CN106511285A - 3D printing breviscapine orally disintegrating tablet and preparation method thereof - Google Patents
3D printing breviscapine orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN106511285A CN106511285A CN201610836143.5A CN201610836143A CN106511285A CN 106511285 A CN106511285 A CN 106511285A CN 201610836143 A CN201610836143 A CN 201610836143A CN 106511285 A CN106511285 A CN 106511285A
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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 3D printing breviscapine orally disintegrating tablet and a preparation method of the 3D printing breviscapine orally disintegrating tablet. The preparation method comprises the following steps: according to weight percentage, uniformly mixing 10-30 % of breviscapine, 30-60 % of dextrin, 25-40 % of microcrystalline cellulose, 10-15 % of povidone, 0-0.5 % of superfine silica powder, and 0-0.5 % of a corrigent, and placing the mixture into a powder box; placing an adhesive into an ink box; according to the preset parameters, carrying out modeling, and introducing into a control system of a 3D printing rapid forming machine; outputting an instruction by the control system, and printing the breviscapine orally disintegrating tablet; and taking out the printed breviscapine orally disintegrating tablet after the dispersible tablet is adhered and dried, thus obtaining the 3D printing breviscapine orally disintegrating tablet. The breviscapine orally disintegrating tablet printed by adopting the 3DP technology has the advantages that the process is simple, the disintegrating speed is high, the bioavailability is high, the taking is convenient, etc., the breviscapine orally disintegrating tablet can disintegrate in saliva in the oral cavity, and is particularly suitable for old people and patients with swallowing difficulty, meanwhile, the effects are rapid, the requirement for treating the acute attack diseases including coronary heart disease and angina is satisfied, and moreover, the individualized drug administration and accurate treatment can be realized.
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 technology
China's cardiovascular disease now suffers from number up to 2.9 hundred million people, just has 1 people to suffer from cardiovascular disease per 5 adults, per 10 seconds just
There is 1 people to die from cardiovascular disease.Cardiovascular disease occupies more than the 40% of people's disease death composition, 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 the first big similar drug of world's medical market.
Breviscapinun (Breviscapine) is from feverfew short booth bitter fleabane [Erigeronbreviscapus (Vant.)
Hand.-Mazz.] be dried herb fleabane flower in the flavonoids effective constituent that extracts, main component is scutellarin and few
Amount oil lamp A prime.Breviscapinun has extensive, definite pharmacologically active, such as the damage of anti-tissue ischemia Reperfu- sion, antithrombotic, increasing
Flow is healed, is improved microcirculation, expansion of blood vessels, is reduced blood viscosity, adjusts the pharmacological action such as blood fat, anti-oxidant.From 20th century 70
Generation end it is isolated first since be variously formulated as, such as tablet (ordinary tablet, chewable tablets, dispersible tablet), dripping pill, injection
Deng, apoplexy sequelae is widely used in, coronary heart disease, the treatment of the relevant disease such as angina pectoris achieve preferable clinical efficacy.
Powder liquid three dimensional printing (3DP) technology is quick by one kind that the Massachusetts Institute of Technology develops at the eighties of last century end of the eighties
Forming technique, this technology stick together the powder of multilayer to form three-dimensional structure using liquid.Specifically, the technology
The medicinal powder of thin layer first being laid, then drop being sprayed in selection area again, drop can make material exist with the interaction of powder
Be bonded together in microcosmic point；Then repave last layer medicinal powder.So it is repeated, until completing the printing of tablet.Relatively
Traditional pressed-disc technique, the tablet prepared using the technology have loose structure, and " just a little saliva can also make tablet quick at last
Dispersion ", so that tablet is conveniently swallowed and quick acting.In August, 2015, food and drug administration (FDA) approval are complete
Ball first 3D printing medicine Spritam (Levetiracetam, or Levetiracetam) rapidly dissolving tablet list, indicate 3D printing into
For a kind of new formulation technology.
Oral disintegrating tablet is a kind of to be not required to the tablet that water can be disintegrated or dissolve in oral cavity.It is not required to use water when taking such preparation
Or a small amount of water need to be only used, without the need for chewing, tablet is placed in lingual surface chance saliva and is disintegrated rapidly, enters stomach action by means of swallowing act.
The content of the invention
It is an object of the invention in place of overcoming the deficiencies in the prior art, there is provided a kind of process is simple, disintegration time be short, rise
Effect speed is fast, be adapted to the 3D printing Breviscapinun oral disintegrating tablet of dysphagia patients.
Further object is that providing the preparation method of above-mentioned Breviscapinun oral disintegrating tablet.
To achieve these goals, the present invention is adopted the following technical scheme that：
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
Divide than calculating, its formula is comprising following components：Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%,
PVP 10-15%, superfine silica gel powder 0-0.5%, flavouring 0-0.5%, are formed by 3D printing.
Count by weight percentage, its formula is comprising following components：It is Breviscapinun 10-20%, dextrin 30%-50%, micro-
Crystalline cellulose 28-35%, PVP 10-12%, superfine silica gel powder 0-0.5%, flavouring 0-0.5%.
Count by weight percentage, its formula is comprising following components：Breviscapinun 13.5%, dextrin 44%, microcrystalline cellulose
Element 32%, PVP 10%, superfine silica gel powder 0.5%.
Described microcrystalline cellulose adopts microcrystalline cellulose PH101.
Described PVP adopts PVP K30.
Described flavouring 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 comprise the following steps：
(1) count by weight percentage, by Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-
40%th, PVP 10-15%, superfine silica gel powder 0-0.5%, flavouring 0-0.5% are mixed in proportion, and load 3D as medicinal powder
Print in the powder box of rapidform machine；
(2) binder is loaded in print cartridge；
(3) according to pre-set parameter, modeling, and import 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 elder generation
In one layer of the medicinal powder in powder bed upper berth, then binder is sprayed in selection area, be the ground floor of dispersible tablet, subsequent power spreading device paving
Second layer powder, so successively prints, and is layering, until completing the printing of dispersible tablet；
(5) take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
In the parameter of step (3), dispersible tablet three-dimensional parameter is：Diameter 5-12mm, thickness 2-5mm, number of plies 15-50
Layer, floor height 0.1-0.2mm, binding agent parameter is：Spray rate 3.5-4.5nL × 10-14kz, spraying number of times 1-3 time.
Described binder is water, 30%～75% ethanol solution, starch slurry, the water of PVP or ethanol solution.
Beneficial effects of the present invention：
Using 3DP technologies print Breviscapinun oral disintegrating tablet have process is simple, disintegration rate faster, bioavilability more
It is high, the features such as take more convenient, be disintegratable in saliva of buccal cavity, be particularly suitable for the elderly and swallow the patient of difficulty；Together
Shi Qixiao faster, reaches the treatment requirement of the acute attack disease such as coronary heart diseases and angina pectoris.And, with respect to existing technology, 3D beats
Print technology can realize individual character according to the customized dosage for being suitable for patient of the order of importance and emergency of the individual difference of patient, disease
Change administration and precisely treatment, piece number is taken so as to reduce patient, make pharmaceutical preparation play 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, its formula is comprising following components：
Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, PVP 10-15%, superfine silica gel powder 0-
0.5%th, flavouring 0-0.5%, is formed by 3D printing.
More preferably, count by weight percentage, its formula is comprising following components：Breviscapinun 10-20%, dextrin
30%-50%, microcrystalline cellulose 28-35%, PVP 10-12%, superfine silica gel powder 0-0.5%, flavouring 0-0.5%.
Most preferably, count by weight percentage, its formula is comprising following components：Breviscapinun 13.5%, dextrin 44%,
Microcrystalline cellulose 32%, PVP 10%, superfine silica gel powder 0.5%.
Preferably, microcrystalline cellulose adopts microcrystalline cellulose PH101.Microcrystalline cellulose PH101 is by cellulosic sections water
Solve and obtained crystal powder.Microcrystalline cellulose is larger to the saturation of medicine, uses frequently as diluent.Microcrystalline cellulose is also
With good mobility and calving disaggregation, meeting water can be disintegrated rapidly to form uniform suspension, with disintegrant and supensoid agent
Double action.
Preferably, PVP adopts PVP K30.PVP K30 (PVP K30) is by NVP (letter
Claiming NVP) Jing radical polymerizations form, and mean molecule quantity is 50,000.PVP is excellent binder, as binder, water-soluble
Liquid, alcoholic solution or pressed powder can all be applied.PVP has hydrophily, easily moistening, infiltration, and tablet easy disintegrating is conducive to medicine
The dissolution of thing.
Preferably, flavouring 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 comprise the following steps：
(1) count by weight percentage, by Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-
40%th, PVP 10-15%, superfine silica gel powder 0-0.5%, flavouring 0-0.5% are mixed in proportion, and load 3D as medicinal powder
Print in the powder box of rapidform machine；
(2) binder is loaded in print cartridge；Wherein described binder be water, 30%～75% ethanol solution, starch slurry,
The water or ethanol solution of PVP；
(3) according to pre-set parameter, modeling, and import 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 elder generation
Medicinal powder of a layer thickness for 0.1-0.2mm on powder bed upper berth, then sprays binder in selection area, is the first of dispersible tablet
Layer, subsequent power spreading device spread second layer powder, so successively print, are layering, until completing the printing of dispersible tablet；
(5) take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
Preferably, step (3) parameter is as follows：
With reference to embodiment, the present invention is further illustrated, but is not intended as limiting protection scope 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：
Preparation method is as follows：
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30, superfine silica gel powder are mixed in proportion, filled
Enter in the powder box of LTY-200 rapid three dimensional printing forming machines；
2. binder is loaded in print cartridge；
3. according to pre-set parameter, using software modelings such as CAD, and be converted into stl formatted files import 3D beat
In the LTY software control systems of print machine；
4. instructed by computer export, control 3D printer prints Breviscapinun oral disintegrating tablet：Power spreading device is first on powder bed
Medicinal powder of the paving a layer thickness for 0.1mm, then sprays binder in selection area, is the ground floor of dispersible tablet.Subsequently under powder bed
Drop, power spreading device paving second layer powder, so successively prints, is layering, until completing the printing of dispersible tablet；
5. take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
Disintegration experiment
The Breviscapinun oral disintegrating tablet as obtained in embodiment 1, with reference to 2015 editions《Chinese Pharmacopoeia》4th " disintegration time limited checks
Method " regulation, determines 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：
Preparation method is as follows：
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30, Sucralose are mixed in proportion, filled
Enter in the powder box of LTY-200 rapid three dimensional printing forming machines；
2. binder is loaded in print cartridge；
3. according to pre-set parameter, using software modelings such as CAD, and be converted into stl formatted files import 3D beat
In the LTY software control systems of print machine；
4. instructed by computer export, control 3D printer prints Breviscapinun oral disintegrating tablet：Power spreading device is first on powder bed
Medicinal powder of the paving a layer thickness for 0.1mm, then sprays binder in selection area, is the ground floor of dispersible tablet.Subsequently under powder bed
Drop, power spreading device paving second layer powder, so successively prints, is layering, until completing the printing of dispersible tablet；
5. take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
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：
Preparation method is as follows：
1. Breviscapinun, dextrin, microcrystalline cellulose PH101, PVP K30 are mixed in proportion, load LTY-200
In the powder box of rapid three dimensional printing forming machine；
2. binder is loaded in print cartridge；
3. according to pre-set parameter, using software modelings such as CAD, and be converted into stl formatted files import 3D beat
In the LTY software control systems of print machine；
4. instructed by computer export, control 3D printer prints Breviscapinun oral disintegrating tablet：Power spreading device is first on powder bed
Medicinal powder of the paving a layer thickness for 0.2mm, then sprays binder in selection area, is the ground floor of dispersible tablet.Subsequently under powder bed
Drop, power spreading device paving second layer powder, so successively prints, is layering, until completing the printing of dispersible tablet；
5. take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
Claims (9)
1. a kind of 3D printing Breviscapinun oral disintegrating tablet, it is characterised in that：Count by weight percentage, its formula is comprising with the following group
Point：Breviscapinun 10-30%, dextrin 30%-60%, microcrystalline cellulose 25-40%, PVP 10-15%, superfine silica gel powder 0-
0.5%th, flavouring 0-0.5%, is formed by 3D printing.
2. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that：Count by weight percentage, its
Formula includes following components：Breviscapinun 10-20%, dextrin 30%-50%, microcrystalline cellulose 28-35%, PVP 10-
12%th, superfine silica gel powder 0-0.5%, flavouring 0-0.5%.
3. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that：Count by weight percentage, its
Formula includes following components：Breviscapinun 13.5%, dextrin 44%, microcrystalline cellulose 32%, PVP 10%, superfine silica gel powder
0.5%.
4. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that：Described microcrystalline cellulose is adopted
Microcrystalline cellulose PH101.
5. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that：Described PVP is using poly- dimension
Ketone K30.
6. 3D printing Breviscapinun oral disintegrating tablet according to claim 1, it is characterised in that：Described flavouring 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 comprise the following steps：
(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%, flavouring 0-0.5% are mixed in proportion, and load 3D printing as medicinal powder fast
In the powder box of fast forming machine；
(2) binder is loaded in print cartridge；
(3) according to pre-set parameter, modeling, and import 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 powder
The medicinal powder on one layer of upper berth of bed, then sprays binder in selection area, is the ground floor of dispersible tablet, subsequent power spreading device paving second
Layer powder, so successively prints, is layering, until completing the printing of dispersible tablet；
(5) take out after dispersible tablet coheres and is dried, clean surrounding residual powder, obtain final product.
8. the preparation method of 3D printing Breviscapinun oral disintegrating tablet according to claim 7, it is characterised in that：The step
(3), in parameter, dispersible tablet three-dimensional parameter is：Diameter 5-12mm, thickness 2-5mm, number of plies 15-50 layer, floor height 0.1-0.2mm,
Binding agent parameter is：Spray rate 3.5-4.5nL × 10-14kz, spraying number of times 1-3 time.
9. the preparation method of 3D printing Breviscapinun oral disintegrating tablet according to claim 7, it is characterised in that：Described bonding
Agent is water, 30%～75% ethanol solution, starch slurry, the water of PVP or ethanol solution.
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| CN201610836143.5A CN106511285B (en) | 2016-09-20 | 2016-09-20 | A kind of 3D printing Breviscapinun oral disintegrating tablet and preparation method thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213126A (en) * | 2017-05-17 | 2017-09-29 | 西安棣加生物科技有限公司 | A kind of method that 3D printing technique prepares the oral quick disintegrating tablet for the treatment of hyperphosphatemia |
| CN107252418A (en) * | 2017-05-17 | 2017-10-17 | 西安棣加生物科技有限公司 | A kind of method that 3D printing technique prepares the oral quick disintegrating tablet for the treatment of hypopotassaemia |
| CN107669648A (en) * | 2017-11-07 | 2018-02-09 | 互竑实业(上海)有限公司 | A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof |
| CN107811987A (en) * | 2017-11-07 | 2018-03-20 | 互竑实业(上海)有限公司 | A kind of 3D printing aminophylline oral disnitegration tablet and preparation method thereof |
| CN107823153A (en) * | 2017-11-07 | 2018-03-23 | 互竑实业(上海)有限公司 | A kind of Amlodipine Besylate Tablet oral disintegrating tablet prepared using 3D printing and preparation method thereof |
| CN107854440A (en) * | 2017-11-07 | 2018-03-30 | 广东药科大学 | A kind of Leponex orally disintegrating tablet prepared using 3D printing and preparation method thereof |
| CN109394708A (en) * | 2017-08-17 | 2019-03-01 | 西安棣加生物科技有限公司 | Oral rapidly disintegrating heart disease first aid piece and its 3D printing method, purposes |
| 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 |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107213126A (en) * | 2017-05-17 | 2017-09-29 | 西安棣加生物科技有限公司 | A kind of method that 3D printing technique prepares the oral quick disintegrating tablet for the treatment of hyperphosphatemia |
| CN107252418A (en) * | 2017-05-17 | 2017-10-17 | 西安棣加生物科技有限公司 | A kind of method that 3D printing technique prepares the oral quick disintegrating tablet for the treatment of hypopotassaemia |
| CN109394708A (en) * | 2017-08-17 | 2019-03-01 | 西安棣加生物科技有限公司 | Oral rapidly disintegrating heart disease first aid piece and its 3D printing method, purposes |
| CN107669648A (en) * | 2017-11-07 | 2018-02-09 | 互竑实业(上海)有限公司 | A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof |
| CN107811987A (en) * | 2017-11-07 | 2018-03-20 | 互竑实业(上海)有限公司 | A kind of 3D printing aminophylline oral disnitegration tablet and preparation method thereof |
| CN107823153A (en) * | 2017-11-07 | 2018-03-23 | 互竑实业(上海)有限公司 | A kind of Amlodipine Besylate Tablet oral disintegrating tablet prepared using 3D printing and preparation method thereof |
| CN107854440A (en) * | 2017-11-07 | 2018-03-30 | 广东药科大学 | A kind of Leponex orally disintegrating tablet prepared using 3D printing 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 |
| 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 |
| EP4110263A4 (en) * | 2020-02-27 | 2024-04-17 | Henkel AG & Co. KGaA | A personal care product and a method for making a personal care product by an additive process |
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