CN1330295C - Slow-releasing tablets of oral medicine and preparation thereof - Google Patents
Slow-releasing tablets of oral medicine and preparation thereof Download PDFInfo
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- CN1330295C CN1330295C CNB2005100376788A CN200510037678A CN1330295C CN 1330295 C CN1330295 C CN 1330295C CN B2005100376788 A CNB2005100376788 A CN B2005100376788A CN 200510037678 A CN200510037678 A CN 200510037678A CN 1330295 C CN1330295 C CN 1330295C
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Abstract
The present invention relates to a slow-release tablet of an oral administration medicine, which is laminated by a blank layer without containing main medicines and a slow-release layer containing the main medicines, wherein the blank layer without containing main medicines is mainly prepared from slow-release materials, adhesive agents and lubricating agents; the slow-release layer containing the main medicines is mainly prepared from high-water solubility oral application medicines, the slow-release materials, the adhesive agents and the lubricating agents; the mass ratio of the blank layer and the slow-release layer is from 0.32 to 2.1:1; the mass proportion of the main medicines in the slow-release layer can be determined by the value of the required dosage of the main medicines, and the mass proportion can be selected from 1% to 75%. After the time curve of blood medicine concentration which is shown after the administration of the slow-release tablet of an oral administration medicine of the present invention is contrasted with that of blood medicine concentration which is shown after the common slow-release tablet of an oral administration medicine is administered, the maintenance time of the blood medicine concentration is long after the slow-release tablet of an oral administration medicine of the present invention is administered, and the concentration is stable. The present invention discloses a preparation method of the slow-release tablet of an oral administration medicine.
Description
One, technical field
The present invention relates to a kind of slow-releasing tablets of oral medicine and preparation method thereof
Two, background technology
Some medicines of Shi Yonging owing to the character of some medicine itself, are made conventional tablet and are taken clinically, can be very fast by metabolism in human body.In order to reach effective therapeutic effect, must increase the number of times of taking of this type of medicine.Will cause the shortcoming that medicining times is many, blood concentration fluctuation is big, side reaction is big like this.In order to improve curative effect of medication, reduce medicining times, guarantee drug safety, these medicines must be made slow releasing tablet.Slow releasing tablet is made the slow releasing tablet of homogeneous usually by the even back of principal agent, slow-release material, binding agent and mix lubricant tabletting.This slow releasing tablet often can not play good slow release effect for the good principal agent of water solublity.
Three, summary of the invention
The present invention provides a kind of double-layered slow releasing tablet at above technical deficiency just.
Technical scheme of the present invention is as follows:
A kind of slow-releasing tablets of oral medicine, it is made of with the slow release layer that contains principal agent is superimposed the blanket layer that does not contain principal agent, wherein, the blanket layer that does not contain principal agent mainly is made up of slow-release material, binding agent and lubricant, the slow release layer that contains principal agent mainly is made up of highly-water-soluble oral medicine, slow-release material, binding agent and lubricant, blanket layer is that 0.32-2.1 is than 1 with the mass ratio of slow release layer, in slow release layer, the principal agent quality accounts for the ratio of slow release layer quality can decide according to the dosage size of principal agent needs, can select for use between 1%-75%.
Specifically, slow-releasing tablets of oral medicine of the present invention, shown in an embodiment of the present invention, by per 1000 tablet qualities: slow-release material is the 50-300 gram in the blanket layer, and binding agent is the 10-50 gram, lubricant is the 1-3 gram; Contain that the highly-water-soluble oral medicine is the 1.5-500 gram in the slow release layer of principal agent, slow-release material is the 80-200 gram, and binding agent is the 5-10 gram, and lubricant is the 0.86-7.1 gram.
Above-mentioned highly-water-soluble oral medicine can be ditropan XL, metformin hydrochloride, Yin Da Paan.
Above-mentioned slow-release material can be Rikemal B 200, hydroxypropyl emthylcellulose (HPMC), ethyl cellulose, or the mixture of their two or more slow-release material.
Above-mentioned binding agent can be sodium carboxymethyl cellulose, polyvinylpyrrolidone K30 (PVP-K30), polyvinylpyrrolidone K90 (PVP-K90), or the mixture of their two or more binding agent.
Above-mentioned lubricant can be magnesium stearate, micropowder silica gel, Pulvis Talci.
Slow-releasing tablets of oral medicine of the present invention can adopt wet method tabletting method for making.
A kind of method for making of slow-releasing tablets of oral medicine of the present invention, it comprises the steps:
Step 1. all placed former, adjuvant under 60 ℃ of conditions dry 4 hours, and it is standby to cross 80 mesh sieves;
Step 2. is mixed the preparation of powder:
1. blanket layer: get slow-release material, binding agent by the charge ratio of blanket layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 1. mixing must mix powder;
2. slow release layer: get highly-water-soluble oral medicine, slow-release material, binding agent by the charge ratio of slow release layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 2. mixing must mix powder;
The preparation of step 3. soft material and wet granular: get mixed powder that step 2 makes 1., mix powder 2., add 20% Diluted Alcohol solution respectively, mediate the system soft material, cross 20 mesh sieves, make wet grain 1. and wet grain 2.;
Step 4. drying and tabletting:
2. 1. the wet grain that step 3 is made placed respectively 50-60 ℃ of oven drying 3-4 hour with wet grain, after crossing 18 mesh sieve granulate, must do granule, add lubricant after weighing respectively, mixing, the wet grain that will be after the drying adds lubricant 1. and wet grain 2. place two hoppers of bi-layer tablet press respectively, compacting promptly gets slow-releasing tablets of oral medicine of the present invention in flakes on bi-layer tablet press.
Slow-releasing tablets of oral medicine of the present invention can adopt the compressing dry granulation method for making.
A kind of method for making of slow-releasing tablets of oral medicine of the present invention, it comprises the steps:
Step 1. all placed former, adjuvant under 60 ℃ of conditions dry 4 hours, and it is standby to cross 80 mesh sieves;
Step 2. is mixed the preparation of powder:
1. blanket layer: get slow-release material, binding agent by the charge ratio of blanket layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 1. mixing must mix powder;
2. slow release layer: get highly-water-soluble oral medicine, slow-release material, binding agent by the charge ratio of slow release layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 2. mixing must mix powder;
Step 3. is done particulate preparation: get mixed powder that step 2 makes 1., mix powder 2., dry granulation respectively;
Step 4. tabletting: behind the granule granulate that step 3 is made, weigh respectively, add lubricant, mixing places two hoppers of bi-layer tablet press respectively with two kinds of granules, and compacting promptly gets slow-releasing tablets of oral medicine of the present invention in flakes on bi-layer tablet press.
Characteristics of the present invention:
1, from pharmaceutical dosage form, general slow releasing preparation mostly adopts the effect that pharmaceutical pack the method in the insoluble macromolecular scaffold of being hidden in is reached slow release.The mechanism that discharges is because thereby the retardation of the slow releasing agent of macromolecular scaffold delays the release of medicine.But, only simply contain and to reach ideal slow release effect for the big medicine of water solublity.For instance:, principal agent and sustained-release matrix are not only reached the good slow release effect by 1: 1 mixed also can cause the heavy overweight problem of sheet if drug content is big; Otherwise even drug content is not high, the ratio of slow releasing agent and principal agent can not play the good slow release effect greater than 10 sometimes.The present invention adopts double-layered slow releasing tablet technology, is hidden in pharmaceutical pack on the basis of high molecular slow-release agent, has increased the not blanket layer of pastille of one deck again, reduced the release area of medicine, reduced the speed of drug release, guaranteed the slow releasing function of medicine, its mechanism is seen accompanying drawing 1.
2, from the angle of absorption of human body, general slow releasing preparation is principal agent and sustained-release matrix uniform mixing, after taking, principal agent in human body from sustained-release matrix to around stripping, reach slow release effect.For the very big medicine of water solublity, increase slow-release material again after sustained-release matrix is increased to a certain degree and can not strengthen slow releasing function.And the present invention has increased the blank slow release layer of one deck, has strengthened the retardation for drug release, can reach ideal slow release effect.
3, will take slow-releasing tablets of oral medicine of the present invention and do contrast (seeing accompanying drawing 2-4) with blood drug level-time graph of taking behind the common slow-releasing tablets of oral medicine, it is long to take the time that the blood drug level of slow-releasing tablets of oral medicine of the present invention keeps as can be seen, and concentration is more steady.
Four, description of drawings
Fig. 1, mechanism of action figure of the present invention;
Fig. 2, metformin hydrochloride double-layer sustained release tablets and ordinary tablet, common slow releasing tablet compare: the blood drug level-time plot after taking;
Fig. 3, ditropan XL double-layer sustained release tablets and ordinary tablet, common slow releasing tablet compare: the blood drug level-time plot after taking;
Fig. 4, Yin Da Paan double-layer sustained release tablets and ordinary tablet, monolayer slow releasing tablet compare: the blood drug level-time plot after taking;
Five, the specific embodiment
Embodiment 1.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, cross 80 mesh sieves, standby; Then, prepared layer one is the pastille blanket layer not: get Rikemal B 200 200g, polyvinylpyrrolidone (PVP) K30 15g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation; Prepared layer two pastille slow-release layers: metformin hydrochloride 500g, Rikemal B 200 150g, polyvinylpyrrolidone (PVP) K30 20g cross 60 mesh sieves by equivalent incremental method mix homogeneously, and dry granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric metformin 500mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is seen Fig. 2.
Embodiment 2.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get full-bodied hydroxypropyl emthylcellulose 275g, polyvinylpyrrolidone (PVP) K30 15g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Prepared layer two slow release layers: get metformin hydrochloride 500g, hydroxypropyl emthylcellulose 150g, polyvinylpyrrolidone (PVP) K30 15g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Tabletting: layer one, layer two add 1% micropowder silica gel mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric metformin 500mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is similar to embodiment's 1.
Embodiment 3.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get ethyl cellulose 300g, polyvinylpyrrolidone (PVP) K30 15g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, water is done binding agent, and wet granulation is weighed; Prepared layer two slow release layers: get metformin hydrochloride 500g, ethyl cellulose 200g, polyvinylpyrrolidone (PVP) K30 10g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, wet granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric metformin 500mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is similar to embodiment 1.
Embodiment 4.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get Rikemal B 200 200g, polyvinylpyrrolidone (PVP) K90 10g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, wet granulation is weighed; Prepared layer two slow release layers: get ditropan XL 10g, Rikemal B 200 100g, polyvinylpyrrolidone (PVP) K90 10g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, wet granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric metformin 500mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is seen Fig. 3.
Embodiment 5.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: full-bodied hydroxypropyl emthylcellulose 150g, polyvinylpyrrolidone (PVP) K90 20g cross 60 mesh sieves by equivalent incremental method mix homogeneously, and dry granulation is weighed; Prepared layer two slow release layers: get ditropan XL 10g, hydroxypropyl emthylcellulose 80g, polyvinylpyrrolidone (PVP) K30 5g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric oxibutynin 10mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is similar to embodiment 4.
Embodiment 6.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get ethyl cellulose 200g, polyvinylpyrrolidone (PVP) K90 10g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Prepared layer two slow release layers: get ditropan XL 10mg, hydroxypropyl emthylcellulose 80g, polyvinylpyrrolidone (PVP) K90 3g by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, weigh; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000, every hydrochloric oxibutynin 10mg on bi-layer tablet press.Blood drug level-time graph after taking medicine is similar to embodiment 4.
Embodiment 7.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get Rikemal B 200 70g, sodium carboxymethyl cellulose 50g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, weigh; Prepared layer two slow release layers: get Yin and reach handkerchief peace 1.5g, Rikemal B 200 100g, polyvinylpyrrolidone (PVP) K30 8g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000 on bi-layer tablet press, and every contains Yin and reaches handkerchief peace 1.5mg.Blood drug level-time graph after taking medicine is seen accompanying drawing 4.
Embodiment 8.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: the 50g, polyvinylpyrrolidone (PVP) the K30 50g that get full-bodied hydroxypropyl emthylcellulose cross 60 mesh sieves by equivalent incremental method mix homogeneously, and dry granulation is weighed; Prepared layer two slow release layers: get Yin and reach handkerchief peace 1.5g, hydroxypropyl emthylcellulose 80g, sodium carboxymethyl cellulose 5g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Tabletting: layer one, layer two add 1% magnesium stearate mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000 on bi-layer tablet press, and every contains Yin and reaches handkerchief peace 1.5mg.Blood drug level-time graph after taking medicine is similar to embodiment 7.
Embodiment 9.
At first, former, adjuvant were all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves; Then, prepared layer one is the pastille blanket layer not: get ethyl cellulose 80g, polyvinylpyrrolidone (PVP) K30 50g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Prepared layer two slow release layers: get Yin and reach handkerchief peace 1.5g, ethyl cellulose 120g, sodium carboxymethyl cellulose 10g by equivalent incremental method mix homogeneously, cross 60 mesh sieves, dry granulation is weighed; Tabletting: layer one, layer two add 1% Pulvis Talci mixing respectively, and two hoppers of particle separate device of layer one, layer two are pressed into 1000 on bi-layer tablet press, and every contains Yin and reaches handkerchief peace 1.5mg.Blood drug level-time graph after taking medicine is similar to embodiment 7.
Claims (4)
1. slow-releasing tablets of oral medicine, it is characterized in that: it is made of with the slow release layer that contains principal agent is superimposed the blanket layer that does not contain principal agent, wherein, the blanket layer that does not contain principal agent is mainly by slow-release material, binding agent and lubricant are formed, the slow release layer that contains principal agent is mainly by the highly-water-soluble oral medicine, slow-release material, binding agent and lubricant are formed, blanket layer is that 0.32-2.1 is than 1 with the mass ratio of slow release layer, in slow release layer, the principal agent quality accounts for the ratio of slow release layer quality and can decide according to the dosage size of principal agent needs, can between 1%-75%, select for use, described highly-water-soluble oral medicine is a ditropan XL, metformin hydrochloride, Yin Da Paan, described slow-release material is a Rikemal B 200, hydroxypropyl emthylcellulose, ethyl cellulose, or the mixture of their two or more slow-release material, described binding agent is a sodium carboxymethyl cellulose, polyvinylpyrrolidone K30, polyvinylpyrrolidone K90, or the mixture of their two or more binding agent, in blanket layer, the mass ratio of slow-release material and binding agent is 20: 1～1: 1, in slow release layer, the mass ratio of slow-release material and binding agent is 26.7: 1～7.5: 1, described lubricant is a magnesium stearate, micropowder silica gel, Pulvis Talci, the quality that lubricant adds is 1% of a gross mass.
2. a method for preparing the described slow-releasing tablets of oral medicine of claim 1 is characterized in that it comprises the steps:
Step 1. all placed former, adjuvant under 60 ℃ of conditions dry 4 hours, and it is standby to cross 80 mesh sieves;
Step 2. is mixed the preparation of powder:
1. blanket layer: get slow-release material, binding agent by the charge ratio of blanket layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 1. mixing must mix powder;
2. slow release layer: get highly-water-soluble oral medicine, slow-release material, binding agent by the charge ratio of slow release layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 2. mixing must mix powder;
The preparation of step 3. soft material and wet granular: get mixed powder that step 2 makes 1., mix powder 2., add 20% Diluted Alcohol solution respectively, mediate the system soft material, cross 20 mesh sieves, make wet grain 1. and wet grain 2.;
Step 4. drying and tabletting:
2. 1. the wet grain that step 3 is made placed respectively 50-60 ℃ of oven drying 3-4 hour with wet grain, after crossing 18 mesh sieve granulate, must do granule, add lubricant after weighing respectively, mixing, the wet grain that will be after the drying adds lubricant 1. and wet grain 2. place two hoppers of bi-layer tablet press respectively, compacting promptly gets slow-releasing tablets of oral medicine in flakes on bi-layer tablet press.
3. a method for preparing the described slow-releasing tablets of oral medicine of claim 1 is characterized in that it comprises the steps:
Step 1. all placed former, adjuvant under 60 ℃ of conditions dry 4 hours, and it is standby to cross 80 mesh sieves;
Step 2. is mixed the preparation of powder:
1. blanket layer: get slow-release material, binding agent by the charge ratio of blanket layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 1. mixing must mix powder;
2. slow release layer: get highly-water-soluble oral medicine, slow-release material, binding agent by the charge ratio of slow release layer, by equivalent incremental method mix homogeneously, cross 60 mesh sieves, 2. mixing must mix powder;
Step 3. is done particulate preparation: get mixed powder that step 2 makes 1., mix powder 2., dry granulation respectively;
Step 4. tabletting: behind the granule granulate that step 3 is made, weigh respectively, add lubricant, mixing places two hoppers of bi-layer tablet press respectively with two kinds of granules, and compacting promptly gets slow-releasing tablets of oral medicine in flakes on bi-layer tablet press.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100376788A CN1330295C (en) | 2005-01-12 | 2005-01-12 | Slow-releasing tablets of oral medicine and preparation thereof |
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| CNB2005100376788A CN1330295C (en) | 2005-01-12 | 2005-01-12 | Slow-releasing tablets of oral medicine and preparation thereof |
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| CN1330295C true CN1330295C (en) | 2007-08-08 |
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| CN101574341B (en) * | 2008-05-05 | 2012-12-19 | 北京德众万全医药科技有限公司 | Oral solid medicine composition containing ropinirole |
| CN103462922B (en) * | 2012-06-06 | 2016-01-20 | 南京亿华药业有限公司 | A kind of levetiracetam sustained-release tablets and method for making thereof |
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| Title |
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| 复方愈创木酚甘油醚双层缓释片释放度及释药机制研究 陈俊、平其能、刘国杰、汪科，中国药学杂志，第34卷第12期 1999 * |
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