CN102349878B - A kind of microporous release osmotic pump controlled release tablet and preparation method thereof - Google Patents
A kind of microporous release osmotic pump controlled release tablet and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of microporous release osmotic pump controlled release tablet and preparation method thereof, this microporous release osmotic pump controlled release tablet is by adding a certain amount of or even a small amount of large molecule hydrophily or water-soluble polymer to provide passage as pore-foaming agent in the mode that forms continuous micropore as the release of medicine, without carrying out mechanical punching, not only simplify preparation process, greatly reduce production cost and labour intensity, and improved stability and the security of preparation.
Description
Technical field
The present invention relates to a kind of microporous release osmotic pump controlled release tablet and preparation method thereof. This microporous release osmotic pump controlled release tabletWithout carrying out laser boring, by the mode that adds a certain amount of large molecule hydrophilic polymer to form micropore as pore-foaming agent beThe release of medicine provides passage, has not only simplified preparation process, greatly reduces production cost, and has improved the safety of preparationProperty. The invention belongs to field of pharmaceutical preparations.
Background technology
Two Australian scholars of nineteen fifty-five Rose and Nelson have invented the easy osmotic pump for animals administer, fromSince 20 century 70 Alza companies have carried out simplifying improvement to osmotic pump, osmotic pump preparation has successively experienced single chamber infiltrationPump,, single chamber double layer osmotic pump, two-chamber osmotic pump, has developed and has discharged the shapes such as osmotic pump while selecting in order to adapt to the circadian rhythm of human bodyFormula, discharges but above-mentioned osmotic pump preparation all needs could to realize medicine by mechanical punching. Although above-mentioned preparation all can be realized medicineThe sustained release of thing, but the operation of above-mentioned osmotic pump preparation suitability for industrialized production is too much, and each operation control index request is very tightLattice, production difficulty is large, and the production cycle is long, and cost is high, and the high deficiency of percent defective has seriously limited the popularization of osmotic pump product. From oozingThe development course of pump is seen thoroughly, and the industrialized development of osmotic pump has all been accelerated in the simplification of osmotic pump structure and technique each time, therefore,Research structure is simple, and suitability for industrialized production difficulty is low, and the osmotic pump of low production cost is the important directions of this area.
Summary of the invention
Object of the present invention aim to provide a kind of microporous release osmotic pump controlled release tablet pharmaceutical preparation without punching andIts preparation method. Not only simplify preparation process, greatly reduced production cost, and improved the security of preparation.
For realizing foregoing invention purport, the present invention adopts following technical scheme:
Prepare a kind of microporous release osmotic pump controlled release tablet, comprise label and coating membrane, wherein label contains main ingredient and penetrating agent,Coating membrane contains filmogen and pore-foaming agent, it is characterized in that, pore-foaming agent is large molecule hydrophily or water-soluble polymer. This divides greatlyThe pore-foaming agent that sub-hydrophily or water-soluble polymer form can make to form on the coating membrane of this controlled release tablet in aqueous solutionMinim channel, and by this passage, the small-molecule substances such as water comprise that medicine can free in and out, thus can will discharge medicineThing. The present invention surprisingly finds, the duct that macromolecule polyalcohol forms forms effective protective layer around tablet, can prevent holeThe obstruction in road.
Further, facts have proved, in the time that above-mentioned pore-foaming agent molecular weight is greater than 2000, the minim channel of formation is applicable to mostlyThe release of number medicines, and, according to the molecular weight difference of medicine, can select the pore-foaming agent of different molecular weight, wherein, due to absolutelyMost compound medicine molecular weight is 10～1000, thus be preferably the pore-foaming agent that molecular weight is 5000-500000, and Chinese medicineActive component and extract or large biological molecule desired molecule amount in above-mentioned scope bigger numerical or higher. Through great many of experimentsProve, molecular weight is at 50～500 medicine, discharge during at 5000-15000 in molecular weight the best comparatively smooth, and molecular weight7000-12000 is better. This is perhaps the impact that as processes such as granulations, medicine is discharged by other auxiliary materials or preparation technology. ButThe consumption that it should be noted that pore-foaming agent changes, and can affect the selection of its molecular weight, in other words, pore-foaming agent molecular weight large/Hour, can suitably reduce/increase the consumption of pore-foaming agent, can make the release profiles of medicine reach unanimity. Meanwhile, due to respectivelyThe space structure difference of individual drug molecule, physicochemical property difference, above data also can change to some extent.
Wherein said pore-foaming agent includes but not limited to polyethylene glycol or hydroxypropyl cellulose or alginic acid (sodium) or Fructus Hordei GerminatusThe analog of magma essence or poloxamer or glucan or PVP or above-claimed cpd.
More surprised discovery, adopts macromolecule polyalcohol, can greatly reduce the consumption of pore-foaming agent, when low to 5%, even moreWhile being low to moderate 1%, duct also can form, but while being greater than 3% consumption, pore distribution is more even.
The experiment proved that, when above-mentioned pore-foaming agent is 3%～45% of coating membrane weight, preferably form 5%～30% timeMicro channel size is more consistent, distributes more even, medicine is discharged more accurate. And for macromolecular drug,Also can meet release request lower than 10%.
Above-mentioned microporous release osmotic pump controlled release tablet, described coating membrane is 10%～35% of label weight, preferably 15%～25％。
Above-mentioned microporous release osmotic pump controlled release tablet, wherein said filmogen is selected from cellulose acetate, ethyl celluloseThe mixture of one or more compositions in element, hydroxypropyl methylcellulose, polyacrylic resin, is preferably acetate fiberElement.
Above-mentioned microporous release osmotic pump controlled release tablet also has penetrating agent, and described penetrating agent is selected from sodium chloride, potassium chloride, sweetThe mixture that reveals one or more compositions in alcohol, sorbierite, is preferably sodium chloride or sweet mellow wine. Meanwhile, also can comprisePenetration-assisting agent, penetration-assisting agent be selected from a kind of in microcrystalline cellulose, alginic acid, alginate, propane diols alginic acid ester, polyethylene glycol orThe mixture of two or more compositions, is preferably microcrystalline cellulose, alginic acid or propane diols alginic acid ester.
Further, described microporous release osmotic pump controlled release tablet, also can comprise plasticizer in wherein said coating membrane.Wherein said plasticizer is selected from one in triethyl citrate, dibutyl sebacate, phthalic acid ester, Macrogol 4000The mixture of kind or two or more compositions, is preferably dibutyl sebacate.
Above-mentioned microporous release osmotic pump controlled release tablet, can also comprise in the tablets such as filler, adhesive, glidant in labelConventional auxiliary material.
And, described microporous release osmotic pump controlled release tablet, it also comprises the film-coating containing main ingredient being positioned at outside coating membraneLayer.
The present invention also comprises the method for described microporous release osmotic pump controlled release tablet, comprising following steps: (1) will makeMain ingredient, the auxiliary material of standby label mix, granulate, and carry out compressing tablet, make label; (2) the material suitable solvent of coating membrane will be preparedBe made into coating solution, the label that step (1) is made is put in seed-coating machine, carries out dressing with coating solution, accounts for label to coating membrane weight10%～35% of weight, volatilizes solvent after taking-up, make coating tablet. Can be found out by above preparation technology, of the present inventionOsmotic pump controlled release tablet can be made by the preparation technology of conventional tablet and equipment completely, the large production of very applicable technique, meanwhile,Without transformation production line and equipment, production cost reduces greatly.
Further, the prepared coating tablet of said method can also be put in seed-coating machine, with containing/do not contain the film bag of main ingredientClothing liquid carries out film-coated step.
As main ingredient of the present invention, refer to and pharmaceutically have finger can affect organism physiology, biochemistry and pathologic process, in order in advanceAnti-, to diagnose, treat disease and family planning chemical substance, can be single compound, can be also composition, effectively portionPoint, extract, large biological molecule etc. And main ingredient can be water soluble drug, also can difficult water-soluble medicine.
As the specific embodiment of the invention, main ingredient is wherein selected desmethylvenlafaxine (Desvenlafaxine) or itsPharmaceutical salts, is preferably butanedioic acid desmethylvenlafaxine, and its chemistry is by name: 1-[2-(dimethylamino)-1-(4-hydroxy phenyl) secondBase] cyclohexanol, have another name called ODV.
As one of embodiment of microporous release osmotic pump controlled release tablet described above, the invention provides a kind of butanedioic acidDesmethylvenlafaxine microporous release osmotic pump controlled release tablet, by label, coating membrane and be positioned at outside coating membrane containing the film-coating of main ingredientComposition.
Wherein, in described label, count by weight percentage, containing reaching butanedioic acid desmethylvenlafaxine 5%～50%, shortPenetration enhancer 10%～35%, penetration-assisting agent 20%～40%, lubricant 0.5%～1%. Can also comprise that filler etc. is medicinal conventional auxiliaryMaterial. In described coating membrane, count by weight percentage, containing filmogen 50%～70%, pore-foaming agent 5%～45%, and bagClothing film is 10%～35% of label weight. In coating membrane, can also contain plasticizer 3%～10%. Wherein, preferred pore-foaming agentFor 10%-30%. In the time containing main ingredient in described film-coating, count by weight percentage, containing butanedioic acid desmethylvenlafaxine10%～40%, filmogen 50%～80%, plasticizer 5%～10%.
Further, above-mentioned Dalfopristin or the first Venlafaxine microporous release osmotic pump controlled release tablet of going, in described label,The filler that also includes but not limited to pharmaceutically to commonly use, lubricant, binder, glidant, wetting agent etc. And, can pass throughAs above-mentioned preparation method's preparation.
The present invention is surprised to find that, microporous release osmotic pump controlled release tablet of the present invention does not need to punch, butA certain amount of by using, or even the pore-foaming agent of a small amount of has formed continuous duct, thus avoid by laser boring techniquePrepare the existing a series of defects of controlled releasing penetrant pump, for example cost is higher, the shortcoming such as the low and labour intensity of yield rate is large.
Microporous release osmotic pump controlled release tablet of the present invention, compared with existing osmotic pump preparation, has outstanding advantages,For example:
(1) without again adopting machinery (as laser etc.) punching, cost. Because manufacturing enterprise does not need purchasing price costlinessLaser drilling device, without often changing the laser tube of rapid wear, otherwise use common sheeting equipment and coating equipment in sugar production lineProduce the controlled release tablet that releasing effect is good, equipment cost is reduced greatly.
(2) work simplification, labour intensity reduces, and the reliability of technique increases. Owing to having reduced laser boring, artificial chip selectEtc. operation, it is relatively simple that technique becomes, thereby improved the reliability and stability of technique. In production due to processing technology mistakeProcess control is improper, occur that the probability of defective batch reduces greatly.
(3) security of preparation improves. Owing to adopting micropore mode to discharge medicine, than adopting single laser duct to pacifyMuch complete, micropore mode runs into digestive juice perforating agent after in medicine enters body can produce duct voluntarily, there will not be laser instrumentNo marking, the problem that the degree of depth is not enough and punching is not positive of beating, punch more; Also there will not be single duct to be stopped up by food occur invalidOr the prominent problem such as release, thereby security improves greatly.
(4) adopt the pore-foaming agent of macromolecule due to the present invention, the micro channel of formation is greater than drug molecule amount, can makeMedicine freely discharges, and release amount is more accurate.
(5) reduced cost. Because preparation technology is simple, without special installation, cost lowers greatly. Meanwhile, pore-foaming agentConsumption is less, and pore-foaming agent often adopts novel auxiliary material conventionally, expensive, in long-term production, and the cost of its input and equipmentEven higher etc. equally matched, therefore when after industrial production, the reduction of pore-foaming agent consumption, will further reduce production costs.
(6) by adjusting pore-foaming agent consumption or kind, can be applicable to the medicine of different molecular weight or space structure, be suitable forScope is wide.
Brief description of the drawings
The drug accumulation release profiles of Fig. 1: embodiment
Detailed description of the invention
Further explain and describe by the following examples content of the present invention. Described embodiment only understands in order to helpContent of the present invention, should not be understood to the restriction to purport of the present invention and protection domain.
Drug release determination method of the present invention is referring to two annex XD first methods of Chinese pharmacopoeia version in 2010, taking water as releaseMedium.
Embodiment 1
Label composition:
Coating membrane composition:
Cellulose acetate 21g
Hydroxypropyl cellulose (KlucelLF) 9g
Dibutyl sebacate 2g
Make 1000 by being prepared as follows method:
(1) label preparation is got sodium chloride and is pulverized, and crosses 100 mesh sieves, mix with medicine, microcrystalline cellulose, taking ethanol asWetting agent, softwood processed, crosses 30 mesh sieves and granulates, and dries 2 hours for 50 DEG C, and whole grain, adds dolomol, mixes, and compressing tablet, adopts conventional1000 of pressed-disc technique compactings.
(2) label dressing: get cellulose acetate, add acetone 600ml, be stirred to dissolve; Separately get hydroxypropyl cellulose(KlucelLF) put in the measuring bottle of 50ml, add water and make, after its dissolving, to join above-mentioned 1500ml cellulose acetate acetone solnIn, limit edged stirs, and hydroxypropyl cellulose (KlucelLF) is all dissolved, and adds dibutyl sebacate to shake up, and makes dressingLiquid. The above-mentioned label making is put in seed-coating machine, and logical hot blast, maintains the temperature between 30-40 DEG C, sprays into coating solution. Be positioned overIn the environment of 40 DEG C, volatilize solvent, to obtain final product.
Adopt two annex XD first methods of Chinese pharmacopoeia version in 2010 to measure the release of said preparations, measurement result is in table 1,Cumulative release curve is shown in accompanying drawing 1.
Embodiment 2
Label composition:
Coating membrane composition:
Ethyl cellulose 6.25g
Poloxamer 2376.75g
Triethyl citrate 2g
Make 1000 by following preparation method:
(1) label preparation is got sweet mellow wine and is pulverized, and crosses 100 mesh sieves, with butanedioic acid desmethylvenlafaxine, HPMC-K4M,HPMC-K100LV mixes, and taking ethanol as wetting agent, softwood processed, crosses 30 mesh sieves and granulate, and dries 2 hours for 45 DEG C, and whole grain, addsEnter dolomol, mix, compressing tablet, adopts 1000 of conventional pressed-disc technique compactings.
(2) label dressing: get poloxamer 237, ethyl cellulose, hydroxypropyl cellulose, add ethanol 1500ml, stirring makesDissolve. Add triethyl citrate, shake up, make coating solution. The above-mentioned label making is put in seed-coating machine, and logical hot blast, keepsTemperature, between 30～40 DEG C, sprays into coating solution. Be positioned in the environment of 40 DEG C and volatilize solvent, to obtain final product.
Adopt two annex XD first methods of Chinese pharmacopoeia version in 2000 to measure the release of said preparations, measurement result is in table 1,Cumulative release curve is shown in accompanying drawing 1.
Embodiment 3
Label composition:
Coating membrane composition:
Cellulose diacetate 26.5g
L-HPC KlucelGF1.5g
Dibutyl sebacate 2g
Film-coating layer composition containing main ingredient:
Butanedioic acid desmethylvenlafaxine 15g
HPMC 20g
Polyethylene glycol (1000) 2g
Make 1000 by following preparation method:
(1) label preparation: sodium chloride is pulverized, added main ingredient, 1/2 microcrystalline cellulose, cross 60 mesh sieves, mix. AddEnter 10% polyvinylpyrrolidone k-30 ethanolic solution and make in right amount softwood, cross 30 mesh sieves and granulate, be placed in 50 DEG C of heating of baking ovenDry. Prepared particle adds remaining microcrystalline cellulose and dolomol mixes, and adds tablet press machine with carrying out compressing tablet.
(2) label dressing: get acetone appropriate, add cellulose diacetate to make to dissolve; Separately get L-HPC KlucelCFAdd water and make in right amount to dissolve, slowly join in above-mentioned cellulose acetate acetone soln, then add dibutyl sebacate to make to dissolve,Obtain coating solution.
Get label, put in coating pan, logical hot blast, maintains the temperature between 30～40 DEG C, sprays into coating solution and carries out dressing. PutThe environment that is placed in 40 DEG C volatilizes solvent, obtains coating tablet.
(3) the film-coating layer that comprises main ingredient: get 70% appropriate amount of ethanol, add HPMC and make to dissolve, then add amberAmber acid desmethylvenlafaxine and polyethylene glycol (2000) make to dissolve, and obtain the film coating liquid containing main ingredient.
Get above-mentioned coating tablet, put in coating pan, logical hot blast, maintains the temperature between 30～35 DEG C, sprays into above-mentioned containingThe film coating liquid of main ingredient carries out dressing. Be positioned in the environment of 40 DEG C and volatilize solvent, to obtain final product.
According to the identical method of embodiment 3, prepare three batches of products. Adopt two annex XD first of Chinese pharmacopoeia version in 2010Method is measured the release of said preparation, and measurement result is in table 1, and cumulative release curve is shown in accompanying drawing 1.
Embodiment 4
Label composition:
Coating membrane composition:
Cellulose diacetate 5g
Hydroxypropyl first fiber KlucelJF3g
Dibutyl sebacate 2g
Film-coating layer composition containing main ingredient:
Butanedioic acid desmethylvenlafaxine 25g
HPMC 20g
Polyethylene glycol (1000) 2g
Make 1000 by following preparation method:
(1) label preparation: sodium chloride is pulverized, added main ingredient, 1/2 microcrystalline cellulose, cross 60 mesh sieves, mix. AddEnter 10% polyvinylpyrrolidone k-30 alcoholic solution and make in right amount softwood, cross 30 mesh sieves and granulate, be placed in 50 DEG C of heating of baking oven and doDry. Prepared particle adds remaining microcrystalline cellulose and dolomol mixes, and adds tablet press machine with carrying out compressing tablet.
(2) label dressing: get acetone appropriate, add cellulose diacetate to make to dissolve; Separately get L-HPC KlucelJFAdd water and make in right amount to dissolve, slowly join in above-mentioned cellulose acetate acetone soln, then add dibutyl sebacate to make to dissolve,Obtain coating solution.
Get label, put in coating pan, logical hot blast, maintains the temperature between 30～40 DEG C, sprays into coating solution and carries out dressing. PutThe environment that is placed in 40 DEG C volatilizes solvent, obtains coating tablet.
(3) the film-coating layer that comprises main ingredient: get 70% alcohol appropriate, add HPMC and make to dissolve, then add amberAcid desmethylvenlafaxine and polyethylene glycol (1000) make to dissolve, and obtain the film coating liquid containing main ingredient.
Get above-mentioned coating tablet, put in coating pan, logical hot blast, maintains the temperature between 30～35 DEG C, sprays into above-mentioned containingThe film coating liquid of main ingredient carries out dressing. Be positioned in the environment of 40 DEG C and volatilize solvent, to obtain final product.
According to the identical method of embodiment 4, prepare three batches of products. Adopt two annex XD first of Chinese pharmacopoeia version in 2010Method is measured the release of said preparation, and measurement result is in table 1, and cumulative release curve is shown in accompanying drawing 1.
Above-mentioned test also illustrates, the operability of microporous release osmotic pump controlled release tablet technique of the present invention is good,There is good repeatability.
The each embodiment desmethylvenlafaxine of table 1 cumulative release degree
It should be noted that, above embodiment is just to illustrating the present invention. Do not depart from spirit of the present invention andUnder the prerequisite of essence, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be byBe interpreted as within protection scope of the present invention.
Claims (5)
1. a microporous release osmotic pump controlled release tablet, comprises label and coating membrane, and wherein label goes first literary composition to draw containing main ingredient butanedioic acidPungent and the penetrating agent of method, coating membrane, containing filmogen and pore-foaming agent, is characterized in that, described pore-foaming agent is selected from poloxamer 237, hydroxylPropyl cellulose KlucelLF, hydroxypropyl cellulose KlucelGF or hydroxypropyl cellulose KlucelJF, and described poreAgent is 5%～30% of coating membrane weight;
Described coating membrane is 15%～25% of label weight, and described filmogen is selected from cellulose acetate, ethyl cellulose, hydroxylThe mixture of one or more compositions in propyl methocel, polyacrylic resin, also wraps in described coating membranePlasticizer-containing and penetrating agent, described plasticizer is selected from dibutyl sebacate, and described penetrating agent is selected from sodium chloride or sweet mellow wine.
2. microporous release osmotic pump controlled release tablet claimed in claim 1, its also comprise be positioned at outside coating membrane containing or containing main ingredientFilm-coating layer.
3. microporous release osmotic pump controlled release tablet claimed in claim 1, comprises following 1) to 4) shown in composition in one:
1) label composition:
Coating membrane composition:
Cellulose acetate 21g
Hydroxypropyl cellulose KlucelLF9g
Dibutyl sebacate 2g;
2) label composition:
Coating membrane composition:
Cellulose acetate 5g
Hydroxypropyl cellulose KlucelJF3g
Dibutyl sebacate 2g
Film-coating layer composition containing main ingredient:
Butanedioic acid desmethylvenlafaxine 25g
HPMC 20g
Cetomacrogol 1000 2g;
3) label composition:
Coating membrane composition:
Cellulose acetate 26.5g
Hydroxypropyl cellulose KlucelGF1.5g
Dibutyl sebacate 2g
Film-coating layer composition containing main ingredient:
Butanedioic acid desmethylvenlafaxine 15g
HPMC 20g
Cetomacrogol 1000 2g;
4) label composition:
Coating membrane composition:
Cellulose acetate 5g
Hydroxypropyl cellulose KlucelJF3g
Dibutyl sebacate 2g
Film-coating layer composition containing main ingredient:
Butanedioic acid desmethylvenlafaxine 25g
HPMC 20g
Cetomacrogol 1000 2g.
4. prepare a preparation method for the microporous release osmotic pump controlled release tablet described in claim 1-3 any one, comprisingFollowing steps:
(1) main ingredient, the auxiliary material of preparing label are mixed, granulated, carry out compressing tablet, make label;
(2) the material suitable solvent of preparing coating membrane is made into coating solution, the label that step (1) is made is put in seed-coating machine,Carry out dressing with coating solution, account for 15%～25% of label weight to coating membrane weight, after taking-up, volatilize solvent, make dressingSheet.
5. preparation method claimed in claim 4, also comprises the prepared coating tablet of step (2) is put in seed-coating machine, with containing orDo not carry out film-coated step containing the film coating liquid of main ingredient.
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| CN102579385A (en) * | 2012-03-02 | 2012-07-18 | 北京科信必成医药科技发展有限公司 | Colon-specific osmotic pump preparation and preparation method thereof |
| CN112999179B (en) * | 2019-12-20 | 2024-02-23 | 成都康弘药业集团股份有限公司 | Pharmaceutical composition containing venlafaxine hydrochloride |
| CN111346067B (en) * | 2020-03-11 | 2022-05-17 | 广东科泰鼎润药业科技有限公司 | Controlled release preparation of guanfacine and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1923184A (en) * | 2006-10-16 | 2007-03-07 | 北京科信必成医药科技发展有限公司 | Multiple apertures releasing osmosis pump and preparation process thereof |
| CN101422443A (en) * | 2008-12-24 | 2009-05-06 | 沈阳药科大学 | Fenofibrate osmotic pump controlled release preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1923184A (en) * | 2006-10-16 | 2007-03-07 | 北京科信必成医药科技发展有限公司 | Multiple apertures releasing osmosis pump and preparation process thereof |
| CN101422443A (en) * | 2008-12-24 | 2009-05-06 | 沈阳药科大学 | Fenofibrate osmotic pump controlled release preparation and preparation method thereof |
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Effective date of registration: 20230314 Address after: 8639, Floor 6, Building 3, No. 3, Yongchang North Road, Daxing District, Beijing, 100176 Patentee after: Beijing Kexin Jurun Pharmaceutical Technology Co.,Ltd. Address before: 100083 15 / F, block a, Tiangong building, 30 Xueyuan Road, Haidian District, Beijing Patentee before: COSCI MED-TECH Co.,Ltd. |
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