CN106265548A - A kind of preparation method of carbamazepine dispersible tablet - Google Patents
A kind of preparation method of carbamazepine dispersible tablet Download PDFInfo
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- CN106265548A CN106265548A CN201510256077.XA CN201510256077A CN106265548A CN 106265548 A CN106265548 A CN 106265548A CN 201510256077 A CN201510256077 A CN 201510256077A CN 106265548 A CN106265548 A CN 106265548A
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- carbamazepine
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- dispersible tablet
- binding agent
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Abstract
The invention provides the preparation method of a kind of carbamazepine dispersible tablet, it comprises the steps: a, the raw material weighing each weight proportion and adjuvant: carbamazepine 10-20 part, disintegrating agent 30-80 part, filler 100-200 part, binding agent 1-3 part, fluidizer 1.5-2.5 part, lubricant 1-3 part；B, carbamazepine and disintegrating agent are dissolved in 50-95% ethanol, are prepared as pastille binding agent；C, take filler, lubricant and binder combination and sieve, mixing；D, the pastille binding agent of b step is joined in mixture prepared by step (c), pelletize, be dried, granulate, total mixed, tabletting, be prepared as tablet.Carbamazepine dispersible tablet preparation method of the present invention ensure that the medicament contg uniformity, and raw material controls particle diameter without micronization, and this invention can increase the dissolution of insoluble drug, and common dissolving reduces technological operation step, saves the energy, and reduces cost.
Description
Technical field
The present invention relates to the preparation method of a kind of carbamazepine dispersible tablet, belong to field of pharmaceutical preparations.
Background technology
Carbamazepine (carbamazepine is called for short CBZ) is the choice drug for treating epilepsy, is also commonly used for
The diseases such as treatment trigeminal neuralgia, manicdepressive, arrhythmia, are clinical conventional medicines, and market is huge.1961
Year is synthesized by the Schneider of Switzerland etc., and nineteen sixty-eight, department of Novartis listed with tablet, and the dosage form of listing also conforms to the principle of simplicity
Single tablet develops into chewable tablet, suspensoid and slow releasing preparation.1997, uncommon Thunder God department develop by rapid release,
The slow releasing capsule of slow release, enteric coated micropill combination, has promoted the formulation development of carbamazepine.2004, uncommon Thunder God
Department carbamazepine sustained-release capsules get back U.S. FDA approval listing, this is currently the only effective treatment two-phase feelings
The molecusol-carbamazepine of sense impaired patients, thus attracted substantial amounts of researcher to study.
Carbamazepine is insoluble in water, and ordinary preparation such as tablet or capsule slowly affect medicine because dissolving with disintegrate
Normal absorption, cause bioavailability low, carbamazepine dispersible tablet disintegration time compared with ordinary preparation is short,
Drug-eluting is rapid, is greatly improved the bioavailability of medicine.
After time prepared by existing carbamazepine dispersible tablet, raw material adds adjuvant mixing, soft material processed, uniformly it is dried, powder
Pelletize with binding agent again after broken, be dried；Two step mixings, two steps are dried, and loaded down with trivial details being unfavorable for produces greatly process,
And the easy consumption energy increases cost.
Summary of the invention
In order to solve above-mentioned technical problem, technical scheme provides a kind of carbamazepine dispersible tablet
Preparation method.
The invention provides a kind of method preparing carbamazepine dispersible tablet, it comprises the steps:
The preparation method of a kind of carbamazepine dispersible tablet, it comprises the steps:
A, the raw material weighing each weight proportion and adjuvant:
Carbamazepine 10-20 part, disintegrating agent 30-80 part, filler 100-200 part, binding agent 1-3 part,
Fluidizer 1.5-2.5 part, lubricant 1-3 part；
B, carbamazepine and binding agent are dissolved in 50-95% ethanol, are prepared as pastille binding agent；
C, take filler, lubricant, fluidizer and disintegrant mixture and sieve, mixing；
D, the pastille binding agent of b step is joined in mixture prepared by step (c), pelletize, be dried,
Granulate, total mixed, tabletting, be prepared as tablet.
As preferably, described filler is selected from pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose extremely
Few one.
As preferably, described binding agent is selected from hydroxypropyl methyl cellulose, polyvidone, sodium carboxymethyl cellulose
In at least one.
As preferably, described disintegrating agent is selected from carboxymethylstach sodium, crospolyvinylpyrrolidone, crosslinking carboxylic first
At least one in base sodium cellulosate；At least one in silicon dioxide, magnesium stearate of described lubricant.
As preferably, described carbamazepine dispersible tablet also includes correctives, and described correctives is selected from from A Siba
At least one in sweet, saccharin sodium.
As preferably, raw material and the part by weight of adjuvant described in step a be:
Carbamazepine 20mg, cross-linking sodium carboxymethyl cellulose 32.5mg, pregelatinized Starch 140mg, polyvidone
2.5mg, Pulvis Talci 2.5mg, magnesium stearate 2.5mg.
As preferably, the ethanol described in step b is 75% ethanol.
As preferably, the method for granulating described in step d is: pastille binding agent b step prepared and c step
Suddenly prepare mixture and put in granulator, mixing speed 400rpm, the pelletize of shear rate 1000rpm are set, take
Go out and pelletize with 18-22 mesh sieve.
As preferably, the total mixing method of granulate described in step d is: by the granule 20-25 after fluid bed drying
Mesh sieve granulate, addition lubricant is put mix homogeneously in Mixers with Multi-direction Movement and is obtained midbody particle.
The invention has the beneficial effects as follows:
Due to the difficult soluble substance of carbamazepine tablet raw material, uniformity of dosage units, dissolution are Carbamazepine Tablets
The index of major control, carries out pretreatment, energy by the method using the present invention to carbamazepine and binding agent
Ensureing the medicament contg uniformity, reduce principal agent particle diameter simultaneously, raw material, without micronization, increases insoluble drug
Dissolution, improve bioavailability, and common dissolving reduce technological operation step, save the energy and reduce and put into
Cost.
Detailed description of the invention
Following embodiment is used for further illustrating but is not limited to the present invention.
The Selection experiment of embodiment 1 carbamazepine dissolution solvent
In taking raw material respectively about 20mg putting beaker, it is gradually added into variable concentrations (50%, 75%, 95%)
Ethanol solution, shaking limit, limit is observed, until solution clarification, weighs added quantity of solvent.Dense according to different ethanol
The consumption of degree, the mixed accessories to 180mg carries out soft material processed respectively, observes the humidity condition of soft material, and uses
20 mesh sieves carry out investigation of sieving, and the results are shown in Table 1.
The selection of table 1 principal agent dissolution solvent and investigation result
Result: the ethanol solution of above-mentioned variable concentrations can dissolve 20mg raw material under a certain amount of very well, to 180mg
Good wetting effect, it has good formability, determines that this product granulation solvent uses material particles
50～the ethanol solution of 95%.
Experimental example 2
The prescription of Carbamazepine Tablets one-tenth as shown in Table 2 is grouped into.
The prescription of table 2 Carbamazepine Tablets
The preparation method of above-mentioned carbamazepine dispersible tablet is as follows:
Preparation technology:
1. by the carbamazepine of recipe quantity, polyvidone ultrasonic dissolution simultaneously in 75% ethanol solution of about 60g,
As the binding agent containing principal agent, this binding agent is water white transparency, without agglomerate and bubble.
2. take the carboxymethyl starch sodium of recipe quantity, pregelatinized Starch, Pulvis Talci, saccharin sodium mixed 100 mesh
Sieve 3 times.
3. the binding agent containing principal agent is joined in the mixture of step 2, prepare soft material 20 mesh sieve and pelletize, dry
60 DEG C of case is dried.
4. granule crosses 24 mesh sieve granulate, and additional magnesium stearate mixes as midbody particle.
5. tabletting, tablet hardness scope control is 50～70N.
Experimental example 3
The prescription of Carbamazepine Tablets one-tenth as shown in Table 3 is grouped into.
The prescription of table 3 Carbamazepine Tablets
The preparation method of above-mentioned carbamazepine dispersible tablet is as follows:
Preparation technology:
1. by the carbamazepine of recipe quantity, hydroxypropyl methyl cellulose ultrasonic dissolution simultaneously in about 60g's
In 50% ethanol solution, as the binding agent containing principal agent, this binding agent is water white transparency, without agglomerate and bubble.
2. take the microcrystalline Cellulose of recipe quantity, crospolyvinylpyrrolidone, Pulvis Talci
, aspartame mixed 100 mesh sieve 3 times.
3. the binding agent containing principal agent is joined in the mixture of step 2, prepare soft material 20 mesh sieve and pelletize, dry
40 DEG C of case is dried.
4. granule crosses 24 mesh sieve granulate, and additional magnesium stearate mixes as midbody particle.
5. tabletting, tablet hardness scope control is 50～70N.
Experimental example 3
The prescription of Carbamazepine Tablets one-tenth as shown in Table 4 is grouped into.
The prescription of table 4 Carbamazepine Tablets
The preparation method of above-mentioned carbamazepine dispersible tablet is as follows:
Preparation technology:
1. by the carbamazepine of recipe quantity, sodium carboxymethyl cellulose ultrasonic dissolution simultaneously in the 85% of about 32g
In ethanol solution, as the binding agent containing principal agent, this binding agent is water white transparency, without agglomerate and bubble.
2. take the lactose of recipe quantity, carboxymethylstach sodium, Pulvis Talci, aspartame mixed 100 mesh sieve 3 times.
3. the binding agent containing principal agent is joined in the mixture of step 2, prepare soft material 20 mesh sieve and pelletize, dry
50 DEG C of case is dried.
4. granule crosses 24 mesh sieve granulate, and additional magnesium stearate mixes as midbody particle.
5. tabletting, tablet hardness scope control is 50～70N.
The carbamazepine dispersible tablet present invention prepared grinds medicine contrast, the carbamazepine dispersible tablet of the present invention with former
With the former medicine that grinds in 0.1 hydrochloric acid solution, aqueous solution and pH4.5 buffer solution, pH6.8 phosphate buffer dissolution
Dependence Results is shown in Table 5.
Table 5 is made sample (embodiment 1) by oneself and is ground commercially available product stripping curve measurement result with former
As can be seen from Table 5, Carbamazepine Tablets of the present invention self-control sample in different dissolution mediums,
Under different time points, dissolution is above the former dissolution grinding medicine.
Claims (8)
1. the preparation method of a carbamazepine dispersible tablet, it is characterised in that: it comprises the steps:
A, the raw material weighing each weight proportion and adjuvant:
Carbamazepine 10-20 part, disintegrating agent 30-80 part, filler 100-200 part, binding agent 1-3 part,
Fluidizer 1.5-2.5 part, lubricant 1-3 part；
B, carbamazepine and binding agent are dissolved in 50-95% ethanol, are prepared as pastille binding agent；
C, take filler, lubricant and disintegrant mixture and sieve, mixing；
D, the pastille binding agent of b step is joined in mixture prepared by step (c), pelletize, be dried,
Granulate, total mixed, tabletting, be prepared as tablet.
The preparation method of carbamazepine dispersible tablet the most according to claim 1, it is characterised in that: described
At least one in pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose of filler.
The preparation method of carbamazepine dispersible tablet the most according to claim 1, it is characterised in that: described
At least one in hydroxypropyl methyl cellulose, polyvidone, sodium carboxymethyl cellulose of binding agent.
The preparation method of carbamazepine dispersible tablet the most according to claim 1, it is characterised in that: described
Disintegrating agent is selected from carboxymethylstach sodium, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose at least
A kind of；At least one in silicon dioxide, magnesium stearate of described lubricant.
The preparation method of carbamazepine dispersible tablet the most according to claim 1, it is characterised in that: described
Carbamazepine dispersible tablet also includes correctives, and described correctives is selected from aspartame, saccharin sodium at least
A kind of.
6. according to the preparation method of the carbamazepine dispersible tablet described in claim 1, it is characterised in that: step a
Described raw material and the part by weight of adjuvant be:
Carbamazepine 20mg, cross-linking sodium carboxymethyl cellulose 32.5mg, pregelatinized Starch 140mg, polyvidone
2.5mg, Pulvis Talci 2.5mg, magnesium stearate 2.5mg.
Preparation method the most according to claim 1, it is characterised in that: the ethanol described in step b is
75% ethanol.
The preparation method of carbamazepine dispersible tablet the most according to claim 1, it is characterised in that: step
Method of granulating described in d is: pastille binding agent b step prepared and step c are prepared mixture and put granulator
In, mixing speed 400rpm, the pelletize of shear rate 1000rpm are set, take out and pelletize with 18-22 mesh sieve.
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| CN201510256077.XA CN106265548A (en) | 2015-05-19 | 2015-05-19 | A kind of preparation method of carbamazepine dispersible tablet |
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| CN201510256077.XA CN106265548A (en) | 2015-05-19 | 2015-05-19 | A kind of preparation method of carbamazepine dispersible tablet |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815126A (en) * | 2018-07-25 | 2018-11-16 | 江苏黄河药业股份有限公司 | A kind of Carbamazepine Tablets and preparation method thereof |
| CN110269845A (en) * | 2019-07-11 | 2019-09-24 | 上海复旦复华药业有限公司 | A kind of novel production prescription and technique of Carbamazepine Tablets |
| CN114392241A (en) * | 2022-01-10 | 2022-04-26 | 安徽贝克生物制药有限公司 | Rilpivirine tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102836137A (en) * | 2012-09-21 | 2012-12-26 | 山东齐都药业有限公司 | Pramipexole dihydrochloride slow-release tablet with high content uniformity and preparation method thereof |
| CN103948560A (en) * | 2014-04-22 | 2014-07-30 | 青岛市中心医院 | Carbamazepine tablet and preparation method thereof |
-
2015
- 2015-05-19 CN CN201510256077.XA patent/CN106265548A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102836137A (en) * | 2012-09-21 | 2012-12-26 | 山东齐都药业有限公司 | Pramipexole dihydrochloride slow-release tablet with high content uniformity and preparation method thereof |
| CN103948560A (en) * | 2014-04-22 | 2014-07-30 | 青岛市中心医院 | Carbamazepine tablet and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815126A (en) * | 2018-07-25 | 2018-11-16 | 江苏黄河药业股份有限公司 | A kind of Carbamazepine Tablets and preparation method thereof |
| CN110269845A (en) * | 2019-07-11 | 2019-09-24 | 上海复旦复华药业有限公司 | A kind of novel production prescription and technique of Carbamazepine Tablets |
| CN114392241A (en) * | 2022-01-10 | 2022-04-26 | 安徽贝克生物制药有限公司 | Rilpivirine tablet and preparation method thereof |
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