activated compositions, 200~900 parts by weight excipient and 5~30 parts by weight lubricants.Tablet composition prepared by the present invention is except applied to medicine, health products trade, emerging field of functional food can also be applied to, not only it can swallow but also can take after mixing it with water, can also be drunk tablet is soluble in water as functional food beverage, it is convenient to carry and take.

Description

A kind of rapidly-soluble tablet and preparation method thereof
Technical field
The present invention relates to a kind of rapidly-soluble tablet and preparation method thereof, more particularly to it is a kind of without disintegrant, can be fast The tablet composition and its preparation technology of instant solution, 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 solution, but be generally unsuitable for swallowing, and take Band is inconvenient.
Contain disintegrant in conventional tablet, it is rapidly dissolvable, but existing disintegrant is mostly the material for being insoluble in water, such as Tablet containing disintegrant is dissolved in water and taken to children, the old man of dysphagia or coma patient by fruit, and insoluble disintegrant mixes It is suspended from water, bad Consumer's Experience can be brought.And the tablet dissolved speed 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 prepare A kind of steady quality, carry convenient transportation, can not only swallow but also the tablet taken as solution that quick and complete can be dissolved in the water It is the blank of this area research.
The content of the invention
In order to solve the above-mentioned technical problem, the present invention provides a kind of without disintegrant, rapidly dissolvable tablet composition And preparation method thereof.
A kind of rapidly-soluble tablet, contain the parts by weight of activated compositions of 10-2100,200-900 parts by weight excipient and 5- 30 parts by weight lubricants；Preferably, active component is water-soluble active ingredient.
Preferably, the tablet contains the parts by weight of activated compositions of 20-1600,500-700 parts by weight excipient and 10-20 weight Part lubricant.
Preferably, for the tablet in 37 DEG C of water, the dissolution rate of 15 minutes is not less than 85%；It is furthermore preferred that the tablet exists In 50 DEG C of water, the dissolution rate of 8 minutes is not less than 85%.
Preferably, excipient is selected from sorbierite, mannitol, lactose, soluble starch, dextrin, fructose, cyclodextrin, grape One or more in sugar, sucrose, sodium chloride, sodium ascorbyl phosphate, sodium carbonate salt, sodium citrate salt, water-soluble amino acids；Lubricant Selected from stearic acid, micronized poloxamers, rich horse odium stearate, polyethylene glycol, lauryl sodium sulfate, dodecyl sulphate One or both of magnesium, magnesium laurylsulfate, fumaric acid.
Preferably, excipient is the one or more in sorbierite, mannitol, lactose, dextrin；Lubricant be stearic acid, One or more in polyethylene glycol, micronized poloxamers, rich horse odium stearate.
Preferably, water-soluble active ingredient is selected from collagen, l-cn, Glucosamine, vitamin C, gluathione Peptide, L-thiamine, barley element, calcium pantothenate, algin, black tea polyphenols, inositol, carob, white of an egg peptide, enzyme modification foreniculin, hydroxyl Base citric acid, hyaluronic acid, coriolan, N- formyls tyrasamine, chondroitin sulfate, taurine, calcium gluconate, gluconic acid Zinc, manganese gluconate, glucose ferrous iron, grape seed extract, vitamin B1, vitamin B2, vitamin B6, vitamin B12, Portugal Mannosan, lipoic acid, water soluble oligosaccharide, chitosan oligosaccharide, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl butyrate, breast Albumin, lactic acid bacteria, Bifidobacterium, lactobacillus acidophilus, lentinan, GL-B, hericium erinaceum polysaccharide, pachymaran, white fungus One or more in polysaccharide, oyster peptide；It is furthermore preferred that water-soluble active ingredient is selected from collagen, l-cn, amino Portugal Grape sugar, vitamin C, glutathione, L-thiamine, barley element, calcium pantothenate, algin, black tea polyphenols, inositol, carob, the white of an egg Peptide, enzyme modification foreniculin, hydroxycitric acid, hyaluronic acid, coriolan, glucomannans, lipoic acid, water soluble oligosaccharide, One or more in chitosan oligosaccharide, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl butyrate, N- formyl tyrasamines.
Preferably, the tablet also contains 40-100 parts by weight flavourings, and flavouring is selected from steviol glycoside, Aspartame, three Chlorine sucrose, 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, water solubility The equivalent essence of natural essence, water-soluble compound essence, water-soluble natural, water-soluble fermentation essence, fruit juice powder, crude vegetable Juice powder, vegetable condensed juice powder, fruit inspissated juice powder, adenosine monophosphate, vitamin C, malic acid, one kind in citric acid or more Kind.
Preferably, flavouring is selected from steviol glycoside, Aspartame, Sucralose, honey element, radix glycyrrhizae, acesulfame potassium, apple One or more in acid, citric acid, oligosaccharide, water-soluble natural essence, fruit juice powder.
Preferably, tablet also contains 5-200 parts by weight of binder, and adhesive is selected from PVP, hydroxypropyl cellulose, hydroxypropyl One kind in ylmethyl cellulose, sodium carboxymethylcellulose, methylcellulose, ethyl cellulose, gelatin, carbomer, starch slurry It is or a variety of.
Preferably, tablet also contains 2-20 parts by weight colouring agents, colouring agent be sunset yellow, lemon yellow, amaranth, newly red, One or more in erythrosine, famille rose, indigo, light blue.
Preferably, tablet also contains 5-30 parts by weight coating agents, and coating agent is selected from sucrose, the high molecular polymerization of good film-forming property Thing, plasticizer, emulsifying agent, water colo(u)r, the one or more in anticaking agent, opacifier, defoamer, brightener.
Preferably, the high molecular polymer of good film-forming property is selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl One or more in sodium cellulosate, polyvinyl pyrrolidone, polyvinyl alcohol；Plasticizer be selected from glycerine, tween, polyethylene glycol, One or more in propane diols；Emulsifying agent is selected from lauryl sodium sulfate.
Preferably, the weight of tablet is 0.1-2.0 grams/piece, more preferably 0.8-1.5 grams/piece.
The tablet of the present invention can be produced by directly compressing or being compressed after granulation technique.Both pressed-disc techniques It is well-known to those skilled in the art.These tablets can be by well known by persons skilled in the art any suitable Suitable mode manufactures.
Preferably, a kind of preparation method of rapidly-soluble tablet comprises the following steps：
Method one：All raw materials are weighed, is well mixed, mixture is placed in tablet press machine, direct tablet compressing.
Or, method two：All raw materials are crossed into 80 mesh sieves, dry method system is used after weighing active component, excipient, other auxiliary materials Particle is made in one kind in grain method, wet granulation process, marumerization, then by particle and mix lubricant, tabletting.
The dry granulation method：Active component, excipient, other auxiliary materials will be weighed up 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：The active component weighed up, excipient, other auxiliary materials in addition to adhesive are put into wet method system It is well mixed in grain machine container, (binder solution or wetting agent dosage are total for solid material for penetrating binder solution or wetting agent The 10-15% of dosage), material is made into particle.Particle is sent to and excessive caking is crushed in pelletizing machine, sieving, then dries Whole grain produces.Binder solution concentration is 1%-25%, from binder aqueous solution or adhesive ethanol water.Wetting agent selects With water or 30%-70% ethanol waters.
The marumerization：The active component weighed up, excipient, other auxiliary materials in addition to adhesive are put into closed In fluid bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into binder aqueous solution, droplet coagulates on powder It is poly-, until required particle size just stops spraying.Finally, by particle drying.Binder aqueous solution concentration is 1%-15%, bonding Agent amount of aqueous solution used is the 10-20% of the total dosage of solid material.
Preferably, the tablet can also be coated.
It has been surprisingly found that it is of the invention in the case where not adding disintegrant, from specific excipient and lubricant Combination, it is possible to quickly dissolve in water, be taken in liquid form, solve that tablet bioavilability is low, difficult swallows patient The problem of can not taking, tablet composition of the invention can be quickly dissolved into water, therefore the present invention can not only swallow, can also be for It is not easy to swallow patient's bath to take.The present invention is free of disintegrant, and solution is as clear as crystal after being dissolved in water, in the absence of suspended matter, user Experience is good.
It is an advantage of the invention that：The tablet of the present invention is free of disintegrant, can from specific excipient and lubricant combination Quickly to be dissolved in water.The tablet composition exists in form of tablets, has accurate dosage, steady quality, storage carrying side Just the advantages that also taking after mixing it with water can, be swallowed.Tablet composition prepared by the present invention is except applied to medicine, health products trade, may be used also Applied to emerging field of functional food, can not only swallow but also can be soluble in water as functional food beverage by tablet Drink, it is convenient to carry and take.
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
800 grams of collagen；The weight in grams of vitamin C 30；605 grams of sorbierite；15 grams of stearic acid；5 grams of sucrose.
2nd, preparation method
Collagen, vitamin C, 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, tablet coating.
Embodiment 2
First, prescription
1600 grams of collagen；500 grams of sorbierite；10 grams of stearic acid；Carmine 0.2g.
2nd, preparation method
Collagen, sorbierite, famille rose are crossed into 80 mesh sieves, the raw material after sieving is weighed by formula and adds dry granulating machine In be well mixed, mixture is pressed into sheet or tabular, then be ground into particle, crosses 40 mesh sieve whole grains.Then by particle with Stearic acid mixes, and the piece weight for adjusting tablet press machine is 0.8 gram, direct tablet compressing.
Embodiment 3
First, prescription
20 grams of calcium pantothenate；700 grams of mannitol；20 grams of stearic acid；19 grams of PVP.
2nd, preparation method
Calcium pantothenate, 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 25%), 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 1 gram, direct tablet compressing.
Embodiment 4
First, prescription
1600 grams of collagen；20 grams of vitamin C；500 grams of sorbierite；10 grams of stearic acid；Micronized poloxamers 10 Gram；30 grams of honey element；Hydroxypropyl cellulose 33g.
2nd, preparation method
Collagen, vitamin C, sorbierite, honey element are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into close In the fluid bed closed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into hydroxypropyl cellulose aqueous solution (concentration For 15%), droplet condenses on powder, until required particle size is that 10 mesh just 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, direct tablet compressing.
Embodiment 5
First, prescription
2100 grams of collagen；500 grams of sorbierite；400 grams of lactose；30 grams of micronized poloxamers；6 grams of PVP；Hydroxyl 20 grams of propyl methocel；2.5 grams of vinyl pyrrolidone；4.5 grams of glycerine；2.5 grams of tween；1.2 grams of water colo(u)r.
2nd, preparation method
Collagen, sorbierite, lactose are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into closed fluid bed Interior, carrying out fluidisation is well mixed powder.Start sprayer unit, spraying into the PVP aqueous solution, (PVP concentration of aqueous solution is 1%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, by particle drying.Then will Particle mixes with micronized poloxamers, and the piece weight for adjusting tablet press machine is 0.8 gram, and direct tablet compressing is made tablet, then by tablet bag Clothing (coating material is made up of hydroxypropyl methyl cellulose, vinyl pyrrolidone, glycerine, tween, water colo(u)r).
Embodiment 6
First, prescription
10 grams of l-cn；200 grams of sorbierite；5 grams of stearic acid；15 grams of steviol glycoside.
2nd, preparation method
L-cn, sorbierite, stearic acid, steviol glycoside are weighed by formula and is well mixed, and mixture is placed in tabletting In machine, after adjustment sheet weight is 1.0 grams, direct tablet compressing.
Embodiment 7
First, prescription
50 grams of Glucosamine；0.5 gram of L-thiamine；600 grams of sorbierite；20 grams of stearic acid；20 grams of Aspartame；Hydroxypropyl Ylmethyl cellulose 21.5g.
2nd, preparation method
Glucosamine, L-thiamine, sorbierite, 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 stop spraying.Finally, by particle Dry.Then particle is mixed with stearic acid, the piece weight for adjusting tablet press machine is 0.8 gram, direct tablet compressing.
Embodiment 8
First, prescription
600 grams of hyaluronic acid；500 grams of soluble starch；Rich 5 grams of horse odium stearate；20 grams of steviol glycoside；Sunset yellow 30 Gram.
2nd, preparation method
Hyaluronic acid, soluble starch, steviol glycoside, sunset yellow 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.
Embodiment 9
First, prescription
10 grams of glutathione；900 grams of zinc gluconate；900 grams of sorbierite；30 grams of stearic acid；40 grams of Aspartame.
2nd, preparation method
Glutathione, zinc gluconate, sorbierite, Aspartame are crossed into 80 mesh sieves, the raw material after sieving is weighed by formula The raw material weighed up is put into wet granulator container and is well mixed, spraying into 30% ethanol water, (ethanol water dosage is Solid material dosage 10%), while material by strong stirring and be cut knife be chopped into particle.Particle is sent in pelletizing machine Excessive caking is crushed, 20 mesh sieves is crossed, is then fed into drying particle in fluid bed.Then particle is mixed with stearic acid, The piece weight for adjusting tablet press machine is 0.1 gram, direct tablet compressing.
Reference examples 1
First, prescription
800 grams of collagen；30 grams of vitamin C；605 grams of dextrin；15 grams of magnesium stearate；150 grams of sodium carboxymethyl starch； Hydroxypropyl cellulose 24g.
2nd, preparation method
Collagen, vitamin C, dextrin, sodium carboxymethyl starch are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put Enter in closed fluid bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into hydroxypropyl cellulose aqueous solution (concentration 15%), droplet condenses on powder, until required particle size is that 20 mesh just stop spraying.Finally, by particle with Magnesium stearate is dried.Then particle is mixed, the piece weight for adjusting tablet press machine is 1.5 grams, direct tablet compressing.
Reference examples 2
First, prescription
2500 grams of collagen；100 grams of sorbierite；10 grams of stearic acid；Hydroxypropyl cellulose 39g.
2nd, preparation method
Collagen, sorbierite are crossed into 80 mesh sieves, the raw material weighed by formula after sieving is put into closed fluid bed, is entered Row fluidisation is well mixed powder.Sprayer unit is started, sprays into hydroxypropyl cellulose aqueous solution (concentration 15%), droplet is in powder Condensed on body, until required particle size is that 20 mesh just stop spraying.Finally, by particle drying.Then by particle and stearic acid Mixing, the piece weight for adjusting tablet press machine are 1.5 grams, direct tablet compressing.
Physical property test experience
First, tested medicine
1st, the medicine of 1~embodiment of the embodiment of the present invention 9.
2nd, drugs compared：The medicine of 1~reference examples of reference examples 2.
2nd, method of testing
1st, dissolution detection method：According to《Second annex XC dissolution method of Chinese Pharmacopoeia 2010 edition》Determination sample Dissolution rate.Using water as dissolution medium.Make to turn inner bottom part 25mm ± 2mm of the basket bottom away from stripping rotor before measure.Measure respectively molten Go out medium to put in each stripping rotor, it is constant after 37 ± 0.5 DEG C after dissolution medium temperature, test sample 6 is taken, it is dry to throw people 6 respectively Dry turns in basket, will turn basket and falls into stripping rotor, starts instrument timing.To defined sample time (actual sample time and rule The difference fixed time must not mistake ± 2%), draw that dissolution fluid is appropriate, filtered immediately with appropriate miillpore filter, from sampling to filtration It should be completed in 30 seconds.Take clear filtrate, the stripping quantity of measure and calculation every.The stripping quantity of every is by mark in 6 test samples The amount of showing calculates, and all should be not less than defined dissolution rate Q (at 37 DEG C, 15 minutes, Q 85%)；It is or low if any 1~2 in 6 In Q, but it is not less than Q~10%, and its average stripping quantity is not less than Q；Or there is 1~2 to be less than Q in 6, wherein only 1 Less than Q~10%, but it is not less than Q~20%, and when its average dissolution rate be not less than Q, should separately takes 6 retrials, it is first, the 12 of retrial There is 1~3 to be less than Q in piece, wherein only 1 is less than Q~10%, but be not less than Q~20%, and its average stripping quantity is not less than Q。
2. clarity detection method：At room temperature, 1.0g test samples are dissolved in 10mL water, take the need testing solution of equivalent It is respectively placed in turbidity standard in the turbid use glass tube of ratio of pairing, it is vertical in darkroom after turbidity standard is prepared 5 minutes With being placed under umbrella canopy lamp, the observation of illumination 10001x horizontal directions, compare；By turbidity to judge the clarity of solution.
It is prepared by turbidity standard：Weigh and dried in 105 DEG C to the hydrazine sulfate 1.0g of constant weight, put in 100mL measuring bottles, added appropriate Water dissolves, and is diluted with water to scale, shakes up, and places 4-6 hours；10% methenamine solution of this solution and equivalent is taken to mix Close, shake up, static 24 hours in 25 DEG C of lucifuges, obtain turbidity standard storing solution.Turbidity standard storing solution 15.0mL is taken, puts 1000mL In measuring bottle, scale is diluted with water to, is shaken up, obtains turbidity standard stoste.This liquid should use in 48 hours, with before shaking up.Take turbid Standard stock solution and water are spent, according to the form below is prepared, produced.This liquid should face used time preparation, fully be shaken up using preceding.
Table 1
Level number 0 0.5 1 2 3 4
Turbidity standard stoste/mL 0 2.50 5.0 10.0 30.0 50.0
Water/mL 100.0 97.50 95.0 90.0 70.0 50.0
3rd, experimental result
Table 2 has recorded the testing result of the dissolution rate of embodiment and reference examples.
The dissolution rate of the embodiment of table 2 and reference examples sample
Observe the dissolution data of embodiment and reference examples, each embodiment was at 2 minutes, 5 minutes, 10 minutes, 15 minutes Dissolution rate is all higher than reference examples, and dissolution rate of each embodiment at 5 minutes is all higher than 80%, dissolution of each embodiment at 15 minutes Degree is all higher than 90%, the dissolution rate highest of embodiment 4.In reference examples 1 containing the scope of the invention outside excipient, lubricant and collapse Agent is solved, the dissolution rate measured is close with embodiment.Vehicle Dose in reference examples 2 outside the scope of the present invention, dissolution It is minimum to spend result.By analyzing these data, embodiment sample is free of disintegrant, rationally compounds excipient and lubricant, Dissolution rate is fast, and formula is excellent.
Table 3 has recorded embodiment and reference examples sample is soluble in water, the clarity testing result of test.
The clarity of the embodiment of table 3 and reference examples
Each technique of formula of embodiment is within the scope of the present invention, and the figuration outside the present invention has been used in reference examples 1 Agent and lubricant, the raw material materials in reference examples 2 are outside the scope of the present invention.It was found from the data of table 3, embodiment it is turbid Degree is 0, and the turbidity of reference examples 1 is 2.0.It is indicated above that the formula and craft science of embodiment are reasonable, our want is met Ask.
Embodiment sample is the tablet without disintegrant containing excipient and lubricant, but can be fast instant in water Solution.The tablet composition of the present invention exists in form of tablets, and dosage is accurate, steady quality, storage is easy to carry, can swallow and also may be used Take after mixing it with water.Rationally compounding excipient and lubricant of the invention, can quickly dissolve in water, be taken in liquid form, solve Tablet bioavilability is low, it is difficult swallow the problem of patient can not take, for being not easy to swallow clothes for patients.The present invention is without disintegration Agent, solution is as clear as crystal after being dissolved in water, good in the absence of suspended matter, Consumer's Experience.Tablet composition prepared by the present invention except Applied to medicine, health products trade, emerging field of functional food can also be applied to, can not only have been swallowed but also can be by tablet Soluble in water to be drunk as functional food beverage, 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 (20)

  1. A kind of 1. rapidly-soluble tablet, it is characterised in that：Assigned by 10~2100 parts by weight of activated compositions, 200~900 parts by weight Shape agent and 5~30 parts by weight lubricants composition.
  2. A kind of 2. rapidly-soluble tablet according to claim 1, it is characterised in that：The tablet is by 20~1600 weight Part active component, 500~700 parts by weight excipient and 10~20 parts by weight lubricants composition.
  3. A kind of 3. rapidly-soluble tablet according to claim 1, it is characterised in that：The tablet in 37 DEG C of water, The dissolution rate of 15 minutes is not less than 85%.
  4. A kind of 4. rapidly-soluble tablet according to claim 1, it is characterised in that：The tablet is in 50 DEG C of water, and 8 The dissolution rate of minute is not less than 85%.
  5. A kind of 5. rapidly-soluble tablet according to claim 1 or 2, it is characterised in that：The excipient is selected from sorb Alcohol, mannitol, lactose, soluble starch, dextrin, fructose, cyclodextrin, glucose, sucrose, sodium chloride, sodium ascorbyl phosphate, sodium carbonate One or more in salt, sodium citrate salt, water-soluble amino acids；The lubricant be selected from stearic acid, micronized poloxamers, One in rich horse odium stearate, polyethylene glycol, lauryl sodium sulfate, Stepanol MG, magnesium laurylsulfate, fumaric acid Kind is a variety of.
  6. A kind of 6. rapidly-soluble tablet according to claim 5, it is characterised in that：The excipient is sorbierite, sweet Reveal the one or more in alcohol, lactose, dextrin；The lubricant is stearic acid, polyethylene glycol, micronized poloxamers, rich horse One or more in odium stearate.
  7. A kind of 7. rapidly-soluble tablet according to claim 1, it is characterised in that：The active component is water-soluble living Property composition.
  8. A kind of 8. rapidly-soluble tablet according to claim 7, it is characterised in that：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, hyaluronic acid, coriolan, N- formyls Tyrasamine, chondroitin sulfate, taurine, calcium gluconate, zinc gluconate, manganese gluconate, glucose are ferrous, grape pip extraction Thing, vitamin B1, vitamin B2, vitamin B6, vitamin B12, glucomannans, lipoic acid, water soluble oligosaccharide, shell are few Sugar, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl butyrate, lactalbumin, lactic acid bacteria, Bifidobacterium, acidophilus breast bar One or more in bacterium, lentinan, GL-B, hericium erinaceum polysaccharide, pachymaran, tremella polysaccharides, oyster peptide.
  9. A kind of 9. rapidly-soluble tablet according to claim 8, it is characterised in that：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, hyaluronic acid, coriolan, Portugal's sweet dew Glycan, lipoic acid, water soluble oligosaccharide, chitosan oligosaccharide, Radix salaciae prinoidis extract, three creatine beta-hydroxies-Beta-methyl butyrate, N- formyls One or more in tyrasamine.
  10. A kind of 10. rapidly-soluble tablet according to any one of claim 1 to 9, it is characterised in that：Also contain 40 ~100 parts by weight flavourings, the flavouring are selected from steviol glycoside, Aspartame, Sucralose, saccharin sodium, honey element, sweet Grass, acesulfame potassium, A Shasufa, neotame, Tagatose, disodium glycyrrhizinate, glucose, fructose, sucrose, xylitol, simple syrup, fruit juice Syrup, honey, glycerine, sorbierite, mannitol, mogroside, oligosaccharide, water-soluble natural essence, water-soluble compound essence, The equivalent essence of water-soluble natural, water-soluble fermentation essence, fruit juice powder, natural vegetable juice powder, vegetable condensed juice powder, fruit are dense One or more in contracting juice powder, adenosine monophosphate, vitamin C, malic acid, citric acid.
  11. A kind of 11. rapidly-soluble tablet according to claim 10, it is characterised in that：The flavouring is selected from stevioside Glycosides, Aspartame, Sucralose, honey element, radix glycyrrhizae, acesulfame potassium, malic acid, citric acid, oligosaccharide, water-soluble natural essence, One or more in fruit juice powder.
  12. A kind of 12. rapidly-soluble tablet according to any one of claim 1 to 9, it is characterised in that：Also contain 5 ~20 parts by weight of binder, it is fine that described adhesive is selected from PVP, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl Tie up the one or more in plain sodium, methylcellulose, ethyl cellulose, gelatin, carbomer, starch slurry.
  13. A kind of 13. rapidly-soluble tablet according to any one of claim 1 to 9, it is characterised in that：Also contain 2 ~20 parts by weight colouring agents, the colouring agent be selected from sunset yellow, lemon yellow, amaranth, newly red, erythrosine, famille rose, it is indigo, One or more in light blue.
  14. 14. according to any one of claim 1 to 9 it is a kind of can rapid dispersion tablet, it is characterised in that：Also contain 5-30 parts by weight coating agents, the coating agent are selected from the sucrose, high molecular polymer of good film-forming property, plasticizer, emulsifying agent, water-soluble One or more in property pigment, anticaking agent, opacifier, defoamer, brightener.
  15. A kind of 15. composition containing collagen according to claim 14, 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 or more in ketone, polyvinyl alcohol.
  16. A kind of 16. composition containing collagen according to claim 14, it is characterised in that：Described plasticizer choosing One or more from glycerine, tween, polyethylene glycol, propane diols.
  17. A kind of 17. composition containing collagen according to claim 14, it is characterised in that：Described emulsifying agent choosing From lauryl sodium sulfate.
  18. A kind of 18. rapidly-soluble tablet according to any one of claim 1 to 17, it is characterised in that：Described The weight of agent is 0.1~2.0 gram/piece.
  19. A kind of 19. rapidly-soluble tablet according to claim 18, it is characterised in that：The weight of the tablet is 0.8 ~1.5 grams/piece.
  20. A kind of 20. preparation method of rapidly-soluble tablet any one of claim 1 to 19, it is characterised in that Comprise the following steps：
    Method one：All raw materials are weighed, is well mixed, mixture is placed in tablet press machine, direct tablet compressing；
    Or method two：All raw materials are crossed into 80 mesh sieves, weigh after active component, excipient, other auxiliary materials using dry granulation method, Particle is made in one kind in wet granulation process, marumerization, then by particle and mix lubricant, tabletting；
    The dry granulation method：Active component, excipient, other auxiliary materials will be weighed up to be well mixed, by mixture with dry granulation Machine is pressed into sheet or tabular, then is ground into sizeable particle, whole grain of sieving；
    The wet granulation process：The active component weighed up, excipient, other auxiliary materials in addition to adhesive are put into wet granulator It is well mixed in container, spraying into binder solution or wetting agent, (binder solution or wetting agent dosage are the total dosage of solid material 10-15%), material is made into particle, and particle is sent to and excessive caking is crushed in pelletizing machine, sieving, then dry whole grain Produce.Binder solution concentration is 1%-25%, and from binder aqueous solution or adhesive ethanol water, wetting agent selects water Or 30%~70% ethanol water；
    The marumerization：The active component weighed up, excipient, other auxiliary materials in addition to adhesive are put into closed fluidisation In bed, carrying out fluidisation is well mixed powder.Sprayer unit is started, sprays into binder aqueous solution, droplet condenses on powder, directly Just stop spraying to required particle size；Finally, by particle drying, binder aqueous solution concentration is 1%-15%, adhesive water Solution usage is the 10-20% of the total dosage of solid material.
    The tablet can also be coated.
CN201711012203.2A 2017-10-25 2017-10-25 A kind of rapidly-soluble tablet and preparation method thereof Pending CN107823168A (en)

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CN108613857A (en) * 2018-06-11 2018-10-02 佛山市顺德区易优生物医药有限公司 The preparation method of buffer solution dispersion instant solid composite
CN108719988A (en) * 2018-05-31 2018-11-02 北京素维生物科技有限公司 A kind of Co-Q10 inclusion compound and its preparation process
CN108783138A (en) * 2018-07-05 2018-11-13 青岛海芬生态科技有限公司 A kind of women face-nourishing health-care beverage and preparation method thereof
CN108815269A (en) * 2018-07-03 2018-11-16 郑州博凯医药保健品有限公司 Folic acid ferrous gluconate vitamin C effervescent tablet and its preparation method and application
CN108813624A (en) * 2018-05-31 2018-11-16 量子高科(中国)生物股份有限公司 It is a kind of with promoted skin elasticity and the composition of moisture content and its preparation method and application
CN108902312A (en) * 2018-08-31 2018-11-30 湖南艾达伦科技有限公司 A kind of Siraitia grosvenorii flavored fermented milk and preparation method thereof
CN110583942A (en) * 2019-09-12 2019-12-20 四川博浩达生物科技有限公司 Solid beverage containing inositol and glutathione
CN110623930A (en) * 2019-10-11 2019-12-31 桂林南药股份有限公司 Riboflavin tablet capable of being rapidly dissolved out and preparation method thereof
CN111084250A (en) * 2018-10-23 2020-05-01 山东坦途农业科技有限公司 Drinking product and preparation process and package thereof
WO2020093192A1 (en) * 2018-11-05 2020-05-14 重庆小丸科贸有限公司 Water-soluble active particle, preparation method therefor and use thereof
CN111481516A (en) * 2020-04-09 2020-08-04 江苏海悦康医药科技有限公司 Medicinal composition containing vitamin B1 and preparation method thereof
CN112806579A (en) * 2021-01-18 2021-05-18 湖南慧泽生物医药科技有限公司 Formula food for gout patients
CN113181129A (en) * 2020-01-14 2021-07-30 亚宝药业集团股份有限公司 Preparation method of stable thioctic acid tablet
CN113974171A (en) * 2021-11-08 2022-01-28 北京素维生物科技有限公司 Slightly water-soluble composition, slightly water-soluble food or medicine and preparation method thereof
CN115212206A (en) * 2022-08-15 2022-10-21 江苏知原药业股份有限公司 Medicinal composition containing pirfenidone and preparation method thereof

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CN108719988A (en) * 2018-05-31 2018-11-02 北京素维生物科技有限公司 A kind of Co-Q10 inclusion compound and its preparation process
CN108813624A (en) * 2018-05-31 2018-11-16 量子高科(中国)生物股份有限公司 It is a kind of with promoted skin elasticity and the composition of moisture content and its preparation method and application
CN108719988B (en) * 2018-05-31 2022-02-15 北京素维生物科技有限公司 Coenzyme Q10 clathrate and preparation process thereof
CN108613857A (en) * 2018-06-11 2018-10-02 佛山市顺德区易优生物医药有限公司 The preparation method of buffer solution dispersion instant solid composite
CN108815269A (en) * 2018-07-03 2018-11-16 郑州博凯医药保健品有限公司 Folic acid ferrous gluconate vitamin C effervescent tablet and its preparation method and application
CN108783138A (en) * 2018-07-05 2018-11-13 青岛海芬生态科技有限公司 A kind of women face-nourishing health-care beverage and preparation method thereof
CN108902312A (en) * 2018-08-31 2018-11-30 湖南艾达伦科技有限公司 A kind of Siraitia grosvenorii flavored fermented milk and preparation method thereof
CN111084250A (en) * 2018-10-23 2020-05-01 山东坦途农业科技有限公司 Drinking product and preparation process and package thereof
WO2020093192A1 (en) * 2018-11-05 2020-05-14 重庆小丸科贸有限公司 Water-soluble active particle, preparation method therefor and use thereof
CN110583942A (en) * 2019-09-12 2019-12-20 四川博浩达生物科技有限公司 Solid beverage containing inositol and glutathione
CN110583942B (en) * 2019-09-12 2022-07-29 四川博浩达生物科技有限公司 Solid beverage containing inositol and glutathione
CN110623930A (en) * 2019-10-11 2019-12-31 桂林南药股份有限公司 Riboflavin tablet capable of being rapidly dissolved out and preparation method thereof
CN113181129A (en) * 2020-01-14 2021-07-30 亚宝药业集团股份有限公司 Preparation method of stable thioctic acid tablet
CN113181129B (en) * 2020-01-14 2022-07-22 亚宝药业集团股份有限公司 Preparation method of stable thioctic acid tablet
CN111481516A (en) * 2020-04-09 2020-08-04 江苏海悦康医药科技有限公司 Medicinal composition containing vitamin B1 and preparation method thereof
CN112806579A (en) * 2021-01-18 2021-05-18 湖南慧泽生物医药科技有限公司 Formula food for gout patients
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CN115212206B (en) * 2022-08-15 2023-04-18 江苏知原药业股份有限公司 Medicinal composition containing pirfenidone and preparation method thereof

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