CN106511285B - A kind of 3D printing Breviscapinun oral disintegrating tablet and preparation method thereof - Google Patents
A kind of 3D printing Breviscapinun oral disintegrating tablet and preparation method thereof Download PDFInfo
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- CN106511285B CN106511285B CN201610836143.5A CN201610836143A CN106511285B CN 106511285 B CN106511285 B CN 106511285B CN 201610836143 A CN201610836143 A CN 201610836143A CN 106511285 B CN106511285 B CN 106511285B
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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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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Abstract
The invention discloses a kind of 3D printing Breviscapinun oral disintegrating tablets and preparation method thereof, count by weight percentage, Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, povidone 10-15%, superfine silica gel powder 0-0.5%, corrigent 0-0.5% are uniformly mixed, are fitted into powder box；Binder is fitted into print cartridge；According to pre-set parameter, modeling, and import in the control system of 3D printing rapidform machine；Control system output order prints Breviscapinun oral disintegrating tablet；It is taken out after dispersible tablet coheres and dries to obtain the final product.The present invention using 3DP technology printing Breviscapinun oral disintegrating tablet have the characteristics that simple process, disintegration rate faster, bioavilability is higher, it is more convenient to take, in saliva of buccal cavity be disintegratable, particularly suitable for the elderly and swallow difficulty patient；It works faster simultaneously, reaches the treatment requirement of the acute attacks disease such as coronary heart diseases and angina pectoris, and Personalized Drug Administration and precisely treatment may be implemented.
Description
Technical field
The present invention relates to pharmaceutical preparations technology field, specially a kind of 3D printing Breviscapinun oral disintegrating tablet and its preparation side
Method.
Background technique
China's cardiovascular disease now suffers from number up to 2.9 hundred million people, and every 5 adults just have 1 people to suffer from cardiovascular disease, and every 10 seconds just
There is 1 people to die of cardiovascular disease.Cardiovascular disease occupies 40% or more of people's disease death composition, is higher than tumour and other diseases, is
The first cause of the death of China resident, and cardiovascular disease illness rate and the death rate are still in ascent stage.As cardiovascular and cerebrovascular disease is suffered from
The increase of patient group, cardiovascular and cerebrovascular medication have become world's medical market first major class drug.
Breviscapinun (Breviscapine) is from the short pavilion bitter fleabane of compositae plant [Erigeronbreviscapus (Vant.)
Hand.-Mazz. the flavonoids effective constituent extracted in drying herb-fleabane flower], main component are scutellarins and lack
Measure oil lamp A prime.Breviscapinun has extensive, exact pharmacological activity, such as damage, antithrombotic, the increasing of anti-tissue ischemia Reperfu- sion
Flow is healed, improves microcirculation, expansion blood vessel, reduces blood viscosity, adjusts the pharmacological actions such as blood lipid, anti-oxidant.From 20th century 70
It has been variously formulated as since generation end is isolated for the first time, such as tablet (ordinary tablet, chewable tablets, dispersible tablet), dripping pill, injection
Deng being widely used in apoplexy sequelae, coronary heart disease, the treatment of the related diseases such as angina pectoris achieves preferable clinical efficacy.
Powder liquid three dimensional printing (3DP) technology be the last century 80's end by the Massachusetts Institute of Technology develop one kind quickly
Forming technique, this technology stick together the powder of multilayer to form three-dimensional structure using liquid.Specifically, the technology
It is first laid with a thin layer of medicinal powder, then sprays drop in selection area again, the interaction of drop and powder can make material exist
It is bonded together in microcosmic point；Then it is then covered with one layer of medicinal powder.It carries out repeatedly, until completing the printing of tablet.Relatively
Traditional pressed-disc technique, the tablet using technology preparation have porous structure, and " just a small saliva also can make tablet quick at last
Dispersion ", so that tablet be made conveniently to swallow simultaneously quick acting.In August, 2015, food and drug administration (FDA) approval are complete
Ball first 3D printing drug Spritam (Levetiracetam or Levetiracetam) rapidly dissolving tablet listing, indicate 3D printing at
For a kind of new formulation technology.
Oral disintegrating tablet is a kind of tablet for being not required to water in oral cavity and being disintegrated or dissolving.It is not required to use water when taking such preparation
Or a small amount of water need to be only used, without chewing, tablet is placed in lingual surface chance saliva and is disintegrated rapidly, enters stomach by means of swallowing act and works.
Summary of the invention
It is an object of the invention to provide in place of overcome the deficiencies in the prior art, a kind of simple process, disintegration time is short, rises
Imitate the 3D printing Breviscapinun oral disintegrating tablet of fast, the suitable dysphagia patients of speed.
It is another object of the present invention to provide the preparation methods of above-mentioned Breviscapinun oral disintegrating tablet.
To achieve the goals above, the present invention adopts the following technical scheme:
The object of the present invention is achieved like this: a kind of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that: by weight hundred
Point than calculate, formula include following components: Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%,
Povidone 10-15%, superfine silica gel powder 0-0.5%, corrigent 0-0.5%, are formed by 3D printing.
Count by weight percentage, formula includes following components: Breviscapinun 10-20%, dextrin 30%-50%, micro-
Crystalline cellulose 28-35%, povidone 10-12%, superfine silica gel powder 0-0.5%, corrigent 0-0.5%.
Count by weight percentage, formula includes following components: Breviscapinun 13.5%, dextrin 44%, microcrystalline cellulose
Plain 32%, povidone 10%, superfine silica gel powder 0.5%.
The microcrystalline cellulose uses microcrystalline cellulose PH101.
The povidone uses PVP K30.
The corrigent is Sucralose, Steviosin, aspartame, Mai Litian or essence.
A kind of preparation method of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that the following steps are included:
(1) count by weight percentage, by Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-
40%, povidone 10-15%, superfine silica gel powder 0-0.5%, corrigent 0-0.5% are mixed in proportion, and are packed into 3D as medicinal powder
In the powder box for printing rapidform machine；
(2) binder is fitted into print cartridge；
(3) it according to pre-set parameter, modeling, and imports in the control system of 3D printing rapidform machine；
(4) control system output order, control 3D printing rapidform machine print Breviscapinun oral disintegrating tablet: power spreading device is first
In one layer of the medicinal powder in powder bed upper berth, binder then is sprayed in selection area, is the first layer of dispersible tablet, subsequent power spreading device paving
Second layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
(5) taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
In the parameter of the step (3), dispersible tablet three-dimensional parameter are as follows: diameter 5-12mm, thickness 2-5mm, number of plies 15-50
Layer, the high 0.1-0.2mm of layer bind agent parameter are as follows: spray rate 3.5-4.5nL × 10-14kz, spraying number 1-3 times.
The binder be water, 30%~75% ethanol solution, starch slurry, povidone water or ethanol solution.
Beneficial effects of the present invention:
Using 3DP technology printing Breviscapinun oral disintegrating tablet have simple process, disintegration rate faster, bioavilability more
Height takes the features such as more convenient, is disintegratable in saliva of buccal cavity, particularly suitable for the elderly and swallows difficult patient；Together
Shi Qixiao faster, reaches the treatment requirement of the acute attacks disease such as coronary heart diseases and angina pectoris.Moreover, relatively existing technology, 3D are beaten
Print technology can realize individual character according to the customized dosage for being suitable for patient of individual difference, the order of importance and emergency of disease of patient
Change administration and precisely treatment, so that reducing patient takes the piece number, so that pharmaceutical preparation is played greatest treatment efficacy, and make poisonous side effect of medicine
It is preferably minimized.
Specific embodiment
The present invention is a kind of 3D printing Breviscapinun oral disintegrating tablet, and count by weight percentage, formula includes following components:
Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, povidone 10-15%, superfine silica gel powder 0-
0.5%, corrigent 0-0.5% is formed by 3D printing.
More preferably, count by weight percentage, formula includes following components: Breviscapinun 10-20%, dextrin
30%-50%, microcrystalline cellulose 28-35%, povidone 10-12%, superfine silica gel powder 0-0.5%, corrigent 0-0.5%.
Most preferably, count by weight percentage, formula include following components: Breviscapinun 13.5%, dextrin 44%,
Microcrystalline cellulose 32%, povidone 10%, superfine silica gel powder 0.5%.
Preferably, microcrystalline cellulose uses microcrystalline cellulose PH101.Microcrystalline cellulose PH101 is by cellulosic sections water
Crystal powder prepared by solution.Microcrystalline cellulose is larger to the saturation of drug, uses frequently as diluent.Microcrystalline cellulose is also
With good mobility and calving disaggregation, meeting water can be disintegrated to form uniform suspension rapidly, have disintegrating agent and suspension
Double action.
Preferably, povidone uses PVP K30.PVP K30 (PVP K30) is by n-vinyl pyrrolidone (letter
Claim NVP) it is formed through free radical polymerization, average molecular weight is 50,000.Povidone is excellent binder, water-soluble as binder
Liquid, alcoholic solution or solid powder can all be applied.Povidone has hydrophily, easily wet, infiltration, and tablet easy disintegrating is conducive to medicine
The dissolution of object.
Preferably, corrigent is Sucralose, Steviosin, aspartame, Mai Litian or essence etc..
A kind of preparation method of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that the following steps are included:
(1) count by weight percentage, by Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-
40%, povidone 10-15%, superfine silica gel powder 0-0.5%, corrigent 0-0.5% are mixed in proportion, and are packed into 3D as medicinal powder
In the powder box for printing rapidform machine；
(2) binder is fitted into print cartridge；Wherein the binder be water, 30%~75% ethanol solution, starch slurry,
The water or ethanol solution of povidone；
(3) it according to pre-set parameter, modeling, and imports in the control system of 3D printing rapidform machine；
(4) control system output order, control 3D printing rapidform machine print Breviscapinun oral disintegrating tablet: power spreading device is first
In the medicinal powder that powder bed upper berth a layer thickness is 0.1-0.2mm, binder then is sprayed in selection area, is the first of dispersible tablet
Layer, subsequent power spreading device spread second layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
(5) taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
Preferably, step (3) described parameter is as follows:
Below with reference to embodiment, the present invention is further illustrated, but is not intended as limiting the scope of protection of the present invention.
Embodiment 1
The 3D printing Breviscapinun orally disintegrating tablet prescription of the present embodiment is as follows:
The 3D printing parameter of the present embodiment is as follows:
The preparation method is as follows:
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30, superfine silica gel powder are mixed in proportion, fill
In the powder box for entering LTY-200 rapid three dimensional printing forming machine；
2. binder is fitted into print cartridge；
3. using software modelings such as CAD, and being converted into stl formatted file importing 3D according to pre-set parameter and beating
In the LTY software control system of print machine；
4. control 3D printer prints Breviscapinun oral disintegrating tablet: power spreading device is first on powder bed by computer output order
The medicinal powder that a layer thickness is 0.1mm is spread, then sprays binder in selection area, is the first layer of dispersible tablet.Under subsequent powder bed
Drop, power spreading device spread second layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
5. taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
Disintegration experiment
By Breviscapinun oral disintegrating tablet made from embodiment 1, referring to 2015 editions " Chinese Pharmacopoeia " the 4th, " disintegration time limited is checked
Method " regulation, measures the disintegration time limited of Breviscapinun oral disintegrating tablet.Disintegration time is 17.5 ± 2.7s, meets regulation.
Embodiment 2
The 3D printing Breviscapinun orally disintegrating tablet prescription of the present embodiment is as follows:
| Title | Ratio (%) |
| Breviscapinun | 15 |
| Dextrin | 49.5 |
| Microcrystalline cellulose PH101 | 25 |
| PVP K30 | 10 |
| Sucralose | 0.5 |
| Binder | Water |
The 3D printing parameter of the present embodiment is as follows:
The preparation method is as follows:
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30, Sucralose are mixed in proportion, fill
In the powder box for entering LTY-200 rapid three dimensional printing forming machine；
2. binder is fitted into print cartridge；
3. using software modelings such as CAD, and being converted into stl formatted file importing 3D according to pre-set parameter and beating
In the LTY software control system of print machine；
4. control 3D printer prints Breviscapinun oral disintegrating tablet: power spreading device is first on powder bed by computer output order
The medicinal powder that a layer thickness is 0.1mm is spread, then sprays binder in selection area, is the first layer of dispersible tablet.Under subsequent powder bed
Drop, power spreading device spread second layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
5. taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
Embodiment 3
The 3D printing Breviscapinun orally disintegrating tablet prescription of the present embodiment is as follows:
| Title | Ratio (%) |
| Breviscapinun | 14 |
| Dextrin | 44 |
| Microcrystalline cellulose PH101 | 32 |
| PVP K30 | 10 |
| Binder | The aqueous solution of 2% PVP K30 |
The 3D printing parameter of the present embodiment is as follows:
The preparation method is as follows:
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30 are mixed in proportion, it is packed into LTY-200
In the powder box of rapid three dimensional printing forming machine；
2. binder is fitted into print cartridge；
3. using software modelings such as CAD, and being converted into stl formatted file importing 3D according to pre-set parameter and beating
In the LTY software control system of print machine；
4. control 3D printer prints Breviscapinun oral disintegrating tablet: power spreading device is first on powder bed by computer output order
The medicinal powder that a layer thickness is 0.2mm is spread, then sprays binder in selection area, is the first layer of dispersible tablet.Under subsequent powder bed
Drop, power spreading device spread second layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
5. taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
Claims (8)
1. a kind of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that: count by weight percentage, formula is comprising with the following group
Point: Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, povidone 10-15%, superfine silica gel powder 0-
0.5%, corrigent 0-0.5% is formed by 3D printing；Three-dimensional parameter are as follows: diameter 5-12mm, thickness 2-5mm, 15-50 layers of the number of plies,
The high 0.1-0.2mm of layer, binds agent parameter are as follows: spray rate 3.5-4.5nL × 10-14kz, spraying number 1-3 times.
2. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that: count by weight percentage,
Formula includes following components: Breviscapinun 10-20%, dextrin 30%-50%, microcrystalline cellulose 28-35%, povidone 10-
12%, superfine silica gel powder 0-0.5%, corrigent 0-0.5%.
3. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that: count by weight percentage,
Formula includes following components: Breviscapinun 13.5%, dextrin 44%, microcrystalline cellulose 32%, povidone 10%, superfine silica gel powder
0.5%.
4. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that: the microcrystalline cellulose uses
Microcrystalline cellulose PH101.
5. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that: the povidone is using poly- dimension
Ketone K30.
6. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that: the corrigent is trichlorine sugarcane
Sugar, Steviosin, aspartame, Mai Litian or essence.
7. a kind of preparation method of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that the following steps are included:
(1) count by weight percentage, by Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, poly-
Dimension ketone 10-15%, superfine silica gel powder 0-0.5%, corrigent 0-0.5% are mixed in proportion, and it is fast to be packed into 3D printing as medicinal powder
In the powder box of fast molding machine；
(2) binder is fitted into print cartridge；
(3) it according to pre-set parameter, modeling, and imports in the control system of 3D printing rapidform machine；；Three-dimensional parameter
Are as follows: diameter 5-12mm, thickness 2-5mm, 15-50 layers of the number of plies, the high 0.1-0.2mm of layer bind agent parameter are as follows: spray rate 3.5-
4.5nL × 10-14kz, spraying number 1-3 times
(4) control system output order, control 3D printing rapidform machine print Breviscapinun oral disintegrating tablet: power spreading device is first in powder
Then the medicinal powder on one layer of upper berth of bed sprays binder in selection area, be the first layer of dispersible tablet, subsequent power spreading device paving second
Layer powder, so successively printing, are layering, until completing the printing of dispersible tablet；
(5) taken out after dispersible tablet coheres and dries, clean surrounding residual powder to get.
8. the preparation method of 3D printing Breviscapinun oral disintegrating tablet according to claim 7, it is characterised in that: the bonding
Agent be water, 30%~75% ethanol solution, starch slurry, povidone water or ethanol solution.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107252418B (en) * | 2017-05-17 | 2020-06-23 | 西安棣加生物科技有限公司 | Method for preparing oral rapidly disintegrating tablet for treating hypokalemia by 3D printing technology |
| CN107213126B (en) * | 2017-05-17 | 2020-06-23 | 西安棣加生物科技有限公司 | Method for preparing oral rapidly disintegrating tablet for treating hyperphosphatemia by 3D printing technology |
| CN109394708B (en) * | 2017-08-17 | 2021-10-08 | 西安棣加生物科技有限公司 | Oral rapidly-disintegrating heart disease first-aid tablet and 3D printing method and application thereof |
| CN107811987B (en) * | 2017-11-07 | 2021-02-09 | 江苏互竑生物医学有限公司 | 3D printing aminophylline orally disintegrating tablet and preparation method thereof |
| CN107669648B (en) * | 2017-11-07 | 2021-02-09 | 江苏互竑生物医学有限公司 | 3D-printed doxofylline orally disintegrating tablet and preparation method thereof |
| CN107823153B (en) * | 2017-11-07 | 2021-02-09 | 江苏互竑生物医学有限公司 | Amlodipine besylate orally disintegrating tablet prepared by 3D printing and preparation method thereof |
| CN107854440B (en) * | 2017-11-07 | 2021-01-26 | 广东药科大学 | Clozapine orally disintegrating tablet prepared by 3D printing and preparation method thereof |
| 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 |
| CN110507811A (en) * | 2019-09-17 | 2019-11-29 | 南京赛弗斯医药科技有限公司 | A kind of sublingual oral disintegrating tablet of 3D printing carbetocin and preparation method thereof |
| WO2021174188A1 (en) * | 2020-02-27 | 2021-09-02 | Henkel IP & Holding GmbH | A personal care product and a method for making a personal care product by an additive process |
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| CN1698638A (en) * | 2004-05-17 | 2005-11-23 | 北京扬新科技有限公司 | Breviscapine orally disintegrating tablet and preparation method thereof |
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