CN107811987B - 3D printing aminophylline orally disintegrating tablet and preparation method thereof - Google Patents
3D printing aminophylline orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN107811987B CN107811987B CN201711129922.2A CN201711129922A CN107811987B CN 107811987 B CN107811987 B CN 107811987B CN 201711129922 A CN201711129922 A CN 201711129922A CN 107811987 B CN107811987 B CN 107811987B
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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
- A61K9/2009—Inorganic compounds
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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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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Abstract
The invention discloses a 3D printing aminophylline orally disintegrating tablet which is mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: 20-40% of aminophylline, 40-80% of filler, 0-10% of disintegrant, 2-10% of adhesive, 0.1-1.0% of micropowder silica gel and 0-2% of flavoring agent. The invention discloses a preparation method of the aminophylline orally disintegrating tablet. The aminophylline orally disintegrating tablet has high drug release speed, can improve the compliance of patients taking drugs, and is particularly convenient for the old, children and dysphagia patients to take.
Description
Technical Field
The invention relates to an aminophylline orally disintegrating tablet, in particular to a 3D printing aminophylline orally disintegrating tablet. The invention also relates to a preparation method of the aminophylline orally disintegrating tablet.
Background
Three-dimensional printing (3 DP) is a rapid prototyping technique based on a digital model. The core concept of 3D printing was originally originated in the united states at the end of the 19 th century, and was not rudimentary until the end of the last 80 th century, when developed by the institute of labor, ma province. The 3D printing technology is that a three-dimensional model is designed and constructed on computer software according to data of a CAD (computer-aided design) model or a CT (computed tomography) model and the like of an object, and the object with a special appearance or a complex internal structure is quickly and accurately manufactured by using adhesive materials such as powdered metal or plastic, viscous liquid and the like through material accumulation according to the concept of 'printing layer by layer and overlapping layer by layer'.
The 3D printing technology is initially applied to the fields of manufacturing industry, aerospace, industrial design, and the like, and with the development and maturation of the 3D printing technology, this emerging technology has begun to enter the medical field, and for example, a series of research results have been obtained in the aspects of medical model manufacturing, tissue and organ regeneration, clinical repair and treatment, drug research and development tests, and the like. On 31/7/2015, the united states Food and Drug Administration (FDA) approved Spritam (levetiracetam) fast dissolving tablet manufactured by Aprecia company in the first global money and prepared by using 3D printing technology, which marked that the 3D printing technology further advanced to the pharmaceutical field after printing human organs.
Along with the gradual deterioration of the global ecological environment, the air quality is reduced, the morbidity and mortality of bronchial asthma of a plurality of countries are in a trend of increasing year by year, about one hundred million patients suffering from bronchial asthma are around the world, the morbidity of China is about 1%, children can reach 3%, about more than 3 million patients suffering from bronchial asthma are calculated in the whole country, the patients are in an acute disease, and if the treatment is improper or the diagnosis and treatment are not timely, the patients are easy to suffocate, and the life and health are threatened. The aminophylline has the strongest relaxing effect on bronchial smooth muscle, can dilate bronchus, increase vital capacity, and has lasting effect, especially on spastic bronchus. It is often used for emphysema in horse and cattle and asthma relief in dog caused by pulmonary congestion (heart-type wheezing) due to heart failure. The indications are that the traditional Chinese medicine is suitable for relieving asthma symptoms such as bronchial asthma, asthmatic bronchitis, obstructive emphysema and the like; it can also be used for treating asthma caused by cardiac pulmonary edema. The existing aminophylline common tablets in the current market have long disintegration time and cannot meet the requirements of emergency patients; in addition, the ammonia tea lye is inhaled in an atomizing way, can take effect quickly, but needs to use atomizing equipment, and can not meet the requirements of patients at any time and any place. The aminophylline orally disintegrating tablet prepared by adopting the 3D printing technology has great significance.
Disclosure of Invention
One of the purposes of the invention is to provide a 3D printed aminophylline orally disintegrating tablet which is short in disintegration time, fast in effect taking speed and suitable for dysphagia patients to take.
The invention also aims to provide a preparation method of the 3D-printed aminophylline orally disintegrating tablet.
In order to realize the first purpose of the invention, the invention adopts the following technical scheme:
A3D printing aminophylline orally disintegrating tablet is mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: 20-40% of aminophylline, 40-80% of filler, 0-10% of disintegrant, 2-10% of adhesive, 0.1-1.0% of micropowder silica gel and 0-2% of flavoring agent.
More preferably, the prescription comprises the following components in percentage by mass: 20-35% of aminophylline, 40-80% of filler, 5-10% of disintegrant, 5-10% of adhesive, 0.1-1.0% of micropowder silica gel and 0-2% of flavoring agent.
The filler includes but is not limited to one or a combination of more than two of sucrose, dextrin, lactose, pregelatinized starch, soluble starch, mannitol, sorbitol and xylitol.
The disintegrant includes but is not limited to one or the combination of more than two of low-substituted hydroxypropyl methylcellulose, cross-linked sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone and microcrystalline cellulose.
The binder includes but is not limited to one or a combination of more than two of povidone K30, hydroxypropyl cellulose and sodium carboxymethyl cellulose.
The flavoring agent includes but is not limited to one or the combination of more than two of stevioside, aspartame, sucralose, maili sweet and essence.
The second invention purpose of the invention is realized by the following technical scheme: the preparation method of the 3D-printed aminophylline orally disintegrating tablet comprises the following steps:
(1) modeling by using software according to preset parameters, converting the parameters into stl format files and importing the stl format files into an LTY software control system of the 3D printer;
(2) according to the mass percentage, 20-40% of aminophylline, 40-80% of filler, 0-10% of disintegrating agent, 2-10% of adhesive, 0.1-1.0% of micro-powder silica gel and 0-2% of flavoring agent are uniformly mixed in proportion, and the mixture is filled into a powder box of a 3D printing rapid forming machine as medicinal powder;
(3) filling the bonding liquid into the ink box;
(4) the control system outputs an instruction to control the 3D printing rapid forming machine to print the aminophylline orally disintegrating tablet: the powder spreading device firstly spreads a layer of medicinal powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays bonding liquid, so that the first layer of the orally disintegrating tablet is formed; then the powder bed integrally descends in the Z-axis direction, the descending distance is equal to the height of the spraying layer, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the layer-by-layer printing is carried out until the number of the spraying layers is reached, so that the printing of the orally disintegrating tablets is completed;
(5) taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying to obtain the orally disintegrating tablet.
In the parameters of the step (1), the three-dimensional parameters of the orally disintegrating tablet are as follows: radius of 4-7mm, thickness of 2.00-6.00mm, height of each layer of 0.1-0.3mm, and number of layers of 20-30, wherein the parameters of the bonding liquid are as follows: spraying speed of 4nL 12kz and spraying times of 2-3. The layer height is the spraying layer height during printing.
In the step (3), the binding liquid is a 25-50% ethanol solution, or a water or ethanol solution of povidone K30.
The invention has the beneficial effects that:
1. the 3D printed aminophylline orally disintegrating tablet provided by the invention has the characteristics of high drug release speed, capability of improving the compliance of patients taking drugs and the like, and is particularly convenient for the old, children and dysphagia patients. Moreover, compared with the prior art, the 3D printing technology can customize the dosage suitable for the patient according to the individual difference of the patient, and realize individualized administration and accurate treatment, thereby reducing the number of tablets taken by the patient or the steps of cutting tablets by pharmacists, enabling the pharmaceutical preparation to exert the maximum curative effect and minimizing the toxic and side effects of the pharmaceutical preparation.
2. The invention utilizes the 3D printing technology to prepare the tablet medicament, can realize the personalized printing of the medicament, and can also effectively solve the problems of tablet collapse, tablet loosening and the like in the traditional pressing method for preparing the tablet medicament.
3. The invention adopts the process method of spraying the binding liquid on the medicine powder to print the medicine, so that the prepared tablet has good formability and better mechanical property.
Detailed Description
The present invention will be further described with reference to the following examples, which should not be construed as limiting the scope of the invention.
Example 1
The prescription is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) and modeling by utilizing software such as CAD (computer-aided design) and the like according to preset parameters, converting the parameters into stl format files, and importing the stl format files into an LTY software control system of the 3D printer.
(2) According to the mass percentage, aminophylline, mannitol, povidone K30 and aerosil are uniformly mixed in proportion, and the mixture is filled into a powder box of a 3D printing rapid forming machine as medicinal powder.
(3) The ink cartridge was filled with a 1% povidone K30-50% ethanol solution.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the aminophylline orally disintegrating tablet: the powder spreading device firstly spreads a layer of 0.1mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays bonding liquid, so that the first layer of the orally disintegrating tablet is formed; and then the powder bed is integrally descended by 0.1mm in the Z-axis direction, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablets is finished.
(5) Taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying to obtain the orally disintegrating tablet.
Disintegration time test of aminophylline orally disintegrating tablets:
the disintegration time limit of the aminophylline orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time was 39. + -.1 s. Meets the requirements of 'Chinese pharmacopoeia' 2015 edition.
Example 2
The prescription is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) and modeling by utilizing software such as CAD (computer-aided design) and the like according to preset parameters, converting the parameters into stl format files, and importing the stl format files into an LTY software control system of the 3D printer.
(2) Uniformly mixing aminophylline, pregelatinized starch, cross-linked polyvinylpyrrolidone, povidone K30, micro-powder silica gel and aspartame in proportion according to mass percentage, and putting the mixture into a powder box of a 3D printing rapid forming machine as medicinal powder.
(3) The ink cartridge was filled with a 1% povidone K30-50% ethanol solution.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the aminophylline orally disintegrating tablet: the powder spreading device firstly spreads a layer of 0.2mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays bonding liquid, which is the first layer of the orally disintegrating tablet; and then the powder bed is integrally descended by 0.2mm in the Z-axis direction, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablets is finished.
(5) Taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying to obtain the orally disintegrating tablet.
Disintegration time test of aminophylline orally disintegrating tablets:
the disintegration time limit of the aminophylline orally disintegrating tablet is determined according to the disintegration time limit determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time was 45. + -.1 s. Meets the requirements of 'Chinese pharmacopoeia' 2015 edition.
Example 3
The prescription is as follows:
the 3D printing parameters were as follows:
the preparation method comprises the following steps:
(1) and modeling by utilizing software such as CAD (computer-aided design) and the like according to preset parameters, converting the parameters into stl format files, and importing the stl format files into an LTY software control system of the 3D printer.
(2) Uniformly mixing aminophylline, sucrose, low-substituted hydroxypropyl methylcellulose, povidone K30, micropowder silica gel and sucralose according to the mass percentage, and filling the mixture serving as medicinal powder into a powder box of a 3D printing rapid forming machine.
(3) The cartridge was filled with a 50% ethanol solution.
(4) The control system outputs an instruction to control the 3D printing rapid forming machine to print the aminophylline orally disintegrating tablet: the powder spreading device firstly spreads a layer of 0.2mm thick powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays bonding liquid, which is the first layer of the orally disintegrating tablet; and then the powder bed is integrally descended by 0.2mm in the Z-axis direction, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the layer-by-layer printing is carried out until the number of spraying layers is reached, so that the printing of the orally disintegrating tablets is finished.
(5) Taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying to obtain the orally disintegrating tablet.
Disintegration time test of aminophylline orally disintegrating tablets:
the disintegration time of the aminophylline orally disintegrating tablet is determined according to the disintegration time determination method of 'Chinese pharmacopoeia' 2015 edition. The disintegration time was 17. + -.1 s. Meets the requirements of 'Chinese pharmacopoeia' 2015 edition.
Claims (6)
1. A3D printing aminophylline orally disintegrating tablet is characterized by being mainly prepared from the following components in percentage by mass by adopting a 3D printing technology: 20-40% of aminophylline, 40-80% of filler, 0-10% of disintegrating agent, 2-10% of adhesive, 0.1-1.0% of micropowder silica gel and 0-2% of flavoring agent, wherein the total amount of the components is 100%; the disintegrating agent is low-substituted hydroxypropyl methylcellulose or cross-linked polyvinylpyrrolidone; the adhesive is one or the combination of more than two of povidone K30, hydroxypropyl cellulose and sodium carboxymethyl cellulose; the filler is one or the combination of more than two of sucrose, dextrin, lactose, pregelatinized starch, soluble starch, mannitol, sorbitol and xylitol.
2. The 3D printing aminophylline orally disintegrating tablet of claim 1, wherein the mass percentage of each component is as follows: 20-35% of aminophylline, 40-80% of filler, 5-10% of disintegrating agent, 5-10% of adhesive, 0.1-1.0% of micropowder silica gel and 0-2% of flavoring agent, wherein the total amount of the components is 100%.
3. The 3D-printed aminophylline orally disintegrating tablet of claim 1, wherein the flavoring agent is one or a combination of more than two of stevioside, aspartame, sucralose, maili sweet and essence.
4. The preparation method of the 3D-printed aminophylline orally disintegrating tablet as claimed in any one of claims 1 to 3, which is characterized by comprising the following steps:
(1) modeling by using software according to preset parameters, converting the parameters into stl format files and importing the stl format files into an LTY software control system of the 3D printer;
(2) uniformly mixing aminophylline, a filler, a disintegrating agent, an adhesive, micropowder silica gel and a flavoring agent in proportion, and filling the mixture serving as medicinal powder into a powder box of a 3D printing rapid forming machine;
(3) filling the bonding liquid into the ink box;
(4) the control system outputs an instruction to control the 3D printing rapid forming machine to print the aminophylline orally disintegrating tablet: the powder spreading device firstly spreads a layer of medicinal powder on a powder bed, and then a printing nozzle moves in a selected area in the X-Y axis direction and sprays bonding liquid, so that the first layer of the orally disintegrating tablet is formed; then the powder bed integrally descends in the Z-axis direction, the descending distance is equal to the height of the spraying layer, the powder spreading device spreads a second layer of powder on the powder bed, the operation is repeated, and the layer-by-layer printing is carried out until the number of the spraying layers is reached, so that the printing of the orally disintegrating tablets is completed;
(5) taking out after the orally disintegrating tablet is bonded, removing redundant powder around the orally disintegrating tablet, and drying to obtain the orally disintegrating tablet.
5. The preparation method of the 3D-printed aminophylline orally disintegrating tablet according to claim 4, wherein, in the parameters of the step (1), the three-dimensional parameters of the orally disintegrating tablet are as follows: radius of 4-7mm, thickness of 2.00-6.00mm, powder thickness of 0.1-0.3mm in each layer, and number of layers of 20-30, wherein the parameters of the bonding liquid are as follows: spraying speed of 4nL 12kz and spraying times of 2-3.
6. The preparation method of the 3D printed aminophylline orally disintegrating tablet of claim 4, wherein in the step (3), the binding solution is 25-50% ethanol solution, or water or ethanol solution of povidone K30.
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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 |
| CN111840243B (en) * | 2020-07-30 | 2021-11-30 | 中国人民解放军军事科学院军事医学研究院 | Levetiracetam 3D printing preparation and preparation method thereof |
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| CN106511285B (en) * | 2016-09-20 | 2019-06-21 | 南方医科大学 | A kind of 3D printing Breviscapinun oral disintegrating tablet and preparation method thereof |
| 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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