CN101288652A - Water-soluble drug sustained-release tablet and preparation method thereof - Google Patents
Water-soluble drug sustained-release tablet and preparation method thereof Download PDFInfo
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- CN101288652A CN101288652A CNA2007100187747A CN200710018774A CN101288652A CN 101288652 A CN101288652 A CN 101288652A CN A2007100187747 A CNA2007100187747 A CN A2007100187747A CN 200710018774 A CN200710018774 A CN 200710018774A CN 101288652 A CN101288652 A CN 101288652A
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Abstract
The invention relates to a water-soluble drug sustained-release tablet and a preparation method thereof, the technology is characterized in that: the components and the weight percentages are as follows: 1 to 20 percent of water-soluble drug, 20 to 70 percent of hydrophilic gel, 30 to 50 of percent waxy material and the rest of filler, lubricant and other excipients that are commonly used for ordinary tablets. The method takes the hydrophilic gel sustained-release material and the waxy sustained-release material as a mixed matrix, the water-soluble drug is added to change the features of fast dissolution and short half life of the drug release, thus achieving the purpose of slow and smooth release. The drug of the invention has good stability, the needed equipment is simple, the manufacturing process is simple and easy, the operatability is strong, the in vitro dissolution test shows that the release rate is 25 to 35 percent in 2 hours, 55 to 65 percent in 5 hours and more than 80 percent in 10 hours, thus having good sustained-release effect. In addition, the sustained-release tablet is less affected by the gastrointestinal tract environment, the absorption is stable, and the individual difference is small, thus being the ideal sustained-release tablet.
Description
Technical field
The present invention relates to a kind of water-soluble drug sustained-release tablet and preparation method thereof, belong to medical technical field.
Background technology
Slow releasing preparation is meant by proper method, improves medicine release, absorption, distribution metabolism and discharge process in vivo, thereby reaches a class preparation of prolong drug effect, minimizing adverse effect.Slow releasing preparation is exactly that a class has long-acting, can reduce medicining times, steadily the novel form that discharges.Slow releasing preparation can be brought into play the optimum therapeuticing effect of medicine.In recent years, comparatively active to slow releasing preparation research, become the direction that domestic and international medical industry develops outbalance.
Matrix tablet (Matrix Tablets) is the important composition of slow releasing preparation, and is short because of having the construction cycle, and production technology is simple and easy to be suitable for big production, and Release Performance is good, and characteristics such as taking convenience are more and more paid attention to by pharmaceuticals industry.In recent years, in the preparation of novel matrix tablet, the research of aspects such as the description of best release configuration design and release in vitro behavior and evaluation all has very much progress.The slow releasing preparation release mainly is stripping principle, diffusion principle and corrosion and diffusion, stripping combination.Matrix tablet mainly contains three types: erodible matrix, insoluble matrix tablet and hydrophilic gel matrix tablet, release mechanism has nothing in common with each other.By dissolving but the erodible matrix that the wax material of erodable is made is passing hole channel diffusion separates the control medicine with erosion and discharge.The drug release of insoluble matrix tablet is that liquid penetrates skeleton, with medicine dissolution, diffuses out from the groove of skeleton then, so the duct is diffused as rate-limiting step, discharges Higuchi equation.The release of hydrophilic gel matrix tablet Chinese medicine is relevant with pharmaceutical properties.Hydrophilic gel forms gel after meeting water, the rate of release of water soluble drug depends on the diffusion velocity of medicine by gel layer, and the little medicine of dissolubility in the water, rate of release is determined by the progressively corrosion speed of gel layer, no matter which kind of releasing mechanism, gel is dissolving fully at last, and medicine all discharges.
Slow controlled-release technology for water soluble drug mainly adopts the waxiness matrix tablet, and ion exchange resin, slow-release material add the release-controlled film coating, slow release medicated layer+ways such as blank slow release layer.Because the initial release of single hydrogel matrix slow releasing tablet is too fast, is difficult to the release of retained water soluble drug, so less employing; And there is the problem that release is incomplete, be easy to screening in single waxiness matrix sustained release tablet; Ion exchange resin, slow-release material add the release-controlled film coating, all be in preparation process with an organic solvent, so finished product preparation can produce organic solvent residual, there is secret worry in human body safety in utilization aspect, and can cause certain pollution to environment; And slow release medicated layer+this method of blank slow release layer, complex process to the requirement height of equipment, must be produced by bi-layer tablet press, and the quality control difficulty is big, and production cost is also than higher.
Summary of the invention
The technical problem that solves
For fear of the deficiencies in the prior art part, the present invention proposes a kind of water-soluble drug sustained-release tablet and preparation method thereof, this method with hydrophilic gel slow-release material and waxiness slow-release material as mixed matrix, add water soluble drug, the release characteristics that its stripping is fast in the hope of changing, the half-life is short reach the purpose that slowly steadily discharges.
Technical scheme
Technical characterictic of the present invention is: it is formed and percentage by weight comprises: water soluble drug 1～20%, and hydrophilic gel 20～70%, wax material 30～50%, surplus is filler, lubricant and other a conventional tablet adjuvant commonly used.
Described water soluble drug can be dissolved in less than in the 30ml water for the 1g medicine.
Described hydrophilic gel comprises hypromellose (HPMC), hydroxyethyl-cellulose (HEC), hyprolose (HPC), sodium carboxymethyl cellulose (CMC-Na), methylcellulose (MC), carbomer (Carbopol), sodium alginate and chitosan, one or more during optional usefulness is above-mentioned.
Described wax material is the insoluble but wax material of erodable of water, comprise Glyceryl Behenate (Compritol 888ATO), Brazil wax, stearic acid, Cera Flava, hydrogenated vegetable oil, octadecanol, hexadecanol, polyethylene glycol mono stearate, triglyceride and glyceryl stearate, one or more during optional usefulness is above-mentioned.
Described filler comprises starch, lactose, calcium sulfate and microcrystalline Cellulose, one or more during optional usefulness is above-mentioned.
Described lubricant comprises magnesium stearate, micropowder silica gel, Pulvis Talci, one or more during optional usefulness is above-mentioned.
A kind of method for preparing water-soluble drug sustained-release tablet is characterized in that: technique of direct powder compression: be applicable to pulverous wax material, concrete steps are:
1) with water soluble drug, hydrophilic gel, pulverous wax material and filler, with the moderate lubrication agent, said components is all crossed 80 mesh sieves;
2) by extraordinarily dilution method is just mixed, after 3 abundant mixings of 80 mesh sieves;
3) above-mentioned powder is dropped into direct powder compression machine tabletting promptly.
A kind of method for preparing water-soluble drug sustained-release tablet, it is characterized in that: preparation technology adopts melt granulation: be applicable to be difficult for being crushed to the wax material that requires fineness, concrete steps are:
1) hydrophilic gel, wax material are mixed, be heated to fusing point, make its complete fusion a little more than wax material;
2) adding water soluble drug stirs;
3) fused material spreads out condensation, solidifies;
4) cross 16 order to 20 mesh sieves and granulate, 16 mesh sieve granulate are again with an amount of filler and lubricant mixing;
5) above-mentioned granule dropped into common tablet machine tabletting.
Described tablet weight is 50mg～500mg, preferred 150mg～400mg.
The method that a kind of mixed matrix slow release layer powder of method for preparing and release layer are prepared into double-layer tablet is characterized in that:
1), prepares the powder of slow release layer according to the step in first three step of claim 7 or claim 8;
2) powder of preparation release layer;
Two kinds of drug powders that 3) will obtain are made double-layer tablet through twice tabletting, the heavy 400mg of sheet.
Beneficial effect
Water-soluble drug sustained-release tablet that the present invention proposes and preparation method thereof is a kind of composite material matrix sustained release tablet, composite material matrix sustained release tablet system with medicine with make after insoluble wax material and hydrophilic gel matrix material etc. mix mutually.This kind mixed matrix slow releasing tablet had both avoided the initial release of simple hydrogel matrix slow releasing tablet too fast, was difficult to control the shortcoming that water soluble drug slowly discharges, and had solved the problem that the release of simple waxiness matrix sustained release tablet is incomplete, be easy to screening again; Compare with the slow releasing tablet or the ion exchange resin of coating, preparation technology is simple, is easy to industrialization promotion.Especially in preparation process not with an organic solvent, finished product preparation can not produce organic solvent residual, takes safer, and environmentally friendly; And use common tablet machine to produce, and technology is simple, and cost is lower.In a word, mixed matrix tablet combines the characteristics separately of hydrogel matrix tablet and corrosivity matrix tablet simultaneously, is particularly suitable for the preparation of the slow releasing tablet of water soluble drug.
Description of drawings
Fig. 1 is that the stripping of captopril in the recipe captopril double-layer tablet 10 hours changes
The specific embodiment
Now in conjunction with the embodiments the present invention is further described:
But be not limited to following embodiment, wherein " % " is meant " weight % ".
Embodiment 1
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: captopril | 15 | 25.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 20.0 | 33.4 |
| Wax material: Glyceryl Behenate Compritol 888 ATO | 30.0 | 50.0 |
| Filler: lactose | 33.5 | 56.0 |
| Lubricant: magnesium stearate | 1.5 | 2.5 |
| Sheet is heavy | 167mg |
Preparation technology:
Captopril, HPMC-K4M, Glyceryl Behenate (Compritol 888 ATO) and lactose and magnesium stearate (all crossing 80 mesh sieves) with recipe quantity, by extraordinarily dilution method is just mixed, behind 3 abundant mixings of 80 mesh sieves, direct powder compression forms, and makes every slow releasing tablet that contains captopril 25mg.
Embodiment 2
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: diltiazem | 20.0 | 80.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 20.0 | 80.0 |
| Wax material: Glyceryl Behenate Compritol 888 ATO | 30.0 | 120.0 |
| Filler: lactose | 28.0 | 112.0 |
| Lubricant: magnesium stearate | 2.0 | 8.0 |
| Sheet is heavy | 400.0mg |
Preparation technology: with embodiment 1.
Embodiment 3
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: chlorpromazine hydrochloride | 16.0 | 25.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 20.0 | 31.4 |
| Wax material: Glyceryl Behenate Compritol 888 ATO | 30.0 | 47.1 |
| Filler: lactose | 33.0 | 52.0 |
| Lubricant: magnesium stearate | 1.0 | 1.6 |
| Sheet is heavy | 157.0mg |
Preparation technology: with embodiment 1.
The dissolution test:
Embodiment 1, embodiment 2 and embodiment 3 tablets are carried out the dissolution test, measure dissolution respectively in 2h, 5h and 10h, obtain corresponding cumulative release percentage rate (Q2h, Q5h, Q10h), the result is as follows:
Embodiment 4
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: diltiazem | 16.0 | 60.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 22.0 | 82.5 |
| Wax material: hexadecanol | 32.0 | 120 |
| Filler: lactose | 29.0 | 108.8 |
| Lubricant: magnesium stearate | 1.0 | 3.75 |
| Sheet is heavy | 375mg |
Preparation technology:
Diltiazem is crossed 80 mesh sieves, and is standby.Take by weighing the hexadecanol of recipe quantity and HPMC-K4M and put in the water-bath after the fusion, add diltiazem and stir, to be cooled, cross 80 mesh sieves, will make granule and lactose and magnesium stearate (all crossing 80 mesh sieves), by extraordinarily dilution method is just mixed, behind 3 abundant mixings of sieve, powder is directly suppressed in flakes.
Embodiment 5
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: chlorpromazine hydrochloride | 16.0 | 25.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 40.0 | 62.5 |
| Wax material: octadecanol | 20.0 | 31.3 |
| Filler: starch | 23.0 | 35.9 |
| Lubricant: magnesium stearate | 1.0 | 1.6 |
| Sheet is heavy | 157.0mg |
Preparation technology: with embodiment 4.
Embodiment 6
This embodiment relates to the preparation of double-layer tablet, and double-layer tablet comprises mixed matrix slow release layer and release layer two parts, is example with captopril and hydrochlorothiazide, and its invading the exterior 1 is the composition of captopril slow release layer, and table 2 is the composition of hydrochlorothiazide release layer.
The composition of table 1 captopril slow release layer
| Component | ％ | 1000 consumptions (g) |
| Water soluble drug: captopril | 12.5 | 25.0 |
| Hydrophilic gel: hypromellose HPMC-K4M | 30.0 | 60.0 |
| Wax material: Glyceryl Behenate Compritol 888 ATO | 30.0 | 60.0 |
| Filler: starch | 26.5 | 53.0 |
| Lubricant: magnesium stearate | 1.0 | 2.0 |
The composition of table 2 hydrochlorothiazide release layer
| Component | ％ | 1000 consumptions (g) |
| Hydrochlorothiazide | 12.5 | 25.0 |
| Crospolyvinylpyrrolidone | 5.0 | 10.0 |
| Starch | 81.5 | 163.0 |
| Magnesium stearate | 1.0 | 2.0 |
Preparation technology:
With captopril, HPMC-K4M, Glyceryl Behenate (Compritol 888 ATO) and starch and the magnesium stearate (all crossing 80 mesh sieves) of recipe quantity,,, standby after 3 abundant mixings of 80 mesh sieves by extraordinarily dilution method is just mixed.Hydrochlorothiazide, crospolyvinylpyrrolidone (PVPP), starch and the magnesium stearate (all crossing 80 mesh sieves) of recipe quantity are just mixed, after 3 abundant mixings of 80 mesh sieves, two kinds of drug powders that obtain are made double-layer tablet through twice tabletting, the heavy 400mg of sheet.Fig. 1 is that the stripping of captopril in the prepared double-layer tablet 10 hours changes.
Claims (10)
1. water-soluble drug sustained-release tablet is characterized in that: it is formed and percentage by weight comprises: water soluble drug 1～20%, and hydrophilic gel 20～70%, wax material 30～50%, surplus is that filler, lubricant and other conventional tablet are used adjuvant always.
2. water-soluble drug sustained-release tablet according to claim 1 is characterized in that: described water soluble drug can be dissolved in less than in the 30ml water for the 1g medicine.
3. water-soluble drug sustained-release tablet according to claim 1, it is characterized in that: described hydrophilic gel comprises hypromellose (HPMC), hydroxyethyl-cellulose (HEC), hyprolose (HPC), sodium carboxymethyl cellulose (CMC-Na), methylcellulose (MC), carbomer (Carbopol), sodium alginate and chitosan, one or more during optional usefulness is above-mentioned.
4. water-soluble drug sustained-release tablet according to claim 1, it is characterized in that: described wax material is that water is insoluble but the wax material of erodable comprises Glyceryl Behenate (Compritol 888 ATO), Brazil wax, stearic acid, Cera Flava, hydrogenated vegetable oil, octadecanol, hexadecanol, polyethylene glycol mono stearate, triglyceride and glyceryl stearate, one or more during optional usefulness is above-mentioned.
5. water-soluble drug sustained-release tablet according to claim 1 is characterized in that: described filler comprises starch, lactose, calcium sulfate and microcrystalline Cellulose, one or more during optional usefulness is above-mentioned.
6. water-soluble drug sustained-release tablet according to claim 1 is characterized in that: described lubricant comprises magnesium stearate, micropowder silica gel, Pulvis Talci, one or more during optional usefulness is above-mentioned.
7. method for preparing the described water-soluble drug sustained-release tablet of claim 1～6, it is characterized in that: technique of direct powder compression: be applicable to pulverous wax material, concrete steps are:
1) with water soluble drug, hydrophilic gel, pulverous wax material and filler, with the moderate lubrication agent, said components is all crossed 80 mesh sieves;
2) by extraordinarily dilution method is just mixed, after 3 abundant mixings of 80 mesh sieves;
3) above-mentioned powder is dropped into direct powder compression machine tabletting promptly.
8. method for preparing the described water-soluble drug sustained-release tablet of claim 1～6, it is characterized in that: preparation technology adopts melt granulation: be applicable to be difficult for being crushed to the wax material that requires fineness, concrete steps are:
1) hydrophilic gel, wax material are mixed, be heated to fusing point, make its complete fusion a little more than wax material;
2) adding water soluble drug stirs;
3) fused material spreads out condensation, solidifies;
4) cross 16 order to 20 mesh sieves and granulate, 16 mesh sieve granulate are again with an amount of filler and lubricant mixing;
5) above-mentioned granule dropped into common tablet machine tabletting.
9. according to the described water-soluble drug sustained-release tablet of claim 1～8, it is characterized in that: described tablet weight is 50mg～500mg, preferred 150mg～400mg.
10. one kind is utilized the mixed matrix slow release layer powder of claim 7 or 8 preparations and the method that release layer is prepared into double-layer tablet, it is characterized in that:
1), prepares the powder of slow release layer according to the step in first three step of claim 7 or claim 8;
2) powder of preparation release layer;
Two kinds of drug powders that 3) will obtain are made double-layer tablet through twice tabletting, the heavy 400mg of sheet.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007100187747A CN101288652A (en) | 2007-09-30 | 2007-09-30 | Water-soluble drug sustained-release tablet and preparation method thereof |
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| CNA2007100187747A CN101288652A (en) | 2007-09-30 | 2007-09-30 | Water-soluble drug sustained-release tablet and preparation method thereof |
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| CN102091053A (en) * | 2009-12-14 | 2011-06-15 | 常州善美药物研究开发中心有限公司 | Particle composite controlled-release tablets |
| CN103445965A (en) * | 2013-08-29 | 2013-12-18 | 广东环球制药有限公司 | Method for preparing tablets containing high-dose oily components |
| CN103976972A (en) * | 2014-05-26 | 2014-08-13 | 中国药科大学 | Zolpidem tartrate oral pulse controlled-release delivery system and preparation method thereof |
| CN105434386A (en) * | 2015-12-08 | 2016-03-30 | 海南华益泰康药业有限公司 | Sustained release tablet containing high water-soluble active ingredients and preparation method thereof |
| CN105708809A (en) * | 2015-05-09 | 2016-06-29 | 张秋野 | Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent |
| CN108210473A (en) * | 2018-03-09 | 2018-06-29 | 山东省药学科学院 | Slow-releasing medicated composition of hydrochloric Venlafaxine and preparation method thereof |
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| CN109758428A (en) * | 2017-11-09 | 2019-05-17 | 郑州泰丰制药有限公司 | A kind of fast sustained release preparation and preparation method thereof containing captopril |
| CN109864978A (en) * | 2017-12-04 | 2019-06-11 | 深圳奥萨制药有限公司 | A kind of sustained release preparation of 5-methyltetrahydrofolate and preparation method thereof |
| CN113662922A (en) * | 2020-10-29 | 2021-11-19 | 北京莱瑞森医药科技有限公司 | Mirabegron sustained-release composition and preparation method and application thereof |
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| CN115006361A (en) * | 2022-06-10 | 2022-09-06 | 北京诺康达医药科技股份有限公司 | Tofacitinib slow-release core-spun tablet and preparation method thereof |
| CN115192538A (en) * | 2022-08-02 | 2022-10-18 | 沈阳信康药物研究有限公司 | Pressed coated nifedipine sustained release tablet and preparation method thereof |
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- 2007-09-30 CN CNA2007100187747A patent/CN101288652A/en active Pending
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| CN102091053B (en) * | 2009-12-14 | 2017-02-08 | 常州善美药物研究开发中心有限公司 | Particle composite controlled-release tablets |
| CN102091053A (en) * | 2009-12-14 | 2011-06-15 | 常州善美药物研究开发中心有限公司 | Particle composite controlled-release tablets |
| CN103445965A (en) * | 2013-08-29 | 2013-12-18 | 广东环球制药有限公司 | Method for preparing tablets containing high-dose oily components |
| CN103445965B (en) * | 2013-08-29 | 2015-03-18 | 广东环球制药有限公司 | Method for preparing tablets containing high-dose oily components |
| CN103976972A (en) * | 2014-05-26 | 2014-08-13 | 中国药科大学 | Zolpidem tartrate oral pulse controlled-release delivery system and preparation method thereof |
| CN105708809A (en) * | 2015-05-09 | 2016-06-29 | 张秋野 | Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent |
| CN105708809B (en) * | 2015-05-09 | 2018-07-31 | 张秋野 | A kind of heat fusing method of granulating of control sustained release agent pharmaceutic adjuvant |
| CN105434386A (en) * | 2015-12-08 | 2016-03-30 | 海南华益泰康药业有限公司 | Sustained release tablet containing high water-soluble active ingredients and preparation method thereof |
| CN105434386B (en) * | 2015-12-08 | 2018-06-22 | 海南华益泰康药业有限公司 | A kind of sustained-release tablet containing highly-water-soluble active constituent and preparation method thereof |
| CN109758428A (en) * | 2017-11-09 | 2019-05-17 | 郑州泰丰制药有限公司 | A kind of fast sustained release preparation and preparation method thereof containing captopril |
| CN109864978B (en) * | 2017-12-04 | 2022-07-12 | 深圳奥萨制药有限公司 | Sustained-release preparation of 5-methyltetrahydrofolic acid and preparation method thereof |
| CN109864978A (en) * | 2017-12-04 | 2019-06-11 | 深圳奥萨制药有限公司 | A kind of sustained release preparation of 5-methyltetrahydrofolate and preparation method thereof |
| CN108210473A (en) * | 2018-03-09 | 2018-06-29 | 山东省药学科学院 | Slow-releasing medicated composition of hydrochloric Venlafaxine and preparation method thereof |
| CN108904451A (en) * | 2018-07-27 | 2018-11-30 | 广州柏赛罗药业有限公司 | Sustained release preparation |
| CN113662922A (en) * | 2020-10-29 | 2021-11-19 | 北京莱瑞森医药科技有限公司 | Mirabegron sustained-release composition and preparation method and application thereof |
| CN114469886A (en) * | 2021-03-06 | 2022-05-13 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN114469886B (en) * | 2021-03-06 | 2023-01-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN115006361A (en) * | 2022-06-10 | 2022-09-06 | 北京诺康达医药科技股份有限公司 | Tofacitinib slow-release core-spun tablet and preparation method thereof |
| CN115192538A (en) * | 2022-08-02 | 2022-10-18 | 沈阳信康药物研究有限公司 | Pressed coated nifedipine sustained release tablet and preparation method thereof |
| CN115192538B (en) * | 2022-08-02 | 2023-09-15 | 沈阳信康药物研究有限公司 | Compression-coated nifedipine sustained-release tablet and preparation method thereof |
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