CN107510671A - A kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form - Google Patents
A kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form Download PDFInfo
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- CN107510671A CN107510671A CN201610427387.8A CN201610427387A CN107510671A CN 107510671 A CN107510671 A CN 107510671A CN 201610427387 A CN201610427387 A CN 201610427387A CN 107510671 A CN107510671 A CN 107510671A
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- 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
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/01—Hydrolysed proteins; Derivatives thereof
- A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
- A61K38/014—Hydrolysed proteins; Derivatives thereof from animals from connective tissue peptides, e.g. gelatin, collagen
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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
- A61K9/2004—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
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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
- A61K9/2004—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
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Abstract
The present invention is " a kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form ", belongs to field of medicine preparations.The present invention includes 0.1%~80% glycitols filler, 0~20% Icing Sugar class filler, 0~20% other fillers according to mass percent auxiliary material composition), disintegrant 5~20%, lubricant 0.1~5% and flavouring 0.1~5%, glidant 0~2%.The multi-functional auxiliary material mobility and compressibility are good, direct powder compression can not only be applied, it also is adapted for the various oral cavity rapid release tablets that pelletizing press sheet prepares medicine and health food, especially suitable for formulations such as oral disnitegration tablet, chewable tablets, buccal tablet, sublingual tablet, dispersible tablets, it is adapted to industrialization large-scale production, good auxiliary material and process choice is provided to prepare the oral dosage form of excellent mouthfeel, quality and process stabilizing.
Description
Technical field
The invention belongs to field of medicine preparations, is related to a kind of multi-functional auxiliary material composition of oral dosage form, further relates to apply
The multi-functional auxiliary material prepares the preparation method of oral dosage form.
Background technology
Tablet is most widely used a kind of formulation in medicine or health food at present, has steady quality, dosage accurate
Really, the advantages such as and production cost high with easy to carry, production efficiency be low are taken.Meanwhile because its exist disintegration time otherness it is big,
Bioavilability is not high, part population or the problems such as patient swallow's difficulty, is above somewhat limited in application.Especially
For children, swallow the tablet or capsule of medicine or health food, all always one it is challenging the problem of.Mouthful
Sense difference and dysphagia can all reduce the compliance of children, so as to directly affect medication effect or the battalion of disease
Support supplement.The problem of dysphagia, is not only existed only in pediatric population, it is estimated that, 50% people is there are about to swallowing tablet and glue
Capsule is had any problem, and especially most of elderly patients, stroke patient or the patient that can't take care of oneself, which exist, swallows difficulty
Problem, leverage the compliance of drug therapy or nutritional supplementation.Therefore how to improve the mode of taking of oral tablet turns into
One problem of people's growing interest.Some oral dosage forms are quickly grown in recent years, such as oral disnitegration tablet, dispersible tablet etc..Mouthful
Cavity disintegrating tablet abbreviation oral disintegrating tablet, it can be disintegrated or be dissolved in saliva rapidly in mouth, without with water delivery service, medicine or nutritional ingredient
Can be by the mucosal absorption in oral cavity or intestines and stomach, bioavilability is higher than ordinary preparation, the side effect as caused by first-pass metabolism
It can also mitigate.The usual disintegration time of oral disnitegration tablet is several seconds to tens of seconds, is usually no more than 1 minute, especially suitable for gulping down
Swallow difficult patient (such as old man, children) or Parkinson's disease, abalienation, brain paralysis disease and the treatment of some long-term beds
Patient, the also geologist of field work drinking-water inconvenience and the people etc. of desert area.
As conventional tablet, oral dosage form mainly includes medicine or active component and auxiliary material.Auxiliary material is medicine or guarantor
Essential important component in health food, according to its function be respectively filler, adhesive, disintegrant, lubricant, rectify
Taste agent etc..Auxiliary material is not only related to medicine or active component and is applied to suitable dosage form in clinical or life, Er Qiehui
All have a great impact to product quality, medicine or active component speed of action, bioavilability, toxic side effect etc..Suitable
Auxiliary material forms the performance to medicine or the practical application and curative effect of active component, there is positive key effect.Research and development
With security, feature, adaptability, the auxiliary material of high efficiency and its application to improving preparation integral level and exploitation new formulation
Technology is significant.In oral dosage form, usually formed using mannitol and microcrystalline cellulose as auxiliary material, Yin Ganlu
Alcohol taste and sweet mouthfeel is refrigerant, but compressibility is general, the compressibility of microcrystalline cellulose well but mouthfeel is poor, both combination applications can be with
Improve the physical property feature of product formula, meet the requirement of production technology.Because oral dosage form mouthfeel requires higher, microcrystalline cellulose
Plain proportion can not be too big, otherwise has harmful effect to mouthfeel.If contain the medicine that some compressibility are very poor in product formula
It thing or active component, and when ratio is higher, will seem the problem of compressibility than more prominent, realize that big production technology compares and had
Challenge.
A small amount of Icing Sugar (mainly powdered glucose) is introduced in the oral dosage form multi-functional auxiliary material of the present invention, can not only be shown
Writing improves the compressibility of product formula, and can increase the natural sugariness of product, hence it is evident that the mouthfeel of oral dosage form is improved,
Low-sugar type oral dosage form can be prepared.For some products, powdered glucose can not also be introduced, only selects mannitol
Or the sugar alcohol such as antierythrite and a small amount of microcrystalline cellulose prepare Sugarless type oral dosage form as filler and adhesive.
Oral dosage form multi-functional auxiliary material in the present invention is not simply that several single pharmaceutical adjuncts are mutually mixed
Close, but by Scientific experimental design and abundant experimental results, two or more unitary agent auxiliary materials are filtered out according to certain ratio
Example composition can preferably meet the multi-functional auxiliary material of technique productions.The auxiliary material can be applied to technique of direct powder compression, and
According to the property and ratio of medicine or active component different auxiliary material combination can be selected to carry out the preparation of oral dosage form.
Multi-functional auxiliary material in the present invention is chewable tablets, buccal tablet, sublingual tablet, scattered in addition to suitable for oral disnitegration tablet
The formulations such as piece can also use, and the unification of multi-functional, high efficiency, adaptability can be achieved, and be adapted to industrialization large-scale production, to prepare
Mouthfeel is excellent, the oral dosage form of quality and process stabilizing provides good auxiliary material and process choice, while abundant and expand
The applicable medicine or active component of oral dosage form.
The content of the invention
1 present invention aims at solve the deficiency of compressibility and mouthfeel in the prior art, there is provided a kind of oral dosage form
Multi-functional auxiliary material.
2 according to mass percent auxiliary material composition includes 0.1%~80% glycitols filler, 0~20% Icing Sugar class is filled out
Fill agent, 0~20% other fillers, disintegrant 5~20%, lubricant 0.1~5% and flavouring 0.1~5%, glidant 0~
2%.
Further, the multi-functional auxiliary material of the oral dosage form, following components is included according to mass percent meter：Glycitols
Filler 40~65%, Icing Sugar class filler 0~10%, other fillers 0~8%, disintegrant 8~15%, lubricant 0.75
~1.5% and flavouring 0.5~4%, glidant 0.25~0.75%.
Further, the glycitols filler is the one or more in mannitol, antierythrite, maltitol；Icing Sugar
Class filler is cane sugar powder, powdered glucose, the one or more of maltitol powder；Other fillers are starch, pregelatinized starch, paste
One or more in essence, lactose and microcrystalline cellulose；The disintegrant is low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl
One or more in sodium cellulosate, crosslinked carboxymethyl fecula sodium, PVPP；The lubricant is magnesium stearate, talcum
One or more in powder, stearic acid；The glidant is superfine silica gel powder；The flavouring is citric acid, saccharin sodium, A Sipa
The one or more of smooth, Steviosin and lemon-mint or other essence.
Further, the glycitols filler is mannitol, the one or more of antierythrite；Other fillers are crystallite
Cellulose；Icing Sugar class filler is powdered glucose, and the disintegrant is one in PVPP, Ac-Di-Sol
Kind is a variety of, and the lubricant is magnesium stearate；The glidant is superfine silica gel powder；The flavouring is citric acid, Steviosin
With lemon-mint essence.
Further, the preferably 60% vertical compression type mannitol of mass percent or antierythrite filler, preferably 5% vertical compression
Type microcrystalline cellulose, does not contain Icing Sugar class filler, preferably 12% disintegrant PVPP, 1% magnesium stearate lubricant or
2% stearic acid, 0.25% glidant superfine silica gel powder can be as the multi-functional auxiliary material of Sugarless type oral dosage form.
Further, the mannitol or antierythrite filler of mass percent preferably 60%, preferably 6% vertical compression type Icing Sugar class
Filler, preferably 12% disintegrant PVPP, 1% magnesium stearate lubricant or 2% stearic acid, 0.25% glidant micro mist
Silica gel, can be as the multi-functional auxiliary material of low-sugar type oral dosage form.
3 auxiliary materials of the present invention have good mobility and compressibility, and mouthfeel is naturally, can be widely applied to various oral cavities
Fast-release tablet, oral disnitegration tablet is prepared suitable for direct compression method.
Further, multi-functional auxiliary material of the present invention comprises the following steps for direct powder compression：
A sieves：All components are passed through into 20 mesh sieves respectively；
B tablettings：All components after step b is sieved are mixed evenly, and tabletting, produce oral dosage form.
Further, the filler added in the direct powder compression is microcrystalline cellulose and mannitol, and nothing can be made
Sugar-type oral dosage form.
Further, it according to mass percent is 40~60% sweet dews that the filler added in the direct powder compression, which is,
Alcohol and less than 10% powdered glucose, can be made low-sugar type oral dosage form.
Embodiment
Embodiment 1
All components in prescription are crossed 20 mesh sieves by preparation method respectively, are then mixed each component in addition to magnesium stearate equal
Even, the magnesium stearate that recipe quantity is added before tabletting continues mixing 2 minutes, tabletting, irony folic acid oral disnitegration tablet 1000 is made altogether
Piece, every 8 milligrams of iron content, the microgram of folic acid 400.
Irony folic acid oral disnitegration tablet smooth in appearance obtained by quality, it is glossy.Hardness is 4.5Kg, complete in 20 seconds in mouth
Full disintegration, cool taste is sour-sweet, no sand type.
Embodiment 2
Prescription
All components in prescription are crossed 20 mesh sieves by preparation method respectively, are then mixed each component in addition to magnesium stearate equal
Even, the magnesium stearate that recipe quantity is added before tabletting continues mixing 2 minutes, tabletting, collagen oral disnitegration tablet 1000 is made altogether
Piece, every contains 200 milligrams of collagen.
Collagen oral disnitegration tablet smooth in appearance obtained by quality, it is glossy.Hardness is 5.1Kg, complete in 36 seconds in mouth
Full disintegration, cool taste is sour-sweet, no sand type.
Embodiment 3
Prescription
All components in prescription are crossed 20 mesh sieves by preparation method respectively, are then mixed each component in addition to magnesium stearate equal
Even, the magnesium stearate that recipe quantity is added before tabletting continues mixing 2 minutes, tabletting, vitamin C oral disintegration tablet 1000 is made altogether
Piece, every 60 milligrams of containing vitamin C
Vitamin C oral disintegration tablet smooth in appearance obtained by quality, it is glossy.Hardness is 4.5Kg, in mouth in 20 seconds completely
Disintegration, cool taste is sour-sweet, no sand type.
Claims (8)
1. a kind of multi-functional auxiliary material of oral dosage form, it is characterised in that by mass percentage including following components：0.1~
80% glycitols filler, 0~20% Icing Sugar class filler, 0~20% other fillers, disintegrant 5~20%, lubricant
0.1~5% and flavouring 0.1~5%, glidant 0~2%.
2. oral dosage form multi-functional auxiliary material according to claim 1, it is characterised in that by mass percentage include with
Lower component：40%~60% glycitols filler, 0~10% Icing Sugar class filler, other fillers 0~10%, disintegrant 8~
15%th, lubricant 0.1~1.5% and flavouring 0.5~4%, glidant 0.25~0.5%.
3. the oral dosage form multi-functional auxiliary material according to claims 1 or 2, it is characterised in that the glycitols filling
Agent is the one or more in mannitol, antierythrite, maltitol, xylitol；The Icing Sugar class filler is cane sugar powder, Portugal
One or more in grape Icing Sugar, maltitol powder；Other described fillers be dextrin, lactose and microcrystalline cellulose in one kind or
It is a variety of；The disintegrant is low-substituted hydroxypropyl cellulose, Ac-Di-Sol, crosslinked carboxymethyl fecula sodium, crosslinking
One or more in PVP；The lubricant is the one or more in magnesium stearate, talcum powder, stearic acid；It is described to help
Stream agent is superfine silica gel powder；The flavouring is the one or more of citric acid, saccharin sodium, aspartame, Steviosin and essence.
4. according to the oral dosage form multi-functional auxiliary material described in claim 3, it is characterised in that the filler is sweet dew
One or more in alcohol, antierythrite, powdered glucose, microcrystalline cellulose；The disintegrant is PVPP, crosslinking carboxylic first
One or more in base sodium cellulosate, the lubricant are magnesium stearate；The glidant is superfine silica gel powder；The flavouring
For citric acid, Steviosin and lemon-mint essence.
5. oral dosage form multi-functional auxiliary material according to claim 1, it is characterised in that by the active component of recipe quantity or
Main ingredient prepares oral cavity rapid release tablet with filler, disintegrant, lubricant, glidant and flavouring using direct powder compression.
6. oral dosage form multi-functional auxiliary material according to claim 5 prepares oral dosage form, it is characterised in that the powder
Last direct compression method comprises the following steps：
A sieves：All components are passed through into 20 mesh sieves respectively；
B tablettings：All components after step b is sieved are mixed evenly, and tabletting, produce oral dosage form.
7. the multi-functional auxiliary material direct powder compression according to claim 9 prepares oral dosage form, it is characterised in that
The filler added in the step b is 40~60% mannitol and less than 10% powdered glucose according to mass percent, can be made
Obtain low-sugar type oral dosage form.
8. the multi-functional auxiliary material direct powder compression according to claim 9 prepares oral dosage form, it is characterised in that
It is microcrystalline cellulose and mannitol that filler is added in the step b, and Sugarless type oral dosage form can be made.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610427387.8A CN107510671A (en) | 2016-06-16 | 2016-06-16 | A kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610427387.8A CN107510671A (en) | 2016-06-16 | 2016-06-16 | A kind of multi-functional auxiliary material composition of oral dosage form and the preparation of oral dosage form |
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| CN107510671A true CN107510671A (en) | 2017-12-26 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111012755A (en) * | 2020-01-09 | 2020-04-17 | 仁和堂药业有限公司 | Preparation process of vitamin B6 tablets |
| CN111011566A (en) * | 2019-11-07 | 2020-04-17 | 哈尔滨梵境园生物科技有限公司 | Orally disintegrating candy tablet with immunoregulation function |
| 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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440973A (en) * | 2011-12-21 | 2012-05-09 | 西南大学 | Diphenhydramine citrate orally disintegrating tablet and preparation method thereof |
| CN105434376A (en) * | 2014-08-29 | 2016-03-30 | 武汉光谷人福生物医药有限公司 | Meisuoshuli orally disintegrating tablet and preparation method thereof |
-
2016
- 2016-06-16 CN CN201610427387.8A patent/CN107510671A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102440973A (en) * | 2011-12-21 | 2012-05-09 | 西南大学 | Diphenhydramine citrate orally disintegrating tablet and preparation method thereof |
| CN105434376A (en) * | 2014-08-29 | 2016-03-30 | 武汉光谷人福生物医药有限公司 | Meisuoshuli orally disintegrating tablet and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111011566A (en) * | 2019-11-07 | 2020-04-17 | 哈尔滨梵境园生物科技有限公司 | Orally disintegrating candy tablet with immunoregulation function |
| CN111012755A (en) * | 2020-01-09 | 2020-04-17 | 仁和堂药业有限公司 | Preparation process of vitamin B6 tablets |
| 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 |
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Application publication date: 20171226 |
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