CN107669648A - A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof - Google Patents
A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof Download PDFInfo
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- CN107669648A CN107669648A CN201711130911.6A CN201711130911A CN107669648A CN 107669648 A CN107669648 A CN 107669648A CN 201711130911 A CN201711130911 A CN 201711130911A CN 107669648 A CN107669648 A CN 107669648A
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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
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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
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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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
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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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- 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
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Abstract
The invention discloses a kind of 3D printing doxofylline oral disnitegration tablet, mainly it is prepared by the component of following mass percent using 3D printing technique：Doxofylline 40 60%, filler 20 40%, disintegrant 0 10%, adhesive 2% 10%, superfine silica gel powder 0.1 1.0%, flavouring 0 2%.The invention also discloses the preparation method of the doxofylline oral disnitegration tablet.Described doxofylline oral disnitegration tablet drug releasing rate is fast, can improve the compliance of patient on medication, especially facilitate old man, child, dysphagia person to take.
Description
Technical field
The present invention relates to a kind of doxofylline oral disnitegration tablet, more particularly to a kind of 3D printing doxofylline Orally disintegrating
Piece.The invention further relates to the preparation method of the doxofylline oral disnitegration tablet.
Background technology
Three-dimensional printing technology (three dimensionprinting, 3DP) is a kind of fast based on digital model
Fast forming technique.The U.S. in the core concept of 3D printing 19 end of the centurys of earliest origin, until the last century 80's end is by Massachusetts
Institute of Technology's exploitation just has blank.3D printing technique be on computer software according to data such as the CAD model of object or CT,
Design construction three-dimensional stereo model, it is powdered by the accumulation of material, utilization according to the concept of " successively printing, be layering "
Metal or plastics, viscous liquid etc. can jointing material, rapidly and precisely manufacture is with special external form or complex internal structure
Object.
3D printing technique is initially applied to the fields such as manufacturing industry, space flight and aviation and industrial design, with 3D printing technique
Development and maturation, this emerging science and technology initially enters field of medicaments, such as in medical model manufacture, tissue and organ regeneration, clinic
Repairing and treating and medicament research and development experiment etc. all achieve a series of achievement in research.On July 31st, 2015, U.S.'s food medicine
Product Surveillance Authority (FDA) have approved the global Spritam that first uses 3D printing technique to prepare of Aprecia companies production
(Levetiracetam, levetiracetam) rapidly dissolving tablet lists, and this indicates 3D printing technique after human organ is printed further
Strided forward to pharmaceutical field.
As global ecological environment runs down, air quality decreases, the Bronchial Asthma rate of many countries
And the death rate there are about 100,000,000 Bronchial Asthmas in trend, the whole world is raised year by year, the incidence of disease in China is about 1%, children
Up to 3%, more than 3,000 ten thousand Bronchial Asthmas are there are about according to the measuring and calculating whole nation, its onset is hurried, if malpractice or diagnosis and treatment are not
In time, patient Yi Fasheng suffocates, threat to life health.Doxofylline can alleviate bronchial spasm phenomenon, and toxic side effect is small,
And by having inhibitory action to inflammation medium and cell factor, its release can be reduced, and suppress phosphoric acid in smooth muscle cell
The activity of diesterase, the bronchial smooth muscle of relaxation, so as to have the function that to suppress asthma and reduce respiratory tract tension force.City at present
Existing doxofylline ordinary tablet disintegration time length on field, it is impossible to meet the needs of emergent patient；In addition, the more rope tea of Neulized inhalation
Alkali lye, can be with quick acting, but needs to use atomization plant, it is impossible to meets patient demand anywhere or anytime.Using 3D printing skill
Art prepares doxofylline oral disintegrating tablet and is significant.
The content of the invention
An object of the present invention is the provision of a kind of 3D printing doxofylline oral disnitegration tablet, and disintegration time is short, rises
Effect speed is fast, is adapted to dysphagia patients to take.
The second object of the present invention is the preparation method for providing above-mentioned 3D printing doxofylline oral disnitegration tablet.
In order to realize first purpose of the present invention, the present invention adopts the following technical scheme that：
A kind of 3D printing doxofylline oral disnitegration tablet, 3D printing technique is mainly used by the component of following mass percent
It is prepared：Doxofylline 40-60%, filler 20-40%, disintegrant 0-10%, adhesive 2%-10%, superfine silica gel powder
0.1-1.0%, flavouring 0-2%, are prepared using 3D printing technique.
More preferably, calculate by mass percentage, prescription includes following components：Doxofylline 50-60%, filler 20-
40%th, disintegrant 5-10%, adhesive 5%-10%, superfine silica gel powder 0.1-1.0%, flavouring 0-2%.
Described filler includes but is not limited to sucrose, dextrin, lactose, soluble starch, mannitol, sorbierite and xylose
Combination more than one or both of alcohol.
Described disintegrant includes but is not limited to low substituted hydroxy-propyl methylcellulose, crosslinked carboxymethyl fecula sodium, crosslinking
Combination more than one or both of sodium carboxymethylcellulose, PVPP and microcrystalline cellulose.
Described adhesive include but is not limited in PVP K30, hydroxypropyl cellulose and sodium carboxymethylcellulose one
Kind or two or more combinations.
One kind that described flavouring includes but is not limited in stevioside, Aspartame, Sucralose, Mai Litian and essence
Or two or more combination.
Second goal of the invention of the invention is achieved through the following technical solutions：Above-mentioned 3D printing doxofylline Orally disintegrating
The preparation method of piece, comprises the following steps：
(1) according to the parameter set in advance, using software modeling, and stl formatted files is converted into and import 3D printer
In LTY software control systems；
(2) count by weight percentage, doxofylline 40-60%, filler 20-40%, disintegrant 0-10%, adhesive
2%-10%, superfine silica gel powder 0.1-1.0%, flavouring 0-2% are mixed in proportion, and it is rapid-result soon to load 3D printing as medicinal powder
In the powder box of type machine；
(3) liquid will be cohered to be fitted into print cartridge；
(4) control system output order, control 3D printing rapidform machine printing doxofylline oral disintegrating tablet：Power spreading device is first
In one layer of powder bed upper berth medicinal powder, then printing head is mobile in the selection area of X-Y direction of principal axis and liquid is cohered in spraying, is oral disintegrating tablet
First layer；Subsequent powder bed entire lowering in the Z-axis direction, dropping distance is equal with spraying floor height, and power spreading device is on powder bed
Second layer powder is spread, repeats to operate above, so successively prints, until reaching the spraying number of plies, complete the printing of oral disintegrating tablet；
(5) treat that oral disintegrating tablet coheres taking-up, remove the unnecessary powder of surrounding, produced after drying.
In the parameter of the step (1), oral disintegrating tablet three-dimensional parameter is：Radius 5-8mm, thickness 3.00-6.00mm, per layer by layer
High 0.2-0.3mm, number of plies 15-25 layers, cohering liquid parameter is：Spray rate 4nL*12kz, spraying number 1-3 times.
Described coheres liquid for 25-50% ethanol solutions, the water or ethanol solution of PVP K30.The floor height is to beat
Spraying floor height during print.
Beneficial effects of the present invention：
1. 3D printing doxofylline oral disintegrating tablet provided by the invention has, drug releasing rate is fast, can improve patient and take medicine
The features such as compliance of thing, especially facilitate old man, child, dysphagia person；Moreover, relatively existing technology, 3D printing technique
Individual administration and precisely treatment can be realized according to the customized dosage for being suitable for patient of individual difference of patient, so as to
Reduce patient to take piece number or reduce the step of pharmacist cuts tablet, pharmaceutical preparation is played greatest treatment efficacy, and make medicine poison secondary
Effect is preferably minimized.
2. the present invention prepares tablet medicine using 3D printing technique, it is possible to achieve the personalized printing of medicine, can also have
The problems such as traditional pressing of solution of effect prepares the disintegrating tablet occurred during tablet medicine, loose pieces.
3. the present invention is using the process printing medicine that binding liquid is sprayed on drug powder, so obtained tablet shaping
Property is good, while mechanical property is more preferable.
Embodiment
With reference to embodiment, the present invention is further illustrated, but not as restriction protection scope of the present invention.
Embodiment 1
Prescription is as follows：
3D printing parameter is as follows：
Preparation method is as follows：
(1) according to the parameter set in advance, using software modelings such as CAD, and stl formatted files is converted into and import 3D printing
In the LTY software control systems of machine.
(2) count by weight percentage, by doxofylline (50%), sucrose (39%), PVP K30 (10%), micro mist
Silica gel (1%) mixes in proportion, and is fitted into as medicinal powder in the powder box of 3D printing rapidform machine.
(3) ethanol solution of 1% PVP K30-50% is fitted into print cartridge.
(4) control system output order, control 3D printing rapidform machine printing doxofylline oral disintegrating tablet：Power spreading device is first
On powder bed upper berth, a layer thickness is 0.3mm medicinal powder, and then printing head is mobile in the selection area of X-Y direction of principal axis and sprays viscous
Liquid is tied, is the first layer of oral disintegrating tablet；Subsequent powder bed entire lowering 0.3mm in the Z-axis direction, power spreading device is on powder bed upper berth second
Layer powder, repeat to operate above, so successively print, until reaching the spraying number of plies, complete the printing of oral disintegrating tablet.
(5) treat that oral disintegrating tablet coheres taking-up, remove the unnecessary powder of surrounding, produced after drying.
The disintegration time limited experiment of doxofylline oral disintegrating tablet：
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determine the disintegration time limited of doxofylline oral disintegrating tablet.Collapse
The solution time is 24 ± 1s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Embodiment 2
Prescription is as follows：
3D printing parameter is as follows：
Preparation method is as follows：
(1) according to the parameter set in advance, using software modelings such as CAD, and stl formatted files is converted into and import 3D printing
In the LTY software control systems of machine.
(2) count by weight percentage, by doxofylline (52%), sucrose (30%), low substituted hydroxy-propyl Methyl cellulose
Plain (5%), PVP K30 (10%), superfine silica gel powder (1%), Sucralose (2%) mix in proportion, and are filled as medicinal powder
In the powder box for entering 3D printing rapidform machine.
(3) 50% ethanol solution is fitted into print cartridge.
(4) control system output order, control 3D printing rapidform machine printing doxofylline oral disintegrating tablet：Power spreading device is first
On powder bed upper berth, a layer thickness is 0.25mm medicinal powder, and then printing head is mobile in the selection area of X-Y direction of principal axis and sprays
Liquid is cohered, is the first layer of oral disintegrating tablet；Subsequent powder bed entire lowering 0.25mm in the Z-axis direction, power spreading device is on powder bed upper berth
Second layer powder, repeat to operate above, so successively print, until reaching the spraying number of plies, complete the printing of oral disintegrating tablet.
(5) treat that oral disintegrating tablet coheres taking-up, remove the unnecessary powder of surrounding, produced after drying.
The disintegration time limited experiment of doxofylline oral disintegrating tablet：
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determine the disintegration time limited of doxofylline oral disintegrating tablet.Collapse
The solution time is 16 ± 1s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Embodiment 3
Prescription is as follows：
3D printing parameter is as follows：
Preparation method is as follows：
(1) according to the parameter set in advance, using software modelings such as CAD, and stl formatted files is converted into and import 3D printing
In the LTY software control systems of machine.
(2) count by weight percentage, by doxofylline (57%), sucrose (20%), crosslinked carboxymethyl fecula sodium
(10%), PVP K30 (10%), superfine silica gel powder (1%), stevioside (2%) mix in proportion, and load 3D as medicinal powder
In the powder box for printing rapidform machine.
(3) ethanol solution of 1% PVP K30-50% is fitted into print cartridge.
(4) control system output order, control 3D printing rapidform machine printing doxofylline oral disintegrating tablet：Power spreading device is first
On powder bed upper berth, a layer thickness is 0.2mm medicinal powder, and then printing head is mobile in the selection area of X-Y direction of principal axis and sprays glutinous
Liquid is tied, is the first layer of oral disintegrating tablet；Subsequent powder bed entire lowering 0.2mm in the Z-axis direction, power spreading device is on powder bed upper berth second
Layer powder, repeat to operate above, so successively print, until reaching the spraying number of plies, complete the printing of oral disintegrating tablet.
(5) treat that oral disintegrating tablet coheres taking-up, remove the unnecessary powder of surrounding, produced after drying.
The disintegration time limited experiment of doxofylline oral disintegrating tablet：
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determine the disintegration time limited of doxofylline oral disintegrating tablet.Collapse
The solution time is 8 ± 1s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Claims (9)
1. a kind of 3D printing doxofylline oral disnitegration tablet, it is characterized in that, 3D is mainly used by the component of following mass percent
Printing technique is prepared：It is doxofylline 40-60%, filler 20-40%, disintegrant 0-10%, adhesive 2%-10%, micro-
Powder silica gel 0.1-1.0%, flavouring 0-2%.
2. 3D printing doxofylline oral disnitegration tablet according to claim 1, it is characterized in that, the mass percent of each component
For：Doxofylline 50-60%, filler 20-40%, disintegrant 5-10%, adhesive 5%-10%, superfine silica gel powder 0.1-
1.0%th, flavouring 0-2%.
3. 3D printing doxofylline oral disnitegration tablet according to claim 1 or 2, it is characterized in that, described filler bag
Include but be not limited to sucrose, be more than one or both of dextrin, lactose, soluble starch, mannitol, sorbierite and xylitol
Combination.
4. 3D printing doxofylline oral disnitegration tablet according to claim 1 or 2, it is characterized in that, described disintegrant bag
Include but be not limited to low substituted hydroxy-propyl methylcellulose, crosslinked carboxymethyl fecula sodium, Ac-Di-Sol, the poly- second of crosslinking
Combination more than one or both of alkene pyrrolidone and microcrystalline cellulose.
5. 3D printing doxofylline oral disnitegration tablet according to claim 1 or 2, it is characterized in that, described adhesive bag
Include but be not limited to PVP K30, combination more than one or both of hydroxypropyl cellulose and sodium carboxymethylcellulose.
6. 3D printing doxofylline oral disnitegration tablet according to claim 1 or 2, it is characterized in that, described flavouring bag
Include but be not limited to stevioside, combination more than one or both of Aspartame, Sucralose, Mai Litian and essence.
7. the preparation method of the 3D printing doxofylline oral disnitegration tablet described in claim any one of 1-6, it is characterized in that, including
Following steps：
(1) according to the parameter set in advance, using software modeling, and the LTY for being converted into stl formatted files importing 3D printer is soft
In part control system；
(2) count by weight percentage, doxofylline 40-60%, filler 20-40%, disintegrant 0-10%, adhesive 2%-
10%th, superfine silica gel powder 0.1-1.0%, flavouring 0-2% are mixed in proportion, and load 3D printing rapidform machine as medicinal powder
Powder box in；
(3) liquid will be cohered to be fitted into print cartridge；
(4) control system output order, control 3D printing rapidform machine printing doxofylline oral disintegrating tablet：Power spreading device is first in powder
Bed one layer of upper berth medicinal powder, then printing head is mobile in the selection area of X-Y direction of principal axis and sprays and coheres liquid, is the of oral disintegrating tablet
One layer；Subsequent powder bed entire lowering in the Z-axis direction, dropping distance is equal with spraying floor height, and power spreading device is on powder bed upper berth the
Two layers of powder, repeat to operate above, so successively print, until reaching the spraying number of plies, complete the printing of oral disintegrating tablet；
(5) treat that oral disintegrating tablet coheres taking-up, remove the unnecessary powder of surrounding, produced after drying.
8. the preparation method of 3D printing doxofylline oral disnitegration tablet according to claim 7, it is characterized in that, the step
(1) in parameter, oral disintegrating tablet three-dimensional parameter is：Radius 5-8mm, thickness 3.00-6.00mm, every layer of powder thickness 0.2-0.3mm,
Number of plies 15-25 layers, cohering liquid parameter is：Spray rate 4nL*12kz, spraying number 1-3 times.
9. the preparation method of 3D printing doxofylline oral disnitegration tablet according to claim 7, it is characterized in that, the step
(3) in, liquid is cohered for 25-50% ethanol solutions, the water or ethanol solution of PVP K30.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110269844A (en) * | 2018-03-15 | 2019-09-24 | 互竑实业(上海)有限公司 | A kind of preparation method based on ink-jet 3D printing olanzapine orally-disintegrating tablet |
| CN110354089A (en) * | 2018-04-09 | 2019-10-22 | 互竑实业(上海)有限公司 | A kind of 3D printing perphenazine oral disintegrating tablet and preparation method thereof |
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| CN106821755A (en) * | 2017-02-17 | 2017-06-13 | 广东药科大学 | A kind of preparation method of any dose tablet based on 3D printing |
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| CN101028254A (en) * | 2007-04-05 | 2007-09-05 | 合肥合源医药科技有限公司 | Sustaining agent of Duosuo theosine and its preparation |
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| CN110354089A (en) * | 2018-04-09 | 2019-10-22 | 互竑实业(上海)有限公司 | A kind of 3D printing perphenazine oral disintegrating tablet and preparation method thereof |
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| CN107669648B (en) | 2021-02-09 |
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