CN106562935A - Colored spray coating liquid and acetaminophen colored cartoon orally disintegrating tablet for 3D printing, and preparation method thereof - Google Patents
Colored spray coating liquid and acetaminophen colored cartoon orally disintegrating tablet for 3D printing, and preparation method thereof Download PDFInfo
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- CN106562935A CN106562935A CN201610847287.0A CN201610847287A CN106562935A CN 106562935 A CN106562935 A CN 106562935A CN 201610847287 A CN201610847287 A CN 201610847287A CN 106562935 A CN106562935 A CN 106562935A
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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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
- A61K9/205—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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- 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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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
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Abstract
The invention provides colored spray coating liquid and an acetaminophen colored cartoon orally disintegrating tablet for 3D (3-Dimension) printing, and a preparation method thereof. The colored spray coating liquid for 3D printing can be combined with medicine powder for spray coating printing, and the medicine powder is jointly mixed to be printed into a colored 3D finished product. The colored cartoon orally disintegrating tablet is prepared by a 3D printing technology. Compared with a conventional pharmaceutical method, the preparation method has the advantages that the preparation process is simple; the processes of preparing a special-shaped sheet stamping die, preparing particles, performing heating drying and the like are not needed; the cartoon shape and the tablet color can be freely regulated according to the fondness of children; and the compliance of children patients is greatly improved.
Description
Technical field
The present invention relates to drug design techniques field, particularly relates to a kind of chromatic spray painting liquid for 3D printing and to acetyl
Amino phenols colorful cartoon oral cavity disintegration tablet and preparation method.
Background technology
The U.S. in the core concept of 3D printing (three dimension printing, 3DP) 19 end of the centurys of earliest origin,
American Charles Hull in 1986 have invented First 3D printer, and China is for the 3D printing skill that begins one's study from nineteen ninety
Art.Hu Dilipusen (Hod Lipson) etc. is written《3D printing:From imagining reality》In book, 3D printing is manufactured into skill
Important symbol of the art as the third time industrial revolution, although and point out still to be left to be desired, 3D printing technique market potential is huge,
In traditional manufacture to the stage of intelligent, the continuous evolution of Digitized manufacturing industry, the Fashion of Future manufacturing industry trend certainly will be become
One of numerous breakthroughs, and promote the different army of new industry situation, new model, new mechanism, new technique and new leader to dash forward.
3D printing technique is initially applied to the fields such as manufacturing industry, Aero-Space 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
The aspect such as repairing and treating and medicament research and development test all achieves a series of achievement in research.
In conventional pharmaceutical technology, preparing Special-shaped sheet needs first to produce punch die, according still further to traditional technique for preparing tablet
Process is produced, including pelletize, drying, granulate, tabletting etc., not only long preparation period, complex process, prepare Special-shaped sheet punch die into
This is very high, and cannot change shape at any time according to the hobby of child, cannot more prepare the tablet of colour.
Acetaminophen is child's first-selection antipyretic that WHO recommends, relative to other conventional ntipyretic analgesic medicines, by
It is safer, and cheap in the little asthmatic patient to other ntipyretic analgesic medicine allergy of its GI irritation and child, should
Medicine is one of most widely used medicine in the whole world.Acetaminophen oral cavity disintegration tablet is listed by CFDA approvals, is classified as national base
This assigned drug of medical insurance catalogue kind, is mainly used in the child of about 6 months to ten years old, its commercially available specification be 160mg/ pieces, youngster
Virgin (about 6～24 months) dosage is 1 piece/times, and child (about 2～10 years old) dosage is 2 pieces/times.According to the physiological feature of child, 2
Child's cognitive competence certain for things has more than year, usually occurs the problems such as resisting medication, clothes in drug administration process
Medicine is more difficult, and the tablet of outward appearance colorful cartoon can mitigate the psychology that this kind of child patient resists medication.And traditional preparation side
Method cannot prepare the oral cavity disintegration tablet of colorful cartoon, the poor compliance of child's medication according to the hobby of child.
3D printing technique prepares colorful cartoon oral cavity disintegration tablet, compared with conventional pharmaceutical method：Preparation process is simple, without the need for preparing
Special-shaped sheet punch die, without the need for the process such as granulation, heat drying, and cartoon shape and tablet can arbitrarily be adjusted according to the hobby of child
Color, be greatly enhanced the compliance of child patient.
The content of the invention
One purpose of the present invention is to propose a kind of chromatic spray painting liquid for 3D printing, can be entered with bound drug powder
Row spraying is printed, and by drug powder, mixing is printed as colored 3D finished products jointly.
What the technical scheme of this purpose was realized in：A kind of chromatic spray painting liquid for 3D printing, including edible color
Plain solution and binding liquid.
Further, the binding liquid is ethanol solution, starch solution, methylated cellulose aqueous solution or sodium carboxymethyl cellulose
Aqueous solution.
Further, in the ethanol water, the percent by volume of ethanol is 5～90%.
More preferred, the ethanol solution is the aqueous solution for only containing ethanol, or added with polyvidone, Polyethylene Glycol, hydroxypropyl
The ethanol water of base cellulose or hydroxypropyl methyl cellulose.
Further, the edible pigment solution includes yellow, carmetta, cyan edible pigment solution, these three face
Color belongs to three primary colories, can mix other colors as needed.
Another object of the present invention is to propose a kind of acetaminophen colorful cartoon oral cavity disintegration tablet for 3D printing, energy
Enough made by the means of 3D printing, the color of cartoon shape and tablet can be arbitrarily adjusted according to the hobby of child, greatly
Improve the compliance of child patient.What the technical scheme of this purpose was realized in：A kind of acetparaminosalol for 3D printing
Phenol colorful cartoon oral cavity disintegration tablet, including：Drug powder containing acetaminophen, the chromatic spray painting liquid for 3D printing, he
Proportioning specifically determined according to the actual pattern for printing.
Further, the drug powder includes the acetaminophen 50～65% of mass percent, and adjuvant 35～
50%.
Further, the adjuvant includes disintegrating agent 1-10%, binding agent 4-15% and correctivess 25-30%.
Further, the disintegrating agent is dried starch, sodium alginate, alginic acid, Microcrystalline Cellulose, carboxymethyl starch sodium, low
Replace hydroxypropyl cellulose, Croscarmellose Sodium or crospolyvinylpyrrolidone；Described adhesive is PVPK30、
HPMC、HPC、CMC-Na；The correctivess are sucrose, Mannitol, essence.
Another object of the present invention is to a kind of method of 3D printing acetaminophen colorful cartoon oral cavity disintegration tablet is proposed, with
Conventional pharmaceutical method is compared：Preparation process is simple, need not prepare Special-shaped sheet punch die, without the need for processes such as granulation, heat dryings, and
The compliance of child patient can be greatly enhanced according to the color of the hobby of child arbitrarily adjustment cartoon shape and tablet.This mesh
Be achieved through the following technical solutions：A kind of method of 3D printing acetaminophen colorful cartoon oral cavity disintegration tablet, employs
The acetaminophen colorful cartoon oral cavity disintegration tablet for 3D printing.
Further, the method for the 3D printing acetaminophen colorful cartoon oral cavity disintegration tablet, first by computer software
The colorful cartoon shape of design acetaminophen colorful cartoon oral cavity disintegration tablet, then using double print cartridge spraying edibles of 3D printer
Pigment solution and binding liquid are by drug powder molding bonded.
More specific, comprise the following steps：
S1. the design of the colorful cartoon shape of oral cavity disintegration tablet is carried out, and imports 3D printer；
S2. pre-set 3D printing molding parameter；
S3. acetaminophen and adjuvant are mixed into into drug powder according to proportioning；
S4. the bonding solution for preparing, edible pigment solution are encased in different printer ink cartridges；
S5. the powder obtained by S3 is transported on 3D printing platform carries out powdering, is existed by the printing head of 3D printing system
X-Y direction of principal axis is moved, and first spraying one time according to the colour information of each layer cross section profile of software design colorful cartoon model can
Edible pigment solution, then binding liquid is sprayed, by powder bonding layered piece；Meanwhile, in the Z-axis direction, will by axis body motion
Floor height is sprayed described in print platform entire lowering, spraying edible pigment solution again, binding liquid are printed repeatedly, until
The spraying number of plies is reached, after printing terminates, tablet is taken out, surrounding residual powder is cleaned and is obtained final product the acetaminophen colorful cartoon
Oral cavity disintegration tablet.
The present invention for prior art, with following technical advantage：
The chromatic spray painting liquid for 3D printing of the present invention, can carry out spraying printing with bound drug powder, by medicine
Mixing is printed as colored 3D finished products to thing powder jointly.
The acetaminophen colorful cartoon oral cavity disintegration tablet for 3D printing of the present invention, can be by the handss of 3D printing
Section is made, compared to oral cavity disintegration tablet prepared by traditional handicraft, with rich color (tradition is single color), and in the structure of product
More enrich.
The method of the 3D printing acetaminophen colorful cartoon oral cavity disintegration tablet of the present invention, with conventional pharmaceutical method phase
Than：Preparation process is simple, need not prepare Special-shaped sheet punch die, without the need for processes such as granulation, heat dryings, and can be according to the happiness of child
The color of good arbitrarily adjustment cartoon shape and tablet, is greatly enhanced the compliance of child patient.
Specific embodiment
In below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely retouched
State, it is clear that described embodiment is only a part of embodiment of the invention, rather than the embodiment of whole.Based on the present invention
In embodiment, the every other enforcement obtained under the premise of creative work is not made by those of ordinary skill in the art
Example, belongs to the scope of protection of the invention.
Unless stated otherwise, the present invention is adopted reagent, method and apparatus for the art conventional reagent, method and set
It is standby.
In the present invention, primary raw material information is as follows：
Acetaminophen crude drug, wherein acetaminophen mass content 99%.
Embodiment 1
(1) software design of 3D printing acetaminophen colorful cartoon tablet
It is by the shape of computer Magics software design colorful cartoon shape oral cavity disintegration tablets, size, color and suitable
The parameters such as number of copies, are translated into the file of the discernible stl forms of 3D printer (LTY～200 type), import 3D printing
In machine software system.
(2) three-dimensional printing-forming parameter
Wherein, spray rate is spraying drop amount * spraying frequency；
(specification is spraying quantity 40：320mg/ pieces)
(3) drug powder
Drug powder：Each composition in following prescription is crossed 80 mesh sieves, mix homogeneously respectively, and is suitably dried.
(4) allotment of binding liquid
Binding liquid (single-color ink box)：25% ethanol solution；
Colour print (colour ink box)：Edible pigment solution (yellow, carmetta, cyan)；
(5) preparation of acetaminophen colorful cartoon oral cavity disintegration tablet
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.10mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.
(6) acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Visual examination
Prepared by 3D printing bright and clean to acetyl colorful cartoon oral cavity disintegration tablet complete appearance, and uniform color has suitable hardness, can
To meet the requirement of packaging, transport.
Acetaminophen colorful cartoon oral cavity disintegration tablet drug content is analyzed
HPLC methods are adopted to determine the content of acetaminophen in acetaminophen colorful cartoon oral cavity disintegration tablet for 325mg/
Piece.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Experiment disintegration of acetaminophen colorful cartoon oral cavity disintegration tablet
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determines acetaminophen colorful cartoon oral cavity disintegration tablet
Disintegration.Disintegration time is 35s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Embodiment 2
(1) software design of 3D printing acetaminophen colorful cartoon tablet
It is by the shape of computer Magics software design colorful cartoon shape oral cavity disintegration tablets, size, color and suitable
The parameters such as number of copies, are translated into the file of the discernible stl forms of 3D printer (LTY～200 type), import 3D printing
In machine software system.
(2) three-dimensional printing-forming parameter
(3) drug powder
Drug powder：Each composition in following prescription is crossed 80 mesh sieves respectively, mix homogeneously is suitably dried.
(4) allotment of binding liquid
Binding liquid (single-color ink box)：25% ethanol solution；
Colour print (colour ink box)：Edible pigment solution (yellow, carmetta, cyan)；
(5) preparation of acetaminophen colorful cartoon oral cavity disintegration tablet
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.10mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.
(6) acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Visual examination
Prepared by 3D printing bright and clean to acetyl colorful cartoon oral cavity disintegration tablet complete appearance, and uniform color has suitable hardness, can
To meet the requirement of packaging, transport.
Acetaminophen colorful cartoon oral cavity disintegration tablet drug content is analyzed
HPLC methods are adopted to determine the content of acetaminophen in acetaminophen colorful cartoon oral cavity disintegration tablet for 322mg/
Piece.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Experiment disintegration of acetaminophen colorful cartoon oral cavity disintegration tablet
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determines acetaminophen colorful cartoon oral cavity disintegration tablet
Disintegration.Disintegration time is 19s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Embodiment 3
(1) software design of 3D printing acetaminophen colorful cartoon tablet
It is by the shape of computer Magics software design colorful cartoon shape oral cavity disintegration tablets, size, color and suitable
The parameters such as number of copies, are translated into the file of the discernible stl forms of 3D printer (LTY～200 type), import 3D printing
In machine software system.
(2) three-dimensional printing-forming parameter
The spray rate is spraying drop amount * spraying frequency；
(specification is spraying quantity 40：320mg/ pieces)
(3) drug powder
Drug powder：Each composition in following prescription is crossed 80 mesh sieves respectively, mix homogeneously is suitably dried.
(4) allotment of binding liquid
Binding liquid (single-color ink box)：25% ethanol solution；
Colour print (colour ink box)：Edible pigment solution (yellow, carmetta, cyan)；
(5) preparation of acetaminophen colorful cartoon oral cavity disintegration tablet
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.20mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.
(6) acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Visual examination
Prepared by 3D printing bright and clean to acetyl colorful cartoon oral cavity disintegration tablet complete appearance, and uniform color has suitable hardness, can
To meet the requirement of packaging, transport.
Acetaminophen colorful cartoon oral cavity disintegration tablet drug content is analyzed
HPLC methods are adopted to determine the content of acetaminophen in acetaminophen colorful cartoon oral cavity disintegration tablet for 318mg/
Piece.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Experiment disintegration of acetaminophen colorful cartoon oral cavity disintegration tablet
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determines acetaminophen colorful cartoon oral cavity disintegration tablet
Disintegration.Disintegration time is 30s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Embodiment 4
(1) software design of 3D printing acetaminophen colorful cartoon tablet
It is by the shape of computer Magics software design colorful cartoon shape oral cavity disintegration tablets, size, color and suitable
The parameters such as number of copies, are translated into the file of the discernible stl forms of 3D printer (LTY～200 type), import 3D printing
In machine software system.
(2) three-dimensional printing-forming parameter
(3) drug powder
Drug powder：Each composition in following prescription is crossed 80 mesh sieves respectively, mix homogeneously is suitably dried.
(4) allotment of binding liquid
Binding liquid (single-color ink box)：25% ethanol solution；
Colour print (colour ink box)：Edible pigment solution (yellow, carmetta, cyan)；
(5) preparation of acetaminophen colorful cartoon oral cavity disintegration tablet
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.40mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.
(6) acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Visual examination
Prepared by 3D printing bright and clean to acetyl colorful cartoon oral cavity disintegration tablet complete appearance, and uniform color has suitable hardness, can
To meet the requirement of packaging, transport.
Acetaminophen colorful cartoon oral cavity disintegration tablet drug content is analyzed
HPLC methods are adopted to determine the content of acetaminophen in acetaminophen colorful cartoon oral cavity disintegration tablet for 325mg/
Piece.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Experiment disintegration of acetaminophen colorful cartoon oral cavity disintegration tablet
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, determines acetaminophen colorful cartoon oral cavity disintegration tablet
Disintegration.Disintegration time is 13s.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Comparative example 1
(1) software design of 3D printing acetaminophen colorful cartoon tablet
It is by the shape of computer Magics software design colorful cartoon shape oral cavity disintegration tablets, size, color and suitable
The parameters such as number of copies, are translated into the file of the discernible stl forms of 3D printer (LTY～200 type), import 3D printing
In machine software system.
(2) three-dimensional printing-forming parameter
(3) drug powder
Drug powder：Each composition in following prescription is crossed 80 mesh sieves respectively, mix homogeneously is suitably dried.
(4) allotment of binding liquid
Binding liquid (single-color ink box)：25% ethanol solution；
Colour print (colour ink box)：Edible pigment solution (yellow, carmetta, cyan)；
(5) preparation of acetaminophen colorful cartoon oral cavity disintegration tablet
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.60mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.
(6) acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Outward appearance：Prepared by 3D printing coarse to acetyl colorful cartoon oral cavity disintegration tablet complete appearance, and tablet is taken out by uniform color
It is placed in the palm of the hand acutely to shake, it is few due to spraying floor height height, printing times, there is fracture, abrasion, broken or dry linting phenomenon, it is impossible to
Meet the needs of molding and transport.
Comparative example 2：
, with embodiment 1, except for the difference that a height of 0.10mm of sprayed coating in 3D printing parameter, sprays for preparation method and proportioning raw materials
The number of plies is 61 layers, and printing times are 4 times.
Acetaminophen colorful cartoon oral cavity disintegration tablet quality examination
Outward appearance：, uniform color bright and clean to acetyl colorful cartoon oral cavity disintegration tablet complete appearance prepared by 3D printing, has suitable hard
Degree, can meet packaging, the requirement of transport.
Acetaminophen colorful cartoon oral cavity disintegration tablet drug content is analyzed
HPLC methods are adopted to determine the content of acetaminophen in acetaminophen colorful cartoon oral cavity disintegration tablet for 323mg/
Piece.Meet《Chinese Pharmacopoeia》The requirement of version in 2015.
Experiment disintegration of acetaminophen colorful cartoon oral cavity disintegration tablet
According to《Chinese Pharmacopoeia》Version disintegration time mensuration method in 2015, when determining the disintegrate of fast-acting heart disease curing oral cavity disintegration tablet
Limit, disintegration time is 157s.Can not meet《Chinese Pharmacopoeia》Requirement of the version in 2015 to disintegrating tablet disintegration time.
Comparative example 3
Preparation method and proportioning raw materials with embodiment 2, the volume basis Particle density of the ethanol solution for except for the difference that adopting for
90%.The tablet for preparing taking-up is placed in the palm of the hand to be shaken, dry linting is occurred and Fragmentation Phenomena is serious, can not meet completely
The needs of disintegrate sheetmolding.If also illustrate that, in ethanol solution, ethanol content is too high, can cause into type hardness tester not enough, and tablet is easy
Dissipate, adhesive property is poor.
Comparative example 4
Preparation method and proportioning raw materials are with embodiment 2, the volume basis Particle density of the ethanol water for except for the difference that adopting
For 5%.
3D printer operation is directly controlled by terminal output order to prepare.A layer thickness 0.10mm is spread first deployed
Drug powder, an edible is first sprayed according to the colour information of each layer cross section profile of software design colorful cartoon model
Pigment solution, then 25% ethanol solution is sprayed as binding liquid bonding shaping, it is the ground floor of tablet, subsequent piston rod band
The powder bed entire lowering of dynamic workbench, prepares one layer of new drug powder of paving.It is spraying edible pigment solution again, viscous
Knot liquid, so repeatedly, until print terminating.After printing terminates, it is found that per layer of tablet has dislocation, and easily glue medicine around glutinous
Powder can not realize good molding, rough surface, untidy, not meet the basic demand of molding tablet.
For in the present invention, the selection of each component, and the scope of content selectes is inventor through substantial amounts of experiment
Obtain with research：
1. in adjuvant screening process, the species of binding agent is screened；
Employ conventional three kind binding agent to be printed in prescription, all with necessarily can formability, but invent
Preparation needs to meet requirement disintegration for oral cavity disintegration tablet, and optimum selection PVP is used as its binding agent.
2. in adjuvant screening process, the consumption of binding agent is screened；
Three kinds of ratios of PVP are printed in prescription, all with good forming effect, because considering disintegration
Require, 10% ratio of optimum selection.
3. disintegrating agent species screening in adjuvant screening process；
Above-mentioned prescription is screened to the five kinds of disintegrating agents commonly used, and is printed, as a result all has good forming effect,
The CMC-Na of optimal disintegration be have selected as the disintegrating agent in prescription.
4. in adjuvant screening process, other filler species are screened；
5. mixed filler species screening in adjuvant screening process：
Above-mentioned prescription is screened to the five kinds of filleies commonly used, and is printed, as a result all has good disintegration,
The sucrose of optimal hardness be have selected as the filler in prescription, then carry out the screening of mixed filler, have selected best collapsing
The prescription of solution time limit and optimal hardness is consisted of：
1. the component in pair prescription carries out orthogonal test, carries out formulation optimization
Orthogonal table L16_4_4
| Ethanol (%) | PVPk30 | CCMC-Na | The sweet ratio of sugarcane | |
| Level 1 | 15 | 5 | 3 | 3:1 |
| Level 2 | 25 | 10 | 5 | 2:1 |
| Level 3 | 35 | 15 | 7 | 1:1 |
| Level 4 | 45 | 20 | 9 | 1:2 |
Best prescription composition is determined finally：
Presently preferred embodiments of the present invention is the foregoing is only, not to limit the present invention, all essences in the present invention
Within god and principle, any modification, equivalent substitution and improvements made etc. should be included within the scope of the present invention.
Claims (12)
1. a kind of chromatic spray painting liquid for 3D printing, it is characterised in that：Including edible pigment solution and binding liquid.
2. the chromatic spray painting liquid of 3D printing is used for as described in the appended claim 1, it is characterised in that：The binding liquid is that ethanol is molten
Liquid, starch solution, methylated cellulose aqueous solution or sodium carboxymethyl cellulose solution.
3. the chromatic spray painting liquid of 3D printing is used for as stated in claim 2, it is characterised in that：In the ethanol water, second
The percent by volume of alcohol is 5～90%.
4. the chromatic spray painting liquid of 3D printing is used for as claimed in claim 3, it is characterised in that：The ethanol solution is for only containing second
The aqueous solution of alcohol, or added with the ethanol water of polyvidone, Polyethylene Glycol, hydroxypropyl cellulose or hydroxypropyl methyl cellulose.
5. the chromatic spray painting liquid of 3D printing is used for as described in the appended claim 1, it is characterised in that：The edible pigment solution bag
Include yellow, carmetta, cyan edible pigment solution.
6. a kind of acetaminophen colorful cartoon oral cavity disintegration tablet for 3D printing, it is characterised in that include：Containing acetparaminosalol
Arbitrary chromatic spray painting liquid for 3D printing in the drug powder of phenol, claim 1-5.
7. the acetaminophen colorful cartoon oral cavity disintegration tablet of 3D printing is used for as recited in claim 6, it is characterised in that：It is described
Drug powder includes the acetaminophen 50～65% of mass percent, and adjuvant 35～50%.
8. the acetaminophen colorful cartoon oral cavity disintegration tablet of 3D printing is used for as recited in claim 6, it is characterised in that：It is described
Adjuvant includes disintegrating agent 1-10%, binding agent 4-15% and correctivess 25-30%.
9. the acetaminophen colorful cartoon oral cavity disintegration tablet of 3D printing is used for as recited in claim 7, it is characterised in that：It is described
Disintegrating agent is dried starch, sodium alginate, alginic acid, Microcrystalline Cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, friendship
Connection sodium carboxymethyl cellulose or crospolyvinylpyrrolidone；Described adhesive is PVPK30、HPMC、HPC、CMC-Na；It is described to rectify
Taste agent is sucrose, Mannitol, essence.
10. a kind of method of 3D printing acetaminophen colorful cartoon oral cavity disintegration tablet, it is characterised in that：Using claim 6-9
In arbitrary acetaminophen colorful cartoon oral cavity disintegration tablet for 3D printing.
The method of 11. 3D printing acetaminophen colorful cartoon oral cavity disintegration tablets as claimed in claim 10, it is characterised in that：It is first
The colorful cartoon shape of computer software design acetaminophen colorful cartoon oral cavity disintegration tablet is first passed through, then using 3D printer
Double print cartridges spray edible pigment solutions and binding liquid by drug powder molding bonded.
The method of 12. 3D printing acetaminophen colorful cartoon oral cavity disintegration tablets as claimed in claim 11, it is characterised in that bag
Include following steps：
S1. the design of the colorful cartoon shape of oral cavity disintegration tablet is carried out, and imports 3D printer；
S2. pre-set 3D printing molding parameter；
S3. acetaminophen and adjuvant are mixed into into drug powder according to proportioning；
S4. the bonding solution for preparing, edible pigment solution are encased in different printer ink cartridges；
S5. the powder obtained by S3 is transported on 3D printing platform carries out powdering, by the printing head of 3D printing system in X-Y axles
Direction is moved, and first sprays an edible color according to the colour information of each layer cross section profile of software design colorful cartoon model
Plain solution, then binding liquid is sprayed, by powder bonding layered piece；Meanwhile, in the Z-axis direction, moved by axis body and will print flat
Floor height is sprayed described in platform entire lowering, spraying edible pigment solution again, binding liquid are printed repeatedly, until it reaches spray
The number of plies is applied, after printing terminates, tablet is taken out, residual powder obtains final product the acetaminophen color chart port and collapses around cleaning
Piece.
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| CN201610847287.0A CN106562935B (en) | 2016-09-23 | 2016-09-23 | A kind of paracetamol colorful cartoon oral disintegrating tablet and preparation method for 3D printing |
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