CN101152156A - Domperidone orally disintegrating tablets and method for preparing the same - Google Patents
Domperidone orally disintegrating tablets and method for preparing the same Download PDFInfo
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- CN101152156A CN101152156A CNA2006101167407A CN200610116740A CN101152156A CN 101152156 A CN101152156 A CN 101152156A CN A2006101167407 A CNA2006101167407 A CN A2006101167407A CN 200610116740 A CN200610116740 A CN 200610116740A CN 101152156 A CN101152156 A CN 101152156A
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- domperidone
- agent
- tablet
- orally disintegrating
- dilution
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Abstract
The invention discloses a domperidone orally disintergrating tablet and the preparation method. The domperidone orally disintergrating tablet of the invention contains effective dose of domperidone and pharmaceutical excipient which is capable of rapidly disintegrating and releasing medicine in the oral cavity. The preparation method adopts modern preparation technology and the product has stable quality. So the preparation method provides patients with a safe and effective domperidone orally disintergrating tablet which is absorbed rapidly.
Description
Technical field
The invention belongs to the medicine preparation field, be specifically related to a kind of domperidone orally disintegrating tablet that adopts modern tablet technology preparation and preparation method thereof.
Background technology
Domperidone (domperidone) is a Drags for Digestive Diseases of Belgian Janssen Pharmaceutica exploitation.This product is the stronger periphery dopamine-receptor antagonist of an effect, directly acts on gastrointestinal wall, can increase the about muscular tension of esophagus expansion down moderately, prevents stomach-esophageal reflux; Strengthen the tail wriggling, promote gastric emptying, improve gastroduodenal sports coordination, prevent bile reflux, regulate and recover the motion of upper gastro-intestinal tract; Suppress to feel sick vomiting.Do not influence gastric acid secretion.Oral post-absorption is rapid.
Mere formality is offered report, and domperidone not only is used for chronic gastritis, atrophic gastritis, and the dyspepsia that straight reflux gastritis of gallbladder and reflux esophagitis cause is felt sick, vomiting, stomach burn feeling; Also be used for functional, infectivity, what diet and medicine caused feels sick, vomiting.
At present, existing conventional tablet of domperidone and suspensoid, but all there is defective in various degree in this concentrated preparation, conventional tablet is taken convenient inadequately, drug precipitation can appear in suspensoid storage for a long time, and then influence the absorption of medicine, because that above-mentioned dosage form exists is above obviously not enough, press for the oral formulations of the new better effects if of exploitation.Take medicine conveniently because oral cavity disintegration tablet is compared with other preparations, improve patient's drug compliance, can produce excellent curative, so medicine oral disintegrated preparation technology has become one of high-tech technology of contemporary field of medicaments.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of stable in properties, domperidone orally disintegrating tablet easy to use, evident in efficacy.
Another object of the present invention provides a kind of preparation method of domperidone orally disintegrating tablet agent, and it adopts modern technology of preparing, but commercial scale, high efficiency production, and it is stable that product quality keeps.
Domperidone orally disintegrating tablet of the present invention, the effective dose of its contained domperidone is preferably 3%～10% of total content, can comprise fluidizer, dilution/binding agent, disintegrating agent, sweeting agent, aromatic, lubricant by the pharmaceutic adjuvant of rapid disintegrate release medicine in the oral cavity.
It is made up of above-mentioned pharmaceutic adjuvant of the present invention following weight percentage ratio:
Dilution/binding agent 50%～90%
Disintegrating agent 5%～15%
Sweeting agent 1%～3%
Aromatic 1%～4%
Fluidizer 0.5%～3%
Lubricant 0.5%～3%
Select suitable pharmaceutic adjuvant that the oral cavity disintegration tablet of preparation is had a significant impact, preferred adjuvant can make that disintegrate is rapid, mouthfeel good, to the oral mucosa nonirritant etc.So the present invention has carried out preferably adjuvant.
Fluidizer in the medicines dressing of the present invention is that silicon dioxide, dilution/adhesive are that mannitol, disintegrating agent are that crospolyvinylpyrrolidone, sweeting agent are that aspartame, aromatic are that fragrant citrus and Herba Menthae essence, lubricant are magnesium stearate.
The preparation method of domperidone orally disintegrating tablet of the present invention, its preparation technology can be divided into preliminary mixing, middle mixing, mixing at last, tabletting, packing etc., and its concrete steps are as follows:
1) the domperidone raw material is mixed with the principle that equivalent increases progressively with part dilution/adhesive, 20 orders twice that sieve are poured mix homogeneously in the three-dimensional mixer then into;
2) 20 orders that sieve with fluidizer, disintegrating agent, sweeting agent, aromatic and after residue dilution/adhesive mixes are poured in the three-dimensional mixer mixed powder mix homogeneously with previous step into;
3) add lubricant, mixed 1-2 minute;
4) mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N;
5) two aluminum cold forming blister packages.
The domperidone orally disintegrating tablet that the present invention makes has the following advantages:
1) taking convenience can be swallowed by common dose, can be placed in the water again to take after the disintegrate, can also not need to take medicine with water swallow.Being particularly useful for the patient of old man, children's's dysphagia and the inconvenient person that fetches water takes medicine convenience is provided, in addition when this tablet of preparation owing to adopted certain method of improving the preparation mouthfeel, improve the drug compliance of child patient, preferably resolved the problem that it is difficult that infant is taken medicine;
2) intestinal is residual few, and side effect is low;
3) this product adopts the technology of direct compression, and easy flow process shortens man-hour.
The specific embodiment
Embodiment 1
Domperidone 50g
Mannitol 700g
Crospolyvinylpyrrolidone 80g
Aspartame 15g
Fragrant citrus essence 7.5g
Herba Menthae essence 7.5g
Silicon dioxide 7.5g
Magnesium stearate 15g
The domperidone raw material is mixed with the principle that equivalent increases progressively with part mannitol, and 20 orders twice that sieve are poured into then in the three-dimensional mixer and were mixed 15 minutes; 20 orders that sieve with silicon dioxide, aspartame, fragrant citrus essence, Herba Menthae essence, crospolyvinylpyrrolidone and after residue mannitol mixes are poured in the three-dimensional mixer and were mixed 30 minutes with the mixed powder of previous step; Add magnesium stearate, mixed 1-2 minute; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Embodiment 2
Domperidone 50g
Mannitol 950g
Crospolyvinylpyrrolidone 100g
Aspartame 20g
Fragrant citrus essence 9g
Herba Menthae essence 9g
Silicon dioxide 9g
Magnesium stearate 15g
The domperidone raw material is mixed with the principle that equivalent increases progressively with part mannitol, and 20 orders twice that sieve are poured into then in the three-dimensional mixer and were mixed 15 minutes; 20 orders that sieve with silicon dioxide, aspartame, fragrant citrus essence, Herba Menthae essence, crospolyvinylpyrrolidone and after residue mannitol mixes are poured in the three-dimensional mixer and were mixed 30 minutes with the mixed powder of previous step; Add magnesium stearate, mixed 1-2 minute; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Embodiment 3
Domperidone 50g
Mannitol 550g
Crospolyvinylpyrrolidone 60g
Aspartame 10g
Fragrant citrus essence 5g
Herba Menthae essence 5g
Silicon dioxide 5g
Magnesium stearate 7.5g
The domperidone raw material is mixed with the principle that equivalent increases progressively with part mannitol, and 20 orders twice that sieve are poured into then in the three-dimensional mixer and were mixed 15 minutes; 20 orders that sieve with silicon dioxide, aspartame, fragrant citrus essence, Herba Menthae essence, crospolyvinylpyrrolidone and after residue mannitol mixes are poured in the three-dimensional mixer and were mixed 30 minutes with the mixed powder of previous step; Add magnesium stearate, mixed 1-2 minute; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Claims (5)
1. domperidone orally disintegrating tablet, comprise effective dose domperidone and can be in the oral cavity rapidly disintegrate discharge the pharmaceutic adjuvant of medicine.
2. domperidone orally disintegrating tablet as claimed in claim 1, the weight percent content that it is characterized in that described domperidone is 3%～10%.
3. domperidone orally disintegrating tablet as claimed in claim 1 or 2 is characterized in that pharmaceutic adjuvant is: dilution/adhesive, disintegrating agent, sweeting agent, aromatic, fluidizer, lubricant, and it is made up of following weight percentage ratio:
Dilution/binding agent 50%～90%
Disintegrating agent 5%～15%
Sweeting agent 1%～3%
Aromatic 1%～4%
Fluidizer 0.5%～3%
Lubricant 0.5%～3%
4. a domperidone orally disintegrating tablet as claimed in claim 3 is characterized in that dilution/adhesive is that mannitol, disintegrating agent are that crospolyvinylpyrrolidone, sweeting agent are that aspartame, aromatic are that fragrant citrus and Herba Menthae essence, fluidizer are that silicon dioxide, lubricant are magnesium stearate.
5. the preparation method of a domperidone orally disintegrating tablet as claimed in claim 1, its preparation process is as follows:
1) the domperidone raw material is mixed with the principle that equivalent increases progressively with part dilution/adhesive, 20 orders twice that sieve are poured mix homogeneously in the three-dimensional mixer then into;
2) 20 orders that sieve with disintegrating agent, sweeting agent, aromatic, fluidizer and after residue dilution/adhesive mixes are poured in the three-dimensional mixer mixed powder mix homogeneously with previous step into;
3) add lubricant, mixed 1-2 minute;
4) mixed material is poured in the hopper of tablet machine, carried out tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101167407A CN101152156A (en) | 2006-09-29 | 2006-09-29 | Domperidone orally disintegrating tablets and method for preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101167407A CN101152156A (en) | 2006-09-29 | 2006-09-29 | Domperidone orally disintegrating tablets and method for preparing the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101152156A true CN101152156A (en) | 2008-04-02 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006101167407A Pending CN101152156A (en) | 2006-09-29 | 2006-09-29 | Domperidone orally disintegrating tablets and method for preparing the same |
Country Status (1)
| Country | Link |
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| CN (1) | CN101152156A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804036B (en) * | 2009-02-13 | 2013-05-08 | 北京以岭生物工程技术有限公司 | Domperidone orally disintegrating tablet and preparation method thereof |
| CN103877048A (en) * | 2014-03-26 | 2014-06-25 | 邵娜 | Orally-disintegrating progesterone tablet and preparation method thereof |
| CN104042578A (en) * | 2014-06-13 | 2014-09-17 | 青岛市市立医院 | Domperidone orally disintegrating tablet and preparation method thereof |
| CN105267166A (en) * | 2014-07-21 | 2016-01-27 | 常州制药厂有限公司 | Preparation method of domperidone composition |
| CN107432868A (en) * | 2017-09-04 | 2017-12-05 | 广州和实生物技术有限公司 | A kind of Orally-disintegrating tablet |
| CN110151711A (en) * | 2019-04-25 | 2019-08-23 | 广东人人康药业有限公司 | A kind of domperidone orally disintegrating tablet and preparation method thereof |
-
2006
- 2006-09-29 CN CNA2006101167407A patent/CN101152156A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804036B (en) * | 2009-02-13 | 2013-05-08 | 北京以岭生物工程技术有限公司 | Domperidone orally disintegrating tablet and preparation method thereof |
| CN103877048A (en) * | 2014-03-26 | 2014-06-25 | 邵娜 | Orally-disintegrating progesterone tablet and preparation method thereof |
| CN104042578A (en) * | 2014-06-13 | 2014-09-17 | 青岛市市立医院 | Domperidone orally disintegrating tablet and preparation method thereof |
| CN105267166A (en) * | 2014-07-21 | 2016-01-27 | 常州制药厂有限公司 | Preparation method of domperidone composition |
| CN107432868A (en) * | 2017-09-04 | 2017-12-05 | 广州和实生物技术有限公司 | A kind of Orally-disintegrating tablet |
| CN110151711A (en) * | 2019-04-25 | 2019-08-23 | 广东人人康药业有限公司 | A kind of domperidone orally disintegrating tablet and preparation method thereof |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20080402 |