CN1931168A - Oral disintegrated difenidol hydrochloride tablet and its prepn process - Google Patents
Oral disintegrated difenidol hydrochloride tablet and its prepn process Download PDFInfo
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- CN1931168A CN1931168A CN 200510102544 CN200510102544A CN1931168A CN 1931168 A CN1931168 A CN 1931168A CN 200510102544 CN200510102544 CN 200510102544 CN 200510102544 A CN200510102544 A CN 200510102544A CN 1931168 A CN1931168 A CN 1931168A
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Abstract
The present invention discloses oral disintegrated difenidol hydrochloride tablet prepared through freeze- drying process and its preparation process. The oral disintegrated difenidol hydrochloride tablet has difenidol hydrochloride as main medicine component, solid dispersing carrier, disintegrant, effervescent agent, taste masking agent, excipient, etc. and features the freeze- drying preparing process. It may be disintegrated in oral cavity into particles smaller than 250 microns within 30 sec without need of water, and is especially suitable for patient with dysphagia. It has fast leaching out and absorption, fast acting and high bioavailability.
Description
Technical field
The invention belongs to medical technical field, relate to the oral cavity disintegration tablet dosage form, relate in particular to a kind of oral disintegrated difenidol hydrochloride tablet that adopts the freeze-drying preparation and preparation method thereof with rapid release effect.
Background technology
Difenidol hydrochloride (difcnidol hydrochloride) chemical name is α, α-diphenyl-1-piperidine butanol hydrochlorate, has another name called diphenidol, difenidol, diphenidol etc., is a non-phenothiazines medicine.This product has intensive town to tell effect, is used for dizzy, vomiting that multiple disease causes.This product is with determined curative effect, and few side effects only has the conventional tablet and the injection of this medicine at present on the medical market.
Conventional tablet need be drunk water and be finished drug administration process by swallowing act, and for child, old people with to swallow inconvenient patient dependence poor, the use under some specific conditions is restricted and quotes water as shortage.Though drug administration by injection is rapid-action, must medical personnel assist, the patient uses inconvenience.
Oral cavity disintegration tablet (orally disintegrating tablet) is emerging in recent years dosage form, compare with conventional tablet, this dosage form need not water and also need not chew, medicine places on the tongue, after meeting the rapid disintegrate of saliva, borrow swallowing act to go into the stomach onset, also can place the Sublingual, medicine absorbs onset by mucosa after the disintegrate rapidly.This dosage form is particularly suitable for some old peoples, child, swallow inconvenient patient or the hydropenia condition of going out under patient take and rapid-action bioavailability height.
The oral disintegrated difenidol hydrochloride tablet direct compression process is by Jiangxi Prov. Medicine Inst application, patent name: difenidol hydrochloride oral disintegrant tablet preparation and method for making thereof, application number: 03119043.X.Oral cavity disintegration tablet granularity 80 mesh sieves of direct compression process preparation, disintegration is many more than 30 seconds.The weight of common oral cavity disintegration tablet is 100mg, and the weight of the oral disintegrated difenidol hydrochloride tablet that employing lyophilization principle is made only has 50-75mg, is easy to carry.When taking, medicine is contained in does not need moisture just fully disintegrate and do not have sand type in the oral cavity in the mouth, especially is fit to part dysphagia patien medication; Finished the disintegration of said preparation in 5 seconds, and the particle diameter I after the medicine disintegrate is by G3 filter, easier absorption.The quick stripping of medicine absorbs, and rapid-action, bioavailability is more taller than other oral cavity disintegration tablet.Being particularly suitable for the work high above the ground personnel carries and takes.
Summary of the invention
The present invention fully takes into account the deficiency that above-mentioned prior art condition exists, and to people provide that a kind of fabricating technology content is higher, the oral disintegrated difenidol hydrochloride tablet agent of taking convenience and preparation method thereof.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, the pharmaceutical formulation each component is 1 part of a difenidol hydrochloride by weight, 0～10 part in solid dispersion carrier, disintegrating agent, effervescent, odor mask, excipient add 10～100 parts of injection waters.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, the solid dispersion carrier can be selected polyvinylpyrrolidone (PVP), Polyethylene Glycol (PEG4000, PEG6000) and composition thereof.First-selected PEG6000.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, disintegrating agent can be crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), microcrystalline Cellulose (MCC), low-substituted hydroxypropyl cellulose (L-HPC) and composition thereof.First-selected L-HPC.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, effervescent can be the mixture of citric acid or citric acid and sodium bicarbonate.First-selected sodium bicarbonate.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, odor mask can be artificial sweetening agent, aspartame, stevioside, natural erythritol, and the gelatin of passivation taste bud etc.First-selected aspartame, gelatin.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, excipient can be mannitol, lactose, glucose and dextran.First-selected mannitol, lactose.
The present invention is to provide oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, particle diameter is less than 250 μ m after the oral cavity disintegration tablet disintegrate that makes, and disintegration was less than 30 seconds.
Advantage of the present invention is: the present invention utilizes freeze-drying to prepare oral disintegrated difenidol hydrochloride tablet, and the tablet granularity after the lyophilizing is littler, and intraoral disintegration is faster, is stranded and onset is faster, and bioavailability is higher.
The specific embodiment
Embodiment 1: take by weighing mannitol 4.0g, add in the 20ml water, stirring makes dissolving, add gelatin 1.0g, difenidol hydrochloride 1.0g and make dissolving, add the sweet 1.0g of A Siba again, stir or ultrasonic or grind and make dissolving, add water to 40ml, mixing filters back, fill, lyophilizing, plastic-aluminum, packing, promptly through the G3 filter.
Embodiment 2: take by weighing HP-20g, add the stirring of 40ml water and make dissolving, add difenidol hydrochloride 1.0g, stir or ultrasonic or grind and make dissolving, add water to 80ml, mixing filters back, fill, lyophilizing, plastic-aluminum, packing, promptly through the G3 filter.
Embodiment 3: take by weighing HP-2.0g, add the stirring of 10ml water and make dissolving, add difenidol hydrochloride 1.0g, stir or ultrasonic or grind and make dissolving, add the sweet 1.0g dissolving of A Siba, add water to 20ml, mixing filters back, fill, lyophilizing, plastic-aluminum, packing, promptly through the G3 filter.
Embodiment 4: take by weighing Polyethylene Glycol (PEG6000) 2.0g, add to stir in the 20ml water and make dissolving, add difenidol hydrochloride 1.0g, stir or ultrasonic or grind and make dissolving, add the sweet 1.0g dissolving of A Siba, add water to 40ml, mixing filters back, fill, lyophilizing, plastic-aluminum, packing, promptly through the G3 filter.
Claims (8)
1, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation and preparation method thereof, it is characterized in that: said " freeze-dry orally disintegrating tablet " is difenidol hydrochloride, add solid dispersion carrier, disintegrating agent, effervescent, correctives, excipient etc., the oral cavity disintegration tablet of making through lyophilization.
2, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: each component is by weight being 1 part of difenidol hydrochloride, 0～10 part in solid dispersion carrier, disintegrating agent, effervescent, odor mask, excipient add 10～100 parts of injection waters.
3, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: the solid dispersion carrier can be selected polyvinylpyrrolidone (PVP), Polyethylene Glycol (PEG4000, PEG6000) and composition thereof.First-selected PEG6000.
4, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: said disintegrating agent is meant crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), microcrystalline Cellulose (MCC), low-substituted hydroxypropyl cellulose (L-HPC) and composition thereof.First-selected L-HPC.
5, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: said effervescent is meant the mixture of citric acid or citric acid and sodium bicarbonate.First-selected sodium bicarbonate.
6, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: said odor mask is meant artificial sweetening agent, aspartame, stevioside, natural erythritol, and the gelatin of passivation taste bud etc.First-selected aspartame, gelatin.
7, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: said excipient is meant mannitol, lactose, glucose and dextran.First-selected mannitol, lactose.
8, oral disintegrated difenidol hydrochloride tablet of freeze-drying preparation according to claim 1 and preparation method thereof, it is characterized in that: particle diameter is less than 250 μ m after the oral cavity disintegration tablet disintegrate that makes, and disintegration was less than 30 seconds.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510102544 CN1931168A (en) | 2005-09-12 | 2005-09-12 | Oral disintegrated difenidol hydrochloride tablet and its prepn process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510102544 CN1931168A (en) | 2005-09-12 | 2005-09-12 | Oral disintegrated difenidol hydrochloride tablet and its prepn process |
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| CN1931168A true CN1931168A (en) | 2007-03-21 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200510102544 Pending CN1931168A (en) | 2005-09-12 | 2005-09-12 | Oral disintegrated difenidol hydrochloride tablet and its prepn process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525979A (en) * | 2012-02-07 | 2012-07-04 | 海南卫康制药(潜山)有限公司 | Infant ibuprofen composition |
| CN106924203A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of Eptifibatide sublingual administration composition |
-
2005
- 2005-09-12 CN CN 200510102544 patent/CN1931168A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525979A (en) * | 2012-02-07 | 2012-07-04 | 海南卫康制药(潜山)有限公司 | Infant ibuprofen composition |
| CN102525979B (en) * | 2012-02-07 | 2013-03-27 | 海南卫康制药(潜山)有限公司 | Infant ibuprofen composition |
| CN106924203A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of Eptifibatide sublingual administration composition |
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